Point-of-care medical diagnostic analyzer, and devices, systems, and methods for medical diagnostic analysis of samples

Abstract

To automatically perform a blood analyzing operation.SOLUTION: An analyzer includes: a sample probe and a dilution probe; a mixing housing including first and second mixing chambers; a flow cytometer including a flow cell; and sample and sheath pumps configured to perform first and second pluralities of tasks, respectively. The first plurality of tasks includes: aspirating sample into the sample probe; dispensing sample from the sample probe into the first and second mixing chambers; delivering a mixture of a first sample and diluent to the flow cell; and delivering a mixture of a second sample and diluent to the flow cell. The second plurality of tasks includes: dispensing sheath fluid to the flow cell in cooperation with the delivery of the mixture of the first sample and diluent to the flow cell; and dispensing sheath fluid to the flow cell in cooperation with the delivery of the mixture of the second sample and diluent to the flow cell.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 050,129, filed July 10, 2020, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to medical diagnostics, and more particularly to point-of-care medical diagnostic analyzers, as well as devices, systems, and methods for medical diagnostic analysis of samples. [Background technology]

[0003] Medical guidance for many medical diagnostic systems, such as hematology analyzers, recommends analyzing samples as soon as possible after collection. This recommendation can be difficult to follow when samples are obtained at the point of care but testing is performed externally or in a remote laboratory. Therefore, many physicians and veterinarians choose to use point-of-care medical diagnostic analyzers to analyze fresh samples.

[0004] Point-of-care medical diagnostic analyzers, such as hematology analyzers, may use flow cytometry to determine the cellular content of a blood sample. Blood cell measurements performed using flow cytometry often require at least two separate measurements: one for red blood cells ("RBCs") and platelets, and one for white blood cells ("WBCs").

[0005] Hematology analyzers often automatically dilute whole blood samples in at least two steps, performed serially or in parallel, to prepare the sample for delivery to a flow cytometer. Whether performed serially or in parallel, a minimum of two reaction chambers are used. One chamber may be used for RBCs and the other for WBCs. Some analyzers use additional chambers, for example, to perform an analysis of hemoglobin concentration. Each of these reaction chambers in such hematology analyzers is typically housed within the instrument and must be rinsed between sample runs to prevent sample carryover.

[0006] As can be appreciated, multiple fluid-handling components are required for hematology analyzers to perform the necessary tasks within the reaction chamber, deliver the sample to the flow cytometer, and rinse the fluid paths between sample runs. These components include, for example, pumps for moving diluents and / or wash solutions around the system, pumps for removing fluids from the reaction chamber, valves for controlling fluid movement, metering devices for accurately dispensing sample and reagents into the reaction chamber, and tubing for connecting all of the fluid-handling components. Thus, hematology analyzers are complex instruments with many cooperating systems and components. Summary of the Invention

[0007] To the extent consistent, any of the aspects and features detailed herein may be used with or without any of the other aspects and features detailed herein, regardless of whether such aspects and features are listed collectively or individually below. Furthermore, reference to any specific numerical value herein is understood to encompass a range of values ​​taking into account material and manufacturing tolerances generally accepted in the art and / or error ranges of measuring equipment generally accepted in the art.

[0008] According to an aspect of the present disclosure, there is provided an analyzer including an inner chassis, a housing surrounding the inner chassis, a sample probe operably coupled to the inner chassis within the housing and movable relative to the housing, a diluent probe operably coupled to the inner chassis within the housing and movable relative to the housing, a mixing housing supported within the housing by the inner chassis and defining first and second mixing chambers, each configured to receive a diluent, and a flow cytometer supported within the housing by the inner chassis and including a flow cell, a sample pump, and a sheath pump. The sample pump is disposed within the housing and configured to perform a first plurality of tasks, including aspirating a sample into the sample probe, dispensing the sample from the sample probe into the first mixing chamber, dispensing the sample from the sample probe into the second mixing chamber, delivering a mixture of the first sample and diluent to the flow cell, and delivering a mixture of the second sample and diluent to the flow cell. The sheath pump is disposed within the housing and configured to perform a second plurality of tasks, including dispensing sheath fluid into the flow cell in cooperation with delivering a mixture of the first sample and diluent to the flow cell, and dispensing sheath fluid into the flow cell in cooperation with delivering a mixture of the second sample and diluent to the flow cell.

[0009] In one aspect of the disclosure, the analyzer further includes a carrier supporting the sample probe and the diluent probe in a fixed orientation relative to one another, the carrier being operably coupled to the inner chassis within the housing and movable relative to the housing to operably position the sample probe and the diluent probe to effectuate at least some of the first and second plurality of tasks.

[0010] In another aspect of the present disclosure, a robotic assembly is provided configured to position a sample probe and a diluent probe to effectuate at least some of the first and second plurality of tasks by manipulating the carrier in a y-direction and a z-direction relative to the inner chassis. The robotic assembly, in some aspects, can include y-axis and z-axis potentiometers configured to enable feedback-based control of the movement of the carrier in the y-direction and the z-direction, respectively.

[0011] In yet another aspect of the present disclosure, the analyzer further includes first and second dilution pumps disposed within the housing and configured to deliver diluent to the first and second mixing chambers, respectively.

[0012] In yet another aspect of the present disclosure, the analyzer further includes a peristaltic pump configured to perform a third plurality of tasks, including aspirating a mixture of the first sample and diluent from the first mixing chamber to the diluent probe, aspirating a mixture of the second sample and diluent from the second mixing chamber to the diluent probe, aspirating a mixture of the first sample and diluent through the diluent probe in preparation for delivery to the flow cell, aspirating a mixture of the second sample and diluent through the diluent probe in preparation for delivery to the flow cell, aspirating residual fluid in the first mixing chamber to waste, and aspirating residual fluid in the second mixing chamber to waste.

[0013] In yet another aspect of the present disclosure, the second plurality of tasks further includes dispensing sheath fluid into the first mixing chamber to clean the first mixing chamber, and dispensing sheath fluid into the second mixing chamber to clean the second mixing chamber.

[0014] In another aspect of the present disclosure, the mixing housing further defines a cleaning chamber, and the second plurality of tasks further includes dispensing sheath fluid into the cleaning chamber to clean a portion of the sample probe disposed in the cleaning chamber. The mixing housing additionally or alternatively defines a clearance cavity configured to receive the other of the sample probe or the diluent probe when the other of the sample probe or the diluent probe is inserted into one of the first or second mixing chambers.

[0015] In yet another aspect of the present disclosure, the analyzer further includes a hemoglobin assembly disposed in parallel with the flow cell.

[0016] In yet another aspect of the present disclosure, the analyzer includes a door that provides selective access from the outer housing to the inner chassis for selective insertion and removal of at least one pack containing reagent fluids and sheath fluid.

[0017] In another aspect of the present disclosure, the analyzer includes a drawer that provides selective access from the outer housing to the inner chassis for selective insertion and removal of sample tubes containing samples.

[0018] In yet another aspect of the present disclosure, the analyzer further includes a fluidic capacitor-filter-resistor circuit disposed in the sheath flow line such that sheath fluid dispensed into the flow cell passes through the fluidic capacitor-filter-resistor circuit.

[0019] Another analyzer provided according to an embodiment of the present disclosure includes an inner chassis, a housing surrounding the inner chassis, a drawer including a sample tube receptacle configured to hold a sample tube therein, a shoer assembly, and a robot assembly. The drawer is disposed within the housing and is at least partially removable from the housing. The shoer assembly is disposed within the housing and includes a shoer body, the shoer body defining a cam surface and having a sample tube retainer. The shoer body is pivotally coupled to the inner chassis and is pivotable relative to the inner chassis between a storage position and a use position. The robot assembly is mounted on the inner chassis and includes a stationary frame, a y-axis body operably coupled to the stationary frame and movable in a y-direction relative to the stationary frame, and a carrier operably coupled to the y-axis body. The y-axis body includes legs extending from the y-axis body, with feet defined at free ends of the legs. The carrier is movable in the y-direction with the y-axis body and movable in the z-direction relative to the y-axis body along the legs of the y-axis body. Movement of the y-axis body in the y-direction toward vertical alignment with a sample tube held in the sample receptacle urges the foot into contact with the cam surface, which pivots the shoe body from a storage position to a use position, and the sample tube retainer clamps and centers the sample tube relative to the sample tube retainer.

[0020] In one aspect of the present disclosure, the carrier is configured to support a sample probe therein and move the sample probe in a y-direction into vertical alignment with the sample tube and move the sample probe in a z-direction into the sample tube to aspirate sample therefrom. The carrier may further support a diluent probe in a fixed orientation relative to the sample probe.

[0021] In another aspect of the present disclosure, the robot assembly further includes y-axis and z-axis potentiometers configured to enable feedback-based control of the carrier's movement in the y- and z-directions, respectively.

[0022] In yet another aspect of the present disclosure, the robot assembly further includes a y-axis lead screw motor assembly including a motor, a lead screw operably coupled to the motor, and a nut threadably engaged about the lead screw. The nut engages with the y-axis body such that actuation of the motor rotates the lead screw to translate the nut and the y-axis body in the y-direction. Additionally or alternatively, the robot assembly further includes a z-axis lead screw motor assembly including a motor, a lead screw operably coupled to the motor, and a nut threadably engaged about the lead screw. The nut engages with the carrier such that actuation of the motor rotates the lead screw to translate the carrier in the z-direction.

[0023] In yet another aspect of the present disclosure, the analyzer further includes a camera configured to recognize a type of sample tube held in the sample tube receptacle, and the robotic assembly is configured to control at least one of the y-direction movement or the z-direction movement based on the identified sample tube type.

