Diagnostic performance of influenza viruses and RSV rapid antigen detection tests in children in tertiary care

J Clin Virol. 2016 Jun:79:12-17. doi: 10.1016/j.jcv.2016.03.022. Epub 2016 Mar 25.

Abstract

Background: Rapid antigen detection tests (RADTs) are increasingly used to detect influenza viruses and respiratory syncytial virus (RSV). However, their sensitivity and specificity are a matter of debate, challenging their clinical usefulness.

Objectives: Comparing diagnostic performances of BinaxNow Influenza AB(®) (BNI) and BinaxNow RSV(®) (BNR), to those of real-time reverse transcriptase PCR (RT-PCR), virus isolation and direct immunofluorescence (D-IF) in paediatric patients.

Study design: Between November 2005 and September 2013, 521 nasal washings from symptomatic children (age <5 years) attending our tertiary care centre were tested, with a combination of the respective assays using RT-PCR as gold standard.

Results: Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of BNI were 69% (confidence interval [CI] [51-83]), 96% [94-97], 55% [39-70] and 98% [96-99] respectively. Of eleven false-negative samples, RT-PCR Ct-values were higher than all RT-PCR positive test results (27 vs 22, p=0.012). Of twenty false-positive samples, none were culture positive and two tested positive in D-IF. Sensitivity, specificity, PPV and NPV for BNR were 79% [73-85], 98% [96-99], 97% [93-99] and 88% [84-91]. Of the 42 false-negative samples the median Ct-value was higher than that of all RT-PCR positive samples (31 vs 23, p<0.0001). Five false-positive samples were detected. Three of these tested positive for RSV in virus isolation and D-IF.

Conclusions: RADTs have a high specificity with BNR being superior to BNI. However, their relative low sensitivity limits their usefulness for clinical decision making in a tertiary care paediatric hospital.

Keywords: Influenza; Paediatrics; Rapid antigen detection tests; Respiratory syncytial virus; Tertiary care.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Antigens, Viral / analysis*
  • Child, Preschool
  • Diagnostic Tests, Routine / methods*
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Influenza, Human / diagnosis*
  • Male
  • Orthomyxoviridae
  • Predictive Value of Tests
  • Respiratory Syncytial Virus Infections / diagnosis*
  • Sensitivity and Specificity
  • Tertiary Healthcare / methods*
  • Time Factors

Substances

  • Antigens, Viral