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Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals
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Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals

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  • 1. Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Infected Individuals OraSure Technologies, Inc. 2011 National HIV Prevention Conference * In development. Not FDA approved1
  • 2. OraQuick® Rapid Test Platform• OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is widely used for rapid HIV testing• Same test platform supports blood and oral fluid specimens• Enhanced version of the OraQuick HIV test was released in early 2009 – Extended shelf life (30 months) – Improved specificity1• First FDA approved rapid HCV test uses the same OraQuick test platform2 1HIV Diagnostic Conference (2010)
  • 3. Key Design Goals of a Next Generation OraQuick® HIV Test• Earlier detection of antibody in acute infection • Detection of antibody contemporaneous with 3rd generation antibody EIAs• Reduced assay time • 10-minute test• Retain simplicity and flexibility • Low sample size (5uL) for whole blood • Retain oral fluid capability• Maintain high specificity3
  • 4. Defining the Target: Reducing the Time to Detection of HIV Antibodies in Early Infection Procleix (NAT) Time to Detection of HIV antibody (Days) Rapid HIV Tests WB Indeterminate Lateral Flow 3rd Gen EIA WB Positive 25 20 15 10 5 0 (Days) Delay in time to detection between rapid lateral flow tests and 3rd Gen EIA4 Adapted from: Owen SM et al. (2008) J. Clin Microbiol. 46; 1588-1595
  • 5. Prototype Next Generation OraQuick® HIV Test* Test Device Developer Reusable Vial Test Stand Solution Absorbent Packet Specimen Collection Loop5 *In development. Not FDA approved
  • 6. Prototype Next Generation OraQuick® HIV Test: Device Design• Intended Use – Single-use, qualitative immunoassay – HIV-1 and HIV-2 antibody detection – Compatible with whole blood, oral fluid, serum and plasma• Test Design – Use of combination of HIV recombinant antigens and synthetic peptides – Novel biochemistry allows for improved reaction kinetics and high affinity antibody capture – Improved seroconversion sensitivity and improved analytical sensitivity6
  • 7. Seroconversion Sensitivity of Prototype Next Gen OraQuick® HIV Test vs. 3rd Generation EIA Average Number Average Number Time to Delay DaysNumber of Number of Detected Time to Detected Detection (OQ HIV Next Gen Panels Concordant Earlier by Detection Earlier by OQ HIV -EIA) Tested Series OQ HIV by EIA EIA* Next Gen (95% CIs) Next Gen (Days) (Days) 0.54 24 14 7 3 32.21 32.75 (-0.93 – 2.01) *FDA approved 3rd Generation EIA 7
  • 8. Comparison of Seroconversion Sensitivity vs FDA Approved Rapid Test OQ HIV Rapid Test A HIV-1/2/O• 24 seroconversion panels tested by Panel Next Gen (15 min) EIA (10 min) prototype OraQuick Next Gen Test 916 30 30 30 and currently approved rapid test 925 44 44 44 926 27 27 27 (Test A) 930 7 10 7• 12/24 (50%) panels detected earlier 933 21 27 21 934 7 7 0 by the prototype OraQuick test 943 19 21 19• 4 series did not seroconvert in 947 9 11 9 952 17 17 14 available bleeds in the FDA 957 23 28 28 approved rapid test 959 14 14 9 6243 32 32 32• In the other 8 panels detected 9012 21 DNS 21 9015 35 DNS 35 earlier by the prototype Next Gen 9019 38 38 38 Test, the average difference in time 9021 57 DNS 57 to detection was 5 days 9032 29 38 36 9076 69 74 60 9077 52 52 52 9079 47 55 49 9081 26 26 24 9089 20 DNS 24 9096 18 18 18 12007 124 124 119 DNS = Did Not Seroconvert 8
