23 October 2020 - - The US Food and Drug Administration for their VioOne HIV Profile Supplemental Assay, US-based Avioq, Inc. said.

The HIV Profile assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M and Group O) and HIV-2 in human serum or plasma.

It is intended as an additional, more specific test to confirm the presence of antibodies in specimens repeatedly reactive in diagnostic procedures.

The CE Mark version can also be used in epidemiological studies to distinguish recent from longstanding HIV-1 infection for incidence estimation.

In 2014 the CDC released a new algorithm for HIV testing. 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.

Historically this has been done using Western Blot, or more recently a HIV 1/2 immunochromatographic assay.

The HIV Profile assay is an improved alternative with exceptional performance that aligns with the CDC algorithm.

Avioq, Inc., located in Research Triangle Park, North Carolina, is a medical device company established to develop and market immunodiagnostic products.