长春地区成人血清甲胎蛋白、癌胚抗原参考区间适用性验证

目的 验证卫生行业标准WS/T 645.2-2018中血清甲胎蛋白、癌胚抗原参考区间是否适用于长春地区。方法 按照WS/T 645.2-2018参考区间验证方法,入组2016年1月-2019年4月在吉林大学第一医院体检中心体检的20~79岁健康体检者5420例,根据年龄和性别划分为12个亚组,验证各组落入参考区间的检测值是否>90%,分析血清甲胎蛋白、癌胚抗原随年龄及性别变化趋势。计量资料两组比较采用Mann-Whitney U检验。结果 血清甲胎蛋白和癌胚抗原各亚组测量值90%以上落在参考区间内,通过参考区间验证。血清甲胎蛋白在30~39岁存在性别差异(Z=-4.51, P<0.05),血清癌胚抗原在20~29岁、30~39岁、40~49岁、50~59岁、60~69岁均存在性别差异(Z值分别为-13.45、-18.15、-17.34、-10.82、-3.65,P值均<0.05);血清甲胎蛋白在女性20~69岁随年龄缓慢上升,70~79岁男性及女性均随年龄下降;血清癌胚抗原在女性20~79岁、男性20~79岁随年龄上升,且男性检测值高于女性。结论 国家卫生健康委员会发布的WS/T 645.2-2018中血清甲胎蛋白、癌胚抗原参考区间适用于长春地区。

Validation of applicability of reference intervals for serum alpha-fetoprotein and carcinoembryonic antigen for adults in Changchun,China

Objective To 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. Methods According 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. Results More 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. Conclusion Reference intervals for serum AFP and CEA in WS/T 645.2-2018 issued by National Health Commission are applicable to the adults in Changchun.