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ISSN 1068-1760 Vol. 28 No.6 • 10/2011 DAILY CLINICAL LAB NEWS

Tumor Profiling Assay to Clinical and Virological Factors Gene Test Predicts Improve Cancer Care Influence Dengue Immunoassay Cancer in Pancreatic Cysts tumor-profiling assay will be n evaluation has been made early detection of dengue virus gene-based test has been AAbased on targeted panel AAof the factors that influence infection. AAdeveloped that distinguishes enrichment and next generation the performance of an antigen A team from the Institute precancerous pancreatic cysts sequencing (NGS). It will improve capture assay and other markers Pasteur in Phnom Penh (Cam- from benign vesicles by parallel cancer care by providing specific of dengue disease severity. bodia; www.pasteur-kh.org) col- sequencing. information about individual Dengue nonstructural protein lected blood from patients hospi- Genetic analysis of precancer- patients, thereby facilitating per- 1 (NS1) may be used in simple talized during the 2006 and 2007 ous fluid filled cysts and the search sonalized treatment strategies. antigen-capture enzyme-linked dengue epidemics in Cambodia. for mutations may eventually help The assay will detect mutations immunosorbent assay (ELISA) for Blood samples were tested for more than a million patients each Cont’d on page 8 Cont’d on page 4 Cont’d on page 6 Sensitive Blood Test Multiplex Assay Detects Prion Diseases Detects Drugs novel assay has been devel- Detects Drugs AAoped that will rapidly screen blood plasma for variant in Oral Fluid Creutzfeldt-Jacob disease (vCJD). An integrated antibody-based solid-state device onto approach with an improved real- Awhich antibodies spe- time quaking-induced protein cific to different drug com- conversion (RT-QuIC) reaction pounds are immobilized enhanced the detection of vCJD and stabilized, allows the Cont’d on page 4 simultaneous detection of multiple drug classes and INSIDE drug metabolites from a single undivided specimen. Clinical News ...... 2-26 See article on page 12 IFCC News ...... 27

Image: Courtesy of Randox Laboratories EFCC Corner ...... 30 VISIT ® Digital Pathology Application LINKXPRESS COM Released for iPad and iPhone Product News . . . . . 16-22 READER SERVICE PORTAL digital pathology viewing application with Renew/Start your Technical Literature . . . 26 Abuilt-in educational content from insti- Free Subscription tutes and pathologists was released for iPad Industry News ...... 33 Access Interactive and iPhone. Digital Magazine Users can try Digital Pathology for free International Calendar . 34 and view, zoom and navigate digital slides Instant Online through the high performance viewer. PUBLISHED IN COOPERATION WITH Product Information: Cont’d on page 8

® International Federation Identify LinkXpress codes of Genetic Test Diagnoses Breath Test for Immune of Clinical Chemistry 1 and Laboratory Medicine interest as you read magazine Lipid Metabolism Disorder Response to H1N1 Virus Click on LinkXpress.com GLOBETECH 2 to reach reader service portal genetic diagnostic platform can novel breath test detects peo- >>>MEDIA <<< be used to identify patients ple who have an immune Mark code(s) of interest on AA AA with inherited disorder of lipopro- response to the Influenza A virus 3 ® Scan with LinkXpress inquiry matrix tein metabolism characterized by strain H1N1. The test would help elevated levels of total and low-den- to ease future vaccine shortages by Smartphone If your subscription sity lipoprotein (LDL) cholesterol. identifying the people who have to Access is not renewed every 12 months The platform includes the use of already been infected with the flu your Free Subscription may be Latest News automatically discontinued a DNA micro array, the detection of virus. Cont’d on page 8 Cont’d on page 2 LabMedica for daily laboratory medicine news click to www.labmedica.com Breath Test for Immune Response to H1N1 Virus In a study, published July 15, 2011, in H1N1 vaccine via a nasal spray and the IOP Publishing’s Journal of Breath breath test was administered on each of the Research, scientists investigated the easy, following seven days. noninvasive breath test to measure biomol- Samples of exhaled NO were provided ecules that accumulate in response to the by six participants prior to vaccination. H1N1 strain of the flu virus. Nitric oxide is a test approved by the US Investigators from Cleveland Clinic Food and Drug Administration (FDA; (Ohio, USA; http://my.clevelandclinic.org) Silver Spring, MD, USA; www.fda.gov) for and Syft Technologies (Christchurch, New monitoring inflammation and asthma. Zealand; www.syft.com) included 11 indi- Production of exhaled nitric oxide (NO) viduals in their study. Nine of these partic- has also been linked to influenza and viral ipants were given the live attenuated infection. The breath test examined exhaled nitric oxide (NO) – a biomolecule whose production has previously been linked to influenza and viral infection and has been speculated to play a ben- eficial role in viral clearance. The results showed a peak in NO levels in all subjects on the third day after vaccination. There were no significant differences in NO levels on any other day. Of the 11 other compounds examined in the study, only one compound – isoprene – showed an elevated level, also on day three. Increased levels of isoprene, a compound produced within the body and a major constituent of exhaled breath, have been reported to reflect oxidative stress in airways. Previous findings show that the highest number, and severity, of symptoms related to a H1N1 infection occur on day three, suggesting, along with this study, that this is when an immune response is triggered in the body. A breath test, measuring the immune response to the H1N1 flu virus, could help to ease future vaccine shortages by identifying the people who have already been infected with the flu virus. Study coauthor Dr. Raed Dweik, professor of medicine and director of the pulmonary vascular program at the Cleveland Clinic, said when the H1N1 epidemic occurred in 2009 physicians were faced with a dilemma related to patient treatment. “We all have nitric oxide in our breath because our lungs make it, but with different levels,” said Prof. Dweik. “If you have an infection or an inflammation or if you have asthma, it goes up.” Prof. Dweik cautions that while the work is “rather preliminary,” he sees it as proof of the concept that breath can be used to monitor the vaccination and, it is hoped, the infection.

Image: Colored scanning electron micro- graph (SEM) of H1N1 flu virus particles (virions, orange) on a cell (Photo courtesy of the NIBSC).

LabMedica International October/2011 2 LINKXPRESS COM LMI-10-11 101 VISIT US AT Stand: Curie E65 / D68

LINKXPRESS COM LMI-10-11 102 LabMedica Clinical and Virological Factors labmedica.com EDITORIAL BOARD Influence Dengue Immunoassay Rosa I. Sierra-Amor Mexico Robby Bacchus United Kingdom cont’d from cover Edward J. Bottone United States Claus Christiansen Denmark hematocrit and platelet count as well as for other bio- Bernard Gouget France logical parameters necessary for patients’ follow-up. Anders Kallner Sweden Sera were tested for dengue using serology and Tadashi Kawai Japan John A. Koepke United States molecular methods at the Institute Pasteur in John B. Lines United Kingdom Cambodia. Dengue infection was confirmed in 243 Donald Moss United Kingdom Andreas Rothstein Colombia of 339 symptomatic patients and in 17 asymptomatic Dmitry B. Saprygin Russia individuals out of 214 household members tested. Gérard Siest France Overall sensitivity and specificity of Platelia NS1 Andrew Wootton Australia Ag kit were 57.5% and 100% respectively. When the A GLOBETECH PUBLICATION

NS1 Ag assay was combined with immunoglobulin Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and IgM antibody capture ELISA, the sensitivity was sig- European Federation of Clinical Chemistry and Laboratory nificantly increased for dengue diagnosis. NS1 Ag Medicine (EFCC). positivity rate was found significantly higher in Publishers of: HospiMedica International • HospiMedica en Español HospiMedica China • Medical Imaging International • LabMedica International dengue fever (DF) cases than in fatal dengue hemor- LabMedica en Español • LabMedica China • Bio Research International ly across the various forms of dengue infection or dis- HospiMedica.com • LabMedica.com • Medimaging.net • BiotechDaily.com rhagic fever (DHF) and dengue shock syndrome ease. Sensitivity was highest in patients sampled dur- Dan Gueron Publisher (DSS). It was higher in primary rather than in second- ing the first three days after onset of fever, in patients Jill Roberge Editorial Director ary infections, in patients with a high viremia (>5 Jacqueline Miller, PhD News Director with primary infection, DENV-1 infection, with high Raymond L Jacobson, PhD News Editor log/mL), and in patients infected with the dengue Jerry Slutzky, PhD News Editor level of viremia and in DF rather than DHF/DSS. The viral strain DENV-1. In asymptomatic individuals, the Andreas Rothstein News Editor semi-quantitative approach of the test, demonstrated Marcela Jensen Assistant Editor NS1 Ag capture sensitivity tends to be lower than Joseph Ciprut Assistant Editor that the NS1 antigen level was significantly correlat- that in symptomatic patients. Milder disease severity Brenda Silva New Products Editor ed to the level of viremia and that the low level of Paul Mills Regional Director was observed independently in patients with ribonu- Doris Mendieta Regional Director NS1 antigen was associated with more severe dis- Renata Castro Regional Director cleic acid (RNA) copy number >5 log10 complemen- ease. The study was published online on July 19, Dr. Jutta Ciolek Regional Director tary DNA (cDNA) equivalents/mL or in high level of Christina Chang Regional Director 2011, in the Public Library of Science Neglected Arda Turac Production Director NS1 antigen ratio or in DENV-1 infection. Tropical Diseases. Elif Erkan Reader Service Manager The authors concluded that the overall sensitivity HOW TO CONTACT US of the Platelia Dengue NS1 Ag detection kit (BioRad; Image: The Platelia Dengue NS1 Ag detection kit (Photo Subscriptions: www.LinkXpress.com Hercules, CA, USA; www.bio-rad.com) varied wide- courtesy of Bio-Rad Laboratories). Send Press Releases to: [email protected] Advertising & Ad Material: [email protected] Other Contacts: [email protected] Sensitive Blood Test Detects Prion Diseases ADVERTISING SALES OFFICES cont’d from cover in purified form, resembles amyloid fibrils. This com- USA P.O.Box 800806, Miami, FL 33280, USA [email protected] Tel: (1) 954-893-0003 brain tissue diluted into human plasma. Scientists at the bined assay, which they call enhanced QuIC (eQuIC), GERMANY, SWITZ., AUSTRIA Bad Neustadt, Germany -18 US National Institute of Allergy and Infectious Diseases, detects approximately 2 attograms (10 grams) per mL [email protected] Tel: (49) 9771-3528 14 (NIAID; Bethesda, MD, USA; www.niaid.nih.gov), col- of proteinase K–resistant prion protein, a 10 -fold dilu- UK, FRANCE, NORDIC REG. Gerrards Cross, UK laborated with scientists from Prionics AG, (Schlieren- tion, indicating a 10,000-fold increase in sensitivity [email protected] Tel: (44) 1753-892-791 Zurich, Switzerland; www.prionics.com), to develop compared with previously reported methods of vCJD ITALY Genoa, Italy the sensitive bioassay. RT-QuIC, developed only recent- brain tissue detection. [email protected] Tel: (39) 10-570-4948 JAPAN Tokyo, Japan ly, detects the abnormal form of prion protein, which, In addition, in early preclinical studies, the eQuIC [email protected] Tel: (81) 3-5691-3335 screening tool has been found to distinguish between CHINA Shenzen, Guangdong, China plasma and serum samples from scrapie-infected and [email protected] Tel: (86) 755-8375-3877 VISIT uninfected hamsters. 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Mail your paid subscription order accompa- “The eQuIC assay in particular provides a practical, nied with payment to Globetech Media, P.O.B. 800806, Digital Magazine high-throughput, and rapid means of testing for Miami, FL 33280-2410. Instant Online amounts of partially protease-resistant form of the host’s For change of address or questions on your subscription, write to: LabMedica Product Information: prion protein that are several orders of magnitude lnternational, Circulation Ser- vices at above address; or ® below those typically required to cause prion disease by Identify LinkXpress codes of visit: www.LinkXpress.com 1 interest as you read magazine intracerebral inoculation into animals.” The authors concluded that the remarkable resist- ISSN 1068-1760 Click on LinkXpress.com ance to inactivation of prions relative to other Vol.28 No.6. Published, under license, by Globetech Media 2 to reach reader service portal LLC; Copyright © 2011. All rights reserved. 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LINKXPRESS COM LMI-10-11 103 Now Accessible Online: Gene Test Predicts LabMedica Cancer in Pancreatic Cysts INTERNATIONAL INTERACTIVE DIGITAL EDITION

