Modular Wet Composite Sampling for Pathogen Detection
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Solution Overview
Problem
Current microbial pathogen testing protocols result in the unnecessary destruction of large quantities of food and pharmaceutical products due to the inability to pinpoint the source of contamination within composite production lots, leading to economic losses and reduced sensitivity in detection.
Innovation Solution
Implementing modular wet composite sampling methods where individual sublots are enriched and tested separately, allowing for the identification of positive units within a composite sample, thereby enabling targeted remedial actions and increased sensitivity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If multiple samples are combined into a composite sample for testing, then the cost of sampling is reduced, but the ability to pinpoint contamination source is lost and sensitivity is reduced
Solution Approach 1:
The patent divides the composite sample testing into segmented individual lot testing. Instead of combining multiple production lots into one composite sample, the method tests each lot separately while maintaining a modular structure that allows results to be aggregated. This segmentation enables identification of which specific lot contains contamination while preserving detection sensitivity through individual lot enrichment and testing.
2Loss of substance
If multiple samples are combined into a composite sample for testing, then the cost of sampling is reduced, but the ability to trace contamination source is lost
Solution Approach 1:
The patent segments the testing process to maintain traceability information. Each production lot is tested independently, preserving the association between test results and specific production lots. This modular approach allows the system to track which specific lot caused contamination while still achieving cost efficiency through selective retesting of only positive lots rather than destroying entire composite batches.
3Measurement precision
If a large number of samples are composited to increase detection sensitivity, then the limit of detection is improved, but the complexity of the testing protocol increases
Solution Approach 1:
The patent segments the testing protocol into modular, standardized steps that can be applied to each production lot independently. This modular enrichment and testing approach maintains detection sensitivity through individual lot processing while reducing overall protocol complexity by eliminating the need for complex composite sample preparation and the inability to trace sources.
4Loss of information
If individual lots are tested separately instead of compositing, then the ability to pinpoint contamination source is improved, but the cost of testing increases
Solution Approach 1:
The patent implements segmented testing where individual production lots are tested separately through a standardized modular protocol. This approach identifies contamination sources precisely by maintaining lot-specific test results. The cost is managed through the efficiency of the modular protocol and the ability to process lots independently, avoiding the waste of destroying entire composite batches when contamination is detected.
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
This approach reduces unnecessary product destruction, enhances detection sensitivity by 5- to 50-fold, and facilitates effective tracing and remediation of contamination sources, providing economic savings and improved safety assurance.
Implementation Method 1
incubating the set of test lot samples under conditions suitable to allow levels of a target agent or organism that is present in one or more of the samples to reach detectable levels
Data Source
AI summary
Provided are methods for sampling, testing and validating test lots, comprising: assembling a plurality of product portions from each of a plurality of test lots and combining the portions to provide a corresponding set of test lot samples; enriching the test lot samples; removing portions of each enriched sample, and combining the removed portions to provide a modular composite sample; and testing of the modular composite sample, and individual testing of the enriched test lot samples, using at least one suitable detection assay for a target microbe or organism, wherein when such testing is negative all test lots are validated, and wherein when such testing is positive with respect to the modular composite sample, or with respect to an individual enriched test lot sample, individual test lots may nonetheless yet be validated by further testing of a portion of respective initially-negative enriched test lot samples and obtaining negative results.