Dry test strip comprising a dextran barrier for excluding erythrocytes

• US 5,212,060 A
• Filed: 04/27/1990
• Issued: 05/18/1993
• Est. Priority Date: 04/27/1990
• Status: Expired due to Term

• Current Assignee: Chronimed, Inc. (Madison Dearborn Partners LLC)
• Original Assignee: Genesis Labs, Inc. (BREX, Inc.)
• Inventors: Maddox, Catherine B.
• Primary Examiner(s): Kepplinger, Esther L.
• Assistant Examiner(s): Spiegel, Carol A.
• Application Number:
  US07/517,399
• Time in Patent Office: 1,117 Days
• Field of Search: 422/56, 422/57, 435/4, 435/7.92-7.95, 435/970, 435/962, 435/11, 435/14, 435/805, 435/810, 436/529, 436/175, 436/808, 436/810, 436/825
• US Class Current: 435/7.1
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/825 Pretreatment for removal of interfering factors from sample
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials

Abstract

A dry test strip for the detection of an analyte in a test fluid is disclosed. The test strip comprises a porous detection zone containing a reactant system that can generate a signal in the presence of an analyte. The detection zone further comprises dextran as a barrier to prevent penetration of RBC'"'"'s into the detection zone.

Claims

1. A dry test strip for detection of an analyte in a test fluid comprising:

(a) a porous detection zone having a test fluid application site physically separate from a visualization site containing a signal generating system that produces a signal in the presence of the analyte, wherein the detection zone pores are about 0.04 to 1 micron; and

(b) dextran, having a molecular weight of about 10,000 to 50,000 dispersed in the detection zone at a concentration effective to prevent penetration of red blood cells through the detection zone to the visualization site;

wherein any red blood cells present in the test fluid interact with the dextran adjacent the test fluid application site to prevent their penetration through the detection zone to the visualization site thereby essentially eliminating red blood cell interference with the signal generation.

2. The dry test strip of claim 1 wherein the dextran comprises a polymer of D-glucose having α

D-(1→

6) linkages.

3. The dry test strip of claim 1 wherein the signal generating system contained within the detection zone comprises a chemical assay.

4. The dry test strip of claim 3 wherein the chemical assay comprises a glucose assay reagent.

5. The dry test strip of claim 3 wherein the chemical assay comprises a cholesterol assay reagent.

6. The dry test strip of claim 1 wherein the signal generating system in the detection zone comprises an immunoassay.

7. The dry test strip of claim 6 wherein the detection zone comprises a first labeled reagent zone containing a labeled antibody or fragment thereof specific for the analyte, a second trapping zone comprising immobilized antigen which specifically binds unbound labeled antibody or fragment thereof, and a third signal generation zone containing means to detect the presence of the label.

8. The dry test strip of claim 1 wherein the detection zone is adhered to a polymeric carrier strip.

9. A dry test strip for detection of an analyte, in a test fluid containing red blood cells which comprises a carrier strip having a porous detection zone having pores of about 0.04 to 1 micron and containing a signal generating system that produces a signal in the presence of the analyte, said detection zone having a discrete barrier layer on the surface of the detection zone comprising a sufficient amount of dextran having a molecular weight of about 10,000 to 50,000 to prevent the penetration through the porous detection zone and interference with the signal generation system by the red blood cells.

10. The dry test strip of claim 9 wherein the dextran comprises a polymer of D-glucose having α

D-(1→

6) linkages.

11. The dry test strip of claim 9 wherein the signal generating system contained in the detection zone comprises a chemical assay.

12. The dry test strip of claim 9 wherein the signal generating system in the detection zone comprises an immunoassay.

13. The dry test strip of claim 12 wherein the detection zone comprises a first labeled reagent zone containing a labeled antibody or fragment thereof specific for the analyte, a second trapping zone comprising immobilized antigen which specifically binds unbound labeled antibody or fragment thereof, and a third single generation zone containing means to detect the presence of the label.

14. A method for detecting an analyte in a test fluid which method comprises:

(a) applying the test fluid to a dry test strip comprising

a porous detection zone having pores of about 0.04 to 1 micron and a test fluid application site physically separate from a visualization site containing;

(i) a signal generating system that produces a signal in the presence of the analyte; and

(ii) dextran having a molecular weight of about 10,000 to 50,000, dispersed through the detection zone at a concentration effective to prevent penetration of any red blood cells present in the fluid through the detection zone; and

(b) detecting the concentration of the analyte;

wherein any red blood cells present in the test fluid interact with the dextran adjacent the application site to prevent their penetration through the detection zone to the visualization site thereby essentially eliminating red blood cell interference with the signal generation.

15. The method of claim 14 wherein the dextran comprises a polymer a D-glucose having α

D-(1→

6) linkages.

16. The method of claim 14 wherein the signal generating system contained within the detection zone comprises a chemical assay.

17. The method of claim 14 wherein the signal generating system in the detection zone comprises an immunoassay.

18. The method of claim 17 wherein the detection zone comprises a first labeled reagent zone containing a labeled antibody or fragment thereof specific for the analyte, a second trapping zone comprising immobilized antigen which specifically binds unbound labeled antibody or fragment thereof, and a third single generation zone containing means to detect the presence of the antibody label.

19. The method of claim 14 wherein the test fluid is selected from the group consisting of serum, plasma, urine, cerebral spinal fluid, ascites, and saliva.

20. The method of claim 14 wherein the test fluid comprises whole blood, a red blood cell containing fraction thereof or a red blood cellular suspension in a compatible diluent.

21. The method of claim 14 wherein the detection zone is adhered to a polymeric carrier strip.