# US 2013/0280699 A1 · Assay device

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- Number: US 2013/0280699 A1
- Document ID: US20130280699A1
- Status: Published application
- Kind: A1
- Application number: 13/879,500
- Filed: 2011-10-17
- Published: 2013-10-24
- Earliest claimed: 2010-10-15
- Assignees: Moorlodge Biotech Ventures Limited
- Inventors: Stephen John Minter; Georgios Patsos
- Web page: https://patentgrep.com/patent/US20130280699A1

## CPC

- G01N 33/5308: {for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites}
- G01N 33/54366: {Apparatus specially adapted for solid-phase testing}
- C12Q 1/6816: characterised by the detection means (C12Q1/6804 takes precedence)
- G01N 33/543: with an insoluble carrier for immobilising immunochemicals
- G01N 33/54306: {Solid-phase reaction mechanisms}
- G01N 2333/4724: Lectins
- G01N 2400/00: Assays, e.g. immunoassays or enzyme assays, involving carbohydrates
- 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

An assay device (1) for determining the presence and/or amount of an analyte present or potentially present in a liquid sample comprises: (i) a capillary tube (2) having an upstream region (3) into which the sample to be assayed is introduced for transfer by capillary action along the capillary tube to a downstream region thereof; (ii) a collection of first binding partners (5) immobilised within the capillary tube (2), said first binding partners (5) being capable of specifically binding to the analyte; (iii) a collection of second binding partners (6) displaceabley bound to a fraction of said first binding partners (5) whereby there are free first binding partners (5) immobilised within the capillary tube, said second binding partners (6) having a label and being displaceable from the first binding partners (5) by the analyte to be detected; and (iv) a detection region (4) for sample that has transferred to said downstream region of said capillary tube, said detection region being adapted to generate a detectable signal from the label on displaced second binding partners (6) that have transferred to the downstream region.

## Claims

### Claim 1

An assay device for determining the presence and/or amount of an analyte present or potentially present in a liquid sample, the device comprising:
(i) a capillary tube having an upstream region into which the sample to be assayed is introduced for transfer by capillary action along the capillary tube to a downstream region thereof;
(ii) a collection of first binding partners immobilised within the capillary tube, said first binding partners being capable of specifically binding to the analyte;
(iii) a collection of second binding partners displaceabley bound to a fraction of said first binding partners whereby there are free first binding partners immobilised within the capillary tube, said second binding partners having a label and being displaceable from the first binding partners by the analyte to be detected; and
(iv) a detection region for sample that has transferred to said downstream region of said capillary tube, said detection region being adapted to generate a detectable signal from the label on displaced second binding partners that have transferred to the downstream region.

### Claim 2 (depends on 1)

A device as claimed in claim 1 wherein 10-90% by mole of said first binding partners have said second binding partners bound thereto.

### Claim 3 (depends on 1)

A device as claimed in claim 1 wherein the first binding partners are covalently immobilised within the capillary tube.

### Claim 4 (depends on 1)

A device as claimed in claim 1 wherein the first and second binding partners comprise nucleic acid sequences and the second binding partners comprise nucleic acid sequences hybridised thereto.

### Claim 5 (depends on 4)

A device as claimed in claim 4 wherein the nucleic acid sequences of the first binding partners and the nucleic acid sequences of the second binding partners comprise DNA, RNA, mRNA or PNA sequences.

### Claim 6 (depends on 1)

A device as claimed in claim 1 wherein the first binding partners comprise antibodies and the second binding partners comprise antigens.

### Claim 7 (depends on 1)

A device as claimed in claim 1 wherein the first binding partner comprises a polysaccharide and the second binding partner comprises a lectin.

### Claim 8 (depends on 1)

A device as claimed in claim 1 wherein the detection region incorporates a reagent system which is capable of interacting with said label of the second binding partners to generate said detectable signal.

### Claim 9 (depends on 8)

A device as claimed in claim 8 wherein the label is an enzyme and said reagent system comprises a substrate for the enzyme.

### Claim 10 (depends on 8)

A device as claimed in claim 8 wherein said reagent system comprises an enzyme and said label is a substrate for the enzyme.

### Claim 11 (depends on 8)

A device as claimed in claim 8 wherein said label and said reagent system interact to produce a light signal.

### Claim 12 (depends on 11)

A device as claimed in claim 11 wherein said light signal is a colour change.

### Claim 13 (depends on 7)

A device as claimed in claim 7 wherein the detection region comprises a well and the device is configured so that liquid exiting from a downstream end of the capillary is discharged into the well, said reagent system being present in said well.

### Claim 14 (depends on 1)

A device as claimed in claim 1 additionally comprising a control capillary tube into which a portion of the sample is adapted to be introduced for transfer by capillary action along the control capillary tube to a downstream region thereof, and a detection region for sample that has transferred to the downstream region of the control capillary tube, said control capillary tube being devoid of said second binding partners.

### Claim 15 (depends on 1)

The combination of an assay device as claimed in claim 1 with a detection arrangement for detecting said detectable signal.

### Claim 16 (depends on 15)

The combination as claimed in claim 15 wherein the assay device incorporates a reagent system which is capable of interacting with said label of the second binding partners to generate a light signal as the detectable signal and the detection arrangement is adapted to detect the light signal by light reflectance.

### Claim 17 (depends on 15)

The combination as claimed in claim 15 wherein the detection region of the assay device incorporates a reagent system which is capable of interacting with said label of the second binding partners to generate a light signal as the detectable signal and the detection arrangement is adapted to detect the light signal by light transmission.

### Claim 18

A method of assaying a liquid sample for determining the presence and/or amount of an analyte present or potentially present in the sample, the method comprising the steps of:
(a) providing a capillary tube having immobilised therein a collection of first binding partners capable of specifically binding to the analyte, said capillary tube further incorporating a collection of second binding partners displaceably bound to a fraction of said first binding partners whereby there are free first binding partners immobilised within the capillary tube, said second binding partners having a label and being displaceable from the first binding partners by the analyte to be detected;
(b) causing the liquid sample to flow from an upstream end of the capillary tube to a downstream end thereof; and
(c) detecting for the presence of the label at the downstream end of the capillary tube.

### Claim 19 (depends on 18)

A method as claimed in claim 18 wherein 10-90% by mole of said first binding partners have said second binding partners bound thereto.

### Claim 20 (depends on 18)

A method as claimed in claim 18 wherein the first binding partners are covalently immobilised within the capillary tube.

### Claim 21 (depends on 18)

A method as claimed in claim 18 wherein the first and second binding partners comprise nucleic acid sequences and the second binding partners comprise nucleic acid sequences hybridised thereto.

### Claim 22 (depends on 21)

A method as claimed in claim 21 wherein the nucleic acid sequences of the first binding partners and the nucleic acid sequences of the second binding partners comprise DNA, mRNA, RNA or PNA sequences.

### Claim 23 (depends on 18)

A method as claimed in claim 18 wherein the first binding partners comprise antibodies and the second binding partners comprise antigens.

### Claim 24 (depends on 18)

A method as claimed in claim 18 wherein the first binding partners comprise a polysaccharide and the second binding partners comprise a lectin.

### Claim 25 (depends on 24)

A method as claimed in claim 24 for the detection of an organism having surface lectins capable of displacing the labelled, lectin second binding partner.
