cobas® TaqScreen MPX Test, v2.0

One test, three results

Detects and discriminates the most critical viral targets in one easy-to-use assay.

A multiplex, real-time PCR test that offers immediate virus discrimination of HIV, HCV and HBV in donations of human whole blood and blood components including source plasma.

Features and Benefits

  • Real-time detection and identification of 3 viruses in a single test (HIV, HCV and HBV)
  • Covers 5 critical viral targets (HIV-1 Group M, HIV-1 Group O, HIV-2, HCV and HBV) in one easy-to-use assay
  • Increases operational efficiency by removing the need for viral discriminatory testing
  • Improved sensitivity compared to the previous version of the test
  • Increased inclusivity of viral targets based on new viral sequences
  • Improved workflow on a single platform
  • No calibration required for real-time PCR
  • Ready-to-use reagents that do not require freezing

Intended Use

(CE-IVD, 01/2011, v1.0)
The cobas® TaqScreen MPX Test, version 2.0 (v2.0) for use with the cobas s 201 system, 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 donor samples for HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, HCV RNA and HBV DNA in plasma specimens from individual human donors, including donors of whole blood, blood components (red cells, platelets and plasma) and other living donors. This test is also intended for use to screen organ and tissue donors when specimens are obtained while the donor’s heart is still beating.

Plasma from all donors may be screened as individual specimens. For donations of whole blood and blood components, plasma specimens may be tested individually or in pools comprised of aliquots of individual specimens in conjunction with serology tests for HIV, HCV and HBV. For an individual specimen, results are simultaneously detected and discriminated for HIV, HCV and HBV.

This test is not intended for use as an aid in diagnosis of infection with HIV, HCV or HBV.