Evaluation of the Consistency for Thyroid Function Detection with the Domestic and Imported Chemiluminescent Immunoassay Analyzers
Objective:Aim to explore the feasibility of clinical application for thyroid function detection by Mindray CL-6000i automated chemiluminescence immunoassay analyzer.Methods:According to CLSI EP15-A2 and CLSI EP9-A2 protocols for performance verification and methodological comparison,the levels of free triiodothyronine(FT3),free thyroxine(FT4),and thyroid-stimulating hormone(TSH)in 103 fresh serum samples were respectively detected by Mindray CL-6000i and LIAISON XL automated chemiluminescence immunoassay analyzers.Then the results were used to compared the correlation and consistency.Results:The coefficients of determination(R2)of FT3,FT4 and TSH between in Mindray CL-6000i and LIAISON XL analyzers respectively are 0.9525,0.9500 and 0.9741.The expected bias of two detection systems FT3,FT4,and TSH at the medical decision level were-0.30%~6.10%;7.20%~26.00%;-18.40%~-3.60%,respectively.Conclusion:Mindray CL-6000i and LIAISON XL analyzers are highly correlated.There is a good consistency in FT3 detection result,and there is a certain difference in the expected bias of the detection systems for FT4 and TSH results.
thyroid function testschemiluminescencemethod comparison