Reference Intervals and Cut-Off Values for Thyroid Tests in the Croatian Adult Population on the Snibe MAGLUMI X6 Immunoassay Analyzer.

Abstract

Background/Objectives: To establish reference intervals (RIs) and cut-off values for thyroid-related tests on the MAGLUMI X6 immunoassay analyzer (Snibe Diagnostic, Shenzhen, China) in an adult Croatian population. Methods: This study included 305 healthy individuals who underwent regular preventive medical checkup. The following tests were determined in serum: thyroid-stimulating hormone (TSH), total triiodothyronine (TT3), total thyroxine (TT4), free triiodothyronine (FT3), free thyroxine (FT4), thyroglobulin (Tg), reverse triiodothyronine (revT3), total binding capacity of thyroglobulin (T-uptake), thyroglobulin antibodies (anti-Tg), anti-thyroid peroxidase antibodies (anti-TPO) and thyroid receptor antibodies (TRAb). TSH, TT3, TT4, FT3, FT4, Tg, revT3 and T-uptake results were used for calculating double-sided 95% RIs between the 2.5th and 97.5th percentiles. For anti-Tg, anti-TPO and TRAb, right-sided cut-offs that correspond to the 95th percentile were determined. Results: Reference intervals for TSH, TT4, FT3, FT4, Tg, T-uptake and revT3 did not differ by gender (p > 0.05) and were 0.77-5.04 mIU/L, 69.9-127.7 nmol/L, 3.84-6.20 pmol/L, 13.8-19.7 pmol/L, 1.8-51.2 µg/L, 0.9-1.2 TBI and 0.44-0.73 ng/mL, respectively. The RI for TT3 was different for males (1.49-2.53 nmol/L) and females (1.43-2.81 nmol/L), p = 0.021. A single cut-off for anti-TPO was established (<18 kIU/L). Differences in cut-offs for males and females were obtained for anti-Tg (<72 and <104 kIU/L, respectively) and TRAb (0.6 and 0.9 IU/L, respectively). Conclusions: This is the first study to determine RIs for thyroid function tests in Croatian adults on the Snibe analytical platform. The obtained results point out to the use of population- and immunoassay-specific RIs. For TT3, anti-Tg and TRAb gender-specific RIs should be considered.