Test strip for simultaneous detection of a plurality of analytes

• US 6,524,864 B2
• Filed: 12/28/2000
• Issued: 02/25/2003
• Est. Priority Date: 12/28/2000
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Aurora L. Fernandez Decastro
• Inventors: Fernandez Decastro, Aurora L.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/749,439
• Publication Number:
  US 20020086435A1
• Time in Patent Office: 789 Days
• Field of Search: 422/56, 422/58, 422/61, 422/82.05, 422/82.06, 422/82.09, 436/63, 436/86, 436/95, 436/98, 436/163, 436/164, 436/166, 436/169
• US Class Current: 436/164
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/147777 Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

A test strip for simultaneously measuring a plurality of analytes in blood or other fluids comprising a plurality of reagent pads containing reagents specific to particular analytes located on a support. Each reagent pad is covered and in close contact with a sample distributing layer and an optional blood filtering layer. Color produced by analytes in the sample is viewed through apertures in the support. The colors of the pads are read simultaneously with an instrument such as a reflectance meter containing individual LED'"'"'s as light sources for each reagent pad. The intensity of the color of the individual pad can be used to detect semi-quantitative or quantitative concentration of analytes in a sample on site, allowing for quick communication of results to a remote site by electronic means.

Claims

1. A test strip for simultaneously detecting and measuring more than one analyte in a sample comprising in the following order:

(a) a distribution layer across the length of the test strip wherein a sample can be applied at any spot on the distribution layer which distribution layer breaks the surface tension of a drop of sample and permits uniform distribution of the sample across the distribution layer;

(b) an optional blood filtration layer;

(c) a plurality of reagent pads for each analyte to be measured, wherein each reagent pad containing dry reagents for detection of the analyte to be detected by a specific reagent pad, wherein said reagents produce a change in color proportional to the concentration of the analyte detected in the sample;

(d) a support for the reagent pads wherein changes in the color of the reagent pads can be viewed;

(e) a light measuring device comprising a light source for each reagent pad and a light detector source for each reagent pad enabling simultaneous measurement of each reagent pad.

2. The test strip according to claim 1 further comprising an impermeable top layer over all of the reagent pads, said impermeable top layer being affixed to said support.

3. The test strip according to claim 1 wherein said reagent pads comprise from one to three layers.

4. The test strip according to claim 1 wherein the support for the reagent pads is provided with a single opening for viewing all of the reagent pads.

5. The test strip according to claim 1 wherein the support for the reagent pads is provided with a separate opening for viewing each reagent pad.

6. The test strip according to claim 1 wherein the distribution layer is selected from the group consisting of polyester filtration media, nylon mesh, titanium dioxide, barium sulfate, and combinations thereof.

7. The test strip according to claim 1 containing reagents for measuring analytes selected from the group consisting of blood urea nitrogen, creatinine, glucose, cholesterol, alanine aminotransferase, bilirubin, albumin, total protein, and combinations thereof.

8. The test strip according to claim 1 containing reagents for measuring analytes selected from the group consisting of cholesterol, HDL, LDL, triglycerides, and combinations thereof.

9. The test strip according to claim 1 containing reagents for measuring analytes selected from the group consisting of creatine kinase, creatine kinase-MB, lactate dehydrogenase, aspartate aminotransferase, and combinations thereof.

10. The test strip according to claim 1 containing reagents for measuring analytes selected from the group consisting of bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, albumin, lactate dehydrogenase, and combinations thereof.

11. The test strip according to claim 1 containing reagents for measuring analytes selected from the group consisting of sodium, potassium chloride, carbon dioxide, and combinations thereof.

12. The test strip according to claim 1 containing reagents for measuring analytes selected from the group consisting of blood urea nitrogen, creatinine, protein, albumin, phosphate, and combinations thereof.

13. The test strip according to claim 1 containing reagents for measuring analytes selected from the group consisting of PKU, galactosemia, T₄, and combinations thereof.

14. The test strip according to claim 1 wherein the light sources are light emitting diodes.

15. The test strip according to claim 1 wherein the light measuring device comprises at least one light emitting diode and at least one light detector.

16. A method for simultaneously measuring more than one analyte in a sample comprising:

(a) applying said sample to a test strip by spreading the sample across the top of the test strip, said test strip comprising;

(i) a distribution layer whereby the sample is uniformly distributed across the zest strip;

(ii) an optional blood filtration layer;

(iii) a plurality of reagent pads for each analyte to be measured, wherein each reagent pad contains dry reagents for detection of the analyte to be detected in a specific reagent pad, wherein said reagents produce a change in color proportional to the concentration of the analyte detected in the sample; and

(iv) a support for the reagent pads wherein changes in the color of the reagent pads can be viewed; and

(b) detecting said changes in color simultaneously with a light measuring device wherein each reagent pad has its own light measuring device enabling simultaneous measurement of each reagent pad.

17. The method according to claim 16 wherein the reaction color produced is viewed with light of about 360 to about 800 nm.

18. The method according to claim 16 wherein the sample is whole blood.

19. The method according to claim 16 wherein up to eight analytes are measured for early detection of dysfunction for general health, said analytes being selected from the group consisting of blood urea nitrogen, creatinine, glucose, cholesterol, alanine aminotransferase, bilirubin, total protein, and albumin.

20. The method according to claim 16 wherein the sample is measured for lipid disorders and the analytes are selected from the group consisting of cholesterol, HDL, LDL, triglycerides, and combinations thereof.

21. The method according to claim 16 wherein the sample is measured for cardiac disorders and the analytes are selected from the group consisting of creatine kinase, creatine kinase-MB, lactate dehydrogenase, aspartate aminotransferase, and combinations thereof.

22. The method according to claim 16 wherein the sample is measured for liver disorders and the analytes are selected from the group consisting of bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, albumin, lactate dehydrogenase, and combinations thereof.

23. The method according to claim 16 wherein the sample is measured for kidney disorders and the analytes are selected from the group consisting of blood urea nitrogen, creatinine, protein, albumin, phosphate, and combinations thereof.

24. The method according to claim 16 wherein the sample is measured for electrolytes selected from the group consisting of sodium, potassium, chloride, and carbon dioxide.

25. The method according to claim 16 wherein the light measuring device comprises a reflectance meter.

26. The method according to claim 16 wherein the light measuring device measures reflected light including a separate light source and a separate light detector for each reagent pad.

27. The method according to claim 18 wherein the whole blood is capillary blood.

28. The method according to claim 27 wherein the capillary blood is obtained from the finger, heel, or earlobe.

29. The method according to claim 16 wherein the color measuring device comprises a reflectance meter with a plurality of light sources and a detector for each reagent pad.

30. The method according to claim 29 wherein the light sources are light emitting diodes.