Calypte HIV test for same-day use cleared in US:
This article was originally published in Clinica
Executive Summary
The US FDA has cleared Calypte Biomedical's serum HIV-1 assay for same-day (five-hour response) use, supplementing its existing licence under which it can be sold as an overnight test. The assay confirms the presence of HIV-1 antibodies in serum by Western blotting. Calypte, of Alameda, California, assigned Carter-Wallace the exclusive US marketing rights for the test in September. It also appointed distributors for 13 countries in Asia, Eastern Europe and the Middle East.