# US 11,149,322 B2 · Methods and compositions for human papillomaviruses and sexually transmitted infections detection, identification and quantification

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- Number: US 11,149,322 B2
- Document ID: US11149322B2
- Status: Granted
- Kind: B2
- Application number: 16/435,017
- Filed: 2019-06-07
- Published: 2020-12-10
- Granted: 2021-10-19
- Earliest claimed: 2019-06-07
- Assignees: Chapter Diagnostics, Inc.
- Applicants: Chapter Diagnostics, Inc.
- Inventors: Chunlin Wang; Zhihai Ma; Baback Gharizadeh
- Web page: https://patentgrep.com/patent/US11149322B2

## CPC

- C12Q 1/708: {for papilloma}
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 1/689: for bacteria
- C12Q 1/705: {for herpetoviridae, e.g. herpes simplex, varicella zoster}
- C12Q 2600/16: Primer sets for multiplex assays
- 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 present disclosure relates to compositions and methods for detection, identification and quantification of human papillomaviruses (HPV) and clinically significant sexually transmitted infections (STI) in a single amplification reaction. The disclosed method utilizes next-generation sequencing (NGS) to sequence amplified products. The present disclosure is also directed to kits containing primers specific to multiple HPV and STI targets.

## Claims

### Claim 1

A method of screening a sample from each of one or more subjects, comprising the steps of:
for each sample, hybridizing a plurality of target-specific primers with nucleic acid from the sample in the presence of barcoded universal primers to form a test reaction, wherein at least one target-specific primer is configured to bind to a target sequence specific to sexually transmitted infection and wherein each target-specific primer comprises a specific sequence portion directed to a target nucleic acid sequence and a universal priming portion;
subjecting each test reaction to amplification conditions to generate amplicons;
subjecting at least a portion of the amplicons generated from each sample to bead cleanup to form enriched amplicons; and
sequencing the enriched amplicons, formed from each sample, by next-generation sequencing;
wherein each barcoded universal primer comprises: a universal priming portion at the 3′-end; a barcode portion in the middle; and a universal priming portion at the 5′-end.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sample is obtained from a subject suspected of having or diagnosed with at least one sexually transmitted infection.

### Claim 3 (depends on 1)

The method of claim 1, further comprising the step of pooling the enriched amplicons from each sample prior to sequencing.

### Claim 4 (depends on 1)

The method of claim 1, further comprising the step of quantifying each type and species in each sample after sequencing the enriched amplicons.

### Claim 5 (depends on 1)

The method of claim 1, wherein the test utilizes a polymorphic gene with unique sequence for every individual as internal control to monitor cross-contamination.