Claims for Patent: 10,175,239

Summary for Patent: 10,175,239

Title:	Beta lactamase as biomarker for the specific detection of tuberculosis-complex bacteria
Abstract:	The present disclosure provides methods, reagents, systems, and devices that target .beta. 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 .beta.-lactamase protein and nucleic acid sequences to indicate the presence of tuberculosis-complex bacteria.
Inventor(s):	Cirillo; Jeffrey D. (College Station, TX), Norman; Michael T. (Temple, TX)
Assignee:	THE TEXAS A&M UNIVERSITY SYSTEM (College Station, TX)
Application Number:	15/504,633
Patent Claims:	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 .beta.-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-Guerin (BCG), Mycobacterium africanum, Mycobacterium microti, Mycobacterium canettii, Mycobacterium pinnipedii, and Mycobacterium mungi.

Details for Patent 10,175,239

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2034-08-18