1887

Abstract

Serological analysis is an essential tool for the diagnosis of pertussis or whooping cough, disease surveillance and the evaluation of vaccine effectiveness against . Accurate measurement of anti-pertussis toxin (anti-PT) IgG antibody levels in sera is essential. These measurements are usually performed using immunological methods such as ELISA and multiplex immunoassays. However, there are a large number of different assay systems available, and therefore standardization and harmonization between the methods are needed to obtain comparable data.

In collaboration with ECDC, the EUPert-LabNet network has organized three External Quality Assessment (EQA) schemes (2010, 2012 and 2016), which initially identified the diverse range of techniques and reagents being used throughout Europe. This manuscript discusses the findings of each of the EQA rounds and their impact on the participating laboratories.

The studies have shown an increasing number of laboratories (from 65% to 92%) using only the recommended coating antigen, purified PT, in immunoassays, as this allows exact quantification of serum anti-PT IgG and since PT is only produced by this prevents cross-reactivity with other species. There has also been an increase in the numbers of laboratories (from 59% to 92%), including a WHO reference serum in their assays, which allows anti-PT IgG concentrations to be measured in International Units, thus enabling the comparison of results from different methods and laboratories. In addition, manufacturers have also considered these recommendations when they produce commercial ELISA kits.

The three EQA rounds have resulted in greater harmonization in methods among different laboratories, showing a significant improvement of the ELISA methods used for serodiagnosis of pertussis.

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2019-05-01
2019-10-21
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References

