Self-contained reagent package device and an assay using same

• US 4,675,299 A
• Filed: 12/12/1984
• Issued: 06/23/1987
• Est. Priority Date: 12/12/1984
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Witty, Thomas R., Curry, Robert E., Smith, Roger E.
• Primary Examiner(s): Lacey, David L.
• Application Number:
  US06/681,034
• Time in Patent Office: 923 Days
• Field of Search: 422/57, 422/58, 422/61, 422/101, 422/102, 422/104, 206/569, 435/300, 435/301, 435/311, 435/810, 436/165, 436/807, 436/808, 356/246
• US Class Current: 436/165
• 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 2001/2893 Preparing calibration standards
• CPC Class Codes: G01N 2035/00702 Curve-fitting; Parameter matching; Calibration constants
• CPC Class Codes: G01N 2035/00752 bar codes
• CPC Class Codes: G01N 2035/1053 for separating part of the liquid, e.g. filters, extraction phase
• CPC Class Codes: G01N 33/5304 Reaction vessels, e.g. agglutination plates for solid-phase systems G01N33/543
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/808 Automated or kit

Abstract

A self-contained reagent package device for an assay comprises a support member and a plurality of wells in the support member. All of the wells are capable of retaining liquids therein. At least one of the wells has an aperture at its bottom end for the passage of liquids therethrough. The one well includes a carrier to which a reagent is bound and further includes a porous filter positioned between the carrier and the aperture which is capable of retaining liquids used in the assay under normal atmospheric pressure conditions. The filter permits the passage of those liquids, including unbound and soluble substances, at increased pressure within the one well. Further, the filter is capable of retaining the carrier and substances bound thereto. At least one of the wells includes a predetermined amount of reagent therein. Another of the wells is empty so that the specimen to be assayed may be deposited therein. A removable protective cover is sealed over the open ends of the wells to maintain the incorporated reagents in stable form prior to use. A method for the performance of an assay using the above-described device is another aspect of the present invention.

Claims

1. A self-contained reagent package device useful in the performance of chemical and biological assays comprising:

a rack;

a plurality of wells in said rack, all of said wells having open top ends for access thereto, and all but one of said wells having closed bottom ends, said one well having an aperture at its bottom end for the passage of liquids therethrough, said one well including beads to which a reagent is bound and further including a porous filter positioned between said beads and said aperture which is constructed so as to retain liquids used in the assay under normal atmospheric pressure conditions but permitting the passage of said liquids, including unbound and soluble substances, therethrough at increased pressure within said one well, said filter further being constructed so as to retain the beads and substances bound thereto;

at least one of said wells with a closed bottom having a predetermined amount of reagent therein;

another of said wells with a closed bottom being empty so that the specimen to be assayed may be deposited therein; and

a removable protective cover sealed over the open ends of said wells to maintain the incorporated reagents in stable form prior to use thereby providing a self-contained reagent package device.

2. The device of claim 1 wherein the open top ends of said wells lie substantially in the same plane.

3. The device of claim 2 wherein said rack is a substantially planar strip member having the open top ends of said wells coextensive therewith.

4. The device of claim 3 wherein said wells are linearly arranged in single file in said rack.

5. The device of claim 4 wherein said one well is positioned at one end of said rack and said empty well for the specimen is positioned at the other end of the rack.

6. The device of claim 5 wherein the open top end of said empty specimen well is downwardly displaced with respect to the top ends of the remaining wells.

7. The device of claim 1 wherein the removable cover is positioned such that the open top end of said empty specimen well remains uncovered and open for access prior to the removal of said cover for using of the device.

8. The device of claim 1 wherein said rack and said wells are made of rigid plastic.

9. The device of claim 8 wherein said rack and said wells are integrally formed as a unitary structure.

10. The device of claim 1 wherein said protective cover includes labeling information thereon which is related to the nature of an assay to be performed.

11. The device of claim 10 wherein said information is in the form of a bar code constructed and arranged so as to be read electronically to determine said information.

12. The device of claim 1 wherein said beads are made of plastic and said reagent bound thereto is an immunologic composition.

13. The device of claim 1 wherein said filter is made of tetrafluoroethylene and has a pore rating between 0.5 and 10 microns.

14. A self-contained reagent package device for an assay comprising:

a support member;

a plurality of wells in said support member, all of said wells being constructed so as to retain liquids therein under normal atmospheric pressure conditions, at least one of said wells having an aperature at its bottom end for the passage of liquids therethrough;

a carrier to which a reagent is bound in said at least one well with an aperture;

a porous filter positioned between said carrier and said aperture which is constructed so as to retain liquids used in the assay under normal atmospheric pressure conditions but permitting the passage of said liquids, including unbound and soluble substances, therethrough at increased pressure within said one well, said filter further being constructed so as to retain the carrier and substances bound thereto;

at least one of said wells including a predetermined amount of reagent therein;

another of said wells being empty so that the specimen to be assayed may be deposited therein; and

a removable protective cover sealed over the open ends of said wells to maintain the incorporated reagents in stable form prior to use.

