Packaging tray and multifunctional micro-fluidic assembly with same

Abstract

Packaging trays, tray assemblies, support packs, and other devices for use in centrifugal microfluidics are disclosed. The tray includes a stepped support for stacking a plurality of tray assemblies. The tray also includes a retaining member for preventing undesired movement of a tray assembly when the tray assembly is placed in the tray.

Description

Technical Field

[0001] This disclosure relates to devices used in centrifugal microfluidics and methods for manufacturing such devices.

[0002] Cross-reference to related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 498,228, filed April 25, 2023, the entire contents of which are incorporated herein by reference. Background Technology

[0003] Currently, 70% of all medical decisions rely on lab-based diagnoses, but the diagnostic process is now disconnected from how care is delivered. Primary care systems require patients to travel to external blood collection points, where the blood is then shipped to a central lab and processed overnight. This means lab results don't reach healthcare professionals until long after the patient has left. This friction between care delivery and disease management leads to significant waste within the healthcare system. a. Patients frequently postpone laboratory tests or fail to comply with laboratory test or follow-up care recommendations. b. Interruptions in the diagnostic process lead to missed detections, missed diagnoses, and lack of intervention, ultimately resulting in adverse outcomes. c. Healthcare professionals waste time tracking lab results and patient records. When intervention is needed, even more time is wasted on reaching patients and advancing subsequent steps in the patient care pathway.

[0004] These problems are even more pronounced when providing care to patients in rural areas or those belonging to groups facing adverse social determinants of health, as there are many challenges in ensuring successful follow-up from the initial patient visit in these groups.

[0005] Several companies have manufactured point-of-care testing instruments to bridge this gap. However, these instruments are limited to single types of tests and cannot fully meet the workflow needs of primary care providers for a single system that provides simple, comprehensive, and rapid test results. Products that meet these needs are currently under development. This goal is achieved through a highly automated workflow enabled by using centrifugal microfluidic discs.

[0006] Therefore, there is still a need for improved devices and methods in centrifugal microfluidics. Summary of the Invention

[0007] This disclosure addresses these and other needs in the art by providing packaging trays, tray assemblies, support packs, and other devices for use in centrifugal microfluidics.

[0008] In one aspect, this disclosure provides a tray including a first compartment configured for stacking a plurality of tray assemblies. The first compartment is generally circular and includes a stepped support. The stepped support includes a plurality of steps along an axial direction of the first compartment and is configured to receive corresponding tray assemblies of the plurality of tray assemblies, characterized by corresponding diameters of a plurality of diameters. In some embodiments, the tray includes at least one axial retaining member formed at or adjacent to each of the plurality of steps and configured to prevent undesired axial movement of the corresponding tray assemblies of the plurality of tray assemblies when placed in the first compartment. In some embodiments, the tray includes at least one angular retaining member formed at or adjacent to each of the plurality of steps and configured to prevent undesired rotation of the corresponding tray assemblies of the plurality of tray assemblies about an axis of the first compartment when placed in the first compartment.

[0009] In some embodiments, multiple steps are configured such that when adjacent disk assemblies in a plurality of disk assemblies are placed in a first compartment, these adjacent disk assemblies are spaced apart from each other along the axial direction of the first compartment.

[0010] In some implementations, multiple steps include two, three, four, five or more steps.

[0011] In some embodiments, the plurality of steps includes: a first step located at a first level and configured to receive a first tray assembly; and a second step located at a second level above the first level and configured to receive a second tray assembly larger than the first tray assembly. In some such embodiments, the plurality of steps further includes a third step located at a third level above the second level and configured to receive a third tray assembly larger than the second tray assembly.

[0012] In some embodiments, the plurality of disk assemblies includes disk assemblies configured for hematological testing, disk assemblies configured for clinical chemistry testing, disk assemblies configured for immunoassay testing, or any combination thereof. In some such embodiments, the disk assembly configured for immunoassay testing is larger than the disk assembly configured for clinical chemistry testing, and the disk assembly configured for clinical chemistry testing is larger than the disk assembly configured for hematological testing.

[0013] In some embodiments, at least one axial retaining member formed at different steps or adjacent locations in a plurality of steps is circumferentially staggered relative to each other.

[0014] In some embodiments, at least one axial retaining member formed at each respective step in a plurality of steps comprises two, three, four or more axial retaining members spaced circumferentially apart from each other.

[0015] In some embodiments, each of at least one angular retaining member formed at or adjacent to each of the plurality of steps is configured to engage with a notch at the outer periphery of a corresponding disk assembly formed in the plurality of disk assemblies.

[0016] In some embodiments, at least one angular retaining member formed at or adjacent to each of the multiple steps is composed of a single angular retaining member.

[0017] In some embodiments, the first compartment further includes a bottom wall and a central positioning feature formed in the bottom wall of the first compartment and configured to engage with an instrument placement feature to prevent lateral and angular movement of the tray when it is placed in the instrument. In some such embodiments, the central positioning feature has a generally triangular cross-section.

[0018] In some implementations, a support feature is formed on the bottom wall of the first compartment and flush with the bottom wall of the central positioning feature and the second compartment to facilitate placing the tray on the surface.

[0019] In some implementations, the first compartment includes a designated area on the inner surface of the bottom wall for placing one or more detection strips.

[0020] In some embodiments, the tray also includes a second compartment configured to contain a desiccant and a passage connecting the second compartment to the first compartment.

[0021] In some implementations, the tray also includes a third compartment configured to accommodate vials for one or more external processes from multiple tray assemblies.

[0022] In some embodiments, the tray also includes a flange formed together with the first, second, and / or third compartments and configured to engage with the instrument's guide rails. In some such embodiments, the flange includes a chamfered edge to prevent misplacement of the flange within the instrument.

[0023] In some embodiments, the tray further includes: a plurality of sealing ribs formed on the upper surface of the flange and configured to engage with a sealing membrane; at least one gripping member formed on the flange and configured to facilitate easy gripping of the tray; a plurality of structural ribs formed on the stepped supports of the flange and / or the first compartment and configured to enhance the strength of the tray; at least one guide member formed on the flange and configured to indicate the proper orientation of the tray; a feedback member formed on the flange and configured to provide feedback on the placement of the tray; a fourth compartment for accommodating a reagent pack, a pipette pack, or both; or any combination thereof.

[0024] In some embodiments, this disclosure provides a reagent kit comprising a plurality of wells. Each corresponding well in the plurality of wells includes a corresponding opening, a corresponding closed bottom, and a corresponding circumferential sidewall located between the corresponding opening and the corresponding closed bottom and formed with a corresponding predefined profile. The angle of the corresponding predefined profile relative to the axis of the corresponding well increases from the corresponding opening of the corresponding well to the corresponding closed bottom.

