Automated immunoassay analyzer

US 5,885,529 A
Filed: 06/28/1996
Issued: 03/23/1999
Est. Priority Date: 06/28/1996
Status: Expired due to Term

First Claim

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1. An automated immunoassay analyzer, comprising:

an instrument which includes(I) means for receiving a plurality of sample tubes containing a fluid sample to be assayed;

(II) means for supplying a plurality of reaction tubes in which an assay on said samples can be performed;

(III) inert support and dispensing means for receiving a plurality of inert support dispensing packs each storing a single type of biomaterial-coated inert support, said biomaterial capable of selectively binding an analyte of interest in a sample, and said dispensing packs capable of storing and dispensing said supports, individually, into a reaction tube at a support dispensing station, whereby a plurality of different biomaterial coated supports stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube, said inert support supply and dispensing means comprising(1) a plurality of bead dispenser devices supported on a common bead dispenser device carousel capable of rotation, wherein each dispenser device comprises(a) a track capable of storing and feeding a plurality of substantially spherical beads by effect of gravity to a lower track end,(b) an enclosure sealingly housing said track comprisinga side wall enclosing outer lateral surfaces of said track,a cover sealingly enclosing an upper track end of said track and upper end of said side wall, anda base including upper and lower sections defining a plunger chamber, and a first bead chamber defined in said upper section communicating with said lower track end and said first bead chamber being offset along said plunger chamber relative to a bead exit opening in said lower section,c) a plunger sealingly provided in said plunger chamber and being capable of horizontal reciprocal movement within said plunger chamber, said plunger having a throughhole defining a second bead chamber normally aligned with said first bead chamber at said lower track end and with a plunger portion concurrently blocking said exit opening via a biasing means imposing a normal horizontal bias force on said plunger, wherein when a horizontal force is exerted in opposition to and adequate to overcome said normal bias force, said plunger being capable of horizontal movement to align said second bead chamber with said exit opening, said normal horizontal biasing force of said biasing means capable of horizontally moving said plunger effective to reblock said exit opening upon removal of said opposing force, and wherein said plunger further comprises first and second resilient rings spaced apart and seated on respective first and second collar portions of said plunger, and said plunger chamber having first and second flanges capable of sealingly engaging said first and second resilient sealing rings, respectively, where said first flange is located between said exit opening and said first bead chamber and said second flange is located between said biasing means and a distal end of said plunger at which said horizontal force is exerted, and(2) identifying means for identifying each of said bead dispenser devices;

(IV) means for receiving a plurality of reagent storage packs capable of storing and permitting reagent withdrawal, in a self-sealing manner, whereby a plurality of different reagents stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube;

(V) means for pipetting sample and means for pipetting reagent into a support-containing reaction tube at a reaction tube pipetting station;

(VI) an incubating station for incubating reaction tubes received from said reaction tube pipetting station containing sample, reagent and inert support;

(VII) a washing station for washing bound biomaterial in said reaction tube after said reaction tubes have been incubated at said incubating station;

(VIII) a detection station for detecting a quantity of analyte bound to said biomaterial in said reaction tubes after said reaction tubes have been washed at said washing station, said detection station producing a signal proportional to the quantity of analyte for each reaction tube;

(IX) a reaction tube transport pathway connecting, in this sequence, said reaction tube supply means, said inert support supply and dispensing means, said reaction tube pipetting station, said incubating station, said washing station and said detection station;

(X) means for identifying said sample tubes, said reagent packs, and said inert support dispensing packs on-board the analyzer;

(XI) control means for automatic controlling of various components of said analyzer in a coordinated manner and being capable of executing assay selection orders for a given sample by selecting and coordinating the introduction of a particular type of reagent and particular type of biomaterial-coated inert support effective to perform a particular requested assay on said sample in a reaction tube; and

(XII) means for determining and displaying and/or recording the concentration of analyte in a particular sample based on said signal produced and detected at said detection station.

