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why isn't DNA PCR HIV test approved for...

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Why do you think the DNA PCR HIV test is not approved by the FDA for early HIV diagnosis?
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replied February 29th, 2012
Hello and welcome to E health forum. ‎

Polymerase chain reaction (PCR) for proviral DNA (PCR -DNA) is a important test that can detect ‎proviral DNA during window ‎period, (before 4 weeks) can ‎differentiate latent HIV infection from active viral transcription ‎and can quantitate the copy ‎number of HIV DNA ‎when used with external standards (e.g. viral load ‎assays). ‎ The DNA PCR is the absolute most sensitive test for HIV (100%) In terms of measurement capacity, it ‎can detect as little as 10 copies of proviral DNA per milliliter of whole blood. ‎

But usually PCR tests are advised only in high risk conditions, it is not needed in low risk situations. Eg ‎for high risk ‎situations include traumatic risk, needle injections, condom break with a known HIV ‎positive partner, symptomatic ‎acute HIV seroconversion, and babies born to HIV-positive mothers. ‎

Since PCR tests are very expensive, and need a very sophisticated laboratory set up, they cannot be used as a routine screening test for HIV. In addition, when much cost effective and easy tests like ELISA and western blot tests with sensitivity of about 100% are available, there is no need for higher end tests like PCR.

Hence PCR tests are not approved for use as a screening tests for HIV.

I hope this helps.‎



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replied February 29th, 2012
thank you for taking the time to reply DR. I appreciate it very much.
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