化学发光法检测反三碘甲状腺原氨酸的临床应用评价

doi:10.3969/j.issn.1673-8640.2018.06.017

摘要/Abstract

摘要：

目的评价化学发光法检测反三碘甲状腺原氨酸（rT₃）的分析性能,并探讨rT₃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rT₃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（T₃）、甲状腺素（T₄）、促甲状腺激素（TSH）及rT₃]并作比较。结果化学发光法检测rT₃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rT₃、T₃、T₄水平明显升高（P<0.05）,TSH水平明显降低（P<0.05）;甲减组T₄和rT₃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rT₃、T₃、T₄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rT₃、T₄水平明显升高（P<0.05）,TSH水平明显降低（P<0.05）。ESS组rT₃水平明显高于甲减组和正常对照组（P<0.05）,T₃和T₄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rT₃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。rT₃可用于鉴别甲减与ESS。

关键词: 反三碘甲状腺原氨酸, 化学发光法, 方法学评价

Abstract:

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/mL,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.

Key words: Reverse triiodothyronine, Chemiluminescence assay, Methodological evaluation

中图分类号:

R446.1

宋云霄, 邬建民, 张海晨. 化学发光法检测反三碘甲状腺原氨酸的临床应用评价[J]. 检验医学, 2018, 33(6): 543-548.

SONG Yunxiao, WU Jianmin, ZHANG Haichen. Determination of reverse triiodothyronine by chemiluminescence assay[J]. Laboratory Medicine, 2018, 33(6): 543-548.

图/表 5

参考文献 19

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质控品	批内精密度			批间精密度
质控品	x（ng/mL）	s（ng/mL）	CV（%）	x（ng/mL）	s（ng/mL）	CV（%）
低值	0.785	0.039	4.95	1.13	0.067	5.90
高值	2.535	0.122	4.82	2.28	0.171	7.51

质控品	批内精密度			批间精密度
质控品	x（ng/mL）	s（ng/mL）	CV（%）	x（ng/mL）	s（ng/mL）	CV（%）
低值	0.785	0.039	4.95	1.13	0.067	5.90
高值	2.535	0.122	4.82	2.28	0.171	7.51

样本	标定值（ng/mL）	测定值（ng/mL）	偏移（%）
低值	0.84	0.85	1
高值	2.98	2.94	-1

样本	标定值（ng/mL）	测定值（ng/mL）	偏移（%）
低值	0.84	0.85	1
高值	2.98	2.94	-1

组别	例数	T₃（nmol/L）	T₄（nmol/L）	rT₃（ng/mL）	TSH（μIU/L）
甲亢组	30	10.27±5.48^*	398.23±121.54^*	1.57±0.76^*	6.40±4.50^*
甲亢治疗组	28	5.23±2.31^#	212.21±35.78^#	1.22±0.32^#	14.20±11.20
甲减组	25	0.65±0.23	45.65±10.32^*	0.29±0.11^*	352.30±225.90^*
甲减治疗组	23	1.98±1.01	68.34±15.23	0.42±0.17	52.40±44.70^△
正常对照组	50	1.51±0.37	100.94±20.32	0.55±0.10	24.10±13.30