Multiplanar lateral flow assay with sample compressor

• US 9,939,434 B2
• Filed: 03/17/2014
• Issued: 04/10/2018
• Est. Priority Date: 12/04/2009
• Status: Active Grant

• Current Assignee: Rapid Pathogen Screening, Inc
• Original Assignee: Rapid Pathogen Screening, Inc
• Inventors: Sambursky, Robert P., Babu, Uma Mahesh, VanDine, Robert W., Kanaujia, Ganga V., Orsini, Thomas
• Primary Examiner(s): Long, Scott
• Assistant Examiner(s): Hollinden, Gary E
• Application Number:
  US14/215,602
• Publication Number:
  US 20140199710A1
• Time in Patent Office: 1,485 Days
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2400/0633 with moving parts
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/543 with an insoluble carrier for immobilising immunochemicals
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• 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: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

A sample compressor applies pressure to a sample collector and a sample application zone of a test strip to transfer a sample from the sample collector and a binding partner of an analyte to the sample application zone in a lateral flow device. At least one of the binding partners of the analyte is not located on the test strip prior to use of the lateral flow device. The test strip may be a universal test strip with no molecule that specifically binds the analyte is located on the test strip. The sample compressor may be a universal sample compressor also with no molecule that specifically binds the analyte on the sample compressor. The lateral flow device may also include one or more enhancement elements, where the enhancement elements bind to the analyte sandwich to increase a detection signal in the test zone.

Claims

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

a sample compressor comprising a pad with a first mobile control binding partner and a first analyte binding partner on the pad, wherein the first analyte binding partner binds the target analyte;

a lateral flow chromatographic test strip comprising a control zone comprising a second control binding partner immobilized in the control zone, wherein the first mobile control binding partner is a binding partner for the second control binding partner and a positive result in the control zone indicates that an assay on the lateral flow device has been run correctly;

wherein the first mobile control binding partner and the second control binding partner do not bind to the target analyte.

2. The lateral flow device of claim 1, further comprising a sample collector comprising a sample collection portion for collection of a sample.

3. The lateral flow device of claim 2, wherein the sample compressor, the sample collector, and the lateral flow chromatographic test strip form a vertical stack to apply the sample to the lateral flow chromatographic test strip by compression;

and

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

15. The method of claim 1, wherein the first mobile control binding partner is chicken IgY conjugated to latex beads and the second control binding partner is immobilized rabbit anti-chicken IgY.

18. The device of claim 1, wherein the sample compressor further comprises a ledge portion connected to the pad, an extended portion extending from the ledge portion and a handle extending from the extended portion in a direction away from the pad.

4. A lateral flow device for detecting a target analyte in a sample comprising:

a sample compressor comprising a pad;

a lateral flow chromatographic test strip comprising a sample application zone and a test zone laterally downstream from the sample application zone;

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

a second binding partner for the target analyte;

a first mobile control binding partner located on the pad of the sample compressor; and

the lateral flow chromatographic test strip further comprising a control zone comprising a second control binding partner immobilized in the control zone, wherein the first mobile control binding partner is a binding partner for the second control binding partner;

wherein the conjugate, the second binding partner, or both the conjugate and the second binding partner are located on the pad of the sample compressor prior to use of the lateral flow device; and

wherein the first mobile control binding partner and the second control binding partner do not bind to the target analyte.

5. The lateral flow device of claim 4, further comprising a sample collector comprising a sample collection portion for collection of the sample.

6. The lateral flow device of claim 5, wherein the sample compressor, the sample collector, and the lateral flow chromatographic test strip form a vertical stack to apply the sample to the lateral flow chromatographic test strip by compression;

and

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

7. The lateral flow device of claim 4, wherein the conjugate is located on the pad and the second binding partner is located on an external medium.

8. The lateral flow device of claim 4, wherein the second binding partner is located on the pad and the conjugate is located on an external medium.

9. The lateral flow device of claim 4, wherein the lateral flow device is formed such that a positive result is only achieved by capture of the target analyte in the test zone through formation of a complex between the target analyte, the first binding partner, and the second binding partner.

10. The lateral flow device of claim 4, wherein the target analyte does not bind directly to an immobilized binding partner in the test zone.

11. The lateral flow device of claim 4, wherein the second binding partner comprises a tag and the test zone comprises an immobilized binding partner of the tag.

12. The lateral flow device of claim 4, further comprising a housing surrounding at least a portion of the lateral flow chromatographic test strip, wherein a rotatable portion of the housing forms the sample compressor.

13. The lateral flow device of claim 4, further comprising a housing surrounding at least a portion of the lateral flow chromatographic test strip, wherein an insertable cartridge forms the sample compressor.

16. The method of claim 4, wherein the first mobile control binding partner is chicken IgY conjugated to latex beads and the second control binding partner is immobilized rabbit anti-chicken IgY.

14. A method of ensuring proper operation of a lateral flow device for detecting a target analyte, comprising a sample compressor comprising a pad and a first mobile control binding partner on the pad;

and a lateral flow chromatographic test strip comprising a control zone comprising a second control binding partner immobilized in the control zone, wherein the first mobile control binding partner is a binding partner for the second control binding partner, comprising the step of;

a) running an assay on the lateral flow device such that the sample compressor exerts pressure to transfer the first mobile control binding partner to the lateral flow chromatographic test strip, and a positive result in the control zone indicates that the assay on the lateral flow device has been run correctly;

wherein the first mobile control binding partner and the second control binding partner do not bind to the target analyte.

17. The method of claim 14, wherein the first mobile control binding partner is chicken IgY conjugated to latex beads and the second control binding partner is immobilized rabbit anti-chicken IgY.