  • 9. Performance with Commercial Low Titer Panel PRB107 US FDA-Licensed Anti-HIV OraQuick Confirmatory Test HIV-1/2 HIV Ag HIV Next EIA EIA Gen Western Blot 10-min Banding Specimen # s/co Result s/co read Pattern 107-1 R 6.6 No Bands Neg 5.1 107-2 R 3.7 24, 55 Ind 14.0 107-3 R 4.5 No Bands Neg 0.8 107-4 R 9.7 No Bands Neg 1.2 107-5 NR 0.1 No Bands Neg 0.4 107-6 R 7.3 No Bands Neg 4.4 107-7 R 1.0 No Bands Neg 0.4 107-8 R 7.1 No Bands Neg 19.3 107-9 NR 2.4 No Bands Neg >29.9 107-10 R 3.5 No Bands Neg 24.5 107-11 R 3.3 24, 55, 160 Pos 3.9 107-12 NR 5.0 No Bands Neg 11.3 107-13 R 3.3 24 Ind 0.8 107-14 R 14.3 24, 160 Pos 1.7 107-15 R 2.7 24 Ind 0.89
  • 10. Performance with Commercial Low Titer Panel PRB108 US FDA-Licensed Anti-HIV Confirmatory Test OQ HIV Rapid HIV-1/2 Next Gen Test “A” EIA Western Blot 10-min 15-min Specimen # s/co Banding Pattern Result read read 108-1 R R 10.4 24, 55, 160 Pos 108-2 NR NR 0.2 No Bands Neg 108-3 R R 9.3 160 Ind 108-4 R R 15.7 41, 120, 160 Pos 108-5 R R 4.8 24, 41, 55, 120, 160 Pos 108-6 R R 6.4 160 Ind 108-7 R R 7.3 24, 160 Pos 108-8 R R 11.0 24, 160 Pos 108-9 R R 11.8 24, 160 Pos 108-10 R R 9.6 24 Ind 108-11 R R 10.1 24, 160 Pos 108-12 R NR 2.8 No Bands Neg 108-13 R NR 13.1 24 Ind 108-14 R NR 9.6 No Bands Neg 108-15 R R 16.2 160 Ind10
  • 11. Genotype Performance with Worldwide Panel US FDA-Licensed Anti-HIV Confirmatory Test OraQuick HIV-1/2 HIV Next EIA Gen HIV-1 Western Blot 10-min Specimen # Origin Genotype s/co Banding Pattern Result read 303-1 Ghana A R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos 303-2 Ghana A R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos 303-3 South Africa C R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos 303-4 South Africa C R >15.9 18, 24, 41, 51, 55, 66, 120, 160 Pos 303-5 Uganda D R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos 303-6 Uganda D R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos 303-7 Ghana G R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos 303-8 Ivory Coast G R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos 303-9 Spain O R 2.4 31, 51, 66, 160 Ind 303-10 Argentina F R >15.9 18, 24, 31, 41, 51, 66, 120, 160 Pos 303-11 Ivory Coast HIV-2 R 0.3 24 Ind 303-12 Argentina Neg NR 0.4 No Bands Neg 303-13 Uganda A R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos 303-14 Zimbabwe C R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos 303-15 USA B R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos11
  • 12. HIV-2 Sensitivity HIV-2 EIA + - + 171 0 Prototype Next Gen OraQuick - 0 012
  • 13. Specificity of Prototype OraQuick Next Gen Test (Plasma) HIV-1/2/O EIA + - + 0 1 Prototype Next Gen OraQuick - 0 749 99.87% specificity (99.26% - 100%)13
  • 14. Performance in Preclinical Human Subject Testing Prospective Testing of 198 Low Risk Subjects Specimen Fingerstick Oral Fluid Type 100% 99.50% Specificity (98.15% - 100%) (97.22% - 99.99%)14
  • 15. Conclusions• Design goals of the Next Generation OraQuick HIV test have been achieved• Earlier detection of antibody in seroconversion – Sensitivity similar to 3rd generation EIA – Improved detection in early HIV infection compared to current lateral flow rapid tests – Measured difference in time to detection of antibody between EIA and current rapid tests appears smaller than previously reported• Shortened testing time – 10 minute prototype• Retains oral fluid and blood capability• Public health value of rapid HIV tests continues to reside in identification of established, undiagnosed infection and the immediacy of test results15

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