HYBRID STRIP

• US 20110155590A1
• Filed: 06/11/2009
• Published: 06/30/2011
• 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: Sutor, James J., Huffstodt, Robert
• Granted Patent: US 8,460,539 B2
• Time in Patent Office: Days
• US Class Current: 205/792
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: Y10T 29/49817 with other than ancillary treating or assembling

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;

(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 into a capillary tube;

(e) contacting said portion of said single blood sample with an electrode and a counter-electrode; 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 as in claim 1 wherein the drawing of (d) is accomplished by a capillary effect of said capillary tube.

3. A method of determining concentrations of a plurality of analytes from a single blood sample, placed in a single opening, 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 an end of a capillary tube such that a portion of said single blood sample is drawn into said capillary tube;

(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 capillary tube 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.

4. A method as in claim 3 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.

5. A method as in claim 3 wherein said first, second, and third analytes are Total Cholesterol, HDL Cholesterol, and Triglycerides, respectively.

6. A method as in claim 3 wherein said fourth analyte is glucose.

7. A method as in claim 6 wherein a selectively permeable membrane is introduced between said electrode and counter-electrode in order to lessen interferents.

8. A method as in claim 6 wherein a selective electrocatalyst is introduced in order to lessen interferents.

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 capillary tube having a first and second end;

(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

(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 said first end of said capillary tube; 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. A method of customizing a hybrid test strip for determining concentrations of a plurality of analytes from a single blood sample, placed in a single opening, the method comprising:

(a) separating a top portion of said hybrid test strip holder from a bottom portion of said hybrid test strip holder, said bottom portion of said hybrid test strip holder having a rod;

(b) placing an electrode chemical testing member on said bottom portion of said hybrid test strip holder such that a hole in said electrode chemical testing member is on said rod of said bottom portion; and

(c) connecting said top portion of said hybrid test strip holder and said bottom portion of said hybrid test strip holder such that said electrochemical testing member is sandwiched therebetween;

wherein said hybrid test strip holder houses a test matrix comprising;

(i) an elongated porous disbursement layer;

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

(iii) at least two vertically aligned stacks spaced apart and adjacent to said 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.