A New Rapid Test for Detection of HIV

December 13, 2010 | Rochelle P. Walensky, MD, MPH

Published in Journal Watch HIV/AIDS Clinical Care December 13, 2010

Citation(s):

FDA approves bioLytical Laboratories' INSTITM rapid HIV test [press release]. Vancouver, British Columbia, and Chicago, Illinois: bioLytical Laboratories; Dec 1 , 2010. (http://www.biolytical.com/media.html)


The INSTI HIV-1 antibody test delivers results in as little as 60 seconds.

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.

Comment:

INSTI offers the unique attribute of faster test processing with nearly immediate delivery of results. Having results within a minute or two alleviates many of the logistical concerns related to patient flow that have challenged clinic-based point-of-care HIV screening programs.

Other tests will probably still have a role, however; the OraQuick rapid HIV test is currently under FDA review for over-the-counter use.