Michael Schmidt, Lutz Pichl and Christine Jork contributed equally to this study.
Blood donor screening with cobas s 201/cobas TaqScreen MPX under routine conditions at German Red Cross institutes
Article first published online: 4 AUG 2009
© 2009 The Author(s). Journal compilation © 2009 International Society of Blood Transfusion
Volume 98, Issue 1, pages 37–46, January 2010
How to Cite
Schmidt, M., Pichl, L., Jork, C., Hourfar, M. K., Schottstedt, V., Wagner, F. F., Seifried, E., Müller, T. H., Bux, J. and Saldanha, J. (2010), Blood donor screening with cobas s 201/cobas TaqScreen MPX under routine conditions at German Red Cross institutes. Vox Sanguinis, 98: 37–46. doi: 10.1111/j.1423-0410.2009.01219.x
- Issue published online: 9 DEC 2009
- Article first published online: 4 AUG 2009
- Received: 27 March 2009, revised 10 June 2009, accepted 13 June 2009
- real-time MP NAT;
- s 201
Background In 1997 the German Red Cross (GRC) blood donor services introduced mini-pool nucleic acid testing (NAT) for human immunodeficiency virus (HIV)-1, hepatitis C virus (HCV) and hepatitis B virus (HBV) to increase blood safety. With the new cobas s 201/cobas TaqScreen MPX, a fully automated extraction method and a multiplex amplification system specifically adapted to the needs of blood donation services is available.
Methods The cobas s 201 system was evaluated at the GRC BTS locations Hagen, Springe and Frankfurt. In phase A, the analytical sensitivity for the detection of HBV, HCV and HIV-1 was investigated and in phase B, at least 60 000 samples at each test site were screened in parallel with the MPX test on s 201 system and the existing routine mini-pool NAT system to compare the diagnostic specificity and the diagnostic sensitivity.
Results Comparable analytical sensitivities in a range of 1·6–3·6 IU/ml, 4·9–10·9 IU/ml and 14·7–26·6 IU/ml for HBV, HCV HIV, respectively, for the MPX test on s 201 system (95% probability based on probit analysis) were determined at all test sites. The diagnostic sensitivity was 99·8% and the diagnostic specificity was 99·85%.
Conclusions The MPX test on s 201 system is a fully automated NAT system suitable for routine blood donor screening. The analytical sensitivity as well as the diagnostic sensitivity fulfilled all requirements of the Paul Ehrlich Institute for blood donor screening in mini-pools up to 96 donations per pool. A major benefit of the automated NAT system is the reduced personnel time and the extensive complete barcode-controlled process documentation.