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May 23, 2011

Roche’s Multivirus Blood-Screening Assay Achieves CE Mark

  • Roche’s combination HIV, HCV, and HBV screening test, the cobas® TaqScreen MPX Test version 2.0, has been granted a CE mark in Europe for use on the cobas s 201 system. The qualitative in vitro test, designed to screen donated whole blood and blood components, allows the direct detection of HIV type I group M RNA, HIV-1 group 0 RNA, HIV type 2 RNA, hepatitis C virus RNA, and hepatitis B virus DNA in human plasma.

    Roche says the latest version of the real-time PCR assay has been reformulated to include new viral sequences, features increased sensitivity, and is the only commercially available automated test that provides simultaneous detection and identification of HIV, HCV, and HBV in an individual specimen, which removes the need for additional discriminatory tests. The TaqScreen MPX Test v.2 is not yet approved or available in the U.S.

    The firm has developed a range of blood-screening tests for the cobas s 201 system, including West Nile virus, parvovirus B19, and hepatitis A virus.

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