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. 2020 Jun;24(31):1–232. doi: 10.3310/hta24310

Rapid antigen detection and molecular tests for group A streptococcal infections for acute sore throat: systematic reviews and economic evaluation.

Hannah Fraser, Daniel Gallacher, Felix Achana, Rachel Court, Sian Taylor-Phillips, Chidozie Nduka, Chris Stinton, Rebecca Willans, Paramjit Gill, Hema Mistry
PMCID: PMC7355404  PMID: 32605705

Abstract

BACKGROUND

Sore throat is a common condition caused by an infection of the airway. Most cases are of a viral nature; however, a number of these infections may be caused by the group A Streptococcus bacterium. Most viral and bacterial sore throat infections resolve spontaneously within a few weeks. Point-of-care testing in primary care has been recognised as an emerging technology for aiding targeted antibiotic prescribing for sore throat in cases that do not spontaneously resolve.

OBJECTIVE

Systematically review the evidence for 21 point-of-care tests for detecting group A Streptococcus bacteria and develop a de novo economic model to compare the cost-effectiveness of point-of-care tests alongside clinical scoring tools with the cost-effectiveness of clinical scoring tools alone for patients managed in primary care and hospital settings.

DATA SOURCES

Multiple electronic databases were searched from inception to March 2019. The following databases were searched in November and December 2018 and searches were updated in March 2019: MEDLINE [via OvidSP (Health First, Rockledge, FL, USA)], MEDLINE In-Process & Other Non-Indexed Citations (via OvidSP), MEDLINE Epub Ahead of Print (via OvidSP), MEDLINE Daily Update (via OvidSP), EMBASE (via OvidSP), Cochrane Database of Systematic Reviews [via Wiley Online Library (John Wiley & Sons, Inc., Hoboken, NJ, USA)], Cochrane Central Register of Controlled Trials (CENTRAL) (via Wiley Online Library), Database of Abstracts of Reviews of Effects (DARE) (via Centre for Reviews and Dissemination), Health Technology Assessment database (via the Centre for Reviews and Dissemination), Science Citation Index and Conference Proceedings [via the Web of Science™ (Clarivate Analytics, Philadelphia, PA, USA)] and the PROSPERO International Prospective Register of Systematic Reviews (via the Centre for Reviews and Dissemination).

REVIEW METHODS

Eligible studies included those of people aged ≥ 5 years presenting with sore throat symptoms, studies comparing point-of-care testing with antibiotic-prescribing decisions, studies of test accuracy and studies of cost-effectiveness. Quality assessment of eligible studies was undertaken. Meta-analysis of sensitivity and specificity was carried out for tests with sufficient data. A decision tree model estimated costs and quality-adjusted life-years from an NHS and Personal Social Services perspective.

RESULTS

The searches identified 38 studies of clinical effectiveness and three studies of cost-effectiveness. Twenty-six full-text articles and abstracts reported on the test accuracy of point-of-care tests and/or clinical scores with biological culture as a reference standard. In the population of interest (patients with Centor/McIsaac scores of ≥ 3 points or FeverPAIN scores of ≥ 4 points), point estimates were 0.829 to 0.946 for sensitivity and 0.849 to 0.991 for specificity. There was considerable heterogeneity, even for studies using the same point-of-care test, suggesting that is unlikely that any single study will have accurately captured a test's true performance. There is some randomised controlled trial evidence to suggest that the use of rapid antigen detection tests may help to reduce antibiotic-prescribing rates. Sensitivity and specificity estimates for each test in each age group and care setting combination were obtained using meta-analyses where appropriate. Any apparent differences in test accuracy may not be attributable to the tests, and may have been caused by known differences in the studies, latent characteristics or chance. Fourteen of the 21 tests reviewed were included in the economic modelling, and these tests were not cost-effective within the current National Institute for Health and Care Excellence's cost-effectiveness thresholds. Uncertainties in the cost-effectiveness estimates included model parameter inputs and assumptions that increase the cost of testing, and the penalty for antibiotic overprescriptions.

LIMITATIONS

No information was identified for the elderly population or pharmacy setting. It was not possible to identify which test is the most accurate owing to the paucity of evidence.

CONCLUSIONS

The systematic review and the cost-effectiveness models identified uncertainties around the adoption of point-of-care tests in primary and secondary care settings. Although sensitivity and specificity estimates are promising, we have little information to establish the most accurate point-of-care test. Further research is needed to understand the test accuracy of point-of-care tests in the proposed NHS pathway and in comparable settings and patient groups.

STUDY REGISTRATION

The protocol of the review is registered as PROSPERO CRD42018118653.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 31. See the NIHR Journals Library website for further project information.

Plain language summary

Sore throat is a common condition caused by an infection of the airway. Most cases are viral; however, a small number may be caused by the group A Streptococcus bacterium. Most viral and bacterial sore throat infections resolve spontaneously within a few weeks; however, some may be more serious and require antibiotics. Currently, National Institute for Health and Care Excellence guidance recommends the use of clinical scoring tools to identify patients for whom antibiotic treatment is appropriate. Ideally, a throat swab culture should be obtained to identify the organism causing the infection in cases in which diagnosis is uncertain. However, this takes time, causing potential delays in administering the correct treatment. Point-of-care tests can be administered at or near the site of the patient; therefore, they are much faster. Our review considered evidence for the test accuracy and cost-effectiveness of 21 point-of-care tests for detecting group A Streptococcus bacteria. We built an economic model, predicting costs and benefits for adults and children in a primary care or hospital setting. The findings will support the National Institute for Health and Care Excellence to make recommendations about the use of these point-of-care tests for detecting group A Streptococcus bacteria in the NHS in England and Wales. The clinical effectiveness review found 38 relevant studies; of these, 26 reported on the accuracy of point-of-care tests. These studies found wide variation in the accuracy of the tests. The quality of the evidence was weak and there was little information on some of the 21 tests. As the studies were all so different, it was not possible to identify which test is the most accurate. The economic model found considerable uncertainty about how costs and benefits would change if point-of-care tests were introduced in different care settings. Further research is needed to see whether or not point-of-care testing provides value for money.

