Avioq HIV Profile Supplemental Assay Approved

FDA has approved Avioq’s VioOne HIV Profile Supplemental Assay, an enzyme-linked immunosorbent assay for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma. The company says the assay is intended as an additional, more specific test to confirm the presence of antibodies in specimens repeatedly reactive in diagnostic procedures.

The assay was developed in response to a new CDC algorithm for HIV testing released in 2014, according to Avioq. “The second step of the algorithm includes a supplemental assay that can detect and differentiate HIV-1 and HIV-2 for confirmation of repeatedly reactive HIV-1/HIV-2 screening results,” it says. Historically this step has been done using Western Blot, or more recently an HIV-1/2 immunochromatographic assay.