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

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

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OraQuick Advance <strong>HIV</strong>-1/2FDA-approved claims <strong>for</strong>:Sensitivity (<strong>HIV</strong>-1):Whole blood 99.6% (98.5 - 99.9)Oral fluid 99.3% (98.4 - 99.7)Specificity (<strong>HIV</strong>-1):Whole blood 100% (99.7-100)Oral Fluid 99.8% (99.6 – 99.9)<strong>CLIA</strong>-<strong>waived</strong>:Whole blood: Jan 2003Oral fluid: Jul 2004

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