# US 11,079,378 B2 · Detection of analytes in bodily fluid to determine the initiation of parturition

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- Number: US 11,079,378 B2
- Document ID: US11079378B2
- Status: Granted
- Kind: B2
- Application number: 15/534,287
- Filed: 2015-12-10
- Published: 2017-12-21
- Granted: 2021-08-03
- Earliest claimed: 2014-12-10
- Assignees: Xpecting Diagnostics, Inc.
- Applicants: Xpecting Diagnostics, Inc.
- Inventors: R. Tanner Hagelstrom
- Web page: https://patentgrep.com/patent/US11079378B2

## CPC

- G01N 33/54388: {based on lateral flow}
- C12Q 1/00: Measuring or testing processes involving enzymes, nucleic acids or microorganisms (measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34); Compositions therefor; Processes of preparing such compositions
- G01N 33/689: {related to pregnancy or the gonads}
- C12Q 2525/205: Aptamer
- C12Q 2525/207: siRNA, miRNA
- C12Q 2537/125: Sandwich assay format
- 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)
- 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

Devices and kits for detecting molecular targets involved in the onset of parturition are presented, as are methods of using the same. The devices and kits include one or more associators specific for molecular targets, such as microRNAs and proteins and peptide fragments thereof. The associators, such as aptamers or antibodies, bind their targets, when such targets are present in a fluid sample from a pregnant woman, to produce a detectable signal. The signal may be produced in a lateral flow device.

## Claims

### Claim 1

A lateral flow device for predicting the initiation of parturition comprising:
a sample pad;
a conjugate pad to which a plurality of first associators are releasably bound, the plurality of first associators capable of binding a microRNA; and
a capture pad to which a plurality of second associators are fixedly bound,
wherein at least one of the first associator and second associator is an aptamer and the other of the first associator and second associator is selected from an aptamer and an antibody.

### Claim 2 (depends on 1)

The device of claim 1, wherein the expression level of the microRNA is increased in the initiation of parturition.

### Claim 3 (depends on 1)

The device of claim 1, wherein the microRNA is selected from miR-429, miR-200a, and miR-200b.

### Claim 4 (depends on 1)

The device of claim 1, wherein the expression level of the microRNA is decreased in the initiation of parturition.

### Claim 5 (depends on 1)

The device of claim 1, wherein the microRNA is selected from miR-199a-3p and miR-214.

### Claim 6 (depends on 1)

The device of claim 1, wherein each associator in the plurality of first associators is conjugated to a reporter molecule.

### Claim 7 (depends on 6)

The device of claim 6, wherein the reporter molecule is selected from a gold nanoparticle and latex.

### Claim 8 (depends on 1)

The device of claim 1, wherein each associator in the plurality of second associators is capable of binding a complex of the first associator bound to the microRNA.

### Claim 9 (depends on 1)

The device of claim 1, wherein the sample pad may receive a sample from a pregnant woman and the sample is selected from urine, blood, saliva, plasma, amniotic fluid, and peritoneal fluid.

### Claim 10 (depends on 9)

The device of claim 9, wherein the sample comprises exosomes.

### Claim 11 (depends on 10)

The device of claim 10, wherein the sample pad comprises a delay zone comprising an exosome-lysing detergent.

### Claim 12 (depends on 1)

A method of predicting the initiation of parturition comprising:
providing the lateral flow device of claim 1, and
applying a sample to the device, the sample comprising the microRNA,
wherein the microRNA contact the plurality of first associators to form first complexes,
wherein the first complexes contact the plurality of second associators to form second complexes, and
wherein the formation of second complexes produces a signal that provides a prediction of the initiation of parturition .

### Claim 13 (depends on 12)

The method of claim 12, wherein the first associators are conjugated to reporter molecules and the detectable signal is a visually detectable signal.

### Claim 14 (depends on 12)

The method of claim 12, comprising incubating the sample in an exosome-lysing detergent prior to contacting with the plurality of first associators.

### Claim 15

A kit for predicting the initiation of parturition comprising:
a lateral flow device comprising:
a sample pad;
a conjugate pad to which a plurality of first associators are releasably bound, the plurality of first associators capable of binding a microRNA; and
a capture pad to which a plurality of second associators are fixedly bound,
wherein at least one of the first associator and second associator is an aptamer and the other of the first associator and second associator is selected from an aptamer and an antibody;
a sample vessel;
a detergent solution; and
instructions for using the device.

### Claim 16 (depends on 15)

The kit of claim 15, wherein the lateral flow device comprises a backing affixed to each of the sample pad, the conjugate pad, and the capture pad .