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Image: A diagram showing five different types of pancreatic cysts (Photo courtesy of Johns Hopkins Medical Institutions).

cont’d from cover year avoid the possibility of needless surgery to remove the benign growths. Scientists at Johns Hopkins Kimmel Cancer Center (Baltimore, MD, USA; www.hopkinskimmelcancercenter.org) analyzed DNA from the cyst fluid of 19 intraductal pap- illary mucinous neoplasms and the corresponding normal tissue by massively parallel sequencing for mutations in 169 cancer genes. Fourteen of the 19 tumors showed mutations in the known pancreatic oncogene Kirsten rat sarcoma viral oncogene homolog (KRAS), and 6 of the 19 carried a mutation in the stimulatory G-protein alpha subunit (GNAS), a well-known oncogene in other tumor types. A Interactive Ad with larger set of fluid samples from these cystic neo- Interactive Ad Streaming Video plasms, 96% carried a mutation in at least one of the two oncogenes. In contrast, 44 benign cysts exhib- ited no GNAS or KRAS mutations. KRAS mutations You can now access your latest copy of LabMedica International – as did appear occasionally in a rare type of cyst with a well as archives of past issues – instantly and in full digital format, from relatively low potential to become cancerous. According to the investigators, these rare, mostly the comfort of your computer screen... benign cysts are less challenging to diagnose because of their location within the pancreas and The digital edition, an exact copy of the original print version, is fully type of patient. interactive and allows the reader to reach hundreds of links by way of a Generally, patients with a cyst that appears simple click: harmless and is less than 3 cm in size are moni- tored to watch for growth of the cyst or other con- Click on headlines to read full articles in larger cerning features such as a solid nodule. With cysts NEWS ARTICLES that appear more worrisome, surgical removal is type, with links for further reference often recommended, but the procedure requires Click on the advertisement itself to instantly removal of a portion of the pancreas as well, and ADVERTISEMENTS complications like a pancreatic fistula where fluid reach key product data or vendor contacts from the pancreas leaks through the surgical inci- Click on "LinkXpress" box below each advertise- sion, eating difficulties, and prolonged recovery PRODUCT NEWS can develop. ment or item for further information Bert Vogelstein, MD, a lead author of the study, said, “Further studies on a larger number of patients All links appearing in the digital edition are fully VISIT ® must be done before the gene-based test can be enabled by LinkXpress.com, Globetech’s propri- LINKXPRESS COM widely offered. However, that the technology for etary real-time reader information system developing a gene-based test in this case is relative- READER SERVICE PORTAL ly straightforward because the mutation occurs at one spot in both of the genes.” The study was pub- WORLD LEADERS IN INTERNATIONAL lished the July 20, 2011, issue of Science BIOMEDICAL COMMUNICATIONS Translational Medicine.

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LINKXPRESS COM LMI-10-11 104 LabMedica to read this issue in an interactive digital magazine format click to www.LinkXpress.com Genetic Test Diagnoses Lipid Metabolism Disorder cont’d from cover young relatives that have not large gene rearrangements and the complete rese- developed the clinical symptoms. quencing of the low-density lipoprotein receptor The description of the mutation(s) gene and identifies patients with familial hyperc- encountered will confirm the exis- holesterolemia (FH). tence of FH or not. The platform, called the LipoChip, provides a The detection of a Class A rapid diagnosis, studying all the genes known to mutation is directly associated cause FH, such as low density lipoprotein recep- with FH, and these are mutations tor, (LDLR), apolipoprotein B (APOB), proprotein whose pathogenicity has been vali- convertase subtilisin/kexin type 9 (PCSK9), dated in vitro, or they produce a which permits the specialist to include them in null allele. For Class B mutations, their daily routine. It identifies the large the analysis of the LDLR and rearrangements of at least 10% of the mutations APOB genes will define the presence of a muta- not been described in the literature. The muta- not detected by sequencing. tion that has been previously associated with FH tions occur in regions of the genes where they The LipoChip genetic test (Progenika Biophar- in reports where it has been described in other could have a functional effect related to FH, and ma; SA, Vizcaya, Spain; www.progenika.com) is populations with FH, or that its association with are known as class C mutations. CE-marked (European Conformity), and needs the phenotype has been validated in familial stud- Image: The LipoChip, designed as a genetic diag- only to be performed once in a life time at any age ies. These are mutations in the LDLR and APOB nostic platform to diagnose lipid metabolism disorder to identify the mutations that cause FH, even in genes that could be associated with FH, but have (Photo courtesy of Progenika Biopharma). Tumor Profiling Assay to Improve Cancer Care Digital Pathology Application cont’d from cover ices to develop a flexible tumor-profiling assay that Released for iPad and iPhone at informative loci, forming part of an integrated reduces sample processing costs and turnaround cont’d from cover workflow that translates test results into clear clini- times. In addition, OGT will use its experience in cal decisions. Such a solution would ultimately be data interpretation to adapt its CytoSure Interpret Existing Digital Image Hub users can connect provided either as a testing service or by an analy- software to analyze the results provided by the new the application to their own server to explore and sis kit that could be used in-house by existing clini- assays, making it simple to generate informative, view images from their own image collection. cal laboratories. easy-to-understand reports. SlidePath Gateway provides access to high qual- Oxford Gene Technology (OGT; Oxford, United The new assay will minimize the use of untar- ity whole slide images captured on the kingdom; www.ogt.co.uk), a provider of clinical geted, aggressive primary treatments, which are Leica Microsystems (Wetzlar, Germany; www. genetics and diagnostic solutions, has received a often unnecessary and ineffective, while simultane- leica-microsystems.com) SCN400 slide scanner, funding award of US$1.86 million from the UK ously improving the patient experience and increas- with expert review findings and content provided government-backed Technology Strategy Board ing survival rates. by contributing bodies including the American (Swindon, United Kingdom; www.innovateuk.org) James Clough, OGT’s vice president of clinical Society for Clinical Pathology (ASCP) CheckPath to develop the tumor profiling assay. OGT has con- and genomic solutions, commented, “The new can- Anatomical Pathology External Quality Assessment siderable experience in providing solutions to the cer profiling assay will complement OGT’s other (EQA) Program (2006), Cerviva Cervical Cytology clinical research market and already offers sequenc- microarray and sequencing solutions, further EQA Pilot (2009), National health Service (NHS) ing and microarray services and products as part of expanding the analytical options we provide. Such Breast Screening Pathology EQA Program (2010), its Genefficiency and CytoSure offerings a service facility is novel in the UK and will benefit UK National Urologic Pathology EQA Program For the new project, OGT will utilize its expert- the patient, clinician, and healthcare funder in (2009), and the United Kingdom National External ise in the design of high-throughput genomic serv- terms of quality of care and cost-effectiveness.” Quality Assessment Service (UKNEQAS) HER2 Breast Interpretive EQA Pilot (2011). Browsing folders of images from each of the EQA programs is possible. Individual cases can be selected and the user can view, zoom, and navigate around the slides. Each case includes expert pathol- ogist assessments, which can be viewed with the slides, giving increased insight into the samples. They can also see a sample set of Leica Biosystems’ Novocastra antibody range. Leica Microsystems’ Biosystems Division, also known as Leica Biosystems, offers histopathology laboratories a large product range with appropriate products for each work step in histology and for a high level of productivity in the working processes of the entire laboratory. Dr. Donal O’Shea, Head of Digital Pathology in Leica Microsystems says, “The release of the SlidePath Gateway App displays Leica Micro- systems’ commitment to develop and expand its Digital Pathology portfolio. With this App we are giving everyone the opportunity to try Digital Pathology, access high resolution whole slide images and expert opinions, through a highly intu- itive user interface.”

