Differentiation of lyme disease and southern tick-associated rash illness
Inventors
Belisle, John T. • Molins, Claudia R. • Wormser, Gary P.
Assignees
US Department of Health and Human Services • Colorado State University Research Foundation
Publication Number
US-11230728-B2
Publication Date
2022-01-25
Expiration Date
2038-06-08
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Abstract
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.
Core Innovation
The invention provides a biosignature that distinguishes Lyme disease, including early Lyme disease, from southern tick-associated rash illness (STARI). It offers methods for detecting Lyme disease and STARI by analyzing blood samples, specifically by deproteinizing the sample to produce a metabolite extract, performing liquid chromatography coupled to mass spectrometry (LC-MS) on the extract, and providing abundance values for molecular features listed in Tables A, B, C, or D. The biosignature is used in classification models that produce disease scores distinguishing patients with Lyme disease from those with STARI.
The problem addressed is the clinical indistinguishability between early Lyme disease and STARI due to similar erythema migrans (EM) or EM-like skin lesions, shared systemic symptoms, and no existing laboratory tool to differentiate the two. Current antibody-based diagnostics have poor sensitivity for early Lyme disease, and no reliable differential biomarker exists for STARI. The geographic overlap and co-prevalence of the two diseases further complicate diagnosis, creating the need for improved diagnostic methods to facilitate proper treatment, patient management, and surveillance.
Claims Coverage
The patent contains two independent claims focused on methods for treating subjects diagnosed with Lyme disease or STARI.
Mass spectrometry based diagnosis for Lyme disease treatment
This feature describes a method for treating a subject with Lyme disease by obtaining a disease score from a mass spectrometry based test, diagnosing the subject with Lyme disease based on that score, and administering a pharmacological treatment such as an antibiotic, antibacterial agent, immune modulator, anti-inflammatory agent, or combinations thereof.
Treatment application specifically for Stage 1 Lyme disease
This feature specifies that the treatment method applies to subjects diagnosed with Stage 1 Lyme disease based on the obtained disease score.
The claims cover methods of diagnosing Lyme disease using a disease score obtained from mass spectrometry-based tests and providing targeted treatments, including specifics for early stage Lyme disease; no explicit claims for STARI treatment are provided in the claims excerpt.
Stated Advantages
The biosignature provides high accuracy in distinguishing Lyme disease from STARI, improving diagnosis compared to antibody-based tests.
The diagnostic method allows differentiation between Lyme disease, STARI, and healthy subjects with high sensitivity and specificity.
Accurate differentiation facilitates appropriate treatment, patient management, antibiotic stewardship, and disease surveillance.
The biosignature supports the development of robust diagnostic tools to manage clinical overlap in symptoms between Lyme disease and STARI.
Mass spectrometry-based approaches offer an orthogonal, biochemical methodology to existing diagnostic assays, enabling detection in early disease stages when antibody tests have poor sensitivity.
Documented Applications
Diagnostic testing of human blood samples to detect and differentiate Lyme disease and STARI using metabolite abundance profiles obtained via liquid chromatography coupled to mass spectrometry.
Classifying subjects as having Lyme disease or STARI by inputting molecular feature abundance values into classification models to generate disease scores.
Treating subjects diagnosed with Lyme disease or STARI based on disease scores generated from metabolomic analysis.
Using the biosignature and associated mass spectrometry methods to monitor disease progression or response to treatment over time by serial blood sampling.
Supporting vaccine efficacy studies and epidemiologic surveillance by accurately differentiating Lyme disease from STARI cases.
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