[1]周建平,宋晓龙,常　琳,等.国产化学发光免疫试剂检测TRAb的性能评估及临床应用价值[J].现代检验医学杂志,2021,36(02):92-97.[doi:doi:10.3969/j.issn.1671-7414.2021.02.022]
　ZHOU Jian-ping,SONG Xiao-long,CHANG Lin,et al.Performance Evaluation and Clinical Application Value of Domestic Chemiluminescence Immunoassay Reagent in Detecting Thyrotropin Receptor Antibody[J].Journal of Modern Laboratory Medicine,2021,36(02):92-97.[doi:doi:10.3969/j.issn.1671-7414.2021.02.022]
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国产化学发光免疫试剂检测TRAb的性能评估及临床应用价值()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第36卷
期数:
2021年02期
页码:
92-97
栏目:
论　著
出版日期:
2021-04-30

文章信息/Info

Title:
Performance Evaluation and Clinical Application Value of Domestic Chemiluminescence Immunoassay Reagent in Detecting Thyrotropin Receptor Antibody
文章编号:
1671-7414（2021）02-092-06
作者:
周建平; 宋晓龙; 常　琳; 等
（陕西省人民医院放免中心，西安 710068）
Author(s):
ZHOU Jian-ping;  SONG Xiao-long;  CHANG Lin;  et al
(Department of Radioimmunity Center, Shaanxi Provincial People’s Hospital, Xi’an 710068, China)
关键词:
国产化学发光免疫试剂; 促甲状腺激素受体抗体; 临床应用价值;  格雷夫斯病
分类号:
R446
DOI:
doi:10.3969/j.issn.1671-7414.2021.02.022
文献标志码:
A
摘要:
目的　对某国产化学发光免疫（chemiluminescence immunoassay，CLIA）试剂检测促甲状腺激素受体抗体（thyrotropin receptor antibody，TRAb）的性能进行评估，并探讨其临床应用价值。方法　参考美国临床实验室标准化协会系列文件，对国产CLIA试剂检测血清TRAb的精密度、特异度、正确度、线性范围以及参考区间进行评价；收集2019年6~12月在陕西省人民医院内分泌科就诊的168例甲状腺相关疾病患者（格雷夫斯病121例；桥本氏甲状腺炎22例；非自身免疫性良性甲状腺结节19例；分化型甲状腺癌6例）及60例健康体检者的血清样本，分别用国产CLIA试剂和进口电化学发光免疫（electrochemiluminescence immunoassay，ECLIA) 试剂检测血清TRAb水平，对两种试剂的检测结果进行相关性和一致性评价，并评价国产TRAb CLIA试剂诊断格雷夫斯病的效能。结果　国产CLIA试剂检测高、低水平TRAb的重复性（coefficient of variation，CV）分别为2.04%和6.08%，实验室内不精密度分别为2.62%和6.50%；检测2 000 IU/ml的甲状腺球蛋白抗体、2 000 IU/ml的甲状腺过氧化物酶抗体、1 000 mIU/L的促甲状腺激素、10 000 IU/L的促黄体生成素、10 000 IU/L的促卵泡生成素和50 000IU/L的人绒毛膜促性腺激素，结果均< 0.3 IU/L；高、低水平国际标准品的相对偏差分别为5.05%和1.33%；在0.65 IU/L～44.21 IU/L之间呈良好的线性关系（r2=0.999，P﹤0.000 1）；参考区间验证结果显示20例健康体检者血清TRAb水平均< 2.0 IU/L；两种试剂检测结果相关性r2=0.939 6，斜率为1.058；定性分析结果显示，两种试剂检测结果的总体符合率为97.37%，Kappa值为0.947（P﹤0.000 1） ；国产TRAb CLIA试剂诊断格雷夫斯病的灵敏度为95.04%。结论　国产CLIA试剂检测血清TRAb的各项性能指标均表现良好，能够满足临床要求，有较好的临床应用前景。

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备注/Memo

备注/Memo:
作者简介：周建平（1974-），男，硕士，副主任医师，主要从事肿瘤早期筛查和诊断工作， E-mail: zjp868@163.com。
更新日期/Last Update: 2021-04-10