LabMedica International October/2011 8 LINKXPRESS COM LMI-10-11 105 LINKXPRESS COM LMI-10-11 106 LabMedica to read this issue in an interactive digital magazine format click to www.LinkXpress.com Different Methods Compared for Diagnosis of Clostridium Difficile Infection our diverse methods were evaluated for the The analytic sensitivity and specificity of each as infection with increasing prevalence. The authors FFdetection of Clostridium difficile in stool speci- determined using a combined gold standard were as concluded that while CT remains a sensitive method mens collected in liquid transport medium. follows: for the Wampole C. DIFF CHEK-60 Assay, for the detection of CDI, GDH offers an excellent ini- The methods for detection included an enzyme GDH (Inverness Medical; Princeton, NJ, USA; tial screening method to rule out CDI. The authors immunoassay for the antigen glutamate dehydroge- www.invernessmedicalpd.com) were 100% and concluded that while the performance of each assay nase (GDH), a toxin A and B enzyme immunoassay 93.2%, respectively; for the C. difficile Toxin A/B did not appear to be affected by collection in Cary- (Toxin EIA), cell culture cytotoxicity neutralization Microplate Assay, Toxin EIA (Remel; Lenexa, KS, Blair medium, the PCR method performed better assay (CT) and a real time polymerase chain reac- USA; www.remel.com) were only 82.9% for both. using fresh specimens. While PCR on all stool speci- tion (PCR) assay. The cell culture cytotoxicity neutralization assay mens currently carries a high cost per test, this Scientists from the University of Michigan Health (TrinityBioTech; Carlsbad, CA; USA; www.trinity- method may offer a more rapid alternative to CT for System (Ann Arbor, MI, USA; www.med.umich.edu) biotech.com) achieved 100% sensitivity and specifici- the confirmation GDH-positive samples. The study analyzed a total of 357 stool specimens collected in ty, while for the PCR that was performed on frozen was published in July 2011 in the online journal Cary-Blair transport media (Meridian Diagnostics, specimens, they were 74.3% and 96.6%, respective- Infectious Disease Reports. Cincinnati, OH, USA; www.meridianbioscience. ly. However, the sensitivity and specificity of the com). The goal of their study was to establish an ana- GeneOhm Cdiff PCR Assay improved to 100%, lytically accurate and efficient algorithm for the detec- when performed on 50 fresh stool samples collected Blood Test for Predicting tion of C. difficile infection (CDI) in a patient popula- in Cary-Blair media. This molecular assay is a prod- Childhood Diabetes tion using samples collected in a specific transport uct of Becton, Dickinson and Company (Franklin medium and to determine whether the sensitivity Lakes, NJ, USA; www.bd.com). Reconsidered and specificity of PCR was affected by freezing sam- Clostridium difficile infection (CDI) caused by tox- ples before testing. igenic strains of C. difficile is primarily a nosocomial he glycosalated hemoglobin (HbA1c) blood test TTis a rapid and convenient way of diagnosing diabetes. The HbA1c test has become the preferred way to diagnose diabetes among the millions of patients who have the disease, but are asymptomatic. The simple test measures longer-term blood sugar levels without requiring patients to fast overnight. Scientists at the University of Michigan, (Ann Arbor, MI, USA; www.umich.edu), studied whether the assay could be used to make a diagnosis of diabetes mellitus in adolescents, using the standardized values for adults. For the study, they evaluated the testing results of 1,156 obese and overweight adolescents, aged 12-18 years. The American Diabetes Association, (Alexandria, VA, USA; www.diabetes. org), recommends screening only obese and overweight children because their weight puts them at higher risk for developing diabetes. Individuals were defined as having diabetes mellitus if their fasting plasma glucose (FPG) was equal to or greater than 126 mg/dL; a 2-hour plasma glucose (2-hr PG) equal to or greater than 200 mg/dL or were prediabetic where the FPG is between 100 and 126 mg/dL; and the 2-hr PG is between 140 and 200 mg/dL. According to the guidelines, individuals without symptoms would be classified as having diabetes if HbA1c values reach 6.5% and as having prediabetes if HbA1c values were between 6.0% and 6.4% on two separate tests. Only four of the adolescents studied had undiagnosed diabetes mellitus. When assessing FPG to detect diabetes, an HbA1c of 6.5% had sensitivity rates of 75.0% for adolescents and 53.8% adults, although the specificity was higher. Additionally, when assessing FPG to detect diabetes mellitus, an HbA1c of 5.7% had sensitivity rates of 5.0% and 23.1%, and specificity rates of 98.3% and 91.1% for adolescents and adults, respectively. These analyses suggest that HbA1c is a poorer predictor of diabetes mellitus and prediabetes for adolescents compared with adults and performance was poor regardless of whether FPG or 2- hr PG measurements were used. Joyce M. Lee, MD, MPH, a pediatric endocrinol- ogist, and lead author of the study, said, “We found that hemoglobin A1c is not as reliable a test for identifying children with diabetes and prediabetes compared with adults and using this test in children may lead to missed cases.” The study was published online ahead of print on December 30, 2010, in the Journal of Pediatrics. LabMedica International October/2011 10 LINKXPRESS COM LMI-10-11 107 LINKXPRESS COM LMI-10-11 108 LabMedica to read this issue in an interactive digital magazine format click to www.LinkXpress.com Modified Tuberculosis Stain Reveals Worm Eggs he Ziehl-Neelsen staining (ZNS) technique has appeared brownish-reddish in ZNS and TTbeen evaluated for the diagnosis of helminth were detected in six of 263 archived ZNS eggs in sputum and different modifications of the slides corresponding to five patients. One technique have been compared. hundred sputum samples from 43 Eggs of the parasitic lung fluke, that causes patients were examined with three tech- paragonimiasis, can be found in sputum and can niques, which revealed that six patients be stained with the classical reagents for acid – fast had paragonimiasis, from 13 positive bacilli, and with some alterations, ZNS is very samples. Sensitivity per slide of the FECT effective for diagnostic purposes. was 84.6%; for ZNS it was 76.9%; and for An international team working with a non- the WF technique, it was 61.5%. Briefly in geographic areas where paragonimiasis may be governmental organization in Laos, (Service heated ZNS slides contained more eggs than slides endemic. Fraternel d’Entraide; Vientiane, Lao People’s heated for five minutes, 42 eggs per slide (eps) ver- Paragonimiasis is a food-borne parasitic infec- Democratic Republic; www.sfe-laos.org), exam- sus 29 eps. Bloodstained sputum portions con- tion caused by the lung fluke, most commonly ined a paragonimiasis index case’s sputum with tained more eggs than unstained parts. Paragonimus westermani. It infects an estimated wet film direct examination (WF) and ZNS. They The authors concluded that Paragonimus eggs 22 million people worldwide and Paragonimus also reexamined stored ZNS slides from two could easily be detected in today’s widely used species are distributed throughout the Americas, provinces and compared prospectively WF, ZNS, ZNS of sputum slides. The ZNS technique appears Africa, and Southeast Asia. P. westermani is dis- and formalin-ether concentration technique superior to the standard WF sputum examination tributed in Southeast Asia and Japan and P. kelli- (FECT) for sputum examination of patients with for paragonimiasis and eliminates the risk of tuber- cotti is endemic to North America. The study was chronic cough, from September 2009 until April culosis transmission. Additional operational costs published online on May 17, 2011, in the journal 2010. Finally, they compared the three techniques per slide were zero for ZNS, US$0.10 for WF, and Public Library of Science Neglected Tropical and assessed excess direct costs associated with $0.79 for FECT. The authors recommend that in Diseases. the use of different diagnostic methods. addition to ZNS use for the diagnosis of TB, rou- Paragonimus eggs were clearly visible in WF tine examination for Paragonimus eggs of each Image: An egg from the parasite Paragonimus west- and ZNS sputum samples of the index case. They slide with the x10 lens, total magnification x100, ermani (Photo courtesy of the CDC). Multiplex Assay Detects Drugs in Oral Fluid single multiplex assay detects up to 97 drugs A point of collection biochip analyzer was guidelines for oral fluid testing (2010) and the AAand drug metabolites from an undivided oral recently launched by Randox – the “Evidence Australian and New Zealand procedures for speci- fluid sample. Matrix dedicated kits ensure reliable MultiStat,” which processes multiple results in less men collection and the detection and quantification assay performance including good specificity, even than twenty minutes. The Biochip platform is mul- of drugs in oral fluid AS 4760-2006 (2006). at lower drug concentrations. timatrix; therefore, a number of sample types Testing of oral fluid specimens is becoming Randox Laboratories (Crumlin, United King- including oral fluid, whole blood, urine, and post- increasingly popular in the workplace, prisons, and dom; www.randox.com) biochip array technology mortem tissue can be run on the system. The in drug rehabilitation clinics. With a number of ben- offers a diagnostic grade testing solution with repro- Randox line of Evidence immunoassay analyzers efits to be gained from onsite testing, oral fluid will ducible results. The Biochip arrays provide a rapid generate quality control data automatically with continue to be put into practice for drugs of abuse turnaround time, which is advantageous for onsite every run, ensuring that each test has been carried screening. As the prevalence of designer drugs and workplace drug testing. In comparison, a four-plate out successfully. new variations of drugs enter the market, work- automated enzyme linked immunosorbent assay Randox biochip arrays meet the limit of detec- place drug testing is set to increase in a bid to detect (ELISA) system requires thirteen times longer to tion requirements for both the European Workplace and deter use. Oral fluid testing is also used as an process the same results. Drug Testing Society (EWDT; www.ewdts.org) aid in clinical diagnosis.

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LINKXPRESS COM LMI-10-11 109 for daily laboratory medicine news click to www.labmedica.com LabMedica Real-Time PCR Assay Diagnoses Cutaneous Leishmaniasis real-time polymerase chain reaction (PCR) assay pro- AAvides consistent results for cutaneous leishmaniasis within hours of sample receipt. The diagnostic test, which is called the SMART Leish Real- Time PCR assay, gives results even when the numbers of parasites in the skin are so low that microscopy and culture results will be negative at day 30. The SMART Leish PCR assay was developed in partner- ship among Walter Reed Army Institute of Research (WRAIR; Silver Spring, MD, USA; http://wrair-www.army.mil), the Army Medical Research and Materiel Command (Fort Detrick, MD, USA; https://mrmc.detrick.army.mil), and the commercial partner, Cepheid USA, Inc. (Sunnyvale, CA, USA; www.cepheid.com) to address the global health issue of cutaneous leishmaniasis that occurred in thousands of US troops serving in Iraq and Afghanistan. The SMART Leish Real-Time PCR assay has now been approved by the US Food and Drug Administration (FDA; Silver Spring, MD, USA; www.fda.gov). “In the near future, this assay may be utilized at additional strategically located [Department of Defense] DoD medical facilities, enhancing our capability to provide rapid diagnosis to service members and improve patient management,” said Col. Max Grogl, Walter Reed Army Institute of Research’s director. Endemic throughout Africa, Asia, Europe, as well as the Americas, leishmaniasis is a protozoan parasitic disease caused by single-cell organisms transmitted through the bite of a sand fly. Cutaneous leishmaniasis is the most common form of the disease. Though not considered life threatening, the disease can cause disfiguring skin ulcers that take months to heal and cause scarring. Traditional testing methods require a small tissue sample of the skin ulcer lesion. The samples are examined under microscope and culture to determine the presence of the intracellular form of the Leishmania parasites called amastigotes. These traditional testing methods can require anywhere from 30 minutes to four weeks to produce results.

Image: Colored scanning electron micro- graph (SEM) of Leishmania sp. protozoa (Photo courtesy of SPL).

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LabMedica International 13 October/2011 LINKXPRESS COM LMI-10-11 110 LabMedica Millions of PCR Reactions Occur in Single Tube

mproved polymerase chain reac- vides a ‘lab-in-a-tube’ solution, which IItion (PCR) technology enables greatly simplifies PCR workflow, with millions of PCR reactions in a single no need for expensive instrumenta- tube. Following fragmentation using tion or automation. With next-genera- specifically selected restriction tion nanoscale PCR, reactions are par- endonucleases, and denaturing of allelized at the molecular level so that the DNA sample, a selector probe no separate time-consuming library library is added. Each probe can preparation stage is required. For a hybridize to both ends of a targeted project targeting 100 genes in 1,000 DNA restriction fragment; it guides samples, HaloPlex Target Enrichment the targeted fragments to form cir- Kit reduces the total sample prepara- cular DNA molecules. Only circular tion time by as much as 80 percent. DNA targets are amplified, ready for Genomic regions of interest are sequencing using any next-genera- enriched at the same time as the tion procedure, and results are high- introduction of sample barcoding and ly reproducible. sequence motifs.” The new HaloPlex Target Enrich- The HaloPlex PCR reagent kit for ment Kit is available exclusively in high performance targeted rese- the UK from Cambio (Cambridge, quencing applications include studies United Kingdom; www.cambio.co. of candidate genes involved in rare uk). It represents a new concept in inherited diseases, pathway sequenc- next-generation sequencing, reducing in matched tumor and normal ing costs and saving up to 80 % in samples, and clinical sequencing for sample preparation time. BRCA gene assays. According to Dr. Naeem Ahmed, Cambio’s technical support specialist, Image: The HaloPlex Target Enrichment Kit (Photo courtesy of Cambio). LINKXPRESS COM LMI-10-11 128 “This new Halo Genomics kit pro-

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LABORATORY LABELS SPECIFIC AUTOMATIC SLIDE SCANNER CILS PROTEIN ANALYZER CHEMISTRY ANALYZER Ventana Medical Systems The CILS-9000 computer-printable, Goldsite Diagnostics iCubio Biomedical Technology The iScan HT holds 360 slides, and durable label range provides perma- The Nephstar analyzer is a benchtop The iChem-740 offers constant is designed to increase operational nent bonding to tubes, straws, and nephelometric analyzer for rapid speed 400T/H or 500T/H with ISE, efficiencies in anatomic pathology other container stored at -196 °C. quantitative measurements of spe- designed with a user-friendly soft- laboratories. Key features include The labels are considered ideal for cific proteins in blood and urine sam- ware interface, automatic barcode, fast scan speeds and high quality sample identification during long- ples. Key features include automatic and LIS system. Additional benefits images, along with a slide transport term, multi-freeze thaw cycles and calibration and blanking, with results include high performance and accu- system that improves reliability and cryogenic storage. available in less than three minutes. rate results. safe handling of slides.

