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.
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。