Self-contained reagent package device and an assay using same

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.

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.

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.

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.