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Human Papillomavirus Assays Identify Risk of Cervical Cancer n assay has been evaluated that May 2008 to August 2009 at 61 clin- dard parameters of test performance high-risk HPV genotypes provides AAgenotypes human papillo- ical centers across the US. The study for those diagnosed with cervical important additive information to mavirus (HPV) in cytology samples focused on 1,578 (82.3%) of the intraepithelial neoplasia (CIN) 2 or Papanicolaou (Pap) testing. Screening from women with atypical squamous 1,918 women who had ASC-US worse and CIN 3 or worse end for the two highest risk types, HPV- cells of undetermined significance cytology; all 1,578 women under- points. Both tests were highly concor- 16 and HPV-18, can provide predic- (ASC-US). The qualitative multiplex went colposcopy and had valid HPV dant for patients characterized as less tive information about a woman’s assay provides specific genotyping tests and cervical biopsy results. Two than CIN 2 and for those equal to or risk for having cervical precancer or information for HPV Types 16 and first generation HPV assays were greater than CIN 2 with minor cancer.” The cobas 4800 HPV Test 18, while concurrently detecting the compared to the second-generation insignificant disagreement. has now been granted US Food and other 12 high-risk HPV types in a cobas 4800 HPV test. Mark H. Stoler, MD, professor of Drug Administration, (FDA; Silver pooled result. From cellular input, ß- The cobas 4800 HPV Test (Roche surgical pathology at the University of Springs, MD, USA; www.fda.gov) globin is used as an internal control Molecular Systems; Pleasanton, CA, Virginia Health System, (Charlottes- approval. The study was published in to assess specimen quality and identi- USA; http.// molecular.roche.com) ville, VA, USA; www.healthsystem. March 2011, in the American fy specimens containing factors that detected an overall prevalence rates virginia.edu), said, “Screening for Journal of Clinical Pathology inhibit the amplification process. of 32.6% with high risk HPV (14 In a collaborative study, the clini- genotypes), 8.2% with HPV-16, and cal performance of the cobas 4800 2.9% with HPV-18. The performance Dual Testing Recommended HPV Test was evaluated by genotyp- of the cobas 4800 HPV Test is very for Diabetic Children ing liquid cytology samples of 47,208 similar to that of the Hybrid Capture he hemoglobin A1C (HbA1C) results. women during routine screening. 2 test (Qiagen; Gaithersburg, MD, TTblood test should be used in con- The study found that the recom- The screening was carried out from USA; www.qiagen.com) for all stan- junction with the oral glucose toler- mended blood test may not be enough ance test for screening overweight to detect type 2 diabetes in over- children for diabetes. weight children, missing more than Although the glycosalated HbA1C two-thirds of children at high-risk for blood test is easier on the patient, as it the condition. The investigators found does not require fasting, it may not be that performing two tests, both the sensitive to catch overweight children recommended hemoglobin A1C test who are at a high risk of developing and an oral glucose tolerance test, type 2 diabetes. could dramatically reduce the risk of Scientists at the Children’s Mercy delayed diagnosis in overweight chil- Hospital (Kansas City, MO, USA; dren. www.childrensmercy.org) evaluated Wayne Moore, MD, PhD, chief the charts of 629 overweight and ado- and medical director of the en- lescent patients who had both the docrine/diabetes section at Children’s HbA1c and an oral glucose test. They Mercy Hospital, said, “Lifestyle found that 40% of type 2 diabetes changes and early treatment can help patients and 67% of high-risk patients delay disease progression of diabetes. identified through the oral glucose tol- It is important that patients are diag- erance test would have shown a nor- nosed as early as possible for the best mal glycemic status if only the hemo- outcomes.” The findings were pre- globin A1C test were used to diagnose sented at the Pediatric Academic them. Nearly nine out of ten patients Societies Annual Meeting, held from had normal blood glucose levels April 30 – May 3, 2011, in Denver according to their hemoglobin A1C (CO, USA; www.pas-meeting.org).

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LINKXPRESS COM LMI-10-11 115 LabMedica to read this issue in an interactive digital magazine format click to www.LinkXpress.com Wireless Connectivity Transforms POC Blood Glucose Testing he National Health Service (NHS; United details, configuration information, and comments. TTKingdom; www.nhs.uk) Trust has installed The data transmitted by the meters is managed by wireless blood glucose meters in wards, clinics, cobas IT 1000, which permits patient validation, and theaters across all three of its acute hospital operator recognition, and material lot tracking. sites in Mid Yorkshire (United Kingdom). Wireless “Our new blood glucose testing system helps devices, connected by intelligent IT systems are us to fulfill CPA requirements in a number of vital for patient safety and for meeting Clinical ways,” explained Tracey Eastwood, senior BMS Pathology Accreditation (CPA) requirements for responsible for POC testing within the Trust. “It Point of Care (POC) testing. provides a central record of all data, including QC The meters are linked wirelessly to the records, which, in turn, provide an important Hospital Information System (HIS) via the Roche audit trail. The system also enables us to manage POC data management solution, cobas IT 1000, reagents, calibrations, and quality control central- allowing them to be managed centrally in accor- ly. Centralized calibration of glucose meters has dance with national guidelines for POC devices. removed the risk of operator errors and the QC In addition to transmitting patient results, Roche lockout feature ensures that operators perform the Diagnostic’s (Burgess Hill, United Kingdom necessary QC activities at the required intervals, www.roche-diagnostics.co.uk) blood glucose meter, otherwise the meter cannot be used.” While there Image: The Accu-Chek Inform II blood glucose meter Accu-Chek Inform II records quality control (QC) is no cure for diabetes at the moment, manage- (Photo courtesy of Roche Diagnostics). results, operator and patient details, consumable ment of the disease has become more effective. Alcohol Overuse Often Undiagnosed in HIV-Infected Persons cientists evaluated the ability of the carbohy- SSdrate-deficient transferrin (CDT) biomarker to detect unhealthy alcohol consumption among people infected with Human immunodeficiency virus (HIV). Although CDT, often measured as %CDT, can detect very heavy drinking, whether it does so in people with HIV in a clinically useful manner has yet to be established. Investigators at the Boston University School of Medicine (BUSM; MA, USA; www.bumc.bu.edu) and colleagues evaluated the ability of %CDT and gamma glutamyltransferase to detect three levels of unhealthy alcohol consumption: at-risk, heavy, and frequent heavy drinking as determined by a reference standard questionnaire. Of 300 subjects, 103 reported current consumption at at-risk amounts, and 47 reported heavy amounts. For at-risk drinking, sensitivity of %CDT was 28%, meaning the test detected only 28% of those with unhealthy alcohol use. For heavy drinking, sensitivity was 36%. According to the scientists, these findings suggest that %CDT is not sufficiently sensitive for use in screening for unhealthy alcohol use by people with HIV infection. “There is evidence that early intervention for unhealthy alcohol use can be effective but early clinical signs are often missed and unhealthy alcohol use often goes undiagnosed by HIV healthcare providers,” explained principal investigator Jeffrey Samet, MD, MA, MPH, professor of medicine at BUSM. “Unfortunately among HIV-infected adults with alcohol problems, %CDT had poor overall accuracy for detecting unhealthy drinking,” he added. Alcohol use is common in HIV-infected persons. It can interfere with HIV medication adherence, lower CD4 cell count, and even cause hepatic injury. Furthermore, HIV coinfection with viral hepatitis is common and both HIV and viral hepatitis are adversely impacted by alcohol. For these reasons, detection of unhealthy alcohol use is important in the clinical care of HIV-infected individuals.

LabMedica International October/2011 18 for daily laboratory medicine news click to www.labmedica.com LabMedica Electronic Pipette Dispenses Volumes of 0.1 µL - 5 µL new electronic pipette accurately dispenses small piston movement allows complete emptying of the tip, AAvolumes of liquid. The pipette is suitable for han- making it possible to dispense very small volumes from dling 0.1 µL - 5 µL of liquid and is targeted especially the air. for molecular biology laboratories. It is especially useful Pipetting small volumes against receiving vessel for applications such as polymerase chain reaction wall or under the liquid surface to get all liquid out of (PCR) and microplate pipetting. the tip causes contamination risk, decreased precision, The liquid is dispensed from the pipette tip very and slow pipetting work. Usually contaminations can rapidly, which ensures that the tip is completely emp- be avoided by changing the tip between dispensing, tied. There is no need to touch the receiving vessel but with the eLINE 0.1–5 µL dispensing from the air wall during pipetting and no drop of liquid is left at enables continuous work with the same tip, as there is the tip. As a result, the handling of the liquid is con- no need to touch the vessel or liquid. tamination free, more precise, and faster than with Biohit Inc. is a subsidiary of Biohit Oyj (Helsinki, other pipettes. Finland) a company that develops, manufactures, and The biotechnology company Biohit (Neptune, NJ, markets liquid handling and diagnostic products for use USA; www.biohit.com) launched the electronic pipette in health care, research, and industrial laboratories. under the commercial name eLINE 0.1–5 µL. The new pipette has a Super Pipetting (SP) feature and its rapid Image: The eLINE electronic pipette (Photo courtesy of Biohit). Phagocyte Signatures Differentiate Between Viral and Bacterial infections rapid blood test that accurately tells the differ- AAence between bacterial and viral infections will lead to better treatment outcomes for infected patients. The immune systems of patients with bacterial infections behave differently than the immune systems of patients with viral infections, and the test was based on these differences. Robert S. Marks at National Institute of Biotechnology in the Negev, Ben-Gurion University of the Negev (Be’er Sheva, Israel; www.bgu.ac. il/nibn), Daria Prilutsky, and colleagues differentiat- ed between viral and bacterial acute infections using chemiluminescent signatures of circulating phago- cytes. Bacterial and viral infections can produce the same symptoms but it is very important to distinguish between them when deciding on treatment. For example, antibiotics work for bacterial infections but not for viruses. If left untreated until results of a throat culture, for instance, are received, bacterial infections can get worse. But needlessly giving antibiotics to patients with a viral infection could contribute to the growing problem of antibiotic-resistant bacteria. Since current diagnostic methods to sort out the two kinds of infection are time-consuming and may not be completely accurate, the scientists decided to develop a new test that would enable doctors to make the right diagnosis rapidly. The method is time saving, easy to perform and can be commercially available. It could be implemented in various medical institutions as an adjunct to clinical decision making said the scientists. A report of the new rapid blood test appears in ACS’ journal Analytical Chemistry. The scientists LINKXPRESS COM LMI-10-11 116 concluded, “The two infections exhibit completely different types of chemiluminescent signatures, each one described by its own characteristics, proving that the oxidative potential of the innate immunity can indeed serve as a prognostic or diagnostic marker.”

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IMMUNOASSAY READER URINALYSIS SYSTEM CHEMISTRY ANALYZER PIPETTE SERIES NewScen Coast BioPharmaceutical Ave Science & Technology Beckman Coulter Biohit The NewSign is an open system The fully automated system com- The AU5800 series is designed to The eLINE 0.1-5 µl single-channel reader, and can read any manufac- bines the efficiency of AVE-764B improve processing time, and meet family of pipettes with Super turer’s test strips or cassettes with- and AVE-752, maximizing the bene- the demands of high- and ultra-high- Pipetting feature offers rapid piston out any modification to the instru- fits of both into one effective and reli- volume clinical labs. Specific models movement and complete emptying ment. The easy-to-use system also able system. Key features include in the series are available in one- to of the tip, making it possible to dis- allows the input of all patient data. accurate results, rapid processing, four-module configurations, with the pense small volumes from the air. and comprehensive reporting. option of including either a single or The pipettes serve to avoid contam- dual ISE flow cell. ination, while increasing throughput.

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Multiplex Analytical Control Introduced for Cystic Fibrosis Testing multiplex analytical control for cystic fibrosis rotating genomic DNA controls – enabling labs to AAtesting is now labeled for in vitro diagnostic improve error detection with fewer controls, reduc- use. The Accurun 644 cystic fibrosis control is ing costs, improving throughput, and increasing available to clinical pathologists in the European revenue potential. market. The synthetic, multiplex control is an effec- A product of SeraCare (Milford, MA, USA; tive mechanism for identifying mutations in the cys- www.seracare.com), the Accurun 644 control for tic fibrosis CFTR gene, covering all mutations in the cystic fibrosis testing with CE marking is available Luminex (Austin, TX, USA; www.luminexcorp. in Europe for IVD testing after serving as a highly com) xTag cystic fibrosis 39 kit v2 IVD assay. The effective tool for research purposes in the United kit is a device used to simultaneously detect and States for two years. identify a panel of mutations and variants in the Cystic Fibrosis (CF) is a multisystem disease that cystic fibrosis transmembrane conductance regula- can affect the respiratory tract, pancreas, sweat tor (CFTR) gene in human blood specimens. glands, intestine, male genital tract, and liver. By covering the largest number of mutations in Pulmonary disease is one of the most notable char- a single vial of any commercial control, the acteristics of CF and is the leading cause of death in Accurun 644 control offers labs advantages in CF patients. terms of both quality control and cost. Using the SeraCare’s portfolio includes diagnostic controls, multiplex control allows for detection of significant plasma-derived reagents and molecular biomarkers, Image: The Accurun 644 cystic fibrosis control (Photo errors missed or more difficult to identify using biobanking, and contract research services. courtesy of SeraCare).

