OBJECTIVES: Meta-analyses based on peer-reviewed publications report a sensitivity of approximately 85% for rapid antigen streptococcus tests to diagnose group A streptococcal (GAS) @entity7551 . Because these meta-analyses excluded package inserts, we examined the test characteristics of rapid antigen streptococcal tests and molecular methods that manufacturers report in their package inserts. METHODS: We included tests available in the US market (Food and Drug Administration, period searched 1993-2015) and used package insert data to calculate pooled sensitivity and specificity. To examine quality, we used the Quality Assessment of Diagnostic Accuracy Studies-2. We excluded 26 tests having different trade names but identical methods and data. RESULTS: The study design was prospective in 41.7% (10 of 24). The pooled sensitivity of the most commonly used method, lateral flow/immunochromatographic, was 95% (95% confidence interval [CI] 94-96) and the pooled specificity was 98% (96-98); 7108 @entity1 . The pooled sensitivity of the polymerase chain reaction or molecular methods was 98% (95% CI 96-98) and the pooled specificity was 96% (95% CI 95-97); 5685 @entity1 . CONCLUSIONS: Package inserts include sponsored studies that overestimate the sensitivity of rapid tests to diagnose @entity883 by approximately 10%. Physicians should understand that package inserts overestimate diagnostic test utility; a negative test cannot be used to exclude @entity883 .

Sensitivity for Diagnosing Group A XXXX from Manufacturers is 10% Higher than Reported in Peer-Reviewed Publications.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity7551 :: ('MESH:D010612', 'Disease') :: ['pharyngitis'] @entity883 :: ('MESH:D013290', 'Disease') :: ['GAS pharyngitis']
@entity883 :: (MESH:D013290,Disease) :: ['Streptococcal Pharyngitis']
