CN220490845U - Automatic analyzer - Google Patents

Abstract

The utility model provides an automated analyzer. An automated analyzer includes a housing and a robotic arm disposed within the housing, the robotic arm having an end effector for carrying an article, the end effector comprising: a body rotatably connected to the articulated arm, the body including a pair of connection members; first and second fingers of a connecting member coupled to the body, each of the first and second fingers extending between first and second ends, each of the first and second fingers having an angular offset formed and located at the second end; and a wedge comprising an angled side and a protrusion formed and protruding from the angled side, the angled side and protrusion configured to engage with an offset of the finger to connect the finger to the body, wherein an angled wedge surface is complementary to a surface of the angled offset to which it is attached.

Description

Automatic analyzer

Cross Reference to Related Applications

The present application claims priority from U.S. provisional application Ser. Nos. 63/271,332 and 63/271,475, filed on 10/25 of 2021, both of which are incorporated herein by reference. The present application also relates to U.S. application number 16/088,531, filed on day 26 9 in 2018, which is a national phase entry according to 35u.s.c. ≡371, filed on day 17 in 2017, published in english, international application number PCT/US2017/018346, which claims priority from U.S. provisional application number 62/326,259, filed on day 22 in 2016, both of which are incorporated herein by reference.

Technical Field

The present technology relates to systems for automatically preparing biological samples for testing. In some embodiments, the system may include advantageous features for calibrating one or more robots. In some embodiments, the system may include advantageous features for managing consumables.

Background

Diagnostic testing of biological samples has been helpful in the healthcare industry for rapid and effective diagnosis and treatment of disease. Clinical laboratories that conduct such diagnostic tests have received thousands of samples per day and the demand is increasing. The challenge of handling such large numbers of samples is aided by sample analysis automation. Automated sample analysis is typically performed by an automated analyzer, which is typically a self-contained system, that performs multi-step processing on biological samples to obtain diagnostic results.

Several automated clinical analyzers currently offer users a series of automated tests or trials that can be performed on a provided sample. However, when samples arrive at the laboratory, they are often not ready for analysis. To prepare a sample for testing by an automated analyzer, a laboratory technician typically transfers an aliquot of the sample from a primary container received in the laboratory to a secondary container suitable for the analyzer. In addition, the skilled artisan typically must know what test is to be performed on the sample so that the skilled artisan can select the test specific reagent or diluent to be matched to the sample. This can be time consuming and can lead to operator error and exposure to infectious disease.

The pre-analysis system is intended to help prepare the sample for analysis and further to eliminate the operator still present from the workflow between the laboratory receipt of the sample and the test results of the analyzer. However, many such systems still require significant technician involvement, e.g., prior to loading the sample in the pre-analysis system; and after the sample has been prepared by the pre-analysis system; and after the analyzer has completed analysis.

For example, some pre-analytical systems may automatically transfer an aliquot of a sample from a first container to a second container. However, such systems often require a technician to manually pair the identification codes of the first and second containers and then load them into the system, which can be time consuming and prone to error.

In addition, many such systems are not capable of being integrated with one or more analyzers, and, conversely, the analyzers are not capable of being integrated with such systems. In this regard, a technician must be present to manually transfer the sample from the pre-analysis system to the analyzer and from the analyzer to a storage location at the end of the analysis. This will make the technician doing insignificant work and may cause interference because the technician must often pay attention to the progress of the sample in the pre-analytical system and analyzer so that the technician transfers the sample when ready to minimize downtime.

Moreover, current pre-analytical systems generally prepare the sample at a different rate than the analyzer evaluates the sample, thus further complicating integration between the pre-analytical system and the analyzer. In this regard, a technician may be required to continually take care of the sample prepared by the pre-analysis system until an entire batch of sample is accumulated for manual transfer to the analyzer. Alternatively, the technician may transfer a portion of the batch to the analyzer, which may reduce the productivity of the analyzer.

Thus, while current automated pre-analytical systems and analyzers are beneficial to clinical laboratories, there is still room for further improvement in the integration and automation of the different systems.

Disclosure of Invention

The present disclosure describes devices, systems for sample processing and analysis. In particular, an analyzer included in a high throughput system is described. In one embodiment, the high throughput system may also include a second analyzer and a pre-analysis system integrated with the first and second analyzers. These components (i.e., the analyzer and the pre-analysis system) are modular and can be integrated in several different configurations to accommodate the diagnostic needs of a particular laboratory.

The particular analyzers described herein typically have multiple platforms (ck) or layers (levels) arranged vertically. One platform may store consumables for various tests and may contain consumable waste, including waste fluids. In one embodiment, sufficient consumables may be stored within the analyzer to allow it to run for a long period of time (e.g., 24 hours or more in succession) without reloading the system. Thus, such devices only need to load consumables once and empty waste only once over a 24 hour period. The platform may also include a detector for detecting an analyte (e.g., a DNA target).

In some embodiments, a system may include advantageous features for calibrating one or more robots. For example, a robot comprising two or more downwardly extending columns is disclosed. The system may calibrate the robot by lowering each post into a corresponding cutout or slot and then moving each post closer together or farther apart until each post contacts a corner of each corresponding cutout or slot. The position of one or more components of the robot may then be saved in memory and used as a reference point for future movements of the robot.

In some embodiments, a system may include advantageous features for managing consumables. For example, a system may include a consumable reservoir coupled to a housing by one or more drawer slides. The stopper may alternate between two positions as the consumable reservoir is pulled out and pushed into the housing. In one position, the stopper may prevent the door of the housing from being closed. This may prevent a user from damaging the door and/or the consumable storage. In another position, the stopper may assist in pushing the consumable reservoir into the housing.

One aspect of the present disclosure relates to an automated analyzer having a housing with a robotic arm disposed therein, the robotic arm adapted to move a consumable within the housing. The robotic arm has an end effector for carrying an article. The end effector includes a body rotatably coupled to an articulating arm, the body including a pair of connecting members. The end effector has first and second fingers coupled to the connecting member of the body. Each of the first and second fingers extends between a first end and a second end, each of the first and second fingers having an offset formed and located at the second end. The offset has a first angled surface. The robotic arm also has a wedge including an angled side and a protrusion formed and protruding from the angled side. The angled sides and protrusions are configured to engage and attach to the offset portions of the fingers to connect the fingers to the body of the end effector. Optionally, the angled wedge surface is complementary to a surface of the inclined offset to which it is attached.

Optionally, the wedge and the offset are fastened together. In one aspect, the wedge and the offset have complementary holes therein that align when the wedge and the offset are fastened together. Optionally, the wedge and the offset have complementary holes therein that align when the wedge and the offset are fastened together. In one aspect, the wedge further comprises a protrusion, wherein the protrusion is received by a protrusion aperture in the offset when the wedge and the offset are engaged. In another aspect, a screw is received into each of the complementary holes to secure the wedge to the offset.

An automated analyzer having a housing is also described herein. An inventory robot is disposed within the housing. Optionally, the inventory robot has a scanner. The housing also optionally includes a processing platform disposed therein. The processing platform includes at least one processing module having a first position for receiving dry reagent consumables, a second position for receiving liquid reagent consumables, a third position for receiving processing plate consumables, a fourth position for receiving amplification cassette consumables; and a plurality of machine-readable labels disposed on each of the first, second, third, and fourth locations for scanning and reading by the scanner of the inventory robot to detect the presence of the consumable on the processing module for controlling inventory of the processing platform.

The processing platform may have an opening below which a magnetic extractor is disposed, and the automated analyzer further includes a processing plate support assembly disposed in the opening above the magnetic extractor. A machine-readable label may be placed on each of the first location, the second location, the third location, or the fourth location. In one aspect, a machine readable label may be placed in a fifth position, wherein the fifth position is between the fourth position and the opening under which the magnetic extractor is disposed. The machine readable label placed in the fifth position may be covered by the process plate support assembly when the process plate support assembly is placed over the opening.

The process plate support assembly may have a cutout configured to receive a structure extending from a bottom of the process plate consumable, the structure including a plurality of extraction tubes, mixing holes, and pipette tip holding stations. The process plate support assembly may have at least two tapered cut-outs on its surface. The tapered cut-out may be configured to receive an engagement feature from an end effector. The process plate support assembly may have at least one machine readable label placed on a top surface thereof, and the process plate consumable may be placed over the machine readable label when the process plate consumable is present on the process plate support assembly.

Also described herein is an automated analyzer having a housing and a consumable reservoir disposed within the housing, the consumable reservoir having a base, a plurality of columns extending upwardly from the base, a plurality of support structures connected to the plurality of columns. Each of the plurality of support structures is disposed in the compartment for receiving therein a consumable of one of at least two types. In one aspect, the two types of consumables may be a dry reagent plate and a liquid reagent plate. Each support structure may have a first arm and a second arm, each of the first and second arms extending between first and second ends thereof. Optionally, each of the first and second arms may include a tab at the second end of each arm to retain the reagent plate within the compartment.

The consumable storage may be positioned below a processing platform. The one of the first arm and the second arm may have a flange that is received within a complementary recess on the consumable when the consumable is properly placed in the compartment. The flange may have a first size and placement in the compartment receiving the first type of consumable and the flange may have a second size and placement in the compartment receiving the second type of consumable such that each compartment is configured to receive only one type of consumable. The compartment receiving the first type of consumable may have a planar surface on which the consumable is supported and the compartment receiving the second type of consumable has a flange supporting a skirt of the second type of consumable. The compartment receiving the first type of consumable includes an offset that receives a portion of a frame of the first type of consumable.

Another aspect of the present disclosure relates to a system including a robot having an end effector with two or more downwardly extending posts, a cutout or slot for each post, and one or more processors. The cross-sectional area of each cutout or slot may be greater than the cross-sectional area of each corresponding post, and each cutout or slot may include at least one corner. The one or more processors may be configured to calibrate the robot at least in part by: controlling the robot to position each post of the end effector over the corresponding cutout or slot; controlling the robot to lower the end effector until each post extends at least partially through a corresponding cutout or slot; controlling the robot to move each column closer together or farther apart until each column contacts the at least one corner of each corresponding cutout or slot; and storing the position of the end effector in a memory as each post contacts the at least one corner of each corresponding cutout or slot.

In some embodiments, each cutout or slot is positioned at a location where the robot is configured to retrieve or store one or more consumables. In some embodiments, each cutout or notch is provided in the teaching tool. In some embodiments, at least one cut or notch is triangular, heart-shaped, or tear-drop shaped.

In some embodiments, the end effector further has two or more fingers, and each finger has at least one of the two or more posts. In some embodiments, the one or more processors are further configured to calibrate the robot at least in part by storing the position of each finger in memory as each post contacts the at least one corner of each corresponding cutout or slot. In some embodiments, each post is removably coupled to a corresponding finger of the end effector.

In some embodiments, each post is coupled to a teaching tool held by the end effector of the robot. In some embodiments, at least one post includes an engagement feature sized to engage a corresponding notch in the consumable.

In some embodiments, the edges on both sides of the at least one corner of at least one cutout are straight. In some embodiments, the edges on both sides of the at least one corner of at least one cutout are curved. In some embodiments, the angle between the edges on both sides of the at least one corner of at least one cutout is between 85 degrees and 95 degrees.

Yet another aspect of the present disclosure relates to a calibration robot that includes an end effector having two or more downwardly extending posts. The calibrating may include: controlling the robot to position each post over a corresponding cutout or slot, wherein a cross-sectional area of each cutout or slot is greater than a cross-sectional area of each corresponding post, and wherein each cutout or slot includes at least one corner; controlling the robot to lower the end effector until each post extends at least partially through a corresponding cutout or slot; controlling the robot to move each column closer together or farther apart until each column contacts the at least one corner of each corresponding cutout or slot; and storing the position of the end effector in a memory as each post contacts the at least one corner of each corresponding cutout or slot.

Yet another aspect of the present disclosure relates to a system that includes a housing, a consumable reservoir, one or more drawer slides, a rail, and a stop. The housing may include a side wall and a door, wherein the door is hingedly coupled to the side wall of the housing. The consumable storage may include a side panel and one or more storage compartments extending from the side panel. The one or more drawer slides may couple the side panels of the consumable storage to the side walls of the housing such that the consumable storage can be pulled out of or pushed into the housing when the door is open. The rail may be coupled to the side plate of the consumable storage and include an angled portion. The stopper may be hingedly coupled to the side wall of the housing. The stopper may also be coupled to a support configured to slide along the track when the consumable reservoir is pulled out of or pushed into the housing. The stop is movable between a first position in which the door is prevented from closing and a second position in which the door is allowed to close as the support slides along the track.

In some embodiments, the stop moves to the first position when the consumable reservoir is pulled out of the housing, and the stop moves to the second position when the consumable reservoir is pushed into the housing. In some embodiments, the support contacts the sloped portion of the track when the stop is in the second position. In some embodiments, the rail further comprises a horizontal portion, and the support contacts the horizontal portion when the stop is in the first position.

In some embodiments, the stop is a member of a hinge coupled to a side wall of the housing. In some embodiments, the system may further include a hinge coupled to the side wall of the housing, wherein the stopper is coupled to a member of the hinge through the support. In some embodiments, the system may further comprise a torsion spring disposed within the hinge, wherein the torsion spring provides a downward force on the support as the support slides along the track.

Drawings

FIG. 1 is a front perspective view of a high throughput diagnostic system according to one embodiment of the present disclosure.

FIG. 2 is a front partially transparent view of the first analyzer of the system of FIG. 1, with its outer housing and some components therein removed, according to one embodiment of the present disclosure.

Fig. 3 is a front perspective view of the analyzer of fig. 2.

Fig. 4A is a perspective view of a first pipette tip according to one embodiment of the present disclosure.

Fig. 4B is a perspective view of a second pipette tip according to one embodiment of the present disclosure.

Fig. 5 is a perspective view of a sample container shuttle according to one embodiment of the present disclosure.

Fig. 6 is a perspective view of a process plate according to one embodiment of the present disclosure.

Fig. 7 is a perspective view of a dry reagent board according to one embodiment of the present disclosure.

Fig. 8 is a perspective view of a liquid reagent plate according to one embodiment of the present disclosure.

FIG. 9 is a top view of an amplification cassette according to one embodiment of the present disclosure.

Fig. 10A is a rear perspective view of a consumable storage according to one embodiment of the present disclosure.

Fig. 10B is a rear perspective view of a waste reservoir according to one embodiment of the present disclosure.

Fig. 10C is a front perspective view of a pipette tip drawer according to one embodiment of the present disclosure.

Fig. 11A is a top view of a processing platform according to one embodiment of the present disclosure.

Fig. 11B is a top view of a first process module of the process platform of fig. 11A according to one embodiment of the present disclosure.

FIG. 11C is a schematic view of a sample container engaged by the sample container holding assembly of the processing platform of FIG. 11A.

Fig. 12A is a front perspective view of an extractor of the process module of fig. 11B, according to one embodiment of the present disclosure.

Fig. 12B is a top view of the extractor of fig. 12A.

Fig. 12C is a perspective view of an alternative embodiment of an extractor and process plate.

Fig. 12D is a side view of the extractor and process plate of fig. 12C.

Fig. 12E is a partial perspective view of a processing platform of the system of fig. 1 including the extractor and processing plate of fig. 12C.

Fig. 13A is a front perspective view of an inventory robot according to one embodiment of the present disclosure.

Fig. 13B is an end effector of the robot of fig. 13A according to one embodiment of the present disclosure.

FIG. 13C is an amplification cassette engagement member of the end effector of FIG. 13B.

FIG. 13D is a side view of the engagement member of FIG. 13C engaged with an amplification cassette.

Fig. 14A is a front view of a liquid handling assembly according to one embodiment of the present disclosure.

Fig. 14B is a front perspective view of the multi-channel pipette of the liquid handling assembly of fig. 14A.

FIG. 15 is a block diagram of an exemplary architecture of a computing system incorporating the analyzer of FIG. 2, wherein the analyzer includes exemplary components suitable for performing the devices and/or systems of the present disclosure.

Fig. 16 is a flow chart of the operation of the analyzer of fig. 2 according to one embodiment of the present disclosure.

Fig. 17A is a front view of an analyzer according to another embodiment of the present disclosure.

Fig. 17B is a front perspective view of the analyzer of fig. 17A.

Fig. 17C is a side view of the analyzer of fig. 17A.

Fig. 18A is a front perspective view of the analyzer of fig. 17A including a housing but lacking a front door.

Fig. 18B is a partial front perspective view of the analyzer of fig. 18A including a separate front door.

Fig. 18C is a perspective view of a removable consumable inventory.

Fig. 19 is a front perspective view of a consumable reservoir according to another embodiment.

Fig. 20 is a partial rear perspective view of the consumable reservoir of fig. 19.

Fig. 21 is a partial front view of the consumable reservoir of fig. 19.

Fig. 22 is a partial cross-sectional view of the consumable reservoir of fig. 19.

Fig. 23 is a rear perspective view of an internal consumable storage according to one embodiment of the present disclosure.

Fig. 24 is a front perspective view of the internal consumable reservoir of fig. 23.

Fig. 25 is a partial front view of the internal consumable reservoir of fig. 23 with a reagent plate placed therein.

FIG. 26 is a partial cross-sectional view of the internal consumable reservoir of FIG. 23 with a reagent plate disposed therein.

Fig. 27 is a front perspective view of an internal consumable reservoir according to another embodiment.

Fig. 28A is a perspective view of a consumable storage according to one embodiment of the present disclosure.

Fig. 28B is a front view of the consumable reservoir of fig. 28A.

Fig. 28C is a perspective view of the consumable reservoir of fig. 28A within an analyzer.

Fig. 28D is a side view of the consumable reservoir of fig. 28A.

Fig. 28E is a perspective side view of the consumable storage of fig. 28A.

Fig. 28F is a perspective view of a portion of the consumable reservoir of fig. 28A and a portion of the analyzer of fig. 28C.

FIG. 29A is a top view of a process module of the process platform of FIG. 11A without a process plate support assembly, reagent plates, and cassettes disposed thereon.

Fig. 29B is a top view of the process module of fig. 29A with a process plate support assembly disposed thereon.

Fig. 29C is a perspective view of the process plate support assembly of fig. 29B.

Fig. 30 is a top perspective view of an end effector according to another embodiment.

Fig. 31 is a portion of a partially exploded front perspective view of the end effector of fig. 29.

Fig. 32A is a perspective view of an end effector of a robot according to one embodiment of the present disclosure.

Fig. 32B is a top view of the end effector of fig. 32A.