LINKXPRESS COM LMI-10-11 117 for daily laboratory medicine news click to www.labmedica.com LabMedica Noninvasive Cholesterol Testing Becomes Available to Public oninvasive cholesterol testing technology will Gamma-Dynacare Medical Laboratories (Brampton, NNbe available to the public through a clinical ref- Canada; www.gamma-dynacare.com), one of erence laboratory testing for the first time. PreVu is Canada’s largest and medical laboratories, to intro- a noninvasive risk assessment technology that eval- duce a laboratory processed format of its PreVu non- uates the additional risk a person may have for coro- invasive cholesterol test technology. nary artery disease (CAD) by conveniently and pain- Under the terms of the agreement, Gamma- lessly testing their skin cholesterol level. Dynacare will be responsible for all costs related to High levels of skin cholesterol have been shown the final development stages of the PreVu LP test as to be correlated to CAD as measured by stress test, well as the development and implementation of an The PreVu LP test noninvasively measures the angiography, coronary calcium, carotid intima- automated system to process the test at a central- amount of cholesterol that has been deposited in media thickness, inflammatory markers of vascular ized facility. Gamma-Dynacare will also provide skin tissues by painlessly and rapidly collecting skin disease, previous heart attack incidents, and logistical support for collection, transportation and cells from the palm of the hand using a medical Framingham risk score. results reporting utilizing Gamma’s internal infra- adhesive collection device, which would then be Miraculins Inc. (Winnipeg, Canada; www. structure, which handles tens of thousands of spec- sealed and sent to a Gamma-Dynacare laboratory for miraculins.com), a medical diagnostic company imens daily, and delivers more than 40 million tests processing. focused on developing and commercializing diag- annually. As part of the agreement, Miraculins has nostic tests and risk assessment tools for unmet clin- awarded Gamma-Dynacare the exclusive rights to Image: The PreVu point-of-care skin cholesterol test ical needs, has signed a Letter of Intent with process all PreVu LP Tests sold in Canada. (Photo courtesy of Miraculins). Protein Biomarker Improves Early Diagnosis of Alzheimer’s he level of specific biomarkers in the plasma and TTcerebrospinal fluid (CSF) facilitates the early diagnosis of dementia in Alzheimer patients. The biomarker, soluble circulating low-density lipoprotein receptor-related protein-1 (sLRP), provides key plasma binding activity for Alzheimer’s disease (AD) amyloid-β peptide (Aβ). Scientists at the University of Gothenburg (Gothenburg, Sweden; www.gu.se) investigated the presence of sLRP in a total of 60 patients who were being investigated for dementia and took part in the study, along with 20 healthy controls. The study group included 14 patients with mild cognitive impairment (MCI) who progressed to AD (MCI-AD), 14 with AD, and 14 neurologically healthy controls. The investigators determined the amount of plasma oxidized sLRP and Aβ40/42 sLRP-bound, other proteins-bound and free plasma fractions, CSF tau/Aβ42 ratios, and mini- mental state examination (MMSE) scores in the study participants. The sLRP normally binds 70% - 90% of plasma Aβ preventing free Aβ access to the brain. In AD, Aβ binding to sLRP is compromised by increased levels of oxidized sLRP, which does not bind. In MCI-AD patients prior to conversion to AD and AD patients, the increases in oxidized sLRP and free plasma Aβ40 and Aβ42 levels were 4.9 and 3.7-fold, 1.8, and 1.7-fold and 4.3 and 3.3-fold, respectively. In MCI-AD and AD patients, increases in oxidized sLRP and free plasma Aβ40 and Aβ42 correlated with increases in CSF tau/Aβ42 ratios and reductions in MMSE scores. The 24 patients who were considered as stable MCI patients were followed over a 2-4 years period had normal CSF tau/Aβ42 ratios, but increased oxidized sLRP levels. The scientists concluded that these measurements could also be used to identify AD during the early stages of the disease. In such cases, the biomarkers can be used to identify those patients with mild symptoms who are most likely to benefit from treatment. The investigators also saw that patients who had not yet met all the clinical criteria for AD had similar levels of the biomarkers in their spinal fluid to patients who had developed the disease fully. The study was published in April 2011, in the Journal of Alzheimer’s Disease.

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RANDOM ACCESS SYSTEM TURBIDIMETRY REAGENT MOLECULAR HBA1C/HEMOGLOBIN Bio-Rad Laboratories BioSystems DIAGNOSTICS SYSTEM ANALYZER The Tango Optimo benchtop, fully The latest reagent is designed for Cepheid Ceragem Medisys automated system is designed for the measurement of AT-III concen- The GeneXpert Infinity-80 has been The Cera-Stat 2000 features a full- blood group serology assays, with tration in human serum or plasma. redesigned for increased capacity, color touch screen, built-in printer, seven-day on-board reagent stor- AT-III plays an important role in mod- improved efficiency of operation, and and multilingual operation. Additional age. Key benefits include flexible ulating hemostasis as a natural anti- greater reliability. Added features features include voice guide, patient operations, low operating costs, coagulant mechanism, with individu- include adjustable touch screen, ID, large capacity memory, fast and easy sample loading and operation, als with low AT-III levels reported to expanded conveyor and loading reliable results, and a three-minute and increased productivity. have an increased thrombosis risk. zone, and expanded test shuttle. assay time.

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Genomic DNA from Fecal Specimens Helps Identify EHEC igh throughput pathogen examination of stool HHsamples identifies the enterohemorrhagic Escherichia coli (EHEC) responsible for the epidemic of bloody diarrhea associated with hemolytic-uremic syndrome (HUS) that appeared in Germany. The automated MagNA pure sample preparation system for nucleic acid isolation and LightCycler Real-Time polymerase chain reaction (PCR) instrument from Roche Applied Science (Penzberg, Germany; www.roche-applied-science.com) have been used for high throughput examination of EHEC pathogens in primary stool samples during the E.coli epidemic. In a study carried out by Ralf Bialek [Laboratory of Dr. Krause and colleagues] (MVZ GmbH; Kiel, curve analysis discriminating the toxin gene sub- Germany), human stool samples were processed types. The bacterial parC gene (encoding the topoi- using the high throughput MagNA Pure 96 work- somerase IV subunit of Enterobacteriaceae) was station, isolating high quality total genomic DNA used as an extraction control to prove presence of from primary fecal specimens. Targeting the toxin extracted DNA and to exclude PCR inhibitors. genes of EHEC by a LightCycler Real-Time PCR The team evaluated a novel four-color multiplex test demonstrated that fecal specimens could be assay using hydrolysis probes for the LightCycler used as starting material to detect EHEC infection 480 Instrument, targeting both toxin genes (stx1 in epidemic situations reducing the turnaround and stx2), the wzx gene (marker for the O104 from at least overnight incubation to hours. serotype), and an internal control. This new assay The fully automated robotic MagNA Pure 96 enables the analysis of suspected samples in a sin- Instrument used in this study isolates nucleic acids gle reaction, for a faster more cost-effective time-to- from 96 samples in approximately one hour. The result, which is particular important during an out- Roche platform is an efficient, cost-effective way to break, when many samples have to be studied in prepare template DNA from large numbers of stool short time. samples in epidemic situations. Subsequent More than 3,400 laboratory confirmed EHEC LightCycler 480 Real-Time PCR was found to be and HUS cases have been reported, 39 of them accurate and reproducible using proven specific, with fatal outcome according to the Robert Koch .rki.de) report, sensitive PCR primers and probes, targeting the Institute’s (Berlin, Germany; www dated June 20, 2011. The majority of EHEC infect- Shiga toxin genes of EHEC, available as LightMix ed individuals live in Germany, but significant num- kit EHEC. bers of infections have also been reported in A new pathogen universal protocol was estab- Sweden, Russia, as well as other European coun- lished using a 200 µL sample volume and 100 µL tries. elution volume. E. coli Shiga toxin genes were amplified in the presence of two pairs of fluores- Image: The MagNA Pure 96 instrument, designed to cently labeled hybridization probes targeting stx-1 isolate nucleic acids from samples (Photo courtesy of and stx-2, followed by LightCycler system melting Roche Applied Science).

LabMedica International October/2011 22 LINKXPRESS COM LMI-10-11 119 for daily laboratory medicine news click to www.labmedica.com LabMedica Chromogenic Screening Plate Production for E. coli Increased he current outbreak strain of the antimicrobial susceptibility testing on TTenterohemorrhagic Escherichia coli Oxoid Iso-Sensitest agar or Mueller- (EHCH) in Germany belongs to the Hinton agar with cefpodoxime combina- Escherichia coli O104 serogroup. tion discs and identification using the Production and distribution of a chro- DuPont Qualicon RiboPrinter microbial mogenic screening plate for rapid detec- characterization system. tion of extended spectrum β-lactamase- Oxoid and Remel are brands of producing (ESBL) organisms, such as E. Thermo Fisher Scientific. coli O104, has been increased. In the past, most outbreaks of Image: The Brilliance ESBL is a chromogenic screening plate for the detection of hemolytic uremic syndrome (HUS) have ESBL organisms within 24 hours (Photo been associated with E. coli O157, but courtesy of Oxoid). the current outbreak strain belongs to the E. coli O104 serogroup. The causative strain produces Shiga toxin 2 and shows high resistance to 3rd generation cephalosporins (due to the ESBL resistance mechanism), as well as broad antimicrobial resistance to, among others, trimethoprim/ sulphonamide and tetracycline. The Oxoid (Basingstoke, England; www.oxoid.com) and Remel (Lenexa, KS, USA; www.remel.com) include culture on Oxoid brilliance ESBL agar, which gives results within 24 hours. Dr. Roger Stephan, Institute for Food Safety and Hygiene, University of Zurich (Switzerland; www.ils.uzh.ch), suggested a diagnostic strategy based on the capability of the VTEC O104 outbreak strain to produce an ESBL. He commented, “Positive fecal samples or food enrichment cultures can be streaked onto Brilliance ESBL agar. On this medium, ESBL-producing E. coli appear as blue colonies after 24 hr. incubation. Suspect colonies will then be confirmed by [polymerase chain reaction] PCR for the vtx genes. Since the prevalence of ESBL-producing E. coli in healthy people and food items should be low, this could really improve chances to isolate the strains responsible for the positive PCR screening.” Other methods of identification include direct toxin detection using the Remel ProSpecT Shiga Toxin E. coli microplate assay; isolation on media, such as Oxoid MacConkey Agar; toxin detection using the Oxoid VTEC-RPLA kit, following growth on Oxoid brain heart infusion agar;