[0024] According to the present disclosure, there is provided a filter holder-ejector system for use with an analyzer or other suitable device, comprising a base, a bottom cup, a top cap, and a handle. The base defines an upper end, a lower end, a front side, and a rear side and is configured to receive a filter having a filter body, an inlet fitting, and an outlet fitting. The bottom cup is disposed at the lower end of the base, defines an outlet, and includes a first gasket disposed therein. The bottom cup is configured to receive at least a portion of the outlet fitting of the filter. The top cap is movably supported toward the upper end of the base, defines an inlet, and includes a second gasket disposed therein. The handle is pivotally coupled to the base and operably coupled to the top cap. The handle is pivotable relative to the base from a neutral position to an engaged position to bias the top cap around at least a portion of the filter inlet fitting such that the first gasket establishes a seal around the interface between the filter outlet fitting and the outlet of the bottom cup, and the second gasket establishes a seal around the interface between the filter inlet fitting and the inlet of the top cap.

[0025] In one embodiment of the present disclosure, the filter holder-ejector system further includes a clip disposed between the upper and lower ends of the base and extending from the front side of the base. The clip is configured to internally engage with the body of the filter. In this embodiment, a rear bracket may be provided pivotally coupled to the rear side of the base about the pivot axis. The rear bracket includes at least one foot positioned to extend through a window defined in the base upon pivotal movement of the rear bracket about the pivot axis relative to the base. The at least one foot is configured to contact the body of the filter and disengage from the clip when the at least one foot extends through the window.

[0026] In another aspect of the present disclosure, the rear bracket further includes at least one cam lobe positioned on an opposite side of the pivot relative to the at least one foot such that the at least one foot extends through the window in response to an opposing bias of the at least one cam lobe.

[0027] In yet another aspect of the present disclosure, the handle is operatively disposed relative to the at least one cam lobe and is further pivotable from a neutral position to an eject position, wherein movement of the handle from the neutral position to the eject position urges the at least one cam lobe in an opposing direction, thereby pivoting the rear bracket such that the at least one foot extends through the window.

[0028] In yet another aspect of the present disclosure, the handle is coupled to the top cap via at least one linkage.

[0029] A hemoglobin detection cell for use in determining hemoglobin concentration in a blood sample, for example, within an analyzer, a separate device, or independently, is also provided according to an aspect of the present disclosure. The hemoglobin detection cell includes first and second pieces, each including a body, a cutout, a block, and a fitting. The body defines an upper surface and has a first end and a second end. A channel extends along the upper surface. The cutout is defined within the body at the first end, while the block is complementary to the cutout and is disposed on the upper surface of the body at the second end. The block defines a channel that cooperates with a portion of the channel in the body to define an enclosed lumen segment. The fitting extends from an end surface of the body at the second end and defines an internal passageway in communication with the enclosed lumen segment. The second piece is inverted, turned over, and placed on the first piece so that their top surfaces abut each other, the cutouts receive the blocks to define a generally rectangular body, and a continuous lumen extends between the interior passages of the fitting.

[0030] In one aspect of the present disclosure, the first and second pieces are secured together, for example, by laser welding.

[0031] In another aspect of the present disclosure, the first and second pieces are formed from plastic, for example, acrylic.

[0032] In yet another aspect of the present disclosure, the cutout and the block define complementary angled surfaces.

[0033] The analyzer debris trap includes a first disk body, a second disk body, and a filter screen. The first disk body includes an inlet fitting, defines a first cavity, and includes a first annular surface surrounding the first cavity. The first cavity defines an at least partially angled floor such that the depth of the first cavity decreases diametrically from a first position adjacent the inlet fitting to a second position remote from the inlet fitting. The second disk body engages the first disk body to define a disk housing, includes an outlet fitting and an inlet fitting, defines a second cavity, and includes a second annular surface surrounding the second cavity. The filter screen is disposed between the first disk body and the second disk body, separating the first cavity from the second cavity.

[0034] In one aspect of the present disclosure, the first and second disc bodies are configured to mutually engage an annular periphery of a filter screen held between the first annular surface of the first disc body and the second annular surface of the second disc body, respectively.

[0035] In another aspect of the present disclosure, the first and second disc bodies are secured together by ultrasonic welding.

[0036] In yet another aspect of the present disclosure, the inlet and outlet fittings are positioned in substantially diametrically opposed positions relative to the disc housing.

[0037] In yet another aspect of the disclosure, the second cavity defines a substantially uniform depth diametrically from a third location adjacent the outlet fitting to a fourth location remote from the outlet fitting.

[0038] A coupling for coupling a tube to a fitting, for example, in an analyzer, is provided in accordance with the present disclosure. The coupling comprises a body including first and second open ends and a lumen extending between the first and second open ends. The lumen tapers in diameter from the second open end of the body inwardly to a first interior location within the body, and from the second open end of the body inwardly to a second interior location within the body. The taper of the lumen is configured to facilitate press-fit engagement of one of the tube or the fitting into the lumen from the first and second open ends of the body.

[0039] In one aspect of the present disclosure, the body further includes a first flared end surrounding the lumen at the first open end configured to facilitate insertion and centering of one of the tube or fitting into the lumen. Additionally or alternatively, the body further includes a second flared end surrounding the lumen at the second open end configured to facilitate insertion and centering of one of the tube or fitting into the lumen.

[0040] In another aspect of the present disclosure, the body defines an elbow and the internal lumen substantially conforms to the elbow. Alternatively, the body extends substantially linearly.

[0041] Another analyzer provided in accordance with the present disclosure includes an inner chassis, a housing surrounding the inner chassis, a sample tube receptacle positionable within the housing and configured to hold a sample tube therein, and a robot assembly mounted on the inner chassis. The robot assembly includes a stationary frame, a y-axis body operably coupled to the stationary frame and movable in a y-direction relative to the stationary frame, and a carrier operably coupled to the y-axis body. The carrier is movable in the y-direction together with the y-axis body and supports a sample probe and a diluent probe in fixed positions and orientations relative to each other.

[0042] In one aspect of the present disclosure, the y-body includes legs extending from the y-body, and the carrier is movable in the z-direction relative to the y-body along the legs of the y-body.

[0043] In another aspect of the present disclosure, the carrier is configured to move in the y direction to vertically align the sample probe with the sample tube and move in the z direction to move the sample probe into the sample tube and aspirate the sample therefrom.

[0044] In yet another aspect of the present disclosure, an analyzer includes a plurality of mixing chambers disposed within a housing and mounted on an inner chassis. In a first action, the carrier is configured to move a sample probe in a y direction to vertically align it with one of the mixing chambers and move in a z direction to move the sample probe into one of the mixing chambers. In a second action, the carrier is configured to move a diluent probe in the y direction to vertically align it with one of the mixing chambers and move in the z direction to move the diluent probe into one of the mixing chambers.

[0045] In yet another aspect of the present disclosure, the robot assembly further includes at least one of a y-axis potentiometer or a z-axis potentiometer configured to enable feedback-based control of movement of the carrier in the y-direction or z-direction, respectively.

[0046] In yet another aspect of the present disclosure, the analyzer further includes at least one of a y-axis lead screw motor assembly configured to move the carrier in a y-direction or a z-axis lead screw motor assembly configured to move the carrier in a z-direction.

[0047] Various aspects and features of the disclosure are described below with reference to the drawings. [Brief explanation of the drawings]

[0048] [Figure 1] FIG. 1 is a front perspective view of a hematology analyzer provided in accordance with the present disclosure. [Figure 2] FIG. 2 is a rear perspective view of the hematology analyzer of FIG. 1. [Figure 3] FIG. 2 is a front perspective view of the hematology analyzer of FIG. 1 with the outer housing removed. [Figure 4] FIG. 2 is a rear perspective view of the hematology analyzer of FIG. 1 with the outer housing removed. [Figure 5] FIG. 2 is a side perspective view of the hematology analyzer of FIG. 1 with the outer housing and sheath fluid and waste pack removed. [Figure 6] FIG. 2 is a schematic diagram of the fluidics system of the hematology analyzer of FIG. 1. [Figure 7] FIG. 2 is a first side perspective view of the syringe pump, peristaltic pump, mixing assembly, and associated tubing of the hematology analyzer of FIG. 1. [Figure 8] FIG. 2 is a second side perspective view of the syringe pump, peristaltic pump, mixing assembly, and associated tubing of the hematology analyzer of FIG. 1. [Figure 9] 8 is an enlarged perspective view of a portion of the syringe pump of FIG. 7 illustrating the couplings connecting associated tubing with the syringe pump. [Figure 10] 1 is a perspective view of a tube with different types of fittings attached to both ends. FIG. [Figure 11] FIG. 1 is a perspective view of a tube with similar fittings attached to both ends. [Figure 12] FIG. 12 is a cross-sectional view taken along the line "12-12" in FIG. [Figure 13A] FIG. 2 is a top perspective view of the robotic assembly of the hematology analyzer of FIG. 1. [Figure 13B] FIG. 13B is a bottom perspective view of the robot assembly of FIG. 13A. [Figure 14A] 13B is a perspective view of a portion of the hematology analyzer of FIG. 1 with the outer housing removed, illustrating the robot assembly of FIG. 13A in a first position with its shoer body disposed in a storage position. FIG. [Figure 14B] 13B is a perspective view of a portion of the hematology analyzer of FIG. 1 with the robotic assembly of FIG. 13A in a second position and the sucker body in a use position. [Figure 15] FIG. 13B is an exploded perspective view of the robot assembly of FIG. 13A. [Figure 16] FIG. 2 is a front perspective view of one of the syringe pumps of the hematology analyzer of FIG. 1. [Figure 17] FIG. 2 is a side perspective view of one of the syringe pumps of the hematology analyzer of FIG. 1. [Figure 18] FIG. 18 is an exploded perspective view of the syringe pump of FIGS. 16 and 17. [Figure 19] 2 is an enlarged exterior perspective view of a portion of the hematology analyzer of FIG. 1 illustrating the debris trap of the analyzer. [Figure 20] 2 is an enlarged interior perspective view of a portion of the hematology analyzer of FIG. 1 illustrating the debris trap of the analyzer. [Figure 21] FIG. 21 is a front perspective view of the debris trap of FIGS. 19 and 20. [Figure 22] FIG. 21 is a rear perspective view of the debris trap of FIGS. 19 and 20. [Figure 23] FIG. 21 is an exploded perspective view of the debris trap of FIGS. 19 and 20. [Figure 24] FIG. 24 is a cross-sectional view taken along the section line "24-24" in FIG. 22. [Figure 25] 2 is an enlarged perspective view of a portion of the hematology analyzer of FIG. 1 illustrating the hemoglobin detection cell of the analyzer. [Figure 26] FIG. 26 is an exploded perspective view of the hemoglobin detection cell of FIG. 25. [Figure 27] FIG. 26 is a perspective view of the hemoglobin detection cell of FIG. 25. [Figure 28A] FIG. 2 is a perspective view of the filter holder-ejector assembly of the hematology analyzer of FIG. 1. [Figure 28B] FIG. 28B is an exploded perspective view of the filter holder-ejector assembly of FIG. 28A. [Figure 29A] 28B is a perspective view illustrating the insertion and engagement of a filter in the filter holder-ejector assembly of FIG. 28A. [Figure 29B] 28B is a perspective view illustrating the insertion and engagement of a filter in the filter holder-ejector assembly of FIG. 28A. [Figure 29C] 28B is a perspective view illustrating the insertion and engagement of a filter in the filter holder-ejector assembly of FIG. 28A. [Figure 29D] 28B is a perspective view illustrating the insertion and engagement of a filter in the filter holder-ejector assembly of FIG. 28A. [Figure 30] FIG. 2 is a front perspective view of a mixing assembly of the hematology analyzer of FIG. 1. [Figure 31] FIG. 2 is a rear perspective view of the mixing assembly of the hematology analyzer of FIG. 1. [Figure 32] FIG. 32 is an exploded perspective view of the mixing assembly of FIGS. 30 and 31. DETAILED DESCRIPTION OF THE INVENTION

