Pathogen Detection Microarray for Broad Blood Screening

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Solution Overview

Problem

Current blood screening methods fail to detect a wide range of transfusion-transmitted pathogens, particularly during the window period, and multiplex PCR-based devices are limited in their ability to test for multiple agents simultaneously, making it logistically impractical and costly to screen for all known and potential agents.

Innovation Solution

Development of customized probe sets and microarrays that include probes with high identity to nucleic acid sequences of various pathogens, allowing for simultaneous detection of RNA and DNA viruses, bacteria, and protozoan pathogens in a single blood sample, with the flexibility to adapt to emerging agents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If individual qPCR or serologic testing is performed for each pathogen, then detection specificity is improved, but device complexity and cost increase significantly

Engineering Contradiction:
Improvepathogen detection specificityVSAvoidtesting system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple pathogen detection capabilities into a single microarray platform. The microarray integrates numerous probes targeting different pathogens (viruses, bacteria, parasites) on one chip, allowing simultaneous detection of multiple agents in a single blood sample. This merging approach maintains the specificity of individual pathogen detection while eliminating the need for separate testing systems for each pathogen.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The microarray platform serves as a universal detection system that can identify multiple types of pathogens including RNA viruses, DNA viruses, bacteria, and protozoan parasites. The system uses a common hybridization-based detection mechanism for all pathogen types, making the platform multi-functional and adaptable to emerging pathogens through probe addition rather than requiring entirely new testing systems.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If comprehensive screening for all known and potential pathogens is implemented, then blood supply safety is improved, but productivity and cost-effectiveness deteriorate

Engineering Contradiction:
Improveblood supply safetyVSAvoidscreening efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The microarray consolidates screening for dozens of pathogens into a single test performed on one blood sample. By combining multiple detection functions into one platform, the system achieves comprehensive pathogen screening without the multiplicative cost and time burden of performing separate tests for each pathogen, thereby maintaining high productivity while improving blood supply safety.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system is designed to detect more pathogens than currently required by screening guidelines, including emerging and rare pathogens. This excessive detection capability provides a safety buffer without significantly increasing operational complexity, as all detections occur within the same microarray platform. The ability to detect beyond current requirements enhances safety while maintaining cost-effectiveness through platform consolidation.

Inventive Principle:
Principle #16Partial or excessive action

3Adaptability or versatility

If the screening system is designed to detect all known pathogens, then adaptability to emerging pathogens is improved, but device complexity increases

Engineering Contradiction:
Improveresponse to emerging pathogensVSAvoidassay system complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The microarray platform is designed with dynamic adaptability through its probe-based architecture. New probes targeting emerging pathogens can be added to the existing microarray without redesigning the entire system. This dynamic capability allows the platform to evolve with emerging threats while maintaining the core detection infrastructure, thereby improving adaptability without proportionally increasing device complexity.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The detection system is segmented into modular probe units, each targeting specific pathogens or pathogen groups. This segmentation allows individual probes to be added, removed, or modified independently based on emerging epidemiological threats. The modular probe design enables flexible adaptation to new pathogens without requiring changes to the underlying microarray platform or detection methodology.

Inventive Principle:
Principle #1Segmentation

4Productivity

If multiplex PCR-based devices are used for pathogen detection, then productivity is improved, but measurement precision and detection sensitivity worsen due to limited multiplexing capacity

Engineering Contradiction:
Improvethroughput of pathogen detectionVSAvoidpathogen detection sensitivity
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The system transitions from the linear limitation of multiplex PCR (which is constrained by the number of primers and reactions that can be performed in parallel) to the two-dimensional space of the microarray chip. This dimensional change allows hundreds of probes to be arranged on a single chip surface, dramatically increasing the multiplexing capacity from dozens of pathogens in PCR to potentially hundreds in the microarray, thereby improving both productivity and maintaining measurement precision through increased spatial resolution.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Solution Approach 2:

The microarray uses multiple identical or variant probes for the same pathogen target, arranged in parallel on the chip. This copying approach provides redundant detection opportunities for each pathogen, improving sensitivity through signal amplification and confirmation. Multiple probes targeting the same pathogen can compensate for individual probe failures or variations, maintaining high measurement precision while detecting a broader range of pathogens simultaneously.

Inventive Principle:
Principle #26Copying

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, including those not currently detectable, and allows for rapid addition and validation of probes to detect new agents, enhancing the safety and adaptability of the blood supply.

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

Methodology Applied
Scientific EffectHybridization:

Data Source

PatentEP3918096B1Methods and compositions for detecting transfusion-transmitted pathogens
Publication Date: 2026.03.04 THE UNITED STATES OF AMERICA AS REPRESENTED BYTHE SECRETARY DEPT OF HEALTH & HUMANSERVICES
  • EP3918096B1 patent drawingFigure 1A~1C
  • EP3918096B1 patent drawingFigure 2A~2B
  • EP3918096B1 patent drawingFigure 2C

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.