化学发光免疫分析法检测成年人甲状腺激素参考区间的建立

Establishment of reference interval of LIAISON■ XL chemiluminescence immunoassay for detecting thyroid hormone in adults

目的:建立实验室促甲状腺激素(TSH)、三碘甲状腺原氨酸(T3)、四碘甲状腺原氨酸(T4)、游离三碘甲状腺原氨酸(FT3)和游离四碘甲状腺原氨酸(FT4)检测指标的正常参考区间。方法:采用前瞻性采样法进行参考个体的选择,在河南三门峡地区按需招募120名健康志愿者,其中男性60名,女性60名;按照年龄将其分为18~60岁组(80名),61~70岁组(20名)和>70岁组(20名)。使用LIAISON~?XL化学发光免疫分析仪测定3组健康志愿者空腹血TSH、T3、T4、FT3及FT4等5项指标。分析年龄、性别因素对甲状腺激素水平的影响的相关性,对组间均值差异、组间标准差之比等指标进行评价。依据检测数据类型选择参数法或非参数法,统计分析确定甲状腺激素的参考区间。结果:T3、FT4激素水平与性别和年龄无相关,参考区间分别为0.86~1.55 nmol/L和9.95~21.31 pmol/L。建立的FT3参考区间为2.97~5.44 pmol/L,激素水平与性别相关(r=-0.47,P=0.028),男性与女性间均值差为14.5%。建立的TSH参考区间0.82~5.59 mIU/L,激素水平与性别相关(r=0.23,P=0.861),组间均值差为-20.1%。建立的T4参考区间为57.69~138.45 pmol/L,激素水平与年龄相关(r=0.34,P=0.005)。经敏感性分析,剔除>70岁参考个体,组间比较差异无统计学意义;>70岁组T4检测水平与61~70岁组比较差异无统计学意义,与18~60岁组比较差异有统计学意义(F=4.552,P<0.035)。结论:三门峡地区成年健康人群甲状腺激素的参考区间的建立,为临床医生对甲状腺疾病的筛查、诊断及治疗效果的监测提供确切的实验诊断依据。其中TSH、T3、T4及FT4的参考区间均与厂家声明差异较大,TSH或FT3的异常结果需考虑性别差异,>60岁人群的T4检测结果的评估需关注年龄因素。

Objective: To establish the normal reference interval of a series of detection indicators included thyrotropin stimulating hormone(TSH), T3, T4, free triiodothyronine 3(FT3), free tetraiodothyronine 4(FT4) in laboratory. Methods: The prospective sampling method was used to select reference individuals. 120 healthy volunteers(60 males and 60 females) were recruited from Sanmenxia area of Henan Province, and they were divided into 18-60 years old group(80 cases), 61-70 years old group(20 cases) and above 70 years old group(20 cases). The five fasting plasma indicators included TSH, T3, T4, FT3 and FT4 of the healthy volunteers in three groups were measured by LIASON? XL chemiluminescence immunoassay. The correlation of age and gender on thyroid hormone level was analyzed. And the mean difference between groups and the ratio of standard deviation between groups were evaluated. The parametric method or nonparametric method was selected as the type of detection data to analyze and determine the reference interval of thyroid hormones. Results: The hormone levels of T3 and FT4 were not related to gender and age, and the reference intervals of them were 0.86~1.55 nmol/L and 9.95~21.31 pmol/L, respectively. The established reference interval of FT3 was 2.97-5.44 pmol/L, and the correlation coefficient between hormone level of FT3 and gender was significant(r=-0.47, P=0.028), and the mean difference between male and female was 14.5%. The established reference interval of TSH was 0.82~5.59 mIU/L, and the correlation coefficient between hormone level of TSH and gender was significant(r=0.23, P=0.861), and the mean difference between two groups was-20.1%. The established reference interval of T4 was 57.69~138.45 pmol/L, and the correlation coefficient between hormone level of T4 and age was significant(r=0.34, P=0.005). The sensitivity analysis showed that there was no significant difference in T4 level between the two groups after the reference individuals above 70 years old were excluded. There was no significant difference in the T4 detection level between the above 70 years old group and the 61~70 years old group, but there was significant difference in that between the above 70 years old group and the 18-60 year old group(F=4.552, P=0.035). Conclusion: The establishment of reference interval of thyroid hormone of healthy adult population in Sanmenxia area can provide exactly experimental diagnostic basis for the monitoring of clinicians in screening, diagnosis and therapeutic effect of thyroid diseases. And the reference intervals of TSH, T3, T4 and FT4 are significantly different from the manufacturer’s statement. The abnormal results of TSH or FT3 should consider gender differences, and the assessment of T4 test results of people above 60 years old should pay attention to the age factor.