Tuesday, July 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo Section A Clinical Applications of miRNAs A New Frontier in Molecular Diagnostics? By Melanie Yarbrough, PhD transcription, they undergo a series of processing steps that culminate in a he discovery that noncoding small, 22-nucleotide RNA that binds to regions of the genome such as target mRNAs with imperfect comple- TmicroRNAs (miRNAs) can influ- mentarity. miRNAs can bind to multiple ence the pathogenesis of cancer has led targets, precipitating global changes investigators to consider using these in expression patterns. Consequently, molecules to guide clinical decision aberrant expression of miRNAs can making. In a symposium this morning, contribute to the pathogenesis of many miRNAs in Practice: Little Molecules human diseases. With A Lot of Punch, Muller Fabbri, There are many potential uses for MD, PhD, and Vincent De Guire, PhD, miRNAs in medicine. For example, will discuss new research on the biology global alterations in miRNA expression of miRNAs and explore their potential have been described in a large number Tian Yu describes his poster on the Integrative Analysis of the Hippo clinical applications. of malignancies, giving rise to the idea Pathway Mutations in Cancer Genome with M. Laura Parnas, during miRNAs are endogenous, small that miRNAs can serve as biomarkers for the Student Poster Contest. See p. 6 for Student Research Awards. RNAs that inhibit gene function by detection of cancer and prognostics to targeting mRNA for either degrada- tion or inhibition of translation. After ›› see page 12

When It Comes to Data, Size Matters By Christopher McCudden, PhD “small” data, a researcher has to choose Other big-data leaps for just what to focus on. With big data, she healthcare include unusual ig data refers to massive amounts does not need to make the choice, and corporate ventures. Mayer- of raw information that require can grapple with everything, “zooming Schönberger described how Bnew paradigms of storage, vi- in and out at will,” he said. “Letting the FICO, traditionally known as sualization, and analysis. With the data speak.” a credit score company, was ‘datafication’ of the world, these datasets For evidence-based medicine, algo- able to use third party data are more available than ever, offering rithms can help make predictions even sources to predict medication extraordinary opportunities to make pre- in the absence of an understanding of adherence. Incredibly, is now dictions and discover new connections. causation, and multiple correlations possible for a single entity Attendees were taken beyond the may be enough to derive useful mean- to predict whether you will hype of big data at Monday’s ple- ing. “If correlations yield insights, default on your mortgage, nary session, where Viktor Mayer- then we should use them,” Mayer- get a car loan, qualify for life Schönberger offered real examples of Schönberger said. “We should go for insurance, and be compliant how big data analysis has revolution- causality if we can get it, but don’t put with your drug prescriptions. ized traditional analytical approaches. it on a pedestal as the be all and end all.” Of course, big-data predic- Big data is transforming hypothesis Mayer-Schönberger also asserted tions are not perfect. Mayer- testing, where millions of ideas can that, in healthcare, we are over or under- Schönberger described the be tested simultaneously rather than treating all the time. Best practices are Google Flu project, where flu having to limit focus to a single ques- based on averages, where no particular outbreaks are predicted from tion due to data sampling restrictions, treatment or therapy is really optimized keyword searches combining Mayer-Schönberger explained. With for an individual. As our genetic make- known outbreaks with epi- up, metabolic state, and disease severity demiological data from the become better known and understood, Centers for Disease Control INSIDE personalized medicine will rely on big and Prevention. The Google data. With more information from sen- Flu project has been criticized sor technology, real-time measurements recently for apparent inac- of basic chemistry analytes can lead curacies in the model. Society LDTs ...... A-8 to remarkable improvements in out- will certainly have to tackle comes. Mayer-Schönberger described difficult questions resulting Test Interpretation ...... A-12 an example of real-time monitoring from big data and predictive in preemies, where thousands of data analytics. There are many Viktor Mayer-Schönberger, Oxford Internet Big Data Analytics ...... A-14 points per second can predict a blood Institute, discusses the limitations and value stream infection before it is detectable of “Big Data” at Monday morning’s plenary by traditional methods. ›› see page 12 session. Grifols_AACC Daily Ads_10x14in_4C_R2.pdf 3 7/8/14 9:21 AM

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The Official Publication of the AACC Annual Meeting & Clinical Lab Expo What’s a Müllerian? By Ann Gronowski, PhD greater the chance for fertilization and pregnancy,” Straseski said. “As we age, There’s a new biomarker on the block for both the number and quality of those assessing ovarian reserve and it’s called follicles declines.” As a result, markers anti-Müllerian hormone (AMH). But of ovarian reserve have received a lot of what is a Müllerian? In a mid-day short attention in reproductive medicine. course yesterday moderated by Alicia Lambert-Messerlian introduced the Algeciras-Schimnich, PhD—Banking on audience to AMH. “Early studies have the Numbers: Laboratory Assessment of shown that AMH concentrations cor- Ovarian Reserve—Joely Straseski, PhD, relate well with antral follicle counts, and Geralyn Lambert-Messerlian, PhD, the gold standard of ovarian function,” answered this question and many more she said. “It is an excellent marker of related to the assessment of a woman’s ovarian reserve because of its biology. reproductive status. Straseski began the AMH is produced by small follicles session with an overview of female fer- of the ovary, those that are not grow- tility. “We have to understand fertility ing in response to follicle-stimulating before we can understand infertility,” hormone. This is unlike other markers she said. of ovarian reserve such as estradiol and Straseski then quoted current statis- inhibin B.” tics showing that one in seven couples AMH plays a role at various stages have difficulty conceiving and one-third throughout the lifespan, Lambert- 2014 AACC Annual Meeting & Clinical Lab Expo attendees participate in of couples with female partners over the Messerlian explained. First discovered the Banking on the Numbers: Laboratory Assessment of Ovarian Reserve age of 35 have fertility problems. Simple to have an essential role in embryonic short course on Monday afternoon. math tells us that this is a problem af- development, AMH inhibits the for- fecting a lot of people and it does not mation of the Müllerian ducts, which going forward. “Currently, the assays ductive years? Will AMH become a appear to be going away anytime soon. develop into the female reproductive for measurement of AMH are being common tool to aid in women’s repro- While a woman’s age is one of the tract. Fast forward through those early developed and refined and efforts to ductive decisions? If menopause could leading causes of infertility, the ability years, and AMH also helps tell the story standardize among methods are under- be predicted, could that information to predict a woman’s reproductive po- of a woman’s ovarian function, and may way,” Lambert-Messerlian said. “Once accelerate a woman’s timetable for hav- tential, termed ovarian reserve, has the even help predict menopause. reliable standards and reference data are ing children? As every good research potential to be very helpful in develop- The session also dealt with problems available, widespread use of AMH can article ends—more studies are needed. ing treatment plans. Straseski defined in defining normative data and assay be expected in the clinical laboratory.” One thing that is for certain is that we ovarian reserve as the quality and size standardization. Lambert-Messerlian Could this be a game-changer for can expect to hear a lot more about the of the follicle pool present in a woman’s emphasized that laboratorians are going women, as recent trends show child- marker highlighted in this short course ovary. “Basically, the more follicles, the to play a crucial role in AMH testing birth being delayed to later repro- in the future. PAGE A-4 Tuesday, July 29, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo The Best Offense Is a Good Defense New Approaches to Combat Multi-Drug Resistant Microorganisms By Melanie Yarbrough, PhD has contributed to the emergence of dysbiosis that allows a hostile takeover diagnosis of prosthetic joint infection resistant strains of bacteria that cause by pathogens usually kept at bay by can be a challenge, and many of the A minor cut or scratch can progress to common diseases such as infections our normal flora. One such pathogen, bacteria that cause these infections exist a life-threatening illness with startling of the urinary tract, wounds, and Clostridium difficile, is the number one in a biofilm. This makes them difficult speed if a multi-drug resistant microor- bloodstream. For example, strains of cause of hospital-acquired diarrhea and to recover in culture. Therefore, the ganism takes hold. In the 2014 annual carbapenem-resistant Enterobacteriaceae rates of community onset of infection causative agent—and thus best course antimicrobial resistance global surveil- have been isolated that are resistant to are on the rise. of treatment—often remains elusive. lance report from the World Health almost all antibiotics, including many Both diagnosis and treatment of this Susan Butler-Wu, PhD, will review Organization, the assistant director- last-resort drugs. Multidrug-resistance infection are major challenges. Carey- the increasing role of molecular diag- general for health security, Keiji Fukuda, is also found with increasing frequency Ann Burnham, PhD, will discuss the nostics and novel culture techniques MD, warns that “a post-antibiotic in strains of Mycobacterium tuberculosis, challenges faced in the diagnosis of in the identification of these bacteria, era—in which common infections and which infects an estimated one third of C. difficileinfection and strategies for in addition to exploring the potential minor injuries can kill—is a very real the world’s population, making these treatment. One novel idea is the use of diagnostic utility of serum and synovial possibility for the 21st century.” infections almost impossible to treat. fecal transplants to restore the normal biomarkers of infection. In today’s afternoon short course, These trends threaten to turn back flora in affected patients. Although not Today’s session on Hot Topics Hot Topics in Clinical Microbiology, the clock on one of the singular achieve- without problems, such alternatives to in Clinical Microbiology illustrates three experts will discuss new strategies ments of modern medicine. Infectious traditional antimicrobial therapy are a that laboratory professionals must to combat resistance, including improv- diseases had been the leading cause welcome strategy to combat infection. continue to develop and implement ing diagnostics and novel therapeutics of death until breakthroughs like the Another problem is that the availabil- multiple approaches to deal with the for some of the most common hospital discovery of penicillin by Sir Alexander ity of invasive and indwelling medical prevention and diagnosis of multi- and community-acquired infections. Fleming in 1928.Countless lives were devices has created new niches for the drug resistant pathogens. Moreover, The speakers will make the case that saved by the subsequent antibiotic proliferation of drug-resistant bacteria. the emerging technology in this area laboratory medicine serves as a hub, revolution. For instance, prosthetic joints provide emphasizes the importance of an in- providing data to detect emerging Treatment of infections caused by an ideal access point for bacteria, which terdisciplinary approach—both within resistance phenotypes and facilitating drug-resistant bacteria creates a vicious can lead to septic arthritis in these laboratory medicine and among our judicious use of antimicrobial therapy. cycle in which physicians administer patients. Unfortunately, the specific clinical colleagues. The first speaker, Christopher more antibiotics to treat the infection, Doern, PhD, will highlight trends in which can lead to development of even the development and mechanisms of more resistant strains. In addition, the resistance among the various resistant overuse of antibiotics, especially in a pathogens. hospital setting, can eliminate or disrupt CLN Daily Editorial Board 2014 Worldwide selective pressure due the balance of many of the so-called to misuse and overuse of antibiotics “good” bacteria in the body, creating a Editor Ann Gronowski, PhD Washington University School of Medicine St. Louis, Missouri, United States

Authors Mark Cervinski, PhD Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire, United States

David Colantonio, PhD The Hospital for Sick Children Toronto, Ontario, Canada

Mari DeMarco, PhD St Paul’s Hospital Vancouver, British Columbia, Canada

Chris McCudden, PhD The Ottawa Hospital Ottawa, Ontario, Canada

Amy Saenger, PhD Roche Diagnostics Indianapolis, Indiana, United States

Joely Straseski, PhD University of Utah and ARUP Laboratories Salt Lake City, Utah, United States

Melanie Yarbrough, PhD Washington University School of Medicine St. Louis, Missouri, United States Little Things Make a Big Difference

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The Official Publication of the AACC Annual Meeting & Clinical Lab Expo Spotlight on Young Scientists

The following AACC Student Research Awards were presented Oral at the joint ABCC-SYCL reception on Monday evening. John Mills – Mayo Clinic High Sensitivity Detection of Residual Disease in Multiple Poster Presentations Myeloma Using Mass Spectrometry

Garrett Mullins – University of Virginia Jeff Meeusen – Mayo Clinic Lipolysis Suppresses Insulin Signaling and Glucose Uptake Analytical and Clinical Validation of an LC-MS/MS Method for Urine Leukotriene E4: a Marker of Systemic Mastocytosis Maria Willrich – Mayo Clinic Antibodies-to-Infliximab: Assay Development and Correlation Trevor Pitcher – University of Louisville with Infliximab Concentrations in Serum Samples of Treated A Urine-Based Immunoassay for Urocortin 3 and Diagnosis Patients of Sleep Apnea

Sarah Delaney – University of Toronto Shuhei Mamiya – Tokyo Medical and Dental University Bupropion Exposure in an Infant: A Case Report Lipid Hydroperoxides in Apolipoprotein E-containing High- Density Lipoprotein Abstract Control Number Chris Crutchfield –Johns Hopkins University Alternative Calibration Strategies for LC-MS Based Analysis of Broad Reportable Range Analytes

Presenters demonstrate their work to attendees during the Student Poster Contest.

Brenda Suh-Lailam discusses her poster with William Link, Bio-Rad Laboratories, Hercules, CA, during the Student Poster Contest.

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The Official Publication of the AACC Annual Meeting & Clinical Lab Expo The Wild West of Laboratory-Developed Tests By David Colantonio, PhD spectrophotometer); Class II, moderate Hung Luu, PhD will review practical risk (e.g. routine chemistry assays); and examples of how to validate LDTs. Park Most testing conducted in today’s Class III, high risk (e.g. in vitro diagnos- will use the example of gene sequenc- clinical laboratories uses commercial tic multivariate index assays for cancer ing to highlight that a minimum level reagent kits, manufactured and mar- diagnosis). High risk LDTs would of validation should be conducted for keted by in vitro diagnostics companies. require the strictest FDA oversight. any new or existing technology, as well However, many new and existing Although many in the laboratory com- as how different approaches to valida- biomarkers do not have commercial munity agree that FDA should improve tion are related to how test results are reagents available, resulting in the need oversight for some LDTs—especially for interpreted. for labs to develop and validate their high risk or direct-to-consumer tests— Luu will offer his experience with own tests. These laboratory-developed how FDA regulates LDTs is a big cause CellaVision, a digital hematology ana- tests (LDT) are primarily for internal use for concern, Clarke noted. lyzer that uses neural networks to locate, and are not distributed or sold to other Among these concerns are that FDA digitize, and pre-classify leukocytes, labs. However, they present unique would end up classifying most LDTs as as well as characterize red blood cell regulatory and validation challenges. high-risk; the problem of inconsistent morphology. One of the requirements William Clarke, PhD clarified the evaluation of analytical and clinical for evaluating a peripheral blood smear evolving regulatory landscape for LDTs validity between laboratories; and a is assessing red blood cell morphology, during yesterday afternoon’s sympo- minimized role for laboratory directors including identification of intracellular sium, Understanding and Implementing if FDA tries to supplant their scientific parasites such as malaria. Although it has LDTs: What Should We Know? Clarke and consultative responsibility through become widely adopted for performing reviewed the role that the Centers for regulation. Clarke also mentioned The manual differentials for CBCs, Luu’s is Medicare and Medicaid Services and Modernizing Laboratory Test Standards the first institution to use this technology the Food and Drug Administration for Patients Act (HR 3207), introduced Ross Molinaro, PhD, discusses pro- for routine screening of malaria. (FDA) play in LDTs. Although FDA this year by representative Michael posed regulatory approaches for “In searching the literature, I real- regulates ‘primary ingredients’ for Burgess, (R-Texas), which removes FDA laboratory developed tests (LDTs) ized there was no data comparing analyte-specific reagents—such as anti- from the LDT loop. The Burgess legis- at Monday’s morning symposia, the sensitivity of CellaVision versus bodies, nucleic acids, and enzymes—the lation proposes oversight of LDTs by Understanding and Implementing conventional microscopy for routine agency does so to ensure the quality of the department of Health and Human LDTs: What Should We Know. screening of malaria,” Luu said. The these test components: it does not cur- Services rather than FDA, creation of an last part of his talk will focuses on the rently regulate LDTs themselves. LDT test registry, and the requirement Validating Laboratory Developed Tests: approach used to validate the use of However, FDA recently concluded that data on analytical and clinical valid- Practical Application Examples, from CellaVision for routine screening of that LDTs should be regulated at ity be submitted for new LDTs. 2:30–5:00 pm. Jason Park, PhD and intracellular parasites. some level. In moving towards more Experts will also tackle the need for oversight, three classes of risk have rigorous validation procedures for LDTs been established: Class I, low risk (e.g. at a Wednesday afternoon short course, Hidden Gems By Chris McCudden, PhD lab and physical findings in patients with Lassa fever, and found that With 873 accepted abstracts repre- patients with confirmed Lassa fever senting 21 different areas of labora- exhibited elevated creatinine and tory medicine, it’s easy to miss some BUN, with higher respiratory rates. great abstracts. Here I highlight a few This characterization data may aid in hidden gems that did not necessarily Lassa fever diagnosis and help iden- win awards, but are worth a look. tify which patients require further workup and treatment. Fructosamine and Glycated Albumin with Risk of Coronary Heart Disease and Iatrogenic Vitamin D Toxicity in an Death, by E. Selvin, et al. Poster A-138 Infant: Clinical Relevance of Vitamin D Fructosamine and glycated albu- Metabolic Profiling, by H. Ketha et al. min have long been known as alter- Poster A-190 nate measures of glycemic control. Vitamin D has been at the fore- AACC Booth #4328 The authors examined long-term front of discussions of test utiliza- cardiovascular (CVD) outcomes as tion, measurement accuracy, and part of the Atherosclerosis Risk in epidemiology. This abstract provides Communities (ARIC) study. The a case report of a vitamin D overdose MOVE IT authors measured fructosamine and in a 4 month-old child. The remark- glycated albumin in >11,000 patients able part of the case is that it was a WITH KNF without pre-existing CVD over two combination of both gross overdos- decades and found that fructosamine ing of over-the-counter vitamin D Moving liquids here and there, and moving gases in and out. That’s and glycated albumin were both sig- and inaccurate vitamin D content what medical diagnostics and device engineers rely on KNF pumps to nificant independent risks factors for in the supplement. The authors do day after day, and year after year. Simple, yet critical tasks, including: coronary heart disease and mortality. highlight how metabolite profiling of Interestingly, low concentrations vitamin D metabolites can help work n Liquid transfer n Liquid dosing/metering of these markers also conferred up cases of apparent vitamin D toxic- n Liquid aspiration n Degassing and vacuum increased CVD risk. ity. They also highlight the risk of over-supplementation and the need KNF makes selecting and optimizing the right pump for your application Suspected Lassa Fever (LF) Case for better regulation of supplements. simple as well, with engineer-to-engineer consultation, spec-driven Outcomes: A Comparison to a Non- configurations, and optional material and motor choices. Febrile Population in Sierra Leone, by New Instrument Interface Standard Move your next project with KNF. B. L. Brown et al. Poster A-143 to Enable Improved Interoperability with Learn more at www.knfusa.com/move-it Lassa fever is an acute viral hem- Integrated Information Systems, by J. B. orrhagic disease endemic to Western Jones et al. Poster B-009 Africa. Patients with Lassa fever Existing standards for LIS in- KNF Neuberger, Inc. exhibit a variety of non-specific terfaces are highly flexible and not 609-890-8600 symptoms making diagnosis diffi- [email protected] cult. The authors examined common ›› see page 14

›› see page 10 Redef ining the value of the laboratory. Together.

