Here’s the Point! Rapid, Point-of-Care Testing for Sexually Transmitted Infections
Charlotte Gaydos, MD, MPH, DrPH Professor, Division of Infectious Diseases Johns Hopkins University, Baltimore, MD Anne Rompalo, MD, ScM Professor, Division of Infectious Diseases Johns Hopkins University, Baltimore, MD Lea Widdice, MD Assistant Professor, Division of Adolescent Medicine Cincinnati Children's Hospital Medical Center Society for Adolescent Health and Medicine Annual Meeting New Orleans, LA March 8, 2017 Workshop Objectives
• Part 1 – Review POC tests on the market and in the pipeline – Demonstrate different venues for STI testing • Part 2 – Discuss barriers and benefits of POC STI testing • Part 3 – Apply ASSURED criteria to available POC tests Here is the Point: New Point of Care Tests for STIs
SAHM Workshop New Orleans March 8-11, 2017
Charlotte A. Gaydos, MS, MPH, DrPH Professor, Division of Infectious Diseases Johns Hopkins University Baltimore, Maryland Objectives
1. To review the characteristics of POC STI tests currently on the U.S. and international markets and in clinical trials 2. To discuss new POC tests in the pipeline
3. To demonstrate different venues for STI testing outside the clinic, OTC or home STI testing WHO Estimates of Global Prevalence of STIs in 2012
143 Million 160 131 Million 140 HIV Total: 36.7 million
120 Newly infected with 100 78 Million HIV in 2015: 2.1 M; 80 AIDS deaths in 2015: 60 1.1 M 40
20 6 Million 0 Chlamydia Gonorrhea Trichomonas143 Syphilis
Newman et al. PLOS ONE | OI:10.1371/journal.pone.0143304 December 8, 2015 7 / Background: U.S. Estimates
Estimated Prevalence of Estimated New Sexually Sexually Transmitted Transmitted Infections in the Infections in the U.S. U.S. Each Year (Total 110,197,000) (Total 19,738,800)
Satterwhite CL et al. Sexually Transmitted Diseases 2013;40:187-93. Overview: Point-of-Care Tests for STIs Chlamydia trachomatis (CT) Neisseria gonorrhoeae (NG) Trichomonas vaginalis (TV) Syphilis Herpes Simples Virus (HSV) HIV
Gaydos, C. Rapid Tests for STDs Current Infect Dis Reports 2006;8:115-124 Huppert et al. Point of Care tests for STIs: What’s the Point? Point of Care Journal, 2009 Gaydos and Hardick POC diagnostics for sex transmit infect: Perspectives and advances. Expert Review of Anti-infective Therapy. 12:657-672, 2014. Self-Collected Vaginal Swabs • All 5 commercial NAAT assays have approval for clinician-collected and self-collected vaginal swabs for CT/NG (Aptima, M-2000, ProbeTech Qx Amplified DNA, Cobas 4800, Cepheid)
• Sensitivities and specificities 94.5%-100% • Self-collected vaginal swabs are not FDA cleared for home collection for mailing but used in research studies
Schachter STD 2005; Gaydos JCM 2010; Taylor JCM 2011; Van Der Pol STD 2012; Van Der Pol STD 2013; Gaydos JCM 2013 POC tests for STIs •Chlamydia
•Gonorrhea
•Trichomonas
•Syphilis •HSV HIV Gaydos and Hardick, POC diagnostics for sex transmit infect: Perspectives and advances. Expert Review of Anti-infective Therapy. 12:657-672, 2014. Chlamydia trachomatis and Neisseria gonorrhoeae Old: Culture and staining. New: PCR and other nucleic acid amplification tests (NAATs) “Near Patient” Test for Chlamydia and Gonorrhea
GeneXpert® CT/NG, Cepheid (90 minutes)
Sensitivity: 95-100% Specificity 99-100%
FDA Cleared: CT/NG,TV; urine, cervical, vaginal swabs
Gaydos et al. J Clin Microbiol. 51:1666-1672, 2013 Ease of Use
Gene Xpert by Cepheid is FDA Cleared for use for chlamydia gonorrhea & trichomonas for women and men.
