采用健康体检人群甲状腺激素数据估计和验证参考区间

Estimation and verification of reference interval of thyroid hormone data in healthy population

目的验证实验室估计的甲状腺激素参考区间与现行使用的试剂说明书推荐参考区间和WS/T 404.10—2022推荐参考区间的一致性,选择适合该院健康人群甲状腺激素的参考区间。方法使用间接取样技术,通过回顾性分析2022年12月至2023年8月期间,苏州市独墅湖医院体检中心健康体检者甲状腺激素检测结果,采用非参数法估计不同性别及年龄的甲状腺激素P2.5~P97.5参考区间和95%置信区间,探讨不同性别、年龄组的数据分布及差异的显著性,与行业标准(WS/T 404.10—2022)及罗氏试剂说明书推荐的参考区间进行差异比较。结果TSH、FT3、FT4、TT3性别分组差异具有统计学意义(P<0.001,Z>Z*),TT4性别分组差异无统计学意义(P=0.998,Z<Z*)。TSH水平女性根据年龄分为20~60岁组(参考区间:0.62~6.40 mIU/L)和≥61岁组(参考区间:0.85~7.47 mIU/L),组间差异有统计学意义(P<0.001),男性年龄组间差异无统计学意义(参考区间:0.79~5.64 mIU/L);FT3男性分为20~40岁组(参考区间:4.37~6.36 pmol/L)和≥41岁组(参考区间:4.02~6.34 pmol/L),组间差异有统计学意义(P<0.001),女性年龄组间差异无统计学意义(参考区间:3.44~5.63 pmol/L);FT4男性分为20~50岁组(参考区间:13.7~21.4 pmol/L)和≥51岁组(参考区间:12.0~20.4 pmol/L),女性分为20~50岁组(参考区间:12.5~20.25 pmol/L)和≥51岁组(参考区间:11.34~19.18 pmol/L),男、女年龄分组差异均有统计学意义(P<0.001);TT3男性和女性不分年龄段,男性(参考区间:1.18~2.18 nmol/L),女性(参考区间:1.10~2.23 nmol/L);TT4水平在性别和年龄间的差异均无统计学意义(参考区间:64.1~127 nmol/L)。罗氏试剂说明书推荐的参考区间与实验室估计的FT4参考区间差异无统计学意义,TSH、FT3、TT3、TT4参考区间差异有统计学意义;行业标准推荐的参考区间与实验室估计参考区间差异无统计学意义。结论TSH、FT3、FT4水平存在性别和年龄差异,TT4水平不存在性别和年龄差异,TT3水平存在性别差异但不存在年龄差异。实验室通过估计的参考区间验证与行业标准WS/T 404.10—2022推荐一致,与现行使用的罗氏试剂说明书推荐存在差异。

Objective To verify the consistency of the reference intervals of thyroid hormone estimated in this investigation with the reference interval in the manual of the currently used reagent and industrial standard(WS/T 404.10—2022),and select the reference interval of thyroid hormone suitable for the healthy subjects at this hospital.Methods The indirect sampling technique was used to retrospectively analyze the results of thyroid hormone tests of healthy subjects in the Clinical Testing Center of Suzhou Dushu Lake Hospital from December 2022 to August 2023.Nonparametric method was used to estimate thyroid hormone P2.5-P97.5 reference intervals and 95%confidence intervals of the testing subjects with different genders and ages,and to explore the significant differences in the data distribution among different gender and age groups.The differences were compared with the reference intervals recommended by the industrial standard(WS/T 404.10—2022)and Roche reagent specification.Results There were significant differences in TSH,FT3,FT4 and TT3 between sexes(P<0.001,Z>Z*),but there was no significant difference in TT4 between sexes(P=0.998,Z<Z*).In terms of TSH levels,the women were divided into 20 to 60-year-old group(reference interval:0.62-6.40 mIU/L)and≥61-year-old group(reference interval:0.85-7.47 mIU/L).There was significant difference between the 2 groups(P<0.001),but there was no significant difference of TSH levels among the male groups with different age(reference interval:0.79-5.64 mIU/L).In terms of FT3 levels,the males were divided into 20 to 40-year-old group(reference interval:4.37-6.36 pmol/L)and≥41-year-old group(reference interval:4.02-6.34 pmol/L).There was significant difference between the 2 groups(P<0.001),but there was no significant difference in the female among various age groups ( reference interval: 3.44-5.63 pmol /L) . In terms of FT4 level,the males were divided into 20to 50-year-old group ( reference interval: 13.7-21.4 pmol /L) and ≥51-year-old group ( reference interval: 12.0-20.4 pmol /L) ,andthe females were divided into 20 to 50-year-old group ( reference interval: 12.5-20.25 pmol /L) and ≥ 51-year-old group ( referenceinterval: 11.34-19.18 pmol /L) . There was all significant difference between various age groups in both male and female ( P<0.001) .In terms of TT3 level,no difference was found between male and female regardless of age ( male [reference interval: 1. 18-2. 18nmol /L]and female [reference interval: 1.10-2.23 nmol /L]) . In terms of TT4 level,there was no significant difference between sexand age ( reference interval: 64.1-127 nmol /L) . There was no significant difference between the reference interval recommended byRoche reagent manual and the laboratory estimated FT4 reference interval,but there were significant differences in reference interval ofTSH,FT3,TT3 and TT4. There was no significant difference between the industrial standard recommended reference interval and thelaboratory estimated reference interval. Conclusion There were differences of TSH,FT3 and FT4 levels for gender and age,but nodifferences of TT4 levels for sex and age. There was gender difference of TT3 levels but no differences for age. The estimated referenceinterval verified by the laboratory was consistent with the industrial standard recommendation of WS /T 404.10—2022,but it was differentfrom the recommendation of current Roche reagent manual.