Automated diagnostic analyzer and method for its operation

Abstract

To provide an automated analyzer for analysis in an automated pre-analytical module and a method for operation of the analyzer.SOLUTION: An automated analyzer includes a shuttle transfer station that receives a shuttle carrier from an automated pre-analytical module and has a clamping assembly for a shuttle, The shuttle conveys a container in which samples prepared by a pre-analytical system are arranged, the assembly has jaws that advance engagement members into contact with a bottom portion of sample containers arranged in the shuttle, the assembly secures the containers in the shuttle when the assembly comes into a closed state, then sample is aspirated from the containers using a robot pipetter, the analyzer also includes a plurality of multichannel puncture tools, and the puncture tool is adapted to be conveyed by a robot gripper mechanism.SELECTED DRAWING: Figure 11B

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of the filing date of U.S. Provisional Application No. 62 / 326,395, filed on April 22, 2016, the disclosure of which is incorporated herein by reference.

Background Art

[0002] Diagnostic tests of biological samples have contributed to the efforts of the medical industry to diagnose and treat diseases quickly and effectively. Clinical laboratories that perform such diagnostic tests already receive hundreds or thousands of samples daily, and the demand continues to grow. The challenge of managing such large volumes of samples has been assisted by the automation of sample analysis. Automated sample analysis is typically performed by an automated analyzer, which is generally a self - contained system that performs a multi - step process on a biological sample to obtain a diagnostic result.

[0003] Some current automated clinical analyzers present users with an array of automated tests or assays that can be performed on a provided sample. Additionally, when samples arrive at the laboratory, they are often not ready for analysis. To prepare samples for testing by an automated analyzer, a technician typically transfers an aliquot of the sample from a primary container as received by the laboratory to a secondary container that is suitable for the analyzer. In addition, the technician must typically know what tests are to be performed on the sample and be able to select test - specific reagents or diluents that will be paired with the sample. This can be time - consuming and can lead to operator error and exposure to infectious diseases.

[0004] In addition, a pre - analysis system exists, which is intended to assist in preparing samples for analysis and further remove the operator from the workflow between the laboratory acceptance of the sample and the test results of the analyzer. However, many of these systems still require a significant amount of technician involvement, for example, before loading samples into the pre - analysis system; after the samples are prepared by the pre - analysis system; and after the analyzer has completed the analysis.

[0005] For example, some pre - analysis systems can automatically transfer aliquots of samples from a first container to a second container. However, such systems often require the technician to manually match the identification codes of the first and second containers before loading them into the system, which can be time - consuming and error - prone.

[0006] In addition, many of these systems cannot be integrated with one or more analyzers, and conversely, the analyzers cannot be integrated with such systems. In this regard, a technician must be present to manually transfer samples from the pre - analysis system to the analyzer and, upon completion of the analysis, from the analyzer to the storage location. This requires skilled labor for a mundane task and can lead to distraction in that the technician must pay attention to the progress of the samples in the pre - analysis system and the analyzer, and technicians are expected to be available to transfer samples when ready in order to minimize downtime.

[0007] Moreover, current pre - analysis systems generally prepare samples at a rate different from that at which an analyzer evaluates such samples. This further complicates the integration between the pre - analysis system and the analyzer. In this regard, a technician may need to continuously track samples prepared by the pre - analysis system until a full batch of samples has been accumulated for manual transfer to the analyzer. Alternatively, a technician can transfer partial batches to the analyzer, which may reduce the productivity of the analyzer.

[0008] Accordingly, current automated pre - analysis systems and analyzers are beneficial to a clinical laboratory, but there is room for better integration and automation of the various systems.

Prior Art Documents

Patent Documents

[0009]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0010] The present disclosure describes devices, systems, and methods for sample processing and analysis. In particular, analyzers included within high - throughput systems are described. In one embodiment, a high - throughput system includes a pre - analysis system integrated with an analyzer. In another embodiment, a high - throughput system includes at least an additional analyzer and a pre - analysis system integrated with both analyzers. These components (i.e., the analyzer and the pre - analysis system) are modular and can be integrated in several different configurations to suit the diagnostic needs of a particular laboratory.

[0011] The specific analyzer described herein generally has a plurality of decks or levels in a vertical arrangement. One deck is capable of accommodating electronic components and consumable waste, and the consumable waste includes liquid waste and solid waste. Another deck is a processing deck where sample processing and analysis are performed. Also, this deck can store or inventory a large amount of consumables, which include pipette tips, reagent troughs, amplification plates, extraction container holders, and rolls of plate sealing materials, etc. In one embodiment, sufficient consumables can be stored on top of the analyzer, enabling the analyzer to operate at maximum throughput over the entire 8-hour work shift without reloading the system. Also, this deck can include a plate sealer, an orbital shaker, a reagent trough piercing tool, and a reader / detector for detecting specimens such as DNA targets.

[0012] A further deck includes a multi-purpose robot, the multi-purpose robot includes a Cartesian movement system, and the Cartesian movement system enables a payload suspended from such a system to traverse the interior of the analyzer above the processing deck. The payload includes a vision system, a consumable gripper, and a multi-channel pipette. The vision system provides barcoding / identification capabilities and, among other things, performs other machine vision tasks. The reason is that they are related to functions that require grippers. The consumable gripper moves consumables for the analyzer, such as reagent trough piercing tools and amplification plates. The multi-channel pipette performs all of the analyzer's liquid handling requirements.

[0013] The features, aspects, and advantages of the present invention will be better understood with reference to the following description, the appended claims, and the accompanying drawings.

Brief Description of the Drawings

[0014]

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[0015] Definitions As used herein, the terms "about," "generally," and "substantially" are intended to mean that a slight deviation from an absolute value is included within the scope of the term so modified. Also, in the following discussion, when referring to specific directions such as left, right, front, back, top, and bottom, it should be understood that such directions are described from the perspective of a user facing the system described below during an exemplary operation.

[0016] Overview of the HT System Figure 1 shows a high-throughput system 00, which includes a first analyzer 2000, a second analyzer 4000, and a pre-analysis system 10. The pre-analysis system 10 is, for example, the pre-analysis system described in U.S. Provisional Application No. 62 / 296,349 (the “’349 application”), the disclosure of which is incorporated herein by reference in its entirety. The analyzers 2000, 4000, and the pre-analysis system 10 are modular, and they can be physically connected to each other and separated from each other, and can also be electronically connected to each other and separated from each other. The second analyzer 4000 is different from the first analyzer 2000 in terms of the operations and assays they perform, but the first analyzer 2000 can be a replica of the second analyzer 4000, and it should be understood that the pre-analysis system 10 is configured to connect to at least two of the same analyzers. Also, it should be understood that the modularity of the pre-analysis system 10 enables it to connect to any analyzer configured as such. As shown, the first and second analyzers 2000, 4000 are disposed on both sides of the pre-analysis system 10 in a linear arrangement. The pre-analysis system 10 and the analyzers 2000, 4000 are configured for this physical arrangement, but it is contemplated that the pre-analysis system 10 can be configured to accommodate more than three analyzers, and that the pre-analysis system 10 and the analyzers 2000, 4000 can be configured to be installed in other physical arrangements, such as an L-shape, for example.

[0017] Analyzers in relation to System 10 and VIPER LT The second analyzer 4000 can be connected to either side of the pre - analysis system 10. In this regard, the sample - container shuttle transport assembly 300b of the pre - analysis system 10, as shown in FIG. 7 of the '349 application, can extend towards the analyzer 4000 when the analyzer 4000 is located to the left of the system 10 (illustrated in FIG. 1), or the sample - container shuttle transport assembly 300a of the pre - analysis system 10 can extend towards the analyzer 4000 when the analyzer 4000 is located to the right of the system 10. Such assemblies 300a - b can terminate adjacent to the threshold of the analyzer. However, as described below, the analyzer 4000 has a conveyor, and the conveyor can continue the path of each shuttle transport assembly 300 into the analyzer 4000. As used herein, a "shuttle" can be a rack or carrier structure with a plurality of receiving portions, and each receiving portion is sized and configured to receive a sample - container.

[0018] Analyzer 4000 is similar to the BD Viper™ LT system (Becton Dickinson, Franklin Lakes, NJ) and shares many characteristics with the BD Viper™ LT system, some of which are identified below. The BD Viper™ LT system is not described in detail herein. However, as described above, analyzer 4000 is a modular system, and that modular system is configured to operate in cooperation with an automated system for pre - analysis processing of samples to be assayed using the BD Viper™ LT system. Such a pre - analysis system is illustrated as system 10. In this regard, analyzer 4000 is an adaptation of the BD Viper™ LT system with respect to modular connectivity as well as high - throughput processing and analysis, and thus includes many additional features, which are also described below.

[0019] Structural frame As shown in FIGS. 2 and 3, the analyzer 4000 includes a structural frame composed of several support components 4011, such as segments of metal tubing, and the support components 4011 are configured to support and define various decks or levels for sample processing and analysis. Such decks can include an auxiliary deck 4012, a processing deck 4014, and a multi-purpose robot deck 4016. The analyzer 4000 also includes a housing or shell 4010, and the housing or shell 4010 surrounds its internal components as shown in FIG. 1.

[0020] Consumables Introduction part FIGS. 4-7 show various consumables that can be automatically utilized to perform assays on samples, such as liquid-based cytological samples. In particular, the analyzer and its consumables are configured to perform an HPV assay, which detects multiple stereotypical types of HPV (e.g., HPV16, HPV18, HPV33, HPV45, HPV58, etc.). Such an HPV assay can include, for example, the BD Onclarity™ HPV Assay (Becton Dickinson, Franklin Lakes, NJ). The ability to perform such assays is partially supported by the consumable design. Such consumables include pipette tips 4062, sample containers 03, sample container shuttles 4030, extraction container holders 4020, amplification plates 4040, and liquid reagent trough assemblies 4050.

[0021] Extraction container holder The extraction container holder 4020 (Figs. 4A and 4B) is preferably a plastic thermoformed clam shell, which includes a lower portion 4025, an upper portion 4022, and a plurality of extraction containers 4026. Each extraction container 4026 can contain iron oxide (“FOX”) particles disposed on a strip for extracting DNA from a sample, and is sealed by a lightweight foil 4023, which can be penetrated by a pipette tip prior to addition of the sample.

