Chun Sejong, Rhie Su Yeon, Ki Chang-Seok, Kim Jee Eun, Park Hyung-Doo
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Seoul, Republic of Korea.
Center for Health Promotion, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.
Ann Hepatol. 2015 Nov-Dec;14(6):882-8. doi: 10.5604/16652681.1171776.
The objective of this study was to establish modified cutoff values of serum alpha-fetoprotein (AFP) according to hepatitis status. While AFP is used as a serum marker in the diagnosis or monitoring of hepatocellular carcinoma (HCC), its use as a screening method to the general population is controversial. We evaluated its screening performance in a hepatitis prevalent East Asian population, and suggest different cutoff values according to the individual's hepatitis status. We evaluated the performance of AFP as a screening test in 48,123 consecutive Koreans during the period from March, 2012 to August, 2013 who underwent routine health checks at a single institution. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated with fixed cutoff and with modified cutoffs according the individual's hepatitis status. A total of 24 out of 48,123 subject (0.05%) were newly diagnosed with HCC after screening. Among the 1,874 subject with positive hepatitis B virus surface antigen (HBsAg), 17 (0.91%) developed HCC, compared with two out of 393 (0.51%) individuals with hepatitis C virus antibody (anti-HCV). Five out of 45,855 (0.01%) subject with neither HBsAg nor anti-HCV developed HCC. Compared to the performance of a fixed cutoff, specificity, PPV, and NPV improved without sacrificing sensitivity when applying modified cutoff. In conclusion, our findings suggest that AFP with modified cutoffs according to the individual's hepatitis status might be a useful screening marker for HCC in hepatitis prevalent areas.
本研究的目的是根据肝炎状态建立血清甲胎蛋白（AFP）的修正临界值。虽然AFP被用作肝细胞癌（HCC）诊断或监测的血清标志物，但其作为普通人群筛查方法的应用存在争议。我们评估了其在肝炎流行的东亚人群中的筛查性能，并根据个体的肝炎状态提出不同的临界值。我们评估了2012年3月至2013年8月期间在单个机构接受常规健康检查的48123名连续韩国人AFP作为筛查试验的性能。使用固定临界值以及根据个体肝炎状态的修正临界值计算敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。48123名受试者中有24名（0.05%）在筛查后被新诊断为HCC。在1874名乙型肝炎病毒表面抗原（HBsAg）阳性的受试者中，17名（0.91%）发生了HCC，相比之下，丙型肝炎病毒抗体（抗-HCV）阳性的393名个体中有2名（0.51%）发生了HCC。45855名既无HBsAg也无抗-HCV的受试者中有5名（0.01%）发生了HCC。与固定临界值的性能相比，应用修正临界值时特异性、PPV和NPV在不牺牲敏感性的情况下得到了改善。总之，我们的研究结果表明，根据个体肝炎状态采用修正临界值的AFP可能是肝炎流行地区HCC的一种有用筛查标志物。
