# US 11,028,439 B2 · Assay for detecting hepatitis B virus (HBV)

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- Number: US 11,028,439 B2
- Document ID: US11028439B2
- Status: Granted
- Kind: B2
- Application number: 16/143,904
- Filed: 2018-09-27
- Published: 2019-05-23
- Granted: 2021-06-08
- Earliest claimed: 2017-09-27
- Assignees: Abbott Molecular Inc.
- Applicants: Abbott Molecular Inc.
- Inventors: Dominik Duelli; Wai-Bing Mak; Brian Erickson; Amanda Goldston
- Web page: https://patentgrep.com/patent/US11028439B2

## CPC

- C12Q 1/6876: Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
- C12Q 1/6806: Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay (C12Q1/6804 takes precedence)
- C12Q 1/686: Polymerase chain reaction [PCR]
- C12Q 1/706: {for hepatitis}
- C12Q 2600/112: Disease subtyping, staging or classification
- C12Q 2600/16: Primer sets for multiplex assays
- C12Q 2600/166: Oligonucleotides used as internal standards, controls or normalisation probes
- 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

The disclosure is directed to methods, kits, and compositions, for amplifying and detecting a human hepatitis B virus (HBV) in a sample, which comprises a variety of combinations of forward oligonucleotide primers, reverse oligonucleotide primers, and oligonucleotide probes.

## Claims

### Claim 1

A set of oligonucleotide sequences for amplifying and detecting a nucleic acid sequence from a hepatitis B virus (HBV) capable of infecting humans in a sample, which comprises:
(a) a forward primer oligonucleotide sequence comprising SEQ ID NO: 1;
(b) a reverse primer oligonucleotide sequence comprising SEQ ID NO: 2;
(c) a first probe oligonucleotide sequence comprising SEQ ID NO: 3 and a detectable label;
(d) a second probe oligonucleotide sequence comprising SEQ ID NO: 4 and a detectable label,
(e) an internal control forward primer oligonucleotide sequence comprising SEQ ID NO: 5,
(f) an internal control reverse primer oligonucleotide sequence comprising SEQ ID NO: 6, and
(g) an internal control probe oligonucleotide sequence comprising SEQ ID NO: 7 and a detectable label.

### Claim 2 (depends on 1)

The set of claim 1, wherein the detectable label is a fluorophore.

### Claim 3 (depends on 1)

The set of claim 1, wherein each of the probe oligonucleotides further comprises a quencher moiety.

### Claim 4 (depends on 1)

A method for detecting hepatitis B virus (HBV) capable of infecting humans in a sample suspected of containing HBV, which method comprises:
(a) contacting a sample obtained from a human with the set of oligonucleotide sequences of claim 1 and reagents for amplification and detection of nucleic acid sequences,
(b) amplifying a first target HBV nucleic acid sequence present in the sample,
(c) hybridizing the first and second oligonucleotide probes to the first target HBV nucleic acid sequence, and
(d) detecting hybridization of the first and second probe oligonucleotide sequences to the first target HBV nucleic acid sequence by assessing a signal from each of the detectable labels, whereby
(i) the presence of the signals indicates hybridization of the first and second probe oligonucleotide sequences to the first target HBV nucleic acid sequence and the presence of HBV in the sample, and
(ii) the absence of the signals indicates the absence of HBV in the sample.

### Claim 5 (depends on 4)

The method of claim 4, wherein the sample comprises serum or plasma.

### Claim 6

A kit for detecting hepatitis B virus (HBV) capable of infecting humans in a sample comprising:
(a) a forward primer oligonucleotide sequence comprising SEQ ID NO: 1;
(b) a reverse primer oligonucleotide sequence comprising SEQ ID NO: 2;
(c) a first probe oligonucleotide sequence comprising SEQ ID NO: 3 and a detectable label;
(d) a second probe oligonucleotide sequence comprising SEQ ID NO: 4 and a detectable label;
(e) an internal control forward primer oligonucleotide sequence comprising SEQ ID NO: 5;
(f) an internal control reverse primer oligonucleotide sequence comprising SEQ ID NO: 6; and
(g) an internal control probe oligonucleotide sequence comprising SEQ ID NO: 7 and a detectable label;
(h) reagents for amplifying and detecting nucleic acid sequences; and
(i) instructions for use.

### Claim 7 (depends on 6)

The kit of claim 6, wherein the primers, probes, and reagents are lyophilized.

### Claim 8

A composition for amplifying and detecting a hepatitis B virus (HBV) capable of infecting humans in a sample, which comprises:
(a) a forward primer oligonucleotide sequence comprising SEQ ID NO: 1;
(b) a reverse primer oligonucleotide sequence comprising SEQ ID NO: 2;
(c) a first probe oligonucleotide sequence comprising SEQ ID NO: 3 and a detectable label; and
(d) a second probe oligonucleotide sequence comprising SEQ ID NO: 4 and a detectable label;
(e) a forward primer oligonucleotide sequence comprising SEQ ID NO: 5;
(f) a reverse primer oligonucleotide sequence comprising SEQ ID NO: 6; and
(g) a probe oligonucleotide sequence comprising SEQ ID NO: 7 and a detectable label.

### Claim 9 (depends on 8)

The composition of claim 8, wherein the primer oligonucleotides and probe oligonucleotides are lyophilized.