云南玉溪地区成人甲状腺功能5项指标的参考区间调查

Investigation on the reference intervals of 5 items for thyroid function in adults in Yunnan Yuxi

目的建立区域性成人甲状腺功能5项指标化学发光法的参考区间,验证厂家提供的参考区间能否直接转移引用。方法参照美国临床实验室标准化协会C28-A3文件要求,结合LIAISON试剂说明书提供的参考区间,应用LIAISON化学发光免疫分析系统检测5 070名正常人游离三碘甲状腺原氨酸(FT_3)、游离甲状腺素(FT_4)、三碘甲状腺原氨酸(T_3)、甲状腺素(T_4)、促甲状腺素(TSH)水平。选取20份正常值对厂家提供的参考区间进行验证,分析上述5项指标的年龄差异及性别差异。根据98%(TSH为95%)可信限范围,建立本地区的参考区间。结果 FT_3、FT_4、T_3、T_4、TSH总体样本参考区间分别为3.34~6.35 mmol/L、10.28~20.96 mmol/L、0.67~1.82μg/L、52.16~133.92μg/L、0.31~5.25 m IU/L;男性、女性结果分开统计时,FT_3、FT_4、TSH结果差异有统计学意义(P<0.05);男性51岁前后2个年龄段FT_3结果差异有统计学意义(P=0.000),女性61岁前后2个年龄段FT_3结果差异有统计学意义(P=0.000);男、女性71岁前后2个年龄段FT_4结果差异有统计学意义(P<0.05)。20份正常值验证上述项目参考区间时,T_3、TSH验证未能通过,必须重新建立适合的参考区间。结论厂家提供的参考区间相对宽泛,除T_3和TSH外,其余项目基本能满足要求,但没有年龄段和性别的区分,各实验室有必要结合实际,建立区分年龄及性别的个性化参考区间,为临床提供更可靠的诊断依据。

Objective To establish the regional reference intervals of 5 items for thyroid function by chemiluminescence,and to verify the regional reference intervals used directly or not. Methods According to the Clinical and Laboratory Standards Institute(CLSI) C28-A3 and the reference intervals supplied by LIAISON specification,free triiodothyronine(FT3),free thyroxine(FT4),triiodothyronine(T3),thyroxine(T4)and thyroid stimulating hormone(TSH) were determined by LIAISON chemiluminescence assay system in 5 070 healthy adults,and the reference intervals supplied by manufacturers were verified with 20 normal cases. The differences for age and sex were analyzed. The reference intervals were established according to 98% confidence intervals(95% confidence interval for TSH). Results The overall reference intervals of FT3,FT4,T3,T4 and TSH were 3.34-6.35 mmol/L,10.28-20.96 mmol/L,0.67-1.82 μg/L,52.16-133.92 μg/L and 0.31-5.25 mIU/L.The levels of FT3,FT4 and TSH had statistical significance between males and females(P<0.05). In males,the level of FT3 had statistical significance between before and after 51 years old(P=0.000). In females,the statistical significance appeared before and after 61 years old(P=0.000). In males and females,the level of FT4 had statistical significance between before and after 71 years old(P<0.05). The reference intervals of T3 and TSH could not pass the verification,when the reference intervals were verified by 20 normal cases. So,the reference intervals of T3and TSH must be re-established. Conclusions Reference intervals supplied by manufacturers are wide relatively.The reference intervals could meet related requirements basically except those of T3 and TSH. However,there is no difference for ages and sex. Laboratories should establish individual reference intervals for different ages and sex in order to provide a reference for reliable sensitive diagnosis.