[0049] The present disclosure relates to point-of-care medical diagnostic analyzers, as well as devices, systems, and methods for the medical diagnostic analysis of samples. Although aspects and features of the present disclosure are described in detail herein with respect to hematology analysis of blood samples, e.g., hematology analyzers including flow cytometers for testing samples of human or animal blood, the aspects and features of the present disclosure are equally applicable with other suitable analyzers, devices, systems, and methods, and for use with other diagnostic tools in place of or in addition to flow cytometers.

[0050] 1-8 , a hematology analyzer incorporating a flow cytometer provided in accordance with the present disclosure is shown, generally identified by the reference numeral 10. The analyzer 10 includes an outer housing 12 and an inner chassis 14, which cooperate to enclose and support the internal working components of the analyzer 10. A door 20, hinged or otherwise operably coupled to the inner chassis 14, provides selective access to the interior of the outer housing 12 to allow insertion and removal of a sheath fluid and waste pack 30, a reagent pack 40, and a filter 50 therein. Any suitable sheath fluid and waste pack 30 and reagent pack 40 may be used, such as those detailed in patent application publication number US2019 / 0299213, entitled “POINT-OF-CARE DIAGNOSTIC SYSTEMS AND CONTAINERS FOR SAME,” filed March 30, 2018, the entire contents of which are incorporated herein by reference. A drawer 60, slidably or otherwise operably coupled to the inner chassis 14, includes first and second receptacles 62, 64 selectively accessible by opening the drawer 60 to allow for the insertion and removal of sample tubes 70 and on-board control tubes 80 (see FIG. 14B). The first receptacle 62 is configured as a universal receptacle capable of holding multiple different types of sample tubes therein, e.g., 20 or more different types of sample tubes, both capped and uncapped (see FIG. 14B). Multiple ports, such as a power port 92, a data port 94, and a peripheral port 96, are accessible from the exterior of the outer housing 12 to allow for the connection of a power cord, an Ethernet cable, and a peripheral cable to the analyzer 10, respectively.

[0051] The internal working components of analyzer 10 include robot assembly 100, four syringe pumps 210-240, mixing assembly 300, peristaltic pump 400, debris trap 500, hemoglobin assembly 600, filter holder and ejector assembly 700, and flow cytometer assembly 800. Analyzer 10 also includes various tubing, valves, and associated connections that fluidly couple the above-described internal working components to one another so as to selectively establish various fluid pathways, as described in detail below, sheath fluid and waste pack 30, reagent pack 40, filter 50, sample tubing 70 (FIG. 14B), and / or on-board control tubing 80 (FIG. 14B). Additionally, various sensors, other electrical hardware, electrical connectors, and circuit boards are provided for controlling the operation and functionality of analyzer 10, as also described in detail below.

[0052] The robotic assembly 100 defines a dual-probe configuration in which the carrier 102 engages the sample probe 110 and the diluent probe 120 in a fixed, spaced-apart orientation. When a sample run is initiated, the robotic assembly 100 is configured to manipulate the sample probe 110 to aspirate the sample from the sample tube 70, deposit a first portion of the sample into the WBC chamber 310 of the mixing assembly 300, deposit a second portion of the sample into the RBC chamber 320 of the mixing assembly 300, and dip the sample probe 110 into the cleaning chamber 330 of the mixing assembly 300. When a control run is initiated, the robotic assembly 100 is configured to operate the sample probe 110 to aspirate a control sample from the on-board control tube 80, deposit a first portion of the control sample into the WBC chamber 310 of the mixing assembly 300, deposit a second portion of the control sample into the RBC chamber 320 of the mixing assembly 300, and immerse the sample probe 110 into the cleaning chamber 330 of the mixing assembly 300. The robotic assembly 100 is further configured to operate the diluent probe 120 to immerse the diluent probe 110 into the cleaning chamber 330 of the mixing assembly 300. The robotic assembly 100 is described in more detail below.

[0053] 1-8 generally, and with further reference to FIG. 6, the four syringe pumps include a sample syringe pump 210, a WBC reagent syringe pump 220, an RBC reagent syringe pump 230, and a sheath syringe pump 240. Sample syringe pump 210 is operably coupled to sample probe 110 and, more particularly, is configured to provide suction through sample probe 110 to draw a sample from sample tubing 70 (FIG. 14B) (or a control sample from on-board control tubing 80 (FIG. 14B)) into sample probe 110, to force first and second portions of the sample into WBC chamber 310 and RBC chamber 320, respectively, of mixing assembly 300, and to provide pressure through sample probe 110 to deliver the sample and reagent mixture to flow cell 810 of flow cytometer assembly 800. The WBC and RBC reagent syringe pumps 220, 230 are coupled between the reagent pack 40 and the WBC and RBC chambers 310, 320, respectively, of the mixing assembly 300. More specifically, the WBC and RBC reagent syringe pumps 220, 230 are configured to provide suction to draw reagent from the reagent pack 40 and to provide pressure to force the reagent into the WBC and RBC chambers 310, 320, respectively, of the mixing assembly 300. The sheath syringe pump 240 is operably coupled to the sheath fluid and waste pack 30, the sample probe 110, and the flow cell 810 of the flow cytometer assembly 800. More specifically, sheath syringe pump 240 is configured to provide suction to draw sheath fluid from sheath fluid and waste pack 30, provide pressure to deliver sheath fluid to flow cell 810 of flow cytometer assembly 800, and provide pressure to deliver sheath fluid into cleaning chamber 330 of mixing assembly 300. Syringe pumps 210-240 are described in more detail below.

[0054] The mixing assembly 300 of the analyzer 10 includes a multi-chamber mixing housing 302 that defines a WBC chamber 310, an RBC chamber 320, and a cleaning chamber 330, as previously described. The multi-chamber mixing housing 302 further defines a clearance cavity 340 disposed relative to the WBC chamber 310, the RBC chamber 320, and the cleaning chamber 330 to allow operable interfacing of the sample probe 110 and the diluent probe 120 with one or more of the chambers 310, 320, 330 without interference from the other probes 110, 120 with the multi-chamber mixing housing 302. The WBC and RBC reagent syringe pumps 220, 230 are mounted as part of the mixing assembly 300, although other configurations are contemplated. The mixing assembly 300 is described in more detail below.

[0055] The peristaltic pump 400 is operably coupled to the mixing assembly 300, the sheath fluid and waste pack 30, the flow cell 810 of the flow cytometer assembly 800, and the diluent probe 120. The peristaltic pump 400 is more particularly configured to draw fluid from the system and into the sheath fluid and waste pack 30. More particularly, for example, the peristaltic pump 400 is configured to aspirate the WBC chamber 310, the RBC chamber 320, and the cleaning chamber 330 of the mixing assembly 300 to expel waste fluid into the sheath fluid and waste pack 30, and to draw the sample and reagent mixture from the WBC chamber 310 and the RBC chamber 320 through the diluent probe 120 for delivery to the flow cell 810 of the flow cytometer assembly 800 (via the sample syringe pump 210).

[0056] A debris trap 500 of the analyzer 10 is positioned in the fluid path between the cleaning chamber 330 of the mixing assembly 300 and the sheath fluid and waste pack 30 to capture debris washed out of the cleaning chamber 330 as waste fluid from the cleaning chamber 330 is pumped into the sheath fluid and waste pack 30. The debris trap 500 does not require replacement over the life of the analyzer 10, but rather is configured to capture debris over the life of the analyzer 10. The debris trap 500 is described in more detail below.