[0025] In another embodiment, a tray includes a first compartment configured for stacking a plurality of tray assemblies. The first compartment is generally circular and includes a stepped support comprising a plurality of steps along an axial direction of the first compartment and configured to receive corresponding tray assemblies of the plurality of tray assemblies, each corresponding tray assembly characterized by a corresponding diameter among a plurality of diameters. The first compartment also includes at least one axial retaining member formed at or adjacent to each of the plurality of steps and configured to prevent axial movement of the corresponding tray assemblies of the plurality of tray assemblies when placed in the first compartment. The first compartment also includes at least one angular retaining member formed at or adjacent to each of the plurality of steps and configured to prevent rotation of the corresponding tray assemblies of the plurality of tray assemblies about an axis of the first compartment when placed in the first compartment. The tray also includes a second compartment configured to contain a desiccant, a third compartment configured to contain vials for one or more external processes from the plurality of tray assemblies, and a reagent pack comprising a plurality of orifices, each corresponding orifice comprising a corresponding opening, a corresponding closed bottom, and a corresponding circumferential sidewall located between the corresponding opening and the corresponding closed bottom and formed with a corresponding predefined profile, wherein the angle of the corresponding predefined profile relative to the axis of the corresponding orifice increases from the corresponding opening to the corresponding closed bottom. The tray also includes: a fourth compartment for containing a reagent pack, a pipette pack, or both or any combination thereof; and one or more test strips comprising a reaction pad for colorimetric determination of samples such as urine, whole blood, plasma, serum, or other processed samples.

[0026] The apparatuses, systems, and methods disclosed herein have other features and advantages that will be apparent from or set forth in more detail in the accompanying drawings and the following detailed description, which together serve to explain certain principles of the exemplary embodiments of this disclosure. Attached Figure Description

[0027] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more exemplary embodiments of the present disclosure and, together with the detailed description, serve to explain the principles and specific implementation of the exemplary embodiments of the invention. The drawings are not necessarily drawn to scale. Specific design features of the invention disclosed herein (including, for example, specific dimensions, orientations, locations, and shapes) will be determined in part by the particular intended application and environment of use. Furthermore, the components shown in the figures can be combined in any useful number and combination.

[0028] In the attached diagram: Figure 1An exemplary tray assembly according to some exemplary embodiments of this disclosure is shown in an exploded view; Figures 2A to 2E An exemplary tray according to some embodiments of this disclosure is shown in top view; Figures 3A to 3J Together, they illustrate exemplary processes for manufacturing exemplary pallet assemblies according to some embodiments of this disclosure; Figure 4A An exemplary open support kit assembly and an exemplary open tray assembly prepared for insertion into an exemplary instrument drawer are shown in perspective view according to some embodiments of the present disclosure; Figure 4B A perspective view shows an exemplary instrument drawer inserted according to some embodiments of the present disclosure. Figure 4A Exemplary open support kit components and exemplary open tray components; Figure 5 The perspective view illustrates the engagement of an exemplary disk assembly with an exemplary tray according to some embodiments of the present disclosure; Figure 6 A perspective view illustrates a detection strip for transferring a sample onto an exemplary tray according to some embodiments of this disclosure; Figure 7 Perspective views illustrate the return of used components to an exemplary open support kit assembly and an exemplary open tray assembly according to some embodiments of this disclosure; Figure 8 An exemplary support package component according to some embodiments of this disclosure is illustrated in an exploded view; Figure 9A Exemplary reagent kits according to some embodiments of this disclosure are shown in top, side, and bottom views; Figures 9B to 9D An exemplary reagent package according to some embodiments of this disclosure is shown in perspective view; Figures 9E to 9J Exemplary reagent kits according to some embodiments of this disclosure are shown; Figures 10A to 10H Together, we illustrate exemplary processes for manufacturing exemplary support packages according to some embodiments of this disclosure; Figure 11A An exemplary integrated kit according to some embodiments of this disclosure is illustrated in an exploded diagram; Figure 11B Shown in perspective Figure 11A An exemplary integrated kit.

[0029] Figure 12A An exemplary integrated support package according to some embodiments of this disclosure is shown in perspective view; Figure 12B and Figure 12C Some embodiments according to this disclosure are shown. Figure 12A An exemplary integrated support package in the case of folding and unfolding; Figure 13A A second embodiment of the tray according to some aspects of this disclosure is shown in a perspective top view; Figure 13B Shown in top view Figure 13A An example tray; Figure 13C Shown from below Figure 13A An exemplary tray; and Figure 14 A third embodiment of the tray according to some aspects of this disclosure is shown in top view. Detailed Implementation

[0030] Referring now to the accompanying drawings, the same reference numerals always denote the same elements. Figure 1 Exemplary tray assembly 100 according to some embodiments of the present disclosure is shown. Tray assembly 100 includes a tray 102, a detection strip 104, an outer vial 106, a desiccant 108, a first capping layer 110, a first lyophilized reagent bead 112, a first tray 114, a second capping layer 116, a second lyophilized reagent bead 118, a second tray 120, a third capping layer 122, a third lyophilized reagent bead 124, a third tray 126, and a tray sealing film 128. In some embodiments, the first capping layer 110, the first lyophilized reagent bead 112, and the first tray 114 are partially assembled to form a first tray assembly 109. In some embodiments, the second capping layer 116, the second lyophilized reagent bead 118, and the second tray 120 are partially assembled to form a second tray assembly 115. In some embodiments, the third capping layer 122, the third lyophilized reagent bead 124, and the third tray 126 are partially assembled to form a third tray assembly 121.

[0031] Although Figure 1 The tray assembly 100 is shown to include three tray assemblies, but it should be noted that this is by way of example and the invention is not limited thereto. For example, in some embodiments, the tray assembly 100 may include a single tray assembly (e.g., any one of the first tray assembly 109, the second tray assembly 115, and the third tray assembly 121) or two tray assemblies (e.g., any two of the first tray assembly 109, the second tray assembly 115, and the third tray assembly 121). In some embodiments, the tray assembly 100 may be configured to have more than three tray assemblies. Furthermore, in Figure 1In the case shown where the tray assembly 100 includes a detection strip 104, an outer vial 106, and a desiccant 108, it should be noted that the tray assembly 100 may, but does not necessarily, include the detection strip 104, the outer vial 106, and the desiccant 108. In other words, the detection strip 104, the outer vial 106, and the desiccant 108 are optional or additional components. Furthermore, in some embodiments, the tray assembly 100 may include... Figure 1 Other alternative, optional, or additional components not shown. Furthermore, the reagent can be in various forms and can be dry or wet. For example, the reagent can be in many other forms different from reagent beads. The reagent can be dispensed and dried in a dish or on a capping layer.