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LabMedica International 23 October/2011 LINKXPRESS COM LMI-10-11 120 LabMedica to read this issue in an interactive digital magazine format click to www.LinkXpress.com Handheld Microscope Detects Melanomas new type of microscope provides a high-resolu- roughly 300 µm x 300 µm in size and fits AAtion image of skin areas of any size with results seamlessly alongside the neighboring in just a few fractions of a second. It can be held by slice; a computer program then assembles hand without blurring the resulting picture. these to generate the overall picture. The The new microscope examines to a resolution of difference between this technology and a five µm–for results with comparable resolution val- scanner microscope: all of the image ues, a conventional microscope would either be slices are recorded simultaneously. restricted to a tiny field forced to scan the surface: The imaging system consists of three conventional equipment slowly sweeps the surface, glass plates with the tiny lenses applied to point by point, recording countless images before them, both on top and beneath. These combining them to create a complete picture. The three glass plates are then stacked on top drawback–it takes quite a while before the image is of one another. Each channel also con- complete. tains two achromatic lenses, so the light passes tion of the lenses: simply take a glass substrate, Designed by researchers at the Fraunhofer through a total of eight lenses. Several steps are apply liquid polymer, press the die down into it, and Institute for Applied Optics and Precision Engineer- involved in applying the lenses to glass substrates: expose the polymer layer to UV light. In a process ing IOF (Jena, Germany; www.|fraunhofer.de), the first, the scientists coat a glass plate with photoresis- similar to the dentist’s method of using UV light to new microscope combines the best of both types of tant emulsion and expose this to UV light through a harden fillings, here, too, the polymer hardens in microscope: because it foregoes the grid, it needs to mask. The portions exposed to the light become the shape the die has printed into it. What remains make just a single measurement, and that is what hardened. If the plate is then placed in a special are tiny lenses on the glass substrate. “Because we makes it very fast. solution, all that remains on the surface are lots of can mass-produce the lenses, they’re really pretty “Our ultrathin microscope consists of not just tiny cylinders of photoresist; the rest of the coating low-cost,” Wippermann added. one but a multitude of tiny imaging channels, with dissolves away. Now, the scientists heat the glass lots of tiny lenses arrayed alongside one another. plate: the cylinders melt down, leaving spherical Image: The thin handheld microscope, designed for obtaining high-quality images in less time than tradi- Each channel records a tiny segment of the object at lenses. Working from this master tool, an inverse tional scanning microscopes (Photo courtesy of the same size for a 1:1 image,” explained IOF group tool is developed that can be used use as a die. A die Fraunhofer Institute for Applied Optics and Precision manager Dr. Frank Wippermann. Each slice is like this can then be used to launch mass produc- Engineering). Rapid Blood Test for Clinical Depression Details of the new testing regimen were dis- cussed at a conference of the Japanese Society of blood test for depression has been simplified Using the concentration of ethanolamine phos- Biological Psychiatry in Tokyo (Japan) on May 22, AAand it could contribute to early detection of phate as a diagnostic tool, the investigators were 2011. the condition if performed during regular med- able to identify the clinically depressed patients ical checkups. According to Human Metabolome 82% of the time. They deduced that subjects came Technologies (Tsuruoka, Japan; http://human from the healthy group 95% of the time. C-Reactive Protein Levels metabolome.com), clinical depression can be Human Metabolome Technologies is developing detected by measuring the concentration of a reagent to determine the level of ethanolamine Predict Breast Cancer Prognosis phosphoric acid in blood. The company did a phosphate in minutes. The company expects to levated C-reactive Protein (CRP) levels were comparative study of 66 people – 31 patients complete the reagent in a year. Several other meth- EEpredictive of a poor prognosis for breast cancer diagnosed with depression at the National ods of diagnosing depression using blood tests sufferers. This was independent of their lifestyle, Center of Neurology and Psychiatry in Kodaira, under development involve analysis of about 20 dif- menopause status, and presence of cardiovascular (Japan) and 35 healthy test subjects of similar age ferent types of white-blood cell DNA, a time-con- disease. Danish investigators studied more than and gender. suming process. 2,000 breast cancer patients and followed their progress for up to seven years from diagnosis (aver- age follow up was three years). The five-year survival decreased from 90% for low CRP to 74% for high levels of CRP, disease-free survival reduced from 87% to 74%, and deaths from breast cancer increased from 11% to 20%. Dr. Kristine Allin from Herlev Hospital (Denmark; www.herlevhospital.dk) said, “While measuring VISIT US AT CRP levels gives a general indication of health and Stand: Curie B19 longevity, measuring CRP levels for breast cancer patients seems to be an easy way to predict the severity of the patient’s disease. This may allow clinicians to alter their treatment tactics and improve cancer survival rates.” CRP is a critical component of the immune system, a complex set of proteins that are produced by the liver, in response to infection or injury, when stimulated by the cytokine IL-6. Tumor sites are often associated with inflammation and this inflammation contributes to tumor growth, invasion, and metastasis. The study was published in BioMed Central’s open access journal Breast Cancer Research (www.biomedcentral.com/bmccancer).

LabMedica International October/2011 24 LINKXPRESS COM LMI-10-11 121 LINKXPRESS.COM LMI-10-11 172 LINKXPRESS.COM LMI-10-11 173

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Rapid Virological Response Predicts Patients Prognosis apid virological response (RVR) toxylin–eosin and reviewed by local RRis now considered the strongest pathologists blinded to clinical and predictor of sustained prognosis in biochemical data. patients with Hepatitis C (HCV) RVR was observed in 68% of undergoing antiviral treatment. the patients, 42% patients with The HCV ribonucleic acid (RNA) HCV-1, 90% with HCV-2, and 64% can be quantified and antibodies to with HCV-3. An end-of-treatment HCV and genotyping can all be used response was observed in 86% of to follow the sustained virological the patients, 68% of those with response (SVR) of patients who HCV-1, all the patients with HCV-2, have persistently normal alanine and 91% with HCV-3. SVR was aminotransferase (ALT) levels. maintained 46% of the HCV-1 In a multicenter study carried patients, 97% from the HCV-2 out in Italy, scientists assessed group, and 82% with HCV-3. whether RVR might be predictive of Overall, 92% patients with rapid SVR also in a particular subset of response did obtain HCV eradica- patients with HCV, and to evaluate tion versus only 38% of those with- the cost effectiveness to determine out rapid response. HCV-1 patients HCV RNA at four weeks in these with baseline HCV RNA less than subjects. A total of 137 patients 400 x 103 IU/mL as measured by with persistently normal ALT were PCR-based commercially available treated appropriately, and their test (Cobas Amplicor HCV Monitor response to the drug therapy was v 2.0; Roche Molecular Systems; measured. Basel, Switzerland; www.roche. Antibodies to HCV were tested com), were more likely to achieve by an enzyme-linked immunosor- RVR and SVR than those with high- bent assay (ELISA III); HCV RNA er HCV RNA levels. quantification was obtained using a The ELISA III test used was a polymerase chain reaction (PCR)- product of Ortho Diagnostic System based commercially available test; (Raritan, NJ, USA; www.ortho and genotyping was performed clinical.com), and the HCV geno- using a commercial kit (INNO-LiPA typing was performed using the HCV II). Aminotransferases and commercial kit INNO-LiPA HCV II other serum liver function tests from Innogenetics (Ghent, Belgium; were determined by routine meth- www.innogenetics.be). The authors ods in the local laboratory. The concluded that those patients with upper limit of normal ALT value was HCV genotype 1 and normal ALT 40 IU/L. Liver biopsy specimens and reached HCV RNA negativity at obtained within six months before week four, might have excellent study onset were evaluated using probability to eradicate their infec- the Metavir classification. Formalin- tion. The study was published in fixed, paraffin-embedded specimens June 2011, in the Journal of Viral were routinely stained with hema- Hepatitis.

LabMedica International October/2011 26 LINKXPRESS COM LMI-10-11 111 Edited by Edgard Delvin, Ph.D., FCACB IFCC members may send news to: Edgard Delvin, Ph.D., FCACB, Head, Dept of Clin Biochemistry, CHU Ste-Justine, 3175 Cote Ste-Catherine, Montreal, Quebec H3T1C5 Tel: (1) 514-345-4831 (ext. 5635); E-mail: [email protected] NEWS Introducing: The IFCC Office he IFCC Office is based in Milan Scholarships, and Awards. Tand is responsible for carrying out, Silvia Colli-Lanzi has been work- under the direction of the EB and in ing in the communication industry for conjunction with Division and Com- more than a decade and she is mittee members, all the administrative responsible for the office activities for and communication activities of the two Italian scientific Associations. Federation. The IFCC Office reports She is also responsible for the press to the EB through the Secretary. desk and the communication activi- The IFCC Office is responsible for ties for some Italian and international the efficient administration of IFCC companies, managing the relations affairs and maintains the Archives of with the press and carrying on all the the organization. The IFCC Office is PR activities on their behalf. responsible for day-to-day financial operations, for all contacts with Photo: (From left to right) Silvia Colli- Member societies and it also assists Lanzi, Paola Bramati, and Silvia the regional organizations with which Cattaneo. the IFCC has agreements. The IFCC Office is staffed by two full-time and one part-time paid employee. Paola Bramati, in IFCC since 2005, is responsible for the contacts with the Executive Board Members. She is in charge for the activities related to the IFCC membership (Full Members, Affiliates and Corporate), as well as the Scientific Division, Task Forces and Administrative duties linked to IFCC Finances. Paola’s background is connected to communication, tourism and marketing. Before joining IFCC, she has been working for more than 15 years in the airline business dealing with day-to-day passengers’ operations, sales, marketing, and pricing. Her education is related to foreign cultures and languages, as she had the chance to study abroad learning English, Spanish, French, and German. Silvia Cattaneo, in IFCC since February 2010, is in charge for the activities of the Congresses and Conferences Committee, as well as of the Education and Management Division. She is also the contact person inside the IFCC Office for the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). Silvia has a past as Congress Organizer. For more than two decades, she collaborated with the Italian Society of Clinical Chemistry and Clinical Molecular Biology where she was responsible for the organization of the educational activities. Silvia has strong organizational skills and a great aptitude for analyzing problems and developing solutions as well as creating logical working procedures. Silvia Colli-Lanzi, in IFCC since January 2011, is in charge for the activities of the Communication and Publications Division as well as those related to IFCC special projects, such as Professional Exchange Programs,

IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846 E-mail: [email protected] • Web: www.ifcc.org Office Hours: 9.00-13.00 and 14.00-18.00 Staff Members: Paola Bramati, Silvia Cattaneo, Silvia Colli-Lanzi

LabMedica International 27 October/2011 News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine NEWS Visit www.ifcc.org for more information

of TDM-Tox in Barcelona with 1,300 registered par- Spanish Society of Clinical ticipants, 30 symposia, four plenary conferences, 22 Biochemistry and Molecular workshops, 475 posters, 37 oral presentations, 1,400 m2 of commercial area and 35 exhibitors. Pathology: A History In 1993, the SEQC changed its name to the “Sociedad Española de Bioquímica Clínica y by Felip Antoja, Secretary of the Spanish Society Patología Molecular” (Spanish Society of Clinical of Clinical Biochemistry and Molecular Pathology, Biochemistry and Molecular Pathology) to reflect the Member of the IFCC Newsletter Working Group scientific and professional development that had occurred in the last 20 years. The acronym SEQC, is he Sociedad Española de Bioquímica Clínica y publishes books and translations of NCCLS docu- however, still widely used, as it is deeply rooted in the TPatología Molecular (Spanish Society of ments, in addition to the newsletter and the scientific professional community. Clinical Biochemistry and Molecular Pathology), journal. The establishment of the Society’s website in first known as the Sociedad Española de Química The year 1980 saw the creation of the Quality 1997, which coincided with new phase of the annual Clínica, SEQC (Spanish Society of Clinical Control Commission with the initial participation of Education program, is another hallmark of the SEQC Chemistry), was founded in 1975 by Prof. Enrique 147 laboratories. This achievement was however history as it led in 1992 to the creation of the IFCC Concustell and counted 25 Founding Members. It marred by the premature death of the Society’s Rincón Iberoamericano website that was hosted and is presently presided over by Prof. Francisco President Prof. Enrique Concustell, in car acci- maintained by the Society for many years. Alvarez. dent. The involvement of the SEQC in the development The first scientific meeting was held in the first The 1980’s reflected an intense scientific involve- of the profession has never failed through the years. year, and the General Assembly of members creat- ment of the SEQC. The first issue of Society’s journal It did so by organizing or sponsoring National and ed the first two committees: Education and Quality. Quimica Clinica appeared in 1982. It was also the International meetings such as the Congreso The Commission of Units, Standards and same year that the Society organized the First Nacional del Laboratorio Clínico and the 3rd Nomenclature rapidly followed in 1977, and a rela- International Congress on Automation and New International Symposium of the Federation of tionship with the IUPAC Committee of Clinical Technologies in Barcelona, and that was followed by European Societies on Trace Elements and Minerals Chemistry was established in 1978. The same year a second congress in 1984. In 1986, it hosted the (FESTEM) in Santiago de Compostela in 2007, and the SEQC organized its First National Congress, Third Mediterranean and Near East African the 22nd AACC International Symposium on Critical which was followed by an International Symposium Congress of Clinical Chemistry in Seville. At the local and Point-of-Care testing. In terms of publication, the on Automation in Clinical Chemistry in 1979: that level, the SEQC has regularly organized courses on Society together with 2 other sister societies sponsor was the beginning of the future International various topics and annual scientific “Jornadas” since the new journal Revista del Laboratorio Clínico since Congress of Automation. 1987. 2008. The Scientific Committee that joined all the com- The scientific activities culminated in 1990 with Nowadays, SEQC counts more than 2,100 mem- missions and working groups, and the first Bulletin the organization of the joint IX National Congress, bers of which over 300 are involved in commissions, (Newsletter) were created the same year. In 1992, the IV International Congress on Automation and committees, and working groups including those of SEQC created the Publications Committee, which New Technologies and the II International Congress IFCC and EFCC.

