Microfabricated aperture-based sensor

• US 6,379,883 B2
• Filed: 12/21/2000
• Issued: 04/30/2002
• Est. Priority Date: 01/23/1998
• Status: Expired due to Term

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: i STAT Corporation (Abbott Laboratories Incorporated)
• Inventors: Lin, Chao, Davis, Graham, Lauks, Imants R., Pierce, Raymond J.
• Primary Examiner(s): Gitomer, Ralph
• Assistant Examiner(s): CHAUDHRY, MAHREEN F
• Application Number:
  US09/741,347
• Publication Number:
  US 20010003045A1
• Time in Patent Office: 495 Days
• Field of Search: 435/287.1, 435/4, 435/69.2, 435/14, 435/25, 435/11, 436/135, 436/175
• US Class Current: 435/4
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode

Abstract

A chemical sensor includes an enzyme layer, a diffusion layer and an analyte barrier layer positioned over the diffusion layer. Apertures are formed by microfabrication in the analyte barrier layer to allow controlled analyte flux to the diffusion layer.

Claims

1. A method of measuring the concentration of an analyte in a sample that contains a co-reactant, the method comprising:

(a) providing a sample suspected of containing an analyte of interest, the sample comprising a co-reactant;

(b) contacting the sample with a layer comprising a microfabricated aperture and a layer comprising a catalyst, wherein the co-reactant contacts the catalyst by diffusing substantially freely through the layer comprising the microfabricated aperture, and the analyte contacts the catalyst substantially through the aperture;

(c) obtaining at least one detectable product from a reaction between the analyte, the co-reactant and the catalyst; and

(d) detecting the product with a sensor thereby producing an output that depends upon the concentration of the analyte in the sample.

2. The method of claim 1 in which the analyte is glucose, lactate, pyruvate, bilirubin, cholesterol, sarcosine, creatine, or creatinine.

3. The method of claim 1 in which said sample is a biological fluid.

4. The method of claim 1 in which said fluid is blood.

5. The method of claim 1 in which said catalyst comprises at least one enzyme.

6. The method of claim 1 in which said co-reactant is oxygen.

7. The method of claim 1, further comprising, subsequent to performing step (d), repeating steps (a) to (d) with a sample comprising a predetermined analyte concentration and a co-reactant.

8. The method of claim 1, further comprising, prior to performing step (a), performing steps (a) to (d) with a sample comprising a predetermined analyte concentration and a co-reactant.

9. The method of claim 1 in which said sensor is an electrode and said detecting step comprises electrochemically detecting the product.

10. The method of claim 1 in which said sample further comprises one or more interfering substances and said layer comprising said catalyst further comprises one or more reagents capable of converting said one or more interfering substances into one or more non-interfering substances, the method comprising the further step of converting said one or more interfering substances into non-interfering substances.