Patent Description:
In medical testing and processing (e.g., immunoassay testing), robotics have been used to minimize exposure to, or contact with, bodily fluid samples (otherwise referred to as "specimens") and/or to increase productivity. For example, in some existing automated testing and processing systems, reagent dispenser packs may be provided in accessible locations, such as in rotating carousels. Dispenser packs may be provided that have multiple compartments containing different reagents, for example. Likewise, sample containers (such as blood collection tubes or the like) may be provided at another location, such as in sample container racks. Conventionally, both the blood collection tubes and the reagent dispenser packs have been accessed by pipettes. Each pipette aspirates a predetermined amount of the specimen and the reagent and dispenses them into a reaction vessel (e.g., a reaction cuvette). Typically, the reagent pipette is a separate device from the sample pipette. The cuvette is then incubated for a defined period of time in an incubation ring, and may undergo a wash operation therein. The reacted sample or portion thereof is then read by a suitable testing component, such as luminometer to determine a predetermined characteristic.

Although existing immunoassay apparatus and methods may provide suitable efficiencies, more efficient and cost-effective immunoassay apparatus and methods are sought to further reduce both processing time and cost, as well as overall immunoassay apparatus cost and size. Accordingly, systems, apparatus, and methods that may improve speed and/or cost of immunoassay testing or reduce their size are desired.

The present invention is an immunoassay apparatus and a method of dispensing a reagent as defined in the appended claims. In a first aspect, a reagent dispenser apparatus is provided. The dispenser apparatus includes a reagent container having a dispense port operable to open and close to dispense reagent.

According to another aspect, an immunoassay apparatus is provided. The immunoassay apparatus includes a reaction vessel carrier containing one or more reaction vessel, and a dispenser support containing one or more reagent dispenser apparatus wherein at least one of the reagent dispenser apparatus includes a plurality of dispense ports operable to open and close to dispense a reagent directly into the one or more of the reaction vessel located below the dispenser support.

In another apparatus aspect, a reagent dispensing apparatus is provided. The reagent dispensing apparatus includes a dispenser support, and a plurality of reagent dispenser apparatus provided in the dispenser support, wherein at least one of the reagent dispenser apparatus includes a plurality of dispense ports operable to open and close to dispense a reagent.

In a method aspect, a method of dispensing a reagent is provided. The method of dispensing a reagent includes providing a reagent dispenser apparatus, and dispensing reagent from the reagent dispenser apparatus without a pipetting operation.

Still other aspects, features, and advantages of the present invention may be readily apparent from the following detailed description by illustrating a number of example embodiments and implementations, including the best mode contemplated for carrying out the present invention. The present invention may also be capable of other and different embodiments, and its several details may be modified in various respects, all without departing from the scope of the present invention which is defined by the claims. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The drawings are not necessarily drawn to scale.

In existing immunoassay apparatus, it may be desired to provide multiple reagents within a particular immunoassay instrument such that a wide variety of tests may be carried out. Prior art systems have included multi-well reagent dispenser apparatus, such as the DIMENSION® ABS FLEX® reagent cartridges available from Siemens Healthcare Diagnostics Inc. Such wells of these multi-well reagent containers may be accessed through the top by one or more aspirating probes, which may pierce a thin film that may be adhered atop of the reagent dispenser container. Multiple probes may be used in current systems to prevent reagent carryover. Moreover, separate probes may be used to dispense sample fluid (e.g., blood or blood constituent). Furthermore, existing conventional systems may have multiple probe washing stations, water backing systems per probe, and even a robot per probe in order to accomplish the desired movements of the respective probes. Such systems are therefore relatively complex requiring multiple robots to move the numerous aspirating probes between the reagent container wells, sample containers, and the reaction vessels (e.g., cuvettes), as well as multiple probe washing stations and water backing systems. Examples of known automatized fluid dispensing systems that allow metering and dispensing a fluid without a pipetting operation are known from <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

In view of the foregoing problems and complexities of conventional reagent dispenser systems, embodiments of the present invention provide reagent dispenser apparatus, reagent dispensing apparatus adapted to dispense reagent from the reagent dispenser apparatus, and dispensing methods adapted and operational to readily dispense reagent, but without requiring a dispensing probe. Accordingly, the reagent dispensing apparatus and immunoassay instrument including the reagent dispensing apparatus may be made much less complex by reducing the number of robots, number of wash stations, water backing lines and pumps, as well as the number of aspiration probes. The reagent dispensing apparatus in accordance with one or more embodiments may also reduce the overall time it takes to dispense reagent. In some embodiments, the relative size of the immunoassay instrument may be made smaller.

