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Usefulness of Sofia Pneumococcal FIA® test in comparison with BinaxNOW® Pneumococcal test in urine samples for the diagnosis of pneumococcal pneumonia

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Abstract

The Sofia Pneumococcal FIA® test is a recently introduced immunofluorescent assay automatically read aimed to detect Streptococcus pneumoniae antigen in urine. The aim of this study was to evaluate the usefulness of SofiaFIA® urinary antigen test (UAT) in comparison with classical immunochromatographic BinaxNOW® test for the diagnosis of pneumococcal pneumonia (PP). Observational study was conducted in the Hospital Universitari Vall d’Hebron from December 2015 to August 2016. Consecutive adult patients diagnosed of pneumonia and admitted to the emergency department in whom UAT was requested were prospectively enrolled. Paired pneumococcal UAT was performed (BinaxNOW® and SofiaFIA®) in urine samples. To assess the performance of both tests, patients were categorized into proven PP (isolation of S. pneumoniae in sterile fluid) or probable PP (isolation of S. pneumoniae in respiratory secretion). Sensitivity, specificity, and concordance were calculated. A total of 219 patients with pneumonia were enrolled, of whom 14% had a proven or probable PP, 22% a non-pneumococcal etiology, and 64% an unidentified pathogen. Concordance between tests was good (κ = 0.81). Sensitivity of SofiaFIA® and BinaxNOW® UAT was 78.6 and 50% for proven PP (p = 0.124), and 74.2 and 58% for proven/probable PP (p = 0.063). Specificity for both tests was 83.3 and 85.5% for proven and proven/probable PP. In patients without an identified pathogen, SofiaFIA® test was positive in 33 (23.6%) cases and BinaxNOW® in 25 (17.8%), so Sofia Pneumococcal FIA® detected 32.6% more cases than BinaxNOW® (p = 0.001). Sofia Pneumococcal FIA® test showed an improved sensitivity over visual reading of BinaxNOW® test without a noticeable loss of specificity.

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Authors and Affiliations

  1. Infectious Diseases Department, Hospital Universitari Vall d’Hebron, Vall d’Hebron Research Institute (VHIR), Universitat Autònoma de Barcelona, Passeig Vall d’Hebron 119-129, 08035, Barcelona, Spain

    Joaquin Burgos, Jorge N. Garcia-Pérez, Vicenç Falcó & Benito Almirante

  2. Microbiology Department, Hospital Universitari Vall d’Hebron, Vall d’Hebron Research Institute (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain

    Sabina González di Lauro, Tomás Pumarola & M. Teresa Martín Gomez

Authors
  1. Joaquin Burgos
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  2. Jorge N. Garcia-Pérez
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  3. Sabina González di Lauro
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  4. Vicenç Falcó
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  5. Tomás Pumarola
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  6. Benito Almirante
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  7. M. Teresa Martín Gomez
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Correspondence to Joaquin Burgos.

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The authors declare that they have no conflicts of interest.

Ethical approval

The study was approved by the Ethics Board of the hospital (Ethics Committee of Clinical Investigation [Hospital Vall d’Hebron. PR(AG)368/2015]).

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Informed consent was waived due to the observational nature of the study.

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Burgos, J., Garcia-Pérez, J.N., di Lauro, S.G. et al. Usefulness of Sofia Pneumococcal FIA® test in comparison with BinaxNOW® Pneumococcal test in urine samples for the diagnosis of pneumococcal pneumonia. Eur J Clin Microbiol Infect Dis 37, 1289–1295 (2018). https://doi.org/10.1007/s10096-018-3248-0

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  • DOI: https://doi.org/10.1007/s10096-018-3248-0

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