WHAT'S KNOWN ON THIS SUBJECT:Sensitivities of RIDTs have varied widely for the diagnosis of seasonal influenza. Few pediatric-specific data are available on RIDT performance for H1N1 2009 influenza A.
WHAT THIS STUDY ADDS:To the best of our knowledge, this is the largest series reported to date of a comparison of RIDT performance to 2 reference standards, viral culture and rRT-PCR, for the detection of influenza A H1N1 2009 in respiratory specimens from pediatric patients. abstract 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. Commercially available rapid influenza diagnostic tests (RIDTs) offer the advantages of low cost, ease of use, and rapid turnaround time. 6 The RIDTs also have shown consistently high specificity for both seasonal (92%-100%) and H1N1 2009 (86%-100%) influenza A virus detection. [6][7][8][9][10][11][12][13][14][15] However, the sensitivity of these assays has varied considerably for both seasonal influenza viruses (49%-95%) 6-10 and H1N1 2009 influenza A (10%-53%). [11][12][13][14][15] Furthermore, few data exist on the performance of RIDTs for detection of influenza A H1N1 2009 in children, with sensitivities ranging from 42% to 74%, 16,17 and few data exist on the performance of these assays in clinical settings. We present her...