Performance of a rapid influenza test in children during the H1N1 2009 influenza a outbreak

Pediatrics. 2010 Mar;125(3):e645-50. doi: 10.1542/peds.2009-3060. Epub 2010 Feb 15.

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.

Publication types

  • Comparative Study

MeSH terms

  • Child, Preschool
  • Cross-Sectional Studies
  • Diagnostic Tests, Routine / standards
  • Disease Outbreaks*
  • Female
  • Humans
  • Infant
  • Influenza A Virus, H1N1 Subtype*
  • Influenza, Human / diagnosis*
  • Influenza, Human / epidemiology*
  • Male
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Time Factors