Chromatographic Analyzer Mode Switching for HbA1c Accuracy

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Solution Overview

Problem

Current glycosylated hemoglobin analyzers using liquid chromatography face challenges in achieving both measurement speed and accuracy due to interference from variants like HbE, HbD, and HbS, requiring multiple sets of eluents and chromatographic columns, and often cannot determine the appropriate mode for unknown samples.

Innovation Solution

A sample analyzer with a controller that supplies different specimens to a single chromatographic column, using varying eluent concentrations in distinct operation modes to analyze glycosylated hemoglobin and interfering substances, allowing for rapid and accurate measurements by switching between modes based on feedback.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If two sets of eluents and two chromatographic columns are used to provide both fast mode and variant mode, then measurement speed and accuracy can be achieved, but device complexity and cost increase

Engineering Contradiction:
Improvemeasurement accuracyVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple eluent types (first eluent for fast mode, second eluent for variant mode) into a single eluent storage device, and uses one chromatographic column to perform both fast mode and variant mode analyses. This merging approach eliminates the need for separate eluent storage devices and chromatographic columns for each mode, thereby reducing device complexity while maintaining both measurement speed and accuracy capabilities

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The single chromatographic column is designed to perform multiple functions: it can conduct fast mode analysis using the first eluent and variant mode analysis using the second eluent. The eluent storage device is also designed to store and supply multiple types of eluents. This multi-functionality allows the system to achieve both fast mode and variant mode capabilities without requiring separate dedicated components for each mode

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

2Device complexity

If one set of eluent and one chromatographic column are used for variant mode, then device complexity is reduced, but measurement speed becomes slow

Engineering Contradiction:
Improvedevice complexityVSAvoidmeasurement speed
Core Design Contradiction:
Device complexityVSSpeed

Solution Approach 1:

The system dynamically switches between different eluents based on the analysis mode required. The controller selectively supplies the first eluent for fast mode analysis when speed is prioritized, and the second eluent for variant mode analysis when accuracy is prioritized. This dynamic adaptability allows the single-column system to achieve fast mode measurement speeds comparable to dedicated fast mode systems

Inventive Principle:
Principle #15Dynamics

3Productivity

If two sets of eluents and one chromatographic column are used, then fast mode and variant mode are available, but the user cannot determine which mode to use for unknown samples

Engineering Contradiction:
Improvemeasurement speedVSAvoidease of operation
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The controller automatically determines the appropriate analysis mode based on feedback from preliminary analysis or sample characteristics. The system can analyze the sample using the first eluent in fast mode, detect the presence of variants through chromatographic peak patterns, and then automatically switch to the second eluent for variant mode analysis if needed. This automated feedback mechanism eliminates the need for users to manually determine which mode to use

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

Enables simultaneous achievement of measurement speed and accuracy by automatically determining the appropriate operation mode, reducing the need for multiple eluents and columns, and improving usability by handling unknown samples effectively.

Implementation Method 1

liquid chromatography is a common method to measure HbA1c

Methodology Applied
Scientific EffectChromatography: Chromatography

Implementation Method 2

chromatographic analysis

Methodology Applied
Scientific EffectAbsorption Spectroscopy: Absorption Spectroscopy

Data Source

PatentUS20240118249A1Sample analyzer and sample analyzing system
Publication Date: 2024.04.11 SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
  • US20240118249A1 patent drawing
  • US20240118249A1 patent drawing
  • US20240118249A1 patent drawing

AI summary

The disclosure discloses a sample analyzer and a sample analysis system. The sample analyzer includes a first specimen supply device, a chromatographic separation device and a first controller. The chromatographic separation device is controlled by the first controller to elute and chromatograph a first specimen in a first operation mode and to elute and chromatograph a second specimen in a second operation mode. The first controller is configured to: analyze feedback information from the chromatographic separation device in the first operation mode to obtain a parameter of glycosylated hemoglobin in the first specimen and a conclusion as to whether an interfering substance exists in the first specimen, and to analyze feedback information from the chromatographic separation device in the second operation mode to obtain a parameter of glycosylated hemoglobin in the second specimen and a parameter of an interfering substance in the second specimen.