Source Plasma Screened For HIV and Hepatitis Viruses

A nucleic acid test screens source plasma in pools comprised of up to 96 individual donations.

The test, called the cobas TaqScreen MPX test for use on the cobas s 201 system, is a qualitative, in vitro test for the simultaneous, direct detection of the human immunodeficiency virus (HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA), hepatitis C virus (HCV) RNA, and hepatitis B virus (HBV) DNA in human plasma.

The cobas TaqScreen MPX test was designed to increase processing efficiency with a modular design and ready-to-use reagents. The system can run multiple channels using multidye technology, enabling simultaneous detection of several viruses. Roche is developing another multidye assay on the same platform, the cobas TaqScreen DPX test that is designed to simultaneously provide a quantitative result for B19 virus and a qualitative result for hepatitis A virus.

Roche (Pleasanton, CA, USA) announced today that the US Food & Drug Administration (FDA; Silver Springs, MD, USA) approved the additional intended use for its licensed nucleic acid test screens of pooled source plasma.

"As a stand-alone PCR system the cobas s 201 system and cobas TaqScreen MPX Test for HIV, HBV, and HCV, provides a simple user interface while improving process control and lab efficiencies," said Douglas Lee, PhD, senior director pathogen safety and research, Talecris Biotherapeutics (Research Triangle Park, NC, USA), one of the largest fractionators in the US and a clinical trial site for the cobasTaqScreen MPX test.

Human plasma is fractionated into its components, such as immunoglobulins, albumin, and clotting factors, which have therapeutic uses including treatment of chronic and hereditary diseases and disorders such as hemophilia and primary immunodeficiency diseases. Plasma is also used to treat patients who have suffered severe burns or trauma, and during major surgery.

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Roche
US Food & Drug Administration
Talecris Biotherapeutics