Midolo P D, Lambert J R, Russell E G, Lin S K
Gastroenterology Research Group, Mornington Peninsula Hospital, Melbourne, Victoria, Australia.
J Clin Pathol. 1995 Oct;48(10):969-71. doi: 10.1136/jcp.48.10.969.
Assessment of a single serum sample for Helicobacter pylori antibodies is frequently requested in routine diagnostic laboratories. Current enzyme linked immunosorbent assay (ELISA) kits are not ideal for testing small numbers of serum samples and some have low sensitivities, specificities or large grey zones. A panel of 90 serum samples from patients who had presented for routine upper endoscopy was used to compare three kits for the detection of H pylori antibodies: (1) Pyloriset Dry, total antibody latex agglutination, Orion Diagnostica, Espoo, Finland; (2) Pyloriset enzyme immunoassay (EIA), IgG ELISA, Orion; and (3) Hel-p, IgG ELISA, Amrad, Kew, Victoria, Australia. Diagnosis of H pylori positivity was made if culture results and either rapid urease test or histopathology were positive. The sensitivity, specificity, positive, and negative predictive value for each test was as follows: Orion: latex 93.3%, 95.6%, 95.5%, 93.3%, respectively; Orion: EIA-G 84.4%, 97.8%, 97.4%, 84.4%, respectively; and Amrad: EIA-G 100%, 88.9%, 90%, 100%, respectively. The latex test performed better than the EIAs with respect to sensitivity and specificity.
常规诊断实验室经常要求对单个血清样本进行幽门螺杆菌抗体检测。目前的酶联免疫吸附测定（ELISA）试剂盒并不适合检测少量血清样本，而且有些试剂盒的敏感性、特异性较低或存在较大的灰色区域。我们使用了一组来自接受常规上消化道内镜检查患者的90份血清样本，比较了三种检测幽门螺杆菌抗体的试剂盒：（1）Pyloriset Dry，总抗体乳胶凝集法，芬兰埃斯波的Orion Diagnostica公司生产；（2）Pyloriset酶免疫测定（EIA），IgG ELISA法，Orion公司生产；（3）Hel-p，IgG ELISA法，澳大利亚维多利亚州基尤的Amrad公司生产。如果培养结果以及快速尿素酶试验或组织病理学检查呈阳性，则诊断为幽门螺杆菌阳性。每种检测方法的敏感性、特异性、阳性预测值和阴性预测值如下：Orion公司的乳胶法分别为93.3%、95.6%、95.5%、93.3%；Orion公司的EIA-G法分别为84.4%、97.8%、97.4%、84.4%；Amrad公司的EIA-G法分别为100%、88.9%、90%、100%。在敏感性和特异性方面，乳胶试验比酶免疫测定法表现更好。
