1887

Journal of Medical Microbiology logo

Volume 72, Issue 2

Oral fluid-based lateral flow point-of-care assays for pertussis serology No Access

Abstract

Current serological diagnosis of pertussis is usually performed by ELISA, which is typically performed in larger diagnostic or reference laboratories, requires trained staff, and due to sample batching may have longer turnaround times.

A rapid point-of-care (POC) assay for pertussis serology would aid in both the diagnosis and surveillance of the disease.

A quantitative lateral flow (LF)-based immunoassay with fluorescent Eu-nanoparticle reporters was developed for the detection of anti-pertussis toxin (PT) and adenylate cyclase toxin (ACT) antibodies from oral fluid samples (=100), from suspected pertussis cases with respiratory symptoms.

LF assay results were compared to those obtained with anti-PT IgG oral fluid ELISA. For an ELISA cut-off value of 50 arbitrary units, the overall agreement between the assays was 91/100 (91 %), the sensitivity was 63/70 (90 %) and the specificity was 28/30 (93 %). No ACT-specific antibodies were detected from oral fluid samples; however, the signal readout positively correlated to those patients with high anti-PT IgG antibodies.

The developed LF assay was a specific, sensitive and rapid test for serological diagnosis of pertussis with anti-PT antibodies and is a suitable POC test using oral fluid samples.

  • Received:
  • Accepted:
  • Published Online:
Keyword(s): in vitro diagnostics , lateral flow , oral fluid , pertussis , point-of-care and serology
© 2023 The Authors
Loading

Article metrics loading...

/content/journal/jmm/10.1099/jmm.0.001668
2023-02-10
2024-04-19
Loading full text...

Full text loading...

