FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C

The United States Food & Drug Administration (FDA) today approved a new nucleic acid test from Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay. The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C Virus RNA and hepatitis B Virus DNA in human plasma. The test, which is not intended for use as an aid in diagnosis, is designed to further increase the safety of blood supplies by identifying infections earlier than traditional serology tests.

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