甲胎蛋白全血一步法快速检测试剂盒在江苏启东肝癌高风险人群中的筛查应用  

Screening of high-risk HCC population with AFP one-step rapid detect kit in Qidong, Jiangsu

作　　者：金杰 张小燕[1] 赵志东[2] 陈建国[3] JIN Jie;ZHANG Xiaoyan;ZHAO Zhidong;CHEN Jianguo(National Engineering Center for Biochip at Shanghai,Shanghai 201203,China;Shanghai Eighth People′s Hospital,Shanghai 200235,China)

机构地区：[1]生物芯片上海国家工程研究中心,上海201203 [2]上海市第八人民医院,上海200235 [3]启东肝癌防治研究所,江苏启东226200

出　　处：《中国热带医学》2019年第10期931-933,971,共4页China Tropical Medicine

基　　金：卫生部“十二五”肝癌重大专项（No.2013ZX10002007001）

摘　　要：目的研究一种快速、简便检测AFP的方法,为有助肝癌早筛、早诊提供技术支撑。方法采用上海芯超AFP全血一步法快速检测试剂盒,对江苏启东市肝癌高发区859例HBsAg阳性的高风险人群进行AFP筛查,并与郑州安图生物AFP酶联免疫法试剂盒同步比对检测。对于AFP阳性者,进一步结合B超,观察是否已经出现肝占位性病变,从而对病情进行初步诊断。结果以郑州安图AFP检测试剂(酶联免疫法)为标准,上海芯超AFP快速检测试剂的灵敏度为95.65%(22/23),特异度为99.40%(831/836),总符合率为99.30%(853/859)。两种试剂盒检测结果具有较高的符合率。同时结合B超结果发现,在检测出AFP阳性人群中有两例出现了肝占位现象,初步判断为早期肝癌。结论AFP全血上海芯超AFP全血一步法快速检测试剂能实现AFP高风险人群家庭自测,提高肝癌的早诊率。Objective Serum AFP is the major methods for diagnosis,relapse monitor and effect evaluation for HCC.A rapid,convenient home-test kit for AFP is necessary for the hepatitis patients,which will greatly improve the early diagnosis rate of HCC.Methods AFP one-step rapid detect kit produced by Shanghai Outdo Biotech Co.,Ltd was used to screen 859 individuals with positive HBsAg who were at-risk for HCC in Qidong,Jiangsu.The result was compared with that of the ELISA kit produced by Zhenzhou Autobio Diagnostics Co.,Ltd.According to the AFP result,combined with the B-mode ultrasonography to found placeholder,primary diagnosis could be concluded.Results The results showed that the positive accordance rate(sensitivity)and the negative accordance rate(specificity)between AFP one-step rapid detect kit and the Autobio ELISA kit were 95.65%(22/23)and 99.40%(831/836),respectively.The total diagnose accordance rate reached up to 99.30%(853/859).The screening results proved a high accordance rate of the two methods.Combined with the results of Bmode ultrasonography,two patients were primary diagnosed as early HCC.Conclusion The AFP one-step rapid detect kit had a great significance in the realization of home-detect and in the improvement of the early screening and diagnosis of HCC.

关 键 词：甲胎蛋白 全血一步检测 符合率 早诊 肝肿瘤 

分 类 号：R735.7[医药卫生—肿瘤]