1. Collect 2. Transfer 3. Insert 4. Detect
Not yet CLIA Waived Atlas Genetics io™ System • Low cost instrument • All reagents are on the Cartridge • Ambient storage >12 month shelf-life • Broad range of clinical sample types • Disposable cartridge for sample • Results provided as clear output • CE Marked (CT); FDA clinical starting soon (CT/NG) • Electrochemical label released from probe hybridized by nuclease enzyme Mobi-NAAT Chlamydia Test / PCR Droplet PCR microfluidic platform / Smartphone
Droplet cartridge platform
16000 14000 12000 10000 8000 6000 4000 2000 AUC AUC Fluorescence (AU) 0 0 10 20 Sample identification number C. Chiou and D. J. Shin et al., Biosens Bioelectron, 2013 Novel Diagnostics
Hands-on time <2 minutes Hand-held Assay Automation Instrument
Insert chip Transfer sample On-chip DNA On-chip DNA Detection and into device into chip, start purification amplification result display
<1 <1 2 15 <1 Time to Result <20 minutes
• Sensitivity equivalent to lab qPCR test Self-contained Microfluidic Cartridge • Assay was able to detect <5 EB of Chlamydia • Highly specific to only Chlamydia strains • Preclinical evaluation using clinical samples underway. Trichomonas vaginalis Diagnostics
Stained Wet Preparation showing Trichomonas Electron microscope view of motile trichomonads trichomonas on epithelial cell
• NAAT • Wet Preparation AmpliVue POC • Culture Solana POC • Affirm VPIII AptimaT. vaginalis (ATV) • OSOM POC Becton Dickinson (TVQ) Trichomonas Test Comparisons TEST Sensitivity Specificity Wet prep 55%–65% 100% Culture 75%* 100% Affirm VPIII 46.3%** 100% OSOM POC* 83-86% >97% AmpliVue® TV POC+ 87.2-90.1% 98.2% Solana® TV POC₺ 89-100% 98-99% TMA AptimaTV 100% 100% ProbTec TVQ 98.3% 98.3% Cepheid Xpert 98.4% 99.7% *Huppert JS. J Clin Microbiol. 2005; Nye MB. Am J Obstet Gynecol. 2009; Schwebke. JCM, 2011 Van Der Pol B. J Clin Microbiol. 2006. Van Der Pol, JCM 2014;52:885-889, Schwebke; Taylor: Posters STI & AIDS, 2013 ** Affirm compared to nucleic acid amplification test, JCM, Cartwright et al. (2013). + Gaydos et al. STD 43:369, 2016 ₺ Gaydos, et al. Expert Rev Molec Diag. 2017 OSOM Rapid TV Antigen Test •Immunochromato-graphic •TV membrane proteins •Mouse antibodies •Latex beads/ capillary action
Sensitivity 83-90%, Specificity 98-100%
Huppert et al , JCM 2005; STI 2007: AmpliVue® Trichomonas HDA Assay
1) simple sample preparation with 1-step dilution/heating 2) isothermal DNA amplification of target sequence specific to T. vaginalis by Helicase Dependent Amplificat. 3) lateral-flow strip based colorimetric detection in a self- contained, disposable device. FDA cleared Sensitivity 100%; specificity 98.2% vs. culture/wet prep. Vs. NAAT PPA: 87.2-90.1%
Gaydos et al. STD 43:369,2016 Clinical performance of the Solana POC Trichomonas Assay from clinician- collected vaginal swabs and female urines Compared to NAAT reference Sample Sensitivity Specificity Swabs 89.7% 99.0% Urine 100% 98.9%
Compared to wet prep/culture Vaginal Sensitivity Specificity Asym. 100% 98.9% HDA amplification Sympt. 98.6% 98.5% Recently FDA Cleared TV prevalence swabs and/or urines 11.5% Moderately Complex Gaydos et al. CDC STD meet. Atlanta Sept 2016 Syphilis: Serologic DX requires detection of two types of antibodies •Non-Treponemal RPR, VDRL •Treponemal FTA-abs, TPPA, Many new automated, POC
Both test types have imperfect specificity •Reactive treponemal test cannot distinguish active from inactive infection
VDRL: Venereal Disease Research Laboratory
RPR: Rapid Plasma Reagin Evolution of Syphilis Test
Traditional syphilis tests - Manual • RPR Nontreponemal • FTA Treponemal
Automated Test • Treponemal platforms
Rapid syphilis POC test • Treponemal Treponemal Syphilis Tests: EIA/CIA/POC Advantages: Disadvantages:
