Blood Products

BPAC recommends COBAS AmpliScreen HBV Test for donated blood

Published in Blood Weekly, September 9th, 2004

Roche Diagnostics announced that the Blood Products Advisory Committee (BPAC) of the United States Food and Drug Administration (FDA) voted overwhelmingly that the sensitivity and specificity of Roche's COBAS AmpliScreen HBV Test in a minipool format supported licensing as a screening test for the detection of hepatitis B (HBV) in donated whole blood.

The advisory committee's 15-1 vote supporting licensure was made July 24, 2004, after Roche Molecular Systems (RMS) presented results from their clinical study at a meeting of the BPAC. The test is the first nucleic acid test designed for screening whole blood for HBV to be accepted for review by the FDA.

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Source: Blood Weekly (2004-09-09)

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