Meter strip and method for lateral flow assay devices

• US 7,838,258 B2
• Filed: 09/30/2009
• Issued: 11/23/2010
• Est. Priority Date: 12/14/2005
• Status: Expired due to Fees

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Wei, Ning, Yang, Kaiyuan, Feaster, Shawn R., Chidebelu-Eze, Chibueze O., Kaylor, Rosann M.
• Primary Examiner(s): Cook; Lisa V
• Application Number:
  US12/570,713
• Publication Number:
  US 20100015658A1
• Time in Patent Office: 419 Days
• Field of Search: None
• US Class Current: 435/7.21
• 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 method for detecting the presence of an analyte within a test sample, comprising:

placing a first end of a sample meter in contact with the test sample and absorbing at least a portion of the test sample with the sample meter;

filtering the absorbed test sample with a filtering section of the sample meter that is adjacent to the first end of the sample meter;

storing the filtered test sample that passes through the filtering section in a storage section that is adjacent to the filtering section in the sample meter;

inserting the sample meter through an opening in a housing of an assay device after the meter has been used for absorption, filtering, and storage of the test sample, the housing including a membrane disposed therein having a detection region and a collection region;

said insertion step causing the storage section of the sample meter to be disposed in fluid communication with the collection region of the membrane such that the filtered test sample is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region; and

cutting or scoring the sample meter along the storage section so as to present a desired length of the storage section to the collection region of the membrane.

2. The diagnostic test method of claim 1, wherein a plurality of detection probes within the detection region produce a detectable signal upon the presence of the analyte in the filtered test sample.

3. The diagnostic test method of claim 2, wherein a receptive material immobilized within the detection region binds to the detection probes or conjugates thereof.

4. The diagnostic test method of claim 1, wherein the sample meter includes a separation membrane attached to a storage membrane with an overlap between said separation and storage membranes in said filtering section, the separation and storage membranes attached to a sufficiently transparent backing strip so as to view the presence of filtered test sample in the storage section through the backing strip.

5. The diagnostic test method of claim 1, further comprising introducing a diluent to the collection region subsequent to insertion of the sample meter into the housing.

6. The diagnostic test method of claim 5, wherein the diluent is stored in a rupturable container within the housing and is introduced by rupturing the container subsequent to insertion of the sample meter into the housing.

7. The diagnostic test method of claim 5, wherein the diluent is supplied from an external source through a port in the housing.

8. The diagnostic test method of claim 1, wherein the sample meter is cut or scored with a finger actuated member configured with the housing having blades positioned to cut or score the sample meter.

9. The diagnostic test method of claim 1, wherein the method is for detecting the presence of an analyte within a blood test sample.

10. The diagnostic test method of claim 1, wherein the sample meter is a blood sample meter, and further comprising filtering red blood cell components from the blood test sample with the filtering section of the sample meter strip and storing plasma or serum in the filtering section of the sample meter strip for subsequent transfer to the collection region of the membrane upon insertion of the blood sample meter into the housing.