Spectrum and Inoculum Size Effect of a Rapid Antigen Detection Test for Group A Streptococcus in Children with

Background: The stability of the accuracy of a diagnostic test is critical to whether clinicians can rely on its result. We aimed to assess whether the performance of a rapid antigen detection test (RADT) for group A streptococcus (GAS) is affected by the clinical spectrum and/or bacterial inoculum size. Methods: Throat swabs were collected from 785 children with pharyngitis in an office-based, prospective, multicenter study (2009–2010). We analysed the effect of clinical spectrum (i.e., the McIsaac score and its components) and inoculum size (light or heavy GAS growth) on the accuracy (sensitivity, specificity, likelihood ratios and predictive values) of a RADT, with laboratory throat culture as the reference test. We also evaluated the accuracy of a McIsaac-score–based decision rule. Results: GAS prevalence was 36 % (95CI: 33%–40%). The inoculum was heavy for 85 % of cases (81%–89%). We found a significant spectrum effect on sensitivity, specificity, likelihood ratios and positive predictive value (p,0.05) but not negative predictive value, which was stable at about 92%. RADT sensitivity was greater for children with heavy than light inoculum (95 % vs. 40%, p,0.001). After stratification by inoculum size, the spectrum effect on RADT sensitivity was significant only in patients with light inoculum, on univariate and multivariate analysis. The McIsaac-score–based decision rule had 99 % (97%–100%) sensitivity and 52 % (48%–57%) specificity. Conclusions: Variations in RADT sensitivity only occur in patients with light inocula. Because the spectrum effect does no