FDA Approves 60-Second HIV Test
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved a single-use rapid test that detects antibodies to HIV-1 in as little as 60 seconds. INSTI HIV-1, made by bioLytical Laboratories Inc., is designed for use with whole blood, finger-stick blood or plasma specimens and uses flow-through, rather than lateral-flow, technology to reduce processing time. The test also includes a “unique antigen construct” composed of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36).
FDA approval was based on clinical trial data showing minimum sensitivity and specificity of 88.8 percent and 99.5 percent, respectively, in finger-stick whole blood samples and 99.9 percent sensitivity and 100 percent specificity in venipuncture whole blood and plasma samples. As with all rapid HIV tests, positive findings must be confirmed before a diagnosis of HIV infection can be established.
The test previously was approved for use in 56 other countries, including Canada and member states of the European Union.