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Ortho-Clinical granted approval for new HIV test

Ortho-Clinical Diagnostics has received the FDA approval for a new diagnostic test, Vitros Anti-HIV 1+2 assay for the detection of antibodies to human immunodeficiency virus types 1 and 2.

The new assay 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 US, Puerto Rico and US 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. The features of automation and random access are said to increase productivity and efficiency in the laboratory.

The Vitros Anti-HIV 1+2 assay can help meet the demand on laboratories created by new US Centers for Disease Control and Prevention (CDC) testing recommendations. The Vitros Anti-HIV 1+2 Assay has been co-developed with Chiron, a business of Novartis Vaccines and Diagnostics.