中国汉族健康成年人中ARCHITECT甲胎蛋白的血清参考区间：一项前瞻性多中心研究的亚分析

Serum reference interval of ARCHITECT alpha-fetoprotein in healthy Chinese Han adults: Sub-analysis of a prospective multi-center study.

作者信息

Yan Cunling, Yang Jia, Wei Lianhua, Hu Jian, Song Jiaqi, Wang Xiaoqin, Han Ruilin, Huang Ying, Zhang Wei, Soh Andrew, Beshiri Agim, Fan Zhuping, Zheng Yijie, Chen Wei

机构信息

Department of Clinical Laboratory, Peking University First Hospital, Beijing 100000, China.

Department of Clinical Laboratory, Provincial People's Hospital, Chengdu, Sichuan 610000, China.

出版信息

Clin Biochem. 2018 Feb;52:164-166. doi: 10.1016/j.clinbiochem.2017.11.002. Epub 2017 Nov 10.

DOI:10.1016/j.clinbiochem.2017.11.002

PMID:29129627

Abstract

OBJECTIVES

Alpha-fetoprotein (AFP) has been widely used in clinical practice for decades. However, large-scale survey of serum reference interval for ARCHITECT AFP is still absent in Chinese population. This study aimed to measure serum AFP levels in healthy Chinese Han subjects, which is a sub-analysis of an ongoing prospective, cross-sectional, multi-center study (ClinicalTrials.gov Identifier: NCT03047603).

METHODS

This analysis included a total of 530 participants (41.43±12.14years of age on average, 48.49% males), enrolled from 5 regional centers. Serum AFP level was measured by ARCHITECT immunoassay. Statistical analysis was performed using SAS 9.4 and R software.

RESULTS

AFP distribution did not show significant correlation with age or sex. The overall median and interquartile range of AFP was 2.87 (2.09, 3.83) ng/mL. AFP level did not show a trend of increasing with age. The new reference interval was 2.0-7.07ng/mL (LOQ- 97.5th percentiles).

CONCLUSIONS

The reference interval for ARCHITECT AFP is updated with the data of adequate number of healthy Han adults. This new reference interval is more practical and applicable in Chinese adults.

摘要

目的

几十年来，甲胎蛋白（AFP）一直在临床实践中广泛应用。然而，中国人群中仍缺乏对ARCHITECT AFP血清参考区间的大规模调查。本研究旨在测定健康中国汉族受试者的血清AFP水平，这是一项正在进行的前瞻性、横断面、多中心研究（ClinicalTrials.gov标识符：NCT03047603）的子分析。