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RNA testing has FDA approval (APTIMA HIV-1 RNA Qualitative Assay)
Nov 28, 2006

Hi Dr. B - Wondering if you can comment on the October 2006 press release (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01479.html) where the FDA has approved RNA testing as a means to find HIV-1. Could this finally be what worried-sick people can use to avoid waiting a stressful 12-weeks for an antibody test? I would think this is a win-win... early detection can get folks on meds earlier, and could prevent HIV spreading within the traditional 3-month "window period" (since people would be aware of their status sooner).

Thanks for all you do! -A

Response from Dr. Frascino

Hi A,

Yes, the FDA did indeed approve the APTIMA HIV-1 RNA Qualitative Assay test in October (2006) and yes, it is approved to detect HIV-1 infection, including acute or primary infection before the appearance of anti-HIV antibodies. This type of test, a nucleic acid test (NAT) detects nucleic acid of HIV-1 in human plasma rather than antibodies. The presence of HIV-1 RNA in the plasma of folks without anti-HIV antibodies is indicative of acute HIV-1 infection. So is this the end of all those antibody tests and window periods? Nope. Sorry to disappoint. But at this time, APTIMA HIV-1 RNA tests are not meant to be used as a stand-alone test for the diagnosis of HIV-1 infection. A positive NAT result indicates a "probable" infection and must be followed up later with traditional antibody testing to confirm the HIV diagnosis. In other words there may be false-positive tests with this type of testing. The recent FDA approval of this test is indeed another step forward for HIV testing, but not the quantum leap you suggested in your question.

Dr. Bob



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