Fig. 32C is a front view of the end effector of fig. 32A.

Fig. 32D is a side view of the end effector of fig. 32A.

Fig. 32E is a perspective view of the end effector of fig. 32A over a pair of incisions.

Fig. 33A is a perspective view of a pair of cutouts in accordance with one embodiment of the disclosure.

Fig. 33B is a top view of the incision of fig. 33A.

FIG. 34 is a perspective view of the end effector of FIG. 32A and a plurality of cutouts disposed in a consumable storage compartment.

35A-35D each illustrate steps within a calibration process according to one embodiment of the present disclosure.

36A-36D each illustrate steps within a calibration process according to one embodiment of the present disclosure.

Detailed Description

Embodiments of the present disclosure will be described in detail with reference to the drawings, wherein like reference numerals identify similar or identical elements. It is to be understood that the disclosed embodiments are merely exemplary of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

As used herein, the words "about," "generally," and "substantially" are intended to mean that slight deviations from the absolute value are included within the scope of the terms so modified. Further, in the following discussion, when referring to particular directions, such as left, right, front, rear, up and down, it should be understood that these directions are described with respect to the perspective of a user facing the system described below during exemplary operation.

As used herein, the singular forms "a", "an" and "the" include the singular and plural forms as well, unless the context clearly indicates otherwise.

Fig. 1 depicts a high throughput system 00 comprising a first analyzer 2000, a second analyzer 4000, and a pre-analysis system 10, such as described in U.S. application No. 16/077,875 ("the' 875 application") filed on 8-month 14 of 2018, which is a national phase entry according to 35u.s.c. ≡371 filed on 2-month 17 of 2017, published in english, international application No. PCT/US2017/018358, which claims priority from U.S. provisional application No. 62/409,013 filed on 10-month 17 of 2016 and U.S. provisional application No. 62/296,349 filed on 2-month 17 of 2016, both of which are incorporated herein by reference. The analyzers 2000, 4000 and the pre-analysis system 10 are modular such that they can be physically connected and disconnected from each other and also electronically connected and disconnected from each other. While the first analyzer 2000 and the second analyzer 4000 differ in the operation and testing they implement, it should be appreciated that the second analyzer 4000 may be a duplicate (duplicate) of the first analyzer 2000 such that the pre-analysis system 10 is coupled to at least two identical analyzers. It should also be appreciated that the modularity of the pre-analysis system 10 allows it to be coupled to any analyzer so configured. As shown, the first analyzer 2000 and the second analyzer 4000 are disposed in a linear arrangement on opposite sides of the pre-analysis system 10. Although the pre-analysis system 10 and analyzers 2000, 4000 are configured in this physical arrangement, it is contemplated that the pre-analysis system 10 may be configured to accommodate more than two analyzers and that the pre-analysis system 10 and analyzers 2000, 4000 may be configured such that they can be placed in other physical arrangements, such as an L-shape.

Analyzer associated with a pre-analysis system

As shown in fig. 2, a first analyzer may be coupled to either side of the pre-analysis system 10. In this regard, with analyzer 2000 positioned on the right side of system 10, sample container shuttle transport assembly 300a of pre-analysis system 10 extends toward the left side of analyzer 2000, or with analyzer 2000 positioned on the left side of system 10, sample container shuttle transport assembly 300b of pre-analysis system 10 extends toward the right side of analyzer 2000. Such assemblies 300a-b may terminate adjacent to the inlet of the analyzer, as shown. However, in some embodiments, such assemblies 300a-b may extend through an inlet of the analyzer and into the analyzer 2000. The inventory robot 2300, as described further below, may retrieve sample container shuttles 2030 from such assemblies 300a-b, regardless of which side of the analyzer 2000 the sample container shuttles 2030 are transported to.

Structural frame

As further described in fig. 2 and 3, the analyzer 2000 includes a structural frame 2011 that is comprised of several support members, such as metal tube segments, configured to support and define various platforms or layers for sample processing and analysis. Such platforms may include a detection/analysis platform 2012, an inventory platform 2014, a process platform 2016, and a liquid robotic process platform 2018. However, more or fewer platforms may be provided to reduce the horizontal length or vertical height of analyzer 2000. The analyzer 2000 also includes a housing or casing 2010 surrounding its internal components as shown in fig. 1.

Platform relationship

The detection/analysis platform 2012 is disposed near the bottom of the analyzer 2000 and is positioned below the inventory platform 2014. Inventory platform 2014 is disposed between processing platform 2016 and detection/analysis platform 2012. The process platform 2016 is disposed between the inventory platform 2016 and the liquid handling robot platform 2018. A liquid handling robotic platform 2018 is provided near the top of the analyzer 2000. The detection/analysis platform 2012, the inventory platform 2014, and the process platform 2016 are each positioned at the front of the analyzer 2000 and terminate before reaching the back of the analyzer so as to provide space that spans the length of the analyzer 2000 in a side-to-side direction and also extends along the height of the analyzer 2000 so as to intersect the detection/analysis platform 2012, the inventory platform 2014, and the process platform 2016. The inventory robot 2300 is disposed in the space thus provided, which allows it to approach each of the three aforementioned platforms.

Consumable material

Fig. 4A-8 show different consumables that can be automatically processed and used to perform in-broad-menu tests on several types of samples, including blood, mucus, sputum, urine, stool, liquid-based cytology samples, and the like. Such options include assays involving detection of chlamydia trachomatis, neisseria gonorrhoeae, trichomonas vaginalis, group B streptococcus, intestinal bacteria (e.g. campylobacter, salmonella, shigella, escherichia coli, shigella), and intestinal parasites (e.g. giardia, cryptosporidium, amoeba histolytica) and assays involving determination of blood viral load (e.g. HIV, HCV and HBV). The ability to implement such a broad menu is supported in part by the consumable design. Such consumables include pipette tips, sample containers, sample container shuttles, processing plates, dry reagent plates, liquid reagent plates, and amplification cartridges.

Pipette tip

The pipette tip 2020 includes a first pipette tip 2020a (fig. 4A) and a second pipette tip 2020B (fig. 4B). The first pipette tip 2020a is larger than the second pipette tip 2020 b. For example, the first pipette tip 2020a may be a 1mL tip and the second pipette tip 2020b may be a 175 μL tip. However, the analyzer 2000 can be adapted for any size pipette tip as desired.

Sample shuttle and sample container

Sample container shuttle 2030 (fig. 5) is similar to shuttle 284 of the' 875 application and includes receptacles 2032, each configured to receive a sample container 03. The particular shuttle 2030 described includes two rows of 6 receivers 2032 for a total of 12 receivers. However, any number of receivers 2032 may be provided. For example, shuttle 2030 may include two rows of 12 receivers 2032 for a total of 24 receivers. In the particular analyzer 2000 described, a batch of samples may include a total of 24 samples, which should be equal to a total of 24 sample containers. However, the analyzer 2000 may perform a two-channel test, or other multi-channel test, in which a single sample is processed and analyzed two or more times in one run. Thus, some batches of a total of 24 samples may only require a total of 12 sample containers to obtain the total sample count. In this manner, each shuttle 2030 is made to accommodate half of the complete sample lot for the analyzer to effectively accommodate the flexibility of a two-channel test or other multi-channel test.

The shuttle 2030 further includes a first transverse opening 2034 for engaging with the inventory robot 2300 and a second transverse opening 2036 that intersects with a corresponding receiver 2032 to allow access to a container 03 placed therein by a sample container holding assembly (described below). The sample container 03 is identical to the third type of container 03 in the' 875 application. In this regard, the sample container 03 includes a cap with a penetrable seal 09.

Treatment plate

The processing board 2040 (fig. 6) includes a board main body 2041. The joint member 2049 extends from the upper surface of the plate main body 2041. Such engagement members 2049 include engagement notches 2042. Thus, the notch 2042 is provided above the plate body 2041 and inwardly with respect to the side of the plate body 2041. This allows an end effector (such as end effector 2360 described further below) to clamp the processing plate 2040 from above the plate body 2041. However, in some embodiments of the plate 2040, slots 2042 may extend into a side surface of the body 2041 that allows the inventory robot 2300 to engage the process plate 2400 from the periphery of the body 2041.

The plate body 2041 at least partially defines a plurality of extraction tubes 2044, mixing holes 2046, and pipette tip holding station 2047. Each extraction tube 2044 has a corresponding mixing hole 2046 and pipette tip holding station 2047 aligned therewith. The extraction tube 2044 is positioned closer to the midline of the body 2041 than the mixing hole 2046, and the mixing hole 2046 is positioned closer to the midline of the body 2041 than the pipette tip holding station 2047. The extraction tube 2044 has an opening defined by the body 2041 and has a tube body 2045 extending from a bottom surface 2043 of the body 2041. The tube body 2045 defines a rotating outer surface, such as a rotating cone. Pipette tip holding station 2047 also has an opening defined by body 2041 and a sleeve 2048 extending from bottom surface 2043. The sleeve 2048 holds the pipette tip 2020 stable even when the treatment plate is moving when the pipette tip is disposed in the sleeve. Two rows of extraction tubes 2044, mixing holes 2046 and pipette tip holders 2047 are provided and arranged parallel to each other. In the particular embodiment depicted, the processing plate 2040 includes two rows of six extraction tubes 2044, six mixing holes 2046, and six pipette tip holding stations 2047, which allow for 12 samples to be processed therein. However, a greater or lesser number is contemplated. For example, the processing plate 2040 may include two rows of twelve extraction tubes 2044, twelve mixing holes 2046, and twelve pipette tip holding stations 2047 or even one row of such arrangements. The processing board 2040 includes an identifier (e.g., a bar code) on a side surface or other surface thereof that aids the analyzer 2000 in identifying the board.

Dry reagent plate

The dry reagent plate 2050 (fig. 7) includes a plate body 2051. The engagement notches 2052 extend into a side surface 2053 of the body 2051 that allow the inventory robot 2300 to engage the dry reagent plate 2050 from any two opposing sides thereof. The plate body 2051 defines a plurality of dry reagent compartments 2054. A penetrable membrane (not shown) is placed over each of these compartments 2054 and sealed to the plate body 2051 such that if the membrane is pierced to access one compartment, the remaining compartments remain sealed. This allows the plate 2050 to be stored until needed for another batch of samples. As shown, there are a total of 96 reagent compartments 2054 that allow the reagent pad 2050 to be used for 4 separate runs of a batch containing 24 samples. However, the total number may vary. The dry reagent plate 2050 also includes an identifier (e.g., a bar code) on its side surface 2053 or other surface that aids the analyzer 2000 in identifying the plate.

In one embodiment, a dry reagent plate 2050 is used for each test: a first dry reagent plate or extraction reagent plate 2050a and a second dry reagent plate or amplification reagent plate 2050b (see fig. 10C). In this regard, the extraction reagent plate 2050a is loaded with a lysis buffer and extraction microbeads, and the amplification reagent plate 2050b is loaded with a primary mixing reagent.

Each reagent compartment 2054 within the same plate 2050 is loaded with the same reagent so that the reagent plate is assay specific. Thus, when the analyzer 2000 performs more than one analysis, separate reagent plates each with reagents for the test are used. Thus, for one test performed by the analyzer 2000, at least two dry reagent plates 2050 (e.g., one extraction reagent plate 2050a and one amplification reagent plate 2050 b) are used. Similarly, at least four dry reagent plates 2050 (e.g., two extraction reagent plates 2050a and two amplification reagent plates 2050 b) are used when the analyzer 2000 performs two different assays. Although the extraction and amplification dry reagent plates 2050a-b are described as being separate, it is contemplated that they may be combined into a single reagent plate.

Liquid reagent plate

The liquid reagent plate 2060 (FIG. 8) includes a plate body 2061 defined by upper and lower surfaces and a side surface 2062 extending therebetween. An engagement notch 2064 extends into the side surface 2062 of the body 2061 that allows the inventory robot 2300 to engage the liquid reagent plate 2060 from any two opposing sides thereof. The liquid reagent plate 2060 includes a plurality of reagent compartments 2066 organized in four processing rows 2066. Each of these rows 2066 includes four compartments 2066a-d, each of which contains reagents for a sample processing step. For example, each processing row 2066 includes a first compartment 2066a for a recovery buffer, a second compartment 2066b for a wash buffer, a third compartment 2066c for an elution buffer, and a fourth compartment 2066d for a neutralization buffer. The compartments 2066a-d are arranged in the order in which they are used. However, they may be arranged in other ways. In addition, each compartment 2066 contains reagents sufficient to perform processing of samples of an entire batch (e.g., a batch of 24 samples in total). A penetrable membrane (not shown) is placed over each of these compartments 2066 and sealed to the plate body 2061 such that if the membrane is pierced to access one compartment, the remaining compartments remain sealed. This allows the liquid reagent plate 2060 to be stored until needed for another batch of sample. The liquid reagent plate 2060 also includes an identifier (e.g., a bar code) on its side surface 2062 or other surface that aids the analyzer 2000 in identifying the plate.

Amplification box

The amplification cassette 2070 (FIG. 9) is similar to BD MAX ^TM System-related BD MAX ^TM PCR cassettes (Becton Dickinson, franklin lake, new jersey) and are described in us patent No. 7,332,130;7,998,708;8,105,783;8,440,149;8,709,787;8,765,076, the disclosure of which is incorporated herein by reference in its entirety. Amplification cassette 2070 comprises an inlet port 2073, microfluidic tubing (not shown), a wax valve 2074, an amplification chamber 2075 and a vent 2076. The processed sample is inserted into the cassette 2070 through the inlet port 2073, which follows the microfluidic channel into the amplification chamber 2075. Vent 2076 allows air to escape as the sample travels down the tubing. The wax valve 2074 seals the chamber 2075 when melted so that amplification of the sample can occur inside it. A transparent or translucent window partially defining the chamber 2075 allows the detector to detect the presence of an analyte or target therein.

The amplification cassette 2070 also includes engagement notches 2072 extending into the side surfaces of the cassette 2070. These slots 2072 extend into the box 2070 on opposite sides of the box 2070 and taper inwardly toward the midline of the box. In addition, the notch 2072 is positioned adjacent to the sides of the case including the inlet port 2073 and the vent 2076. This prevents notch 2072 from interfering with these structures. The slots 2072 allow the inventory robot 2300 to engage the amplification cassette 2070 so that the cassette 2070 may be carried by the robot 2300. In some embodiments, however, the amplification cassette 2070 may not have such a notch 2072 and other features for engagement with the robotic gripper may be used. The lower surface 2079 of the box 2070 that intersects the notch 2072 is beveled or otherwise shaped to match the profile of the engagement post 2365 of the robot, which forms a recess or depression 2077 in the lower surface 2079 around the notch 2072 to further facilitate the robot engagement, as further described below and shown in fig. 13D. The amplification cassette also includes an identifier (e.g., a bar code) on its top or bottom surface 2078, 2079 that aids the analyzer 2000 in identifying the cassette. .

Consumable frame (training)

Fig. 10A-10C depict various aspects of the consumable framework within the inventory platform 2014 and the processing platform 2016. The inventory platform 2014 includes at least one consumable reservoir, such as consumable reservoir 2110 (fig. 10A) and an internal consumable reservoir 4020 (see fig. 23, 24, and 27). The inventory platform 2014 also includes at least one waste reservoir, such as waste reservoir 2130 (fig. 10B). The processing platform 2016 also includes a plurality of pipette tip drawer assemblies 2140 (fig. 10C). The consumable reservoir 2110, the waste reservoir 2130, and the pipette tip drawer 2140 are each accessible to a user from the front of the analyzer 2000 so that the user can load or unload a variety of consumables used by the analyzer 2000. However, the internal consumable reservoir 4020 is not readily accessible to a user to load/unload consumables therefrom. The internal consumable reservoir 4020 is accessible for repair/maintenance.

Consumable storage device

As shown in fig. 10A, the consumable storage 2110 includes a support structure or beam 2114 extending horizontally from a column 2118, having a plurality of sheet metal tracks (not shown) extending vertically from a base 2119. The support structure 2114 defines a compartment for individual consumable items such that consumable items can be loaded into the compartment from a first side of the column 2118 and unloaded from a second side of the column 2118. For example, as shown in fig. 10A, the support structure 2114 can slidably receive and support the dry reagent plate 2050 or the liquid reagent plate 2060. Such plates 2050 and 2060 may be slid by a user into their respective compartments from the front of column 2118 such that the identifier (e.g., bar code) faces the interior of system 2000. As described further below, inventory robot 2300 may scan the identifiers as needed to identify a particular plate and remove the appropriate plate 2050, 2060 from the rear side of column 2118. In this regard, consumable items, such as plates 2050 and 2060, may be loaded by a user in any order, as the system 2000 may inventory via the robot 2300 and automatically determine the order in which the consumables were loaded by the user. In addition, the support structure 2114 holds the plates 2050, 2060 at their lower ends such that their openings 2052, 2064 are exposed, thereby allowing the robot 2300 to engage the selector plate for removal from their respective compartments. As also shown, the amplification cassette 2070 may be stacked within a corresponding cassette storage compartment 2116 located at the top end of the consumable storage 2110. The cassettes 2070 may be stacked by a user in the storage compartment 2116 from the front side of the system 2000 and removed from the front side by the robot 2300.

In one embodiment, the consumable reservoir 2110 may be attached to a set of rails, which allows the reservoir 2110 to be pulled out like a drawer for refilling. A pneumatic plunger (not shown) may assist in opening the reservoir 2110 and may also provide damping to prevent the reservoir 2110 from closing too quickly and pushing the consumable out of place. In other embodiments, the reservoir 2110 may be hinged so that the door 2112 may be rotated open toward the user to display the reservoir for refilling.

Referring to fig. 19-22, in an alternative embodiment, the consumable reservoir 4010 can include a plurality of fully machined columns 4012 extending vertically upward from a bottom 4014 of the consumable reservoir 4010. The consumable reservoir 4010 can further comprise a plurality of support structures 4016 integrally connected to the column 4012. Each of the support structures 4016 defines a compartment 4018, which compartment 4018 is adapted to receive and retain a reagent plate 2050, 2060 therein after loading the reagent plate 2050, 2060 from the front opening 4022 of the consumable reservoir 4010. As shown, the reagent plate 2050 is adapted to receive dry reagents and the reagent plate 2060 is adapted to receive liquid reagents. The total length and width of the reagent plate are the same so that any reagent plate can be inserted into any compartment. However, as shown, the liquid reagent plate 2060 is slightly taller than the dry reagent plate 2050. Those skilled in the art will appreciate that the consumable reservoir 4010 can be adapted to accommodate any conventionally sized reagent plate having conventional dimensions.

