Quality assurance and quality control in the routine molecular diagnostic laboratory

Molecular Diagnostics of Infectious Diseases

Volumn , Issue , 2010, Pages 35-46

  Rabenau, Holger ^a   Raggam, Reinhard ^b   Kessler, Harald ^b  

^a GOETHE UNIVERSITY   (Germany)

^b MEDICAL UNIVERSITY OF GRAZ   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84880188119     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1515/9783110214864     Document Type: Chapter

References (5)

1. Bossuyt, P.M., Reitsma, J.B., Bruns, D.E., Gatsonis, C.A., Glasziou, P.P., Irwig, L.M., Moher, D., Rennie, D., de Vet, H.C., Lijmer, J.G. (2003) Standards for Reporting of Diagnostic Accuracy (2003): the STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin. Chem. 49:7-18.
2. Commission Decision of7May 2002 on common technical specifications for in vitro-diagnostic medical devices (2002) Official J. Eur. Commun. L131:17-30.
3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (1998) Official J. Eur. Commun. L331:1-37.
4. Linnet, K., Boyd, J.C. (2006) Selection and analytical evaluation of methods - with statistical techniques. In: Burtis, C.A., Ashwood, E.R., Bruns, D.E., Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th edn., St. Louis: Saunders, 353-407.
5. Madej, R.M., Davis, J., Holden, M.J., Kwang, S., Labourier, E., Schneider, G.J. (2010) International standards and reference materials for quantitative molecular infectious disease testing. J. Mol. Diagn. Jan 14 [Epub ahead of print].