Automatic Blood Coagulation Analysis Signal Referencing for Reliable Results
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Solution Overview
Problem
Existing automatic analysis devices face challenges in ensuring reliable measurement results for blood clotting time and nucleic acid amplification due to variations in reagent conditions and device settings, particularly when using different reagent lots or dissolving conditions, without the ability to create standard curves for these measurements.
Innovation Solution
The device and method utilize a blood clotting time reference sample to ascertain reagent and device conditions by setting a signal reference value for each reagent vessel, adjusting measurement conditions to minimize variations and improve reliability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard curves are created using standard samples in biochemical analysis, then measurement reliability is improved by absorbing device and reagent variations, but this approach cannot be applied to blood clotting time measurement where results are reported as time values rather than concentrations
Solution Approach 1:
The invention changes the parameter used for standardization from concentration (in biochemical analysis) to time-based signal reference values (in blood clotting time analysis). By setting signal reference values at specific time points during the clotting process, the method adapts the standardization approach to match the temporal nature of blood clotting measurements while maintaining reliability control.
Solution Approach 2:
The invention performs preliminary measurement of signal reference values using control samples before actual sample analysis. This preliminary action establishes baseline signal characteristics that account for device and reagent conditions, enabling subsequent reliable measurement of blood clotting times without requiring standard curves.
2Ease of operation
If reagents are dissolved by users in lyophilized form, then ease of operation is improved by allowing user preparation, but measurement reliability deteriorates due to variations in dissolving conditions
Solution Approach 1:
The invention implements feedback by measuring signal reference values using control samples prepared with the same reagents. This feedback mechanism detects variations introduced during user dissolving operations and enables correction through appropriate signal reference value settings, maintaining measurement reliability despite user preparation variations.
3Adaptability or versatility
If different reagent lots are used, then adaptability is improved by allowing flexibility in reagent selection, but measurement precision deteriorates due to reactivity variations between lots
Solution Approach 1:
The invention performs preliminary measurement of signal reference values specific to each reagent lot using control samples. By establishing lot-specific signal reference values before actual measurements, the system maintains measurement precision across different reagent lots while preserving the flexibility to use multiple lots.
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 approach enhances the reliability of measurement results by correcting for device and reagent lot differences, ensuring accurate blood clotting time and nucleic acid amplification measurements without the need for standard curves.
Implementation Method 1
an optical detection system (detection of transmitted light or detection of scattered light)
Implementation Method 2
a mechanical system (detection of viscosity)
Implementation Method 3
mainly an electrical resistance detection system
Data Source
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Figure 4
AI summary
A signal reference value (SLocal) is set at which a blood coagulation reaction time (T) of a blood coagulation time reference sample measured on the basis of the result of comparing a signal value (amount of transmitted light, amount of scattered light, amount of fluorescence, or turbidity) pertaining to blood coagulation time that varies temporally according to the mixing and reaction of the blood coagulation time reference sample and a reagent and a signal reference value (S) corresponds to an expected value (Te) for the blood coagulation reaction time that has been set beforehand so as to correspond to the blood coagulation time reference sample. As a result, it is possible to use the blood coagulation time reference sample to determine the state of the reagent and enhance the reliability of measurement results by setting a unique signal reference value for each reagent container.