Human Immunodeficiency Virus 1 & 2 (HIV-1/HIV-2), Qualitative, RNA

This test is intended for use as an aid in the diagnosis of HIV-1 or HIV-2 infection, including acute or primary infection. Presence of HIV-1 or HIV-2 RNA in the plasma of patients without antibodies to HIV-1 or HIV-2 is indicative of acute or primary HIV-1 or HIV-2 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 and/or HIV-2 antibodies. This assay is not intended for use in donor testing.

Methodology: RT-PCR