BIOSENSOR AND ULTRASONIC METHOD OF MAKING A BIOSENSOR

• US 20080311004A1
• Filed: 06/18/2007
• Published: 12/18/2008
• Est. Priority Date: 06/18/2007
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Harvey, Keith A., GILMOUR, Steven B.
• Granted Patent: US 7,972,866 B2
• Time in Patent Office: Days
• US Class Current: 422/82.01
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding

Abstract

There is provided a test strip for testing a fluid sample, including a sample cavity configured to receive the fluid sample and an ultrasonically-spread reagent layer arranged on at least one surface of the sample cavity. There is also provided a method for making a biosensor, including providing a substrate having a region for receiving a sample; dispensing a liquid substance on at least one surface of the region for receiving a sample; and subjecting the substrate to ultrasonic vibrations to quickly and uniformly spread the liquid substance on the at least one surface of the region for receiving a sample.

Claims

1. A test strip for testing a fluid sample, comprising:

a sample cavity configured to receive the fluid sample; and

an ultrasonically-spread reagent layer arranged on at least one surface of the sample cavity.

2. The test strip of claim 1, comprising:

at least two electrodes disposed in the sample cavity and configured to measure at least one electrical characteristic of the fluid sample in the sample cavity, the electrodes including a working electrode and a counter electrode.

3. The test strip of claim 2, wherein the sample cavity comprises a first opening for receiving the fluid sample and a second opening for venting the sample cavity.

4. The test strip of claim 3, wherein the sample cavity is dimensioned to draw the blood sample in through the first opening by capillary action.

5. The test strip of claim 3, further comprising a proximal end and a distal end, the first opening being located at the proximal end.

6. The test strip of claim 1, wherein the ultrasonically-spread reagent layer comprises at least an enzyme specific for glucose.

7. The test strip of claim 1 wherein the ultrasonically-spread reagent layer comprises at least an electron mediator.

8. The test strip of claim 1, wherein the ultrasonically-spread reagent layer is spread using ultrasonic vibrations applied between about 60-90 degrees to the at least one surface of the sample cavity.

9. The method of claim 8, wherein the ultrasonically-spread reagent layer was spread using ultrasonic vibrations having a frequency between about 18 kHz and 50 kHz.

10. The method of claim 9, wherein the ultrasonically-spread reagent layer is spread using ultrasonic vibrations having a frequency between about 20 kHz and 40 kHz.

11. A method for making a biosensor, comprising the steps of:

providing a substrate having a region for receiving a sample;

dispensing a liquid substance on at least one surface of the region for receiving a sample; and

subjecting the substrate to ultrasonic vibrations to quickly and uniformly spread the liquid substance on the at least one surface of the region for receiving a sample.

12. The method of claim 11, wherein the providing step comprises providing the substrate with a sample cavity having a volume between about 0.0001 mL and 1 mL.

13. The method of claim 11, wherein the providing step comprises providing the substrate with a sample cavity having a volume between about 0.0001 mL and 0.001 mL.

14. The method of claim 11, wherein the dispensing step comprises dispensing at least one droplet of a reagent including and enzyme specific for glucose.

15. The method of claim 11, wherein the dispensing step comprises dispensing at least one droplet of a reagent including an electron mediator.

16. The method of claim 14, wherein the subjecting step comprises subjecting the sample cavity to ultrasonic vibrations that are between about 60-90 degrees to the bottom of the substrate.

17. The method of claim 11, wherein the subjecting step comprises subjecting the substrate to ultrasonic vibrations having a frequency between about 18 kHz and 50 kHz.

18. The method of claim 17, wherein the subjecting step comprises subjecting the substrate to ultrasonic vibrations having a frequency of about 20 kHz.

19. The method of claim 17, wherein the subjecting step comprises subjecting the substrate to ultrasonic vibrations having a frequency of about 40 kHz.

20. The method of claim 11, wherein the subjecting step comprises subjecting the substrate to ultrasonic vibrations using an ultrasonic horn.

21. A method for manufacturing a plurality of biosensors, comprising:

arranging a plurality of test strip substrates into an array;

providing each test strip substrate in the array with a sample cavity;

dispensing a liquid solution on at least one surface of the sample cavity of each test strip in the array; and

subjecting the sample cavity of each test strip in the array to ultrasonic vibrations to quickly and uniformly spread the liquid solution on the at least one surface of the sample cavity of each test strip in the array.

22. The method of claim 21, wherein the providing step comprises providing each test strip in the array with a sample cavity having a volume between about 0.0001 mL and 1 mL.

23. The method of claim 21, wherein the providing step comprises providing each test strip in the array with a sample cavity having a volume between about 0.0001 mL and 0.001 mL.

24. The method of claim 21, wherein the dispensing step comprises dispensing a reagent on a bottom surface of the sample cavity of each test strip in the array, the reagent including an enzyme specific for glucose.

25. The method of claim 21, wherein the dispensing step comprises dispensing a reagent on a bottom surface of the sample cavity of each test strip in the array, the reagent including an electron mediator.

26. The method of claim 24, wherein the subjecting step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations that are between about 60-90 degrees to the bottom of the sample cavity of each test strip in the array.

27. The method of claim 21, wherein the subjecting step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations having a frequency between about 18 kHz and 50 kHz.

28. The method of claim 27, wherein the subjecting step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations having a frequency of about 20 kHz.

29. The method of claim 27, wherein the subjecting step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations having a frequency of about 40 kHz.

30. The method of claim 21, wherein the subjecting step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations by passing the array of test strips over an ultrasonic horn.

31. A method for making a plurality of test strips, comprising the steps of:

arranging a plurality of test strips into an array, each test strip comprising (1) a base layer, (2) a spacer layer arranged on the base layer, and (3) a sample cavity defined by the base and spacer layers;

dispensing a liquid reagent layer on a surface of the sample cavity; and

passing the array over an ultrasonic generator to subject the sample cavity of each test strip to ultrasonic vibrations to quickly and uniformly spread the liquid reagent layer.

32. The method of claim 31, comprising the step of passing the array over, under, or through drying equipment to dry the ultrasonically-spread liquid reagent layer.

33. The method of claim 31, wherein the arranging step comprises:

forming a plurality of electrodes on the base layer of each test strip, the plurality of electrodes comprising a working electrode, a counter electrode, and at least one fill-detect electrode; and

forming a plurality of electrical contacts on the base layer of each test strip, the plurality of electrical contacts being electrically connected to the plurality of electrodes.

34. The method of claim 31, wherein the dispensing step comprises dispensing a liquid reagent layer including an enzyme specific for glucose and an electron mediator.

35. The method of claim 31, wherein the passing step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations that are between about 60-90 degrees to the surface of the sample cavity.

36. The method of claim 31, wherein the passing step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations having a frequency between about 18 kHz and 50 kHz.

37. The method of claim 36, wherein the passing step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations having a frequency of about 20 kHz.

38. The method of claim 36, wherein the passing step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations having a frequency of about 40 kHz.

39. The method of claim 33, wherein the passing step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations having a frequency between about 18 kHz and 50 kHz.

40. The method of claim 39, wherein the passing step comprises subjecting the sample cavity of each test strip in the array to ultrasonic vibrations having a frequency between about 20 kHz and 40 kHz.