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Abstract

An improved automated immunoassay analyzer including a high throughput automated immunoassay system which can perform high volume testing on a broad range of analytes while selecting from among a diverse set of immunoassays for any given sample. The immunoanalyzer has the capacity to perform a wide range of different types of immunoassays by facile storage and automated combination aboard the instrument among a wide variety of different types of reagents and heterogenous immunoassay beads stored on-board the instrument. The automated design allows reduced user interface (e.g., tests are performed automatically from computer input) including the ability to order, perform and reassay tests reflexively based on test results without operator intervention. Further, the inventive analyzer is not sample tube specific; that is, an instrument that can accept sample tube sizes within a broad size range. The inventive automated immunoassay analyzer also provides a re-useable sample dilution well, and a high speed bead washing station that eliminates the need for assay tubes having integral, waste fluid collection chambers.

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17 Claims

1. An automated immunoassay analyzer, comprising:
- an instrument which includes(I) means for receiving a plurality of sample tubes containing a fluid sample to be assayed;
  
  (II) means for supplying a plurality of reaction tubes in which an assay on said samples can be performed;
  
  (III) inert support and dispensing means for receiving a plurality of inert support dispensing packs each storing a single type of biomaterial-coated inert support, said biomaterial capable of selectively binding an analyte of interest in a sample, and said dispensing packs capable of storing and dispensing said supports, individually, into a reaction tube at a support dispensing station, whereby a plurality of different biomaterial coated supports stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube, said inert support supply and dispensing means comprising(1) a plurality of bead dispenser devices supported on a common bead dispenser device carousel capable of rotation, wherein each dispenser device comprises(a) a track capable of storing and feeding a plurality of substantially spherical beads by effect of gravity to a lower track end,(b) an enclosure sealingly housing said track comprisinga side wall enclosing outer lateral surfaces of said track,a cover sealingly enclosing an upper track end of said track and upper end of said side wall, anda base including upper and lower sections defining a plunger chamber, and a first bead chamber defined in said upper section communicating with said lower track end and said first bead chamber being offset along said plunger chamber relative to a bead exit opening in said lower section,c) a plunger sealingly provided in said plunger chamber and being capable of horizontal reciprocal movement within said plunger chamber, said plunger having a throughhole defining a second bead chamber normally aligned with said first bead chamber at said lower track end and with a plunger portion concurrently blocking said exit opening via a biasing means imposing a normal horizontal bias force on said plunger, wherein when a horizontal force is exerted in opposition to and adequate to overcome said normal bias force, said plunger being capable of horizontal movement to align said second bead chamber with said exit opening, said normal horizontal biasing force of said biasing means capable of horizontally moving said plunger effective to reblock said exit opening upon removal of said opposing force, and wherein said plunger further comprises first and second resilient rings spaced apart and seated on respective first and second collar portions of said plunger, and said plunger chamber having first and second flanges capable of sealingly engaging said first and second resilient sealing rings, respectively, where said first flange is located between said exit opening and said first bead chamber and said second flange is located between said biasing means and a distal end of said plunger at which said horizontal force is exerted, and(2) identifying means for identifying each of said bead dispenser devices;
  
  (IV) means for receiving a plurality of reagent storage packs capable of storing and permitting reagent withdrawal, in a self-sealing manner, whereby a plurality of different reagents stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube;
  
  (V) means for pipetting sample and means for pipetting reagent into a support-containing reaction tube at a reaction tube pipetting station;
  
  (VI) an incubating station for incubating reaction tubes received from said reaction tube pipetting station containing sample, reagent and inert support;
  
  (VII) a washing station for washing bound biomaterial in said reaction tube after said reaction tubes have been incubated at said incubating station;
  
  (VIII) a detection station for detecting a quantity of analyte bound to said biomaterial in said reaction tubes after said reaction tubes have been washed at said washing station, said detection station producing a signal proportional to the quantity of analyte for each reaction tube;
  
  (IX) a reaction tube transport pathway connecting, in this sequence, said reaction tube supply means, said inert support supply and dispensing means, said reaction tube pipetting station, said incubating station, said washing station and said detection station;
  
  (X) means for identifying said sample tubes, said reagent packs, and said inert support dispensing packs on-board the analyzer;
  
