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Roche's HIV, hep C and B test can now be used in pooled plasma

This article was originally published in Clinica

Executive Summary

The US FDA has extended the intended use for Roche’s cobas TaqScreen MPX Test, an assay that detects HIV as well as hepatitis B and C in donated blood and plasma. It can now be used to screen source plasma in pools comprised of up to 96 individual donations. The test was approved in the US in December 2008 to screen plasma specimens from blood donors, and is also CE marked for sale in Europe for screening source plasma. Specifically, the test detects HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C virus RNA and hepatitis B virus DNA. It is carried out on the cobas s 201 system.

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