[0022] The lower portion 4025 of the clam shell is a shallow rectangular container with a through hole extending through the lower portion 4025, enabling the extraction containers to extend partially through such holes. The thermoformed feature 4028 on the side wall portion 4027 of the lower clam shell 4025 provides an interference fit with a feature on the consumable drawer of the analyzer 4000. Each of the extraction containers 4026 is loaded into the lower portion 4025 such that their foil sides face in the same direction as the side wall portion 4027.

[0023] The upper portion 4022 of the clam shell is in the form of a ribbed insert that drops into the space formed by the side wall 4027 of the lower portion 4025 and locks via a set of protrusions (not shown) in the lower portion 4025. A plurality of ribs 4024 extend in a direction transverse to the extraction container 4026, providing structural rigidity to the extraction container holder 4020, which provides a holding force that helps keep the upper clam shell 4022 during aspiration via a pipette. A plurality of through-holes 4021 extend through the upper portion 4022 between adjacent ribs 4024, enabling the foil seal 4023 of the tube 4026 to be accessed by a pipette tip. A barcode is located on the upper portion 4022, which helps track information such as the lot, expiration date, and serial number of the contents of the tube 4026. The extraction container holder 4025 is assembled with enough extraction containers 4026 to perform a single run, which in the illustrated embodiment is 32 extraction containers in a 4×8 arrangement.

[0024] Sample Container Shuttle The sample container shuttle 4030 (FIG. 5) is similar to the shuttle 284 of the '349 application and includes receiving portions 4032 each configured to receive a sample container 03. The particular shuttle 4030 shown includes two rows of six receiving portions 4032 for a total of twelve receiving portions. However, any number of receiving portions 4032 can be provided. For example, the shuttle 4030 can include two rows of twelve receiving portions 4032 for a total of twenty-four receiving portions. In the particular analyzer 4000 shown, a batch of samples can include from 12 to 32. Thus, one to three shuttles can provide a full batch to the analyzer 4000.

[0025] Also, the shuttle 4030 includes a transverse opening 4036 that intersects with a corresponding receiving portion 4032, enabling access to the container 03 in which a sample-container holding assembly (described below) is disposed. The sample container 03 is the same as the third type of container 03 of the '349 application. In this regard, the sample container 03 includes a cap with a penetrable seal 09.

[0026] Amplification plate The amplification plate assembly 4040 (FIG. 6) includes a plate body portion 4051. Engagement openings 4044 extend into respective side surfaces 4042 of the body portion 4041, enabling the grippers of the versatile robot 4300 (FIG. 10A) to engage the amplification plate assembly 4040 from both sides thereof. For example, the opening 4044a extends through the side surface 4042a and the side surface (not shown) opposite to that of the side surface 4042a. In addition thereto, the opening 4044b extends through the side surface 4042b and the side surface (not shown) opposite to that of the side surface 4044b. This enables the robot 4300 to grip and lift the plate 4040 while the plate is in different orientations. A plurality of tubes defining an amplification compartment 4045 are connected to the plate body portion 4041 within the opening thereof. Such tubes may be provided in the form of a 1×8 strip of polypropylene tubes inserted into the plate body portion 4051. The compartment 4054 is provided with a dried reagent utilized for the amplification of the DNA target. In this regard, the amplification plate 4040 can have color-coding for the visual identification of the reagents contained within the compartment 4045 of the plate 4040. However, in some embodiments, the color-coding may not be present.

[0027] Liquid reagent plate The liquid reagent trough assembly 4050 includes approximately four separately linearly arranged troughs 4052 that contain bulk reagent. For example, four troughs 4052a - d may be provided, with the first trough 4052a containing wash buffer, the second trough 4052b containing acid buffer, the third trough 4052c containing neutralization buffer, and the fourth trough 4052d containing elution buffer. The volume of such troughs 4052 is such that they can each contain sufficient reagent to perform at least 20 assay runs. This enables a sufficient volume of reagent to be loaded onto the analyzer 4000 and sustain over the entire 24 - hour period without the need for replenishment. The first trough 4052a includes tracks 4056 integrated into its side walls, allowing baffling walls (not shown) to be inserted between such tracks 4056 and into the trough 4052a, helping to reduce splashing during the filling process. The second trough 4052b generally has a minimum volume and defines a trapezoidal - shaped cavity. This shape provides the necessary volume while also providing a relatively large opening area on one side of the cavity, allowing it to be pierced by a tool 4240 large enough, such as through which a pipette tip accesses the trough 4052b.

[0028] The assembly includes a rugged and pierceable lid material 4058 (see FIG. 11C), which can be pierced by a piercing tool 4240 (see FIG. 11B), enabling a pipette tip 4062 to access the reagent as described below. Also, the liquid reagent trough assembly 4050 includes a collar 4054 that extends around the perimeter of the liquid reagent trough assembly 4050, which can be placed on the deck surface and engaged on the deck surface by a toggle to hold the assembly 4050.

[0029] Pipette tip The pipette tip 4062 is provided within a tip holder 4060 (see FIG. 8B). In one embodiment of the analyzer, four 1000 μL tips are used to process each sample. In addition, a single reagent pipette tip is used by each batch of samples. This helps reduce the number of tips utilized since the reagent pipette tip does not come into direct contact with the sample.

[0030] Referring back to FIGS. 2 and 3, the auxiliary deck 4012 is disposed adjacent to the bottom of the analyzer 4000 and is located below the processing deck 4014. The auxiliary deck 4012 houses electronic components and a waste repository. For example, the auxiliary deck 4012 can include a liquid waste repository 4002, which receives and stores all liquid waste, for example, from the extraction tube 4026 during the DNA extraction process and from the liquid reagent trough assembly 4050 during the emptying process. This repository 4002 includes a sensing device for monitoring the empty volume. The auxiliary deck 4012 also includes one or more solid waste repositories 4004, which are located below respective solid waste chutes 4210 (see FIGS. 8A and 8B), and the solid waste chutes 4210 extend through the processing deck 4014. For example, a single waste repository can be located below the waste chute 4210 and can collect all solid waste. In another example, two solid waste repositories can be used to collect the used pipette tips 4062 and the amplification plates 4040, respectively. Each of the above-described solid waste repositories can include a sensing device, similar to the liquid waste repository 4002, for detecting the solid waste level. Such a sensing device can include, for example, an optical sensor or an ultrasonic sensor.

[0031] Processing deck Layout Figures 8A and 8B show the processing deck 4014. The processing deck includes a consumable drawer 4100, a plate sealer 4220, an orbital shaker 4230, a punching tool 4240, a reagent trough assembly 4050, a shuttle transfer station 4250, a waste chute 4210, and a reader / detector.

[0032] Drawer In the illustrated embodiment, the processing deck 4014 includes six consumable drawer assemblies 4120, each of which houses most of the consumables utilized in the assay workflow, as shown in FIGS. 8A, 8B, and 12. In this regard, each of the six drawers 4100 includes, from front to back, a pipette tip station 4124, an extraction container station 4126, and an amplification plate station 4128. Stations 4124, 4126, and 4128 are each configured to hold a pipette tip holder 4060, an extraction container holder 4020, and an amplification plate 4040, respectively. In addition, each consumable drawer 4120 houses an extractor module 4125 within its housing 4122, and the extractor module 4125 is similar to the extractor module of the BD Viper (trademark) LT system and includes a movable magnet that provides a movable magnetic field that is utilized to extract DNA from a sample. Such a magnet is housed within each consumable drawer 4120 under the extractor container station 4126 and is selectively movable vertically along a rail 4127, which is disposed on an upper portion of a side wall separating compartments under each of stations 4124, 4126, and 4128. As shown in FIG. 12, the extractor 4125 is in the upper / extraction position. The consumable drawer assembly 4120 is located in front of the analyzer 4000 between two detectors / readers 4260a-b and includes visual indicators, such as colored LEDs, on its front end, respectively, which indicate its status to the user, informing the user whether the drawer is currently in use, ready for use, or in need of replenishment of consumables.

[0033] In addition, the drawer assembly 4120 includes a hinged retaining feature 4121. In the illustrated embodiment, the retaining feature 4121 is a spring-loaded arm that is hingedly connected to the housing 4122 just behind the extraction container station 4126. The retaining feature 4121 has a retaining position and a consumable replacement position. In the retaining position, as shown in FIG. 12, the retaining feature 4121 extends above the stations 4124 and 4126. In this position, the retaining feature 4121 is configured to encompass the respective perimeters of the pipette tip holder 4060 and the extraction container holder 4020, and the pipette tip holder 4060 and the extraction container holder 4020 are positioned within their respective stations 4124, 4126 while allowing access thereto through openings in the retaining feature 4121. In this regard, the retaining feature 4121 prohibits the extraction container holder 4020 and the pipette tip holder 4060 from being inadvertently moved during operation. When it is necessary to replace a consumable within the drawer 4120, the drawer 4120 is spread and a locking feature (not shown) that locks the retaining feature 4121 in the retaining position is released. Under the biasing of a torsion spring (not shown) located within the hinge 4123, the retaining feature 4121 rotates about the hinge 4123 to the consumable replacement position, which provides clearance for the user to replenish the consumables within the drawer 4120.

[0034] In addition, the processing deck 4014 includes a single chip extraction assembly 4110, and the single chip extraction assembly 4110 houses five 96-well chip carriers 4060. Also, it is constructed similarly to the extraction 4120 in that it includes visual indicators on its front end. However, the chip extraction assembly 4110 does not include an extractor and is configured to hold a plurality of chip carriers 4060. These chip carriers 4060 provide both a fourth pipette tip for use with reagent chips for their respective sample extractions (performed within the consumable extraction) and any surplus tips that may be required due to pick-up failures or jams. This extraction 4110 is located to the left of the consumable extraction 4120. These extractions 4110, 4120 can be accessed by the user from the front of the analyzer 4000 and can be automated in that they can be automatically locked or unlocked by the analyzer 4000 depending on their current state and the state of the analyzer as a whole.

[0035] Reagent trough station The reagent trough assembly 4050 is located within the reagent trough station positioned between the consumable extraction 4120 and the orbital shaker 4230. These assemblies 4050 remain in a fixed position. The reagent trough assembly 4050 remains in a fixed position and generally is not accessible during operation, like the consumable extraction 4100. However, it should be understood that the reagent trough assembly 4050 contains sufficient reagents such that it should not be necessary to access this area during operation.

