VioOne HIV Profile Supplemental Assay is as an additional and more specific test to confirm the presence of antibodies in specimens repeatedly reactive in diagnostic procedures. Credit: Shameer Pk from Pixabay.

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).

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.