# US 11,028,451 B2 · Compositions and methods for detection of Mycobacterium tuberculosis

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- Number: US 11,028,451 B2
- Document ID: US11028451B2
- Status: Granted
- Kind: B2
- Application number: 15/952,133
- Filed: 2018-04-12
- Published: 2019-10-24
- Granted: 2021-06-08
- Earliest claimed: 2015-08-06
- Assignees: Roche Molecular Systems, Inc.
- Applicants: Roche Molecular Systems, Inc.
- Inventors: Jenny A. Johnson
- Web page: https://patentgrep.com/patent/US11028451B2

## CPC

- C12Q 1/689: for bacteria
- C12Q 2600/158: Expression markers
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

Methods for the rapid detection of the presence or absence of Mycobacterium tuberculosis (MTB) and other members of the MTB-complex in a biological or non-biological sample are described. The methods can include performing an amplifying step, a hybridizing step, and a detecting step. Furthermore, primers, probes targeting the esxJ gene, along with kits are provided that are designed for the detection of MTB.

## Claims

### Claim 1

A kit for detecting a nucleic acid of Mycobacterium tuberculosis (MTB) and other members of the MTB-complex comprising:
a first primer consisting of SEQ ID NO: 1, or the complement thereof, and optionally having at least one modified nucleotide, or SEQ ID NO: 7, or the complement thereof, and optionally having at least one modified nucleotide, or SEQ ID NO: 8, or the complement thereof, and optionally having at least one modified nucleotide;
a second primer consisting of SEQ ID NO: 15, or the complement thereof, and optionally having at least one modified nucleotide, or SEQ ID NO: 16, or the complement, thereof and optionally having at least one modified nucleotide, or SEQ ID NO: 17, or the complement thereof, and optionally having at least one modified nucleotide; and
a third fluorescently detectably labeled probe consisting of SEQ ID NO: 30, or the complement thereof, and optionally having at least one modified nucleotide, at least one donor fluorescent moiety and at least one corresponding acceptor moiety.

### Claim 2 (depends on 1)

The kit of claim 1, further comprising nucleoside triphosphates, nucleic acid polymerase, and buffers necessary for the function of the nucleic acid polymerase.

### Claim 3 (depends on 2)

The kit of claim 2, wherein the nucleic acid polymerase has 5′ to 3′ nuclease activity.

### Claim 4 (depends on 1)

The kit of claim 1, wherein the at least one modified nucleotide is selected from t-butylbenzyldeoxyadenine or t-butylbenzyldeoxycytosine.

### Claim 5 (depends on 1)

The kit of claim 1 wherein the first oligonucleotide sequence consists of SEQ ID NO: 1, and contains t-butylbenzyldeoxyadenine on its 3′ terminal nucleotide.

### Claim 6 (depends on 1)

The kit of claim 1 wherein the first oligonucleotide sequence consists of SEQ ID NO: 7 and contains t-butylbenzyldeoxycytosine on its 3′ terminal nucleotide.

### Claim 7 (depends on 1)

The kit of claim 1 wherein the first oligonucleotide sequence consists of SEQ ID NO: 8 and contains t-butylbenzyldeoxycytosine on its 3′ terminal nucleotide.

### Claim 8 (depends on 1)

The kit of claim 1 wherein the second oligonucleotide sequence consists of SEQ ID NO: 15 and contains t-butylbenzyldeoxycytosine on its 3′ terminal nucleotide.

### Claim 9 (depends on 1)

The kit of claim 1 wherein the second oligonucleotide sequence consists of SEQ ID NO: 16 and contains t-butylbenzyldeoxycytosine on its 3′ terminal nucleotide.

### Claim 10 (depends on 1)

The kit of claim 1 wherein the second oligonucleotide sequence consists of SEQ ID NO: 17 and contains t-butylbenzyldeoxycytosine on its 3′ terminal nucleotide.