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FDA has approved RNA PCR
Sep 6, 2008

Hey Doctor Bob,

Thanks for all of the great follow up's to some very strange and rather important questions. I was just curious as to why you are always telling people that the FDA has not approved RNA PCR testing for HIV.

http://www.fda.gov/cber/products/ultraqualhiv1.htm

That link states that the FDA has approved it.

Where does it state otherwise??

Thanks!

Response from Dr. Frascino

Hello,

HIV plasma RNA PCR is FDA approved and very useful when appropriately used. It is used primarily to help physicians determine how much HIV is reproducing in an HIV-infected individual. It allows us to know how well antiretroviral medications are working. This is the use for which the FDA approved this test assay. It is not FDA approved for routine HIV screening or HIV diagnosis, due to cost, technical considerations and the rate of false-positive results. In other words it was not designed to be used in HIV negative folks for diagnostic purposes! That said, some physicians do use it in specialized circumstances for diagnostic purposes, particularly in the case of suspected acute retroviral syndrome (ARS) when the PCR RNA may be detectable, but anti-HIV antibodies have yet to reach detectable levels in the blood. However, there is no doubt that HIV-antibody tests (ELISA, EIA, rapid tests, etc.) are the cheapest, easiest and overall most reliable and available method of determining HIV status. And now with the availability of rapid tests, antibody tests are now also by far the fastest method with accurate results available within 20 minutes! Hope that clears up any confusion.

Dr. Bob



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