Sample Metering Device and Assay Device with Integrated Sample Dilution

• US 20120142020A1
• Filed: 12/01/2011
• Published: 06/07/2012
• Est. Priority Date: 12/03/2010
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Inventors: Miller, Cary James
• Granted Patent: US 9,061,283 B2
• Time in Patent Office: Days
• US Class Current: 435/7.1
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0631 Purification arrangements, e.g. solid phase extraction [SPE]
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/126 Paper
• CPC Class Codes: B01L 3/52 Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• CPC Class Codes: G01N 1/38 Diluting, dispersing or mixing samples
• CPC Class Codes: G01N 2001/385 diluting by adsorbing a fraction of the sample
• CPC Class Codes: G01N 2333/4737 C-reactive protein
• CPC Class Codes: Y10T 436/25625 Dilution

Abstract

In one embodiment, the invention is to a sample metering device, comprising a sample holding chamber oriented between a sample entry port and a sample extraction unit, wherein a portion of said extraction unit defines a metered volume of a sample. A diluent may be transported over and/or through the extraction unit to form a diluted sample for sample analysis. In another embodiment, the invention is to an apparatus and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature, capable of being used in the point-of-care diagnostic field is provided. The devices and methods of the invention preferably are well-suited for high range sample dilution.

Claims

1. A sample metering device, comprising:

a sample holding chamber oriented between a sample entry port and a sample extraction unit, wherein a portion of said sample extraction unit defines a metered volume of a sample.

2. The device of claim 1, wherein a distal portion of said extraction unit defines said metered volume of said sample.

3. The device of claim 1, wherein the sample is selected from the group consisting of blood, plasma, serum, urine, interstitial fluid and cerebrospinal fluid.

4. The device of claim 1, wherein said extraction unit comprises a porous hydrophilic material.

5. The device of claim 1, wherein said extraction unit comprises a cellulose material.

6. The device of claim 1, wherein said extraction unit comprises nitrocellulose.

7. The device of claim 1, wherein said extraction unit comprises cotton fiber.

8. The device of claim 1, wherein said extraction unit comprises paper.

9. The device of claim 1, wherein said extraction unit comprises glass-filled paper.

10. The device of claim 1, wherein said extraction unit comprises a transverse filter material.

11. The device of claim 1, wherein said extraction unit comprises a porous outer coating.

12. The device of claim 1, wherein said extraction unit comprises a lysing agent.

13. The device of claim 12, wherein said lysing agent comprises sodium deoxycholate.

14. The device of claim 12, wherein said lysing agent comprises saponin.

15. A sensor cartridge for sensing at least one analyte in a sample, comprising:

at least one sensor in an analysis conduit;

a sample chamber between a sample entry port and a sample extraction unit;

a diluent package containing a diluent;

a diluent conduit configured for transporting diluent from the diluent package to the sample extraction unit; and

a pump configured to transfer said diluent through said diluent conduit, over and/or through said sample extraction unit, and into said analysis conduit.

16. The sensor cartridge of claim 15, wherein a distal portion of said extraction unit defines a metered volume of said sample.

17. The sensor cartridge of claim 15, wherein said extraction unit comprises a porous hydrophilic material.

18. The sensor cartridge of claim 15, wherein said extraction unit comprises a cellulose material.

19. The sensor cartridge of claim 15, wherein said extraction unit comprises nitrocellulose.

20. The sensor cartridge of claim 15, wherein said extraction unit comprises cotton fiber.

21. The sensor cartridge of claim 15, wherein said extraction unit comprises paper.

22. The sensor cartridge of claim 15, wherein said extraction unit comprises glass-filled paper.

23. The sensor cartridge of claim 15, wherein said extraction unit comprises a transverse filter material.

24. The sensor cartridge of claim 15, wherein said extraction unit comprises a porous outer coating.

25. The sensor cartridge of claim 15, wherein said extraction unit comprises a lysing agent.

26. The sensor cartridge of claim 25, wherein said lysing agent comprises sodium deoxycholate.

27. The sensor cartridge of claim 25, wherein said lysing agent comprises saponin.

28. The sensor cartridge of claim 15, wherein said diluent conduit defines a metered volume of diluent.

29. The sensor cartridge of claim 15, wherein said cartridge has opposing surfaces that are folded together.

30. The sensor cartridge of claim 15, wherein said cartridge is a single-use cartridge.

31. The sensor cartridge of claim 15, wherein said sensor is an immunosensor.

32. The sensor cartridge of claim 15, wherein said sensor is selected from the group consisting of an ion sensor, a metabolite sensor, an enzymatic sensor, an enzyme activity sensor and a nucleotide sensor.

33. The sensor cartridge of claim 15, wherein said cartridge is configured to dilute said sample at a dilution ratio of about 50:

1 to about 50,000;

1 (v/v diluent;

sample).

34. A method of performing an assay for an analyte in a sample, said method comprising the steps of:

introducing a sample into a sample chamber of a cartridge, wherein the sample chamber terminates in a sample extraction unit;

loading said extraction unit with said sample;

washing a portion of said sample from the extraction unit using a volume of diluent from a diluent conduit to form a diluted sample; and

analyzing said diluted sample for an analyte.

35. The method of claim 34, wherein the volume of diluent is a metered volume of diluent.

36. The method of claim 34, further comprising:

transporting said diluted sample to a sensor; and

performing an analyte assay at said sensor.

37. The method of claim 34, wherein the diluted sample has a dilution ratio of from about 50:

1 to about 50,000;

1 (v/v diluent;

sample).