Referring to fig. 20, each support structure 4016 includes a first arm 4024 and a second arm 4026 having a space therebetween. Each of the first arm 4024 and the second arm 4026 extends horizontally between a first end 4028 and a second end 4030 thereof. As shown in fig. 20, a tab 4032 is formed at the second end 4030 of each arm 4023, 4026 to support the reagent plates 2050, 2060 in the support structure 4016 and to retain the reagent plates 2050, 2060 within the compartments 4018 after placement of the reagent plates 2050, 2060 into the compartments 4018 from the front openings 4022 of the compartments 4018.

The first arm 4024 includes flanges 4034, 4036 extending horizontally between the first end 4028 and the second end 4030 of the first arm 4024 as shown in fig. 21. As shown, the flanges 4034, 4036 have a vertical height. The flanges 4034, 4036 provide stability and retainability to the reagent plates 2050, 2060 while the reagent plates 2050, 2060 are retained within the compartment 4018. For example, when the reagent plates 2050, 2060 are slid into the compartments 4018, the grooves formed in the bottom of the reagent plates 2050, 2060 allow the flanges 4034, 4036 of the support structure 4016 to be received therein such that the reagent plates 2050, 2060 can be securely retained in the compartments 4018. Further, the flange 4034 is configured to receive only the dry reagent plate 2050 and the flange 4036 is configured to receive only the liquid reagent plate 2060. This selectivity is achieved by positioning a mating groove 2055 (shown in fig. 7) in the dry reagent plate 2050, the mating groove 2055 will selectively mate with the flange 4034, and the mating groove 2067 (shown in fig. 8) will selectively mate with the flange 4036. Thus, the flanges 4034, 4036 prevent a user from inserting the dry reagent plate 2050 into the compartment for the liquid reagent plate 2060, and vice versa.

The length of each of the first arm 4024 and the second arm 4026 is approximately equal to the length of the reagent plates 2050, 2060, allowing the reagent plates 2050, 2060 to fit snugly within the compartment 4018.

Although in the illustrated embodiment the consumable reservoir 4010 has nine compartments and is thus configured to store nine sets of reagent plates, it is contemplated that the consumable reservoir 4010 may be configured to store any number of sets of reagent plates deemed suitable by those skilled in the art for the intended use of the consumable reservoir 4010. In the illustrated embodiment, a set of reagent plates has two dry reagent plates 2050 and one liquid reagent plate 2060. As described above, the reagent plates have about the same height and about the same width, although configured differently.

23-26, there may be one or more internal consumable reservoirs 4040 for storing additional reagent plates 2050, 2060 and/or used reagent plates 2050, 2060 from previous sample processing by the system. The internal consumable reservoir 4040 is a modular unit that is not accessible to a user under normal operation. However, the inventory robot may access the internal consumable storage 4040 during normal operation. Further, the internal consumable storage 4040 may be accessible for maintenance, repair, and the like.

The internal consumable reservoir 4040 includes a frame 4042 and a plurality of compartments having shelves 4044 or flanges 4048 configured to receive and hold reagent plates 2050, 2060. The compartments with shelves 4044 for the dry reagent plates 2050 and the compartments with flanges for receiving the liquid reagent plates 2060 are thus configured differently. For example, the shelf 4044 for the dry reagent plate 2050 includes a base 4046 upon which the dry reagent plate 2050 may rest. For the liquid reagent plate 2060, the shelf 4044 includes a pair of flanges 4048 extending from each side of the frame 4042 toward each other with a space therebetween. As shown in fig. 25, when the liquid reagent plate 2060 is placed in the inner consumable reservoir 4040, the flange 4048 supports each side portion of the body of the liquid reagent plate 2060 placed thereon. This configuration is desirable for the liquid reagent plate 2060 because the liquid reagent compartments 2066 extend below the body 2061 of the reagent plate 2060. More generally, the internal consumable storage can receive reagent plates that can be stabilized when placed on a flat surface, as well as reagent plates that are more securely supported by their frame than by structures that extend below the frame. Sometimes the reagent plate has compartments extending different distances from the reagent container body. In this case, if the reagent plate is placed on a flat surface, the reagent plate will only be supported by the compartment extending furthest below the body. Such a reagent plate will tend to sit less securely than a reagent plate that utilizes compartments that extend a consistent distance from the body of the reagent plate. Thus, as shown in fig. 23-26, the compartment with shelf 4044 is referred to as a "shelf compartment" and the compartment with flange 4048 is referred to as a "flange compartment".

Each shelf compartment 4044 includes a plurality of first side offsets 4050 and a plurality of second side offsets 4052 defined and located at a first side 4054 and a second side 4056, respectively, of the shelf compartment 4044. The side offsets 4050, 4052 are used to guide the inventory robot to center the reagent plate 2050 when placing the reagent plate 2050 onto the rack compartment 4044, as shown in fig. 25. Each side offset 4050, 4052 extends between a side wall 4058 of the shelf compartment 4044 and a flange 4048 of the base 4046 or flange compartment at an angle that is neither perpendicular to the side wall 4058 nor to the base 4046. The body or frame of the reagent plates 2050, 2060 is sized to fit within the space provided between the first and second side offsets 4050, 4052.

Each rack compartment 4044 for the dry reagent boards 2050 also includes a plurality of front offsets 4060 defined and located in front of the rack compartments 4044 for providing for the introduction of inventory robots to accurately place the dry reagent boards 2050 on the racks 4044. Each of the plurality of front offsets 4060 extends upwardly from the base 4046 of the shelf compartment 4044 at an angle that is not perpendicular to the base 4046 of the shelf compartment 4044. The plurality of front offsets 4060 are positioned and oriented such that when the dry reagent plate 2050 is placed on the shelf of the shelf compartment 4044, a front portion of the body of the dry reagent plate 2050 (i.e., the plate frame instead of the frame receiver) fits between the plurality of front offsets 4060, as shown in fig. 26.

Although in the illustrated embodiment the internal consumable reservoir 4040 includes four shelf compartments 4044 and two flange compartments 4048 for storing two sets of reagent plates 2050, 2060, the internal consumable reservoir 4040 may be configured to store any number of sets of reagent plates 2050, 2060 deemed suitable by those of skill in the art for the intended use of the internal consumable reservoir 4040.

Referring to fig. 27, in an alternative embodiment, the internal consumable storage 4062 includes a plurality of shelf compartments 4064, wherein each shelf compartment 4064 has a U-shaped flange 4066 for holding a reagent plate 2050, 2060 and a plurality of front offsets 4068 defined and located in front of the shelf compartment 4064 for providing for the introduction of an inventory robot for precisely placing the reagent plate 2050, 2060 on the shelf compartment 4064. The plurality of front offsets are similarly configured and positioned as the front offsets of the embodiment shown in fig. 23-26.

The consumable and internal consumable reservoirs 4010, 4040 are made of one or more materials having suitable properties (including strength, weight, rigidity, etc.) for the desired application. Corrosion resistant metals (e.g., stainless steel, etc.) are generally preferred. Metals coated with liquid impermeable polymers are also contemplated.

Fig. 28A-28E illustrate aspects of another consumable reservoir. For example, the consumable reservoir 4120 includes a front plate 4121 and a side plate 4122. The front plate 4121 includes a handle 4123. Side plate 4122 is slidingly coupled to side wall 5001 of analyzer 5000 by drawer slides 4124 and 4125. In some embodiments, dampers (not shown) may be incorporated into drawer slides 4124 and 4125 or added as separate subassemblies. As best seen in fig. 28C, the user may access the consumable reservoir 4120 by opening the door 4112 and pulling the handle 4123. As shown, the wall 4114 and the base 4115 extend horizontally from the side panels 4122. The wall 4114 and the base 4115 together form a storage compartment at the bottom end of the consumable reservoir 4120. Consumable materials (e.g., processing board 2040) may be stacked in these storage compartments by a user from the front side of analyzer 5000 and removed therefrom by an inventory robot (e.g., inventory robot 2300). In some embodiments, the angle between the side plate 4122 and the base 4115 may be less than 90 degrees to ensure that the process plate 2040 is biased against the side plate 4122. For example, the angle between the side plate 4122 and the base 4115 may be 89 degrees. As shown, the support structure 4116 also extends horizontally from the side panels 4122. The support structure 4116 defines a storage compartment at the top end of the consumable reservoir 4120. Consumables (e.g., amplification cassette 2070) may be stacked in these storage compartments by a user from the front side of the analyzer 5000 and removed therefrom by an inventory robot (e.g., inventory robot 2300).

Analyzer 5000 may be similar to analyzer 2000. For example, analyzer 5000 may include a housing, one or more processing platforms, an inventory robot, a liquid handling robot, a consumable storage area, and a detector. In addition, the analyzer 5000 may utilize the same consumables as the analyzer 2000, such as the pipette tips 2020, shuttle 2030, processing plate 2040, liquid reagent plate 2060, dry reagent plate 2050, and amplification cassette 2070 previously described. However, the analyzer 5000 may be different with respect to the arrangement and configuration of consumable storage areas. For example, as best seen in fig. 28C, the analyzer 5000 may include a consumable reservoir 4120 and an additional consumable reservoir 4110. The additional consumable reservoir 4110 can be positioned between the consumable reservoir 4120 and the waste reservoir 4130. Much like the consumable reservoir 2110, the additional consumable reservoir 4110 can include a support structure configured to slidingly receive and support the dry reagent plate 2050 and/or the liquid reagent plate 2060. However, the additional consumable storage 4110 may not include a storage compartment configured to receive the amplification cassette 2070. Alternatively, as described above, the consumable reservoir 4120 may comprise a storage compartment configured to receive the amplification cassette 2070. The waste reservoir 4130 may be compared to the waste reservoir 2130, as will be described in more detail below.

The consumable reservoir 4120 can include one or more advantageous features. For example, as best seen in fig. 28A, the consumable reservoir 4120 can include one or more cutouts 5701. As explained in more detail below, these cutouts may be used to quickly and efficiently calibrate an inventory robot (e.g., inventory robot 2300). As shown, the base 4115 includes a cutout 5701. However, the support structure 4116 may also include similar features. In some embodiments, the support structure 4116 may include similarly shaped cutouts. In other embodiments, the support structure 4116 may include differently shaped cutouts and/or notches.

As another example, as best seen in fig. 28B, 28E, and 28F, the analyzer 5000 may advantageously include a stopper 4151, a torsion spring 4153, a hinge 4154, and a rail 4155. As shown, the torsion spring 4153 is positioned within the hinge 4154, the hinge 4154 being coupled to the side wall 5001. The rail 4155 is coupled to the side plate 4122. As best seen in fig. 28E, unlike the generally horizontal drawer slides 4124 and 4125, the track 4155 can include both a horizontal portion 4155a and an angled portion 4155 b. As best seen in fig. 28F, the stop 4151 may be connected to the member 4152 of the hinge 4154 by a support 4156. With the assistance of the downward force provided by the torsion spring 4153, the support 4156 may slide along the track 4155 when the consumable reservoir 4120 is opened or closed by a user. As explained in more detail below, these components may prevent a user from damaging the analyzer 2000 by closing the door 4112 when the consumable reservoir 4120 is in an open or partially open position. In addition, these components may assist the user in pushing the consumable reservoir 4120 back into the housing of the analyzer 5000.

As best seen in fig. 28F, the support 4156 may rest on the horizontal portion 4155a of the track 4155 when the consumable reservoir 4120 is in an open or partially open position (e.g., when the consumable reservoir 4120 is fully or partially pulled out of the analyzer 5000). The stopper 4151 prevents the user from closing the door 4112 when the support 4156 is positioned on the horizontal portion 4155 a. As shown, the door 4112 is coupled to the side wall 5001 via a hinge 4113. Hinge 4113 is a "swing back" or "offset" hinge. However, in other embodiments, hinge 4113 may be replaced with another type of hinge, such as a "ball bearing" hinge, a "butt" hinge, or a "spring loaded" hinge. When the support 4156 is positioned on the horizontal portion 4155a, the stopper 4151 restricts the rotation of the hinge 4113 so that the user cannot close the door 4112.

The support 4156 may rest on the angled portion 4155B of the track 4155 when the consumable reservoir 4120 is in the closed position or partially closed position (e.g., when the consumable reservoir 4120 is fully or partially pushed into the analyzer 5000). When the support 4156 is located on the inclined portion 4155b, the stopper 4151 may be located below the hinge 4113. Accordingly, when the support 4156 is positioned on the inclined portion 4155b, the stopper 4151 may not interfere with the rotation of the hinge 4113, and the user may be able to close the door 4112. In some embodiments, the stop 4151 may prevent a user from closing the door 4112 when the support 4156 positions the upper section of the inclined portion 4155b (e.g., the half of the inclined portion 4155b directly coupled to the horizontal portion 4155 a). In such an embodiment, the user may only be able to close the door 4112 when the support 4156 is located in the lower section of the inclined portion 4155b (e.g., the half of the inclined portion 4155b that is not directly coupled to the horizontal portion 4155 a).

In some embodiments, the weight of the stopper 4151 in combination with the downward force generated by the torsion spring 4153 may cause the consumable reservoir 4120 to slide back into the housing of the analyzer 5000. More specifically, when the support 4156 is positioned on the inclined portion 4155b, the downward force exerted on the support 4156 by the stopper 4151 and the torsion spring 4153 may cause the support 4156 to push the consumable reservoir 4120 back into the housing of the analyzer 5000. In other words, the sloped portion 4155b redirects the downward force generated by the stop 4151 and the torsion spring 4153 to generate a horizontal force that causes the support 4156 to push the consumable reservoir 4120 back into the housing of the analyzer 5000.

In some embodiments, the hinge 4154 may include holes 4157 configured to receive, for example, pins or screws. The member 4152 may also include holes (not shown) configured to receive, for example, similarly sized pins or screws. The holes may be aligned so that a user may insert a pin or screw into both holes. By doing so, the user may hold the door 4112 in an open position or a partially open position. More specifically, when the consumable reservoir 4120 is in the closed or partially closed position, the pin or screw may prevent the stopper 4151 from falling below the hinge 4113. This may be particularly advantageous during assembly of the analyzer 5000.

As best seen in fig. 28D, the side panels 4122 may advantageously include cutouts 4161. The cutout 4161 may allow a user and/or an inventory robot (e.g., the inventory robot 2300) to access the compartment 4162 within the sidewall 5001 when the consumable storage 4120 is in a closed position or partially closed position (e.g., when the consumable storage 4120 is fully or partially pushed into the analyzer 5000). The compartment 4162 may be configured to receive any of the consumables described above. Additionally, as best seen in fig. 28E, the cutout 4161 may allow a user to service one or more cables within the analyzer 5000 through the panel 4163 when the consumable reservoir 4120 is in an open or partially open position (e.g., when the consumable reservoir 4120 is fully or partially pulled out of the analyzer 5000).

Various modifications may be made to analyzer 5000 while still maintaining one or more of the above-described advantages. For example, the consumable storage 4120 may be configured more like the consumable storage 2110 with the support structure 2114, the storage compartment 2116, and the column 2118. However, in such embodiments, the consumable reservoir 4120 can still include, for example, the cutouts 5701, the rail 4155, and/or the cutouts 4161. As another example, the stopper 4151 may be replaced with a stopper having a different shape. As shown, the stop 4151 is generally rectangular. However, various shapes are suitable to prevent the rotation of the hinge 4113. Similarly, the member 4152, torsion spring 415, hinge 4154, and rail 4155, support 4156, and/or aperture 4157 may be differently configured. For example, in other embodiments, the horizontal portion 4155a and/or the angled portion 4155b of the track 4155 may be replaced by curved track portions rather than straight track portions. As another example, the horizontal portion 4155a may be replaced by an inclined rail, for example. In such embodiments, the slope of the portion of track 4155 may be less than or equal to the slope of sloped portion 4155 b. As yet another example, the stop 4151 may be removed and, alternatively, the member 4152 may be used to prevent the user from closing the door 4112. In some such embodiments, the shape of the member 4152 may vary. For example, the length of the member 4152 may be increased.

Waste storage device

The waste reservoir 2130 (fig. 10B) includes a door 2132 that is accessed by a user in front of the analyzer 2000. The waste compartment 2134 has an opening 2136 parallel to the door 2132, the waste compartment 2134 being attached to the back side of the door 2132. The store 2130 also includes a shelf 2138 extending from the waste compartment 2134. The shelf 2138 allows the used processing board 2040 to be stacked thereon by an inventory robot, as shown. The reservoir 2130 may also include a liquid container within an opening 2136, which may be in communication with one or more liquid waste receptacles 2260 (see fig. 11B) located on the processing platform 2016. The waste reservoir 2130 may be attached to a set of rails, which allows the reservoir 2130 to be pulled out like a drawer for emptying. A pneumatic plunger (not shown) may assist in opening the reservoir 2130 and may also provide damping to prevent the reservoir 2130 from opening too fast to push against the processing plate 2040. Alternatively, the reservoir 2130 may be hinged so as to be rotatable open towards the user for emptying.

Pipette tip drawer

The hydraulic tube tip drawer assembly 2140 (fig. 10C) includes a tip drawer 2142, which is generally a box-like structure, including side walls 2144 and a lateral wall 2145 that includes one or more openings for receiving pipette tip holders carrying a plurality of pipette tips. In the illustrated embodiment, there are two openings in the lateral wall 2145 of the tip drawer 2142 for receiving two pipette tip holders (not shown). The first rack may include a first pipette tip and the second rack may include a second pipette tip. Pipette tip drawer 2142 is attached to one or more rails 2148 that allow drawer 2142 to be partially pulled out of analyzer 2000 to remove an empty tip rack and to recharge a new tip rack. A door (not shown) may be attached to one end of drawer 2142 such that when drawer 2142 is closed, the door forms a portion of the outer housing of the analyzer. The pneumatic plungers 2149 may assist in opening the drawers 2142 and may also provide damping to prevent the drawers 2142 from opening or closing too quickly.

Processing module

Processing module/channel

Fig. 11A shows a processing platform 2016 comprising a plurality of processing modules 2200 arranged side-by-side. As shown, the processing platform 2016 includes three processing modules: a first processing module 2200a, a second processing module 2200b, and a third processing module 2200c. However, the analyzer 2000 may include more or fewer processing modules 2200 to accommodate throughput needs and space requirements of a particular laboratory. The process modules 2200a-c are similarly configured in their physical arrangement, with their difference in their position relative to a shuttle platform having a jaw assembly that serves as a sample container holding assembly 2210 that can be shared by adjacent modules. For example, the first and second process modules 2200a-b may both use the first sample container holding assembly 2210ab to thereby hold the sample container 03, and the second and third process modules 2200b-c may both use the second sample container holding assembly 2210bc to thereby hold the sample container 03.