• Automated or • Less clinical POC and are cost experience with saving for large interpretation volume laboratories • May be less sensitive than FTA- • May detect old ab in early primary untreated syphilis syphilis Some Rapid Syphilis Tests
• Available in the U. S. - Immunochromatographic strip tests (ICS) • Syphilis Health Check – Trinity Biotech (FDA cleared, CLIA waived)
• Available Internationally • SD Bioline Syphilis 3.0 – Standard Diagnostics/ Alere • Determine Syphilis TP – Standard Diagnostics/ Alere
• Dual HIV/ Syphilis assays • Multiplo TP/HIV – Medmira Inc. • DPP HIV/ Syphilis – Chembio Diagnostics • SD Bioline HIV Syphilis Duo – Standard Diagnostics/ Alere (WHO Premarket qualified) • INSTI™ HIV/Syphilis Multiplex Test - bioLytical • OnSite™HIV/Syphilis Ab Combo Rapid Test - CTK Biotech • CTK Biotech, Inc. • mChip Assay POC Syphilis Health CheckTM Syphilis Antibody Rapid Immunochromatographic Test
•Rapid qualitative screening for human TP antibodies • Results in 10 minutes; 2 steps; room temperature FDA • 98% agreement to other treponemal tests Cleared CLIA • Serum, plasma, whole blood or finger-stick Waived Negative: 1 colored band in control area Positive: Colored bands in test area and control area Inconclusive: No distinct color bands in either area Laboratory evaluations of syphilis rapid test performance 2010-2014
PPV
• Meta-analysis of 33 studies from POCs Sensitivity: 75.12% to 83.78% for blood 75.98% to 92.03% for serum Specificity: 98.39% to 99.44% for blood 92.68% to 98.51% in serum
Bristow et al Sex Health 12: 119-125, 2015 HSV POC Diagnostics The IsoAmp® HSV Assay (Biohelix Corp) 25 ul Master mix
25 ul
25 ul 1 ml buffer VTM
640 60 min • FDA-cleared for HSV in genital and oral lesions • The IsoAmp HSV has a test-to-result time of <1.5 hr. • Isothermal helicase-dependent amplification (HDA) technique; no nucleic acid extraction • The rapid and simple characteristics of the IsoAmp HSV assay make it potentially suitable for POC testing
Lemieux et al. Expert Reviews Ltd. 437-443, 2012; HIV CLIA-Waived Point-of-Care Rapid HIV Tests
OraQuick Clearview Complete Advance
Uni-Gold Recombigen Clearview Stat Pak INSTI HIV-1/2 antigen/antibody combination immunoassay
(+) (-) Negative for HIV-1 and HIV-2 antibodies and p24 antigen HIV-1/HIV-2 antibody differentiation immunoassay
HIV-1 (+) HIV-1 (-) HIV-1 (+) HIV-1 (-) or Indeterminate HIV-2 (-) HIV-2 (+) HIV-2 (+) HIV-2 (-) HIV-1 antibodies HIV-2 antibodies HIV antibodies detected detected detected NAT
(+) indicates reactive test results NAT (+) NAT (-) (-) indicates negative test results Acute HIV-1 Infection Negative for HIV-1 NAT: nucleic acid test
http://www.cdc.gov/hiv/testing/lab/guidelines/ Alere Determine™ HIV-1/2 Ag/Ab Combo
Method: Lateral flow Time to Results: 20 minutes Storage Conditions: 2 - 30°C Shelf Life: 9 months Sample Type: Serum/plasma/whole blood Distinguishes Ag/Ab reactivity
Unknown performance characteristics in the lab algorithm Data collection is underway CLIA waived for whole blood Data from plasma suggests the assay detects infection ~ 3-5 days after instrumented Ag/Ab combo assays and possibly longer delays with whole blood
Masciotra et al. JCV 2013 Bio-Rad Geenius™
Supplemental assay - Confirmation and differentiation of HIV-1 and HIV-2 antibodies in initially repeatedly reactive specimens
HIV confirmation and differentiation in less than 30 minutes 3 sample types : serum, plasma (5ul), whole blood (15 ul) Software that uses a validated algorithm Full traceability Limited data on performance in the lab algorithm suggests comparable to Mutlispot Delaney et al CROI 2015 abstract #621 Cepheid GeneXpert® System Multiplex Real-Time PCR- Viral Load Plasma 1ml Qualitative Dx test from Whole blood ~ 2hour run-time AC power with potential for battery Coming ? Liat™ Analyzer Roche