  (XI) control means for automatic controlling of various components of said analyzer in a coordinated manner and being capable of executing assay selection orders for a given sample by selecting and coordinating the introduction of a particular type of reagent and particular type of biomaterial-coated inert support effective to perform a particular requested assay on said sample in a reaction tube; and
  
  (XII) means for determining and displaying and/or recording the concentration of analyte in a particular sample based on said signal produced and detected at said detection station.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 11, 12, 13, 14)
- - 2. The automated immunoassay analyzer of claim 1, wherein each of said rotatable sample tube carousel, said rotatable reagent pack carousel, and said rotatable inert support pack carousel, are associated with a bar code reader, whereby said control means can controllably track and advance said sample tubes to said sample pipetting means, said reagent packs to said reagent pipetting means, and said inert support dispensing packs to said inert support dispensing station.
  - 3. The automated immunoassay analyzer of claim 1, wherein said control means includes a computer connected to said analyzer via data communication lines.
  - 4. The automated immunoassay analyzer of claim 3, wherein said computer is connected via data communication lines to (a) a display means which visually displays operator commands and data collected from the instrument, and (b) a keyboard allowing input of patient information associated with test samples.
  - 5. The automated immunoassay analyzer of claim 3, wherein said analyzer includes microprocessing means on-board the analyzer directing operation of said analyzer.
  - 6. The automated immunoassay analyzer of claim 1, wherein said detection station includes a means for detecting light.
  - 7. The automated immunoassay analyzer of claim 6, wherein said means for detecting light is a photomultiplier tube.
  - 8. The automated immunoassay analyzer of claim 1, wherein said sample tube receiving means comprises:
    - a rotatable sample rack carousel supporting at least one sample container rack, said at least one sample container rack comprising;
      
      a base;
      
      a sample container holder sleeve, including;
      
      a cylindrical-shaped shell defining a sidewall structure, an upper opening, and an interior space, and said shell being oriented vertically relative to said base and including a vertically extending slot opening in said sidewall structure, anda plurality of sample container gripping means attached to said sidewall structure each having at least one projection tab resiliently urged inward, said projection tabs capable of gripping a sidewall of a sample container inserted into said shell to maintain said sample container in a centered, upright orientation.
  - 11. The automated immunoassay analyzer of claim 1, wherein said means for receiving a plurality of sample tubes containing a fluid sample to be assayed further receives tubes containing diluent material, and said analyzer further comprising a sample dilution station, comprising:
    - (a) a dilution tube well capable of receiving sample and diluent via said sample pipetting means, and (b) means on-board the analyzer to rotate said dilution tube well sufficient to form a homogenous mixture, wherein said sample pipetting means being capable of transferring portions of said mixture to reaction pipetting station, and said dilution well rotation means capable of high speed rotation of said dilution tube well to eliminate excess mixture fluid, and (c) means on-board the analyzer for catching said mixture fluid expelled during said high speed rotation.
  - 12. The automated immunoassay analyzer of claim 11, wherein said sample dilution station further comprises, in combination:
    - a dilution well waste chamber defined by (a) a chamber body having inner sidewalls and a bottom defining a space, wherein said bottom includes a drainage port and a centrally located opening, and (b) a dilution well cover having a central hole, said dilution well cover being removably fitted upon said chamber body to cover said space;
      
      a dilution well, including;
      
      an elongated hollow cylinder having inside walls, an upper end and a lower end, said upper end having an opening and said lower end having a plurality of inward projecting fins integral with said inside tube walls;
      
      a dilution well spinning means, including;
      
