ASSAY DEVICE AND METHOD OF ASSAYING

• US 20130052748A1
• Filed: 08/30/2011
• Published: 02/28/2013
• Est. Priority Date: 08/30/2011
• Status: Abandoned Application

• Current Assignee: Supernova Diagnostics Incorporated (Jupiter Diagnostics Holding Co. Ltd.)
• Original Assignee: Supernova Diagnostics Incorporated (Jupiter Diagnostics Holding Co. Ltd.)
• Inventors: Campbell, Neil J., Moravick, Keith Edward, Richardson, Bruce J.
• Application Number:
  US13/221,381
• Publication Number:
  US 20130052748A1
• Time in Patent Office: Days
• US Class Current: 436/501
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/53 Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/54389 with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

A device for testing an analyte comprises a pathway allowing passage of analyte from an application zone to a waste zone. The device includes label material that emits or modifies light and which binds to the analyte. Between the application and waste zones there is a capture zone having capture material for binding any analyte traversing the pathway to the pathway. A first optical filter on one surface of the device allows transmission of light emitted or modified by the label and blocks light of at least one other wavelength range. This enables the device to be illuminated from one surface and light emitted or modified by the label to be detected from the opposite surface. The device may include a second filter allowing shorter wavelength light to reach the label. The device may be viewed using an illuminating reader or held up to a light source for viewing.

Claims

1. An assay device for enabling a test to be performed on an analyte, the device having an application zone for application of a quantity of the analyte, a waste zone, and a pathway for allowing passage of the analyte from the application zone to the waste zone, the device including a quantity of a label material which will emit or modify light at least when activated and which will bind to the analyte, the pathway also including a capture zone located between the application zone and the waste zone that has a quantity of capture material which is bound to the pathway and which will bind to analyte that passes along the pathway so that the analyte will be bound to the pathway, the device having a first optical filter on a side thereof for allowing transmission of light emitted or modified by the label material and for blocking light of at least one other wavelength range in order to enable the device to be illuminated from one side thereof and for light emitted or modified by the label material located in the pathway to be detected from the opposite side thereof.

2. A device as claimed in claim 1, which includes a second optical filter located on the side thereof that will be illuminated, which second filter has a different optical transmission characteristic from that of the first optical filter.

3. A device as claimed in claim 2, wherein the second optical filter will allow transmission of light of shorter wavelength than light transmitted by the first optical filter.

4. A device as claimed in claim 3, wherein the label material is a fluorescent or phosphorescent material or a precursor thereof, and the first optical filter will allow transmission of light only after modification by the label material.

5. A device as claimed in claim 1, wherein the first optical filter will allow transmission of light of different wavelengths that correspond to light emitted or modified by different label materials.

6. A device as claimed in claim 1, which includes a plurality of different filters that are located at different positions on the pathway.

7. A device as claimed in claim 1, which includes a plurality of pathways for passage of different analytes.

8. A device as claimed in claim 7, which includes a plurality of different filters for allowing transmission of light emitted or modified by the label material, each such filter being associated with a different pathway.

9. A device as claimed in claim 1, wherein the label material is held in a label zone that is located between the application zone and the capture zone.

10. A device as claimed in claim 1, which includes a process control zone located between the capture zone and the waste zone to enable visual inspection of the pathway at the process control zone in order to determine the extend of passage of the sample.

11. A device as claimed in claim 1, which includes a reservoir of a carrier for enabling the sample to pass along the pathway to the waste zone.

12. A device as claimed in claim 11, wherein the reservoir is manually rupturable.

13. A device as claimed in claim 12, wherein the reservoir is in the form of a bladder, blister pack or sachet.

14. A device as claimed in claim 1, which includes an additional pathway for receiving a control sample and allowing the control sample to pass to the capture zone.

15. A device as claimed in claim 1, which includes a plurality of pathways extending generally in parallel with one another from an application zone to a waste zone, the pathways containing different capture materials to enable a test to be performed on a plurality of different samples.

16. A device as claimed in claim 1, which is arranged for enabling a lateral flow or microfluidic test to be performed on the analyte.

17. An arrangement for performing an assay, which comprises a device as claimed in claim 1 and a reader for detecting an output from the device, which comprises a body having an orifice that is capable of receiving the assay device, a light source for illuminating the device from one side thereof once it has been received in the reader, a terminal for receiving a power source for the light source, an optical detector located in the body on the opposite side of the orifice for detecting light that has been emitted by the device, and a detector for detecting the optical power of light detected by the optical detector.

18. An arrangement as claimed in claim 17, wherein the reader includes a display for displaying data defining the optical power of light detected by the optical detector or relating to absorption of light by material in the device.

19. An arrangement as claimed in claim 17, wherein the reader includes a protuberance that will cause a stress to be applied to part of the device when the device is inserted into the slot.

20. An arrangement as claimed in claim 17, which includes a plurality of optical detectors for detecting light from the light source that has passed through a cartridge inserted in the slot, the optical detectors being located at different positions in the body of the reader.

21. A method of performing a test on an analyte, by means of an assay device having an application zone for application of the analyte, a waste zone, and a pathway for allowing passage of the analyte from the application zone to the waste zone, the pathway also including a capture zone located between the application zone and the waste zone that has a quantity of capture material which is bound to the pathway and which will bind to any analyte, which method comprises:

applying a quantity of the analyte to the application zone and allowing the analyte to pass along the pathway to and beyond a capture zone where the pathway includes a quantity of capture material which will bind the analyte to the pathway,

causing the analyte to contact a quantity of a label material (either before or after it has reached the capture zone) which will emit or modify light at least when activated and which will bind to the analyte so that the analyte and label material will be bound to the pathway at the capture zone;

applying a quantity of a wash to the application zone in order to cause excess analyte and label material to flow along the pathway to the waste zone; and

illuminating one side of the assay device and detecting light that is emitted or modified by the label material from the opposite side of the device, the said opposite side of the device including an optical filter for allowing transmission of light emitted or modified by the label material and for blocking light of at least one other wavelength so that detection of the light will indicate the presence or quantity of the analyte.

22. A method as claimed in claim 21, wherein the assay device includes the label material before commencement of the method.

23. A method as claimed in claim 22, wherein the label material has been provided during manufacture of the assay device.

24. A method as claimed in claim 21, wherein the pathway includes the label material in a zone between the application zone and the capture zone so that the label material will be associated with the label material as it passes along the pathway to the capture zone.

25. A method as claimed in claim 21 which includes the step of applying a quantity of the label material to the device.

26. A method as claimed in claim 21, which is a lateral flow or microfluidic test.

27. A method as claimed in claim 21, which comprises inserting the device into a reader for detecting an output from the device, the reader comprising a body having a slot that is capable of receiving the assay device, a light source for illuminating the device from one side thereof once it has been received in the reader, an optical detector located in the body on the opposite side of the slot for detecting light that has been emitted by the device, and an arrangement for detecting the optical power of light detected by the optical detector.

28. A method as claimed in claim 21, which comprises illuminating the device with white light on one surface thereof and observing the opposite surface to determine the presence or quantity of analyte from the label material.

29. A method as claimed in claim 28, wherein the label material comprises a fluorescent or phosphorescent material.

30. A method as claimed in claim 28, which comprises determining positions on the pathway where light has been absorbed by the label material.