[0057] With continued reference to FIGS. 1-8 and further reference to FIG. 25, a hemoglobin assembly 600 is mounted as part of a flow cytometer assembly 800, which may be mounted as part of another assembly or may be mounted separately. The hemoglobin assembly 600 is positioned in parallel with a flow cell 810 of the flow cytometer assembly 800. The hemoglobin assembly 600 includes a hemoglobin detection cell 610, a light source (not shown), and a sensor (not shown). The hemoglobin detection cell 610 is operably coupled to the WBC chamber 310 of the mixing assembly 300 and the peristaltic pump 400 so as to draw the sample from the WBC chamber 310 through the diluent probe 120, into the hemoglobin detection cell 610, and ultimately into the sheath fluid and waste pack 30. Pulling a slug of sample, e.g., lysed whole blood, through the hemoglobin detection cell 610 releases hemoglobin from the red blood cells. The lysed whole blood slug passes through the hemoglobin detection cell 610, where a light source and sensor can measure the absorption at one or more distinct wavelengths of light to determine the hemoglobin concentration in the sample. The hemoglobin assembly 600 is described in more detail below.

[0058] 1-8 , filter holder and ejector assembly 700 removably holds filter 50 therein. With filter 50 engaged within filter holder and ejector assembly 700, filter 50 is operably coupled between sheath syringe pump 240 and flow cell 810 of flow cytometer assembly 800. Filter 50, along with fluidic capacitor 732 and fluidic register 734, form fluidic capacitor-filter-register circuit 730 through which sheath fluid passes. This circuit 730 controls the flow of sheath fluid surrounding the sample core stream as it passes through flow cell 810, thereby facilitating the establishment of the core stream. Filter holder and ejector assembly 700 is described in further detail below.

[0059] Flow cytometer assembly 800 includes a flow cell 810 configured to facilitate the flow of a sample core stream and surrounding sheath fluid, as described above. Flow cytometer assembly 800 further includes a mounting platform 820 to which a laser optics assembly (not shown), flow cell 810, and a forward scatter / side scatter sensor assembly (not shown) are mounted, and an outer cover 830 disposed on mounting platform 820 and enclosing the laser optics assembly, flow cell 810, and forward scatter / side scatter sensor assembly. Any suitable flow cytometer assembly 800 may be used, such as the flow cytometer detailed in Patent Application Publication No. US2019 / 0302391, filed March 28, 2019, entitled "FLOW CYTOMETER, LASER OPTICS ASSEMBLY THEREOF, AND METHODS OF ASSEMBLING THE SAME," the entire contents of which are incorporated herein by reference.

[0060] With particular reference to FIG. 6, as previously described, the various tubing, valves, and associated connections fluidly coupling the internal working components of the analyzer 10 to one another, the sheath fluid and waste pack 30, the reagent pack 40, the filter 50, the sample tubing 70, and / or the on-board control tubing 80, allow for the selective establishment of various fluid pathways. With regard to the valves (which may be electrically controlled solenoid valves or other suitable valves) disposed in the various fluid lines, more particularly, a sample vent valve 902 is disposed in the sample probe line between the sample probe 110 and the sample syringe pump 210, a sample flow cell valve 904 is disposed in the sample probe line between the sample syringe pump 210 and the sample vent valve 902, a diluent valve 906 is disposed in the diluent probe line between the diluent probe 120, the sample syringe pump 210 and the flow cell 810, a flow cell valve 908 is disposed in the branch of the sample line that branches the flow cell 810 and the hemoglobin assembly 600, and WBC and RBC mixing valves 910, 912 are disposed in the outlets of the WBC and RBC reagent syringe pumps 220, 230, respectively. , WBC and RBC clean valves 914, 916 are located at the outlets of WBC and RBC chambers 310, 320 and in the drain line from cleaning chamber 330, respectively, hemoglobin clean valve 918 is connected to the outflow hemoglobin line, sample clean valve 920 is located in the fluid line connecting sample syringe pump 210 with clean chamber 330, flow cell clean valve 922 is located in the output line of sheath syringe pump 240 at the junction of the fluid line to flow cell 810 and the fluid line to cleaning chamber 330, sheath flow cell valve 924 is located at the outlet of sheath syringe pump 240, and sheath hemoglobin valve 926 is located between sheath syringe pump 240 and hemoglobin assembly 600. The various fluid lines of analyzer 10 may share segments and / or be operatively interconnected with one or more other fluid lines via branches, valves, etc.Additionally, although each particular fluid line and / or portion thereof of the analyzer 10 may not be explicitly described herein, when the flow of fluid from one component to another is detailed, it is understood that direct or indirect fluid lines or portions thereof extend between the fluidly coupled components.

[0061] 6 , pressure sensors 932, 934, 936, 938, and 940 are associated with sample syringe pump 210, WBC reagent syringe pump 220, RBC reagent syringe pump 230, sheath syringe pump 240, and peristaltic pump 400, respectively, to provide feedback regarding the associated pressures. Pressure sensors 932 and 940 may be configured as flow-through pressure sensors, and pressure sensors 934, 936, and 938 may be configured as board-mounted pressure sensors, although other configurations are contemplated. A fluidic capacitor-filter-resistor circuit 730 formed by filter 50, fluidic capacitor 732, and fluidic resistor 734 is provided in the sheath flow line between sheath syringe pump 240 and flow cell 810. With further brief reference to Figures 3-5, analyzer 10 includes various PCBAs, flex circuits, electrical connectors, and / or other circuits that mount and / or interconnect various electronic devices (hardware and / or implemented software) associated with analyzer 10 to enable powering, sensing, use, and / or control of various components and assemblies of analyzer 10.

[0062] 9-12, tubing 950 (and / or other conduits, channels, etc.) connects the various components of the analyzer 10 detailed above to establish various fluid lines between the various components. The tubing 950 may be formed from PTFE or other suitable materials. Couplings 970, 980 are provided to connect the tubing 950 with fittings 960 (FIG. 7) associated with the various components of the analyzer 10. The fitting 970 is configured as an elbow fitting and may define an approximately 90-degree elbow angle or other suitable elbow angle. The fitting 980 is configured as a straight fitting, although other configurations are contemplated. Different configurations of the fittings 970, 980 allow for connection to the fitting 960 (FIG. 7) in a variety of different orientations and / or with a variety of different access clearances.

[0063] Each fitting 970 defines a body 972 having an internal lumen 974 and first and second open ends 976, 978, respectively, that communicate with the internal lumen 974. The internal lumen 974 defines an angled or curved configuration to substantially match the elbow configuration of the fitting 970 and interconnect the open ends 976, 978. The internal lumen 974 tapers in diameter from the first and second open ends 976, 978 of the body 972 through at least a portion of the internal lumen 974. The body 972 further includes flared ends 977, 979 disposed at the first and second open ends 976, 978, respectively, and surrounding the lumen 974. The flared ends 977, 979 facilitate insertion and centering of the ends of the tube 950 and the fitting 960 (FIG. 7). The first and second open ends 976, 978 of the body 972 may be dedicated to receiving the end of the tube 950 and the fitting 960 ( FIG. 7 ), respectively, or may be universal to allow for either reception. The tapered configuration of the internal lumen 974 from the first and second open ends 976, 978 of the body 972 provides an increased press-fit engagement of the end of the tube 950 and the fitting 960 ( FIG. 7 ) into the internal lumen 974, ensuring a secure engagement thereof. The coupling 980 is configured similarly to the coupling 970, except that the coupling 980 defines a liner configuration rather than an elbow configuration. The couplings 970, 980 advantageously enable a quick, secure, and reliable connection via a push-to-connect assembly.

[0064] 13A-15, the robot assembly 100 includes a carrier 102 that supports the sample probe 110 and the diluent probe 120 in fixed positions, as described in detail above. The robot assembly 100 further includes a fixed frame 130, a y-axis body 140, a y-axis lead screw motor assembly 150, a z-axis lead screw motor assembly 160, a y-axis linear potentiometer 170, and a z-axis potentiometer 180. The fixed frame 130 is configured to be fixedly mounted to the inner chassis 14 of the analyzer 10 and has a pair of spaced-apart, internally engaged support rails 132 that extend along the y-axis. The support rails 132 slidably support the y-axis body 140 such that the y-axis body 140 is constrained to move in the "y" direction relative to the fixed frame 130. The y-axis potentiometer 170 is fixed relative to the fixed frame 130 and extends in the "y" direction along at least a portion of the fixed frame 130.

[0065] The y-axis leadscrew motor assembly 150 includes a motor 152 mounted on the stationary frame 130, a leadscrew 154 operably coupled to the motor 152 and extending from the motor 152 along the y-axis, and a nut 156 threadably engaged around the leadscrew 154. The nut 156 is fixedly engaged with the y-axis body 140, such that actuation of the motor 152 rotationally drives the leadscrew 154, thereby causing the nut 156, and thus the y-axis body 140, to translate left or right relative to the stationary frame 130 along the "y" direction (and along the support rail 132), depending on the direction of actuation of the motor 152. The y-axis body 140 further includes a leg 142 depending therefrom, the leg 142 defining a foot 144 at its free end. The z-axis potentiometer 180 is fixed relative to the leg 142 and extends in the "z" direction along at least a portion of the leg 142.

[0066] Z-axis lead screw motor assembly 160 is supported on y-axis body 140 and, more particularly, includes a motor 162 mounted on y-axis body 140, a lead screw 164 operably coupled to motor 162 and extending in the "z" direction from motor 162, and a nut 166 threadably engaged about lead screw 164. Carrier 102 is fixedly engaged with nut 166, such that actuation of motor 162 rotationally drives lead screw 164, which causes nut 166, and thus carrier 102 (including sample probe 110 and diluent probe 120), to translate up or down in the "z" direction relative to y-axis body 140, depending on the direction of actuation of motor 162. Z-axis lead screw motor assembly 160 and carrier 102 are coupled to y-axis body 140 in a fixed position relative to the y-axis such that z-axis lead screw motor assembly 160 and carrier 102 translate in the "y" direction in response to translation of y-axis body 140 along the y-axis. However, carrier 102 is configured to translate in the “z” direction relative to y-axis body 140 in response to, for example, actuation of motor 162 .

