The FDA approved the marketing of the Aptima HIV-1 RNA qualitative assay, a product of Gen-Probe. The assay may be used as an aid in the diagnosis of acute and primary HIV-1 infection and to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 antibodies. The assay is the first FDA-approved qualitative nucleic acid test for these uses.

The assay detects the presence of viral genetic material and gives a yes-or-no answer as to whether the target virus is present. According to the FDA, the test's efficacy is comparable to FDA-approved viral load assays that measure serum levels of HIV-1 RNA for treatment and disease-monitoring purposes.

The assay is expected to become available immediately, along with the Aptima hepatitis C virus RNA qualitative assay.

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