Cobas® TaqScreen MPX Test
COBAS® TaqScreen MPX Test
The cobas® TaqScreen MPX Test is a qualitative in vitro multiplex real-time PCR test that detects the presence 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 used for screening whole blood donations and is run on the cobas s 201 system. The cobas s 201 system is a complete nucleic acid testing solution able to meet both current and future needs of blood screening labs. It consists of 3 instruments - the Hamilton MICROLAB STAR pipettor, the COBAS® AmpliPrep instrument, and the COBAS® TaqMan® analyser - automates every step of the real-time PCR-based blood screening process including automated pooling.
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 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.
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.