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References

  1. Hannaford PC, Simpson JA, Bisset AF, Davis A, McKerrow W, Mills R. The prevalence of ear, nose and throat problems in the community: results from a national cross-sectional postal survey in Scotland. Fam Pract 2005;22:227–33. https://doi.org/10.1093/fampra/cmi004 doi: 10.1093/fampra/cmi004. [DOI] [PubMed]
  2. Smith S, Smith GE, Heatlie H, Bashford JN, Ashcroft DM, Verlander NQ, et al. Reducing variation in antibacterial prescribing rates for ‘cough/cold’ and sore throat between 1993 and 2001: regional analyses using the general practice research database. Public Health 2006;120:752–9. https://doi.org/10.1016/j.puhe.2006.02.007 doi: 10.1016/j.puhe.2006.02.007. [DOI] [PubMed]
  3. Clinical Knowledge Summaries. Sore Throat – Acute: Background Information. Leeds: NICE; 2018. URL: https://cks.nice.org.uk/sore-throat-acute#!background (accessed 5 April 2019).
  4. Martin E. Concise Medical Dictionary. New York, NY: Oxford University Press; 2015. https://doi.org/10.1093/acref/9780199687817.001.0001 doi: 10.1093/acref/9780199687817.001.0001. [DOI]
  5. Ashworth M, Charlton J, Ballard K, Latinovic R, Gulliford M. Variations in antibiotic prescribing and consultation rates for acute respiratory infection in UK general practices 1995–2000. Br J Gen Pract 2005;55:603–8. [PMC free article] [PubMed]
  6. Little P, Hobbs FD, Moore M, Mant D, Williamson I, McNulty C, et al. Clinical score and rapid antigen detection test to guide antibiotic use for sore throats: randomised controlled trial of PRISM (primary care streptococcal management). BMJ 2013;347:f5806. https://doi.org/10.1136/bmj.f5806 doi: 10.1136/bmj.f5806. [DOI] [PMC free article] [PubMed]
  7. Centor RM, Witherspoon JM, Dalton HP, Brody CE, Link K. The diagnosis of strep throat in adults in the emergency room. Med Decis Making 1981;1:239–46. https://doi.org/10.1177/0272989X8100100304 doi: 10.1177/0272989X8100100304. [DOI] [PubMed]
  8. National Institute for Health and Care Excellence (NICE). Sore Throat (Acute): Antimicrobial Prescribing: NICE Guideline [NG84]. Leeds: NICE; 2018. URL: www.nice.org.uk/guidance/ng84 (accessed 2 April 2019).
  9. Linder JA, Stafford RS. Antibiotic treatment of adults with sore throat by community primary care physicians: a national survey, 1989-1999. JAMA 2001;286:1181–6. https://doi.org/10.1001/jama.286.10.1181 doi: 10.1001/jama.286.10.1181. [DOI] [PubMed]
  10. Gulliford MC, Dregan A, Moore MV, Ashworth M, Staa TV, McCann G, et al. Continued high rates of antibiotic prescribing to adults with respiratory tract infection: survey of 568 UK general practices. BMJ Open 2014;4:e006245. https://doi.org/10.1136/bmjopen-2014-006245 doi: 10.1136/bmjopen-2014-006245. [DOI] [PMC free article] [PubMed]
  11. National Institute for Health and Care Excellence (NICE). Rapid Tests for Group A Streptococcal Infections in People with a Sore Throat: Final Scope. Leeds: NICE; 2018. URL: www.nice.org.uk/guidance/gid-dg10025/documents/final-scope (accessed 10 April 2019).
  12. Public Health England (PHE). Third Report on Seasonal Activity of Group A Streptococcal Infections in 2017/18. London: PHE; 2018. URL: www.gov.uk/government/publications/group-a-streptococcal-infectionsactivity-during-the-2017-to-2018-season (accessed 7 April 2019).
  13. Petersen I, Johnson AM, Islam A, Duckworth G, Livermore DM, Hayward AC. Protective effect of antibiotics against serious complications of common respiratory tract infections: retrospective cohort study with the UK General Practice Research Database. BMJ 2007;335:982. https://doi.org/10.1136/bmj.39345.405243.BE doi: 10.1136/bmj.39345.405243.BE. [DOI] [PMC free article] [PubMed]
  14. Public Health England (PHE). Invasive Group A Streptococcal Disease: Managing Close Contacts. London: PHE; 2008. URL: www.gov.uk/government/publications/invasive-group-a-streptococcal-disease-managing-community-contacts (accessed 5 April 2019).
  15. Corner M. ONS: Sickness Absence in the UK Labour Market: 2016. Newport: Office for National Statistics; 2017. URL: www.ons.gov.uk/employmentandlabourmarket/peopleinwork/labourproductivity/articles/sicknessabsenceinthelabourmarket/2016 (accessed 10 April 2019).
  16. Newcastle and York External Assessment Centre. Point-of-Care Diagnostic Testing in Primary Care for Strep A Infection in Sore Throat. Leeds: NICE; 2018. URL: www.nice.org.uk/advice/mib145 (accessed 21 September 2018).
  17. McCormick A, Fleming D, Charlton J. Morbidity Statistics from General Practice: Fourth National Study 1991–1992. London: HMSO; 1995.
