Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the cobas® TaqScreen MPX Test, version 2.0 for use on the cobas s 201 system is now commercially available in Europe.
This latest version of the widely used cobas® TaqScreen MPX Test provides increased sensitivity and is the only commercially available test that provides simultaneous viral target resolution on an automated system, removing the need for further time-consuming testing of positive units.
The test 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. This test is intended for use to screen samples of donations of human whole blood and blood components including source plasma.
"Roche is the global market leader in testing sites and donations tested," said Paul Brown, Head of Roche Molecular Diagnostics, the business area of Roche that developed the test. "By continually developing innovative products we are striving for the highest level of blood safety for patients and efficiency for blood centers. This test takes us one step closer to those goals."
As a result of Roche's process to globally monitor viral genome databases to track changes that may occur in viral sequences, the assay has been reformulated to include as many recent viral sequences as possible increasing the inclusivity range of viral targets.
The cobas® TaqScreen MPX Test, v2.0 also offers increased efficiencies for blood centers by removing the need for viral discriminatory testing, thereby reducing the sample volume required and the turnaround time for donor testing. By utilizing real-time, multi-dye PCR technology, results are simultaneously detected and discriminated for HIV, HCV and HBV for an individual specimen, eliminating the need for additional time-consuming discriminatory tests that other commercially available tests require.
The test runs on the fully automated cobas s 201 system, which is designed to increase processing efficiency in a unique modular design with ready-to-use reagents. The multi-dye technology allows signal detection in four separate channels, facilitating simultaneous monitoring of three viral targets (HIV, HCV and HBV) plus a full-process internal control. In addition to HIV, HCV and HBV, the menu of the cobas s 201 system includes tests for West Nile virus, parvovirus B19 (B19V) and hepatitis A virus (HAV). All Roche blood screening tests are based on Nucleic Acid Amplification Technology (NAT) which offers earlier detection of viruses than traditional serology testing. The cobas s 201 system offers the most comprehensive NAT test menu available on a single automated platform.