cobas^® MPX

One test, three results

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

The cobas^® MPX Test is a multi-dye, real-time PCR multiplex test for HIV, HCV and HBV for use on the cobas^® 6800/8800 Systems.

Features and benefits

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

Advanced diagnostic technology for donor screening

The cobas^® MPX test enables donor screening laboratories to reliably test for 3 viruses and 5 critical viral targets with a single assay, boosting operational efficiency by eliminating the need for additional discriminatory testing.

Intended use

US-IVD

cobas® MPX, 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, HCVRNA, 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 or from 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 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. For all other donors, samples may only be screened as 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.cobas®

MPX 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.

cobas® MPX 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.

cobas® MPX 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.