Phosphorylcholine Polymer Reagents for Reliable APTT Testing

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Solution Overview

Problem

Existing blood coagulation tests struggle to accurately detect specimens with coagulation abnormalities such as coagulation factor deficiency, lupus anticoagulant positivity, and heparin presence, leading to inconsistent sensitivity in measuring activated partial thromboplastin time (APTT).

Innovation Solution

A reagent and regulator using a polymer with 2-methacryloyloxyethyl phosphorylcholine as a constitutional unit, optionally combined with other monomers and compounds, to regulate and measure blood coagulation time in LA-positive or heparin-containing specimens, enhancing sensitivity and precision in APTT measurement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional APTT measurement reagents are used, then the measurement can be performed, but the sensitivity and precision for detecting LA-positive and heparin-containing specimens are insufficient

Engineering Contradiction:
ImproveAPTT measurement precisionVSAvoiddetection reliability of coagulation abnormalities
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent changes the chemical composition parameters of the APTT reagent by incorporating a polymer with 2-methacryloyloxyethyl phosphorylcholine as a constitutional unit, along with specific phospholipids and metal ion activators. This parameter change in reagent composition improves the measurement precision and reliability for detecting LA-positive and heparin-containing specimens by enhancing the reagent's ability to differentiate between normal and abnormal coagulation samples.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs a composite reagent system combining multiple components: a polymer with 2-methacryloyloxyethyl phosphorylcholine, phospholipids (phosphatidylcholine, phosphatidylserine, phosphatidylethanolamine), and metal ion activators (calcium, manganese, zinc, copper). This composite material approach creates synergistic effects that improve both measurement precision and detection reliability for various coagulation abnormalities including LA-positive and heparin-containing specimens.

Inventive Principle:
Principle #40Composite materials

2Reliability

If existing reagents are used for APTT measurement, then the test can be conducted, but the sensitivity to detect coagulation abnormalities is inconsistent

Engineering Contradiction:
Improvedetection reliability of coagulation abnormalitiesVSAvoidAPTT measurement precision
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent optimizes the concentration parameters of each reagent component, specifically using phospholipid concentrations of 0.01-1.0 mM for phosphatidylcholine, 0.01-0.5 mM for phosphatidylserine, and 0.01-0.1 mM for phosphatidylethanolamine. The metal ion activator concentrations are also optimized (calcium 1-10 mM, manganese 0.1-1 mM, zinc 0.1-1 mM, copper 0.1-1 mM). These parameter changes ensure consistent sensitivity across different specimen types while maintaining measurement precision.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The composite reagent formulation combines multiple phospholipid types and metal ion activators in specific ratios, creating a synergistic system that provides consistent detection sensitivity for various coagulation abnormalities. The polymer with 2-methacryloyloxyethyl phosphorylcholine serves as a stabilizing matrix that enhances the overall performance and consistency of the reagent system.

Inventive Principle:
Principle #40Composite materials

3Ease of operation

If standard APTT reagents are used, then the measurement process is simple, but the ability to accurately regulate blood coagulation time in abnormal specimens is limited

Engineering Contradiction:
Improveoperation simplicityVSAvoidblood coagulation time regulation precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent creates a universal APTT reagent that can handle multiple specimen types (normal blood, LA-positive blood, heparin-containing blood) with a single reagent formulation. The polymer with 2-methacryloyloxyethyl phosphorylcholine provides a stable base that works across different specimen types, while the phospholipid and metal ion combination provides the necessary coagulation activation. This multi-functional reagent maintains ease of operation while achieving precise blood coagulation time regulation across various pathological conditions.

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

Data Source

PatentEP4603841A1Reagent for measuring activated partial thromboplastin time, and blood coagulation time regulator for lupus anticoagulant-positive blood specimen or heparin-containing blood specimen
Publication Date: 2025.08.20 SEKISUI MEDICAL CO LTD
  • EP4603841A1 patent drawing
  • EP4603841A1 patent drawing
  • EP4603841A1 patent drawing

AI summary

An activated partial thromboplastin time measurement reagent contains a polymer having 2-methacryloyloxyethyl phosphorylcholine as a constitutional unit. A blood coagulation time regulator for a lupus anticoagulant-positive blood specimen or a heparin-containing blood specimen in activated partial thromboplastin time measurement includes, as an active ingredient, a polymer having 2-methacryloyloxyethyl phosphorylcholine as a constitutional unit.