Coagulation Time Extension Factor Estimation from Reaction Curves

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Solution Overview

Problem

Conventional methods for determining the cause of extended coagulation time in blood samples are labor-intensive and time-consuming, requiring long incubation times and complex calculations.

Innovation Solution

A method for estimating coagulation time extension factors by analyzing the shape of the coagulation reaction curve without incubation, using indices such as R1(X) and R2(X1, X2) to differentiate between lupus anticoagulant positivity, coagulation factor deficiency, and coagulation factor inhibitor positivity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a conventional cross mixing test is conducted to determine coagulation time extension factor, then the cause of coagulation time extension can be identified, but the test requires a great deal of labor and time

Engineering Contradiction:
Improvecoagulation time extension factor identification accuracyVSAvoidtest duration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The invention changes the parameter used for analysis from traditional APTT time points to specific percentage points (30%, 60%, 90%) of the coagulation reaction curve. This parameter transformation enables rapid calculation of the correction index without requiring long incubation periods, thus reducing test duration while maintaining diagnostic accuracy for identifying coagulation time extension factors

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention extracts only the essential information needed for diagnosis by calculating the correction index at specific percentage points of the coagulation reaction curve. This extraction approach eliminates the need for complete cross-mixing test procedures including long incubation periods and multiple time point measurements, significantly reducing test time while preserving the ability to identify coagulation time extension factors

Inventive Principle:
Principle #2Taking out (Extraction)

2Measurement precision

If a cross mixing test with incubation is performed to determine coagulation time extension factor, then accurate diagnosis can be obtained, but the procedure requires a great deal of labor

Engineering Contradiction:
Improvecoagulation time extension factor identification accuracyVSAvoidtest procedure complexity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The invention extracts only the critical percentage points (30%, 60%, 90%) from the complete coagulation reaction curve for calculation of the correction index. This extraction eliminates the need for complex incubation procedures and multiple time point measurements, significantly simplifying the test procedure while maintaining the ability to accurately identify coagulation time extension factors

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention transforms the analysis parameter from traditional APTT time-based measurements to percentage-based positions on the coagulation reaction curve. This parameter change simplifies the calculation process and eliminates complex incubation requirements, making the test easier to perform while preserving diagnostic accuracy

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If a method requiring long incubation time is used to obtain coagulation time extension information, then diagnostic accuracy can be achieved, but the method is time-consuming

Engineering Contradiction:
Improvecoagulation time extension factor identification accuracyVSAvoidincubation time
Core Design Contradiction:
Measurement precisionVSDuration of action of moving object

Solution Approach 1:

The invention changes the measurement parameter from time-based APTT values to percentage-based positions (30%, 60%, 90%) on the coagulation reaction curve. This parameter transformation enables the calculation of the correction index using data from a single time point without incubation, eliminating the need for long incubation periods while maintaining the ability to accurately identify coagulation time extension factors

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention performs preliminary calculation of the correction index using specific percentage points of the coagulation reaction curve before any incubation would be required. This preliminary action using transformed parameters enables rapid identification of coagulation time extension factors without waiting for incubation results

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20250216405A1Coagulation time extension factor estimation method
Publication Date: 2025.07.03 SEKISUI MEDICAL CO LTD
  • US20250216405A1 patent drawing
  • US20250216405A1 patent drawing
  • US20250216405A1 patent drawing

AI summary

Provided is a coagulation time extension factor estimation method, comprising: 1) obtaining Tm(X) and Tn(X); and 2) estimating a coagulation time extension factor for a test blood sample on the basis of Tm(X), wherein Tm(X) represents a measurement point or a time at which a coagulation reaction curve of sample M reaches X % of coagulation reaction end point Em, Tn(X) represents a measurement point or a time at which a coagulation reaction curve of sample N reaches X % of coagulation reaction end point En, Em is a coagulation reaction end point in the coagulation reaction curve of sample M, En is a coagulation reaction end point in the coagulation reaction curve of sample N, the sample S is a test blood sample having an extended coagulation time, the sample N is a normal blood sample, the sample M is a sample mixture of the sample S and the sample N, and X is larger than 0 and 100 or smaller.