Although each processing module 2200 is similarly configured, each processing module 2200 is capable of performing a wide range of trials, such that each processing module 2200 may run a different trial than the trial run simultaneously on another processing module. In this regard, each processing module 2200 may be automatically assigned and reassigned to conduct any number of trial types depending on the processing requirements at a particular point in time. For example, a first processing module 2200a can be designated to perform a first trial, a second processing module 2200b to perform a second trial, and a third processing module 2200c to perform a third trial, wherein each trial is different. However, when those trials are completed, any of the processing modules 2200a-c may be automatically reassigned to conduct a different trial so that, for example, each of the first, second and third processing modules 2200a-c runs the same trial. In this manner, the analyzer 2200 is flexible to accommodate real-time needs, provided that sufficient consumables suitable for a particular test are stored within its housing 2010.

Examples of processing modules

Fig. 11B shows a first processing module 2200a, and is an example of other processing modules. The first process module 2200a generally includes a first sample container holding assembly 2210ab (which is shared by the second process module 2200 b), a dry reagent station 2220, a liquid reagent station 2230, an extractor 2240, an amplification cassette station 2250, a pipette drawer 2140, and a waste receptacle 2260. These components may be arranged in any configuration. However, in the illustrated embodiment, the dry reagent station 2220 and the liquid reagent station 2230 are positioned at the rear end of the processing platform 2016 and are disposed adjacent to one another. The first and second extractors 2240a-b are positioned adjacent to the reagent stations 2220 and 2230 and between the amplification cassette station 2250 and the reagent stations 2220, 2230. This allows for efficient transfer of liquid therebetween. Pipette tip drawer 2140 is positioned in front of the processing platform 2016, which allows for easy access by a user. The processing module 2200a preferably includes three pipette tip drawers 2140, each housing a first pipette tip rack 2022a carrying a first pipette tip 2020a and a second pipette tip rack 2022b carrying a second pipette tip 2020 b. The amount of pipette tip 2020 allows for approximately 12 test runs to be performed by processing module 2200a without the need for re-replenishment. The sample container holding assembly 2210ab is disposed to the sides of the extractors 2240a-b and reagent plate stations 2220, 2230 and between the first and second process modules 2200 a-b. The waste receiver 2260 is also interposed between the first and second processing modules 2200 a-b. The waste receptacle allows the used pipette tips to be discarded from the upper disposal platform 2016 into the waste reservoir 2130. The waste receiver 2260 may also include a liquid waste inlet (not shown) that allows the liquid waste to be placed into a bottle or some other container within the waste reservoir 2130.

Sample container holding assembly

Sample container holding assembly 2210ab is similar to sample container holding assembly 1100 of the' 875 application in that it includes a clamp assembly 2212 that closes toward a shuttle 2030 disposed within the clamp assembly to hold shuttle 2030 and to hold container 03 within shuttle 2030 as aliquots are drawn from within container 03. In this regard, the clamp assembly 2212 includes an engagement member 2214, the engagement member 2214 being configured to protrude through a second transverse opening 2036 in the shuttle 2030 when the clamp assembly 2212 is closed to engage the skirt 07 of the bottom end of the sample container 03, as best shown in fig. 11C. These engagement members 2214 pierce/bite into the skirt 07 of the respective container 03 to prevent the container 03 from being inadvertently removed from the shuttle 2030 during aspiration. However, unlike the retention assembly 1100, the retention assembly 2210ab has a fixed platform 2216 upon which the shuttle 2030 rests, and the retention assembly 1100 utilizes a moving conveyor 1116. Thus, instead of a conveyor for transporting the shuttle 2030 to a location within the clamp assembly 2210ab, the inventory robot 2300 places the shuttle 2030 in a location within the clamp assembly 2212.

Reagent plate station

The dry reagent plate station 2220 and the liquid reagent plate station 2230 may each include a receiver defined by a support structure (not shown) (e.g., a pair of rails) extending from a surface of the platform 2016. Such a receiver may receive corresponding reagent plates to help ensure that each plate is placed in a precise location. As shown, the process module 2200a includes a dry reagent plate station 2220 and a liquid reagent plate station 2230. Because the analyzer 2000 typically uses two dry reagent plates 2050a-b for each test performed, the dry reagent plates 2050a-b are replaced during operation. However, it is contemplated that another dry reagent plate station may be incorporated within the process module 2200a to allow each of the reagent plates 2050a-b to be positioned once on the process platform 2016. The processing module 2200a can also include a recess support structure that allows the amplification cassette 2070 to be accurately placed by the inventory robot 2300.

29A-C, each of the process modules 2200a-2200C can further include a plurality of identification tags 2232 for detecting the presence of consumables on the process modules 2200a-2200C for controlling the inventory of the process platform 2016 and the process plate support assembly 2090 (FIGS. 29B and 29C). Only one of the three processing modules 2200a-2200C shown in fig. 11A is illustrated in fig. 29A-29C. The processing module is simply enumerated as 2200 in fig. 29A. However, deployment in any or all of the processing modules 2200a-2200C is also contemplated as depicted in FIGS. 29A-29C. In particular, a plurality of identification tags 2232 in each of the process modules 2200a-2000c are used to detect the presence of the dry reagent plate 2050, the liquid reagent plate 2060, the amplification cassette 2070, the process plate 2040, and the process plate support assembly 2090 on the process modules 2200a-2200 c. As can be seen from fig. 29B, the process plate support assembly 2090 is configured to be placed over the extractor 2240 and within a recess 2238 defined on the process modules 2200a-2200c to support the process plate 2040 during a pipetting operation. The process plate 2040 is illustrated as being placed directly over the extractor 2240 shown in fig. 29A. The extractor 2240 is illustrated in detail in fig. 12A-12D and described in detail elsewhere herein.

The process plate support assembly 2090 includes a support plate 2092 and a plurality of drip receivers 2094 removably attached to a bottom surface of the support plate 2092, as shown in fig. 29C. The plurality of drip receivers 2094 are configured to receive used pipette tips (not shown) and collect any waste that drips from those pipette tips placed in a respective one of the plurality of drip receivers 2094. Each of the plurality of drip receivers 2094 includes a plurality of individual bottom closed receivers 2096 connected via a divider wall 2098 to prevent cross-contamination of pipettes placed in a respective one of the plurality of drip receivers 2096 and liquids collected in a respective one of the plurality of drip receivers 2096 of the plurality of drip receivers 2094. The plurality of drip receivers 2094 of the process plate support assembly 2090 are sized to be placed and inserted into the recesses 2238 of the process modules 2200a-2200 c. The process plate support assembly 2090 is accessible to a user such that it is removable from the recess 2238 in the process modules 2200-2200c for cleaning.

A plurality of identification tags 2232, 2233, 2235 are placed on the surface of each of the dry reagent plate station 2220, the liquid reagent plate station 2230, and the amplification cassette station 2250, respectively. For the process plate support assembly 2090, an identification tag 2234 is placed on the surface of the process module 2200 between the amplification cassette station 2250 and the recess 2238, as shown in fig. 29A. Identification tag 2234 allows the system to detect whether the process plate support assembly is in the correct position. In particular, the system can detect the identification tag only if the processing board is not in the correct position. This is apparent from fig. 29B. For process plate 2040, identification tag 2236 is placed on top surface 2092 of process plate support assembly 2090, as shown in fig. 29B and 29C.

Each of the plurality of identification tags 2232-2236 is positioned such that identification tags 2232-2236 are covered when the associated consumable or process plate support assembly is placed on its designated location on the surface of process modules 2200a-2200 c. To detect the presence of consumables and process plate support assemblies on the process modules 2200a-2200c, optionally, a liquid handling robot 2400 (shown in FIG. 14A) moves across the process platform 2016 and scans for identification tags 2232-2236 that are not covered by the associated consumables or process plate support assemblies. For example, if the dry reagent plate 2050 is not present in the dry reagent plate station 2220 on one of the process modules 2200a-2200c, the identification tag 2232 positioned on the dry reagent plate station 2220 for the dry reagent plate 2050 will not be covered and thus exposed, allowing the liquid handling robot to read the identification tag 2232 placed on the dry reagent plate station 2220 and record that the dry reagent plate 2050 is not present in one of the process modules 2200a-2200c that detected the barcode 2232.

The identification tag carries a machine readable code or image. In one embodiment, identification tags 2232-2236 are bar codes, and a scanner mounted on an end effector of the inventory robot may be capable of scanning and reading the tags. Alternatively, other identification tags may be implemented, such as Radio Frequency Identification (RFID) tags, near field tags, and the like.

Extractor

As shown in fig. 12A and 12B, the extractor assembly includes two extractors: a first extractor 2240a and a second extractor 2240b. Each extractor 2240a-b includes a housing 2242, a printed circuit board 2247 ("PCB"), a motor 2244, a drive mechanism 2246, a permanent magnet 2241, and a heating element 2248. Other exemplary extractor components include MBD MAX ^TM The extractor of the system (Becton Dickinson, franklin lake, new jersey) is described and described in U.S. patent No. 8,133,671, the disclosure of which is incorporated herein by reference in its entirety. The permanent magnet 2241 is mounted to the drive mechanism 2246 and is disposed within the housing 2242. The permanent magnets 2241 are arranged in two rows of six magnets, thereby forming six pairs of adjacent magnets 2241a-b. It has been found that such side-by-side pairs of magnets 2241a-b enhance the magnetic attraction of the beads within the processing plate 2040 relative to a single magnet. The row of magnets 2241 is movably connected to a drive mechanism 2246 and can be moved into and out of the housing 2242 through an opening in the top of the housing 2242 via the drive mechanism 2246, wherein the drive mechanism 2246 is operated by the motor 2244.

PCB 2247 and heating element 2248 are connected to opposite sides of housing 2242. The heating elements 2248 are arranged in two rows of six and extend above the housing 2242. Each heating element 2242 defines a recess 2249 forming a cup-like structure having a geometry conforming to the outer surface of rotation of the extraction tube 2045 of the processing plate. This allows the heating elements 2248 to directly contact such a rotating surface to transfer heat into the extraction tube 2045, and also allows the process plate 2040 to be supported by the extractor 2240 in a stable manner. In addition, the width of extractors 2040a-b is such that pipette tips 2020 may be placed into the pipette tip holding station and extend through processing plate 2040 without any interference from extractors 2240 when the processing plate is held thereby. When the motor 2244 is operated, the row of permanent magnets 2241 may be moved upward into the space 2243 between the heating elements 2248 and adjacent the extraction aperture 2045 to attract the magnetic beads that may be placed in the extraction aperture.

Fig. 12C and 12D depict an extractor 2240' and a processing plate 2040 according to further embodiments of the present disclosure. As previously described, the processing plate may include engagement slots 2042 in opposite sides of the plate body 2041. However, instead of the engagement notches 2042 being positioned on the side of the plate body 2041, the process plate 2040 preferably includes engagement members 2049 that extend from the upper surface of the plate body 2041. Such engagement members 2049 include engagement notches 2042. Thus, the processing plate 2040 positions the slot 2042 above the plate body 2041 and inward relative to the sides of the plate body 2041. This allows the end effector 2360 to grip the handle plate 2040 from above the plate body 2041 rather than at its sides, which allows the end effector 2360 to operate in a space with little clearance, as described in more detail below.

The extractor 2240 'is similar to the extractor 2240 except that the extractor 2240' includes a drip tray 2280. As shown, the drip tray 2280 includes trough members 2281a-b connected by an intermediate member 2088. Accordingly, the drip tray 2280 is of a different construction than the drip receiver shown in fig. 29C. The intermediate member 2088 extends between opposite sides of the extractor 2240 'and includes openings for the extraction tube 2045 and the mixing holes 2046 to extend therethrough so that the extraction tube 2045 can engage the heating elements 2248 of the extractor 2240', as best shown in fig. 12D. In addition, because the intermediate member 2088 generally has a flat upper surface that allows the process plate body 2041 to rest thereon, the intermediate member 2088 helps support the process plate 2040. Each of the trough members 2281a-b includes an outer shield 2082, an inner shield 2084, and a lower shield 2086. The inner shield 2084 is connected to the intermediate member 2088 and extends downwardly therefrom such that when the process plate 2040 is mounted to the extractor 2240', the inner shield 2084 is positioned between the heating element 2248 and a row of pipette sleeves 2048, as best shown in fig. 12D. The lower shield 2086 is connected to the outer shield and extends between the outer shield 2082 and the inner shield 2084. The outer shield 2082 extends upwardly from the lower shield 2082. This configuration forms a slot sized to receive a row of pipette tips 2020 when such pipette tips 2020 are placed within a corresponding pipette sleeve 2048. In this regard, the trough members 2281a-b form a barrier within the system 2000 that helps prevent contamination from the pipette tips 2020, which pipette tips 2020 may be stored within the pipette sleeve 2048 for reuse.

Fig. 12E depicts a third processing module 2210c that includes an extractor 2240'. The process plate 2040 is mounted to the extractor 2240'. The extractor 2240' and the processing plate 2040 are disposed between the dry reagent plate 2050, the liquid reagent plate 2060, and the pipette tip chute 2135, the amplification card station 2070. However, as shown, the process plate 2040 is generally located at a lower position on the process platform 2016 than those surrounding components. However, to help conserve the overall size of the system 2000, the lateral clearance between these components and the process plate 2040 is minimized. Thus, it may be difficult for the end effector 2360 to have sufficient clearance to place the process plate 2040 onto the extractor 2240 'and pick up the process plate 2040 from the extractor 2240'. In this regard, the processing plate 2040 provides an engagement member 2049 that provides sufficient clearance for the end effector 2360 to pick up and place the processing plate 2040. Also, as shown, an elongated opening 2017 extends through the treatment platform surface 2016 that allows a reusable pipette tip 2020 mounted to the treatment plate 2040 to extend through the treatment platform surface. The trough members 2281a-b of the drip tray are aligned with such openings 2017 to prevent contamination of the system 2000 by drops from the pipette tips 2020.

Detector for detecting a target object

Each processing module 2200A-c has an associated detector 2270, which in the embodiment depicted in fig. 10A is each located within a detection/analysis platform 2012 at the bottom of the analyzer 2000. For example, a first processing module 2200a is associated with a first detector 2270a, a second processing module 2200b is associated with a second detector 2270b, and a third processing module 2200c is associated with a third detector 2270 c. The positioning of the detectors 2270a-c below the processing platform 2016 helps isolate the detectors 2270a-c from possible contamination. An exemplary detector is MBD MAX ^TM The detector of the system (Becton Dickinson, franklin lake, n.j.) and described in U.S. patent No. 8,133,671, the disclosure of which is incorporated herein by reference in its entirety. Each detector 2270a-c packageIncluding a reader head 2271 and a thermal cycler 2275. The reader head 2271 includes a light emitter and detector (not shown) configured to detect the presence of fluorescent probes within the chamber 2075 of the amplification cassette 2070. The thermal cycler 2275 includes a movable platform 2276 having a recess 2277 configured to receive an amplification cassette 2070. The thermal cycler 2275 has a heating element (not shown) that periodically heats the contents (e.g., purified DNA) of the amplification cassette 2070 to a predetermined temperature to aid in the amplification of such contents. The reader head 2271 is suspended from the structure of the analyzer 2000 such that its reader is pointed in a downward direction. A thermal cycler 2275 is disposed below the reader head 2271 and includes a motor 2278 and a drive screw that moves a platform 2276 in a vertical direction to press the amplification cassette 2070 against the reader head 2271. The space existing between the thermal cycler 2275 and the reader head 2271 is wide enough to allow the inventory robot 2300 to place the amplification cassette 2070 onto the thermal cycler 2275.

Consumable handling

13A-13D depict an inventory robot 2300 according to one embodiment of the disclosure. Inventory robot 2300 helps inventory all consumables within analyzer 2000 and also processes all consumables within analyzer 2000. In addition, the inventory robot 2300 may reach outside the analyzer 2000 to access the pre-analysis system 10 such that the shuttle with the sample containers 03 is moved back and forth between the analyzer 2000 and the pre-analysis system 10. In this regard, the housing of the analyzer 2000 may include a side opening on its left or right side that is sized to allow the robot 2300 to reach therethrough. The inventory robot 2300 includes a track member 2300, a body/post 2320, a shoulder 2330, a first arm member 2340, a second arm member 2350, and an end effector or hand 2360.

Robot arm

Rail member 2310 extends in a left-right direction from one side of analyzer 2000 to the other and is positioned closer to the back end of analyzer 2000 than the front-positioned platforms 2012, 2014, and 2016 described above. Body 2320 is slidably attached to track member 2310 and extends orthogonally therefrom. Body 2320 is coupled to track member 2310 by bracket 2322. The bracket 2322 and rail member 2310 form a linear motor that allows the body 2320 to translate along a single axis in the left-right direction. An example of a linear motor that may be implemented within analyzer 2000 is a Festo linear motor actuator ("FLMA") (Festo AG & co.kg, angstrom root, inner kahe, germany). However, other drive mechanisms (e.g., belt and pulley mechanisms) are contemplated for driving the body 2320 along the track member 2310.

The shoulder 2330 is slidably attached to the body 2320 such that the shoulder 2330 may be driven along a vertical axis of the body 2320, which movement may also be accomplished by a linear motor or some other driving mechanism. The shoulder 2330 is attached to the first arm member 2340 at one end of the first arm member 2340 such that the first arm member 2340 is rotatable about a vertical axis shared by the shoulder 2330 and the first arm member 2340. The second arm member 2350 is connected to the other end of the first arm member 2340 such that the second arm member 2350 can rotate about a vertical axis shared by the two arm members 2340 and 2350. The end effector 2360 is connected to an end of the second arm member 2350 remote from the first arm member 2340 and rotates about a vertical axis shared by the end effector 2360 and the second arm member 2350.

End effector

The end effector 2360 includes a body 2362 and a pair of movable fingers 2363a-b coupled to the body 2362. The movable fingers 2363A-b are operable such that they move together closer or farther apart to grasp or release an article, as shown in fig. 13A. In this regard, the movable fingers 2363a-b generally remain parallel during operation. The end effector 2360 also includes an identifier reader 2366, such as a bar code scanner, in a surface of the body 2362 that generally faces away from the fingers 2363a-b. The main body 2362 can be rotated approximately 180 degrees relative to the second arm member 2350 to allow such an identifier reader 2366 to face forward of the analyzer 2000 and scan consumables located at the inventory platform 2014 or other locations. The body 2362 may also include identifier readers in its bottom surface such that such readers may read upwardly facing identifiers, such as those that may be located on the amplification cassette 2070.