      a holding means for conformably receiving and supporting said dilution well,a drive means capable of effecting rotation of said holding means and said dilution well, wherein said drive means includes a motor, and said holding means comprises a spindle where said motor controllably drives said spindle in rotation, and said spindle comprising a hollow sleeve defining a recess sized to permit nesting of said dilution well inside said spindle whereby said dilution well is capable of traveling in rotation with said spindle.
  - 13. The automated immunoassay analyzer of claim 1, wherein said first collar is a rectangular-shaped recess in said plunger and said first resilient ring comprises a rectangular-shaped O-ring, and said second collar is circular-shaped recess in said plunger and said second resilient ring comprises a circular-shaped O-ring.
  - 14. The automated immunoassay analyzer of claim 1, wherein during said blocking of said exit opening by said plunger portion, said first resilient sealing ring sealingly confronts said first flange of said plunger chamber inclined at a first acute inclination angle from vertical, and said second resilient sealing ring sealingly confronts said second flange of said plunger chamber inclined at a second acute inclination angle from vertical, wherein said second inclination angle is smaller in inclination than said first inclination angle an amount effective to permit said second resilient sealing ring to variably compress until said first resilient sealing ring stops on said first flange.

9. An automated immunoassay analyzer, comprising:
- an instrument which includes(I) means for receiving a plurality of sample tubes containing a fluid sample to be assayed;
  
  (II) means for supplying a plurality of reaction tubes in which an assay on said samples can be performed;
  
  (III) insert support and dispensing means for receiving a plurality of inert support dispensing packs each storing a single type of biomaterial-coated inert support, said biomaterial capable of selectively binding an analyte of interest in a sample, and said dispensing packs capable of storing and dispensing said supports, individually, into a reaction tube at a support dispensing station, whereby a plurality of different biomaterial coated supports stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube;
  
  (IV) means for receiving a plurality of reagent storage packs capable of storing and permitting reagent withdrawal, in a self-sealing manner, whereby a plurality of different reagents stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube, said means for receiving a plurality of reagent storage packs comprisinga plurality of reagent containers removably fitted into a common reagent carousel, each said reagent container comprisinga vessel having a plurality of separate compartments defined by sidewalls and a cover as an upper surface, each compartment having an opening in said upper surface;
  
  a self-sealing lid attached to the exterior of a sidewall of said vessel, comprisinga first arm confronting said upper surface of said vessel, said first arm supporting a plurality of caps interspaced by openings extending through said arm, said first arm capable of reciprocal movement over said upper surface of said vessel to permit covering and uncovering of said compartment openings by said caps,a second arm confronting said exterior sidewall of said vessel, said second arm having a lower end attached to said sidewall of said vessel and an upper end connected to said first arm via a first hinge,guide means maintaining reciprocal displacement of said first arm along a single horizontal line of movement,whereby said first arm of said lid is subject to a normal bias force created by said second arm whereby said plurality of caps normally covers said compartment openings, wherein when a horizontal external force is exerted in opposition to and adequate to exceed said normal bias force said first arm being capable of horizontal displacement adequate to uncover said caps from said compartment openings, and upon removal of said horizontal external forces said normal bias force acting on said first arm of said lid to re-cover said compartment openings with said caps;
  
  (V) means for pipetting sample and means for pipetting reagent into a support-containing reaction tube at a reaction tube pipetting station;
  
  (VI) an incubating station for incubating reaction tubes received from said reaction tube pipetting station containing sample, reagent and inert support;
  
  (VII) a washing station for washing bound biomaterial in said reaction tube after said reaction tubes have been incubated at said incubating station;
  
  (VIII) a detection station for detecting a quantity of analyte bound to said biomaterial in said reaction tubes after said reaction tubes have been washed at said washing station, said detection station producing a signal proportional to the quantity of analyte for each reaction tube;
  
  (IX) a reaction tube transport pathway connecting, in this sequence, said reaction tube supply means, said inert support supply and dispensing means, said reaction tube pipetting station, said incubating station, said washing station and said detection station;
  
  (X) means for identifying said sample tubes, said reagent packs, and said inert support dispensing packs on-board the analyzer;
  
  (XI) control means for automatic controlling of various components of said analyzer in a coordinated manner and being capable of executing assay selection orders for a given sample by selecting and coordinating the introduction of a particular type of reagent and particular type of biomaterial-coated inert support effective to perform a particular requested assay on said sample in a reaction tube; and
  
  (XII) means for determining and displaying and/or recording the concentration of analyte in a particular sample based on said signal produced and detected at said detection station.