  1. Melvin JA, Scheller EV, Miller JF, Cotter PA. Bordetella pertussis pathogenesis: current and future challenges. Nat Rev Microbiol 2014;12:274–288 [CrossRef]
    [Google Scholar]
  2. Borba RC, Vidal VM, Moreira LO. The re-emergency and persistence of vaccine preventable diseases. An Acad Bras Ciênc 2015;87:1311–1322 [CrossRef]
    [Google Scholar]
  3. Dorji D, Mooi F, Yantorno O, Deora R, Graham RM et al. Bordetella pertussis virulence factors in the continuing evolution of whooping cough vaccines for improved performance. Med Microbiol Immunol 2018;207:3–26
    [Google Scholar]
  4. Kilgore PE, Salim AM, Zervos MJ, Schmitt HJ. Pertussis: Microbiology, Disease, Treatment, and Prevention. Clin Microbiol Rev 2016;29:449–486 [CrossRef]
    [Google Scholar]
  5. Locht C. Live pertussis vaccines: will they protect against carriage and spread of pertussis?. Clin Microbiol Infect 2016;22:S96–S102 [CrossRef]
    [Google Scholar]
  6. Xing D, Markey K, Newland P, Rigsby P, Hockley J et al. EUVAC.NET collaborative study: evaluation and standardisation of serology for diagnosis of pertussis. J Immunol Methods 2011;372:137–145 [CrossRef]
    [Google Scholar]
  7. van der Zee A, Schellekens JF, Mooi FR. Laboratory diagnosis of pertussis. Clin Microbiol Rev 2015;28:1005–1026 [CrossRef]
    [Google Scholar]
  8. Guiso N, Berbers G, Fry NK, He Q, Riffelmann M et al. What to do and what not to do in serological diagnosis of pertussis: recommendations from EU reference laboratories. Eur J Clin Microbiol Infect Dis 2011;30:307–312 [CrossRef]
    [Google Scholar]
  9. van Gageldonk PG, van Schaijk FG, van der Klis FR, Berbers GA. Development and validation of a multiplex immunoassay for the simultaneous determination of serum antibodies to Bordetella pertussis, diphtheria and tetanus. J Immunol Methods 2008;335:79–89 [CrossRef]
    [Google Scholar]
  10. Barkoff AM, Gröndahl-Yli-Hannuksela K, He Q. Seroprevalence studies of pertussis: what have we learned from different immunized populations. Pathog Dis 2015;73:ftv050 [CrossRef]
    [Google Scholar]
  11. He Q, Barkoff AM, Mertsola J, Glismann S, Bacci S et al. High heterogeneity in methods used for the laboratory confirmation of pertussis diagnosis among European countries, 2010: integration of epidemiological and Laboratory Surveillance must include standardisation of methodologies and quality assurance. Euro Surveill 2012;17:20239 [CrossRef]
    [Google Scholar]
  12. European Centre for Disease Prevention and Control 2014; External quality assurance scheme for Bordetella pertussis serology 2013. https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/EQA-pertussis-bordetella-serology.pdf
  13. European Centre for Disease Prevention and Control 2017; EUVAC-NET. https://ecdc.europa.eu/en/about-uswho-we-workdisease-and-laboratory-networks/euvacnet
  14. Kosters K, Riffelmann M, Dohrn B, von Konig CHW. Comparison of five commercial enzyme-linked immunosorbent assays for detection of antibodies to Bordetella pertussis. Clin Diagn Lab Immunol 2000;7:422–426 [CrossRef]
    [Google Scholar]
  15. Lynn F, Reed GF, Meade BD. Collaborative study for the evaluation of enzyme-linked immunosorbent assays used to measure human antibodies to Bordetella pertussis antigens. Clin Diagn Lab Immunol 1996;3:689–700
    [Google Scholar]
  16. Meade BD, Deforest A, Edwards KM, Romani TA, Lynn F et al. Description and evaluation of serologic assays used in a multicenter trial of acellular pertussis vaccines. Pediatrics 1995;96:570–575
    [Google Scholar]
  17. Tondella ML, Carlone GM, Messonnier N, Quinn CP, Meade BD et al. International Bordetella pertussis assay standardization and harmonization meeting report. Centers for Disease Control and Prevention, Atlanta, Georgia, United States, 19–20 July 2007. Vaccine 2009;27:803–814 [CrossRef]
    [Google Scholar]
  18. Wirsing von König CH, Gounis D, Laukamp S, Bogaerts H, Schmitt HJ. Evaluation of a single-sample serological technique for diagnosing pertussis in unvaccinated children. Eur J Clin Microbiol Infect Dis 1999;18:341–345 [CrossRef]
    [Google Scholar]
  19. de Melker HE, Versteegh FG, Conyn-Van Spaendonck MA, Elvers LH, Berbers GA et al. Specificity and sensitivity of high levels of immunoglobulin G antibodies against pertussis toxin in a single serum sample for diagnosis of infection with Bordetella pertussis. J Clin Microbiol 2000;38:800–806
    [Google Scholar]
  20. Horby P, Macintyre CR, McIntyre PB, Gilbert GL, Staff M et al. A boarding school outbreak of pertussis in adolescents: value of laboratory diagnostic methods. Epidemiol Infect 2005;133:229–236 [CrossRef]
    [Google Scholar]
  21. Martini H, Rodeghiero C, van den Poel C, Vincent M, Pierard D et al. Pertussis diagnosis in Belgium: results of the National reference centre for Bordetella anno 2015. Epidemiol Infect 2017;145:1–8
    [Google Scholar]
  22. Pebody RG, Gay NJ, Giammanco A, Baron S, Schellekens J et al. The seroepidemiology of Bordetella pertussis infection in Western Europe. Epidemiol Infect 2005;133:159–171 [CrossRef]
    [Google Scholar]
  23. Sakakibara Y, Ohtani Y, Jinta T, Fujie T, Miyazaki Y et al. Concentrations of immunoglobulin G antibodies against pertussis toxin does not decrease over a long period of time in Japan. Intern Med 2016;55:3257–3263 [CrossRef]
    [Google Scholar]
  24. Riffelmann M, Thiel K, Schmetz J, Wirsing von Koenig CH. Performance of commercial enzyme-linked immunosorbent assays for detection of antibodies to Bordetella pertussis. J Clin Microbiol 2010;48:4459–4463 [CrossRef]
    [Google Scholar]
  25. Fedele G, Leone P, Bellino S, Schiavoni I, Pavia C et al. Diagnostic performance of commercial serological assays measuring Bordetella pertussis IgG antibodies. Diagn Microbiol Infect Dis 2018;90:157–162 [CrossRef]
    [Google Scholar]
  26. Klement E, Kagan N, Hagain L, Kayouf R, Boxman J et al. Correlation of IgA, IgM and IgG antibody-detecting assays based on filamentous haemagglutinin, pertussis toxin and Bordetella pertussis sonicate in a strictly adult population. Epidemiol Infect 2005;133:149–158 [CrossRef]
    [Google Scholar]
  27. European Centre for Disease Prevention and Control Guidance and Protocol for the Serological Diagnosis of Human Infection with Bordetella pertussis Stockholm; 2012
    [Google Scholar]
  28. Xing D, Wirsing von Konig CH, Newland P, Riffelmann M, Meade BD et al. Characterization of reference materials for human antiserum to pertussis antigens by an international collaborative study. Clin Vaccine Immunol 2009;16:303–311 [CrossRef]
    [Google Scholar]
  29. Xing D, Wirsing von Konig CH, Newland P, Riffelmann M, Meade B. International collaborative study: evaluation of proposed International Standard for pertussis antiserum (human). World Health Organization, Expert Committee onBiological Standardization WHO/BS/08 2083 2008
    [Google Scholar]
  30. European Centre for Disease Prevention and Control 2018; External quality assurance scheme for Bordetella pertussis serology 2016. https://ecdc.europa.eu/en/publications-data/external-quality-assessment-scheme-bordetella-pertussis-serology-2016
  31. Riffelmann M, Hunfeld KP, Müller I, Xing D, Kennerknecht N et al. External quality assessment of pertussis serology in Germany. Eur J Clin Microbiol Infect Dis 2013;32:421–423 [CrossRef]
    [Google Scholar]
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