HIV-1, HCV and HBV seronegative window reduction by the new Roche cobas TaqScreen MPX test in seroconverting donors.

摘要

BACKGROUND: By shortening the pre-seroconversion window in the viral screening of donated blood, nucleic acid amplification testing greatly improves safety and efficiency, particularly when combined with multiple target detection and maximal automation. OBJECTIVES: Evaluation of seronegative window reduction during HIV-1, HCV and HBV infection by the novel cobas TaqScreen MPX test for simultaneous nucleic acid detection of HIV-1 (groups M and O), HIV-2, HCV and HBV using the cobas s 201 system. STUDY DESIGN: Testing of HIV-1, HCV, and HBV seroconversion panels (20 each) using the cobas TaqScreen MPX test versus reference immuno- and nucleic acid technology assays. RESULTS: The cobas TaqScreen MPX test detected HIV-1 and HCV infection earlier than immunoassays in 20/20 and 19/20 panels, and HBV DNA earlier than or on the same day as HBsAg in 19/20 and 18/20 panels, and later in 1 and 2 panels on neat samples and 1:6 dilutions. Pre-seroconversion sensitivity exceeded that of COBAS AmpliScreen testing in pools of 24. CONCLUSION: The cobas TaqScreen MPX test shortens the pre-seroconversion window in minipools of six, evidencing high sensitivity, and significantly enhances blood-screening efficiency by the simultaneous automated detection of multiple viruses in a single test.