Chemiluminescence Analysis HD-HOOK Effect Detection

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Solution Overview

Problem

The high dose hook effect (HD-HOOK effect) in chemiluminescence immune analysis leads to false negatives, as it limits the detection range and results in inaccurate concentration readings due to the linear orientation of the dose response curve dropping instead of rising indefinitely, frequently occurring in 30% of positive samples.

Innovation Solution

A chemiluminescence analytical method that involves mixing a sample with reagents to form a mixture, initiating chemiluminescence reactions multiple times, recording signal values, selecting growth rates from these values, and plotting standard curves to determine the concentration of the analyte, thereby broadening the detection range and avoiding HD-HOOK effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional single-point detection is used in chemiluminescence immune analysis, then the detection process is simple and fast, but the detection range is limited and false negatives occur due to HD-HOOK effect

Engineering Contradiction:
Improvedetection accuracyVSAvoiddetection process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The detection process is segmented into multiple measurement points (first signal value and second signal value at different time points), allowing the system to distinguish between linear range and HD-HOOK effect by comparing signals at different stages of the reaction

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system performs preliminary measurements at multiple time points before final concentration calculation, enabling early detection of HD-HOOK effect patterns and preventing false negative results

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If multiple measurements are performed to avoid HD-HOOK effect, then detection range is broadened and accuracy is improved, but the detection time and complexity increase

Engineering Contradiction:
Improveconcentration measurement precisionVSAvoiddetection time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system performs periodic measurements at specific time intervals (first time point and second time point) to capture the dynamic signal changes, enabling identification of HD-HOOK effect through temporal patterns while maintaining efficient detection throughput

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The system uses feedback from multiple signal measurements to determine whether HD-HOOK effect is present, adjusting the concentration calculation approach accordingly (using growth rate for HD-HOOK samples vs. direct concentration for linear range samples)

Inventive Principle:
Principle #23Feedback

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

This method accurately determines HD-HOOK-effect samples, improving the accuracy of double-antibody sandwich immunoassays and reducing false negatives by calculating concentrations based on growth rates within the rising or dropping sections of the standard curve.

Implementation Method 1

a donor reagent and an acceptor reagent, the donor reagent includes a donor, and the donor is capable of generating singlet oxygen in an initiated state; and the acceptor reagent includes a acceptor, and the acceptor is capable of reacting with the singlet oxygen so as to generate a detectable chemiluminescence signal value

Methodology Applied
Scientific EffectChemiluminescence: Chemiluminescence

Data Source

PatentEP3798615B1Chemiluminescence analytical method and system and kit using same
Publication Date: 2023.12.20 BEYOND DIAGNOSTICS (SHANGHAI) CO LTD
  • EP3798615B1 patent drawingFigure 1~2
  • EP3798615B1 patent drawingFigure 3~4
  • EP3798615B1 patent drawingFigure 5~6

AI summary

Disclosed is a chemiluminescence analytical method in the technical field of chemiluminescence. The present method broadens a detection range and indicates an HD-HOOK sample or a sample that is beyond the detection range by way of selecting two signal values from signal values that are read in multiple times, and simply and quickly calculates the concentration of an analyte during detection. Disclosed are a system using the chemiluminescence analytical method and a kit for the chemiluminescence analytical method.