In a first embodiment, an immunoassay apparatus is provided. The immunoassay apparatus includes a reaction vessel carrier (e.g., a cuvette-carrying ring) containing one or more reaction vessels, and a dispenser support containing one or more reagent dispenser container wherein at least some of the reagent dispense container, and preferably all, include a dispense mechanism. The dispense mechanism includes a plurality of dispense ports operable to open and close to dispense a reagent. The dispense port is operable to dispense reagent directly into the one or more of the reaction vessels contained in the reaction vessel carrier located below the dispenser support. In some embodiments, the dispense mechanism may be actuatable to dispense reagent. Mechanical and pneumatic dispensing actuation is described. The actuation may comprise one to several actuation cycles in order to dispense a predefined volume "shots" of the reagent.

In another aspect, a reagent dispensing apparatus is provided having a dispenser support and one or more reagent dispenser containers provided in the dispenser support. At least one (and preferably all) of the reagent dispenser containers includes a dispense mechanism. The dispense mechanism includes a plurality of dispense ports and is operable to open and close to dispense a reagent. The dispense mechanism may include a valve or other suitable structure operable to enable dispensing of reagent from, for example, a bottom of the reagent container body directly into the reaction vessel (e.g., cuvette).

In another non-claimed aspect, a reagent dispenser apparatus is provided, comprising a reagent container having a dispense mechanism. The dispense mechanism includes a dispense port operable to open and close to dispense reagent.

These and other aspects and features of embodiments of the invention will be described with reference to <FIG> herein.

In accordance with one or more embodiments of the invention, as best shown in <FIG>, <FIG>, and <FIG>, an immunoassay apparatus <NUM> containing an improved reagent dispensing apparatus <NUM> and one or more reagent dispenser apparatus 102A, 102B is described. Reagent dispensing apparatus <NUM> may have a single well or multiple-wells, or combinations thereof, as shown. Thus, each reagent dispenser apparatus 102A, 102B may be operational to dispense either a single reagent type or multiple reagent types. Reagent dispenser apparatus 102A, 102B may alternatively be referred to as a reagent dispenser herein. The immunoassay apparatus <NUM> is useful for carrying out immunoassay testing to determine the presence of a particular analyte or other material or substance of interest contained within a specimen (e.g., a sample of a biofluid).

In particular, the described embodiment includes a housing <NUM> (shown dotted in <FIG>) that may fully or partially surround the various internal components. The reagent dispensing apparatus <NUM> may be received in the housing <NUM>, which may be made of plastic or other suitable rigid material. The reagent dispensing apparatus <NUM> may be made up of at least a dispenser support <NUM> and a reaction vessel carrier <NUM>, which is configured to contain one or more reaction vessels <NUM>. The dispenser support <NUM>, which may be in the form of a carousel, may have any suitable shape adapted to receive and position one or more reagent dispensers 102A, 102B thereon. The reaction vessel carrier <NUM> may have any suitable shape adapted to support one or more reaction vessels underneath the dispenser support <NUM>.

In particular, the reagent dispensers 102A, 102B may be arranged with their long dimension oriented radially along the dispenser support <NUM> in some embodiments. For example, the reagent dispensers 102A, 102B may extend radially along a radius of the dispenser support <NUM> from a rotational axis <NUM> thereof. Suitable pockets or other retaining or locking features may be provided on the dispenser support <NUM> to position and secure the reagent dispensers 102A, 102B in a defined orientation thereon. The dispenser support <NUM> may be rotatable about the rotational axis <NUM> by a suitable dispenser support motor <NUM> (shown dotted) in some embodiments. Dispenser support motor <NUM> may be a stepper motor or the like and may receive control signals from a controller <NUM>. Other suitable motors and/or drive systems may be used to accomplish rotation and/or positioning of the dispenser support <NUM>. For example, in some embodiments, the dispenser support motor <NUM> may directly drive a shaft coupled to or integral with the dispenser support <NUM> and may have a rotational shaft located in line with the rotational axis <NUM>. In other embodiments, the motor may be offset from the rotational axis <NUM> and drive the dispenser support <NUM> via a suitable drive system, such as a gear, pulley and belt, chain, worm gear, combination, or the like. Any suitable means for causing movement (e.g., rotation) of the dispenser support <NUM> may be used.