[0036] Waste chute An amplification plate 4050, a pipette tip 4062, and a separate waste chute 4210 for liquid waste extend through the processing deck 4014 and communicate with respective waste repositories 4002, 4004. These enable used consumables to be passed to the waste repositories 4002, 4004 located below the processing deck. The waste chute 4210 is positioned behind the chip drawer 4110 and facing the rear of the analyzer 4000.

[0037] Sealer Figures 13A and 13B show a fully automated plate sealer 4220, which is located at the left rear corner of the analyzer 4000. The plate sealer 4220 has a movable platform 4224 that receives the inoculated amplification plate 4040 and moves it into the plate sealer 4220 (best shown in FIG. 13A). The plate sealer 4220 attaches a clear optical seal to the top of the amplification plate 4040. The analyzer 4000 uses the automated plate sealer 4220 to seal the amplification plate 4040 following elution and prior to plate mixing and target amplification. For single load times, to provide a multi-sealing capability, the sealer 4220 utilizes a roll-based seal, which can be provided by a single roll 4222 of seal material that can be loaded in one go, such as an 800-meter roll. This volume of seal material is sufficient to seal the plates 4040 for nearly a year for most applications. However, the plate sealer 4220 can include an optical sensor (not shown) configured to sense when the amount of seal material drops below a specific threshold level, indicating that the seal material should be replaced.

[0038] The plate sealer 4220 is located behind the analyzer 4000, but it is desirable to be able to access the sealer 4220 from the front of the analyzer 4000 for replenishment of the seal material. Being able to access components behind the analyzer 4000 through the front of the analyzer 4000 allows the analyzer 4000 to be installed directly against a wall in the laboratory, which helps to save floor space. To facilitate access from the front, the plate sealer 4220 can be mounted on a lifting and pivoting mechanism 4226, as best shown in FIG. 13B. The lifting and pivoting mechanism 4226 includes a movable base 4227 mounted on a drive shaft (not shown) (see FIG. 13A). The drive shaft is surrounded by a rotatable sleeve 4229, and the rotatable sleeve 4229 is also connected to the movable base 4227 and is rotatable therewith. When the optical sensor senses that the seal material is running out, the user is notified. The user can then manually or automatically operate the crank 4228 to raise the movable base 4227 via the drive shaft until it clears the deck surrounding it. In this lifted position, the movable base 4227 is rotated manually or automatically counterclockwise to present the rear of the sealer 4220 to the front of the analyzer 4000. This rotation is limited by the presence of a rotation stop arm 4223, which is connected to a rotatable sleeve 4229 surrounding the drive shaft. In this regard, the rotation stop arm rotates in harmony with the sleeve 4229 and the base 4227 until the stop arm abuts against a stationary structure, thereby preventing further rotation. This helps to prevent excessive rotation, which could result in accidental contact between the plate sealer 4220 and other equipment. In this position, the empty or nearly empty roll 4222 of seal material can be easily reached from the front of the analyzer 4000 for replacement.When a new roll 4222 is attached, the sealer 4220 can be rotated clockwise, the crank 4228 can be operated, and the sealer 4220 can be lowered back to its operating position.

[0039] Puncture tool The puncture tool 4240 (see FIGS. 11A - 11D) includes a plurality of cannula - shaped puncture members 4244 that extend from a tool body portion 4241 and have puncture ends 4246 shaped to puncture a robust seal of the reagent trough assembly 4050. Such cannula - shaped puncture members 4244 may or may not be co - located within a vertical plane parallel to the longitudinal axis of the tool body portion 4241. The cannula - shaped puncture members 4244 define an opening 4242 large enough to receive the pipette tip 4062 therein. Also, the tool 4240 includes a pair of linking members 4248 that extend upwardly from the body portion 4241 and have an engagement opening 4249 that receives a holding member 4346 of the gripper 4340 of the robot 4300 as shown in FIG. 11C. The puncture tool 4240 punctures the seal of the reagent trough assembly and is left in place to provide a channel through which the pipette tip 4062 can aspirate liquid reagent as best shown in FIG. 11D.

[0040] Puncture tool nest / carrier Two piercing / perforating tools, each associated with a reagent trough assembly 4050, are located within respective nests or carriers 4270, oriented toward the rear center of the processing deck 4014 until they are used to pierce the reagent trough assembly 4050. The carrier 4270 includes a platform 4272, which is within a cavity 4274 that houses the tool 4240. The platform 4272 has a raised side edge that is keyed to the periphery of the tool 4240 and is adapted to hold the tool 4240 in an exact location on the platform 4272 as it awaits being picked up by the robot 2300 when the tool 4240 is installed within the carrier 4270, as best shown in FIG. 11A.

[0041] Figures 11E - 11G illustrate an alternative puncture tool nest / carrier 4280. The carrier 4280 includes a base 4282, one or more side wall portions 4288, alignment posts 4287a - b, and a retaining member 4284. The posts 4287a - b extend from the base 4282 and have tapered end portions 4289 that are configured to interface with an opening (not shown) at the bottom of the puncture tool body 4241. The tapered end portions 4289 are best shown in Figure 11G and help align the tool 4240 within the carrier 4280 when installed thereon. One or more side wall portions 4288 generally extend from the base 4282 on the front and back sides of the carrier 4280 and define a housing space for the tool 4240. As shown, the side wall portions 4288 do not extend from the base 4282 on its left and right sides, which provides space for the retaining member 4284 to pivot. However, side wall portions extending from the left and right sides of the base 4282 to further define a housing for the puncture tool 4240 are contemplated, provided that such side wall portions provide sufficient clearance for the movement of the retaining member 4284, as described below.

[0042] The retaining member 4284 extends from the base 4282 and is located at both side ends of the carrier 4280 at a distance sufficient to allow the piercing tool 4240 to be disposed therebetween. The retaining member 4284 includes one or more inclined surfaces 4285, such as the first and second inclined surfaces 4285a - b. The inclined surfaces 4285a - b face inwardly towards the center of the carrier 4280. In addition, the second inclined surface 4285b is generally positioned more inwardly than the first inclined surface 4285a. Each retaining member 4284 also has an overhang surface 4286 that faces the base 4282. The retaining member 4284 is movable between a first position and a second position, for example, by means of a pin connection to the base 4280, and is biased to the first position by, for example, a spring (not shown). In this regard, when the retaining member 4284 is in the first position, the piercing tool 4240 supported by the carrier 4280 is restrained from vertical movement by the overhang surface 4286 of the retaining member 4284, as shown in FIG. 11E. While in the second position, as shown in FIG. 11F, the overhang surface 4286 is disengaged from the piercing tool 4240. Thus, the piercing tool 4240 is no longer restrained by the retaining member 4284 and can be lifted from the carrier 4280 while the retaining member 4284 is in the second position.

[0043] Sample Container Holding Assembly The sample container holding assembly 4250 (Figs. 9A and 9B) is similar to the sample container holding assembly 1100 of the '349 application in that it includes a clamping assembly 4252. The clamping assembly 4252 closes towards the shuttle 4030 disposed within the clamping assembly and holds the shuttle 4030 and the container 03 within the shuttle 4030 while aliquots are being aspirated from the container 03. In this regard, the clamping assembly 4252 includes an engagement member 4253, and when the clamping assembly 4250 is closed to engage the skirt 07 at the bottom end of the sample container 03, as best seen in Fig. 11C, the engagement member 4253 is configured to project through a second transverse opening 4036 within the shuttle 4030. These engagement members 4253 penetrate / bite into the skirt 07 of their respective container 03 to prevent the container 03 from being inadvertently removed from the shuttle 4030 during aspiration. In addition, each clamping assembly 4252 includes a drip shield 4251 connected thereto. Each drip shield 4251 includes a plurality of semi-circular cutouts configured to partially receive the sample container 03. In this regard, when the clamping assembly 4252 engages the sample container 03 as shown in Fig. 9A, the drip shield 4251 of each clamping assembly 4252 interfacially connects to substantially fill the gap between the sample containers 03, which helps prevent sample fluid drips from falling from between the containers 03 onto the shuttle 4030 or the conveyor 4254. To provide additional drip protection, a drip shroud 4259 can cover the clamping assembly 4250, except directly above the sample container 03 and the conveyor 4254, as best shown in Fig. 9C. The drip shield 4251 and the drip shroud 4259 provide surfaces that are easy to clean in the event of sample fluid drips.

[0044] In addition, the sample container holding assembly 4250 includes a conveyor belt 4254 that receives the shuttle from the pre-analysis system 10 and moves it to a position between the clamping assemblies 4252. In this regard, the conveyor belt 4254 receives the shuttle 4030 from the output lane of the shuttle transport assembly 300 of the pre-analysis system 10. When it comes time to return the shuttle 4030 to the pre-analysis system 10, the motor 4256 operates a drive mechanism (not shown), which slides the holding assembly 4250 along the track 4257 over the suspended platform 4255 so that the conveyor 4254 aligns with the output lane of the shuttle transport assembly 300. The conveyor 4254 operates in two directions to receive and return the shuttle 4030.

[0045] Orbital shaker The orbital shaker 4230 (see FIG. 14) vibrates a sealed amplification plate 4040 in a circular motion to fully rehydrate the dried reagent mixed with the eluted sample within the compartment 4045 of the sealed amplification plate 4040. Two of these are positioned behind the extraction reagent trough 4050 and centrally rearward of the analyzer 4000. Of course, more or fewer may be provided as needed. The orbital shaker 4040 includes a platform 4042 on which the amplification plate 4040 is placed, and the orbital shaker 4040 includes at least two automated arms 4046 configured to hold the plate 4040 on the platform 4042 during operation. In this regard, the arms 4046 can be positioned at the corners of the platform 4042 and are capable of moving radially inward to hold the amplification plate 4040 in place and radially outward to release the amplification plate 4040 for pickup by the robot 4300.

[0046] Detector / Reader Two detector / readers 4260a - b are located at both side ends of the analyzer 4000 and have a cavity facing the center of the analyzer 4000. These readers 4260a - b are similar to the readers used in the Viper (trademark) LT system. In this regard, the readers 4260a - b have a housing for receiving the sealed amplification plate 4040. Also, the readers 4260a - b have a thermocycler and a detector. The thermocycler is used to amplify the target analyte in the amplification plate 4040, and the detector is used to detect the target analyte, for example, using a set of LED illuminators.

