Ortho Clinical Diagnostics (Ortho) has received FDA approval for Anti-HIV 1+2. Its a diagnostic assay for the detection of 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.
The company claims that this is the first HIV diagnostic assay approved for an integrated system in the US. It allows laboratories to run HIV and other routine tests on a single testing platform and eliminate the need for expensive batch testing of multiple patient samples. Approval of the complete Vitros menu of 114 assays is expected by mid-2010.
Ortho’s Vitros 5600 Integrated System is expected to offer a complete infectious disease testing menu in the US, including HIV and rubella, in addition to a comprehensive menu of routine assays that can be run on a single platform.
Reportedly, the Vitros Anti-HIV 1+2 Assay is an in-vitro diagnostic immunoassay for the qualitative detection of HIV 1+2 in human serum and plasma.
Moreover, the product may also be used to screen for HIV in pregnant women to identify neonates who are at high risk of acquiring HIV during the perinatal period. Being aware of a mother’s HIV status enables physicians to prevent mother-to-child HIV transmission by providing antiretroviral treatment to both mothers and their babies.
Mike Samoszuk, chief medical officer of Ortho, said: “For testing HIV, the Vitros Anti-HIV 1+2 assay will help enhance the clinical laboratory’s ability to adhere to the Centers for Disease Control and Prevention (CDC) HIV screening guidelines, while at the same time increasing the lab’s productivity and efficiency.”