Hybrid strip

• US 9,395,373 B2
• Filed: 03/15/2013
• Issued: 07/19/2016
• Est. Priority Date: 06/13/2008
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Inventors: Huffstodt, Robert, Sutor, James J.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US13/843,116
• Publication Number:
  US 20130217054A1
• Time in Patent Office: 1,222 Days
• US Class Current: 1/1
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743

Abstract

A method of determining concentrations of a plurality of analytes from a single blood sample placed in a single opening. A portion of the single blood sample is absorbed by a test matrix that includes a plurality of layers and a chromogenic agent. A colored response is generated by the test matrix. The colored response is proportional to the concentration of a first analyte. A portion of the single blood sample is drawn into a capillary tube and placed in contact with an electrode and a counter-electrode. An electrical property of the single blood sample is analyzed through the electrode and counter-electrode. The electrical property is proportional to the concentration of a second analyte in the single blood sample.

Claims

1. A method of determining concentrations of a plurality of analytes from a single blood sample, placed in a single opening, the method comprising:

(a) placing said single blood sample in an opening;

(b) absorbing said blood sample with a test matrix that includes a plurality of layers and a chromogenic agent, the test matrix including a disbursement layer;

(c) generating a colored response with said test matrix wherein said colored response is proportional to a concentration of a first analyte;

(d) drawing a portion of said single blood sample to a sample area by laterally spreading through the disbursement layer;

(e) contacting said portion of said single blood sample with an electrode and a counter-electrode in the sample area; and

(f) measuring an electrical property of said single blood sample though said electrode and counter-electrode wherein said electrical property is proportional to a concentration of a second analyte in said single blood sample.

2. A method of determining concentrations of a plurality of analytes from a single blood sample, the method comprising:

(a) contacting said single blood sample with a top surface of an elongated disbursement layer and spreading said single blood sample substantially throughout an entire length of said disbursement layer;

(b) contacting said single blood sample with a sample area such that a portion of said single blood sample is drawn to the sample area by passing through the disbursement layer;

(c) delivering said single blood sample from said disbursement layer to a first stack, a second stack, and a third stack, each of said first, second, and third stacks positioned adjacent to and in constant contact with said disbursement layer,

(d) moving the sample downward through the stacks in a direction substantially normal to the plane defined by the stacks;

(e) producing a colored response at the bottom of each of the three stacks, the colored response at the bottom of the first stack being proportional to the concentration of a first analyte in the blood sample, the colored response at the bottom of the second stack being proportional to the concentration of a second analyte in the blood sample, and the colored response at the bottom of the third stack being proportional to the concentration of a third analyte in the blood sample;

(f) delivering the portion of the single blood sample drawn into the sample area to an electrode and a counter-electrode; and

(g) measuring an electrical property of the single blood sample using the electrode and counter-electrode wherein the electrical property is proportional to the concentration of a fourth analyte in the blood sample.

3. A method as in claim 2 wherein at least one of said stacks includes a blank layer, said blank layer being a different layer than said disbursement layer, wherein said blank layer primarily functions to maintain all stacks at substantially the same thickness.

4. A method as in claim 2 wherein said first, second, and third analytes are Total Cholesterol, HDL Cholesterol, and Triglycerides, respectively.

5. A method as in claim 2 wherein said fourth analyte is glucose.

6. A method of determining concentrations of a plurality of analytes from a single blood sample, the method comprising:

(a) contacting a single blood sample from a lance with a top surface of an elongated disbursement layer of a test strip and spreading said single blood sample substantially throughout an entire length of said disbursement layer;

(b) contacting said single blood sample with a sample area of an electrochemical portion of the test strip, wherein a residual amount of said single blood sample remaining after the contacting of (a) is used;

(c) delivering said single blood sample from said disbursement layer to a first stack, a second stack, and a third stack, each of said first, second, and third stacks positioned adjacent to and in constant contact with said disbursement layer,

(d) moving the sample downward through the stacks in a direction substantially normal to the plane defined by the stacks;

(e) producing a colored response at the bottom of each of the three stacks, the colored response at the bottom of the first stack being proportional to the concentration of a first analyte in the blood sample, the colored response at the bottom of the second stack being proportional to the concentration of a second analyte in the blood sample, and the colored response at the bottom of the third stack being proportional to the concentration of a third analyte in the blood sample; and

(f) measuring an electrical property of the single blood sample using the electrode and counter-electrode in the electrochemical portion, wherein the electrical property is proportional to the concentration of a fourth analyte in the blood sample.

