Method for determining an analyte in a bodily fluid sample

• US 20080101984A1
• Filed: 10/31/2006
• Published: 05/01/2008
• Est. Priority Date: 10/31/2006
• Status: Abandoned Application

• Current Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Mills, Leanne, Saini, Selwayan, Blythe, Stephen Patrick, Cardosi, Marco Fabio
• Application Number:
  US11/591,316
• Publication Number:
  US 20080101984A1
• Time in Patent Office: Days
• US Class Current: 422/52
• CPC Class Codes: G01N 2021/6439 with indicators, stains, dyes, tags, labels, marks
• CPC Class Codes: G01N 21/69 specially adapted for fluids , e.g. molten metal
• CPC Class Codes: G01N 21/76 Chemiluminescence; Bioluminescence

Abstract

A method for the determination of an analyte in a bodily fluid sample includes transferring a bodily fluid sample (such as a whole blood sample) to a sample chamber of an analytical test strip. The analytical test strip to which the bodily fluid sample is transferred has a substrate layer, an electroluminescent module disposed on the substrate layer and in optical communication with the sample chamber, and a fluorophore-containing photometric enzymatic reagent disposed within the sample chamber. In addition, the electroluminescent module is configured to emit light that facilitates a fluorescent chemical reaction sequence involving the fluorophore-containing photometric enzymatic reagent and the analyte. The method also includes exposing the fluorophore-containing photometric enzymatic reagent to the bodily fluid sample and to light emitted from the electroluminescent module such that photons are emitted from the fluorophore-containing photometric enzymatic reagent via a fluorescent chemical reaction sequence. Moreover, the method includes detecting the photons with a photodetector.

Claims

1. A method for the determination of an analyte in a bodily fluid sample, the method comprising:

transferring a bodily fluid sample to a sample chamber of an analytical test strip, the analytical test strip including;

a substrate layer;

an electroluminescent module disposed on the substrate layer and in optical communication with the sample chamber;

a fluorophore-containing photometric enzymatic reagent disposed within the sample chamber; and

the sample chamber, and

wherein the electroluminescent module is configured to emit light that facilitates a fluorescent chemical reaction sequence involving the fluorophore-containing photometric enzymatic reagent and the analyte;

exposing the fluorophore-containing photometric enzymatic reagent to the bodily fluid sample and to light emitted from the electroluminescent module such that photons are emitted from the fluorophore-containing photometric enzymatic reagent via a fluorescent chemical reaction sequence; and

detecting the photons with a photodetector.

2. The method of claim 1 wherein the electroluminescent module includes:

a rear electrode layer;

an electrically-insulating layer disposed over the rear electrode layer;

a phosphor layer disposed over the electrically insulating layer; and

a front electrode layer, at least a portion of which is translucent, disposed over the phosphor layer.

3. The method of claim 2 wherein the electroluminescent module further includes an encapsulant layer.

4. The method of claim 2 wherein the electroluminescent module further includes a wavelength modulation layer configured to shift the wavelength of light emitted by the phosphor layer.

5. The method of claim 4 wherein the wavelength modulation layer includes fluorescein.

6. The method of claim 4 wherein the wavelength modulation layer includes rhodamine.

7. The method of claim 4 wherein the wavelength modulation layer shifts the wavelength of light emitted by the phosphor layer via a Stoke'"'"'s shift.

8. The method of claim 1 wherein the analytical test strip further including a photodetector disposed above the substrate layer, and wherein the photodetector is positioned to detect, during the detecting step, photons emitted from the fluorophore-containing photometric enzymatic reagent subsequent to exposure of the fluorophore-containing photometric enzymatic reagent to the bodily fluid sample and to light from the electroluminescent module.

9. The method of claim 8 wherein the photodetector is disposed coplanar with the electroluminescent module.

10. The method of claim 8 wherein the photodetector is disposed co-facial with the electroluminescent module.

11. The method of claim 1 wherein the fluorophore-containing photometric enzymatic reagent includes glucose oxidase, horseradish peroxidase and Amplex Red reagent. 12. The method of claim 1 wherein the fluorescent chemical reaction sequence produces resorufin such that fluorescence of the resorufin emits photons proportional to the concentration of analyte in the bodily fluid sample.