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

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Data Sources1. Four CDC-sponsored studies, 2000-20052. Post-marketing surveillance, 2004-20053. Selected health departments, 2005-2006
Post-marketing Surveillance,2004-2005*Objectives‣ Evaluate use and performance of OraQuick‣ Characterize quality assurance practices and outcomesMethods‣ 17 participating health departments, 368 sites, Aug 2004 – June 2005‣ Predominately CTS, STD, outreach, and correctional settings‣ Tests administered by counselors and lab techs‣ Preliminary positive results subject to WB/IFA confirmation, clients withdiscordant test results were counseled to re-test.‣ Active surveillance of all discordant test results‣ False positive results based on initial or repeat WB/IFA confirmation*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: Investigation & Incidence Study*Inv
Page 17 and 18: 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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