cobas® TaqScreen MPX Test 

 
Registration Status

Canada-IVD
CE-IVD
US-IVD
Detects the most critical viral targets in one easy-to-use assay
A multiplex, real-time PCR test that detects the presence of human immunodeficiency virus type 1 (HIV-1, groups M and O), human immunodeficiency virus type 2 (HIV-2), hepatitis C virus (HCV) and hepatitis B virus (HBV) in  plasma from blood, organ and tissue donors.
Features and Benefits
  • Simultaneous testing for multiple viruses in a single sample: HIV-1 group M, HIV-1 group O, HIV-2, HCV and HBV – saves time and increases process efficiencies
  • Signal detection in two separate channels allows simultaneous monitoring of viral targets and full process internal control during real-time PCR – helps ensure result integrity
  • No calibration required for real-time PCR and stabilized reagents – saves time and reduces costs
  • Ready-to-use reagents that do not require freezing
Intended Use
 
(CE-IVD, 3/2010, v5.0)
The cobas® TaqScreen MPX Test, 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, human immunodeficiency virus type 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 as a donor screening test to detect HIV-1 group M, HIV-1 group O, HIV-2, HCV RNA and HBV DNA in plasma specimens from individual blood donors, including donors of whole blood and blood components, source plasma and other living donors. This test is also intended for use to screen individual 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) organ and tissue 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 equal aliquots of individual specimens in conjunction with serology tests for HIV, HCV or HBV.
 
This test is not intended for use as an aid in diagnosis.
 
(FDA-IVD, 1/2010, Rev. 5.0)
The cobas® TaqScreen MPX Test, 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, 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.
This test is also intended for use in testing plasma specimens to screen individual organ donors when specimens are obtained while the donor’s heart is still beating and in testing blood specimens from cadaveric (non-heartbeating) 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 six equal aliquots of 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 equal aliquots of not more than 6 individual donor specimens.
 
For donations from cadaveric (non-heart-beating) organ and tissue donors, specimens may only be screened as individual specimens. For donations of source plasma, plasma may be tested in pools comprised of up to 96 individual donations.
 
This test is intended to be used in conjunction with licensed serology tests for HIV, HCV and HBV.
 
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 not intended for use as an aid in diagnosis of infection with HIV, HCV or HBV.
 
 
More Information
 
For regulatory reasons we are not able to provide further details on our products on this website, but more information may be available from our regional sales representatives.
 
 
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