Seroprevalence of IgG antibody positive and negative–responses in patients with uninvestigated dyspepsia, blood donor healthy individuals, and patients confirmed with viral and parasitic diseases using H. pylori autochthonous-ELISA in comparison with H. pylori reference-ELISA
Subjects
Serology result by ELISA n (%)
κ (95% CI)
H. pylori autochthonous
H. pylori reference
IgG+
IgG–
IgG+
IgG–
Patients with uninvestigated dyspepsia (n = 121)
92 (76.0)
29 (24.0)
93 (76.9)
28 (23.1)
0.93(0.81–1.01)
Healthy individuals (n = 227)
131 (57.7)
96 (42.3)
145 (63.9)
82 (36.1)
0.76(0.67–0.85)
Patients confirmed with viruses and parasites (n = 57)
We would like to acknowledge our technical assistants Tatiana Almaguer and Cecia Torres for their excellent technical support during the conduct of the study. The authors are grateful for the contribution of Mr. Mercedes Díaz and Mr. Ana Gloria Arteaga of the Polyclinic Eduardo Díaz Ortega endoscopy service for their demonstrative support during the study.
Author contributions
RC: Conceptualization, Investigation, Validation, Data curation, Writing—original draft. RF: Conceptualization, Methodology, Formal analysis, Writing—original draft, Writing—review & editing. SV: Methodology, Formal analysis, Supervision, Writing—review & editing. OF: Conceptualization, Formal analysis, Writing—review & editing. RM: Investigation, Validation, Writing—review & editing. AD and OG: Methodology, Formal analyses, Writing—review & editing. RL: Conceptualization, Methodology, Formal analysis, Writing—review & editing. All authors have read and agreed to the published version of the manuscript.
Conflicts of interest
The authors declare that they have no conflicts of interest.
Ethical approval
The project was approved from the Ethical Review Committee of the “Pedro Kourí” Institute of Tropical Medicine (IPK), Cuba.
Consent to participate
Informed consent was obtained from all participants and institutions involved in the study.
Consent to publication
Not applicable.
Availability of data and materials
The data presented in this study are available from the corresponding author upon reasonable request.
Fong IW. Helicobacter pylori Infection: When should it be treated?In: Current trends and concerns in infectious diseases. Cham: Springer; 2020. pp. 81–102. [DOI] [PubMed] [PMC]
Lee YC, Dore MP, Graham DY. Diagnosis and treatment of Helicobacter pylori infection.Annu Rev Med. 2022;73:183–95. [DOI] [PubMed] [PMC]
Tacconelli E, Carrara E, Savoldi A, Harbarth S, Mendelson M, Monnet DL, et al. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis.Lancet Infect Dis. 2018;18:318–27. [DOI] [PubMed]
Galbán E, Arús E, Periles U. Endoscopic findings and associated risk factors in primary health care settings in Havana, Cuba.MEDICC Rev. 2012;14:30–7. [DOI] [PubMed]
Chávez AR, Caballero RL, Núñez MB, Rizo JL, Corcho DV, de Paz ARA, et al. Infección por Helicobacter pylori en pacientes atendidos en el Hospital General Docente Iván Portuondo.Cuba Salud. 2014;8:26–32.
Zamani M, Ebrahimtabar F, Zamani V, Miller WH, Alizadeh-Navaei R, Shokri-Shirvani J, et al. Systematic review with meta-analysis: the worldwide prevalence of Helicobacter pylori infection.Aliment Pharmacol Ther. 2018;47:868–76. [DOI] [PubMed]
Curado MP, de Oliveira MM, de Araújo Fagundes M. Prevalence of Helicobacter pylori infection in Latin America and the Caribbean populations: a systematic review and meta-analysis.Cancer Epidemiol. 2019;60:141–8. [DOI] [PubMed]
Cardos AI, Maghiar A, Zaha DC, Pop O, Fritea L, Miere Groza F, et al. Evolution of diagnostic methods for Helicobacter pylori infections: from traditional tests to high technology, advanced sensitivity and discrimination tools.Diagnostics (Basel). 2022;12:508. [DOI] [PubMed] [PMC]
Liu WZ, Xie Y, Lu H, Cheng H, Zeng ZR, Zhou LY, et al.; Chinese Society of Gastroenterology; Chinese Study Group on Helicobacter pylori and Peptic Ulcer. Fifth Chinese National Consensus Report on the management of Helicobacter pylori infection.Helicobacter. 2018;23:e12475. [DOI] [PubMed]
Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, et al.; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report.Gut. 2022;gutjnl–2022–327745. [DOI] [PubMed]
Dore MP, Pes GM. What is new in Helicobacter pylori diagnosis. An overview.J Clin Med. 2021;10:2091. [DOI] [PubMed] [PMC]
Gisbert JP. Critical review of diagnostic methods of Helicobacter pylori infection.Gastroenterol Hepatol. 2000;23:135–43. Spanish.
Pandya HB, Patel JS, Agravat HH, Singh NK. Non-invasive diagnosis of Helicobacter pylori: evaluation of two enzyme immunoassays, testing serum IgG and IgA Response in the Anand district of Central Gujarat,India.J Clin Diagn Res. 2014;8:DC12–5. [DOI] [PubMed] [PMC]
Yu JH, Zhao Y, Wang XF, Xu YC. Evaluation of anti-Helicobacter pylori IgG antibodies for the detection of Helicobacter pylori infection in different populations.Diagnostics (Basel). 2022;12:1214. [DOI] [PubMed] [PMC]
Mahato M. Detection of H. pylori IgG by using ELISA.J Pharm Res Int. 2020;32:102–6.
