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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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) |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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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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