The dispenser support <NUM> includes a dispenser support body, which may be a molded body, having one or more reagent dispenser apparatus 102A, 102B mounted thereto. In particular, as shown, the dispenser support <NUM> may have mounted therein, a plurality of reagent dispenser apparatus 102A, 102B (a few labeled). At least some of the reagent dispenser apparatus 102A, 102B, and preferably all of them, include a dispense mechanism adapted and operational to open and close to dispense reagent. The dispense mechanism includes a dispense port, such as dispense port 314A (See <FIG>). The dispense port 314A may include any suitable functionality (e.g., one or more valves) that is operable to open and close the dispense port, i.e., control flow there through, to dispense a reagent 316A directly into the one or more of the reaction vessels <NUM>. The reaction vessels <NUM> may be located in the reaction vessel carrier <NUM>, wherein at least a portion of the reaction vessel carrier <NUM> may lie below the dispenser support <NUM>. In the depicted embodiment, the reaction vessel carrier <NUM> is provided as a carrier ring configured to rotate underneath a portion of the dispenser support <NUM>. When dispensing takes place, a particular reaction vessel <NUM> to receive reagent is positioned directly below particular dispense port 314A of a reagent dispenser apparatus 102A. Thus, dispensing occurs without any pipetting operation with a probe, as was the case in conventional immunoassay instruments.

As shown in <FIG>, the footprint of the dispenser support <NUM> at least partially overlaps the reaction vessel carrier <NUM> such that dispensing of reagent 316A may be accomplished directly into a reaction vessel <NUM>. Accordingly, the operation of dispensing a reagent 316A is substantially improved. In particular, a number of aspiration probes provided in the immunoassay apparatus <NUM> may be reduced, a number of probe wash stations may be reduced, water backing systems may be reduced, and dispensing speed may possibly be increased.

In one or more embodiments, the reaction vessel carrier <NUM> may comprise a carrier ring having a plurality of receptacles (e.g., pockets or the like) configured to receive reaction vessels <NUM> and rotate them underneath a portion of the dispenser support <NUM>. Reaction vessel carrier <NUM> comprising a carrier ring may hold the reaction vessels <NUM> (e.g., clear cuvettes) and provide them in a circle-shaped orientation arranged at a common radius. More than one radius may be provided in some embodiments, wherein a first plurality of reaction vessels may be provided at a first radius, and a second plurality of reaction vessels may be provided at a different radius. Reaction vessel carrier <NUM> may include any suitable construction enabling the carrying of reaction vessels <NUM>, and may include a plurality of suitable receptacles adapted to receive reaction vessels <NUM> therein. Like dispenser support <NUM>, reaction vessel carrier <NUM> may be rotated incrementally by a suitable rotational member, such as carrier motor <NUM> (shown dotted in <FIG>). Carrier motor <NUM> may be a stepper motor or other motor as described for the dispenser support <NUM>. Rotation of the reaction vessel carrier <NUM> may be controlled via control signals from the controller <NUM>.

Again referring to <FIG>, and <FIG>, the immunoassay apparatus <NUM> includes a specimen staging area <NUM>. Specimens contained in specimen containers <NUM> (e.g., sample tubes or blood collection vessels) may be provided to the specimen staging area <NUM> in one or more sample racks <NUM>. In the depicted example, the sample rack <NUM> is a <NUM> x <NUM> position rack enabling the processing of <NUM> specimens. Other sizes of sample racks <NUM> may be used. One or more than one sample rack may be provided at the specimen staging area <NUM>. The one or more sample racks <NUM> may be inserted into and/or removed from the immunoassay apparatus <NUM> through an opening <NUM> formed in the housing <NUM>. Opening <NUM> may include an opening, removable or openable door in some embodiments. Locating features (not shown) within the immunoassay apparatus <NUM> may function to precisely position the one or more sample racks <NUM> within the interior of the immunoassay apparatus <NUM>, and may secure it to a portion of the housing <NUM> or an internal frame of the immunoassay apparatus <NUM>, for example.

A sample probe <NUM> may also be provided within the immunoassay apparatus <NUM>. The sample probe <NUM> may include a proboscis portion 107P and a body 107B. The body 107B may be connected to a pump or other source of vacuum pressure (not shown) such that specimen aspiration may take place. Suitable configurations of aspiration systems which may be used with embodiments of the present invention are described in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>, for example. Other suitable aspiration systems may be used.

