Metering technique for lateral flow assay devices

• US 7,790,471 B2
• Filed: 10/05/2007
• Issued: 09/07/2010
• Est. Priority Date: 12/13/2005
• 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, Song, Xuedong, Feaster, Shawn R., Takeuchi, James M.
• Primary Examiner(s): Gabel; Gailene R
• Assistant Examiner(s): DIRAMIO, JACQUELINE A
• Application Number:
  US11/867,788
• Publication Number:
  US 20080026484A1
• Time in Patent Office: 1,068 Days
• Field of Search: 422 55- 57, 422/61, 422/68.1, 422/100, 422/101, 435/4, 435/7.1, 435/286.4, 435/286.5, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/288.5, 435/288.7, 436/501, 436/518, 436/17, 436/18, 436/825
• US Class Current: 436/518
• 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
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/25625 Dilution

Abstract

A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Claims

1. A method for performing a lateral flow assay, the method comprising:

providing a sampling membrane with a receiving region, a collection region and a detection region;

defining a barrier between the collection region and the detection region so that the collection region has a known saturation volume that is less than about 100 microliters;

supplying a test sample to a receiving region of the membrane and saturating the collection region with the test sample so that a known volume of the test sample is contained in the collection region that corresponds to the known saturation volume of the collection region;

removing the barrier between the collection region and detection region of the membrane;

supplying a diluent to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane; and

defining the collection region by separating the collection region from the receiving region prior to supplying the diluent to the collection region.

2. The method of claim 1, wherein the barrier is defined by a soluble composition in a defined band across the width of the membrane, the soluble composition present throughout the membrane in an amount to prevent migration of the test sample from the collection region to the detection region of the membrane, and further comprising dissolving the soluble composition with the diluent.

3. The method of claim 1, wherein the barrier is defined by a separation in the membrane, said step of removing the barrier comprising forming a bridge across the divide so that the test sample flows from the collection region to the detection region with the diluent.

4. The method of claim 3, wherein the test sample is whole blood, the bridge also functioning as a blood separation filter.

5. The method of claim 1, wherein the collection region is separated from the receiving region by scoring or cutting the membrane along a line that defines the collection region.

6. The method of claim 1, wherein the test sample is whole blood, and further comprising separating plasma, serum, or both from the whole blood for analysis.

7. The method of claim 1, wherein the test sample is conveyed to the collection region by defining a channel in the membrane.

8. The method of claim 7, wherein a sampling tip is formed at an end of the channel, and further comprising placing the tip adjacent to the skin of a user for receipt of a test sample of blood.

9. The method of claim 7, further comprising separating the channel from the collection region prior to supplying the diluent to the collection region.

10. The method of claim 7, wherein the channel is formed using one of a laser ablation or solvent microfabrication technique that renders at least a portion of the channel essentially non-conductive to the test sample.

11. The method of claim 7, further comprising laminating the membrane to a support, and defining a bottom surface of the channel with the support.

12. The method of claim 7, further comprising treating the channel with a hydrophobic agent.

13. A method for performing a lateral flow assay, the method comprising:

providing a sampling membrane with a collection region and a detection region;

conveying a test sample to the collection region by defining a channel in the membrane;

defining a barrier between the collection region and the detection region so that the collection region has a known saturation volume that is less than about 100 microliters;

saturating the collection region with a test sample so that a known volume of the test sample is contained in the collection region that corresponds to the known saturation volume of the collection region;

removing the barrier between the collection region and detection region of the membrane;

supplying a diluent to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane; and

separating the channel from the collection region prior to supplying the diluent to the collection region.

14. The method of claim 13, wherein the barrier is defined by a soluble composition in a defined band across the width of the membrane, the soluble composition present throughout the membrane in an amount to prevent migration of the test sample from the collection region to the detection region of the membrane, and further comprising dissolving the soluble composition with the diluent.

15. The method of claim 13, wherein the barrier is defined by a separation in the membrane, said step of removing the barrier comprising forming a bridge across the divide so that the test sample flows from the collection region to the detection region with the diluent.

16. The method of claim 15, wherein the test sample is whole blood, the bridging member also functioning as a blood separation filter.

17. The method claim 13, wherein the collection region is separated from the receiving region by scoring or cutting the membrane along a line that defines the collection region.

18. The method of claim 13, wherein the test sample is whole blood, and further comprising separating plasma, serum, or both from the whole blood for analysis.

19. The method of claim 13, wherein a sampling tip is formed at an end of the channel, and further comprising placing the tip adjacent to the skin of a user for receipt of a test sample of blood.

20. The method of claim 13, wherein the channel is formed using one of a laser ablation or solvent microfabrication technique that renders at least a portion of the channel essentially non-conductive to the test sample.

21. The method of claim 13, further comprising laminating the membrane to a support, and defining a bottom surface of the channel with the support.

22. The method of claim 13, further comprising treating the channel with a hydrophobic agent.