Blood donors were prospectively investigated for the presence of anti-HBc-antibodies (Anti-HBc II, ARCHITECT, ABBOTT, Wiesbaden, Germany) in addition to standard HBV screening consisting of HBV-ID-NAT (Cobas MPX-assay, Roche) and HBs-antigen chemiluminescent immunoassay (ARCHITECT, Abbott). During March 2017 (period I), all donations of whole blood, platelets, and plasma were included into the study. From April 2017 to February 2018 (period II), only first-time whole blood donors were included into the study. Anti-HBc-positive samples were confirmed using an anti-HBc inhibition assay performed at the Institute of Virology in Freiburg, Germany [12 (link)]. The assay applies a recombinant core antigen of HBV. The assay is approved by the Federal Institute for Vaccines and Biomedics Paul-Ehrlich Institute, Langen, Germany, for confirmatory testing of blood donors. In this study, discarded fresh frozen plasma (dFFP) of anti-HBc-confirmed positive donors were ultracentrifuged and reanalyzed by standard HBV-ID-NAT.
Cobas mpx assay
Manufactured by Roche
Sourced in Germany
The Cobas MPX-assay is a laboratory diagnostic instrument manufactured by Roche. It is designed to detect and identify multiple pathogens in a single test. The Cobas MPX-assay utilizes advanced molecular testing technology to provide accurate and reliable results. Its core function is to enable efficient and comprehensive testing for infectious diseases.
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2 protocols using cobas mpx assay
1
Screening Blood Donors for Anti-HBc
2
HCV Detection in Plasma and DBS
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HCV RNA in plasma samples were either determined by the quantitative cobas®HCV assay (Roche Diagnostics GmbH, Mannheim, German) run at the cobas®6800 system (Roche Molecular system) or by the Aptima HCV Quant Dx assay (Hologic GmbH, Vienna, Austria) run at the Panther® system (Hologic, Marlborough, MA, USA). The lower quantification limit were 15 IU/mL and 10 IU/mL, respectively, and all analyses were performed according to the manufacturer’s instructions.
DBS were obtained on Whatman® 903 protein saver cards (Sigma-Aldrich, Copenhagen, Denmark) and were allowed to dry for 1 to 3 days before they were eluted and tested for anti-HCV. HCV antibodies were determined by the Alinity i Anti-HCV assay (Abbott Diagnostics, Delkenheim, Germany). Anti-HCV positive samples were tested for the presence of HCV RNA by nucleic acid amplification testing using the cobas® MPX assay (Roche Diagnostics GmbH, Mannheim, German) run at the cobas® 6800 system (Roche Molecular system). The sensitivity when using DBS samples has previously been reported to be >95% [22 (link)].
DBS were obtained on Whatman® 903 protein saver cards (Sigma-Aldrich, Copenhagen, Denmark) and were allowed to dry for 1 to 3 days before they were eluted and tested for anti-HCV. HCV antibodies were determined by the Alinity i Anti-HCV assay (Abbott Diagnostics, Delkenheim, Germany). Anti-HCV positive samples were tested for the presence of HCV RNA by nucleic acid amplification testing using the cobas® MPX assay (Roche Diagnostics GmbH, Mannheim, German) run at the cobas® 6800 system (Roche Molecular system). The sensitivity when using DBS samples has previously been reported to be >95% [22 (link)].
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