The method comparison and the verification of precision of Mindray CL-6000i thyroid function tests (TFTs)

Abstract

Abstract Objectives Thyroid diseases are the most frequent endocrine disorders and thyroid function tests (TFTs) are the most commonly requested endocrine tests. The reliable measurements of these tests are quite important. The aim of our study was to determine the bias and to verify the precision of the newly introduced Mindray CL-6000i immunoassay system in the guidance of CLSI guidelines. Methods A precision and bias study was performed in Mindray CL-6000i analyzer for FT3, FT4, TSH, Anti-TG, and Anti-TPO tests by using BioRad quality control (QC) materials and serum samples, respectively. Bland–Altman difference plot and Passing-Bablok regression analysis was made for method comparison with Beckman Coulter DXI 800 analyzer. Results The repeatability coefficient of variations (CVs) of FT3, FT4, TSH, Anti-TG, and Anti-TPO tests were ≤2.36, ≤1.66, ≤2.38, ≤3.48, and ≤3.31% while within laboratory CVs were ≤2.85, ≤4.61, ≤2.59, ≤3.78, and ≤3.60%, respectively. The mean differences between the two methods obtained from Bland–Altman analysis for FT3, FT4, TSH, Anti-TG, and Anti-TPO were defined to be −19%, 1.95%, −5.9%, −3.5%, and 7.3%, respectively. Conclusions Mindray CL-6000i had good precision in all tests, but the difference between the two methods in some tests shows that the harmonization and standardization of TFTs initiated globally is required.