The fingers 2363a-b are specifically configured to engage a number of different consumables. In this regard, the fingers 2363a-b include a first engagement feature 2361 and a second engagement feature 2364. As shown, the first engagement feature 2361 is a tab or protrusion extending inwardly from one finger 2363 toward the other finger 2363. The first engagement feature 2361 is sized to fit within the engagement slots 2042, 2052, 2062 of the plates 2040, 2050, 2060, respectively, and the first transverse opening 2034 of the shuttle 2030. In operation, when the fingers 2363a-b are closed onto a consumable article, the first engagement feature 2361 extends into a slot or opening of the corresponding consumable article, preventing the consumable article from falling off while the fingers 2363a-b themselves grip onto the side surfaces of the consumable article to further control and retain the article. As shown, each finger 2363a-b preferably includes two engagement features 2361 that help prevent inadvertent rotation of the consumable item during finger gripping.

The second engagement feature 2364 is generally located on the opposite side of the fingers 2363a-b as compared to the first engagement feature 2361 and includes a downwardly extending post or dovetail 2365. The posts 2365 extend from and taper outwardly from the generally flat bottom surface 2366 of the engagement feature 2364 to form a frustoconical surface of rotation, as best shown in fig. 13C. These posts 2365 engage corresponding notches 2072 in the amplification cassette 2070. As discussed above, the amplification cassette 2070 includes a beveled or contoured surface surrounding each notch 2072 that forms a recess 2077. In operation, as the post 2365 slides into the corresponding notch 2072, the post 2365 eventually reaches the recess 2077. When it reaches the recess 2077, the post 2365 is received in the recess 2077 in a conforming manner, as shown in fig. 13D. This helps provide a stable platform for the magazine 2070 to move around the analyzer 2000 when the recess 2077 mates with the rotating surface of the column. In addition, the flared or tapered shape of the post 2365 helps prevent the box 2070 from falling out.

As shown in fig. 13B, each finger 2363a-B includes three engagement features 2364. However, it is preferred that each finger 2363a-b include a single second engagement feature 2364, although more or fewer engagement features 2364 are contemplated. This allows the fingers 2363 to adequately engage the amplification cassette 2070, which may inadvertently rotate about a vertical axis such that its sides are not parallel to the fingers 2363 a. This may be a significantly more difficult task for fingers 2363a-b with more than a single engagement feature 2364 because if the cassette 2070 is inadvertently rotated, at least some features 2364 are not able to properly align with corresponding notches 2072 of the amplification cassette 2070.

Moreover, each finger 2363a-b may be flexible so as to be able to bend downward or upward about a horizontal axis while being resilient enough so as not to easily yield to fail to contact. Such flexibility may be imparted to each finger 2363a-b along a length proximate to the finger termination end, the finger including a second engagement feature 2364. This allows the fingers 2363a-b to automatically adjust to engage an amplification cassette 2070, which amplification cassette 2070 may tilt about a horizontal axis such that the cassette 2070 is not parallel to the fingers 2363 a-b.

Referring to fig. 30 and 31, an end effector 5002 in accordance with an alternative embodiment of the present disclosure is illustrated. End effector 5002 includes a pair of fingers 5004 attached to a body 5006 of end effector 5002. The engagement features 5008 of the end effector 5002 are substantially similar to the engagement features of the end effector of the previous embodiment.

As shown in fig. 30, each finger 5004 extends between a first end 5010 and a second end 5012, with an offset 5014 formed and positioned at the second end 5012. Offset 5014 extends upward from the bottom of finger 5004 at an angle that is not perpendicular to the elongated portion 5016 of finger 5004. When the top surface 5018 of the offset 5014 and the bottom surface (not shown) of the connection member 5020 of the body 5006 of the end effector 5002 are engaged for attachment, the offset 5014 allows the top surface 5018 of the offset 5014 to tightly engage with the bottom surface (not shown) of the connection member 5020 of the body 5006 of the end effector 5002.

The offset 5014 can include a first offset orifice 5022, a second offset orifice 5024, and a raised orifice 5026 defined and disposed between the first and second offset orifices 5022, 5024 as shown in fig. 31. When the offset 5014 is engaged with the connecting member 5020 to attach the finger 5004 to the body 5006 of the end effector 5002, the first offset aperture 5022, the second offset aperture 5024, and the boss aperture 5026 are closely sized to align with the first connecting member aperture 5028, the second connecting member aperture 5030, and the boss aperture 5032 defined on the connecting member 5020 of the body 5006, respectively.

The end effector 5002 may further include a wedge 5034 for securing each finger 5004 to the connection member 5020 of the body 5006 of the end effector 5002. The wedge 5034 is configured and designed to prevent displacement (and/or rotation) of the finger 5004 and to provide stability when forced contact (e.g., picking up a consumable) occurs on the finger 5004. The wedge 5034 may be an angled surface that is generally complementary to the offset 5014. As used herein, about or about a 10% variation is contemplated. When assembled together, the offset 5014 and the wedge 5034 form a complementary and strong angled interface.

Referring to fig. 31, the wedge 5034 can include an angled (or sloped) side 5036 for the wedge 5034 to tightly engage with the offset 5014 of the finger 5004 to connect the finger 5004 to the body 5006. A first wedge aperture 5038 and a second wedge aperture 5040 are defined on the wedge 5034, with a protrusion 5042 formed and disposed between the first wedge aperture 5038 and the second wedge aperture 5040. A protrusion 5042 protrudes from the angled side 5036 of the wedge 5034. The protrusions 5042 are configured to be inserted through the protrusion apertures 5026 of the offset 5014 of the fingers 5004 and mate with the protrusion apertures 5032 of the connecting member 5020 of the body 5006 to accurately position the fingers 5004 from front to back.

Once the finger 5004 is attached to the connection member 5020 of the body 5006 with the projection 5042 of the wedge 5034 inserted through the finger 5004 and the connection member 5020 of the body 5006, a screw 5044 or other suitable connector can be inserted through the aligned holes/apertures to attach the wedge 5034 to the offset 5014 of the finger 5004 and to attach the offset 5014 of the finger 5004 to the connection member 5020 of the body 5006.

Liquid treatment

Fig. 14A and 14B depict a liquid handling robot 2400 according to an embodiment of the present disclosure. The liquid handling robot 2400 is suspended from the liquid handling robot platform 2018 and above the handling platform 2016. The liquid handling robot 2400 includes a rail member 2405 that extends in a left-right direction from one side of the analyzer 2000 to the other. A plurality of multi-tubing pipettes 2440 are connected to the track member 2405 by brackets 2420 and transverse arms 2430. The arm 2430 is connected to the bracket 2420, and the bracket 2420 is slidably connected to the track member 2405 such that the arm 2430 extends in a lateral direction relative to the track member 2405. The carriage 2420 and rail member 2405 form a linear motor that allows the multi-channel pipette 2440 and arm 2430 to be driven in a left-right direction along the rail member 2405. An example of such a linear motor is the Festo linear motor actuator ("FLMA") (Festo AG & co.kg, eastern root, inner kahe, germany). As shown, there is one multi-channel pipette 2440 per processing module 2200. Thus, in this particular embodiment, there are three pipette assemblies: a first multi-tubing pipette 2440a, a second multi-tubing pipette 2440b, and a third multi-tubing pipette 2440c. The first multi-tubing pipettor 2440a corresponds to a first processing module 2200a, the second multi-tubing pipettor 2440b corresponds to a second processing module 2200b, and the third multi-tubing pipettor 2440c corresponds to a third processing module 2200c. However, more or fewer multi-channel pipettes 2440 are possible and are based on the number of processing modules 2200.

Multi-pipeline pipettor

Fig. 14B depicts a multi-tubing pipette 2440, which is an example of a multi-tubing pipette 2440a-c, according to an embodiment of the present disclosure. The multi-tubing pipettor 2440 includes a back plate connector 2450 and a plurality of liquid handling assemblies 2442 connected to the back plate connector 2450. In the depicted embodiment, there are three liquid handling assemblies 2442a-c: a first fluid handling assembly 2442a, a second fluid handling assembly 2442b, and a third fluid handling assembly 2442c. However, more or fewer liquid handling assemblies are contemplated. Each of the liquid handling assemblies 2442a-c includes a main plate assembly 2460a-c and a pipette assembly 2470a-c. The liquid handling assemblies 2442a-c are connected to the back plate connector 2450 in close proximity to one another.

Each motherboard assembly 2460 facilitates providing data, power, and positive/negative air pressure to a corresponding pipette assembly 2470. In the illustrated embodiment, there are three pipette assemblies 2460: first pipette assembly 2460a, second pipette assembly 2460b, and third pipette assembly 2460c. These assemblies 2460a-c correspond to respective liquid handling assemblies 2442a-c. Each motherboard assembly 2460 is similar to motherboard assembly 1401 described in the' 875 application. In this regard, each main board assembly 2460 includes a housing 2462 within which various components (e.g., PCB, positive and negative pressure inputs, valves, and liquid/gas conduits in communication with the inputs and valves) are disposed. The main plate assemblies 2460a-c also include a z-drive mechanism that includes a vertical rail 2464 and a motor 2466 and drive shaft (not shown) on one side of the housing 2462. The drive shaft is disposed within the housing 2462.

Each pipette assembly 2470 is similar to the pipette assemblies 502 and 1402 described in the' 875 application, except that each pipette assembly 2470 is not hingedly connected to its corresponding main plate assembly 2460 and does not rotate into multiple hinge positions. Each pipette assembly 2470 is limited in rotation and is moved in the z-direction along vertical guide 2464 by motor 2466. Thus, the first, second, and third pipette assemblies 2470a-c are independently movable in the vertical or z-direction. In addition, pipette assembly 2470 is configured (particularly with respect to its pipette tubing assembly (not shown) and pipette tip ejector assembly 2472) similarly to pipette assemblies 502 and 1402.

The back plate connector 2450 is similar to the back plate connector 1600 described in the' 875 application except that the back plate connector 2450 is configured with a plurality of liquid handling assemblies 2442 mounted thereto, such as the first, second, and third assemblies 2442a-c shown. In this regard, the backplane connector 2450 is connected to the motherboard assemblies 2470a-c of each of the liquid handling assemblies 2442 and includes several connectors (not shown) for providing the necessary power, pressure, and data signals to the liquid handling assemblies 2442a-c, such as Ethernet, multi-pin, positive pressure input, and negative pressure input connectors. This helps reduce or eliminate external cables that may snag and may be difficult to manage if multiple liquid handling assemblies 2442 are connected in such close proximity.

Automation of

Fig. 15 depicts the general architecture of the computing system of analyzer 2000. The computing system 2510 may be a subsystem within the system 1300 of the' 875 application that depicts a computing system schematic of the high-throughput system 00. In this regard, the bus 1320 and computing device 1330 described in the cross-instrument bus 2504 and workflow computing devices 2540 and' 875 applications are identical. In addition, computing device 2510 is similar to computing device 1360 and its inputs and outputs within analyzer 2000 are described in greater detail herein.

The computer control 2510 may be any general purpose computer and may include a processor 2512, a memory 2514, and other components typically found in general purpose computer control devices. And the computer control 2510 may include dedicated hardware components to perform specific computing processes. Processor 2512 may be any conventional processor such as a commercially available CPU. Alternatively, the processor 2512 may be a dedicated component, such as an application specific integrated circuit ("ASIC") or other hardware-based processor.

Memory 2514 may store information accessible by processor 2512, including instructions 2516 that may be executed by processor 2512. Memory 2514 may also include data 2518, which may be retrieved, manipulated, or stored by processor 2512. Memory 2514 may be any non-transitory type capable of storing information accessible by processor 2512, such as a hard disk drive, memory card, ROM, RAM, DVD, CD-ROM, writable memory, and read-only memory.

The instructions 2516 may be any set of instructions that can be directly executed by the processor 2512, such as machine code, or indirectly executed, such as a script program. In this regard, the terms "instruction," "application," "process," and "program" may be used interchangeably herein. The instructions 2516 may be stored in an object code format for direct processing by the processor 2512, or as any other computing device language, including a script program or collection of independent source code modules that are interpreted or precompiled as needed.

In one embodiment of analyzer 2000, computing system 2510 may comprise several instruction sets. For example, each test to be performed may have several instruction sets associated with it that may include instructions to operate inventory robot 2300 to perform inventory checks and to retrieve the appropriate reagents and other consumables for the test. In another embodiment, the instruction set may determine a sequence of operations to be performed by a particular multi-tubing pipette 2440 to assist in processing analysis of a sample.

Data 2518 is entered and viewed via a graphical user interface ("GUI") that may be displayed on display interface 2500 particularly relevant to analyzer 2000 or on display interface 1332 of the' 875 application associated with the overall high-throughput system 00. Data 2518 may be input from a scanner, such as scanner 2366 on end effector 2360 of inventory robot 2300 or a scanner within pre-analysis system 10. The data may also be obtained by sensors, such as optical sensors, temperature sensors, etc., to obtain information about certain conditions and activities occurring within the analyzer, such as the location of particular consumables and air quality.

This data 2518 may be digitally tagged as a particular identification code (e.g., bar code serial number) in a field implementation or relational database, which may also be stored within memory 2514. This helps analyzer 2000 keep track of the different consumables within analyzer 3000 and helps provide certain information to processor 2512 during execution of processor instructions 2516 without requiring user input. For example, the liquid reagent plate 2060 may have an identification code that may be associated with a bar code on its outer surface, which may be marked in a database with certain stored data (e.g., the type of reagent stored therein and which reagents have been used). This allows the analyzer to check its inventory to determine when reagents and other consumables are under run or insufficient to perform additional tests. In another embodiment, shuttle 2030 may have an identification code that may be tagged with certain stored data in a database, such as data including sample container 03 (e.g., patient name, test to be performed, process parameters, etc.) carried by shuttle 2030. In a further example, when a test is completed, the results of the test may be associated with a particular sample in the database such that when such results may be communicated to workflow computing device 2540 through device 2510, the user may easily retrieve the results by accessing workflow computing device 2540.

While fig. 15 functionally illustrates the processor 2512, memory 2514, and other elements of the computer control 2510 as being within the same block, the computer control 2510, processor 2512, and/or memory 2514 may be comprised of multiple processors, computer control devices, and memories, respectively, which may or may not be stored in the same physical housing. For example, memory 2514 may be a hard disk drive or other storage medium located in a different location within the housing than computer control 2510. Thus, reference to processor 2512, computer control 2510 and memory 2514 should be understood to include reference to a collection of processors, computer control and memory that may or may not operate in parallel.

Display interface

The display interface 2520 may be specifically associated with the analyzer 2000 and may display only information about the analyzer 2000 and may also be integrated into the structure of the analyzer 2000. However, the display interface 2520 is optional (shown by dashed lines in fig. 15) and, in the embodiment shown in fig. 1, is not included, but rather uses the overall system display interface 1332. However, when display interface 2520 is included, interface 2520 may be a front panel coupled to housing 2010 or a monitor, LCD panel, or the like positioned remotely from analyzer 2000. The display interface may display a GUI, user prompts, user instructions, and other information that may be relevant to the user.

Input interface

The user control/input interface 2530 allows a user to manipulate the GUI and, again, may optionally be provided as a separate component from the overall system input interface provided through the display interface 1332 of fig. 1. However, when a user control/input interface 2530 is provided, such an interface may be, for example, a touchpad, keyboard, or mouse. Additionally, input interface 2530 may be integrated into display interface 2520 such that the same device that displays prompts, etc., is the same device that allows the user to respond to the prompts.

As shown in fig. 15, the computer control 2510 may be connected to a workflow computing device 2540, which is used to integrate all components of the high-throughput system 00, such as the second analyzer 4000 and the pre-analysis system 10, and with a laboratory information system ("LIS") of a particular laboratory. Information pertaining to the analyzer 2000 originating from the pre-analysis system 10 may be communicated to the analyzer 2000 through the workflow calculation device 2540. Similarly, information pertaining to the pre-analysis system 10 from the analyzer 2000 may be communicated by the computer control device 2500 to the workflow calculation device 2540, which communicates this information to the pre-analysis system 10. Such information may also be supplemented by workflow computation means 2540 with information obtained from the LIS, such as patient information, etc.

Computer control devices are also connected to various components within analyzer 3000 to share information, such as instructions and data, back and forth. Some of the components connected to the computer control device via an internal bus include each of the processing modules 2200a-c, the inventory robot 2300, the detectors 2270a-c, and the liquid handling robot 2400. This connection to the computer control 2510 allows the computer control 2510 to provide instructions to and obtain information from such components. For example, inventory robot 2300 may receive instructions from computer control 2510 to retrieve certain consumables and place them in a particular location, and may communicate inventory information to computer control 2510. Thus, when the analyzer 2000 is fully automated, the operations performed by the internal components of the analyzer 2000 are typically as a result of instructions provided by the processor 2512.

Operation of

Step 1: receiving commands

In one aspect, the operation of the operational analyzer 2000 (fig. 16) includes commands for testing that may be received 2602 by the analyzer 2000 from the workflow computing device 2540. When a batch of samples is pre-processed by the pre-analysis system 10 and ready to be analyzed, the command may be first communicated from the pre-analysis system 10 to the workflow computation means 2540. In this regard, the pre-analysis system 10 may load the shuttle 2030 with an entire batch, which in this embodiment includes two shuttles 2030, each shuttle 2030 carrying 12 sample containers 03. Such a shuttle 2030 is parked at the docking station 260 described in the' 875 application.

Step 2: counting

Once the command is received by the analyzer 2000, the inventory robot 2300 inventories 2604 the consumable to determine whether there will be enough consumable to perform the specified test. Such inventory may be performed by inventory robot 2300. In this regard, upon receiving the command, the inventory robot 2300 moves the end effector 2360 toward the inventory platform 2014 below the processing platform 2016. The end effector 2360 is rotated approximately 180 degrees such that the identifier reader 2366 faces the inventory platform 2014. Inventory robot 2300 then scans the consumables located therein to determine which consumables are loaded into analyzer 2000. The analyzer 2000 then determines whether there are sufficient consumables for performing the commanded test. Other automated devices for monitoring consumable inventory are contemplated. Such other automated operations or tracking of consumable inventory are well known to those skilled in the art and are not discussed herein.