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Reference: 1. Data on file with Roche Diagnostics Market Intelligence, Basel. © 2014 Roche. 461-60220-0714 PAGE A-10 Tuesday, July 29, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo NACB Distinguished Abstracts Highlights

By Mari DeMarco, PhD Albumin Italian Outcome Sepsis study photometric Albumin Cobalt Bindng was undertaken, whereby blood speci- test (ACB test). They found some key Poster Tip Every year the National Academy of men were collected from septic patients differences between the two assays when Clinical Biochemistry (NACB) selects over the course of a week. They then examining specimens from ischemic and To help navigate the many in- the most outstanding abstracts accepted evaluted presepsin concentration, as non-ischemic patients. teresting posters presented at the to the AACC annual meeting. This year compared to procalcitonin concentra- meeting, you can attend one of the NACB Fellows selected 34 abstracts for tion, as a prognostic biomarker. In their Saturated and unsaturated dietary fat Guided Poster Tours. Each 30-min- their scientific excellence from more multicenter trial, enrolling 997 septic differentially modulate ethanol-mediated ute tour will be led by an expert than 870 abstracts. “Recognition of patients, they identified an incremental changes in gut microbiome, intestinal bar- from one of the AACC Divisions excellence in research is a primary goal role for presepsin in predicting 90-day rier integrity and liver in an experimental and will highlight a handful of of the NACB, and the Distinguished mortality. animal model of alcoholic liver disease, by outstanding posters from the Abstracts program is one of the ways Irina Kirpich. Poster B-120 event. The tours are free and will we advance that initiative,” said Roger Development and validation of a X-ray The authors fed mice either an un- run Tuesday and Wednesday dur- Bertholf, PhD, chair of the NACB fluorescence method for ischemia-modified saturated fat or a saturated fat Lieber- ing the regular poster sessions. See awards committee. protein detection, by Yang Luo. Poster DeCarli diet (containing ethanol), and page B-21 for the full schedule. Attendees can easily identify the B-350 also maintained a control group fed on winning abstracts by attending the During myocardial ischemia, the an isocaloric basis. Stool metabolomics poster sessions held Tuesday and N-terminus of albumin can be modified, analysis was performed to character- The goal of this study was to evaluate Wednesday from 9:30 am to 5:00 pm, affecting the binding capacity of transi- ize ethanol and dietary fat mediated the specificity and epitopes recognized and keeping an eye out for the NACB tion metals—cobalt in particular—to changes in the stool metabolome. In by antibodies used for the quantita- blue ribbons. Below are just a few of the albumin. To measure ischemia-modified addition, the mice were evaluated for tion of human chorionic gonadotropin award winners and highlights from their albumin in serum, the authors developed liver injury, steatosis, intestinal and (hCG) and its variants. The authors research studies. a quantum dot sandwich immunoassay hepatic inflammation, intestinal per- tested 69 different antibodies, provided and X-ray fluorescence spectroscopy meability, and blood endotoxin levels. to the study team by companies and Circulating presepsin (soluble CD14 method. Ischemia-modified albumin The authors found that both the stool research groups. They used the First subtype) in patients with severe sepsis concentration was determined by sub- metabolome and intestinal microbiome WHO International Reference Reagents and septic shock. Data from the Albumin stracting the intact (unmodified) albu- were differentially modulated by the for six hCG variants (hCG, hCGβ, Italian Outcome Sepsis (ALBIOS) study, min—determined based on the amount type of dietary fat in their diet. hCGβn, hCGβcf, hCGn and hCGα) in by Roberto Lantini. Poster A-146 of cobalt bound to albumin—from total their analysis. They were able to identify “The cornerstone of the emergency serum albumin, which they measured by hCG candidate epitopes for improving the variable specificity of the antibodies treatment of severe sepsis and septic immunoassay. As there is no gold stan- the measurement of hCG: results from the for each of the hCG variants, as well shock is an early, goal-directed therapy,” dard for testing, the authors compared second ISOBM TD-7 workshop, by Philip as their degree of cross-reactivity with Lantini noted. Toward that end, the their assay to the FDA-cleared spectro- Hemken. Poster A-64 luteinizing hormone.

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RELEASE DATE 07-07-14 PAGE A-12 Tuesday, July 29, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo Right Test, Right Patient, Right Time…Wrong Interpretation? By Amy Saenger, PhD or limited confidence in requesting and individuals to objectively examine and/or diagnosis; degree or severity interpreting results. A recent survey at their practice and approach the assess- of abnormality; and suggested follow- Providing accurate test results is a his institution, the Royal Perth Hospital ment as a quality activity, while func- up or specialist referral. Undesirable critical function of the clinical labora- showed that most junior doctors tioning as a component of a larger QA comments may include restating the tory—but our responsibility doesn’t and general practitioners would like scheme. The assessment also contains a obvious (“normal” or “elevated”); sug- end there. Clinicians depend on the more help with test interpretation. strong educational component, making gesting obvious clinical interventions laboratory to provide vital interpretive Furthermore, studies have demon- it more than just a traditional exam or (check blood pressure, conduct physical comments to give meaning to these strated that well written interpretive checklist item. exam); restating the clinical question if results. However, there is a fine line comments improved test utilization Graham Jones, DPhil, MBBS, high- known; and suggesting any invasive between providing helpful information and patient outcome. lighted the lessons learned from the interventions, such as a biopsy. to the end user versus contributing to Vasikaran recommends that labo- RCPA QAP external quality assess- Both Jones and Vasikaran predicted information overload. Moreover, the ratorians only add comments to a test ments, one of which focuses on improv- that in the future, participating in end user is no longer only the physi- result if the results are unexpected, ing deficiencies in the quality of com- external QA schemes for interpretive cian, but extends to other healthcare influence decisions on management ments in patient reports. Jones walked comments will largely become more of providers and even to patients them- or treatment, or if the test is fairly the audience through several examples a contractual obligation rather than a selves who increasingly access their esoteric. Ideally, the laboratory should of case interpretations which illustrated professional one. They also emphasized results via patient portals. individualize comments in the context the difficulty in proper interpretations. that the visibility of the laboratory A Monday morning interactive of the patient’s clinical condition and According to Jones, desirable comments depends primarily on the results and short course developed with the Royal in conjunction with other test results may include: absence or presence of ab- interpretive comments laboratorians College of Pathologists of Australasia or clinical parameters. Unfortunately, normality; possible clinical implications provide to physicians and patients. (RCPA) Quality Assurance Program this is not always feasible. (QAP) grappled with this issue, linking An interactive survey of the audi- the quality of interpretive comments ence showed that 100% of attendees directly to patient outcomes and pa- provide some type of interpretive miRNAs molecule miRNAs are highly stable, tient satisfaction. comments to their test results, but abundant, and specific for certain cell Now that we have improved analyti- 57% had no mechanism to assess the ›› from page 1 types, and research has shown that cal test results, we need to improve the quality of the comments they provide. amounts correlate with several diseas- pre and post analysis, noted Samuel Until recently, laboratorians did not define therapeutic response. Hundreds es. Fabbri will discuss recent findings Vasikaran, MD. “If we don’t interpret have mechanisms available for peer of studies have found circulating miR- showing that dysregulated miRNAs test results right then the effect of test- reviewed quality assessment (QA) and NAs in biological fluids such as blood, are secreted from tumor cells in small ing won’t be correct,” he said. support for continuous professional urine, and many others. vesicles called exosomes. Intriguingly, Vasikaran explained that most junior education. The RCPA QAP developed De Guire will discuss different ap- Fabbri’s research has shown that sur- doctors feel they only have moderate its assessment as a solution to enable plications for the use of these small rounding immune cells can engulf RNAs in diagnostics and therapeutics. these vesicles, and the resulting activa- He will also discuss preanalytical and tion is thought to trigger an inflamma- the world better and make better analytical variables that influence tory response that promotes cancer cell Data decisions,” Mayer-Schönberger said. measurement of circulating miRNAs. growth. These changes in expression ›› from page 1 “But also brings new challenges and Reliable measurement of these mol- of tumor-expressed miRNAs can alter dramatic dangers. We must remain its ecules can be challenging due to the the surrounding tumor microenviron- fascinating—and perhaps somewhat master. With a vital need to learn from lack of standardization of variables ment, raising the possibility that a frightening—implications to this new the data, we need to allow for human such as collection, processing, and relationship between a primary tumor world of big data. One safe prediction creativity, and even defiance against the storage of specimens. and circulating miRNAs may serve is that policy makers globally will be at data. Data is a shadow of reality and Fabbri will explain how profiles of as useful noninvasive biomarkers for least a few steps behind. therefore always incomplete. We must miRNA expression may differentiate some cancers. “Big data will help us understand use humility and humanity.” normal versus disease tissue. Small Because miRNAs can regulate entire pathways rather than single targets, their use as therapeutic agents would have a key advantage over currently available selective protein inhibitors that target only one piece of a pathway and are prone to acquired resistance. If miRNAs can be harnessed in this way as tumor suppressors, they will be an appealing target for develop- ing new therapeutics. At the same time, there are several technical challenges to overcome be- fore miRNAs fulfill their promise, such as finding a non-toxic delivery system and concerns about off-target effects. Ultimately, a better understanding of the contribution of miRNAs to complex biological networks is critical before miRNAs can be applied to clinical therapeutics. “This field is still in relative in- fancy,” according to the moderator of today’s session, Tina Lockwood, PhD. “Although several challenges remain, miRNAs undoubtedly have enormous potential to provide diagnostic, prog- nostic, and theranostic information in human disease.” Indeed, if miRNAs continue to show promise as biomarkers, they will be very welcome additions to today’s era of personalized medicine. sk500_aacc_ad_r3.qxp_Layout 1 7/8/14 8:57 AM Page 1 PAGE A-14 Tuesday, July 29, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo Big Data Analytics of using thrombin-containing rapid Hidden Gems serum tubes for blood separation. By Chris McCudden, PhD good business.” He also points out that current federal reimbursement incen- ›› from page 8 They report that the tubes cause an apparent thrombin-mediated Effective data analytics promise to save tives mesh well with this data-driven entirely standardized, making it degradation of PTH. This serves as costs, improve processes, and achieve approach to integrated care. difficult to integrate information a cautionary tale and a template for better patient outcomes. But how can In the second session, Brimhall will from different sources. The authors additional studies where labs may laboratorians play a role in this emerg- provide further examples of the ben- describe a new, plug-and-play inter- employ rapid serum tubes. ing area of research and practice? At efits of using data to direct laboratory face standard. Rather than requiring today’s afternoon symposium, Big strategies. Discussing the combination unique instrument-interface builds Development and Validation of a High Data: Applying Analytics to the Practice of LIS and EMR data with accurate to connect each device to an LIS, Performance Liquid Chromatography of Laboratory Medicine, Jay Jones, financial information, he will provide this standard promises simpler Tandem Mass Spectrometry 9 Steroid PhD, Brad Brimhall, MD, and Nicole examples laboratorians can use to iden- connectivity and less extensive Panel using Minimal Sample Volume B. DeHoratius, PhD, offer a tour de force tify savings due to inappropriate test testing and validation. This abstract Stolze, et al. Poster A-408 that explains in practical terms how utilization. For example, he describes provides a window into some of the Soldin’s group has a rich history big data can translate into measurable how physician-level analysis identified detailed requirements for integrating of developing multiplex HPLC-MS/ quality improvements. From health patterns of ineffective test use, such as health information. Jones describes MS assays for steroids. Here he and system-wide data integration to im- physicians either always ordering TSH in his symposium on Wednesday collaborators at NIH describe an proved operational efficiency in a busy and FT4 at the same time or never—of the benefits of such integration in improved method for simultaneous emergency department (ED), this session course, both practices can’t be right. the form of patient outcomes and detection of 9 steroids using small will provide a plethora of examples These kinds of data analyses require reduced cost. sample volume and limited prepara- from the cutting-edge of laboratory data both an analytical skillset and domain tion time. This third generation assay analysis. expertise. Laboratorians who produce Thrombin-Mediated Degradation of offers 11.5 minute run times and 50 uL This session is divided into three data will have a better understand- Parathyroid Hormone in Rapid Serum sample volumes while achieving an parts: integrated big data, new value ing of its provenance, limitations, Tubes, by S. L. La’ulu et al. Poster A-235 order of magnitude greater limit of propositions, and ED performance. The and value than a third party or non- In an effort to reduce turnaround detection. Performance characteris- first of these, presented by Jones, will laboratorian would. times, some labs have turned to tics are also improved. The new gen- relate the journey of data integration In the third part of the session, special serum collection tubes de- eration assay is particularly amenable across a regional healthcare system that DeHoratius will talk about process signed to increase the speed of clot to steroid measurement in children has demonstrated improved patient redesign using point-of-care (POC) test formation. The authors describe the where detection limits and sample outcomes. Jones will discuss how strategies to improve the efficiency of an potential unintended consequence size requirements are demanding. Geisinger Health System relies on a ED. She will describe a unique study of single laboratory information system the impact of POC on hospital emergen- (LIS), standardized instrumentation, cy departments. DeHoratius’s work is and an in-house clinical decision intel- motivated by emergency overcrowding ligence system (CDIS) to implement and uses a branch of operations research system-wide standards of best practice. known as queuing theory. Queuing At Geisinger, physicians implement best theory is used to generate hypotheses practices by using technological support about ED performance, which is then from the CDIS to integrate care using tested using data from a large urban data from the laboratory, pharmacy, di- tertiary care center. Results from the agnostic imaging, and electronic health study show reductions in service time records (EHR). in patients who receive tests as well as FOR EXCELLENCE One of the many remarkable aspects a small, but significant improvement in of this data integration system is the service time for patients who do not get IN DIAGNOSTICS outcome data Jones says is now being lab tests. This fringe benefit of POC has yielded. After nearly a decade of col- not previously been reported, but makes – We’re bound to deliver lecting data and implementing stan- sense from an operational standpoint dardization and best practices, there where the workload for laboratory staff is evidence that patients participating is reduced, enabling them to produce in this system are healthier. This is real results on a smaller number of patients delivery on the promise of big data. more efficiently. MedixMAB monoclonal antibodies Jones also says that better outcomes Collectively these speakers offer tre- naturally lead to economic benefits, mendous insight into the benefits of data stating that “improved outcomes are analytics using real-world examples. MedixMAB by design - Recombinant antibodies

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The Official Publication of the AACC Annual Meeting & Clinical Lab Expo Section B Guided Poster Tours Offer Inside Look at Latest Science By Elizabeth Grisham environment,” said Vincent Ricchiuti, PhD. ttendees of the 2014 AACC Ricchiuti, who also served as a Annual Meeting & Clini- poster tour leader last year, is one of Acal Lab Expo have many several volunteers from each AACC opportunities to explore the latest division who choose abstracts that innovations in laboratory medicine, they think exemplify the best schol- but experts say this week’s guided arship for that specialty. They select poster tours are among the best such abstracts based on several criteria: occasions. science, study design, experimental “I believe the guided tour is a approach, methods used, and transla- unique opportunity to review and tional medicine relevance and clarity, discuss among a peer group and according to Ricchiuti. From there, colleagues the work accomplished the volunteers assign a score to each by authors in a casual and collegial abstract using a scale of one to five for each criterion, with one being poor and five being outstanding. I am convinced that Next, “a first round of abstracts is “ narrowed down to the six best abstracts by the end of a guided with the highest average scores,” Expert guides from AACC Divisions will be on hand to help attendees make the most of the poster sessions. tour, the attendee Ricchiuti said. “A second round of participants may have selection leads to the best abstract out by division experts,” Ricchiuti said. For new members of AACC or learned as much from of the six initially selected abstracts.” “I am convinced that by the end of a first-time attendees, Ricchiuti said During guided poster tours, tour guided tour, the attendee participants guided poster tours are important the division leaders as leaders discuss the posters from the may have learned as much from the opportunities for learning and interac- they have from the top six abstracts, including the one division leaders as they have from the tion. “I consider that the guided tour attendees themselves. with the abstract deemed the best. attendees themselves, especially if the for a new AACC member or a new ” “The concept is to review posters from topic or methods used in the posters abstracts that are considered relevant are new to the viewers.” ›› see page B-21 Plug Into the Digital Pulse of #AACC2014 By Bill Malone social media wall us- a.m. to 5 p.m. and and Rewards of Social Media for ing SMS texting from Thursday, 9:30 a.m. Laboratory Professionals. In this ith hundreds of exhibi- cell phones and even to 2 p.m. The person webcast, Tiffany Roberts, PhD, makes tors and myriad symposia, email. Send mes- whose photo receives the case that social media is, in fact, a Wbrown bags, and other edu- sages and photos to the most likes on great way to enhance your career and cational sessions to choose from, the 87884 and include Facebook will win a become known for your expertise, AACC Annual Meeting & Clinical Lab the #AACC2014 $200 gift card. whether it’s connecting with other Expo has more to offer every year. To hashtag. For email, AACC is also laboratorians or helping spread the help capture all the excitement of the attach a photo to your once again offering word more broadly about the value meeting, this year AACC is making it message and send the popular digital of laboratory medicine in healthcare. easier than ever to follow events and it to AACC2014@ companion for the As she says in the webcast, “you will share your own #AACC2014 stories wiffiti.com with the The AACC Pathfinder App meeting—the AACC via social media. #AACC2014 hashtag. is available for Apple and Pathfinder App. ›› see page B-5 In the registration area in the con- Attendees can Android devices. Available for smart- vention center attendees will find the also stop by the phones and tablets INSIDE first of two social media walls—large AACC booth (1531) to get their photo from the Apple iTunes store and on screens showing photos and messages posted on the AACC Facebook photo Google Play for Android devices, from across the various social media album and Twitter. At the AACC the app allows users to keep track of New Product platforms. The second screen is at the photo booth, you can take your own educational sessions, plan each day Showcase ...... B-3 AACC booth in the exhibit hall. Want picture with some fun props, add a with a built-in calendar, map out a Clinical Lab Expo Floor to see your own photo or message on quote, and it will post to AACC media path through the expo, and even check Plan and Exhibitor List ...... B-12 the social media wall? Just be sure to galleries automatically. Attendees off visits to exhibitors. use the official hashtag, #AACC2014. can also tag photos and share them If you’re still a social media nov- Poster Tours Schedule ...... B-21 This year, attendees can also with friends. The photo booth is ice, AACC is now offering a free, share messages and photos on the open Tuesday and Wednesday, 9:30 members-only webinar, The Risks You always put accurate patient results first. It is our common mission.

We understand the many demands you face.

ONLY THE CAP can provide the comprehensive programs and services to help you consistently deliver accurate test results, monitor overall laboratory performance, and increase and sharpen your staff’s skills.

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© 2014 College of American Pathologists. All rights reserved. cap.org 23040.0614 TUESDAY, JULY 29, 2014 Monday, July 28, 2014 PAGE B-3

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase

9 is Divine ProTime InRhythm™ With the recent FDA clearances for Abbott Informatics’ Mobile Takes ProTime InRhythm™ is the next gen- 4 new RealTime PCR assays on the Inventory Manager by Abbott – LIS Out Of The Lab eration IVD device for the quantita- m2000, let Abbott demonstrate how Optimizing the Inventory Access your lab remotely and stay tive measurement of PT/INR from our menu expansion on a single plat- Abbott’s Inventory Manager combines connected. Using your smartphone or Accriva Diagnostics. The InRhythm form may benefit your laboratory. RFID and current electronic purchasing tablet to connect to Abbott Informatics test system is intended for healthcare Today’s menu includes: HIV, HCV, systems to automate the lab inven- Mobile solution, you can now easily professionals in the management HCV GT, HBV, CTNG, Flu A/B & tory monitoring, tracking, stocking view key performance indicators, ap- of patients treated with oral anti- RSV, VRE, C. diff, and now HSV-1/2. and ordering processes, providing the prove results, view status reports, and coagulant therapy. The InRhythm The broad m2000 system test menu potential for fewer inventory errors and more, so you can make decisions and instrument is a handheld device with for infectious disease allows for lower inventory labor requirements. take action quickly. We’ve optimized a touch screen that operates with a platform consolidation. The solution works DYN Sapphire and the user experience with larger icons, stylus or finger. InRhythm features For more information on how Ruby, ABBOTT PRISM and Molecular stackable screens, and touch controls connectivity capability, a barcode Abbott can partner with you on product lines as well as non-Abbott to make it easier to scroll, tap, or swipe scanner to help reduce transcription developing and implementing solu- products, making inventory s inven- through your records. As part of a errors, and a USB port for printer tions that fit the needs of your institu- tory management practices providing comprehensive informatics solution, capabilities. Tests are performed with tion, stop by Abbott booth #2012 or accurate patient results. For more infor- our Mobile solution can interface with single-use disposable InRhythm test visit www.abbottmolecular.com. mation, stop by Abbott booth #2012 or mobile device capabilities such as the cuvettes. Each cuvette has a bar- Abbott Diagnostics visit us at www.abbottdiagnostics.com. camera, GPS, barcode scanner to bring coded label that contains lot number Booth 2012 Abbott Diagnostics an abundance of technology into the and expiry dating. This product has Booth 2012 palm of your hands. For more informa- not been cleared by the FDA and is tion, stop by Abbott booth #2012 or visit not available for sale in the USA. us at www.stalims.com. Accriva Diagnostics, Representing Abbott Diagnostics ITC and Accumetrics Booth 2012 Booth 4612