Multiplex Real-Time PCR- Viral Load 30 min-500-1000 cp/ml; 60 min-50 cp/ml Whole blood, plasma
Qualitative Dx Blood or plasma AC power/battery Integrated disposable cartridge contains all reagents for prep, amp & detection Alere™ Q System Alere™ q HIV-1/2 Detect Sample: 25 μL fingerstick whole blood Sealed system PCR Results in 50 minutes Data Matrix: Expiry QC, assay type, lot Information Kit shipped and stored at room temperature
Alere™ q Analyzer
Built in battery Simple procedure with built in controls Touch screen Data storage of 1000 tests Easily transportable, 17.2 lbs. Considerations for HIV POC Testing
Locations/populations that lab testing is difficult or not feasible . Better to use POC than no test POC assays continue to improve and have good sensitivity and specificity for established infections but… . Be aware of assay limitations • Provide informed counseling messages . Oral Fluid assays will miss acute infections and some early infections 1,2
1 Stekler et al, JCV 2013, 2 Luo et al JCV 2013 Self-Testing Instruction Guide Emergency Departments: Critical Venue HIV Tests Feasibility, Acceptability, and Accuracy Correct Result? Trust the Result? 3.3% 0.2% 8.0% 0.2%
Definitely Very Correct Much
96.4% 91.7%
Would Test Themselves if Available Ease of Performance OTC 0.7%0.2% 3.1% 11.8% Easy Definitely
Somewha Probably t Easy Not Easy Would Not Test 85% 99%
473/955 (49.5%) consented; Median age was 41 years, 59.6 % were female, 74.8% African American Female Preference for Type Specimen Collection
Self-collected vaginal swabs are acceptable and preferred over urine and cx to women
Gaydos et al. STD Use of POC Outside the Clinic Emergency Department • 80% of women would “definitely” test themselves at home if a TV test were available OTC Pharmacy • Pharmacists are ranked among the most trusted health care professionals; are accessible 24/7 Internet Iwantthekit Internet Smart Phone Key Applications POC Tests Sexually Transmitted Infections • Immediate treatment of positive patients • Expedite appropriate therapy • Reduce empirical treatment • Lower risk of antibiotic resistance • Improve compliance / minimize loss to follow-up • Decrease forward transmission • Lower risk of sequelae • Improve the patient experience Conclusions
• POCTs in primary/STI care and perhaps OCT have great potential • But there are barriers to successful implementation that need to be overcome which can be costly, time consuming, and require learning new skill sets • Better POC tests are coming; the future is promising
POCTs for STDs What do you use? What would you use? Anne Rompalo, MD, ScM Getting to know you….
• How often do you diagnose STDs among patients in your practice? 1.Every day 2.Once or twice per week 3.Once or twice per month 4.Once or twice per year 5.Don’t see STDs in my patients Getting to know you…
• Which POCTs are currently available to you? 1. Vaginal pH 2. Urine dipstick 3. Wet mount test 4. Gram Stain 5. Affirm VP III 6. State RPR 7. Pregnancy test 8. Rapid HIV test 9. NONE! Getting to know you… • In your opinion which is the GREATEST barrier to using POCTs in your practice 1.Too complicated – Too many steps – too many TIME DRIVEN steps – Too much ambiguity in reading results – Have to purchase an instrument 2.Increased patient wait time (interruption of work flow) 3.Reliability of the test What we think we know… Pros Cons • Immediate • Barriers to use in disease specific clinical settings treatment • Diffusion of • Decrease disease innovation spread • Costs/reimbursem • Confidential ents notification • Follow up/return • Counseling on risk rate reduction Rapid tests for sexually transmitted infections: the way forward. Peeling RW, et al. Sex Trams Infect 2006;82:v1-v6 Needs Assessment of Clinicians
Which organisms do Clinicians want a POC test?
