Assay system

• US 20040161368A1
• Filed: 04/09/2004
• Published: 08/19/2004
• Est. Priority Date: 05/09/2001
• Status: Active Grant

• Current Assignee: Axis-Shield ASA
• Original Assignee: Axis-Shield ASA
• Inventors: Seim, Thorstein, Karlson, Jan Roger, Holtlund, Jostein, Janson, Tore, Borch, Stig Morten, Lauvstad, Inger Lise, Ton, Hege
• Granted Patent: US 7,632,462 B2
• Time in Patent Office: Days
• US Class Current: 422/68.1
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/1805 Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
• CPC Class Codes: B01L 2300/1844 using fans
• CPC Class Codes: B01L 3/0275 Interchangeable or disposable dispensing tips
• CPC Class Codes: B01L 3/5085 for multiple samples, e.g. microtitration plates
• CPC Class Codes: G01N 2021/0325 Cells for testing reactions, e.g. containing reagents
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 2021/0357 Sets of cuvettes
• CPC Class Codes: G01N 2021/0382 Frustoconical, tapered cell
• CPC Class Codes: G01N 2035/0436 with pre-packaged reagents, i.e. test-packs
• CPC Class Codes: G01N 2035/1053 for separating part of the liquid, e.g. filters, extraction phase
• CPC Class Codes: G01N 21/0303 Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence
• CPC Class Codes: G01N 21/11 Filling or emptying of cuvettes
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/723 Glycosylated haemoglobin
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: G01N 35/10 Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices G01N35/0099 takes precedence
• CPC Class Codes: Y10T 436/119163 with aspirator of claimed structure
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

An assay apparatus comprising: i) an assay cartridge (52, 53) comprising at least one well (57-62) and a pipette (50) positionable in at least one said well; ii) a holder arranged to receive said cartridge; iii) drive means operable to position said pipette in selected wells of said cartridge; iv) a gas pressure applicator couplable to said pipette whereby to cause liquid flow through said membrane; and v) a radiation detector operable to detect radiation from a well of said cartridge or from said pipette.

Claims

1. An assay apparatus comprising:

i) an assay cartridge (52,53) comprising at least two wells (57-62) and a pipette (55) positionable in at least two of said wells, said pipette having a proximal end and a distal end, said distal end being closed by a liquid permeable membrane;

ii) a holder arranged to receive said cartridge;

iii) drive means operable to position said pipette in selected wells of said cartridge;

iv) a gas pressure applicator couplable to said pipette whereby to cause liquid flow through said membrane; and

v) a radiation detector operable to detect radiation from a well of said cartridge or from said pipette.

4. Apparatus as claimed in any one of claims 1 to 3 wherein said cartridge comprises a capillary-tipped pipette (50) and a membrane-tipped pipette (55).

5. Apparatus as claimed in any one of claims 1 to 4 wherein said cartridge comprises a pipette (55) the distal end whereof is closed by a sloping liquid permeable membrane.

6. Apparatus as claimed in claim 5 wherein said sloping membrane lies in a plane at an angle of 20 to 40°

to the axis of the pipette to which it is attached.

7. Apparatus as claimed in any one of claims 1 to 6 wherein said cartridge comprises a membrane-tipped pipette the membrane-tipped end whereof is of rectangular cross section.

8. Apparatus as claimed in any one of claims 1 to 7 wherein said cartridge comprises detachable base and cap members, said wells being disposed in said base member and said cap member being arranged to carry said pipette.

9. Apparatus as claimed in claim 8 wherein said cap member comprises means to receive a capillary-tipped pipette.

10. Apparatus as claimed in either one of claims 8 and 9 wherein at least-one of said wells is sealed at its upper end by a frangible seal and wherein said cap member is provided with a cutter arranged to pierce said seal.

11. Apparatus as claimed in any one of claims 8 to 10 wherein said base member comprises an absorbent wiper arranged to wipe the outside of a capillary-tipped pipette inserted therein.

12. Apparatus as claimed in any one of claims 1 to 11 wherein said cartridge comprises a membrane-tipped pipette the proximal end whereof is closed by a piercable self-sealing membrane.

13. Apparatus as claimed in any one of claims 1 to 12 wherein the wells in said cartridge are arranged in a linear array.

14. Apparatus as claimed in any one of claims 1 to-13 wherein said radiation detector comprises a digital camera.

15. Apparatus as claimed in claim 14 wherein the base wall of at least one of the wells in said cartridge is planar and non-perpendicular to the contiguous side walls of the well.

16. Apparatus as claimed in any one of claims 1 to 15 further comprising a light source arranged to illuminate said cartridge.

17. Apparatus as claimed in any one of claims 1 to 16 further comprising a magnet.

18. Apparatus as claimed in any one of claims 1 to 17 further comprising a heater arranged to heat said cartridge.

19. Apparatus as claimed in any one of claims 1 to 18 further comprising a controller arranged to control assay performance by said apparatus.

20. Apparatus as claimed in any one of claims 1 to 19 wherein said gas pressure applicator comprises a piston disposed within a cylindrical housing and a drive motor arranged to drive said piston.

