Goossens H, Glupczynski Y, Burette A, Van den Borre C, Butzler J P
World Health Organization Collaborating Centre for Enteric Campylobacter, St-Pieters University Hospital, Brussels, Belgium.
J Clin Microbiol. 1992 Jan;30(1):176-80. doi: 10.1128/jcm.30.1.176-180.1992.
We evaluated a commercially available second-generation anti-H. pylori immunoglobulin G enzyme immunoassay (EIA) (Cobas Core Anti-Helicobacter pylori EIA; Roche S. A., Basel, Switzerland) for serodiagnosis of H. pylori infection. The results of the assay were assessed in relation to the results of bacterial culture, urease testing, and histological Giemsa stain of gastric biopsy specimens from 1,134 patients with a variety of symptoms relating to the upper gastrointestinal tract. H. pylori was detected in biopsy specimens from 660 (58.2%) patients: 6 had a normal mucosa, 123 had chronic gastritis only, and 531 were found to have chronic active gastritis by histology; endoscopy showed duodenal and gastric ulcers in 137 and 64 patients of the last two groups, respectively. The test was evaluated with different age and ethnic groups. The prevalence, sensitivity, specificity, and positive and negative predictive values were, respectively, (i) for Belgian patients between 18 and 40 years old, 34, 93, 95, 91, and 96%; (ii) for Belgian patients more than 40 years old, 53, 96, 91, 93, and 95%; and (iii) the Mediterranean patients more than 17 years old, 87, 94, 70, 95, and 64%. All sera showing discordant immunoassay results compared with the results of histology and culture of biopsy specimens, as well as those with borderline immunoassay results, were tested further by immunoblotting. Among the EIA results considered false negative, we demonstrated an absence of seroconversion in 14 of 19 patients tested by immunoblotting. Among the EIA results considered false positive, immunoblotting showed the presence of specific antibodies in 28 of 37 patients tested. Among the borderline results obtained in the first assay with 22 patients' sera, a second assay showed positive results in 10 patients (8 were positive by immunoblotting) and negative reactions in 10 patients (9 were negative by immunoblotting), whereas 2 remained borderline. These data indicate that sera showing borderline immunoassay results must be tested again. In conclusion, this commercially available second-generation EIA, which is easy and quick to perform, was found highly reliable for the serodiagnosis of H. pylori infection.
我们评估了一种市售的第二代抗幽门螺杆菌免疫球蛋白G酶免疫测定法（EIA）（Cobas Core抗幽门螺杆菌EIA；罗氏公司，瑞士巴塞尔）用于幽门螺杆菌感染的血清学诊断。根据1134例有各种上消化道相关症状患者的胃活检标本的细菌培养、尿素酶检测及组织学吉姆萨染色结果，对该测定法的结果进行了评估。在660例（58.2%）患者的活检标本中检测到幽门螺杆菌：6例黏膜正常，123例仅患有慢性胃炎，531例经组织学检查发现患有慢性活动性胃炎；内镜检查显示，后两组中分别有137例和64例患者患有十二指肠溃疡和胃溃疡。该检测针对不同年龄和种族群体进行了评估。患病率、敏感性、特异性以及阳性和阴性预测值分别为：（i）18至40岁的比利时患者，分别为34%、93%、95%、91%和96%；（ii）40岁以上的比利时患者分别为53%、96%、91%、93%和95%；（iii）17岁以上的地中海患者分别为87%、94%、70%、95%和64%。所有免疫测定结果与活检标本的组织学和培养结果不一致的血清，以及免疫测定结果处于临界值的血清，均通过免疫印迹法进一步检测。在被认为是假阴性的EIA结果中，我们通过免疫印迹法检测的19例患者中有14例未出现血清转化。在被认为是假阳性的EIA结果中，免疫印迹法显示37例检测患者中有28例存在特异性抗体。在首次检测中，22例患者血清获得临界结果，第二次检测显示10例患者呈阳性结果（8例经免疫印迹法检测为阳性），10例患者呈阴性反应（9例经免疫印迹法检测为阴性），而2例仍为临界值。这些数据表明，免疫测定结果处于临界值的血清必须再次检测。总之，这种市售的第二代EIA操作简便快捷，被发现对幽门螺杆菌感染的血清学诊断高度可靠。
