Combination Rapid Test Kit for Synchronous Biomarker Detection
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Solution Overview
Problem
Current screening methods for colon cancer, such as colonoscopy, are invasive and have low participation rates due to psychological barriers and inefficiencies, while existing stool tests like guaiac and immunological FOBTs have low sensitivity and specificity, missing early and non-bleeding forms of colon cancer.
Innovation Solution
A combination rapid test kit using a lateral flow cassette for synchronous detection of tumor M2-PK and hemoglobin in stool samples, optimizing chromatographic conditions and cut-offs to improve clinical sensitivity and specificity, serving as a pre-filter for colonoscopy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If colonoscopy is used for screening, then detection accuracy is improved, but psychological barriers and invasiveness reduce participation rates
Solution Approach 1:
The screening process is segmented into two stages: first a non-invasive stool test (combination rapid test detecting M2-PK and hemoglobin), then colonoscopy only for positive cases. This segmentation allows initial screening to be simple and non-invasive, improving participation while maintaining high detection accuracy through the second stage.
Solution Approach 2:
The combination rapid test acts as an intermediary between the patient and colonoscopy. It provides a non-invasive preliminary assessment that filters patients before the invasive procedure, reducing psychological barriers while ensuring accurate detection through the intermediary testing step.
2Device complexity
If single biomarker stool tests are used, then simplicity is improved, but sensitivity and specificity are insufficient
Solution Approach 1:
The patent combines detection of two different biomarkers (M2-PK and hemoglobin) into a single rapid test cassette. This merging maintains simplicity for the patient (one test) while significantly improving sensitivity and specificity through multi-marker detection, resolving the contradiction between simplicity and precision.
Solution Approach 2:
The combination rapid test cassette serves multiple functions simultaneously: it detects both M2-PK and hemoglobin, provides a single comprehensive result, and acts as an effective filter for colonoscopy referral. This multi-functionality improves measurement precision without increasing device complexity from the user perspective.
3Reliability
If all patients undergo colonoscopy, then detection completeness is improved, but healthcare costs and unnecessary procedures increase
Solution Approach 1:
The combination rapid test is performed as a preliminary action before colonoscopy. It screens all patients first, then only those with positive results proceed to colonoscopy. This preliminary filtering ensures detection completeness for referred patients while reducing overall healthcare resource consumption by excluding negative cases from expensive procedures.
Solution Approach 2:
Different testing strategies are applied to different patient groups based on preliminary test results. Patients with positive rapid tests receive comprehensive colonoscopy evaluation, while negative patients avoid unnecessary procedures. This local differentiation of care quality optimizes resource allocation while maintaining detection completeness for at-risk individuals.
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
The test kit significantly increases the detection rate of colon cancer and its precursors, reducing unnecessary colonoscopies and healthcare costs, while enhancing participation in screening programs and improving patient prognosis.
Implementation Method 1
The test kit is used for carrying out a method for detecting biomarkers in human stool... synchronous implementation of an immunochromatographic detection method... synchronous detection of two biomarkers tumor M2-PK and hemoglobin
Implementation Method 2
synchronous in the technical significance the joint, optimal coordination of effect pairs (the chromatographic conditions, membranes, reagents, dispensing rate, etc.)... optimal coordination of the chromatographic conditions for the detection of the two biomarkers
Data Source
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AI summary
The invention relates to a test kit for improving the performance of a method for proving biomarkers in human or animal faeces, which can serve as an indication of a pathological, particularly a malign occurrence in the gastrointestinal tract (oesophagus, stomach, small intestine, biliary tract, pancreas and large intestine). The invention teaches and describes methods, as well as the use and the embodiments of a combi-quick test which is novel and more efficient with respect to the prior art. The combi-quick test cartridge used to execute the test kit and the optimally-matched reagents thereof contains 2 lateral flow test strips, which are novel and more efficient with respect to the prior art, for the synchronous - in the technical sense - proof of the M2-PK biomarker and the haemoglobin biomarker. The test serves as a "double filter" for diagnosing probands as part of an intestinal cancer screening programme (intestinal cancer early detection examination). The positive diagnosis of an M2-PK and/or haemoglobin biomarker prompts a coloscopy for the purposes of further diagnosis by the physician. The test is very cost-efficient and cuts costs in the health system by detecting intestinal cancer and the consequences thereof at an early stage. The test result is preferably shown in the form of various colours, letters, numerals and/or geometric figures.