[0032] As shown in the following figures, in some embodiments, one or more test strips 104 are inserted into tray 102. In some embodiments, the outer vial 106 may include additional lyophilized reagent beads and may be sealed, for example, with foil that can be punctured during liquid filling and mixing of the outer vial 106. In some embodiments, a desiccant 108 may be placed in tray 102 and provides drying for the test strips 104, the first lyophilized reagent bead 112, the second lyophilized reagent bead 118, the third lyophilized reagent bead 124, and the additional lyophilized reagent beads in the outer vial 106. In some embodiments, the first tray assembly 109, the second tray assembly 115, and / or the third tray assembly 121 are clamped into tray 102, as shown in the following figures. After placing one or more test strips 104, the outer vial 106, the desiccant 108, the first tray assembly 109, the second tray assembly 115, the third tray assembly 121, and the additional lyophilized beads into tray 102, the tray is sealed with tray sealing film 128.

[0033] Figure 2ASome additional or optional features of a tray 102 according to some embodiments of the present disclosure are shown. In some embodiments, the tray 102 includes feedback members (such as haptic feedback recesses 204), one or more positioning flanges 206, one or more guide members (such as guide arrows 208), one or more gripping members (such as thumb handles 210), identification marks 212, tray chamfers 205, or any combination thereof. In some embodiments, the haptic feedback recesses 204 provide haptic feedback to the user when the tray 102 is inserted into the instrument, as shown in the following figures. When the tray 102 is fully inserted, the tray snaps into place as the haptic feedback recesses 204 fall into matching recesses in the instrument. In some embodiments, as the tray 102 is inserted into the instrument, one or more positioning flanges 206 align the tray 102 (e.g., from left to right). Sufficient clearance is provided on each side to allow easy insertion of the tray 102 into the instrument. In some implementations, the tray chamfer 205, guide arrow 208, and / or identification mark 212 indicate the correct insertion orientation to the user, while one or more thumb handles 210 provide a gap for removing the previously shown tray sealing film 128.

[0034] Figure 2B Some additional or optional features of a tray 102 according to some embodiments of the present disclosure are shown. In some embodiments, the tray 102 includes a first compartment 215 (e.g., a space surrounded by a stepped tray support 218) configured to accommodate one or more tray assemblies, such as a first tray assembly 109, a second tray assembly 115, a third tray assembly 121, or any combination thereof. In some embodiments, the tray 102 includes one or more additional compartments configured to accommodate one or more additional components, such as a second compartment (e.g., a desiccant recess 220) and / or a third compartment (an external vial recess 222). In some embodiments, the tray 102 includes other additional or optional features.

[0035] For example, in some embodiments, tray 102 includes one or more sealing ribs 214, one or more structural ribs 216, stepped tray support 218, desiccant recess 220, external vial recess 222, or any combination thereof. In some embodiments, one or more sealing ribs 214 provide surfaces on tray 102 for bonding to the previously shown tray sealing film 128. The total surface area of ​​the sealing ribs 214 may be increased or decreased to increase or decrease the bonding strength between tray 102 and tray sealing film 128, thereby making removal of tray sealing film 128 from tray 102 more or less difficult. In some embodiments, one or more structural ribs 216 may be added at various locations on tray 102 to increase the flexural strength of tray 102. In some embodiments, desiccant recess 220 receives the previously shown desiccant 108, thereby providing an unobstructed path for moisture to migrate throughout tray 102. In some embodiments, external vial recess 222 may receive the previously shown external vial 106. The outer vial 106 can accommodate additional lyophilized reagent beads and provides an off-disc manner for reconfiguring additional lyophilized reagent beads. In some embodiments, the stepped disk support 218 provides unique positioning for each disk inserted into the tray 102. When inserted into the tray 102, the first disk assembly 109 is located on the bottom step of the stepped disk support 218, the second disk assembly 115 is located on the middle step of the stepped disk support 218, and the third disk assembly 121 is located on the top step of the stepped disk support 218. This provides precise positioning of the first disk assembly 109, the second disk assembly 115, and the third disk assembly 121 on the tray 102.

[0036] Although the stepped disk support 218 is shown to include three steps, it should be noted that this is exemplary and not limiting. The stepped disk support 218 can be configured to include any suitable number of steps, such as one, two, three, four, five, or more than five steps. In some embodiments, the stepped disk support 218 is configured for vertically stacking multiple disk assemblies, wherein when adjacent disk assemblies are placed in the first compartment 215 (e.g., when located on the steps of the stepped disk support 218), the adjacent disk assemblies are spaced apart from each other along the axial direction of the first compartment 215. It should be noted that the stepped disk support 218 with multiple steps can, but does not necessarily have to, hold multiple disk assemblies. For example, the stepped disk support 218 with multiple steps can be used to hold a single disk assembly.

[0037] Figure 2CSome additional or optional features of a tray 102 according to some embodiments of the present disclosure are shown. In some embodiments, the tray 102 includes a detection strip area 224, a support feature 226, a code placement feature 228, a center positioning feature 230, a detection strip positioning mark 232, a desiccant channel 234, or any combination thereof. In some embodiments, the detection strip area 224 provides an area on the tray 102 for placing one or more detection strips 104 as previously shown. Positioning one or more detection strips 104 in the detection strip area 224 allows easy access to these tray assemblies after removal of the first tray assembly 109, the second tray assembly 115, and the third tray assembly 121 from the tray 102. A sample can be applied to one or more detection strips 104, and the color of one or more detection strips 104 can be read by an imaging device in an instrument. In some embodiments, one or more detection strips 104 can be adhesively attached to the detection strip area 224, or can be clipped into a recess in the detection strip area 224. In some embodiments, the test strip positioning mark 232 may be used in the manufacture of the tray assembly 100 and may also be used by the instrument when inspecting one or more test strips 104. In some embodiments, a support feature 226 may be included in the tray 102 to provide balance when the tray 102 is placed on a surface before insertion into the instrument. For example, in some embodiments, the support feature 226 is flush with the bottom of the center positioning feature 230 and / or the second compartment to facilitate placing the tray on the surface. In some embodiments, the code placement feature 228 allows machine-readable information (such as calibration information, test menus, expiration dates, etc.) to be placed on tray 102. In some embodiments, the centering feature 230 engages with a recess in the instrument (e.g., placement feature 401) to provide precise positioning of tray 102 within the instrument (e.g., to prevent lateral and angular movement of the tray when it is placed in the instrument). In some embodiments, the centering feature has a generally triangular cross-section. In some embodiments, the desiccant channel 234 provides an unobstructed path between the first tray assembly 109, the second tray assembly 115, the third tray assembly 121, the detection strip 104, and the desiccant 108, thereby allowing moisture to be absorbed by the desiccant 108.