Dr. Jocelyn Naicker appointed Chair of the News from the South African Association National Health Laboratory Services (NHLS) for Clinical Biochemistry (SAACB) Expert Committee on Chemical Pathology SAACB Council member Dr. Jocelyn Naicker was by Prof. Rajiv Erasmus, IFCC eNewsletter WG Member appointed to Chair the National Health Laboratory Services (NHLS) Expert Committee on Chemical College of Pathologists of East, Central bers of the newly established College of Pathology. The SAACB would like to congratulate and Southern Africa established Pathologists of East, Central and Southern Africa. her on this appointment. SAACB members Dr. Zemlin, Dr. George, Mr. The College was inaugurated on September 16, Hassan, Dr. Hoffman and Prof. Matsha as well as 2010, and a Council established. Prof. Erasmus the SAACB involved in the organization its president, Prof. Erasmus were founding mem- current SAACB president was elected to be its first of the Africa Health Medilab Meeting Vice President. SAACB was involved in the organization of the Academic Program of the Africa Health Medilab Educational Workshop of Inborn Errors of meeting that took place at NASREC, Johannesburg Metabolism held January 2011 in Durban from May 10-12, 2011. This meeting brought vari- SAACB held an educational workshop of Inborn ous health organizations and medical specialties Errors of Metabolism in the last week of January including Surgery, Medicine, Obstetrics, and 2011 in Durban. It was hosted by the University of Radiology under one roof. SAACB would like to Kwazulu Natal, one of the premier universities of thank Prof. Delport, Prof. Erasmus, Dr. Naicker and South Africa. It was hugely successful and very Dr. Zemlin for participating in this meeting. informative. Dr. Remaley from the NIH (USA) Prof. Steenkamp elected to Guest at the SAACB Annual Congress the IFCC Executive Board This year’s invited guest to the South African Former president of the IFCC, Prof. Steenkamp Association for Clinical Biochemistry (SAACB) was elected to the IFCC Executive Board at the annual congress (Sandton City Convention Center) IFCC meeting in Berlin on May 15, 2011. is Dr. Remaley (NIH) from the USA. Please visit the SAACB website to get more details. The meeting Hosting IFCC Congress in 2017 will be held from September 1-4, 2011. This year’s Durban, South Africa will be the venue for the IFCC meeting will also involve medical technologists. Congress in 2017.

Prof. Erasmus invited by IFCC VISIT ® Prof. Erasmus has been invited by the IFCC to be LINKXPRESS COM part of a Laboratory Management Course to be READER SERVICE PORTAL given just before the Africa Federation of Clinical Chemistry Congress (AFCC) in Nairobi on Access Interactive September 26, 2011. Digital Magazine

LINK PRESS COM X LMI-10-11 125 LabMedica International October/2011 28 News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information NEWS Chamber of Biochemists: Beginning the New Age of Laboratory Practice in Serbia by Dr. Snezana Jovicic, Institute of Medical Biochemistry, Belgrade, Serbia

or many years, the leading organization that dealt with the develop- Fment of the profession of medical biochemistry in Serbia has been the Society of Medical Biochemists of Serbia (formerly Society of Medical Biochemists of Yugoslavia). As part of the healthcare system reforms conducted in the last decade, the Law of Healthcare Workers Chambers, was adopted six years ago. Medical biochemists were the first that completely implemented the law, constituted Assembly of the Chamber and five years ago delivered the first licenses. Prof. Dr. Nada Majkic-Singh was the first elected president of the Assembly, and Dr. Photo: Assembly of the Chamber of Biochemists of Serbia Velibor Canic the first elected director of the Chamber. The Chamber of Biochemists is professional organization of medical biochemists and clinical chemists with the mandatory membership for colleagues working in public healthcare institutions and private practice. In accordance with the Law, the Chamber has a number of public authorities, including the definition of codex of professional ethics, keeping directory of all the members of the Chamber, issuing, renewing and depriving the licenses for independent practice to all of the members, representing and protecting professional interests of members, proposing the list of supervisors for external quality audit, organizing Court of Honor for determination of viola- tion of professional duties and responsibilities of members, and many others. What are the first and obvious benefits of the work of such an organization? First of all, with the introduction of licenses, which have to be renewed every seven years, professional development has achieved continuity. Medical biochemists and clinical chemists in Serbia today are more focused to continuous education after graduation - in order to keep their license they need to collect 24 credits per year minimum. Thanks to attendance of various courses, seminars, symposia, congresses, more colleagues are now up-to-date with latest developments in the practice of laboratory medicine, which enable them to implement this new knowledge in their every day workload. Also, more educational courses are organized throughout the year than before. In addition, with one of the major activities of the Chamber- -the enhancement of control of the work of laboratories throughout the whole territory of Republic of Serbia, the quality of their work is significantly improving, which is evident in the results of our national external quality assessment scheme (SNEQAS). Furthermore, all laboratories, both in private and in public healthcare system, are encouraged and advised by the Chamber to commence the accreditation process according to standard ISO 15189. The Chamber of Biochemists of Serbia has been created five years ago. Every four years delegates for the Assembly, Super- visory Board, Steering Committee, Commis- sion for Mediation, Director, and Court of Honor are elected. Last year, we had elec- tions and the first convening, when the ses- sion of the constituent assembly handed over its duties to new delegates. We are all confident that they will continue the fruitful work of their predecessors.

LabMedica International 29 October/2011 LINKXPRESS COM LMI-10-11 126 EFCC CORNER European Federation of Clinical Edited by Dr. Bernard Gouget Chemistry and Laboratory Medicine

mation about risk provided by the media and certain websites. Websites and other sources of vac- Promoting Vaccination Programs cine information might be inaccurate or incomplete. The specialist in laboratory medicine together with health- by Dr. Bernard Gouget care providers can be a pivotal SFBC-EFCC Representative; Secretary General International source of science-based credible Francophone Federation of Clinical Biology and Laboratory information by discussing the risks Medicine (FIFBCML); IFCC Executive Board Member, Secretary General from and benefits of vaccines, which help patients make informed deci- mmunizations are a cornerstone of American Institute of Medicine (IOM) encephalitis with inclusions that dam- sions. When a parent or patient initi- Ia nation's efforts to protect people published a well-documented report age the nervous system. However, in ates a discussion about a perceived from a host of infectious diseases. on the risks linked to eight common- the large majority of cases, the exist- vaccine adverse reaction, the health- Large-scale implementation of vacci- ly administered vaccines. This syn- ing studies are not sufficient for the care provider should discuss the nation programs during the past thir- thesis of more than a thousand stud- experts to be able to validate or reject specific concerns and provide factu- ty years has led to a spectacular ies shows that serious side effects the cause-effect link. This was al information. Effective, empathetic reduction in illness and death due to caused as a result of injections notably the case when the number of vaccine risk communication using diseases preventable by vaccines. remain very rare. The vaccines stud- cases counted was too low to gener- appropriate language is essential in The European region of World ied are those that protect against alize, like for the papillomavirus vac- responding to misinformation and Health Organization (WHO) was seasonal influenza (H1N1 excluded), cine. In France, two girls filed a claim concerns. declared free of poliomyelitis in 2002, hepatitis B, papillomavirus (HPV) because they believed they were the Vaccines are continually moni- and for these past 6 years, cases of (notably responsible for cervical can- victim of Gardasil side effects. tored for safety and like any medica- measles in the Region have cer), hepatitis A, meningitis (menin- However, the link yet remains to be tion; a decision not to immunize a decreased by more than 90%. gococcal vaccines), the measles- proven scientifically. child also involves risk and could put However, further efforts are neces- mumps-rubella (MMR) triple combi- The IOM report was not intended the child and others who come into sary. In Europe, nearly 650,000 chil- nation, tetanus, or even varicella. to guide nervous parents, but rather contact with him or her at risk of con- dren do not receive their first dose of The IOM has studied more than a to inform the organization that com- tracting a potentially deadly disease. measles vaccine, a fundamental hundred cause-effect relationships pensates people who contracted an Every year, vaccination saves requirement to satisfy for vaccination; between a vaccine and a more or illness after a vaccine. It does not millions of human lives and this great and there remain still vulnerable pop- less serious side effect. They reject- specify the frequency at which success in terms of public health ulations in every country. Para- ed the existence of a link between adverse effects are observed. Its must continue. European countries doxically, the fact that vaccination has MMR and autism; a study published authors point out, however, that vac- must share precise, nuanced, and led to a situation where numerous in 1998 on this subject had created a cines remain one of the most power- clear information on the risks linked infectious disease have become rare panic in the English-speaking world. ful tools in the health system. to diseases and the advantages of or seldom heard from, sometimes The same vaccine does not lead to Nevertheless, having a basic under- vaccination. By recognizing that leads some parents and health pro- type 1 diabetes either. As for season- standing of how patients and parents each child deserves good health fessionals to believe that vaccines are al flu vaccines, they do not aggra- of patients view vaccine risk and from the beginning of their existence, no longer necessary. As a result, the vate asthma and are not responsible developing effective approaches to specialists in laboratory medicine public confidence in these vaccina- for peripheral facial paralysis. address vaccine safety concerns are can benefit from the impetus given tions is regularly shaken by accused Conversely, side effects already imperative for vaccination providers. by WHO to conduct an awareness harmful, even dramatic, side effects, known to physicians were confirmed. Each person understands and reacts campaign and to enhance vaccina- and may be threatened by the influ- All the vaccines studied, except to vaccine information based on dif- tion systems. As health care ence of groups opposed to vaccina- those against hepatitis A and papillo- ferent factors, including previous provider, we should work closely with tion and websites dedicated to their mavirus (HPV), can cause strong experience, education, personal val- public health agencies and other movement. It has reached the point allergic reactions called anaphylactic ues, method of data presentation, health partners to improve and sus- that parents are increasingly hesitant shock. All, without exception, regular- perceptions of the risk for disease tain immunization coverage and to to immunize their children, because ly cause shoulder pain and fainting. and perceived ability to control monitor the safety of vaccines so they are afraid of making them sick MMR may cause febrile convulsions these risks, and risk preference. that this public health success story rather than protecting them. following very high fevers in young Increasingly, decisions about vacci- can be maintained and expanded in For the first time since 1994, the children, even rare cases of nation are based on inaccurate infor- this beginning of this new century. New EFCC Executive Board Members Prof. Mauro Panteghini Dr. Ana-Maria Simundic Dr. Huibert Storm Prof. Mauro Panteghini, MD, is full professor of Clinical Ana-Maria Simundic, PhD, heads the Emergency Dr. Huibert Storm is a clinical chemist, head of labora- Biochemistry and Clinical Molecular Biology at Laboratory department at the Sestre Milosrdnice tory at the Stichting KCL Medical Center in University of Milan (Italy) Medical School. Prof. University Hospital in Zagreb (Croatia). Dr. Simundic Leeuwarden (The Nederlands). Dr. Storm, a graduate Panteghini holds directorships in the chairs of Clinical graduated from the faculty of Pharmacy and biochemist, received his PhD from the University of Biochemistry and Clinical Molecular Biology at the Biochemistry University of Zagreb, where she defend- Leiden (The Nederlands). He is the past president of Medical School of the University of Milan and at the ed her masters and PhD theses, and was awarded the the Netherlands Society for Clinical Chemistry and Center for Metrological Traceability in Laboratory title Assistant Professor. Dr. Simundic also received Laboratory Medicine (NVKC). During his tenure as Medicine (CIRME) of the University of Milan, and leads training at the university of Connecticut (USA) Health president of NVKC he hosted the successful the Accredited Reference Laboratory for Enzyme Center, where worked on molecular genetic techniques EUROMEDLAB 2007 in Amsterdam (The Standardization (a JCTLM listed reference laboratory). and did research on developmental biology. Currently Nederlands), which was honored by a visit from HM Prof. Panteghini has served in numerous international Dr. Simundic is the Editor-in-Chief of Biochemia Queen Beatrix. Dr. Storm founded the NVKC working and national scientific capacities in laboratory medi- Medica, the journal of the Croatian Society of Medical group for molecular biology, and was member of a cine, and has held many positions within the IFCC and Biochemists. She chairs the Committee for Public committee on DNA-diagnostics of the Health Council the JCTLM. He is editor-in-chief of Biochimica Clinica, Relations for the Croatian Society of Biochemistry, and of The Netherlands advising the minister of health. At the official journal of the Italian Society of Clinical is the EFCC National representative for Croatia. Dr. present, Dr. Storm is the national representative of Biochemistry and Clinical Molecular Biology (SIBioC). Simundic also functions as ISO 15189 accreditation NVKC for IFCC and EFCC. His major professional, He has published numerous manuscripts and abstract, assessor for Molecular Diagnostics and General clini- scientific, and clinical interests lie in the field of molec- and lectures at many national and international con- cal chemistry. Her work experience includes teaching ular biology, hematooncology, and flow cytometry. gresses, meetings, and symposia. courses at the undergraduate and postgraduate levels. Cont’d on page 32