The body 107B may be coupled to, and moved by, a suitable robot <NUM>, which may be coupled to the housing <NUM> either directly, or through an internal frame. The robot <NUM> may be any suitable robot adapted to move the sample probe <NUM> from the specimen containers <NUM> at the specimen staging area <NUM> to the reaction vessel <NUM> resident in the reaction vessel carrier <NUM>. The robot <NUM> may be a multi-arm robot, a gantry robot, or the like. Other types of robots may be used. The robot <NUM> may include suitable elements to accomplish three-dimensional motion of the proboscis portion 107P of the sample probe <NUM>. For example, the robot <NUM> may be capable of motion in the X, Y and Z directions as shown. The means for moving the sample probe <NUM> may include any suitable conventional motion-producing mechanism, such as one or more stepper motors, servo motors, pneumatic or hydraulic motors, electric motors, or the like. Furthermore, drive systems including chains, guides, pulleys and belt arrangements, gear or worm drives or other conventional drive components may be utilized to cause the motion of the sample probe <NUM>.

Adjacent to the specimen staging area <NUM>, may be one or more probe tip supply <NUM> that includes probe tips that may be picked up by the proboscis portion 107P. Immunoassay apparatus <NUM> may include a reaction vessel supply <NUM>, which may be a cuvette loader, for example. Reaction vessel supply <NUM> may be a conventional cuvette loader and is operational to load reaction vessels <NUM> into the reaction vessel carrier <NUM>.

The immunoassay apparatus <NUM> also includes a test component <NUM>, that may determine an analyte, substance, or characteristic, or the like of the reaction fluid contained in the reaction vessel <NUM>, such as after undergoing a reaction. For example, in some embodiments, test component <NUM> may be an apparatus (e.g., a luminometer) that operates to measure luminescence of the reaction sample through a reaction vessel <NUM> (e.g., a clear cuvette). In some embodiments, the testing is carried out while the reaction vessel <NUM> is resident in reaction vessel carrier <NUM>. In other embodiments, an elevator may be used to lift or remove the reaction vessel <NUM> from the reaction vessel carrier <NUM> during the test. In some embodiments, the test component <NUM> may send a light signal and determine therefrom (e.g., via a sensor) another characteristic of the reaction fluid (containing specimen, one or more reagents, and possibly a dilutant). For example, the test component <NUM> may determine luminescence, absorbance, or the like of the reaction fluid contained in the reaction vessel <NUM>. Other types of testing may be carried out on the reaction liquid in the reaction vessel <NUM>. For example, photometric, turbidimetric, chemiluminescence, nephelometric, or other testing may be carried out. More than one test component <NUM> may be provided. The test component <NUM> may be tested after undergoing a suitable incubation period and wash process at wash station <NUM> while resident in reaction vessel carrier <NUM>. The reaction process carried out in the reaction vessel <NUM> and wash process carried out in wash station <NUM> are entirely conventional.

The immunoassay apparatus <NUM> may also include an identification reader <NUM>, such as a barcode reader, or any suitable identification code, indicia, device, or the like. The identification reader <NUM> may be provided at any suitable position to enable identification of, for example, the sample rack <NUM> that has been inserted into the immunoassay apparatus <NUM>. Identification of, and location of the individual specimen containers <NUM> in the sample rack <NUM> may be known based upon stored data that is contained in, or assessable by, the controller <NUM>. The identification reader <NUM> may also read codes (e.g., barcodes, indicia or other identification devices) located on one or more (preferably all) of the reagent dispenser apparatus 102A, 102B mounted on the dispenser support <NUM>. This allows the type of reagent contained therein, and possibly other information about the reagent dispenser apparatus 102A, 102B, such as the location, number of dispensed shots, and/or lot number, manufacture date, calibration data, or the like to be readily accessed and/or verified. As the dispenser support <NUM> is first mounted in the immunoassay apparatus <NUM>, the dispenser support <NUM> may be rotated so that each reagent dispenser apparatus 102A, 102B passed by the identification reader <NUM> so that the identity, location, and/or content of the reagent dispenser apparatus 102A, 102B may be determined and stored in memory of the controller <NUM>. As the reagent in the reagent dispenser apparatus 102A, 102B becomes all used up, the dispenser support <NUM> may be removed, refilled, and then replaced in the immunoassay apparatus <NUM>. A door 103D above the dispenser support <NUM>, which may be removable or hinged, may be provided.

