Pooled Donor Basophil Activation Test for CSU

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Solution Overview

Problem

Current assays for chronic spontaneous urticaria (CSU) require three basophil donors with high anti-FcεRI activation, which is challenging to maintain and results in intra-individual variability, limiting the reliability of indirect basophil activation tests.

Innovation Solution

The method involves pooling biological samples from multiple donors that consistently show a strong response to anti-FcεRI, creating a pooled donor basophil activation test (PD-BAT) that uses a combination of low, intermediate, and high serum pools to standardize and validate the assay, ensuring consistent and reliable results.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If three basophil donors with high anti-FcεRI activation are used for the assay, then the test can detect CSU, but the reliability is reduced due to intra-individual variability and difficulty in maintaining consistent donor quality

Engineering Contradiction:

Improveassay reliabilityVSAvoiddonor management complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Multiple individual donor samples are combined into a single pooled sample containing basophils from multiple donors. This merging approach eliminates the need to maintain and manage multiple individual donors with consistent high activation levels, while the pool itself provides consistent and reliable basophil activation responses for CSU detection.

Inventive Principle:

Principle #5Merging (Combining)

2Measurement precision

If multiple individual donors are used for basophil activation testing, then the test can be performed, but measurement precision is reduced due to intra-individual variability

Engineering Contradiction:

Improveactivation response precisionVSAvoidassay throughput

Core Design Contradiction:

Measurement precisionVSProductivity

Solution Approach 1:

Individual donor samples are merged into a pooled sample that combines basophils from multiple donors. This pooling strategy averages out intra-individual variability among donors, resulting in more precise and consistent basophil activation responses when exposed to CSU patient serum, thereby improving measurement precision without significantly reducing assay throughput.

Inventive Principle:

Principle #5Merging (Combining)

3Manufacturing precision

If donors with high anti-FcεRI activation are selected, then basophil activation can be achieved, but manufacturing precision is reduced due to difficulty in maintaining consistent donor characteristics

Engineering Contradiction:

Improvedonor sample consistencyVSAvoiddonor screening difficulty

Core Design Contradiction:

Manufacturing precisionVSEase of manufacture

Solution Approach 1:

Multiple donor samples are combined into a pooled sample, which naturally averages out variations in anti-FcεRI activation levels among individual donors. This approach maintains consistent basophil activation characteristics without requiring rigorous screening and selection of individual donors with high activation levels, thereby improving manufacturing precision while easing the ease of manufacture.

Inventive Principle:

Principle #5Merging (Combining)

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 provides a robust and reliable testing method for CSU, reducing variability and improving diagnostic accuracy by using pooled samples that consistently activate basophils, thus enhancing the precision and reproducibility of the test.

Implementation Method 1

pooling biological samples from multiple donors that consistently show a strong response to anti-FcεRI, creating a pooled donor basophil activation test (PD-BAT)

Methodology Applied

Scientific EffectBasophil activation:

Data Source

PatentUS20250020647A1Methods, compositions and systems for using pooled donor samples for laboratory testing

Publication Date: 2025.01.16 LABORATORY CORPORATION OF AMERICA HOLDINGS INC

AI summary

Disclosed are methods, compositions and systems for making and using pooled biological samples for laboratory testing. In certain embodiments, the methods and systems may be used for pooling basophil donors for laboratory testing for chronic spontaneous urticaria.