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Ortho-Clinical Diagnostics' HIV test

This article was originally published in Clinica

Executive Summary

The US FDA has granted premarket approval (PMA) for a new assay that detects antibodies to HIV types 1 and/or 2. The VITROS Anti-HIV 1+2 assay, developed by Johnson & Johnson subsidiary Ortho-Clinical Diagnostics, can provide results in less than 50 minutes. It can be run at any time, in any order and with other types of tests, thereby increasing productivity and efficiency in the laboratory. The diagnostic may help meet the demand on laboratories created by new US Centers for Disease Control and Prevention (CDC) testing recommendations, the Raritan, New Jersey firm said. These recommendations call for routine, voluntary HIV testing in all healthcare settings for all individuals ages 13-64, without written informed consent.

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