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Seronegative AIDS

Jul 19, 1999

Dear Dr. Holodniy,

It has come to my attention that a post of May 4, 1999 ( asked about the value of combination HIV testing. The subject of urine positive/serum negative HIV tests referred to our Nature Medicine article of Nov 97. You responded that "No other confirmatory tests (ie HIV DNA PCR or plasma viral load, culture) were performed on those samples to determine whether they were true or false positives." This is a false and misleading answer. The Nature Medicine article clearly points out 2 subjects that had viral confirmation. The first subject on follow up had 46,600 copies/ml of HIV-1 RT-PCR on a licensed viral load test (and was still seronegative). The second subject had an HIV-1 Group O variant isolated from her lymphocytes. She died of AIDS in 1992 having never seroconverted. In January of 1999, the CDC published its results of 8 subjects who died of AIDS and were persistently seronegative (no urine or oral fluid tests were run on these subjects). The blood tests are very good and accurate. They are not 100%. I cannot think of any laboratory test that is 100% accurate. This is why we suggested combination testing of multiple fluids so as to achieve a higher accuracy in testing.


Howard Urnovitz, PhD

Calypte Biomedical

Response from Dr. Holodniy

Thanks for the clarification. But your sample size was much larger than two subjects. Where are the confirmatory tests on all the other patients that have had discordant results with your urine test and serum testing? What followup data on other subject cohorts has been published since 1997? The topic has generated alot of interest on this forum, but other than press releases and general lay information, there is little information in peer reviewed literature.


Blood group and false negative?
Quanitative PCR Test Accuracy 3 weeks following exposure!

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