基于实验室数据建立并验证成人糖链抗原72-4的参考区间  

Establishment and validation of reference intervals of serum carbohydrate antigen 72-4 among adults based on laboratory information system

作　　者：宋晓妍[1] 张玉瑢 丁杨楠 张琳琳[1] 袁恩武[1] SONG Xiao-Yan;ZHANG Yu-Rong;DING Yang-Nan;ZHANG Lin-Lin;YUAN En-Wu(Department of Clinical Laboratory,the Third Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第三附属医院检验科,郑州450052

出　　处：《医药论坛杂志》2023年第4期104-107,112,共5页Journal of Medical Forum

摘　　要：目的基于实验室数据建立本实验室成人血清CA72-4医学参考区间,并验证其适应性。方法回顾性分析2018年1月至2022年6月间至郑州大学第三附属医院进行健康体检的成人血清CA72-4检测数据。采用独立样本K-S检验对数据进行正态性检验,将数据转换近似正态分布后采用Tukey法剔除离群高值后获得入组数据8667例,年龄分布18~94岁,其中男性1878例,女性6789例。采用Spearman评估血清CA72-4水平与年龄之间的相关性;采用Z检验比较性别、仪器型号及年龄的不同时血清肿瘤标志物CA72-4水平是否存在差异;采用非参数法建立成人不同年龄段血清CA72-4的P95医学参考区间及90%的置信区间。通过每组20健康成人CA72-4结果验证参考区间的设置合理性。结果郑州地区CA72-4水平与年龄呈微弱负相关(r=-0.023,P=0.03),且18~50岁组与≥50岁组间差异有统计学意义(Z=21.56,Z∗=18.03;Z>Z∗)。不同性别、仪器型号的差异无统计学意义(Z<Z∗)。郑州地区成人CA72-4参考区间为<15.26 U/mL,18~50岁组为<15.90 U/mL,≥50岁组参考区间为<14.11 U/mL。对建立的血清CA72-4的参考区间进行验证符合标准。结论基于LIS数据建立郑州地区成人血清肿瘤标志物CA72-4的参考区间,比试剂说明书推荐的参考区间更符合临床需求。Objective To establish reference intervals of serum carbohydrate antigen 724(CA724)based on a laborato⁃ry data and verify the applicability.Methods The data of healthy subjects were collected in the Third Affiliated Hospi⁃tal of Zhengzhou University from January 2018 to June 2022.After the data were converted to approximate normal distri⁃bution,the key method was used to eliminate the high outliers,and the enrolled data of 8667 cases were obtained.The age distribution was 18-94 years old,including 1878 males and 6789 females.Spearman was used to evaluate the correlation between serum CA72-4 level and age.The P95reference interval and 90%confidence interval of serum CA72-4 in different age groups of adults were established by non-parametric method.CA72-4 results of 20 healthy adults in each group were used to verify the rationality of setting the reference interval.Results CA72-4 level in Zhengzhou area was weakly negatively correlated with age(r=-0.023,P=0.03),and there was a statistically signifi⁃cant difference between 18~50 years old group and≥50 years old group(Z=21.56,Z∗=18.03;Z>Z∗).There was no significant difference in gender and instrument type(Z<Z∗).The reference interval of CA72-4 was<15.26 U/mL for adults in Zhengzhou area,with the reference intervals of<15.90 U/mL(18~50 years old)and<14.11 U/mL(>70 years old),respectively.Validation of reference intervals met standards.Conclusion The refer⁃ence interval of serum tumor marker CA72-4 in adults in Zhengzhou was established based on LIS data,which was more suitable for clinical requirements than the reference interval provided by the manufacturer.

关 键 词：肿瘤标志物 CA72-4 成人 参考区间 

分 类 号：R446.1[医药卫生—诊断学]