Chey W D, Murthy U, Shaw S, Zawadski A, Montague J, Linscheer W, Laine L
Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor 48109, USA.
Am J Gastroenterol. 1999 Jun;94(6):1512-6. doi: 10.1111/j.1572-0241.1999.1135_x.x.
We compared three whole blood antibody tests for Helicobacter pylori (H. pylori) in a United States, multicenter trial.
Patients referred for EGD at three medical centers were recruited. During EGD, biopsies were taken for histology and rapid urease testing (RUT). Immediately after endoscopy, patients underwent the antibody tests (FlexPack HP, Abbott Diagnostics; QuikVue, Quidel Corporation; AccuMeter, ChemTrak) using whole blood obtained by two to three fingersticks. Performance characteristics were calculated for each antibody test using the biopsy-based methods as a gold standard.
A total of 131 patients participated; 50 (38%) patients had histological evidence of H. pylori infection. Using histology as a gold standard, the sensitivities of FlexPack HP, QuikVue, and Accumeter were 76%, 78%, and 84%, respectively. Specificity was 79% with FlexPack HP and 90% with QuikVue and Accumeter. There were no significant differences in the performance of the three antibody tests though there was a trend toward superior performance for AccuMeter compared to FlexPack HP (p = 0.019). However, RUT proved superior to FlexPack HP using histology as a gold standard (p = 0.008). Using either concordant histology and RUT results or a positive histology or RUT to define active H. pylori infection, there was no statistically significant difference between the antibody tests.
There were no statistically significant differences in the performance of the three antibody tests. These tests proved only marginally sensitive in detecting patients infected with H. pylori. Clinicians should be aware of the limitations of these tests, particularly when using them as a sole means of testing for H. pylori.
在美国的一项多中心试验中，我们比较了三种用于检测幽门螺杆菌（H. pylori）的全血抗体检测方法。
招募了在三个医疗中心接受内镜逆行胰胆管造影（EGD）检查的患者。在进行EGD检查期间，采集活检组织用于组织学检查和快速尿素酶试验（RUT）。内镜检查结束后，立即使用通过两到三次手指采血获得的全血对患者进行抗体检测（FlexPack HP，雅培诊断公司；QuikVue，Quidel公司；AccuMeter，ChemTrak）。以基于活检的方法作为金标准，计算每种抗体检测方法的性能特征。
共有131名患者参与；50名（38%）患者有幽门螺杆菌感染的组织学证据。以组织学作为金标准，FlexPack HP、QuikVue和AccuMeter的敏感性分别为76%、78%和84%。FlexPack HP的特异性为79%，QuikVue和AccuMeter的特异性为90%。三种抗体检测方法的性能没有显著差异，尽管与FlexPack HP相比，AccuMeter有表现更优的趋势（p = 0.019）。然而，以组织学作为金标准时，RUT被证明优于FlexPack HP（p = 0.008）。使用组织学和RUT结果一致或组织学或RUT阳性来定义活动性幽门螺杆菌感染时，抗体检测方法之间没有统计学上的显著差异。
三种抗体检测方法的性能没有统计学上的显著差异。这些检测方法在检测幽门螺杆菌感染患者方面仅具有微弱的敏感性。临床医生应意识到这些检测方法的局限性，尤其是在将其作为检测幽门螺杆菌的唯一手段时。
