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

Publication date: Available online 10 November 2017
Source:Clinical Biochemistry
Author(s): 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
ObjectivesAlpha-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).MethodsThis 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.ResultsAFP 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).ConclusionsThe 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.



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