Tests de diagnostic rapide des angines à streptocoque du groupe A : étude comparative de la sensibilité et de la praticabilité de 16 dispositifs médicaux de diagnostic in vitro dans le cadre d'un contrôle du marché effectué par l'Afssaps en juillet 2002

Autor: C.T. Ho, Edouard Bingen, N. Charlier-Bret, C. Poyart, B. Boucher, M. Deschênes, G. Quesne, C. Doit, P. Maisonneuve
Rok vydání: 2004
Předmět:
Zdroj: Pathologie Biologie. 52:438-443
ISSN: 0369-8114
DOI: 10.1016/j.patbio.2004.07.013
Popis: Within the scope of its health products control mission, the French Health Products Safety Agency (Afssaps) collaborating with two expert's sites, has assessed the 16 tests available on the French market in 2002 for rapid diagnosis of the Streptococcus A tonsillitis. The purpose of this study was to verify the reliability and rapidity of these tests and to give some information to the users about their analytical criteria and practicability characteristics. The analytical study has been performed on a same panel of four reference strains of Streptococcus pyogenes dilutions to determine the limit of detection of all the reagents in the same condition of methodology. The limit of detection has been calculated with the results expressed in colony forming unit by ml (CFU/ml). The practicability study has permitted to analyze the quality of the presentation, the easiness of the final reading and of performing tests. A score has been established for each rapid test. A classification of the analytical sensitivity (limit of detection) and practicability (score) of these 16 devices has been established. The limit of detection of the reagents giving the best results allows the detection of the lowest bacterial concentration of the panel which is 10(5) CFU/ml. Regarding practicability, the results suggest that, the immunochromatographic strip methods have the best score in a view with the use by a non medical laboratory.
Databáze: OpenAIRE
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