# US 10,371,698 B2 · Sample testing apparatus and method

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,371,698 B2
- Document ID: US10371698B2
- Status: Granted
- Kind: B2
- Application number: 15/606,631
- Filed: 2017-05-26
- Published: 2018-01-18
- Granted: 2019-08-06
- Earliest claimed: 2010-08-25
- Assignees: Alere Toxicology PLC
- Applicants: Alere Toxicology PLC
- Inventors: Alan Pang; Gordon Jowett; Barry Lillis; Jack Fairbank
- Web page: https://patentgrep.com/patent/US10371698B2

## CPC

- G01N 33/5302: {Apparatus specially adapted for immunological test procedures}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 33/559: through a gel, e.g. Ouchterlony technique
- B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis}
- B01L 2200/04: Exchange or ejection of cartridges, containers or reservoirs
- B01L 2200/0689: Sealing
- B01L 2200/16: Reagents, handling or storing thereof
- B01L 2300/0636: Integrated biosensor, microarrays
- B01L 2300/0672: Integrated piercing tool
- B01L 2300/0681: Filter
- B01L 2300/0825: Test strips
- B01L 2300/1827: using resistive heater
- B01L 2400/0677: phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
- B01L 2400/0683: mechanically breaking a wall or membrane within a channel or chamber
- 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)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

Apparatus for performing an assay to detect the presence of an analyte in a test sample. A housing defines a slot for receiving a sample collector, and a capsule contains a buffer liquid, the capsule being sealed by an openable lid, and being connected to the housing such that insertion of a sample collector into the slot causes the lid to open releasing the buffer liquid into the slot. The housing further defines an incubation chamber containing or configured to receive a reagent, and an aperture permitting liquid communication between the slot and the incubation chamber. The apparatus comprises one or more test elements, a substantially liquid tight sealing member separating the incubation chamber and the test element(s), and an activation mechanism operable to open the liquid tight sealing member thereby bringing at least a portion of the or each test element into liquid communication with the incubation chamber.

## Claims

### Claim 1

A method of performing an assay to detect the presence of an analyte or analytes in a test sample, the method comprising:
1) inserting a sample collector comprising a swab with a sample into a receiving slot of a cartridge, the cartridge containing one or more test elements, such that insertion of the collector opens a lid of a capsule containing buffer liquid and causes said liquid to be expelled from the capsule under pressure to communicate the buffer liquid and at least a portion of the sample via the slot into an incubation chamber of the cartridge;
2) mixing the buffer liquid and sample portion with a reagent contained within or introduced into the chamber; and
3) causing at least a part of each test element to come into contact with the fluid in the chamber, resulting in the lateral flow immunoassay being initiated.

### Claim 2 (depends on 1)

A method according to claim 1 and comprising, prior to step 3), inserting the cartridge into a reading system, the system operating to initiate step 3).

### Claim 3 (depends on 2)

A method according to claim 2, wherein said cartridge is inserted into the reading system prior to step 1), the method further comprising detecting operation of step 1) and as a result initiating a timer and upon expiry of that timer initiating step 3).

### Claim 4 (depends on 2)

A method according to claim 2 and comprising one or both of vibrating and heating the cartridge or a part of the cartridge within the reading system.

### Claim 5 (depends on 4)

A method according to claim 4, wherein said cartridge is inserted into the reading system prior to step 1), the method further comprising detecting operation of step 1) and as a result initiating a timer and upon expiry of that timer initiating step 3) and comprising controlling the initiation and duration of one or both of the vibration and heating of the cartridge in dependence upon the timer value.

### Claim 6 (depends on 2)

A method according to claim 2 and comprising a step of preheating the cartridge within the reading system prior to step 1).

### Claim 7 (depends on 6)

A method according to claim 6 and comprising directing said pre-heating at the test element within said cartridge, and maintaining the test element temperature substantially at a predefined temperature for the duration of the test.

### Claim 8 (depends on 1)

A method according to claim 1, wherein said assay is an immunoassay.

### Claim 9 (depends on 8)

A method according to claim 8, wherein each test element is a test strip.

### Claim 10 (depends on 1)

A method according to claim 1, wherein the step of mixing the reagent with the buffer liquid and sample portion or analyte further comprises applying a varying magnetic field to a magnetic flea located within the incubation chamber.