Evaluation of novel second-generation RSV and influenza rapid tests at the point of care

Diagn Microbiol Infect Dis. 2015 Mar;81(3):171-6. doi: 10.1016/j.diagmicrobio.2014.11.013. Epub 2014 Dec 3.


Acute respiratory infections represent common pediatric emergencies. Infection control warrants immediate and accurate diagnoses. In the past, first-generation respiratory syncytial virus (RSV) rapid tests (strip tests) have shown suboptimal sensitivities. In 2013, the Food and Drug Administration licensed a second-generation RSV rapid test providing user-independent readouts (SOFIA™-RSV) using automated fluorescence assay technology known to yield superior results with influenza rapid testing. We are reporting the first point-of-care evaluation of the SOFIA™-RSV rapid test. In the Charité Influenza-Like Disease Cohort, 686 nasopharyngeal samples were tested in parallel with SOFIA™-RSV and SOFIA™-Influenza A+B. Compared to real-time PCR, SOFIA™-RSV sensitivities/specificities were 78.6%/93.9%, respectively (SOFIA™-Influenza A: 80.6%/99.3%). Performance was greatest in patients below 2 years of age with a test sensitivity of 81.8%. RSV sensitivities were highest (85%) in the first 2 days of illness and with nasopharyngeal compared to nasal swabs (P=0.055, McNemar's test). Second-generation RSV and influenza rapid testing provides highly accurate results facilitating timely patient cohortation and management.

Keywords: Influenza-like illness; Minimally-invasive testing; Point-of-care diagnostics; Rapid testing; Respiratory syncytial virus.

Publication types

  • Evaluation Study

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Diagnostic Tests, Routine / methods*
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Influenza A virus / isolation & purification
  • Influenza B virus / isolation & purification
  • Influenza, Human / diagnosis*
  • Male
  • Nasopharynx / virology
  • Point-of-Care Systems*
  • Prospective Studies
  • Respiratory Syncytial Virus Infections / diagnosis*
  • Respiratory Syncytial Viruses / isolation & purification
  • Sensitivity and Specificity
  • Time Factors