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Effect of clinical spectrum, inoculum size and physician characteristics on sensitivity of a rapid antigen detection test for group A streptococcal pharyngitis

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Abstract

We aimed to assess the independent effect of clinical spectrum, bacterial inoculum size and physician characteristics on the sensitivity of a rapid antigen detection test (RADT) for group A streptococcus (GAS) in children. Double throat swabs were collected from 1,482 children with pharyngitis and 294 asymptomatic children in a French prospective, office-based, multicenter (n = 17) study, from October 2009 to May 2011. Patient- and physician-level factors potentially affecting RADT sensitivity were studied by univariate and multivariate multilevel analysis, with laboratory throat culture as the reference test. In children with pharyngitis and asymptomatic children, the prevalence of GAS was 38 % (95 % confidence interval 36–41 %) and 11 % (7–14 %), respectively. Overall, RADT sensitivity was 87 % (84–90 %). On stratified and multivariate multilevel analysis, RADT sensitivity was higher for children with pharyngitis than asymptomatic children (89 % vs. 41 %), children <9 than ≥9 years old (88 % vs. 79 %) and those with heavy than light inoculum (94 % vs. 53 %). RADT sensitivity was influenced by the physician performing the test (range 56–96 %, p = 0.01) and was higher for physicians with hospital-based clinical activity in addition to office-based practice (adjusted odds ratio 3.4 [95 % confidence interval 1.9–6.3], p < 0.001); inter-physician variations in RADT sensitivity were largely explained by this variable (proportional change in variance >99 %). The sensitivity of the RADT is independently affected by patient- and physician-level factors. Physicians who base their diagnosis of GAS pharyngitis on the results of a RADT alone should consider diagnostic accuracy monitoring and adequate training when needed.

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References

  1. Shaikh N, Leonard E, Martin JM (2010) Prevalence of streptococcal pharyngitis and streptococcal carriage in children: a meta-analysis. Pediatrics 126:e557–e564

    Article  PubMed  Google Scholar 

  2. Gerber MA, Shulman ST (2004) Rapid diagnosis of pharyngitis caused by group A streptococci. Clin Microbiol Rev 17:571–580

    Article  PubMed  Google Scholar 

  3. American Academy of Pediatrics (2006) Group A streptococcal infections. In: Pickering L, Baker C, Long S, McMillan J (eds) Red book: 2006 report of the committee on infectious disease, 27th edn. American Academy of Pediatrics, Elk Grove Village, pp 616–628

    Google Scholar 

  4. Shulman ST, Bisno AL, Clegg HW, Gerber MA, Kaplan EL, Lee G, Martin JM, Van Beneden C (2012) Clinical practice guideline for the diagnosis and management of group a streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis 55:e86–e102

    Article  PubMed  Google Scholar 

  5. Ransohoff DF, Feinstein AR (1978) Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med 299:926–930

    Article  PubMed  CAS  Google Scholar 

  6. Goehring C, Perrier A, Morabia A (2004) Spectrum bias: a quantitative and graphical analysis of the variability of medical diagnostic test performance. Stat Med 23:125–135

    Article  PubMed  Google Scholar 

  7. Hall MC, Kieke B, Gonzales R, Belongia EA (2004) Spectrum bias of a rapid antigen detection test for group A beta-hemolytic streptococcal pharyngitis in a pediatric population. Pediatrics 114:182–186

    Article  PubMed  Google Scholar 

  8. Edmonson MB, Farwell KR (2005) Relationship between the clinical likelihood of group a streptococcal pharyngitis and the sensitivity of a rapid antigen-detection test in a pediatric practice. Pediatrics 115:280–285

    Article  PubMed  Google Scholar 

  9. Tanz RR, Gerber MA, Kabat W, Rippe J, Seshadri R, Shulman ST (2009) Performance of a rapid antigen-detection test and throat culture in community pediatric offices: implications for management of pharyngitis. Pediatrics 123:437–444

    Article  PubMed  Google Scholar 

  10. Cohen JF, Chalumeau M, Levy C, Bidet P, Thollot F, Wollner A, Bingen E, Cohen R (2012) Spectrum and inoculum size effect of a rapid antigen detection test for group A streptococcus in children with pharyngitis. PLoS One 7:e39085

    Article  PubMed  CAS  Google Scholar 

  11. Gerber MA, Randolph MF, Chanatry J, Wright LL, DeMeo KK, Anderson LR (1986) Antigen detection test for streptococcal pharyngitis: evaluation of sensitivity with respect to true infections. J Pediatr 108:654–658

    Article  PubMed  CAS  Google Scholar 

  12. Kuhn S, Davies HD, Katzko G, Jadavji T, Church DL (1999) Evaluation of the strep A OIA assay versus culture methods: ability to detect different quantities of group A Streptococcus. Diagn Microbiol Infect Dis 34:275–280

    Article  PubMed  CAS  Google Scholar 

  13. Kurtz B, Kurtz M, Roe M, Todd J (2000) Importance of inoculum size and sampling effect in rapid antigen detection for diagnosis of Streptococcus pyogenes pharyngitis. J Clin Microbiol 38:279–281

    PubMed  CAS  Google Scholar 

  14. Gerber MA, Tanz RR, Kabat W, Dennis E, Bell GL, Kaplan EL, Shulman ST (1997) Optical immunoassay test for group A beta-hemolytic streptococcal pharyngitis. An office-based, multicenter investigation. JAMA 277:899–903

    Article  PubMed  CAS  Google Scholar 

  15. Fox JW, Cohen DM, Marcon MJ, Cotton WH, Bonsu BK (2006) Performance of rapid streptococcal antigen testing varies by personnel. J Clin Microbiol 44:3918–3922

