Methods of diagnosing tuberculosis and differentiating between active and latent tuberculosis
AssigneeCepheid
InventorMalin Nygren
Life of this patent
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Abstract
Compositions and methods for detecting Mycobacterium tuberculosis (MTB) infection in a patient suspected of being infected with Mycobacterium tuberculosis and for distinguishing between active and latent tuberculosis infection are provided. The methods may also be used to monitor progression of MTB infection or to monitor treatment of MTB infected patients. Changes in the expression level of genes are used to aid in the diagnosis, prognosis and treatment of tuberculosis.
Claims22
A method for (i) diagnosing a patient as being infected with tuberculosis and (ii) determining if the infected patient has ATB or LTBI in a single assay, the method comprising:
- (a) obtaining a biological sample from the patient;
- (b) exposing the sample to MTB antigens for at least 0.1 hour in a single tube to obtain an antigen stimulated sample;
- (c) measuring levels of expression of at least 3 biomarkers selected from IFN-γ, MIG, IP10, IL2, FoxP3, PLAU, SLPI, VEGFA, DUSP3, GBP5, GBP1P1, ANKRD22, SERPING1, PTGS2, and IL10 in the biological sample;
- (d) comparing the levels of expression of each of the at least 3 biomarkers to a control,
- (e) diagnosing the patient as being infected with tuberculosis based on the expression level of a first combination of 2 or more of the at least 3 biomarkers, and
- (f) determining if the patient has ATB or LTBI based on the expression levels of a second combination of 2 or more of the at least 3 biomarker.
A method for (i) diagnosing a patient as being infected with MTB or not-infected in a first analysis and (ii) determining if the patient has ATB or LTBI in a second analysis, the method comprising:
- (a) obtaining a biological sample from the patient;
- (b) exposing the biological sample to MTB antigens for at least 0.1 hour in a single tube to obtain an antigen stimulated sample;
- (c) measuring levels of expression of at least 3 biomarkers selected from IFN-γ, MIG, IP10, IL2, FoxP3, PLAU, SLPI, VEGFA, DUSP3, GBP5, GBP1P1, ANKRD22, SERPING1, PTGS2, and IL10 in the antigen stimulated sample;
- (d) performing a first statistical analysis of a first set of the biomarkers measured in step (c);
- (e) performing a second statistical analysis of a second set of the biomarkers measured in step (c);
- (f) diagnosing the patient as being infected with MTB, not infected with MTB or having an inconclusive diagnosis based on the first statistical analysis;
- and
- (g) diagnosing the patient as having ATB or LTBI based on the second statistical analysis.
A kit comprising primer pairs for amplifying each of at least 4 biomarkers selected from IFN-γ, MIG, IP10, IL2, FoxP3, PLAU, SLPI, VEGFA, DUSP3, GBP5, GBP1P1, ANKRD22, SERPING1, PTGS2, and IL10 biomarkers, and a primer pair for amplifying a control from a sample.
Dependencies are inferred from the claim text.