SYSTEMS, DEVICES AND METHODS FOR A HYDROSCOPIC BASED LATERAL FLOW ASSAY

• US 20160169881A1
• Filed: 12/15/2014
• Published: 06/16/2016
• Est. Priority Date: 12/15/2014
• Status: Active Grant

• Current Assignee: Church & Dwight Company Incorporated
• Original Assignee: Church & Dwight Company Incorporated
• Inventors: Nazareth, Albert, Li, Shang, Snowden, Timothy, Sanders, Giles H.W., Cass, Anthony
• Granted Patent: US 10,001,449 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G01N 27/02 by investigating impedance
• CPC Class Codes: G01N 33/5438 Electrodes
• 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

Abstract

Systems, methods, and test kits for detecting and quantifying an analyte level in a biological fluid sample using impedance measurements, are disclosed. The fluid sample is applied to a lateral flow strip, and impedance of the strip is measured as the assay dries. Analysis of the drying-dependent impedance measurements indicates the presence and quantity of the analyte in the fluid sample.

Claims

1. A device for detecting an analyte in a fluid sample, the device comprising:

a strip comprising;

a sample receiving region configured to receive the fluid sample;

a capture region; and

a non-capture region;

wherein the strip is configured such that when a fluid sample is applied to the sample receiving region, the fluid sample flows laterally to the capture region and the non-capture region;

a plurality of electrodes at least partially aligned with the capture region;

a plurality of electrodes at least partially aligned with the non-capture region; and

an electronic circuit comprising a processor coupled to the electrodes, the processor configured to execute a set of instructions to perform a method for detecting the analyte in the fluid sample, the method comprising;

measuring a drying-dependent impedance difference between the capture region and the non-capture region.

2. The device of claim 1, the measuring comprising:

measuring the drying-dependent impedance difference over a drying time period,

wherein the drying time period comprises a length of time sufficient for the impedance difference to reach a maximum.

3. The device of claim 2, the method further comprising:

analyzing the impedance difference over the drying time period; and

determining whether the analyte is present in the fluid sample based in part on the analysis of the impedance;

difference.

4. The device of claim 3, wherein measuring the drying-dependent impedance difference between the capture region and the non-capture region comprises:

measuring a first impedance of the capture region;

measuring a second impedance of the non-capture region; and

determining a first impedance difference based on subtracting the first impedance from the second impedance.

5. The device of claim 2, wherein the method further comprises:

measuring the impedance difference over a range of frequencies.

6. The device of claim 1, further comprising:

a mechanism for drying the capture region and the non-capture region.

7. The device of claim 1, wherein at least two of the electrodes are positioned along the capture region.

8. The device of claim 1, wherein at least two of the electrodes are positioned along the non-capture region.

9. The device of claim 1, wherein at least two of the electrodes are positioned across the capture region.

10. The device of claim 1, wherein at least two of the electrodes are positioned across the non-capture region.

11. The device of claim 1, the strip further comprising:

a first antibody region comprising a first antibody that recognizes an epitope of the analyte; and

a second antibody region comprising a second antibody that recognizes a different epitope of the analyte.

12. The device of claim 11, wherein the first antibody is bound to a first label, and wherein the second antibody is bound to a second label.

13. The device of claim 1, the strip further comprising a release medium a capture medium, an absorbent medium and a backing.

14. The device of claim 13, wherein the release medium comprises:

the sample receiving region;

a first antibody region comprising a first antibody that recognizes an epitope of the analyte; and

a second antibody region comprising a second antibody that recognizes a different epitope of the analyte.

15. The device of claim 2, further comprising:

a control region of the strip, wherein the strip is further configured such that when a fluid sample is applied to the sample receiving region, the fluid sample flows laterally to the control region;

a plurality of electrodes at least partially aligned with the control region, and

wherein the method further comprises measuring impedances of the control region over the drying time period.

16. A method for detecting an analyte in a fluid sample, the method comprising:

applying a fluid sample to a strip, wherein the strip is configured such that the fluid sample flows laterally to a capture region and a non-capture region of the strip; and

measuring a drying-dependent impedance difference between the capture region and the non-capture region.

17. The method of claim 16, further comprising:

measuring the drying-dependent impedance difference over a drying time period,

wherein the drying time period comprises a length of time sufficient for the impedance difference to reach a maximum.

18. The method of claim 17, further comprising:

analyzing the impedance difference over the drying time period; and

determining whether the analyte is present in the fluid sample based in part on the analysis of the impedance difference.

19. The method of claim 18, wherein measuring the drying-dependent impedance difference between the capture region and the non-capture region comprises:

measuring a first impedance of the capture region;

measuring a second impedance of the non-capture region; and

determining a first impedance difference by subtracting the first impedance from the second impedance.

20. The method of claim 17, wherein measuring the drying-dependent impedance difference over a drying time period comprises:

calculating drying rates of the capture and non-capture regions.

21. The method of claim 17, further comprising:

measuring the impedance difference over a range of frequencies.