Multiplanar lateral flow assay with diverting zone

• US 8,815,609 B2
• Filed: 03/07/2013
• Issued: 08/26/2014
• Est. Priority Date: 05/20/2008
• Status: Active Grant

• Current Assignee: Rapid Pathogen Screening, Inc
• Original Assignee: Rapid Pathogen Screening, Inc
• Inventors: Babu, Uma Mahesh, Sambursky, Robert P., Condon, Peter, VanDine, Robert W.
• Primary Examiner(s): Chin, Chris L
• Application Number:
  US13/788,616
• Publication Number:
  US 20130230846A1
• Time in Patent Office: 537 Days
• Field of Search: None
• US Class Current: 436/514
• CPC Class Codes: B01J 2219/00576 fluorophore
• CPC Class Codes: B01J 2219/00648 by the use of solid beads
• CPC Class Codes: B01J 2219/00725 Peptides
• CPC Class Codes: B01J 2219/0074 Biological products
• CPC Class Codes: B01J 2219/00743 Cells
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0633 with moving parts
• CPC Class Codes: B01L 2400/0677 phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• 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 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A lateral flow device includes a sample compressor and a test strip comprising a diverting zone. The diverting zone, which may include a barrier and/or a gap or ditch, stops or impedes flow. Flow is reinitiated and diverted into an alternate plane by compression of a sample compressor. Flow returns to the original, lateral plane, at the end of the diverting zone.

Claims

1. A lateral flow device for detecting an analyte in a sample comprising:

a sample compressor;

a test strip comprising a test zone and a diverting zone upstream of the test zone, wherein the diverting zone interrupts lateral flow on the test strip;

a conjugate comprising a first binding partner for the analyte and a label; and

a second binding partner for the analyte; and

a sample application zone where sample is applied to the lateral flow device, wherein the sample application zone is located in a location selected from the group consisting of;

i) on the test strip upstream of the detection zone;

ii) on the sample compressor; and

iii) on a sample collector comprising a sample collection portion for collection of the sample;

wherein a component selected from the group consisting of the conjugate, the second binding partner and both the conjugate and the second binding partner is not located on the test strip prior to use of the lateral flow device; and

wherein the sample compressor creates a bridge over the diverting zone to divert flow onto the sample compressor and return flow to the test strip at the end of the diverting zone.

2. The lateral flow device of claim 1, wherein, when the sample application zone is on a sample collector, the sample collector is located between the sample compressor and the test strip in a vertical stack.

3. The lateral flow device of claim 1, wherein the diverting zone comprises a physical barrier that stops or delays flow in a lateral direction on the test strip.

4. The lateral flow device of claim 3, wherein the physical barrier comprises encapsulated components, and the physical barrier dissolves upon application of an elution medium.

5. The lateral flow device of claim 1, wherein the diverting zone comprises a chemical barrier that stops or delays flow in a lateral direction on the test strip.

6. The lateral flow device of claim 1, wherein the diverting zone comprises a gap that stops flow in a lateral direction on the test strip.

7. The lateral flow device of claim 1, wherein the sample compressor comprises a pad and wherein the conjugate or the second binding partner is located on the pad prior to use of the lateral flow device.

8. The lateral flow device of claim 1 wherein the sample compressor comprises a pad comprising a first control binding partner located on the pad and a second control binding partner is immobilized in a control zone of the test strip, wherein the first control binding partner is a binding partner for the second control binding partner.

9. The lateral flow device of claim 1, wherein the lateral flow device is formed such that a positive result is only achieved by capture of the analyte in the test zone through formation of a complex between the analyte, the first binding partner, and the second binding partner.

10. The lateral flow device of claim 1, wherein the test zone comprises no molecule which specifically binds the analyte.

11. The lateral flow device of claim 1, wherein the second binding partner comprises a tag and the test zone comprises an immobilized binding partner of the tag.

12. A method of running an assay of a sample on a lateral flow device comprising a test strip and a sample compressor, the method comprising the steps of:

a) placing a sample on the lateral flow device;

b) interrupting lateral flow on the test strip by including a diverting zone on the test strip;

c) diverting the interrupted flow to the sample compressor by applying a pressure to the device using the sample compressor; and

d) returning the flow to the test strip at the end of the diverting zone.

13. The method of claim 12, wherein, in step a), the sample is placed onto a sample application zone located in a location selected from the group consisting of:

i) on the test strip upstream of a detection zone;

ii) on the sample compressor; and

iii) on a sample collector comprising a sample collection portion for collection of the sample.

14. The method of claim 13, wherein, when the sample is placed on a sample collector, the sample collector is located between the sample compressor and the test strip in a vertical stack.

15. The method of claim 14, wherein step a) further comprises placing a pad with a binding partner for an analyte on the vertical stack and wherein in step d) at least a portion of the binding partner is transferred to the test strip.

16. The method of claim 12, wherein the diverting zone comprises a physical barrier that stops or delays flow in a lateral direction on the test strip.

17. The method of claim 16, wherein the physical barrier comprises at least one encapsulated component, further comprising the step of dissolving the physical barrier to release the encapsulated component.

18. The method of claim 12, wherein the diverting zone comprises a gap that stops flow in a lateral direction on the test strip.

19. The method of claim 12, wherein the sample compressor comprises a component selected from the group consisting of a first binding partner, a second binding partner and both the first binding partner and the second binding partner.

20. A lateral flow device for detecting an analyte in a sample comprising:

a sample compressor;

a sample collector comprising a sample collection portion for collection of the sample;

a test strip comprising a sample application zone, a test zone and a diverting zone, wherein the diverting zone interrupts lateral flow on the test strip;

a conjugate comprising a first binding partner for the analyte and a label; and

a second binding partner for the analyte;

wherein a component selected from the group consisting of the conjugate, the second binding partner and both the conjugate and the second binding partner is not located on the test strip prior to use of the lateral flow device;

wherein the sample compressor, the sample collector, and the test strip form a vertical stack to apply the sample to the test strip by compression;

wherein the sample compressor reinitiates flow by creating a bridge over the diverting zone and diverting flow onto the sample compressor and returning flow to the test strip at the end of the diverting zone; and

wherein the sample collector is located between the sample compressor and the test strip in the vertical stack.

21. A method of running an assay of a sample on a lateral flow device comprising a test strip, the method comprising the steps of:

a) placing a sample collector comprising a sample collection portion with the sample in a vertical stack between a sample compressor and a sample application zone of the test strip;

b) interrupting lateral flow on the test strip by including a diverting zone on the test strip;

c) diverting the interrupted flow to the sample compressor by applying a pressure to the vertical stack using the sample compressor; and

d) returning the flow to the test strip at the end of the diverting zone.