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.

中文翻译：

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评估为非洲幽门螺杆菌感染血清流行病学调查而开发的新型 ELISA 系统的诊断准确性和相关性。


除了由于缺乏完美的幽门螺杆菌感染金标准测试而导致的诊断不确定性之外，这种感染的诊断和患病率估计在非洲遇到了特殊的挑战，包括有限的诊断工具和特定的遗传背景。我们开发并评估了专为非洲幽门螺杆菌遗传学定制的酶联免疫吸附测定 (ELISA) 系统 (HpAfr-ELISA) 的准确性。属于感染非洲人的主要遗传群体的菌株被用作全细胞抗原的来源，以建立内部 ELISA 系统。一项无与伦比的 II 期病例对照研究探讨了 HpAfr-ELISA 的诊断准确性，该研究使用从刚果民主共和国 (DRC) 金沙萨的消化不良患者收集的一组训练样本，这些患者经过侵入性标准测试（即组织学检测） 、培养和快速尿素酶测试）于 2017 年进行。然后，通过一项基于社区的调查对 2018 年刚果民主共和国姆布吉马伊 425 名成人的幽门螺杆菌流行率和相关因素进行了交叉验证。使用贝叶斯推理来处理研究人群中估计值（真实患病率、敏感性和特异性）存在统计不确定性。在其最佳截止值 20.2 U/mL 下，该检测的估计灵敏度为 97.6%（95% 可信区间 [95%CrI]：89.2；99.9%），特异性为 90.5%（95%CrI：78.6；99.9%）。 98.5）。重复测试获得的一致结果证明了测定的稳健性（阴性和阳性一致性始终> 70%）。幽门螺杆菌的真实患病率估计为 53.8% [95%CrI: 42.8； 62.7%]。年龄增加（调整后优势比 [aOR] > 1.0 [95% 置信区间 (CI)：> 1.0; 1.1]；p<0.001），家庭过度拥挤（aOR = 3.2 [95%CI：2.0；5.1]；p<0 。001) 和非最佳手部卫生 (aOR = 4.5 [95%CI: 2.0; 11.4]; p = 0.001) 与幽门螺杆菌血清阳性独立相关。新型 ELISA 系统已表现出良好的诊断准确性以及对非洲幽门螺杆菌感染管理和缓解策略的潜在有用性。