Lateral flow assay device

• US 8,377,379 B2
• Filed: 12/15/2006
• Issued: 02/19/2013
• Est. Priority Date: 12/15/2006
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Feaster, Shawn R., Yang, Kaiyuan, Wei, Ning, Chidebelu-Eze, Chibueze O., Takeuchi, James M., Kaylor, Rosann M., DiGiammarino, Enrico L., Fish, Jeffrey E.
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US11/640,435
• Publication Number:
  US 20080145272A1
• Time in Patent Office: 2,258 Days
• Field of Search: 422/69
• US Class Current: 422/69
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• 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 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

A lateral flow assay device includes a housing, and a test strip disposed within the housing having a membrane with a detection region and a collection region. A sample meter includes a first end for absorption of a test sample, and a storage section that receives and stores at least a component of the test sample. 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 adjacent the collection region of the membrane. The test sample component is transferable from the storage section to the collection region for subsequent migration to the detection region. An activatable isolation mechanism is provided within the housing and is disposed so as to isolate portions of the sample meter storage section upon activation thereof such that a defined length of the storage section is presented to the collection region of the membrane.

Claims

1. A lateral flow assay device that further includes:

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

a sample meter comprising a first end for absorption of a test sample, and a storage section that receives and stores at least a component of the test sample;

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 adjacent said collection region of said membrane, the test sample component transferable from said storage section to said collection region for subsequent migration to said detection region; and

an activatable isolation mechanism within said housing and disposed so as to physically detach from said sample meter a defined length of said sample meter storage section upon activation thereof such that said detached defined length of said storage section is presented to said collection region of said membrane.

2. The assay device as in claim 1, wherein said sample meter is a blood sample meter and includes a filtering section adjacent said first end that filters red blood cell components from a blood sample such that said storage section receives plasma or serum components of the blood sample.

3. The assay device as in claim 2, wherein said blood sample meter comprises a separation membrane attached to a storage membrane with an overlap between said separation and storage membranes in said filtering section.

4. The assay device of claim 1, further comprising a source of diluent stored in a rupturable container within said housing, and further comprising a manually activated rupturing mechanism that ruptures said container subsequent to insertion of said sample meter into said housing.

5. The assay device of claim 4, wherein said rupturing mechanism is configured with said scraping mechanism so as to be activated generally simultaneously therewith.

6. The assay device of claim 4, wherein said rupturing mechanism is configured separate from said scraping mechanism so as to be activated separately therefrom.

7. The assay device of claim 1, further comprising a source of diluent external to said housing, said housing further comprising a port for communication with said external diluent source.

8. A lateral flow assay device that further includes:

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

a sample meter comprising a first end for absorption of a test sample, and a storage section that receives and stores at least a component of the test sample;

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 adjacent said collection region of said membrane, the test sample component transferable from said storage section to said collection region for subsequent migration to said detection region; and

an activatable isolation mechanism within said housing and disposed so as to isolate portions of said sample meter storage section upon activation thereof such that a defined length of said storage section is presented to said collection region of said membrane,

wherein said isolation mechanism comprises a scraping mechanism having a pair of spaced apart and movably mounted blades, said blades contacting said sample meter at a first static position that defines said defined length of said storage section between said blades, said blades scraping said storage section on opposite sides of said defined section as said blades move to a second actuated position.

9. The assay device as in claim 8, wherein said blades are pivotally mounted along a respective longitudinal axis on opposite longitudinal sides of said test strip and rotate away from said test strip in said second actuated position, said sample meter disposed generally across said blades perpendicular to said test strip.

10. The assay device as in claim 9, further comprising a manually actuated device configured on said housing that causes said blades to move from said static position to said actuated position.

11. The assay device as in claim 10, wherein said manually actuated device comprises a spring biased plunger that contacts and pushes said sample meter against said blades.

12. The assay device as in claim 11, wherein said test strip is disposed below said sample meter, said plunger pushing said sample meter into contact with said test strip subsequent to scraping of said sample meter.

13. The assay device as in claim 12, further comprising a latch that maintains said plunger in said second actuated position so that said sample meter is maintained in contact with test strip.

14. A method for performing a lateral flow assay on a 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 a sample meter to the test sample, the sample meter absorbing the sample, separating certain components from the sample, and saving the remaining portion of the sample in a storage section of the sample meter;

inserting the sample meter into a lateral flow assay device having a test strip with a collection region and a detection region;

physically detaching a part of the storage section of the sample meter so as to define a metered length of the storage section;

presenting the metered length of the storage section in fluid communication with the collection region of the test strip while supplying a diluent to the collection region; and

whereby the sample is transferred from the metered length of the storage section of the sample meter to the collection region of the membrane and migrates to the detection region of the membrane.

15. The method as in claim 14, further comprising supplying the diluent generally simultaneously with said isolating of the storage section of the sample meter.

16. The method as in claim 14, wherein the test sample is blood and the volume of the blood test sample is less than 5 microliters.

17. The method as in claim 16, wherein the volume of the blood test sample is between about 1 to about 3 microliters.

18. The method as in claim 14, comprising supplying the diluent from a source within the lateral flow assay device.

19. The method as in claim 14, comprising supplying the diluent from a source external to the lateral flow assay device.

20. The method as in claim 14, comprising pushing the metered length of the storage section into fluid communication with the collection region of the membrane immediately subsequent to said isolating of the storage section of the sample meter.

21. The method as in claim 14, wherein said isolating of the storage section comprises scoring and scraping away portions of the storage section to define the metered length of storage section.