The development by the Centers for Disease Control of a specification for streptococcal serogrouping kits and its application to Streptex and to the Phadebact Streptococcus Test.
A Centers for Disease Control (CDC) specification for evaluating commercially produced streptococcal agglutination reagents was developed and used to test Streptex and Phadebact Streptococcus Test kits. Evaluation methods and performance requirements were based on product claims made in the package labelling. Except for the reagent for Streptococcus group D, reagents of both systems identified 100% of the blind-coded reference strains when follow-up methods were done according to the manufacturers' directions. Streptex group D reagent did not identify all group D strains, but the manufacturer instructed the user to test with other methods in certain circumstances. The interaction of personnel of the Center for Infectious Diseases (CID), CDC, with commercial producers and consumers in a pre-market evaluation program is described.
D002487:Centers for Disease Control and Prevention, U.S.; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012703:Serotyping / Q000592:standards*; D013291:Streptococcus / Q000145:classification*; D014481:United States
D011933:Reagent Kits, Diagnostic