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

Claim 2

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.

Claim 3

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.

Claim 4

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.

Claim 5

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).

Claim 6

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.

Claim 7

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).

Claim 8

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.

Claim 9

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.

Claim 10

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.

Claim 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 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.

Claim 12

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.

Claim 13

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.

Claim 14

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.

Claim 15

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.

Claim 16

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

Claim 17

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.

Claim 18

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.