Device for performing enzyme immunoassays

• US 4,690,801 A
• Filed: 06/03/1986
• Issued: 09/01/1987
• Est. Priority Date: 06/03/1986
• Status: Expired due to Fees

• Current Assignee: NPS Pharmaceuticals Incorporated (Shire plc)
• Original Assignee: Allelix Inc (Takeda Pharmaceutical Company Limited)
• Inventors: Anderson, Hugh B.
• Primary Examiner(s): Marcus, Michael S.
• Application Number:
  US06/870,320
• Time in Patent Office: 455 Days
• Field of Search: 422/57, 422/58, 422/61, 422/72, 422/102, 422/100, 422/68, 436/45, 436/543, 436/807, 435/288, 435/291, 435/301, 356/246
• US Class Current: 422/413
• CPC Class Codes: B01L 2400/0644 rotary valves
• 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 33/5304 Reaction vessels, e.g. agglutination plates for solid-phase systems G01N33/543
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10T 436/111666 Utilizing a centrifuge or compartmented rotor

Abstract

An enzyme immunoassay device comprises a disk having a thin flexible membrane applied to one side thereof, the membrane defining a conduit and a plurality of reagent reservoirs. The reservoirs are isolated from one another or from the conduit by frangible seals. An assay tube having an assay reagent bonded to the inner wall thereof is attached to the exit end of the conduit. Means are provided for injecting a test sample into the conduit for flowing thereof through the assay tube. Means are also provided for forcing the contents of each reservoir through the conduit and assay tube in the desired order by causing the rupture of each frangible seal sequentially.

Claims

1. A device for performing chemical and immunochemical assays, comprising:

a disk having a thin flexible membrane applied to one side thereof, the membrane coacting with the disk to form a circumferentially disposed conduit having entrance and exit ends and also a plurality of circumferentially disposed reagent reservoirs, the reservoirs being isolated from one another or from the conduit by frangible seals, the frangible seals being arranged to define the desired flow of reagents through the conduit;

at least one assay tube having entrance and exit ends, the entrance end being attached to the exit end of the conduit, the assay tube having an assay reagent bonded to the inner wall thereof;

test sample injection means for flowing test sample through the assay tube; and

means for forcing the contents of each reservoir through the conduit and the assay tube in the desired order by causing the rupture of each frangible seal sequentially, said means preventing back flow of reagent in the conduit.

2. A device as claimed in claim 1, further comprising a waste reservoir in communication with the exit end of the assay tube.

3. A device as claimed in claim 1, further comprising a reference tube connected in series to the assay tube and through which the test sample and all reagents may flow, said reference tube not having an assay reagent bonded to the inner wall thereof.

4. A device as claimed in claim 1, wherein the means for forcing the contents of each reservoir through the conduit and assay tube is a roller.

5. A device as claimed in claim 1, wherein the means for forcing the contents of each reservoir through the conduit and assay tube is a wiper blade.

6. A device as claimed in claim 1, wherein the sample injection means comprises a resiliently flexible dome and a tube with a one way valve, the dome being connectable to the entrance end of the conduit and the tube being capable of having one end immersed in a volume of test sample liquid, the injection means operating to pump the sample through the conduit by repeatedly collapsing and expanding the dome thereby causing suction of the sample liquid through the valve and expulsion of sample into the conduit.

7. A device as claimed in claim 2, wherein the sample injection means comprises a resiliently flexible dome positioned centrally on the disk and in communication with the entrance end of the conduit, a tube extending through the disk beneath the dome and into the waste reservoir so that an end thereof may be immersed in a volume of test sample liquid contained therein, and a one way valve positioned on the disk at the other end of the tube, the dome and valve being capable of coacting to pump sample from the reservoir and through the conduit.

8. A device as claimed in claim 1, wherein one or more reagent reservoirs comprises a liquid containing compartment and a solids containing compartment, the compartments being separated by means of a frangible seal, and the compartments being arranged on the disk so that the means for forcing the reagent reservoirs'"'"' contents into the conduit acts first on the liquid containing compartment.

9. A device as claimed in claim 2, wherein the conduit is positioned circumferentially near the center of the disk and the assay tube is positioned longitudinally on the surface of the disk.

10. A device as claimed in claim 9, wherein the exit end of the assay tube is connected to the waste reservoir, and the sample injection means is located about the center of the disk.

11. A device as claimed in claim 1, further comprising a base having a platform for receiving the disk and a cover for the base being rotatable about the base, the cover having said means for forcing the contents of each reservoir through the conduit.

12. A device as claimed in claim 11, further comprising a waste reservoir located beneath the platform, the platform defining an aperture therethrough in communication with the waste reservoir.

13. A device as claimed in claim 12, wherein conduit means are provided from the exit end of the assay tube and through the disk and aperture in the platform.

14. A device as claimed in claim 13, wherein the platform defines an aperture therethrough at the center thereof in communication with the waste reservoir, and the sample injection means comprises a resiliently flexible dome positioned centrally on the disk and in communication with the entrance end of the conduit, a tube extending through the disk beneath the dome through the central aperture in the platform and into the waste reservoir so that an end thereof may be immersed in a volume of test sample liquid contained therein, and a one way valve positioned on the disk at the other end of the tube, the dome and valve being capable of coacting to pump sample from the reservoir and through the conduit.

15. A device as claimed in claim 14, wherein the cover has a roller attached underneath the top surface positioned to engage the disk surface when the device is assembled and to force the contents of each reagent reservoir through the conduit and assay tube upon rotation of the cover about the base.

16. A device as claimed in claim 15, wherein the cover and base have coacting means for positioning the cover and roller at the desired starting point on the disk and said means also locking the cover on the base while allowing unidirectional rotation thereof about the base.

17. A device as claimed in claim 16, wherein the base has a flanged upper rim which is provided with at least two notches for receiving projections located on the inner side surface of the cover, the notches and projections being located to ensure the proper initial orientation of the roller before the first reagent reservoir, and said projections engaging the underside of the flange upon rotation of the cover.

18. A device as claimed in claim 1, wherein the assay reagent is an antibody, antigen or hapten.