# US 2025/0154612 A1 · Compositions and Methods for Detecting or Quantifying Hepatitis B Virus

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- Number: US 2025/0154612 A1
- Document ID: US20250154612A1
- Status: Published application
- Kind: A1
- Application number: 19/025,006
- Filed: 2025-01-16
- Published: 2025-05-15
- Earliest claimed: 2016-11-21
- Assignees: Gen-Probe Incorporated
- Applicants: Gen-Probe Incorporated
- Inventors: Kui Gao; Jeffrey M. Linnen
- Web page: https://patentgrep.com/patent/US20250154612A1

## CPC

- C12Q 1/706: {for hepatitis}
- C12Q 1/6851: Quantitative amplification
- C12Q 1/686: Polymerase chain reaction [PCR]
- C12Q 2600/112: Disease subtyping, staging or classification
- C12Q 2600/156: Polymorphic or mutational markers
- C12Q 2600/158: Expression markers
- C12Q 2600/16: Primer sets for multiplex assays
- C12Q 2600/172: Haplotypes
- 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

This disclosure provides oligomers, compositions, and kits for detecting and quantifying Hepatitis B virus (HBV), including different genotypes and variants thereof, and related methods and uses. In some embodiments, oligomers target the P and/or S open reading frames of HBV and are configured to provide substantially equivalent quantification of different genotypes and variants of HBV.

## Claims

### Claim 1

A composition or kit comprising at least first, second,
third, and fourth amplification oligomers, wherein:
the first amplification oligomer comprises a target-hybridizing sequence comprising at least 10 contiguous nucleotides of one of SEQ ID NOs: 2 or 3;
the second amplification oligomer comprises a target-hybridizing sequence comprising at least 10 contiguous nucleotides of one of SEQ ID NOs: 20, 21, or 22;
the third amplification oligomer comprises a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO: 41; and
the fourth amplification oligomer comprises a target-hybridizing sequence comprising at least 10 contiguous nucleotides of one of SEQ ID NOs: 34 or 35;
wherein the target-hybridizing sequences of the first, second, third, and fourth amplification oligomers each comprise at least about 14 contiguous nucleotides of Hepatitis B virus sequence or a complement thereof, and
one or more of the first, second, third, and fourth amplification oligomers is a promoter-primer and/or comprises a non-nucleotide detectable label, and/or the composition or kit further comprises at least one probe oligomer comprising a non-nucleotide detectable label.

### Claim 2 (depends on 1)

A method of detecting Hepatitis B virus in a sample, comprising:
contacting the sample with at least first, second, third, and fourth amplification oligomers, thereby forming a composition which is the composition of claim 1 further comprising the sample,
performing a nucleic acid amplification reaction in the composition which produces at least first and second amplicons in the presence of a Hepatitis B virus nucleic acid,
and quantifying the first and second amplicons,
wherein:
the first amplicon is produced through extension of the first and second amplification oligomers in the presence of the Hepatitis B virus nucleic acid;
the second amplicon is produced through extension of the third and fourth amplification oligomers in the presence of the Hepatitis B virus nucleic acid.

### Claim at position 3

3-6. (canceled)

### Claim 7 (depends on 1)

The composition or kit of claim 1, wherein one or more promoter-primers comprises the sequence of SEQ ID NO: 8, 9, 10, 11, 12, or 13.

### Claim at position 5

8-13. (canceled)

### Claim 14 (depends on 1)

The composition or kit of claim 1, wherein the first amplification oligomer comprises the sequence of SEQ ID NO: 3.

### Claim 15

(canceled)

### Claim 16 (depends on 1)

The composition or kit of claim 1, wherein the first amplification oligomer comprises the sequence of SEQ ID NO: 2.

### Claim 17 (depends on 1)

The composition or kit of claim 1, wherein the composition or kit further comprises an additional amplification oligomer different from the first amplification oligomer, comprising at least 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 contiguous nucleotides of SEQ ID NO: 3.

### Claim 18

(canceled)

### Claim 19

(canceled)

### Claim 20 (depends on 1)

The composition or kit of claim 1, wherein the second amplification oligomer comprises the sequence of SEQ ID NO: 21.

### Claim 21

(canceled)

### Claim 22

(canceled)

### Claim 23 (depends on 1)

The composition or kit of claim 1, wherein the second amplification oligomer comprises the sequence of SEQ ID NO: 22.

### Claim 24

(canceled)

### Claim 25

(canceled)

### Claim 26 (depends on 1)

The composition or kit of claim 1, wherein the second amplification oligomer comprises the sequence of SEQ ID NO: 20.

