If this test is positive for HIV-1 antibodies or HIV-2 antibodies, HIV antibodies are confirmed, and clinicians may proceed with tests appropriate for initial evaluation of an infected individual. The first is a supplemental test that has been FDA-approved to detect and differentiate HIV-1 and HIV-2 antibodies. In the new algorithm, confirmation is provided by a specific sequence of supplemental tests. When the 4th generation test result is "Reactive" this is considered to be a presumptive positive result and additional testing is required for confirmation. The benefit of this technology is that it can detect HIV-1 during the acute state via antigen detection as well as chronic stages of infection via antibody detection. The new algorithm is intended to begin with an HIV-1/2 immunoassay capable of detecting HIV antigens (Ag) and antibodies (Ab), commonly referred to as an Ag/Ab combo or 4th generation immunoassay. The HIV Diagnostic Testing Algorithm is a multi-test algorithm, incorporating tests that detect HIV antigens, antibodies and RNA, and the final interpretation is based on a combination of test results rather than a single confirmatory test such as the Western blot.Īn important factor in HIV diagnostic testing is the sensitivity of the initial test. ![]() This algorithm differs significantly from the conventional strategy of antibody screening followed by the Western Blot. The new HIV Diagnostic Testing Algorithm is described in Attachment 1.
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