Avioq, Research Triangle Park, NC, has received the CE mark for its VioOne HIV Profile supplemental assay and has begun selling the test in the European Union and other countries that recognize the CE mark. The product has also been submitted for FDA approval.
“We are pleased to provide the CE marked HIV Profile assay to countries outside the United States,” says Chamroen Chetty, CEO of Avioq. “We are also looking for distribution partners to expand the global availability.”
The HIV Profile 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 that were repeatedly reactive in diagnostic screening procedures. Results can also be used to distinguish recent from longstanding HIV-1 infection for HIV-1 incidence estimation.
In 2014 the Centers for Disease Control and Prevention (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 or HIV-2 screening results. In the United States this algorithm has typically been performed using an FDA-approved Western blot or immunofluorescence assay. The HIV Profile assay is a faster and easier alternative to these tests and one that aligns with the 2014 CDC algorithm.
For more information visit Avioq.