Inventory robot 2300 may not need to scan consumables each time a command is received. Instead, the analyzer 2000 keeps track of consumables input to the analyzer 2000 by a user. For example, when a user loads consumables, inventory robot 2300 scans the consumables and registers them in a database within memory 2514. The analyzer 2000 keeps track of when consumables are used. Thus, the analyzer 2000 may inventory consumables in response to instructions (via the processor 2512) to scan a database within its memory 2514 to determine which consumables have been used and which consumables have not been used to obtain a complete record.

In one example, a test command to identify the presence of a particular test target (e.g., chlamydia) is received by the analyzer 2000. The analyzer 2000 knows which reagents must be present inside the analyzer 2000 to perform the test. In addition, the analyzer 2000 knows which other consumables must be used, such as pipette tips 2020, process plates 2040, and amplification cassette 2070. Such information may be preprogrammed into its memory 2514. The analyzer 2000 scans its database in memory 2514 or uses the inventory robot 2300 to verify that the necessary consumables are available.

If the consumable available is insufficient to conduct the test of the command, the user is notified 2620, which may be in the form of a warning displayed on the display 1332 or 2520, a push notification of the mobile device, or a mail. If other samples required for different tests are ready to be processed by the analyzer 2000 and there are enough consumables to perform the test, the analyzer 2000 can receive those containers 03 in order to avoid downtime until the user loads the analyzer 2000 with the necessary consumables.

When a user loads consumables and such consumables are received 2622 by the analyzer 2000, for example at the beginning of a work shift or in response to a warning that the consumables are insufficient, the user loads the consumables through the front of the analyzer 2000. Thus, a user can load pipette tips 2020 into pipette drawer 2142, and load reagent plates 2050 and 2060, amplification cassette 2070, and/or process plate 2040 into consumable reservoir 2110. Enough consumables may be loaded to allow the analyzer 2000 to run continuously for 24 hours without interruption.

When such consumables are loaded by a user, the analyzer 2000 recognizes, for example, through a door sensor that the inventory platform 2014 has been accessed. Inventory robot 2300 may then automatically perform an inventory scan to identify any new consumables loaded into analyzer 2000. Identifiers located on consumables (e.g., reagent plates 2050, 2060, process plate 2040, tip holder 2022, and amplification cassette 2070) are used to determine what consumables are and what they contain, e.g., reagents in the case of reagent plates 2050 and 2060.

Step 3: sample container

Once the analyzer 2000 determines that there are sufficient consumables to perform the test and one of the processing modules 2200 can be used, the analyzer 2000 communicates its readiness to the workflow computation device 2540. The workflow-computing device 2540 then notifies the pre-analysis system 10, which in response loads the shuttle 2030 containing the sample containers 03 onto the shuttle-carrying assembly 300 and sends it to the analyzer 2000. Shuttle 2030 may stop just before it reaches the entrance of analyzer 2000. However, in some embodiments, shuttle 2030 may be directly transferred into analyzer 2000.

Inventory robot 2300 then moves toward pre-analysis system 10 and reaches 2606 inside pre-analysis system 10. The end effector 2360 clamps the shuttle 2030 such that the first engagement feature 2361 is received within the second lateral opening 2036. The shuttle 2030 is then transported into the analyzer 2000 and reaches the shuttle holding assembly 2210 in the vicinity of the designated processing module 2200 and places the shuttle 2030 onto the fixed platform 2216. The clamp assembly 2212 is then closed such that the engagement members 2214 extend through the second transverse openings 2034 and pierce the skirt 07 of the respective container 03, thereby holding the container 03 in position for aspiration by the multi-tubing pipette 2440.

Step 4: stage consumable and aliquot

With the sample container 03 adequately held, the processing module 2200 is provided with appropriate consumables in stages. In this regard, inventory robot 2300 takes two process plates 2040 and places one plate on each extractor 2240a-b such that extraction tubes 2044 of each plate 2040 are received by heating elements 2248 of the respective extractor 2240 a-b. The inventory robot 2300 also takes the first dry reagent plate 2050a and the liquid reagent plate 2060 and places them at the dry reagent station 2220 and the liquid reagent station 2230, respectively. Typically, the liquid reagent plate 2060 and the dry reagent plate 2050 provide more reagent than the number of samples carried by the shuttle 2030. Thus, the analyzer 2000 may not need to provide a reagent plate each time the shuttle 2030 is placed into the analyzer. Additionally, the inventory robot 2300 retrieves the amplification cassette 2070 from the inventory platform 2014 by engaging the second engagement feature 2364 with the notch 2072. The amplification cassette 2070 is placed at the amplification cassette station 2250 such that the inlet opening 2073 is located adjacent to the extractor 2240 a.

Thereafter, the multi-channel pipette 2440 takes a first pipette tip 2020a, one tip for each of the three pipette assemblies 2470 a-c. An aliquot of 2607 is taken from each sample container 03 by puncturing the penetrable seal 09 of the sample container with a pipette tip 2020 and aspirating the sample therein. Aliquots are drawn into respective extraction tubes 2044 of the processing plate 2040. After each mixing tube 2044 is inoculated with an aliquot, the multi-channel pipette 2440 inserts the pipette tip 2020a into an adjacent tip holding station 2047 for later use. This process is carried out until an aliquot is extracted from each container 03. In the event that there is a failure such that an aliquot cannot be taken, for example, because the seal is not pierced, the analyzer 2000 retains this information in its memory 2514 so that this information can be communicated to the pre-analysis system 10, which will properly organize the defective sample, as discussed in the' 875 application.

Step 5: returning the sample container shuttle and retrieving another sample container shuttle

Once an aliquot is taken from each sample container 03 within shuttle 2030, analyzer 2000 communicates to workflow computing device 2540 to return 2608 shuttle 2030 to pre-analysis system 10. The workflow computation means 2540 relays this communication to the pre-analysis system 10, which moves another shuttle 2030 containing the other half of the batch to the shuttle transport assembly 300. Within the analyzer 2000, the clamp assembly 2212 releases the shuttle 2030 and the inventory robot 2300 returns the shuttle 2030 containing the used containers 03 to the pre-analysis system 10 by placing the shuttle 2030 into the return channel of the shuttle transport assembly 300. Inventory robot 2300 then engages and moves 2610 the second shuttle 2030 of the batch and carries it to shuttle holding assembly 2210 where it is held and the remaining aliquot of the batch is withdrawn. Once the aliquot is transferred into the remaining extraction tube 2044 of the processing plate 2040, the shuttle 2030 is returned again to the pre-analysis system 10 by the inventory robot 2300.

In some embodiments, a two-channel assay may be performed by the analyzer 2000, wherein aliquots from each sample container 03 are drawn into two (rather than one) extraction tubes 2044. In such an embodiment, a single shuttle 2030 with 12 sample containers 03 would be filled with two processing plates 2040, each with 12 extraction tubes 2044. Thus, in this embodiment, inventory robot 2300 takes only one shuttle 2030 for the trial and does not take any additional shuttles 2030.

Step 6: treatment of samples

As the processing plate 2040 is inoculated with an aliquot of the sample, the analyzer 2000 processes 2612 the sample. The procedure is generally the same, irrespective of the test. There is no great difference in the handling, in terms of the reagents used. Thus, the processing module 2200 can perform a wide range of tests. Treatments typically include extraction, isolation, and amplification of analytes (e.g., DNA targets).

Extraction includes reconstitution of the dried lysing agent, which may comprise magnetic beads configured to bind to DNA. In this regard, the multi-channel pipette 2440 picks up a previously used pipette tip 2020a from a pipette tip holding station 2047 within the processing plate 2040. While the multi-channel pipette 2440 generally includes multiple pipette assemblies 2470a-c, individual pipette assemblies 2470 can be driven along respective z-rails 2464 independent of other pipette assemblies 2470 to retrieve a previously used pipette tip 2020a from the processing plate 2040. Once the tip 2020a is retrieved, the pipette assembly 2470 punctures the seal of buffer in the liquid reagent plate 2060, retrieves an aliquot of buffer, and transfers it to the dry reagent plate 2050a, where it punctures the seal over one of the compartments 2044, and inoculates the compartment 2054 with buffer to rehydrate the lysing agent. The reconstituted lysing agent is then aspirated and transferred to extraction tube 2044. This process was repeated until all extraction tubes 2044 were inoculated with lysing agent and magnetic beads.

The extractors 2240a-c then heat the extraction tube 2044 and the contents therein via a heating element 2248 in contact with the extraction tube 2044. When the mixture is inoculated, the inventory robot 2300 removes the first dry reagent plate 2050 from the process module 2200 and takes the second dry reagent plate 2050b from the inventory platform 2014 and places it into the dry reagent plate station 2220.

When inoculation is complete, the motors 2244 of the extractors 2240a-b move the permanent magnets 2241 out of their respective housings 2242 and place the permanent magnets adjacent the extraction tube 2044, where the magnetic beads, and the extracted DNA attached to the magnetic beads, are attracted to the sides of the tube 2044. Then, the multi-channel pipette 2440 takes an aliquot of wash buffer from the reagent plate 2060 and washes the tube mixture. The magnets 2241 are moved back into their housing 2242 and the supernatant removed from the mixing tube and discarded through the liquid waste inlet in communication with the liquid waste bottle of the inventory platform 2014. The neutralization buffer is transferred from the liquid reagent plate 2060 to the mixing holes 2046 in the processing plate 2040 adjacent to the extraction tubes 2044. Then, the pipette 2440 takes the elution buffer from the liquid reagent plate 2040 and dispenses the elution buffer into the extraction tube 2044 to separate the magnetic beads from the isolated DNA. Magnet 2241 is moved back in place and the eluate is withdrawn and transferred into mixing well 2046 where it is mixed with the neutralising buffer. The neutralized sample is then used to reconstruct the master mix within the second dry reagent plate 2050 b. Next, the mixture is loaded into the amplification cassette 2070 by the multi-channel pipette 2440 and the second pipette tip 2020b, and the second pipette tip 2020b inoculates the cassette 2070 by sucking the mixture into the inlet opening 2073 of the cassette 2070. The amplification cassette 2070 may receive the entire batch.

Step 7: amplification/analysis/detection

Thereafter, the end effector 2360 of the inventory robot 2300 engages the cassette 2070 and carries it to the detector 2270 associated with the processing module 2200. The inventory robot 2300 places the boxes 2070 on the platform 2276 of the thermal cycler 2275 without significantly tilting the boxes 2070. This is possible at least because the magazine 2070 is suspended or carried such that it is positioned below the fingers 2363a-b of the end effector 2360. If the fingers 2363a-b are positioned lower than the magazine 2070, the magazine 2070 may fall off of the end effector 2360. The motor 2278 then raises the thermal cycler 2275 to press the cassette 2070 against the reader 2271. The cassette 2070 is then subjected to thermal cycling such that amplification of the test target is performed. The reader 2271 detects the presence of the test target within the chamber 2075 of the 2614 box 2070.

Step 8: discarding and repeating

Once the detection is complete, the results are transferred to workflow calculation means 2540. The used amplification cassette 2070 is moved 2616 by the inventory robot 2300 to the amplification cassette waste, which may be elsewhere in the waste reservoir 2130 or analyzer 2000. The inventory robot 2300 also discards the used disposal plate 2040 by stacking the disposal plate 2040 onto the shelf 2138 of the waste bin 2130. The dry reagent plate 2050 and the liquid reagent plate 2060 are returned to their respective compartments in the consumable reservoir 2110 for use in another test. The dry reagent plate 2050 and the liquid reagent plate 2060 may be used in generally 4 test runs. The computing device 2510 keeps track of how many times the plates 2050 or 2060 are used and the analyzer 2000 automatically discards the plates 2050, 2060 after their final operation by placing them in the waste reservoir 2130. Once the consumable is discarded, the processing module 2200 may perform 2618 another test.

Multiple tests at a time

Each processing module 2200 can perform any test on the test sheet at any given time if the appropriate consumables are in stock within its housing 2010. This allows analyzer 2000 to flexibly respond to optimize throughput. For example, the first processing module 2200a can perform several runs on the first trial. However, if there is a backlog of samples within the pre-analysis system 10 that requires a second test (which is different from the first test), the first processing module 2200a may assist in processing and analyzing such samples by performing the second test. This process may be accomplished automatically by the analyzer 2000 without the assistance of a user, as the analyzer 2000 and the pre-analysis system 10 remain in continuous communication.

Numerous additional, variations and combinations of the features discussed above can be applied without departing from the disclosure. 17A-17C depict an analyzer 3000 according to another embodiment of the present disclosure. Analyzer 3000 is similar to analyzer 2000 in that it includes a processing platform 3016 with a plurality of processing modules 3200a-c, an inventory robot 3300 with a clamping end effector 3360, a liquid handling robot including a plurality of multi-channel pipettes 3440a-c, a consumable storage area 3014, and detectors 3270a-c for detecting analytes. In addition, the analyzer 3000 employs the same consumables as the analyzer 2000, such as the pipette tips 2020, shuttle 2030, process plate 2040, liquid reagent plate 2060, dry reagent plate 2050, and amplification cassette 2070 described previously. However, the difference is in the arrangement of consumable storage 3014 and detectors 3270a-c of analyzer 3000, as well as in some consumable reservoirs.

In particular, analyzer 2000 includes a detection/analysis platform 2012 that is located below an inventory platform 2014. However analyzer 3000 separates these platforms horizontally rather than vertically. Thus, analyzer 3000 includes an inventory portion 3014 and a detection/analysis portion 3012. In the particular embodiment depicted, the inventory portion 3014 is located to the left of the analyzer 3000 and the detection/analysis portion is located to the right of the analyzer 3000.

The inventory portion 3014 includes a first consumable reservoir 3110, a second consumable reservoir 3120, and a waste reservoir 3130. The first receptacle 3110 is similar to the receptacle 2110 in that it receives and stores consumable items such as reagent plates 2050, 2060 and cassettes 2070. The second reservoir 3120 is located between the first reservoir 3110 and the waste reservoir 3130.

The second reservoir 3120, as best shown in fig. 18C, has a vertical compartment defined by a wall 3122 and a vertical rod/column disposed opposite the wall 3122. These compartments are sized to receive a stack of processing plates 2040. The lever 3124 helps to prevent the stack of processing plates 2040 from falling, while allowing the processing plates 2040 to be sufficiently exposed so that the robot 2300 can retrieve the plates 2040 from the corresponding stack.

The waste reservoir 3130 is generally identical to the waste reservoir 2130. The waste reservoir 3130 defines a side boundary of the inventory portion 3140 of the analyzer 300 and helps to separate the unused consumables and the detection/analysis portion 3012, which can help isolate any potential sources of contamination from any areas.

The detection/analysis portion 3012 includes a waste reservoir 3130 (in one embodiment, the waste is an amplification cassette), a liquid waste reservoir 3170, and a plurality of detectors 3270. The waste reservoir 3160 has an opening for receiving and containing waste (e.g., used amplification cassette 2070) until the user empties the reservoir 3160. The amplification waste reservoir 3160 may be slidably attached to one or more rails to control movement into and out of the analyzer 3000. The liquid waste reservoir 3170 is connected to the processing platform 3016 by hoses or some other plumbing arrangement (not shown) so that liquid waste can be disposed of from the processing platform 3016. Detectors 3270a-c are identical to detectors 2270a-c and each include a thermal cycler 3275 and a reader head 3271. The detectors 3270a-c are positioned in a vertical arrangement such that the second detector 3270b is positioned directly above the third detector 3270c and the first detector is positioned directly above the second detector 3270 b. The detectors 3270a-c open in the same direction for access by the gripper 3360 of the inventory robot 3300. In some embodiments, at least one detector 3270 may be positioned on the same horizontal plane as another detector and may be arranged orthogonally relative thereto.

Fig. 18A-18C depict an analyzer 3000' according to another embodiment of the present disclosure. Analyzer 3000' is similar to analyzer 3000 except that one or more consumable reservoirs are movable for ease of access. For example, as shown in fig. 18B, the second consumable storage 3120 may be movable like a drawer such that a user may access each vertical compartment to replenish the processing plate 2040. In another embodiment shown in fig. 18C, a first waste reservoir 3110 and a second waste reservoir 3120 may be positioned on a removable base 3144 such that a removable consumable inventory 3142 is formed. In this regard, the pedestal 3144 may slide on a rail (not shown) such that the first and second consumable reservoirs 3110 and 3120 may be moved to a position outside of the system 3000' to replenish consumables. In a further example, a carousel consumable inventory (not shown) may include a plurality of compartments that may be rotated about a vertical axis. Such carousel inventory may be rotated to expose its compartments to a user for replenishment while also allowing consumables stored therein to be positioned for access by robot 3300.

The analyzer 3000' also includes a housing 3010 that includes holes 3012 in its front face so that various reservoirs, such as first and second reservoirs 3110 and 3120, solid waste reservoir 3130, liquid waste reservoir 3170, and amplified waste reservoir 3160, can be moved or removed, as shown in fig. 18A. A door 3140, which may be hingedly connected to the housing 3010, and may be opened to allow a user access to such a reservoir.

One example of an analyzer described herein includes: i) A housing; ii) a robotic arm comprising an end effector comprising: a) A body rotatably connected to the articulated arm; and b) first and second fingers coupled to the body and movable relative to each other in a first direction, each of the fingers having an engagement feature projecting inwardly from each of the first and second fingers and toward the other of the first and second fingers, the engagement feature configured to engage a recess of an article, wherein the recess is configured to receive the engagement feature such that when the engagement feature is so engaged with the article, the robotic arm can carry the article hanging from the first and second fingers. The analyzer further includes: iii) At least one shuttle platform for receiving a shuttle carrying sample containers, the sample carrying containers being evaluated by an analyzer; wherein the shuttle platform has a jaw assembly that automatically moves from an open position to a closed position, the jaw assembly including an engagement member that does not contact a bottom of a sample container carried by the shuttle when the jaw assembly is in the open position and engages the bottom of the sample container when the jaw assembly is in the closed position. The analyzer may further comprise an automated pipettor that aspirates a sample from the sample container, and wherein the jaw assembly of the shuttle platform is closed when the automated pipettor aspirates a sample from the sample container. The robotic arm places the shuttle on the shuttle platform when the jaw assembly of the shuttle platform is in the open position. The automated analyzer may also have a magnetic extractor. The magnetic extractor may include: i) A housing defining a cavity; ii) adjacent rows of permanent magnets movably disposed within the cavity of the housing; iii) A drive mechanism connected to the row of permanent magnets and configured to move the row of permanent magnets into or out of the cavity; and iv) a plurality of heating elements extending from the housing along rows disposed on opposite sides of the cavity. Moving the magnets from the first position to the second position positions the rows of multiple magnets directly between the rows of heating elements such that each permanent magnet is aligned with a respective heating element. The magnetic extractor may also have drip plates defining slots, each of which is disposed adjacent a respective row of heating elements.