  18. Fine AM, Nizet V, Mandl KD. Large-scale validation of the Centor and McIsaac scores to predict group A streptococcal pharyngitis. Arch Intern Med 2012;172:847–52. https://doi.org/10.1001/archinternmed.2012.950 doi: 10.1001/archinternmed.2012.950. [DOI] [PMC free article] [PubMed]
  19. Bryant AE, Stevens DL. 199: Streptococcus pyogenes. In Bennett JE, Dolin R, Blaser MJ, editors. Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases. 8th edn. Philadelphia, PA: Elsevier/Saunders; 2015. pp. 741–69.
  20. Berry GJ, Miller CR, Prats MM, Marquez C, Oladipo OO, Loeffelholz MJ, Petersen JR. Comparison of the Alere i Strep A Test and the BD Veritor System in the detection of group A Streptococcus and the hypothetical impact of results on antibiotic utilization. J Clin Microbiol 2018;56:e01310–17. https://doi.org/10.1128/JCM.01310-17 doi: 10.1128/JCM.01310-17. [DOI] [PMC free article] [PubMed]
  21. Uhl JR, Adamson SC, Vetter EA, Schleck CD, Harmsen WS, Iverson LK, et al. Comparison of LightCycler PCR, rapid antigen immunoassay, and culture for detection of group A streptococci from throat swabs. J Clin Microbiol 2003;41:242–9. https://doi.org/10.1128/JCM.41.1.242-249.2003 doi: 10.1128/JCM.41.1.242-249.2003. [DOI] [PMC free article] [PubMed]
  22. Kocoglu E, Karabay O, Yilmaz F, Ekerbicer H. The impact of incubating the throat culture for 72 h on the diagnosis of group A beta-hemolytic streptococci. Auris Nasus Larynx 2006;33:311–13. https://doi.org/10.1016/j.anl.2005.11.011 doi: 10.1016/j.anl.2005.11.011. [DOI] [PubMed]
  23. Lacroix L, Cherkaoui A, Schaller D, Manzano S, Galetto-Lacour A, Pfeifer U, et al. Improved diagnostic performance of an immunofluorescence-based rapid antigen detection test for group A streptococci in children with pharyngitis. Pediatr Infect Dis J 2018;37:206–11. https://doi.org/10.1097/INF.0000000000001825 doi: 10.1097/INF.0000000000001825. [DOI] [PubMed]
  24. Wang F, Tian Y, Chen L, Luo R, Sickler J, Liesenfeld O, Chen S. Accurate detection of Streptococcus pyogenes at the point of care using the cobas Liat Strep A Nucleic Acid Test. Clin Pediatr 2017;56:1128–34. https://doi.org/10.1177/0009922816684602 doi: 10.1177/0009922816684602. [DOI] [PubMed]
  25. EUR-Lex. Document 31998L0079. URL: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A31998L0079 (accessed May 2020).
  26. Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med 2011;155:529–36. https://doi.org/10.7326/0003-4819-155-8-201110180-00009 doi: 10.7326/0003-4819-155-8-201110180-00009. [DOI] [PubMed]
  27. National Institute for Health and Care Excellence (NICE). Fever in Under 5s: Assessment and Initial Management: Clinical Guideline [CG160]. Leeds: NICE; 2013. URL: nice.org.uk/guidance/cg160 (accessed 27 March 2019).
  28. Roper SM, Edwards R, Mpwo M, Mutandiro C, Devaraj S. Reducing errors in an emergency center setting using an automated fluorescence immunoassay for group A Streptococcus identification. Clin Pediatr 2017;56:675–7. https://doi.org/10.1177/0009922816678184 doi: 10.1177/0009922816678184. [DOI] [PubMed]
  29. Public Health England (PHE). UK Standards for Microbiology Investigations: Investigation of Throat Related Specimens. London: Standards Unit, Microbiology Services, PHE; 2015. URL: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/423204/B_9i9.pdf (accessed 27 March 2019).
  30. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011;343:d5928. https://doi.org/10.1136/bmj.d5928 doi: 10.1136/bmj.d5928. [DOI] [PMC free article] [PubMed]
  31. Joanna Briggs Institute. The Joanna Briggs Institute Critical Appraisal Tools for Use in JBI Systematic Reviews: Checklist for Analytical Cross Sectional Studies. Adelaide, SA: Joanna Briggs Institute; 2017. URL: http://joannabriggs.org/research/critical-appraisal-tools.html (accessed 1 May 2019).
  32. Macaskill P, Gatsonis C, Deeks JJ, Harbord RM, Takwoingi Y. Chapter 10 Analysing and Presenting Results. In Deeks JJ, Bossuyt PM, Gatsonis C, editors. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy. Version 1. 0. London: Cochrane Collaboration; 2010.
  33. Takwoingi Y, Guo B, Riley RD, Deeks JJ. Performance of methods for meta-analysis of diagnostic test accuracy with few studies or sparse data. Stat Methods Med Res 2017;26:1896–911. https://doi.org/10.1177/0962280215592269 doi: 10.1177/0962280215592269. [DOI] [PMC free article] [PubMed]
  34. Azrad M, Danilov E, Goshen S, Nitzan O, Peretz A. Detection of group A Streptococcus in pharyngitis by two rapid tests: comparison of the BD VeritorTM and the QuikRead go Strep A. Eur J Clin Microbiol Infect Dis 2019;38:1179–85. https://doi.org/10.1007/s10096-019-03527-w doi: 10.1007/s10096-019-03527-w. [DOI] [PubMed]
