Control solution and method for testing the performance of an electrochemical device for determining the concentration of an analyte in blood

• US 5,723,284 A
• Filed: 04/01/1996
• Issued: 03/03/1998
• Est. Priority Date: 04/01/1996
• Status: Expired due to Term

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Ye, Ling
• Primary Examiner(s): LEARY, LOUISE N
• Application Number:
  US08/625,132
• Time in Patent Office: 701 Days
• Field of Search: 435/4, 435/14, 435/18, 435/25, 435/817, 435/287, 435/2, 422/44, 422/50, 422/68.1, 205/81, 204/660, 204/193, 204/291, 436/63
• US Class Current: 435/4
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: G01N 2496/35 Polyvinylpyrrolidone, e.g. PVP
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode

Abstract

The present invention relates to a control solution for and a method of testing the performance of an electrochemical sensing device for determining the concentration of an analyte in a blood sample. The device contains a sensing means having a working electrode on which is deposited an enzyme capable of reacting with the analyte to provide electrons and a mediator to shuttle the electrons to the surface of the working electrode. The control solution is formulated so that the device will recognize the control solution as being something other than blood and automatically exclude the results obtained with the control solution from its memory unit.

Claims

1. An aqueous control solution for testing the performance of an electrochemical sensing device useful for determining the concentration of an analyte in a blood sample which device comprises a working electrode and a reference electrode which working electrode has on its surface a composition comprising an enzyme specific for the analyte, a mediator which is a species reduced in response to a reaction between the analyte and the enzyme, and wherein the concentration of the analyte in the fluid test sample is determined as a function of the current measured which passes the working electrode which control solution provides a dynamic current which is distinctly different from the dynamic current profile which would be obtained in the electrochemical sensor with blood.

2. The control solution of claim 1 which comprises:

a) a polymeric material which mimics the fluid mechanics of blood;

b) a predetermined amount of the analyte;

c) a buffering system capable of maintaining the solution'"'"'s pH at a range of from about 4.8 to about 7.5;

d) a material which affects the sensor in a manner that causes the control solution to provide a dynamic current profile distinctly different than that of blood without substantially affecting the function of the enzyme; and

e) water.

3. The control solution of claim 2 wherein the polymeric material which mimics the fluid dynamics of blood is polyethylene oxide, polyhydroxyethyl methacrylate and polyvinyl pyrrolidone.

4. The control solution of claim 2 wherein the buffering system is comprised of citric acid/sodium citrate, phosphoric acid or sodium phosphate.

5. The control solution of claim 2 wherein the material which affects the sensor affects the mediator.

6. The control solution of claim 5 wherein the material that affects the mediator to cause a current profile different than blood is an organic solvent which results in slower dissolution and/or diffusion of the mediator when the control solution is applied to the sensor than is the case with blood.

7. The control solution of claim 5 wherein the mediator is a ferricyanide and the solvent is ethylene glycol, N-methylpyrrolidone or N-propanol.

8. The control solution of claim 1 wherein the dynamic current profile is determined by applying an initial potential across the electrodes to oxidize at least a portion of the mediator which has undergone reduction and measuring the current which flows between the electrodes to provide a burn current, switching the system to an open circuit for a set delay period and then determining the concentration of the analyte by applying a second potential between the electrodes and measuring the current which flows therebetween to provide a read current and the dynamic current profile is the ratio of read current to burn current.

9. The control solution of claim 6 wherein the material which causes the current profile different from that of blood is an oxidizing agent.

10. The control solution of claim 9 wherein the oxidizing agent is potassium permanganate, potassium perchromate, potassium dichromate, sodium perchlorate or sodium periodate.

11. A method for testing the performance of an electrochemical sensing device for determining the concentration of an analyte in a blood sample which device comprises a meter and electrochemical sensing means wherein the method comprises the steps of:

a) providing the electrochemical sensing device having a sensing means which includes a working electrode and a reference electrode which working electrode has on its surface a composition comprising an enzyme specific for the analyte and a partially reduced mediator which is a species reduced in response to a reaction between the analyte and the enzyme;

b) placing a control solution between the working electrode and the reference electrode of the sensing means which control solution is capable of electrically connecting these electrodes and which control solution contains a known concentration of the analyte and provides a dynamic current profile which is distinctly different than that which is provided by a blood sample under similar conditions;

c) applying a potential between the electrodes to return at least a portion of the mediator back to its oxidized form to provide a measurable burn current which current is measured;

d) terminating the potential applied to the electrodes to provide an open circuit for a set delay period;

e) applying a second voltage between the electrodes and measuring the current in the control solution to provide a read current and measuring the read current; and

f) determining the dynamic current profile of the control solution in terms of the ratio of read current to burn current which dynamic current profile is distinctly different from the dynamic current profile which would be obtained with a blood sample.

12. The method of claim 11 wherein the control solution comprises:

a) a polymeric material which mimics the fluid mechanics of blood;

b) a predetermined amount of the analyte;

c) a buffering system capable of maintaining the control solution'"'"'s pH at a range of from about 4.8 to about 7.5;

d) a material which affects the sensor in a manner that causes the control solution to provide a dynamic current profile which is distinctly different than that of blood without substantially affecting the function of the enzyme; and

e) water.

13. The method of claim 11 wherein the control solution provides a distinctly different dynamic profile by affecting the mediator.

14. The method of claim 13 wherein the material that affects the mediator is an organic solvent which results in slower dissolution and/or diffusion of the mediator than would be the case if blood rather than the control solution were applied to the sensing means.

15. The method of claim 14 wherein the mediator is ferricyanide and the solvent is ethylene glycol, N-methylpyrrolidone or N-propanol.

16. The method of claim 11 wherein the material that affects the mediator is an oxidizing agent.

17. The method of claim 16 wherein the oxidizing agent is potassium permanganate, potassium perchromate, potassium dichromate, sodium perchlorate or sodium periodate.

18. The method of claim 11 wherein the electrochemical sensing device has a microprocessor and a memory unit for maintaining test results and wherein the microprocessor, contains a range of ratios of the read current to the burn current, which range corresponds to that which would be obtained with blood, which microprocessor will exclude the testing result from being stored in the memory unit when the current profile in terms of the ratio of the read current to burn current obtained from the test is determined to be for a control solution upon comparing it to the range of ratios of read current to burn current for blood stored within the microprocessor.