Technopath QC Solutions: A Total Solution for ARCHITECT Abbott’s QC portfolio includes Technopath QC Solutions. This solu- tion is comprised of Multichem QC third-party multi-analyte controls FreeStyle Precision Pro: for immunoassay, chemistry and Performance That Protects Your immunology testing. Additionally Patients ARCHITECT Hemoglobin A1c Assay to complement Multichem QC the FreeStyle Precision Pro Blood Glucose Abbott’s comprehensive menu of as- following informatics services are and β-Ketone Monitoring System deliv- says includes the ARCHITECT Clinical AUTION HYBRID™ AU-4050 available: IAMQCTM Peer software ers multiple patient safety benefits: Chemistry Hemoglobin A1c assay. The Automated Urine Analyzer for interlaboratory reporting, auto- • Improved Hematocrit performance availability of this assay highlights The ARKRAY AUTION HYBRID™ mated QC setup and reagent lot con- • Wireless capability Abbott’s continued commitment to AU-4050, a fully automated analyzer, firmation. The majority are assayed • Individually wrapped test strips expanding its ARCHITECT metabolic integrates proven urine chemistry controls that provide a unique level facilitate no-touch procedure assay menu and providing solutions and flow cytometry technology into of consolidation and high-quality • 1D/2D barcode reader designed to help the core lab with the smallest space-saving footprint performance to assist in satisfying FreeStyle Precision Pro System is not improving clinical outcomes. For in the market. your laboratories QC needs for our for use in diagnosing of or screening for more information on how Abbott can • Standardizes workflow and re- ARCHITECT analyzers. For more in- diabetes mellitus, but is used as an aid in partner with you on developing and duces tech-to-tech subjectivity formation on how Abbott can partner monitoring the effectiveness of diabetes implementing solutions like these that • Processes up to 200 chemistry with you on implementing solutions control programs. FreeStyle and related fit the needs of your institution, stop by tests/hour and provides a high like these that fit the needs of your in- brand marks are trademarks of Abbott the Abbott booth #2012 or visit www. level of bacteria detection stitution, stop by Abbott booth #2012 Diabetes Care Inc. abbottdiagnostics.com. • High capacity with minimal or visit www.abbottdiagnostics.com. Visit Abbott booth 2012 or http:// Abbott Diagnostics operator intervention for true Abbott Diagnostics www.3pillarsofpatientsafety.com/FSPP/. Booth 2012 walk-away capabilities Booth 2012 Abbott Diagnostics • Streamlines urinalysis testing Booth 2012 with automatic reflex testing, no manual dilutions and minimal maintenance based service which enables m2000 order to present information in a user- • Easy training and competency users to accurately monitor the op- friendly format. retention erating efficiency of their systems. For more information on how Abbott The AUTION HYBRID AU-4050 Developed by LTS Consulting and can partner with you on developing and is an efficient, easy to use analyzer Abbott Molecular, it uses proven implementing solutions that fit the needs that provides high quality results AbbottLink technology to link of your institution, stop by Abbott booth and improved bacteria detection for mView RealTime systems to a central da- #2012 or visit www.abbottmolecular.com. better patient outcomes. Abbott Molecular introduces Abbott Diagnostics tabase server. The mView engine ARKRAY, Inc. Booth 2012 mView, a groundbreaking web- analyzes and interprets data in Booth 2056

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The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase Alifax TEST 1 The Alifax TEST 1 Erythrocyte Sedimentation Rate System, available from Beckman Coulter, is designed Access 25(OH) Vitamin D Total for to fit all workloads, including small Access 2 and DxI hospitals, large reference laboratories, Plate Streaking System for ChemWell® FUSION, automates Pending FDA Clearance- Vitamin D is core laboratories and satellite locations. Positive Samples & MRSA both CLIA and ELISA a lipid-soluble steroid hormone that is Alifax’s technology measures the Alifax presents the first fully auto- ChemWell® FUSION is a fully-au- essential to the maintenance of overall kinetics of red blood cell aggregation mated MRSA screening with PenOK tomatic combination analyzer for bone health because of its key role in by capillary photometry and reads Swab collecting device and its selec- processing both colorimetric and chemi- maintaining calcium and phosphorus aggregation over a ten second period. tive media (both CE marked) for a luminescent microwell assays. The homeostasis. In adults, vitamin D With this patented technology, Alifax phenotype culture test in 1-6 hours economical open system accepts both deficiency can lead to bone pain, osteo- TEST 1 provides a fully automated, with Alfred60/AST and the new types of tests on the same plate, even malacia and proximal muscle weakness; hands-off operation that processes SIDECAR instruments. SIDECAR at the same time. Its windows-based in infants and children, chronic severe the same whole blood tubes from is the first walk-away system which software package makes it easy to cre- deficiency can cause the bone defor- the hematology analyzer, resulting detects and streaks only positive ate and store a menu of test programs mation known as rickets. In the body, in ESR analysis in 20 seconds*, which samples on up to 240 Petri dishes including pipetting and customized vitamin D2 and D3 are converted to reduces turnaround times and helps loaded in a dedicated refrigerated pipet washing, pre-dilutions, mixing, 25(OH) vitamin D which is the major improve patient outcomes and physi- area. Dishes are incubated onboard timed room temperature or 37C incu- circulating metabolite of vitamin D. cian satisfaction. *8.3 minutes to first at 37°C for the requested analysis bations, and 8-well strip washing. The Serum concentration of total 25(OH) result with other results following time. New phenotype culture tests unique patented reader automatically vitamin D is considered the standard every 20 seconds. will be shortly available for emerging switches between absorbance and che- clinical measure of vitamin D status Beckman Coulter multi-drugs resistant bacteria like mi-luminescence. Computer-controlled and reflects inputs from sources of both Booth 2812 KPC, VRE, ESBL and GBS. ChemWell® FUSION handles a wide vitamin D2 and D3. Alifax S.p.a. variety of calibration calculations and Beckman Coulter Booth 442 QC criteria. A compact design with Booth 2812 minimized footprint and maximized durability. Awareness Technology, Inc. Booth 1814

OVA1 ASPiRA LABS offers a continuum of care with personalized reporting for the ovarian mass, applying innova- Access Total βhCG(5th IS) tive methods to detect and monitor The Access Total βhCG (5th IS) assay the treatment of ovarian cancer. BioCode 3000 – High Throughput is the first βhCG assay standardized For the Women’s Healthcare MDx System to the highly purified World Health Provider, OVA1 is the first FDA- Applied BioCode is introducing Organization (WHO) 5th International cleared blood test to help evaluate their new high throughput system Standard (IS) for chorionic gonadotropin, an ovarian mass for cancer prior for highly multiplexed MDx assays. ReQuest™ 25OH Vitamin D Total a glycoprotein hormone most commonly to a planned surgery. The OVA1 The BioCode 3000, with integrated ELISA measured for pregnancy determina- result may help determine whether Amplification, Hybridization and ReQuest™ 25OH Vitamin D kit contains tion. The assay is critical in routine and consult or referral to the Gynecologic Detection, can process up to 96 calibrators, controls and reagents to per- emergency diagnosis as it is frequently Oncologist is the best course of action. samples in ~3 hours. The automated form 96 microwell assays of both forms, ordered on women of childbearing-age For the Gynecologic Oncologist, system was designed to reduce D2 and D3, for use in determination of who require treatment which could Longitudinal CA125 is offered in a manual labor steps, maximize testing Vitamin D deficiency, insufficiency or potentially be harmful to a fetus. multi-point graphing system to moni- throughput and minimize the poten- intoxication. A competitive assay with The new Access Total βhCG (5th IS) as- tor ovarian cancer once it has been tial for any sample contamination. room temperature incubations and less say is an example of Beckman Coulter’s diagnosed. When OVA1 has been Based on the 96-well microplate the than 3 hour turnaround time, its major continuing dedication to lead the way in ordered through ASPiRA LABS, the system offers throughput and cost benefits include precision, sensitivity this important diagnostic field. Longitudinal CA125 report will in- advantages over Sample-to-Answer and economy. Beckman Coulter clude the pre-surgical CA125 baseline systems. Applied BioCode will also The assay can be performed manu- Booth 2812 value from the original OVA1 result. be exhibiting their new multiplex ally or easily automated with no need ASPiRA LABS Gastrointestinal Pathogen Panel for a pretreatment step outside the Booth 663 which includes the 17 most common micro-plate. Instrumentation for both methods is also available: reader, wash- pathogenic bacteria, viruses, and par- sive prospective clinical trial that er and shaker or fully automated ELISA asites. The Gastrointestinal Pathogen enrolled over 1,900 subjects, and analyzer. The test has been cleared by Panel will be the first of many tests confirmed that our assay provides US FDA 510(k). developed for the BioCode 3000. the clinical performance you need Reconstituted calibrators and con- Applied Biocode, Inc. for optimal patient management. trols are stable for one week refrigerated Booth 1844 The AccuTnI+3 assay delivers the and up to 3 months frozen. Access 2 and DxI precision, and the clinical sensi- Awareness Technology, Inc. The AccuTnI assay has a long history tivity and clinical specificity that Booth 1814 of proven clinical performance in the are necessary to assist physicians diagnosis of myocardial infarction with the diagnosis of MI. (MI). The new Access AccuTnI+3 as- Beckman Coulter say was evaluated through an exten- Booth 2812

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The Official Publication of the AACC Annual Meeting & Clinical Lab Expo social media—or don’t see a reason #AACC2014 why they should in the first place. In this two-part webcast, Tiffany ›› from page B-1 Roberts, PhD, explains why labora- tory professionals should explore be Googled!” An AACC member and social media as part of their profes- active social media user, Roberts of- sional life, as well as how novices can fers expert advice on how to craft a get started if they’re not sure where personal brand on social media, how to begin. to assess the benefits of different so- The program also includes ac- cial media platforms for your content, cess to a curated collection of peer- and how to start using Twitter in a reviewed research on social media for AACC offers 1 ACCENT few simple steps. scientists, getting started guides, and continuing education credit for Confused, stressed about, or afraid articles from around the web. this program. of taking the plunge into social Access the webcast on the media? You’re not alone. Many sci- AACC website, http://tinyurl. Tiffany Roberts, PhD, explains her com/AACCsocial. entists, including laboratory profes- approach to social media in a sionals, feel uneasy about sharing on members-onlyads 7 x 10_Layout AACC 1 7/9/14 webcast. 11:48 AM Page 3

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New for 2014 AuTOMATEd ESR ANALYzERS Visit us at: Share via Text and Email AACC Your photos and messages will July 29–31 appear on the #AACC2014 Excyte Chicago, Illinois social media walls! Booth: #741

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Special Programming An endearing family on Twitter with a performance Follow the AACC Annual history Meeting & Clinical Lab Expo on Twitter using #AACC2014

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➨ Live tweeting the Sunday plenary by @ClinChemDoc and @clinchemgirl Closed tube sampling and testing excellent correlation to Westergren Complimentary peer QC program (VQC) ➨ Live tweeting of the random access Dedicated Accu-sed esr controls Plastic tubes available Wednesday plenary by @mcervinski on board mixing and scanning*

➨ Live tweeting of the *certain models Thursday morning symposium on laboratory test utilization by @pathology_nerd ➨ A special annual meeting w w w . e l i t e c h g r o u p . c o m ELITechGroup i n f o @ e l i t e c h g r o u p . c o m S O L U T I O N S Tweet-Up t a i l o r e d t o y o u r n e e d s ➨ And more! PAGE B-6 Monday, July 28, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase

UniCel DxH Connected Workcell Immunosuppressant Drug BioPlex® 2200 Solution Power Express Automation Monitoring Assays for AU Series 25-OH Vitamin D Kits* With the UniCel DxH Workcells*, labs System Beckman Coulter offers a new com- BioPlex® 2200 25-OH Vitamin D kit can streamline workflow management Designed to meet the needs of prehensive menu of immunosup- is a fully–automated, random access while delivering comprehensive and ac- the most demanding laboratories, pressive drug monitoring kits de- method for the quantitative measure- curate patient results. With the ability to Power Express is a high-through- signed to work across multiple AU ment of total 25-hydroxyvitamin D connect up to three DxH 800 analyzers put automated sample handling chemistry system platforms. Thermo in human serum. The kit features with one DxH Slidemaker Stainer, labs system that processes Chemistry, Fisher Scientific Immunoassays – a broad reportable range, internal can create a scalable workflow solution Immunochemistry, Hematology and QMS® Tacrolimus, QMS® Everolimus, quality control flags, and equimolar that builds on Beckman Coulter’s in- Coagulation tubes. Utilizing a high CEDIA® Cyclosporine Plus and measurement of 25-OH Vitamin D2 novative cellular science. speed 4-lane track and an intelligent CEDIA® Mycophenolic Acid – distrib- and D3 as an aid in the assessment of Performance, low review rates sample handling system, Power uted by Beckman Coulter, Inc., are now Vitamin D sufficiency. Enhance your and first past accuracy are all driv- Express performs centrifugation, available on the AU480/680/5800 laboratory workflow efficiency with a en by Beckman Coulter’s exclusive decapping/recapping, aliquoting, series. convenient 200 test kit, 30-day calibra- Automated Intelligent Morphology and refrigerated/ambient storage The new assays offer: tion curve stability, and long open vial (AIM), a multidimensional, flow cyto- to give labs the ability to offer rapid • Proprietary Quantitative stability for reagents, calibrators and metric technology that improves analy- and predictable turn-around times, Microsphere System technology controls. The BioPlex® 2200 system now sis of abnormal specimens. Workflow is reduced errors, and improved overall (Tacrolimus/Everolimus) offers menu consolidation of specialty managed efficiently through the DxH laboratory productivity. • Cloned Enzyme Donor autoimmune, infectious disease serol- Workcell’s automated sample routing Beckman Coulter Immunoassay technology ogy and 25-OH Vitamin D all on one and increased data management capa- Booth 2812 (Cyclosporine Plus, Mycophenolic platform. *Pending FDA clearance. bilities. *Not available in the U.S. for in Acid) Bio-Rad Laboratories vitro diagnostic use. • Correlation to well established Booth 2031 Beckman Coulter (LC-MS/MS, HPLC) reference Booth 2812 methods. QMS® is a registered trademark of Thermo Fisher Scientific Inc. CEDIA® is a registered trademark of Roche Diagnostics. Beckman Coulter Booth 2812 REMISOL Advance Data Manager With 3,000 installations worldwide, REMISOL Advance is an enterprise BioPlex® 2200 HIV Ag-Ab Kit* Powerful, Dependable 10-Color data management solution that Bio-Rad Laboratories’ BioPlex 2200 Flow Cytometry helps manage lab workflow, improve HIV Ag-Ab kit simultaneously screens The Navios flow cytometer delivers quality of patient care, standardize and differentiates antibodies to HIV-1 highly sensitive detection, unsurpassed operations across multiple sites and (Groups M & O) and HIV-2, and HIV-1 data interrogation, more information increase productivity. It provides p24 antigen. This 5th generation kit per event, and exceptional workflow ef- critical results faster to help enable offers enhanced performance over 4th ficiencies. The Navios enables seamless labs to empower clinicians to make generation kits, with the lowest Limit of transition from lower complexity assays more informed decisions. Alifax Roller 20PN Detection available for screening. Using to advanced applications. You can trust REMISOL Advance features vir- The Alifax Roller 20PN Erythrocyte proprietary multiplex technology, the the Navios to deliver consistent results, tualization capability to help reduce Sedimentation Rate System, available kit simultaneously detects and reports with software tools that ensure robust failure points, increase uptime and from Beckman Coulter, is designed up to 3 individual HIV results plus a quality control and audit capabilities, enhance patient data security. It offers to fit all workloads, including small traditional screen. Differentiating HIV- as well as hardware features such as an integrated visual management hospitals, large reference laboratories, 1 from HIV-2 antibodies and detecting single tube vortex capability, built-in system to track and trace transported core laboratories and satellite locations. HIV-1 p24 antigen can save time and thermoregulation, and 1,048,576 chan- samples from the draw site to the Alifax’s technology measures the resources by directing supplemental nel resolution for high quality results. lab assisting your lab to become kinetics of red blood cell aggregation testing and potentially detecting acute Backed by the proven expertise of ISO15189 compliant. It is a key to by capillary photometry and reads HIV infections sooner. The kit expands Beckman Coulter, the Navios gives your helping you develop a comprehen- aggregation over a ten second pe- the BioPlex 2200 System’s infectious lab powerful, worry-free performance sive lab management solution. Not riod. With this patented technology, disease menu. *Pending FDA Approval. along with reduced costs and a highly available in all geographies. Alifax Roller 20PN provides a fully Available outside the U.S. streamlined workflow. Beckman Coulter automated, hands-off operation that Bio-Rad Laboratories Beckman Coulter Life Sciences Booth 2812 processes the same whole blood tubes Booth 2031 Booth 3417 from the hematology analyzer, result- ing in ESR analysis in 35 seconds*, LiquichekTM Cardiac Troponins Control LiquichekTM Cardiac Troponins which reduces turnaround times and LiquichekTM Cardiac Troponins Control Control is human based, has tri- helps improve patient outcomes and is now available to monitor the precision level utility and is available in 6 x physician satisfaction. *7 minutes to of Troponin I and Troponin T. Values 3 mL (two per level) as well as 3 first result with other results following are assigned for Roche platforms. x 3 mL (one per level) packaging. every 35 seconds. For laboratories outside the U.S., values Bio-Rad Laboratories Beckman Coulter are also assigned for Troponin T hs. Booth 2031 Booth 2812

ADVERTISEMENT TUESDAY, JULY 29, 2014 Monday, July 28, 2014 PAGE B-7

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase Abbott, Ortho®, Tosoh, Trinity, and Pointe control flags, and equimolar measure- Scientific with target values ranging from ment of 25-OH Vitamin D2 and D3 as 3.3% to 19.5% (NGSP). Customers can an aid in the assessment of Vitamin D compare their results with both target sufficiency. Enhance your laboratory values and peer group data through workflow efficiency with a convenient Bio-Rad’s Linearity Web tool which 200 test kit, 30-day calibration curve can be accessed from QCNetTM (www. stability, and long open vial stability for qcnet.com) under “LabToolsTM”. Reports reagents, calibrators and controls. The with useful graphics for linear regression BioPlex® 2200 system now offers menu and percent bias are available instantly BioPlex® 2200 25-OH Vitamin D Kits* consolidation of specialty autoimmune, and provide an easy to use solution BioPlex® 2200 25-OH Vitamin D kit infectious disease serology and 25-OH LiquichekTM Immunology Control to meet CLIA and CAP requirements is a fully–automated, random access Vitamin D all on one platform. *Pending with Anti-CCP for Calibration Verification and AMR method for the quantitative measure- FDA clearance. LiquichekTM Immunology now includes Verification. ment of total 25-hydroxyvitamin D Bio-Rad Laboratories Anti-Cyclic Citrullinated Peptide (Anti- Bio-Rad Laboratories in human serum. The kit features a Booth 2031 CCP) along with Rheumatoid Factor Booth 2031 broad reportable range, internal quality (RF), to assist clinical laboratories in their QC for rheumatoid arthritis markers. Liquichek Immunology Control is human serum based, offers trilevel utility and is available in 1 mL as well as 3 mL vials. Bio-Rad Laboratories Booth 2031

AACC Booth #1928

Lyphochek® Allergen sIgE Controls Bio-Rad, the QC market leader, in- troduces Lyphochek® Allergen sIgE Controls, Negative and Panel A. These independent quality control products are assayed for 15 frequently tested allergen specific IgE’s providing quantitative insert values for up to three of the major automated test systems commonly used for in-vitro allergy diagnostics. Lyophilized for maximum stability, the control offers a three year shelf life and reconstituted open-vial stability of 28 days when stored at 2°C to 8°C. Lyphochek® Allergen sIgE Controls offers a superior option for routine qual- ity control and will allow participation in Bio-Rad’s Unity™ Interlaboratory Program, the worldwide peer group comparison program. Bio-Rad Laboratories Booth 2031 Internal standards for critical Ro mass spectrometry applications. Ravi Orugunty, PhD ANALYTICAL R&D Quality and lot-to-lot consistency of internal Cerilliant – standards can impact laboratory results. when results matter.

