Assay system

• US 8,545,756 B2
• Filed: 09/14/2012
• Issued: 10/01/2013
• 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, Tn, Hege, Karlson, Jan Roger, Lauvstad, Inger Lise
• Primary Examiner(s): Nagpaul, Jyoti
• Application Number:
  US13/615,943
• Publication Number:
  US 20130065256A1
• Time in Patent Office: 382 Days
• Field of Search: 422 63- 67, 422/50, 422500-503, 738/640.3, 436/54, 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 received 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 of said cartridge or from said pipette.

Claims

1. An assay cartridge comprising detachable base and cap members;

at least one well being disposed in said base member and a membrane-tipped pipette positionable in at least one said well, wherein said pipette is closed at one end by a liquid permeable membrane, said membrane being planar and angled relative to an axis of the pipette, and wherein said well comprises a base or side wall through which radiation from the membrane may pass when the pipette is in the well;

said cap member being arranged to carry said membrane tipped pipette and wherein said well is sealed at its upper end by a frangible seal wherein said cap member is provided with a cutter arranged to pierce said seal.

2. The assay cartridge of claim 1 wherein said membrane lies at an angle of 20 to 40°

to the axis of said pipette.

3. The assay cartridge of claim 1 wherein said base or side wall is planar.

4. The assay cartridge of claim 1 wherein at least a portion of said base or side wall is of light-transparent plastic.

5. The assay cartridge of claim 1 wherein at least a portion of said base or side wall is of a copolymer comprising an alpha-olefin and a cyclic olefin.

6. The assay cartridge of claim 5 wherein said copolymer has a light transmission of at least 80% and a water vapour permeability of less than 0.2 g·

mm·

m<sup>−

2</sup>·

d<sup>−

1</sup>.

7. The assay cartridge of claim 1 wherein the base of said well is planar and is angled so as to be substantially parallel to the membrane when the pipette is in the well.

8. The assay cartridge of claim 1 wherein the membrane-tipped end of said pipette has a rectangular cross section.

9. The assay cartridge of claim 1 wherein said cap member comprises means to receive a further pipette, said further pipette being a capillary-tipped pipette.

10. The assay cartridge of claim 1 wherein said base member comprises an absorbent wiper arranged to wipe the outside of a capillary-tipped pipette inserted therein.

11. The assay cartridge of claim 1 comprising a plurality of wells arranged in a linear array, the pipette being positionable in at least two of said wells.

12. The assay cartridge of claim 1 wherein said well 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.

13. The assay cartridge of claim 1 wherein at least one said well contains an assay reagent.

14. An assay device comprising:

a) a cartridge holder, capable of receiving an assay cartridge comprising (i) at least one well and (ii) a membrane-tipped pipette positionable in at least one said well, wherein said pipette is closed at one end by a liquid permeable membrane, said membrane being planar and angled relative to an axis of the pipette, and wherein said well comprises a base or side wall through which radiation from the membrane may pass when the pipette is in said well;

b) drive means operable to position the membrane-tipped pipette of a said cartridge in at least one selected well of said cartridge;

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

d) a radiation detector operable to detect radiation from the membrane of a membrane-tipped pipette of a said cartridge through a base or side wall of a well of the said cartridge when the pipette is in the well.

15. The assay device of claim 14 wherein said radiation detector comprises a digital camera.

16. The assay device of claim 14, wherein said radiation detector is arranged to detect radiation through a side wall of a well of a said cartridge.

17. The assay device of claim 14 further comprising a light source arranged to illuminate a said cartridge.

18. An assay apparatus comprising:

a) a cartridge holder;

b) a removable assay cartridge comprising (i) at least one well and (ii) a membrane-tipped pipette positionable in at least one said well, wherein said pipette is closed at one end by a liquid permeable membrane, said membrane being planar and angled relative to an axis of the pipette, and wherein said well comprises a base or side wall through which radiation from the membrane may pass when the pipette is in said well;

c) drive means operable to position the membrane-tipped pipette of said cartridge in at least one selected well of said cartridge;

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

e) a radiation detector operable to detect radiation from the membrane of the membrane-tipped pipette of said cartridge through a base or side wall of said well when the pipette is in the well.

19. 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 18 and which further comprises the steps of:

a) lifting the liquid permeable membrane on the membrane-tipped pipette of said apparatus out of liquid contained in a well of the apparatus, or sucking liquid through the membrane into the pipette, so as to leave the membrane surface exposed for reading; and

b) using the radiation detector of said apparatus to detect radiation from the membrane through a base or side wall of the well.

20. An assay cartridge comprising detachable base and cap members;

at least one well being disposed in said base member and a membrane-tipped pipette positionable in at least one said well, wherein said pipette is closed at one end by a liquid permeable membrane, said membrane being planar and angled relative to an axis of the pipette, and wherein said well comprises a base or side wall through which radiation from the membrane may pass when the pipette is in the well;

said cap member being arranged to carry said membrane tipped pipette and wherein said base member comprises an absorbent wiper arranged to wipe the outside of a capillary-tipped pipette inserted therein.