References

  1. Khetsuriani N, Bisgard K, Prevots DR, Brennan M, Wharton M et al. Pertussis outbreak in an elementary school with high vaccination coverage. Pediatr Infect Dis J 2001; 20:1108–1112 [View Article] [PubMed]
     [Google Scholar]
  2. Huang H, Gao P, Gao Z, Wang L, Hao B et al. A big pertussis outbreak in a primary school with high vaccination coverage in northern China: an evidence of the emerging of the disease in China. Vaccine 2018; 36:7950–7955 [View Article]
     [Google Scholar]
  3. Sin MA, Zenke R, Rönckendorf R, Littmann M, Jorgensen P et al. Pertussis outbreak in primary and secondary schools in Ludwigslust, Germany demonstrating the role of waning immunity. Pediatr Infect Dis J 2009; 28:242–244 [View Article] [PubMed]
     [Google Scholar]
  4. Nieves DJ, Heininger U. Bordetella pertussis. Microbiol Spectr 2016; 4: [View Article]
     [Google Scholar]
  5. 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 [View Article]
     [Google Scholar]
  6. Guiso N. How to fight pertussis?. Ther Adv Vaccines 2013; 1:59–66 [View Article]
     [Google Scholar]
  7. Leber AL. Pertussis: relevant species and diagnostic update. Clin Lab Med 2014; 34:237–255 [View Article] [PubMed]
     [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 [View Article] [PubMed]
     [Google Scholar]
  9. Hallander HO. Microbiological and serological diagnosis of pertussis. Clin Infect Dis 1999; 28 Suppl 2:S99–106 [View Article]
     [Google Scholar]
  10. Yih WK, Lett SM, des Vignes FN, Garrison KM, Sipe PL et al. The increasing incidence of pertussis in Massachusetts adolescents and adults, 1989-1998. J Infect Dis 2000; 182:1409–1416 [View Article] [PubMed]
     [Google Scholar]
  11. 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 [View Article]
     [Google Scholar]
  12. Giammanco A, Chiarini A, Maple PAC, Andrews N, Pebody R et al. European Sero-Epidemiology Network: standardisation of the assay results for pertussis. Vaccine 2003; 22:112–120 [View Article] [PubMed]
     [Google Scholar]
  13. Dalby T, Petersen JW, Harboe ZB, Krogfelt KA. Antibody responses to pertussis toxin display different kinetics after clinical Bordetella pertussis infection than after vaccination with an acellular pertussis vaccine. J Med Microbiol 2010; 59:1029–1036 [View Article]
     [Google Scholar]
  14. Pawloski LC, Kirkland KB, Baughman AL, Martin MD, Talbot EA et al. Does tetanus-diphtheria-acellular pertussis vaccination interfere with serodiagnosis of pertussis infection?. Clin Vaccine Immunol 2012; 19:875–880 [View Article] [PubMed]
     [Google Scholar]
  15. Fry NK, Litt DJ, Duncan J, Vaghji L, Warrener L et al. Modelling anti-pertussis toxin IgG antibody decay following primary and preschool vaccination with an acellular pertussis vaccine in UK subjects using a modified oral fluid assay. J Med Microbiol 2013; 62:1281–1289 [View Article] [PubMed]
     [Google Scholar]
  16. Knuutila A, Barkoff A-M, Mertsola J, Osicka R, Sebo P et al. Simultaneous determination of antibodies to pertussis toxin and adenylate cyclase toxin improves serological diagnosis of pertussis. Diagnostics 2021; 11:180 [View Article]
     [Google Scholar]
  17. Subissi L, Rodeghiero C, Martini H, Litzroth A, Huygen K et al. Assessment of IgA anti-PT and IgG anti-ACT reflex testing to improve Bordetella pertussis serodiagnosis in recently vaccinated subjects. Clin Microbiol Infect 2020; 26:645 [View Article]
     [Google Scholar]
  18. Litt DJ, Samuel D, Duncan J, Harnden A, George RC et al. Detection of anti-pertussis toxin IgG in oral fluids for use in diagnosis and surveillance of Bordetella pertussis infection in children and young adults. J Med Microbiol 2006; 55:1223–1228 [View Article]
     [Google Scholar]
  19. Tessier E, Campbell H, Ribeiro S, Andrews N, Stowe J et al. Investigation of a pertussis outbreak and comparison of two acellular booster pertussis vaccines in a junior school in South East England, 2019. Euro Surveill 2021; 26:10 [View Article] [PubMed]
     [Google Scholar]
  20. Kara EO, Campbell H, Ribeiro S, Fry NK, Litt D et al. Survey of household contacts of infants with laboratory-confirmed pertussis infection during a National pertussis outbreak in England and Wales. Pediatr Infect Dis J 2017; 36:140–145 [View Article]
     [Google Scholar]
  21. Amirthalingam G, Brown CS, Campbell H, Chand MA, Fry NK. New Public Health England guidelines for managing pertussis in England. J Infect 2017; 74:202–204 [View Article] [PubMed]
     [Google Scholar]
  22. Campbell H, Amirthalingam G, Fry NK, Litt D, Harrison TG et al. Oral fluid testing for pertussis, England and Wales, June 2007-August 2009. Emerg Infect Dis 2014; 20:968–975 [View Article]
     [Google Scholar]
  23. Philipson K, Goodyear-Smith F, Grant CC, Chong A, Turner N et al. When is acute persistent cough in school-age children and adults whooping cough? A prospective case series study. Br J Gen Pract 2013; 63:e573–9 [View Article] [PubMed]
