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

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

doi:10.1016/j.clinbiochem.2017.11.002

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

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

Authors

Cunling Yan¹, Jia Yang², Lianhua Wei³, Jian Hu⁴, Jiaqi Song⁵, Xiaoqin Wang⁴, Ruilin Han¹, Ying Huang², Wei Zhang⁵, Andrew Soh⁶, Agim Beshiri⁷, Zhuping Fan⁸, Yijie Zheng⁹, Wei Chen¹⁰

Affiliations

¹ Department of Clinical Laboratory, Peking University First Hospital, Beijing 100000, China.
² Department of Clinical Laboratory, Provincial People's Hospital, Chengdu, Sichuan 610000, China.
³ Department of Clinical Laboratory, Provincial People's Hospital, Lanzhou, Gansu 730000, China.
⁴ Department of Laboratory Medicine, The First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University, Xi'an 710000, China.
⁵ Department of Health Statistics, Second Military Medical University, Shanghai 200433, China.
⁶ Medical Scientific Liaison Asian Pacific, Abbott Diagnostics Division, Abbott Laboratories, Singapore 189352, Singapore.
⁷ Medical Scientific Affairs, Abbott Diagnostics Division, Abbott Laboratories, Abbott Park, IL 60064, USA.
⁸ Department of Health Manage Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China. Electronic address: zhuping_fan@163.com.
⁹ Medical Scientific Liaison Asian Pacific, Abbott Diagnostics Division, Abbott Laboratories, Shanghai 200032, China. Electronic address: yijie.zheng@abbott.com.
¹⁰ Department of Laboratory Medicine, The First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University, Xi'an 710000, China. Electronic address: chenwei808@mail.xjtu.edu.cn.

PMID: 29129627
DOI: 10.1016/j.clinbiochem.2017.11.002

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.

Keywords: Alpha-fetoprotein; Hepatocellular carcinoma; Reference interval.

MeSH terms

Adult
Age Factors
Biomarkers, Tumor / blood
Carcinoma, Hepatocellular / blood
Carcinoma, Hepatocellular / diagnosis
China
Cross-Sectional Studies
Ethnicity
Female
Humans
Immunoassay / methods
Liver Neoplasms / blood
Liver Neoplasms / diagnosis
Male
Middle Aged
Prospective Studies
Reference Standards
Reference Values
Serum
Sex Factors
alpha-Fetoproteins / analysis*
alpha-Fetoproteins / standards*

Substances

Biomarkers, Tumor
alpha-Fetoproteins

Associated data

ClinicalTrials.gov/NCT03047603