Clinical and Experimental Vaccine Research

The Korean Vaccine Society (대한백신학회)
권호 표지
DOI QR코드

DOI QR Code

Development and validation of enzyme-linked immunosorbent assay for anti-mouse pertussis immunoglobulin G using international reference anti-Bordetella pertussis mouse serum NIBSC 97/642

  • Kyu-Ri Kang (The Vaccine Bio Research Institute, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Yi-Hyeon Kwon (The Vaccine Bio Research Institute, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Gyu-Won Cho (The Vaccine Bio Research Institute, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Gi-Sub Choi (CLIPS BnC, Research Center) ;
  • Joon-Hwan Ji (CLIPS BnC, Research Center) ;
  • Hyun-Mi Kang (The Vaccine Bio Research Institute, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Soo-Young Lee (The Vaccine Bio Research Institute, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Jin-Han Kang (The Vaccine Bio Research Institute, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea)
  • Received : 2024.05.27
  • Accepted : 2024.06.26
  • Published : 2024.07.31
Download PDF
⟨ Previous Next ⟩

Abstract

Purpose: In this study, an in-house enzyme-linked immunosorbent assay (ELISA) was developed and validated. The titer of ELISA was calculated using the reference line (RFL) method based on the standard curve drawn using the international reference anti-mouse serum NIBSC (National Institute for Biological Standards and Control) 97/642. Materials and Methods: In the development step, signal to noise was depicted to select the buffers that showed the most appropriate ratio. In the validation step, standard range, precision, dilution linearity, and specificity were confirmed, and RFL and parallel line (PLL) methods were compared in precision and dilution linearity. Results: Coating concentration for plate was achieved at 0.1 ㎍/mL for pertussis toxin (PT), 0.15 ㎍/mL for filamentous hemagglutinin antigen (FHA), and 0.25 ㎍/mL for pertactin (PRN). The signal to noise ratio was 22.02 for PT, 14.93 for FHA, and 8.02 for PRN with 0.25% goat serum in phosphate-buffered saline (PBS) as a dilution buffer, and 2% skim milk in PBS as a blocking buffer. Based on the precision results, we assessed the lower limit of quantification by 1, 0.2, and 1.5 EU/mL concentration for PT, FHA, and PRN which met the ICH (International Council for Harmonization) M10 criteria of a 25% accuracy and total error of 40%. In specificity, homologous serum was spiked into heterologous serum and the accuracy met the criteria. There was no difference in the results between RFL and PLL calculations (p-value=0.3207 for PT, 0.7394 for FHA, 0.2109 for PRN). Conclusion: ELISA validated with RFL calculation method in this study is a relatively accurate assay for mouse humoral immunogenicity test.

Keywords

Acknowledgement

This research was supported by grant from the Korea Health Industry Development Institute through Ministry of Health and Welfare, Republic of Korea (grant number: HV22C0246).