[0038] Figure 2DSome additional or optional features of a tray 102 according to some embodiments of the present disclosure are shown. In some embodiments, the tray 102 includes at least one axial retaining member, such as a first tray retaining feature 236, a second tray retaining feature 238, or a third tray retaining feature 240, which is formed at or adjacent to each step (e.g., a bottom step, a middle step, or a top step) and configured to prevent undesirable axial movement of the corresponding tray assembly (e.g., the first tray assembly 109, the second tray assembly 115, or the third tray assembly 121) when the corresponding tray assembly is placed in a compartment (e.g., when placed on the step of a stepped tray support 218). In some embodiments, at least one axial retaining member formed at or adjacent to different steps is circumferentially staggered relative to each other. In some embodiments, at least one axial retaining member formed at each step comprises two, three, four, or more axial retaining members circumferentially spaced apart from each other.

[0039] As a non-limiting example, tray 102 is shown to include one or more first tray retaining features 236, one or more second tray retaining features 238, and one or more third tray retaining features 240. As the first tray assembly 109 is pressed into tray 102 during assembly, the outer periphery of the first tray assembly 109 contacts one or more first tray retaining features 236, providing a slight interference fit to retain the first tray assembly 109 in tray 102. This interference fit is not excessive, allowing the first tray assembly 109 to be easily removed by the instrument in subsequent steps. As the second tray assembly 115 is pressed into tray 102 during assembly, the outer periphery of the second tray assembly 115 contacts one or more second tray retaining features 238, providing a slight interference fit to retain the second tray assembly 115 in tray 102. As the third tray assembly 121 is pressed into tray 102 during assembly, the outer periphery of the third tray assembly 121 contacts one or more third tray retaining features 240, providing a slight interference fit to retain the third tray assembly 121 in tray 102. The first tray assembly 109 has the smallest tray diameter and is inserted into the tray 102 first during manufacturing. The second tray assembly 115 has the second largest diameter and is inserted into the tray 102 after the first tray assembly 109. The third tray assembly 121 has the largest tray diameter and is inserted into the tray 102 after the second tray assembly 115. Tray retaining features secure the trays during transport, provide precise positioning within the tray 102, and allow for removal of the trays from the tray 102 by instruments at the appropriate time.

[0040] Figure 2ESome additional or optional features of a tray 102 according to some embodiments of the present disclosure are shown. In some embodiments, the tray 102 includes at least one angular retaining member, such as a first angular lock 242, a second angular lock 244, or a third angular lock 246, which is formed at or adjacent to each step (e.g., a bottom step, a middle step, or a top step) and is configured to prevent undesirable rotation of the corresponding tray assembly (e.g., the first tray assembly 109, the second tray assembly 115, or the third tray assembly 121) about the axis of the compartment when the corresponding tray assembly is placed in the compartment (e.g., when placed on the step of the stepped tray support 218). In some embodiments, at least one angular retaining member formed at one or more steps consists of a single angular retaining member.

[0041] As a non-limiting example, tray 102 is shown including a first angular lock 242, a second angular lock 244, and a third angular lock 246. In some embodiments, the first angular lock 242 is a molded feature in tray 102 that engages a notch in the side of a first tray assembly 109, thereby providing precise rotational positioning of the first tray assembly 109 in tray 102. As shown in the following figures, it is important to position the tray in tray 102 precisely and rotationally along the x, y, and z axes. In some embodiments, the second angular lock 244 is a molded feature in tray 102 that engages a notch in the side of a second tray assembly 115, thereby providing precise rotational positioning of the second tray assembly 115 in tray 102. In some embodiments, the third angular lock 246 is a molded feature in tray 102 that engages a notch in the side of a third tray assembly 121, thereby providing precise rotational positioning of the third tray assembly 121 in tray 102. One important function of tray 102 is to precisely position the first tray assembly 109, the second tray assembly 115, and the third tray assembly 121 for subsequent processing by the instrument.

[0042] Figures 3A to 3J The step-by-step assembly of a tray assembly 100 according to some embodiments of the present disclosure is shown.

[0043] Figure 3A The tray 102 is shown to be empty and ready to be loaded with various parts.

[0044] exist Figure 3BIn some embodiments of this disclosure, one or more test strips 104 are placed in tray 102. As previously described, one or more test strips 104 can be attached to tray 102 in various ways, such as adhesive bonding or interference bonding such as clamping recesses. One or more test strips 104 can perform a wide variety of colorimetric determinations on samples such as urine, whole blood, plasma, serum, or other processed samples. It should be noted that placing one or more test strips 104 in tray 102 is an optional or additional step. Depending on the application, tray assembly 100 may or may not include one or more test strips 104.

[0045] exist Figure 3C In some embodiments of this disclosure, an external vial 106 is placed in a tray 102. The external vial 106 provides an additional extra-disc chamber for sample processing. Samples and / or diluents can be added to and mixed in the external vial 106. The external vial 106 may contain reagents, such as liquids and / or lyophilized reagent beads. Although a single external vial 106 is shown in tray 102, additional external vials may be added in other locations within tray 102. The external vial 106 may be sealed with a membrane or foil, which can be punctured by the instrument using a pipette tip. The solution in the external vial 106 can be transferred back to the first tray assembly 109, the second tray assembly 115, and / or the third tray assembly 121 for further processing and analysis. It should be noted that placing the external vial 106 in tray 102 is an optional or additional step. Depending on the application, tray assembly 100 may or may not include the external vial 106.

[0046] exist Figure 3D In some embodiments of this disclosure, a desiccant 108 is placed in a tray 102. The desiccant 108 controls the humidity level in the tray 102 and may include various desiccant materials, such as silica gel, molecular sieves, etc. The desiccant 108 is typically packaged in a material that transmits water vapor, such as Tyvek. The function of the desiccant 108 is to keep the lyophilized reagent beads and one or more test strips 104 dry, thereby extending their shelf life. It should be noted that placing the desiccant 108 in the tray 102 is an optional or additional step. In some embodiments, the tray assembly 100 may or may not include the desiccant 108.

[0047] exist Figure 3EAccording to some embodiments of this disclosure, a first tray assembly 109 is placed in a tray 102. The first tray assembly 109 is inserted into the tray 102 until it rests on the bottom step of the stepped tray support 218 and is held in the tray 102 by an interference fit with the first tray retaining feature 236. The bottom step of the stepped tray support 218 and the interference fit with the first tray retaining feature 236 provide precise positioning of the first tray assembly 109 in the tray 102 and provide secure packaging for storage and transport.

