Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings.

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...

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Autores principales: Evariste Tshibangu-Kabamba, Bui Hoang Phuc, Vo Phuoc Tuan, Kartika Afrida Fauzia, Augustin Kabongo-Tshibaka, Nadine Kalenda Kayiba, Angel Rosas-Aguirre, Brecht Devleesschauwer, Alain Cimuanga-Mukanya, Patrick de Jésus Ngoma Kisoko, Takashi Matsumoto, Junko Akada, Ghislain Tumba Disashi, Dieudonné Mumba Ngoyi, Yasutoshi Kido, Niko Speybroeck, Yoshio Yamaoka
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spelling oai:doaj.org-article:00bf71d771d0426eb23ee667b66a83f02021-12-02T20:24:09ZAssessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings.1935-27271935-273510.1371/journal.pntd.0009763https://doaj.org/article/00bf71d771d0426eb23ee667b66a83f02021-09-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0009763https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735Beside 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.Evariste Tshibangu-KabambaBui Hoang PhucVo Phuoc TuanKartika Afrida FauziaAugustin Kabongo-TshibakaNadine Kalenda KayibaAngel Rosas-AguirreBrecht DevleesschauwerAlain Cimuanga-MukanyaPatrick de Jésus Ngoma KisokoTakashi MatsumotoJunko AkadaGhislain Tumba DisashiDieudonné Mumba NgoyiYasutoshi KidoNiko SpeybroeckYoshio YamaokaPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 9, p e0009763 (2021)
institution DOAJ
collection DOAJ
language EN
topic Arctic medicine. Tropical medicine
RC955-962
Public aspects of medicine
RA1-1270
spellingShingle Arctic medicine. Tropical medicine
RC955-962
Public aspects of medicine
RA1-1270
Evariste Tshibangu-Kabamba
Bui Hoang Phuc
Vo Phuoc Tuan
Kartika Afrida Fauzia
Augustin Kabongo-Tshibaka
Nadine Kalenda Kayiba
Angel Rosas-Aguirre
Brecht Devleesschauwer
Alain Cimuanga-Mukanya
Patrick de Jésus Ngoma Kisoko
Takashi Matsumoto
Junko Akada
Ghislain Tumba Disashi
Dieudonné Mumba Ngoyi
Yasutoshi Kido
Niko Speybroeck
Yoshio Yamaoka
Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings.
description 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.
format article
author Evariste Tshibangu-Kabamba
Bui Hoang Phuc
Vo Phuoc Tuan
Kartika Afrida Fauzia
Augustin Kabongo-Tshibaka
Nadine Kalenda Kayiba
Angel Rosas-Aguirre
Brecht Devleesschauwer
Alain Cimuanga-Mukanya
Patrick de Jésus Ngoma Kisoko
Takashi Matsumoto
Junko Akada
Ghislain Tumba Disashi
Dieudonné Mumba Ngoyi
Yasutoshi Kido
Niko Speybroeck
Yoshio Yamaoka
author_facet Evariste Tshibangu-Kabamba
Bui Hoang Phuc
Vo Phuoc Tuan
Kartika Afrida Fauzia
Augustin Kabongo-Tshibaka
Nadine Kalenda Kayiba
Angel Rosas-Aguirre
Brecht Devleesschauwer
Alain Cimuanga-Mukanya
Patrick de Jésus Ngoma Kisoko
Takashi Matsumoto
Junko Akada
Ghislain Tumba Disashi
Dieudonné Mumba Ngoyi
Yasutoshi Kido
Niko Speybroeck
Yoshio Yamaoka
author_sort Evariste Tshibangu-Kabamba
title Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings.
title_short Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings.
title_full Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings.
title_fullStr Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings.
title_full_unstemmed Assessment of the diagnostic accuracy and relevance of a novel ELISA system developed for seroepidemiologic surveys of Helicobacter pylori infection in African settings.
title_sort assessment of the diagnostic accuracy and relevance of a novel elisa system developed for seroepidemiologic surveys of helicobacter pylori infection in african settings.
publisher Public Library of Science (PLoS)
publishDate 2021
url https://doaj.org/article/00bf71d771d0426eb23ee667b66a83f0
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