# US 12,077,830 B2 · Methods for detecting norovirus

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- Number: US 12,077,830 B2
- Document ID: US12077830B2
- Status: Granted
- Kind: B2
- Application number: 18/097,004
- Filed: 2023-01-13
- Published: 2023-09-07
- Granted: 2024-09-03
- Earliest claimed: 2016-06-03
- Assignees: Quest Diagnostics Investments Incorporated
- Applicants: Quest Diagnostics Investments LLC
- Inventors: Peter Lee; Raymond Huang; Kristin Ramos; Jules Chen; Michelle Tabb
- Web page: https://patentgrep.com/patent/US12077830B2

## CPC

- C12Q 1/701: {Specific hybridization probes}
- A61P 31/14: for RNA viruses
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12Q 1/68: involving nucleic acids
- C12Q 1/686: Polymerase chain reaction [PCR]
- C12Q 1/70: involving virus or bacteriophage {(immunoassay for viruses G01N33/56983)}
- G01N 33/56983: {Viruses}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- C12N 2770/16021: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/112: Disease subtyping, staging or classification
- G01N 2333/08: RNA viruses
- 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
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

The present disclosure provides methods and compositions for determining whether a patient exhibiting acute gastroenteritis will benefit from treatment with therapeutic agents that inhibit Norovirus genogroup I (GI) or Norovirus genogroup II (GII). The methods disclosed herein are based on detecting Norovirus genogroup I (GI) and Norovirus genogroup II (GII) in a stool sample without extracting viral nucleic acids from a clinical specimen prior to performing real-time reverse transcription PCR. Kits for use in practicing the methods are also provided.

## Claims

### Claim 1

A kit for detecting the presence of Norovirus genogroup I (GI) in a biological sample comprising a first primer pair that amplifies a Norovirus genogroup I (GI) target nucleic acid of SEQ ID NO: 2 or a complement thereof, wherein the first primer pair consists of a first forward primer comprising 5′d CGYTGGATGCGITTYCATGA 3′ (SEQ ID NO: 5) and a first reverse primer comprising 5′d TCCTTAGACGCCATCATCATTTAC 3′(SEQ ID NO: 6).

### Claim 2 (depends on 1)

The kit of claim 1, further comprising a second primer pair that amplifies a control target nucleic acid of SEQ ID NO: 12 or a complement thereof.

### Claim 3 (depends on 2)

The kit of claim 2, wherein the second primer pair consists of a second forward primer comprising 5′d CTCGTCGACAATGGCGGAA 3′ (SEQ ID NO: 13) and a second reverse primer comprising 5′d TTCAGCGACCCCGTTAGC 3′ (SEQ ID NO: 14).

### Claim 4 (depends on 1)

The kit of claim 1, wherein the kit further comprises:
a first nucleic acid probe that is capable of specifically hybridizing to a segment of the Norovirus genogroup I (GI) target nucleic acid sequence of SEQ ID NO: 2 or a complement thereof, wherein the first nucleic acid probe is detectably labeled and optionally comprises 5′d TGGACAGGAGAYCGCIATCTCYTGCCCGA 3′ (SEQ ID NO: 7), or a complement thereof; and/or
a second nucleic acid probe that is capable of specifically hybridizing to a segment of the Norovirus genogroup I (GI) target nucleic acid sequence of SEQ ID NO: 2 or a complement thereof, wherein the second nucleic acid probe is detectably labeled and optionally comprises 5′d TGGACAGGAGATCGCAATCTACTGCCTGA 3′(SEQ ID NO: 8), or a complement thereof; and/or
a third nucleic acid probe that specifically hybridizes to a segment of the control target nucleic acid of SEQ ID NO: 12 or a complement thereof, wherein the third nucleic acid probe is detectably labeled and comprises 5′d GCTTGGGGCGACAGTCACGTCGC 3′ (SEQ ID NO: 15), or a complement thereof.

### Claim 5 (depends on 4)

The kit of claim 4, wherein the first nucleic acid probe is detectably labelled with CFR610 fluorophore.

### Claim 6 (depends on 4)

The kit of claim 4, wherein the second nucleic acid probe is detectably labelled with CFR610 fluorophore.

### Claim 7 (depends on 4)

The kit of claim 4, wherein the third nucleic acid probe is detectably labelled with Q670 fluorophore.

### Claim 8

A kit for detecting the presence of Norovirus genogroup II (GII) in a biological sample comprising a primer pair that amplifies a Norovirus genogroup II (GII) target nucleic acid of SEQ ID NO: 4 or a complement thereof, wherein the primer pair consists of a second forward primer comprising 5′d TGTTYAGGTGGATGAGRTTCTCIGA 3′ (SEQ ID NO: 9) and a second reverse primer comprising 5′d TCGACGCCATCTTCATTCACA 3′ (SEQ ID NO: 10).

### Claim 9 (depends on 8)

The kit of claim 8, further comprising a control primer pair that amplifies a control target nucleic acid of SEQ ID NO: 12 or a complement thereof.

### Claim 10 (depends on 9)

The kit of claim 9, wherein the control primer pair consists of a second forward primer comprising 5′d CTCGTCGACAATGGCGGAA 3′ (SEQ ID NO: 13) and a second reverse primer comprising 5′d TTCAGCGACCCCGTTAGC 3′ (SEQ ID NO: 14).

### Claim 11 (depends on 8)

The kit of claim 8, wherein the kit further comprises:
a nucleic acid probe that is capable of specifically hybridizing to a segment of the Norovirus genogroup II (GII) target nucleic acid sequence of SEQ ID NO: 4 or a complement thereof, wherein the third nucleic acid probe is detectably labeled and optionally comprises 5′d ACGTGGGAGGGCGATCGCAATCT 3′ (SEQ ID NO: 11) or a complement thereof; and/or
a control nucleic acid probe that specifically hybridizes to a segment of the control target nucleic acid of SEQ ID NO: 12 or a complement thereof, wherein the fourth nucleic acid probe is detectably labeled and comprises 5′d GCTTGGGGCGACAGTCACGTCGC 3′ (SEQ ID NO: 15), or a complement thereof.

### Claim 12 (depends on 11)

The kit of claim 11, wherein the nucleic acid probe is detectably labelled with FAM fluorophore.

### Claim 13 (depends on 11)

The kit of claim 11, wherein the control nucleic acid probe is detectably labelled with CFR610 fluorophore.