cobas® MPX

One test, three results

Image cobas® MPX assay for the detection of HIV, HCV, and HBV in donated blood

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

Nucleic Acid Testing (NAT) has been proved to significantly reduce the risk of transmission during "window periods" and improve the detection of infectious diseases. The cobas® MPX Test is a multi-dye, real-time PCR multiplex test for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) for use on the cobas® 6800/8800 Systems. The single assay allows for simultaneous detection of three targets, improving efficiency and accuracy.

Advanced diagnostic technology for HIV and hepatitis

The cobas® MPX test enables donor screening laboratories to reliably test for 3 viruses and 5 critical viral targets with a single assay. This boosts operational efficiency as the need for additional discriminatory testing is completely eliminated. Streamlining results increases laboratory efficiency, saves precious donor material, eliminates the need to store additional test kits, and allows for earlier counseling of infected donors.

Lab technician loading assays onto a Roche system

Test plasma or serum for increased flexibility

Protect against new virus variants with a dual-target, dual-probe approach

 

  • Real-time detection and identification of HIV, HCV and HBV
  • Covers 5 critical viral targets in a single test (HIV-1 group M, HIV-1 group O, HIV-2, HCV and HBV)
  • Dual-target approach with amplification of separate regions of HIV-1
  • Dual probes for HCV to improve coverage of new virus variants
  • Highly sensitive HBV detection of occult and low titer HBV infection

 

Streamline your workflow and ensure reliable results, with automated multiplex testing

 

  • Eliminates the need for discriminatory testing and potential for discrepant results
  • Ready-to-use reagents — no thawing, pouring or mixing required
  • Stabilized real-time PCR reagents do not require calibration
  • Full-process internal control helps ensure result integrity
  • True external positive controls that have no effect on result calculation, with cobas® MPX Control Kit
  • Can be run simultaneously with other assays on the cobas® 6800/8800 Systems

Real-time virus discrimination in a growing assay portfolio

Each new multiplex test in the cobas® family brings increased innovation and improved performance to the Roche blood screening assay portfolio. All donor screening assay reagents were designed for workflow efficiency —ready-to-use reagents and controls save labor time, and only require refrigeration.

 

Truly external controls do not influence the result calculation and stabilized PCR reagents don’t require calibration, unlike other available tests.

Lab technician reviewing results
lab technician automating workflows with cobas® 8800 system

Donor Screening - Personalized Lab Automation

Simplify operations, reduce manual tasks and increase both efficiency and quality with automation solutions for labs of all sizes.

Explore
Intended use

Intended use

The cobas® MPX test is a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type 1 (HIV1) 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 and serum.
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 and serum samples from individual human donors, including donors of whole blood, blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor's heart is still beating and in testing of cadaveric (non-heart beating) donors. Plasma and serum from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma and serum samples are tested individually. For donations from cadaveric (non-heart beating) organ and tissue donors, samples are tested individually.

For an individual sample, results are simultaneously detected and discriminated for HIV, HCV, and HBV.

 

The cobas® MPX test can be considered a supplemental test that confirms HIV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HIV and reactive on the cobas® MPX test.

 

The cobas® MPX test can be considered a supplemental test that confirms HCV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HCV and reactive on the cobas® MPX test.

 

The cobas® MPX test can be considered a supplemental test that confirms HBV infection for samples that are repeatedly reactive on a CE-IVD test for Hepatitis B surface antigen and reactive on the cobas® MPX test.

 

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

The cobas® MPX test, for use on cobas® 6800 and cobas® 8800 Systems, is a qualitative in vitro nucleic acid 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 and serum. The cobas® MPX test simultaneously detects and discriminates for HIV, HCV, and HBV. The assay does not discriminate between HIV-1 Group M, HIV-1 Group O, and HIV-2.

This test is intended for use to screen donor samples for HIV-1 Group M RNA, HCV RNA, and HBV DNA in plasma and serum samples from individual human donors, including donors of whole blood, blood components, Source Plasma and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Plasma and serum from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma and serum samples may be tested individually or plasma may be tested in pools comprised of not more than six individual samples. For donors of hematopoietic stem/progenitor cells (HPCs) sourced from bone marrow, peripheral blood or cord blood, and for donors of donor lymphocytes for infusion (DLI), plasma may be tested in pools comprised of not more than six individual samples. For donations of source plasma, samples may be tested in pools comprised of not more than 96 individual samples.

 

This test is intended to be used in conjunction with licensed serology tests for HIV-1, HCV, and HBV.

 

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

 

This test is not intended for use on samples of cord blood.

 

This test is not intended for testing cadaveric blood specimens.

 

The cobas® MPX test can be considered a supplemental test that confirms HIV infection for specimens that are repeatedly reactive on a licensed donor screening test for antibodies to HIV and reactive for HIV on the cobas® MPX test.

 

The cobas® MPX test can be considered a supplemental test that confirms HCV infection for specimens that are repeatedly reactive on a licensed donor screening test for antibodies to HCV and reactive for HCV on the cobas® MPX test.

 

The cobas® MPX test can be considered a supplemental test that confirms HBV infection for specimens that are repeatedly reactive on a licensed donor screening test for Hepatitis B surface antigen, and reactive for HBV on the cobas® MPX test.

cobas® 6800/8800 Systems are not available in all markets.

Registration status

CE-IVD, US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics website.

Related systems

RMD_cobas_p_680_pooler_280x184.jpg

cobas p 680 Instrument

Automate pooling and pipetting while ensuring reliable sample transfer and tracking for the cobas® 6800 and cobas® 8800 Systems.

More
cobas® 6800 System image

cobas® 6800 System

Transform your testing experience for IVD applications—just 2 simple user interactions per run and up to 8 hours of walk-away time.

More
cobas® 8800 System image

cobas® 8800 System

Unparalleled performance with minimal operator interaction revolutionizes the future of high-throughput applications. 

More