Reagents test strip adapted for receiving an unmeasured sample while in use in an apparatus

• US 6,887,426 B2
• Filed: 06/24/2002
• Issued: 05/03/2005
• Est. Priority Date: 08/13/1986
• Status: Expired due to Fees

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Phillips, Roger, McGarraugh, Geoffery, Jurik, Franklin A., Underwood, Raymond D.
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US10/179,140
• Publication Number:
  US 20030073153A1
• Time in Patent Office: 1,044 Days
• Field of Search: 435/14, 435/28, 435/815, 435/808, 422 56- 58
• US Class Current: 422/404
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 2021/4757 Geometry 0/45° or 45/0°
• CPC Class Codes: G01N 21/314 with comparison of measurements at specific and non-specific wavelengths dual wavelength spectrometry G01J3/427
• CPC Class Codes: G01N 21/4738 Diffuse reflection precedence is given to G01N21/55 - G01N21/57 if specular component is taken into consideration, e.g. also for testing fluids, fibrous materials
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 35/1016 Control of the volume dispensed or introduced
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A method for determining the presence of an analyte in a fluid is described along with various components of an apparatus specifically designed to carry out the method. The method involves taking a reflectance reading from one surface of an inert porous matrix impregnated with a reagent that will interact with the analyte to produce a light-absorbing reaction product when the fluid being analyzed is applied to another surface and migrates through the matrix to the surface being read. Reflectance measurements are made at two separate wavelengths in order to eliminate interferences, and a timing circuit is triggered by an initial decrease in reflectance by the wetting of the surface whose reflectance is being measured by the fluid which passes through the inert matrix. Repeatability is insured by a normalization technique performed on the light source before each reading, and an alignment method operated on the reagent strip prior to emplacement on the apparatus. The method and apparatus are particularly suitable for the measurement of glucose levels in blood without requiring separation of red blood cells from serum or plasma.

Claims

1. A regent test strip for use in an apparatus for determining a blood glucose concentration of a sample of whole blood, the apparatus including optical means for detecting intensity of light reflected from a reading surface portion of the reagent test strip, the reagent test strip comprising:

a reagent pad including;

a sample receiving surface portion for receiving an unmeasured whole blood sample; and

a reading surface portion, other than the sample receiving surface portion, from which reflectance is read by the apparatus; and

a rigid handle to which the reagent pad is attached, wherein the rigid handle is configured to provide access to the sample receiving portion by the sample and access to the reading surface by incident light from the optical means such that the reagent test strip is adapted for receiving the unmeasured whole blood sample while in use in the apparatus.

2. The reagent test strip of claim 1 further adapted for receiving the unmeasured whole blood sample while the reading surface portion is in register with the optical means of the apparatus.

3. The reagent test strip of claim 2, wherein the reading surface portion and the sample receiving surface portion are on different surfaces of the reagent test strip.

4. The reagent test strip of claim 3, wherein at least a portion of the surface with the reading surface portion thereon is substantially reflective.

5. The reagent test strip of claim 1 adapted for impregnation of a reagent therein that reacts with blood glucose to cause a change in the reflectance at the reading surface portion.

6. The reagent test strip of claim 1 adapted for allowing a portion of the unmeasured whole blood sample to travel from the sample receiving surface portion to the reading surface portion.

7. A reagent test strip for use in an apparatus for determining a blood glucose concentration of a sample of whole blood, the apparatus including optical means for detecting intensity of light reflected from a reading surface portion of the reagent test strip, the reagent test strip comprising:

a reagent pad with a sample receiving surface portion for receiving an unmeasured whole blood sample and a reading surface portion, other than the sample receiving surface portion, from which reflectance is read by the apparatus; and

a rigid handle to which the reagent pad is attached, wherein the rigid handle includes a hole therethrough configured to provide access to one of the sample receiving portion by the sample and the reading surface by incident light from the optical means such that the reagent test strip is adapted for receiving the unmeasured whole blood sample while in use in the apparatus.

8. The reagent test strip of claim 7, wherein the reagent pad comprises pores of a size sufficient to exclude red blood cells.

9. A reagent test strip for use in an apparatus for determining an analyte concentration of a biological fluid sample, the apparatus including optical means for detecting intensity of light reflected from a reading surface portion of the reagent test strip, the reagent test strip comprising:

a reagent pad including;

a sample receiving surface portion for receiving an unmeasured biological fluid sample; and

a reading surface portion, other than the sample receiving surface portion, from which reflectance is read by the apparatus without removing excess biological fluid sample from the sample receiving surface portion; and

a rigid handle to which the reagent pad is attached, wherein the rigid handle is configured to provide access to the sample receiving portion by the sample and access to the reading surface by incident light from the optical means such that the reagent test strip is adapted for receiving the unmeasured biological fluid sample while in use in the apparatus.