10. An automated immunoassay analyzer, comprising:
- an instrument which includes(I) means for receiving a plurality of sample tubes containing a fluid sample to be assayed;
  
  (II) means for supplying a plurality of reaction tubes in which an assay on said samples can be performed;
  
  (III) insert support and dispensing means for receiving a plurality of inert support dispensing packs each storing a single type of biomaterial-coated inert support, said biomaterial capable of selectively binding an analyte of interest in a sample, and said dispensing packs capable of storing and dispensing said supports, individually, into a reaction tube at a support dispensing station, whereby a plurality of different biomaterial coated supports stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube;
  
  (IV) means for receiving a plurality of reagent storage packs capable of storing and permitting reagent withdrawal, in a self-sealing manner, whereby a plurality of different reagents stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube;
  
  (V) means for pipetting sample and means for pipetting reagent into a support-containing reaction tube at a reaction tube pipetting station;
  
  (VI) an incubating station for incubating reaction tubes received from said reaction tube pipetting station containing sample, reagent and inert support;
  
  (VII) a washing station for washing bound biomaterial in said reaction tube after said reaction tubes have been incubated at said incubating stations, said washing station comprisesa tube spinning station havinga rotatable chuck, wherein said chuck comprises a body portion and a plurality of spaced apart teeth defining intervening grooves extending through said body portion with at least one of said grooves permitting passage of fluid through said body portion and at least one other of said grooves providing means to receive and mechanically connect a projection on an open end of a tube,a fluid waste chamber housing said chuck, and said waste chamber comprises means to collect and drain fluid, and an aperture defined in a lower side of said chamber having a size effective to permit entry of said tube into said chamber,a pipette for dispensing wash water into said tube, said pipette located centrally within said chuck,drive means to rotate said chuck, anda tube elevating means located beneath said tube spinning station, said tube elevating means comprising a freely rotatable tube holder, and lifting means provided to vertically move said tube holder towards and away from said chuck;
  
  (VIII) a detection station for detecting a quantity of analyte bound to said biomaterial in said reaction tubes after said reaction tubes have been washed at said washing station, said detection station producing a signal proportional to the quantity of analyte for each reaction tube;
  
  (IX) a reaction tube transport pathway connecting, in this sequence, said reaction tube supply means, said inert support supply and dispensing means, said reaction tube pipetting station, said incubating station, said washing station and said detection station;
  
  (X) means for identifying said sample tubes said reagent packs, and said inert support dispensing packs on-board the analyzer;
  
  (XI) control means for automatic controlling of various components of said analyzer in a coordinated manner and being capable of executing assay selection orders for a given sample by selecting and coordinating the introduction of a particular type of reagent and particular type of biomaterial-coated inert support effective to perform a particular requested assay on said sample in a reaction tube; and
  
  (XII) means for determining and displaying and/or recording the concentration of analyte in a particular sample based on said signal produced and detected at said detection station.

15. An automated immunoassay analyzer, comprising:
- an instrument which includes(I) means for receiving a plurality of sample tubes containing a fluid sample to be assayed;
  
  (II) means for supplying a plurality of reaction tubes in which an assay on said samples can be performed;
  
  (III) insert support and dispensing means for receiving a plurality of inert support dispensing packs each storing a single type of biomaterial-coated inert support, said biomaterial capable of selectively binding an analyte of interest in a sample, and said dispensing packs capable of storing and dispensing said supports, individually, into a reaction tube at a support dispensing station, whereby a plurality of different biomaterial coated supports stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube, said inert support supply and dispensing means comprises(1) a plurality of bead dispenser devices supported on a common bead dispenser device carousel capable of rotation, wherein each dispenser device comprises(a) a track capable of storing and feeding a plurality of substantially spherical beads by effect of gravity to a lower track end,(b) an enclosure sealingly housing said track, comprisinga side wall enclosing outer lateral surfaces of said track,a cover sealingly enclosing an upper track end of said track and upper end of said side wall, anda base including upper and lower sections defining a plunger chamber, and a first bead chamber defined in said upper section communicating with said lower track end and said first bead chamber being offset along said plunger chamber relative to a bead exit opening in said lower section,c) a plunger sealing provided in said plunger chamber and being capable of horizontal reciprocal movement within said plunger chamber, said plunger having a throughhole defining a second bead chamber normally aligned with said first bead chamber at said lower track end and with a plunger portion concurrently blocking said exit opening via a biasing means imposing a normal horizontal bias force on said plunger, wherein when a horizontal force is exerted in opposition to and adequate to overcome said normal horizontal bias force said plunger being capable of horizontal movement to align said second bead chamber with said exit opening, said normal biasing force of said biasing means capable of horizontally moving said plunger effective to reblock said exit opening upon removal of said opposing force, and wherein said plunger further comprises a notch receiving a fingered free end of said horizontal biasing means, said horizontal biasing means having an upper end attached to said track and a medial portion extending substantially perpendicularly relative to a longitudinal axis of the plunger to terminate in said free end, and(2) identifying means for identifying each of said bead dispenser devices;
  