Lyphochek® Hemoglobin A1C Linearity Set, Six (6) Level The new Lyphochek® Hemoglobin A1C Linearity Set from Bio-Rad provides six levels for HbA1c assay linearity 800/848-7837 USA or CANADA 512/238-9974 INTERNATIONAL Cerilliant.com verification. Assayed values are avail- able for popular analyzers from Bio-Rad, © 2014 Cerilliant Corporation C L N 0 7/14 Siemens, Roche, Beckman Coulter®, PAGE B-8 Monday, July 28, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase

Access AccuTnI+3 troponin I for Theater Slim PCR Cycler Access 2 and DxI Burkert Pneumatic Dosing Unit Vitamin D-direct™ Moderately http://www.coyotebio.com/en/ The AccuTnI assay has a long history The unique Pneumatic Dosing unit from Complex, No Pre-Treat Theater Slim PCR Cycler is the thin- of proven clinical performance in the Burkert – ultra precision and repeatabil- Vitamin D-direct™ is a moderate com- nest PCR cycler and is the only por- diagnosis of myocardial infarction ity of fluid dosing come together with a plexity assay for the CLC720 chemistry table PCR cycler in the market,which (MI). The new Access AccuTnI+3 flexible, customizable design giving you analyzer that requires no manual pre- makes the transition of PCR cycler assay was evaluated through an precisely the results that matter to you. treatment of the sample or reagent. A from Desktop to Laptop. The op- extensive prospective clinical trial Features you can rely on: sample can run in 20 minutes (up to eration of the Slim PCR Cycler is that enrolled over 1,900 subjects, and • Defined volumes with high precision 400 tests/hr) and can be run in random extrmely simple and beats any other confirmed that our assay provides and repeatability up to +/- 2% access mode with other chemistries, cyclers. This cutting-edge product the clinical performance you need • Dosing accuracy independent of eliminating the need for batch testing. will open new markets in education for optimal patient management. temperature Vitamin D-direct™ measures total and molecular diagnostics. The AccuTnI+3 assay delivers the • Highly integratable technology 25-Hydroxy (sum of D3 + D2), is Features: precision, and the clinical sensitiv- • Media separation with high quality traceable to NIST standard reference • 12V DC Powered for field ap- ity and clinical specificity that are materials material, features wide dynamic range, plications necessary to assist physicians with • Single use wetted parts improved precision, eliminates washing • From Desktop to Laptop the diagnosis of MI. • Easy to use robust system and less steps, and eliminates inaccurate results • Touch Screen&EASY Operation Beckman Coulter maintenance caused by “matrix effects.” • Precise Temperature Control Booth 2812 Your customization options: Competitively priced reagents and • And Quiet • Variable dosing volume to fit your the economical CLC720 make Vitamin Coyote Bioscience application D-direct™ a great choice for laborato- Booth 2655 • Different materials to fit your needs ries seeking to reduce costs. For more • With or without internal pressure information, visit carolinachemistries. supply to fit your device com/vitamind. • Flexible design to fit your package Carolina Liquid Chemistries Burkert Fluid Control Systems Booth 1019 Booth 3848 UniPOC UniPOC, CLC6410™ High Volume Modular the new Chemistry Analyzer CONWORX The new, FDA-cleared CLC6410™ POC data from Carolina Liquid Chemistries manage- is a high volume, modular clinical ment system Homogenous Assay for HDL chemistry analyzer capable of meet- successfully Subfraction (HDL3) ing the needs of large hospitals and organizes the Denka Seiken introduces a homog- clinical reference laboratories. The The daily Point of enous, direct assay for the fast and CLC6410™ has an economical, modu- Lyphochek® Specialty Immunoassay Care Testing easy quantification of HDL3. The test lar design that allows laboratories to Control (POCT) op- does not require any off-line manual expand its throughput as their needs Lyphochek® Specialty Immunoassay erations of process such as for sample pretreat- grow. A single module can run up to Control is a perfect companion for hospitals. In a single system it manages all ment but can run fully automated 1600 tests/hr, while four modules LiquichekTM Immunoassay Plus, accreditation requirements, presents data on routine clinical chemistry analyz- can be joined to achieve 6400 tests/ Lyphochek® Immunoassay Plus, and in a clear and structured format. Utilizing ers. The test employs of two liquid, hr. All configurations include a 300 LiquichekTM Specialty Immunoassay our core expertise in POCT interface de- ready-to-use reagents and consists of sample loader and intuitive software controls. It offers specialty analytes velopment gained over 15 years, UniPOC two steps: the 1st step to selectively that automates numerous operational such as Procalcitonin (PCT), 25-OH guarantees a secure connection for more decompose chylomicron and VLDL, and quality control procedures. The Vitamin D, intact PTH, Sex Hormone than 100 various POCT device models. and the 2nd step to specifically mea- CLC6410™ also features technological Binding Globulin (SHBG), and The benefit of complete manufacturer sure cholesterol in HDL3 particles. advances that save time, water, and Erythropoietin (EPO). Lyphochek® independence and POCT experience HDL2 is also quantified by a simple energy. For more information, visit Specialty Immunoassay Control has a allows you full flexibility in the selection subtraction of HDL3 from total HDL. carolinachemistries.com/clc6410. 3-year shelf life when stored at 2–8ºC. of the appropriate Point of Care Testing Not for use in diagnostic procedures, Carolina Liquid Chemistries Once reconstituted, most analytes are devices. With extensive know-how in for research use only. Booth 1019 stable for 30 days (at 2–8°C). Lyphochek® implementing over 1700 systems world- Denka Seiken Co., Ltd. Specialty Immunoassay Control is part wide, we would be pleased to assist you Booth 2052 of the UnityTM QC program for bench- in the organization of all your POCT in marking laboratory performance. accordance with your exact requirements. Bio-Rad Laboratories Conworx Data Solutions America, Inc. Booth 2031 Booth 1375

Homogenous Assay for line manual process such as for HDL and the 2nd step to spe- Triglycerides in LDL Particles sample pretreatment but can run cifically measure triglycerides (LDL) fully automated on routine clini- in LDL particles. Not for use Denka Seiken introduces a ho- cal chemistry analyzers. The test in diagnostic procedures, for mogenous, direct assay for the employs of two liquid, ready-to- research use only. fast and easy quantification of use reagents and consists of two Denka Seiken Co., Ltd. triglycerides in LDL particles. steps: the 1st step to selectively Booth 2052 The test does not require any off- decompose chylomicron, VLDL,

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TE1410158 Shaping the lab oem 14x10_AW.indd 1 6/12/14 5:50 PM PAGE B-10 Monday, July 28, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase

EasyCell Assistant Cell Image Analysis for Hematology EasyCell Remote software can in- crease staffing efficiency in reviewing slides by physicians remotely. Tomcat™ Instrument Improve productivity by auto- CueSee® Glucose The Tomcat general purpose instrument matically locating white cells and Ultra-sensitive TIA for Ferritin CueSee® Glucose is the new generation performs a full range of processing pre-classifying them on a display, Introducing a latex-enhanced turbi- for validating precision and accuracy activities for liquid-based cytology grouped by cell type. Red cells dimetric immunoassay for the fast of glucose meters. Its real blood matrix samples including: and platelets are also displayed for and easy determination of ferritin makes it highly commutable and com- • Barcode validation morphology and platelet estimates. levels in blood samples with ultra- patible with all glucose devices with • Vortexing Lowers costs by reducing tech- sensitivity. The new assay does not minimal matrix effects. Its low impreci- • De-capping nologist time required to perform require off-line sample pretreatment sion makes it comparable with that of • Re-capping manual differentials. or presample dilution, and it can human whole blood. • Aliquoting Automates data access by provid- give results in 10 minutes. The new ACU-Drop II is the packaging form • Reagent dispensing ing convenient access to previous test uses polystyrene particles coated key to deliver this control in a dual- • Incubating cell images to track patient status with anti-human ferritin that form chambered device keeping the various The Tomcat instrument accommo- storing up to 10,000 slides on-board a complex with ferritin present in fractions separated to prevent reactions dates multiple sample types concur- the system. blood samples (serum or plasma) and between components of the desired ma- rently, with the ability to continuously Assures accurate performance with can be measured with routine clinical trix. Push a button to allow fractions to load and unload samples, waste and built-in quality control software that chemistry analyzers. Available only combine, mix, and the sample is ready consumables. By eliminating manual verifies that nucleated cells are pre- outside the U.S. to use either from the built-in dropper aliquoting steps, the Tomcat instrument sented to the technologist for review. Denka Seiken Co., Ltd. bottle or by attaching a syringe. can help laboratories improve work- Checks for acceptable slide prepara- Booth 2052 Ideal for QC, calibration verifica- flow, free skilled labor for other tasks, tion and ensures quality results. tion, proficiency testing, competency improve confidence in positive sample HORIBA Medical assessment, method validations and lot ID/chain of custody, reduce the risk of Booth 2063 comparisons. cross-contamination, standardize the Eurotrol, Inc. aliquoting process and reduce the risk Booth 1144 of repetitive motion injuries. Hologic, Inc. Booth 4012

25-OH Vitamin D Assay for Chemistry Analyzers Diazyme’s 25-OH Vitamin D Assay is intended for use in clinical labo- Moderately Complex Vitamin D ratories for the quantitative deter- assay for Pentra 400 mination of 25-hydroxyvitamin D Moderately Complex Vitamin D as- (25-(OH)D) in human serum and CueSee® VeriSTAT with CueSee® Online say for Pentra 400 Chemistry System. plasma on automated chemistry CueSeeVeriSTAT all-in-one quality This innovative Vitamin D assay analyzers. The tests provides rapid control and linearity product for use HRDR 200: Holomic Rapid enables clinical laboratories of vir- results with calibrator traceabil- with Abbott i-STAT analyzers contains Diagnostic Reader tually all sizes to run Vitamin D ity to NIST 972a. The assay has hematocrit, blood gases, electrolytes, The Smartphone based Holomic Rapid tests in house without the need for excellent correlations to LC-MS/ and chemistries with a blue dye for Diagnostic Reader or HRDR-200, is an expensive specialized instruments. MS and leading 25-OH Vitamin D visibility. It has optimal target ranges, economical, handheld, quantitative reader The high-throughput liquid stable Immunoassays. Furthermore, the longest shelf life and longest room for lateral flow immunoassay tests. The assay provides precise test results, is cost effective assay does not re- temperature stability. reader features instant access to electronic user friendly, cost effective and has quire dedicated immunochemistry The product eliminates the need to health records, and real-time, wide area excellent correlation to the existing analyzer. The test is based on the use two separate cartridges with each diagnostic data collection via a secure commercial methods. The HORIBA principle of α-complementation of control check, cutting time and costs. CLOUD service. It provides exceptional Medical Pentra 400 Vitamin D assay the enzyme β-galactosidase and the Meet regulatory requirements with three sensitivity and accuracy for your tests. The can help clinical laboratories improve competition between an enzyme levels of quality control and the five level reader is ideal for point-of-care, telemedi- their workflow and reduce their donor-25-OH Vitamin D conjugate, AMR/calibration verification panel. cine, public health monitoring, as well as turnaround time for test results. This an anti-Vitamin D antibody and the Also included is CueSeeOnline, a free for lab and factory needs. Available in both assay also eliminates the need for a 25-OH Vitamin D content of a serum web-based data submission program chromatographic and fluorescent versions, customer to purchase expensive and sample. For in vitro diagnostic use for peer comparison, statistics and the reader also features Test Developer highly complex instruments. This only. graphical presentations. Enhancement software for R&D and manufacturing of method of Vitamin D measures total Diazyme of the quality control program is further rapid tests. Reader customization to your 25-hydroxy Vitamin D (sum of 25- Booth 1238 simplified via the data import tool. requirements is fast, easy, and low cost. (OH)D3 + 25-(OH)D2 ) levels. Eurotrol, Inc. Holomic LLC HORIBA Medical Booth 1144 Booth 2043 Booth 2063

Hypoxic QC inspectors. With its active hemoglobin ER or NICU. Also included with Report pO2 results as low as 15 mmHg on buffering and real O2 saturation curve, Hypoxic QC is CueSee®Online, a any blood gas analyzer with the world’s Hypoxic QC has a 10 minute open ampule free web-based data submission only available extremely low pO2 con- stability time and precision comparable to service used for peer comparisons trol, Eurotrol’s Hypoxic QC. Critical for that of real patient blood. and to generate statistics, graphs Analytical Measurement Range valida- It is ideal for the laboratory, point and reports. tion, it is now recommended by many of care sites, respiratory departments Eurotrol, Inc. instrument manufacturers and regulatory and critical care areas such as ICU, OR, Booth 1144

ADVERTISEMENT TUESDAY, JULY 29, 2014 Monday, July 28, 2014 PAGE B-11

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase genotypes may help clinicians tailor drug treatment to patients by selection All materials contained in this newspaper are protected by copyright laws and may not be of appropriate therapies. used, reproduced, or otherwise exploited in The xTAG® CYP2D6 and xTAG any manner without the express prior permis- CYP2C19 assays are IVD tests that allow sion of AACC. detection of major alleles associated The information contained in the CLN Daily is xTAG® CYP2D6 Kit v3 & xTAG® with variant drug metabolism. Both as- provided solely for educational purposes. A CYP2C19 Kit v3 says have reported high reproducibility diversity of opinions exists in the field of labo- ratory medicine, and the articles in this pub- Adverse Drug Reactions (ADRs) are a and accuracy providing confidence in lication are often intended to inform readers Interferon-Omega Autoantibody RIA leading cause of morbidity and mortal- results. about more than one point of view. The views † Test Kit ity in the U.S. One of the reasons attrib- These assays are not indicated for expressed in the CLN Daily do not necessarily KRONUS® is proud to offer the represent AACC’s views, and their inclusion uted to the occurrence of ADRs is the stand-alone diagnostic purposes, nor in this publication should not be interpreted Interferon-Omega Autoantibody (IFN- prescription of more drugs per patient intended to be used to predict drug as an endorsement by AACC. AACC is not ωAb) RIA Kit† for the accurate determi- and an increase in the combination of response or non-response. responsible for any inaccurate or inappropriate nation of autoantibodies to interferon- use of the information, publications, products, drugs being used. Luminex or services discussed or advertised within. omega (IFN-ω) in serum. Please visit Identification of CYP2D6 & CYP2C19 Booth 738 the KRONUS exhibit booth at number 1931 to learn more about our innovative product line. †For Research Use Only. Not for use in diagnostic procedures. KRONUS, Inc. Booth 1931

ARIES ARIES™ – Available Soon. Revolution-izing Molecular diag- nostics with a sys- tem that integrates seamlessly into the lean laboratory workflow, right out of the box. Come by the Luminex® booth 738 to lean how ARIES™ can help maximize laboratory productivity with: • Minimal footprint • Menu consolidation • Open platform and LDT capable • Laboratory efficiency • Improved healthcare Ask about our growing IVD menu! The launch menu includes: • ARIES HSV 1&2 Assay • ARIES C. difficile Assay • ARIES Norovirus Assay Visit us at • ARIES Flu A/B and RSV Assay AACC/ASCLS Booth #509 • ARIES GBS Assay ARIES is the next generation of sample-to-answer testing, providing simplified workflow and accurate, rapid results. www.Luminexcorp.com. Luminex Changing lives. One test at a time. Booth 738 Siemens answers help deliver timely, accurate results so clinicians can provide

A91DX-9348-A1-4A00. Siemens © 2014 Healthcare Diagnostics Inc. All rights reserved. the best in patient care.

siemens.com/changing-lives

Diagnostics—it’s at the heart of decision making. Our leading portfolio of tests and technologies is designed Every day, clinicians depend on the power of science to help detect diseases earlier and make more accurate to make better and more informed decisions. And every diagnoses. And by leveraging our disease-state expertise day, their patients depend on timely, accurate test and educational resources, you can stay at the forefront Mouse Monoclonal to Human IP 10 results to live longer, healthier lives. That’s why clinical of science. A monoclonal antibody specific to hu- excellence isn’t optional. It’s a requirement. Together, we have the answers to change lives—one test man IP10 was generated at Lampire From our comprehensive assay menu and scalable, at a time. Learn how at siemens.com/changing-lives. through a rapid, efficient, hybridoma multidisciplinary solutions to lab-transforming development program. All aspects of automation and powerful IT, Siemens is shaping antibody generation were performed the future of patient care. in-house in less than 8 weeks. The IP- 10 antibody is available for purchase or license from Lampire. Lampire offers Answers for life. custom, reliable, antibody development to meet any client specification. Lampire Biological Laboratories, Inc. Booth 746

9348_Clinical Excellence Ad_2014_AACC-EC_7x10.indd 1 6/25/14 3:29 PM FE FE FHEC DOWN EE EE FHEC FHEC EE DF

DOWN 2014 AACC Annual Meeting & Clinical Lab Expo FE EE

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SD62 The Official Publication of the AACC Annual Meeting & Clinical Lab Expo The Official Publication of the AACC Annual Meeting & Clinical Lab Expo FE FHC FHC FHC FHC FHC FHC FHC

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2014 AACC Annual Meeting & Clinical Lab Expo EE EMERGENCY EXIT EMERGENCY

EXHIBITING AS ...... BOOTH NUMBER Applied Biocode, Inc...... 1844 Biolabo ...... 4160 EE

20' OEM OEM OEM OEM 11 OEM OEM OEM 3M ...... 2169 APTEC Diagnostics NV ...... 856 Bioline USA ...... 2145 OEM 1479 1679 1779 1879 1979 2079 2179

3M Health Information Systems ...... 1076 Arise Biotech Corp...... 2069 BIOLYPH, LLC ...... 1162 10 20' 20' 20' 20' 1078 1178 1278 1378 1478 1578 1678 1778 2078 2178 2378 2478 2578 2678 2778 3678 3778 3878 3978 4278 30'

A-B-C 20' 20' Arista Biologicals Inc...... 3656 Biomatik Corporation ...... 1778 EE 1077 1177 1277 1377 1477 1577 1677 1777 1877 1977 2077 2177 2277 2577 2677 2777 2877 2977 3277 3377 3677 3777 3877 3977 4177

A/C Diagnostics LLC ...... 4555 ARK Diagnostics, Inc...... 1122 BioMedica Diagnostics Inc...... 2752 20' 20' 20' 1076 1176 1476 1576 1676 1876 1976 2076 2176 2276 2376 2476 2576 2676 2776 2876 2976 3076 3176 3276 3376 3476 3576 3776 3876 3976 4076 4176 4276 4376 4476 4576 4676 4776 4876 20' 20' 20' 20'

A2LA American Association ARKRAY, Inc...... 2056 Biomerica, Inc...... 4254 UP UP 1075 1175 1275 1375 1475 1575 1675 1775 1875 1975 2075 2175 2275 2375 2475 2575 3675 3775 3875 3975 4075 4175 4275 4375 4475 4575 4675 4775 4875

EE INLINE BOOTHS ONLY for Laboratory ...... 1176 Arlington Scientific Inc...... 4219 bioMerieux Inc ...... 4639 OEM PAVILION INLINE BOOTHS ONLY AACC ...... 1531 Artel ...... 4226 Biomiga, Inc...... 2076 INLINE BOOTHS ONLY EE 1373 1473 1573 1673 1773 2073 2173 2273 2373 2473 2573 3673 3873 3973 4073 4173 4473 4573 4773 FHC FHC FHC FHC FHC FHC

FHEC B 20' A B A 20' 20' B B Artron BioResearch Inc...... 3654 Bioneer Corporation ...... 4648 1272 1372 1472 1572 1672 1772 2172 2272 2372 2472 2572 3672 3772 3872 3972 4072 4172 4472 4572 4772

AAFP- PT ...... 4317 30' 30' FOOD / SEATING AREA FHEC 20' Aalto Scientific, Ltd...... 962 ARUP Laboratories ...... 1235 Bionovation Image Cytometry ...... 3672 1671 1771 2071 2171 2271 2371 2471 2571 3671 3771 3871 3971 4071 4171 4471 4571 4671 4771 EE FOOD / SEATING AREA AB SCIEX ...... 3418 Asahi Kasei Fibers Corporation ...... 4057 BioPorto Diagnostics A/S ...... 2646 SD47 1270 1370 1470 1670 1770 1870 1970 2570 3670 3770 4270 4370 4470 4570 4670 4770 EMERGENCY EXIT EMERGENCY 20' 20' 20' 20' Abbott Diagnostics ...... 2012 ASCLS ...... 1225 Bio-Rad Laboratories ...... EMERGENCY2031 EXIT 1069 1169 1269 1369 1469 1569 1869 1969 2069 2169 2269 2369 2469 2569 3669 3769 3869 3969 4069 4369 4669 20' 20' 20' 20' 20' Abingdon Health ...... 1377 ASCO Numatics ...... 3245 BioreclamationIVT ...... 364 1368 1868 2168 2568 3668 3768 3868 3968 4068 4168 4268 4668 4768

UP 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' UP Accel Biotech, Inc...... 2543 Aspen Med ...... 4175 Bioresource Technology Co. Ltd...... 4362 1067 1167 1267 1367 1467 1567 1667 1867 1967 2067 2167 2267 2367 2467 2567 3667 3767 3867 3967 4067 4167 4267 4367 4467 4667 4767 SD44 UP Access Bio, Inc...... 4753 ASPiRA LABS ...... 663 Bioresource Technology, Inc...... 4652 DOWN DOWN WEST LOBBY DOWN TO DOWN Access Biologicals, LLC ...... 3443 Assaypro ...... 2560 Biosearch Technologies, Inc...... 2753 20' 20' 20' 40' 20' 364 464 864 1064 2564 3664 3864 4064 Accriva Diagnostics, Representing Assoc. for Molecular Pathology ...... 1834 BioSell Solutions ...... 4444 UP UP 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' EE 363 463 563 663 763 863 1863 2463 2563 RECHARGING RECHARGING 3663 3763 3863 3963 4063 4163 4263 4363 4663 4763 30' 30' 1263 1463 30' 30' 2063 STATION 2 STATION 4 4463

ITC and Accumetrics ...... 4612 Associates of Cape Cod ...... 3877 BioSero, LLC ...... 362 20' FHEC 362 862 962 1062 1162 1662 1862 1962 2562 3662 3762 3862 3962 4262 4362 4662 4762 20' 20' 20' 20' 20'

AccuBioTech Co., Ltd...... 2269 Atlas ...... 2077 Biosino Bio-Technology & Science Inc...... 852 20' 361 2061 2161 2461 2561 3661 3761 3861 3961 4061 4461 4561 FE FE EE FHC 20' 20' FHC FHC 20' FHC

