Jin Jie, Zhang Xiao-Yan, Shi Jin-Lei, Xue Xue-Feng, Lu Ling-Ling, Lu Jian-Hua, Jiang Xiao-Ping, Hu Jiang-Feng, Duan Ben-Song, Yang Chang-Qing, Lu Da-Ru, Lu De-Li, Chen Jian-Guo, Gao Heng-Jun
National Engineering Center for Biochip at ShanghaiShanghai 201203, China.
State Key Laboratory of Genetic Engineering, School of Life Sciences, Fudan UniversityShanghai, China.
Am J Cancer Res. 2017 Jun 1;7(6):1384-1388. eCollection 2017.
Hepatocellular carcinoma (HCC) is a big problem in China where the Hepatitis B (HBV) infection patients are near to 120 million. Early screening and diagnosis is the key to reduce the incidence and mortality of HCC. Serum AFP detection is the main methods for diagnosis, recurrent monitoring and therapeutic evaluation of primary HCC. Hepatitis patients should detect the AFP at least once every six months to help early diagnosis of HCC. Unfortunately, most hepatitis and other liver disease patients do not test their AFP regularly. Therefore, a rapid, convenient detect kit for AFP is necessary for the hepatitis patients to test AFP at home by themselves. It will be very helpful to the HCC early screening and early diagnosis. We screened 859 individuals who were HBsAg positive and had high risk of HCC in Qidong by using two different kits, AFP one-step rapid detection kit (Shanghai Outdo Biotech) and AFP Diagnostics ELISA kit (Zhengzhou Autobio Diagnostics), and compared the results. As a result, the positive accordance rate and the negative accordance rate of AFP one-step rapid detection 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 showed a high accordance rate of two methods. It is so meaningful to achieve home-test and improve HCC early screening and diagnosis by using AFP one-step rapid detection kit.
在中国，乙型肝炎（HBV）感染患者接近1.2亿，肝细胞癌（HCC）是一个重大问题。早期筛查和诊断是降低HCC发病率和死亡率的关键。血清甲胎蛋白（AFP）检测是原发性HCC诊断、复发监测及治疗评估的主要方法。肝炎患者应至少每六个月检测一次AFP，以助于HCC的早期诊断。不幸的是，大多数肝炎及其他肝病患者并未定期检测AFP。因此，需要一种快速、便捷的AFP检测试剂盒，以便肝炎患者在家自行检测AFP。这将对HCC的早期筛查和早期诊断非常有帮助。我们使用两种不同的试剂盒，即AFP一步快速检测试剂盒（上海奥普生物医药股份有限公司）和AFP诊断酶联免疫吸附测定试剂盒（郑州安图生物工程股份有限公司），对启东市859名HBsAg阳性且有HCC高风险的个体进行了筛查，并比较了结果。结果，AFP一步快速检测试剂盒与安图酶联免疫吸附测定试剂盒的阳性符合率和阴性符合率分别为95.65%（22/23）和99.40%（831/836）。总诊断符合率高达99.30%（853/859）。筛查结果显示两种方法的符合率很高。使用AFP一步快速检测试剂盒实现居家检测并改善HCC早期筛查和诊断具有重要意义。
