Performance of the ImmuView and BinaxNOW assays for the detection of urine and cerebrospinal fluid Streptococcus pneumoniae and Legionella pneumophila serogroup 1 antigen in patients with Legionnaires' disease or pneumococcal pneumonia and meningitis

PLoS One. 2020 Aug 31;15(8):e0238479. doi: 10.1371/journal.pone.0238479. eCollection 2020.

Abstract

The performances of the ImmuView Streptococcus pneumoniae (Sp) and Legionella pneumophila (Lp) urinary antigen test were compared to that of the BinaxNOW Sp and Lp assays, using frozen urine from 166 patients with Legionnaires' disease (LD) and 59 patients with pneumococcal pneumonia. Thirty Sp-positive or contrived cerebrospinal fluids (CSF) were also tested. Test specimens were collected and tested at different sites, with each site testing unique specimens by technologists blinded to expected results. No significant differences in test concordances were detected for the ImmuView and BinaxNOW assays for the Sp or Lp targets for urine from patients with pneumococcal pneumonia or LD when performance from both sites were combined. At one of two test sites the ImmuView Lp assay was more sensitive than the BinaxNOW assay, with no correlation between test performance and Lp serogroup 1 monoclonal type. Urines from six of seven patients with LD caused by Legionella spp. bacteria other than Lp serogroup 1 were negative in both assays. Both tests had equivalent performance for Sp-positive CSF. The clinical sensitivities for pneumococcal pneumonia were 88.1 and 94.4% for the ImmuView and Binax assays, and 87.6 and 84.2% for the Lp assays, respectively. Test specificities for pneumococcal pneumonia were 96.2 and 97.0% for the ImmuView and Binax assays, and 99.6 and 99.1% for the Lp assays. Both assays were highly specific for Sp in pediatric urines from children with nasopharyngeal colonization by the bacterium. ImmuView and BinaxNOW assay performance was equivalent in these studies.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antigens, Bacterial / metabolism*
  • Antigens, Bacterial / urine*
  • Biological Assay / methods*
  • Cerebrospinal Fluid / microbiology*
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Immunologic Tests / methods
  • Infant
  • Legionella pneumophila / isolation & purification*
  • Legionnaires' Disease / metabolism
  • Legionnaires' Disease / microbiology
  • Legionnaires' Disease / urine
  • Male
  • Meningitis / metabolism
  • Meningitis / microbiology
  • Meningitis / urine
  • Pneumonia, Pneumococcal / metabolism
  • Pneumonia, Pneumococcal / microbiology
  • Pneumonia, Pneumococcal / urine
  • Sensitivity and Specificity
  • Serogroup
  • Streptococcus pneumoniae / isolation & purification*
  • Urine / microbiology*
  • Young Adult

Substances

  • Antigens, Bacterial

Grants and funding

This study was supported by SSI Diagnostica (https://www.ssidiagnostica.com/) in the form of a salary provided to PHE. This salary support, which was required and administered by the University of Pennsylvania, amounted to 1% of his annual salary, and was used for study planning, study supervision, data analysis from all three study sites and writing the manuscript. The specific role of this author is articulated in the ‘author contributions’ section. SSI Diagnostica paid for the study reagents and supplies at each study site. Additionally, at the University of Pennsylvania and University of Louisville sites, SSI Diagnostica paid for the performing technologist’s time. SSI Diagnostica reviewed the manuscript for accuracy of the reported data. The funders had no further role in data analysis, decision to publish, or preparation of the manuscript.