36. An assay device comprising a) a cartridge holder (24) capable of receiving an assay cartridge (23) according to any one of claims 20 to 33;

b) drive means (25) operable to position the pipette (6) of a said cartridge in selected wells of said cartridge;

c) a gas pressure applicator (27) couplable to the pipette of a said cartridge whereby to cause liquid flow therethrough the membrane thereof; and

d) a radiation detector (32) operable to detect radiation from a well of a said cartridge or from the pipette thereof.

37. A device as claimed in claim 36 wherein said radiation detector comprises a digital camera.

38. A device as claimed in either of claims 36 and 37 further comprising a light source arranged to illuminate said cartridge.

39. A device as claimed in any one of claims 36 to 38 further comprising a magnet.

40. A device as claimed in any one of claims 36 to 39 further comprising a heater arranged to heat said cartridge.

41. A device as claimed in any one of claims 36 to 40 further comprising a controller arranged to control assay performance by said apparatus.

42. A device as claimed in any one of claims 36 to 41 wherein said gas pressure applicator comprises a piston disposed within a cylindrical housing and a drive motor arranged to drive said piston.

45. The use of apparatus as claimed in any one of claims 1 to 20 to assay for an analyte in a biological sample or for a property of a biological sample.

46. Use as claimed in claim 45 to assay for clotting time in a blood or blood-derived sample.

47. Use as claimed in claim 45 to assay for a protein analyte in a body fluid or body fluid-derived sample.

2. An assay apparatus comprising:

i) an assay cartridge (52,53) comprising at least one well (57-62) and a pipette (50) positionable in at least one said well, said pipette having a capillary tip;

ii) a holder arranged to receive said cartridge;

iii) drive means operable to position said pipette in selected wells of said cartridge;

iv) a gas pressure applicator couplable to said pipette whereby to cause liquid flow through said membrane; and

v) a radiation detector operable to detect radiation from a well of said cartridge or from said pipette.

3. An assay apparatus comprising:

i) an assay cartridge (52,53) comprising at least one well (57-62) and a pipette (50) positionable in at least one said well, at least one said well having two parallel planar side walls joined by a base wall comprising at least one planar face the normal to the surface whereof is coplanar to and non-perpendicular to normals to the parallel planar surfaces of said side walls;

ii) a holder arranged to receive said cartridge;

iii) drive means operable to position said pipette in selected wells of said cartridge;

iv) a gas pressure applicator couplable to said pipette whereby to cause liquid flow through said membrane; and

v) a radiation detector operable to detect radiation from a well of said cartridge or from said pipette.

21. An assay cartridge (52,53) comprising at least two wells (57-62) and a pipette (55) positionable in at least two of said wells, said pipette having a proximal end and a distal end, said distal end being closed by a liquid permeable membrane.

25. An assay cartridge as claimed in any one of claims 21 to 24.wherein said cartridge comprises a capillary-tipped pipette (50) and a membrane-tipped pipette (55).

26. An assay cartridge as claimed in any one of claims 21 to 25 wherein said cartridge comprises a pipette (55) the closed end whereof is closed by a sloping liquid permeable membrane.

27. An assay cartridge as claimed in claim 26 wherein said membrane-lies in a plane at an angle of 20 to 40°

to the axis of the pipette to which it is attached.

28. An assay cartridge as claimed in any one of claims 21 to 27 wherein said cartridge comprises a membrane-tipped pipette the membrane-tipped end whereof is of rectangular cross section.

29. An assay cartridge as claimed in any one of claims 21 to 28 wherein said cartridge comprises detachable base and cap members, said wells being disposed in said base member and said cap member being arranged to carry said pipette.

30. An assay cartridge as claimed in claim 29 wherein said cap member comprises means to receive a capillary-tipped pipette.

31. An assay cartridge as claimed in either one of claims 28 and 30 wherein at least one of said wells is sealed at its upper end by a frangible seal and wherein said cap member is provided with a cutter arranged to pierce said seal.

32. An assay cartridge as claimed in any one of claims 21 to 31 wherein said base member comprises an absorbent wiper arranged to wipe the outside of a capillary-tipped pipette inserted therein.

33. An assay cartridge as claimed in any one of claims 21 to. 32 wherein said cartridge comprises a membrane-tipped pipette the proximal end whereof is closed by a piercable self-sealing membrane.

34. An assay cartridge as claimed in any one of claims 21 to 33 wherein the wells in said cartridge are arranged in a linear array.

35. An assay cartridge as claimed in any one of claims 21 to 34 wherein at least one of said wells contains an assay reagent.

22. An assay cartridge (52,53) comprising at least one well (57-62) and a pipette (50) positionable in at least one said well, said pipette having a capillary tip.

23. A cartridge as-claimed in claim 22 wherein said capillary tip (95) is provided with a detachable sleeve (96).

24. An assay cartridge (52,53) comprising at least one well (57-62) and a pipette (50) positionable in at least one said well, at least one said well having two parallel planar side walls joined by a base wall comprising at least one planar face the normal to the surface whereof is coplanar to and non-perpendicular to normals to the parallel planar surfaces of said side walls.

43. An assay method wherein a liquid is transferred from a container into a pipette, characterised in that the end of said pipette through which liquid enters is sealed by a liquid permeable membrane.

44. A pipette the distal end whereof is cylindrical and tipped by a porous membrane the outer surface whereof is angled away from the plane perpendicular to the cylindrical axis of said distal end.