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Generation of a Mouse Spontaneous Autoimmune Thyroiditis Model

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Published on: March 17, 2023

A novel bioassay for thyroid-blocking immunoglobulins.

Augustine George¹, Johannes Lotz², Maximilian Luffy¹

¹Molecular Thyroid Research Lab, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany.

Frontiers in Endocrinology

|November 13, 2024

Summary

A new Turbo™ bioassay for thyroid-blocking immunoglobulins (TBI) shows superior sensitivity and reliability in detecting TBI in autoimmune thyroid disease patients compared to existing methods. This assay offers improved analytical performance for better patient management.

Keywords:

autoimmune thyroid disease blocking TSH-R bioassay homogeneous cAMP biosensor thyroid-blocking immunoglobulins thyrotropin receptor blocking antibodies

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Area of Science:

Endocrinology
Immunology
Clinical Diagnostics

Background:

Thyroid-blocking immunoglobulins (TBI) are found in 10%-15% of autoimmune thyroid disease (AITD) patients and impact thyroid function.
Accurate detection of TBI is crucial for managing AITD and predicting thyroid dysfunction.

Purpose of the Study:

To evaluate the analytical performance of a novel TBI bioassay, the Turbo™ cyclic adenosine 3',5'-monophosphate (cAMP) assay.
To compare the Turbo™ assay's sensitivity and reliability against a previous TBI bioassay (Thyretain®) and TSH-R binding immunoassays.

Main Methods:

Sera from 1,011 AITD patients were tested using the Thyretain® and Turbo™ TBI bioassays, alongside two TSH-R binding immunoassays.
Statistical analyses included Passing-Bablok regression, Bland-Altman plots, and user/lot comparisons.
Dose-response curves were generated to compare half-maximal and 80% inhibitory concentrations (IC50/IC80).

Main Results:

The Turbo™ assay detected TBI in 100% (212/212) of TBI-positive samples, significantly outperforming Thyretain® (79%) and binding assays (65%).
Turbo™ assay results showed a strong correlation with thyroid function (p<0.001) and TSH-R-Ab binding positivity.
The Turbo™ assay demonstrated higher sensitivity (lower IC50/IC80 values) and excellent intra-assay precision (average CV 5.4%).

Conclusions:

The novel Turbo™ TSH-R blocking bioassay exhibits superior analytical performance and clinical utility for detecting TBI in AITD patients.
This rapid, reliable, and easy-to-perform assay enhances the management of patients with autoimmune thyroid disease.