HIV-1, HCV and HBV seronegative window reduction by the new Roche cobas TaqScreen MPX test in seroconverting donors
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Michael Wiedmann1, Sabine Kluwick, Martina Walter
1Roche Diagnostics GmbH, Roche Molecular Diagnostics, Werk Penzberg, Nonnenwald 2, 82377 Penzberg, Germany. michael.wiedmann@roche.com
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.
