Multiplanar lateral flow assay with sample compressor

• US 8,609,433 B2
• Filed: 12/02/2010
• Issued: 12/17/2013
• 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): Haq, Shafiqul
• Assistant Examiner(s): Hollinden, Gary E
• Application Number:
  US12/958,454
• Publication Number:
  US 20110136258A1
• Time in Patent Office: 1,111 Days
• Field of Search: 436/513, 436/514, 436/525, 436/807
• US Class Current: 436/513
• 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 an analyte in a sample comprising:

a sample compressor comprising a pad;

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

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 analyte and a label;

a second binding partner for the analyte;

a first 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 control binding partner is a binding partner for the second control binding partner

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.

2. The lateral flow device of claim 1, 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.

3. The lateral flow device of claim 2, wherein the conjugate is located on the pad and the second binding partner is located on an external medium.

4. The lateral flow device of claim 2, wherein the second binding partner is located on the pad and the conjugate is located on an external medium.

5. 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.

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

7. 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.

8. The lateral flow device of claim 1 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.

9. The lateral flow device of claim 1 further comprising a housing surrounding at least a portion of the lateral flow chromatographic test strip, wherein an insertable cartridge forms the sample compressor.

10. A method of applying a sample to a lateral flow chromatographic test strip of a lateral flow device, 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 comprising a pad and a sample application zone of the lateral flow chromatographic test strip; and

b) applying a pressure to the sample collection portion using the sample compressor to transfer at least a portion of the sample to the sample application zone;

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

wherein a control zone on the lateral flow chromatographic test strip comprises a second control binding partner immobilized in the control zone, wherein the first control binding partner is a binding partner for the second control binding partner.

11. The method of claim 10, wherein the pad of the sample compressor further comprises a component selected from the group consisting of a first binding partner for the analyte, a second binding partner for the analyte and both the first binding partner for the analyte and the second binding partner for the analyte.

12. The method of claim 10, wherein the sample collector delivers the sample passively by contact or through pressure onto the test strip prior to applying the sample compressor to the vertical stack.

13. The method of claim 10, wherein step a) further comprises placing a pad with a binding partner for an analyte on the vertical stack and wherein in step b) at least a portion of the binding partner is transferred to the sample application zone.

14. The method of claim 10, wherein step b) occurs without capillary flow.

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

a sample compressor comprising a sample compressor pad;

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

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 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 are located on an independent pad separate from the test strip, the sample collector, and the sample compressor; and

wherein the sample compressor, the sample collector, and the independent pad form a vertical stack to apply the sample to the lateral flow chromatographic test strip by compression;

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

16. The lateral flow device of claim 15, further comprising a first control binding partner located on the sample compressor pad;

and a control zone on the lateral flow chromatographic test strip comprising a second control binding partner immobilized in the control zone, wherein the first control binding partner is a binding partner for the second control binding partner.

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

a sample compressor comprising a pad;

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

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 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 are located on the pad of the sample compressor;

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.