The FDA recently approved the new VITROS® Anti-HIV 1+2 from Ortho Clinical Diagnostics, Raritan, NJ, a diagnostic assay for detecting antibodies to HIV types 1 and/or 2 (anti-HIV-1 and anti-HIV-2).

The fully automated test provides immediate results upon test completion, and results are available in less than 50 minutes.

“The VITROS Anti-HIV 1+2 assay is a new diagnostic tool that can help health clinics, emergency rooms and other screening facilities meet the demand of these new CDC testing recommendations by delivering fast, quality-controlled HIV test results,” said Michael Waller, MD, the company’s VP of clinical and medical affairs.

The Centers for Disease Control and Prevention recommends routine, voluntary HIV testing in all health care settings for people 13 to 64 without written informed consent. Testing is recommended at least once a year for those at high risk and during pregnancy, to assess the risk of transmission to newborns.  

The assay can be run any time on the VITROS ECi/ECiQ immunodiagnostic system along with other types of tests—and in any order—which may increase labs’ productivity and efficiency.
Two multi-center 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 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.
The assay is being shipped to clinical labs nationwide, and in Puerto Rico and US territories.