[0067] As a result of the configuration detailed above, motors 152, 162 can move carrier 102 (including sample probe 110 and diluent probe 120) left or right in the "y" direction and up or down in the "z" direction to manipulate sample probe 110 and diluent probe 120 into various operable positions, as described below. Y-axis and z-axis potentiometers 170, 180 encode "y" and "z" positions, respectively, during such movement to provide feedback that enables the positions of sample probe 110 and diluent probe 120 to be determined so that precise movement and positioning is achieved. Position and / or impedance-based feedback can be utilized to precisely control the movement of probes 110, 120 using potentiometers 170, 180.

[0068] 14A and 14B, the chassis 14 of the analyzer 10 pivotally supports a sucker assembly 190. The sucker assembly 190 includes a sucker body 192 pivotally coupled to the chassis 14 about a pivot 194 to allow the sucker body 192 to pivot between a storage position (FIG. 14A) and a use position (FIG. 14B). In some embodiments, the sucker body 192 is biased toward the storage position.

[0069] The shoer body 192 defines a sample tube retainer 196, a control tube retainer 198, and a cam surface 199. The sample tube retainer 196 and the control tube retainer 198 are configured to clamp and center the sample tube 70 and the control tube 80, respectively, in the use position. The cam surface 199 is disposed along the y-axis and within the path of travel of the foot 144 of the leg 142 of the y-axis body 140 of the robot assembly 100, such that when the y-axis body 140 is moved in the "y" direction toward the sample tube 70 to aspirate sample from the sample tube 70, the foot 144 contacts the cam surface 199 and is cammed along the cam surface 199, thereby pivoting the shoer body 192 from the retracted position to the use position.

[0070] The sample tube retainer 196 is configured as a universal retainer capable of clamping and centering multiple different types of sample tubes, e.g., 20 or more different types of sample tubes, both capped and uncapped. Additionally, cameras, barcode readers, and / or other suitable sensors can be incorporated into the robotic assembly 100 (or within the analyzer 10) to enable detection of the type and / or classification of a sample tube from multiple (e.g., 20 or more different types and / or classifications) of sample tubes. Additionally or alternatively, measurements, assumptions, etc. of unidentifiable sample tubes can be obtained by the sensor(s). Based on the identified sample tube or other obtained information, a database or other suitable data storage file storing configuration information can be accessed to facilitate use and control of the robotic assembly 100, e.g., based on one or more of: whether a cap is used, sample tube dimensions (height and diameter), sample tube volume, sample tube bottom curvature, etc. When a sample tube cannot be readily identified, default configuration information and / or a higher degree of confidence or feedback-based control can be utilized.

[0071] 16-18, the syringe pumps 210-240 are substantially similar to one another, except that their capacities are described in detail below, e.g., the sample syringe pump 210 includes a 250 μL syringe and manifold, while the other syringe pumps 220-240 may include a 5 mL syringe and manifold, although other configurations are also contemplated. The syringe pumps 210-240 are configured to aspirate and dispense fluid and provide position and pressure feedback to enable precise control thereof. Each syringe pump 210-240 includes a solenoid valve 252, a manifold 254, a PCBA 256, a stepper motor 258, a lead screw 260, a travel nut 262, a syringe 264, a pump base 266, and a hitch pin 268. A lead screw 260 is operatively engaged with and extends from the stepper motor 258, onto which a travel nut 262 is threadably engaged. The plunger of a syringe 264 seats on and engages the travel nut 262 with a hitch pin 268, while the body of the syringe 264 is fixed relative to a pump base 266. The pump base 266 is supported by the stepper motor 258 and receives the lead screw 260, travel nut 262, and syringe 264 therein. Thus, actuation of the stepper motor 258 rotationally drives the lead screw 260, which translates the travel nut 262 through the pump base 266, which in turn slides the plunger of the syringe 264 through its body to dispense or withdraw fluid, depending on the direction of movement. Manifold 254 is supported on the end of pump base 266 opposite stepper motor 258 and supports solenoid valve 252 thereon and is configured to direct fluid dispensed from syringe 264 to solenoid valve 252 for dispensing from the desired port. PCBA 256 extends along the exterior surface of pump base 266 and, in at least some syringe pumps 210-240, has pressure sensor 257a mounted thereon to provide feedback regarding the pump pressure within syringe 264.Linear potentiometer 257b is disposed on PCBA 256 and extends along at least a portion of the length of PCBA 256, allowing for determination of the position of travel nut 262 (based on potentiometer wiper 263 associated with travel nut 262) and therefore the deployed state of syringe pumps 210-240. Fittings 960 associated with manifold 254 allow for connection of tubing 950 to manifold 254 for flow of fluid into and out of syringe pumps 210-240.

[0072] 19-24 illustrate an example debris trap 500 of the analyzer 10. As previously described, the debris trap 500 is disposed in the fluid path between the cleaning chamber 330 of the mixing assembly 300 and the sheath fluid and waste pack 30 to capture debris washed out of the cleaning chamber 330 as waste fluid from the cleaning chamber 330 is pumped into the sheath fluid and waste pack 30. The debris trap 500 is configured to capture debris over its lifetime and is therefore not intended to require replacement.

[0073] The debris trap 500 includes a disk-shaped housing 510 formed from first and second disk bodies 520, 530, secured together by ultrasonic welding (or other suitable engagement), and holding a filter screen 540, e.g., a 100 μm screen or other suitable filter, therebetween. The first and second disk bodies 520, 530 include fittings 522, 532, respectively, extending outwardly therefrom in opposite directions and substantially diametrically opposed to the disk-shaped housing 510. The first disk body 520 defines a cavity 524 having a maximum width dimension at the fitting 522 and tapering in width substantially radially toward the fitting 532 to a minimum width dimension. The second disk body 530 defines a cavity 534 of substantially constant width, although other configurations are contemplated. With the first and second disk bodies 520, 530 secured together, the inner annular surface 526 of the first disk body 520 holds the annular periphery of the filter screen 540 against the opposing annular surface 536 of the second disk body 530 so that the filter screen 540 is held in a position that separates the cavities 524, 534 but allows fluid communication therebetween.

[0074] The fittings 522, 532 define lumens therein that communicate with the respective cavities 524, 534. The fitting 522 is configured as an inlet, while the fitting 532 is configured as an outlet. More specifically, the fitting 522 is configured to engage with a tube connected to the cleaning chamber 330 to receive effluent from the cleaning chamber 330, while the fitting 532 is configured to engage with a tube connected to the sheath fluid and waste pack 30 to deliver effluent from the debris trap 500 to the sheath fluid and waste pack 30. The effluent enters the cavity 524 of the debris trap 500 via the fitting 522, and the above-detailed configuration of the cavity 524 ensures that debris is trapped within the cavity 524 without clogging the filter screen 540, thereby allowing the fluid to pass through the filter screen 540, enter the cavity 534, and ultimately exit the fitting 532 and enter the sheath fluid and waste pack 30.

[0075] 25-27, the hemoglobin assembly 600 is positioned in parallel with the flow cell 810 of the flow cytometer assembly 800. The hemoglobin assembly 600 includes a hemoglobin detection cell 610 housed within a complementary shaped pocket 642 of a support structure 644 associated with the mixing assembly 300. As further described above, the hemoglobin assembly 600 includes a light source and a sensor configured to enable absorption measurements at one or more distinct wavelengths of light to determine the hemoglobin concentration in a sample.

[0076] The hemoglobin detection cell 610 is formed from two identical pieces 612, 614. Each piece 612, 614 is formed from a highly optically clear, light-transmitting material, such as acrylic, and may be molded or otherwise formed. One piece 612, 614 is inverted and opposed relative to the other piece 612, 614, and the pieces 612, 614 are secured together, for example, by laser welding, to form the hemoglobin detection cell 610. More specifically, each piece 612, 614 defines a rectangular body 652 having a channel 654 defined in a top surface 656 thereof and extending along its length. An angled cutout 658 is defined at a first end 659 of the rectangular body 652, and an angled block 660 is disposed at a second end 661 of the rectangular body 652. The angled cutout 658 is in the top surface 656 of the rectangular body 652 and extends to the free end of the first end 659 such that the height of the first end 659 of the rectangular body 652 tapers from the top surface 656 to the free end of the first end 659.

[0077] The angled block 660 is disposed at the second end 661 of the rectangular body 652, as previously described. The angled block 660, more particularly, is seated on the second end 661 of the rectangular body 652 and defines a channel that cooperates with a portion of the channel 654 to define a lumen 662 extending between the angled block 660 and the rectangular body 652. The angled block 660 defines an angled inner surface 664 that is complementary to the angled surface defined by the angled cutout 658. The angled block 660 defines a maximum height equal to the maximum height of the rectangular body 652. The fitting 666 is formed at the end surface 667 defined by the angled block 660 and the rectangular body 652, extends outwardly therefrom, and includes a lumen 668 disposed in communication with the lumen 662. The fitting 666 is centered relative to the end surface 667.

[0078] As a result of the configuration detailed above, when one of the pieces 612, 614 is inverted and opposed relative to the other piece 612, 614, and the top surfaces 656 are positioned to mate with one another, the angled cutout 658 receives the angled block 660, thereby forming a fully rectangular body 670 and a continuous lumen extending between the fittings 666.

[0079] 28A-29D, filter holder and ejector assembly 700, as previously described, removably holds filter 50 therein. Filter 50 includes filter body 52, inlet fitting 54 disposed at one end of filter body 52, and outlet fitting 56 disposed at the other end of filter body 52.

