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

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...

Performance Evaluation and Clinical Application Value of Domestic Chemiluminescence Immunoassay Reagent in Detecting Thyrotropin Receptor Antibody

Objective To evaluate the performance of a domestic chemiluminescence immunoassay(CLIA)reagentin detecting of Thyrotropin receptor antibody(TRAb)and furtherly explore its clinical application value.Methods According to the series documents of American Clinical and Laboratory Standards Institute(CLSI),evaluated the precision,specificity,accuracy,linear range and reference interval of the domestic CLIA reagent in detecting serumTRAb.The serum samples in this study were collected from patients who were admitted to department of Endocrinology,Shaanxi Provincial People’s Hospital from June to December 2019(121 cases of Graves’disease,22 cases of Hashimoto’s thyroiditis,19 cases of non-autoimmune benign thyroid nodule,and 6 cases of differentiated thyroid cancer)and 60 healthy persons.All serum samples were subjected to analyze the TRAb levels by CLIA assay and electrochemiluminescence immunoassay(ECLIA)assay.A comparative evaluation between the two assays was performed and the concordance of qualitative results was also assessed.Additionally,the diagnostic efficacy of CLIA assay for detecting TRAb in Graves’disease was also evaluated.Results The repeatability and within-laboratory imprecision(%coefficient of variation)of the CLIA were 6.08%and 6.50%at 1.87 IU/L,and 2.04%and 2.62%at 24.07 IU/L,respectively.The results of detecting 2000IU/mL thyroglobulin antibody,2000 IU/mL thyroid peroxidase antibody,1000 mIU/L thyroid stimulating hormone,10000IU/L luteinizing hormone,10000 IU/L follicle stimulating hormone,and 50000IU/L of human chorionic gonadotropin were all less than 0.3IU/L.The relative biases of high and low levels of World Health Organization international standard 2nd international standard for thyroid stimulating antibody were 5.05%and 1.33%,respectively.Meanwhile,the 0.65~44.21 IU/L range of CLIA assay showed a good linear(r²=0.999,P﹤0.0001).The serum TRAb levels of 20 healthy people were less than 2.0 IU/L.The two assays had a good correlation(r²=0.9396,slope=1.058).The overall coincidence rate of the two assays was 97.37%.The Kappa value was 0.947(P<0.0001).The sensitivity of CLIA assay in detecting TRAb for Graves’disease was 95.04%.Conclusion The main performance of the domestic TRAb CLIA reagentmeets the requirements of the relevant standards,which can satisfy the clinical requirements.