[0047] Robot As shown in FIGS. 10A-10F, the multi-purpose robot 4300 is suspended at the robot deck 4016. The multi-purpose robot 4300 is an automated system for material transfer and optical interrogation (e.g., barcode reading), which hangs above the processing deck 1014 and includes a Cartesian robot 4301 that carries a payload.

[0048] The Cartesian robot 4301 includes two linearly mounted orthogonal rails 4302a-b. Each of the two linear rails 4302a-b has at least two optical limit sensors (not shown) to ensure that the payload 4306 is not driven beyond their range and to facilitate initialization. Due to the size of the payload 4306 and the fact that the payload 4306 hangs near the processing deck 4014, there is a potential for collision, which it is desirable to avoid. To help prevent collisions, a third optical sensor is provided on the first linear rail 4302a. This allows the robot 4300 to instantaneously sense on which half (left / right) of the analyzer the robot 4300 is located, ensures that the center of the analyzer 4000 can be found, and ensures that safe startup and initialization procedures can be used.

[0049] Payload and Rotating Stage Robot Payload 4306 is located below Cartesian Robot 4301 and provides vision, pipetting, and plate transfer functionality. In this regard, Payload 4306 includes a Rotation Stage 4310, a Vision System 4320, a Gripper Module 4340, a Multi-Channel Pipettor 4350, and a Backplane Connector 4360. Robot Payload 4306 is connected to Cartesian Robot 4301 via Rotation Stage 4310. Rotation Stage 4310 is capable of rotating Payload 4306 approximately 180 degrees around a vertical axis, which provides movement flexibility to Gripper 4340, Pipettor 4350, and Vision System 4320.

[0050] Consumable Handling Section Vision System Vision System 4320 and Gripper 4340 include a Consumable Handling Module 4320. Vision System 4320 can be any conventional vision system capable of reading barcodes and performing other machine vision tasks. An exemplary vision system includes the In-Sight 5600 Vision System (Cognex Corporation, Natick, Massachusetts). This Vision System 4320 is attached to a vertical stage 4322 together with Gripper 4340, enabling Vision System 4320 to move up and down along Gripper 4340 and enabling Vision System 4320 to focus on a target. Such movement along the vertical stage is performed by Motor 4330.

[0051] Gripper The gripper module 4340 is located on the opposite side of the backplane connector 4360 from the multi-channel pipettor 4350. As described, the gripper module 4340 is connected to a vertical translation stage 4322 that varies the height of the gripper 4340 and also includes arms 4344a - b that translate horizontally relative to each other and engage consumable items. Such arms 4344 have gripper fingers 4349 (see FIG. 11C), which can have engagement features or protrusions 4345 that project laterally from the gripper fingers 4349 and are used to help secure consumable items having corresponding engagement notches (see FIG. 11C). The gripper 4340 also includes retaining members 4346 that project downward from horizontal members 4347 of respective arms 4344a - b (see FIG. 11C). Such retaining members 4346 each include a laterally projecting member 4348 that is configured to be received by an engagement opening 4249 in a linking member 4248 of the piercing tool 4240. Since respective arms 4344 can move relative to each other, respective retaining members 4346 can move relative to the other retaining member. This enables the retaining members 4346 to engage the linking member 4248 and securely fix the piercing tool 4240 during the piercing operation and also to disengage the piercing tool 4240 and place the piercing tool 4240 in an appropriate location within the carriers 4270, 4280 or above the liquid reagent trough assembly 4050. Similar to the movement of the gripper arms described elsewhere in this specification, the retaining members can effect relative horizontal movement such that they are horizontally further apart at one position and horizontally closer at another position.

[0052] Figure 10E shows an alternative gripper module 4340'. The gripper module 4340' is similar to the gripper module 4340 in that it includes gripper arms 4344a'-b' that include a protrusion 4345. However, the gripper module 4340 also includes a presence sensor 4341, which is configured to detect the presence of a consumable item between the gripper arms 4344a'-b'. For example, as shown, each arm 4344a' and 4344b' includes a sensor 4341, which is a switch-type sensor. The sensor 4341 is positioned such that it can be deflected by a consumable item such as a plate 4040 when the gripper arms 4344a'-b' grip such a consumable item therebetween. Thus, as long as the gripper arms 4344a'-b' grip the consumable item and the sensor 4341 is deflected, its presence is detected. However, when the gripper arms 4344a'-b' release their grip, the sensor 4341 returns to its normal position, indicating that no consumable item is present. Although a deflectable switch-type sensor is shown, other sensors such as, for example, an optical sensor are contemplated.

[0053] A method of piercing the liquid reagent trough assembly 4050 is shown in FIGS. 11E-11G and also in FIGS. 11C-11D. As shown in FIG. 11E, the piercing tool carrier 4280 is mounted on the processing deck 4014, and the piercing tool 4240 is held within the carrier 4280 by a retaining member 4284 in a first position. Such a carrier 4280 can be located at the upper right rear corner of the system 4000 adjacent to the orbital shaker 4230 shown in FIG. 8B. The multi-purpose robot 4300 moves to the piercing tool carrier 4280, lowers the gripper module 4340 to a height above the piercing tool 4240, and the protruding member 4348 of the gripper is aligned with the engagement opening 4249 of the piercing tool 4240 (see FIG. 11B with respect to the opening), which is best shown in FIG. 11E.

[0054] While in this position, the gripper arms 4344a-b are moved apart so that the protruding member 4348 can be received into the corresponding engagement opening 4249. When this occurs, the gripper fingers 4349 engage the retaining member 4284 at or adjacent to the first inclined surface 4285a and overcome their biasing to push the retaining member 4284 outwardly towards a second position, as best shown in FIG. 11F. This provides clearance for the piercing tool 4240 to be lifted from contact with the carrier 4280. Thus, with the retaining member 4284 held in the second position by the fingers 4349 and the protrusion 4348 engaged with the opening 4249, the piercing tool 4240 is removed from the carrier 4280 via the gripper module 4340 until the piercing tool body portion 4241 clears the overhang surface 4286 of the retaining member 4284.

[0055] When the piercing tool 4280 clears the holding member 4284, the multi-purpose robot 4300 moves the gripper module 4340 and the piercing tool 4280 toward the liquid reagent trough assembly 4050, which can be positioned in front of the tool carrier 4280 and more centrally within the system 4000 as shown in FIG. 8B. The robot 4300 then positions the piercing tool 4280 above the trough assembly 4050 such that the cannula-shaped piercing member 4244 is aligned with each of the respective troughs 4052a - d, as best shown in FIG. 11C. Thereafter, the gripper module 4340 lowers the piercing tool 4240 such that the piercing member 4244 pierces the lid material 4058. When the lid material 4058 is fully pierced, the tool body portion 4241 is positioned on the wall portion 4051 that separates each of the respective troughs 4052a - d. Such a wall portion 4051 supports the weight of the piercing tool 4240. The cannula-shaped piercing member 4244 has a length sufficient to completely penetrate the lid material, while the length is short enough to position the piercing member 4244 completely above the surface of the reagent, regardless of what reagent is located in each of the respective troughs 4052a - d. In addition, the cannula-shaped piercing member 4244 provides a uniform opening 4242 that is large enough to allow easy passage of the pipette tip 4062. This helps prevent accidental contact with the lid material 4058, which can displace a large amount of reagent without the pipette tip 4062 when the pipette tip 4062 is used to withdraw reagent from the trough assembly 4050.

[0056] When the lid material 4058 is punctured and the tool 4240 is well supported by the trough assembly 4050, the gripper module 4340 releases its grip on the tool 4240 by moving the arms 4344a - b towards each other, such that the protrusion 4348 is removed from the opening 4249. Thereafter, the robot 4300 transports the payload 4310, which includes the gripper module 4340, away from the trough assembly 4050. In this regard, the payload 4310, which also includes the pipetter 4350, can be moved to the location of an unused disposable pipette tip 4062, which can be located within the tip drawer 4110 shown in FIG. 8B. Thereafter, the pipetter 4350 is lowered to retrieve one or more pipette tips 4062. Next, the robot 4300 can move the pipetter 4350 above the piercing tool 4240 and the trough assembly 4050 and align the pipette tip 4062 with the opening 4242 of the tool 4240. Next, the pipette tip 4062 is lowered through the corresponding opening 4242 into the selected trough 4052, as shown in FIG. 11D, to aspirate reagent from the trough 4052. The aspirated reagent can then be transported to another location within the system 4000, if necessary. The reagent is then dispensed into a suitable container and the pipette tip 4062 is discarded. The retrieval of the pipette tip 4062, the aspiration of the reagent through the piercing tool, and the discarding of the pipette tip 4062 can occur multiple times until the reagent is depleted. The system 4000 will track the amount of reagent remaining and will alert the user when such reagent needs to be changed. This is explained elsewhere in this specification.

[0057] When the piercing tool 4240 is returned to the carrier 4280, for example, when the liquid reagent trough 4050 needs to be replaced, or for some other reason, the robot 4300 moves the gripper module 4340 above the piercing tool 4240 placed on the reagent trough assembly 4050 and engages the piercing tool 4240 by moving the protrusion 4348 into the opening 4249 as previously described. When the piercing tool 4240 is engaged by the gripper assembly 4340, the robot 4300 transports the piercing tool 4240 to a position above the carrier 4280 away from the reagent trough assembly 4050. Then, the gripper assembly 4340 is lowered so that the piercing tool body 4241 comes into contact with one or more of the inclined surfaces 4285a - b. When the piercing tool 4240 is lowered towards the carrier 4280, the piercing tool body 4241 slides along one or more of the inclined surfaces 4285a - b, which, as best shown in FIG. 11G, pushes the retaining member 4284 outward from the first position to the second position. With the retaining member 4284 positioned to provide clearance for the piercing tool 4240, the piercing tool 4240 is further lowered and engages the posts 4287a - b, which align the piercing tool 4240 with respect to the carrier 4280. Near the bottom of the descent of the piercing tool 4240, the gripper fingers 4349 can also engage the retaining member 4284 on the inclined surface 4285a or adjacent to the inclined surface 4285a and help maintain them in the second position, which is illustrated in FIG. 11F. When the tool 4240 is fully seated on the carrier 4280, the gripper arms 4344a - b are moved horizontally towards each other, which disengages the protruding member 4348 from the piercing tool 4240 and also disengages the gripper fingers 4349 from the retaining member 4284. In other words, a pair of gripper arms move horizontally from a first position where the arms are further apart to a second position where the arms are closer together.The gripper fingers engage the retaining member at a more distant position, pushing the retaining member back, and at the position where they come together closer, they are not engaged with the retaining member. In this regard, the retaining member 4284 returns to the first position shown in FIG. 11E under its own biasing force, thereby holding the piercing tool 4240 until the piercing tool 4240 is required again.

