Assay system

• US 8,293,175 B2
• Filed: 11/13/2009
• Issued: 10/23/2012
• Est. Priority Date: 05/09/2001
• Status: Expired due to Term

• Current Assignee: Axis-Shield ASA (Abbott Laboratories)
• Original Assignee: Axis-Shield ASA (Abbott Laboratories)
• Inventors: Holtlund, Jostein, Borch, Stig Morten, Seim, Thorstein, Janson, Tore, Tøn, Hege, Karlson, Jan Roger, Lauvstad, Inger Lise
• Primary Examiner(s): Nagpaul, Jyoti
• Application Number:
  US12/591,229
• Publication Number:
  US 20100159487A1
• Time in Patent Office: 1,075 Days
• Field of Search: 422 63- 67, 422500-503, 422/50, 222/187, 436/180
• US Class Current: 422/65
• 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 cartridge comprising at least two wells and a membrane-tipped pipette 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, and wherein said assay cartridge comprises detachable base and cap members, said wells being disposed in said base member, and said cap member being arranged to carry said membrane-tipped pipette.

2. An assay cartridge as claimed in claim 1 wherein the distal end of said membrane-tipped pipette is closed by a sloping liquid permeable membrane.

3. An assay cartridge as claimed in claim 2 wherein said membrane lies in a plane at an angle of 20 to 40°

to the axis of said membrane-tipped pipette.

4. An assay cartridge as claimed in claim 1 wherein said membrane-tipped pipette has a membrane-tipped end of rectangular cross section.

5. An assay cartridge as claimed in claim 1, further comprising a capillary-tipped pipette, wherein said cap member comprises means to receive said capillary-tipped pipette.

6. An assay cartridge as claimed in claim 1 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.

7. An assay cartridge as claimed in claim 1 wherein said base member comprises an absorbent wiper arranged to wipe the outside of a capillary-tipped pipette inserted therein.

8. An assay cartridge as claimed in claim 1 wherein the proximal end of said membrane-tipped pipette is closed by a piercable self-sealing membrane.

9. An assay cartridge as claimed in claim 1 wherein the wells in said cartridge are arranged in a linear array.

10. An assay cartridge as claimed in claim 1 wherein the base wall of at least one of the wells is planar and non-perpendicular to the contiguous side walls of the well.

11. An assay cartridge as claimed in claim 1 wherein at least one of the wells has two parallel planar side walls, joined by a base wall comprising at least one planar face a normal to the surface whereof is coplanar to and non-perpendicular to normals to the parallel planar surfaces of said side walls.

12. An assay cartridge as claimed in claim 1 wherein at least one of said wells contains an assay reagent.

13. An assay apparatus comprising an assay device comprising:

a) a cartridge holder capable of receiving an assay cartridge according to claim 1;

b) drive means operable to position the membrane-tipped pipette of a said cartridge in selected wells of said cartridge;

c) a gas pressure applicator couplable to the membrane-tipped pipette of a said cartridge whereby to cause liquid flow therethrough;

d) a radiation detector operable to detect radiation from a well of a said cartridge or from the membrane-tipped pipette thereof; and

a removable assay cartridge comprising at least two wells and a membrane-tipped pipette 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, and wherein said assay cartridge comprises detachable base and cap members, said wells being disposed in said base member, and said cap member being arranged to carry said membrane-tipped pipette.

14. An assay for an analyte in a biological sample or for a property of a biological sample which comprises assaying a biological sample in the apparatus of claim 13.

15. An assay as claimed in claim 14 to assay for clotting time in a blood or blood-derived sample.

16. An assay as claimed in claim 14 to assay for a protein analyte in a body fluid or body fluid-derived sample.