ON-BOARD CONTROL DETECTION

• US 20120040369A1
• Filed: 04/16/2010
• Published: 02/16/2012
• Est. Priority Date: 04/17/2009
• Status: Active Grant

• Current Assignee: Universal Biosensors Pty Ltd. (Universal Biosensors, Inc.)
• Original Assignee: Universal Biosensors Pty Ltd. (Universal Biosensors, Inc.)
• Inventors: Newman, Peter Michael, Hodges, Alastair M.
• Granted Patent: US 9,863,931 B2
• Time in Patent Office: Days
• US Class Current: 435/7.1
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

Embodiments disclosed herein relate to a sensor comprising an on-board control system and a testing system. The on-board system can determine viability of the control system or the testing system. Also disclosed are methods of using such a sensor.

Claims

1. A sensor for assessing a sample, wherein the sensor comprises an on-board control system and a testing system, wherein the control system comprises at least one reagent for determining viability of at least one of the control system and the testing system via a control reaction, wherein the at least one reagent is free of N-oxide or a nitroso compound, wherein the control reaction generates a control signal.

2. The sensor of claim 1, wherein the control signal comprises at least one selected from an electrical signal, an optical signal, a color, and a chemical signal.

3. The sensor of claim 1, wherein the control system comprises an electrochemical control system.

4. The sensor of claim 3, wherein the control reaction is assessed without an external voltage.

5. The sensor of claim 1, wherein the control reaction is activated upon contacting the at least one reagent with a composition, wherein the contacting generates the control signal.

6. The sensor of claim 5, wherein the composition comprises the sample.

7. The sensor of claim 5, wherein the composition comprises an external stress, wherein the external stress comprises at least one selected from temperature, pH, humidity, oxygen, light, shelf time, and a chemical contamination.

8. The sensor of claim 3, wherein the control system comprises at least two electrodes, wherein the at least one reagent is coated on at least one of the electrodes.

9. The sensor of claim 8, wherein the at least two electrodes are coplanar or opposing to each other.

11. The sensor of claim 3, wherein the control reaction generates an electromotive force.

12. The sensor of claim 11, wherein the electromotive force is generated by dissolution of the at least one reagent into the sample.

13. The sensor of claim 3, wherein the at least one reagent comprises ferricyanide.

14. The sensor of claim 13, wherein the area loading of ferricyanide coated on at least one of the electrodes is from about 10×

10<sup>−

6</sup> to about 200×

10<sup>−

6</sup> moles per square meter.

15. The sensor of claim 1, wherein the at least one reagent comprises a neutralizing agent, wherein the neutralizing agent neutralizes the control signal via a neutralizing effect.

16. The sensor of claim 15, wherein the neutralizing effect comprises at least one selected from a chemical reaction and a physical effect.

17. The sensor of claim 16, wherein the physical effect comprises at least one selected from precipitation and diffusion.

18. The sensor of claim 1, wherein the testing system comprises at least one selected from an immunological testing system, a blood glucose testing system, and a blood coagulation testing system.

19. The sensor of claim 1, wherein the control system and the testing system are located in one chamber.

20. The sensor of claim 1, wherein the control system is located in a first chamber, wherein at least part of the testing system is located in a second chamber.

21. The sensor of claim 20, wherein the first chamber and the second chamber are in parallel fluid connection or in serial fluid connection via a sample passageway.

10. (canceled)

22. (canceled)

23. A method of assessing a sample using a sensor comprising:

applying the sample to the sensor, wherein the sensor comprises an on-board control system and a testing system, wherein the control system comprises at least one reagent for determining viability of at least one of the control system and the testing system via a control reaction, wherein the at least one reagent is free of N-oxide or a nitroso compound, wherein the control reaction generates a control signal,

comparing the control signal with a standard signal to determine viability of the at least one of the control system and the testing system; and

assessing the sample in the testing system.

24. The method of claim 23, wherein the control system comprises an electrochemical control system, wherein the control reaction is assessed without an external voltage.

33. The method of claim 24, wherein the at least one reagent comprises ferricyanide.

47. The method of claim 24, wherein the sample comprises blood, wherein the measuring comprises measuring blood coagulation rate.

25-32. -32. (canceled)

34-46. -46. (canceled)