[Rapid antigen detection tests for diagnosis of group A streptococcal pharyngitis: comparative evaluation of sensitivity and practicability of 16 in vitro diagnostics medical devices performed in July 2002 by the French health products safety agency (Afssaps) as part of its market control mission].
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.
Agence française de sécurité sanitaire des produits de santé (Afssaps)/DEDIM/ UECM-DIV (Unité évaluation et contrôle du marché - Diagnostic in vitro), 93000 Saint-Denis, France. natacha.charlier-bret@afssaps.sante.fr
N
N
Charlier-Bret
B
B
Boucher
C
C
Poyart
G
G
Quesne
E
E
Bingen
C
C
Doit
C T
CT
Ho
M
M
Deschênes
P
P
Maisonneuve
D000942:Antigens, Bacterial / Q000032:analysis*; D001431:Bacteriological Techniques / Q000592:standards; D005602:France; D006801:Humans; D010612:Pharyngitis / Q000175:diagnosis* / Q000382:microbiology; D011786:Quality Control; D015203:Reproducibility of Results; D013290:Streptococcal Infections / Q000175:diagnosis*; D013297:Streptococcus pyogenes / Q000302:isolation & purification*; D014069:Tonsillitis / Q000175:diagnosis / Q000382:microbiology
D000942:Antigens, Bacterial