[0058] Multi-channel pipette The multi-channel pipette 4350 is connected to the backplane connector 4360 on the side opposite to the consumable handling portion. The multi-channel pipette 4350 includes a plurality of liquid handling assemblies 4352a - e, and the plurality of liquid handling assemblies 4352a - e are directly connected to the backplane connector 4360. In the illustrated embodiment, there are five liquid handling assemblies 4352, namely, a first liquid handling assembly 4352a, a second liquid handling assembly 4532b, a third liquid handling assembly 4532c, a fourth liquid handling assembly 4532d, and a fifth liquid handling assembly 4532e. Each liquid handling assembly 4532 includes a main board assembly 4370 and a pipette assembly 4380. The liquid handling assemblies 4352a - e are connected to the backplane connector 4360 adjacent to each other in extremely close proximity.

[0059] Each main board assembly 4370a - e helps provide data, power, and positive / negative air pressure to the corresponding pipette assemblies 4380a - e. In the illustrated embodiment, there are five pipette assemblies 4380a - e. Each main board assembly 4370a - e is similar to the main board assembly 1401 described and shown in FIGS. 27A and 27B of the '349 application. In this regard, each main board assembly 4370a - e includes a housing 4372, and various components such as, for example, a PCB, positive and negative pressure inputs, valves, and liquid / gas conduits that communicate with the inputs and valves are disposed therein. Also, the main board assembly 4370a - e includes a z - drive mechanism, which includes a vertical rail 4374 on one side of the housing 4372 and also includes a motor 4376 and a drive shaft (not shown). The drive shaft is disposed within the housing 4372.

[0060] One of the pipette assemblies 4380a - e is reserved for clean reagent transfer. Thus, the pipette tip 4062 carried by such a reserved assembly 4380 is never contaminated by the sample. This allows a single reagent tip 4062 to be used throughout the extraction process and minimizes the number of tips required for the assay workflow. Since each pipette assembly 4380a - e can travel independently in the z - direction, the pipette tip 4062 from such a reserved pipettor 4380 can be independently inserted through the channel 4242 of the piercing tool 4240 into the appropriate liquid - containing reservoir of the plate 4050, as best shown in FIG. 11. There is no contact between the pipette tip 4062 and the solid surface.

[0061] Each pipette assembly 4380a - e is hingedly connected to its respective main board assembly 4370a - e and is otherwise similar to pipette assemblies 502 of FIGS. 17A - 17D of the '349 application and pipette assembly 1402 of FIGS. 27A and 27B, except that it does not rotate to multiple hinge positions. Each pipette assembly 4380a - e is constrained from rotation and moves in the vertical z - direction along the vertical rail 4374 via the motor 4376. Thus, the first, second, third, fourth, and fifth pipette assemblies 4380a - e can move independently in the vertical or z - direction. Otherwise, the pipette assemblies 4380a - e are constructed similarly to pipette assemblies 502 and 1402, particularly with respect to their pipette channel assemblies (not shown) and pipette tip ejector assemblies.

[0062] The backplane connector 4360 is similar to the backplane connector 1600 of FIGS. 29A and 29B of the '349 application, except that the backplane connector 4360 is configured to have a plurality of liquid handling assemblies 4352a - e and a consumable handling assembly 4320 connected thereto. In this regard, the backplane connector 4360 is connected to the main board assemblies 4370a - e of the respective liquid handling assemblies 4352a - e, and is also connected to the corresponding electronic board that operates the consumable handling portion. The backplane connector 4360 includes several input and output connectors (not shown), such as Ethernet (registered trademark), multi - pin, positive pressure input connector, and negative pressure input connector. The positive pressure input connector and the negative pressure input connector are for supplying the necessary power, pressure, and data signals to the consumable handling module 4320 and the liquid handling assemblies 4352a - e. This helps to reduce or eliminate external cabling, which can be snagged and can be difficult to manage by the plurality of liquid handling assemblies 4352a - e connected so closely. The necessary inputs can be provided to the backplane connector 4360 via the rotary stage 4310. In this regard, the backplane connector 4360 can act as a manifold for pneumatic pressure and other input / outputs.

[0063] Figure 15 shows the overall architecture of the computing system of the analyzer 4000. The computing system can be a subsystem within system 1300 of FIG. 26 of the '349 application, which shows a computing system diagram of the high-throughput system 00. In this regard, the cross-instrument bus 4404 and the workflow computing device 4540 are the same as the bus 1320 and the computing device 1330 shown in FIG. 26 of the '349 application. In addition, the computing device 4410 is similar to the computing device 1360 and is described in more detail herein along with its input and output within the analyzer 4000.

[0064] Computer control device and processor The computer control device 4400 can be any general-purpose computer and can include a processor 4412, a memory 4414, and other components typically present in a general-purpose computer control device. The computer control device 4410 can include dedicated hardware components for performing a specific computing process, but the processor 4412 can be any conventional processor such as a commercially available CPU. Alternatively, the processor 4412 can be a dedicated component such as an application-specific integrated circuit ("ASIC") or other hardware-based processor.

[0065] Memory 4414 can store information accessible by processor 4412, including instructions 4416 that can be executed by processor 4412. Further, memory 4414 can include data 4418, which can be obtained, manipulated, or stored by processor 4412. Memory 4414 can be of any non-transitory type capable of storing information accessible by processor 4410, which can be, for example, a hard drive, memory card, ROM, RAM, DVD, CD-ROM, writable memory, and read-only memory, etc.

[0066] Instructions 4416 can be any set of instructions that are either directly executed by processor 4412 (such as machine code, etc.) or indirectly executed (such as a script, etc.). In that regard, the terms "instructions", "application", "step", and "program" can be used interchangeably herein. Instructions 4416 can be stored in object code format for direct processing by processor 4412, or can be stored in any other computing device language, which can include a collection of scripts or independent source code modules that are interpreted on demand or pre-compiled.

[0067] In one embodiment of analyzer 4000, computing device 4410 can include some sets of instructions 4416. For example, each assay to be performed can have some sets of associated instructions, which can include instructions to operate multi-purpose robot 4300 to optically scan consumables, grip and move consumables, and aspirate liquid samples.

[0068] Data 4418 can be input and viewed through a graphical user interface (“GUI”), and the graphical user interface can be displayed on the display interface 4420 specifically associated with the analyzer 4000, or can be displayed on the display interface 1332 of FIGS. 1 and 26 of the ’349 application, which is associated with the entire high-throughput system 00. Also, data 4418 can be input from the vision system 4320 of the multipurpose robot 4300, or from a scanner in the pre-analysis system 10. Also, data 4418 can be obtained by sensors, door sensors, temperature sensors, etc., for example, to obtain information about specific conditions and activities occurring in the analyzer, such as the location of specific consumables and air quality.

[0069] This data 4418 can be digitally tagged to a specific identification code (e.g., barcode serial number) in the implemented field or relational database, which can also be stored in the memory 4414. This helps the analyzer 4000 track various consumables in the analyzer 4000 and also helps provide specific information to the processor 4412 during the execution of the processor instructions 4416 without the need for user input. For example, the amplification plate 4050 can have an identification code, which can be associated with a barcode located on its outer surface, which can be tagged in the database along with specific stored data such as, for example, the type of reagent stored therein and which reagents have already been used. This enables the analyzer to check its inventory and determine when reagents and other consumables are likely to run out or become insufficient for performing additional assays. In another example, the shuttle 4030 can have an identification code, which can be tagged in the database along with specific stored data, which can be, for example, data regarding each of the sample containers 03 carried by the shuttle 4030, such as patient name, the assay to be performed, and processing parameters. In a further example, when the analysis is complete, the results of the assay can be associated with a specific sample in the database, enabling the user to easily retrieve the results via access to the workflow computing device 4540. The reason is that such results can be communicated to it by the device 4410.

[0070] FIG. 15 functionally illustrates the processor 4412, the memory 4414, and other elements of the computer control device 4410 as being within the same block, but the computer control device 4410, the processor 4412, and / or the memory 4414 may each be composed of a plurality of processors, computer control devices, and memories, which may or may not be stored within the same physical housing. For example, the memory 4414 can be a hard drive or other storage medium located within a housing different from that of the computer control device 4410. Thus, references to the processor 4412, the computer control device 4410, and the memory 4414 are to be understood to include references to collections of processors, computer control devices, and memories that may or may not operate in parallel.

[0071] Display Interface The display interface 4420 can specifically be associated with the analyzer 4000 and can display only information regarding the analyzer 4000 and can also be integrated into the structure of the analyzer 4000. However, the display interface 4420 is optional (shown by the dashed line in FIG. 15) and is not included in the embodiment shown in FIG. 1. The reason is that the overall system display interface 1332 is used instead. However, if the display interface 4420 is included, the interface 4420 can be a monitor or an LCD panel, etc., which is connected to the front panel of the housing 4010 or is located remotely from the analyzer 4000. The display interface can display a GUI, user prompts, user commands, and other information that may be related to the user.

[0072] Input Interface The user control / input interface 4430 enables the user to navigate the GUI and, although repetitive, may optionally be provided as a component separate from the overall system input interface provided by the display interface 1332 of FIG. 1. However, when the user control / input interface 4430 is provided, such an interface can be, for example, a touch panel, keyboard, or mouse. In addition, the input interface 4430 can be integrated into the display interface 4420 such that the same device that displays prompts, etc., also enables the user to respond to said prompts.

[0073] As shown in FIG. 15, the computer control device 4410 can be connected to the workflow computing device 4540, which is utilized to integrate all of the components of the high-throughput system 00, such as the first analyzer 2000 and the pre-analysis system 10, etc., and is also utilized, inter alia, to integrate with the laboratory information system ("LIS") 4550 of the laboratory. Thus, information related to the analyzer 4000 that occurs within the pre-analysis system 10 can be communicated to the analyzer 4000 via the workflow computing device 4540. Similarly, information related to the pre-analysis system 10 that occurs within the analyzer 4000 can be communicated to the workflow computing device 4540 via the computer control device 4540, which communicates that information to the pre-analysis system 10. Also, such information can be supplemented by information obtained by the workflow computing device 4540 from the LIS 4550, such as patient information, etc.

