Objective. The sensitivity of a rapid antigen-detection test (RADT) for group A streptococcal (GAS) pharyngitis is critical to whether the test is cost-effective and to whether a confirmatory throat culture is needed. We evaluated a second-generation RADT to determine if its sensitivity varies across the broad clinical spectrum of patients tested for GAS in pediatric outpatient practice.
Methods. We used laboratory logbooks from a single pediatric clinic to identify 1184 consecutive patient visits at which an RADT was performed. In a blinded chart review, we calculated McIsaac scores to separately estimate the pretest clinical likelihood of GAS pharyngitis for visits at which the RADT result was positive (n = 384) and for visits at which the result proved to be false-negative (n = 65). Positive RADT results were assumed to be true positives, and test sensitivity was estimated by dividing the number of positive results by the sum of positives and false-negatives.
Results. As the clinical likelihood of GAS increased, there were stepwise increases in RADT sensitivity (from 0.67 to 0.88). Sensitivity was low (0.73; 95% confidence interval [CI]: 0.62–0.86) in patients clinically unlikely to have GAS (McIsaac score ≤2) and high (0.94; 95% CI: 0.89–0.99) in patients <15 years old who had tonsillar exudate and no cough. False-negative RADT results were associated with lighter growth of GAS than found on specimens obtained from a random sample of clinic patients who had only primary throat cultures ordered.
Conclusions. For pediatric patients who are clinically unlikely to have GAS pharyngitis, as indicated by a McIsaac score ≤2, the sensitivity of a second-generation RADT may drop below thresholds reported for cost-effectiveness. For children who have tonsillar exudate and no cough, the test may be sensitive enough to meet current pediatric practice guidelines for stand-alone testing.