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首页> 外文期刊>Sao Paulo Medical Journal >Development and validation of a whole-cell ELISA for serologically diagnosing Helicobacter pylori infection in Brazilian children and adults: a diagnostic accuracy study
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Development and validation of a whole-cell ELISA for serologically diagnosing Helicobacter pylori infection in Brazilian children and adults: a diagnostic accuracy study

机译：用于巴西儿童和成人的血清学诊断幽门螺杆菌感染的全细胞ELISA的开发和验证：诊断准确性研究

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ABSTRACT BACKGROUND: Serological tests are practical, with low cost, but no noninvasive tests are available for diagnosing Helicobacter pylori (H. pylori) infection in Brazil. The aim here was to develop and validate enzyme-linked immunosorbent assay (ELISA) serological tests to detect anti-H. pylori immunoglobulin G antibodies, based on cultured strains from Brazilian patients. DESIGN AND SETTING: Cross-sectional, diagnostic accuracy study comparing a locally developed and validated ELISA and invasive tests among dyspeptic patients at two public hospitals in S?o Paulo, Brazil. METHODS: An ELISA test was prepared using whole-cell antigen from 56 strains. After genotypic characterization, it was standardized and optical density (OD) cutoffs were determined based on the serum antibody response of 100 H. pylori-negative samples, compared with 82 H. pylori-positive samples. Validation was performed on 174 symptomatic patients. RESULTS: The optimal OD cutoffs established (for monoclonal and polyclonal tests, respectively) were 0.167 and 0.164; overall ELISA sensitivity: 84.3%, 78.9%; specificity: 88.6%, 90.6%; positive predictive value (PPV): 75.4%, 80%; negative predictive value (NPV): 93.1%, 81.8%; accuracy: 87.3%, 86.2%; child and adolescent ELISA sensitivity: 74.2%, 81.8%; specificity: 90.8%, 86.7%; PPV: 66.6%, 84.3%; NPV: 95.8%, 84.8%; accuracy: 88.5%, 84.6; adult ELISA sensitivity: 84.4%, 75%; specificity: 86.9%, 93%; PPV: 81.8%, 78.3%; NPV: 88.9%, 91.8%; accuracy: 85.9%, 88.5%. CONCLUSION: The polyclonal serological test developed using local strains presented better diagnostic performance among children and adolescents, while the monoclonal test was better among adults. The results from both tests suggest that these in-house serological tests could be used to detect anti-H. pylori antibodies in our population, for screening purposes.
机译：摘要背景：血清学检查很实用，成本很低，但是没有可用于诊断巴西幽门螺杆菌（H. pylori）感染的非侵入性检查方法。此处的目的是开发和验证酶联免疫吸附测定（ELISA）血清学测试以检测抗H抗体。幽门螺杆菌免疫球蛋白G抗体，基于巴西患者的培养菌株。设计与设置：横断面诊断准确性研究，比较了巴西圣保罗的两家公立医院消化不良患者的局部开发和验证的ELISA和侵入性检测。方法：采用56株全细胞抗原进行ELISA检测。基因型鉴定后，将其标准化，并根据100例幽门螺杆菌阴性样本与82例幽门螺杆菌阳性样本的血清抗体反应，确定光密度（OD）的临界值。对174例有症状的患者进行了验证。结果：确定的最佳OD截止值（分别用于单克隆和多克隆试验）为0.167和0.164; ELISA总灵敏度：84.3％，78.9％;特异性：88.6％，90.6％;阳性预测值（PPV）：75.4％，80％;阴性预测值（NPV）：93.1％，81.8％;准确度：87.3％，86.2％;儿童和青少年ELISA灵敏度：74.2％，81.8％;特异性：90.8％，86.7％; PPV：66.6％，84.3％;净现值：95.8％，84.8％;准确度：88.5％，84.6;成人ELISA灵敏度：84.4％，75％;特异性：86.9％，93％; PPV：81.8％，78.3％;净现值：88.9％，91.8％;准确度：85.9％，88.5％。结论：使用本地菌株开发的多克隆血清学检测在儿童和青少年中表现出更好的诊断性能，而单克隆检测在成人中表现更好。两种测试的结果表明，这些内部血清学测试可用于检测抗H。人群中的幽门螺杆菌抗体，用于筛选目的。

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