Device platform for point of care testing

• US 10,620,198 B2
• Filed: 08/29/2017
• Issued: 04/14/2020
• Est. Priority Date: 09/09/2016
• Status: Active Grant

• Current Assignee: Invitron Limited
• Original Assignee: Invitron Limited
• Inventors: Woodhead, Andrew James, Woodhead, James Stuart
• Primary Examiner(s): Whatley, Benjamin R
• Assistant Examiner(s): Brazin, Jacqueline
• Application Number:
  US16/328,475
• Publication Number:
  US 20190346438A1
• Time in Patent Office: 959 Days
• Field of Search: 422414
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing

Abstract

The invention concerns a cartridge for performing sample analysis in a portable point of care test device (POCT); a point of care assay device, comprising said cartridge and a reader for accommodating said cartridge, for detecting and/or quantifying an analyte in a sample; and a kit of parts comprising the said components of said point of care assay device.

Claims

1. A cartridge for performing sample analysis, comprising a plurality of compartments, wherein

a first compartment comprising at least one reaction chamber for holding a sample and having attached to at least a part of its surface a capture reagent;

a second compartment comprising at least one receptacle for housing at least one reagent, wherein said at least one reagent is in fluid communication with said first compartment; and

a third compartment, integral with said first or second compartment or separate therefrom, comprising an extraction device in fluid and/or operable communication with said at least one reaction chamber for removing said at least one reagent and/or unreacted products from said at least one reaction chamber, wherein said extraction device comprises wicking or absorbent material mounted on a conveyor which is movable in a first direction, to advance said wicking or absorbent material and, in an opposite direction to retract said wicking or absorbent material into or from said at least one reaction chamber.

2. The cartridge according to claim 1, wherein said wicking or absorbent material is mounted on said conveyor in the form of a spool whose circular motion, in a first direction, advances said wicking or absorbent material and whose circular motion, in an opposite direction, retracts said wicking or absorbent material.

3. The cartridge according to claim 1, wherein said conveyor is arranged such that said wicking or absorbent material, when advancing, dips into the at least one reaction chamber and, when retracting, is removed from said at least one reaction chamber.

4. The cartridge according to claim 1, wherein said conveyor is associated with a blade that cuts said wicking or absorbent material.

5. The cartridge according to claim 1, wherein said sample is a biological sample.

6. The cartridge according to claim 1, wherein said capture reagent is a substance or reagent that can bind, reversibly or irreversibly, to a target analyte in said sample.

7. The cartridge according to claim 6, wherein said capture reagent is selected from the group consisting of:

antibodies, aptamers and fragments thereof, oligonucleotides, and other specific ligands or receptors for the target analyte.

8. The cartridge according to claim 1, wherein said capture reagent is bound directly onto at least a part of a surface of the at least one reaction chamber.

9. The cartridge according to claim 1, wherein said capture reagent is bound indirectly onto at least a part of a surface of the at least one reaction chamber by the use of an anchor substance that binds the capture reagent.

10. The cartridge according to claim 9, wherein said anchor substance is selected from the group consisting of:

avidins, oligonucleotides, polynucleotides, proteins and lectins.

11. The cartridge according to claim 10, wherein said anchor substance is avidin and said capture reagent comprises a biotin binding partner, or vice versa.

12. The cartridge according to claim 10, wherein said anchor substance is streptavidin and said capture reagent comprises a biotin binding partner, or vice versa.

13. The cartridge according to claim 1, wherein said at least one reaction chamber is in the form of a well comprising a base wherein said base is coated with the capture reagent and/or an anchor substance.

14. The cartridge according to claim 1, wherein the at least one reaction chamber of said first compartment comprises

a plurality of reaction chambers, or

one reaction chamber in the form of a well to the base of which are attached a plurality of capture reagents each specific for a different target analyte in said sample.

15. The cartridge according to claim 1, wherein the capture reagent and/or an anchor substance are coupled to paramagnetic particles.

16. The cartridge according to claim 1, wherein said second compartment comprises a plurality of receptacles for housing a number of different reagents wherein each receptacle is in fluid communication with the at least one reaction chamber.

