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

  • J. F. Cohen
  • M. Chalumeau
  • C. Levy
  • P. Bidet
  • M. Benani
  • M. Koskas
  • E. Bingen
  • R. Cohen
Article

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.

References

  1. 1.
    Shaikh N, Leonard E, Martin JM (2010) Prevalence of streptococcal pharyngitis and streptococcal carriage in children: a meta-analysis. Pediatrics 126:e557–e564PubMedCrossRefGoogle Scholar
  2. 2.
    Gerber MA, Shulman ST (2004) Rapid diagnosis of pharyngitis caused by group A streptococci. Clin Microbiol Rev 17:571–580PubMedCrossRefGoogle Scholar
  3. 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 616–628Google Scholar
  4. 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–e102PubMedCrossRefGoogle Scholar
  5. 5.
    Ransohoff DF, Feinstein AR (1978) Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med 299:926–930PubMedCrossRefGoogle Scholar
  6. 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 23:125–135PubMedCrossRefGoogle Scholar
  7. 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 114:182–186PubMedCrossRefGoogle Scholar
  8. 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 115:280–285PubMedCrossRefGoogle Scholar
  9. 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 123:437–444PubMedCrossRefGoogle Scholar
  10. 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:e39085PubMedCrossRefGoogle Scholar
  11. 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 108:654–658PubMedCrossRefGoogle Scholar
  12. 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 34:275–280PubMedCrossRefGoogle Scholar
  13. 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 38:279–281PubMedGoogle Scholar
  14. 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 277:899–903PubMedCrossRefGoogle Scholar
  15. 15.
    Fox JW, Cohen DM, Marcon MJ, Cotton WH, Bonsu BK (2006) Performance of rapid streptococcal antigen testing varies by personnel. J Clin Microbiol 44:3918–3922PubMedCrossRefGoogle Scholar
  16. 16.
    Tanz RR, Shulman ST (2007) Chronic pharyngeal carriage of group A streptococci. Pediatr Infect Dis J 26:175–176PubMedCrossRefGoogle Scholar
  17. 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 7:847–854PubMedGoogle Scholar
  18. 18.
    Nsanze H, Dawson KP, Ameen AS, Mustafa N (1998) Group A streptococcal antigen detection in schoolchildren. East Mediterr Health J 4:260–264Google Scholar
  19. 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 16:123–127PubMedGoogle Scholar
  20. 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 105:200–205PubMedGoogle Scholar
  21. 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–W12PubMedCrossRefGoogle Scholar
  22. 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 163:281–282PubMedCrossRefGoogle Scholar
  23. 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 39:889–905PubMedCrossRefGoogle Scholar
  24. 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 51:1106–1107PubMedGoogle Scholar
  25. 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 117:1871–1878PubMedCrossRefGoogle Scholar
  26. 26.
    Diez-Roux AV (2000) Multilevel analysis in public health research. Annu Rev Public Health 21:171–192PubMedCrossRefGoogle Scholar
  27. 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 45:1–7PubMedCrossRefGoogle Scholar
  28. 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 34:101–104PubMedGoogle Scholar
  29. 29.
    Bell SM, Smith DD (1976) Quantitative throat-swab culture in the diagnosis of streptococcal pharyngitis in children. Lancet 2:62–63PubMedGoogle Scholar
  30. 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 50:481–490PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • J. F. Cohen
    • 1
    • 2
  • M. Chalumeau
    • 1
    • 2
  • C. Levy
    • 3
    • 4
  • P. Bidet
    • 5
  • M. Benani
    • 3
  • M. Koskas
    • 3
  • E. Bingen
    • 5
  • R. Cohen
    • 3
    • 6
  1. 1.INSERM, UMR S953Epidemiological Research Unit on Perinatal Health and Women’s and Children’s HealthParisFrance
  2. 2.Department of Pediatrics, Necker-Enfants-Malades Hospital, Assistance Publique-Hôpitaux de ParisUniv Paris Descartes, Sorbonne Paris CitéParisFrance
  3. 3.Association Clinique et Thérapeutique du Val-de-Marne (ACTIV)Saint-Maur-des-FossésFrance
  4. 4.Centre de Recherche Clinique (CRC)Centre Hospitalier Intercommunal de CréteilCréteilFrance
  5. 5.Department of Microbiology, Robert Debré Hospital, Assistance Publique-Hôpitaux de ParisUniv Paris Diderot, Sorbonne Paris CitéParisFrance
  6. 6.Department of MicrobiologyCentre Hospitalier Intercommunal de CréteilCréteilFrance

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