Sample Metering Device and Assay Device with Integrated Sample Dilution

• US 20120142019A1
• 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 Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Miller, Cary James
• Granted Patent: US 9,034,634 B2
• Time in Patent Office: Days
• US Class Current: 435/7.1
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/045 whereby the whole cover is slidable
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• 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 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/126 Paper
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502753 characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: G01N 1/38 Diluting, dispersing or mixing samples
• CPC Class Codes: G01N 2333/4737 C-reactive protein
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• 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 isolation unit and having a diluent introduction port disposed therebetween for introduction of a diluent into the sample holding chamber. The volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines a metered volume of a sample for 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, preferably suitable for low range sample dilution, and preferably capable of being used in the point-of-care diagnostic field.

Claims

1. A sample metering device, comprising a sample holding chamber oriented between a sample entry port and a sample isolation unit and having a diluent introduction port disposed therebetween for introduction of a diluent into the sample holding chamber, wherein the volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines a metered volume of a sample for analysis.

2. The device of claim 1, further comprising a dilution chamber for mixing said diluent with the metered volume of sample to form a diluted sample.

3. The device of claim 2, wherein said volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines said dilution chamber, and wherein a lysing agent is disposed within said dilution chamber.

4. The device of claim 3, wherein said lysing agent comprises sodium deoxycholate.

5. The device of claim 3, wherein said lysing agent comprises saponin.

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

7. The device of claim 1, wherein the sample isolation unit comprises a capillary stop.

8. The device of claim 1, wherein said sample isolation unit comprises a porous hydrophilic material.

9. The device of claim 1, wherein said sample isolation unit comprises a cellulose material.

10. The device of claim 1, wherein said sample isolation unit comprises nitrocellulose.

11. The device of claim 1, wherein said sample isolation unit comprises cotton fiber.

12. The device of claim 1, wherein said sample isolation unit comprises paper.

13. The device of claim 1, wherein said sample isolation unit comprises glass-filled paper.

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

at least one sensor;

a sample chamber between a sample entry port and a sample isolation unit and including a diluent introduction port therebetween for introducing diluent into said sample chamber, wherein a region of the sample chamber between said dilution introduction port and said sample isolation unit defines a dilution chamber and a metered volume of sample for dilution;

a diluent package containing a diluent;

a diluent conduit configured for transporting diluent from the diluent package to the diluent introduction port; and

a pump configured to transfer said diluent through the diluent conduit and the diluent introduction port, and into said dilution chamber to form a diluted sample, and further configured to transport the diluted sample to the at least one sensor.

15. The cartridge of claim 14, wherein the volume within the sample chamber between the diluent introduction port and the sample isolation unit defines a metered volume of a sample for analysis.

16. The cartridge of claim 14, wherein the cartridge includes a pump conduit beginning at the pump and ending at an air introduction port on the diluent conduit, and wherein a region in the diluent conduit between the air introduction port and the diluent introduction port defines a metered diluent.

17. The cartridge of claim 14, wherein the diluent conduit defines a metered volume of diluent.

18. The cartridge of claim 14, wherein said cartridge is a single-use cartridge.

19. The cartridge of claim 14, wherein said cartridge has opposing surfaces that are folded together.

20. The cartridge of claim 14, wherein the sample is selected from the group consisting of blood, plasma, serum, urine, interstitial fluid and cerebrospinal fluid.

21. The cartridge of claim 14, wherein the at least one analyte is CRP.

22. The cartridge of claim 14, wherein said dilution chamber includes a lysing agent disposed therein.

23. The cartridge of claim 22, wherein said lysing agent comprises sodium deoxycholate.

24. The cartridge of claim 22, wherein said lysing agent comprises saponin.

25. The cartridge of claim 14, wherein said sample isolation unit comprises a capillary stop.

26. The cartridge of claim 14, wherein said sample isolation unit comprises a porous hydrophilic material.

27. The cartridge of claim 14, wherein said sample isolation unit comprises a cellulose material.

28. The cartridge of claim 14, wherein said sample isolation unit comprises nitrocellulose.

29. The cartridge of claim 14, wherein said sample isolation unit comprises cotton fiber.

30. The cartridge of claim 14, wherein said sample isolation unit comprises paper.

31. The cartridge of claim 14, wherein said sample isolation unit comprises glass-filled paper.

32. The cartridge of claim 14, wherein said diluent package is a rupturable pouch.

33. The cartridge of claim 14, further comprising a reagent fluid package containing a reagent fluid.

34. The cartridge of claim 14, where the sensor is an immunosensor.

35. The cartridge of claim 14, where the 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.

36. 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 said chamber is located between a sample entry port and a sample isolation unit and includes a diluent introduction port for receiving diluent, and wherein the volume between the diluent introduction port and the sample isolation unit defines a metered volume of said sample for dilution;

transporting a volume of diluent from a diluent conduit to the metered volume of sample, wherein said volume of diluent is combined with said metered volume of sample to form a diluted sample;

transporting said diluted sample to a sensor; and

performing an analyte assay at said sensor.

37. The method of claim 36, wherein the at least one analyte for sensing is CRP.

38. The method of claim 36, wherein the volume of diluent comprises a metered volume of diluent.

39. The method of claim 38, wherein the cartridge includes a pump conduit beginning at a pump and ending at an air introduction port on the diluent conduit, and wherein a region in the diluent conduit between the air introduction port and the diluent introduction port defines the metered volume of diluent.

40. The method of claim 36, wherein the sample is selected from the group consisting of blood, plasma, serum, urine, interstitial fluid and cerebrospinal fluid.

41. The method of claim 36, wherein said sample isolation unit comprises a capillary stop.

42. The method of claim 36, wherein said sample isolation unit comprises a porous hydrophilic material.

43. The method of claim 36, wherein said sample isolation unit comprises a cellulose material.

44. The method of claim 36, wherein said sample isolation unit comprises nitrocellulose.

45. The method of claim 36, wherein said sample isolation unit comprises cotton fiber.

46. The method of claim 36, wherein said sample isolation unit comprises paper.

47. The method of claim 36, wherein said sample isolation unit comprises glass-filled paper.

48. The method of claim 36, wherein the diluted sample is at a dilution ratio of from 1:

1 to 50;

1 parts by volume diluent;

sample.

49. The method of claim 36, further comprising the steps of:

dissolving a dry reagent into said sample from a wall of the dilution chamber; and

detecting the dry reagent in the diluted sample.

50. The method of claim 49, wherein said dry reagent comprises a lysing agent.

51. The method of claim 50, wherein said lysing agent comprises sodium deoxycholate.

52. The method of claim 50, wherein said lysing agent comprises saponin.

53. The method of claim 51, wherein the analyte assay is an immunoassay.

54. The method of claim 51, wherein the analyte assay is selected from the group consisting of an ion assay, a metabolite assay, an enzymatic assay, an enzyme activity assay and a nucleotide assay.