17. The cartridge according to claim 1, wherein said cartridge comprises a number of further compartments wherein at least one of said number of further compartments includes at least one receptacle for housing a further reagent wherein said reagent is in fluid communication with said at least one reaction chamber.

18. The cartridge according to claim 1, wherein said at least one reagent of the second compartment is a washing reagent, labelling or labelled reagent, detection reagent, the capture reagent, or a second capture reagent.

19. The cartridge according to claim 18 wherein said at least one reagent is a labelling or labelled reagent, and said labelling or labelled reagent is an enzyme;

a chromophore;

a luminophore;

a modulator of emissions from a fluorescent, phosphorescent, chemiluminescent or bioluminescent molecule or ion;

a co-factor for a chemiluminescent or bioluminescent reaction;

a coloured particle;

a magnetic particle;

ELISA system;

pigmented indicator system;

antibodies;

aptamers and fragments thereof;

or an acridinium ester (AE) molecule.

20. The cartridge according to claim 18, wherein said at least one reagent is a detection reagent and said detection reagent is hydrogen peroxide in acid or an alkaline solution.

21. The cartridge according to claim 16, wherein

at least one of said plurality of receptacles houses a washing reagent, at least one of said plurality of receptacles houses a detection reagent, and at least one of said plurality of receptacles houses a labelling or labelled reagent or capture reagent, or

at least one of said plurality of receptacles houses a washing reagent, at least one of said receptacles houses a first detection reagent, at least one of said receptacles houses a second detection reagent, at least one of said receptacles houses the capture reagent or a second capture reagent, and at least one of said receptacles houses labelling or labelled reagent.

22. The cartridge according to claim 21, wherein the first detection reagent is hydrogen peroxide in acid, the second detection reagent is an alkali solution, the capture reagent is a biotinylated antibody, and the labelling reagent is an AE labelled antibody.

23. The cartridge according to claim 1, wherein

said at least one receptacle includes at least one pump for pumping said reagent into said at least one reaction chamber, and/or

said at least one receptacle includes a valve for controlling the flow of reagent into said at least one reaction chamber.

24. The cartridge according to claim 1, wherein each of said at least one reagent is housed in a sealed pouch contained within the at least one receptacle, said pouch being in close proximity to a conduit leading to the at least one reaction chamber whereby application of pressure to the pouch by an activator causes said pouch to release its contents into the conduit and deliver their contents to the said at least one reaction chamber.

25. The cartridge according to claim 1, wherein said cartridge further comprises a control device that synchronises the flow of reagents to the at least one reaction chamber and the use of said wicking or absorbent material.

26. The cartridge according to claim 1, wherein said cartridge further comprises an agitation member whereby components in said at least one reaction chamber are mixed.

27. A point of care assay device comprising the cartridge of claim 1, and a reader adapted to enable the cartridge to be placed in functional communication with said reader.

28. The point of care assay device according to claim 27, wherein

said reader comprises a docking or alignment means to enable the cartridge to be inserted, placed or attached to the reader.

29. The point of care assay device according to claim 27, wherein said reader comprises

a detector for detecting the capture reagent and/or a labelling or labelled reagent;

a motor that is configured to engage the conveyer of said cartridge when the cartridge is inserted into the reader and thereby provide for advancement and retraction of wicking or absorbent material;

a control device that synchronises the flow of said at least one reagent to the at least one reaction chamber and the use of said wicking or absorbent material and/or said motor; and

/or

a device that causes agitation of the at least one reaction chamber or its contents following the introduction of the at least one reagent and/or wash solutions.

30. A kit of parts for a point of care assay (POCT) device comprising:

at least one cartridge according to claim 1; and

at least one reader adapted to functionally communicate with said cartridge whereby said at least one reagent and said capture reagent in said cartridge provide a POCT for identifying at least one analyte in a biological sample.

31. A point of care assay device comprising the cartridge of claim 27, wherein the reader comprises a detector for detecting the capture reagent.