Analyte detection device and process

• US 6,190,918 B1
• Filed: 03/06/1995
• Issued: 02/20/2001
• Est. Priority Date: 08/05/1993
• Status: Expired due to Term

• Current Assignee: Bayer Corporation (Bayer AG)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Wilcox, Michael J., Chu, Amy H.
• Primary Examiner(s): Soderquist, Arlen
• Application Number:
  US08/400,786
• Time in Patent Office: 2,178 Days
• Field of Search: 422/56, 422/57, 422/61, 435/14, 435/22, 435/26, 436/71, 436/95, 436/63, 436/166, 436/169, 436/170, 436/177
• US Class Current: 436/63
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

The present invention provides a device and a process for detecting an analyte in a biological fluid. The device comprises a separating matrix for separating analyte from the fluid and means for detecting the analyte, where the separating matrix contains HEPES buffer, preferably in an amount between 70 and 150 millimolar. The process comprises applying the sample to the device having a separating matrix and then detecting analyte in the sample using the detection means. The presence of HEPES in the separation layer shortened the detection time.

Claims

1. A device for detecting an analyte in a biological fluid, said device comprising:

a) a separation matrix containing an agglutinating agent and between 70 and 150 millimolar of the buffer 4-(2-hydroxyethyl)-1-piperazine-ethanesulfonic acid (HEPES); and

b) means for detecting said analyte, which detection means is vertically adjacent to the separation matrix and substantially coincident with the matrix such that said analyte can move from the separation matrix to the means for detecting said analyte;

wherein said device has a faster endpoint detection speed due to the presence of the HEPES buffer in the separation matrix.

2. The device according to claim 1 wherein said detection means is a membrane containing one or more chemical reagents that interact with the analyte to generate a detectable signal indicative of said analyte presence in said biological fluid.

3. The device according to claim 2 wherein said chemical reagents comprise ATP, NAD, hexokinase, glucose-6-phosphate dehydrogenase, diaphorase and an indicator.

4. The device according to claim 1 wherein said separation matrix is a membrane filter.

5. The device according to claim 4 wherein said membrane filter is a glass fiber filter.

6. The device according to claim 5 wherein said glass fiber filter has a sample application side directed away from said detection means and a reagent side directed toward and adjacent to said detection means, whereby said reagent side has shorter fibers than said application side.

7. The device according to claim 1 wherein said separation matrix also contains an aggregation-promoting substance that promotes aggregation of colloidal particles or cells.

8. The device according to claim 1 wherein said separation matrix also contains a non-hemolytic surfactant.

9. The device according to claim 1 further comprising:

a) a base portion having a transparent window, which base portion is situated such that said detection means is vertically adjacent to said base portion and at least partially coincident with said transparent window;

b) a cover portion having an aperture, which cover portion is vertically adjacent to and coincident with said separation matrix.

10. The device according to claim 1 wherein said window is made of polycarbonate.

11. The device of claim 1 in which the amount of HEPES present in the separation matrix is between 80 and 100 millimolar.

12. A device for assaying blood glucose comprising:

a) a synthetic membrane containing ATP, NAD, hexokinase, glucose-6-phosphate dehydrogenase, diaphorase and an indicator; and

b) a glass fiber filter vertically adjacent to said synthetic membrane and substantially coincident with said synthetic membrane in which the glass fiber contains an agglutinating agent and the buffer 4-(2-hydroxyethyl)-1-piperazine-ethanesulfonic acid (HEPES);

wherein said device has a faster endpoint detection speed due to the presence of HEPES buffer in an amount between 70 to 150 millimolar.

13. A process of detecting an analyte in a biological fluid, said process comprising the steps of:

a) providing a detection device comprising;

i) a separation matrix containing an agglutinating agent and between 70 and 150 millimolar of the buffer 4-(2-hydroxyethyl)-1-piperazine-ethanesulfonic acid (HEPES); and

ii) means for detecting said analyte, which detection means, is vertically adjacent to the separation matrix and substantially coincident with that matrix such that said analyte can move from the separation matrix to the means for detecting said analyte;

b) applying a sample of said biological fluid to said separation matrix; and

c) determining a reaction between said analyte and said detection means, wherein said process has a faster endpoint detection speed due to the presence of HEPES buffer in the separation matrix.

14. The process according to claim 13 wherein said biological fluid is whole blood.

15. The process according to claim 13 in which HEPES is present in an amount between 80 and 100 millimolar.