UV Inactivated Pathogen Positive Control for Antigen Assays

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Solution Overview

Problem

Current antigen-based assays lack reliable positive controls, as recombinant proteins fail to detect whole organisms effectively, and using whole organisms as controls is challenging due to inconsistency in pathogen concentration and potential infectiousness, which complicates the development and testing of these assays.

Innovation Solution

A method involving a culture fluid with a target pathogen exposed to UV irradiation to render it non-infectious, creating a positive control with a detectable antigen concentration that remains stable for use in antigen biomarker assays.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If recombinant proteins are used as positive controls, then the assay can detect free protein, but the control fails to provide reliable data on detection of whole organisms

Engineering Contradiction:

Improvereliability of positive controlVSAvoidability to detect whole organisms

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent uses inactivated whole pathogens as positive controls that replicate the structural and antigenic complexity of actual pathogens while eliminating infectiousness. This copying approach allows the control to detect whole organisms effectively, resolving the contradiction between reliability and adaptability.

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The patent applies parameter changes by inactivating pathogens through methods such as formalin fixation or UV irradiation, which modifies the pathogen's state from infectious to non-infectious while preserving antigenic properties. This enables the use of whole organisms as safe positive controls.

Inventive Principle:

Principle #35Parameter changes

2Adaptability or versatility

If whole organisms are used as positive controls, then the control can detect whole organisms effectively, but the control may remain infectious and pose safety risks

Engineering Contradiction:

Improveability to detect whole organismsVSAvoidinfectiousness of control

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary anti-action by pre-inactivating pathogens through formalin fixation or UV irradiation before using them as positive controls. This preliminary treatment eliminates infectiousness while preserving the ability to detect whole organisms, thus resolving the contradiction between adaptability and harmful factors.

Inventive Principle:

Principle #9Preliminary anti-action

Solution Approach 2:

The patent converts the harmful infectiousness of whole pathogens into a benefit by using inactivated whole pathogens as positive controls. The inactivation process eliminates the harmful infectiousness while maintaining the structural and antigenic properties needed for effective detection.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

3Ease of manufacture

If conventional pathogenic measurements are used to quantify non-infectious organisms, then the measurement can be performed, but the measurements are inconsistent with actual pathogen concentration

Engineering Contradiction:

Improvequantification capabilityVSAvoidconsistency of pathogen concentration

Core Design Contradiction:

Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent replaces conventional pathogenic measurements (e.g., TCID50) with direct antigen quantification methods such as ELISA or qPCR. This substitution provides consistent and accurate measurement of pathogen concentration in inactivated samples, resolving the contradiction between ease of manufacture and measurement precision.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 safe and reliable positive control that maintains antigen concentration consistency, enabling effective detection and quantification, thus addressing the limitations of existing methods.

Implementation Method 1

exposing the culture fluid to UV irradiation for a time period sufficient to render the pathogen inactivated

Methodology Applied

Scientific EffectUV irradiation: Absorption (EM radiation)

Data Source

PatentUS20240003883A1Control for protein-based assay

Publication Date: 2024.01.04 ZEPTOMETRIX LLC

AI summary

A method for producing a positive antigen-based control for detecting a pathogen which includes providing a culture fluid having a pathogen with a first detectable antigen, wherein the culture fluid has a first concentration of the first detectable antigen, and exposing the culture fluid to UV electromagnetic irradiation for a time period sufficient to render the pathogen inactivated, thereby producing a positive antigen-based control, wherein the positive antigen-based control has a second concentration of the first detectable antigen that is no more than about 50% different from the first concentration when determined via ELISA. Also described are positive antigen-based controls and kits having the same.