  35. Bird C, Winzor G, Lemon K, Moffat A, Newton T, Gray J. A pragmatic study to evaluate the use of a rapid diagnostic test to detect group A streptococcal pharyngitis in children with the aim of reducing antibiotic use in a UK emergency department [published online ahead of print July 24 2018]. Pediatr Emerg Care 2018. https://doi.org/10.1097/PEC.0000000000001560 doi: 10.1097/PEC.0000000000001560. [DOI] [PubMed]
  36. Bura M, Michalak M, Chojnicki M, Padzik M, Mozer-Lisewska I. Moderate and severe pharyngitis in young adult inhabitants of Poznan, Western Poland. Fam Med Prim Care Rev 2017;19:12–7. https://doi.org/10.5114/fmpcr.2017.65084 doi: 10.5114/fmpcr.2017.65084. [DOI]
  37. Cohen DM, Russo ME, Jaggi P, Kline J, Gluckman W, Parekh A. Multicenter clinical evaluation of the novel Alere i Strep A isothermal nucleic acid amplification test. J Clin Microbiol 2015;53:2258–61. https://doi.org/10.1128/JCM.00490-15 doi: 10.1128/JCM.00490-15. [DOI] [PMC free article] [PubMed]
  38. Dimatteo LA, Lowenstein SR, Brimhall B, Reiquam W, Gonzales R. The relationship between the clinical features of pharyngitis and the sensitivity of a rapid antigen test: evidence of spectrum bias. Ann Emerg Med 2001;38:648–52. https://doi.org/10.1067/mem.2001.119850 doi: 10.1067/mem.2001.119850. [DOI] [PubMed]
  39. Humair J-P, Revaz SA, Bovier P, Stalder H. Management of acute pharyngitis in adults. Arch Intern Med 2006;166:640. https://doi.org/10.1001/archinte.166.6.640 doi: 10.1001/archinte.166.6.640. [DOI] [PubMed]
  40. Johansson L, Månsson NO. Rapid test, throat culture and clinical assessment in the diagnosis of tonsillitis. Fam Pract 2003;20:108–11. https://doi.org/10.1093/fampra/20.2.108 doi: 10.1093/fampra/20.2.108. [DOI] [PubMed]
  41. Johnson DR, Kaplan EL. False-positive rapid antigen detection test results: reduced specificity in the absence of group A streptococci in the upper respiratory tract. J Infect Dis 2001;183:1135–7. https://doi.org/10.1086/319286 doi: 10.1086/319286. [DOI] [PubMed]
  42. Kurtz B, Kurtz M, Roe M, Todd J. Importance of inoculum size and sampling effect in rapid antigen detection for diagnosis of Streptococcus pyogenes pharyngitis. J Clin Microbiol 2000;38:279–81. doi: 10.1128/jcm.38.1.279-281.2000. [DOI] [PMC free article] [PubMed]
  43. Lindbæk M, Høiby EA, Lermark G, Steinsholt IM, Hjortdahl P. Which is the best method to trace group A streptococci in sore throat patients: culture or GAS antigen test? Scand J Prim Health Care 2004;22:233–8. https://doi.org/10.1080/02813430410006675 doi: 10.1080/02813430410006675. [DOI] [PubMed]
  44. Llor C, Calviño O, Hernández S, Crispi S, Pérez-Bauer M, Fernández Y, et al. Repetition of the rapid antigen test in initially negative supposed streptococcal pharyngitis is not necessary in adults. Int J Clin Pract 2009;63:1340–4. https://doi.org/10.1111/j.1742-1241.2009.02048.x doi: 10.1111/j.1742-1241.2009.02048.x. [DOI] [PubMed]
  45. Llor C, Madurell J, Balagué-Corbella M, Gómez M, Cots JM. Impact on antibiotic prescription of rapid antigen detection testing in acute pharyngitis in adults: a randomised clinical trial. Br J Gen Pract 2011;61:e244–51. https://doi.org/10.3399/bjgp11X572436 doi: 10.3399/bjgp11X572436. [DOI] [PMC free article] [PubMed]
  46. McIsaac WJ, Kellner JD, Aufricht P, Vanjaka A, Low DE. Empirical validation of guidelines for the management of pharyngitis in children and adults. JAMA 2004;291:1587–95. https://doi.org/10.1001/jama.291.13.1587 doi: 10.1001/jama.291.13.1587. [DOI] [PubMed]
  47. Nerbrand C, Jasir A, Schalén C. Are current rapid detection tests for Group A streptococci sensitive enough? Evaluation of 2 commercial kits. Scand J Infect Dis 2002;34:797–9. https://doi.org/10.1080/0036554021000026953 doi: 10.1080/0036554021000026953. [DOI] [PubMed]
  48. Penney C, Porter R, O’Brien M, Daley P. Operator influence on blinded diagnostic accuracy of point-of-care antigen testing for group A streptococcal pharyngitis. Can J Infect Dis Med Microbiol 2016;2016:1710561. https://doi.org/10.1155/2016/1710561 doi: 10.1155/2016/1710561. [DOI] [PMC free article] [PubMed]
  49. Rogo T, Schwartz RH, Ascher DP. Comparison of the Inverness Medical Acceava Strep A test with the Genzyme OSOM and Quidel QuickVue Strep A tests. Clin Pediatr 2011;50:294–6. https://doi.org/10.1177/0009922810385675 doi: 10.1177/0009922810385675. [DOI] [PubMed]
  50. Rosenberg P, McIsaac W, Macintosh D, Kroll M. Diagnosing streptococcal pharyngitis in the emergency department: is a sore throat score approach better than rapid streptococcal antigen testing? CJEM 2002;4:178–84. https://doi.org/10.1017/S1481803500006357 doi: 10.1017/S1481803500006357. [DOI] [PubMed]
