Multiplex PCR Diagnostic Kit for Simultaneous STD Detection
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Solution Overview
Problem
Current diagnostic tests for silent sexually transmitted diseases (STDs) are complex, expensive, and time-consuming, often requiring invasive samples and failing to simultaneously detect multiple pathogens from a single non-invasive sample, leading to inappropriate treatments and potential antibiotic resistance.
Innovation Solution
A diagnostic kit (Kit-U) using 24 specific sequences, including 16 primers and 8 probes, for simultaneous detection of Herpes Virus type 1, Herpes Virus type 2, Chlamydia trachomatis, Ureaplasma urealitycum, Mycoplasma hominis, Mycoplasma genitalium, and Human papillomavirus from a single urine sample through multiplex PCR and hybridization on a nylon membrane, allowing for rapid and economical identification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple separate diagnostic kits are used to detect different STD pathogens, then each pathogen can be detected with high specificity, but the test complexity and cost increase significantly, and multiple samples are required
Solution Approach 1:
The patent combines multiple separate diagnostic kits into a single multiplex diagnostic kit that can simultaneously detect seven different STD pathogens (Herpes Virus type 1, Herpes Virus type 2, Chlamydia trachomatis, Ureaplasma urealitycum, Mycoplasma hominis, Mycoplasma genitalium, and Human papillomavirus) using one urine sample. This merging approach maintains high detection specificity for each pathogen while significantly reducing test complexity and eliminating the need for multiple separate samples.
Solution Approach 2:
The diagnostic kit is designed with universal functionality to detect multiple pathogen types simultaneously using a single urine sample. The kit includes multiple pairs of primers and probes specific to different pathogens, allowing one test to serve multiple detection functions that previously required separate tests, thereby reducing overall complexity while maintaining precision.
2Measurement precision
If invasive samples such as blood or cytobrush are used for STD detection, then pathogen detection accuracy is improved, but patient comfort decreases and the sampling process becomes more complex
Solution Approach 1:
The patent uses urine as an intermediary sample medium that non-invasively captures pathogen DNA from the urinary tract. This intermediary approach allows accurate pathogen detection without requiring direct invasive sampling of blood or cytobrush, thereby maintaining detection accuracy while significantly improving patient comfort and sampling ease.
3Adaptability or versatility
If broad-spectrum antibiotics are used when diagnosis is non-specific, then treatment coverage is maximized, but antibiotic resistance develops and treatment effectiveness decreases
Solution Approach 1:
The multiplex diagnostic kit provides specific feedback about which pathogen(s) are present in the patient's sample. This feedback enables clinicians to select targeted, pathogen-specific treatments rather than using broad-spectrum antibiotics empirically. By knowing the exact pathogen cause (e.g., Herpes Virus, Chlamydia, Mycoplasma, or HPV), the treatment can be precisely directed, improving effectiveness while reducing the development of antibiotic resistance.
4Measurement precision
If traditional diagnostic methods such as cell cultures and Real-Time PCR are used, then detection sensitivity is maintained, but cost and implementation complexity increase significantly
Solution Approach 1:
The patent segments the complex diagnostic process into simplified, modular components that can be implemented in standard laboratories. The multiplex kit uses conventional PCR technology divided into specific amplification steps for different pathogens, with results visualized through distinct probe signals. This segmentation maintains detection sensitivity while reducing implementation cost and complexity compared to full Real-Time PCR systems.
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
Kit-U provides a cost-effective, rapid, and sensitive method for detecting multiple STD pathogens, reducing treatment delays and antibiotic overuse, with higher sensitivity than commercial kits, enabling timely and targeted treatment.
Implementation Method 1
amplifying said DNA through a single-reaction multiplex PCR, amplifying more than one DNA sequence from different pathogens in this case
Implementation Method 2
hybridizing said amplified and labeled DNA on a nylon membrane in a diagnostic strip for visualizing results with specific probes complementary to sequences specific of each pathogen
Implementation Method 3
denaturating and hybridizing said amplified and labeled DNA
Data Source
AI summary
A diagnostic kit for simultaneously detecting at least seven silent sexually transmitted diseases (SSTDs) having a diagnostic strip which has detection zones with at least eight probes with SEQ ID NOs: 3, 6, 9, 12, 15, 18, 21, 24; at least 14 primers with SEQ ID NOs: 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 16, 17, 19, 20, 22, 23; an instruction manual; a nucleotide sequence set for simultaneously detecting at least seven silent sexually transmitted diseases (SSTDs); use of the kit to detect at least the following pathogens: Herpes Virus type 1, Herpes Virus type 2, Chlamydia trachomatis, Ureaplasma urealitycum, Mycoplasma hominis, Mycoplasma genitalium, and Human papillomavirus (HPV); a method for simultaneously detecting at least seven silent sexually transmitted diseases (SSTDs).