    Article  PubMed  Google Scholar 

  16. Tanz RR, Shulman ST (2007) Chronic pharyngeal carriage of group A streptococci. Pediatr Infect Dis J 26:175–176

    Article  PubMed  Google Scholar 

  17. Lieu TA, Fleisher GR, Schwartz JS (1988) Clinical evaluation of a latex agglutination test for streptococcal pharyngitis: performance and impact on treatment rates. Pediatr Infect Dis J 7:847–854

    PubMed  CAS  Google Scholar 

  18. Nsanze H, Dawson KP, Ameen AS, Mustafa N (1998) Group A streptococcal antigen detection in schoolchildren. East Mediterr Health J 4:260–264

    Google Scholar 

  19. Dawson KP, Ameen AS, Nsanze H, Bin-Othman S, Mustafa N (1996) The prevalence of group A streptococcal throat carriage in Al Ain, United Arab Emirates. Ann Trop Paediatr 16:123–127

    PubMed  CAS  Google Scholar 

  20. Gupta R, Kalia A, Rattan A, Kumar R, Gupta SK (1997) Comparative evaluation of two indigenously developed tests for rapid detection of group-A streptococci directly from throat swabs. Indian J Med Res 105:200–205

    PubMed  CAS  Google Scholar 

  21. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG (2003) The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med 138:W1–W12

    Article  PubMed  Google Scholar 

  22. Cohen R, Levy C, Ovetchkine P, Boucherat M, Weil-Olivier C, Gaudelus J, de la Rocque F, Bingen E (2004) Evaluation of streptococcal clinical scores, rapid antigen detection tests and cultures for childhood pharyngitis. Eur J Pediatr 163:281–282

    Article  PubMed  Google Scholar 

  23. Landon BE, Reschovsky J, Reed M, Blumenthal D (2001) Personal, organizational, and market level influences on physicians’ practice patterns: results of a national survey of primary care physicians. Med Care 39:889–905

    Article  PubMed  CAS  Google Scholar 

  24. Tracy CS, Dantas GC, Moineddin R, Upshur RE (2005) Contextual factors in clinical decision making: national survey of Canadian family physicians. Can Fam Physician 51:1106–1107

    PubMed  Google Scholar 

  25. Park SY, Gerber MA, Tanz RR, Hickner JM, Galliher JM, Chuang I, Besser RE (2006) Clinicians’ management of children and adolescents with acute pharyngitis. Pediatrics 117:1871–1878

    Article  PubMed  Google Scholar 

  26. Diez-Roux AV (2000) Multilevel analysis in public health research. Annu Rev Public Health 21:171–192

    Article  PubMed  CAS  Google Scholar 

  27. Coughlin SS, Trock B, Criqui MH, Pickle LW, Browner D, Tefft MC (1992) The logistic modeling of sensitivity, specificity, and predictive value of a diagnostic test. J Clin Epidemiol 45:1–7

    Article  PubMed  CAS  Google Scholar 

  28. Blandino G, Puglisi S, Speciale A, Musumeci R (2011) Streptococcus pyogenes emm types and subtypes of isolates from paediatric asymptomatic carriers and children with pharyngitis. New Microbiol 34:101–104

    PubMed  Google Scholar 

  29. Bell SM, Smith DD (1976) Quantitative throat-swab culture in the diagnosis of streptococcal pharyngitis in children. Lancet 2:62–63

    PubMed  CAS  Google Scholar 

  30. Johnson DR, Kurlan R, Leckman J, Kaplan EL (2010) The human immune response to streptococcal extracellular antigens: clinical, diagnostic, and potential pathogenetic implications. Clin Infect Dis 50:481–490

    Article  PubMed  Google Scholar 

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Acknowledgments

The authors thank A. Liboz (Department of Microbiology, Robert Debré Hospital); M. Boucherat, MD (database design); F. de La Rocque, MD (study conception); I. Ramay, D. Menguy, S. Tortorelli and M. de Pereira (ACTIV); B. Khoshnood, MD, PhD (multilevel analysis methodological support); and all the physician investigators who participated in the RADT GAS study: F. Corrard, MD, P. Deberdt, MD, A. Elbez, MD, M. Goldrey, MD, J. Gosselin, MD, P. Martin, MD, A.S. Michot, MD, N. Panis, MD, D. Qutob, MD, C. Romain, MD, O. Romain, MD, C. Schlemmer, MD, F. Thollot, MD, A. Wollner, MD.

Funding sources

This study was internally funded by ACTIV and externally by Dectrapharm, manufacturer of the RADT (Rapid Antigen Detection Test). JFC was supported by educational grants from Agence Régionale de Santé d’Ile-de-France, Laboratoires Guigoz - Société Française de Pédiatrie - Groupe de Pédiatrie Générale - Groupe de Recherches Epidémiologiques en Pédiatrie, and a research grant from the French Ministry of Health (PHRC Régional 2012, AOR 12089). The external funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Conflicts of interest

The authors declare that they have no conflict of interest.

Previous presentations

This work was presented in part at the 30th Annual Meeting of the European Society for Pediatric Infectious Diseases, Thessaloniki, Greece, May 2012 (Abstract A-435-0007-01213).

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Correspondence to J. F. Cohen.

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Prof. Edouard Bingen, *In memoriam

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Cohen, J.F., Chalumeau, M., Levy, C. et al. Effect of clinical spectrum, inoculum size and physician characteristics on sensitivity of a rapid antigen detection test for group A streptococcal pharyngitis. Eur J Clin Microbiol Infect Dis 32, 787–793 (2013). https://doi.org/10.1007/s10096-012-1809-1

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