Experience with the IVDD performance evaluations of the ADVIA Centaur infectious disease assays

Journal of Clinical Virology

Volumn 30, Issue SUPPL. 1, 2004, Pages

  Van Helden, Josef ^a   Denoyel, Gérard A ^b  

^a Mikrobiologie und Humangenetik   (Germany)

^b LMM Laboratoire Marcel Merieux   (France)

Author keywords

Common Technical Specifications; CTS; EU; European Union; In Vitro Diagnostics; In Vitro Diagnostics Directive; IVD; IVDD; NB; Notified Body

Indexed keywords

HEPATITIS B SURFACE ANTIGEN; HEPATITIS C ANTIBODY; HUMAN IMMUNODEFICIENCY VIRUS ANTIGEN;

ANTIBODY DETECTION; ANTIGEN DETECTION; ARTICLE; BLOOD SAMPLING; DIAGNOSTIC ACCURACY; EUROPE; HEPATITIS B; HEPATITIS B VIRUS; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 2; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOASSAY; NONHUMAN; PRIORITY JOURNAL; VIRUS DIAGNOSIS;

AIDS SERODIAGNOSIS; AUTOANALYSIS; CHEMILUMINESCENT MEASUREMENTS; EUROPE; HEPATITIS B; HEPATITIS B SURFACE ANTIGENS; HEPATITIS C; HEPATITIS C ANTIBODIES; HIV ANTIBODIES; HIV INFECTIONS; HUMANS; IMMUNOASSAY; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 1942484342     PISSN: 13866532     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jcv.2004.03.004     Document Type: Article

References (4)

1. Commission Decision on common technical specifications for in vitro-diagnostic medical devices. Off 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. Off 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 Document EP5-A. Evaluation of precision performance of clinical chemistry devices. Approved guideline. 2nd ed. 1999.