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On November 29, 2010, the FDA approved INSTI, a new rapid point-of-care HIV-1 antibody test that can provide results from blood and plasma specimens in as little as 60 seconds, with a minimum sensitivity of 99.8% and a minimum specificity of 99.5%. Previously approved rapid HIV tests take 10 to 20 minutes to generate results.
Positive results on any rapid HIV test require confirmation, which usually takes 1 to 2 weeks using standard Western blot or enzyme-linked immunosorbent assay. However, because this new test was generated using different antigens than those used to develop other rapid tests, it opens the door to the possibility of a “rapid/rapid” algorithm, in which one rapid test is used to detect infection and another to confirm it.