bioLytical Laboratories announced that the Food and Drug Administration (FDA) has approved its INSTI HIV Antibody Test for the detection of antibodies to HIV type 2 (HIV-2). With this approval, the INSTI HIV-1/2 Antibody Test is available for use in detecting both HIV-1 and HIV-2 antibodies.

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The INSTI HIV-1/2 Antibody Test is a single-use, rapid, in vitro qualitative immunoassay that can detect antibodies in 60 seconds in human venipuncture whole blood, fingerstick blood, or plasma specimens. The FDA’s approval also includes a CLIA waiver, allowing the test to be performed outside a laboratory setting by anyone who has been trained.

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