Avioq, Inc., a medical device maker for immunodiagnostic products, announced that it received FDA approval for its supplemental HIV lab test, the VioOne HIV Profile Supplemental Assay.

According to a press release on Thursday, 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 & Group O) and HIV-2 in human serum or plasma.”

The assay is meant to be an additional yet 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, the release said.

“We are pleased to provide this state of the art HIV Profile™ assay to laboratories in the U.S. The performance has been established in years of clinical trials and we are pleased with the results,” Dr. Chamroen Chetty, CEO of Avioq, said in the release. “We are also looking for distribution partners to expand the global availability of our CE Mark version of the assay.”