Diagnostic sanitary test strip

• US 7,560,288 B2
• Filed: 05/16/2006
• Issued: 07/14/2009
• 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:
  US11/434,063
• Publication Number:
  US 20070048878A1
• Time in Patent Office: 1,155 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: 436/518
• 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 measuring an analyte of interest in a heterogeneous fluid sample, the test strip comprising:

a first support layer having a first interior adhesive surface and a sample receiving port for receiving the fluid sample;

a second support layer having a second interior adhesive surface and a reaction viewing port for displaying the measurement; and

first and second operative layers supported between the first and second support layers;

wherein the first operative layer includes a material for filtering the fluid sample, and the second operative layer includes an optically white membrane for measuring the analyte of interest, and

wherein the first operative layer is in contact with the first interior adhesive surface of the first support layer, and the second operative layer is in contact with the second interior adhesive surface of the second support layer.

2. The diagnostic test strip of claim 1, wherein the first support layer includes a sample receiving port, and the second support layer includes a reaction viewing port.

3. The diagnostic test strip of claim 2, wherein the first operative layer is in vertical alignment with the sample receiving port, and the second operative layer is in vertical alignment with the reaction viewing port.

4. The diagnostic test strip of claim 1, wherein the first operative layer filters at least one undesirable element from the fluid sample prior to passing the fluid sample to the second operative layer.

5. The diagnostic test strip of claim 1, wherein the material of the first operative layer is a woven fabric including a plurality of mesh openings.

6. The diagnostic test strip of claim 1, wherein at least one of the operative layers is pretreated with a reagent.

7. The diagnostic test strip of claim 6, wherein the reagent produces a glucose oxidase/peroxidase reaction.

8. The diagnostic test strip of claim 1, wherein the membrane is pretreated with a reagent for reacting with the analyte of interest to produce a measurable change in color for display in a reaction viewing port.

9. The diagnostic test strip of claim 8, wherein the measurable change in the reagent corresponds to an amount of the analyte of interest present.

10. A diagnostic test strip for measuring an analyte of interest in a heterogeneous fluid sample, the test strip comprising:

a first support layer having a first interior adhesive surface and a sample receiving port for receiving the fluid sample;

a second support layer having a second interior adhesive surface and a reaction viewing port for displaying the measurement;

first and second operative layers supported between the first and second support layers; and

indicia for indicating a proper orientation for insertion of the test strip in a corresponding meter,

wherein the first operative layer includes a material for filtering the fluid sample, and the second operative layer includes a membrane for measuring the analyte of interest, and

wherein the first operative layer is in contact with the first interior adhesive surface of the first support layer, and the second operative layer is in contact with the second interior adhesive surface of the second support layer.

11. The diagnostic test strip of claim 10, wherein the indicia includes at least one arrow on the first support layer to indicate proper direction of insertion.

12. The diagnostic test strip of claim 10, wherein the indicia includes a light absorbing medium on a top surface of the first support layer.

13. The diagnostic test strip of claim 12, wherein the light absorbing medium includes a black region proximate to an end portion of the first support layer near a sample receiving port.

14. A diagnostic test strip for measuring an analyte of interest in a heterogeneous fluid sample, the test strip comprising:

a first support layer including a sample receiving port for receiving the fluid sample and a first interior surface;

a second support layer including a reaction viewing port for displaying the measurement and a second interior surface;

a first operative layer in vertical alignment with the sample receiving port; and

a second operative layer in vertical alignment with the reaction viewing port;

wherein the first and second operative layers are supported between and in contact with the first and second interior surfaces of the first and second support layers, respectively, and

wherein the first operative layer is a separating layer for filtering the fluid sample, and the second operative layer is an optically white membrane for measuring the analyte of interest.

15. The diagnostic test strip of claim 14, wherein at least one of the operative layers is pretreated with a reagent.

16. The diagnostic test strip of claim 14, wherein the separating layer filters at least one undesirable element from the fluid sample prior to passing the fluid sample to the membrane.

17. The diagnostic test strip of claim 16, wherein the membrane further filters the fluid sample that passes through the separating layer.

18. The diagnostic test strip of claim 14, wherein the membrane is pretreated with a reagent for reacting with the analyte of interest to produce a measurable change in color for display in the reaction viewing port.

19. The diagnostic test strip of claim 18, wherein the measurable change in the reagent corresponds to an amount of the analyte of interest present.