Devices for carrying out chemical and clinical tests, and their use

• US 4,980,298 A
• Filed: 06/20/1989
• Issued: 12/25/1990
• Est. Priority Date: 03/15/1984
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Unilever Patent Holdings BV (Unilever PLC)
• Inventors: Smith, Ronald, Coley, John, Blake, Anthony
• Primary Examiner(s): Hill, Jr., Robert J.
• Application Number:
  US07/370,168
• Time in Patent Office: 553 Days
• Field of Search: 422/55, 422/61, 422/102, 422/104, 422/57, 422/58, 422/69, 436/806, 436/807, 436/810, 436/818, 436/510, 436/518
• US Class Current: 436/518
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/818 Human chorionic gonadotropin

Abstract

A device for carrying out chemical or clinical testing of a liquid sample, for example a urine sample, by a specific binding assay, said device comprising a test compoenent (2) which has a sensitised solid surface (2a) carrying an immobilized component of a specific binding pair relevant to the essay, and a handling piece (1), and characterized in that the test component (2) bearing the sensitized surface (2a) is removably mounted in spaced relationship with a removably mounted accessory component (4) carrying an accessory solid surface (5), and in that there is a space (4a) between the sensitized surface (2a) and the removable accessory component (4) to act as a container for sample liquid, so that when the device is contacted with a sample liquid source or immersed in liquid which is to provide the test sample, liquid of the sample can enter the space (4a) to contact the sensitized surface (2a), and the accessory surface (5) acts to retain and contain sample liquid in contact with the sensitized surface (2a) even after removal of the device from further contact with or immersion in the source of sample liquid, and in that the test component (2) is so formed that after removal of the removable accessory component (4) the sensitized surface (2a) is left exposed and accessible to further treatment liquid such as washing liquid and/or reagents.

Claims

1. A device suitable for collecting a liquid sample and testing said sample by a specific binding assay, said device comprising:

(a) a test component having a test component surface, said test component being sensitized with an immobilized component of a specific binding pair relevant to said assay;

(b) a handling-piece connected to said test component;

(c) an accessory component having an accessary solid surface which is of substantially complementary shape to said test component surface and removably fixed in slightly spaced apart relationship therewith, to define therebetween a containing space for retaining a liquid sample;

(d) a means for removably fixing said accessory component (c) to said handling-piece (b) or to said test component (a) to maintain said accessory component (c) in said slightly spaced apart relationship with said test component (a); and

(e) at least one aperture to allow a sample of liquid from an external source when said device is held during use in contact with said source to enter said space and be retained in contact with said test component surface.

2. The sample collecting and testing device according to claim 1, comprising a further aperture in said removable accessary component (c) to allow escape of air from said space when said device is used to collect a sample.

3. The sample collecting and testing device according to claim 1, wherein said space between said test component surface and said accessory component is narrow enough to retain sample liquid by capillarity or surface tension.

4. The sample collecting and testing device according to claim 1, wherein said space between said test component surface and said accessory component defines a constant or standard sample liquid volume.

5. The sample collecting and testing device according to claim 1, wherein said fixing means (d) comprises surfaces providing a removable frictional sliding fit of accessory component (c) on test component (a) or handling-piece (b), with said at least one aperture (e) located between said test component (a) or handling-piece (b) and said accessory component (c).

6. The sample collecting and testing device according to claim 1, further comprising (f) a support component, and (g) a means for interlocking said support component (f) with said accessory component (c) to facilitate removal of said test component (a) from said accessory component (c) without the user handling either said test component (a) or said accessory component (c) directly.

7. The sample collecting and testing device according to claim 6, wherein said support (f) comprises a base unit which also comprises at least one liquid reaction well for containing a reagent for the assay.

8. The sample collecting and testing device according to claim 1, wherein said accessory component (c) is formed to provide a sample liquid holder in the form of a cup which is removably fixed to test component (a) or handling-piece (b).

9. The sample collecting and testing device according to claim 1, wherein said accessory solid surface carries a releasable reagent to disperse in sample liquid during use of said device.

10. The sample collecting and testing device according to claim 1, wherein said test component (a) is sensitized with an immobilized analogue or binding partner of a specific binding pair involving human chorionic gonadotrophin.

11. A process for sampling a liquid and testing said sample by a specific binding assay, comprising the steps of:

(i) contacting a test device with a source of liquid to be sampled, said test device comprising (a) a test component having a test component surface, said test component being sensitized with an immobilized component of a specific binding pair relevant to said assay, (b) a handling piece connected to said test component, and (c) an accessory component which is removably fixed in spaced relationship with said sensitized surface, said accessory component having an accessory solid surface, with said test component surface and said accessory surface defining a space to act as a container for sample liquid, thereby allowing liquid from the source to enter the space as a sample and to contact the sensitized surface;

(ii) removing said test device from further contact with said source of liquid, and allowing said accessory surface to retain and contain sample liquid in contact with said sensitized surface; and

(iii) separating said fixed removably accessory component from said test component to expose said test component surface.

12. The process according to claim 11, wherein there is also used a base unit as a support component for said test device, said base unit and said accessory component having interlocking means thereon so that they can be interlocked together, and said process comprising the further steps of interlocking said accessory component and said support component together, allowing them to stand for a predetermined time, and then removing the test component from the accessory component without direct manual handling of said sensitized surface or said accessory component.

13. The process according to claim 11, wherein said base unit also comprises at least one liquid reaction well containing a liquid reagent for the assay, and said process comprises the further step of transferring said test component into said well after separating it from said accessory component.

14. The process according to claim 11, wherein said accessory component comprises a perforated or apertured removable shroud or cover closely spaced a short distance from said test component surface and removably fixed to said test component or to said handling piece.

15. The process according to claim 11, wherein said removably fixed accessory component is a removable frictional fit on said test component or said handling piece, and wherein said accessory component and said test component or said handling piece are so formed that at least one aperture is left between said test component or said handling piece and said accessory component for penetration of sample liquid into said space therebetween.

16. The process according to claim 11, wherein said space between said accessory surface and said test component surface is narrow enough to retain sample liquid by capillarity or surface tension.

17. The process according to claim 11, wherein said space between said sensitized surface and said accessory component defines a standard volume for sample liquid.

18. The process according to claim 11, wherein said accessory component has an aperture to allow escape of air from said space.

19. The process according to claim 11, wherein said accessory surface carries a releasable reagent, and said process comprises the further step of allowing said reagent to disperse in said sample liquid before removal of said accessory component.

20. The process according to claim 11, wherein said immobilized component of said specific binding pair is selected from specific binding analogues and binding partners of human chorionic gonadotrophin.