Endocrine Abstracts

JOINT2037

Introduction: Hypothyroidism affects 200 million people globally, with 4 million new diagnoses annually. Despite thyroid-stimulating hormone (TSH)-guided levothyroxine (LT4) replacement therapy, many patients experience persistent symptoms and impaired quality of life. TSH monitoring is recommended every 4-8 weeks upon diagnosis or treatment modification, with increased frequency during pregnancy and 1-2 times per year for maintenance. However, up to 50% of patients show TSH levels outside the reference range, increasing the risk of symptoms, pregnancy complications, and comorbidities associated with dysregulation. Current laboratory-based testing is costly and inconvenient, limiting patient compliance, and delaying treatment adjustments.

Objective: We present data on the ThyroSense prototype, a point-of-care (POC) home monitoring device that provides real-time, quantitative TSH measurements. This technology aims to improve disease self-management, reduce healthcare visits, and enhance treatment precision.

Methods: The ThyroSense system comprises a handheld reader, a single-use cartridge containing a test strip, and a companion mobile application. It utilizes a novel proprietary sensing chemistry for TSH detection. Analytical performance was assessed using electrochemical impedance spectroscopy, ELISA (for the selectivity tests), and anonymous clinical plasma samples. Clinical samples were pooled for biological normalization to TSH concentrations of 1, 5, and 10 mIU/l, respectively.

Results: The ThyroSense sensor demonstrated high specificity for TSH, with no significant cross-reactivity to luteinizing hormone, follicle stimulating hormone, and human chorionic gonadotropin hormone, showing relative signal levels of 3%, 4%, and 3%, respectively, at equivalent TSH concentrations. TSH was quantified within a range of 0-10 mIU/l with a detection limit of 0.2 mIU/l and a coefficient of variation of 10.7-13.0%. Results were obtained within 5 minutes of sample application.

Conclusions: There are currently no quantitative home-based TSH monitoring devices available. ThyroSense offers a cost-effective (aimed at <5£/test), user-friendly solution that can enhance treatment adherence and personalized care, particularly for newly diagnosed patients, before and during pregnancy, treatment adjustments, and long-term monitoring. Additionally, this device may facilitate research on TSH kinetics and treatment responses, potentially improving hypothyroidism management.