Immunodiagnostic Test Card Indicator Marks for Agglutination Grading
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Solution Overview
Problem
The grading of agglutination reactions in immunodiagnostic test cards is subjective and difficult, especially for reactions between 4+ and 3+ or 1+ and 0, leading to user-dependent results and challenges in automated image processing, and there are manufacturing errors due to improper inert material addition.
Innovation Solution
Incorporating indicator marks, such as raised or colored lines, into the test card columns to provide a visual reference for accurate agglutinate positioning and reaction grading, facilitating automated machine vision systems to determine reaction grades and ensuring proper manufacturing processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual reading of test cards is used, then ease of operation is maintained, but measurement precision and reliability deteriorate due to subjectivity and user dependency
Solution Approach 1:
The patent introduces indicator marks as intermediary reference elements between the test card columns and the reader. These marks provide objective visual references that mediate the grading process, enabling consistent and reliable reaction grading without requiring skilled manual interpretation. The indicator marks serve as a common reference frame that objective readers can use to accurately determine reaction grades.
2Measurement precision
If automated image processing is used, then measurement precision improves, but device complexity increases due to difficulty in locating columns on smooth surfaces
Solution Approach 1:
The indicator marks act as intermediary reference points that bridge the gap between the automated image processing system and the test card columns. These marks provide distinct visual features that facilitate column localization and enable accurate reaction grading by automated readers, reducing the complexity of the imaging system while maintaining high measurement precision.
3Productivity
If manufacturing processes are automated, then productivity improves, but manufacturing precision deteriorates due to positioning errors and tolerance buildup
Solution Approach 1:
The indicator marks are incorporated into the test card manufacturing process as preliminary reference features. These marks are positioned at predetermined locations before the inert material is added, establishing reference points that can be used to verify manufacturing accuracy. This preliminary action enables detection and correction of positioning errors and tolerance buildup during manufacturing, maintaining precision while achieving automation.
4Measurement precision
If indicator marks are added to test cards, then measurement precision and manufacturing precision improve, but device complexity increases
Solution Approach 1:
The indicator marks are implemented as localized features within specific regions of the test card columns rather than complex system-wide modifications. By concentrating the reference functionality into simple, localized marks at predetermined positions, the patent achieves improved measurement precision without requiring complex modifications to the overall card structure or manufacturing processes.
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 solution reduces subjectivity in manual reading, improves manufacturing efficiency, and enhances the accuracy of reaction grading and manufacturing quality assurance, while also aiding in evaporation detection and label placement verification.
Implementation Method 1
During centrifugation, red blood cells (RBCs) in each reaction chamber are pulled into the gel column. Agglutinated RBCs are too large to pass through the gel matrix, depending on the size of the agglutinates, while unagglutinated RBCs will pass easily through the gel and pellet at the bottom of the chamber.
Implementation Method 2
A predetermined quantity of inert bead or gel material is added to each of the microtubes. This inert material may be coated with an antibody or an antigen or provided with a carrier-bound antibody or antigen or with specific reagents.
Data Source
Figure 1~2
Figure 3
AI summary
An immunodiagnostic test card includes a plurality of transparent chambers wherein each chamber includes a quantity of testing material that combines with a patient sample, when mixed, to produce an agglutination reaction. A plurality of indicia are disposed to aid in the manufacture and determining the usability of the cards prior to test and also in objectively grading the agglutination reactions that are formed or lack of agglutination.