European performance evaluations of the ADVIA Centaur® infectious disease assays: Requirements for performance evaluation according to the European directive on in vitro diagnostics

Journal of Clinical Virology

Volumn 30, Issue SUPPL. 1, 2004, Pages S5-S9

  Dati, Francesco ^a   Denoyel, Gérard ^b   Van Helden, Josef ^c  

^a IVD Consulting   (Germany)

^b LMM Laboratoire Marcel Merieux   (France)

^c Labor Dr Stein and Kollegen   (Germany)

Author keywords

Common technical specifications; CTS; EU; European performance evaluations; European Union; In vitro diagnostics; In vitro diagnostics directive; Infectious disease; IVD; IVDD; NB; NCCLS; Notified Body; US National Committee of Clinical Laboratory Standards

Indexed keywords

HEPATITIS B CORE ANTIBODY; HEPATITIS B CORE ANTIGEN; HEPATITIS B SURFACE ANTIBODY; HEPATITIS B SURFACE ANTIGEN; IMMUNOGLOBULIN M ANTIBODY;

ANTIBODY DETECTION; ANTIGEN DETECTION; ARTICLE; AUTOMATION; CHEMOLUMINESCENCE; CLINICAL TRIAL; DIAGNOSTIC ACCURACY; EUROPE; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; IMMUNOASSAY; INTERMETHOD COMPARISON; NONHUMAN; PRIORITY JOURNAL; SEROCONVERSION; VIRUS DETECTION; VIRUS DIAGNOSIS;

EID: 1942484330     PISSN: 13866532     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jcv.2004.02.003     Document Type: Article

References (4)

1. Commission Decision on common technical specifications for in vitro-diagnostic medical devices. Official J Eur Commun 2002;L131:17-30.
2. 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.
3. Hendriks H.A., Kortlandt W., Verweij W.M. Standardized comparison of processing capacity and efficiency of five new-generation immunoassay analyzers. Clin. Chem. 46:2000;105-111.
4. NCCLS, 1999. Document EP5-A, Evaluation of precision performance of clinical chemistry devices approved guideline. 2nd ed.