[0048] exist Figure 3F In some embodiments of this disclosure, a second tray assembly 115 is placed in a tray 102. The second tray assembly 115 is inserted into the tray 102 until it is positioned on the intermediate step of the stepped tray support 218 and held in the tray 102 by an interference fit with the second tray retaining feature 238. The intermediate step of the stepped tray support 218 and the interference fit with the second tray retaining feature 238 provide precise positioning of the second tray assembly 115 in the tray 102 and provide secure packaging for storage and transport.

[0049] exist Figure 3G In some embodiments of this disclosure, a third tray assembly 121 is placed in a tray 102. The third tray assembly 121 is inserted into the tray 102 until it is positioned on the top step of the stepped tray support 218 and held in the tray 102 by an interference fit with the third tray retaining feature 240. The bottom step of the stepped tray support 218 and the interference fit with the third tray retaining feature 240 provide precise positioning of the third tray assembly 121 in the tray 102 and provide secure packaging for storage and transport.

[0050] Although Figures 3E to 3G Three trays are shown placed in tray 102, but it should be noted that this is exemplary and not limiting. In some embodiments, tray assembly 100 is assembled with one tray (e.g., any one of first tray assembly 109, second tray assembly 115, and third tray assembly 121). In some embodiments, tray assembly 100 is assembled with two trays (e.g., any two of first tray assembly 109, second tray assembly 115, and third tray assembly 121).

[0051] exist Figure 3HIn some embodiments of this disclosure, a tray sealing film 128 is attached to a tray 102 to seal the tray 102 and protect its contents from contamination. The tray sealing film 128 may be made of a moisture-permeable material, such as Tyvek, or it may be moisture-blocking, such as a laminate comprising aluminum foil. In some embodiments, the tray sealing film 128 includes tabs at its corners that can be used when removing the tray sealing film 128 from the tray prior to use of the tray 102.

[0052] exist Figure 3I In some embodiments of this disclosure, code 300 is printed on the back of tray assembly 100. Code 300 provides machine- and / or human-readable information, which may include batch-specific data, calibration information, expiration date, measurement type, etc. If code 300 includes machine-readable data, code 300 may be imaged by the instrument before or after tray assembly 100 is inserted into the instrument. It should be noted that printing code 300 on tray 102 is an optional or additional step. In some embodiments, tray assembly 100 may or may not include code 300 printed on tray 102.

[0053] exist Figure 3J In some embodiments of this disclosure, tray assembly 100 is placed in foil bag 301 and sealed. Foil bag 301 may be made of various materials, such as foil laminates, sputtered films, and / or barrier polymers. Foil bag 301 provides protection against moisture transmission and light. Materials with low moisture transmittance are particularly desirable. Any moisture migrating through foil bag 301 is absorbed by desiccant 108 to protect the first lyophilized reagent beads 112, the second lyophilized reagent beads 118, the third lyophilized reagent beads 124, and lyophilized reagent beads that may be contained in an external vial 106. It should be noted that placing tray assembly 100 in foil bag 301 is an optional or additional step. In some embodiments, tray assembly 100 may or may not be placed in foil bag 301. In some embodiments, tray assembly 100 may be placed in an alternative bag, etc.

[0054] exist Figure 4A In this configuration, the open support kit assembly 402 and the open tray assembly 404 are prepared for insertion into the instrument drawer 400. Before insertion, the sealing film is removed from the open support kit assembly 402 and the open tray assembly 404, which allows the machine to access the contents of the open support kit assembly 402 and the open tray assembly 404.

[0055] exist Figure 4BIn some embodiments of this disclosure, the open support kit assembly 402 and the open tray assembly 404 are inserted into the instrument drawer 400. Regions in the proximal ends of the open support kit assembly 402 and the open tray assembly 404 provide handles for handling the components, while regions on the left and right edges of the components are aligned using guides within the drawer. Upon completion of insertion, features on the open support kit assembly 402 and the open tray assembly 404 provide tactile feedback regarding the completion of insertion. Once the open support kit assembly 402 and the open tray assembly 404 are fully inserted, they are precisely positioned in all directions.

[0056] In some embodiments, each angular retaining member (e.g., a first angular lock 242, a second angular lock 244, or a third angular lock 246) formed at each step (e.g., a bottom step, a middle step, or a top step) is configured to engage with a notch formed at the outer periphery of the corresponding disc assembly (e.g., a first disc assembly 109, a second disc assembly 115, or a third disc assembly 121). As a non-limiting example, Figure 5 The diagram shows the third disc notch 502 of the third disc assembly 121 engaging with the third angular lock 246, thereby providing precise angular positioning of the third disc assembly 121. Precise angular positioning is important in embodiments where the gripper assembly 506 cannot rotate the third disc assembly 121.

[0057] exist Figure 6 In some embodiments of this disclosure, the sample is transferred from the instrument to the test strip 104. Once the first tray assembly 109, the second tray assembly 115, and the third tray assembly 121 are removed from the tray 102 by the instrument, one or more test strips 104 are exposed. At this point, the robotic pipette 600 can apply aliquots of the sample to the reaction pad 602, one pad at a time. Small amounts of sample can be applied to each pad, with a volume of approximately a few microliters. As a non-limiting example, in Figure 6 The diagram shows 14 small reaction pads, each capable of performing different assays. The volume is controlled so that the sample remains within each small reaction pad. After a predetermined time interval, the reaction pad 602 can be imaged by the instrument, thus correlating the color with the analyte concentration. In this way, additional assays and other sample types can be analyzed in addition to those contained in the first disk assembly 109, the second disk assembly 115, and the third disk assembly 121.

[0058] In some implementations, upon completion of inspection, the used components are returned to the open support kit assembly 402 and the open tray assembly 404, such as... Figure 7As shown. The open support kit assembly 402 and the open tray assembly 404 may be biohazardous after use and can be appropriately disposed of. The open support kit assembly 402 will contain unused reagent solutions and used pipette tips. If a biohazardous sample is handled, the open support kit assembly 402 will be biohazardous. The open tray assembly 404 will contain used test strips 104, as well as used first tray assembly 109, second tray assembly 115, third tray assembly 121, and / or external vials 106. If a biohazardous sample is handled, the open tray assembly 404 will be biohazardous. By containing biohazardous components in the open tray assembly 404 and the open tray assembly 405, the disposal of biohazardous components becomes easier. Even with many components, the user only needs to handle two components, namely the open support kit assembly 402 and the open tray assembly 404.

