US-based medical device company Avioq has received approval from the Food and Drug Administration (FDA) for its VioOne HIV Profile Supplemental Assay.
The HIV Profile assay is an enzyme-linked immunosorbent assay (ELISA).
It is intended for the confirmation and differentiation of individual antibodies directed to several gene products of HIV-1 (Group M and Group O), as well as HIV-2 in human serum or plasma.
The assay can be used as an additional and more specific test to confirm the presence of antibodies in specimens repeatedly reactive in diagnostic procedures.
In 2014, the Centers for Disease Control and Prevention (CDC) launched a new algorithm for HIV testing.
The second step of CDC’s algorithm comprises a supplemental assay that is capable of detecting and differentiating HIV-1 and HIV-2 for confirmation of repeatedly reactive HIV-1 / HIV-2 screening results.
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Such confirmatory testing was conducted using Western Blot until HIV 1/2 immunochromatographic assay was introduced.
Avioq’s HIV Profile assay, which aligns with the CDC algorithm, is considered to be a better alternative to these tests.
Avioq CEO Dr Chamroen Chetty said: “We are pleased to provide this state of the art HIV Profile assay to laboratories in the US. The performance has been established in years of clinical trials and we are pleased with the results.
“We are also looking for distribution partners to expand the global availability of our CE Mark version of the assay.”
Located in Research Triangle Park, North Carolina, Avioq specialises in the development and marketing of immunodiagnostic products.
Meanwhile, last month FDA approved Roche’s cobas HIV-1/HIV-2 Qualitative test for use on fully automated cobas 6800/8800 Systems in the US.