# US 10,441,209 B2 · Antigen regional testing kit

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- Number: US 10,441,209 B2
- Document ID: US10441209B2
- Status: Granted
- Kind: B2
- Application number: 15/425,863
- Filed: 2017-02-06
- Published: 2017-08-10
- Granted: 2019-10-15
- Earliest claimed: 2016-02-04
- Assignees: Roca Medical Ltd.
- Applicants: Roca Medical Ltd.
- Inventors: James Strader; Jovan Hutton Pulitzer
- Web page: https://patentgrep.com/patent/US10441209B2

## CPC

- A61B 5/443: {Evaluating skin constituents, e.g. elastin, melanin, water}
- A61B 5/6848: {Needles}
- A61B 10/0035: {Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches}
- A61K 49/0006: {Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity}
- A61B 17/205: {Vaccinating by means of needles or other puncturing devices}
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 35/10: Devices for transferring samples {or any liquids} to, in, or from, the analysis apparatus, e.g. suction devices, injection devices {(G01N35/0099 takes precedence)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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 for administering tests using a regional antigen testing kit is provided. The method comprises providing the regional antigen testing kit, extracting a predetermined amount of concentrated antigen from one of a plurality of concentrated antigens, dispensing the predetermined amount of concentrated antigen into a corresponding one of a plurality of wells, as indicated by visual indicia, repeating the extracting and dispensing steps until a desired number of the plurality of wells contain concentrated antigen, providing a prick tester having a plurality of needles extending thereon, aligning the plurality of needles of the prick tester with the plurality of wells, inserting each of the plurality of needles of the prick tester into one of the plurality of wells, and applying the plurality of needles of the prick tester to the skin of a patient to elicit a potential response.

## Claims

### Claim 1

A regional antigen testing kit, comprising:
a first portion having disposed therein a plurality of concentrated antigens, each one of the plurality of concentrated antigens being disposed in a sealable container, and the first portion further having disposed therein a first control material and a second control material, the first control material and the second control material each being disposed in a sealable container;
a second portion hingedly coupled to the first portion, allowing for the regional antigen testing kit to be opened and closed in a clamshell configuration, wherein the second portion includes a plurality of wells capable of receiving an amount of concentrated antigen;
visual indicia disposed on the first portion and the second portion, in order to correspond each of the plurality of concentrated antigens with one of the plurality of wells; and
a third portion having disposed therein a plurality of sealable containers containing a dilutant.

### Claim 2 (depends on 1)

The regional antigen testing kit of claim 1, wherein the dilutant comprises a saline solution.

### Claim 3 (depends on 1)

The regional antigen testing kit of claim 1, wherein the dilutant comprises a glycerol solution.

### Claim 4 (depends on 1)

The regional antigen testing kit of claim 1, wherein the first control material is water.

### Claim 5 (depends on 1)

The regional antigen testing kit of claim 1, wherein the second control material is a histamine.

### Claim 6 (depends on 1)

The regional antigen testing kit of claim 1, wherein the regional antigen testing kit includes a National Drug Code (NDC) associated with the regional antigen testing kit.

### Claim 7 (depends on 1)

The regional antigen testing kit of claim 1, wherein the plurality of concentrated antigens is associated with a particular geographic area.

### Claim 8 (depends on 7)

The regional antigen testing kit of claim 7, wherein the regional antigen testing kit includes one of a plurality of National Drug Codes (NDCs), the one of the plurality of NDCs being assigned to the antigen regional testing kit based on the particular geographic area.