[0059] Figure 8 This is an exploded view illustrating an exemplary support pack assembly 800 according to some embodiments of the present disclosure. In some embodiments, the support pack assembly 800 includes a reagent pack 802, a reagent pack seal 804, a tip pack 806, a pipette tip 808, and a tip pack seal 810. The reagent pack 802 is described in more detail in the following figures, and in some embodiments, the reagent pack is injection molded from a polyolefin or similar material. It includes various reagent wells. In some embodiments, the reagent pack also includes ribs for sealing, various alignment features, snaps, or any combination thereof. The reagent pack seal 804 is a puncture-resistant sealing membrane that provides an airtight seal around the reagent wells and can be punctured by an instrument if needed. The tip pack 806 is also injection molded from a polyolefin or similar material and provides a housing for the pipette tip 808. The pipette tip 808 can be removed from the tip pack 806 using an instrument if necessary. The pipette tip pack seal 810 provides a temporary cap to prevent removal of pipette tips 808 from the pipette tip pack 806 until necessary. The pipette tip pack seal 810 is typically removed from the pipette tip pack 806 before inserting the support pack assembly 800 into the instrument.

[0060] Figure 9A A reagent pack 802 according to some embodiments of the present disclosure is shown. In some embodiments, the reagent pack 802 includes a first reagent well 900, at least one second reagent well 902, at least one third reagent well 904, at least one fourth reagent well 906, or any combination thereof. The first reagent well 900 has the smallest volume, while the second reagent well 902, the third reagent well 904, and the fourth reagent well 906 have larger volumes, depending on the requirements of the support pack assembly 800. In different embodiments, the number and size of the reagent wells may vary, and Figure 9AThe geometry shown is a non-limiting example. During manufacturing, the reagent orifice is filled with liquid reagent, which is used by the instrument at various points during the measurement.

[0061] Figure 9B Some additional or optional features of a reagent pack 802 according to some embodiments of the present disclosure are shown. In some embodiments, a sealing rib 908 is present around each reagent orifice. The sealing rib 908 provides a specific area around each reagent orifice where a heat seal of the reagent pack seal 804 can occur, thereby providing an airtight seal for each reagent orifice.

[0062] Figure 9C Some additional or optional features of a reagent pack 802 according to some embodiments of the present disclosure are shown. In some embodiments, the reagent pack 802 includes a thumb handle 910 and / or one or more retaining pins 912. The thumb handle 910 provides a recess in which a user can grip the reagent pack 802 when inserting it into and removing it from the instrument. The one or more retaining pins 912 provide a manner for aligning the reagent pack 802 when securing it to the pipette tip pack 806. The one or more retaining pins 912 provide precise positioning of the reagent pack 802 relative to the pipette tip pack 806.

[0063] Figure 9D Some additional or optional features of a reagent pack 802 according to some embodiments of the present disclosure are shown. In some embodiments, the reagent pack 802 includes one or more snap-fit ​​feature cutouts 914. The one or more snap-fit ​​feature cutouts 914 provide a manner for attaching the reagent pack 802 to the pipette tip pack 806. The one or more snap-fit ​​feature cutouts 914 provide precise positioning of the reagent pack 802 relative to the pipette tip pack 806 and prevent them from disengaging.

[0064] Figure 9E Some additional or optional features of a reagent package 802 according to some embodiments of the present disclosure are shown. Cross-sectional view AA shows the geometry of various reagent orifices. As shown in cross-section AA, the reagent orifice includes an opening, a closed bottom, and circumferential sidewalls located between the opening and the closed bottom. The circumferential sidewalls have a variable draft angle 916 relative to the axis of the reagent orifice. In some embodiments, the reagent orifice is formed with a predefined profile such that the draft angle 916 increases from the opening of the reagent orifice to the closed bottom. The variable draft angle 916 assists in the injection molding of the reagent package 802 and also helps in the filling, storage, and removal of reagents from the reagent orifice. The variable draft angle 916 helps to minimize unwanted air bubbles in the reagent orifice.

[0065] In some embodiments, reagent kit 802 includes a plurality of wells. In some embodiments, the plurality of wells includes at least two wells having substantially the same predefined profile. In some embodiments, the plurality of wells includes at least two wells having different predefined profiles. In some embodiments, the plurality of wells includes multiple sets of wells, each set including one or more wells. In some embodiments, the inner surface of each well in the plurality of wells is polished to reduce bubbling during transport.

[0066] Figure 9F Exemplary pipette tip pack 806 according to some embodiments of the present disclosure is shown in top, side, and bottom views. In some embodiments, pipette tip pack 806 includes various pipette tip nests 918, each pipette tip nest capable of accommodating pipette tips. The pipette tips are loaded into pipette tip pack 806 during manufacturing, can be removed by the instrument during assay, and can be returned to pipette tip pack 806 for disposal after use.

[0067] Figure 9G Some additional or optional features of a pipette tip pack 806 according to some embodiments of the present disclosure are shown in top, side, and bottom views. In some embodiments, the pipette tip pack 806 includes one or more snap-fit ​​features 920 for attaching the pipette tip pack 806 to the reagent pack 802 during manufacturing. The one or more snap-fit ​​features 920 provide precise positioning of the pipette tip pack 806 and the reagent pack 802, which is important when inserting the support pack assembly 800 into the instrument.

[0068] Figure 9H Some additional or optional features of a pipette tip pack 806 according to some embodiments of the present disclosure are shown in top, side, and bottom views. In some embodiments, the pipette tip pack 806 includes one or more pipette tip pack placement holes 922 that engage with one or more placement pins 912 on a reagent pack 802, thereby ensuring precise positioning between the pipette tip pack 806 and the reagent pack 802. Precise positioning is important when the instrument picks up and discards pipette tips, picks up and discards reagents, and interacts with the support pack assembly 800.

[0069] Figure 9I Some additional or optional features of a pipette tip pack 806 according to some embodiments of the present disclosure are shown. In some embodiments, the pipette tip pack 806 includes one or more pipette tip pack cutouts 924 that engage with one or more snap-fit ​​feature cutouts 914 on the reagent pack 802, thereby ensuring precise positioning between the pipette tip pack 806 and the reagent pack 802. As previously stated, precise positioning is important when the instrument picks up and discards pipette tips, picks up and discards reagents, and interacts with the support pack assembly 800.

[0070] Figure 9JSome additional or optional features of a pipette tip pack 806 according to some embodiments of the present disclosure are illustrated in top view, side view, and detailed view. In some embodiments, the pipette tip pack 806 includes a pipette tip interface 926. The pipette tip interface 926 provides precise positioning of the pipette tip in the instrument, while allowing the pipette tip to be freely removed from and returned to the pipette tip pack 806. Precise positioning of the pipette tip is particularly important when it is picked up by the pipetting mechanism in the instrument, and although slight movement is required when the tip is engaged with the instrument, it should not be excessive.

[0071] Figures 10A to 10H An exemplary support package assembly according to some embodiments of this disclosure is shown.