The magnetic extractor is adapted to receive a process plate thereon, the heating elements each defining a recess configured to receive and retain an extraction tube of the process plate disposed above the magnetic extractor, the heating elements being connected to a power source that heats the heating elements such that pipette tips retained by the process plate extend into a well of the drip plate when the process plate is placed above the heating elements. In operation of the analyzer, the process plate is placed on the magnetic extractor by the robotic arm. In some examples, the robotic arm delivers the process plate onto the magnetic extractor by engaging engagement features of the robotic fingers with engagement members extending upward from the process plate, wherein the upward extending engagement members have openings that receive the engagement features when the robotic fingers are in a first engaged position, wherein the robotic fingers are closer together in the first engaged position than in a second position, wherein a distance between the robotic fingers is too far apart for the engagement features to engage the engagement members. In some embodiments, the robotic finger has a second engagement feature extending downwardly from the robotic finger. In one example, the feature extending downward from the robotic arm includes a post having an inverted frustoconical protrusion extending therefrom. In operation, the inverted frustoconical feature engages a corresponding notch of a consumable article that is transported from a first location to a second location within an automated analyzer. The automated analyzer may further include a consumable storage for receiving consumable items for use within the automated analyzer. Examples of consumable items include process plates, dry reagent plates, liquid reagent plates, and amplification cartridges. In some embodiments, the robotic arm includes a scanner, wherein the robotic arm retrieves consumables stored in the consumable storage by reading a code on the consumable using the scanner. In one example, a consumable storage receives consumables from a first side, and wherein a robotic arm retrieves consumables from a second side of the consumable storage. In one example, the analyzer has one or more processing modules that include a shuttle platform and a magnetic extractor. In this example, where the analyzer has multiple processing modules, two adjacent processing modules use one shuttle platform. In one example, the processing module includes a dry reagent station and a liquid reagent station adjacent to the magnetic extractor, wherein the magnetic extractor is adapted to receive a processing plate thereon and wherein the processing plate is positioned lower in the processing module relative to the dry reagent plate and the liquid reagent plate positioned at the respective dry reagent station and liquid reagent station.

In another aspect, a process board for an automated diagnostic system includes: i) A plate body defining a plurality of extraction tubes, mixing holes, and pipette tip holding stations, each defining an opening extending through an upper surface of the plate body; and ii) an engagement member extending vertically upward from the upper surface of the plate body and having an opening in a vertical portion of the engagement member, wherein the opening faces the perimeter of the plate body, the opening being configured to receive an engagement feature of an automated transport device. In one example, a process plate includes an upper surface, a lower surface, and an edge extending between the upper surface and the lower surface and defining a perimeter of the plate body. In another example, a process board for an automated diagnostic system includes: i) A plate body having an upper surface, a lower surface, and an edge extending between the upper surface and the lower surface and defining a perimeter of the plate body; and ii) a plurality of sets of openings in and extending through the upper surface of the plate body, wherein the openings terminate at a closed end. For example, each group includes: i) An extraction tube having a tube body extending from a bottom surface and defining a tube opening extending through an upper surface; a hole; and a pipette station configured to receive and hold a pipette tip. In one example, each set of extraction tubes, holes, and pipette stations are aligned in a row, and the pipette stations are positioned closest to an edge on at least one side of the plate body, with the extraction tubes and holes further away from the perimeter of the processing plate.

In yet another aspect, a process plate support assembly suitable for use in an automated analyzer is provided.

In one example, an engagement member extends vertically upward from an upper surface of the plate body and has an opening in a vertical portion of the engagement member, wherein the opening faces a perimeter of the plate body, such opening being configured to receive an engagement feature of an automated transport device.

Also described herein is an inventory robot including a robotic arm with an end effector for carrying an article, the end effector comprising: i) A body rotatably connected to the articulated arm; and ii) at least two fingers coupled to and extending from the body, one of the at least two fingers being movable relative to the other of the at least two fingers. Each of the at least two fingers includes a first projection extending in a first direction toward the other of the at least two fingers to engage a corresponding recess of the article. The respective recess is configured to receive one of the protrusions, wherein each of the at least two fingers includes a second protrusion extending in a downward direction relative to the first direction. The second protrusion is for engaging a recess in the top of the article, wherein the recess is configured to receive the second protrusion.

An automated analyzer is also described herein that includes a robotic arm with an end effector for carrying an article. The end effector includes: i) A body rotatably connected to the articulated arm; and ii) first and second fingers coupled to the body and extending therefrom in a first direction and movable relative to each other in a second direction transverse to the first direction, each of the fingers having a first engagement feature extending therefrom in the second direction and a second engagement feature extending downwardly therefrom, the second engagement feature configured to engage a recess provided in a top of the article, wherein the recess is configured to receive the second engagement feature such that the article is suspended from the first and second fingers when the robotic arm carries the article from the first position to the second position.

Also described herein is an automated analyzer comprising: i) An inventory robot comprising a robotic arm having an end effector thereon, the end effector comprising a body rotatably coupled to an articulating arm; ii) a plurality of gripping fingers extending from the body from a first side of the body, wherein the body is rotatable on a vertical axis; iii) A scanner located on the end effector that is brought into proximity with the item by an inventory robot that scans identifying information disposed on the item and is located on the end effector at a location other than the location where the clamping fingers extend. The analyzer also has a magnetic extractor comprising: i) A housing defining a cavity; ii) adjacent rows of permanent magnets movably disposed within the cavity of the housing; iii) A drive mechanism connected to the row of permanent magnets and configured to move the row of permanent magnets into and out of the cavity; and iv) a plurality of heating elements extending from the housing in rows disposed on opposite sides of the cavity, each heating element defining a recess configured to receive and retain an extraction tube of a process plate disposed above the magnetic extractor, the heating elements being connected to a power source that heats the heating elements. In operation, moving the magnets from the first position to the second position disposes multiple magnet rows directly between the rows of heating elements such that each permanent magnet is aligned with a respective heating element. The magnetic extractor further includes a plurality of heating elements extending from the housing; a drip plate defining slots, the slots all being disposed adjacent to respective rows of heating elements; and a consumable storage adapted to receive a consumable processing plate, the processing plate including a machine readable label thereon, wherein the processing plate is placed into the consumable storage from a first side and the machine readable label on the consumable is read from a second side of the consumable storage by the inventory robot scanner. In one example, the inventory robot is moved to a consumable storage to obtain a process plate and scan labels on items within the consumable storage, and when it identifies a consumable to be retrieved, the consumable is removed from the consumable storage and placed on a magnetic extractor such that a pipette tip held by the process plate extends into a slot of a drip plate.

Also described herein is an exemplary manner of operating an automated analyzer for biological samples, comprising: i) Placing a shuttle support carrying the sample container at a location near the analyzer housing for analysis; ii) moving a robotic arm including an end effector such that the end effector translates to a position adjacent the analyzer while other portions of the robot remain in the analyzer; iii) Advancing the first and second fingers toward the shuttle mount such that engagement features of the first and second fingers enter corresponding slots in the shuttle mount, wherein a distance between the slots in the mount corresponds to a distance between the fingers extending from the body when the fingers are inserted into the slots; iv) once the engagement member is advanced into the slot, translating the fingers of the robotic arm closer together to grasp a shuttle carriage located within the pre-analysis system; and v) moving the shuttle holder from a position adjacent to the analyzer into the analyzer using the robotic arm. In one example, an end effector includes a body having first and second fingers extending from the body, each finger having an engagement feature thereon, wherein the first and second fingers are disposed in a channel in the body and can be moved closer together or further apart by robotic translation. In one example, there is physical proximity between the analyzer and an adjacent pre-analysis system in which the sample is prepared for analysis in the analyzer and the robotic arm removes the shuttle holder from the adjacent pre-analysis system and transports it into the analyzer. The operation of the analyzer may further include: i) Placing a shuttle holder carried into the analyzer on a shuttle stationary platform using a robotic arm, wherein the shuttle stationary platform comprises a jaw assembly having an open position and a closed position, wherein the jaw assembly is in the open position when the shuttle holder is placed on the shuttle stationary platform; ii) releasing tension between the gripping fingers and the shuttle support and withdrawing the gripping fingers extending from the end effector from the slots in the shuttle support; iii) After the gripping fingers are withdrawn, moving the jaw assembly to a closed position, thereby securing the engagement member of the jaw assembly against a lower portion of the sample container in the shuttle when the jaw assembly is in the closed position; iv) inserting the pipette tip into the sample container using a robotic pipette; v) aspirating at least a portion of the sample in the sample container using a robotic pipette; and vi) withdrawing the pipette tip from the sample container when the jaw assembly is in the closed position. After withdrawing the pipette tip from the sample container, the jaws are moved to an open position, immediately following: vii) advancing the first and second fingers of the end effector toward the shuttle mount such that the engagement features of the first and second fingers enter corresponding slots in the shuttle mount, wherein the distance between the slots in the shuttle mount corresponds to the distance between the fingers extending from the body when the fingers are inserted into the slots; viii) translating the fingers closer together after advancement of the engagement member into the slot to grasp a shuttle carriage located within the pre-analysis system; ix) transporting the shuttle support from the shuttle mounting platform back to a position adjacent the analyzer; x) releasing the shuttle scaffold from the end effector; and xi) retracting the end effector into the analyzer.

In another example, an automated analyzer for manipulating a biological sample includes the steps of: i) Moving an end effector of a robotic arm of the inventory robot over an item in a first position, the end effector having a body with a first finger and a second finger positioned in a channel and linearly movable within the channel to a position over the item in the first position, the fingers having engagement features thereon; ii) separating the first and second fingers such that the distance between them is greater than the distance between engagement members as projections extending upwardly from the body of the article, the engagement members being disposed inboard relative to the periphery of the article and having openings facing the periphery of the article; iii) Moving the end effector such that engagement features extending from each finger are aligned with corresponding openings in the engagement member; iv) moving the first and second fingers toward each other to engage the engagement member opening; v) lifting the article with the body of the article under the fingers; and vi) moving the article to the second position.

In another example, the engagement feature is one of a first engagement feature protruding inwardly from each of the first and second fingers and protruding toward the other of the first and second fingers or a second engagement feature extending downwardly from each finger, wherein the feature extending downwardly from the finger comprises a post having an inverted frustoconical protrusion extending from the post. In another example, the first location is a consumable reservoir. The consumable storage may contain a first article including an engagement member in a top surface thereof. This exemplary manner of operation may also include: vii) moving the end effector over the top surface of the first article; and viii) lowering the end effector above the top surface of the article such that the second engagement features engage with corresponding engagement members in the top surface of the first article. The consumable storage may further comprise a second item that is included in the upper surface of the body of the item and that extends through the plurality of sets of openings of the upper surface, wherein the openings terminate at a closed end, wherein each set comprises one of: a) An extraction tube having a tube body extending from a bottom surface and defining a tube opening extending through an upper surface; b) A hole; c) A pipette station configured to receive and hold pipette tips, wherein each set of extraction tubes, holes, and pipette stations are aligned in a row, wherein the pipette stations are positioned closest to an edge on at least one side of the plate body, wherein the extraction tubes and holes are further away from a perimeter of the processing plate; and d) an engagement member inboard on and extending from the top surface thereof, the engagement member having an opening facing the periphery of the top surface, the calibrating further comprising moving the end effector over the top surface of the first article. The calibration may include the steps of: ix) aligning an engagement feature of the end effector with the engagement member; and x) inserting the engagement feature into the engagement member; xi) translating the first finger and the second finger closer together to grasp the engagement member; and xii) bringing the second article to the second position.

In one example, the end effector is advanced horizontally to move the fingers into corresponding recesses. In embodiments wherein the end effector comprises a scanner, the manner of operation may further comprise: i) Instruct the inventory robot to retrieve items from the consumable storage; ii) scanning a machine readable label on an item in the consumable storage; iii) Determining whether the tag information matches an item indicative of inventory robot acquisition; and iv) if a match is determined, engaging an arm of the end effector with an engagement member on the item and transporting the item from the consumable storage to a second location using the inventory robot.

Calibration of

In some embodiments, inventory robot 2300 or 3300 may be calibrated prior to preprocessing a batch of samples. In such an embodiment, a pair of pins may be added to inventory robot 2300 or 3300, either temporarily or permanently. For example, during a calibration procedure, a pin may be threaded into each of the movable fingers 2363a-b of the inventory robot 2300 (e.g., near the first engagement feature 2361 and/or the second engagement feature 2364). In some embodiments, the pins remain attached to the inventory robot 2300 or 3300 during pretreatment of the samples. In some embodiments, the pin may include an engagement feature (e.g., tab or protrusion) sized to fit within an engagement slot of one or more consumables described above, for example. In some embodiments, pins may replace other engagement features of inventory robot 2300 or 3300, such as second engagement feature 2364.

Fig. 32A-32E illustrate aspects of an end effector or hand 5360 having a pair of pins for calibration. As shown, end effector 5360 includes a body 5362 and a pair of moveable fingers 5363a-b coupled to body 5362. The movable fingers 5363a-b are operable such that they move closer together or farther apart in order to grasp or release an item. In this regard, the movable fingers 5363a-b generally remain parallel during operation. The end effector 5360 also includes an identifier reader 5366, such as a bar code scanner. Much like the body 2362 of the end effector 2360, the body 5362 is capable of rotating about 360 degrees. The body 5362 may also include an identifier reader (not shown) in its bottom surface so that such a reader can read upwardly facing identifiers, such as those that may be located on the amplification cassette 2070.

Much like the fingers 2363a-b of the end effector 2360, the fingers 5363a-b may be configured to engage a variety of different consumables. In this regard, the fingers 5363a-b include engagement features 5361. As shown, the engagement feature 5361 is a tab or protrusion extending inwardly from one finger 5363 toward the other finger 5363. The engagement features 5361 may be sized to fit within, for example, the engagement notches 2042, 2052, 2062 of the plates 2040, 2050, 2060, respectively, and the first transverse opening 2034 of the shuttle 2030. In operation, when the fingers 5363a-b are closed onto a consumable article, the engagement features 5361 extend into slots or openings of the corresponding consumable article, thereby preventing the consumable article from falling while the fingers 5363a-b themselves grip onto the sides of the consumable article to further control and retain the article. As shown, each finger 5363a-b preferably includes two engagement features 5361 that help prevent inadvertent rotation of the consumable item during finger gripping.

Unlike end effector 2360, end effector 5360 includes posts 5367, posts 5367 are generally located on opposite sides of fingers 5363a-b between respective pairs of engagement features 5361. As shown, posts 5367 extend downwardly from fingers 2363a-b and have a generally circular cross-section. However, in other embodiments, the posts may be shaped differently. For example, the post may have a generally rectangular, triangular or oval cross-section. As shown, the post 5367 has a generally planar bottom surface. However, in other embodiments, the post 5367 may include a dovetail very similar to the dovetail described above for the second engagement feature 2364 of the end effector 2360. In some such embodiments, the posts 5367 may be sized to engage, for example, corresponding notches 2072 in the amplification cassette 2070.

In some embodiments, each finger 5363a-b may be flexible so as to be able to bend downward or upward about a horizontal axis while being sufficiently resilient so as not to yield too easily to contact. Such flexibility may be applied to each finger 5363a-b along its length near the end that includes the post 5367. This may allow the fingers 5363a-b to automatically adjust to engage consumables that may be tilted about a horizontal axis such that they are not parallel to the fingers 5363 a-b. Similarly, in some embodiments, the engagement feature 5361 and/or post 5367 may also be flexible.

End effector 5360 may be incorporated into any of the analyzers described above (e.g., analyzer 2000, 3000, or 5000). However, to use the column 5367 for calibration, the analyzer may include one or more cutouts and/or notches. For example, as shown in fig. 28A, the analyzer may include a cutout 5701 having a substantially triangular shape. As another example, as shown in fig. 32E, the analyzer may include a heart-shaped incision 5702. As yet another example, as shown in fig. 33A, the analyzer may include a cutout 5703 having a tear drop shape. As yet another example, as shown in fig. 34, the analyzer may include a notch 5704 having a generally triangular shape. As yet another example, as shown in fig. 35A-35D, the analyzer may include a notch 5705 having a generally triangular shape. Alternatively, as explained in more detail below with respect to fig. 36A-36D, a teaching tool may be used with post 5367 for calibration.

In some embodiments, the calibration process may initially include lowering the post 5367 into the central section of any of the cutouts and slots described above. For example, as shown in fig. 33B, the column 5367 may be lowered to a "home" position. When in this "home" position, the post 5367 may extend through some of the above-described cutouts and slots (see, e.g., cutout 5701, cutout 5702, or slot 5704). Alternatively, when in this "home" position, the bottom surface of the post 5367 may contact the bottom surface of some of the above-described cutouts and slots (see, e.g., cutout 5703 or slot 5705). In some embodiments, the column 5367 may be manually lowered to the "home" position by a user manually moving the end effector 5360 when one or more motors of the inventory robot are in a compliant mode of operation. In some embodiments, the column 5367 may be automatically lowered to a "home" position by controlling one or more processors of the inventory robot. Next, as shown in fig. 33B, the fingers 5363a-B may be moved farther apart until the post reaches an "end" position. During this process, one or more motors of the inventory may be placed in a compliant mode of operation, wherein one or more of the components of the inventory robot (e.g., end effector 5360) may be moved by controlling forces external to the respective motors of the components. The "end" position may be located at a corner section of any of the cuts and notches described above. When in the "end" position, the post 5367 may contact one or more edges of the cutout and notch described above. Further, the post 5367 may slide along one or more edges of the cutout and notch described above when moving toward the "end" position. In some embodiments, movement of the fingers 5363a-b may be controlled by one or more processors.

