Diagnostic accuracy of the E-plate serum antibody test kit in detecting Helicobacter pylori infection among Japanese children.
Diagnostic accuracy of the E-plate serum antibody test kit in detecting Helicobacter pylori infection among Japanese children.
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DOI：
10.2188/jea.je20130078
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发表时间：
2014
影响因子：
4.7
通讯作者：
Kikuchi S
中科院分区：
文献类型：
--
作者：
Ueda J;Okuda M;Nishiyama T;Lin Y;Fukuda Y;Kikuchi S
许多非侵入性诊断试验可用于检测幽门螺杆菌感染。然而，缺乏儿童血清学检测的数据，因此仍不清楚成人使用的血清学分界点是否适合儿童。血清和粪便样本取自1993年3月至2009年12月间在日本5家医院就诊的73名儿童。粪便标本分析采用幽门螺杆菌粪便抗原酶联免疫吸附试验(HPSA-ELISA)，血清抗幽门螺杆菌抗体检测采用抗体检测试剂盒(E-PlatelEiken H Pylori抗体)。根据其敏感度、特异度和受试者工作特征曲线评价血清学试验的有效性。在这项研究的73名儿童中，34名HPSA阳性，39名阴性。34例HPSA阳性患者中，32例为免疫球蛋白阳性，2例为阴性。39例HPSA阴性患者中，38例为阴性，1例为阳性。以成人推荐的10U/ml为界值，检测抗体的敏感度、特异度和阳性似然比分别为91.2%、97.4%和35.6%。在儿童中，以7~9U/ml为界值时，敏感度、特异度和阳性似然比均为最佳。E平板抗幽门螺杆菌抗体检测结果与粪便抗原检测结果相当，适用于大样本中幽门螺杆菌感染的流行病学研究。
A number of noninvasive diagnostic tests are available to detect Helicobacter pylori infection. Data on serologic testing of children are lacking, however, and thus it remains unclear whether the serology cutoff points used for adults are appropriate for children. Serum and stool samples were obtained from 73 children who visited 5 hospitals in Japan between March 1993 and December 2009. Analysis of stool samples was carried out using an H pylori stool antigen enzyme-linked immunosorbent assay (HpSA ELISA), and serum antibodies to H pylori were examined using an antibody determination kit (E-Plate Eiken H pylori antibody). The validity of the serologic test was evaluated based on its sensitivity, specificity, and receiver operating characteristics curve. Of the 73 children included in this study, 34 were HpSA-positive and 39 were negative. Among the 34 HpSA-positive patients, 32 were IgG-positive and 2 were IgG-negative. Of the 39 patients who were HpSA-negative, 38 were IgG-negative and 1 was IgG-positive. The sensitivity, specificity, and positive likelihood ratio for IgG antibody testing were 91.2%, 97.4%, and 35.6, respectively, based on the recommended adult cutoff point of 10 U/ml. Among children, use of cutoff points in the range of 7 to 9 U/ml yielded optimal values for sensitivity and specificity, as well as a positive likelihood ratio. The performance of the E-plate anti-H pylori IgG antibody test was comparable to that of the stool antigen test and is therefore suitable for epidemiologic studies of H pylori infection in large samples.