Metering strip and method for lateral flow assay devices

• US 20070134810A1
• Filed: 12/14/2005
• Published: 06/14/2007
• Est. Priority Date: 12/14/2005
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Wei, Ning, Yang, Kaiyuan, Kaylor, Rosann, Feaster, Shawn, Chidebelu-Eze, Chibueze
• Granted Patent: US 7,618,810 B2
• Time in Patent Office: Days
• US Class Current: 436/514
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 436/825 Pretreatment for removal of interfering factors from sample
• CPC Class Codes: Y10T 436/107497 Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Claims

1. A diagnostic test kit for detecting the presence of an analyte within a blood test sample, the test kit comprising a lateral flow assay device that further includes:

a housing, and a membrane disposed within said housing comprising a detection region and a collection region;

a blood sample meter comprising a first end for absorption of a blood sample, a filtering section adjacent said first end that filters red blood cell components from said blood sample, and a storage section adjacent said filtering section that receives plasma or serum from said filtering section;

an opening in said housing sized for insertion of said sample meter into said housing such that said storage section of said sample meter is disposed in fluid communication with said collection region of said membrane; and

wherein, said plasma or serum is transferable from said storage section of said sample meter to said collection region of said membrane for subsequent migration to said detection region.

2. The test kit of claim 1, further comprising a plurality of detection probes within said detection region that are capable of producing a detectable signal.

3. The test kit of claim 2, wherein a receptive material is immobilized within said detection region that is capable of binding to said detection probes or conjugates thereof.

4. The test kit of claim 1, wherein said sample meter comprises a separation membrane attached to a storage membrane with an overlap between said separation and storage membranes in said filtering section.

5. The test kit of claim 4, wherein said separation membrane has a length of between about 3 to about 12 mm, and said overlap with said storage membrane is between about 1 mm to about 3 mm, said storage membrane having a length of between about 10 mm to about 40 mm.

6. The test kit of claim 4, wherein said separation membrane extends to said first end of said sample meter, and said storage membrane extends to an opposite second end of said sample meter.

7. The test kit of claim 3, wherein said separation and storage membranes are attached to a backing strip.

8. The test kit of claim 7, wherein said backing strip is sufficiently transparent to view plasma or serum in said storage section through said backing strip.

9. The test kit of claim 1, wherein said sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 20 mm to about 40 mm.

10. The test kit of claim 1, further comprising a source of diluent, said diluent applied to said collection region subsequent to insertion of said sample meter into said housing.

11. The test kit of claim 10, wherein said diluent is stored in a rupturable container within said housing, and further comprising means for rupturing said container subsequent to insertion of said sample meter into said housing.

12. The test kit of claim 10, wherein said diluent is supplied from a source external to said housing, said housing further comprising a port for communication with said external diluent source.

13. The test kit of claim 1, further comprising means for cutting or scoring said sample meter along said storage section so as to present a desired length of said storage section to said collection region of said membrane.

14. The test kit of claim 13, wherein said cutting or scoring means comprises a finger actuated member configured with said housing with blades positioned to cut or score said sample member upon actuation of said finger actuated member.

15. A blood sample meter for use with a lateral flow assay device for detecting the presence of an analyte within a blood test sample, said meter comprising:

a first end configured for absorption of a blood sample, a separationing section adjacent said first end that filters red blood cell components from said blood sample, and a storage section adjacent said separationing section that receives plasma or serum from said separationing section;

wherein said storage section of sample meter is placed in fluid communication with test membrane in a lateral flow assay for transferring the plasma or serum to said membrane for subsequent detection of the presence of an analyte in the plasma or serum.

16. The sample meter of claim 15, comprising a separation membrane attached to a storage membrane with an overlap between said separation and storage membranes in said filtering section.

17. The sample meter of claim 16, wherein said separation membrane has a length of between about 3 to about 12 mm, and said overlap with said storage membrane is between about 1 mm to about 3 mm, said storage membrane having a length of between about 10 mm to about 40 mm.

18. The sample meter of claim 16, wherein said separation membrane extends to said first end of said sample meter, and said storage membrane extends to an opposite second end of said sample meter.

19. The sample meter of claim 16, wherein said separation and storage membranes are attached to a backing strip.

20. The sample meter of claim 19, wherein said backing strip is generally transparent.

21. The sample meter of claim 15, wherein said sample meter is an elongated member having a width of between about 1 mm to about 5 mm, and a length of between about 10 mm to about 40 mm.

22. A method for performing a lateral flow assay on a blood test sample of less than about 10 microliters to detect the presence of an analyte in the test sample, the method comprising:

exposing an end of sample meter to the blood sample, the sample meter absorbing the blood, separating red blood cell components from the sample, and saving the remaining plasma or serum in a storage section of the sample meter;

inserting the sample meter into a lateral flow assay device having a sampling membrane with a collection region and a detection region such that the storage section of the sample meter is adjacent the collection region of the membrane;

bringing the storage section of the sample meter into fluid communication with the collection region while supplying a diluent to the collection region; and

whereby the plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane and migrates to the detection region of the membrane.

23. The method as in claim 22, further comprising isolating a portion of the storage section of the sample meter prior to or in conjunction with supplying the diluent.

24. The method as in claim 23, comprising scoring or cutting the sample meter within the lateral flow assay to isolate a portion of the sample meter.

25. The method as in claim 22, wherein the volume of the blood test sample is less than 5 microliters.

26. The method as in claim 22, wherein the volume of the blood test sample is between about 1 to about 3 microliters.

27. The method as in claim 22, comprising supplying the diluent from a source within the lateral flow assay device.

28. The method as in claim 22, comprising supplying the diluent from a source external to the lateral flow assay device.

29. The method as in claim 22, comprising using a bridge member to place the storage section of the sample meter in fluid communication with the collection region of the membrane.

30. The method as in claim 22, comprising placing the storage section of the sample meter in direct contact with the collection region of the membrane within the lateral flow assay device.