Method for measuring an analyte in blood

• US 8,168,439 B2
• Filed: 02/18/2010
• Issued: 05/01/2012
• Est. Priority Date: 09/10/2003
• Status: Expired due to Term

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Miller, Cary James, Campbell, John Lewis Emerson
• Primary Examiner(s): Yu, Melanie J
• Application Number:
  US12/708,445
• Publication Number:
  US 20100167308A1
• Time in Patent Office: 803 Days
• Field of Search: 435/7.1, 435/283.1, 435/287.1, 435/287.2, 436/518, 436/174, 436/166, 436/807
• US Class Current: 436/166
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

An electrochemical immunosensor system with reduced interference, comprising: a first immunosensor that generates an electrochemical signal based on the formation of a sandwich between an immobilized antibody, a target analyte and a labeled antibody, wherein a portion of the signal arises from non-specific binding of the labeled antibody in the region of the first immunosensor, and

a second immunosensor that acts as an immuno-reference sensor and generates a signal that is the same as or predictably related to the degree of non-specific binding which occurs in the region of the first immunosensor, and has an immunocomplex between an immobilized antibody and an endogenous or exogenous protein that is in the sample and that is not the target analyte.

Claims

1. A method for measuring an analyte in blood in an immunoassay device while reducing interference associated with a buffy coat, comprising:

receiving a whole blood sample in an immunoassay device comprising a housing, a conduit containing a salt reagent for treating the whole blood sample, an immunosensor comprising a bound antibody, and a pump configured for displacing the whole blood sample within the conduit to the immunosensor;

treating the whole-blood sample with the salt reagent to increase the ionic strength of the sample and thereby reduce interference from the buffy coat; and

measuring a signal generated by the immunosensor,

wherein the salt reagent is a dry reagent containing a mixture of sodium chloride, lactitol, DEAE dextran and Tris buffer.

2. The method of claim 1, wherein the buffy coat interference is from leukocytes.

3. The method of claim 1, wherein the sample is used in a disposable cartridge for measuring analytes in whole blood.

4. The method of claim 3, wherein the salt reagent comprises enough salt to increase the salt concentration of the sample to at least 200 mM.

5. The method of claim 1, wherein the immunoassay device is in an immunosensor system comprising a bulk conductivity sensor and computation means for processing signals from the immunosensor and the bulk conductivity sensor to correct for the hematocrit of the sample and determine the equivalent plasma analyte concentration.

6. A method for measuring an analyte in blood in an immunoassay device while reducing interference associated with a buffy coat, comprising:

receiving a whole blood sample in an immunoassay device comprising a housing, a conduit containing a salt reagent for treating the whole blood sample, an immunosensor comprising a bound antibody, and a pump configured for displacing the whole blood sample within the conduit to the immunosensor;

treating the whole-blood sample with the salt reagent to increase the ionic strength of the sample and thereby reduce interference from the buffy coat; and

measuring a signal generated by the immunosensor,

wherein the salt reagent further comprises a sugar selected from the group consisting of DEAE dextran, lactitol, and mixtures thereof.

7. The method of claim 6, wherein the buffy coat interference is from leukocytes.

8. The method of claim 6, wherein the sample is used in a disposable cartridge for measuring analytes in whole blood.

9. The method of claim 8, wherein the salt reagent comprises enough salt to increase the salt concentration of the sample to at least 200 mM.

10. The method of claim 6, wherein the immunoassay device is in an immunosensor system comprising a bulk conductivity sensor and computation means for processing signals from the immunosensor and the bulk conductivity sensor to correct for the hematocrit of the sample and determine the equivalent plasma analyte concentration.