摘要经创新技术提取、纯化制备幽门螺杆菌（HP）特异性尿素酶抗原，经免疫印渍法分析证实该抗原保持了极好的抗原性。首次在国内成功地研制了商品化、标准化诊断试剂盒，用于ELISA法血清抗HP尿素酶抗体检测（IgG）。经已知的阳性标本与阴性标本检验，符合率100%。1675例病例检测，与胃镜活检取材的细菌培养、组织染色方法对照，敏感性98%、特异性96%，阳性预测值98%，阴性预测值96%。本试剂盒可广泛用于临床，作为HP感染的诊断、疗效判定及流行病学研究的重要指标。

abstractsA commercial ELISA kit for detection of serum IgG against urease of HP was developed. 1675 patients with upper gastrointestinal disease were tested and the results were compared with those of culture and histologic investigation. The ELISA test had a sensitivity of 98%, a specificity of 76%, positive predictive value and a negative predictive value of 96%. Intra-assay variability was 3.1% and inter-assay variability 4.2%. It is cheaper and easier to perform. Also the result would not be influenced by recent ingestion of bismuth compounds or antimicrobial therapy. This serological testing is preferred method for follow up after trestment for HP infection and will probably replace endoscopy or the urea breath test.