Accudynamics LLC ...... 3544 Atlas Link, Inc...... 3076 BiosPacific ...... 1152 20' 20' 20' 20' B A B A B A B 460 1260 1460 2460 2560 3660 3760 3860 3960 4060 4160 4460 4560 30' 30' 9 20' Accumax Lab Technology ...... 4052 Audit MicroControls, Inc...... 1260 Bio-Techne ...... 2469 20' 20' 20' 659 859 1659 2259 3759 4559 4659 SEATING 20' 20' CLOSED 20' ACEA Biosciences, Inc...... 4719 Auer Precision Co...... 4367 biotechrabbit GmbH ...... 4819 20' 20' 20' 8 458 1058 2458 2558 FOOD SERVICE TOWER 3658 3758 4158 4258 4358 4558 30' 20' 20' 81'x142 EXIT EMERGENCY Acktar Ltd...... 4255 Aurora Biomedical ...... 2575 BioTek Instruments ...... 2561 20' 20' 20' 20' 20' 20' 20' 40' CAFE SIGN CAFE SIGN 20' 20' 20' 20' 357 457 557 657 857 1157 1257 1456 1857 1957 3857 4057 4257 4457 4557 4657 4757 4857 HEIGHT 25' HEIGHT 25' 20' 7 20' 20' 20' 20' 20' 20' 20' Acon Laboratories, Inc...... 2256 Aurora Life Sciences ...... 1868 BIT Group ...... 1241 356 656 756 856 1056 1156 1656 1856 2056 2256 2556 2656 2756 3056 3156 3656 3756 4156 4256 4356 4556 4656 4756 30' 20' 20' 20' 20' 20' 20' 20' 20' 20' EE EE Addcare Biotech Co., Ltd...... 3754 AUSBIO R&D Europe ...... 659 Blue Cross Bio-Medical (Beijing) Co., Ltd. ....3759 355 855 955 1055 1955 2655 2755 3155 3455 3555 3655 3855 3955 4055 4255 4355 4455 4555 4855 30' 30' 30' 30' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' ADEMTECH ...... 1819 AutoGenomics ...... 4017 Boditech Med, Inc...... 1771 354 454 1054 1154 1854 2454 2654 2754 2854 2954 3054 3154 3254 3654 3754 3854 3954 4054 4154 4254 4354 4454 4554 4654 4754 30' 20' 40' 40' 20' 20' 20' 1053 1153 1953 2453 2553 2653 2753 3053 3453 3553 3653 3753 4753 4853 Adicon Clinical Laboratory Inc...... 1838 AVE Science & Technology Industrial Co. ...4321 Bomi Group ...... 4268 30' 1653 30' 30'

EE EE FOOD / SEATING 20' 20' 20'

20' 20' 20' 20' 20' 20' AREA 352 652 852 1052 1152 1253 1452 1852 1952 2052 2252 2652 2752 3052 3152 3452 3552 3652 3752 4052 4252 4652 4752 4852

AdvaMed Dx ...... 2071 Aviva Systems Biology Corporation ...... 3776 Boule Medical AB ...... FE 1945 20'

20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' FHEC 451 2451 2551 2851 2951 3051 3151 3251 3351 3651 3851 4051 4151 4351 4451 4851

ADVANCE for Administrators Awareness Technology, Inc...... 1814 Bovogen Biologicals...... SD32 342 20' 20' 20' 20' 30' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' OEM OEM OEM EMERGENCY EXIT EMERGENCY OEM OEM 350 1050 1150 1850 1950 2550 2650 2750 OEM OEM OEM OEM 3450 3550 3650 3750 4050 4150 4250 4350 4850 of the Laboratory ...... 4772 AWEX ...... 1442 Broadmaster Biotech Corp...... 4822 OEM OEM 20' 20' 20' 20' 20' 20' 40'

349 FHC FHC Advanced Instruments, Inc...... 3731 Axxin ...... 1034 BUHLMANN Laboratories AG ...... 3651 30' 30' 30' 30' 30' 30' 30' FHEC FHC FHC FHC FHC FHC FHC 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' Advanced Microdevices Pvt. Ltd...... 4158 Axxin ...... 1810 Burkert Fluid Control Systems ...... 3848 C 448 648 848 D 1248 1448 1648 C 2048 2448 2548 D 2848 3048 3248 C 3648 3748 3848 4048 4148 D 4448 4648 4848 C SD30

Advanced Molecular Systems ...... 1676 B&E Scientific Inc...... 4154 C & A Scientific Co., Inc...... 1953 20' 20' 50' 20' 20' 20' 646 746 846 946 1846 2146 2246 2646 2746 4546

Aesku Diagnostics ...... 4044 Bangs Laboratories/Polysciences ...... 3450 CalBioreagents ...... 3056 EXIT EMERGENCY 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 345 1945 2045 2145 2245 2345 2445 2545 2945 3045 3145 3245 3345 3445 3545 3645 3745 3845 3945 4245 4345 4445 445 30' 30' 1245 1445 30' 30' 4645 4845

Agappe Diagnostics Switzerland GmbH .....2848 Baytree National Bank & Trust Company ....4852 Calbiotech, Inc ...... 3542EE EE 40' 20' 20' 20' 344 1044 1144 1844 2044 2144 2244 2344 2844 2944 3044 3144 3544 3744 4044 4244 4444 4544 30' 20' 20'

Aggredyne, Inc...... 1822 BBI Solutions ...... 2640 Calzyme Laboratories, Inc...... 3758 20' 20' 20' 20' 20' 20' 20' 343 1443 1543 1643 1743 1843 1943 2043 2143 2243 2343 2443 2543 3243 3343 3443 3643 4243

2643 30' 30' 40'

Agilent Technologies, Inc...... 3414 BD ...... 1536 Cambridge Consultants ...... 2536 20' 40' 20' 20' 20' 20' 20' 342 1442 1542 1642 1742 1842 3342 3442 3542 3642 3842 4042 4342 4442 4542

EE EE 442 30' 30' 30' 30' 30' 30' 40' 20' OEM THEATER Ahlstrom Filtration LLC ...... 4250 Beckman Coulter ...... 2812 Cambridge Healthtech Institute ...... 3971 20' 20' 20' 20' 20' 20' 741 1041 1141 1241 1841 1941 2441 2541 3241 3341 3641 3741 4041 4141 4241 4341 50' 40' 20' 20' Ahram Biosystems, Inc...... 2576 Beckman Coulter Life Sciences ...... 3417 Capillary Film Technology ...... 3871 20' 20' 20' 20' 40' 6 1940 2640 3240 3340 3440 3540 4240 4340 40' 30' 20' 20' 40' 20' AIDE Diagnostic Co. Ltd ...... 2876 Beijing Bohui Innovation CapitalBio Corporation ...... 2650 CAFE SIGN CAFE SIGN FE FE

339 30' 30' HEIGHT 25' HEIGHT 25' 4439 4639

Aim Lab Automation Technologies Pty Ltd. .1943 Technology Co., Ltd...... 2075 Capralogics Inc...... 855 20' 40' 20' 20' 20' 20' 20' 40' 40' 20' 20' 20' 5 738 1038 1238 1838 1938 2038 2438 2538 OEM PAVILION 3638 4238 4338 50' 30' 30' 30'

SEATING 30' 20' 30'

ALCOR Scientific Inc...... 1367 Beijing Chemclin Biotech Co., Ltd...... 1670 Capricorn Products LLC ...... 4654 1037 1137 3637 3737 EE EE 3837 4037 FHC FHC FHC FHC

50' 20' 50' UP UP B A B 20' A B A 20' 20' B Alere International ...... 2531 Beijing DDM Technology Co.,Ltd ...... 357 Cardinal Biologicals, Inc...... 3660 1536 2536 4436 4636 30' 30' 20' 20' 20' 20' 20' 20' 20' 20' Alfa Scientific Designs, Inc...... 4853 Beijing Golden Bridge Technology ...... 2563 CARE diagnostica International ...... 3452 435 1235 2435 2535 3635 3735 4335

40' 4234 15' 50' 20' EE EE 1034 1834 Exhibitor Mgt LEAD RETRIEVAL MR 22 Beijing Jyton & Kannel Medical Carolina Liquid Chemistries ...... 1019 30' 30' Algapharma Biotech Corp...... 343 Office 40' 30' 4233 60' 20' 20' 60' 20' 20' 20' 20' 20' 20' 40'

1133 1933 2533 3633 3733 4035 4333 WEST LOBBY WEST LOBBY

50' 50' 4135 Alifax S.p.a...... 442 Tech. Co.,Ltd ...... 1476 Cedarlane ...... SD20 1058

30' 4232 TO DOWN 20' 40' 40' 40' MR 19 MR 20 Allied Media CLP Magazine ...... 4770 Beijing Macro-Union Pharmaceutical ...... 3968 CellaVision AB ...... 1245 30' 30' 30' 30' 20' 20' 20' 20' 20' 20' 20' 20' 20' 331 631 1031 1131 1231 1531 1831 1931 2031 2431 2531 3631 3731 3831 4031 4231 15' 4331 4431 ALPCO Diagnostics ...... 2067 Beijing MDB Co. Ltd...... 2369 Centers for Medicare & Medicaid DOOR UP 20' 20' DOWN DOWN Amano Enzyme USA Co., Ltd...... 3854 Beijing Strong Biotechnologies, Inc...... 3254 Services ...... 127UP MR 17 MR 18 UP SD17 American Board of Clinical Chemistry ...... 1531 Beijing Succeeder Technology Centrak ...... 4257 40' 50' 40' 30' 80' 50' 20' 40' 30'

128 1928 4328 American Medical Technologists ...... 4240 Development Co., Ltd...... 1770 Centurion Scientific Ltd ...... 4572 20' 20' 20' 127 1127 1827 1927 RECHARGING RECHARGING American Proficiency Institute ...... 1659 Beijing Unidiag Technology Co., Ltd...... 2273 Cepheid ...... 3612 30' 30' 30' STATION 1 STATION 3 30' 30' 30' 30' 40' 40' 40' 20' 20' 20' 126 326 1026 1126 1626 1826 1926 4226 4326 4425 MR 15 MR 16 American Screening Corporation ...... 3855 BG Medicine...... 1477 Ceragem Medisys, Inc...... 1133 50' 50' 1225 3625 FHC FHC FHC FHC FHC FHC

30' 40' 20' 20' UP UP

American Society For Clinical BioAssay Works, LLC ...... 2564 Cerilliant ...... 1928 80' A B A B A B B 4025 MR 13 MR 14

30' 624 80' FHEC

Pathology-ASCP ...... 4141 BioChain ...... 2578 Corporation ...... 1667EE EE 123 30' 30' 40' CLOSED 50' 20' 20' 20' Amhyspin ...... 1443 Bio-Chem Fluidics Inc...... 3643 CERTEST BIOTEC S.L...... 4232 40' 1122 1822 FOOD SERVICE TOWER 4022 4122 4422 4822 MR 27 MR 11 MR 12 30' EMERGENCY EXIT EMERGENCY FE FE Analis s.a...... 1543 BIOCLIN ...... 3955 CETICS Healthcare Technologies GmbH ...2177 20' 81'x142' 20' 20' 20' 1121 1821 4221 4321 4821 421 621 1221 30' 2021

EE EE 20' 80' 20' 20' 20' 20' 20' Analytical Sales & Services ...... 2244 BioDot, Inc...... 3550 Chek Diagnostics ...... 4445 40' 1820 1920 4320 4820 MR 26 MR 9 MR 10 50' 50'

EE EE 30' 70' 80' BioFire Diagnostics, Inc...... 1257 Chembio Diagnostic Systems, Inc...... 2451 20' 20' 20' 20' Analyticon Biotechnologies ...... 448 1019 1819 4219 4619 4719 4819 30' 30' 80' 20' 20' 20' 20' 40' 40' 20' 20' 40' Ansh Labs, LLC ...... 352 Biofortuna Ltd...... 3154 Chengdu Rich Science Industry Co., Ltd ....3869 1118 1918 3418 4318 4818 MR 25 MR 7 MR 8

30' 3618 20' 20' 60' 60' 20'

Anteo Diagnostics ...... 3642 BioHit OYJ ...... 4546 China Medical City ...... 4173EE EE 317 1817 3417 3517 4017 4217 4317 4417 4617 4817 50' 20' 20' 20' 20' Biokit ...... 4135 Chinese Association for Clinical 4316 4816 MR 24 MR 5 MR 6 Apacor Ltd...... 3670 90' 20' 20' 20' 60' 40' 20' FE FE 4815

50' 30' 70' 2618 30' 4615 Laboratory Provider ...... 41773 INDUSTRY WORKSHOP THEATER 20' 20' 20' 20' 20' 20' 1814 1914 3414 4214 4314 4814 MR 23 MR 3 MR 4 Chongqing Tianhai Medical Equipment Co. ..4318 110' 110' 50' 50' 20' 40' 40'

3 1013 1113 4813 FE

Chromsystems GmbH ...... 1127 FHC FHC FHC FHC

20' 20' UP UP B A B A B A 20' B 2012 2812 3612 4012 4412 4612 4812 MR 1 MR 2 Chungdo Pharm. Co. Ltd...... 2079 EMERGENCY EMERGENCY

Exhibit Hall Hours EXIT 2 INLINE BOOTHS ONLY CKD USA Corp...... 4768 50' Clemex ...... 2073 1810

20' 20' 20' 20' 11'2"W x 13'7"H 13'7"H x x 11'2"W 11'2"W

ROLL UP DOOR UP ROLL 1 DOOR UP ROLL

Tuesday WEST LOBBY

509 1009 1109 1209 1809 1909 2009 ONE LEVEL TO/FROM TO/FROM EE EE WEST BUILDING WEST BUILDING Cleveland Clinic Laboratories ...... 1827 TOTO McCORMICKMcCORMICK 9:30 am – 5:00 pm Clinical and Laboratory Standards Inst...... 1031 POSTER BOARDS ENTRANCE Clinical Omics & GEN ...... 4771 INLINE BOOTHS ONLY INLINE BOOTHS ONLY EMERGENCY

Wednesday EE EE CLINIQA Corporation ...... EXIT 1050 M W SD1 9:30 am – 5:00 pm CLTech Corp...... 1463 REGISTRATION Thursday COBIO Smarter Healthcare Technology ...... 356 Cognex Corporation ...... 4150 9:30 am – 2:00 pm COLA ...... 1054 ➨ ➨ ENTRANCEFHC FHC FHC A B A OPENING B A

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SD62 The Official Publication of the AACC Annual Meeting & Clinical Lab Expo FE FHC FHC FHC FHC FHC

B B B B B EE EMERGENCY EXIT EMERGENCY EE

20' OEM OEM OEM 11 OEM OEM OEM 1479 1679 1779 1879 1979 2079 2179

10 20' 20' 20' 1078 1178 1278 1378 1478 1578 1678 1778 2078 2178 2378 2478 2578 2678 2778 3678 3778 3878 3978 4278 30' 20' 20' EE 1077 1177 1277 1377 1477 1577 1677 1777 1877 1977 2077 2177 2277 2577 2677 2777 2877 2977 3277 3377 3677 3777 3877 3977 4177 20' 20' 20' 1076 1176 1476 1576 1676 1876 1976 2076 2176 2276 2376 2476 2576 2676 2776 2876 2976 3076 3176 3276 3376 3476 3576 3776 3876 3976 4076 4176 4276 4376 4476 4576 4676 4776 4876 20' 20' 20' 20'

1075 1175 1275 1375 1475 1575 1675 1775 1875 1975 2075 2175 2275 2375 2475 2575 3675 3775 3875 3975 4075 4175 4275 4375 4475 4575 4675 4775 4875 UP

EE INLINE BOOTHS ONLY OEM PAVILION INLINE BOOTHS ONLY

INLINE BOOTHS ONLY

EE 1373 1473 1573 1673 1773 2073 2173 2273 2373 2473 2573 3673 3873 3973 4073 4173 4473 4573 4773 FHC FHC FHC FHC

FHEC B 20' A B A 20' B B 1272 1372 1472 1572 1672 1772 2172 2272 2372 2472 2572 3672 3772 3872 3972 4072 4172 4472 4572 4772 FOOD / SEATING AREA 30' FHEC 20' 1671 1771 2071 2171 2271 2371 2471 2571 3671 3771 3871 3971 4071 4171 4471 4571 4671 4771 EE FOOD / SEATING AREA SD47 1270 1370 1470 1670 1770 1870 1970 2570 3670 3770 4270 4370 4470 4570 4670 4770 EMERGENCY EXIT EMERGENCY 20' 20' 20' 20' EMERGENCY EXIT 1069 1169 1269 1369 1469 1569 1869 1969 2069 2169 2269 2369 2469 2569 3669 3769 3869 3969 4069 4369 4669 20' 20' 20' 20' 20' 1368 1868 2168 2568 3668 3768 3868 3968 4068 4168 4268 4668 4768

UP 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' UP 1067 1167 1267 1367 1467 1567 1667 1867 1967 2067 2167 2267 2367 2467 2567 3667 3767 3867 3967 4067 4167 4267 4367 4467 4667 4767

SD44 UP

DOWN DOWN WEST LOBBY DOWN TO DOWN 20' 20' 20' 40' 20'

364 464 864 1064 2564 3664 3864 4064 UP 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' EE 363 463 563 663 763 863 1863 2463 2563 RECHARGING RECHARGING 3663 3763 3863 3963 4063 4163 4263 4363 4663 4763 30' 30' 1263 1463 30' 30' 2063 STATION 2 STATION 4 4463

FHEC 20' 362 862 962 1062 1162 1662 1862 1962 2562 3662 3762 3862 3962 4262 4362 4662 4762 20' 20' 20' 20' 20' 20'

361 2061 2161 2461 2561 3661 3761 3861 3961 4061 4461 4561 FE EE FHC 20' 20' FHC FHC 20' FHC B 20' A 20' 20' B A B 20' A B 460 1260 1460 2460 2560 3660 3760 3860 3960 4060 4160 4460 4560 30' 30' 9 20' 20' 20' 20' 659 859 1659 2259 3759 4559 4659 SEATING 20' 20' CLOSED 20' 20' 20' 20' 8 458 1058 2458 2558 FOOD SERVICE TOWER 3658 3758 4158 4258 4358 4558 30' 20' 20' 81'x142 EXIT EMERGENCY 20' 20' 20' 20' 20' 20' 20' 40' CAFE SIGN CAFE SIGN 20' 20' 20' 357 457 557 657 857 1157 1257 1456 1857 1957 3857 4057 4257 4457 4557 4657 4757 4857 HEIGHT 25' HEIGHT 25' 20' 7 20' 20' 20' 20' 20' 20' 356 656 756 856 1056 1156 1656 1856 2056 2256 2556 2656 2756 3056 3156 3656 3756 4156 4256 4356 4556 4656 4756 30' 20' 20' 20' 20' 20' 20' 20' 20' 20' EE 355 855 955 1055 1955 2655 2755 3155 3455 3555 3655 3855 3955 4055 4255 4355 4455 4555 4855 30' 30' 30' 30' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 354 454 1054 1154 1854 2454 2654 2754 2854 2954 3054 3154 3254 3654 3754 3854 3954 4054 4154 4254 4354 4454 4554 4654 4754 30' 20' 40' 40' 20' 20' 20' 1053 1153 1953 2453 2553 2653 2753 3053 3453 3553 3653 3753 4753 4853

30' 1653 30' 30'

EE FOOD / SEATING 20' 20' 20'

20' 20' 20' 20' 20' AREA 352 652 852 1052 1152 1253 1452 1852 1952 2052 2252 2652 2752 3052 3152 3452 3552 3652 3752 4052 4252 4652 4752 4852 FE 20'

20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' FHEC 451 2451 2551 2851 2951 3051 3151 3251 3351 3651 3851 4051 4151 4351 4451 4851 SD32 20' 20' 20' 20' 30' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' OEM OEM EMERGENCY EXIT EMERGENCY OEM 350 1050 1150 1850 1950 2550 2650 2750 OEM OEM 3450 3550 3650 3750 4050 4150 4250 4350 4850 OEM 20' 20' 20' 20' 20' 20' 40'

349 FHC FHC 30' 30' 30' 30' 30' 30' 30' FHEC FHC FHC FHC 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' C 448 648 848 D 1248 1448 1648 C 2048 2448 2548 D 2848 3048 3248 C 3648 3748 3848 4048 4148 D 4448 4648 4848 C SD30

20' 20' 50' 20' 20' 20' 646 746 846 946 1846 2146 2246 2646 2746 4546 EMERGENCY EXIT EMERGENCY 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 20' 345 1945 2045 2145 2245 2345 2445 2545 2945 3045 3145 3245 3345 3445 3545 3645 3745 3845 3945 4245 4345 4445 445 30' 30' 1245 1445 30' 30' 4645 4845

