Comparative Evaluation of 29 Commercial Helicobacter pylori Serological Kits
Comparative Evaluation of 29 Commercial Helicobacter pylori Serological Kits
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DOI：
10.1111/hel.12030
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发表时间：
2013-06-01
期刊：
影响因子：
4.4
通讯作者：
Fauchere, Jean-Louis
中科院分区：
文献类型：
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作者：
Burucoa, Christophe;Delchier, Jean-Charles;Fauchere, Jean-Louis
背景：血清学是一种无创性的幽门螺杆菌感染的诊断方法.现在市场上有许多商业试剂盒。有必要评估其性能，以帮助用户选择最合适的。材料和方法使用前瞻性选择的108例患者的血清，从五个法国医院中心的胃肠科29个商业血清学检测幽门螺杆菌抗体（17个酶联免疫吸附试验和12个近病人的测试）的性能进行了评价。根据金标准（培养或组织学加快速尿素酶试验或尿素呼气试验），这些患者被幽门螺杆菌感染（45）或未感染（47），或有可疑结果（16）。通过确定常规性能参数来评价检测：灵敏度、特异性、阳性预测值、阴性预测值和准确性。进行了两项分析，包括或不包括16例疑似感染的患者，作为未感染或未分析。结果根据分析类型的不同，17种酶联免疫吸附试验中有4种或2种表现出优异的结果，5个性能参数> 90%。Youden指数的计算允许显示4种中的一种的显著更好的性能。12个近患者测试的准确性较低
Background Serology is a noninvasive diagnostic method for the detection of Helicobacter pylori infection. Many commercial kits are now on the market. It is necessary to assess their performances to help the user to choose the most appropriate. Material and Methods The performances of 29 commercial serological tests detecting antibodies to Helicobacter pylori (17 enzyme-linked immunosorbent assay and 12 near-patient tests) were evaluated using sera from 108 patients prospectively selected from gastroenterology departments of five French hospital centers. These patients were infected (45) or uninfected (47) by H.pylori, or had doubtful results (16), according to the gold standard (culture or histology plus rapid urease test or urea breath test). The tests were evaluated by determining the usual parameters of performance: sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Two analyzes were performed including or not the 16 patients with doubtful infection as uninfected or not analyzed. Results Depending on the type of analysis, four or two of the 17 enzyme-linked immunosorbent assay tests presented excellent results with the five performance parameters >90%. Calculation of the Youden index allowed to show significantly better performances for one of the 4. Performances of the 12 near-patient tests were lower with accuracies