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Bdna accuracy with high CD4+ levels Oct 5, 2008 Doctor: The FDA states, "A laboratory testing specimens from HIV- positive patients can expect to detect virus in approximately 99% of patients with CD4+ counts of less than 200 cells/mm3, in approximately 89% of patients with CD4+ counts between 200 and 500 cells/mm3, and in approximately 65% of patients with CD4+ counts of greater than 500 cells/mm3". (http://www.fda.gov/Cber/PMAsumm/P0000280S.pdf) If this is the case, why do doctors, including yourself, tell patients they are "not infected" based on a Bdna test? Isn't it likely that people who get a Bdna early (within 6-months of becoming infected) also likely have a high CD4+ level? If so, the Bdna, according to the FDA, would miss at least 35% of all positive cases. Please provide your thoughts on this. Thanks. |
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| Response from Dr. Holodniy
 Although I don't disagree with the FDA statement, I would not tell people they are not infected based only on a bDNA or any viral load test. | |||||||||
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