[0080] The filter holder and ejector assembly 700 includes a base 702, a rear bracket 704, a bottom sheet 706, a bottom cup 708, a clip 710, a cap 712, a pair of linkages 714, a pivot handle 716, and a pair of gaskets 718, 720. The base 702 is configured to be securely fastened to the inner chassis 14 of the analyzer 10 and to directly or indirectly operatively support various other components of the filter holder and ejector assembly 700. The rear bracket 704 includes a pair of spaced apart rails 705a interconnected by a crossbar 705b that pivotally couples the rear bracket 704 to the base 702 at the rear side of the base 702. A pair of cam lobes 705c extend from rail 705a at one end of rear bracket 704 (on one side of crossbar 705b), and a pair of feet 705d extend from rail 705a at an opposite second end of rear bracket 704 (on the opposite side of crossbar 705b). As a result of this configuration, a bias on cam lobes 705c in a first direction biases rear bracket 704 to pivot about crossbar 705b, thus biasing feet 705d in an opposite second direction, and vice versa. More specifically, feet 705d are selectively extendable from a retracted position to an extended position through window 703 defined in base 702 in response to a rearward bias on cam lobes 705c.

[0081] A bottom sheet 706 is supported on and depends from a lower end of the base 702. A bottom cup 708 defines an outlet and is seated within the bottom sheet 706, receiving a first gasket 718 therein. The bottom cup 708 is configured to receive the outlet fitting 56 of the filter 50 therein, while the gasket 718 establishes a seal around the interface between the outlet of the cup 708 and the outlet fitting 56 of the filter 50 when the filter holder and ejector assembly 700 are engaged.

[0082] Clip 710 is supported by base 702 and extends forwardly from base 702 at an approximately intermediate position. Clip 710 is configured to receive filter body 52 of filter 50 therein in a snap-fit ​​engagement, thereby removably engaging filter 50 within filter holder and ejector assembly 700.

[0083] The cap 712 is coupled to the upper end of the base 702 in a longitudinally slidable manner. The cap 712 defines an inlet and retains a second gasket 720 therein. The cap 712 is configured to receive the inlet fitting 54 of the filter 50 therein, while the second gasket 720 establishes a seal around the interface between the inlet of the cap 712 and the inlet fitting 54 of the filter 50 when the filter holder and ejector assembly 700 are engaged. The cap 712 is movable between a disengaged position and an engaged position.

[0084] Linkage 714 is pivotally connected at a first end to boss 713 of cap 712 and pivotally coupled at a second end to a first boss 717a of pivot handle 716. Pivot handle 716 further includes a second boss 717b that pivotally connects pivot handle 716 to base 702 along a common pivot axis when linkage 714 and pivot handle 716 pivot. Pivot handle 716 further includes a lever 717c configured to facilitate pivotal movement of pivot handle 716 between an eject position, a neutral position, and an engaged position.

[0085] 29A-29D, initially referring to Figures 29A and 29B, in use, to prepare filter holder and ejector assembly 700 to receive filter 50 therein, lever 717c of pivoting handle 716 is moved to a neutral position with cap 712 disposed in the disengaged position and foot 705d disposed in the retracted position. Once this is achieved, and with further reference to Figure 29C, filter 50 is inserted into filter holder and ejector assembly 700 such that outlet fitting 56 of filter 50 is at least partially received in bottom cup 708 and clip 710 is at least partially engaged around filter body 52 of filter 50.

[0086] 29D, pivoting lever 717c of pivot handle 716 downward from the neutral position to the engaged position causes cap 712 to slide downward to the engaged position, compressing and retaining filter 50 between gaskets 718, 720 of bottom cup 708 and cap 712, thus retaining filter 50 in sealing engagement within filter holder-ejector assembly 700. Inlet and outlet tubes (not explicitly shown) are connected to bottom cup 708 and cap 712 to allow fluid, e.g., sheath fluid, to flow through filter 50 and filter holder-ejector assembly 700 without leakage.

[0087] 29A-29D, to disengage and remove the filter 50, the pivot handle 716 is pivoted from the engagement position through the neutral position to the eject position. Pivoting the pivot handle 716 from the engagement position to the neutral position moves the cap 712 so that the filter 50 is no longer compressed and held between the bottom cup 708 and the gaskets 718, 720 of the cap 712, while pivoting the pivot handle 716 past the neutral position to the eject position urges the cam surface 717d of the pivot handle 716 into contact with the cam lobe 705c of the rear bracket 704, which pivots the rear bracket 704 and urges the foot 705d into contact with the filter body 52 of the filter 50 through the window 703 defined in the base 702, urging the filter body 52 to disengage from the clip 710. Thus, the filter 50 can be easily removed.

[0088] 6, as previously described, filter 50, in combination with fluidic capacitor 732 and fluidic resistor 734, forms a fluidic capacitor-filter-resistor circuit 730 through which sheath fluid passes. This circuit 730 controls the flow of sheath fluid surrounding the sample core stream as it passes through flow cell 810, thereby facilitating the establishment of core stream flow through flow cell 810.

[0089] 30-32, the mixing assembly 300 includes a multi-chamber mixing housing 302 that is securely fastened to the inner chassis 14 of the analyzer 10. The mixing assembly 300 further includes a bracket 304 that engages with the multi-chamber mixing housing 302 for mounting valves to the multi-chamber mixing housing 302. The multi-chamber mixing housing 302 includes a WBC chamber 310, an RBC chamber 320, a cleaning chamber 330, and a clearance cavity 340, as also described above, which allows operable interfacing of the sample probe 110 and the diluent probe 120 (FIGS. 13A and 13B) with one or more of the chambers 310, 320, 330 detailed herein to generate WBC dilutions, RBC dilutions, and to facilitate cleaning, priming, and rinsing of the probes 110, 120 (FIGS. 13A and 13B) and chambers 310, 320, 330. The use of the mixing assembly 300 is described in more detail below in conjunction with the execution sequence.

[0090] With general reference to FIG. 6, in conjunction with FIGS. 1, 3-5, 7, 8, 14A, 14B, and 30, an execution sequence for analyzing a sample using analyzer 10 will be described. The execution sequence below details the order of various functions performed during a sample run. To avoid obscuring the execution sequence with unnecessary detail, descriptions of some or all of the actions that enable various functions (e.g., energizing valves, reading sensors, providing feedback, refilling syringes, etc.) and / or some intermediate steps or processes have been omitted. Furthermore, unless otherwise contradicted below, various steps may be performed in different orders, simultaneously, or in a temporally overlapping relationship.

[0091] In preparation for a sample run, if not already present, the sheath fluid and waste pack 30, reagent pack 40, and filter 50 are manually loaded into the analyzer 10. A user interface of or associated with the analyzer 10 prompts the user to manually invert the sample tube 70 repeatedly, e.g., ten times, to homogenize the sample before running it on the analyzer 10. Once this is accomplished, the user manually opens the drawer 60, inserts the sample tube 70 into the receptacle 62 of the drawer 60, manually closes the drawer 60, and presses the start button 98 to begin the sample run.

[0092] A sample run is generally divided into four stages: sample draw, dilution generation, dilution processing, and cleanup. First, before starting any of the above four stages, all fluid lines except the waste line from the mixing assembly 300 are primed with sheath fluid and all syringe pumps 210-240 are set to the draw position.

[0093] With respect to sample aspirating, if the sample tube 70 has a stopper or cap, venting of the sample tube 70 is performed first. To vent the sample tube 70, the robot assembly 100 translates the carrier 102 from its home position, thereby moving the sample probe 110 in the "y" direction into y-axis alignment with the sample tube 70. As detailed above, as the robot assembly 100 translates the carrier 102 in this manner, the foot 144 of the y-axis body 140 of the robot assembly 100 contacts the sucker body 192, urging it to pivot from the stowed position to the use position, and the sample tube retainer 194 of the sucker body 192 clamps and centers the stopper or cap on the sample tube 70. The sheath syringe pump 240 then aspirates air through the sample probe 110 until the air passes through the sample vent valve 902. The robotic assembly 100 then translates the carrier 102 to move the sample probe 110 in the "z" direction toward the sample tube 70 so that the sharp tip of the sample probe 110 pierces the septum of the stopper or cap of the sample tube 70 and extends into the sample tube 70. The robotic assembly 100 stops the "z" movement of the sample probe 110 after the sharp tip of the sample probe 110 pierces the stopper or cap but before it reaches the fluid level within the sample tube 70, e.g., the surface of the blood sample. These and / or other movements relative to the sample tube 70 may be accomplished by impedance-based feedback, by identification of the sample tube 70, and / or in any other suitable manner.

[0094] Continuing to vent the sample tube 70, when the sample probe 110 is positioned as described above, for example, slightly below the stopper or cap but before the fluid level in the sample tube 70, the sample vent valve 902 is energized, thereby connecting the interior of the sample probe 110 to atmosphere, venting the sample tube 70 and allowing the pressure to equalize.

[0095] After venting the sample tube 70, the robot assembly 100 moves the carrier 102 to move the sample probe 110 back in the "z" direction away from the sample tube 70, e.g., opposite the "z" movement detailed above. The sample tube retainer 194 of the shoer body 190 holds the sample tube 70 in place and prevents movement of the sample tube 70 with the sample probe 110 in the "z" direction, possibly due to frictional engagement between the sample probe 110 and the punctured septum of the stopper or cap of the sample tube 70.

[0096] If the sample tube 70 was stoppered or capped and therefore vented as detailed above, the robot assembly 100 retracts the sample probe 110 fully in the "z" direction from the sample tube 70 before repriming the sample line. For repriming, the robot assembly 100 translates the carrier 102 to move the sample probe 110 in the "y" direction into y-axis alignment with the cleaning chamber 330 of the mixing assembly 300, and then in the "z" direction to the bottom of the cleaning chamber 330. As the carrier 102 moves in the "y" direction away from the sample tube 70, the shoe body 192 pivots under bias from the use position back to the retracted position.