### Claim 27

(canceled)

### Claim 28 (depends on 1)

The composition or kit of claim 1, wherein the third amplification oligomer comprises the sequence of SEQ ID NO: 41.

### Claim 29 (depends on 1)

The composition or kit of claim 1, wherein the fourth amplification oligomer comprises at least 10 contiguous nucleotides of SEQ ID NO: 35 including the inosine at position 30 of SEQ ID NO: 35.

### Claim 30

(canceled)

### Claim 31 (depends on 1)

The composition or kit of claim 1, wherein the fourth amplification oligomer comprises the sequence of SEQ ID NO: 34.

### Claim 32

(canceled)

### Claim 33 (depends on 1)

The composition or kit of claim 1, wherein the composition or kit further comprises a fifth amplification oligomer comprising at least 10 contiguous nucleotides of the sequence of SEQ ID NO: 69 and at least about 14 contiguous nucleotides of Hepatitis B virus sequence or a complement thereof.

### Claim 34

(canceled)

### Claim 35

(canceled)

### Claim 36 (depends on 33)

The composition or kit of claim 33, wherein the fifth amplification oligomer comprises the sequence of SEQ ID NO: 69.

### Claim 37

(canceled)

### Claim 38

(canceled)

### Claim 39 (depends on 1)

The composition or kit of claim 1, wherein the composition or kit further comprises a sixth amplification oligomer comprising at least 10 contiguous nucleotides of the sequence of SEQ ID NO: 73 and at least about 14 contiguous nucleotides of Hepatitis B virus sequence or a complement thereof.

### Claim at position 32

40-57. (canceled)

### Claim 58 (depends on 1)

The composition or kit of claim 1, wherein the composition or kit further comprises at least one probe oligomer configured to hybridize specifically to an amplicon produced from the first and second amplification oligomers.

### Claim at position 34

59-62. (canceled)

### Claim 63 (depends on 58)

The composition or kit of claim 58, wherein the probe oligomer comprises the sequence of SEQ ID NO: 29.

### Claim 64 (depends on 58)

The composition or kit of claim 58, wherein the composition or kit further comprises at least one probe oligomer configured to hybridize specifically to an amplicon produced from the third and fourth amplification oligomers.

### Claim at position 37

65-67. (canceled)

### Claim 68 (depends on 64)

The composition or kit of claim 64, wherein the probe oligomer comprises at least 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 contiguous nucleotides of SEQ ID NO: 40.

### Claim at position 39

69-88. (canceled)

### Claim 89

A composition or kit comprising:
(A) two or more different capture oligomers selected from the following capture oligomers (i)-(iv):
(i) a first capture oligomer comprising a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO: 49 or 99;
(ii) a second capture oligomer comprising a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO: 53, 100, 101, or 104;
(iii) a third capture oligomer comprising a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO: 57, 96, or 102;
(iv) a fourth capture oligomer comprising a target-hybridizing sequence comprising at least 10 contiguous nucleotides of SEQ ID NO: 61, 97, 98, or 103;
wherein the target-hybridizing sequences of the two or more different capture oligomers each comprise at least about 14 contiguous nucleotides of Hepatitis B virus sequence or a complement thereof; or
(B) a probe oligomer comprising a target-hybridizing region comprising the sequence of SEQ ID NO: 83: or
(C) an amplification oligomer comprising a target-hybridizing region comprising at least 10 contiguous nucleotides of SEQ ID NO: 35 including the inosine at position 30 of SEQ ID NO: 35 and at least 14 contiguous nucleotides of HBV sequence; or
(D) a combination thereof.

### Claim 90 (depends on 89)

A method of isolating HBV nucleic acid from a sample, comprising:
contacting the sample with two or more different capture oligomers, thereby forming a composition which is the composition of claim 89 further comprising the sample, under conditions permissive for forming one or more complexes of a capture oligomer and HBV nucleic acid, wherein the two or more different capture oligomers are selected from the first, second, third, and fourth capture oligomer; and isolating the capture oligomers from the composition.

### Claim at position 42

91-134. (canceled)

### Claim 135

A method of determining a level of Hepatitis B virus in a sample comprising first and second Hepatitis B amplicons associated with first and second labels, respectively, the method comprising:
detecting a first signal emitted from the first label;
detecting a second signal emitted from the second label;
determining whether the first signal or the second signal is above a predetermined threshold;
and calculating a level of Hepatitis B virus in the sample,
wherein if the first signal or the second signal is above a predetermined threshold, the level is calculated from the greater of the first and second signals;
and wherein if the first signal and the second signal are below a predetermined threshold, the level is calculated from an average of the first and second signals.

### Claim at position 44

136-164. (canceled)