摘要
目的 :将研制的单克隆抗体便潜血一步法胶体金检测试纸与已获国家新药证书的万华普曼公司产品进行临床对比实验。方法采集的 10 15例便潜血标本经临床验证比较两种试纸的特异性、灵敏度及阴性、阳性符合率等检测指标。结果两者的对比实验阴性、阳性符合率较高 ,分别达 93.9%和 92 .7%。本产品灵敏度可高达 0 .1μg/ml,优于万华的 0 .2 μg/ml。结论 :研制的单克隆抗体便潜血一步法胶体金检测试纸适用于检测人体粪便中可能出现的微量人血红蛋白 ,对诊断因各种原因引起的上下消化道出血疾病有重要的临床意义。
Objective:To compare monoclonal antibody strips for fecal occult blood colloid gold test developed by us with the product manufactured by Wanhuapuman Corp.which has obtained National New Drug certificate through clinic trial.Methods:Total 1015 samples were collected and objected to the tests for specify and sensitivity.Results:The accordance was 93.9%(negative) and 2.7%(positive),with the sensitivity of 0.1ug/ml for our products,which was higher than the sensitivity of 0.2 ug/ml for strips of Wanhuapuman Corp.Conclusion:Our products are suitable to detect hemoglobin in the stool.
出处
《实用临床医学（江西）》
CAS
2004年第2期10-11,共2页
Practical Clinical Medicine
关键词
单克隆抗体
便潜血
胶体金
特异性
灵敏度
monoclonal antibody
fecal occult blood
colloid gold
specify
sensitivity