  51. Santos O, Weckx LL, Pignatari AC, Pignatari SS. Detection of group A beta-hemolytic Streptococcus employing three different detection methods: culture, rapid antigen detecting test, and molecular assay. Braz J Infect Dis 2003;7:297–300. https://doi.org/10.1590/S1413-86702003000500003 doi: 10.1590/S1413-86702003000500003. [DOI] [PubMed]
  52. Stefaniuk E, Bosacka K, Wanke-Rytt M, Hryniewicz W. The use of rapid test QuikRead go® Strep A in bacterial pharyngotonsillitis diagnosing and therapeutic decisions. Eur J Clin Microbiol Infect Dis 2017;36:1733–8. https://doi.org/10.1007/s10096-017-2986-8 doi: 10.1007/s10096-017-2986-8. [DOI] [PubMed]
  53. Thornley T, Marshall G, Howard P, Wilson AP. A feasibility service evaluation of screening and treatment of group A streptococcal pharyngitis in community pharmacies. J Antimicrob Chemother 2016;71:3293–9. https://doi.org/10.1093/jac/dkw264 doi: 10.1093/jac/dkw264. [DOI] [PMC free article] [PubMed]
  54. Weinzierl EP, Jerris RC, Gonzalez MD, Piccini JA, Rogers BB. Comparison of Alere i Strep A Rapid Molecular Assay with rapid antigen testing and culture in a pediatric outpatient setting [published online ahead of print June 19 2018]. Am J Clin Pathol 2018. https://doi.org/10.1093/ajcp/aqy038 doi: 10.1093/ajcp/aqy038. [DOI] [PubMed]
  55. Worrall G, Hutchinson J, Sherman G, Griffiths J. Diagnosing streptococcal sore throat in adults: randomized controlled trial of in-office aids. Can Fam Physician 2007;53:666–71. [PMC free article] [PubMed]
  56. Andersen JB, Dahm TL, Nielsen CT, Frimodt-Møller N. [Diagnosis of streptococcal tonsillitis in the pediatric department with the help of antigen detection test.] Ugeskr Laeg 2003;165:2291–5. [PubMed]
  57. Pauchard JY, Verga ME, Bersier J, Durusell C, Gehri M, Vaudaux B. Performance of a rapid antigen detection test in group A beta-haemolytic streptococcal pharyngitis in comparison with three clinical decision rule in a tertiary paediatric emergency department. Swiss Med Wkly 2013;197:6S.
  58. Valverde ED, Colmenarejo C, llescas S, Gonzalez JC. P0820: Evaluation of a Rapid Streptococcal Group A Antigen Test in Different Age Groups. Paper presented at ECCMID, Madrid, Spain, 2018.
  59. Food and Drug Administration (FDA). FDA Decision Summary: Substantial Equivalence Determination for the BD Veritor™ System for Rapid Detection of Group A Streptococcus (Group A Strep). K122718. Silver Spring, MD: FDA; 2013. URL: www.accessdata.fda.gov/cdrh_docs/reviews/K122718.pdf (accessed 6 March 2019).
  60. Food and Drug Administration (FDA). FDA Decision Summary: Substantial Equivalence Determination for the Sophia Strep A FIA Assay for Use with the Sophia Analyzer. K123793. Silver Spring, MD: FDA; 2013. URL: www.accessdata.fda.gov/cdrh_docs/reviews/K123793.pdf (accessed 6 March 2019).
  61. Food and Drug Administration (FDA). FDA Decision Summary: Substantial Equivalence Determination for the Alere i Strep A 2 Performed on the Alere i Analyzer for the Detection of Streptococcus pyogenes (Group A Streptococcus). K173653. Silver Spring, MD: FDA; 2018. URL: www.accessdata.fda.gov/cdrh_docs/reviews/K173653.pdf (accessed 6 March 2019).
  62. Food and Drug Administration. FDA Decision Summary: Substantial Equivalence Determination for Xpert Xpress Strep A Test Performed on the GeneXpert Xpress System. K173398. Silver Spring, MD: FDA; 2018. URL: www.accessdata.fda.gov/cdrh_docs/reviews/K173398.pdf (accessed 6 March 2019).
  63. Esposito S, Blasi F, Bosis S, Droghetti R, Faelli N, Lastrico A, et al. Aetiology of acute pharyngitis: the role of atypical bacteria. J Med Microbiol 2004;53:645–51. https://doi.org/10.1099/jmm.0.05487-0 doi: 10.1099/jmm.0.05487-0. [DOI] [PubMed]
  64. Gieseker KE, Roe MH, MacKenzie T, Todd JK. Evaluating the American Academy of Pediatrics diagnostic standard for Streptococcus pyogenes pharyngitis: backup culture versus repeat rapid antigen testing. Pediatrics 2003;111:e666–70. https://doi.org/10.1542/peds.111.6.e666 doi: 10.1542/peds.111.6.e666. [DOI] [PubMed]
  65. Felsenstein S, Faddoul D, Sposto R, Batoon K, Polanco CM, Dien Bard J. Molecular and clinical diagnosis of group A streptococcal pharyngitis in children. J Clin Microbiol 2014;52:3884–9. https://doi.org/10.1128/JCM.01489-14 doi: 10.1128/JCM.01489-14. [DOI] [PMC free article] [PubMed]
  66. Thamlikitkul V, Rachata T, Popum S, Chinswangwatanakul P, Srisomnuek A, Seenama C, et al. Accuracy and utility of rapid antigen detection tests for group A beta-hemolytic Streptococcus on ambulatory adult patients with sore throat associated with acute respiratory infections at Siriraj hospital. J Med Assoc Thai 2018;101:441–9.
