Metabolite Profiling for Lyme Disease and STARI Differentiation

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current diagnostic methods fail to accurately distinguish between Lyme disease and southern tick-associated rash illness (STARI) due to shared symptoms and poor sensitivity in early stages, leading to challenges in proper treatment and disease surveillance.

Innovation Solution

A method involving deproteinization of blood samples followed by liquid chromatography coupled to mass spectrometry to identify molecular features, which are then used to generate a disease score through a classification model trained with control samples, enabling differentiation between Lyme disease and STARI.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If serum antibodies to B. burgdorferi are used as biomarkers for differential diagnosis, then Lyme disease can be detected, but the sensitivity is poor in early stages making it unreliable for distinguishing from STARI

Engineering Contradiction:

Improvedifferential diagnosis accuracyVSAvoidearly stage detection reliability

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The patent shifts from detecting immune response parameters (antibodies) to detecting metabolic parameters (small molecule metabolites). This parameter change enables reliable differentiation between Lyme disease and STARI in early stages, as metabolic profiles change before antibody production occurs.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent introduces small molecule metabolites as intermediary biomarkers that mediate between the infectious agent and the detectable signal. These metabolites serve as early indicators of infection status and disease type, providing a more reliable early-stage diagnostic signal than antibodies.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If traditional diagnostic methods are used, then Lyme disease and STARI can be detected based on symptoms, but the skin lesions are indistinguishable leading to misdiagnosis

Engineering Contradiction:

Improvediagnostic simplicityVSAvoiddisease differentiation accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent introduces metabolic profiles as intermediary diagnostic markers that bridge the gap between simple blood sample collection and accurate disease differentiation. These metabolite patterns provide objective, measurable differences between Lyme disease and STARI that are not visible through clinical examination alone.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/visual examination system (clinician examining skin lesions) with an analytical chemistry system (LC-MS metabolite profiling). This substitution enables precise differentiation of diseases that appear identical through traditional visual inspection methods.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If no specific laboratory tool exists for STARI diagnosis, then STARI cannot be reliably differentiated from Lyme disease, but developing new diagnostic tools increases device complexity

Engineering Contradiction:

ImproveSTARI detection capabilityVSAvoiddiagnostic system complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs a universal diagnostic platform (LC-MS metabolite profiling) that can detect and differentiate multiple tick-borne diseases including Lyme disease, STARI, and potentially other infections. This multi-functional approach enables STARI detection without requiring a completely new specialized tool, as the same platform used for Lyme disease detection can also identify STARI through distinct metabolic signatures.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 high accuracy in detecting Lyme disease and STARI, with a disease score that effectively distinguishes between the two conditions, facilitating appropriate treatment and surveillance.

Implementation Method 1

performing liquid chromatography coupled to mass spectrometry on a sample of the metabolite extract

Methodology Applied

Scientific EffectChromatography: Chromatography

Implementation Method 2

performing liquid chromatography coupled to mass spectrometry on a sample of the metabolite extract

Methodology Applied

Scientific EffectMass spectrometry:

Data Source

PatentUS11230728B2Differentiation of lyme disease and southern tick-associated rash illness

Publication Date: 2022.01.25 THE GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE SECRETARY DEPARTMENT OF HEALTH & HUMAN SERVICES

AI summary

The present disclosure provides a biosignature that distinguishes Lyme disease, including early Lyme disease, from STARI. The present disclosure also provides methods for detecting Lyme disease and STARI, as well as methods for treating subjects diagnosed with Lyme disease or STARI.