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目的:综合评估Elecsys血清异常凝血酶原（PIVKA-Ⅱ）检测试剂在中国人群中辅助诊断肝细胞癌（HCC）的临床价值。方法:研究采用多中心病例-对照设计，连续收集首次确诊且未经治疗的HCC患者样本、良性肝病患者样本和干扰性样本进行Elecsys PIVKA-Ⅱ与甲胎蛋白（AFP）检测，并对受试者的多项临床信息进行汇总分析。计算特定阳性截断值下PIVKA-Ⅱ（21.29 ng/ml）和AFP（400 ng/ml）用于HCC诊断的效能。采用Kruskal-Wallis检验或受试者操作特征曲线进行统计学分析。结果:最终在5家中心共纳入448例受试者，其中包括185例HCC病例。以良性肝病组为对照组时，PIVKA-Ⅱ的诊断灵敏度和准确率均高于AFP：84.86%对比30.81% 和89.01%对比63.66%，而特异度略低。敏感性分析显示在该特定阳性截断值下，PIVKA-Ⅱ的临床性能在AFP阴性受试者亚组、不同病因亚组及多个巴塞罗那癌症分期的HCC患者亚组（含早期HCC）中的灵敏度均>80%。同时，PIVKA-Ⅱ的受试者操作特征曲线下面积亦略高于AFP（0.920 0对比 0.880 9）。结论:Elecsys PIVKA-Ⅱ在中国人群中的临床性能良好且稳定，有潜力改善临床AFP阴性HCC诊断和早期HCC监测中的漏诊现状以进一步提升中国人群HCC精准辅助诊断效率。

Objective:To comprehensively evaluate the clinical value of Elecsys serum abnormal prothrombin (PIVKA-Ⅱ) test reagent for auxiliary diagnosis of hepatocellular carcinoma (HCC) in the Chinese population.Methods:A multicenter case-control design was used in the study. Samples from patients with first-time confirmed, diagnosed, and untreated HCC, benign liver disease and interfering controls were collected continuously. Elecsys PIVKA-II and alpha-fetoprotein (AFP) were tested for analysis. Various clinical details of the subjects were collected and analyzed. The efficacy of PIVKA-II (21.29 ng/ml) and AFP (400 ng/ml) for HCC diagnosis was calculated at specific positive cut-off values. Statistical analysis was performed using the Kruskal-Wallis test or receiver operating characteristic curve.Results:A total of 448 subjects were eventually enrolled from five centers, including 185 HCC cases. PIVKA-II had a higher diagnostic sensitivity and accuracy than AFP (84.86% vs. 30.81% and 89.01% vs. 63.66%) when the benign liver disease group was used as the control group, while the specificity was slightly lower. A sensitive analysis showed that PIVKA-II had a sensitivity of >80% at this specific positive cut-off value in the subgroup of AFP-negative subjects, patients with different etiologies, and HCC patients with multiple Barcelona Clinic liver cancer stages (including early-stage HCC). At the same time, the PIVKA-II subject had a slightly higher area under the receiver operating characteristic curve than the AFP (0.920 0 vs. 0.880 9).Conclusion:The clinical efficacy of Elecsys PIVKA-Ⅱ is good and stable in the Chinese population. Additionally, it has the clinical potential to improve the current missed diagnosis status of AFP-negative HCC and HCC monitoring at an early stage, as well as the effectiveness of accuracy promotion for HCC auxiliary diagnosis in China.