In vitro evaluation and comparison of 5 rapid antigen detection tests for the diagnosis of beta-hemolytic group A streptococcal pharyngitis

Abstract

Streptococcus pyogenes (group A Streptococcus [GAS]) is the leading cause of bacterial pharyngitis. To perform a rapid diagnosis of GAS pharyngitis, rapid antigen detection tests (RADTs) have been developed. In this study, we evaluated and compared the sensitivity and specificity of 5 RADTs (bioNexia Strep A plus™, bioNexia Strep A dipstick™, Clearview Strep A™, QuickVue Strep A plus™, and Streptatest™), using analytical approaches combining dilutions in NaCl 0.9% or in pharyngeal flora. The practicability of each RADT was also determined. Among the 630 RADTs performed in this work, all were specific, as no false positive was found resulting in a specificity of 100%. The 5 RADTs detected GAS at 10(6)CFU/mL in NaCl 0.9% or pooled pharyngeal flora. Regarding the practicability analysis, bioNexia Strep A plus, bioNexia Strep A dipstick and Streptatest RADTs obtained the highest scores for secondary items including kit content and instructions for use information. We concluded that these 5 easy-to-use RADTs are suitable for diagnosis of GAS pharyngitis, as they all detect GAS at a concentration commonly found during pharyngitis.

Keywords: Evaluation; Group A Streptococcus; Pharyngitis; Rapid antigen detection test; Streptococcus pyogenes.