  67. Ramos JL, Fraile MT, Chanza M, Tormo N, Lurbe A, Gimeno C. Rapid detection of Streptococcus pyogenes in peripheral medical centres. A pilot custody assay. Clin Microbiol Infect 2011;17:S250.
  68. Hoffmann K, Reichardt B, Zehetmayer S, Maier M. Evaluation of the implementation of a rapid streptococcal antigen test in a routine primary health care setting: from recommendations to practice. Wien Klin Wochenschr 2012;124:633–8. https://doi.org/10.1007/s00508-012-0225-y doi: 10.1007/s00508-012-0225-y. [DOI] [PubMed]
  69. Lean WL, Arnup S, Danchin M, Steer AC. Rapid diagnostic tests for group A streptococcal pharyngitis: a meta-analysis. Pediatrics 2014;134:771–81. https://doi.org/10.1542/peds.2014-1094 doi: 10.1542/peds.2014-1094. [DOI] [PubMed]
  70. Roveta S, Marchese A, Debbia EA. Evaluation of the Uro-Quick, a new rapid automated system, for the detection of well-characterized antibiotic-resistant bacteria. J Chemother 2004;16:107–18. https://doi.org/10.1179/joc.2004.16.2.107 doi: 10.1179/joc.2004.16.2.107. [DOI] [PubMed]
  71. Ebrahimi S, Mohabatkar H, Behbahani M. Predicting promiscuous T cell epitopes for designing a vaccine against Streptococcus pyogenes. Appl Biochem Biotechnol 2018;11:11. https://doi.org/10.1007/s12010-018-2804-5 doi: 10.1007/s12010-018-2804-5. [DOI] [PMC free article] [PubMed]
  72. Leeflang MM, Bossuyt PM, Irwig L. Diagnostic test accuracy may vary with prevalence: implications for evidence-based diagnosis. J Clin Epidemiol 2009;62:5–12. https://doi.org/10.1016/j.jclinepi.2008.04.007 doi: 10.1016/j.jclinepi.2008.04.007. [DOI] [PubMed]
  73. Gerber MA, Shulman ST. Rapid diagnosis of pharyngitis caused by group A streptococci. Clin Microbiol Rev 2004;17:571–80. https://doi.org/10.1128/CMR.17.3.571-580.2004 doi: 10.1128/CMR.17.3.571-580.2004. [DOI] [PMC free article] [PubMed]
  74. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Cost Eff Resour Alloc 2013;11:6. https://doi.org/10.1186/1478-7547-11-6 doi: 10.1186/1478-7547-11-6. [DOI] [PMC free article] [PubMed]
  75. Philips Z, Ginnelly L, Sculpher M, Claxton K, Golder S, Riemsma R, et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess 2004;8(36). https://doi.org/10.3310/hta8360 doi: 10.3310/hta8360. [DOI] [PubMed]
  76. Little P, Hobbs FD, Moore M, Mant D, Williamson I, McNulty C, et al. PRImary care Streptococcal Management (PRISM) study: in vitro study, diagnostic cohorts and a pragmatic adaptive randomised controlled trial with nested qualitative study and cost-effectiveness study. Health Technol Assess 2014;18(6). https://doi.org/10.3310/hta18060 doi: 10.3310/hta18060. [DOI] [PMC free article] [PubMed]
  77. National Institute for Health and Care Excellence. Guide to the Methods of Technology Appraisal. London: NICE; 2013. URL: www.nice.org.uk/process/pmg9 (accessed 10 March 2019). [PubMed]
  78. Neuner JM, Hamel MB, Phillips RS, Bona K, Aronson MD. Diagnosis and management of adults with pharyngitis. A cost-effectiveness analysis. Ann Intern Med 2003;139:113–22. https://doi.org/10.7326/0003-4819-139-2-200307150-00011 doi: 10.7326/0003-4819-139-2-200307150-00011. [DOI] [PubMed]
  79. Van Howe RS, Kusnier LP. Diagnosis and management of pharyngitis in a pediatric population based on cost-effectiveness and projected health outcomes. Pediatrics 2006;117:609–19. https://doi.org/10.1542/peds.2005-0879 doi: 10.1542/peds.2005-0879. [DOI] [PubMed]
  80. Klepser DG, Bisanz SE, Klepser ME. Cost-effectiveness of pharmacist-provided treatment of adult pharyngitis. Am J Manag Care 2012;18:e145–54. [PubMed]
  81. National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases. Pharyngitis (Strep Throat). Atlanta, GA: Centers for Disease Control and Prevention; 2018. URL: www.cdc.gov/groupastrep/diseases-hcp/strep-throat.html (accessed 17 April 2019).
  82. National Institute for Health Research. Point-of-Care Tests for Group A Streptococcus: Horizon Scanning Report. Oxford: NIHR Community Healthcare MedTech and In Vitro Diagnostics Co-operative; 2015. URL: www.community.healthcare.mic.nihr.ac.uk/reports-and-resources/horizon-scanning-reports/point-of-care-tests-for-group-a-streptococcus (accessed 25 April 2019).
  83. Wessels MR. Streptococcus pyogenes: Basic Biology to Clinical Manifestations. Bethesda, MD: National Center for Biotechnology Information; 2016. URL: www.ncbi.nlm.nih.gov/books/NBK333418/ (accessed 25 April 2019).
  84. Aalbers J, O’Brien KK, Chan WS, Falk GA, Teljeur C, Dimitrov BD, Fahey T. Predicting streptococcal pharyngitis in adults in primary care: a systematic review of the diagnostic accuracy of symptoms and signs and validation of the Centor score. BMC Med 2011;9:67. https://doi.org/10.1186/1741-7015-9-67 doi: 10.1186/1741-7015-9-67. [DOI] [PMC free article] [PubMed]