  (IV) means for receiving a plurality of reagent storage packs capable of storing and permitting reagent withdrawal, in a self-sealing manner, whereby a plurality of different reagents stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube;
  
  (V) means for pipetting sample and means for pipetting reagent into a support-containing reaction tube at a reaction tube pipetting station;
  
  (VI) an incubating station for incubating reaction tubes received from said reaction tube pipetting station containing sample, reagent and inert support;
  
  (VII) a washing station for washing bound biomaterial in said reaction tube after said reaction tubes have been incubated at said incubating station;
  
  (VIII) a detection station for detecting a quantity of analyte bound to said biomaterial in said reaction tubes after said reaction tubes have been washed at said washing station, said detection station producing a signal proportional to the quantity of analyte for each reaction tube;
  
  (IX) a reaction tube transport pathway connecting, in this sequence, said reaction tube supply means, said inert support supply and dispensing means, said reaction tube pipetting station, said incubating station, said washing station and said detection station;
  
  (X) means for identifying said sample tubes, said reagent packs, and said inert support dispensing packs on-board the analyzer;
  
  (XI) control means for automatic controlling of various components of said analyzer in a coordinated manner and being capable of executing assay selection orders for a given sample by selecting and coordinating the introduction of a particular type of reagent and particular type of biomaterial-coated inert support effective to perform a particular requested assay on said sample in a reaction tube; and
  
  (XII) means for determining and displaying and/or recording the concentration of analyte in a particular sample based on said signal produced and detected at said detection station.

16. An automated immunoassay analyzer, comprising:
- an instrument which includes(I) means for receiving a plurality of sample tubes containing a fluid sample to be assayed, wherein said sample tube receiving means comprises at least one sample tube rack supported on a rotatable sample tube carousel;
  
  (II) means for supplying a plurality of reaction tubes in which an assay on said samples can be performed;
  
  (III) insert support and dispensing means comprising a rotatable inert support pack carousel for receiving a plurality of inert support dispensing packs each storing a single type of biomaterial-coated inert support, said biomaterial capable of selectively binding an analyte of interest in a sample, and said dispensing packs capable of storing and dispensing said supports, individually, into a reaction tube at a support dispensing station, whereby a plurality of different biomaterial coated supports stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube;
  
  (IV) means comprising a rotatable reagent pack carousel for receiving a plurality of reagent storage packs capable of storing and permitting reagent withdrawal, in a self-sealing manner, whereby a plurality of different reagents stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube, and wherein said reagent pack carousel is located concentrically within said sample tube carousel, and said sample tube carousel, and said inert support pack carousel are independently rotatable relative to each other, said means for receiving a plurality of reagent storage packs comprisinga plurality of reagent containers removably fitted into a common reagent carousel, each said reagent container comprisinga vessel having a plurality of separate compartments defined by sidewalls and a cover as an upper surface, each compartment having an opening in said upper surface;
  
