Diagnostic sanitary test strip

• US 7,049,130 B2
• Filed: 03/21/2005
• Issued: 05/23/2006
• Est. Priority Date: 06/10/1997
• Status: Expired due to Fees

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Bell, Douglas E., Schneider, Jon, Carroll, Patrick
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US11/084,007
• Publication Number:
  US 20050164406A1
• Time in Patent Office: 428 Days
• Field of Search: 422 55- 58, 422/61, 435/11, 435/14, 435/174, 435/180, 435/287.1, 435/287.2, 435/287.7, 435/287.8, 435/287.9, 435/805, 435/810, 435/970, 436/66, 436/71, 436/164, 436/169, 436/170, 436/514, 436/518, 436/531, 436/805, 436/810, 436/815, 436/827
• US Class Current: 435/287.2
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds
• CPC Class Codes: Y10S 436/827 Lectins

Abstract

An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises no more than two operative layers and: (a) a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; (b) an upper support layer defining a sample receiving port for receiving the fluid sample thereat; (c) one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and (d) a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support being associated with said upper support to secure said reaction membrane in said test strip.

Claims

1. A diagnostic test strip for providing an indication of at least one of the presence, the absence or the amount of an analyte of interest in a heterogeneous fluid sample, the test strip comprising:

a first support layer comprising a sample receiving port for receiving the fluid sample;

a second support layer comprising a reaction viewing port for displaying the indication;

a plurality of operative layers between the first and second support layers, the first and second support layers securing the plurality of operative layers therebetween;

the plurality of operative layers comprising no more than two operative layers, the no more than two operative layers comprising;

a first operative layer in contact with the first support layer and in vertical alignment with the sample receiving port, the first operative layer comprising a material for receiving a fluid sample containing the analyte of interest; and

a second operative layer having a first side at least partially in contact with the first operative layer, and an opposite side in contact with the second support layer and in vertical alignment with the reaction viewing port, the second operative layer comprising a reaction membrane for receiving the analyte of interest through the first operative layer, the second operative layer containing a reagent for reacting with the analyte of interest to produce a measurable change in color for display in the reaction viewing port.

2. The test strip of claim 1, wherein the first operative layer is secured to the first support layer.

3. The test strip of claim 1, wherein the second operative layer is secured to the second support layer.

4. The test strip of claim 1, wherein the first operative layer comprises a material for spreading the fluid sample so as to evenly distribute the analyte of interest to the reaction membrane.

5. The test strip of claim 1, wherein the first operative layer comprises a cloth or a fabric.

6. The test strip of claim 1, wherein the first operative layer is treated with a chemical solution for separating at least one undesirable element from the fluid sample.

7. A test strip of claim 6, wherein the chemical solution comprises a red blood cell binding agent for capturing red blood cells from the fluid sample.

8. The test strip of claim 7, wherein the red blood cell binding agent comprises lectins.

9. The test strip of claim 1, wherein the reaction membrane comprises an isotropic membrane such that the membrane has a substantially uniform porosity.

10. The test strip of claim 9, wherein the membrane comprises polysulfone.

11. The test strip of claim 1, wherein the reagent comprises a reactant for facilitating an end-point test in a corresponding reflectance meter.

12. The test strip of claim 11, wherein the reagent includes an enzyme solution.

13. The test strip of claim 1, wherein the reagent is capable of detecting glucose analytes in the fluid sample.

14. The test strip of claim 13, wherein the reagent includes an indicator chemical capable of visually indicating the amount of glucose analytes in the fluid sample.

15. The test strip of claim 1, wherein the reagent is capable of detecting at least one of:

cholesterol analytes in the fluid sample;

osteoporosis analytes in the fluid sample;

ketones analytes in the fluid sample;

theophylline analytes in the fluid sample;

H1AC analytes in the fluid sample;

or fructosamine analytes in the fluid sample.

16. The test strip of claim 1, wherein the measurable change in the reagent corresponds to the amount of analyte of interest present.

17. The test strip of claim 1, further comprising indicia for indicating a proper orientation for insertion of the test strip in a corresponding meter.

18. The test strip of claim 17, wherein the indicia comprises an arrow on the first support layer to indicate proper direction of insertion.

19. The test strip of claim 18, wherein the indicia comprises a light absorbing medium on an exposed surface of the first support layer.

20. The test strip of claim 19, wherein the light absorbing medium comprises a black region proximate an end of the first support layer.

21. The test strip of claim 1, wherein the dimensions of the test strip are adapted to accommodate a sample volume of about 3 μ

l or less.

22. A diagnostic test strip for providing an indication of at least one of the presence, the absence or the amount of glucose analytes in a blood sample, the test strip comprising:

a first support layer comprising a sample receiving port for receiving the blood sample;

a second support layer comprising a reaction viewing port for displaying the indication;

a plurality of operative layers between the first and second support layers, the first and second support layers being secured together so as to secure the plurality of operative layers therebetween;

the plurality of operative layers comprising no more than two operative layers, the no more than two operative layers comprising;

a first operative layer secured to the first support layer and in vertical alignment with the sample receiving port, the first operative layer comprising a material for receiving a blood sample and for spreading the sample so as to distribute glucose analytes therein to a second operative layer; and

the second operative layer having a first side at least partially in contact with the first operative layer, and an opposite side secured to the second support layer and in vertical alignment with the reaction viewing port, the second operative layer comprising a reaction membrane for receiving glucose analytes from the blood sample through the first operative layer, the second operative layer containing a reagent for reacting with the glucose analytes to produce a measurable change in color for display in the reaction viewing port.

23. The test strip of claim 22 wherein the sample receiving port is substantially circular.

24. The test strip of claim 22 wherein the first and second support layers are substantially rectangular.

25. The test strip of claim 22, wherein the first and second support layers are secured together by glue.

26. The test strip of claim 22, wherein the reagent comprises a reactant for facilitating an end-point test in a corresponding reflectance meter.

27. The test strip of claim 26, wherein the reagent includes an enzyme solution.

28. The test strip of claim 22, wherein the reagent is capable of detecting glucose analytes in the fluid sample.

29. The test strip of claim 28, wherein the reagent includes an indicator chemical capable of visually indicating the amount of glucose analytes in the fluid sample.

30. The test strip of claim 22, further comprising indicia for indicating a proper orientation for insertion of the test strip in a corresponding meter.

31. The test strip of claim 30, wherein the indicia comprises an arrow on the first support layer to indicate proper direction of insertion.

32. The test strip of claim 31, wherein the indicia comprises a light absorbing medium on an exposed surface of the first support layer.

33. The test strip of claim 32, wherein the light absorbing medium comprises a black region proximate an end of the first support layer.

34. The test strip of claim 22, wherein the dimensions of the test strip are adapted to accommodate a sample volume of about 3 μ

l or less.