Ortho-Clinical Diagnostics announced U.S. Food and Drug Administration approval of a new diagnostic assay for the detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti HIV-1 and anti HIV-2). The new VITROS® Anti-HIV 1+2 assay1 can be run in a fully automated, random access format on the VITROS ECi/ECiQ Immunodiagnostic System, with results readily available in less than 50 minutes. This FDA approval and availability to laboratories in the U.S., Puerto Rico and U.S. territories marks the first anti-HIV 1+2 test capable of being run in full random access with other tests and providing immediate result reporting capability upon test completion. VITROS Anti-HIV 1+2 tests can be run at any time, in any order and with other types of tests. The features of automation and random access can increase productivity and efficiency in the laboratory.

The VITROS Anti-HIV 1+2 assay can help meet the demand on laboratories created by new U.S. Centers for Disease Control and Prevention (CDC) testing recommendations. The CDC now 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. In addition, testing is recommended at least once a year for those at high risk.2

By latest estimates, approximately 1,039,000 to 1,185,000 people in the United States are living with HIV/AIDS, with 24 to 27 percent undiagnosed and unaware of their HIV infection.3 Costs associated with unrecognized or late-recognized HIV infection are growing.

Two multicenter research teams supported in part by the National Institute on Drug Abuse, National Institutes of Health, have independently determined through the development of computer models that routine screening for HIV in health care settings is as cost effective as screening for other conditions such as breast cancer and high blood pressure, and can provide important health and survival benefits. The studies also suggest that screening that leads to a diagnosis of HIV infection may further lower health care costs by preventing high-risk practices and decreasing virus transmission.4

The VITROS Anti-HIV 1+2 Assay has been co-developed with Chiron, a business of Novartis Vaccines and Diagnostics Inc.