Bosch DE, Krumm N, Wener MH, Yeh MM, Truong CD, Reddi DM, et al. Serology is more sensitive than urea breath test or stool antigen for the initial diagnosis of Helicobacter pylori gastritis when compared with histopathology.Am J Clin Pathol. 2020;154:255–65. [DOI] [PubMed]
Tuut MK, Burgers JS, van der Weijden T, Langendam MW. Do clinical practice guidelines consider evidence about diagnostic test consequences on patient-relevant outcomes? A critical document analysis.J Eval Clin Pract. 2022;28:278–87. [DOI] [PubMed] [PMC]
Hoang TT, Wheeldon TU, Bengtsson C, Phung DC, Sörberg M, Granström M. Enzyme-linked immunosorbent assay for Helicobacter pylori needs adjustment for the population investigated.J Clin Microbiol. 2004;42:627–30. [DOI] [PubMed] [PMC]
Mohammadi M, Talebkhan Y, Khalili G, Mahboudi F, Massarrat S, Zamaninia L, et al. Advantage of using a home-made ELISA kit for detection of Helicobacter pylori infection over commercially imported kits.Indian J Med Microbiol. 2008;26:127–31. [DOI] [PubMed]
Mathes T, Pieper D. An algorithm for the classification of study designs to assess diagnostic, prognostic and predictive test accuracy in systematic reviews.Syst Rev. 2019;8:226. [DOI] [PubMed] [PMC]
Feliciano-Sarmiento O, Fleitas-Martínez O, Falcón-Márquez R, Almaguer-Rodríguez T, Torres-Rodríguez C, Silega-Coma G, et al. Metodología para la obtención y evaluación de un extracto proteínico de una cepa autóctona de Helicobacter pylori.VacciMonitor. 2018;27:102–9. Spanish.
Duquesne A. Helicobacter pylori: dos sistemas serológicos para su diagnóstico en pacientes con síntomas digestivos. Policlínico 19 de Abril [dissertation]. Havana: University of Havana; 2015. Spanish.
Corrales R. Ensayo inmunoenzimático para la detección de anticuerpos IgG contra Helicobacter pylori [dissertation]. Havana: University of Havana; 2016. Spanish.
Feliciano O, Falcon R, Duquesne A, Fleitas O, Almaguer T, Gutierrez O, et al. Helicobacter pylori antigen recognition patterns among cuban patients using Helicoblot 2.1 diagnostic system.Trop Gastroenterol. 2019;40:93–8.
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies.Int J Surg. 2014;12:1495–9. [DOI] [PubMed]
Feliciano O, Gutierrez O, Valdés L, Fragoso T, Calderin AM, Valdes AE, et al. Prevalence of Helicobacter pylori vacA, cagA, and iceA genotypes in Cuban patients with upper gastrointestinal diseases.Biomed Res Int. 2015;2015:753710. [DOI] [PubMed] [PMC]
McNicholl AG, Ducons J, Barrio J, Bujanda L, Forné-Bardera M, Aparcero R, et al. Accuracy of the Ultra-Rapid Urease Test for diagnosis of Helicobacter pylori infection.Gastroenterol Hepatol. 2017;40:651–7. [DOI] [PubMed]
Negash M, Kassu A, Amare B, Yismaw G, Moges B. Evaluation of SD BIOLINE H. pylori Ag rapid test against double ELISA with SD H. pylori Ag ELISA and EZ-STEP H. pylori Ag ELISA tests.BMC Clin Pathol. 2018;18:4. [DOI] [PubMed] [PMC]
Casagrande A, Fabris F, Girometti R. Beyond kappa: an informational index for diagnostic agreement in dichotomous and multivalue ordered-categorical ratings.Med Biol Eng Comput. 2020;58:3089–99. [DOI] [PubMed] [PMC]
Ailloud F, Didelot X, Woltemate S, Pfaffinger G, Overmann J, Bader RC, et al. Within-host evolution of Helicobacter pylori shaped by niche-specific adaptation, intragastric migrations and selective sweeps.Nat Commun. 2019;10:2273. [DOI] [PubMed] [PMC]
Duquesne A, Falcón R, Galindo B, Feliciano O, Gutiérrez O, Baldoquín W, et al. Diagnostic testing accuracy for Helicobacter pylori infection among adult patients with dyspepsia in Cuba’s primary care setting.Microorganisms. 2023;11:997. [DOI] [PubMed] [PMC]
Seo JH, Jun JS, Youn HS, Yeom JS, Park JS, Park CH, et al. Development of an ELISA for quantitative detection of immunoglobulin G (IgG) and IgA antibodies to Helicobacter pylori for use in Korean patients with H. pylori-associated diseases.Gut liver. 2013;7:437–42. [DOI] [PubMed] [PMC]
Aziz F, Sherwani SK, Akhtar SS, Kazmi SU. Development of an in-house enzyme-linked immunosorbent assay based on surface whole cell antigen for diagnosis of Helicobacter pylori infection in patients with gastroduodenal ulcer disease.World J Microbiol Biotechnol. 2014;30:305–15. [DOI] [PubMed]
Tshibangu-Kabamba E, Phuc BH, Tuan VP, Fauzia KA, Kabongo-Tshibaka A, Kayiba NK, et al. Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings.PLoS Negl Trop Dis. 2021;15:e0009763. [DOI] [PubMed] [PMC]
Ogata SK, Camorlinga-Ponce M, Granato CFH, Rohr MRDS, Artigiani Neto R, Kawakami E. Development and validation of a whole-cell ELISA for serologically diagnosing Helicobacter pylori infection in Brazilian children and adults: a diagnostic accuracy study.Sao Paulo Med J. 2018;136:442–8. [DOI] [PubMed] [PMC]
