Analytical device for the automated determination of analytes in fluids

• US 5,059,394 A
• Filed: 02/11/1988
• Issued: 10/22/1991
• Est. Priority Date: 08/13/1986
• Status: Expired due to Term

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Phillips, Roger, Underwood, Ray, McGarraugh, Geoffery, Jurik, Frank
• Primary Examiner(s): Kepplinger, Esther L.
• Assistant Examiner(s): Spiegel, Carol A.
• Application Number:
  US07/154,941
• Time in Patent Office: 1,349 Days
• Field of Search: 435/14, 435/810, 422/58, 422/68, 422/91, 422/104, 422/82.05, 436/46, 356/39-40, 364/497, 128/770
• US Class Current: 422/68.1
• 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 33/523 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: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10T 436/112499 with sample on test slide

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. 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. An apparatus for measuring reflectance from a porous matrix containing a reagent that reacts with an analyte suspected of being present in a liquid sample applied to a surface in said porous matrix, where said sample can migrate through said porous matrix and react with said reagent if said analyte is present in said sample, which comprises:

a housing;

an internal chamber in said housing;

means for accessing said internal chamber, whereby said porous matrix can be inserted in or removed from said internal chamber through said means for accessing;

means for excluding external light from entering said internal chamber through said means for accessing;

means for retaining said porous matrix in said internal chamber, wherein said porous matrix is retained with a first surface accessable for applying said liquid sample through said means for accessing;

means for illuminating a second surface of said porous matrix when said porous matrix is retained in said internal chamber, wherein said second surface is different from said first surface;

means for detecting intensity of light reflected from said second surface of said porous matrix when said porous matrix is retained in said internal chamber and illuminated by said means for illuminating, wherein said means for detecting produces an output related to said intensity, said means for detecting intensity being adapted to provide a series of outputs;

control means for processing said outputs, said control means including means for comparing outputs in said series and determining whether said outputs decrease by a predetermined difference sufficient to indicate that said sample of body fluid has reached said second surface, wherein said predetermined decrease in outputs causes said control means to initiate a timing period which results in a measurement reading being taken from said surface at a predetermined time after said second timing period is initiated without having determined the time at which said sample of body fluid was initially applied to said porous matrix; and

means for reporting said measurement reading.

2. The apparatus of claim 1, wherein said apparatus further comprises a self-contained electronic power supply operationally connected to said means for illuminating, means for detecting, control means, and means of reporting.

3. The apparatus of claim 1, wherein said means for illuminating and means for detecting light together comprise:

1)two light sources of different wavelengths and a single light detector;

or

     2) a polychromatic light source and two detectors restricted to detecting different wavelegths of light, wherein one of said wavelengths measures a product absorbance and the other of said wavelengths measures a background absorbance.

4. The apparatus of claim 3, wherein the first wavelength of light is from 690 to 710 nm and the second wavelength of light is from 625 to 645 nm.

5. The apparatus of claim 1, wherein said control means is further capable of collecting and storing a background detector current reading in the absence of light reflected from said porous matrex.

6. The apparatus of claim 5, further comprising a power supply, wherein said control means further comprises means for automatically collecting and comparing sequential reflectance readings from said means for detecting when power is supplied to said control means in an analyte detection mode;

means for initiating a timing circuit upon detection of said decrease in reflectance;

means for collecting a reaction reflectance reading at a predetermined interval after said drop in reflectance;

means for calculating a value for concentration of analyte in said liquid being analyzed from said reaction reflectance reading; and

means for transferring said value to said reporting means.

7. The apparatus of claim 6, wherein said control means further comprise means for collecting and storing a base reflectance reading from said matrix when power is supplied to said control means in a base reflectance mode prior to said analyte detection mode and means for subtracting said base reflectance reading from said reaction reflectance reading prior to calculation by said control means of said value.