Reference Intervals and Cut-off Values for Thyroid Tests on the SNIBE MAGLUMI X6
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Background & Objectives
The accuracy of thyroid diagnostics depends largely on population- and method-specific reference intervals (RI). The aim of this independent study (Lapić et al., 2025) was to establish RI and diagnostic cut-offs for a comprehensive thyroid panel on the chemiluminescence immunoassay system SNIBE MAGLUMI X6.
Methodology
In a population-based study, 305 healthy adults (thyroid-healthy cohort according to strict inclusion criteria) were examined. The analysis included 11 parameters:
- Baseline hormones: TSH, TT3, TT4, FT3, FT4
- Special parameters: Thyroglobulin (Tg), Reverse T3 (rT3), T-Uptake
- Autoantibodies: Anti-Tg, Anti-TPO, TRAb
Statistical evaluation was performed using the 2.5th and 97.5th percentiles (two-sided) for hormone parameters and the 95th percentile (one-sided cut-offs) for autoantibodies.
Results
Stability & Precision: The MAGLUMI system demonstrated high reproducibility across the entire panel.
Sex-specific differences: While the majority of parameters (including TSH, FT3, FT4) were independent of sex, significant differences were observed for TT3, Anti-Tg and TRAb, indicating the need for sex-specific reference limits in laboratory reporting.
Autoantibody validation: The established cut-offs for Anti-TPO and TRAb allow for a clear differentiation in the clinical diagnosis of autoimmune diseases (Hashimoto’s thyroiditis, Graves’ disease).
Conclusion for Laboratory Management
The study confirms that the MAGLUMI X series represents a precise and clinically reliable platform for modern thyroid diagnostics. The availability of validated reference intervals for 11 parameters – including less commonly assessed markers such as Reverse T3 – provides laboratories with a high level of diagnostic depth and confidence in result interpretation.
Data source:
Publication: Diagnostics (MDPI), 2025.
Reference: Lapić I, et al. "Reference Intervals and Cut-Off Values for Thyroid Tests in the Croatian Adult Population on the Snibe MAGLUMI X6 Immunoassay Analyzer."
Identification: PMID: 41008732 (Open Access)