Accuracy of Diagnostic Tests for Helicobacter pylori: A Reappraisal
Accuracy of Diagnostic Tests for Helicobacter pylori: A Reappraisal
复制标题
DOI：
10.1086/598198
复制
发表时间：
2009-05-15
影响因子：
11.8
通讯作者：
Segura, Ferran
中科院分区：
文献类型：
--
作者：
Calvet, Xavier;Sanchez-Delgado, Jordi;Segura, Ferran
背景尽管有许多变化，但在过去的10年里，还没有对幽门螺杆菌的不同诊断测试进行比较的大型研究。在这段时间里，出现了单克隆粪便抗原免疫测定和诊所C-13-尿素呼气试验（UBT）。本研究的目的是评估在一个大系列的消化不良患者的侵入性和非侵入性测试的准确性。共有199例消化不良患者既往未接受过H。pylori感染的患者。非侵入性分析包括基于红外线的UBT和市售粪便检测。基于活检的测试包括组织学检查和快速尿素酶试验。当至少2个检测结果为阳性时，患者被认为是感染。计算灵敏度、特异性、阳性和阴性预测值以及95%置信区间。使用McNemar检验比较测试结果。快速尿素酶试验、组织病理学检查和粪便试验的阳性试验结果率相似（54%）。相比之下，75%的UBT结果为阳性，UBT的特异性非常低（60%）。因此，UBT的Δ临界值重新计算为8.5%。快速尿素酶试验的敏感性和特异性分别为95%和100%;组织病理学检查的敏感性和特异性分别为94%和99%;粪便试验的敏感性和特异性分别为90%和93%; UBT的敏感性和特异性分别为90%和90%。组织学检查和快速尿素酶试验显示了极好的诊断可靠性。粪便检查似乎是一个很好的，非侵入性的替代内镜为基础的测试。相比之下，在我们的研究中评估的基于红外的UBT显示出低于预期的性能，当重新计算测试的截止值时，这被部分纠正。
Background. Despite many changes, no large studies comparing the different diagnostic tests for Helicobacter pylori have been performed in the past 10 years. In this time, monoclonal stool antigen immunoassays and in-office C-13-urea breath tests (UBTs) have appeared. The aim of this study was to evaluate the accuracy of invasive and noninvasive tests in a large series of dyspeptic patients.Methods. A total of 199 dyspeptic patients who had not previously been treated for H. pylori infection were prospectively enrolled. Noninvasive analyses included a commercial infrared-based UBT and a commercially available stool test. Biopsy-based tests included histological examination and a rapid urease test. A patient was considered to be infected when at least 2 test results were positive. Sensitivity, specificity, positive and negative predictive values, and 95% confidence intervals were calculated. The test results were compared using the McNemar test.Results. Rates of positive test results were similar (54%) for the rapid urease test, histopathological examination, and the stool test. By contrast, 75% of UBT results were positive, and the UBT was associated with a very low specificity (60%). For this reason, the delta cutoff value for the UBT was recalculated as 8.5%. Sensitivities and specificities with this new cutoff value were 95% and 100%, respectively, for the rapid urease test; 94% and 99%, respectively, for histopathological examination; 90% and 93%, respectively, for the stool test; and 90% and 90%, respectively, for the UBT.Conclusions. Histological examination and rapid urease testing showed excellent diagnostic reliability. The stool test seems to be a good, noninvasive alternative to endoscopy-based tests. By contrast, the infrared-based UBT evaluated in our study showed a lower than expected performance, which was partially corrected when the cutoff value for the test was recalculated.