抗幽门螺杆菌尿素酶抗体商品化诊断试剂盒的研制与临床应用  

RESEARCH AND CLINICAL APPLICATION OF COMMERCIAL KIT FOR DETECTION OF ANTIUREASE ANTIBODIES OF HELJCOBACTER PYLORI IN SERUM.

作　　者：杨昭徐[1] 陈晶晶[1] 梁丕霞[1] 蒋秀高 孟雅君[1] 张建中 陈杰[1] 侯曼岑[1] 

机构地区：[1]首都医科大学附属北京天坛医院,中国预防医学科学院流行病学微生物学研究所

出　　处：《中华消化杂志》1995年第S1期47-49,共3页Chinese Journal of Digestion

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。A 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.

关 键 词：幽门螺杆菌 酶联免疫吸附试验 商品化诊断试剂盒 

分 类 号：R94[医药卫生—药剂学]