EE 40' 20' 20' 20' 344 1044 1144 1844 2044 2144 2244 2344 2844 2944 3044 3144 3544 3744 4044 4244 4444 4544 30' 20' 20' 20' 20' 20' 20' 20' 20' 343 1443 1543 1643 1743 1843 1943 2043 2143 2243 2343 2443 2543 3243 3343 3443 3643 4243

2643 30' 40' 20' 40' 20' 20' 20' 20' 342 1442 1542 1642 1742 1842 3342 3442 3542 3642 3842 4042 4342 4442 4542

EE 442 30' 30' 30' 30' 30' 40' 20' OEM THEATER 20' 20' 20' 20' 20' 20' 741 1041 1141 1241 1841 1941 2441 2541 3241 3341 3641 3741 4041 4141 4241 4341 50' 40' 20' 20' 20' 20' 20' 40' 6 1940 2640 3240 3340 3440 3540 4240 4340 40' 30' 20' 20' 40' 20'

CAFE SIGN CAFE SIGN FE

339 30' 30' HEIGHT 25' HEIGHT 25' 4439 4639 20' 40' 20' 20' 20' 20' 20' 40' 20' 20' 5 738 1038 1238 1838 1938 2038 2438 2538 OEM PAVILION 3638 4238 4338 50' 30' 30'

SEATING 30' 20' 30'

1037 1137 3637 3737 EE 3837 4037 FHC FHC FHC FHC

50' 20' 50' UP B A B 20' A B A 20' 20' B 1536 2536 4436 4636 30' 30' 20' 20' 20' 20' 20' 20' 20' 435 1235 2435 2535 3635 3735 4335

40' 4234 15' 50' 20' EE 1034 1834 Exhibitor Mgt LEAD RETRIEVAL MR 22 Office 30' 30' 40' 30' 4233 60' 20' 20' 60' 20' 20' 20' 20' 40'

1133 1933 2533 3633 3733 4035 4333 WEST LOBBY

50' 4135 SD20

30' 4232 TO DOWN 20' 40' 40' 40' MR 19 MR 20 30' 30' 30' 30' 20' 20' 20' 20' 20' 20' 20' 331 631 1031 1131 1231 1531 1831 1931 2031 2431 2531 3631 3731 3831 4031 4231 15' 4331 4431 DOOR UP 20' 20' DOWN DOWN UP MR 17 MR 18

UP SD17 40' 50' 40' 30' 80' 50' 20' 40' 30'

128 1928 4328 20' 20' 20' 127 1127 1827 1927 RECHARGING RECHARGING 30' 30' 30' STATION 1 STATION 3 30' 30' 30' 40' 40' 20' 20' 126 326 1026 1126 1626 1826 1926 4226 4326 4425 MR 15 MR 16 50' 50'

1225 3625 FHC FHC FHC FHC

30' 40' 20' 20' UP A B A 80' B A B B 4025 MR 13 MR 14

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EE 30' 70' 80' 20' 20' 20' 1019 1819 4219 4619 4719 4819 30' 30' 80' 20' 20' 20' 20' 40' 40' 20' 40' 1118 1918 3418 4318 4818 MR 25 MR 7 MR 8

30' 3618 20' 20' 60' 20'

EE 317 1817 3417 3517 4017 4217 4317 4417 4617 4817 50' 20' 20' 20' 20'

4316 4816 MR 24 MR 5 MR 6 90' 20' 20' 20' 60' 40' 20' FE 4815

50' 30' 70' 2618 30' 4615 4 INDUSTRY WORKSHOP THEATER 20' 20' 20' 20' 20' 1814 1914 3414 4214 4314 4814 MR 23 MR 3 MR 4 110' 110' 50' 20' 40' 40'

3 1013 1113 4813 FE FHC FHC FHC FHC

20' 20' UP B A B A B A 20' B 2012 2812 3612 4012 4412 4612 4812 MR 1 MR 2 EMERGENCY

2 EXIT INLINE BOOTHS ONLY 50' 1810

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11'2"W x 13'7"H x 11'2"W 1 DOOR UP ROLL WEST LOBBY

509 1009 1109 1209 1809 1909 2009 ONE LEVEL TO/FROM EE WEST BUILDING TO McCORMICK POSTER BOARDS ENTRANCE INLINE BOOTHS ONLY INLINE BOOTHS ONLY EMERGENCY EE EXIT M W SD1 REGISTRATION ➨ ENTRANCEFHC FHC A B A OPENING B A

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UP ENTRANCE ARA FEC FHEC FHEC FLOOR PLAN SUBJECT TO CHANGE WITHOUT NOTICE PAGE B-14 Monday, July 28, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo

Enzyme Research Labs/DSM Pentapharm ...4042 Hoover Precision Products, LLC ...... 3476 LabMedica International / Globetech Media ....126 Exhibitors Eppendorf North America ...... 1909 HORIBA Medical ...... 2063 LabProducts, Inc...... 2373 ›› from page B-12 Equitech-Bio, Inc...... 1673 HRA Healthcare Research & Analytics ...... 1577 Labroots, Inc...... 4241 ERBA Diagnostics ...... 4412 HTL-Strefa Inc...... 1573 Labtest...... 451 College of American Pathologists ...... 1626 Eurofins Genomics...... 1576 Hycor Biomedical Inc...... 2048 LabThruPut ...... 1372 CompuGroup Medical ...... 4439 Euroimmun US ...... 4857 HyTest ...... 3631 LABVANTAGE Solutions ...... 1875 Conductive Technology ...... 3345 EUROPEAN HOSPITAL ...... 4773 I.W. Tremont ...... 4669 Lakeland Regional Medical Center...... 1078 Cone Bioproducts ...... 1473 Eurospital ...... 3760 i2a (intelligence artificielle applications) ...... 4075 Lampire Biological Laboratories, Inc...... 746 Conworx Data Solutions America, Inc...... 1375 Eurotrol, Inc...... 1144 IBL- International Corp...... 4455 Landwind Medical ...... 4221 Copan Diagnostics, Inc...... 1263 Evergreen Scientific ...... 1169 IBL-America ...... 4754 LasX /MicroMed Solutions ...... 1567 Core Technology Co., Ltd ...... 2553 EXBIO Praha, a.s...... 3377 IDEX Health & Science ...... 3054 LGP Consulting, Inc...... 2161 Corgenix Medical Corporation ...... 3735 Excel Scientific, Inc...... 3664 IDG Sanzay Corp ...... 345 Life Technologies ...... 3145 Coris Bioconcept ...... 1542 Express Diagnostics ...... 1967 IFCC International Federation of Clinical Liferiver Bio-Tech (United States) Corp...... 3750 Corning Incorporated ...... 3861 Fabrico Medical ...... 3878 Chemistry and Laboratory Medicine ...... 123 LifeSign ...... 3945 Corvalent ...... 4263 Fameco Medical Instruments Sarl ...... 4470 IKO International, Inc...... 3962 LinkTech Couplings ...... 1269 Covaris, Inc...... 2562 Fapon Biotech Inc...... 4461 Iline Microsystems ...... 4238 Liposcience ...... 648 Coyote Bioscience ...... 2655 Festo Corporation ...... 2569 ILS Innovative Labor Systeme GmbH ...... 3775 Liuyang Medical Instrument Factory...... 3655 Creative Laboratory Products Inc...... 2854 Fio Corporation ...... 4851 Immucor ...... 1231 Lohmann Precision Die Cutting ...... 1955 Cross Country TravCorps Allied ...... 1178 Fitzgerald Industries Int’l ...... 4363 Immundiagnostik AG ...... 1131 LPS Industries, LLC ...... 3176 CSP Technologies ...... 2460 FlexLink Systems, Inc...... 4217 Immuno Concepts ...... 3737 LRE Medical, an Esterline Company ...... 1456 CTK Biotech, Inc...... 1962 Fluid Metering, Inc...... 2746 Immunodiagnostic Systems ...... 1445 LSI International Inc...... 3652 Curetis AG ...... 1270 Focus Diagnostics, Inc...... 848 Immunology Consultants Laboratory, Inc. ...4667 Luminex ...... 738 CytoTest, Inc...... 2178 Foliage...... 1569 ImmunoReagents, Inc...... 4122 Lumora Ltd ...... 4544 D-E-F Formulatrix, Inc...... 4767 Immunostics Inc...... 4256 M-N-O DAAN Gene Co., Ltd. of Sun Yat-sen Fraunhofer ICT-IMM...... 1675 IMRA America Inc...... 4171 MagArray, Inc...... 4172 University ...... 1154 FUJIFILM Corporation ...... 463 in.vent Diagnostica GmbH ...... 4820 Magellan Diagnostics, Inc...... 4252 Dako Denmark A/S ...... 3576 Fujirebio Diagnostics, Inc...... 326 InBios International, Inc...... 344 MagnaBioSciences ...... 4022 DAS Srl ...... 4258 Fusion Medical Staffing ...... 1777 InDevR, Inc...... 3155 MagnaMedics ...... 3961 Data Innovations LLC ...... 1137 G-H-I Infopia Co., Ltd...... 4156 Magnisense ...... 3152 Deltalab ...... 4233 GA Generic Assays GmbH ...... 4816 InformedDNA ...... 1278 Magnolia Medical Technologies ...... 4561 Denka Seiken Co., Ltd...... 2052 Gale Force Software Corporation ...... 2944 Innova Biosciences ...... 4069 Magsphere Inc...... 3650 DenLine Uniforms, Inc...... 3667 GE Healthcare ...... 1941 Innovative BioSystems, Inc...... 2343 Maine Biotechnology Services ...... 3748 Desert Biologicals/Omega Biologicals ...... 3156 Gems Sensors & Controls ...... 2463 Innovize ...... 1779 Maine Manufacturing, LLC...... 3658 Dexter Magnetic Technologies...... 2676 General Biologicals Corporation ...... 4645 INOVA Diagnostics, Inc...... 4031 Maine Standards Co. LLC...... 4619 DFI Co., Ltd...... 4073 Genetic Information Management Instrumentation Laboratory (IL) ...... 3831 MAKER Biotechnology ...... 859 Dia & Med (Beijing) Laboratories Co. Ltd. ...4041 Systems ...... 2271 InTec Products, Inc...... 4448 MATEST Systemtechnik GmbH ...... 2951 DiaCarta ...... 3662 GenMark Diagnostics, Inc...... 350 Integra Biosciences (ViaFlo) ...... 1157 Mayo Medical Laboratories...... 3857 diaDexus Inc ...... 4071 Genolution ...... 3675 International Immuno-Diagnostics ...... 2146 MBio DIAGNOSTICS, INC...... 4067 Diagam ...... 1842 GenomeWeb LLC ...... 4177 International Immunology Corporation ...... 2545 MBL International ...... 2443 DiagCor Bioscience Incorporation Limited ....4358 Genova Diagnostics ...... 1064 Interstate Blood Bank, Inc ...... 1877 McKesson Corporation ...... 2438 Diagnostic Automation/ GenPrime Inc...... 2572 Interstate Specialty Products ...... 4557 MediaLab, Inc...... 1126 Cortez Diagnostics ...... 1275 GenWay Biotech, Inc...... 2755 Invetech ...... 1653 Medica 2014/Messe Duesseldorf Diagnostic Consulting Network, Inc...... 2844 Getein Biotechnology Co., Ltd ...... 4176 Ionics Mass Spectrometry Group ...... 355 North America ...... 4855 Diagnostica Stago, Inc...... 3625 Gilson, Inc...... 3555 IQuum, Inc...... 1841 Medica Corporation ...... 2252 Diagnostics Biochem Canada Inc...... 1062 Global Bioingredients Inc ...... 4267 ISTAT Biomedical Co. Inc...... 3341 Medical Device Safety Service GmbH ...... 4350 DiagnostikNet-BB e.V...... 4818 Globe Scientific Inc...... 955 it4ip s.a...... 1843 Medical Electronic Systems, LLC ...... 1775 DIALAB GmbH ...... 1952 GMbiolab Co., Ltd...... 1369 ITSP Solutions Inc...... 2577 Medical Laboratory Evaluation ...... 3744 Diametra ...... 3673 Gold Standard Diagnostics ...... 1914 IVD Industry Connectivity Consortium ...... 2378 Medical Research Networx, LLC ...... 2276 Diamond Diagnostics Inc...... 4338 Golden West Biologicals, Inc...... 3635 IVD Technologies ...... 3753 MedicalLab Management Magazine ...... 2453 DIARECT AG ...... 1940 GoMolecular.com (Abbott Molecular) ...... 1671 Iwaki America Inc...... 3638 MediSensor, Inc...... 1370 DIAsource Immuno Assays S.A...... 1743 Greiner Bio-One, Inc...... 1648 J-K-L Medix Biochemica ...... 1150 DiaSys Diagnostic Systems GmbH ...... 3251 Grifols ...... 1452 JACLaS (Japanese Association of Clinical MedMira Inc...... 2143 Diatron ...... 1118 GSI Technologies ...... 4369 Laboratory Systems) ...... 2277 MedQuery. Inc...... 4375 Diazyme Laboratories ...... 1238 Guangzhou Improve Medical Instruments ....1013 JADAK ...... 4663 MedTest ...... 3517 DIBA Industries, Inc...... 3645 H & H System, Inc...... 2167 Jant Pharmacal Corp...... 3770 MedTox Diagnostics, Inc...... 4576 Diener Precision Pumps LP ...... 4845 Haemonetics Corporation ...... 763 Jei Daniel Biotech Corp...... 4068 Meridian Bioscience, Inc...... 1918 Dierks & Bohle ...... 4818 Hamilton Co ...... 339 Jiangsu Kangjian Medical Apparatus Co. ....1470 Meridian Life Science, Inc...... 2435 DIESSE Diagnostica Senese S.p.A ...... 4615 Hangzhou Bioer Technology Co., Ltd...... 1977 Jiangsu Kangjie Medical Devices Co., Ltd ....4072 Michigan Diagnostics, LLC ...... 4467 Digireco Corporation ...... 3978 Hangzhou Deangel Biological Jinhua YIDI Medical Appliance Co., Ltd...... 2371 Micobiomed Co., Ltd...... 1373 Dino-Lite Scopes (BigC) ...... 3051 Engineering Co., Ltd ...... 2776 JSR Life Sciences ...... 3044 Microbiologics ...... 1575 Dirui Industrial Co., LTD ...... 1253 Hardy Diagnostics ...... 1821 Kamiya Biomedical Company ...... 1831 Microbix Biosystems Inc...... 2573 Dongsheng Biotech Co., Ltd...... 4575 Harlan Bioproducts for Science, Inc...... 4341 KANEKA Corporation ...... 3240 MicroDigital Co., Ltd...... 2473 Douglas Scientific ...... 652 hc1.com ...... 2175 Kawasumi Laboratories America, Inc...... 1167 MicroDiscovery GmbH ...... 4819 Dr. Fooke Laboratorien GmbH ...... 4813 Healgen Scientific LLC ...... 1467 Kawator ...... 4471 Microflex ...... 1969 DRG International, Inc...... 2431 Health Gene Technologies Ltd...... 4659 Kem-En-Tec Diagnostics ...... 646 microfluidic ChipShop GmbH ...... 2550 Drucker Diagnostics ...... 2945 Heathrow Scientific ...... 4812 Kestrel Biosciences LLC ...... 3860 Micropoint Bioscience, Inc...... 1153 Drummond Scientific Co...... 3864 Hebei Bio-High Technology Deve Co. Ltd. ....3376 Kewaunee Scientific Corporation ...... 2267 Microscan ...... 2652 D-Tek ...... 1643 Hebei Xinle Sci. and Tech Co., Ltd...... 4048 Key Tech...... 1055 Midland BioProducts Corp ...... 4243 Dxterity Diagnostics ...... 2171 Helena Laboratories Corporation ...... 1113 Kikkoman Biochemifa Company ...... 1472 MiniFab ...... 656 Dynex Technologies Inc...... 1038 HELMER ...... 3842 Kinbio Tech. Co., Ltd ...... 2467 MiniGrip ...... 1927 EastCoast Bio, Inc...... 3151 HemaCore LLC ...... 1077 Kinematic Automation Inc ...... 3048 Minitubes ...... 3648 Edan Instruments, Inc...... 3863 Hemosure ...... 2533 KMC Systems Inc...... 3741 Mitsubishi Chemical USA, Inc...... 2045 Egemin Automation, Inc...... 4214 Hettich ...... 3248 KMI Diagnostics, Inc...... 4756 MK Fluidic Systems ...... 4167 ELGA Labwater ...... 4345 Hipro Biotechnology Co.,Ltd ...... 3763 KNF Neuberger Inc...... 4328 MLO-Medical Laboratory Observer ...... 2472 Elitech Group Company ...... 741 Hitachi Chemical Diagnostics ...... 3867 KogeneBiotech Co., Ltd ...... 4060 Moduline Systems, Inc...... 4050 Elkay Plastics ...... 3343 Hi-Tech Manufacturing, LLC ...... 1075 Kova International, Inc...... 349 Monobind Inc...... 1950 ELMI North America ...... 1156 Hochuen International Corp ...... 3976 KRONUS, Inc...... 1931 Moss, Inc...... 3144 EMD Millipore ...... 4457 Hologic, Inc...... 4012 LabCorp ...... 1656 Emergo Group, Inc...... 3756 Holomic LLC...... 2043 LABiTec GmbH ...... 3351 ›› see page B-15 TUESDAY, JULY 29, 2014 Monday, July 28, 2014 PAGE B-15

