Granberg C, Mansikka A, Lehtonen O P, Kujari H, Grönfors R, Nurmi H, Räihä I, Ståhlberg M R, Leino R
Orion Corporation, Orion Diagnostica, Espoo, Finland.
J Clin Microbiol. 1993 Jun;31(6):1450-3. doi: 10.1128/jcm.31.6.1450-1453.1993.
We evaluated the performance of new enzyme immunoassay (EIA) kits (Pyloriset; Orion Corporation, Orion Diagnostica, Espoo, Finland) for the detection of immunoglobulin G (IgG) and IgA antibodies to Helicobacter pylori in serum. Serum samples from 195 patients with upper abdominal complaints were collected. Biopsy specimens of the gastric mucosae were taken for histological analysis and bacterial culture. The sensitivity, specificity, and positive and negative predictive values, and efficacy of the Pyloriset EIA-G in detecting IgG antibodies to H. pylori were 92, 84, 88, 90, and 89%, respectively, when compared with those of the reference methods used. The corresponding data for detection of IgA antibodies were 80, 89, 89, 79, and 84%, respectively. The overall prevalence of defined H. pylori positivity was 54%. Moreover, the antibody tests showed a very good correlation with the biopsy findings. IgG antibodies were found in 93% of sera from patients with documented gastritis and H. pylori positivity, whereas only 4% of the sera from patients with documented gastritis and H. pylori-negative patients was positive. The results obtained for IgA antibodies were 81 and 6%, respectively. We conclude that the Pyloriset EIA-G, the test for IgG antibodies, is a good and reliable test for the detection of antibodies to H. pylori and as an indication of H. pylori infection. The determination of IgA antibodies may be used as a test that complements the IgG antibody assay.
我们评估了新型酶免疫分析（EIA）试剂盒（Pyloriset；芬兰埃斯波奥里翁公司旗下的奥里翁诊断公司）检测血清中抗幽门螺杆菌免疫球蛋白G（IgG）和IgA抗体的性能。收集了195例有上腹部不适症状患者的血清样本。采集胃黏膜活检标本进行组织学分析和细菌培养。与所用参考方法相比，Pyloriset EIA - G检测抗幽门螺杆菌IgG抗体的敏感性、特异性、阳性和阴性预测值以及效能分别为92%、84%、88%、90%和89%。检测IgA抗体的相应数据分别为80%、89%、89%、79%和84%。明确的幽门螺杆菌阳性总体患病率为54%。此外，抗体检测结果与活检结果显示出非常好的相关性。在有胃炎记录且幽门螺杆菌阳性患者的血清中，93%检测到IgG抗体，而在有胃炎记录且幽门螺杆菌阴性患者的血清中，只有4%呈阳性。IgA抗体检测结果分别为81%和6%。我们得出结论，检测IgG抗体的Pyloriset EIA - G是一种检测抗幽门螺杆菌抗体以及作为幽门螺杆菌感染指标的良好且可靠的检测方法。IgA抗体的检测可作为补充IgG抗体检测的一项检测。
