An Analytical Performance Evaluation of Thyroid Stimulating Hormone Receptor Antibody(TRAb)Magnetic Particle Chemiluminescence Immunoassay According to Chinese WS/T Document
Objective The current study aims to evaluate the performance of the Mindray magnetic particle chemiluminescence immunoassay (CLIA ) for thyroid stimulating hormone receptor antibody (TRAb ) detection according to Chinese Health Industry Standard (WS/T)document.Methods A total of 50 serum samples were collected from the outpatients and healthy subjects of the Aerospace Central Hospital from April to June,2022.Roche electrochemiluminescence immunoassay (ECLIA)on Cobas e601 was claimed as the validation method by Mindray.The analytical performance of Mindray CLIA were assessed with within-run and inter-laboratory imprecision,relative difference based on patient samples,linearity,limit of detection,reference range,and the clinical agrrement with Roche ECLIA.Results The within-run and inter-laboratory imprecision of Mindray CLIA for TRAb detection ranged from 1.56％ to 4.60％ and 1.65％ to 5.19％,respectively.The relative difference between Mindray CLIA and Roche ECLIA was -3.6％.CLIA showed a linear response ranging from 0.02 IU/L to 44.00 IU/L with a fitted equation:Y=1.040X+0.636 and a linear coefficient R2=0.990.Only two results from twnety four data points (2/24)close to functional assay sensitivity were out of the detection limit (0.3 IU/L).Among 20 serum samples from healthy subjects,only one result exceeded the reference range (≤1.9IU/L).The positive coincidence rate,negative coincidence rate and total coincidence rate of the two assays for detecting TRAb were 75％,100％,and 90％,respectively,and the Kappa value was 0.7826 (P<0.001).Conclusion The Mindray CLIA shows a decent precision and truness based on patient samples and linearity as manufacturer's claims.The valiated reference range can be transferred to our laboratory,and there is a good clinical agreement between the Mindray CLIA and the Roche ECLIA.CLIA can be used as a reliable method for clinical detection of serum TRAb levels in our laboratory.
Thyrotropin receptor antibodyHigh sensitivity magnetic particle chemiluminescence assayPerformance verificationClinical agreement
万方数据
维普
