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 RNA, hepatitis C virus RNA and hepatitis B virus 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.