An embodiment of a reagent dispenser apparatus 102A in accordance with another aspect of the invention will now be described with reference to <FIG>. Reagent dispenser apparatus 102A includes a reagent container formed by a container body <NUM> with one or more reagent storage chambers (e.g., 340A, 340B, and 340C) formed by external and internal walls therein. Each reagent storage chamber (e.g., 340A, 340B, and 340C) may contain a different type of reagent. A reagent is a substance used in a chemical reaction to detect, measure, examine, or produce another substance(s). The reagent may be a chemiluminescence reagent (e.g., chemiluminescence phases such as solid, lite, and buffer solutions), a mitigation agent (such as NaCOI), or the like. A diluting agent (e.g., water) may also be dispensed as part of a chemical or biological reaction in a reaction vessel <NUM> along with the reagent. Reagents, as used herein, are dispensed materials that are used in an immunoassay reaction. The number of agent storage chambers may be one (e.g., <FIG>) or more than one (such as three shown in <FIG>). Other numbers of reagent storage chambers may be used.

The reagent dispenser apparatus 102A further includes a dispense mechanism. The dispense mechanism may include a dispense port (e.g., 314A, 314B, 314C) associated with some or all of the reagent storage chambers (e.g., 340A, 340B, and 340C). Dispense ports (e.g., 314A, 314B, 314C) are operable to open and close to dispense reagent (e.g., reagent 316A, 316B, 316C) from the respective reagent storage chambers (e.g., 340A, 340B, and 340C). "Open" as used herein refers to a condition where flow through a particular dispense port (e.g., 314A, 314B, 314C) is allowed, whereas "close" as used herein refers to a condition where flow through the dispense port (e.g., 314A, 314B, 314C) is not allowed. For a single reagent dispense operation, the dispense port 314A may be opened once and closed once, for example. Once opened, a defined amount (e.g., volume) of reagent 316A may be dispensed. This is otherwise referred to herein as a "shot" of reagent. Defined amounts (e.g., shots) of reagents 316B, 316C may likewise be dispensed by opening and closing of dispense ports 314B, 314C. Dispense operations may be directly into a reaction vessel <NUM>.

In the depicted embodiment, the dispense mechanism includes one or more reagent dispense chambers (e.g., 342A, 342B, 342C). Reagent dispense chambers (e.g., 342A, 342B, 342C) are shown coupled (e.g., fluidly connected) to the respective reagent storage chambers (e.g., 340A, 340B, and 340C) by one or more inlet ports (e.g., inlet ports 344A, 344B, 344C). Inlet ports 344A, 344B, 344C are flow passages that allow reagent 316A, 316B, 316C to flow from the respective reagent storage chambers 340A, 340B, and 340C to the reagent dispense chambers 342A, 342B, 342C. Reagent dispense chambers 342A, 342B, 342C may have a contained volume of, for example, between about 10µl and about 400µl. Reagent storage chambers 340A, 340B, 340C may have a contained volume of, for example, between about <NUM> and about <NUM>. Other volumes may be used. In one or more embodiments, the contained volume of the respective reagent storage chambers (e.g., 340A, 340B, and 340C) is much larger than the contained volume of the reagent dispense chambers (e.g., 342A, 342B, 342C).

Dispense ports 314A, 314B, 314C may include a dispense valve 345A, 345B, 345C either therein or operable therewith. Dispense valve 345A, 345B, 345C may be any suitable valve that may control flow of reagent 316A, 316B, 316C from the reagent dispense chambers 342A, 342B, 342C. For example, the dispense valve 345A, 345B, 345C may be a one-way valve, i.e., allowing flow in one direction only (e.g., out of the respective reagent dispense chambers 342A, 342B, 342C, for example). The dispense valve 345A, 345B, 345C may be a check valve, for example. The dispense valve 345A, 345B, 345C may be a spring-loaded ball valve, a poppet valve, a reed valve, a membrane valve, or the like. Other suitable types of one-way valves may be used. Dispense valve 345A, 345B, 345C may be passive, that is, containing only passive components that open flow in response to a predesigned pressure increase. For example, dispense valve 345A, 345B, 345C may open if the pressure in the reagent dispense chamber exceeds about <NUM> psi, for example. Other suitable opening pressures may be used. Dispense valve 345A, 345B, 345C may be located proximate to a bottom surface 339B of the container body <NUM>. In particular, the dispense ports 314A, 314B, 314C may exit directly from a bottom (e.g., bottom surface 339B) of the container body <NUM> in some embodiments.

In the depicted embodiment, an inlet valve 346A, 346B, 346C may be included in, or operative with, the inlet ports 344A, 344B, 344C. Inlet valve 346A, 346B, 346C may be operable to control and limit flow of reagent through the inlet ports 344A, 344B, 344C, which connect the respective reagent storage chambers 340A, 340B, 340C and the respective reagent dispense chambers 342A, 342B, 342C. Inlet valve 346A, 346B, 346C may be one-way valve, and may be the same or different construction than the dispense valve 345A, 345B, 345C. In the depicted embodiment, the container body <NUM> has the plurality of dispense ports 314A, 314B, 314C spaced along a length thereof. These dispense ports 314A, 314B, 314C may positioned so as to be aligned with desired ones of the reaction vessels <NUM> that are mounted in the reaction vessel carrier <NUM> by appropriate motions (e.g., rotations) of the dispenser support <NUM> and the reaction vessel carrier <NUM>.