7. A method as in claim 6 wherein at least one of said stacks includes a blank layer, said blank layer being a different layer than said disbursement layer, wherein said blank layer primarily functions to maintain all stacks at substantially the same thickness.

8. A method as in claim 6 wherein said first, second, and third analytes are Total Cholesterol, HDL Cholesterol, and Triglycerides, respectively, and wherein said fourth analyte is glucose.

9. An apparatus for measuring concentration of multiple analytes in a whole blood sample, comprising:

(a) a test matrix comprising;

(i) an elongated porous disbursement layer;

(ii) a blood separation layer adjacent to the bottom surface of said disbursement layer; and

(iii) at least two vertically aligned stacks spaced apart and adjacent to the bottom surface of said blood separation layer wherein a first one of said vertically aligned stacks includes multiple layers, said multiple layers including a reagent and a chromagen;

(b) an electrochemical testing member comprising;

(i) a sample area;

(ii) an electrode; and

(iii) a counter-electrode wherein said electrode and counter-electrode are oriented in electrical communication with each other when a blood sample is present, and the electrode and the counter-electrode are located in the sample area; and

(c) a hybrid test strip holder having a top portion and a bottom portion sandwiching said test matrix therebetween;

said top and bottom portions holding said electrochemical testing member;

said top portion of said hybrid test strip holder having a sample application window exposing a top surface of said disbursement layer and a portion of the disbursement layer in contact with the sample area, such that blood from the disbursement layer may reach the sample area when a sample is present; and

said bottom portion of said hybrid test strip holder having at least one test reading window through which bottom surfaces of said first and second stacks can be read.

10. An apparatus as in claim 9 wherein said sample application window is positioned within a periphery defined by said stacks.

11. An apparatus as in claim 9 wherein said bottom surfaces of said stacks are substantially coplanar.

12. An apparatus as in claim 9 wherein said blood separation layer comprises a glass fiber matrix.

13. An apparatus as in claim 9 wherein said electrochemical test panel further comprises:

(iv) enzymatic reactants overlaying said electrode and counter-electrode.

14. An apparatus as in claim 9 wherein a selectively permeable membrane is introduced between said electrode and counter-electrode in order to lessen interferents.

15. An apparatus as in claim 9 wherein a selective electrocatalyst is introduced in order to lessen interferents.

16. An apparatus as in claim 9 wherein said electrochemical testing member is interchangeable.

17. An apparatus for measuring concentration of multiple analytes in a whole blood sample, comprising:

(a) a test matrix comprising;

(i) an elongated porous disbursement layer;

(ii) a blood separation layer adjacent to the bottom surface of said disbursement layer; and

(iii) at least two vertically aligned stacks spaced apart and adjacent to the bottom surface of said blood separation layer wherein a first one of said vertically aligned stacks includes multiple layers, said multiple layers including a reagent and a chromagen;

(b) an electrochemical testing member comprising;

(i) a sample area;

(ii) an electrode; and

(iii) a counter-electrode wherein said electrode and counter-electrode are oriented in electrical communication with each other when a blood sample is present, and the electrode and the counter-electrode are located in the sample area; and

(c) a hybrid test strip holder having a top portion and a bottom portion sandwiching said test matrix there between;

said top and bottom portions holding said electrochemical testing member;

said top portion of said hybrid test strip holder having a sample application window exposing a top surface of said disbursement layer and the sample area, such that blood from a single sample in a lance is received in the sample area and said disbursement layer; and

said bottom portion of said hybrid test strip holder having at least one test reading window through which bottom surfaces of said first and second stacks can be read.

18. An apparatus as in claim 17 wherein said sample application window is positioned within a periphery defined by said stacks.

19. An apparatus as in claim 17 wherein said bottom surfaces of said stacks are substantially coplanar.

20. An apparatus as in claim 17 wherein said blood separation layer comprises a glass fiber matrix.