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.
