Yan Cunling, Hu Jian, Yang Jia, Chen Zhaoyun, Li Huijun, Wei Lianhua, Zhang Wei, Xing Hao, Sang Guoyao, Wang Xiaoqin, Han Ruilin, Liu Ping, Li Zhihui, Li Zhiyan, Huang Ying, Jiang Li, Li Shunjun, Dai Shuyang, Wang Nianyue, Yang Yongfeng, Ma Li, Soh Andrew, Beshiri Agim, Shen Feng, Yang Tian, Fan Zhuping, Zheng Yijie, Chen Wei
Department of Clinical Laboratory, Peking University First Hospital, Beijing 100000, China.
Department of Laboratory Medicine, The First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University, Xi'an 710000, China.
Clin Biochem. 2018 Apr;54:32-36. doi: 10.1016/j.clinbiochem.2018.02.007. Epub 2018 Feb 12.
Protein induced by vitamin K absence or antagonist-II (PIVKA-II) has been widely used as a biomarker for liver cancer diagnosis in Japan for decades. However, the reference intervals for serum ARCHITECT PIVKA-II have not been established in the Chinese population. Thus, this study aimed to measure serum PIVKA-II levels in healthy Chinese subjects.
This is a sub-analysis from the prospective, cross-sectional and multicenter study (ClinicalTrials.gov Identifier: NCT03047603). A total of 892 healthy participants (777 Han and 115 Uygur) with complete health checkup results were recruited from 7 regional centers in China. Serum PIVKA-II level was measured by ARCHITECT immunoassay. All 95% reference ranges were estimated by nonparametric method.
The distribution of PIVKA-II values showed significant difference with ethnicity and sex, but not age. The 95% reference range of PIVKA-II was 13.62-40.38 mAU/ml in Han Chinese subjects and 15.16-53.74 mAU/ml in Uygur subjects. PIVKA-II level was significantly higher in males than in females (P < 0.001). The 95% reference range of PIVKA-II was 15.39-42.01 mAU/ml in Han males while 11.96-39.13 mAU/ml in Han females.
The reference interval of serum PIVKA-II on the Architect platform was established in healthy Chinese adults. This will be valuable for future clinical and laboratory studies performed using the Architect analyzer. Different ethnic backgrounds and analytical methods underline the need for redefining the reference interval of analytes such as PIVKA-II, in central laboratories in different countries.
数十年来，维生素K缺乏或拮抗剂-II诱导蛋白（PIVKA-II）在日本已被广泛用作肝癌诊断的生物标志物。然而，在中国人群中尚未建立血清ARCHITECT PIVKA-II的参考区间。因此，本研究旨在测定健康中国受试者的血清PIVKA-II水平。
这是一项来自前瞻性、横断面多中心研究（ClinicalTrials.gov标识符：NCT03047603）的亚分析。从中国7个地区中心招募了892名健康参与者（777名汉族和115名维吾尔族），他们均有完整的健康检查结果。采用ARCHITECT免疫分析法测定血清PIVKA-II水平。所有95%参考范围均采用非参数方法估计。
PIVKA-II值的分布在种族和性别上存在显著差异，但在年龄上无差异。汉族受试者PIVKA-II的95%参考范围为13.62-40.38 mAU/ml，维吾尔族受试者为15.16-53.74 mAU/ml。男性的PIVKA-II水平显著高于女性（P<0.001）。汉族男性PIVKA-II的95%参考范围为15.39-42.01 mAU/ml，汉族女性为11.96-39.13 mAU/ml。
在健康中国成年人中建立了Architect平台上血清PIVKA-II的参考区间。这对于未来使用Architect分析仪进行的临床和实验室研究将具有重要价值。不同的种族背景和分析方法强调了在不同国家的中心实验室重新定义PIVKA-II等分析物参考区间的必要性。
