摘要
目的评价化学发光法检测反三碘甲状腺原氨酸(rT_3)的分析性能,并探讨rT_3的临床应用价值。方法参照美国临床实验室标准化协会(CLSI)EP系列文件和相关标准,对化学发光法检测rT_3的分析性能(精密度、正确度、分析灵敏度、分析特异性、线性范围、参考区间和方法学比对等)进行验证。检测30例甲状腺功能亢进(简称甲亢)初诊患者(甲亢组)、28例甲亢治疗1个月的患者(甲亢治疗组)、25例甲状腺功能减退(简称甲减)初诊患者(甲减组)、23例甲减治疗1个月的患者(甲减治疗组)、25例明确原发基础疾病的正常甲状腺病态综合征(ESS)患者及50名体检健康者(正常对照组)的甲状腺功能指标[三碘甲状腺原氨酸(T_3)、甲状腺素(T_4)、促甲状腺激素(TSH)及rT_3]并作比较。结果化学发光法检测rT_3高值和低值质控品的批内精密度(CV)分别为4.82%和4.95%,批间精密度(CV)分别为7.51%和5.90%;高值和低值样本的相对偏移分别为-1%和1%,线性范围为0.05～10.07 ng/mL,参考区间为0.20～0.95 ng/mL。化学发光法与放射免疫法的相关性良好(r=0.952)。与正常对照组比较,甲亢组rT_3、T_3、T_4水平明显升高(P<0.05),TSH水平明显降低(P<0.05);甲减组T_4和rT_3水平明显降低(P<0.05),TSH水平明显升高(P<0.05)。与甲亢组比较,甲亢治疗组rT_3、T_3、T_4水平明显降低(P<0.05),TSH水平明显升高(P<0.05)。与甲减组比较,甲减治疗组rT_3、T_4水平明显升高(P<0.05),TSH水平明显降低(P<0.05)。ESS组rT_3水平明显高于甲减组和正常对照组(P<0.05),T_3和T_4水平明显低于正常对照组(P<0.05),但与甲减组比较差异均无统计学意义(P>0.05),TSH水平明显低于甲减组(P<0.05),但与正常对照组比较差异无统计学意义(P>0.05)。结论化学发光法检测rT_3具有良好的精密度、准确度和特异性,线性范围较宽,适用于临床大规模样本的检测。rT_3可用于鉴别甲减与ESS。
Objective To evaluate the performance of reverse triiodothyronine（rT3） determination by chemiluminescence assay. Methods The precision,accuracy,analytical sensitivity,analytical specificity,linearity,reference range and methodological comparison of rT3 determination by chemiluminescence assay were evaluated according to EP documents of the Clinical and Laboratory Standards Institute（CLSI）. The levels of 3,5,3＇-triiodothyronine（T3）,thyroxine（T4）,thyroid-stimulating hormone（TSH） and rT3 were determined in 50 healthy subjects（healthy control group） and 131 patients,including 30 preliminarily diagnosed hyperthyroidism patients（hyperthyroidism group）,28 hyperthyroidism patients with treatment for 1 month（hyperthyroidism treatment group）,25 preliminarily diagnosed hypothyroidism patients（hypothyroidism group）,23 hypothyroidism patients with treatment for 1 month（hypothyroidism treatment group） and 25 primary non-thyroid diseases [euthyroid sick syndrome（ESS）]. Results For high-level and low-level quality control materials of rT3,the within-run coefficients of variation（CV）were 4.82% and 4.95%,and the between-run CV were 7.51% and 5.90%,respectively. The biases were-1% and 1%. The linearity was 0.05-10.07 ng/m L,and the reference range was 0.20-0.95 ng/mL. There was a good correlation between chemiluminescence assay with radioimmunoassay（r=0.952）. Compared with healthy control group,the levels of rT3,T3 and T4 in hyperthyroidism group were increased（P〈0.05）,and TSH was decreased（P〈0.05）. In hypothyroidism group,the levels of rT3 and T4 were decreased（P〈0.05）,and TSH was increased（P〈0.05）. Compared with hyperthyroidism group,hyperthyroidism treatment group had decreased rT3,T3 and T4 levels（P〈0.05）,and TSH was increased（P〈0.05）. Compared with hypothyroidism group,hypothyroidism treatment group had increased rT3 and T4 levels（P〈0.05）,and TSH decreased（P〈0.05）. The level of rT3 in ESS group was higher than those in hypothyroidism and healthy control groups（P〈0.05）,the levels of T3 and T4 were lower than those in healthy control group（P〈0.05）,there was no statistical significance compared with hypothyroidism group（P〉0.05）,TSH level was lower than that in hypothyroidism group（P〈0.05）,and there was no statistical significance compared with healthy control group（P〉0.05）. Conclusions The determination of rT3 by chemiluminescence assay has good precision,accuracy,specificity and linearity,which is suitable for large scale sample determination. It can be used for the differential diagnosis of hypothyroidism and ESS.
作者
宋云霄
邬建民
张海晨
SONG Yunxiao;WU Jianmin;ZHANG Haichen(Department of Clinical Laboratory,Shanghai Xuhui Central Hospital,Shanghai200031,China;Department of Clinical Laboratory,Shanghai Yangpu District Mental Health Center,Shanghai 200093,China)
出处
《检验医学》
CAS
2018年第6期543-548,共6页
Laboratory Medicine
关键词
反三碘甲状腺原氨酸
化学发光法
方法学评价
Reverse triiodothyronine
Chemiluminescence assay
Methodological evaluation
