Swab-based diagnostic systems

• US 7,863,053 B2
• Filed: 12/23/2003
• Issued: 01/04/2011
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Shuty, John Albert, Huang, Lei, Matthews Kaylor, Rosann Marie, Agarwal, Naveen, Lyng, Robert John, Fish, Jeffrey Eldon
• Primary Examiner(s): YU, MELANIE J
• Application Number:
  US10/744,607
• Publication Number:
  US 20050136479A1
• Time in Patent Office: 2,569 Days
• Field of Search: 422/50, 422/61, 422/68.1, 422/255, 422/256, 422/258, 422/261, 422269-271, 422/292, 435/4, 435/7.1, 435/287.1, 435/287.2, 435/287.3, 435/288.2, 435/288.5, 435/810, 435/960, 435/970, 436/518, 436/164, 436/165
• US Class Current: 436/165
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150015 Source of blood
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials

Abstract

A diagnostic test system for detecting the presence or absence of an analyte within a test sample is provided. For instance, the system may include a swab and a detection unit. The detection unit includes a first component that is capable of receiving the swab, the first component defining an insertion chamber within which a fluid is capable of being retained. The detection unit also includes a second component that defines a detection chamber within which an assay for detecting the presence or absence of the analyte is capable of being contained. The first component is rotatable relative to the second component from an inactive position to an active position. In the inactive position, the fluid remains substantially contained within the insertion chamber. In the active position, the fluid may flow from the insertion chamber to the detection chamber and contact the assay.

Claims

1. A diagnostic test system for detecting the presence or absence of an analyte within a test sample, the system comprising a swab for collecting the test sample and a detection unit, the detection unit comprising:

a first component that includes an insertion chamber within which a fluid is capable of being retained, the swab being insertable into the insertion chamber through a sample port;

a hydraulic seal that is capable of forming a sealing fit between the sample port and the swab;

a flexible packet that is capable of retaining the fluid within the insertion chamber;

a second component that includes a connection channel in fluid communication with a detection chamber, wherein an assay device is positioned within the detection chamber, wherein the first component, second component, and assay device extend along a longitudinal axis; and

wherein rotation of the first component about the longitudinal axis relative to the second component allows the fluid to flow from the insertion chamber, through the connection channel, and into the detection chamber to contact the assay device.

2. The diagnostic test system of claim 1, further comprising a delivery channel in fluid communication with the insertion chamber, wherein rotation of the first component relative to the second component places the delivery channel into fluid communication with the connection channel to allow the fluid to flow from the insertion chamber to the detection chamber.

3. The diagnostic test system of claim 2, wherein the delivery channel is connected to the first component.

4. The diagnostic test system of claim 1, further comprising a barrier that is positioned between the connection channel and the detection chamber prior to rotation of the first component relative to the second component, the barrier inhibiting the flow of the fluid from the insertion chamber to the detection chamber.

5. The diagnostic test system of claim 1, wherein the flexible packet is formed from a film, metallic foil, or combinations thereof.

6. The diagnostic test system of claim 1, wherein the first component and the second component have a generally cylindrical shape.