甲胎蛋白胶体金诊断试剂临床应用研究  

Study on the clinical use of alpha-fetoprotein (AFP) colloidal gold diagnostic strip

作　　者：蒋先敏[1] 孔健[1] 林涛[1] 于秀英[2] 陈颖[2] 戴雨[3] 杨航燕[3] 孙晓丽[3] 杨剑[4] 杨永泉[4] 张艳春[4] 

机构地区：[1]卫生部北京生物制品研究所免疫诊断研究室,100024 [2]青岛大学医学院附属医院 [3]空军总医院 [4]中国医学科学院肿瘤医院

出　　处：《中华流行病学杂志》2003年第3期210-212,共3页Chinese Journal of Epidemiology

基　　金：卫生部科学研究基金资助项目 ( 98 2 0 48)

摘　　要：目的　用甲胎蛋白 放射免疫测定 (AFP RIA)试剂盒作对照 ,测定AFP胶体金诊断试剂的灵敏度及特异度。方法　双盲法对 42 6份正常人血清、15 67份临床门诊病人血清标本进行检测 ,以AFP RIA定量测定试剂为判断标准 ,对卫生部北京生物制品研究所研制的AFP胶体金诊断试剂进行客观的临床考核。结果　AFP胶体金诊断试剂在测定正常人血清标本时的假阳性率为1.88% ( 8 42 6) ;该试剂在测定临床病人血清标本时的灵敏度达到 99.3 % ( 2 72 2 74)、特异度为 97.2 %( 12 5 7 12 93 ) ,与AFP RIA诊断结果的符合率为 97.6%。结论　AFP胶体金诊断试剂在灵敏度和特异度上均可以和AFP RIA试剂相媲美 ,可以替代AFP RIA试剂 。Objective To test the sensitivity and specificity of alpha-fetoprotein (AFP) colloidal gold diagnostic strip as compared with RIA-AFP diagnostic kit. Methods Double blind method was used to test sera from 426 healthy people and 1 567 patients selected in two general hospitals and a cancer hospital. Each serum was measured by RIA-AFP and AFP colloidal gold diagnostic strip on the same day. RIA-AFP diagnostic results was identified as true positive or negative. Results Among 426 healthy people, all the RIA-AFP test showed negative result (serum AFP concentration less than 25 IU/ml), but the AFP colloidal gold diagnostic strip had 1.88% false positive. When comparing the result from 1 567 patients measured by RIA-AFP, the sensitivity and specificity of AFP colloidal gold diagnostic strip were 99.3%, and 97.2%, respectively. The crude correspondence rate between the two diagnostic regents was 97.6%. Conclusion AFP colloidal gold diagnostic strip showed very good result and could be used as a screening diagnostic kit in clinic and hospital settings.

关 键 词：原发性肝癌 甲胎蛋白 胶体金诊断试剂 临床应用 

分 类 号：R446.6[医药卫生—诊断学]