# US 10,119,968 B2 · Self-contained diagnostic test with advanceable test strip

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- Number: US 10,119,968 B2
- Document ID: US10119968B2
- Status: Granted
- Kind: B2
- Application number: 13/907,373
- Filed: 2013-05-31
- Published: 2014-03-13
- Granted: 2018-11-06
- Earliest claimed: 2012-06-02
- Assignees: Test Anywhere Technology
- Applicants: Test Anywhere Technology
- Inventors: Bliss Hanlon Lansing
- Web page: https://patentgrep.com/patent/US10119968B2

## CPC

- G01N 33/571: for venereal disease, e.g. syphilis, gonorrhoea {(herpes G01N33/56994; chlamydia G01N33/56927)}
- B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis}
- B01L 3/5029: {using swabs}
- G01N 33/5302: {Apparatus specially adapted for immunological test procedures}
- G01N 33/5304: {Reaction vessels, e.g. agglutination plates (for solid-phase systems G01N33/543)}
- B01L 2200/16: Reagents, handling or storing thereof
- B01L 2300/046: Function or devices integrated in the closure
- B01L 2300/0672: Integrated piercing tool
- B01L 2400/0683: mechanically breaking a wall or membrane within a channel or chamber
- G01N 2001/028: {Sampling from a surface, swabbing, vaporising}
- 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

A test unit collects and analyzes biological specimens on-site. It has one or more openings that allow reagent capsules to be inserted and guided into a testing chamber. Reagent capsules are pre-loaded with chemicals for screening and are configured as blister packs. A button mechanism allows projection(s) to open the blister packs to allow chemicals within the capsules to mix inside the testing chamber. A medical swab is affixed to a pop top dispenser cap and can be pressed to allow the swab to be inserted into the mixed chemicals. A visible test strip mount attached to the testing chamber has a lever to manipulate a test strip in and out of the testing chamber. This test strip may be slid through a uni-directional seal on a capsule and into a chemical for testing. The test strip will test for the presence of an infectious disease.

## Claims

### Claim 1

A self-contained device for determining the presence of an analyte, the device comprising:
a testing chamber comprising an open portion at or near a first end, a reagent mixing portion at or near a second end opposite the first end, and a wall extending from the open portion to the reagent mixing portion;
an articulable element coupled to the testing chamber, wherein the articulable element can be articulated to cause a plurality of reagents held by the testing chamber to mix in the reagent mixing portion;
a cover operably coupled to the open portion of the testing chamber and configured to allow advancement of a specimen into the reagent mixing portion of the testing chamber and close off the open portion; and
a movable test strip located outside the wall of the testing chamber and configured to be actuated by a mechanism coupled to the testing chamber and the movable test strip, wherein actuation by the mechanism is configured to cause the movable test strip to be advanced outside the wall of the testing chamber into the reagent mixing portion of the testing chamber to determine the presence of an analyte in a mixture of the plurality of reagents and the specimen, wherein the determination comprises a visual change on the movable test strip that is read in the self-contained device.

### Claim 2 (depends on 1)

The device of claim 1, wherein the plurality of reagents are held by at least a first reagent storage element and a second reagent storage element, the first reagent storage element comprising a first reagent and the second reagent storage element comprising a second reagent.

### Claim 3 (depends on 2)

The device of claim 2, wherein the first reagent storage element comprises a first blister pack and the second reagent storage element comprises a second blister pack.

### Claim 4 (depends on 3)

The device of claim 3, wherein articulating the articulable element comprises breaking one or more of the first blister pack and the second blister pack.

### Claim 5 (depends on 4)

The device of claim 4, wherein the articulable element comprises one or more projections for tearing or breaking one or more of the first blister pack and the second blister pack.

### Claim 6 (depends on 1)

The device of claim 1, wherein the articulable element comprises a pressable button.

### Claim 7 (depends on 1)

The device of claim 1, further comprising an elongate specimen collection element having a first end for coupling the elongate element to the cover and a second end opposite the first end for carrying the specimen.

### Claim 8 (depends on 7)

The device of claim 7, wherein the cover comprises a depressible button configured to be pressed to advance the second end of the elongate element including the specimen into the reagent mixing portion of the testing chamber.

### Claim 9 (depends on 1)

The device of claim 1, further comprising a sliding mechanism coupled to the testing chamber and the test strip, wherein the sliding mechanism is configured to be actuated to advance the test strip into the reagent mixing portion of the testing chamber.

### Claim 10 (depends on 1)

The device of claim 1, wherein the test strip is configured to detect the presence of an infectious disease.

### Claim 11 (depends on 10)

The device of claim 10, wherein the infectious disease comprises one or more of strep throat, influenza, whooping cough, a sexually transmitted disease, Chlamydia, or Gonorrhea.

### Claim 12

A method for determining the presence of an analyte with a self-contained device, the method comprising:
advancing a specimen collection element carrying a specimen thereon from an open portion into a reagent mixing portion of a testing chamber of the self-contained device, wherein the testing chamber comprises a wall extending from the open portion to the reagent mixing portion;
articulating an articulable element of the self-contained device, thereby causing a first reagent and a second reagent held by the testing chamber to mix in the reagent mixing portion;
actuating and advancing a movable test strip outside the wall of the testing chamber into the reagent mixing portion of the testing chamber with aid of a mechanism coupled to the testing chamber and the movable test strip; and
observing the movable test strip in the self-contained device to determine the presence of the analyte in a mixed sample comprising the first reagent, the second reagent, and the specimen.

### Claim 13 (depends on 12)

The method of claim 12, wherein mixing the first reagent with the second reagent comprises articulating an articulable element coupled to the testing chamber to open a first reagent storage element and a second reagent storage element to one another.

### Claim 14 (depends on 12)

The method of claim 12, wherein advancing the specimen collection element comprises pressing a button of a cover coupled to the testing chamber and the specimen collection element.

### Claim 15 (depends on 12)

The method of claim 12, wherein advancing the test strip into the reagent portion of the testing chamber comprises sliding a sliding mechanism coupled to the testing chamber and test strip.

### Claim 16 (depends on 12)

The method of claim 12, wherein the test strip is observed to determine the presence of the analyte in the mixed sample to determine the presence of a disease.

### Claim 17 (depends on 16)

The method of claim 16, wherein the disease is an infectious disease.

### Claim 18 (depends on 17)

The method of claim 17, wherein the infectious disease comprises one or more of strep throat, influenza, whooping cough, a sexually transmitted disease, Chlamydia, and Gonorrhea.

### Claim 19 (depends on 1)

The device of claim 1, further comprising a specimen extraction element configured to extract the specimen after it has been mixed with the plurality of reagents.

### Claim 20 (depends on 19)

The device of claim 19, wherein the specimen extraction element is a squeegee element configured to squeeze the specimen.

### Claim 21 (depends on 19)

The device of claim 19, wherein the specimen extraction element is actuated by the articulable element.
