Multiplex STI Detection Kit Using Oligonucleotide Primer-Probe Sets
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Solution Overview
Problem
Current methods for diagnosing non-viral sexually transmitted infections (STIs) like Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium are inefficient, requiring separate assays, prone to handling errors, and often fail to detect asymptomatic cases due to low nucleic acid levels, especially in pooled samples.
Innovation Solution
A set of oligonucleotide sequences and a kit for simultaneous detection of these pathogens using primer and probe sets that amplify and detect specific nucleic acid sequences, including 23S rRNA and opa gene targets, with detectable labels for accurate and sensitive detection in a single assay.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If separate assays are run for each STI pathogen, then detection accuracy for each pathogen is maintained, but time consumption and operational complexity increase significantly
Solution Approach 1:
The patent combines multiple separate STI detection assays into a single multiplex assay that can simultaneously detect CT, NG, TV, and MG pathogens in one test. This merging of multiple assays resolves the contradiction by maintaining detection accuracy through specific primer-probe sets for each pathogen while significantly reducing time consumption by eliminating sequential testing requirements.
Solution Approach 2:
The invention creates a universal detection system that can identify multiple different STI pathogens using a single assay platform. The multiplex PCR assay with pathogen-specific primer and probe sets enables one test to perform the function of multiple separate tests, thereby maintaining precision for each pathogen detection while reducing overall time investment.
2Loss of substance
If separate assays are performed sequentially, then reagent waste is minimized per test, but total reagent consumption and storage requirements increase
Solution Approach 1:
By merging multiple detection functions into a single multiplex assay, the system reduces the total quantity of reagents needed compared to running separate assays. The shared PCR master mix and common laboratory procedures eliminate redundant reagent usage while maintaining detection capability for all four pathogens, thereby reducing both storage requirements and overall reagent consumption.
3Reliability
If multiple separate tests are conducted, then handling errors are reduced per test, but overall error probability and operational complexity increase
Solution Approach 1:
The multiplex assay merges multiple detection operations into a single streamlined process, reducing operational complexity by eliminating the need to set up and execute multiple separate assays. While maintaining reliability through pathogen-specific optimized primer-probe sets, the system reduces handling errors by minimizing the number of separate sample handling and processing steps required.
4Measurement precision
If traditional separate assays are used, then sensitivity for low nucleic acid levels is maintained per test, but overall detection capability for asymptomatic cases improves with multiplexing
Solution Approach 1:
The multiplex assay provides enhanced adaptability by enabling simultaneous detection of multiple STI pathogens in a single test, making it particularly valuable for asymptomatic screening where co-infections may occur. The system maintains detection sensitivity for low nucleic acid levels through optimized PCR conditions and specific probe sets, while expanding detection scope to cover four different pathogens, thereby improving overall versatility for comprehensive STI screening.
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 accurate and sensitive simultaneous detection of multiple STI pathogens in a single test, reducing storage requirements and PCR reagent waste, and allowing for faster sample-to-result analysis compared to existing systems.
Implementation Method 1
Nucleic acid tests (NATs) that detect each of C. trachomatis, N. gonorrhoeae, T. vaginalis, and M. genitalium
Implementation Method 2
a first probe oligonucleotide sequence comprising SEQ ID NO: 3; (b) a primer and probe set that amplifies and detects at least a portion of the Neisseria gonorrhoeae opa gene
Data Source
AI summary
The invention is directed to methods, kits, and compositions, for amplifying and detecting Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in a sample, which comprises a variety of combinations of forward oligonucleotide primers, reverse oligonucleotide primers, and oligonucleotide probes.