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This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication: https://creativecommons.org/publicdomain/zero/1.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Beside diagnostic uncertainties due to the lack of a perfect gold standard test for Helicobacter pylori infection, the diagnosis and the prevalence estimation for this infection encounter particular challenges in Africa including limited diagnostic tools and specific genetic background. We developed and evaluated the accuracy of an enzyme-linked immunosorbent assay (ELISA) system tailored for H. pylori genetics in Africa (HpAfr-ELISA). Strains belonging to main genetic populations infecting Africans were exploited as sources for whole-cell antigens to establish in-house the ELISA system. A phase II unmatched case-control study explored the diagnostic accuracy of the HpAfr-ELISA using a training set of samples collected from dyspeptic patients from Kinshasa, the Democratic Republic of Congo (DRC) who had been tested with invasive standard tests (i.e., histology, culture, and rapid urease test) in 2017. Then the assay was cross-validated through a community-based survey assessing the prevalence of H. pylori and associated factors in 425 adults from Mbujimayi, DRC in 2018. Bayesian inferences were used to deal with statistical uncertainties of estimates (true prevalence, sensitivity, and specificity) in the study population. At its optimal cut-off-value 20.2 U/mL, the assay achieved an estimated sensitivity of 97.6% (95% credible interval [95%CrI]: 89.2; 99.9%) and specificity of 90.5% (95%CrI: 78.6; 98.5). Consistent outcomes obtained at repeated tests attested the robustness of the assay (negative and positive agreements always > 70%). The true prevalence of H. pylori was estimated 53.8% [95%CrI: 42.8; 62.7%]. Increasing age (adjusted odds ratio [aOR] > 1.0 [95% confidence interval (CI): > 1.0; 1.1]; p<0.001), overcrowding households (aOR = 3.2 [95%CI: 2.0; 5.1]; p<0.001), and non-optimal hand hygiene (aOR = 4.5 [95%CI: 2.0; 11.4]; p = 0.001) were independently associated with the H. pylori-seropositivity. The novel ELISA system has demonstrated good diagnostic accuracy and potential usefulness for management and mitigation strategies for H. pylori infection in African settings.

Details

Title
Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings
Author
Tshibangu-Kabamba, Evariste  VIAFID ORCID Logo  ; Bui, Hoang Phuc  VIAFID ORCID Logo  ; Vo, Phuoc Tuan  VIAFID ORCID Logo  ; Kartika Afrida Fauzia  VIAFID ORCID Logo  ; Kabongo-Tshibaka, Augustin  VIAFID ORCID Logo  ; Nadine Kalenda Kayiba  VIAFID ORCID Logo  ; Rosas-Aguirre, Angel  VIAFID ORCID Logo  ; Brecht Devleesschauwer  VIAFID ORCID Logo  ; Cimuanga-Mukanya, Alain  VIAFID ORCID Logo  ; Patrick de Jésus Ngoma Kisoko  VIAFID ORCID Logo  ; Matsumoto, Takashi; Akada, Junko; Disashi, Ghislain Tumba; Dieudonné Mumba Ngoyi  VIAFID ORCID Logo  ; Kido, Yasutoshi  VIAFID ORCID Logo  ; Speybroeck, Niko  VIAFID ORCID Logo  ; Yamaoka, Yoshio  VIAFID ORCID Logo 
First page
e0009763
Section
Research Article
Publication year
2021
Publication date
Sep 2021
Publisher
Public Library of Science
ISSN
19352727
e-ISSN
19352735
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2582584918
Copyright
This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication: https://creativecommons.org/publicdomain/zero/1.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.