The FDA is still considering approval for the OraQuick HIV home testing kit, from OraSure and Abbot Labs. But concerns linger about lack of counseling and support (and, frankly, suicide) if people find out their status, at home.
The FDA does have a FAQ available for OraQuick, as does Abbot.
At least, if OraQuick does come to market, it will be extensively monitored, and this comes after years of testing. Even now, there are many ridiculous websites offering kits, with all kinds of undocumented claims. For instance, one site prominently displayed, in red letters on the main page, “FDA Approved” — but that approval is for a different kit, in which you mail your blood to a lab for real testing (and call in for your results days later).
The FDA’s position on home testing is quite explicit:
The advertisers of the unapproved HIV home test kits claim that the presence of a visual indicator, such as a red dot, within 5 to 15 minutes of taking the test shows a positive result for HIV infection. These unapproved test kits use a simple finger prick process for home blood collection or a special sponge device for saliva collection. The blood or saliva sample is then added to a plastic testing device containing a special type of paper. A developing solution is added to determine if the sample is positive for HIV. The samples are not sent to a laboratory for professional analysis. Although this approach may seem faster and simpler, it may provide a less accurate result than can be achieved using an approved test, which is analyzed under more controlled conditions than is possible in the home.
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