For example, in the depicted embodiment, rotation of the dispenser support <NUM> and the reaction vessel carrier <NUM> may be coordinated to vertically align dispense port 314C with a desired reaction cuvette <NUM> that is to receive the reagent 316C. Likewise, dispense port 314B may be aligned with a desired reaction cuvette <NUM> that is to receive the reagent 316B, and dispense port 314A may be aligned with a desired reaction cuvette <NUM> that is to receive the reagent 316A. Through appropriate coordinated rotations of the dispenser support <NUM> and reaction vessel carrier <NUM>, any one reaction cuvette <NUM> may then receive one, more than one, or even more than two reagents. Reagent may be received from a single reagent dispenser apparatus adapted to contain an auxiliary reagent (e.g., reagent dispenser apparatus 102B) or from a multiple reagent dispenser apparatus (e.g., reagent dispenser apparatus 102A).

In operation, the depicted embodiment of dispenser apparatus 102A, as shown in <FIG>, includes the reagent dispense chamber 342A having an inlet port 344A and dispense port 314A. The dispense mechanism includes an inlet valve 346A (e.g., a one-way valve) controlling flow through the inlet port 344A, and a dispense valve 345A (e.g., a one-way valve) controlling flow through the dispense port 314A. The reagent dispense chamber 342A includes a moveable wall 347A adapted to change a volume of the reagent dispense chamber 342A. The moveable wall 347A is a flexible diaphragm. In a non-claimed embodiment, the moveable wall may comprise bellows, or other flexible member.

Moveable wall 347A may be made of any suitable flexible material, such as a polymer (e.g., rubber, silicone, or the like). Moveable wall <NUM> may be molded or bonded to a closure member 348A, which may have the dispense port 314A and dispense valve 345A formed or received thereon. Actuation of the moveable wall 347A, such as by an actuation member 350A (shown dotted), causes movement of the moveable wall 347A. Upward movement of the actuation member 350A displaces reagent 316A from the reagent dispense chamber 342A, as shown by first dotted arrows <NUM>, into a reaction vessel <NUM> positioned in the reaction vessel carrier <NUM> directly vertically below the dispense port 314A. Actuation member 350A may be a rod or other suitable displaceable member coupled to an actuator, such as a solenoid, piezoactuator, or the like. Actuation of the actuation member 350A through a predefined translational distance (e.g., stroke) in the upward direction flexes and displaces the moveable wall 347A and thereby displaces a known amount of reagent 316A (i.e., a "shot" of reagent 316A) from the reagent dispense chamber 342A into the reaction vessel <NUM>, as shown by first dotted arrows <NUM>.

Retraction motion of the actuation member 350A downward through a defined return distance draws in another "shot" of the reagent 316A into the reagent dispense chamber 342A from the reagent storage chamber 340A through inlet port 344A and inlet valve 346A as shown by second dotted arrows <NUM>. Actuation of the actuation member 350A may be carried out once to dispense a single "shot" or multiple times to dispense multiple "shots" of the reagent 316A into a particular reaction vessel <NUM> that has been vertically aligned with the dispense port 314A through appropriate coordinated rotations of the dispenser support <NUM> and reaction vessel carrier <NUM>.

<FIG> illustrates another embodiment of a reagent dispenser apparatus <NUM> that includes reagent dispense chamber 342A having an inlet port 344A and dispense port 314A, not falling under the scope of the claims. The dispense mechanism includes an inlet valve 346A (e.g., a one-way valve) controlling flow through the inlet port 344A, and a dispense valve 345A (e.g., a one-way valve) controlling flow through the dispense port 314A. The reagent dispense chamber 342A includes a moveable wall 347B adapted to change a volume of the reagent dispense chamber 342A. The moveable wall 347B in this embodiment may comprise a puck that is sealed to a closure member 348B, by a suitable sealing member <NUM> (e.g., O-ring, lip seal or other suitable sealing member). Upward motion of the actuation member 350A causes movement of the moveable wall 347B and displaces reagent 316A from reagent dispense chamber 342A. Spring <NUM> returns the moveable wall upon retraction of the actuation member 350A and draws in a new shot of reagent 316A from the reagent storage chamber 340A.