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo

Plasma Services Group ...... 3053 Shandong Yaohua Medical Device thinXXS Microtechnology AG ...... 2571 Exhibitors PlatinumCode ...... 4848 Technology Co., Ltd ...... 2044 Tianjin Era Biology ...... 1460 ›› from page B-14 Plexus...... 4355 Shanghai Chemtron Biotech Co., Ltd...... 1578 Titertek-Berthold Inc...... 3653 PolyAn GmbH ...... 4817 Shanghai Fosun Long March Tokyo Boeki Machinery Ltd...... 4076 Motorola Solutions Inc...... 2678 Polymed Therapeutics, Inc...... 4370 Medical & Science Co. Ltd...... 4326 Tosoh Bioscience ...... 4425 MP Biomedicals ...... 1267 Polymedco, Inc...... 1041 Shanghai Kehua Bioengineering Co., Ltd. ..4063 Toyobo Co. Ltd ...... 4333 MT Promedt Consulting GmbH ...... 4454 PolyMicrospheres ...... 3442 Shanghai Upper Biotech Pharma Co., Ltd. ..3772 Trajan Scientific and Medical ...... 4275 Multisorb Technologies ...... 4436 Pozzetta Scientific ...... 3752 Shel Lab (Sheldon Manufacturing Inc.) ...... 4656 Tricontinent ...... 657 Nanchang Ganda Medical Devices Co., Ltd ...1677 Praemeta GmBH & Co. KG ...... 1879 Shenyang Academy of Instrumentation Trina Bioreactives AG ...... 1852 Nanjing Perlove Medical Precision Converting Solutions, LLC ...... 4542 Science Co., Ltd...... 4657 Trinity Biotech...... 4636 Equipment Co. Ltd ...... 4061 Precision for Medicine ...... 464 Shenzhen Emperor Electronic Technology ...3453 TubeWriter ...... 563 Nanobiosys ...... 1869 Precision Systems Inc...... 1854 Shenzhen Genius Electronics Co., Ltd...... 3963 TWD TradeWinds, Inc...... 4460 nanoComposix ...... 1870 Preco, Inc...... 1053 Shenzhen iCubio Biomedical U-V Nano-Ditech Corporation ...... 2272 Premold Corp ...... 4752 Technology Co ...... 2653 U.S. Export Pavilion ...... 1109 Nanosphere...... 3671 Primer Design Ltd...... 1475 Shenzhen Lifotronic UCLA Health System ...... 4340 NanoString Technologies ...... 2461 Princeton Biomeditech Corp ...... 3845 Technology Co., Ltd...... 4556 UCP Biosciences, Inc...... 862 NanTong HaiLun Bio-Medical Proliant Health and Biologicals ...... 846 Shenzhen Maxchemtech Co., Ltd...... 2471 UNICO/United Products & Instruments ...... 4668 Apparatus Manufacturing Co. Ltd...... 3973 Proton Onsite ...... 1469 Shenzhen Mindray Bio-Medical Uniconnect ...... 2078 National Institute of Standards Puritan Medical Products ...... 1957 Electronics ...... 3618 Union Medical & Pharmaceutical and Technology (NIST) ...... 2458 PZ CORMAY S.A...... 4617 Shenzhen New Industries Biomedical Technology (Tianjin) Group ...... 1052 National Registry of Certified Chemists ...... 128 Qarad ...... 2478 Engineering Co. Ltd. (SNIBE Co. Ltd.) .....4417 United Bioresearch, Inc...... 1672 Neogen Corporation...... 4054 QIAGEN Lake Constance GmbH ...... 3862 Shenzhen Prokan Electronics Inc...... 3663 URIT Medical Electronic Co., Ltd...... 3851 New England Small Tube ...... 2656 Qingdao Hightop Biotech Co., Ltd...... 2654 Shenzhen Xilaiheng Medical Electronics ....3661 US Diagnostics ...... 2246 NewScen Coast Bio-Pharmaceutical QualTex Laboratories ...... 4875 Shenzhen Zhonghe Headway Bio-Sci UTAK Laboratories, Inc...... 4314 Co.,Ltd ...... 4558 Quansys Biosciences ...... 3241 & Tech Co., Ltd...... 1820 V & P Scientific, Inc...... 4262 Nichirei Biosciences, Inc...... 1862 Quanterix ...... 4356 Si02 Medical Products ...... 2375 VACUTEST KIMA srl ...... 2376 Nichiryo America Inc...... 4775 Quantimetrix Corporation ...... 756 Sias AG ...... 2454 Valumax Protective Apparel Inc ...... 946 Nikon Instruments Inc...... 4064 QuantiScientifics LLC...... 3553 Siemens Healthcare Diagnostics ...... 509 VEDALAB...... 4270 Ningbo Purebio Biotechnology Co., Ltd...... 863 Quidel Corporation ...... 445 sifin diagnostics gmbh...... 4814 Viewics, Inc...... 4354 NOEMALIFE SpA ...... 1121 Radiometer America ...... 331 Sigma-Aldrich ...... 458 ViraLab Inc ...... 1277 NOF America Corporation ...... 2977 Ral Tecnica Para El Laboratorio, S.A...... 4234 Sigma-Aldrich ...... 460 Vircell S.L...... 4231 Nor-Lake Scientific ...... 1867 Randox Laboratories...... 631 Simport Scientific ...... 557 ViroStat, Inc...... 4850 Nova Biologics, Inc...... 2568 Randox Life Sciences ...... 1037 Singulex ...... 1826 Visiun ...... 4763 Nova Biomedical Corporation ...... 2618 Rayto Life & Analytical Sinnowa Medical Science Viva Products, Inc...... 1863 Novatec Immundiagnostica GmbH ...... 2750 Sciences Co, Ltd ...... 4245 & Technology Co., Ltd...... 2570 Volpi ...... 2777 Novodiax, Inc ...... 3769 R-Biopharm ...... 2851 SLR Research Corporation ...... 2548 Vonco Products ...... 3975 Nuaire, Inc ...... 2448 Reed Sinopharm Exhibitions Co., Ltd...... 1976 SMC Biosolutions ...... 1572 VWR International ...... 4151 Oak Ridge Products, LLC ...... 3767 Rees Scientific Corp ...... 3777 SMC Corporation of America ...... 3837 W-X-Y-Z Ohaus Corporation...... 4473 Renown Health ...... 2173 SMC Ltd...... 363 Wako Diagnostics ...... 1926 OJ Bio Ltd ...... 4560 Repado ...... 2245 Softtech Health...... 1850 WAMA Diagnostica ...... 2567 Olympus America Inc...... 4316 Response Point of Care ...... 4451 Sol-Millennium Medical Inc...... 3876 Warde Medical Laboratory ...... 4476 Omega Bio-tek ...... 3340 Retractable Technologies, Inc...... 4472 Sony DADC ...... 4351 Waters Corporation ...... 621 Omega Diagnostics Group PLC ...... 3445 Rheonix, Inc...... 1009 Spark Holland B.V...... 4463 Watson Bio Lab ...... 4376 Omnipharma (Pty) Ltd ...... 3972 Risewell Industries Co., Ltd ...... 1368 Sparton Medical ...... 1662 WEIDMANN MEDICAL OMNIPrint, Inc...... 3637 RND Group, Inc., The ...... 2061 SPEware Corporation ...... 3276 TECHNOLOGY AG ...... 4762 OncoDNA ...... 1642 Roche Diagnostics ...... 1209 Spherotech, Inc...... 3668 Werfen Group...... 4035 Oncolab, Inc...... 4051 Roche Diagnostics ...... 2009 Spinreact ...... 4331 WesTgard QC, Inc...... 4320 OPERON S.A...... 4335 Rockland Immunochemicals Inc...... 3677 Staff Icons - Clinical Scientist Wheaton Industries ...... 454 OPTI Medical Systems ...... 1846 ROHM CO., Ltd...... 857 Recruitment Division ...... 2243 WHPM Inc ...... 2535 OptiGene Limited ...... 4244 Rotek Industries ...... 3762 Stanbio Laboratory ...... 1933 Wi Inc...... 4570 opTricon Gmbh ...... 4821 Runlab Labware Mfg. Co., Ltd ...... 3967 STRATEC Biomedical AG...... 4037 Wiener Laboratorios SAIC ...... 1044 OraSure Technologies ...... 1809 S-T Stratos Product Development ...... 2441 Wisepac Active Packaging Orchard Software ...... 1026 SA Scientific LTD ...... 3052 Streck, Inc...... 1920 Components Co., ...... 1876 Orchard Software ...... 4422 Sakae Corporation ...... 2345 Sunostik Medical Technology Co., Ltd...... 4168 Wondfo USA...... 2551 Orla Protein Technologies, LTD ...... 4559 Samsung ...... 2259 Sunquest Information Systems ...... 4431 Worthington Biochemical Corporation ...... 3641 Orochem Technologies Inc...... 2677 Sansure Biotech, Inc...... 2754 Super Brush LLC ...... 3342 WSLH PT ...... 3771 Ortho Clinical Diagnostics ...... 624 SARSTEDT ...... 2038 SurModics IVD ...... 1938 Wuhan Huamei Biotech Co., Ltd ...... 4573 OSMUNDA Group ...... 3872 Sartorius Stedim Biotech ...... 2954 Swisslog ...... 4757 Wuxi Guosheng Bio-Engineering Co., Ltd. ...4662 Owen Mumford ...... 2144 Scantibodies Laboratory Inc...... 3545 Syntron Bioresearch, Inc...... 2538 Xemabio LLC ...... 3875 OWL Metabolomics ...... 2176 SCC Soft Computer ...... 1248 Sysmex ...... 2021 Xi’an Tianlong Science and OYC Americas, Inc...... 2558 Scienion AG ...... 4815 Sysmex Corporation ...... 2344 Technology Co., Ltd...... 2168 Oyster Bay Pump Works, Inc...... 4148 Scienion US, Inc...... 3440 Taigen Bioscience Corporation ...... 4055 Yaskawa America/Motoman P-Q-R Scientific Device Laboratory ...... 2756 Takasago Fluidic Systems ...... 3768 Robotics Division ...... 2643 Pall Life Sciences ...... 3540 Scientific Systems, Inc...... 4571 Tarcine BioMed Inc...... 4670 YD Diagnostics Corp...... 1817 PAML ...... 3455 Scimedx Corporation ...... 2476 Tecan ...... 421 Zentech ...... 1742 Panagene Inc...... 1056 Sclavo Diagnostics International Srl ...... 2367 Technidata America ...... 4554 ZeptoMetrix Corporation ...... 2541 Parker Hannifin, Precision Fluidic Div...... 3045 SCOPELED ...... 2372 Techno Medica Co. Ltd...... 1856 Zeta Corporation ...... 4671 Parter Medical Products, Inc...... 2172 Scripps Laboratories ...... 3954 Teco Diagnostics ...... 1069 Zeus Scientific ...... 4342 Path-Tec ...... 864 ScyTek Laboratories, Inc...... 2556 Tecom Science Corporation...... 1175 Zhejiang Aicor Medical Technology Co...... 3761 PDC Healthcare ...... 3960 SDIX, LLC ...... 1067 Tek-Matic ...... 2475 Zhejiang Gongdong PDC Precision Die Cutting ...... 1970 Sebia, Inc ...... 317 TELCOR ...... 2445 Medical Technology ...... 3733 PDCI Medical/Pacific Die Cut Industries .....4442 Seegene, Inc...... 435 Teledyne CETAC Technologies ...... 2976 Zhejiang KangTe Bio-Tech Co., Ltd ...... 4475 Pel-Freez Biologicals ...... 3669 Sekisui Diagnostics LLC ...... 4025 Tetracore ...... 1772 Zhongke Meiling Cryogenics Limited Co. ....1975 Percorso Life Sciences ...... 3243 SelectScience Ltd ...... 4676 The Binding Site, Inc...... 1448 Zhongshan Chuangyi Biochemical Perfect Ease Biotech (Beijing) Co., Ltd ...... 3633 Seracare Life Sciences, Inc...... 1141 The Joint Commission ...... 1678 Engineering Co., Ltd...... 3868 Pevco ...... 2275 Seramun Diagnostica GmbH ...... 4815 The Lee Company ...... 3745 Zinexts Life Science Corp...... 3873 Pharmasan Labs ...... 354 Serosep Ltd...... 4675 THERADIAG ...... 457 Zyomyx, Inc...... 4163 Phytronix Technologies Inc...... 3552 Shandong Lianfa Medical Plastic Therapak Corporation ...... 1857 Planet Innovation Pty Ltd...... 1177 Products Co.,Ltd ...... 3969 Thermo Scientific ...... 1221 —List as of 7/1/14 PAGE B-16 Monday, July 28, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase

Hemoglobin A1c Reagent, IS 1200 Automatic Stabilized R2 Component Zinc Transporter 8 Autoantibody Chemiluminescence Analyzer Pointe Scientific, A MedTest Company, Orchard® Sequoia™ Enterprise-class ELISA Test Kit† IS 1200 Automatic Chemiluminescence introduces an improved reagent for the LIS KRONUS® is proud to offer the Analyzer and the companion reagents direct determination of Hemoglobin Orchard® Sequoia™ is a new enter- Zinc Transporter 8 Autoantibody are the combination of the advanced A1c on general chemistry analyzers. prise-class LIS designed to be scal- (ZnT8Ab) ELISA Kit† for the accurate precision analytic instrumentation and The methodology uses a highly able to accommodate large volumes determination of autoantibodies magnetic microparticle based enhanced specific monoclonal antibody to HbA1c of laboratory testing across multiple to zinc transporter (ZnT-8). Please immunoassay technology. The assay dy- with HbA1c determined by immuno- laboratories and departments per- visit the KRONUS exhibit booth at namic range is widened and the sensi- turbidimetric analysis. The R2 has been forming clinical, microbiology, mo- number 1931 to learn more about our tivity of detection is also increased. The stabilized so that it is now ready to use. lecular, and pathology testing. innovative product line. †For research assay speed is improved by the patented Mixing two separate R2 components is • Enterprise-class LIS utilizing use only. Not for use in diagnostic technologies. The flexibility of assay no longer necessary. Microsoft® SQL® Server Enterprise procedures. choices and reliability of measurement Automated sample preparation (RBC Edition Architecture KRONUS, Inc. are the characteristics of IS 1200 system. lysing) can be performed on many • Single Application with a Booth 1931 Quality-Assured Disposable sample chemistry analyzers providing a totally Segmental Design, including tips and reaction cuvettes avoid cross- automated test system. Clinical, Anatomic Pathology, & contamination. High-quality reagents The Pointe Scientific Hemoglobin Molecular guarantee the reliability of test results. A1c reagent is NGSP certified, liquid- • Analytics Support Business Better Performance/Cost IS 1200 sys- stable, and has been shown to be ac- Intelligence & Population Health tem not only ensure the reliability of test curate and precise. Management result, but also meets the requirements Liquid Calibrators and Controls are • Rules Enhance Productivity & of reducing costs. also available. Reduce Errors MAKER Biotechnology MedTest • Sample Tracking & Supply Booth 859 Booth 3517 Management • Sophisticated Image Management Automation • SQL Server AlwaysOn technology for High-availability & Disaster LeadCare Ultra Recovery The LeadCare® Ultra™ Blood Lead • Big Data Archival Storage for Testing System is designed to provide Mining Unstructured Data clinical laboratories unmatched ease Orchard® Sequoia™ of use with prepackaged reagents Booth 4422 and electronic calibration. Offering both barcode scanning and LIS com- patibility in a compact footprint, it provides rapid, cost-effective results SE4710 Scan Engine Stat Profile Prime® CCS for labs of all sizes and complexity. 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Stat Profile Prime’s ZERØ main- • Simple interface: Easy to use with maintaining scanning accuracy, all in tenance cartridge technology consists cobas u 601* Urine Analyzer no experience needed the smallest form factor available. of individual cartridges for biosensors, Roche introduces the cobas u 601 • FDA cleared: No method develop- Your product designs can offer the calibrators, and liquid quality control. urine analyzer, a fully automated ment required sleek lines today’s customers demand. This design optimizes the life of each solution for urine strip testing in More cost-effective and flexible And with our patented, proprietary cartridge; improves analyzer uptime; mid- to high-volume labs. Designed than send-outs PRZM Intelligent Imaging technology, and eliminates the waste, downtime, and to automate all manual steps and • Faster turn around time: industry leading decoding algorithms higher costs of older combined calibra- deliver high-quality results using • No batching needed and results and advanced focusing, optical and tor/sensor cartridge systems. Stat Profile proven reagent test strips based on 50 in 3 minute illumination systems, your customers Prime delivers a full 10-test profile in just years of experience and innovation. • Simplified workflow: Barcode can count on class-leading high-perfor- 60 seconds including pH, PCO2, PO2, *Not available for sale in the US. A reader and LIS connectivity mance data capture they need. Na, K, iCa, Cl, Glucose, and Lactate. 510(k) submission is pending. Magellan Diagnostics, Inc. Motorola Solutions Inc. Nova Biomedical Corporation Roche Diagnostics Booth 4252 Booth 2678 Booth 2618 Booth 1209

Cystatin C Liquid Stable Reagent* year. This latex enhanced immunoturbi- precision is less than 4.5%. Pointe Scientific, A MedTest Company, dimetric method is ready to use on your Calibrators and controls for introduces a new reagent for the de- clinical chemistry analyzer. the assay are also available. *Not termination of Cystatin C in serum or The Cystatin C reagent has a linear FDA Cleared; Not for sale in the plasma. range of 0.2 – 8.0 mg/L and obtains United States. The reagent is liquid stable and ready excellent precision: Within Run preci- MedTest to use with a shelf life greater than 1 sion is less than 5.6 %, Between Run Booth 3517

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Current Tm-based Assay MuDT™-based Assay (Ct value) Clinical sample FAM HEX Cal Red 610 Quasar 670 FAM HEX Cal Red 610 Quasar 670 No. UU UP MG MH NG CT TV IC UU UP MG MH NG CT TV IC 1 + + - + - - - + 35.8 29.8 - 32.7 - - - 28.5 2 - - + + - - - + - - 28.3 35.9 - - - 29.0 3 - + - - - + - + - 26.2 - - - 28.6 - 29.1 4 - + - - - + - + - 36.7 - - - 26.3 - 30.2 5 - + - + - + - + - 28.1 - 37.7 - 32.5 - 28.7 6 + + + - - - - + 35.1 32.6 32.1 - - - - 32.1 7 - + - - - + - + - 29.4 - - - 31.9 - 28.5 8 + + - + - - - + 37.2 35.5 - 31.9 - - - 31.2

▶ UU : U. urealyticum, UP : U. parvum, MG : M. genitalium, MH : M. hominis, NG : N. gonorrhoeae, CT : C. trachomatis, TV : T. vaginalis, IC : Internal Control

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Seegene, Inc. Seegene USA Seegene Germany Taewon Bldg., 91, Ogeum-ro, Songpa-gu, Seoul, Korea 9801 Washingtonian Blvd. Suite 290, Gaithersburg, MD 20878, U.S.A. Ludwig-Erhard Str. 30-34, D 65760, Eschborn, Germany TEL : 02-2240-4000 / FAX : 02-2240-4046 TEL : +1-301-762-9066 / FAX : +1-301-762-9088 TEL : +49 (0) 6196-769-3468 / FAX : +49 (0) 6196-769-4137 E-mail: [email protected] E-mail: [email protected] E-mail: [email protected] PAGE B-18 Monday, July 28, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase

Acrodisc® WBC Premium Syringe Filter Sofia hCG FIA Pall Life Sciences New Acrodisc® white Sofia hCG FIA (Fluorescent Immunoassay), blood cell (WBC) premium syringe with Kinetic CheckTM technology detects cobas® HPV Test filter is a key sample prep tool for the human Chorionic Gonadotropin (hCG) Clinically validated in the landmark Elecsys® Calcitonin Immunoassay laboratory. Pall Life Sciences Acrodisc in urine specimens. In addition to excel- ATHENA trial, this DNA-based hu- Roche introduces the Elecsys® WBC filter contains Pall’s patented lent performance and accuracy, the Sofia man papillomavirus test is now FDA- Calcitonin immunoassay, which is Leukosorb® media. Leukosorb is a hCG FIA provides distinct advantages approved for first-line primary screen- intended for use as an aid in the fibrous matrix that uses a multimodal over conventional rapid hCG tests. The ing for cervical cancer in women 25 and diagnosis and treatment of diseases approach to capture and recover test uses monoclonal antibodies specific older. It is the first HPV test approved involving the thyroid and parathy- leukocytes from whole blood samples to the beta subunit of hCG to ensure for this expanded indication in the U.S. roid glands, including carcinoma and while allowing RBCs and platelets to greater specificity. The Kinetic Check The cobas HPV Test provides three hyperparathyroidism in combination flow through the membrane. This filter technology gives the user greater flex- results in one test: individual results with other clinical and laboratory provides a simple and easy method ibility, up to 5 minutes, before placing for HPV 16 and 18—the genotypes findings. The electrochemilumines- to separate blood cells for a variety of the Cassette into Sofia for analysis. responsible for 70 percent of cervical cence immunoassay “ECLIA” is research applications including: cell re- Quick, objective and automated results cancer—and a pooled result for the 12 intended for use on Elecsys and cobas ceptor analysis, antigen specificity, an- help eliminate operator to operator other high-risk types, all in one run, e immunoassay analyzers. tigen modulation studies, cell therapy variability and reduce transcriptional from one patient sample. The test is Roche Diagnostics and stem cell research. To learn more and billing errors. Sofia also prints and/ performed on the cobas 4800 System, Booth 1209 about our WBC Acrodisc Filter please or sends results to the LIS, allowing for which offers walk-away automation of visit our booth 3540 or visit our website easy transfer of patient records. nucleic acid purification, PCR set-up at www.pall.com. Quidel Corporation and real-time PCR amplification and Pall Life Sciences Booth 445 detection. Booth 3540 Roche Diagnostics Booth 1209

Elecsys® CMV IgG Assay The Elecsys® CMV IgG assay, which is an in vitro qualitative test for the A2 Multiplex IA Slide detection of IgG antibodies to CMV QuantiScientifics’ new A2® Multiplex cobas® 8100 Automated Workflow in human serum, lithium-heparin IA slide represents a unique ap- cobas® CT/NG v2.0 Test Series plasma, K2-EDTA plasma and K3- proach for creating custom antibody This highly sensitive and specific test for The cobas® 8100 automated workflow EDTA plasma, is used as an aid in or antigen microarrays without the the detection of Chlamydia trachomatis series delivers automation without determining the serological status need to print. Based upon the com- and Neisseria gonorrhoeae DNA in compromise by providing multilevel, to CMV in individuals in which a pany’s Oligo-Link-it technology, symptomatic and asymptomatic pa- bidirectional sample transport lines that CMV IgG test was ordered, including the slide contains 14 unique capture tients is FDA-cleared for use with six maintain predictable TAT during peak pregnant women. oligos in each of its 8 sub-arrays. specimen types. It may be used with testing hours with two-story system Performance characteristics have Complementary activated oligos are male or female urine, self-collected architecture that separates full sample not been evaluated in immunocom- provided in a spin column-based vaginal (collected in a clinical setting), holders from empty ones. The workflow promised or immunosuppressed conjugation kit enabling the prepara- clinician-collected vaginal, and endo- your way feature enables the instrument individuals. It is not intended for use tion of up to14 unique oligo-antibody cervical swab specimens, all collected to conform to the individual needs of in neonatal screening, point-of-care conjugates. A hybridization kit is used in cobas PCR media, and with cervi- the lab by allowing users to conduct facilities or screening of blood and to assemble the antibody or antigen cal specimens collected in PreservCyt® workflows using primary samples, plasma donors. arrays for use in multiplex immunoas- solution. The fully automated, real- aliquoting, or a mixture of both. Add-on The electrochemiluminescence im- says. The preparation of a quantitative time PCR-based test is performed on buffers allow for flexible mid-term stor- munoassay “ECLIA” is intended for mulitplex immunoassay can be com- the cobas 4800 system and includes age that automates the entire add-on/ use on Elecsys and cobas e immuno- pleted in 2.5 days. The slides maybe an automatic internal control and the repeat testing process. assay analyzers. read using a variety of microarray AmpErase® enzyme, providing labo- Roche Diagnostics Roche Diagnostics imaging readers or scanners. ratories with accurate, efficient results. Booth 1209 Booth 1209 QuantiScientifics LLC Roche Diagnostics Booth 3553 Booth 1209

