Multiplex qPCR Kit for Simultaneous STI Detection
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Solution Overview
Problem
Current methods for detecting sexually transmitted infections (STIs) such as Chlamydia, Gonorrhea, and Trichomoniasis are often inefficient, particularly for asymptomatic cases and extragenital infections, with existing tests being costly, invasive, and lacking in sensitivity and specificity, especially for at-home or clinician-collected samples.
Innovation Solution
A multiplex real-time polymerase chain reaction (qPCR) system and kit for simultaneous detection of nucleic acids associated with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis from various specimen types, enabling rapid, reliable, and accessible testing through an at-home kit and telemedicine platform.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional detection methods are used for STIs, then the testing process is simple and accessible, but the sensitivity and specificity are insufficient especially for asymptomatic cases
Solution Approach 1:
The patent combines multiple detection functions into a single multiplex qPCR system that can simultaneously detect multiple STI pathogens (Chlamydia, Gonorrhea, Trichomoniasis) and control samples in one reaction, thereby improving detection sensitivity and specificity while maintaining reasonable system complexity
Solution Approach 2:
The detection system is designed to universally detect multiple different STI pathogens using a single platform with multiple primer sets and probes, making the system multi-functional and capable of handling various detection scenarios including asymptomatic cases
2Productivity
If multiple separate tests are performed for different STIs, then each test can be optimized for its specific pathogen, but the cost and time required for screening increase
Solution Approach 1:
Multiple separate STI detection reactions are merged into a single multiplex qPCR reaction, allowing simultaneous detection of multiple pathogens in one test run, which improves screening efficiency and reduces per-test costs despite the increased complexity of the reagent mixture
Solution Approach 2:
The multiplex qPCR system provides universal detection capability for multiple STI pathogens using a single standardized protocol and platform, enabling high-throughput screening without requiring separate optimized tests for each pathogen
3Reliability
If invasive collection methods are used to ensure sample quality, then the diagnostic accuracy improves, but patient comfort and accessibility decrease
Solution Approach 1:
The system enables patients to perform self-collecting of samples at home using provided collection devices, eliminating the need for invasive clinical procedures while maintaining sample quality sufficient for accurate multiplex qPCR detection
Solution Approach 2:
The detection methodology is adapted to work with samples collected by non-invasive means, adjusting the sensitivity thresholds and detection parameters of the qPCR system to ensure diagnostic accuracy despite the lower sample quality compared to invasive collection
4Speed
If conventional PCR methods are used, then the equipment requirements are simple, but the detection speed and throughput are limited
Solution Approach 1:
The patent replaces conventional endpoint PCR detection with real-time quantitative PCR that uses fluorescent probes and optical detection systems, substituting mechanical/visual assessment with optical measurement to achieve faster, more sensitive, and automated detection
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 system provides high sensitivity and specificity, reducing the burden of STIs by enabling efficient detection of multiple infections with reduced error and contamination, facilitating timely medical intervention and cost-effective screening.
Implementation Method 1
A multiplex real-time polymerase chain reaction (qPCR) system and kit for simultaneous detection of nucleic acids associated with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis
Data Source
AI summary
The present disclosure provides multiplexed system with methods using a multiplex real-time polymerase chain reaction (qPCR), at-home collection and laboratory testing kits for detecting whether at least one or more sexual health conditions is present in a sample. For example, the multiplex real-time qPCR method can be used for simultaneous detection of target nucleic acids (e.g., DNA) from, for example, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) from clinician-collected or at-home self-collected specimens. The present disclosure also computer implemented methods and non-transitory computer-readable storage medium storing executable computer program constructions comprising code for carrying out steps used in a telehealth platform for communication to and from a client device, provider device, and a pharmacy device.