Swab-Based Diagnostic Systems

• US 20110097820A1
• Filed: 12/30/2010
• Published: 04/28/2011
• Est. Priority Date: 12/23/2003
• Status: Abandoned Application

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Shuty, John Albert, Huang, Lei, Agarwal, Naveen, Lyng, Robert John, Fish, Jeffrey Eldon, Kaylor, Rosann Marie Matthews
• Application Number:
  US12/982,452
• Publication Number:
  US 20110097820A1
• Time in Patent Office: Days
• US Class Current: 436/518
• 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

1-20. -20. (canceled)

21. A method for detecting the presence or absence of an analyte within a test sample, said method comprising:

i) providing a diagnostic test system, said system comprising a swab and a detection unit, said detection unit comprising;

a) a first component that is capable of receiving said swab, said first component defining an insertion chamber within which a fluid is retained; and

b) a second component that defines a detection chamber within which an assay for detecting the presence or absence of the analyte is contained;

ii) contacting said swab with the test sample;

iii) inserting said swab into said insertion chamber of said first component so that said swab contacts said fluid; and

iv) rotating said first component relative to said second component so that said fluid flows from said insertion chamber to said detection chamber and contacts said assay.

22. A method as defined in claim 21, wherein said first component defines a sample port through which said swab is inserted.

23. A method as defined in claim 22, wherein said detection unit further comprises a hydraulic seal that forms a sealing fit between said sample port and said swab.

24. A method as defined in claim 21, wherein a flexible packet is contained within said insertion chamber that retains said fluid, said swab rupturing said flexible packet when inserted into said insertion chamber.

25. A method as defined in claim 21, further comprising determining the intensity of a detection signal generated at a detection zone of said assay, wherein the amount of the analyte within the test sample is determined from said detection signal.

26. A method as defined in claim 25, further comprising calibrating said detection signal with a calibration signal generated at a calibration zone of said assay, wherein the amount of the analyte within the test sample is determined from said detection signal as calibrated by said calibration signal.