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Thanks for the clarification. I won't get into a debate with otheronline resources. However, I will point out that the moderators ofMedHelp's international HIV forum agree that a negative combo (duo)test at 4 weeks is just as definitive as a 3 month antibodytest. Significantly, those moderators are in the UK, where the combotest has been in use for a few years.
The manufacturers' formal advice (and their FDA-approvedinterpretation) for antibody-only testing is that it can take 3 monthsto convert to positive, and many American providers and experts tend tostick with that advice for medicolegal safety -- even though there aresolid data for 6-8 weeks. No matter how strong new data may be, themanufacturer of a test may not legally claim a new standard until andunless they conduct their OWN research and submit the results to FDA --an expensive process, so it rarely happens. (Same thing when drugs arefound to work for medical conditions or in doses which were notinitially approved by FDA. Some of CDC's own recommendations for STDtreatment advise drug doses that are not approved by the FDA.) As longas the manufacturer of a test or drug legally must stick with a certainstandard, you can understand why many doctors, health departments, CDC,and other advisors feel compelled to adhere to the same advice.
The combo HIV p24/antibody test has only recently been approved bythe FDA for use in the US and there is not yet much clinical experiencewith it. My understanding is that the manufacturer has FDA approval toclaim 99% (maybe it's 99.9%, I'm not sure) reliability 4 weeks afterexposure, and I anticipate this interpretation will gradually diffuseto all US based providers and health departments. But it may take awhile.
by H. Hunter Handsfield, M.D. , Sep 18, 2010 05:25PM
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