How sensitive; how specific?
How fast does it have to be?
What about cost?
What about equipment?
Hsieh Y-H et al. Plos One vol 6, issue 4, e19263, 2011. Hsieh Y-H et al. Point of Care 11:126-129, 2012 Needs Assessment of Clinicians: Build Your Own Test • For which organisms do Clinicians want a POC test? (Most say chlamydia) • How sensitive?; (most important -90-99%) • How specific? (99%) • How fast does it have to be? (-20 min)
• What about cost? (second most important- $20) • What about equipment? (no or little equipment) Forced Choice Questions used in a survey with multivariate analysis Hsieh Y-H et al. Plos One vol 6, issue 4, e19263, 2011. Hsieh Y-H et al. Point of Care 11:126-129, 2012 Preferences in Attributes by Prioritized Test
Attributes Odds Ratios * all p-values <0.05 Priority ALL Chlamydia Early HIV Syphilis Force Choice N=218 N= 136 Seroconversion N=21 Questions N=30 Sensitivity 90-99 13.6* 18.2* 10.6* 11.8* (%)
Specificity 99 3.7 3.7 4.7* 5.9* (%)
Cost ($) 20 4.5* 5.2* 3.2 4.3
Time 5 3.0 3.2 2.5 3.6 (minutes)
Forced Choice Questions used in a survey with multivariate analysis Hsieh Y-H et al. Plos One vol 6, issue 4, e19263, 2011 What qualities do providers identify as best for POC STI tests: Do opinions differ by practice, region and country?
Results: • 190 subjects replied to the survey: 46% male and 54% female • Europe (27%), Oceana (26%), America (22%), Africa (11%), Asia (11%) • The majority (61%) were from developed countries • Unreliability (19.5%) was the characteristic considered the greatest barrier for use of POCTs, followed by a technology that was laboratory-driven (12%) and complexity (12%) of performing the test.
Rompalo et al ISSTDR Vienna, Austria, 2014 What about Patients Needs?
• Willingness to wait is important
• Willingness to self-collect specimens is important
• Willingness to pay is important Patient Focus Group and Clinic Questionnaire about POC Tests (N =371) Specimen Type Percent Willingness Percent Preference to Wait Cervical 15.4% 20 min 59.0% Vaginal 50.9% 40 min 20.8% Urine 33.7% 60 min 10.8% 90 min 9.4% Willingness to Pay Percent 16.1Self –collected vaginal $10 46.6% 3.0% $20 31.0% % $30 10.8% 80.9 % $40 2.7% easy hard
$50 8.9% Barnes et al. 2014 CDC STD Conf, Atlanta GA POC tests for STIs: What do “end users” want? (N=58, 5 focus groups)
• Favorable POCTs (Rapid, Easy to read, Simple to use) • Home testing acceptable – better privacy • Clinic-based- definitive results & immediate treatment • Barriers- cost and ability to read and perform tests • Hispanic patients questioned home test reliability, wanted Rompalo et al. Sexual Health 2013;10:541-545 bi-lingual instructions What do OB/GYNs think?
• Between June and August 2016, 1000 members of the American College of OBGYN were randomly selected and invited to complete a Qualtrics survey: 600 were members of the Collaborative Ambulatory Research Network (CARN). • 749 had valid emails; 288 participated in and completed the survey – 70% male – Average year practicing = 18 – 30% diagnosed STDs 1-2 times/week; 45% did so 1-2 times/month – Tests used: preg test (83%); dipstick (83%) wet mount (70%); vaginal pH (55%) – Few used Gram stain (5%) and stat RPRs (4%). – Newer POCTs were used less frequently with 25% reporting Affirm VPIII test use and only 10% using a rapid HIV test. – Most common barriers were the amount of reimbursement received for performing the test (61.9%) and the payment coverage from the patient (61.3%).
