Adenovirus Detection Oligomers for Broad Serotype Coverage
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Solution Overview
Problem
Current adenovirus detection methods are limited in their ability to effectively cover all adenovirus serotypes, particularly in immunosuppressed patients, due to the high genetic variability of adenoviruses, leading to a risk of severe infections and transplant failures in tissue transplant patients.
Innovation Solution
A composition or kit that includes amplification oligomers and detection probe oligomers specific to human adenovirus nucleic acids, allowing for the sensitive and specific detection of adenovirus subgroups A-F, enabling reliable screening across all clinically relevant subtypes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If PCR-based assays are used for adenovirus detection, then detection speed and sensitivity are improved, but the ability to cover all adenovirus serotypes deteriorates due to high genetic variability
Solution Approach 1:
The patent develops a universal PCR assay system with primers and probes that can detect multiple adenovirus serotypes (A-F) simultaneously. The conserved region targeting approach allows a single assay design to function across diverse serotypes, making the detection system multi-functional rather than requiring separate assays for each serotype.
Solution Approach 2:
The patent optimizes PCR assay parameters including primer annealing temperature, Mg2+ concentration, and cycle conditions to achieve high stringency detection. By carefully controlling these parameters, the assay maintains sensitivity while ensuring specific amplification across genetically diverse adenovirus serotypes despite their high variability.
2Adaptability or versatility
If low stringency conditions are used to detect genetically diverse adenoviruses, then broader serotype coverage is achieved, but detection specificity deteriorates
Solution Approach 1:
The patent employs high stringency PCR conditions including optimized annealing temperatures and buffer compositions to maintain detection specificity. By carefully adjusting these parameters, the assay achieves both broad serotype coverage and high specificity, resolving the contradiction between covering diverse serotypes and maintaining precise detection.
Solution Approach 2:
The patent replaces traditional serological testing methods with molecular-based PCR detection. This substitution allows for more precise control of detection conditions and enables simultaneous achievement of broad coverage and high specificity through optimized nucleic acid amplification parameters rather than relying on antibody-based methods.
3Ease of operation
If serological tests are used for adenovirus detection, then simplicity of operation is maintained, but detection reliability deteriorates in immunosuppressed patients due to impaired immune response
Solution Approach 1:
The patent replaces serological testing (antibody-based detection) with molecular PCR-based nucleic acid detection. This substitution directly addresses the limitation in immunosuppressed patients who cannot produce adequate antibody responses, while maintaining operational simplicity through standardized PCR protocols and automated detection 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
The solution enables the sensitive and specific detection of adenovirus subgroups A-F, improving diagnostic capabilities and reducing the risk of infections and transplant failures by covering all clinically relevant subtypes.
Implementation Method 1
performing an in vitro nucleic acid amplification reaction, utilizing at least two amplification oligomers capable of amplifying a target region of a human adenovirus target nucleic acid, to generate an amplification product corresponding to the human adenovirus target region
Implementation Method 2
at least one detection probe oligomer capable of hybridizing to a target region of a human adenovirus target nucleic acid or to an amplicon of said target region
Data Source
AI summary
Nucleic acid oligomers, including amplification oligomers and detection probes, for detection of human adenovirus nucleic acid by binding to the penton gene. Also disclosed are methods of specific nucleic acid amplification and detection using the disclosed oligomers, as well as corresponding formulations, reaction mixtures, and kits and related methods for preparing aqueous reaction mixtures from dried formulations. Nucleic acid oligomers and methods for nucleic acid amplification and detection of one or more adenovirus subgroups A, B, C, D, E and F are also disclosed.