  85. Ferrieri P, Nelson K, Thonen-Kerr E, Arbefeville S. Prospective evaluation of Xpert Xpress Strep A automated PCR assay vs Solana group A streptococcal NAAT vs conventional throat culture. Am J Pathol 2018;150:S157. https://doi.org/10.1093/ajcp/aqy112.367 doi: 10.1093/ajcp/aqy112.367. [DOI]
  86. Little P, Stuart B, Hobbs FD, Butler CC, Hay AD, Campbell J, et al. Predictors of suppurative complications for acute sore throat in primary care: prospective clinical cohort study. BMJ 2013;347:f6867. https://doi.org/10.1136/bmj.f6867 doi: 10.1136/bmj.f6867. [DOI] [PMC free article] [PubMed]
  87. Kind P, Dolan P, Gudex C, Williams A. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ 1998;316:736–41. https://doi.org/10.1136/bmj.316.7133.736 doi: 10.1136/bmj.316.7133.736. [DOI] [PMC free article] [PubMed]
  88. NHS. NHS Supply Chain Catalogue. London: NHS Supply Chain; 2019. URL: https://my.supplychain.nhs.uk/catalogue (accessed 25 April 2019).
  89. Medisave UK Ltd. Clearview Exact Strep A Dipstick x 25. Weymouth: Medisave UK Ltd. URL: www.medisave.co.uk/clearview-exact-strep-a-dipstick-x-25-test-kit-p-7660.html (accessed 17 April 2019).
  90. Curtis L, Burns A. Unit Costs of Health and Social Care. Canterbury: Personal Social Services Research Unit, University of Kent; 2017.
  91. Joint Formulary Committee. BNF 74: September 2017. London: Pharmaceutical Press; 2017.
  92. NHS Improvement. NHS Reference Costs 2017/18. NHS Improvement; 2018. URL: https://improvement.nhs.uk/resources/reference-costs/#rc1718 (accessed 17 April 2019).
  93. Hex N, Retzler J, Bartlett C, Arber M. The Cost of Sepsis Care in the UK: Final Report [YHEC]. North Grey Literature Collection; 2017. URL: http://allcatsrgrey.org.uk/wp/wpfb-file/yhec-sepsis-report-17-02-17-final-pdf/ (accessed 17 April 2019).
  94. Centers for Disease Control and Prevention. Group A Streptococcal Disease (GAS) Disease – Pharyngitis (Strep Throat). Atlanta, GA: Centers for Disease Control and Prevention; 2018. URL: www.cdc.gov/groupastrep/diseases-hcp/strep-throat.html (accessed 20 May 2019).
  95. Vachhani R, Patel T, Centor RM, Estrada CA. Sensitivity for diagnosing group A streptococcal pharyngitis from manufacturers is 10% higher than reported in peer-reviewed publications. South Med J 2017;110:59–64. https://doi.org/10.14423/SMJ.0000000000000597 doi: 10.14423/SMJ.0000000000000597. [DOI] [PubMed]
  96. Stewart EH, Davis B, Clemans-Taylor BL, Littenberg B, Estrada CA, Centor RM. Rapid antigen group A Streptococcus test to diagnose pharyngitis: a systematic review and meta-analysis. PLOS ONE 2014;9:e111727. https://doi.org/10.1371/journal.pone.0111727 doi: 10.1371/journal.pone.0111727. [DOI] [PMC free article] [PubMed]
  97. Parviainen M, Koskela M, Ikäheimo I, Kelo E, Sirola H, et al. A novel strep A test for a rapid test reader compared with standard culture method and a commercial antigen assay. Eur Infect Dis 2011;5:143–5.
  98. Ruiz-Aragon J, Rodriguez Lopez R, Molina Linde JM. [Evaluation of rapid methods for detecting Streptococcus pyogenes. Systematic review and meta-analysis.] An Pediatr 2010;72:391–402. https://doi.org/10.1016/j.anpedi.2009.12.012 doi: 10.1016/j.anpedi.2009.12.012. [DOI] [PubMed]
  99. Cohen JF, Bertille N, Cohen R, Chalumeau M. Rapid antigen detection test for group A Streptococcus in children with pharyngitis. Cochrane Database Syst Rev 2016;7:CD010502. https://doi.org/10.1002/14651858.CD010502.pub2 doi: 10.1002/14651858.CD010502.pub2. [DOI] [PMC free article] [PubMed]
  100. Mlejnek JR, Almulhem K, Spadafore S. Utility and cost effectiveness of throat culture in the treatment of patients with negative rapid strep screens. Acad Emerg Med 2014;21:S51.
  101. Pauchard JY, Verga ME, Bersier J, Prod’Hom G, Gehri M, Vaudaux B. Performance of rapid antigen diagnostic test for group A β-haemolytic streptococcal pharyngitis in a tertiary paediatric emergency department. Swiss Med Wkly 2012;142(Suppl. 192):35S.
  102. Schwartz RH. Evaluation of rapid streptococcal detection tests. Pediatr Infect Dis J 1997;16:1099–100. https://doi.org/10.1097/00006454-199711000-00028 doi: 10.1097/00006454-199711000-00028. [DOI] [PubMed]
  103. Sedki M, Salama H, Salama E, Abdalla N, Ezz H. Rapid diagnostic test for streptococcal throat infection in Egyptian children. Med J Cairo Univ 2010;78:177–82.
  104. Banerjee S, Ford C. Rapid Tests for the Diagnosis of Group A Streptococcal Infection: A Review of Diagnostic Test Accuracy, Clinical Utility, Safety, and Cost-Effectiveness. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health CADTH Rapid Response Reports; 2018. [PubMed]
