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

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Project Areas*ChicagoSanFranciscoNew YorkCity*Wesolowski LG, et al. Post-marketing surveillance of OraQuick wholeblood and oral fluid rapid HIV testing. AIDS 2006;20:1661-1666.
Post-marketing Surveillance,2004-2005*Test andspecimen typeNo. ofTestsHIV +Median %(range)EstimatedSpecificityMedian % (range)PPVMedian %(range)OQ wholeblood135,7240.8 (0.1-2.6)99.98 (99.73-100)99.2 (66.7-100)OQ oral fluid26,0661.0 (0.0-4.0)99.89 (99.44-100)90.0 (50.0-100)Discordant test results‣ Of 124 initially discordant test results: 17 (14%) true positiveReceipt of test results‣ 94% of non-reactive rapid test results provided‣ 95% of reactive rapid test results provided 75% of confirmed results provided*Wesolowski LG, et al. Post-marketing surveillance of OraQuick wholeblood and oral fluid rapid HIV testing. AIDS 2006;20:1661-1666.
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 and 12: False Positive OraQuick Oral Fluid
Page 13 and 14: Investigation & Incidence Study*Inv
Page 15: Post-marketing Surveillance,2004-20
Page 19 and 20: Investigation*Findings‣ 33 false-
Page 21 and 22: New York State AnonymousCounseling
Page 25 and 26: Post-marketing Surveillance,2004-20
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

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