CLIA-waived Rapid HIV Testing in the Public - Centers for Disease ...

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Observed SpecificityUniversity of Minnesota*Time PeriodReferenceNegativeFalsePositiveSpecificityJul 2002 – Apr 20042,017799.7%Apr 2004 – Aug 20043881695.9%Jul 2002 – Aug 200424052399.0%*Jafa K, et al. Investigation of false positive results with an oralfluid rapid HIV-1/2 antibody test. PLos one 2007;1:1-6.
Investigation & Incidence Study*Investigation‣ 16 false-positive results from unexpired devices from 6 lots‣ All lots produced and shipped within specifications‣ Each lot used at other sites without excess false-positive results‣ All temperatures recorded in device storage and test logs were withinmanufacturer’s specifications‣ Devices had very faint, gray, or shadowy test lines‣ Four operators interpreted the results‣ Operator practices observed in accordance with PI‣ Only significant factor: age > 37 yearsIncidence study, Feb-May 2005, 9 cities in 3 states*‣ 2,268 tests, no false-positive results (specificity 100%)‣ Case-control study could not proceed*Jafa K, et al. Investigation of false positive results with an oralfluid rapid HIV-1/2 antibody test. PLos one 2007;1:1-6.
Page 1 and 2: CLIA-waived Rapid HIV Testing in th
Page 3 and 4: Presentation Objectives1. Review th
Page 5 and 6: Uni-Gold RecombigenFDA-approved cla
Page 7 and 8: Data Sources1. Four CDC-sponsored s
Page 9 and 10: Sensitivity Results*Rapid Test(Spec
Page 11: False Positive OraQuick Oral Fluid
Page 15 and 16: Post-marketing Surveillance,2004-20
Page 19 and 20: Investigation*Findings‣ 33 false-
Page 21 and 22: New York State AnonymousCounseling
Page 27 and 28: Quality Assurance PracticesPost-tra
Page 29 and 30: Quality Assurance Practices*Interna
Page 33 and 34: Rapid HIV Test Distribution Program
Page 35 and 36: Rapid Test Distribution ProgramDevi
Page 37 and 38: Rapid HIV Testing Assessment*Object
Page 39 and 40: Projected Purchases, 2006*Quantity
Page 41 and 42: Data Sources1. Rapid Test Distribut
Page 43 and 44: Florida Department of HealthNumber
Page 45 and 46: ConclusionsCLIA-waived Rapid HIV Te
Page 47: Questions

CLIA-waived Rapid HIV Testing in the Public - Centers for Disease ...

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