FDA Approves Premarket Approval Application for OraQuick HIV Self-Test, Expanding ...

The FDA approved OraQuick In-Home HIV Test for ages 14-17, expanding access for adolescents to test for HIV at home. The test detects HIV-1 and HIV-2 with an oral swab, providing results in 20 minutes, and has 99.98% specificity and 92% sensitivity. This decision aims to reduce barriers to testing and HIV spread.


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FDA Approves Premarket Approval Application for OraQuick HIV Self-Test, Expanding ...

The FDA approved OraQuick In-Home HIV Test for ages 14-17, expanding access for adolescents to test for HIV at home. The test detects HIV-1 and HIV-2 with an oral swab, providing results in 20 minutes, and has 99.98% specificity and 92% sensitivity. This decision aims to reduce barriers to testing and HIV spread.

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