Performance of the Alere i RSV assay for point-of-care detection of respiratory syncytial virus in children

BMC Infect Dis. 2017 Dec 13;17(1):767. doi: 10.1186/s12879-017-2855-1.


Background: Respiratory syncytial virus (RSV) is the most important cause of severe acute respiratory tract infection in young children. Alere i RSV is a novel molecular rapid test which identifies respiratory syncytial virus in less than 13 min.

Methods: We evaluated the clinical performance of the Alere i RSV assay in a pediatric point-of-care setting during winter season 2016 / 2017. Test results from 518 nasopharyngeal swab samples were compared to a real-time reverse transcription PCR reference standard.

Results: The overall sensitivity and specificity of the Alere i RSV test assay was 93% (CI95 89% - 96%) and 96% (CI95 93% - 98%), respectively. Alere i RSV performed well in children of all age groups. An optimal sensitivity of 98% (CI95 94% - 100%) and specificity of 96% (CI95 90% - 99%) was obtained in children < 6 months. In children ≥ 2 years, sensitivity and specificity remained at 87% (CI95 73% - 96%) and 98% (CI95 92% - 100%), respectively. False negative Alere i RSV test results mostly occurred in samples with low viral load (mean CT value 31.1; CI95 29.6 - 32.6). The Alere i RSV assay is easy to use and can be operated after minimal initial training. Test results are available within 13 min, with most RSV positive samples being identified after approximately 5 min.

Conclusion: The Alere i RSV assay has the potential to facilitate the detection of RSV in pediatric point-of-care settings.

Publication types

  • Evaluation Study

MeSH terms

  • Child, Preschool
  • False Positive Reactions
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Nasopharynx / virology
  • Point-of-Care Systems
  • RNA, Viral / analysis
  • Reagent Kits, Diagnostic
  • Real-Time Polymerase Chain Reaction
  • Respiratory Syncytial Virus Infections / diagnosis*
  • Respiratory Syncytial Virus Infections / virology
  • Respiratory Syncytial Virus, Human / genetics*
  • Respiratory Syncytial Virus, Human / isolation & purification
  • Sensitivity and Specificity


  • RNA, Viral
  • Reagent Kits, Diagnostic