15. A self-contained reagent package device useful in the performance of chemical and biological assays comprising:

a substantially planar strip member serving as a rack;

a plurality of wells integrally formed and linearly arranged in single file in said rack, all of said wells having top ends for access thereto, all the open top ends of said wells, except for one such open top at a first end of said rack, lying in substantially the same plane coextensive with the rack, the open top of the well at said first end being displaced downwardly with respect to the top ends of the remaining wells, all but one of said wells having closed bottom ends, said one well positioned at the opposite end of said rack and having an aperture at its bottom end for the passage of liquids therethrough, the well with said aperture including beads to which a reagent is bound and further including a porous filter positioned between said beads and said aperture which is constructed so as to retain liquids used in the assay under normal atmospheric pressure conditions but permitting the passage of said liquids, including unbound and soluble substances, therethrough at increased pressure within said one well, said filter further being constructed so as to retain the beads and substances bound thereto;

at least one of said wells with a closed bottom, other than said wells at the respective ends of the rack, having a predetermined amount of reagent therein;

said well at the first end of the rack being empty so that the specimen to be assayed may be deposited therein; and

a removable protective cover sealed over the open ends of said wells except said empty specimen well to maintain the incorporated reagents in stable form prior to use, said cover including labeling information thereon in the form of a bar code constructed and arranged so as to be read electronically to determine said information.

16. A self-contained reagent package and calibration assembly including a plurality of reagent package devices and a reagent standards device, each reagent package device comprising:

a support member

a plurality of wells in said support member, all of said wells being constructed so as to retain liquids therein under normal atmospheric pressure conditions, at least one of said wells having an aperture at its bottom end for the passage of liquids therethrough;

a carrier to which a reagent is bound in said at least one well with an aperture;

a porous filter positioned between said carrier and said aperture which is constructed so as to retain liquids used in the assay under normal atmospheric pressure conditions but permitting the passage of said liquids, including unbound and soluble substances, therethrough at increased pressure within said one well, said filter further being constructed so as to retain the carrier and substances bound thereto;

at least one of said wells including a predetermined amount of reagent therein;

another of said wells being empty so that the specimen to be assayed may be deposited therein; and

a removable protective cover sealed over all the open ends of the wells except said empty specimen well to maintain the incorporated reagents in stable form prior to use;

said reagent standards device comprising;

a support strip from which depends a plurality of receptacles linearly arranged in single file, each receptacle having an open top end sealed closed by a removable protective cover and each receptacle having a reagent therein of known character to serve as a calibrator for one of said reagent package devices, each receptacle sized to slidably fit into the empty specimen well of a different reagent package device so that calibration of a plurality of reagent package devices may be performed during a single procedure.

17. An assay procedure using a self-contained reagent package device including:

a support member;

a plurality of wells in said support member, all of said wells being constructed so as to retain liquids therein under normal atmospheric pressure conditions, at least one of said wells having an aperture at its bottom end for the passage of liquids therethrough;

a carrier to which a reagent is bound in said at least one well with an aperture;

a porous filter positioned between the carrier and the aperture which is constructed so as to retain liquids used in the assay under normal atmospheric pressure conditions but permitting the passage of said liquids, including unbound and soluble substances, therethrough at increased pressure within said one well, said filter further being constructed so as to retain the carrier and substances bound thereto;

at least one of said wells including a predetermined amounts of reagent therein;

another of said wells being empty so that the specimen to be assayed may be deposited therein; and

a removable protective cover sealed over the open ends of said wells to maintain the incorporated reagents in stable form prior to use, said assay comprising the steps of;

depositing the liquid specimen to be assayed in said empty well;

removing said protective cover from the open tops of said wells;

transferring a measured amount of liquid specimen to one of said wells having a reagent therein to thereby form a mixture;

transferring a measured amount of said mixture to said one well with the aperture and filter so that said mixture reacts with the reagent on said carrier and causes select substances to bind to said carrier;

removing the unbound and soluble substances from said one well through said filter and said aperture, said filter preventing the passage of the carrier with bound sustances;

eluting the bound substances from the carrier and removing same from said wells through said filter and said aperture; and

quantifying the bound substrates collected from said one well.

18. The assay procedure of claim 17 wherein said substances are removed from said one well through its aperture by applying positive pressure to the interior of said one well.

19. The assay procedure of claim 17 wherein said substances are removed from said one well through its aperture by applying negative pressure to the exterior of said one well.

20. The assay procedure of claim 17 which further includes a plurality of intermediate transfer steps of said liquid specimen into at least one of said plurality of wells prior to its introduction into said one well with the aperture and filter.

21. The assay procedure of claim 17 wherein both of the transferring steps, the removing step and eluting step are repeated a plurality of times in assaying the liquid specimen deposited in the empty well.