[0074] Also, computer control device 4410 is connected to a plurality of components within analyzer 4000 and shares information such as instructions and data going to and fro. Some of the components connected to the computer control device via internal bus 4502 include some of the previously described components located on the processing deck, such as the plate sealer and the orbital shaker. In addition, the computer control device may be connected to detectors / readers 4260a - b and the multi - purpose robot 4300. Such a connection to computer control device 4410 enables computer control device 4410 to provide instructions to such components and receive information therefrom. For example, the multi - purpose robot 4300 can receive instructions from computer control device 4410, retrieve the piercing tool 4240, and apply the piercing tool 4240 to the reagent trough assembly 4050, or pick up the amplification plate 4040 and move the amplification plate 4040 from one location to another. Thus, since analyzer 4000 is fully automated, the operations performed by the internal components of analyzer 4000 are generally the result of instructions provided by processor 4410.

[0075] In method 4600 (FIG. 16) of processing and analyzing using analyzer 4000, analyzer 4000 moves a sample through four functional stages: sample transfer, extraction, pre - amplification, and amplification / detection. Here, such stages are described.

[0076] Sample transfer There is a notification 4600 from the pre-analysis system 10 that a batch of samples is prepared (up to three shuttles 4030) and ready for transfer. When the analyzer 4000 receives and confirms such a notification, the analyzer 4000 proceeds to the sample transfer stage 4604. In the sample transfer stage, the pre-analysis system 10 feeds the shuttles 4030 to the analyzer 4000 via the shuttle transport assembly 300, with one to three shuttles 4030 in a set. The size of the batch transported into the analyzer 4000 is a matter of design choice. For example, when three shuttles are transferred, the first two shuttles 4030 can contain 12 sample containers 03, and the last shuttle 4030 can contain 8 sample containers. The first shuttle will typically include two control sample containers numbered among the 12 sample containers transported into the analyzer thereby. The two control sample containers will typically be in front of the shuttle when transported into the analyzer. Thus, in this example, 30 sample containers are transported into the analyzer in one batch with two controls. These shuttles 4030 are handled one by one by the analyzer 4000, and the samples contained in the shuttle 4030 are completely moved through the sample transfer process and returned to the pre-analysis system 10 before the next shuttle 4030 in the queue is moved to the analyzer 4000.

[0077] Shuttle reception and clamping As described in the ’349 application, the shuttle transport assembly 300 of the system 10 includes an input lane and an output lane, one of which is dedicated to shuttle transfer to the analyzer 4000 and one of which is dedicated to shuttle return from the analyzer 4000. Before receiving the shuttle 4030 from the pre - analysis system 10, the analyzer 4000 ensures that the conveyor 4254 of the shuttle holding assembly 4250 is aligned with the appropriate lane of the shuttle transport assembly 300. Thereafter, the shuttle 4030 is fed from the pre - analysis system 10 onto the conveyor 4254 in the analyzer 4000 through a port between the side walls of the two systems 10, 4000. Thus, the pre - analysis system 10 delivers the shuttle 4030 to the analyzer 4000.

[0078] When the shuttle 4030 is fully transferred into the analyzer 4000, the pre - analysis system 10 stops its feeding mechanism and waits for an availability confirmation from the analyzer 4000 to send the subsequent shuttle 4030. Meanwhile, the analyzer 4000 moves the shuttle 4030 towards the center of the analyzer 4000 to its dock position until it is positioned between the clamping assemblies 4252. When the shuttle 4030 is aligned to be in its desired location through the use of optical sensors, the clamping assembly 4252 clamps around the shuttle 4030 and the engagement member 4253 engages the skirt 07 of the sample container 03, for example, by piercing them, and holds them in place for liquid transfer.

[0079] Subsequently, the pipette assembly 4380 penetrates through one of the penetrable caps 09 of the sample containers 03 within the shuttle 4030. The geometry of the perforated cap creates the possibility that a significant amount of lift force is generated by the pipette assembly 4380 above the container 03 when the pipette tip 4062 is removed from the container 03 following aspiration. The engagement member 4253 helps ensure that each container 03 remains seated.

[0080] Sample Aspiration and Transfer Once the shuttle 4030 is fully seated and secured with its containers 03, the analyzer 4000 moves to the sample aspiration and transfer portion of the sample transfer stage 4604. For each set of the four containers 03 within the shuttle 4030, starting with the pair of containers 03 in the innermost position, the pipettor 4350 uses two of its five pipette assemblies 4380 with the pipette tips 4062 loaded thereon to pierce the penetrable caps 09 of the respective pair of containers 03, mix the samples, and aspirate the required sample volume from the containers 03. When the correct sample volume has been aspirated, the pipette tip 4062 is removed. A second pair of pipette assemblies 4380 is used to perform the same process on the next pair of sample containers 03 within the shuttle 4030 that are moving away from the center of the shuttle 4030.

[0081] When four samples are aspirated and placed in pipette tips 4062, the multi-purpose robot 4350 moves to a pre-specified consumable drawer 4120 and dispenses four samples into one column of a 4 x 8 grid of pre-pierced extraction containers 4026 prior to the sample transfer process. Following the dispensing of the samples into the extraction containers 4026, four used pipette tips 4062 are discharged through the chip waste chute 4210. This process is repeated for the remaining two sets of four samples (in the case of the third shuttle, the remaining one set of four) in the shuttle 4030 until the entire set of containers 03 contained within a particular shuttle 4030 is transferred to the extraction container 4026.

[0082] Shuttle return Once all samples from the containers 03 have been successfully transferred to the extraction container 4026, the shuttle 4030 can be returned to the pre-analytical system 10. To prepare for this, the clamping mechanism 4252 on the shuttle holding assembly 4250 is released to remove the engagement member 4253 from the containers 03 within the shuttle 4030. Following the negotiation of the readiness between the pre-analytical system 10 and the analyzer 4000, the shuttle holding assembly 4250 shifts itself in the forward-backward direction along the platform 4255 such that its conveyor 4254 aligns itself with the sample return lane of the shuttle transport assembly 300 within the pre-analytical system 10. When the holding assembly 4250 is in the appropriate position, the conveyor 4254 is used to send the shuttle 4030 out from the analyzer 4000 and back to the pre-analytical system 10.

[0083] All three shuttles 4030 are received by the analyzer 4000, their samples are transferred to the extraction container 4026, and these steps are repeated until they are returned to the pre-analysis system 10. At that point, the sample transfer stage 4604 is complete. Thus, in this embodiment, 32 chips are consumed and the analyzer 4000 moves to the extraction stage 4606.

[0084] Extraction Once all samples have been transferred to the extraction container 4026, the analyzer 4000 begins the extraction process 4606. During extraction, DNA is eluted from the samples and isolated to prepare for PCR amplification. The extraction stage 4606 is performed using pipette assemblies 4380a - e on the multi-functional robot 4300 and an extractor built into the specific consumable drawer 4120 where extraction is being performed.

[0085] Pipettor Usage To minimize the number of chips 4062 required to perform the assay workflow, the multi-functional robot 4300 includes five pipette assemblies 4380a - e. This allows the analyzer 4000 to isolate a single pipette assembly 4380 for clean reagent dispensing, which does not come into contact with the samples and thus does not contaminate the chips with the samples. This fifth pipettor 4380 finds its use within the extraction protocol and reduces the frequency with which contaminated chips 4062 need to be discarded.

[0086] At a point prior to initiating extraction (if sufficient bulk liquid reagent remains in trough 4052, either during a previous run or when preparing for the run in question), reagent trough assembly 4050 is pierced by piercing tool 4240, which is left in place to provide channel 4242 through which reagent tip 4062 can aspirate the liquid reagent. The piercing tool application is performed by gripper 4340 of multifunction robot 4300 as described in more detail above.

[0087] Extractor To assist in isolating the DNA extracted from the sample, it is bound to iron oxide particles, which enables their magnetic capture. This allows the DNA to be isolated from the remaining portion of the unwanted sample, which can be washed away from the eluate using the wash buffer located in trough assembly 4050. To perform this isolation, a magnetic field is applied to extraction container 4026. This is achieved through the use of an extractor module that includes sufficient magnets to ensure that each column of extraction container 4026 is adjacent to a magnet on both sides. Such magnets are selectively moved from a position below extraction container 4026 to a position adjacent to such a container. This applies a magnetic field that captures the bound DNA on the sides of extraction container 4026.

[0088] Extraction protocol Systematic addition of various buffers, engagement and disengagement of the extractor magnet housed within the consumable drawer, and through chip mixing, extraction is realized. A complete extraction operation generally requires the use of two pipette tips 4062 per sample and uses acid buffer, wash buffer, elution buffer, and neutralization buffer in the following order. The analyzer 4000 processes a set of four samples at a time, which is made possible by the spacing of the pipettor 4380. To begin, the instrument extracts DNA for a set of four samples using acid buffer, wash buffer, and elution buffer, performs sample mixing using a single set of chips, at which point the neutralization buffer is added, and the analyzer 4000 moves on to the next set of four samples. When the DNA has been eluted from all samples, the analyzer 4000 uses a second set of four chips 4062 for each column of four samples to perform neutralization mixing (discarding the chips after each mixing), at which point the extracted DNA is ready for amplification and the instrument moves on to the pre-amplification stage 4608.

[0089] Pre-amplification When DNA extraction is complete, the pre-amplification stage 4608 occurs, which is responsible for leaving the extracted DNA in the extraction container 4026, using it to rehydrate the master mix reagent in the amplification plate 4040, preparing the amplification plate 4040 for PCR, and moving the plate 4040 to the appropriate reader 4260. This process is realized through the use of the multi-functional robot 4300 (both the pipettor 4380 and the gripper 4340), the plate sealer 4220, and the orbital mixer 4230.

