Analytical validation of the LiCA® high-sensitivity human thyroid stimulating hormone assay

Area of Science:

• Clinical Chemistry
• Immunoassay Technology
• Endocrinology

Background:

• Evaluation of a novel high-sensitivity human thyroid stimulating hormone (hTSH) assay on the LiCA Smart system.
• Assessment of its analytical performance and clinical utility, particularly for detecting profoundly low TSH levels (<0.01 mIU/L).

Purpose of the Study:

• To validate the analytical characteristics of the LiCA Smart hTSH assay.
• To compare its ability to detect low TSH levels against existing ultrasensitive assays.
• To assess its clinical applicability in managing thyroid disorders.

Main Methods:

• Analytical validation including precision, linearity, reportable range, analytical sensitivity, interference, and lot-to-lot variability.
• Method comparison studies with established hTSH assays (Cobas, ADVIA, UniCel, Architect).
• Cross-sectional study on 236 patients with low TSH levels and follow-up of hyperthyroid patients.

Main Results:

• The LiCA Smart assay demonstrated excellent precision (<5% CV) and linearity (R=0.998).
• It showed good agreement with other methods (R>0.99, median bias <5%).
• The limit of quantitation was 0.0019 mIU/L, with a significantly higher detection rate (67.8%) for low TSH levels compared to Cobas (28.0%) and Architect (21.7%).
• Earlier TSH recovery was observed in treated hyperthyroid patients using LiCA.

Conclusions:

• The LiCA Smart hTSH assay is a precise, highly sensitive fourth-generation assay.
• It offers superior detection sensitivity for profoundly low TSH levels.
• The assay is suitable for clinical use in thyroid function testing.