[0072] The assembly process begins with an empty reagent kit 802, such as... Figure 10A As shown.

[0073] Figure 10B A reagent pack 802 according to some embodiments of the present disclosure is shown. In some embodiments, the reagent pack 802 includes a first reagent well 900, a second reagent well 902, a third reagent well 904, and a fourth reagent well 906. The reagent wells can be precisely filled with various liquid reagents.

[0074] like Figure 10C As shown, after filling the first reagent hole 900, the second reagent hole 902, the third reagent hole 904, and the fourth reagent hole 906 with reagent, the reagent package 802 is sealed with the reagent package seal 804, thereby obtaining a sealed reagent package 1000. As previously described, the reagent package seal 804 is sealed to the reagent package 802 using a heat seal, although in an alternative embodiment, an adhesive or inductive seal may be used to seal the reagent package seal 804 to the reagent package 802. It is important that the reagent package seal 804 is fully bonded to the reagent package 802 to prevent reagent leakage or cross-contamination.

[0075] Figure 10D An empty suction head pack 806 is shown. In a preferred embodiment, the suction head pack 806 is injection molded using a polyolefin or similar material.

[0076] exist Figure 10E In this process, pipette tips 808 are inserted into tip pack 806, resulting in a filled tip pack 1002. Although the pipette tips 808 are precisely positioned within the tip pack 806, they can be freely removed from the instrument and then replaced. As previously mentioned, in a preferred embodiment, the pipette tips 808 are injection molded using polyolefin or similar materials.

[0077] exist Figure 10FIn this process, the pipette tip pack seal 810 is sealed to the filled pipette tip pack 1002, resulting in a sealed pipette tip pack 1004. The pipette tip pack seal 810 protects the pipette tips 808 from debris and prevents them from falling out of the pipette tip pack 806 during transport. Since the barrier properties of the pipette tip pack seal 810 are not critical and it does not need to be punctured by the instrument, a variety of materials can be used for the pipette tip pack seal 810. The pipette tip pack seal 810 can be attached to the filled pipette tip pack 1002 using methods such as heat sealing, adhesive bonding, or inductive sealing.

[0078] exist Figure 10G In the middle, the sealed suction head package 1004 is connected by a snap-fit ​​feature cutout 914 and a snap-fit ​​feature 920 (such as...). Figure 9G (As shown) is attached to the sealed reagent pack 1000 to obtain a sealed support pack 1006. When it is necessary to insert the support pack into the instrument, the reagent pack seal 804 and the pipette tip pack seal 810 can be removed before insertion.

[0079] exist Figure 10H In this embodiment, a sealed support package 1006 is packaged within a support bag 1008 for storage. The support bag 1008 can be made of a variety of materials, with materials having low moisture permeability being particularly desirable. Such materials will minimize liquid evaporation from the sealed support package 1006 during long-term storage.

[0080] Figure 11A Exemplary integrated kit 1100 according to some embodiments of this disclosure is shown. In some embodiments, tray 1102 includes a desiccant 1104, a first tray assembly 1106, a second tray assembly 1108, a third tray assembly 1110, pipette tips 1111, tip packs 1112, reagent pack seals 1114, reagent packs 1116, or any combination thereof. In some embodiments, the space and / or features on tray 1102 for receiving pipette tips 1111, tip packs 1112, reagent pack seals 1114, reagent packs 1116, or any combination thereof are referred to herein as a fourth compartment 1117. It is not that the open support kit assembly 402 and the open tray assembly 404 are inserted into the instrument drawer 400 (e.g., Figure 4A and Figure 4B (As shown), instead of inserting the integrated kit 1100 into the instrument.

[0081] like Figure 11B As shown, when manufacturing the integrated kit 1100, a tray sealing film 1118 can be sealed to the tray 1102. The tray sealing film 1118 protects the contents of the integrated kit 1100 from contamination and can be removed before the integrated kit 1100 is inserted into the instrument.

[0082] Figure 12A Alternative embodiments of the support package according to some embodiments of the present disclosure are shown. In some embodiments, the integrated support package 1200 includes a reagent package portion 1202, a pipette tip package portion 1204, and an integrated hinge 1206. Instead of having separate reagent and pipette tip packages connected during manufacturing as shown in the preceding figures, the integrated support package 1200 is characterized in that the reagent and pipette tip packages are connected during the molding process, and thus characterized by an integrated structure. The reagent package portion 1202 and the pipette tip package portion 1204 are connected during injection molding via the integrated hinge 1206. Figure 12B As shown, the reagent kit portion 1202 and the tip kit portion 1204 are pivotable about an axis created by the integrated hinge 1206, thereby providing a smaller profile assembly with a smaller profile for subsequent packaging operations. As described in previous embodiments, the reagent kit portion 1202 may be filled with liquid reagents and sealed with foil during manufacturing, while the tip kit portion 1204 may be filled with pipette tips and sealed with a removable film. The integrated hinge 1206 is typically not covered by foil or film.

[0083] Figure 12B The integrated support package 1200 is shown in both its unfolded and folded states. After the reagent package portion 1202 is filled with liquid reagent and sealed with foil, and after the pipette tip is placed into the tip package portion 1204 and sealed with a membrane, the integrated support package 1200 folds along the integrated hinge 1206, as shown. Figure 12B As shown. In its folded state, the integrated support bag 1200 has a smaller profile, which may be advantageous for packaging and transportation.

[0084] Before use, the integrated support package 1200 is removed from its packaging (not shown) and unfolded, as follows: Figure 12C As shown. In the unfolded state, the sealing film is removed from the suction head package portion 1204, and the integrated support package 1200 can be inserted into the instrument for further processing.

[0085] Figures 13A to 13C A second embodiment of a tray, generally designated 202, is shown according to some aspects of this disclosure. Tray 202 is similar to a first embodiment of tray 102, except that tray 202 includes stacking features 1304, a knurled surface 1306, curved edges 1307, and ribs 1309 located on a central positioning feature. One or more stacking features 1304 may be added at various locations on the tray to protect it when stacked during transport. The knurled surface 1306 and curved edges 1307 provide the user with better grip and improved comfort during placement and retrieval of the tray into the instrument. The ribs 1309 serve as structural support for the central positioning feature and engage with a sensor button on the instrument to alert the instrument that the tray has been placed.

[0086] Figure 14 A third embodiment of a pallet according to some aspects of this disclosure is shown, which is generally designated as pallet 302. Pallet 302 is similar to a second embodiment of pallet 202, except that pallet 302 has a straight edge 1404.