<FIG> illustrates an embodiment of a single-reagent dispenser apparatus <NUM> that includes reagent dispense chamber <NUM> having an inlet port <NUM> and dispense port <NUM> not falling under the scope of the claims. The dispense mechanism includes an inlet valve <NUM> (e.g., a one-way valve) allowing flow into the inlet port <NUM> when sufficient pressure differential across the valve is present, but not allowing backflow, and a dispense valve <NUM> (e.g., a one-way valve) controlling flow out of the dispense port <NUM> once sufficient pressure is reached. The reagent dispense chamber <NUM> includes a moveable wall <NUM> adapted to change a volume of the reagent dispense chamber <NUM>. The moveable wall <NUM> in this embodiment may comprise any of the previously-disclosed structures. Upward motion of an actuation member (not shown) contacts the moveable wall <NUM> and displaces reagent <NUM> from reagent dispense chamber <NUM>. Upon retraction of the actuation member, a new shot of reagent <NUM> from the reagent storage chamber <NUM> is drawn into the reagent dispense chamber <NUM> so that it is now ready for another shot dispense.

In the depicted embodiment, a top of the container body <NUM> may include a top opening <NUM> adapted to receive a probe therein, should the reagent dispenser apparatus <NUM> be used in a conventional, probe-aspirated system. Thus, as configured, the reagent dispenser apparatus <NUM> is capable of either top probe aspiration or bottom probe-less aspiration. However, it should be understood that in a reagent dispensing apparatus as described herein, the top opening <NUM> may not be present. In the case where the top opening <NUM> is present to allow use in conventional, probe-aspirated systems, the top opening <NUM> may be covered with a sealing sheet <NUM>, such as with an adhesive-backed foil. Likewise, such openings 341A-341C may also be present in the multi-chamber configurations, as shown in <FIG> to allow use in either conventional, probe-aspirated systems, or the inventive bottom-aspirated systems as described herein. Likewise, dispenser apparatus 102A may include a sealing sheet <NUM> covering and sealing the openings 341A-341C. Sealing sheet is not shown in <FIG>, for clarity.

<FIG> illustrates a partial cross-sectioned side view of a reagent dispensing apparatus <NUM> including a reagent dispenser apparatus 102A according to embodiments. Reagent dispensing apparatus <NUM> may be included in an immunoassay apparatus <NUM> as described herein. As shown, the reagent dispensing apparatus <NUM> includes a dispenser support <NUM> (a portion shown), and one or more reagent dispenser apparatus 102A provided in the dispenser support <NUM>. The reagent dispensing apparatus 102A may be provided in the dispenser support <NUM> by being registered on one or more features, such as lips, recesses, posts, or the like. Locking features may be provided, such as snap-fit locking tabs or other suitable locking structure that secures the reagent dispenser apparatus 102A to the dispenser support <NUM>. The reagent dispenser apparatus 102A includes a dispense port 314C, as shown, operable to open and close to dispense a reagent <NUM>. The dispense port 314C remains closed (no flow) when the pressure in the reagent dispense chamber 342C is below a predesigned threshold pressure, and the dispense port 314C is opened (flowing) when the pressure in the reagent dispense chamber 342C is above predesigned threshold pressure. As shown, the dispenser support <NUM> with the attached one or more reagent dispenser apparatus 102A, is removable from the housing <NUM>. The dispenser support <NUM> may include a hub <NUM> that receives a locking member <NUM> therein. Locking member <NUM> may be contacted by a fastening member <NUM> (e.g., a threaded knob) to secure the dispenser support <NUM> to a shaft <NUM> of the dispenser support motor <NUM>. A rotation registering feature <NUM> (e.g., a pin or other feature) may be used to allow the dispenser support <NUM> to be mounted on the shaft <NUM> in only one rotational orientation. Rotation registering feature <NUM> may be a pin mounted in a shoulder of the shaft <NUM>. Other suitable rotation registry features may be used.

To dispense reagent 316C, the reaction vessel carrier <NUM> containing a reaction vessel <NUM> is rotated by carrier motor <NUM> and the dispenser support <NUM> is rotated by dispenser support motor <NUM> to appropriate rotational orientations to vertically align the reaction vessel <NUM> below the dispense port 314C. The actuation member 350A may then be actuated by actuator <NUM> to move the moveable wall 347C as shown in <FIG>, which dispenses a predetermined volume (e.g., a shot) of the reagent 316C directly into the reaction vessel <NUM>. A respective actuator and actuator member (e.g., 350A, 350B, and 350C) may be provided at different position to accomplish the dispensing for each reagent 316A, 316B, 316C in the reagent dispenser apparatus 102A.

