Device for analytical determinations

• US 5,116,576 A
• Filed: 08/02/1990
• Issued: 05/26/1992
• Est. Priority Date: 12/08/1987
• Status: Expired due to Fees

• Current Assignee: Scientific Generics Limited (Science Group Plc)
• Original Assignee: Scientific Generics Limited (Science Group Plc)
• Inventors: Stanley, Christopher J.
• Primary Examiner(s): Johnston, Jill
• Assistant Examiner(s): CHAN, KWONG
• Application Number:
  US07/548,971
• Time in Patent Office: 663 Days
• Field of Search: 422/55, 422/61, 422/87, 422/102, 422/68.1, 422/58, 435/291, 435/287, 436/45, 436/44, 436/46, 436/43, 436/518
• US Class Current: 422/413
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0605 check valves
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• 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: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54386 Analytical elements

Abstract

A device for carrying out an analytical determination which comprises an assay cassette and a transport body which is adapted for location in the assay cassette, the assay cassette having a plurality of discrete reagent chambers which are separated from one another by a separation arrangement which, in use, is ruptured or opened by the transport body. An assay cassette is also described which includes a signal detection chamber that is separated from the final reagent chamber by a separation arrangement which, in use, is ruptured or opened by the transport body.

Claims

1. An assay cassette device for carrying out an analytical determination including a body portion containing a plurality of separate discrete reagent chambers each containing, successively, a reagent required to perform the desired analytical determination, the reagent chambers being separated one from another by a separation means which, in use is ruptured or opened,

a sample transport body having a sample collection area located thereon, the sample collection area having a specific binding agent immobilized thereon;

said reagent chambers formed in the body portion of an assay cassette the body portion being closed at one end and has an inlet at the other end for insertion of the sample transport body whereby the sample for analysis is carried to the reagent chambers;

said separation means between the reagent chambers, in use, being ruptured or opened by the transport body; and

a signal detection chamber formed in the body portion of the assay cassette adjacent to the closed end thereof, the signal detection chamber being separated from the final reagent chamber by a separation means which, in use, is ruptured or opened by the transport body and said signal detection chamber being provided with a transparent wall.

2. A device as claimed in claim 1 wherein the assay cassette incorporates a sample metering zone provided in the body portion adjacent the inlet.

3. A device as claimed in claim 2 wherein the sample metering zone includes a wad of an absorbent material positioned adjacent the inlet.

4. A device as claimed in claim 1 wherein at least one of said separation means is a one-way valve.

5. A device as claimed in claim 1 wherein at least one of said separation means comprises a zone of weakness formed in the wall or walls separating the chambers.

6. A device as claimed in claim 1 wherein at least one of said separation means comprises a plastic film separating the chambers.

7. A device as claimed in claim 1 wherein the sample collection area comprises an absorbent body bonded to one end of the sample transport body.

9. A device as claimed in claim 1 wherein the sample transport body has a flange formed at the end thereof remote from the sample collection area which is constructed so as to be located in a recess formed in the inlet area of the body portion of the assay cassette.

10. A device as claimed in claim 1 wherein the sample transport body has a progressively increasing thickness towards the end thereof remote from the sample collection area.

11. A device as claimed in claim 1 wherein the sample transport body is provided with markings in order to assist the operator in carrying out the analysis.

12. A device as claimed in claim 1, including means for the parallel processing of a sample and calibrator and/or controls.

13. A device as claimed in claim 12 wherein the sample transport body has areas formed thereon which are impregnated with the calibrators and/or controls and an area which is adapted for the collection of the sample to be analysed.

14. A device as claimed in claim 13 wherein the pre-impregnated areas are protected from the sample to be analysed by means of a removable cover.

15. A device as claimed in claim 7 wherein the absorbed body for the collection of the sample to be analysed is covered with a peel-off filter layer to remove unwanted materials from the sample before it contacts the absorbent material.

16. A device as claimed in claim 1, wherein the reagent chambers contain the reagents required to carry out a particular immunoassay.

17. A device as claimed in claim 1, wherein the reagent chambers contain the reagents required to carry out a DNA or RNA probe assay.

8. A device as claimed in claim 8 wherein the absorbent body is covered by a protective flap.

18. An assay cassette device for carrying out a plurality of analytical determinations including a body portion containing a plurality of separate discrete reagent chambers each containing successively, a reagent required to perform the desired analytical determinations, the reagent chambers being separated one from another by a separation means which, in use, is ruptured or opened

a sample transport body having a plurality of limbs, each limb having at least one sample collection area and optionally at least one area for the transport of a control and/or optionally at least one area for the transport of a calibrator located thereon, each sample collection area having a specific binding agent immobilized thereon;

at least one longitudinal wall formed in the body portion of an assay cassette to divide the body portion into a number of separate analytical compartments;

said reagent chambers being formed in the body portion, the body portion being closed at one end and has a single inlet or a plurality of inlets at the other end for the insertion of the limbs of the transport body, whereby the samples for analysis are carried to the reagent chambers, the separation means between the reagent chambers, in use, being ruptured or opened by the limbs of the transport body;

and a plurality of signal detection chambers formed in the body portion of the assay cassette adjacent to the closed end thereof, the signal detection chamber in a particular analytical compartment being separated from the final reagent chamber of that analytical compartment by a separation means which, in use, is ruptured or opened by a limb of the sample transport body and each signal detection chamber being provided with a transparent wall.

19. A device as claimed in claim 18 wherein each analytical compartment has a plurality of reagent chambers formed therein.

20. A device as claimed in claim 18 wherein each analytical compartment incorporates a sample metering zone adjacent the inlet thereof.

21. A device as claimed in claim 18 wherein the reagent chambers contain the reagents required to carry out a particular immunoassay.

22. A device as claimed in claim 18 wherein the reagent chambers contain the reagents required to carry out a DNA or RNA probe assay.