Elecsys® HBeAg Immunoassay patients with symptoms of Hepatitis or The electrochemilumines- Roche introduces the Elecsys® HBeAg at risk for Hepatitis B virus (HBV) infec- cence immunoassay “ECLIA” immunoassay, which is intended for the tion. Combined with other serological is intended for use on the in vitro quantitative determination of and clinical information, this test may MODULAR ANALYTICS E170 Hepatitis B e antigen in human serum be used for lab diagnosis of acute or analyzer. or plasma (K2-EDTA, lithium or sodium chronic Hepatitis B or recovery from Roche Diagnostics heparin, and sodium citrate) in adult Hepatitis B infection. Booth 1209

ADVERTISEMENT Visit Parker Booth 3045 to Learn More PAGE B-20 Monday, July 28, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase

Product Name: A1c iGear Capillarys HbA1c Assay PCR Setup Solution A1c iGear is an HbA1c analyzer for The next generation of HbA1c testing, Sekisui Diagnostics SK™500 Are you looking for a small pipetting diabetes. This system offers results as based on the principle of capillary Chemistry System robot to combine with your PCR accurate as lab tests just like its pre- separation, provides high resolution and The SK™500 is a new chemistry system reagents to create a tailored pack- decessor, A1c GEAR (k130014) and clear-cut and precise separation of HbA1c from a global leader in clinical chemis- age? Get to know Xiril’s PCR Setup has more advanced features. Its and HbA0 fractions. Capillary separation try reagents. A high-efficiency system Solution! – a small liquid handling all-in-one cartridge is ideal for point- allows the elimination of direct interfer- combined with Sekure™ assay perfor- workstation for automated PCR of-care settings. The key features ences on the A1c fraction (carbamylated, mance, it is ideal for moderate-volume setups. This ideal fusion of liquid include: acetylated, and labile hemoglobins, plus laboratories. The SK500 provides excep- handling and dedicated software • Compact and simple design common Hb variants, such as, HbS, tional throughput with minimal use of leaves you enough flexibility to • Result available approximate- HbC, HbD, HbE) as well as the analyti- space and low water consumption. The be composed the way you need it. ly in 6 minutes cal exclusion of HbA2 and HbF from the system delivers up to 580 tests per hour The risk of cross-contamination dur- • Easy and simple operation by the measurement. It also allows for high ac- in a small footprint. The intuitive user ing PCR setups is highly reduced touch panel curacy of results and low CVs. Capillarys interface enables simple operation. For and process safety is given due to • Only 1μL of whole blood required 2 Flex Piercing and Minicap Flex Piercing more information, visit booth #4025 or the built-in decontamination features • Excellent correlation with estab- systems, with whole blood-closed tube email us at [email protected] and the use of robotic filter tips. lished methods capacity, offers HbA1c testing with the The SK logo and Sekure are trademarks The PCR Setup Software fully • 3 samples can be loaded with re- best balance in precision, robustness, and of Sekisui Diagnostics, LLC “speaks PCR”: serial dilutions, sults being available sequentially throughput, along with the ability to run Sekisui Diagnostics LLC calculations of quantities and • Patient ID registration capability protein, immunotyping, hemoglobinopa- Booth 4025 complete workflow data process- • Bidirectional communication port thy, and CDT testing. ing from input- to output file. (RS232) and USB external port Sebia Let us support your OEM project Sakae Corporation Booth 317 configuring a comprehensive PCR Booth 2345 Setup Solution! Sias AG Booth 2454

CAL 8000 Cellular Automation Line CAL 8000 Cellular automation line integrates the BC-6800 hematology ana- lyzer and SC-120 slide maker & stainer into one line. There are two tracks in Minicap Flex Piercing Instrument the system automatically deliver the Alk Phos & HRP Substrates from The Minicap Flex Piercing has been FDA samples to different analyzers for rerun 4500MD Scripps Labs cleared for HbA1c and protein testing. and reflex according to the pre-defined The AB SCIEX Triple Quad™ Scripps Laboratories has developed The Minicap Flex Piercing instrument criteria by users. After users input the 4500MD LC/MS/MS system is high quality, one-step chromogenic uses proven capillary separation tech- review criteria, the tracks deliver the a high performance, easy to use, substrates for alkaline phosphatase nology to provide clear-cut and precise abnormal samples to the SC-120 for bench top triple quadrupole mass (BCIP/NBT) and HRP (TMB). These results for the newest generation in slide making and staining as well. spectrometer designed for routine in ready-to-use solutions are designed HbA1c testing. The system’s small foot- All reagents as well as the pneumatic vitro diagnostic testing laboratories. for membrane-based assays like print is able to offer flexibility, scalability unit could be set in the trolley below This instrument provides superior western blot, PCR and dot blot. and full automation to the low to mid respective BC-6800 or SC-120. The CAL quantitative performance, excellent Results appear quickly, within 3-5 volume laboratories. Place a primary 8000 is a scalable system, 1-4 units of BC- robustness, and long term stability, minutes, and color development is tube on the system and walk away; 6800 and 0-2 units of SC-120 could work enabling laboratorians to develop stable, with negligible fading over whole blood samples are automatically together to fit different sizes of labs. tests for even the most demanding time. In a side-by-side comparison, inverted prior to analysis, continuous Shenzhen Mindray Bio-Medical clinical applications. Scripps BCIP/NBT worked faster access sample wheel allows for the Electronics AB SCIEX Diagnostics and identified more bands than did addition of samples at any time. True Booth 3618 Booth 3418 substrate from 2 leading biochemical positive sample ID is achieved with full suppliers. And when you buy from traceability. A complete test menu also Viva-ProE™ System* Scripps, you enjoy the benefits of includes whole blood hemoglobinopa- The Viva-ProE™ System* with Emit® working directly with the manufac- thy* testing, immunotyping* and CDT*. technology is a dedicated drug-testing turer: ISO Certification, controlled *Under development for U.S. market. platform that provides drug-testing production procedures to avoid Sebia performance on a reliable, next- back-orders, and stringent qual- Booth 317 generation benchtop system. It is ity control for lot-to-lot consistency. engineered to meet the demands of Contact us for a FREE SAMPLE. laboratories by offering a self-con- Scripps Laboratories tained design with onboard waste and Booth 3954 water storage, compact footprint, and intuitive software in a touchscreen- availability may vary by country. command center. * Under develop- Siemens Healthcare Diagnostics ment. Not available for sale. Future Booth 509

ADVERTISEMENT TUESDAY, JULY 29, 2014 Monday, July 28, 2014 PAGE B-21

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo Posters the second year. The sessions are of and attendee participants should Guided Poster particular benefit to student attendees assemble outside the entrance to the ›› from page B-1 because tour leaders offer detailed poster session in McCormick Place Tours Schedule explanations of the projects. After about 10–15 minutes prior to their attendee is an opportunity to practice each session, tour participants have walk. “The guided tour usually takes Tuesday explaining a scientific paper to AACC the opportunity to ask questions and less than an hour and occurs when the members, exchanging knowledge, engage in a lively discussion with poster presenter is not supposed to be 10:00 am and fostering new collaborations the tour leader and one another. “It’s at the poster,” Ricchiuti said. Tour Leader: Melissa Snyder especially good for students,” he Ricchiuti will lead a tour of the Organized by: Clinical & between AACC members,” he said. Diagnostic Immunology Division “The guided poster tour during said. This year, annual meeting Clinical Translational Science divi- the poster presentation session is a attendees can choose from among 13 sion on July 30 at 11 a.m. Ritchie, 10:00 am fabulous chance to make a differ- guided poster tours, which will take meanwhile, will lead a tour for the Tour Leader: William Winter ence by having some posters in the place on Tuesday and Wednesday in Therapeutic Drug Management & Organized by: Endocrinology [spotlight].” the Exhibit Hall of the convention Toxicology division on July 30 at 2 Division James Ritchie, PhD, is also par- center. In order to participate in a p.m. ticipating in the poster tours for guided poster tour, division leaders 2:00 pm Tour Leaders: Mike Stocum; Peggy Robinson Organized by: Personalized Medicine Division

3:00 pm Tour Leader: Yan Zhang Organized by: Clinical & Now Available! Diagnostic Immunology Division A Vitamin D Assay Designed for Your Laboratory Needs The First and Only Vitamin D Assay for Clinical Chemistry Analyzers Wednesday

10:00 am Tour Leader: Sarah Brown 25-OH VITAMIN D ASSAY Organized by: Critical & Point-of- FOR CLINICAL CHEMISTRY ANALYZERS Care Testing Division

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2:00 pm Tour Leaders: Jim Ritchie; Patrick Kyle Organized by: Therapeutic Drug Management & Toxicology Division DIAZYME 3:00 pm Tour Leader: Alan Wu Organized by: Biomarkers of Acute Cardiovascular Diseases Division 858.455.4768 888-DIAZYME www.diazyme.com [email protected]

DiazymeAACC Jun14.indd 1 6/10/14 11:15 AM PAGE B-22 Monday, July 28, 2014 TUESDAY, JULY 29, 2014

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase CD-Chex Select™ Immuno- phenotyping Control CD-Chex Select is the first and only commercially avail- able flow cytometry control with the se- lected group of CD ® RAPIDComm Data Management markers used for TM System* DBS Autosampler immunophenotyp- TM Siemens offers an ecosystem approach The new DBS Autosampler from ing. It is an assayed to point-of-care testing (POC) with Spark Holland comprises two main positive procedural ® TM RAPIDComm Data Management elements: The FTD system and a control for reagent StabilZyme® Protein-Free AP System software version 5.0. The card handling robot. Flow-Through staining, erythrocyte lysis, sample Stabilizer* new version of Siemens’ informatics Desorption (FTD™) is an innovative preparation and instrument perfor- Eliminate interference and solution for managing POC testing patented technology for extraction of mance. CD-Chex Select eliminates cross-reactivity with SurModics introduces key enhancements to help Dried Blood Spots without punching the need for labs to hold and validate StabilZyme®Protein-Free Stabilizers, satisfy compliance requirements and discs out of the DBS filter card. FTD™ patient samples to use as a control for now available for AP conjugated pro- efficiently manage operator training enables automation of the entire work- the evaluated markers, saving lab time teins. New StabilZyme Protein-Free and certification. It includes support flow for Dried Blood Spot (DBS) analy- and money. CD-Chex Select is available AP Stabilizer delivers performance for a web application and an inter- sis by LC-MS/MS. A uniquely designed in 3.0ml plastic cap-pierceable vials and comparable to the original StabilZyme face to PEP Administrator, Siemens’ high pressure clamp allows desorption is compatible with automated sample Protein-Free Stabilizer (SZPF; re- web-based learning-management of the sample from the clamped spot preparation instruments. Open-vial sta- tained activity of 86% for more than system. *Product availability varies directly into a (SPE)/LC/MS/MS bility is 30 days. For Research Use Only. 2 years). Both of these breakthrough by country. system – or other analytical systems. Not for use in diagnostic procedures. solutions offer performance similar Siemens Healthcare Diagnostics The system also features: clamp size Streck, Inc. to the market-leading StabiZyme HRP Booth 509 range of 2 - 8 mm, camera for bar-code Booth 1920 Conjugate Stabilizer, only in protein- reading and spot location, automated free formulations. Manufactured in internal standard addition and DBS card ISO 13485:2003 and 9001:2008 certi- capacity ranging from 96 (standard) up fied facilities, SurModics stabilizers to 350, and more. meet your stringent quality and Spark Holland B.V. manufacturing requirements. Rely on Booth 4463 SurModics for stabilization success. (*For further processing.) CD-Chex SurModics IVD CD117™ Plus Booth 1938 Flow Cytometry ELITE Grade Enzymes from Control Sigma-Aldrich CD-Chex CD117 Introducing our ELITE grade en- Plus is the first and zymes designed specifically for only commercially IVD manufacturers. As part of our available positive Enhanced Quality Profile program, procedural control these enzymes cater to the stringent for CD117, CD25 UA-Cellular® Complete Urinalysis needs of today’s diagnostic manufac- and CD71. It was Control turing environment for supply chain developed with UA-Cellular Complete is a compre- transparency, design control and characteristics simi- hensive urinalysis control containing change control notification. Why not lar to the abnormal both chemistry analytes and cellular source from the original biotechnol- peripheral blood components to more closely mimic Cavro® Omni Robot OEM Liquid ogy manufacturer with the experi- leukocytes often a patient sample. Designed for the Handling System ence and resources to provide you found in a hematolymphoid neoplastic Siemens CLINITEK Atlas® and Sysmex® The Cavro Omni Robot is a general with the product quality, documenta- patient sample. The product possesses UF-1000i™ combined urinalysis system, purpose liquid handling component tion of Supply Chain Transparency surface CD117, CD25 and CD71 that are technologists can use one control to designed to offer reliable pipetting and change control parameters you detectable with fluorescent monoclonal test both instruments. Packaged in a for a wide range of applications. need. To learn more about ELITE antibodies by flow cytometry. CD-Chex convenient 120ml squeeze bottle with Its flexible, modular construction grade enzymes such as Proteinase K, CD117 Plus monitors reagent staining, a flip-top cap that accurately dispenses makes the Cavro Omni Robot easy to Thrombin, y-Globulins, Thymidine erythrocyte lysis, sample preparation the amount of control needed into integrate into almost any instrument phosphorylase and Pepsin visit and instrument performance. For sample tubes without waste. Open-vial design, allowing the user to choose sigma-aldrich.com/diagnostics or research use only. Not for use in diag- stability is 30 days. any combination of X-Y, Y-Z or XYZ contact your Sales Rep to learn about nostic procedures. Streck, Inc. axes, plus a range of options to suit our offer for ELITE products. Streck, Inc. Booth 1920 their pipetting needs. The robot’s Sigma-Aldrich Booth 1920 new Embedded Command Processor Booth 460 Mode allows direct, OS-independent communication for precise control and coordination of axis movements POCKit testing solutions. Siemens POCkit and liquid handling operations, help- Siemens POCKit™ is a new web connects people to knowledge, with ing to simplify system integration. based education solution designed just-in-time performance support, These latest updates further extend for healthcare professionals perform- anytime, anywhere from any device. the versatility of the Cavro Omni ing point-of-care testing. It provides Navigate to www.siemens.com/ Robot, providing exceptional flexibil- immediate access to the latest topics, pockit to learn more. ity for OEM liquid handling applica- videos, and links to access informa- Siemens Healthcare Diagnostics tions.www.tecan.com/omnirobot. tion on how to use Siemens POC Booth 509 Tecan Booth 421

ADVERTISEMENT TUESDAY, JULY 29, 2014 Monday, July 28, 2014 PAGE B-23

The Official Publication of the AACC Annual Meeting & Clinical Lab Expo New Product Showcase

LPM Inert Solenoid Pump ZEUS Borrelia VlsE1/pepC10 IgG/ The Lee Company’s new LPM Series Thermo Scientific™ TraceFinder™ 3.2 ciconnect IgM Test System Inert Solenoid Pump was designed software UNIConnect’s PrecisionMDx (PMDx) is ZEUS Scientific’s new Borrelia ELISA to offer greater design flexibility, and Thermo Scientific™ TraceFinder™ 3.2 soft- for lab professionals seeking a focused Test System uses a combination of significant cost savings to the medical ware is an easy-to-use, workflow-driven solution for their CAP/CLIA certi- VlsE1 & pepC10 antigens to test for and scientific industries. software for laboratories performing fied molecular laboratory operations. Lyme Borreliosis simultaneously in The LPM Pump features a revolu- quantitation and targeted screening Ideal for MDx, CDx and PGx pursuits. the same assay. It’s an approach that tionary port head design that allows using GC- MS and LC-MS. TraceFinder Standalone software or integrated increases specificity & sensitivity, tubing connections and manifold software increases productivity with with existing LIS/LIMS and billing & allows you to test with greater mounting. This enables the designer powerful method development, simpli- infrastructure. PMDx will support your confidence at all stages of Lyme to test the fluidic system using con- fied data acquisition and comprehen- molecular requirements from sample disease according to R.M. Bacon et nections to soft 1/16” tubing, and sive data review. TraceFinder software entry to final report. Designed to man- al. Improved Serological Testing for then once the system design has is a single software for nominal mass age the depth and complexity of “omic” Lyme Disease. JID 2003; 187:1187- been finalized, the same pump can and HRAM data analysis for screening science, adaptable to accommodate 1199. The Test System also helps be manifold mounted using standard and quantitation. You can do quantita- change in this dynamic field, PMDx to reduce lab costs for unnecessary O-rings. tion with full scan and confirmation scales from single lab to global network. confirmatory tests, such as Western Available in 10 μL and 25 μL with MS2 spectra, forward and reverse Installed locally or hosted on the Cloud. Blot. The test is capable of being models, the LPM Pump features low library searches, rapid data review and Based on the powerful UNIFlow™ run in a manual, semi-automated, power consumption and a contoured customizable reporting. Laboratory Process Management or fully automated capacity. Go end cap which provides secondary Thermo Scientific Platform, UNIConnect specializes in to www.zeusscientific.com/lyme connector retention and is compatible Booth 1221 rapid implementation. See PMDx at to sign up for our trial evaluation with standard AMP connectors. Booth 2078. Or request an appointment program for qualified customers and The Lee Company at [email protected]. to learn more information. Test with Booth 3745 Uniconnect confidence. Booth 2078 Zeus Scientific Booth 4342

Thermo Scientific™ iRC Pro 1.0 UTAK reveals NEW Steroids Control Meta Calculation Software Thermo Scientific™ Q Exactive™ in SMx® Serum ZEUS Scientific Broad Menu for Thermo Scientific™ iRC Pro software HF Benchtop Orbitrap Mass UTAK proudly announces the launch HSV Test Systems is an automated data processing soft- Spectrometer of our Steroids Control manufactured ZEUS Scientific offers HSV Test ware for SRM based data. It calculates The Thermo Scientific™ Q Exactive™HF with UTAK’s proprietary SMx® Serum. Systems on 3 platforms, ELISA, IFA, the concentration of target analytes mass spectrometer is the next genera- This revolutionary Steroids Control & AtheNA Multi-Lyte®. Our ELISA using mass ion ratios and performs tion HR/AM bench top system with an product is offered in individual packs for & AtheNA Multi-Lyte® Test Systems meta calculations using user-defined ultra-high-field Orbitrap detector, Levels 1, 2, 3, 4 and a Negative Control. feature many universal protocols & formula; removing common errors in providing greater speed, productivity There are seven analytes of interest: reagents, simple automation capa- post-analytical data processing. iRC and confidence for both qualitative and Corticosterone, Cortisol, Cortisone, bility, & a patented SAVe Diluent® PRO software saves data processing quantitative workflows. It takes identi- Dehydroepiandrosterone (DHEA), to assure no well has been missed. time and eliminates transcription fication and quantitation to a new level, Progesterone, 17α-Hydroxyprogesterone, Our ELISA Test Systems also utilize errors from manual calculations to making it possible to identify, quantify, and Testosterone at clinically relevant breakaway, removable test wells in a ensure quick, efficient and accurate and confirm in a single analysis with a levels for most testing methodologies. microplate format to allow the most data processing results. single instrument. UTAK - beyond measure, goes be- efficient workflow for the laboratory. Thermo Scientific Thermo Scientific yond the status quo. UTAK has devel- Our broad menu offers several FDA Booth 1221 Booth 1221 oped Specialty matrices for Oral Fluid, cleared Test Systems, HSV gG-1, HSV Hair, Sweat, Urine, and now Serum is gG-2, HSV-1 IgG, HSV-2 IgG, & HSV- added to the UTAK SMx® line to help 1&2 IGM. Our newest addition to the Laboratorians with their most unique HSV family includes a CE & Health testing requirements. Canada approved HSV gG1&2 IgG All materials contained in this newspaper are protected by copyright laws and may not be UTAK, it’s time to take a closer look, Test System. For our complete list used, reproduced, or otherwise exploited in any manner without the express prior permis- at booth 4314. of HSV products, please visit our sion of AACC. UTAK Laboratories, Inc. website at www.zeusscientific.com/ The information contained in the CLN Daily is provided solely for educational purposes. Booth 4314 products to learn more. A diversity of opinions exists in the field of laboratory medicine, and the articles in this Zeus Scientific publication are often intended to inform readers about more than one point of view. The Booth 4342 views expressed in the CLN Daily do not necessarily represent AACC’s views, and their inclusion in this publication should not be interpreted as an endorsement by AACC. AACC is not responsible for any inaccurate or inappropriate use of the information, publications, products, or services discussed or advertised within.

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