<FIG> illustrates a partial cross-sectioned side view of another alternative embodiment of a reagent dispensing apparatus <NUM> including a reagent dispenser apparatus 102A according to embodiments. The depicted reagent dispensing apparatus <NUM> includes pneumatic actuation of the moveable wall 647C. The actuator <NUM> moves the actuation member 650C into sealed contact with the moveable wall 647C, which may be an elastomer bladder or the like. Once extended into sealed contact, a pneumatic source <NUM>, such as an air pump, may be operated to provide a predetermined gas pressure in a passage 670C in the actuation member 650C, which flexes the moveable wall 747C and causes a shot of the reagent 316C to be dispensed into the reaction vessel <NUM> located below the dispense port 614C. Pneumatic and mechanical actuation apparatus have been described herein. However, any suitable actuation technique that causes reagent to be dispensed from the reagent storage 616C into the reaction vessel <NUM> without a pipetting operation may be used.

<FIG> illustrates another embodiment of immunoassay apparatus <NUM>. In this embodiment, a dispenser support <NUM> of the reagent dispensing apparatus <NUM> having one or more dispenser apparatus 102A, 102B mounted thereon is non-rotary acting, rather than rotary acting as in the previous embodiments. The dispenser support <NUM> may move along a non-rotary path (e.g., linearly along a linear path) on one or more path restraints, such as guide rails 772A, 772B shown. Again, the dispenser support <NUM> overlaps the reaction vessel carrier <NUM> such that an agent (e.g., a reagent) may be dispensed directly into a reaction vessel <NUM> mounted in the reaction vessel carrier <NUM> below the dispenser support <NUM>. Non-rotary motion may be produced by an actuator <NUM> coupled between the housing <NUM> (or to a frame member with the housing <NUM>) and the dispenser support <NUM>. Any suitable actuator <NUM> may be used, such as a linear variable displacement transducer (LVDT) or the like. The other components of the immunoassay apparatus <NUM> may be as discussed above. Thus, in this embodiment, one or more agents (e.g., reagent) may be dispensed directly into a reaction vessel <NUM> from a dispense port (e.g., outlet) without a pipetting operation. As shown, linear actuation of the dispenser support <NUM> coupled with coordinated rotation of the reaction vessel carrier <NUM> can align any desired dispense port of any desired reagent dispenser apparatus 102A, 102B with any desired reaction vessel <NUM>.

An embodiment of a method of dispensing a reagent (e.g., 316A, 316B, 316C, <NUM>, 614C) into a reaction vessel (e.g., reaction vessel <NUM>) will now be described with reference to <FIG>. The method <NUM> includes, in <NUM>, providing a reagent dispenser apparatus (e.g., reagent dispenser apparatus 102A, 102B, <NUM>, <NUM>) having a dispense port (e.g., dispense port 314A, 314B, 314C, <NUM>, 614C).

The method <NUM> includes, in <NUM>, dispensing the reagent from the reagent dispenser apparatus without a pipetting operation. In particular, the reagent is dispensed directly from the reagent dispenser apparatus into the reaction vessel through a dispense port. Reagent may flow from a reagent storage chamber to a reagent dispense chamber and then into the reaction vessel from the dispense port in some embodiments.

Claim 1:
An immunoassay apparatus (<NUM>), comprising
a reaction vessel carrier (<NUM>) containing one or more reaction vessels(s) (<NUM>); and a dispenser support (<NUM>) containing one or more reagent dispenser apparatus (<NUM>) having one or more reagent container(s) (<NUM>), said reagent container comprising (i) a reagent storage chamber (<NUM>) and (ii) a plurality of reagent dispense chambers (<NUM>) having a dispense port (<NUM>) coupled to each of the reagent dispense chamber (<NUM>),
characterized in that said one or more reagent container(s) has a plurality of dispense ports (<NUM>) spaced along a length of the container body, and wherein each of the dispense ports (<NUM>) is operable to individually open and close to dispense a reagent directly into the one or more reaction vessel(s) (<NUM>) located below the dispenser support (<NUM>) and
wherein each of the dispense chambers (<NUM>) has a vertically moveable wall (<NUM>) comprising a flexible diaphragm, said moveable wall being adapted to change a volume of the reagent dispensing chamber (<NUM>) by vertical movement of the vertically moveable wall (<NUM>) and thereby displacing a known amount of the reagent from the reagent dispense chamber (<NUM>) into the reaction vessel (<NUM>).