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
New York State AnonymousCounseling & Testing Program 2005*Rapid Test(specimen type)ReferenceNegativeFalsePositiveSpecificityOraQuick (whole blood)13,473799.9%OraQuick (oral fluid)10,0772999.7%*San Antonio-Gaddy M. CDC Presentation, Jan 10, 2007.
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 and 16: Post-marketing Surveillance,2004-20
Page 19: Investigation*Findings‣ 33 false-
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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