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FDA Approves Blood Screening Assay

About the test approval

On January 9, 2015, Roche announced that the U.S. Food and Drug Administration (FDA) approved the cobas® TaqScreen MPX Test, v2.0. This test is used in the detection and identification of HIV, HCV, and HBV in blood and blood components such as plasma.

This new version of the cobas TaqScreen MPX Test is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use evaluation, and also provides enhanced sensitivity within the testing. A fully automated system of virus detection and identification steps creates workflow advantages to blood and plasma testing centers, as they eliminate the need for consecutive rounds of testing. This also enables donor counseling to occur earlier in the process if the donor tests positive.

Roland Diggelmann, COO of Roche Diagnostics, states that, “By continually developing these innovative products we are striving for the highest level of safety for patients and efficiency for blood and plasma centers. This latest approval supports that commitment.”1

Alongside a wide variety of international approvals, including approvals in Europe, Canada, Brazil, China, and India, this recent FDA approval of the cobas TaqScreen MPX Test, v2.0 supports safety standards of blood and plasma centers worldwide. (insert reference). Individual samples are tested for HIV, HCV and HBV, by the use of real-time, multi-dye PCR technology. This decreases the sample volume required and, in effect, the amount of turnaround time for donor testing.

About the cobas TaqScreen MPX Test, v2.0

The press release states: “The cobas® TaqScreen MPX Test, v2.0 is a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA in human plasma.” The way the blood donations work is with human whole blood components in pools of 6 samples; source plasma donations are in pools of up to 96 samples.

In addition to HIV, HCV, and HBV, it also tests for West Nile virus, parvovirus B19 (B19V) and hepatitis A virus (HAV). Roche blood screening tests are all based on Nucleic Acid Amplification Technology (NAT). This technology provides earlier detection of viruses than traditional serology testing. The cobas s 201 system offers a single automated platform that makes a comprehensive NAT test menu available.

About Roche Blood and Plasma Screening

Nucleic acid-based tests allow for earlier recognition of active viral infections than conventional antibody or antigen tests. In particular, Roche’s real-time PCR-based nucleic acid assays have been used since 1998 to screen blood and plasma products. Right now, over 250 testing centers globally use Roche’s automated systems for blood and plasma screening.

The approval of this test is exciting as it provides earlier resources to patients who test positive as well as faster turnaround time from testing centers.

  1. FDA Approves Roche's Blood Screening Assay for Simultaneous Detection and Identification of Three Major Viral Targets. Roche Media Releases. January 9, 2015. Accessed February 5, 2015.