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

• US 4,742,011 A
• Filed: 05/30/1985
• Issued: 05/03/1988
• Est. Priority Date: 03/15/1984
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Unilever Patent Holdings BV (Unilever PLC)
• Inventors: Smith, Ronald, Coley, John, Blake, Anthony
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US06/740,918
• Time in Patent Office: 1,069 Days
• Field of Search: 422/55, 422/57, 422/58, 422/61, 422/69, 422/71, 422/102, 422/104, 436/810, 436/807, 436/510, 436/518, 436/818, 211/74, 248/500
• 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 component (2) which has a sensitized solid surface (2a) carrying an immobilized component of a specific binding pair relevant to the assay, 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 sample collecting and testing device comprising:

(a) a test component having a test component surface, said test component surface 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 accessory 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) so that said accessory component (c) is maintained in said slightly spaced apart relationship with said test component (a) and so that said accessory component (c) remains fixed to said handling-piece (b) or said test component (a) when said device is held and moved by said handling-piece (b); and

(e) at least one aperture through which a sample of liquid from an external source enters said space when said device is held in contact with said source, said sample being retained in contact with said test component surface, said device 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.

2. A sample collecting and testing device according to claim 1, further comprising an aperture in said accessory component (c) through which air escapes from said space when said device is used to collect a sample.

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

5. A sample collecting and testing device according to claim 1, wherein said support (f) further comprises a base unit comprising at least one liquid reaction well for containing a reagent for said assay.

6. A 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).

7. A sample collecting and testing device according to claim 1, wherein said accessory solid surface carries a releaseable reagent which disperses into said sample of liquid during use of said device.

8. A 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.

9. 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 surface 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 accessory 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) so that said accessory component (c) is maintained in said slightly spaced apart relationship with said test component (a) and so that said accessory component (c) remains fixed to said handling-piece (b) or said test component (a) when said device is held and moved by said handling-piece (b), and (e) at least one aperture through which a sample of liquid from an external source enters said space when said device is held in contact with said source, said sample being retained in contact with said test component surface; and

(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 removably fixed accessory component from said test component to expose said test component surface, said process further comprising the steps of

interlocking said accessory component and a base unit, which base unit is a support component for said test device;

allowing said test device supported by said base unit to stand for a predetermined time; and

removing said test component from said accessory component so that direct manual handling of said sensitized surface or said accessory component does not occur.

10. A process according to claim 9, wherein said process further comprises the step of transferring said test component into at least one liquid reaction well formed on said base unit, which reaction well contains a liquid reagent for said assay.

11. A process according to claim 9, 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.

12. A process according to claim 9, wherein said removably fixed accessory component is frictionally fitted on said test component or said handling piece, and wherein said accessory component and said test component or said handling piece are formed so that there is at least one aperture between said test component or said handling piece and said accessory component through which a sample liquid enters said space therebetween.

13. A process according to claim 9, wherein said space between said accessory surface and said test component surface is narrow enough to retain sample liquid by capillarity or surface tension.

14. A process according to claim 9, wherein said accessory component further comprises an aperture through which air escapes from said space.

15. A process according to claim 9, comprising the step of allowing a releasable reagent carried on said accessory component surface to disperse in said sample liquid before removing said accessory component.

16. A process according to claim 9, wherein said immobilized component of said specific binding pair is selected from the group consisting of specific binding analogues and binding partners of human chorionic gonadotrophin.