Assessed clinical service value of STI POCT use in a “sample first” clinical pathway • Outcomes: – Patient acceptability – Whether NAAT for chlamydia and gonorrhea could be used as a POCT in practice – Feasibility of non-NAAT POCT implementation for trichomonas and BV – Impact on patient diagnosis and treatment
Summary of test results Males Females Total Number of patients recruited 35 35 70 Test results CT/NG Cepheid CT positive: N (% total) 6 (17%) 0 6 (8.6%) Cepheid NG positive: N (% total) 1 (2.9%) 1 (1.4%)
Non-gonococcal urethritis (males) Based on Gram stain microscopy 13 (37.1%) 0 --- (urethral smear) TV (females) Based on wet mount microscopy 2 (5.7%) Based on OSOM 3 (8.6%) BV (females) Based on Gram stain microscopy 7 (20%) Based on VS-SENSE 24 (68.6%) Patient clinical pathway timings (Males & Females) Anonymous feedback questionnaire responses, by duration of patient clinic visit
POC Testing and Improved Antibiotic Stewardship
NG TV p-value
Diagnostic Test Laboratory-Based Point-of-Care
Prevalence 166/1877 (9%) 247/1492 (18%) <.001
Correctly 50% <.001 Treated 78% Undertreated 30% 20% .03 Overtreated 52% 22% <.001
TV infections detected with POC testing were more likely to be treated correctly than NG infections detected with traditional NAAT testing. Undertreatment and overtreatment were both lower when infection was detected with a POC test.
Huppert, et al. STI 2013; 89 POC Test and Improved Antibiotic Stewardship
Before POC TV After POC TV p- Introduced Introduced value Diagnostic test TV Culture + Wet Mount OSOM TV + Wet Mount
Prevalence 50/249 (20%) 34/179 (34%) NS Correctly 79% 88% .02 Treated Undertreated 14% 9% NS
Overtreated 23% 13% .02
Comparing TV treatment before and after the implementation OSOM rapid POC TV testing showed that, when a sensitive and specific POC test was used to detect TV, correct treatment increased and overtreatment decreased compared to before POC testing was introduced.
Postenreider, Pediatrics. 2016 Jun; 137(6) ASSURED Criteria
• Criteria to guide test developers • Can guide end-users in considering the suitability of a test in their clinical setting Affordable Sensitive - few false negatives Specific - few false positives User friendly Rapid Robust Equipment-free Delivered http://www.who.int/std_diagnostics/about_SDI/priorities.htm Affordable
• To patient • To provider Sensitivity and Specificity
• Consider the prevalence of disease in your population User Friendly
• FDA determines test complexity • Clinical Laboratory Improvement Amendments (CLIA) – Assures quality laboratory testing – Regulations include federal standards applicable to all U.S. facilities or sites that test human specimens – Responsible agencies: FDA, CDC, CMS User Friendly
• CLIA – Non-waived • High or moderate complexity • Differ in personnel requirements – Waived • Easy to use • Little risk of incorrect results • Can be performed outside of laboratory
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm User Friendly
• Specimen to be collected – Cleared for asymptomatic? – Cleared for self-collected vaginal samples? • Read-out clarity • Interface with EMR Readout Challenges Read-out Examples Rapid and Robust
• RAPID – Turn-around time – Staff time needed to conduct test • ROBUST – Refrigeration – Clean water – Climate control – Calibration requirements Equipment-free
• Storage – Foot print • Power – Requirements – Source • Portable Delivered
