Diagnostic sanitary test strip

• US 6,991,940 B2
• Filed: 10/31/2001
• Issued: 01/31/2006
• Est. Priority Date: 06/10/1997
• Status: Expired due to Fees

• Current Assignee: Nipro Diagnostics, Inc.
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Bell, Douglas E., Schneider, Jon, Carroll, Patrick
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/984,948
• Publication Number:
  US 20020058330A1
• Time in Patent Office: 1,553 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, 435/81, 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: 436/514
• 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 sanitary test strip device having a unitary construction for measuring an analyte of interest in a heterogeneous fluid sample, said test strip comprising:

no more than two operative layers, one of said no more than two operative layers comprising a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane;

said test strip further comprising;

an upper support layer defining a sample receiving port for receiving the fluid sample thereat;

one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and

a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support layer being associated with said upper support layer to secure said reaction membrane in said test strip.

2. A test strip of claim 1, further comprising a plurality of dam partitions defined by indentations formed in said upper support layer.

3. A test strip of claim 2, wherein said dam partitions are oriented around said receiving port.

4. A test strip of claim 2 wherein said upper support layer comprises at least one detent for mating with securing posts in a corresponding reflectance meter.

5. A test strip of claim 2, wherein said reagent in said reaction membrane is capable of detecting cholesterol analytes in the fluid sample.

6. A test strip of claim 2, wherein said reagent in said reaction membrane is capable of detecting osteoporosis analytes in the fluid sample.

7. A test strip of claim 2, wherein said reagent in said reaction membrane is capable of detecting ketones analytes in the fluid sample.

8. A test strip of claim 2, wherein said reagent in said reaction membrane is capable of detecting theophylline analytes in the fluid sample.

9. A test strip of claim 2, wherein said reagent in said reaction membrane is capable of detecting H1AC analytes in the fluid sample.

10. A test strip of claim 2, further comprising indicia of proper orientation and insertion of said test strip in a corresponding meter.

11. A test strip of claim 10, wherein said indicia comprises a light absorption medium on an exposed surface of said upper support layer.

12. A test strip of claim 10, wherein said indicia comprises an arrow on said upper support layer to indicate proper direction of insertion.

13. A test strip of claim 2, wherein said reagent in said reaction membrane is capable of detecting fructosamine analytes in the fluid sample.

14. A test strip of claim 2 wherein said dam partitions comprise four dam partitions positioned approximately 90°

apart around a sample receiving port.

15. A test strip of claim 1 wherein said sample receiving port is substantially circular.

16. A test strip of claim 1, wherein said reagent comprises reactants that facilitate an end-point test in a corresponding reflectance meter.

17. A test strip of claim 16, wherein said reagent includes an enzyme solution.

18. A test strip of claim 1, wherein one of said no more than two operative layers comprises a red blood cell binding agent for capturing red blood cells from the fluid sample.

19. A test strip of claim 18, wherein said red blood cell binding agent comprises lectins.

20. A test strip of claim 19, wherein said reagent in said reaction membrane includes an indicator chemical capable of visually indicating the amount of glucose analytes in the fluid sample.

21. A test strip of claim 1, wherein said reagent in said reaction membrane is capable of detecting glucose analytes in the fluid sample.

22. A test strip of claim 1, wherein said reaction membrane comprises an isotropic membrane such that said membrane has a substantially uniform porosity.

23. A test strip of claim 22, wherein said membrane comprises a material containing polysulfone.

24. A test strip of claim 1, wherein said measurable change in said reagent corresponds to the amount of analyte of interest present.

25. A test strip of claim 1, wherein said no more than two operative layers further comprises a separating layer, in contiguous contact with said reaction membrane, for receiving the sample containing the analyte of interest from said sample receiving port, said separating layer having mesh openings and being treated with a chemical solution for separating at least one undesirable element from the fluid sample prior to passing the fluid sample through said mesh openings.

26. A test strip of claim 25, wherein said chemical solution comprises a red blood cell binding agent for capturing red blood cells from the fluid sample.

27. A test strip of claim 25, wherein said separating layer overextends said reaction membrane.

28. A test strip of claim 1, having dimensions capable of accommodating sample volume of about 3 μ

l or less.