Assessment of the clinical value with the application of serum abnormal prothrombin for auxiliary diagnosis of hepatocellular carcinoma: a multicenter Chinese population-based case-control study
10.3760/cma.j.cn501113-20240131-00070
- VernacularTitle:血清异常凝血酶原用于辅助诊断肝细胞癌临床价值的评估：一项基于中国人群的多中心病例对照研究
- Author:
Xieer LIANG
1
;
Liming CHENG
;
Songxiao XU
;
Jun ZHANG
;
Hongsong CHEN
;
Cunying PU
;
Rong FAN
;
Jinlin HOU
Author Information
1. 南方医科大学南方医院感染内科暨肝病中心，广州 510515
- Keywords:
Hepatocellular carcinoma;
Alpha-fetal protein;
Elecsys PIVKA-Ⅱ;
Early-stage Primary hepatocellular carcinoma;
Cut-off value;
Diagnosis
- From:
Chinese Journal of Hepatology
2024;32(7):650-656
- CountryChina
- Language:Chinese
-
Abstract:
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.
