Verification and validation of diagnostic laboratory tests in clinical virology

Journal of Clinical Virology

Volumn 40, Issue 2, 2007, Pages 93-98

  Rabenau, Holger F ^a   Kessler, Harald H ^b   Kortenbusch, Marhild ^a   Steinhorst, Andreas ^c   Raggam, Reinhard B ^b   Berger, Annemarie ^a  

^a GOETHE UNIVERSITY   (Germany)

^b MEDICAL UNIVERSITY OF GRAZ   (Austria)

^c DACH Deutsche Akkreditierungsstelle Chemie   (Germany)

Author keywords

CE; Diagnostics; IVD; Validation; Verification; Virology

Indexed keywords

ANTIGEN DETECTION; DIAGNOSTIC TEST; HUMAN; LABORATORY TEST; PRIORITY JOURNAL; REVIEW; VALIDATION PROCESS; VIROLOGY; VIRUS DETECTION; VIRUS DIAGNOSIS; VIRUS INFECTION;

ANIMALS; DNA, VIRAL; HUMANS; POLYMERASE CHAIN REACTION; QUALITY CONTROL; RNA, VIRAL; SEROLOGIC TESTS; VALIDATION STUDIES AS TOPIC; VIROLOGY; VIRUS DISEASES; VIRUSES;

EID: 34548663858     PISSN: 13866532     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jcv.2007.07.009     Document Type: Review

References (6)

1. Bossuyt P.M., Reitsma J.B., Bruns D.E., Gatsonis C.A., Glasziou P.P., Irwig L.M., et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin Chem 49 (2003) 7-18
2. Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices. Official J Eur Commun 2002;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. Official J Eur Commun 1998;L331:1-37.
4. Koidl C., Bozic M., Berg J., Stöcher M., Mühlbauer G., Grisold A.J., Marth E., and Kessler H.H. Detection of transfusion transmitted virus DNA by real-time PCR. J Clin Virol 29 (2004) 277-281
5. Linnet K., and Boyd J.C. Selection and analytical evaluation of methods-with statistical techniques. In: Burtis C.A., Ashwood E.R., and Bruns D.E. (Eds). Tietz textbook of clinical chemistry and molecular diagnostics. 4th ed. (2006), Saunders, St. Louis 353-407
6. Rasmussen R. Quantification on the LightCycler. In: Meuer S., Wittwer C., and Nakagawara K. (Eds). Rapid cycle real-time PCR, methods and applications (2001), Springer-Verlag, Berlin 21-34