FDA OKs Roche's HIV-1 test for plasma:
This article was originally published in Clinica
The US FDA has approved Roche Diagnostics' Cobas AmpliScreen HIV-1 test v1.5 for use as a qualitative in vitro test for the direct detection of HIV-1 in both source plasma and organ donors. The test has already been approved and is in use in the US and other countries for screening whole blood donations. Bayer Healthcare's Biological Products Division (Bayer BP) supplied much of the data required for Roche's submission to the FDA. Bayer BP received simultaneous approval from the FDA to perform in-house nucleic acid testing for HIV-1 in plasma donations using Roche's test with pools of 96 test samples.