References

  1. Sato Y, Sato H. Development of acellular pertussis vaccines. Biologicals 1999;27:61-9. https://doi.org/10.1006/biol.1999.0181
  2. Libster R, Edwards KM. Re-emergence of pertussis: what are the solutions? Expert Rev Vaccines 2012;11:1331-46. https://doi.org/10.1586/erv.12.118
  3. Esposito S, Stefanelli P, Fry NK, et al. Pertussis prevention: reasons for resurgence, and differences in the current acellular pertussis vaccines. Front Immunol 2019;10:1344.
  4. Chiappini E, Stival A, Galli L, de Martino M. Pertussis re-emergence in the post-vaccination era. BMC Infect Dis 2013;13:151.
  5. Althouse BM, Scarpino SV. Asymptomatic transmission and the resurgence of Bordetella pertussis. BMC Med 2015;13:146.
  6. Andre M, Poirier B, Bornstein N, Marmonier D, El Zaouk A, Fuchs F. Key points for the development of mouse immunogenicity test as potency assay for acellular pertussis vaccines. Biologicals 2000;28:217-25. https://doi.org/10.1006/biol.2000.0259
  7. Mills KH, Ryan M, Ryan E, Mahon BP. A murine model in which protection correlates with pertussis vaccine efficacy in children reveals complementary roles for humoral and cell-mediated immunity in protection against Bordetella pertussis. Infect Immun 1998;66:594-602. https://doi.org/10.1128/IAI.66.2.594-602.1998
  8. Coulson BS, Grimwood K, Bishop RF, Barnes GL. Evaluation of end-point titration, single dilution and capture enzyme immunoassays for measurement of antirotaviral IgA and IgM in infantile secretions and serum. J Virol Methods 1989;26:53-65. https://doi.org/10.1016/0166-0934(89)90074-8
  9. Peterman JH, Butler JE. Application of theoretical considerations to the analysis of ELISA data. Biotechniques 1989;7:608-15.
  10. Plikaytis BD, Turner SH, Gheesling LL, Carlone GM. Comparisons of standard curve-fitting methods to quantitate neisseria meningitidis group a polysaccharide antibody levels by enzyme-linked immunosorbent assay. J Clin Microbiol 1991;29:1439-46. https://doi.org/10.1128/jcm.29.7.1439-1446.1991
  11. Sato H, Sato Y. Bordetella pertussis infection in mice: correlation of specific antibodies against two antigens, pertussis toxin, and filamentous hemagglutinin with mouse protectivity in an intracerebral or aerosol challenge system. Infect Immun 1984;46:415-21. https://doi.org/10.1128/iai.46.2.415-421.1984
  12. Xu Y, Tan Y, Asokanathan C, Zhang S, Xing D, Wang J. Characterization of co-purified acellular pertussis vaccines. Hum Vaccin Immunother 2015;11:421-7. https://doi.org/10.4161/21645515.2014.988549
  13. Cheung GY, Xing D, Prior S, Corbel MJ, Parton R, Coote JG. Effect of different forms of adenylate cyclase toxin of Bordetella pertussis on protection afforded by an acellular pertussis vaccine in a murine model. Infect Immun 2006;74:6797-805. https://doi.org/10.1128/IAI.01104-06
  14. Watanabe M, Funaishi K, Takeo T, Endoh M. Efficacy of pertussis vaccines consisted of antigens detoxified with tea-leaf catechins. Vaccine 2000;19:1204-10. https://doi.org/10.1016/S0264-410X(00)00307-8
  15. Choi GS, Huh DH, Han SB, et al. Enzyme-linked immunosorbent assay for detecting anti-pertussis toxin antibody in mouse. Clin Exp Vaccine Res 2019;8:64-9. https://doi.org/10.7774/cevr.2019.8.1.64
  16. Stenger RM, Smits M, Kuipers B, Kessen SF, Boog CJ, van Els CA. Fast, antigen-saving multiplex immunoassay to determine levels and avidity of mouse serum antibodies to pertussis, diphtheria, and tetanus antigens. Clin Vaccine Immunol 2011;18:595-603. https://doi.org/10.1128/CVI.00061-10
  17. Boehm DT, Wolf MA, Hall JM, et al. Intranasal acellular pertussis vaccine provides mucosal immunity and protects mice from Bordetella pertussis. NPJ Vaccines 2019;4:40.
  18. Watanabe M, Nagai M. Reciprocal protective immunity against Bordetella pertussis and Bordetella parapertussis in a murine model of respiratory infection. Infect Immun 2001;69:6981-6. https://doi.org/10.1128/IAI.69.11.6981-6986.2001
  19. Reizenstein E, Hallander HO, Blackwelder WC, Kuhn I, Ljungman M, Mollby R. Comparison of five calculation modes for antibody ELISA procedures using pertussis serology as a model. J Immunol Methods 1995;183:279-90. https://doi.org/10.1016/0022-1759(95)00067-K
  20. Sato Y, Sato H. Development of acellular pertussis vaccines. Biologicals 1999;27:61-9. https://doi.org/10.1006/biol.1999.0181
  21. Cherry JD. Epidemic pertussis in 2012--the resurgence of a vaccine-preventable disease. N Engl J Med 2012;367:785-7. https://doi.org/10.1056/NEJMp1209051
  22. International Council for Harmonisation. ICH guideline M10 on bioanalytical method validation and study sample analysis: step 5 [Internet]. Amsterdam: European Medicines Agency; 2022 [cited 2024 May 10]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m10-bioanalytical-method-validation-step-5_en.pdf
  23. Park C, Huh DH, Han SB, et al. Development and implementation of standardized method for detecting immunogenicity of acellular pertussis vaccines in Korea. Clin Exp Vaccine Res 2019;8:35-42. https://doi.org/10.7774/cevr.2019.8.1.35
  24. Gaines Das R, Xing D, Rigsby P, Newland P, Corbel M. International collaborative study: evaluation of proposed International Reference Reagent of pertussis antiserum (mouse) 97/642. Biologicals 2001;29:137-48. https://doi.org/10.1006/biol.2001.0288
  25. U.S. Food and Drug Administration. Bioanalytical method validation: guidance for industry [Internet]. Rockville (MD): U.S. Food and Drug Administration; 2018 [cited 2024 May 10]. Available from: https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
  26. Kadam L, Patel K, Gautam M, et al. Development and validation of magnetic bead pentaplex immunoassay for simultaneous quantification of murine serum IgG antibodies to acellular pertussis, diphtheria and tetanus antigens used in combination vaccines. Methods 2019;158:33-43. https://doi.org/10.1016/j.ymeth.2019.01.015
  27. Grabowska K, Wang X, Jacobsson A, Dillner J. Evaluation of cost-precision rations of different strategies for ELISA measurement of serum antibody levels. J Immunol Methods 2002;271:1-15. https://doi.org/10.1016/S0022-1759(02)00334-4