     [Google Scholar]
  24. Salminen T, Knuutila A, Barkoff AM, Mertsola J, He Q. A rapid lateral flow immunoassay for serological diagnosis of pertussis. Vaccine 2018; 36:1429–1434 [View Article] [PubMed]
     [Google Scholar]
  25. Harnden A, Grant C, Harrison T, Perera R, Brueggemann AB et al. Whooping cough in school age children with persistent cough: prospective cohort study in primary care. BMJ 2006; 333:174–177 [View Article] [PubMed]
     [Google Scholar]
  26. Osicka R, Osicková A, Basar T, Guermonprez P, Rojas M et al. Delivery of CD8(+) T-cell epitopes into major histocompatibility complex class I antigen presentation pathway by Bordetella pertussis adenylate cyclase: delineation of cell invasive structures and permissive insertion sites. Infect Immun 2000; 68:247–256 [View Article] [PubMed]
     [Google Scholar]
  27. Knuutila A, Rautanen C, Mertsola J, He Q. Multiplex point-of-care tests for the determination of antibodies after acellular pertussis vaccination. Diagnostics 2020; 10:187 [View Article]
     [Google Scholar]
  28. Barkoff AM, Knuutila A, Mertsola J, He Q. Evaluation of anti-PT antibody response after pertussis vaccination and infection: the importance of both quantity and quality. Toxins 2021; 13:508 [View Article]
     [Google Scholar]
  29. Juntunen E, Salminen T, Talha SM, Martiskainen I, Soukka T et al. Lateral flow immunoassay with upconverting nanoparticle-based detection for indirect measurement of interferon response by the level of MxA. J Med Virol 2017; 89:598–605 [View Article] [PubMed]
     [Google Scholar]
  30. Pelkkikangas A-M, Jaakohuhta S, Lövgren T, Härmä H. Simple, rapid, and sensitive thyroid-stimulating hormone immunoassay using europium(III) nanoparticle label. Analytica Chimica Acta 2004; 517:169–176 [View Article]
     [Google Scholar]
  31. Zackrisson G, Lagergård T, Trollfors B, Krantz I. Immunoglobulin A antibodies to pertussis toxin and filamentous hemagglutinin in saliva from patients with pertussis. J Clin Microbiol 1990; 28:1502–1505 [View Article] [PubMed]
     [Google Scholar]
  32. Granström G, Askelöf P, Granström M. Specific immunoglobulin A to Bordetella pertussis antigens in mucosal secretion for rapid diagnosis of whooping cough. J Clin Microbiol 1988; 26:869–874 [View Article] [PubMed]
     [Google Scholar]
  33. Berstad AKH, Holst J, Frøholm LO, Haugen IL, Wedege E et al. A nasal whole-cell pertussis vaccine induces specific systemic and cross-reactive mucosal antibody responses in human volunteers. J Med Microbiol 2000; 49:157–163 [View Article] [PubMed]
     [Google Scholar]
  34. Goodman YE, Wort AJ, Jackson FL. Enzyme-linked immunosorbent assay for detection of pertussis immunoglobulin A in nasopharyngeal secretions as an indicator of recent infection. J Clin Microbiol 1981; 13:286–292 [View Article] [PubMed]
     [Google Scholar]
  35. Cherry JD. Epidemiological, clinical, and laboratory aspects of pertussis in adults. Clin Infect Dis 1999; 28 Suppl 2:S112–7 [View Article]
     [Google Scholar]
  36. Thomas MG, Ashworth LA, Miller E, Lambert HP. Serum IgG, IgA, and IgM responses to pertussis toxin, filamentous hemagglutinin, and agglutinogens 2 and 3 after infection with Bordetella pertussis and immunization with whole-cell pertussis vaccine. J Infect Dis 1989; 160:838–845 [View Article]
     [Google Scholar]
  37. Prince HE, Lieberman JM, Cherry JD. Age-related differences in patterns of increased Bordetella pertussis antibodies. Clin Vaccine Immunol 2012; 19:545–550 [View Article]
     [Google Scholar]
  38. May ML, Doi SA, King D, Evans J, Robson JM. Prospective evaluation of an Australian pertussis toxin IgG and IgA enzyme immunoassay. Clin Vaccine Immunol 2012; 19:190–197 [View Article] [PubMed]
     [Google Scholar]
  39. McKie A, Vyse A, Maple C. Novel methods for the detection of microbial antibodies in oral fluid. Lancet Infect Dis 2002; 2:18–24 [View Article] [PubMed]
     [Google Scholar]
  40. Grimprel E, Bégué P, Anjak I, Njamkepo E, François P. Long-term human serum antibody responses after immunization with whole-cell pertussis vaccine in France. Clin Diagn Lab Immunol 1996; 3:93–97 [View Article]
     [Google Scholar]
  41. Watanabe M, Connelly B, Weiss AA. Characterization of serological responses to pertussis. Clin Vaccine Immunol 2006; 13:341–348 [View Article] [PubMed]
     [Google Scholar]
  42. Wu G, Zaman MH. Low-cost tools for diagnosing and monitoring HIV infection in low-resource settings. Bull World Health Organ 2012; 90:914–920 [View Article] [PubMed]
     [Google Scholar]
http://instance.metastore.ingenta.com/content/journal/jmm/10.1099/jmm.0.001668
Loading
Oral fluid-based lateral flow point-of-care assays for pertussis serology
J. Med. Microbiol. 72, 001668 (2023); https://doi.org/10.1099/jmm.0.001668
/content/journal/jmm/10.1099/jmm.0.001668
/content/journal/jmm/10.1099/jmm.0.001668
Loading

Data & Media loading...

Most cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error