Beta lactamase as biomarker for the specific detection of tuberculosis-complex bacteria

Patent metadata

Field	Value
Publication number	US-10175239-B2
Application number	US-201515504633-A
Country	US
Kind code	B2
Filing date	Aug 17, 2015
Priority date	Aug 18, 2014
Publication date	Jan 8, 2019
Grant date	Jan 8, 2019

Abstract

The present disclosure provides methods, reagents, systems, and devices that target β lactamase as a biomarker for the sensitive and specific detection of tuberculosis-complex bacteria. Specifically, the present disclosure relates to methods and compositions for the detection of specific β-lactamase protein and nucleic acid sequences to indicate the presence of tuberculosis-complex bacteria.

First claim

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A method of detecting the presence of tuberculosis-complex bacteria in a biological sample, the method comprising contacting the sample with an antibody or antibody fragment that specifically binds to a β-lactamase (BlaC) of a tuberculosis-complex bacteria, and detecting the formation of a complex between the BlaC and the antibody or antibody fragment, wherein the formation of a complex is indicative of the presence of tuberculosis-complex bacteria in the sample.

2. The method of claim 1 , wherein the antibody or antibody fragment specifically binds to BlaC with an amino acid sequence set forth in SEQ ID NO:2.

3. The method of claim 1 , wherein the antibody or antibody fragment comprises a detectable label.

4. The method of claim 1 , wherein the formation of a complex between the BlaC and the antibody or antibody fragment is detected by further contacting the complex with an affinity reagent that contains a detectable label and that specifically binds to the complex.

5. The method of claim 1 , further comprising contacting the biological sample with an immobilized BlaC protein or immobilized antibody or antibody fragment.

6. The method of claim 1 , wherein the biological sample is obtained from a subject suspected of having tuberculosis-complex bacteria, and wherein the presence of tuberculosis-complex bacteria in the biological sample is indicative of a tuberculosis infection in the subject.

7. The method of claim 6 , wherein the subject is human.

8. The method of claim 1 , wherein the antibody is a polyclonal antibody, a monoclonal antibody, a single chain antibody, an antigen binding enzymatic digestion product of the antibody, a chimeric antibody, or a humanized antibody.

9. The method of claim 1 , wherein the tuberculosis-complex bacteria are from one or more of the species selected from the group consisting of: Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium bovis - Bacillus Calmette-Guérin (BCG), Mycobacterium africanum, Mycobacterium microti, Mycobacterium canettii, Mycobacterium pinnipedii , and Mycobacterium mungi.

Assignees

• Texas A & M Univ Sys

Inventors

• Cirillo Jeffrey D
• Norman Michael T

Classifications

• G01N33/5695

  Mycobacteria · CPC title

• G01N2333/35

  from Mycobacteriaceae (F) · CPC title

• C12Y305/02006

  Beta-lactamase (3.5.2.6) · CPC title

• G01N2800/52

  Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis · CPC title

• C12N9/86

  acting on amide bonds in cyclic amides, e.g. penicillinase {(3.5.2)} · CPC title