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1. WO2020141525 - CAPTURE FLOW ASSAY DEVICE AND METHODS

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[ EN ]

CLAIMS

What is claimed is:

1. A device comprising a section 1, a section 2, a section 3 and a section 4, wherein: a. said section 2 is coupled to said section 1 ;

b. said section 3 is coupled to said section 2 and to said section 4, said section 3 comprises a surface functionalized with an analyte or equivalent thereof; and c. sections 1 to 4 are arranged along a horizontal axis and in fluid communication allowing lateral flow of fluid from said section 1 through said section 2 and said section 3 to section 4.

2. The device of claim 1, wherein

(i) said section 1 comprises a sample collecting surface;

(ii) said section 2 comprises a surface comprising a recognition molecule having specific affinity to said analyte, wherein said recognition molecule is linked to a reporter molecule, and wherein said reporter molecule generates a trigger; and

(iii) said section 4 comprises a surface in contact with a substrate molecule generating a signal in response to said trigger.

3. The device of any one of claims 1 or 2, further comprising a calibration area disposed between section 2 and section 3, wherein said calibration area comprises a surface in contact with said substrate molecule.

4. The device of any one of claims 1 to 3, further comprising a section 5 coupled to said section 4 and in fluid communication with said section 4.

5. The device of any one of claims 1 to 4, wherein said coupled is in contact or partially overlapping.

6. The device of any one of claims 1 to 5, wherein said trigger comprises at least one of: a reactive compound, electromagnetic radiation, and a charged particle or a combination thereof.

7. The device of any one of claims 1 to 6, wherein said section 3 is devoid of said recognition molecule and said reporter molecule.

8. The device of any one of claims 1 to 7, wherein the concentration of said recognition molecule in section 2 and said analyte in section 3 is in the range of 0.01 mg/mL to 100 mg/mL.

9. The device of any one of claims 1 to 8, wherein said reporter molecule is selected from an enzyme, luminescent compound, fluorescent compound, magnetic particle, electrochemically active compound.

10. The device of any one of claims 1 to 9, wherein at least three sections are disposed along one or more planes.

11. The device of claim 10, wherein two consecutive sections are disposed along one or more planes.

12. The device of any one of claims 1 to 9, wherein all of said sections are disposed along the same plane.

13. The device of any one of claims 1 tol2, wherein said overlapping is in the range of 0.01% to 99% of the total surface of said section.

14. The device of any one of claims 1 to 13, further comprising a detection unit in operable communication with said device, and wherein said detection unit is configured to detect said signal.

15. The device of claim 14, wherein said detection unit comprises an element selected form the group consisting of an active-pixel sensor (APS), an electrode, an excitation source with active-pixel sensor, or any combination thereof.

16. The device of any one of claims 1 to 13, wherein said analyte or equivalent thereof is selected from virus, proteins, biological cells, toxins and pathogens, pharmaceuticals and drugs.

17. The device of any one of claims 1 to 14, wherein said sample is selected from water, blood, urine, sweat, saliva, and serum.

18. A method for determining the presence of an analyte in a sample, comprising:

a. contacting a sample with a device of any one of claims 1 to 17; and

b. detecting the presence of a signal,

thereby determining the presence of said analyte in a sample.

19. The method of claim 18 for quantifying the amount of an analyte in a sample, further comprising:

(i) quantifying the amount of said signal in calibration area; and

(ii) correlating the signal intensity data from calibration area with signal intensity data from section 4.

20. The method of anyone of claims 18 and 19 for diagnosing an infectious disease.

21. A kit, comprising:

(i) a section 1, a section 2, a section 3, and a section 4;

(ii) an analyte or equivalent thereof;

(iii) a recognition molecule having specific affinity to said analyte linked to a reporter molecule, wherein said reporter molecule generates a chemically and/or electrically and/or a physically detectable reaction; and

(iv) a substrate molecule reacting in the presence of said reporter molecule.

22. The kit of claim 21, further comprising instructions for depositing said section 2 with said reporter molecule, said section 3 with said analyte and said section 4 with said substrate molecule.

23. A kit, comprising:

(i) a section 1 comprising a sample collecting surface,

(ii) section 2, comprising a surface deposited with a recognition molecule having specific affinity to said analyte linked to a reporter molecule, wherein said reporter molecule generates a chemically and/or electrically and/or a physically detectable reaction;

(iii) a section 3 functionalized with said analyte; and

(iv) a section 4 comprising a surface deposited with a substrate molecule;

(v) a section 5 comprising a surface available for holding excess sample.

24. The kit of any one of claims 22 to 23, further comprising a calibration area.

25. The kit of claim 24, further comprising instructions for arranging section 1, section 2, calibration area, section 3, section 4 and section 5 along a horizontal axis and in fluid communication allowing lateral flow from section 1 throughout all sections to section 5.

26. The kit of any one of claims 22 to 25, further comprising a sample collecting instrument.

27. The kit of anyone of claims 22 to 26, comprising at least two sections 4 each one of them comprising different substrate molecules.

28. The kit of claim 27, wherein at least one of said substrate molecules comprises an active-pixel sensor (APS), an electrode or an excitation device with an active-pixel sensor (APS).

29. The kit of any one of claims 22 to 28, for diagnosing an infectious disease.