  a self-sealing lid attached to the exterior of a sidewall of said vessel, comprisinga first arm confronting said upper surface of said vessel, said first arm supporting a plurality of caps interspaced by openings extending through said arm, said first arm capable of reciprocal movement over said upper surface of said vessel to permit covering and uncovering of said compartment openings by said caps,a second arm confronting said exterior sidewall of said vessel, said second arm having a lower end attached to said sidewall of said vessel and an upper end connected to said first arm via a first hinge,guide means maintaining reciprocal displacement of said first arm along a single horizontal line of movement,whereby said first arm of said lid is subject to a normal bias force created by said second arm whereby said plurality of caps normally covers said compartment openings, wherein when a horizontal external force is exerted in opposition to and adequate to exceed said normal bias force said first arm being capable of horizontal displacement adequate to uncover said caps from said compartment openings, and upon removal of said horizontal external forces said normal bias force acting on said first arm of said lid to re-cover said compartment openings with said caps;
  
  (V) means for pipetting sample and means for pipetting reagent into a support-containing reaction tube at a reaction tube pipetting station;
  
  (VI) an incubating station for incubating reaction tubes received from said reaction tube pipetting station containing sample, reagent and inert support;
  
  (VII) a washing station for washing bound biomaterial in said reaction tube after said reaction tubes have been incubated at said incubating station;
  
  (VIII) a detection station for detecting a quantity of analyte bound to said biomaterial in said reaction tubes after said reaction tubes have been washed at said washing station, said detection station producing a signal proportional to the quantity of analyte for each reaction tube;
  
  (IX) a reaction tube transport pathway connecting, in this sequence, said reaction tube supply means, said inert support supply and dispensing means, said reaction tube pipetting station, said incubating station, said washing station and said detection station;
  
  (X) means for identifying said sample tubes, said reagent storage packs, and said inert support dispensing packs on-board the analyzer;
  
  (XI) control means for automatic controlling of various components of said analyzer in a coordinated manner and being capable of executing assay selection orders for a given sample by selecting and coordinating the introduction of a particular type of reagent and particular type of biomaterial-coated inert support effective to perform a particular requested assay on said sample in a reaction tube; and
  
  (XII) means for determining, and displaying and/or recording the concentration of analyte in a particular sample based on said signal produced and detected at said detection station.

17. An automated immunoassay analyzer, comprising:
- an instrument which includes(I) means for receiving a plurality of sample tubes containing a fluid sample to be assayed, wherein said sample tube receiving means comprises at least one sample tube rack supported on a rotatable sample tube carousel;
  
  (II) means for supplying a plurality of reaction tubes in which an assay on said samples can be performed;
  
  (III) insert support and dispensing means comprising a rotatable inert support pack carousel for receiving a plurality of inert support dispensing packs each storing a single type of biomaterial-coated inert support, said biomaterial capable of selectively binding an analyte of interest in a sample, and said dispensing packs capable of storing and dispensing said supports, individually, into a reaction tube at a support dispensing station, whereby a plurality of different biomaterial coated supports stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube, said inert support supply and dispensing means comprises(1) a plurality of bead dispenser devices supported on a common bead dispenser device carousel capable of rotation, wherein each dispenser device comprises(a) a track capable of storing and feeding a plurality of substantially spherical beads by effect of gravity to a lower track end,(b) an enclosure sealingly housing said track, comprisinga side wall enclosing outer lateral surfaces of said track,a cover sealingly enclosing an upper track end of said track and upper end of said side wall, anda base including upper and lower sections defining a plunger chamber, and a first bead chamber defined in said upper section communicating with said lower track end and said first bead chamber being offset along said plunger chamber relative to a bead exit opening in said lower section,c) a plunger sealingly provided in said plunger chamber and being capable of horizontal reciprocal movement within said plunger chamber, said plunger having a throughhole defining a second bead chamber normally aligned with said first bead chamber at said lower track end and with a plunger portion concurrently blocking said exit opening via a biasing means imposing a normal horizontal bias force on said plunger, wherein when a horizontal force is exerted in opposition to and adequate to overcome said normal horizontal bias force said plunger being capable of horizontal movement to align said second bead chamber with said exit opening, said normal horizontal bias force of said biasing means capable of horizontally moving said plunger effective to reblock said exit opening upon removal of said opposing force, and wherein said plunger further comprises first and second resilient sealing rings, respectively, where said first flange is located between said exit opening and said first bead chamber and said second flange is located between said biasing means and a distal end of said plunger at which said horizontal force is exerted, and(2) identifying means for identifying each of said bead dispenser devices;
  
