HBsAg Detection Kit Using TCEP and Urea

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Solution Overview

Problem

Current HBsAg quantitative detection methods require sample dilution, which is time-consuming and reduces detection accuracy, as most clinical samples have HBsAg levels above the upper limit of detection for existing commercial reagents.

Innovation Solution

A kit and method using a reagent composition comprising tris(2-carboxyethyl)phosphine hydrochloride (TCEP) and urea, along with a monoclonal antibody, that allows for HBsAg detection up to 100,000 IU/mL without dilution, using a non-ionic surfactant, inorganic salt, and a buffer, simplifying the detection process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If sample dilution is performed to detect HBsAg levels above the upper limit of detection, then the detection range is extended, but the detection time increases and detection accuracy decreases

Engineering Contradiction:
Improvedetection rangeVSAvoiddetection time
Core Design Contradiction:
Quantity of substanceVSLoss of time

Solution Approach 1:

The patent changes the chemical parameters of the detection reagent by incorporating TCEP (tris(2-carboxyethyl)phosphine hydrochloride) and urea, which modify the detection system's ability to handle high-concentration samples without dilution, thereby expanding the detection range while maintaining speed and accuracy

Inventive Principle:
Principle #35Parameter changes

2Quantity of substance

If sample dilution is performed to detect HBsAg levels above the upper limit of detection, then the detection range is extended, but detection accuracy decreases

Engineering Contradiction:
Improvedetection rangeVSAvoiddetection accuracy
Core Design Contradiction:
Quantity of substanceVSMeasurement precision

Solution Approach 1:

The patent modifies the reagent composition parameters by adding TCEP and urea, which improve the detection system's linearity and accuracy for high-concentration HBsAg samples, allowing accurate measurement without dilution-induced errors

Inventive Principle:
Principle #35Parameter changes

3Quantity of substance

If sample dilution steps are added to detect high HBsAg levels, then the detection range increases, but the operational complexity increases

Engineering Contradiction:
Improvedetection rangeVSAvoidoperational simplicity
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The patent extracts the dilution step from the detection process by developing a reagent system that can directly detect high-concentration samples, eliminating the need for preliminary sample dilution operations

Inventive Principle:
Principle #2Taking out (Extraction)

4Ease of operation

If the upper limit of detection is increased to 100,000 IU/mL, then the need for dilution is eliminated, but the reagent composition complexity increases

Engineering Contradiction:
Improvedetection process simplicityVSAvoidreagent composition
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent adjusts the chemical parameters of the reagent by incorporating specific concentrations of TCEP and urea, which enable the simplified detection process while the reagent complexity is managed through controlled composition specifications

Inventive Principle:
Principle #35Parameter changes

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

The method ensures accurate detection of HBsAg levels within the range of most clinical samples without the need for dilution, improving detection efficiency and accuracy by expanding the upper limit of detection to 100,000 IU/mL.

Implementation Method 1

a first antibody capable of specifically binding to HBsAg

Methodology Applied
Scientific EffectAntibody-antigen binding:

Implementation Method 2

the reagent composition comprising tris(2-carboxyethyl)phosphine hydrochloride (TCEP) and urea

Methodology Applied
Scientific EffectChemical interaction enhancement by TCEP and urea:

Data Source

PatentUS11543413B2Kit and method for quantitative detection of HBsAg
Publication Date: 2023.01.03 XIAMEN INNODX BIOTECH CO LTD
  • US11543413B2 patent drawing
  • US11543413B2 patent drawing

AI summary

A kit for quantitatively detecting HBsAg and a method for quantitatively detecting an HBsAg content in a sample containing HBsAg. The kit comprises a first antibody specifically binding to HBsAg and a reagent composition. The reagent composition comprises tris(2-carboxyethyl)phosphine hydrochloride (TCEP) and urea.