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.
Highlights
Thyroid gland dysfunctions can be regarded as the most frequent endocrine disorders and laboratory tests are essential for screening, diagnosing and follow-up of these conditions
A precision and bias study was performed in Mindray CL-6000i analyzer for Free T3 (FT3), free T4 tests (FT4), thyroid-stimulating hormone (TSH), Anti-TG, and Anti-TPO tests by using BioRad quality control (QC) materials and serum samples, respectively
The mean differences between the two methods obtained from Bland-Altman analysis for FT3, FT4, TSH, AntiTG, and Anti-TPO were defined to be −19%, 1.9%, −5.9%, −3.5%, and 7.3%, respectively (Figure 1A–E)
Summary
Thyroid gland dysfunctions can be regarded as the most frequent endocrine disorders and laboratory tests are essential for screening, diagnosing and follow-up of these conditions. When the prevalence of thyroid disorders and symptoms are taken into account, especially TSH measurement methods are important for reliable laboratory results [6, 7]. The measurement of TSH, as well as the other TFTs, is routinely performed using immunoassay methods in automated platforms in clinical laboratories [8, 9]. In order to attain comparability of measurement results between different methods, TFT methods should be standardized. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) initiated a phase IV study aiming to cover the benefits, risks and practical implementation of standardization and harmonization [10] in which some manufacturers re-calibrated their methods to participate in harmonization [14]. This work is licensed under the Creative Commons
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