Pathogen Probe Microarrays for Multiplex Transfusion Screening
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current blood screening technologies are inadequate for detecting a wide range of transfusion-transmitted pathogens, particularly during the window period, and existing multiplex PCR-based devices are limited in their ability to test for multiple agents simultaneously with high sensitivity and specificity, making it logistically impractical and costly to screen for all known pathogens.
Innovation Solution
Development of customized probe sets and microarrays that include probes with high sequence identity to nucleic acid sequences of various pathogens, allowing for simultaneous detection of RNA viruses, DNA viruses, bacteria, and protozoan pathogens in a single blood sample, with the flexibility to adapt to emerging agents and detect low levels of pathogens using hybridization and amplification protocols.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If individual qPCR or serologic testing is performed for each pathogen, then detection sensitivity and specificity for each agent can be maintained, but the cost and logistical complexity become prohibitive for screening all known pathogens
Solution Approach 1:
The patent combines multiple individual pathogen detection assays into a single multiplex microarray platform. Multiple probes targeting different pathogens (viruses, bacteria, parasites) are arrayed on a single chip, allowing simultaneous detection of numerous agents in one test. This merging approach maintains the sensitivity and specificity of individual qPCR tests while eliminating the need to perform separate tests for each pathogen, thereby reducing logistical complexity and cost.
Solution Approach 2:
The microarray platform is designed as a universal detection system that can screen for multiple classes of pathogens (RNA viruses, DNA viruses, bacteria, parasites) using a single assay platform. The system uses standardized probes and detection methodologies that can be applied across different pathogen types, making the system multi-functional and eliminating the need for pathogen-specific testing protocols.
2Reliability
If current serologic and NAT screening methods are used, then detection of licensed pathogens is achieved, but the vast majority of bloodborne agents remain undetected
Solution Approach 1:
The microarray platform extends screening capability beyond the limited panel of licensed pathogens to include a comprehensive array of bloodborne agents. By incorporating probes for RNA viruses, DNA viruses, bacteria, and parasites in a single platform, the system achieves universal detection coverage for virtually all known bloodborne pathogens, dramatically expanding the screening scope while maintaining reliability.
Solution Approach 2:
The system is designed with pre-configured probes for emerging and re-emerging pathogens, allowing detection capability to be prepared in advance. This preliminary preparation of detection panels ensures that when new pathogens emerge or re-emerge, the system can detect them without requiring time-consuming development and validation of new assays, thus maintaining both reliability and adaptability.
3Productivity
If multiplex PCR-based devices are used for testing blood-borne pathogens, then some simultaneous detection capability is achieved, but sensitivity and specificity are limited and adaptability to new agents is restricted
Solution Approach 1:
The patent merges the advantages of multiplex PCR (simultaneous detection) with the precision of individual probe-based hybridization assays. The microarray platform combines multiple pathogen-specific probes on a single chip, enabling simultaneous detection of numerous pathogens while maintaining the high sensitivity and specificity of individual probe-target interactions, overcoming the limitations of multiplex PCR.
Solution Approach 2:
The system uses variable probe design parameters (sequence, length, concentration, labeling) to optimize detection sensitivity and specificity for each pathogen while maintaining simultaneous detection capability. By adjusting these parameters, the system achieves high measurement precision across multiple targets that would be difficult to accomplish with fixed multiplex PCR assays.
4Measurement precision
If individual pathogen testing is performed, then detection accuracy for each agent is maintained, but the time and resources required to screen for all pathogens become excessive
Solution Approach 1:
The microarray platform merges multiple individual testing procedures into a single parallel assay. All pathogen-specific probes are exposed to the sample simultaneously, and detection results are obtained in one workflow rather than sequentially. This maintains the detection accuracy of individual tests while reducing total screening time from days to hours.
Solution Approach 2:
The system enables continuous detection across multiple pathogen targets in a single uninterrupted assay. Rather than completing one test then moving to the next, all detection reactions proceed simultaneously and continuously, maximizing productivity while maintaining precision through standardized probe-based detection methodology.
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 provides high sensitivity and specificity for detecting multiple pathogens in a single blood sample, enhancing the safety of the blood supply and enabling rapid adaptation to new pathogens, while overcoming limitations of traditional NAT and EIA assays.
Implementation Method 1
contacting a sample with a disclosed probe set or microarray under conditions sufficient to allow hybridization of pathogen nucleic acids present in the sample to the probes of the probe set or microarray and measuring hybridization of the sample to one or more of the probes
Data Source
AI summary
Probe sets capable of detecting pathogen nucleic acids in a sample are described. The probe set can be provided on a solid support, such as a microarray. Methods of detecting pathogen nucleic acids in a sample using the probe set are also provided. In some examples, the probes and methods are capable of detecting one or more RNA viruses, one or more DNA viruses, one or more bacterial nucleic acids, and/or one or more protozoan nucleic acids in a sample.