中文摘要：

目的建立和评价一种检测血清幽门螺杆菌（HP）尿素酶B（ureB）抗原的免疫放射分析（IRMA）法。方法以50例行胃镜检查的慢性胃病患者为研究对象，其中胃十二指肠球部溃疡36例，慢性胃炎9例，胃癌5例。利用基因体外重组技术制备ureB，用杂交瘤技术制备抗ureB单克隆抗体，建立检测HPureB的IRMA法。以IRMA法检测50例患者血清ureB抗原，并与快速尿素酶试验（RUT）、聚合酶链反应（PCR）及测血清抗体（直接ELISA）法比较，所有检测法均以所取胃黏膜活组织的HP培养作为“金标准”。结果检测HPureB血清抗原的IRMA法灵敏度为94．6％，特异性为76．9％，阳性预测值为92．1％，阴性预测值为83．3％；RUT法灵敏度为94．6％，特异性为23．1％；PCR法灵敏度为66．8％，特异性为84．6％；测血清抗体法灵敏度为86．5％，特异性为38．5％。IRMA法联合测血清抗体法与“金标准”法差别无统计学意义（χ^2=1．165，P〉0．05），而与RUT、PCR法差别具有统计学意义（χ^2=5．333和9．436，P均〈0．05）。结论IRMA法检测HPureB抗原是诊断HP感染的一种灵敏、特异的新方法，在胃部疾病及其他有关疾病的病因与发病机制研究中具有重要意义。

英文摘要：

Objective The aim of this study was to establish and evaluate a novel immunoradiometric assay （IRMA） for detecting helicobacter pylori （HP） urease B （ureB） in serum. Methods HP ureB was prepared by the DNA recombinant technique. Monoclonal antibodies against HP ureB were produced by hybridoma technique and were used to establish IRMA for detecting HP ureB. Fifty patients with chronic gastric diseases were recruited in this study, including 36 with gastric ulcer disease, 9 with chronic gastritis and 5 with gastric cancer. The IRMA was compared with rapid urease test （RUT） , polymerase chain reaction （PCR） test and direct-ELISA test of serum anti-ureB antibody, using HP culture from gastric biopsy samples as a ＂ golden standard＂. Results The sensitivity and specificity of IRMA for HP ureB were 94. 6% and 76.9% , respectively, with positive and negative predictive values being 92.1% and 83.3%. The sensitivity and specificity of RUT, PCR and serum anti-ureB antibody test were 94.6% and 23.1% , 66.8% and 84.6% , 86.5% and 38.5% , respectively. IRMA and the test of serum anti-ureB antibody was not significantly different from the ＂golden standard＂ （χ^2 = 1. 165, P 〉 0.05 ） , but RUT and PCR showed statistically significant difference with the ＂gold standard＂ （χ^2 = 5. 333, 9. 436 ; all P 〈 0.05 ）. Conclusion IRMA for HP ureB antigen is a sensitive and specific method for detection of HP infection, and can be used in the study of etiology and pathogenesis of gastric and some other related diseases.