Evaluation of immuview RSV antigen test (SSI siagnostica) and BinaxNOW RSV card (alere) for rapid detection of respiratory syncytial virus in retrospectively and prospectively collected respiratory samples

J Med Virol. 2020 Dec;92(12):2992-2998. doi: 10.1002/jmv.26369. Epub 2020 Aug 13.

Abstract

Human orthopneumovirus, formerly known as respiratory syncytial virus (RSV), is a frequent cause of hospitalization among infants due to respiratory tract infection. Fast, reliable, and easy to perform tests are needed to optimize treatment and to identify children that should be contact isolated to avoid nosocomial outbreaks. We prospectively tested 200 respiratory samples with a new assay (ImmuView RSV Antigen Test, SSI Diagnostica) and compared the results to the Alere BinaxNOW RSV Card by using our laboratory-developed real-time reverse transcription polymerase chain reaction (PCR) as reference. In addition, 300 retrospectively collected respiratory samples were included in the study. The sensitivities of both antigen kits were very low (<50%). Sensitivities were higher when samples came from children less than 6 years, when samples came from nasopharynx or lower respiratory airways, or when samples were positive for RSV serotype A compared to when samples came from adults, samples were throat swabs, or samples were positive for RSV serotype B. In conclusion, the ImmuView RSV antigen kit did not perform well and may at the most be used as a quick guidance for clinical decision. Thus, it cannot stand alone without reverse transcription PCR confirmation of negative results.

Keywords: Binax; ImmuView; RSV; age; antigen test; point-of-care.

Publication types

  • Evaluation Study
  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antigens, Viral* / analysis
  • Antigens, Viral* / immunology
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Middle Aged
  • Nasopharynx / virology
  • Prospective Studies
  • Reagent Kits, Diagnostic / standards
  • Respiratory Syncytial Virus Infections* / diagnosis
  • Respiratory Syncytial Virus Infections* / virology
  • Respiratory Syncytial Virus, Human* / genetics
  • Respiratory Syncytial Virus, Human* / immunology
  • Respiratory Syncytial Virus, Human* / isolation & purification
  • Respiratory Tract Infections / diagnosis
  • Respiratory Tract Infections / virology
  • Retrospective Studies
  • Sensitivity and Specificity*
  • Young Adult

Substances

  • Antigens, Viral
  • Reagent Kits, Diagnostic

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