[0097] With the sample probe 110 positioned at the bottom of the cleaning chamber 330, the sheath syringe pump 240 is activated to dispense sheath fluid through the sample probe 110 (with some sheath fluid exiting the sample probe 110 and entering the cleaning chamber 330), thus repriming the sample line. The robot assembly 100 then moves the carrier 102 back in the "z" direction to withdraw the sample probe 110 from the cleaning chamber 330.

[0098] Once venting and re-priming are complete (if necessary), sample aspirating can begin by the robot assembly 100 translating the carrier 102 to move the sample probe 110 in the "y" direction into y-axis alignment with the sample tube 70. This movement urges the foot 144 of the y-axis body 140 of the robot assembly 100 back into contact with the sucker body 192, urging the sucker body 192 to pivot from the stowed position to the use position, clamping and centering the sample tube 70.

[0099] The robot assembly 100 then translates the carrier 102 to move the sample probe 110 in the "z" direction into the sample tube 70 to the bottom, or far enough below the sample surface to allow aspirating an appropriate sample volume. The sample syringe pump 210 is then activated to aspirate a predetermined amount of sample from the sample tube 70 through the sample probe 110 and into the sample probe line. The robot assembly 100 then translates the carrier 102 to retract the sample probe 110 (by its movement in the "z" direction) from the sample tube 70.

[0100] Concurrent with the sample extraction detailed above, or at any other suitable point in the execution sequence, a dark read can be performed from the hemoglobin assembly 600, for example with the light source turned off, followed by a sheath read from the hemoglobin assembly 600 with the light source turned on.

[0101] Continuing to generally refer to FIG. 6 in conjunction with FIGS. 1, 3-5, 7, 8, 14A, 14B, and 30, the next stage in the execution sequence, generating a dilution, involves cleaning the sample probe 110, generating an RBC dilution, and generating a WBC dilution. Cleaning the sample probe 110 is accomplished by the robot assembly 100 first translating the carrier 102 to move the sample probe 110 into y-axis alignment with the cleaning chamber 330, and then moving the sample probe 110 in the "z" direction to advance the sample probe 110 to the bottom of the cleaning chamber 330. With the sample probe 110 positioned at the bottom of the cleaning chamber 330, the sheath syringe pump 240 is activated to pump sheath fluid into the cleaning chamber 330 to a volume sufficient to be above the outlet of the sharp tip of the sample probe 110. In some embodiments, the cleaning chamber 330 is substantially filled. Next, the peristaltic pump 400 is activated to pump the sheath fluid out of the cleaning chamber 330 and into the sheath fluid / waste pack 30. This serves to rinse the exterior surface of at least the tip of the sample probe 110 (e.g., to remove any debris accumulated from puncturing the stopper or cap). In some embodiments, the above rinsing can be repeated one or more times.

[0102] After rinsing the sample probe 110 in the cleaning chamber 330, the robot assembly 100 moves the carrier 102 to retract the sample probe 110 in the "z" direction and out of the cleaning chamber 330. Next, or simultaneously, the peristaltic pump 400 draws fluid from the cleaning chamber 330 into the sheath fluid and waste pack 30.

[0103] The robotic assembly 100 translates the carrier 102 to move the sample probe 110 in the "y" direction into y-axis alignment with the RBC chamber 320 of the mixing assembly 300, the RBC reagent syringe pump 230 first delivers a predetermined amount of RBC reagent into the RBC chamber 320, and the robotic assembly 100 translates the carrier 102 to move the sample probe 110 in the "z" direction to the bottom of the RBC chamber 320 (or below the reagent fluid level). Next, in parallel (substantially simultaneously, overlapping, etc.), the sample syringe pump 210 is actuated to deliver a predetermined amount of sample through the sample probe 110 into the RBC chamber 320, and the RBC reagent syringe pump 230 delivers a predetermined amount of RBC reagent from the reagent pack 40 into the RBC chamber 320 in multiple pulses. The diameter of the reagent inlet port to the RBC chamber 320 and its offset location increase the flow rate of the incoming RBC reagent, agitating the RBC reagent and sample and uniformly mixing the dilution.

[0104] After the sample and RBC reagents have been dispensed into the RBC chamber 320 (although some dispensing may still occur), the robotic assembly 100 translates the carrier 102 to withdraw the sample probe 110 from the RBC chamber 320.

[0105] The production of the WBC dilution is accomplished in a manner similar to the production of the RBC dilution detailed above, except that a WBC reagent syringe pump 220 and WBC chamber 310 are used and the predetermined volume and number of pulses may vary.

[0106] The third phase of the sample run is diluent processing, which includes WBC diluent transport, WBC diluent collection, cleaning the sample probe 110, and repriming the sample syringe pump 210, RBC diluent transport, and RBC diluent collection. WBC diluent transport begins with the robotic assembly 100 translating the carrier 102 to move the diluent probe 120 in the "y" direction into y-axis alignment with the WBC chamber 310 of the mixing assembly 300. Next, the peristaltic pump 400 pumps air through the diluent transport line to clear the line. Once the line is clear, the robotic assembly 100 moves the carrier 102 to extend the diluent probe 120 to the bottom of the WBC chamber 310. The peristaltic pump 400 then pumps the WBC diluent through the hemoglobin detection cell 610 toward the flow cell 810 of the flow cytometer assembly 800.

[0107] Collection of the WBC dilution is achieved by dispensing the WBC dilution into the flow cell 810 (via the sample syringe pump 210) and dispensing sheath fluid into the flow cell 810 (via the sheath syringe pump 240) in parallel. This dispensing establishes and stabilizes the flow of the core stream through the flow cell 810 and facilitates data collection of the core stream using the flow cytometer assembly 800. With regard to sheath fluid delivery, this may be achieved by first dispensing a first volume of sheath fluid into the flow cell 810 at a first rate, followed by dispensing a second, different volume of sheath fluid into the flow cell 810 at a second, different rate. With regard to sample delivery, first a first volume of sample is delivered into the flow cell 810 at a first rate, followed by a second volume of sample into the flow cell 810 at a second rate, followed by a third volume of sample into the flow cell 810 at a third rate. The laser optics assembly of the flow cytometer assembly 800 is activated to begin data collection a predetermined delay after the completion of the second sample delivery / the start of the third sample delivery. The laser optics assembly of the flow cytometer assembly 800 is deactivated to end data collection after the completion of the third delivery. The sample and sheath fluid passing through the flow cell 810 proceed to the sheath fluid and waste pack 30.

[0108] Once collection of the WBC dilution as detailed above is complete, the robotic assembly 100 translates the carrier 102 to move the dilution probe 120 in the "z" direction to withdraw it from the WBC chamber 310.

[0109] Cleaning the sample probe 110 and repriming the sample syringe pump 210 involves first using the peristaltic pump 400 to aspirate any residual fluid in the cleaning chamber 330 into the sheath fluid and waste pack 30, and then using the robot assembly 100 to translate the carrier 102 to move the sample probe 110 in the "y" direction into y-axis alignment with the cleaning chamber 330. With the sample probe 110 in this position, the following actions are accomplished in parallel: operating the sheath syringe pump 240 to pump sheath fluid through the sample probe 110 and into the cleaning chamber 330, using the robot assembly 100 to translate the carrier 102 to move the sample probe 110 to the bottom of the cleaning chamber 330, and operating the peristaltic pump 400 to aspirate fluid from the cleaning chamber 330 and expel it from the cleaning chamber 330 into the sheath fluid and waste pack 30. These parallel actions clean the interior of the sample probe 110 and also rinse the interior of the cleaning chamber 330. Following this cleaning, repriming of the sample syringe pump 210 is accomplished by actuating the sheath syringe pump 240 to dispense sheath fluid through the sample probe 110 into the cleaning chamber 330, for example, in some embodiments until the cleaning chamber 330 is substantially filled, and actuating the sample syringe pump 210 to draw sheath fluid from the cleaning chamber 330 into the sample probe lines, thereby repriming the lines for subsequent RBC dilution transport and collection. Finally, the robot assembly 100 translates the carrier 102 to move the dilution probe 120 in the "z" direction to withdraw it from the cleaning chamber 330.

[0110] Concurrent with cleaning the sample probe 110 and repriming the sample syringe pump 210, or at any other suitable point during the execution sequence, the hemoglobin assembly 600 performs a sample read of the WBC dilution still in the hemoglobin detection cell 610 from the transport of the dilution described above.

[0111] 6 in conjunction with FIGS. 1, 3-5, 7, 8, 14A, 14B, and 30, collection of the RBC dilution is accomplished in a manner similar to the generation of the WBC dilution detailed above, except that an RBC chamber 320 is used and some of the fluid volumes and flow rates may differ. In particular, collection of the RBC dilution involves dispensing the RBC dilution (via sample syringe pump 210) into flow cell 810 in parallel with dispensing sheath fluid (via sheath syringe pump 240) into flow cell 810. More particularly, this dispensing may be accomplished by initially dispensing a first volume of sheath fluid into flow cell 810 at a first rate, followed by dispensing a second, different volume of sheath fluid into flow cell 810 at a second, different rate, with respect to sheath fluid delivery. With respect to sample delivery, a first volume of sample is delivered to the flow cell 810 at a first velocity, followed by a second volume of sample delivered to the flow cell 810 at a second velocity, and then a third volume of sample delivered to the flow cell 810 at a third velocity. The laser optics assembly of the flow cytometer assembly 800 is activated to begin data collection a predetermined delay after the completion of the second sample delivery / the start of the third sample delivery. The laser optics assembly of the flow cytometer assembly 800 is deactivated to end data collection after the completion of the third delivery. The sample and sheath fluid passing through the flow cell 810 proceed to the sheath fluid / waste pack 30. Finally, the robot assembly 100 translates the carrier 102 to move the diluent probe 120 in the "z" direction to withdraw it from the RBC chamber 320.

