Thyroglobulin Immunoassay Pretreatment for TgAb Interference

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Solution Overview

Problem

Existing methods struggle to accurately measure thyroglobulin levels in biological samples with anti-thyroglobulin antibodies, leading to inaccurate results, especially in patients with thyroid diseases like Hashimoto's disease and Basedow's disease.

Innovation Solution

A pretreatment step involving a mixture of a biological sample with a pretreatment liquid containing an alkaline substance and surfactants or urea to release thyroglobulin from anti-thyroglobulin antibodies, followed by an immunoassay.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a pretreatment liquid containing acidifier and surfactant is used to treat samples, then thyroglobulin can be released from antibody complexes, but the antibody used in the immunoassay must be resistant to the acidifier and surfactant

Engineering Contradiction:
Improvethyroglobulin measurement accuracyVSAvoidantibody selection flexibility
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The invention changes the chemical parameters of the pretreatment liquid by replacing acidifier with alkaline substance (pH adjustment from acidic to alkaline range). This parameter change allows the use of conventional antibodies that are not resistant to alkaline conditions, thereby resolving the contradiction between achieving accurate Tg measurement and maintaining antibody selection flexibility.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If conventional immunoassay is used without pretreatment, then the measurement process is simple, but inaccurate results are obtained in TgAb-positive patients

Engineering Contradiction:
Improvemeasurement process simplicityVSAvoidthyroglobulin measurement accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The invention introduces a preliminary action step (pretreatment with alkaline substance and surfactant/urea) before the main immunoassay measurement. This preliminary step releases Tg from TgAb complexes, ensuring accurate measurement in TgAb-positive patients while maintaining overall process simplicity through automated workflow integration.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If pretreatment with alkaline substance, surfactant, and urea is performed, then thyroglobulin measurement accuracy is improved in TgAb-positive samples, but the measurement process complexity increases

Engineering Contradiction:
Improvethyroglobulin measurement accuracyVSAvoidmeasurement process complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention merges multiple functions into a single pretreatment liquid formulation that contains alkaline substance, surfactant, and urea. This combination approach achieves multiple objectives (Tg release, antibody denaturation, complex disruption) simultaneously, reducing the number of separate steps and reagents needed, thereby mitigating process complexity while maintaining measurement accuracy.

Inventive Principle:
Principle #5Merging (Combining)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables accurate measurement of thyroglobulin levels without interference from anti-thyroglobulin antibodies, allowing the use of antibodies less resistant to acidifiers and surfactants, and improving sensitivity in immunoassays.

Implementation Method 1

a pretreatment step of mixing the biological sample with a pretreatment liquid containing an alkaline substance

Methodology Applied
Scientific EffectChemical denaturation:

Implementation Method 2

the pretreatment liquid further contains at least one selected from the group consisting of nonionic surfactants, zwitterionic surfactants, anionic surfactants, and urea

Methodology Applied
Scientific EffectSurfactant action: Surfactant

Data Source

PatentEP3978921B1Method and reagent for measuring thyroglobulin
Publication Date: 2026.03.04 FUJIREBIO CO LTD

AI summary

Disclosed are a measurement method and a measurement reagent for thyroglobulin, which measurement method and measurement reagent enable more accurate measurement of the thyroglobulin level by a single test without being influenced by interference of anti-thyroglobulin antibody, and which measurement method and measurement reagent allow use of even an antibody less resistant to an acidifier and/or a surfactant in an immunoassay. A method of measuring, by an immunoassay, thyroglobulin in a sample separated from a living body includes a pretreatment step of mixing the sample separated from the living body with a pretreatment liquid containing an alkaline substance.