LabMedica International October/2011 30 European Federation of Clinical EFCC CORNER Chemistry and Laboratory Medicine

7th EFCC Symposium for Balkan Region Biomarkers: From Standardization to Performance by Snezana Jovicic, Institute of Medical Biochemistry, Clinical Centre of Serbia, Belgrade, Serbia t the end of June this year, the Society of Medical Biochemists of Serbia once again had Athe pleasure to welcome colleagues to the 7th IFCC Symposium for the Balkan Region organized traditionally under the auspices of the International Federation of Clinical Photo IMG-0961: Symposium lecturers dur- Chemistry (IFCC) and European Fede- ing trip to Mokra Gora (from left to right): ration of Clinical Chemistry and Laboratory Aslan Diler, Grazyna Sypniewska, Bernard Medicine (EFCC) in Belgrade. This year, Gouget, Nada Majkic-Singh, Patrick MM the Symposium was dedicated to the Bossuyt, Sanja Stankovuc, Victor Blaton. burning issue of biomarkers, entitled “Biomarkers: From Standardization to Performance.” As in the past six years, many prominent lecturers marked this meeting. In the first section, Prof. Nada Majkic- Singh (Institute for Medical Biochemistry, Clinical Center of Serbia, Belgrade, Serbia) acquainted us with biomarkers, the process of their validation, and development of guidelines for biomarker application in her lecture entitled “What is a Biomarker? From Discovery to Clinical Application.” Prof. Mauro Pantheghini's lecture (Department of Clinical Sciences “Luigi Sacco,” University of Milan, Italy) was about standardization approaches and definition of performance requirements for heterogeneous biomarker assays. Professor Patrick M. M. Bossuyt (Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University Amsterdam, The Netherlands) defined biomarker performance and clinical validity, expressed in terms of the marker's accuracy, and summarized and presented the available measures of diagnostic accuracy. The second section was dedicated to the use of biomarkers in cardiovascular events and it opened with Prof. Victor Blaton's talk (Department of Clinical Chemistry, Hospital AZ Sing-Jan AV, Brugge, Belgium) about novelties among prospective markers in this field. Prof. Grazyna Sypniewska (Department of Laboratory Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland) presented results of her group's study about the performance of apolipoproteins B and A by comparing apolipoprotein concentrations and apoB:apoA-I with traditional lipid measures and atherogenic indices as biomarkers in acute coronary syndrome patients. Adriana Unic (Clinical Department of Laboratory Diagnostics, Dubrava University Hospital, Zagreb, Croatia) summarized the recent progress in the diagnostic use of copep- tine, C-terminal part of the arginine vasopressin precursor peptide found to be stable and sensitive marker for anti- diuretic hormone release in cardiovascular diseases. The section was closed by Sanja Stankovic (Institute of Medical Biochemistry, Clinical Centre of Serbia, Cont’d on page 32

LabMedica International 31 October/2011 EFCC CORNER European Federation of Clinical Chemistry and Laboratory Medicine

cine guidelines were reviewed and accommodation, working conditions Biomarkers: From Standardization the results of several clinical studies and opportunity to complete all proto- to Performance were summarized. col obligations while traveling, this The fourth section started with the train was real residence on wheels in cont’d from page 31 University Hospital of Reims and lecture about a novel combination of the country and abroad. The destina- Belgrade, Serbia) with an overview of Laboratory of Medical Biochemistry biomarkers for the prediction of ovari- tion was Mokra Gora, a mountain in potential new roles for myeloperoxi- and Molecular Biology, Faculty of an cancer, including human epididymis the western part of Serbia, between dase as biomarker in cardiovascular Medicine of Reims, France) intro- protein 4 (HE4) and CA125, presented mountains Zlatibor and Tara. There disease. duced non-enzymatic posttransla- by Prof. Demetrios Rizos (Medical they have changed the accommoda- The second day of the symposium tional modification-derived products School, University of Athens, Greece). tions of the presidential train with started with Dr. Bernard Gouget as new biomarkers of protein aging. Prof. Andrea Griesmacher (Central “Sargan eight,” another curiosity of (Federation Hospitailiere France, This section was concluded with Institute of Medical and Chemical the Railway Museum of Serbia. From Paris, France), who opened the third Prof. Diler Aslan's lecture (Pamuk- Laboratory Diagnostics, LKH - 1925 to 1974, this was the popular section with his special lecture on kale University School of Medicine, University Hospital of Innsbruck, route from Belgrade to Dubrovnik and biomarkers, biospecimen and Department of Medical Biochemistry, Austria) continued with the overview of Zelenika on the Adriatic coast, where European biobanking infrastructures Denizli, Turkey), where biomarkers biomarkers for bone turnover. This on 760 mm narrow-gauge track, for translational research. Prof. recommended for prediction or diag- section was concluded with the review through tunnels, over the bridges and Philippe Gillery (Laboratory of nosis of diabetes complications in the of biomarkers of fetal anomalies incor- through mountain gorges, ran the Pediatric Biology and Research - clinical practice and laboratory medi- porated in first and second trimester famous steam locomotive train “Cira.” screening strategies presented by Now, one part of this railway is Prof. Svetlana Ignjatovic (Institute of renewed on the route from station Medical Biochemistry, Clinical Center Sargan Vitasi to Mokra Gora, which of Serbia, Belgrade, Serbia). represents unique construction work, The fifth and last section was tra- as it passes through 22 tunnels, over ditionally dedicated to experience five bridges, overcoming a grade of from Balkan region in the use and 300 meters, and all that on a total dis- development of biomarkers. It started tance of 15,440 meters. Here, the with the lecture of Miroslava Jankovic participants had an opportunity to see (Institute for the application of all the beauty and richness of the Nuclear Energy - INEP, University of nature of this region. The visit to the Belgrade, Serbia) about the status town of Drvengrad was unforgettable. and perspective of glycans as bio- Situated on the top of Mecavnik hill, markers, and about the glycome as Drvengrad (Wooden Town) was built promising source of new biomarkers. by the world famous film director Emir Afterwards, Prof. Majkic-Singh, Prof. Kusturica after the shooting of his film Blaton, and Prof. Ignjatovic chaired “Life is a miracle” in the site of Mokra the round table discussion on pre- Gora. Drvengrad presents unique sented topics. ethno village, typical settlement of this This closed the formal part of the area of 19th century, consisting of symposium, but it continued outside wooden buildings, such as so-called Belgrade. The two following weekend cottages, characteristic for living on days the participants and lecturers the nearby mountains. spent on the road, or on the railroad After two days of enjoying the to be precise. They went on the nos- intact nature of Western Serbia and talgic travel through time with the its food specialties, the caravan of Blue Train - a special train used for biochemists arrived back to the needs of Josip Broz Tito, lifelong Belgrade's Main Railway Station. President of the Socialistic Federal This definitely ended this year's Republic of Yugoslavia. It is one of EFCC Symposium for Balkan the most famous and most popular Region, leaving all participants with trains in the whole world, built in 1959 valuable new knowledge of biomark- for special needs of President Tito. ers, as well as with some unforget- Designed as a place that provides table memories.

New EFCC Executive Board Members cont’d from page 30 screening for Down's syndrome, tumor markers, and the metabolism of alco- Prof. Tomás Zima hol. He is a PhD lecturer in Biochem- Prof. Tomás Zima, MD, DSc, PhD, istry and Pathobiochemistry. Prof. Zima MBA, is the Dean of the First Faculty of is the author of four monographs and Medicine, Charles University Prague many articles. He is the winner of (Czech Republic), consultant to the numerous awards, among them Award Czech Republic Ministry of Education, of the Rector of Charles University. and professor of Medical Chemistry Prof. Zima is a member of the Czech and Biochemistry. Prof. Zima graduat- Medical Academy, president of the ed with honors from Charles University, Czech Society of Clinical Biochem- where he obtained his MD, a PhD in istry, Chairperson of the Executive biochemistry, and the higher doctorate, Committee of FEBS (Federation of the DSc. He has also earned an MBA from Societies of Biochemistry and Molecu- Prague International Business School lar Biology), and several other national at the University of Economics (PIBS). and international professional organi- His research is focused on oxidative zations. He is the Editor-in-Chief of stress, new diagnostic techniques, Folia Biologica and Addictology.

LINKXPRESS COM LMI-10-11 129 LabMedica International October/2011 32 INDUSTRYINDUSTRY NEWS NEWS Roche and Stago BioSystems Marks 30 Years in Service of Healthcare to Part Ways ioSystems SA (Barcelona, Spain; www. ical diagnosis. The company has sustained its biosystems.es) a researcher, designer, manufac- growth through an innovative research and develop- oche Professional Diagnostics (Basel, BB turer, and marketer of reagents and instruments for ment, production, and marketing teams dedicated Switzerland; www.roche.com) and RR clinical laboratories, marks the 30th year of its estab- to quality and service. Biosystems’ products are sub- Diagnostica Stago (Asnières sur Seine, lishment. jected to a continuous process of improvement and France; www.stago.com) announced that The company, now headquartered in an 18,000-m2 innovation. the companies have decided to pursue sep- facility in Barcelona (Spain), was founded by Dr. Josep BioSystems offers a comprehensive range of clinical arate paths in the business of Laboratory Bach in 1981. Today, the company headed by Dr. diagnostic products that help to streamline laboratory Coagulation in the territories where Roche Antonio Elduque has an extensive commercial sales workflow, enhance operational efficiency, and distributed the Stago product range. The network of representatives and subsidiaries supplying improve patient treatment. The range of products exclusive sales of Stago products by Roche worldwide customers. The company exports 98% of its comprises five segments: clinical chemistry, automat- will continue throughout the entire year of sales to 106 countries overseas. ed systems, autoimmunity, quality control, and rapid 2011. With the exception of Japan where BioSystems' evolution has been marked by adap- tests. BioSystems notes their 30th anniversary with Roche Diagnostics Japan will continue to tation to the continuous changes in the area of clin- various events held around the world. distribute the Stago portfolio within the Japanese market under a separate agreement, Stago will sell its products directly or through other distribution channels. PerkinElmer to Acquire Caliper for $600 Million erkinElmer, Inc. (Waltham, MA, USA; PPwww.perkinelmer.com) announced that it has signed a definitive agreement to acquire Caliper Life Sciences, Inc. (Hopkin- ton, MA, USA; www.caliperls.com), a company that develops imaging and detection solutions for life sciences research, diagnostics, and environmental markets, for a total net purchase price of approximately $600 million in cash. Robert F. Friel, chairman and chief executive officer, PerkinElmer, said, “The acqui- sition of Caliper Life Sciences brings innovative molecular imaging and detection technologies to our portfolio, complement- ing our world-leading offerings in life science, diagnostics, environmental, and food markets. The R&D, application expertise, and intellectual property of the combined organization will provide our customers with enhanced knowledge and services and a strong pipeline of innovation.”

Siemens and Nephromics in Preeclampsia Alliance iemens Healthcare Diagnostics (Tarry- SStown, NY, USA; www.medical.siemens. com) has entered into a licensing agreement with Nephromics, LLC (Chestnut Hill, MA, USA) to develop two assays to be used as an aid in the diagnosis of preeclampsia. The assays being developed are for the detection of two biomarkers, soluble fms- like tyrosine-kinase-1 (SFLT-1) and placental growth factor (PLGF). Clinical studies have shown that these two assays, when used in conjunction with each other, are better pre- dictors of preeclampsia than either marker alone. Under the terms of the agreement, Siemens Healthcare Diagnostics will obtain rights for the development of the SFLT-1 and PLFG assays.

LabMedica International 33 October/2011 INTERNATIONAL CALENDAR

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