This test is intended for use as an aid in the diagnosis of HIV-1 infection, including acute or primary infection. Presence of HIV-1 RNA in the plasma of patients without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection. This assay may also be used as an additional test, when it is reactive, to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 antibodies.
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