Performance of a Rapid Influenza Test in Children During the H1N1 2009 Influenza A Outbreak

OBJECTIVE: To evaluate the performance of a rapid influenza diagnostic test (RIDT) in detecting H1N1 2009 influenza A virus in respiratory samples from pediatric patients in comparison to that of real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) and viral culture. METHODOLOGY. This was a cross-sectional diagnostic-accuracy study conducted at a tertiary care children's hospital. Patients for whom the RIDT (BinaxNOW [Binax, Inc, Portland, ME]), viral culture, and rRT-PCR results were known were included. Sensitivity, specificity, and likelihood ratios (LRs) were calculated. RESULTS: A total of 3030 specimens had RIDT results paired with both rRT-PCR and viral culture results. With rRT-PCR as the reference, overall test sensitivity was 45% (95% confidence interval [CI]: 43.3%-46.3%) and specificity was 98.6% (95% CI: 98.1%-99%). Positive and negative LRs were 32.9 (95% CI: 22.9-45.4) and 0.56 (95% CI: 0.54-0.58), respectively. RIDT sensitivity was significantly higher in young infants and children younger than 2 years than in older children. Using viral culture as the reference standard, RIDT sensitivity was 55.5% (95% CI: 51.9%-95.6%) and specificity was 95.6% (95% CI: 95%-96.1%). The positive and negative LRs were 12.6 and 0.47, respectively. CONCLUSIONS: The RIDT had relatively poor sensitivity but excellent specificity in this consecutive series of respiratory specimens obtained from pediatric patients. Although a positive RIDT result was highly accurate in predicting infection with influenza type A H1N1 2009 in children, a negative RIDT result did not preclude a child having H1N1. Therefore, for children at high risk with influenza-like illnesses during high-prevalence periods of influenza, empiric initiation of antiviral therapy should be considered for patients with a negative RIDT result. Pediatrics 2010; 125: e645-e650