[0090] Eluate transfer To transfer the eluted DNA from the extraction container 4026 to the amplification plate 4040, the analyzer 4000 uses a pipette tip that is isolated / secured for each sample. Each of the 32 DNA samples is transferred into three wells 4042 in the amplification plate 4040. This is accomplished through triple dispense, and for all three dispenses, sufficient sample is aspirated from four extraction containers 4026 at once using four sample pipettors 4380. Following aspiration, the robot 4300 moves above the amplification plate 4040 and sequentially dispenses into each of the three wells 4042 filled by each sample. Following this dispense, the three (predetermined) wells 4042 are each filled with neutralized DNA eluate. The used tip 4062 is then dropped into the waste 4210, and the process is repeated for the remaining seven columns of the four extraction containers 4020.

[0091] Plate Sealing Once the eluted DNA has been transferred into the amplification plate 4040, the plate 4040 is moved to the plate sealer 4220 where the plate 4040 is sealed. To transport the plate 4040, the robot 4300 positions the gripper mechanism 4340 so that it covers over the amplification plate 4040. The gripper arms 4344a - b are opened, the gripper 4340 is lowered, the arms 4344a - b are closed, and engage the plate 4040. Sensors in the gripper arms 4344a - b indicate when the teeth of the gripper have engaged the plate 4040.

[0092] When engaged, the plate 4040 is lifted by the robot 4300 and transported to the plate sealer 4220. The plate 4040 is accurately placed within the standby stage 4224 of the sealer 4220, the arms 4344a - b disengage, and the gripper 4340 is cleared vertically. To apply the plate seal, the sealer 4220 positions the amplification plate 4040 under the heated platen, feeds a section of the cut seal material above the plate 4040, lowers the platen, and uses heat and pressure to bond the seal material to the plate 4040. After sealing, the stage 4224 is discharged and the plate 4040 is available for transport.

[0093] Plate Mixing When the plate 4040 is sealed, rehydration of the master mix dry-down reagent in the amplification plate 4040 is performed. Again, the plate gripper module 4340 of the robot 4300 engages and lifts the plate 4040 and transports it to a preselected orbital mixer 4230. When the plate 4040 is placed within the mixer 4230, the gripper arms engage to lock the plate in place. To complete rehydration, the plate 4040 is spun at a predetermined speed, which ensures complete mixing of the eluate and dry-down reagent while avoiding splashing of the liquid onto the plate seal.

[0094] Transfer to Reader Once the plate 4040 is fully processed for PCR amplification, it is transported into the reader 4260 for amplification. To prepare the reader 4260 to receive the plate 4040, the reader cavity is opened and any plate 4040 held within the reader is moved to the waste 4004 using the plate transfer module 4320 over the robot 4300. The robot 4300 then retrieves the freed plate 4040 from the mixer 4230 and moves it to the preselected reader 4260. Once the plate 4040 is placed within the reader 4260, amplification and detection can begin.

[0095] Amplification and detection Once the plate 4040 is placed within the reader 4260, the analyzer control software initiates the PCR protocol via the processor 4412, which enables the reader 4260 to amplify the sample in place, monitor its real-time amplification, and return curve data that can be converted into results for each of the molecular assay targets and enable the detection and genotyping of HPV.

[0096] Assay timing The PCR protocol takes approximately two hours after initiation to complete. To maximize throughput, the Analyzer 4000 takes advantage of the difference between the extraction process (about one hour) and the amplification / detection (about two hours) processes. Once a sample is placed in the reader 4260 and the amplification and detection stage 4610 begins, a second set of samples can begin moving through the process. These samples will be fed into the second reader 4260b and start PCR approximately one hour after the protocol in the first reader 4260a has started. Next, a third set of samples can be moved through the extraction process and placed in the first reader 4260a for PCR in time to finish just as its first amplification has recently finished. By changing samples between the two readers 4260a-b, it is possible to maximize the number of samples that can be moved through the extraction process.

[0097] Multiple consumables are loaded by the user on either a run-by-run or daily basis to ensure a complete assay throughput. In one embodiment, the consumable drawer 4100 in the analyzer 4000 provides a platform on which the sample 03 is processed and DNA is extracted. Each of these is used one at a time, meaning that at any point some are not in use (and are either loaded or consumed). The analyzer 4000 is set up via the instructions 4416 in its memory 4414 such that these drawers 4100 can be ejected and accessed without the user having to access the internal envelope of the analyzer 4000 and pause the movement of the robot 4300. At any point, visual indicators (e.g., colored LEDs) on each of the drawers 4110, 4120 indicate their status (ready for use, in use, used). The user can access all drawers 4100 that are not currently in use at any point, and all used drawers can be replenished when convenient for the user.

[0098] When each drawer 4120 is ejected, the user removes and replaces the used amplification container holder 4020 and the emptied chip holder 4060. The user also adds an unused amplification plate 4040 to the drawer 4120. When the drawer 4120 is reinserted, the instrument reinspects the inventory of that particular drawer 4120, checks for loading errors, updates its internal inventory, and flags the drawer as ready for extraction.

[0099] Extraction trough reloading The extraction trough assembly 4050 contains sufficient liquid reagent for approximately 18 extractions, which is sufficient to sustain over a full 24 - hour period at maximum throughput. Since it may be unknown how much throughput may be required for a particular day, instead of one large trough assembly, two reagent trough assemblies 4050 are located on the deck. This allows each trough to be completely consumed before using the second trough and minimizes waste. Since such troughs are capable of sustaining over a 24 - hour period, such troughs 4050 are typically re - loaded during the daily cleaning protocol. During operation, the analyzer 4000 monitors the volume and indicates to the user which trough 4050 may need to be replaced if present.

[0100] One example of what is described herein is an automated analyzer, the automated analyzer having: i) a processing deck including a shuttle transfer station, the shuttle transfer station further including a conveyor for transporting a shuttle received by the automated analyzer to the shuttle transfer station, the shuttle being a rack including a plurality of receptacles, each receptacle being adapted to receive a sample container, the processing deck; ii) a carrier for at least one piercing tool disposed on the processing deck; iii) a robot including a gripper; and iv) a station configured to receive a consumable reagent trough. In this example, the robot uses the gripper to move the piercing tool from the carrier to the station configured to receive the consumable reagent trough and lower the piercing tool above the station configured to receive the consumable reagent trough. In one example, the robot is a multi-purpose robot having: i) a gantry; and ii) a payload movably connected to the gantry, the payload carrying the gripper and a pipettor module having a plurality of pipettor heads each connectable to a pipettor tip. The gripper has a plurality of movable arms capable of performing cooperative horizontal movement to grasp and release an article. The robot also has a backplane connector having a housing and a plurality of utility connectors coupled to the housing. In this example, the pipettor module and the gripper are each connected to the housing of the backplane connector and its plurality of utility connectors.

[0101] The above-described puncture tool carrier has a housing that defines a cavity sized to receive a puncture tool, and a plurality of retaining members movably connected to the housing. The plurality of retaining members are movable from a first position to a second position. In the first position, the retaining members engage the puncture tool when the puncture tool is present within the puncture tool carrier, and in the second position, the retaining members are disengaged from the puncture tool, enabling the puncture tool to be installed within and removed from the carrier. In one example, the puncture tool carrier includes a plurality of posts extending from a base of the housing. The posts can be tapered from the base to a distal end of the post.

[0102] In one example, the gripper has at least two gripper arms. Each of the at least two gripper arms has a gripper finger attached thereto, and the gripper arms move horizontally relative to each other and are spaced apart by a greater horizontal distance in a first position than the horizontal distance by which they are horizontally spaced apart in a second position. In a further example, the gripper has at least two retaining members. For example, each of the at least two retaining members moves horizontally relative to each other and is spaced apart by a greater horizontal distance in a first position than the horizontal distance by which they are horizontally spaced apart in a second position.

[0103] In a further example, the at least two gripper fingers and / or the at least two retaining members each have a protrusion. In one example, when the gripper is installed within the carrier, the gripper fingers engage and are biased against the retaining members when the gripper fingers are in a first position and are not engaged with the retaining members when in a second position.

[0104] In one example, the piercing tool has a tool body portion and a plurality of cannula-shaped piercing members extending from the tool body portion. The cannula-shaped piercing members each define an opening that extends through the tool body portion and is sized to allow a pipette tip to pass therethrough. Each cannula-shaped piercing member also defines an edge configured to penetrate a pierceable lid. The piercing tool includes an opening configured to receive a post when the piercing tool is installed in a carrier.

[0105] In a further example, the shuttle transfer station has a shuttle-holding platform that includes a jaw assembly having an open position and a closed position. The jaw assembly is in the open position when the shuttle is received within the shuttle-holding platform. The jaw assembly also has an engagement protrusion. When the jaw assembly is in the closed position, the engagement protrusion secures against the lower portion of a container being transported by the shuttle. The jaw assembly is configured such that when the jaw is in the closed position, the engagement protrusion passes through an opening in the side of the shuttle received by the shuttle-holding platform, thereby urging the engagement protrusion into contact with the lower portion of a sample container disposed within the shuttle. The engagement protrusion does not extend into the shuttle opening when the jaw is in the open position. In a further example, the jaw assembly has a drip shield that closes around a sample container disposed within the shuttle when the jaw is in the closed position. In a further example, the shuttle-holding platform has an input lane and an output lane. The shuttle-holding platform receives a shuttle in the output lane and is equipped with a driver that moves the shuttle, with the jaw assembly therein, from the output belt to the input belt.

[0106] Also described herein is an extraction container holder assembly comprising i) a bottom tray including an array of openings, and ii) an upper tray having an array of openings. When the bottom tray and the upper tray are assembled together, the bottom openings align with the upper openings. The assembly includes an array of extraction tubes joined together as a strip. When the strip of extraction tubes is assembled with the bottom tray, the extraction tubes fit through the openings in the bottom tray and the strip prevents the tubes from passing through the openings and is positioned on top of the bottom tray. In one example, there is a layer disposed above the strip and an array of extraction tubes supported by the strip, and the layer formed above the extraction tubes is a seal, and the seal is a pierceable seal. In a further example, the bottom tray has an upwardly facing sidewall portion and when the upper tray is assembled with the bottom tray, the upper tray fits into the enclosed space of the upwardly facing sidewall portion of the bottom tray. The upper tray of the assembly can have support ribs positioned on top of the upper tray in a direction orthogonal to the strip supported by the bottom tray. When the upper tray and the bottom tray are assembled together with a strip therebetween, the seal above the extraction tubes is exposed through the openings in the upper tray. In a further example, a barcode is installed on the upper tray and the information associated with the barcode includes at least one of the manufacturing lot of the extraction tubes, the expiration date of the extraction tubes, or the serial number of the extraction tubes. In a further example, the bottom tray has features on top of its upwardly extending sidewall portion and the features engage corresponding features in a drawer for housing the extraction container assembly and provide interference for the extraction tube container assembly in the drawer.

