Methods for testing the concentration of an analyte in a body fluid

• US 5,962,215 A
• Filed: 04/05/1996
• Issued: 10/05/1999
• Est. Priority Date: 04/05/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Mercury Diagnostics, Inc.
• Inventors: Douglas, Joel S., Wilson, James N., Drexler, Karen R.
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US08/628,489
• Time in Patent Office: 1,278 Days
• Field of Search: 435/4, 435/14, 435/25, 435/28, 435/805, 435/808, 435/968, 435/970, 435/13, 422/56, 422/57, 422/58, 210/617, 210/631
• US Class Current: 435/4
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/805 Test papers

Abstract

Devices and methods for utilizing dry chemistry dye indicator systems for body fluid analysis such as glucose level in whole blood are provided by incorporating a porous membrane with a skin side which enables separation of whole blood and visually reading the indicator without removing the red blood cell portion of the blood from the membrane. The devices also enable visual reading of the indicator by use of a cellulose fiber glass composite matrix which provides separation of whole blood in a lateral flow of the blood through the matrix from the input area to a test area of the matrix. Another aspect of the device provides a determination of hematocrit level in whole blood by measuring flow rate through a restricted passageway in the device.

Claims

1. A method for determining a corrected concentration of an analyte present in a fluid comprising:

providing a device comprising;

a member comprising a first opening for receiving a fluid sample and a second opening for receiving fluid from the first opening;

a restricted passageway communicating with the first opening and the second opening whereby the fluid sample flows from the first opening to the second opening;

a detector for measuring a rate of flow of the fluid sample through the restricted passageway; and

a porous matrix positioned in the second opening which comprises an indicator regent for measuring the concentration of the analyte in the fluid sample;

applying the fluid to the first opening;

measuring the rate of flow of the fluid through the passageway;

measuring the analyte concentration from the indicator reagent;

correlating said rate of flow to known hematocrit values;

calculating a hematocrit correction factor from the correlation; and

applying the hematocrit correction factor to the measured analyte concentration in the fluid to obtain a corrected concentration of the analyte.

2. A method according to claim 1 wherein the porous matrix comprises a polyethersulfone membrane.

3. A method according to claim 1 wherein the porous matrix comprises a cellulose and fiber glass matrix.

4. A method according to claim 1 Wherein the porous matrix and indicator regent is positioned in said second opening having a predetermined volume.

5. A method according to claim 2 wherein the porous matrix and indicator reagent is positioned in said second opening having a predetermined volume.

6. A method according to claim 3 wherein the porous matrix and indicator reagent is positioned in said second opening having a predetermined volume.