Licencing of diagnostic HIV kits - To keep a sensible standpoint in an area of permanent revolution

Clinical and Diagnostic Virology

Volumn 5, Issue 2-3, 1996, Pages 137-146

  Schüpbach, Jörg ^a  

^a UNIVERSITY OF ZURICH   (Switzerland)

Author keywords

Diagnostic tests; Evaluation; Sensitivity; Specificity

Indexed keywords

DIAGNOSTIC ACCURACY; DIAGNOSTIC ERROR; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LABORATORY DIAGNOSIS; LICENSING; PRIORITY JOURNAL; REVIEW; SEROCONVERSION; STANDARD; VIRUS DIAGNOSIS;

HUMAN IMMUNODEFICIENCY VIRUS;

EID: 0030151345     PISSN: 09280197     EISSN: None     Source Type: Journal    
DOI: 10.1016/0928-0197(96)00215-2     Document Type: Review

References (5)

1. Commission of the European Communities. (1995) Proposal for a European Parliament and Council directive on in vitro diagnostic medical devices, Brussels 19 April 1995.
2. Constantine, N.T., van dery Groen, G., Belsey, E.M. and Tamashiro, H. (1994) Sensitivity of HIV-antibody assays determined by seroconversion panels. AIDS 8, 1715-1720.
3. Dondero, TJ., Hu, DJ. and George. J.R. (1994) HIV-1 variants: yet another challenge to public health. Lancet 343, 1376.
4. Sachs, L. (1992) Angewandte Statistik, 7 auflage. Springer Verlag, Berlin, Heidelberg, New York, p. 433.
5. WHO Expert Committee on Biological Standardization 31st Report (1981) Technical Report Series 658. WHO, Geneva.