| 蒋先敏,孔健,林涛,于秀英,陈颖,戴雨,杨航燕,孙晓丽,杨剑,杨永泉,张艳春.甲胎蛋白胶体金诊断试剂临床应用研究[J].Chinese journal of Epidemiology,2003,24(3):210-212 |
| 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 |
| Received:June 20, 2002 |
| DOI： |
| KeyWord: 胶体金试验 甲胎蛋白 临床研究 |
| English Key Word: Colloidal gold test Alpha-fetoprotein Clinical study |
| FundProject:卫生部科学研究基金资助项目(982048) |
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| Abstract: |
| 目的用甲胎蛋白放射免疫测定(AFPRIA)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426份正常人血清、1567份临床门诊病人血清标本进行检测,以AFPRIA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%(8426);该试剂在测定临床病人血清标本时的灵敏度达到99.3%(272274)、特异度为97.2%(12571293),与AFPRIA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AFPRIA试剂相媲美,可以替代AFPRIA试剂,用于原发性肝癌的筛查 |
| English Abstract: |
| 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 1567 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. |
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