• FDA Clearance – Test system has been reviewed by the FDA and has been determined to be substantially equivalent to a test system already legally marketed for the same use • CE Mark – The manufacturer has demonstrated their device complies with one of the European Union’s Directives related to medical products ASSURED Criteria Scoring System
Score 0 1 2 3 Affordable - cost/test $>$26 $11-$25 $3-$10 <$3
Sensitivity &Specificity <65% 66%-85% 83%-94% >95%
User friendly Asymptomatic Asymptomatic Symptomatic only Specimen used in OR AND OR performance studies Self-collected Self-collected Endocervical only vaginal vaginal CLIA waived No Possible Yes
Read-out clarity Subjective Not subjective
Interface with EMR Not built in Built in
RAPID – Minutes to result >45 21-45 10-20 <11
ROBUST - Refrigeration Required None
Intermittent OR EQUIPMENT - Power Continuous AC None Battery available
DELIVERED - FDA cleared No In trials Yes Applied ASSURED Criteria Scoring
Test OIA CT Test Clearview QuickVue io Xpert CT/NG
Manufacturer BioStar Alere Quidel Atlas Genetics Cepheid
Affordable/cost
Sensitivity
User friendly
Specimen (asymptomatic/vaginal)
CLIA waived
Read-out clarity
Built-in interface EMR
RAPID – Minutes to result
ROBUST - Refrigeration
EQUIPMENT - Power
DELIVERED - FDA cleared
TOTAL Applied ASSURED Criteria Scoring
Test OIA CT Test Clearview QuickVue io Xpert CT/NG
Manufacturer BioStar Alere Quidel Atlas Genetics Cepheid
Affordable/cost
Sensitivity 59%-74%
User friendly
Specimen No/No (asymptomatic/vaginal)
CLIA waived No
Read-out clarity Visual
Built-in interface EMR No
RAPID – Minutes to result 20
ROBUST - Refrigeration No
EQUIPMENT - Power No
DELIVERED - FDA cleared 1995
TOTAL Applied ASSURED Criteria Scoring
Test OIA CT Test Clearview QuickVue io Xpert CT/NG
Manufacturer BioStar Alere Quidel Atlas Genetics Cepheid
Affordable/cost
Sensitivity 59%-74% 0
User friendly
Specimen No/No 0 (asymptomatic/vaginal)
CLIA waived No 0
Read-out clarity Visual 0
Built-in interface EMR No 0
RAPID – Minutes to result 20 2
ROBUST - Refrigeration No 0
EQUIPMENT - Power No 0
DELIVERED - FDA cleared 1995 3
TOTAL 5 Applied ASSURED Criteria Scoring
Test OIA CT Test Clearview QuickVue io Xpert CT/NG
Manufacturer BioStar Alere Quidel Atlas Genetics Cepheid
Affordable/cost
Sensitivity 59%-74% 0 50%-95% 0 25%-65% 0 95.5% 3 95%-100% 3
User friendly
Specimen No/No 0 No 0 Yes/No 1 Yes/Yes 3 Yes/Yes 3 (asymptomatic/vaginal)
CLIA waived No 0 No 0 No 0 Possible 1 Possible 1
Read-out clarity Visual 0 Visual 0 Visual 0 Pos/Neg/Ind 1 Pos/Neg/Ind 1
Built-in interface EMR No 0 No 0 No 0 Yes 3 Yes 3
RAPID – Minutes to result 20 2 15 2 ~12 2 ~30 min 1 ~90 min 0
ROBUST - Refrigeration No 0 Required 0 Yes 0 Required 0 None 3
Continuous, EQUIPMENT - Power No 0 Intermittent 1 None 3 Continuous 0 1 battery
DELIVERED - FDA cleared 1995 3 1993 3 1995 3 In trials 1 2013 3
TOTAL 5 6 9 13 18 Considerations for Your Clinic
• What test is currently used? – What is the current turn-around time – Problems with the current method • Will POC test allow treatment at 1st visit? • Monthly test volume? • Prevalence of infection in your community? • Where will test be conducted: clinic, central lab, home? • Regulatory system in place to support POC? We are trying to POINT the WAY for POC Tests Acknowledgments •Anne Rompalo •Mary Jett-Goheen •Mathilda Barnes •Justin Hardick •Jeff Holden •Laura Dize •Perry Barnes •Barbara Silver •Lea Widdice •DeAnna Owens •Hillary Purcell [email protected] 410-614-0932 [email protected]