甲胎蛋白家用检测试纸(爱福陪)在肝癌高危人群中的应用价值研究

Study on the Application Value of α-Fetoprotein Household Test Paper (Aifupei) in a High Risk Group of Liver Cancer

目的:评价国家“十二五”重大科技转化产品甲胎蛋白家用检测试纸(爱福陪)在肝癌高危人群中的应用价值。方法:收集国家传染病重大专项甘肃省武威市乙肝防治示范区乙肝抗原表面阳性的血清标本,采用爱福陪和化学发光法分别检测血清标本的甲胎蛋白,进行对比分析。结果:本研究共收集血清标本4277例,其中有肝癌患者104例(肝癌组),肝硬化402例(肝硬化组),乙肝患者2437例(乙肝患者组),乙肝携带者1334例(携带者组)。以化学发光法为金标准分析得出爱福陪检测甲胎蛋白灵敏度为22.5% (95% CI: 0.18~0.27),特异度96.9% (95% CI: 0.96~0.97),阳性预测值36.2% (95% CI: 0.29~0.43),阴性预测值94.1% (95% CI: 0.93~0.94),ROC曲线下分析显示爱福陪检测甲胎蛋白的AUC为0.597 (95% CI: 0.56~0.63)。爱福陪在肝癌组和肝硬化组的甲胎蛋白检出阳性率大于乙肝患者组以及乙肝病毒携带者组,且差异有统计学意义(P < 0.05)。结论:研究表明,爱福陪应用于肝硬化肝炎等人群可能比应用于全部乙肝表面抗原阳性人群效果较好。与化学发光法相比,爱福陪的灵敏度较低,但是特异度较高,操作简单方便,适用于无专业甲胎蛋白检测仪器基础医疗机构以及家庭内部进行甲胎蛋白检测。

Objective: To evaluate the application value of AFP household test paper in the high-risk group of liver cancer. Methods: To collect the serum samples of hepatitis B antigen surface positive in the hepatitis B prevention and treatment demonstration area of Wuwei City, Gansu Province. The AFP of serum samples was detected by the methods of Aifupei and chemiluminescence, and carry out comparative analysis. Results: A total of 4277 serum samples were collected, among them, 104 pa-tients with liver cancer (HCC group), 402 cases of cirrhosis (cirrhosis group), Hepatitis B patients 2437 (hepatitis B patients group), Hepatitis B carrier 1334 cases (carrier group). By using chemi-luminescence as the gold standard, the sensitivity of Aifupei was 22.5% (95% CI: 0.025~0.037), specificity 96.9% (95% CI: 0.72~0.82), a positive predictive value of 36.2% (95% CI: 0.56~0.70), a sexual predictive value of 94.1% (95% CI: 0.05~0.07). The analysis under ROC curve showed that the AUC of alpha AFP was 0.597 (95 CI: 0.56~0.63). The positive rate of AFP in the liver cancer group and liver cirrhosis group was higher than that in the hepatitis B group and hepatitis B virus carrier group, the difference was statistically significant (P < 0.05). Conclusion: Studies have shown that the application of Aifupei in cirrhotic hepatitis and other populations may be better than the applica-tion of hepatitis B surface antigen positive population. Compared with the chemiluminescence method, the sensitivity of Aifupei company is low, but the specificity is high, the operation is simple and convenient, and it is suitable for self-test of AFP in basic medical institutions and in non-professional people outside the hospital.