[0112] The fourth stage of the sample run, cleanup, involves draining the chambers 310, 320, 330 of the mixing assembly 300, refilling the reagent syringe pumps 220, 230, rinsing the cleaning chamber 330, cleaning the diluent probe 120, cleaning the flow cell 810, cleaning the RBC chamber 320, and cleaning the WBC chamber 310.

[0113] A peristaltic pump 400 pumps air out of the diluent probe lines to clear residual diluent, and evacuates the chambers 310, 320, 330 by pumping residual fluid from the WBC chamber 310, RBC chamber 320, and / or cleaning chamber 330 into the sheath fluid and waste pack 30. Refilling of the reagent syringe pumps 220, 230 is accomplished by activating the WBC reagent syringe pump 220 and the RBC reagent syringe pump 230 to draw reagent from the reagent pack 40 into the respective syringe pumps 220, 230.

[0114] The robot assembly 100 then first translates the carrier 102 to move the sample probe 110 in the "y" direction into y-axis alignment with the cleaning chamber 330, then, in parallel, the sheath syringe pump 240 pumps sheath fluid through the sample probe line into the cleaning chamber 330, the robot assembly 100 translates the carrier 102 to move the sample probe 110 in the "z" direction to advance it to the bottom of the cleaning chamber 330, and the peristaltic pump 400 aspirates fluid from the cleaning chamber 330 into the sheath fluid / waste pack 30, thereby rinsing the cleaning chamber 330. The robot assembly 100 then translates the carrier 102 to withdraw the sample probe 110 in the "z" direction from the cleaning chamber 330. In some embodiments, the above rinsing can be repeated one or more times.

[0115] Next, for cleaning the diluent probe 120, the robot assembly 100 translates the carrier 102 to move the diluent probe 120 in the "y" direction to align it with the cleaning chamber 330, and then in the "z" direction to the bottom of the cleaning chamber 330. Then, in parallel, the sheath syringe pump 240 pumps sheath fluid through the diluent probe line into the cleaning chamber 330, and the peristaltic pump 400 pumps fluid from the cleaning chamber 330 into the sheath fluid and waste pack 30. In some embodiments, the above rinsing can be repeated one or more times.

[0116] To perform flow cell cleaning, the sheath syringe pump 240 dispenses a sufficient amount of sheath fluid into the cleaning chamber 330, in some embodiments substantially filling the cleaning chamber 330. The peristaltic pump 400 then draws sheath fluid from the cleaning chamber 330 through the diluent probe line and into the flow cell 810. In parallel, both the sample syringe pump 210 and the sheath syringe pump 240 dispense sheath fluid into the flow cell 810. In some embodiments, the above rinse can be repeated one or more times. After this rinse(s), the peristaltic pump 400 draws fluid from the cleaning chamber 330 into the sheath fluid / waste pack 30, and the robot assembly 100 translates the carrier 102 to withdraw the diluent probe 120 from the cleaning chamber 330 in the "z" direction.

[0117] Cleaning the RBC chamber 320 involves the robot assembly 100 translating the carrier 102 to move the sample probe 110 in the "y" direction to align it with the RBC chamber 320, and then translating it in the "z" direction so that the outlet of the sample probe 110 is slightly below the top of the RBC chamber 320. Once this position is achieved, the sheath syringe pump 240 pumps the sheath (or dispenses another volume) through the sample probe line until it substantially fills the RBC chamber 320, and the peristaltic pump 400 aspirates fluid from the RBC chamber 320 into the sheath and waste pack 30. This rinsing process can be repeated one or more times. Finally, the robot assembly 100 translates the carrier 102 to move the sample probe 110 in the "z" direction to withdraw it from the RBC chamber 320.

[0118] Cleaning of the WBC chamber 310 is accomplished in a manner similar to cleaning of the RBC chamber 320 detailed above, except that after the WBC chamber 310 has been used and rinsed(s), the robot assembly 100 moves the carrier 102 back to the home position. In this manner, the analyzer 10 is reset for subsequent sample run(s), which are accomplished by repeating the run sequence described above.

[0119] With particular reference to FIG. 14B , the run sequence detailed above is substantially the same (e.g., except for the use of a different dilution ratio) for a run sequence of fluid from an on-board control tube 80 containing synthetic particles suspended in fluid. These control runs may be performed periodically at regular intervals (e.g., elapsed time, time of use, date and time, number of runs, etc.), on demand, and / or upon the occurrence of one or more conditions (e.g., migration threshold, temperature change threshold, extended inactivity threshold, replacement of component(s)), etc. The on-board control tube 80 is configured to remain within the analyzer 10 through multiple runs; therefore, a motor (not explicitly shown) is provided in the drawer 60 to rotate the control tube 80 and mix its contents before a sample from the control tube 80 is used in a control run sequence. The run sequence of fluid from the on-board control tube 80 is used to check calibration, if necessary, to perform self-calibration.

[0120] The analyzers, devices, systems, and / or methods described herein may use one or more controllers to receive various information and transform the received information to generate output. The controller may include any type of computing device, calculation circuit, or any type of processor or processing circuit capable of executing a sequence of instructions stored in memory. The controller may include multiple processors and / or multi-core central processing units (CPUs), and may include any type of processor, such as a microprocessor, digital signal processor, microcontroller, programmable logic device (PLD), field programmable gate array (FPGA), etc. The controller may be located within a device or system at an end user's location, within a device or system at a manufacturer or service provider's location, or may be a cloud computing processor residing at a cloud computing provider. The controller may also include memory that stores data and / or instructions that, when executed by the one or more processors, cause the one or more processors to perform one or more methods and / or algorithms.

[0121] It will be understood that various modifications can be made to the aspects and features disclosed herein. Accordingly, the above description should not be construed as limiting, but merely as illustrative of various aspects and features. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

1. 1. An analyzer comprising: an inner chassis; an outer housing surrounding the inner chassis; a sample probe operably coupled to the inner chassis within the outer housing and movable relative to the outer housing; a diluent probe operably coupled to the inner chassis within the outer housing and movable relative to the outer housing; a mixing housing supported by an inner chassis within the outer housing, the mixing housing defining a first mixing chamber and a second mixing chamber, each of the first mixing chamber and the second mixing chamber configured to receive a diluent; a flow cytometer supported by the inner chassis within the outer housing, the flow cytometer including a flow cell; a sample pump disposed within the outer housing and configured to perform a first plurality of tasks, including drawing sample into the sample probe, dispensing sample from the sample probe into the first mixing chamber, dispensing sample from the sample probe into the second mixing chamber, delivering a first sample-diluent mixture to the flow cell, and delivering a second sample-diluent mixture to the flow cell; a sheath pump disposed within the outer housing and configured to perform a second plurality of tasks, including dispensing sheath fluid into the flow cell in cooperation with delivering the first sample and diluent mixture to the flow cell, and dispensing sheath fluid into the flow cell in cooperation with delivering the second sample and diluent mixture to the flow cell; a carrier supporting the sample probe and the diluent probe in a fixed orientation relative to one another, the carrier being operably coupled to the inner chassis within the outer housing and movable relative to the outer housing to operably position the sample probe and the diluent probe to enable at least some of the first plurality of tasks and the second plurality of tasks; An analyzer comprising:

2. 10. The analyzer of claim 1, further comprising a robotic assembly configured to manipulate the carrier in y and z directions relative to the inner chassis, thereby positioning the sample probe and the diluent probe to enable at least some of the first and second plurality of tasks.

3. The analyzer of claim 2 , wherein the robotic assembly further includes y-axis and z-axis potentiometers configured to enable feedback-based control of the carrier's movement in the y- and z-directions, respectively.

4. 3. The analyzer of claim 2, further comprising a first dilution pump and a second dilution pump disposed within the outer housing and configured to deliver the diluent to the first mixing chamber and the second mixing chamber, respectively.

5. 3. The analyzer of claim 2, further comprising a peristaltic pump configured to perform a third plurality of tasks, including aspirating the first sample-diluent mixture from the first mixing chamber to the diluent probe, aspirating the second sample-diluent mixture from the second mixing chamber to the diluent probe, aspirating the first sample-diluent mixture through the diluent probe in preparation for its delivery to the flow cell, aspirating the second sample-diluent mixture through the diluent probe in preparation for its delivery to the flow cell, aspirating residual fluid in the first mixing chamber to waste, and aspirating residual fluid in the second mixing chamber to waste.

6. 3. The analyzer of claim 2, wherein the second plurality of tasks further comprises dispensing the sheath fluid into the first mixing chamber to clean the first mixing chamber, and dispensing the sheath fluid into the second mixing chamber to clean the second mixing chamber.

7. 3. The analyzer of claim 2, wherein the mixing housing further defines a cleaning chamber, and the second plurality of tasks further includes dispensing the sheath fluid into the cleaning chamber to clean a portion of the sample probe disposed within the cleaning chamber.

8. The analyzer of claim 2 further comprising a hemoglobin detection assembly disposed in parallel with the flow cell.

9. 3. The analyzer of claim 2, further comprising a fluid circuit configured to control the flow of sheath fluid therethrough, the fluid circuit being disposed within a sheath flow line such that sheath fluid dispensed into the flow cell passes through the fluid circuit.

10. 3. The analyzer of claim 2, further comprising a drawer providing selective access from said outer housing to said inner chassis for selective insertion and removal of sample tubes containing samples.

11. 3. The analyzer of claim 2, further comprising a fluidic capacitor-filter-resistor circuit, the fluidic capacitor-filter-resistor circuit being disposed within a sheath flow line such that sheath fluid dispensed into the flow cell passes through the fluidic capacitor-filter-resistor circuit.

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