cobas^® MPX

The cobas^® MPX test, for use on cobas^® 5800/6800/8800 Systems is a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type 1 (HIV1) 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.

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 and serum samples from individual human donors, including donors of whole blood, blood components, 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 and in testing of 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 aliquots of individual samples. For donations from cadaveric (non-heart beating) organ and tissue donors, samples may only be screened as individual sample.

For an individual sample, results are simultaneously detected and discriminated for HIV, HCV, and HBV.

The cobas^® MPX test can be considered a supplemental test that confirms HIV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HIV and reactive on the cobas® MPX test.

The cobas^® MPX test can be considered a supplemental test that confirms HCV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HCV and reactive on the cobas^® MPX test.

The cobas^® MPX test can be considered a supplemental test that confirms HBV infection for samples that are repeatedly reactive on a CE-IVD test for Hepatitis B surface antigen and reactive on the cobas^® MPX test.

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

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, HCV RNA, 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.