# US 2021/0172005 A1 · Infection-related preterm birth diagnostic method

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- Number: US 2021/0172005 A1
- Document ID: US20210172005A1
- Status: Published application
- Kind: A1
- Application number: 16/771,733
- Filed: 2018-11-22
- Published: 2021-06-10
- Earliest claimed: 2017-11-24
- Assignees: The University of Western Australia
- Applicants: The University of Western Australia
- Inventors: Jeffrey Keelan; Matthew Scott Payne
- Web page: https://patentgrep.com/patent/US20210172005A1

## CPC

- C12Q 1/689: for bacteria
- C12Q 1/04: Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor {(C12Q1/6897 takes precedence)}
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- G01N 2333/30: from Mycoplasmatales, e.g. Pleuropneumonia-like organisms [PPLO]
- G01N 2333/335: from Lactobacillus (G)
- G01N 2333/40: from Candida
- G01N 2800/368: Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour
- 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
- 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)

## Abstract

A method to determine if a pregnant woman is at risk of infection-associated spontaneous pre-term birth (sPTB), the method comprising the steps of: b) testing a sample of vaginal fluid for the presence of the following bacteria: iv) Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6; v) Gardnerella vaginalis ; and vi) Lactobacillus iners wherein the presence of the bacteria indicates that the subject is at risk of sPTB.

## Claims

### Claim 1

A method to determine if a pregnant woman is at risk of infection-associated spontaneous pre-term birth (sPTB), the method comprising the steps of:
a) testing a sample of vaginal fluid for the presence of the following bacteria:
i) Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6;
ii) Gardnerella vaginalis; and
iii) Lactobacillus iners
wherein the presence of the bacteria indicates that the subject is at risk of sPTB.

### Claim 2 (depends on 1)

The method of claim 1 wherein the testing method also tests for the presence of Fusobacterium nucleatum and wherein the presence of either:
Fusobacterium nucleatum in the absence of Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6; or
Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6, Gardnerella vaginalis, and Lactobacillus iners
indicates that the subject is at risk of a sPTB.

### Claim 3 (depends on 1)

The method of claim 1 wherein the testing method is qPCR.

### Claim 4 (depends on 1)

The method of claim 1 wherein the testing is carried out at between 10 and 24 weeks' gestation.

### Claim 5

A method to determine if a pregnant woman would benefit from treatment to prevent infection-associated spontaneous pre-term birth (sPTB), the method comprising the steps of:
a) testing a sample of vaginal fluid for the presence of the following bacteria:
i) Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6;
ii) Gardnerella vaginalis; and
iii) Lactobacillus iners
wherein the presence of the bacteria indicates that the subject is at risk of a sPTB and therefore would benefit from treatment to prevent sPTB.

### Claim 6

A method to treat a pregnant woman at risk of infection-associated spontaneous pre-term birth (sPTB), comprising the steps of:
a) testing a sample of vaginal fluid for the presence of the following bacteria:
i) Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6;
ii) Gardnerella vaginalis; and
iii) Lactobacillus iners
b) if the bacteria are present, giving the pregnant woman antibiotic therapy to eliminate the bacteria.

### Claim 7

A method of reducing the risk of a pregnant woman having a infection-associated spontaneous pre-term birth (sPTB), comprising the steps of:
a) testing a sample of vaginal fluid for the presence of the following bacteria:
i) Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6;
ii) Gardnerella vaginalis; and
iii) Lactobacillus iners
b) if the bacteria are present, giving the pregnant woman antibiotic therapy to eliminate the bacteria and therefore reduce the risk of sPTB.

### Claim 8

A kit to determine if a pregnant woman is at risk of infection-associated spontaneous pre-term birth (sPTB), the kit comprising:
a) a means for testing a sample of vaginal fluid for the presence of the following bacteria:
i) Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6;
ii) Gardnerella vaginalis; and
iii) Lactobacillus iners
b) instructions for use.

### Claim 9 (depends on 5, 6, 7, 8)

The method of any one of claims 5 to 7 or kit of claim 8 wherein the testing method also tests for the presence of Fusobacterium nucleatum and wherein the presence of either:
Fusobacterium nucleatum in the absence of Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6; or
Ureaplasma parvum genotype SV3 and/or Ureaplasma parvum genotype SV6, Gardnerella vaginalis, and Lactobacillus iners
indicates that the subject is at risk of a sPTB.

### Claim 10 (depends on 5, 6, 7, 8)

The method of any one of claims 5 to 7 or kit of claim 8 wherein the testing method is qPCR.

### Claim 11 (depends on 5, 6, 7, 8)

The method of any one of claims 5 to 7 or kit of claim 8 wherein the testing is carried out at between 10 and 24 weeks' gestation.