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cobas® TaqScreen MPX Test, v2.0

Reduce transmission risk of HIV, HBV and HCV with one testing kit

cobas® TaqScreen MPX test, v2.0 rapid testing kit for HIV, HCV and HBV

Improve efficiency with simultaneous testing

The cobas® TaqScreen MPX Test, v2.0 is a multiplex, real-time PCR test that offers immediate virus discrimination of human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) in donations of human whole blood and blood components, including source plasma.

 

Under new rules from the FDA, nucleic acid tests will now be used to screen potential donors for HBV as it offers significant improvement in early HBV detection. The change is to reduce the risk of infection during the “window period of infection”.

Real-time automated detection for viral infections

  • Real-time detection and identification of 3 viruses in a single test (HIV, HCV and HBV)
  • Covers 5 critical viral targets in one easy-to-use assay (HIV-1 Group M, HIV-1 Group O, HIV-2, HCV and HBV)
  • Increased inclusivity of viral targets based on new viral sequences

 

For simpler, more efficient testing

 

  • No calibration required for real-time PCR
  • Ready-to-use reagents that do not require freezing
  • Increases operational efficiency by removing the need for viral discriminatory testing
  • Improved workflow on a single platform

Advanced diagnostic technology for donor screening

 

The cobas® TaqScreen MPX Test, v2.0 reduces the risk of blood samples infected with HIV, HBV and HCV being transmitted by enabling 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 discriminatory testing with rapid lab tests.

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Intended use

Intended use

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 and in blood specimens from cadaveric (non-heart-beating) donors. 

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.

 

The cobas® TaqScreen MPX Test, v2.0 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 on the cobas® TaqScreen MPX Test, v2.0.

 

The cobas® TaqScreen MPX Test, v2.0 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 on the cobas® TaqScreen MPX Test, v2.0. 


The cobas® TaqScreen MPX Test, v2.0 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 on the cobas® TaqScreen MPX Test, v2.0.

 

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

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 for HIV-1 Group M RNA, HCV RNA, and HBV DNA in plasma specimens from individual human donors, including donors of whole blood, blood components, source plasma and other living donors. The test is also intended for use in testing plasma specimens to screen organ and tissue donors for HIV-1 Group M RNA, HCV RNA, and HBV DNA when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens from cadaveric (non-heart beating) donors. This test is not intended for use on samples of cord blood. 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 not more than 6 individual specimens. 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 6 individual specimens. For donations of source plasma, sample may be tested in pools comprised of not more than 96 individual specimens.
Whereas this test can detect HIV-1 Group O RNA and HIV-2 RNA, detection of HIV-1 Group O RNA or HIV-2 RNA in donor specimens negative for anti-HIV-1 Group O antibodies or anti-HIV-2 antibodies, respectively, has not been demonstrated in clinical studies.

 

This test is intended to be used in conjunction with licensed 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.

 

The cobas® TaqScreen MPX Test, v2.0 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® TaqScreen MPX Test, v2.0.

 

The cobas® TaqScreen MPX Test, v2.0 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® TaqScreen MPX Test, v2.0.

 

The cobas® TaqScreen MPX Test, v2.0 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® TaqScreen MPX Test, v2.0.

Registration status

CE-IVD, US-IVD

 

Package inserts

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

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