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

  • Joaquin Burgos
  • Jorge N. Garcia-Pérez
  • Sabina González di Lauro
  • Vicenç Falcó
  • Tomás Pumarola
  • Benito Almirante
  • M. Teresa Martín Gomez
Original Article

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.

Keywords

Pneumococcal urinary antigen test Sofia Pneumococcal FIA® test BinaxNOW® Pneumococcal test Community-acquired pneumonia 

Notes

Compliance with ethical standards

Conflict of interest statement

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]).

Informed consent

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

References

  1. 1.
    Musher DM, Abers MS, Bartlett JG (2017) Evolving understanding of the causes of pneumonia in adults, with special attention to the role of pneumococcus. Clin Infect Dis 65:1736–1744CrossRefPubMedGoogle Scholar
  2. 2.
    File TM (2003) Community-acquired pneumonia. Lancet 362:1991–2001CrossRefPubMedGoogle Scholar
  3. 3.
    Blaschke AJ (2011) Interpreting assays for the detection of Streptococcus pneumoniae. Clin Infect Dis 52(Suppl. 4):S331–S337CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Selickman J, Paxos M, File TM, Seltzer R, Bonilla H (2010) Performance measure of urinary antigen in patients with Streptococcus pneumonia bacteremia. Diagn Microbiol Infect Dis 67:129–133CrossRefPubMedGoogle Scholar
  5. 5.
    Genne D, Siegrist HH, Lienhard R (2006) Enhancing the etiologic diagnosis of community-acquired pneumonia in adults using the urinary antigen assay (Binax NOW). J Infect Dis 10:124–128Google Scholar
  6. 6.
    Sordé R, Falco V, Lowak M et al (2011) Current and potential usefulness of pneumococcal urinary antigen detection in hospitalized patients with community-acquired pneumonia to guide antimicrobial therapy. Arch Intern Med 171:166–172CrossRefPubMedGoogle Scholar
  7. 7.
    Roson B, Carratala J, Verdaguer R, Dorca J, Manresa F, Gudiol F (2000) Prospective study of the usefulness of sputum Gram stain in the initial approach to community-acquired pneumonia requiring hospitalization. Clin Infect Dis 31:869–874CrossRefPubMedGoogle Scholar
  8. 8.
    Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM, Jr, Musher DM, Niederman MS, Torres A, Whitney CG. 2007. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community acquired pneumonia in adults. Clin Infect Dis 44(Suppl 2):S27–S72Google Scholar
  9. 9.
    Menéndez R, Torres A, Aspa J, Capelastegui A, Prat C, Rodríguez de Castro F (2010) Community acquired pneumonia. New guidelines of the Spanish Society of Chest Diseases and Thoracic Surgery (SEPAR). Arch Bronconeumol 46:543–558CrossRefPubMedGoogle Scholar
  10. 10.
    Roson B, Fernandez-Sabe N, Carratala J et al (2004) Contribution of a urinary antigen assay (Binax NOW) to the early diagnosis of pneumococcal pneumonia. Clin Infect Dis 38:222–226CrossRefPubMedGoogle Scholar
  11. 11.
    Lasocki S, Scanvic A, Le Turdu F et al (2006) Evaluation of the Binax NOW Streptococcus pneumoniae urinary antigen assay in intensive care patients hospitalized for pneumonia. Intensive Care Med 32:1766–1772CrossRefPubMedGoogle Scholar
  12. 12.
    Sinclair A, Xie X, Teltscher M, Dendukuri N (2013) Systematic review and meta-analysis of a urine-based pneumococcal antigen test for diagnosis of community-acquired pneumonia caused by Streptococcus pneumoniae. J Clin Microbiol 51:2303–2310CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Horita N, Miyazawa N, Kojima R, Kimura N, Inoue M, Ishigatsubo Y, Kaneko T (2013) Sensitivity and specificity of the Streptococcus pneumoniae urinary antigen test for unconcentrated urine from adult patients with pneumonia: a meta-analysis. Respirology 18:1177–1183CrossRefPubMedGoogle Scholar
  14. 14.
    European Centre for Disease Prevention and Control. European Legionnaires’ Disease Surveillance Network (ELDSNet): Operating procedures. Stockholm: ECDC; 2012Google Scholar
  15. 15.
    Vicente D, López-Olaizola M, de la Caba I, Cilla G (2017) Evaluation of Sofia fluorescent immunoassay analyzer for pneumococcal urinary antigen detection in hospitalized patients with community-acquired pneumonia. J Microbiol Methods 141:25–27CrossRefPubMedGoogle Scholar
  16. 16.
    Beraud L, Gervasoni K, Freydiere AM, Descours G, Ranc AG, Vandenesch F, Lina G, Gaia V, Jarraud S (2015) Comparison of Sofia Legionella FIA and BinaxNOW® Legionella urinary antigen card in two national reference centers. Eur J Clin Microbiol Infect Dis 34:1803–1807CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Rath B, Tief F, Obermeier P, Tuerk E, Karsch K, Muehlhans S, Adamou E, Duwe S, Schweiger B (2012) Early detection of influenza A and B infection in infants and children using conventional and fluorescence-based rapid testing. J Clin Virol 55:329–333CrossRefPubMedGoogle Scholar
  18. 18.
    Lewandrowski K, Tamerius J, Menegus M, Olivo PD, Lollar R, Lee-Lewandrowski E (2013) Detection of influenza A and B viruses with the Sofia analyzer: a novel, rapid immunofluorescencebased in vitro diagnostic device. Am J Clin Pathol 139:684–689CrossRefPubMedGoogle Scholar
  19. 19.
    Leonardi GP, Wilson AM, Zuretti AR (2013) Comparison of conventionallateral-flow assays and a new fluorescent immunoassay to detect influenza viruses. J Virol Methods 189:379–382CrossRefPubMedGoogle Scholar
  20. 20.
    Lee CK, Cho CH, Woo MK, Nyeck AE, Lim CS, Kim WJ (2012) Evaluation of Sofia fluorescent immunoassay analyzer for influenza A/B virus. J Clin Virol 55:239–243CrossRefPubMedGoogle Scholar
  21. 21.
    Congestrì F, Crepaldi E, Gagliardi M, Pedna MF, Sambri V (2016) Comparative evaluation of the novel bioNexia Legionella test with the BinaxNOW Legionella card assay and the Sofia Legionella FIA assay for detection of Legionella pneumophila (serogroup 1) antigen in urine samples. J Clin Microbiol 54:1164–1166CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Infectious Diseases Department, Hospital Universitari Vall d’Hebron, Vall d’Hebron Research Institute (VHIR)Universitat Autònoma de BarcelonaBarcelonaSpain
  2. 2.Microbiology Department, Hospital Universitari Vall d’Hebron, Vall d’Hebron Research Institute (VHIR)Universitat Autònoma de BarcelonaBarcelonaSpain

Personalised recommendations