[0107] Also described herein is a piercing tool assembly, the piercing tool assembly comprising: i) a piercing tool including a tool body portion and a plurality of cannula-shaped piercing members extending from the tool body portion, the cannula-shaped piercing members each defining an opening that extends through the tool body portion and is sized to allow a pipette tip to pass therethrough, each cannula-shaped piercing member also defining an edge configured to penetrate a penetrable lid, each trough being covered by a penetrable lid prior to being penetrated by a respective cannula-shaped piercing member; and ii) a piercing tool carrier defining a cavity sized to receive the piercing tool and having a plurality of retaining members movably connected to the housing, the plurality of retaining members being movable from a first position to a second position, in the first position the retaining members engaging the piercing tool and in the second position the retaining members being disengaged from the piercing tool. The piercing tool carrier can have a plurality of posts extending from the base of the housing. The posts can be tapered from the base to the distal ends of the posts.

[0108] Also described herein is a multi-purpose robot, which has i) a gantry and ii) a payload movably connected to the gantry. The payload has i) a pipettor module having a plurality of pipette heads each connectable to a pipette tip, ii) a gripper module having a plurality of movable arms for gripping consumable items, and iii) a backplane connector having a housing and a plurality of utility connectors coupled to the housing, the utility connectors being configured to supply at least one of power, data, or vacuum pressure to the payload, and the pipettor module and the gripper module are each connected to the housing of the backplane connector and its plurality of utility connectors. In one example, the gripper has at least two gripper arms, and each of the at least two gripper arms has a gripper finger attached thereto. The gripper arms move horizontally relative to each other and, in a first position, are spaced apart by a horizontal distance greater than the distance by which the gripper arms are horizontally spaced apart in a second position. The gripper can have a plurality of retaining members. In this example, at least two retaining members move horizontally relative to each other and, in a first position, are spaced apart by a horizontal distance greater than the distance by which the retaining members are horizontally spaced apart in a second position. In a further example, at least two gripper fingers and / or at least two retaining members each have a protrusion.

[0109] Also described is a method for obtaining reagents for an assay in an automated analyzer, the method comprising the following steps: i) moving a robot payload to a puncture tool carrier, wherein a puncture tool is disposed in the puncture tool carrier, the robot payload carrying a pipetter module and a gripper module, the gripper module including at least two gripper arms, each gripper arm including a holding member and fingers; ii) engaging a protrusion from the holding member of the gripper arm with a corresponding linking member of the puncture tool by moving the gripper arm from a first position to a second position; iii) moving a robot carrying the puncture tool to a liquid container at a second location, the liquid container having one or more penetrable lids covering a plurality of compartments containing liquid reagents; iv) lowering the puncture tool onto the liquid container, wherein a cannula-shaped puncture member extending from the puncture tool is adapted to penetrate one or more lids of the liquid container, and each cannula-shaped puncture member is adapted to enter a different compartment of the liquid container; v) releasing the puncture tool from the robot by translating the gripper arms inwardly and closer together so that the protrusion withdraws from the linking member of the puncture tool; vi) introducing a pipette tip of the pipetter module through at least one of the cannula-shaped puncture members to contact a liquid reagent disposed in the compartment penetrated by the puncture member; vii) aspirating the liquid reagent from the compartment; and viii) transferring the liquid reagent to a tube adapted to receive a sample for analysis. In the method, each pipette tip can be introduced through a respective cannula-shaped puncture member to contact a liquid reagent in the compartment punctured by the respective puncture member.

[0110] In another exemplary method for obtaining a sample for analysis, such method comprises: i) conveying a first shuttle carrying one or more sample containers into a sample analyzer and into a shuttle holding mechanism, the shuttle holding mechanism having opposing arms disposed along the sides of the shuttle being conveyed therein; ii) moving the opposing arms from a first position to a second position, wherein at the first position the shuttle is received, and at the second position, engagement members extending from the respective opposing arms engage the bottom portions of the respective sample containers disposed within the shuttle, the engagement members being adapted to extend through an opening in the shuttle when in the second position; iii) lowering a pipette tip through the sample cap of the container, thereby piercing the seal within the cap, the pipette tip extending into the sample disposed within the sample container; iv) aspirating the sample from the sample container of the first shuttle by a pipettor; v) withdrawing the pipette tip from the sample container, the engagement members remaining engaged with the bottom portions of the respective sample containers as the pipette is withdrawn; vi) moving the opposing arms back from the second position to the first position; and vii) conveying the first shuttle away from the shuttle holding mechanism in a second direction opposite the first direction. In such method, the following additional step, namely, viii) horizontally moving the shuttle from a first lane to a second lane, wherein through the first lane the shuttle is advanced into the shuttle holding mechanism and through the second lane the shuttle is conveyed out of the analyzer, may be performed.

[0111] In this specification, although the present invention has been described with reference to specific embodiments, it should be understood that these embodiments are merely for illustrative purposes of the principles and applications of the present invention. Therefore, it is understood that numerous modifications can be made to the illustrative embodiments, and other arrangements can also be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

Claims

1. 1. An automated analyzer comprising: a processing deck including a shuttle transfer station, the shuttle transfer station further including a conveyor for transporting a shuttle received by the automated analyzer to the shuttle transfer station, the shuttle being a rack including a plurality of receptacles, each receptacle adapted to receive a sample container; a shuttle holding platform for receiving a shuttle from said conveyor; The shuttle holding platform comprises: a jaw assembly having an open position and a closed position, said jaw assembly being in said open position when said shuttle is received within said shuttle holding platform, said jaw assembly further including an engagement protrusion adapted to secure against a lower portion of a container being carried by said shuttle when said jaw assembly is in said closed position; the jaw assembly is configured such that when the jaw assembly is in the closed position, the engagement protrusion passes through an opening in a side of the shuttle that is received by the shuttle holding platform, thereby urging the engagement protrusion into contact with the lower portion of a sample container disposed in the shuttle; The automated analyzer, wherein the engagement protrusion does not extend into an opening in a side of the shuttle when the jaw assembly is in the open position.

2. 2. The automated analyzer of claim 1, wherein the jaw assembly further includes a drip shield that clamps around a sample container disposed in the shuttle when the jaw assembly is in the closed position.

3. 2. The automated analyzer of claim 1, wherein the shuttle holding platform includes an input lane and an output lane, the shuttle holding platform receives the shuttle in the output lane, and the shuttle holding platform further includes a driver that moves the jaw assembly with the shuttle therein from an output belt in the output lane to an input belt in the input lane.

4. 4. The automated analyzer of claim 3, wherein the output belt receives the shuttle from the conveyor and the input belt delivers the shuttle back to the conveyor.

5. moreover, a puncture tool carrier disposed on the processing deck; a puncture tool disposed within the puncture tool carrier; a robot comprising a gripper comprising at least two gripper arms, a horizontal member connecting the at least two gripper arms, and at least two retaining members projecting downwardly from the horizontal member, each of the at least two retaining members configured to move laterally relative to one another to engage the puncture tool, each gripper arm further comprising a gripper finger attached thereto, the gripper arms moving laterally relative to one another such that in a first position the gripper arms are spaced apart at a lateral distance greater than the lateral distance in a second position; a reagent trough station configured to receive a consumable reagent trough; Including, 2. The automated analyzer of claim 1, wherein the robot is configured to use the gripper to transport the puncture tool from the puncture tool carrier to the reagent trough station and further configured to lower the puncture tool over the reagent trough station.

6. The robot is a multipurpose robot, The gantry, a payload movably connected to the gantry; and the payload comprises: The gripper; a pipetter module having a plurality of pipette heads each connectable to a pipette tip; a backplane connector having a housing and a plurality of utility connectors coupled to the housing, the pipettor module and the gripper module each including a backplane connector connected to the housing of the backplane connector and the plurality of utility connectors; At least two of the gripper arms are horizontally movable in concert to grip and release an item.

6. An automated analyzer according to claim 5.

7. 7. The automated analyzer of claim 6, wherein the puncture tool carrier includes a housing defining a cavity dimensioned to receive a puncture tool, and a plurality of retaining members movably connected to the housing, the plurality of retaining members being movable from a first position to a second position, wherein in the first position the retaining members engage the puncture tool when present in the puncture tool carrier, and wherein in the second position the retaining members are disengaged from the puncture tool, allowing the puncture tool to be installed in and removed from the puncture tool carrier.

8. The automated analyzer of claim 7 , wherein the lancing tool carrier further includes a plurality of posts extending from a base of the housing.

9. The automated analyzer of claim 8 , wherein the post is tapered from the base at a distal end of the post.

10. 8. The automated analyzer of claim 7, wherein in the first position, the retaining members are spaced apart a horizontal distance greater than the distance they are spaced apart horizontally in the second position.

11. The automated analyzer of claim 5 , wherein each of the gripper fingers further includes a protrusion.

12. The automated analyzer of claim 10 , wherein each of the at least two retaining members further includes a protrusion.

13. 8. The automated analyzer of claim 7, wherein when the gripper is installed in the puncture tool carrier, the gripper fingers engage and are biased against the retaining member when the gripper fingers are in the first position and do not engage the retaining member when the gripper fingers are in the second position.

14. 10. The automated analyzer of claim 9, wherein the puncture tool includes a tool body and a plurality of cannula-shaped puncture members extending from the tool body, the plurality of cannula-shaped puncture members each defining an opening extending through the tool body and each sized to allow a pipette tip to pass therethrough, each cannula-shaped puncture member also defining an edge configured to pierce a pierceable lid.

15. The automated analyzer of claim 14 , wherein the puncture tool includes an opening configured to receive the post when the puncture tool is installed in the puncture tool carrier.

16. 3. The automated analyzer of claim 2, wherein the drip shield comprises a plurality of notches, each notch conforming to a shape of the sample container.

17. 10. The automated analyzer of claim 1 further comprising a drip shroud covering said jaw assembly, said sample container extending above said drip shroud.

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