When the post 5367 is in the "end" position, the corresponding positions of, for example, the end effector 5360 and fingers 5363a-b may be saved in memory and used as a reference point for future movement (e.g., delivery of any of the consumables described above). For example, in some embodiments, any of the analyzers described above (e.g., analyzer 2000, 3000, or 5000) can include a first motor for rotating end effector 5360 and a second motor for moving fingers 5363 a-b. The first and second motors may be, for example, rotary positioning servomotors with feedback lines. In such an embodiment, when the post 5367 is in the "end" position, the signal from the feedback line may be used by one or more processors to determine the position of the end effector 5360 and fingers 5363 a-b. In some implementations, the signal from the feedback line of the second motor may also be used by one or more processors to determine that the column 5367 is in the "end" position. For example, a signal from the feedback line may indicate that the fingers 5363a-b are no longer able to move farther apart. Those skilled in the art will readily appreciate that other types of motors (e.g., AC motors, DC motors, or stepper motors) may be used in combination with the feedback circuit to achieve similar functionality to the first and second servomotors described above. For example, a DC motor may be used in combination with a sensor (e.g., potentiometer or optical encoder) configured to generate a feedback signal related to the position of the motor's shaft.

Fig. 35A-35D illustrate some steps of an embodiment of a calibration process. As shown in fig. 35A, the analyzer may include a cartridge storage compartment 5116 at the top end of the consumable storage. The cartridge storage compartment 5116 includes a pair of slots 5705. First, as shown in fig. 35B, inventory robot 5300 may position end effector 5360 such that it is generally above a pair of slots 5705. As shown in fig. 35C, the fingers 5363a-b may then be moved to a position where the posts 5367 are generally above the center section of the pair of slots 5705. In this particular example, this step involves moving the fingers 5363a-b farther apart. However, this step may also involve moving the fingers 5363a-b closer together. As shown in fig. 35D, inventory robot 5300 may then lower end effector 5360 to a position where the bottom surface of post 5367 contacts the bottom surface of slot 5705. In some implementations, this may be detected when one or more motors of inventory robot 5300 stall. During stall, the motor may indicate that a predetermined amount of torque has been achieved. In some implementations, the corresponding vertical position of inventory robot 5300 may be saved for future reference. After the vertical position has been preserved, the end effector 5360 may be raised to a position directly above the bottom surface of the slot 5705 (e.g., within 1cm to 3 cm) such that the bottom surface of the post 5367 no longer contacts the bottom surface of the slot 5705. The fingers 5363a-b may be moved farther apart from this position until the posts 5367 contact the respective corners of the pair of notches 5705. In some embodiments, post 5367 may slide along one or more edges of notch 5705 during this process. Further, in some such embodiments, end effector 5360 may be rotated as a result of post 5367 sliding along one or more edges of slot 5705. When the posts 5367 contact respective corners of the pair of slots 5705, corresponding positions of one or more components of the inventory robot 5300 (e.g., the end effector 5360 and/or the fingers 5363 a-b) can be saved in memory and used as reference points for future movement.

Various modifications may be made to the above described notch, slot and/or calibration procedure. For example, fig. 32E-35D illustrate just a few different examples of the types of cuts and notches that may be used during the calibration process. In other implementations, the cuts and notches may be shaped differently. For example, cutouts or slots having various different regular or irregular shapes may be used with the column 5367 to calibrate the inventory robot 5300. Regardless of the particular shape, however, the cutout and/or notch preferably includes at least one corner section and has a cross-sectional area that is greater than the cross-sectional area of the post 5367. Preferably, at least one corner section is shaped to force the post 5367 into a predetermined position as the fingers 5363a-b move farther apart. For example, at least one corner section may comprise a sharp corner between two substantially straight edges, as shown in most of the above-described cuts and notches. The at least one corner section may further comprise rounded corners between the two edges. In such embodiments, the radius of the rounded corners is preferably smaller than the radius of the posts 5367 to ensure that the posts 5367 consistently reach the predetermined position as the fingers 5363a-b move farther apart. In some embodiments, the edges on either side of the corner may be curved, rather than substantially straight. In some embodiments, the angle between the two edges on either side of the corner may be between 45 degrees and 135 degrees. In some embodiments, the angle between the two edges on either side of the corner may be between 85 degrees and 95 degrees. In some embodiments, the cross-sectional area of the cutout or notch may be 2 to 30 times the cross-sectional area of the post 5367. In some embodiments, the cross-sectional area of the cutout or notch may be 10 to 20 times the cross-sectional area of the post 5367. Larger cutouts or slots may advantageously provide greater tolerance for initial positioning of the post 5367 within these cutouts or slots. However, larger cuts and notches also require more space, and thus, these two competing considerations may need to be balanced.

As another example, in fig. 32E-35D, the cutouts and notches described above are oriented such that the post 5367 reaches a predetermined position when the fingers 5363a-b are moved farther apart. However, the cutouts and notches described above may be oriented such that the post 5367 reaches a predetermined position when the fingers 5363a-b are moved closer together. For example, in such embodiments, the cutouts 5701, 5702, and 5703 may simply be rotated 180 degrees. As another example, in such an embodiment, the notches 5704 and 5705 may be rotated 180 degrees and positioned along opposite edges.

As yet another example, in fig. 32E-35D, the cuts and notches described above are provided in pairs. This is done to supplement the number of posts 5367 on end effector 5360. However, in other embodiments, the number of posts, cutouts, and/or slots may vary. For example, end effector 5360 may include three, four, or five posts, and a corresponding set of cutouts and/or notches may be provided in the analyzer for calibration, in such embodiments, fingers 5363a-b may or may not be symmetrical. For example, finger 5363a may include more posts than finger 5363 b. Alternatively, end effector 5360 may be modified to include additional fingers, and each of these fingers may include at least one post.

36A-36D illustrate that a teaching tool can replace post 5367 and/or any of the above-described cutouts and notches. For example, teaching tool 6710 may replace post 5367. As another example, teaching tool 6720 may replace any of the cuts and notches shown in fig. 32E-35D. As shown, teaching tool 6710 includes L-shaped members 6712a-b and springs 6714. Each of the members 6712a-b includes a post 6711 and a track 6715. The members 6712a-b may be coupled to each other via springs 6714 and rails 6715. Teaching tool 6710 can be sized and configured to be held by end effector 6360 having body 6362 and movable fingers 6363 a-b. In some embodiments, end effector 6360 may be configured in substantially the same manner as end effector 2360. As shown, teaching tool 6720 includes a cutout 6721 having a triangular shape. The teaching tool 6710 may be sized and configured to interface with existing components in the analyzer. For example, the teaching tool 6720 can be sized and configured to fit within any of the consumable storage compartments described above (e.g., the storage compartments defined by the wall 4114, the base 4115, and/or the support structure 4116). As another example, the teaching tool 6720 can be sized and configured to interface with one or more platforms of an analyzer (e.g., detection/analysis, inventory and processing platforms 2012, 2014, 2016).

The calibration process using teaching tools 6710 and 6720 may initially involve clamping teaching tool 6710 with fingers 6363a-b of end effector 6360 and positioning teaching tool 6720 in place within an analyzer. In some embodiments, the teaching tool 6710 can include engagement notches (e.g., engagement notches 2042, 2052, 2064, or 2072) sized to receive engagement features (e.g., engagement features 2361, 2364, or 5361) on fingers 6363 a-b. As shown in fig. 36A, the inventory robot may position the end effector 6360 such that the post 6711 of the teaching tool 6710 is generally above the central section of the cutout 6721 of the teaching tool 6720. As shown in fig. 36B, the inventory robot may then lower the end effector 6360 to a position where the post 6711 extends completely or partially through the cutout 6721. From this position, the fingers 6363a-b may be moved closer together. When this occurs, the posts 6711 move farther apart. As the fingers 6363a-b move closer together, the post 6711 may also slide along one or more edges of the cutout 6721. As shown in fig. 36C and 36D, this may cause the end effector 6360 to rotate. In this particular example, as the fingers 6363a-b move closer together, the end effector 6360 rotates clockwise. However, depending on the initial position of post 6711, end effector 6360 may instead be rotated counterclockwise. When the post 6711 contacts a respective corner of the cutout 6721, as shown at 36D, the corresponding position of one or more components of the inventory robot (e.g., the end effector 6360 and/or the fingers 6363 a-b) may be saved in memory by one or more processors and used as a reference point for future movement.

Many modifications may be made to the teaching tool described above. For example, in much the same way that post 5367 can be differently shaped, post 6711 of teaching tool 6710 can also be differently shaped. Similarly, in much the same way that the cuts and notches shown in fig. 32E-35D can be differently shaped and/or oriented, the cuts 6721 of the teaching tool 6720 can also be differently shaped and/or oriented. In embodiments where cutout 6721 is rotated 180 degrees, teaching tool 6710 may be reconfigured, for example, such that as fingers 6363a-b move closer together, posts 6711 also move closer together.

Existing calibration methods typically rely on what the operator can see. For example, these calibration methods may involve electronically controlling the motion of the robot or physically moving the robot while the robot is in a compliant mode. This may be an intuitive way of calibrating the robot, but it may also lack some accuracy and precision, as it is limited by the operator's ability. On the other hand, existing vision systems and other dedicated sensors are more capable of accurately and precisely tracking the robot and target site. However, these vision systems and other specialized sensors are often accompanied by increased complexity, cost, and development.

The calibration process disclosed above may advantageously provide greater accuracy and precision than existing calibration methods that rely on what an operator can see, while also being less costly than existing vision systems and other dedicated sensors. Simply adding posts and adding cutouts and/or notches can be relatively less costly than adding vision systems and other dedicated sensors. Furthermore, the calibration process disclosed above does not depend on what the operator can see. Alternatively, the signals from the feedback lines of one or more servomotors may be used, for example, to determine the position of the robot.

From the foregoing, and with reference to the various drawings, a person of ordinary skill in the art will understand that certain modifications may be made to the disclosure without departing from the scope of the disclosure. Although several embodiments of the present disclosure have been illustrated in the accompanying drawings, it is not intended to limit the disclosure thereto, as it is intended to bring the scope of the disclosure within the scope of the art as allowed and to allow the specification to be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims (41)

1. An automated analyzer, the automated analyzer comprising:

a housing; and

a robotic arm disposed within the housing, the robotic arm having an end effector for carrying an article, the end effector comprising:

a body rotatably connected to the articulated arm, the body including a pair of connection members;

first and second fingers coupled to the connecting member of the body, each of the first and second fingers extending between first and second ends, each of the first and second fingers having an angled offset formed and located at the second end; and

a wedge comprising an angled side and a protrusion formed and protruding from the angled side, the angled side and protrusion configured to engage with the offset of the finger to connect the finger to the body, wherein an angled wedge surface is complementary to a surface of the angled offset to which it is joined.

2. The automated analyzer of claim 1, wherein the wedge and the offset are secured together.

3. The automated analyzer of claim 2, wherein the wedge and the offset each have complementary holes therein that align when the wedge and the offset are fastened together.

4. The automated analyzer of claim 3, wherein the wedge further comprises a protrusion, wherein the protrusion is received by a protrusion aperture in the offset when the wedge and the offset are engaged.

5. The automated analyzer of claim 3, wherein a screw is received into each of the complementary holes to secure the wedge to the offset.

6. An automated analyzer, the automated analyzer comprising:

a housing;

an inventory robot disposed within the housing, the inventory robot having a scanner; and

a processing platform disposed within the housing, the processing platform including at least one processing module, the at least one processing module comprising:

A first location for receiving a consumable of dry reagent,

a second position for receiving a consumable of liquid reagent,

a third location for receiving at least one process plate consumable,

a fourth position for receiving the amplification cassette consumable; and

a plurality of machine-readable labels placed on at least one of the first location, the second location, the third location, and the fourth location for scanning and reading by the scanner of the inventory robot to detect the presence of the consumable on the processing module for controlling inventory of the processing platform.

7. The automated analyzer of claim 6, wherein the processing platform includes an opening below which a magnetic extractor is disposed, the automated analyzer further comprising a processing plate support assembly disposed in the opening above the magnetic extractor.

8. The automated analyzer of claim 7, wherein a machine readable label is placed on each of the first location, the second location, the third location, or the fourth location.

9. The automated analyzer of claim 8, wherein a machine readable label is placed in a fifth position, wherein the fifth position is between the fourth position and the opening under which the magnetic extractor is disposed.

10. The automated analyzer of claim 9, wherein the machine readable label placed in the fifth position is covered by the process plate support assembly when the process plate support assembly is placed over the opening.

11. The automated analyzer of claim 10, wherein the process plate support assembly comprises a cutout configured to receive a structure extending from a bottom of the process plate consumable, the structure comprising a plurality of extraction tubes, mixing holes, and pipette tip holding stations.

12. The automated analyzer of claim 11, wherein the process plate support assembly comprises at least two tapered cutouts on a surface thereof.

13. The automated analyzer of claim 12, wherein the tapered cutout is configured to receive an engagement feature from an end effector.

14. The automated analyzer of any of claims 7-12, wherein the process plate support assembly has at least one machine readable label placed on a top surface thereof, and the process plate consumable is placed over the at least one machine readable label when the process plate consumable is present on the process plate support assembly.

15. An automated analyzer, the automated analyzer comprising:

a housing; and

a consumable holder disposed within the housing, the consumable holder comprising:

a base;

a plurality of columns extending upward from the base;

a plurality of support structures connected to the plurality of columns, each of the plurality of support structures disposed in a compartment for receiving one of a plurality of consumables therein, the consumables having at least a first type and a second type, each support structure including a first arm and a second arm, each of the first arm and the second arm extending between a first end and a second end thereof; and

wherein each of the first and second arms includes a tab at the second end of each of the first and second arms to retain the consumable within the compartment.

16. The automated analyzer of claim 15, wherein the consumable storage is positioned below a processing platform.

17. The automated analyzer of claim 15 or 16, wherein the one of the first arm and the second arm includes a flange that is received within a complementary groove on the consumable when the consumable is properly placed in the compartment.

18. The automated analyzer of claim 17, wherein the flange has a first size and placement in a compartment receiving the first type of consumable and the flange has a second size and placement in a compartment receiving the second type of consumable such that each compartment is configured to receive only one type of consumable.

19. The automated analyzer of claim 18, wherein the compartment receiving the first type of consumable has a planar surface on which the consumable is supported and the compartment receiving the second type of consumable has a flange that supports a skirt of the second type of consumable.

20. The automated analyzer of claim 19, wherein the first type of consumable and the second type of consumable are reagent plates, and the first type of consumable is a dry reagent plate, and the second type of consumable is a liquid reagent plate.

21. The automated analyzer of claim 19 or 20, wherein the compartment receiving the first type of consumable comprises an offset that receives a portion of a frame of the first type of consumable.

22. The automated analyzer of claim 16, wherein the processing platform further comprises at least one processing module, the at least one processing module comprising:

a first location for receiving a consumable of dry reagent,

a second position for receiving a consumable of liquid reagent,

a third location for receiving at least one process plate consumable,

a fourth position for receiving the amplification cassette consumable; and

a plurality of machine-readable labels placed on at least one of each of the first location, the second location, the third location, and the fourth location for scanning and reading by a scanner of an inventory robot to detect the presence of the consumable on the processing module for controlling inventory of the processing platform.

23. An automated analyzer, the automated analyzer comprising:

a robot comprising an end effector having two or more downwardly extending columns;

A cutout or slot for each post, wherein the cross-sectional area of each post is less than the cross-sectional area of each corresponding cutout or slot, and wherein each cutout or slot includes at least one corner; and

one or more processors configured to calibrate the robot at least in part by:

controlling the robot to position each post of the end effector over the corresponding cutout or slot;

controlling the robot to lower the end effector until each post extends at least partially through the corresponding cutout or slot;

controlling the robot to move each column closer together or farther apart until each column contacts the at least one corner of each corresponding cutout or slot; and

the position of the end effector is stored in memory as each post contacts the at least one corner of each cutout or notch.

24. The automated analyzer of claim 23, wherein each cutout or slot is positioned at a location where the robot is configured to retrieve or store one or more consumables.

25. The automated analyzer of claim 24, wherein each cutout or slot is provided in a teaching tool.

26. The automated analyzer of any of claims 23-25, wherein the end effector further comprises two or more fingers, and wherein each finger comprises at least one of the two or more posts.

27. The automated analyzer of claim 26, wherein the one or more processors are further configured to calibrate the robot at least in part by storing a position of each finger in memory as each post contacts the at least one corner of each corresponding cutout or slot.

28. The automated analyzer of claim 26, wherein each post is removably coupled to a corresponding finger of the end effector.

29. The automated analyzer of claim 28, wherein each column is coupled to a teaching tool held by the end effector of the robot.

30. The automated analyzer of claim 29, wherein at least one cutout or notch is triangular, heart-shaped, or tear-drop-shaped.

31. The automated analyzer of claim 30, wherein edges on both sides of the at least one corner of at least one cutout are straight.

32. The automated analyzer of claim 31, wherein edges on both sides of the at least one corner of at least one cutout are curved.

33. The automated analyzer of claim 32, wherein an angle between edges on both sides of the at least one corner of at least one cutout is between 85 degrees and 95 degrees.

34. The automated analyzer of claim 33, wherein at least one column includes an engagement feature sized to engage a corresponding notch in the consumable.

35. An automated analyzer, the automated analyzer comprising:

a housing comprising a sidewall and a door, wherein the door is hingedly coupled to the sidewall of the housing;

a consumable storage comprising a side panel and one or more storage compartments extending from the side panel;

one or more drawer slides coupling the side panels of the consumable storage to the side walls of the housing such that the consumable storage can be pulled out of or pushed into the housing when the door is open;

A rail coupled to the side panel of the consumable storage, wherein the rail includes an angled portion;

a stopper hingedly coupled to the side wall of the housing, wherein the stopper is further coupled to a support configured to slide along the track when the consumable reservoir is pulled out of or pushed into the housing, and wherein the stopper moves between a first position in which the door is prevented from closing and a second position in which the door is allowed to close when the support slides along the track.

36. The automated analyzer of claim 35, wherein the stop moves to the first position when the consumable reservoir is pulled out of the housing, and wherein the stop moves to the second position when the consumable reservoir is pushed into the housing.

37. The automated analyzer of claim 35 or 36, wherein the support contacts the sloped portion of the rail when the stop is in the second position.

38. The automated analyzer of claim 37, wherein the rail further comprises a horizontal portion, and wherein the support contacts the horizontal portion when the stop is in the first position.

39. The automated analyzer of claim 38, wherein the stop is a member of a hinge coupled to the side wall of the housing.

40. The automated analyzer of claim 39, further comprising a hinge coupled to the side wall of the housing, wherein the stop is coupled to a member of the hinge through the support.

41. The automated analyzer of any of claims 39-40, further comprising a torsion spring disposed within the hinge, wherein the torsion spring provides a downward force on the support as the support slides along the track.