HBV Test for Cadaver Organs, Tissue

This application has been cleared by the U.S. Food and Drug Administration (FDA).

The expanded claims add to existing approvals for testing whole blood, blood components, and source plasma from living donors. Tissues from cadavers include skin, bone, and ligaments. Products from a single donation may be transplanted in as many as 100 patients. These tissues can transmit the same viral infection as blood.

The Cobas AmpliScreen was developed by Roche Diagnostics (Basel, Switzerland). The company's blood and tissue screening tests are based on a patented and highly sensitive polymerase chain reaction (PCR), which has become the global standard for fast and reliable replication of minute amounts of genetic material at detectable levels. Most tissue donors are tested by immunoassays, which detect antibodies to the target virus late in the infection cycle. Nucleic acid tests (NATs), such as the Cobas AmpliScreen, can detect HBV DNA much earlier and can reduce the "window period” of detection, which is the time between infection and the first detection of antigen or antibody. This shortening enables labs to further ensure the safety of tissues.

"This is very good news for patients awaiting much-needed transplants, as well as for tissue and organ banks worldwide,” noted Heiner Dreismann, head of Roche Molecular Diagnostics. "We are proud to be the only company that has both FDA approval and CE Mark certification for cadaveric claims for human immunodeficiency virus (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) nucleic acid tests.”




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