Validation of applicability of reference intervals for serum alpha-fetoprotein and carcinoembryonic antigen for adults in Changchun, China / 临床肝胆病杂志

ABSTRACT

ObjectiveTo investigate whether the reference intervals for serum alpha-fetoprotein (AFP) and carcinoembryonic antigen (CEA) in WS/T 645.2-2018 are applicable to the adults in Changchun, China. MethodsAccording to the validation method for the reference intervals in WS/T 645.2-2018, 5420 subjects, aged from 20-79 years, who underwent physical examination from January 2016 to April 2019 were enrolled and divided into 12 subgroups based on age and sex. Each subgroup was analyzed in terms of whether more than 90% of the measured values fell into the reference intervals, and the changing trend of AFP and CEA with age and sex was analyzed. The Mann-Whitney U test was used for comparison between two groups. ResultsMore than 90% of the measured values of serum AFP and CEA fell into the reference intervals, which passed the validation test. There was a significant difference in serum AFP between male and female subjects aged 30-39 years (Z=-4.51, P＜0.05), and there was a significant difference in serum CEA between male and female subjects aged 20-29, 30-39, 40-49, 50-59, and 60-69 years (Z=-13.45, -18.15, -17.34, -10.82, and -3.65, all P＜0.05). Serum AFP increased slowly with age in female subjects aged 20-69 years and decreased with age in male and female subjects aged 70-79 years. Serum CEA increased with age in male and female subjects aged 20-79 years, and male subjects had a higher measured value than female subjects. ConclusionReference intervals for serum AFP and CEA in WS/T 645.2-2018 issued by National Health Commission are applicable to the adults in Changchun.