Dual Brucellosis Test Strip for On-Site Sheep Antibody Diagnosis
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Solution Overview
Problem
Current brucellosis detection methods require laboratory settings and lack rapid, accurate on-site diagnostic solutions, especially for sheep brucellosis, which complicates cross-regional allocations and increases the risk of spreading the disease.
Innovation Solution
A dual-test strip system integrating a primary screening test strip and a diagnostic test strip, both coated with specific antibodies, allowing simultaneous detection of IgG and IgM antibodies in sheep blood, providing rapid and accurate on-site diagnosis using colloidal gold technology without additional equipment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional agglutination assays (Rose-Bengal, SAT, MRT) are used for brucellosis detection, then the detection can be performed with simple equipment and procedures, but the sensitivity and specificity are lower compared to modern methods
Solution Approach 1:
The patent combines the high sensitivity of competitive ELISA (for IgM detection) with the high specificity of indirect ELISA (for IgG detection) into a single integrated test strip system. This merging allows the device to achieve both high measurement precision and maintain operational simplicity through colloidal gold visualization
Solution Approach 2:
The test strip is designed to simultaneously detect both IgM and IgG antibodies against Brucella, making it a multi-functional diagnostic tool that replaces multiple separate tests. The single strip performs primary screening (IgM) and confirmatory diagnosis (IgG) functions, reducing the need for multiple devices while maintaining high detection accuracy
2Measurement precision
If complement fixation test (CFT) is used for brucellosis diagnosis, then the specificity is superior to other methods, but the operation is cumbersome and requires difficult preparations of complement and hemolysin
Solution Approach 1:
The patent replaces the complex, reusable CFT system requiring fresh complement and hemolysin preparations with a disposable colloidal gold test strip. The test strip contains pre-coated antibodies and colloidal gold labels that eliminate the need for difficult biological material preparations while maintaining high diagnostic specificity through the same antibody-antigen reaction principles
Solution Approach 2:
The patent substitutes the complex biochemical CFT system with a simpler immunochromatographic assay using colloidal gold particles. The visual detection method replaces the complex CFT readout requiring observation of hemolysis inhibition, making the diagnostic process much easier to perform and interpret while maintaining comparable specificity
3Measurement precision
If ELISA methods (iELISA and cELISA) are used for brucellosis detection, then the sensitivity and specificity are high and large numbers of samples can be detected at one time, but the assays must be done in the laboratory with serum separation required
Solution Approach 1:
The patent extracts the core detection function from the laboratory-based ELISA system and transfers it to a portable test strip format. By taking out the essential antibody-antigen reaction and colloidal gold detection components, the system achieves high detection accuracy while enabling on-site use without requiring serum separation or laboratory equipment
Solution Approach 2:
The patent introduces colloidal gold particles as an intermediary detection marker that bridges the gap between laboratory ELISA accuracy and field-deployable simplicity. The colloidal gold labels provide visual detection through color changes, eliminating the need for plate readers and complex ELISA procedures while maintaining high sensitivity and specificity
4Ease of operation
If commercial colloidal gold test strips are used for brucellosis detection, then the operation is simple and rapid, but the test results are only for reference and laboratory diagnosis is still required for confirmation
Solution Approach 1:
The patent segments the diagnostic process into two distinct detection channels within a single test strip: one for IgM (primary screening) and one for IgG (confirmatory diagnosis). This segmentation allows the device to provide both rapid screening results and confirmatory diagnostic results simultaneously, eliminating the need for separate laboratory confirmation while maintaining high accuracy
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 simple, rapid, and accurate on-site diagnosis of brucellosis with sensitivities comparable to the gold standard CFT method, facilitating timely identification of infected or suspicious animals.
Implementation Method 1
The colloidal gold labeled pad of the test strip 1 is coated with a colloidal gold labeled Brucella lipopolysaccharide (LPS)... a test line of the test strip 1 is coated with a Brucella monoclonal antibody M4
Implementation Method 2
Each of the test strip and the test strip 2 includes a polyvinyl chloride (PVC) base plate, a sample pad, a colloidal gold labeled pad, a nitrocellulose membrane and an absorbent pad
Data Source
AI summary
An antibody detection test strip of integrating primary screening and diagnosis of sheep brucellosis includes: a test strip 1 of primary screening and a test strip 2 of diagnosis, each including a PVC base plate, a sample pad, a colloidal gold labeled pad, a nitrocellulose membrane and an absorbent pad. For the test strip 1, the colloidal gold labeled pad is coated with colloidal gold labeled Brucella LPS and mouse anti Flag monoclonal antibody, and test and control lines are respectively coated with a Brucella monoclonal antibody M4 and a sheep anti-mouse IgG antibody. For the test strip 2, the colloidal gold labeled pad, and test and control lines are respectively coated with a colloidal gold labeled Brucella LPS, a rabbit anti-sheep IgG antibody and a Brucella monoclonal antibody M4. When in use, a serum is dripped into its sample-loading hole, and brucellosis determination can be made on site according to results presented by the test strips 1 and 2.