Ortho-Clinical Diagnostics, Raritan, NJ has received FDA approval for a new diagnostic assay for the detection of antibodies to HIV types 1 and/or 2 (anti HIV-1 and anti HIV-2).

The new Vitros® Anti-HIV 1+2 assay runs in a fully automated, random-access format on the Vitros ECi/ECiQ immunodiagnostic system, with results available in less than 50 minutes.

The test is available to labs nationwide, in Puerto Rico, and US territories, and may help meet the demand on labs created by new US Centers for Disease Control and Prevention (CDC) testing recommendations.

The CDC recommends routine, voluntary HIV testing in all health care settings, including health clinics and emergency rooms, for all individuals ages 13 to 64 without written informed consent. Testing is recommended at least once a year for those at high risk.  

It is estimated some 1,039,000 to 1,185,000 people in the United States are living with HIV/AIDS, with 24 to 27% undiagnosed and unaware of their HIV infection.  

Studies suggest screening that leads to a diagnosis of HIV infection may help lower health care costs by preventing high-risk practices and decreasing virus transmission.

The assay has been co-developed with Chiron, Emeryville, Calif, a business of Novartis Vaccines and Diagnostics Inc.