Multiplex PCT and Presepsin Detection Kit for Sepsis Diagnosis

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Solution Overview

Problem

Current biomarkers for sepsis, such as procalcitonin (PCT) and soluble CD14 subtype (Presepsin), have limitations in specificity and sensitivity for early diagnosis and prognosis, leading to a need for a more effective combined detection method.

Innovation Solution

A kit and method for combined detection of PCT and Presepsin using a capture antibody mixture and labeled detection antibodies, where both antibodies share the same label, allowing for simultaneous detection on a solid phase, enhancing diagnostic efficacy and prognostic power.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If separate detection of PCT and Presepsin is performed using different kits, then detection specificity is maintained, but detection time and operational complexity increase

Engineering Contradiction:
Improvedetection specificityVSAvoiddetection time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent combines separate detection of PCT and Presepsin into a single multiplex detection system by coating both capture antibodies on the same solid phase carrier, allowing simultaneous detection of both biomarkers in one assay, thereby reducing detection time while maintaining specificity through antibody-specific binding

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The solid phase carrier serves multiple functions by simultaneously supporting both PCT capture antibody and Presepsin capture antibody coating, enabling a single platform to perform what previously required two separate detection systems

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If separate detection of PCT and Presepsin is performed using different kits, then detection accuracy is maintained, but economic cost increases

Engineering Contradiction:
Improvedetection accuracyVSAvoidreagent consumption
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The invention merges two separate detection systems into one multiplex assay, reducing reagent consumption and economic cost by performing both PCT and Presepsin detections simultaneously in a single reaction system rather than requiring two separate kits

Inventive Principle:
Principle #5Merging (Combining)

3Measurement precision

If separate detection of PCT and Presepsin is performed, then individual biomarker analysis is accurate, but overall diagnostic efficacy is limited

Engineering Contradiction:
Improvebiomarker detection accuracyVSAvoiddiagnostic efficacy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent combines detection of both PCT and Presepsin in a single multiplex system, enabling comprehensive sepsis diagnosis through simultaneous analysis of both biomarkers, thereby improving overall diagnostic efficacy and reliability while maintaining individual detection accuracy

Inventive Principle:
Principle #5Merging (Combining)

4Reliability

If multiple detection systems are used for PCT and Presepsin, then comprehensive analysis is achieved, but impact of reagent batch variations increases

Engineering Contradiction:
Improveanalysis comprehensivenessVSAvoidreagent batch consistency
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The invention uses a single detection system for both PCT and Presepsin, eliminating the problem of reagent batch variations between different kits while maintaining comprehensive analysis capability through simultaneous detection of both biomarkers in the same reaction environment

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

The combined detection method improves diagnostic accuracy and prognostic capability for sepsis, reduces economic and time costs, and minimizes blood consumption, while reducing the impact of reagent batch variations.

Implementation Method 1

a procalcitonin capture antibody coated on a solid phase and a soluble CD14 subtype capture antibody coated on a solid phase; and a detection antibody mixture, the detection antibody mixture comprising a labeled procalcitonin detection antibody and a labeled soluble CD14 subtype detection antibody

Methodology Applied
Scientific EffectAntigen-antibody binding:

Data Source

PatentEP4060338B1Kit and method for mixed detection of PCT and presepsin, and use thereof
Publication Date: 2024.07.17 SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
  • EP4060338B1 patent drawingFigure 1~2
  • EP4060338B1 patent drawingFigure 3
  • EP4060338B1 patent drawingFigure 4

AI summary

A kit and a method for combined detection of PCT and Presepsin in a sample to be tested, and use thereof. The kit comprises: a capture antibody mixture, the capture antibody mixture comprising a procalcitonin capture antibody coated on a solid phase and a soluble CD14 subtype capture antibody coated on a solid phase; and a detection antibody mixture, the detection antibody mixture comprising a labeled procalcitonin detection antibody and a labeled soluble CD14 subtype detection antibody. The kit, method and use thereof can detect a combined signal value of PCT and Presepsin in a sample in a reaction system, the comparison between the combined signal value and a reference value can be used for evaluating the possibility of a patient suffering from sepsis and evaluating the prognosis of a suspected sepsis patient, and compared with detecting PCT or Presepsin in a sample alone, a more efficient diagnosis and a better prognostic power are provided.