  (IV) means comprising a rotatable reagent pack carousel for receiving a plurality of reagent storage packs capable of storing and permitting reagent withdrawal, in a self-sealing manner, whereby a plurality of different reagents stored on-board said analyzer can be selected from for addition to said reaction tube for performing a particular assay in said reaction tube, and wherein said reagent pack carousel is located concentrically within said sample tube carousel, and said sample tube carousel, and said inert support pack carousel are independently rotatable relative to each other;
  
  (V) means for pipetting sample and means for pipetting reagent into a support-containing reaction tube at a reaction tube pipetting station;
  
  (VI) an incubating station for incubating reaction tubes received from said reaction tube pipetting station containing sample, reagent and inert support;
  
  (VII) a washing station for washing bound biomaterial in said reaction tube after said reaction tubes have been incubated at said incubating station;
  
  (VIII) a detection station for detecting a quantity of analyte bound to said biomaterial in said reaction tubes after said reaction tubes have been washed at said washing station, said detection station producing a signal proportional to the quantity of analyte for each reaction tube;
  
  (IX) a reaction tube transport pathway connecting, in this sequence, said reaction tube supply means, said inert support supply and dispensing means, said reaction tube pipetting station, said incubating station, said washing station and said detection station;
  
  (X) means for identifying said sample tubes, said reagent storage packs, and said inert support dispensing packs on-board the analyzer;
  
  (XI) control means for automatic controlling of various components of said analyzer in a coordinated manner and being capable of executing assay selection orders for a given sample by selecting and coordinating the introduction of a particular type of reagent and particular type of biomaterial-coated inert support effective to perform a particular requested assay on said sample in a reaction tube; and
  
  (XII) means for determining, and displaying and/or recording the concentration of analyte in a particular sample based on said signal produced and detected at said detection station.

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Current Assignee
Siemens Healthcare Diagnostics Incorporated (Siemens AG)
Original Assignee
DPC Cirrus, Inc.
Inventors
Palmieri, Thomas, Fleischer, Eric C., Montalbano, Greg A., Montalbano, Chris P., Montalbano, Anthony P., Babson, Arthur L.
Primary Examiner(s)
Le, Long V.

Application Number

US08/672,654
Time in Patent Office

998 Days
Field of Search

422/63-65, 422/67, 422/68.1, 422/81, 422/100, 422/101, 422/102, 422/103, 422/104, 436/43, 436/47, 436/48, 436/49, 436/54, 436/174, 436/177, 436/179, 436/180, 206/569, 220/253, 220/255, 220/264, 220/281, 220/348, 222/518, 222/559, 222/482, 215/315, 221/264, 221/266, 134/150, 134/157
US Class Current

422/65
CPC Class Codes

B01L 3/50853   with covers or lids

G01N 2035/00435   Refrigerated reagent storage

G01N 2035/0405   manipulating closing or ope...

G01N 2035/0451   composed of interchangeable...

G01N 35/02   using a plurality of sample...

G01N 35/1002   Reagent dispensers

Y10T 436/11   Automated chemical analysis

Y10T 436/113332   with conveyance of sample a...

Y10T 436/114165   with step of insertion or r...

Y10T 436/114998   with treatment or replaceme...

Y10T 436/115831   Condition or time responsive

Y10T 436/25375   Liberation or purification ...

Y10T 436/25625   Dilution

Y10T 436/2575   Volumetric liquid transfer

Automated immunoassay analyzer

First Claim

4 Assignments

0 Petitions

Accused Products

Abstract

283 Citations

17 Claims

Specification

Solutions

Use Cases

Quick Links

Automated immunoassay analyzer

First Claim

4 Assignments

Subscription Required

Subscription Required

0 Petitions

Subscription Required

Accused Products

Subscription Required

Abstract

283 Citations

17 Claims

Specification

Subscription Required

Solutions

Use Cases

Quick Links