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What does this mean?

Aug 16, 2001

Dear Dr. Holodniy,

You have said in the past that you cannot comment on performance, and that we should ask the comapny ourselves. I took your advise and did some research and found this on the FDA site regarding the Roche Amplicor test that was approved in 1999.

"This test will amplify HIV-1 DNA if it is present in the processed specimen. Roche performed in-house testing using a modification of the Amplicor HIV-1 Monitor test which made the test specific and more sensitive for the qualitative detection of HIV-1 DNA. This modified kit was used on fifty-five HIV positive plasma specimens. This testing showed that fourteen specimens had plasma DNA present. Five of the fourteen specimens that were shown to contain plasma DNA were retested by the AMPLICOR HIV-1 Monitor Test but without the reverse transcription steps so that only plasma DNA would be amplified. The results from these tests showed that DNA was undetectable by the AMPLICOR-1 HIV MONITOR Test in four of the specimens and contributed to less than 10 of the apparent HIV-1 RNA test result in the other specimen."

Are they talking about an PCR DNA test here, or are they saying that if you perform the VL test it can still pick up DNA during the VL test which is different than a DNA test from the start, but not as well? If not, these are really POOR results for the PCR DNA test. IS there something I'm missng here? Typically you read that the PCR DNA test is around 90 (low) 98 (high) percent accurate in infected specimans...doesn't look that way with these results.

Your insight would be greatly appreciated.



Response from Dr. Holodniy

They are talking about validation of the Roche HIV viral load (HIV RNA test). Depending on how blood samples are processed, there can be cell contamination of plasma, and thus contribute DNA to a plasma sample, when in fact if the sample is handled correctly, there should be no HIV DNA.

Viral load
PCR RNA - Please answer

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