FDA approves Roche’s hepatitis B test
Cadaveric organ and tissue donations

Basel/Switzerland – Roche Diagnostics has announced that the United States Food and Drug Administration (FDA) approved its Cobas AmpliScreen Hepatitis B Test to screen individual cadaveric organ and tissue donations for Hepatitis B (HBV) infection. This expanded claim adds to existing approvals for testing whole blood, blood components, and source plasma from living donors. Roche Diagnostics’ blood and tissue screening tests are based on the company’s patented PCR. Currently, most tissue donors are tested using enzyme immunoassays, which detect antibodies to the target virus. PCR-based tests, in contrast to enzyme immunoassays, enable detection of the genetic material of infectious agents directly, making it possible to detect infections earlier in the infection cycle than with immunoassay testing, often before the individual making the donation shows any symptoms of disease.