  105. Kose E, Sirin Kose S, Akca D, Yildiz K, Elmas C, Baris M, Anil M. The effect of rapid antigen detection test on antibiotic prescription decision of clinicians and reducing antibiotic costs in children with acute pharyngitis. J Trop Pediatr 2016;62:308–15. https://doi.org/10.1093/tropej/fmw014 doi: 10.1093/tropej/fmw014. [DOI] [PubMed]
  106. Benjamin JT. The costs of testing for streptococcal pharyngitis in the office laboratory. Arch Pediatr Adolesc Med 2000;154:93–4. [PubMed]
  107. Tsevat J, Kotagal UR. Management of sore throats in children: a cost-effectiveness analysis. Arch Pediatr Adolesc Med 1999;153:681–8. https://doi.org/10.1001/archpedi.153.7.681 doi: 10.1001/archpedi.153.7.681. [DOI] [PubMed]
  108. Boyler PA, Humair J, Revaz SA, Stalder H. A cost-effectiveness analysis of recommended strategies for acute pharyngitis. J Gen Intern Med 2002;17:135–6.
  109. Ehrlich JE, Demopoulos BP, Daniel KR, Ricarte MC, Glied S. Cost-effectiveness of treatment options for prevention of rheumatic heart disease from group A streptococcal pharyngitis in a pediatric population. Prev Med 2002;35:250–7. https://doi.org/10.1006/pmed.2002.1062 doi: 10.1006/pmed.2002.1062. [DOI] [PubMed]
  110. Giraldez-Garcia C, Rubio B, Gallegos-Braun JF, Imaz I, Gonzalez-Enriquez J, Sarria-Santamera A. Diagnosis and management of acute pharyngitis in a paediatric population: a cost-effectiveness analysis. Eur J Pediatr 2011;170:1059–67. https://doi.org/10.1007/s00431-011-1410-0 doi: 10.1007/s00431-011-1410-0. [DOI] [PubMed]
  111. Klepser D, Grismer SE, Klepser ME. Cost-effectiveness of pharmacist provided care for the treatment of adult pharyngitis. J Manag Care Pharm 2011;17:241. [PubMed]
  112. Komaroff AL, Pass TM, Pappius EM. A cost-effectiveness analysis of alternate strategies for management of sore throat. Clin Res 1983;31:A299.
  113. Lathia N, Sullivan K, Tam K, Brna M, MacNeil P, Saltmarche D, Agro K. Cost-minimization analysis of community pharmacy-based point-of-care testing for strep throat in 5 Canadian provinces. Can Pharm J 2018;151:322–31. https://doi.org/10.1177/1715163518790993 doi: 10.1177/1715163518790993. [DOI] [PMC free article] [PubMed]
  114. Maizia A, Letrilliart L, Colin C. [Diagnostic strategies for acute tonsillitis in France: a cost-effectiveness study.] Presse Med 2012;41:e195–203. https://doi.org/10.1016/j.lpm.2011.10.021 doi: 10.1016/j.lpm.2011.10.021. [DOI] [PubMed]
  115. Malecki M, Mazur A, Sobolewski M, Binkowska-Bury M, Marc M, Januszewicz P. Rapid strip tests as a decision-making tool about antibiotic treatment in children – a prospective study. Pediatr Pol 2017;92:149–55. https://doi.org/10.1016/j.pepo.2017.01.006 doi: 10.1016/j.pepo.2017.01.006. [DOI]
  116. Meier FA, Howland J, Johnson J, Poisson R. Effects of a rapid antigen test for group A streptococcal pharyngitis on physician prescribing and antibiotic costs. Arch Intern Med 1990;150:1696–700. https://doi.org/10.1001/archinte.1990.00040031696018 doi: 10.1001/archinte.1990.00040031696018. [DOI] [PubMed]
  117. Polisena J, Spry C. Point of Care Testing for Streptococcal Sore Throat: A Review of Diagnostic Accuracy, Cost-Effectiveness, and Guidelines. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health; 2009. URL: www.cadth.ca/media/pdf/htis/L0088%20Point%20of%20Care%20Testing%20for%20Streptococcal%20Sore%20Throat%20final.pdf (accessed 23 January 2019).
  118. National Institute for Health and Care Excellence (NICE). Resource Impact Report: Sepsis: The Recognition, Diagnosis and Early Management (NG51). London: NICE; 2016. URL: www.nice.org.uk/guidance/ng51/resources/resource-impact-report-pdf-2549846269 (accessed 17 April 2019).
  119. Matthys J, De Meyere M, van Driel ML, De Sutter A. Differences among international pharyngitis guidelines: not just academic. Ann Fam Med 2007;5:436–43. https://doi.org/10.1370/afm.741 doi: 10.1370/afm.741. [DOI] [PMC free article] [PubMed]
  120. Gazzano V, Berger A, Benito Y, Freydiere A-M, Tristan A, Boisset S, et al. Reassessment of the role of rapid antigen detection tests in diagnosis of invasive group A streptococcal infections. J Clin Microbiol 2016;54:994. https://doi.org/10.1128/JCM.02516-15 doi: 10.1128/JCM.02516-15. [DOI] [PMC free article] [PubMed]
  121. Shallcross LJ, Davies SC. Antibiotic overuse: a key driver of antimicrobial resistance. Br J Gen Pract 2014;64:604–5. https://doi.org/10.3399/bjgp14X682561 doi: 10.3399/bjgp14X682561. [DOI] [PMC free article] [PubMed]

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