Devices for testing for the presence and/or concentration of an analyte in a body fluid

• US 6,818,180 B2
• Filed: 06/14/2001
• Issued: 11/16/2004
• Est. Priority Date: 04/05/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wilson, James N., Drexler, Karen R., Douglas, Joel S.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/879,898
• Publication Number:
  US 20010039057A1
• Time in Patent Office: 1,251 Days
• Field of Search: 422/56, 422/57, 422/58, 436/170, 436/165, 436/166, 435/14
• US Class Current: 422/417
• 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 membrane or 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. The devices also provide for microtitration of fluid samples in fixed volumetric openings containing indicator reagent. Another aspect of the device provides a determination of hematocrit level in whole blood in combination with indicator indication of analyte concentration which can be compensated for the hematocrit level. The devices provided are low cost.

Claims

1. A device for the testing of the presence or concentration of an analyte in a fluid sample comprising:

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

the member having a restricted passageway communicating with the first opening and the second opening whereby the fluid sample can flow from the first opening to the second opening; and

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

a porous matrix in the second opening, where the porous matrix comprises and indicator for indicator the presence or concentration of an analyte in the fluid sample.

2. A device according to claim 1, wherein the porous matrix comprises a polyethersulfone polymer.

3. A device according to claim 1, wherein the porous matrix includes a portion received in the restricted passageway that corresponds in shape to the restricted passageway.

4. A device according to claim 1, further comprising a cover layer having an opening positioned at a location corresponding to the first opening.

5. A device according to claim 1, further comprising a support member having an opening positioned at a location corresponding to the second opening.

6. A device according to claim 5, wherein the support member is transparent.

7. A device according to claim 6, further comprising a cover layer having an opening positioned at a location corresponding to the first opening.

8. A device for the testing of the presence or concentration of an analyte in a fluid sample comprising:

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

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

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

a porous matrix positioned in the second opening, wherein the porous matrix comprises an indicator for indicating the presence or concentration of an analyte in the fluid sample; and

wherein the porous matrix comprises a skin side positioned to receive the fluid sample from the passageway and capable of blocking the passage of solids in the fluid and of allowing passage of fluids containing an analyte to enter the matrix for reaction with an indicator in the porous matrix.

9. A device according to claim 8, wherein the porous matrix comprises a polyethersulfone polymer.

10. A device according to claim 8, wherein the porous matrix includes a portion received in the restricted passageway that corresponds in shape to the restricted passageway.

11. A device according to claim 8, further comprising a cover layer having an opening positioned at a location corresponding to the first opening.

12. A device according to claim 8, further comprising a support member having an opening positioned at a location corresponding to the second opening.

13. A device according to claim 12, wherein the support member is transparent.

14. A device according to claim 13, further comprising a cover layer having an opening positioned at a location corresponding to the first opening.

15. A device according to claim 8, wherein the member defines the restricted passageway.

16. A device according to claim 8, wherein the first opening and the second opening are laterally offset from one another to limit biohazard exposure.