FDA Approves Anti-HIV Test
The FDA has approved Ortho Clinical Diagnostics' diagnostic assay for detecting antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS 5600 Integrated and VITROS 3600 immunodiagnostic systems. According to Ortho Clinical Diagnostics, this is the first HIV diagnostic assay approved for an integrated system in the United States, allowing laboratory professionals to run HIV and other routine tests on a single testing platform, eliminating the need for expensive batch testing of multiple patient samples.
"By providing a fast, cost-effective and reliable method for testing HIV, the VITROS Anti-HIV 1+2 assay will help enhance the clinical laboratory's ability to adhere to the CDC HIV screening guidelines, while at the same time increasing the lab's productivity and efficiency," said Mike Samoszuk, MD, chief medical officer, Ortho Clinical Diagnostics. Approval of the complete VITROS menu of 114 assays is expected by mid-2010.