High sensitivity method for early lyme disease detection
AssigneesColorado State University Research Foundation, The U.S.A., as represented by the Secretary, Department of Health and Human Services, New York Medical College
InventorsJohn T. Belisle, Claudia R. Mollins, Gary P. Wormser
Life of this patent
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Abstract
The present disclosure provides methods for detecting early Lyme disease. The present disclosure provides a biosignature indicative of the presence or absence of Borrelia burgdorferi infection.
Claims30
A method for analyzing a test biological sample from a subject, the method comprising:
- subjecting the test biological sample to a high resolution mass spectrometry (MS) analysis to provide a first set of abundance values comprising an abundance value for each of at least forty-four molecular features in the biological sample, the at least forty-four molecular features comprising MF #1-44 in Table A.
A system for analyzing a test biological sample from a subject at risk of having Lyme disease, the system comprising a high resolution mass spectrometry (MS) apparatus configured to provide a first set of abundance values comprising an abundance value for each of at least forty-four molecular features in the test biological sample, the at least forty-four molecular features comprising MF #1-44 in Table A.
A method of correctly distinguishing a subject with early Lyme disease from a control subject, with a sensitivity of at least 84%, the method comprising:
- a) obtaining a test biological sample from the subject with early Lyme disease;
- b) analyzing the test biological sample with an LC-MS apparatus to obtain an abundance value for each of at least forty-four molecular features in the sample, the at least forty-four molecular features comprising MF #1-44 in Table A;
- and c) determining the relative abundance of each molecular feature in the biological sample with respect to a control sample from the control subject, wherein the profile of relative abundances for the molecular features in the test sample is indicative of early Lyme disease.
A method for selecting a biosignature for Lyme disease, the method comprising:
- a) obtaining test biological samples and control biological samples, wherein the test biological samples are from subjects with confirmed Lyme disease and control biological samples are from subjects without Lyme disease;
- b) analyzing the test biological samples and control biological samples with an LC-MS apparatus to obtain abundance values for a plurality of molecular features in the test biological samples and the control biological samples;
- and c) applying a statistical modeling technique to select for molecular features that distinguish subjects with Lyme disease from subjects without Lyme disease, wherein the molecular features that distinguish subjects with Lyme disease from subjects without Lyme disease comprise the biosignature for Lyme disease.
Dependencies are inferred from the claim text.