[0087] The apparatus and methods disclosed herein can be used in a variety of applications, including but not limited to clinical chemistry, immunoassays, and hematology. Examples of clinical chemistry, immunoassays, and / or hematology are disclosed in WO 2018 / 119437, WO 2018 / 140719, WO 2022 / 029731, and WO 2022 / 029732, the contents of each of which are incorporated herein by reference in their entirety. The apparatus and methods disclosed herein can be operated or performed by systems similar to those disclosed in U.S. Patent Application No. 17 / 371,746, the contents of which are incorporated herein by reference in their entirety.

[0088] The following clauses describe some implementation plans or specific implementations: Clause A1. A pallet comprising: A first compartment, configured for stacking multiple disk assemblies, wherein the first compartment is generally circular and comprises: (i) A stepped support comprising a plurality of steps along the axial direction of the first compartment and configured to accommodate a corresponding disk assembly among the plurality of disk assemblies, the corresponding disk assembly being characterized by a corresponding diameter among a plurality of diameters; (iii) at least one axial retaining member, said at least one axial retaining member being formed at or adjacent to each of the plurality of steps and configured to prevent the corresponding disk assembly of the plurality of disk assemblies from moving in the axial direction when the corresponding disk assembly of the plurality of disk assemblies is placed in the first compartment; and (iv) At least one angular retaining member, the at least one angular retaining member being formed at or adjacent to each of the plurality of steps and being configured to prevent the corresponding disk assembly of the plurality of disk assemblies from rotating about the axis of the first compartment when the corresponding disk assembly of the plurality of disk assemblies is placed in the first compartment.

[0089] Clause A2. The tray as described in Clause A1, wherein the plurality of steps are configured such that when adjacent tray assemblies of the plurality of tray assemblies are placed in the first compartment, the adjacent tray assemblies are spaced apart from each other along the axial direction of the first compartment.

[0090] Clause A3. The tray as described in any of the preceding clauses, wherein the plurality of steps comprises two, three, four, five or more steps.

[0091] Clause A4. The tray as described in any of the preceding clauses, wherein the plurality of steps comprises: A first step, located at a first level and configured to accommodate a first disk assembly; and The second step is located at a second level above the first level and is configured to accommodate a second disk assembly that is larger than the first disk assembly.

[0092] Clause A5. The pallet as described in Clause A4, wherein the plurality of steps comprises: The third step is located at a third level above the second level and is configured to accommodate a third disk assembly that is larger than the second disk assembly.

[0093] Clause A6. The tray as described in any of the preceding clauses, wherein the plurality of tray assemblies comprises: A disk assembly designed for hematological testing; A disk assembly designed for clinical chemistry testing; A disk assembly constructed for performing immunochemical detection; or Any combination of them.

[0094] Clause A7. The tray as described in Clause A6, wherein the tray assembly configured for performing the immunochemical test is larger than the tray assembly configured for performing the clinical chemistry test, and the tray assembly configured for performing the clinical chemistry test is larger than the tray assembly configured for performing the hematological test.

[0095] Clause A8. The pallet as described in any of the preceding clauses, wherein the at least one axial retaining member formed at different or adjacent steps in the plurality of steps is circumferentially staggered relative to each other.

[0096] Clause A9. The pallet as described in any of the preceding clauses, wherein the at least one axial retaining member formed at each respective step of the plurality of steps comprises two, three, four or more axial retaining members spaced circumferentially from each other.

[0097] Clause A10. The tray as described in any of the preceding clauses, wherein each of the at least one angular retaining member formed at or adjacent to each of the plurality of steps is configured to engage with a notch formed at the outer periphery of the corresponding tray assembly in the plurality of tray assemblies.

[0098] Clause A11. The tray as described in any of the preceding clauses, wherein the at least one angular retaining member formed at or adjacent to each of the plurality of steps is composed of a single angular retaining member.

[0099] Clause A12. The pallet as described in any of the preceding clauses, wherein the first compartment further comprises: bottom wall; and A center positioning feature is formed on the bottom wall of the first compartment and configured to engage with an instrument placement feature to prevent lateral and angular movement of the tray when it is placed in the instrument.

[0100] Clause A13. The pallet as described in Clause A12, wherein the center positioning feature has a generally triangular cross-section.

[0101] Clause A14. The tray as described in any one of Clauses A12 to A13, wherein a support feature is formed at the bottom wall of the first compartment and flush with the bottom wall of the center positioning feature and the second compartment to facilitate placing the tray on the surface.

[0102] Clause A15. The tray as described in any one of Clauses A12 to A14, wherein the first compartment includes a designated area on the inner surface of the bottom wall for placing one or more detection strips.

[0103] Clause A16. The pallet as described in any of the preceding clauses, the pallet further includes: A second compartment, configured to contain a desiccant; and A passageway connecting the second compartment to the first compartment.

[0104] Clause A17. The pallet as described in any of the preceding clauses, the pallet further includes: A third compartment is configured to accommodate vials for one or more external processes from the plurality of disc assemblies.

[0105] Clause A18. The pallet as described in any of the preceding clauses, the pallet further includes: A flange, which is formed together with the first compartment, the second compartment and / or the third compartment and is configured to engage with the instrument's guide rail.

[0106] Clause A19. The tray as described in Clause A18, wherein the flange includes a chamfered edge to prevent misplacement of the flange in the instrument.

[0107] Clause A20. The pallet as described in any one of Clauses A18 to A19, wherein the pallet further comprises: Multiple sealing ribs are formed on the upper surface of the flange and are configured to engage with a sealing membrane; At least one gripping member is formed at the flange and configured to facilitate easy gripping of the tray; Multiple structural ribs are formed at the stepped support of the flange and / or the first compartment and are configured to enhance the strength of the tray. At least one guide member is formed at the flange and configured to indicate the proper orientation of the tray; A feedback member is formed at the flange and configured to provide feedback regarding the placement of the tray; A fourth compartment, said fourth compartment being used to accommodate a reagent pack, a pipette pack, or both; or Any combination of them.

[0108] Clause B1. A pallet assembly comprising: The tray as described in any of the preceding claims; At least one tray assembly, the at least one tray assembly being placed in the first compartment of the tray; and A sealing film, which engages with the tray to seal the at least one tray assembly within the first compartment of the tray.

[0109] Clause B2. The tray assembly as described in Clause B1, wherein the at least one tray assembly comprises two or more of the plurality of tray assemblies.

[0110] Clause B3. The tray assembly as described in Clause B1, wherein the at least one tray assembly comprises each of the plurality of tray assemblies.

[0111] Clause B4. The pallet assembly as described in any one of Clauses B1 to B3, wherein the pallet assembly further comprises: The desiccant is placed in the second compartment of the tray; The vial is placed in the third compartment of the tray; One or more detection strips placed on the bottom wall of the first compartment of the tray; or Any combination of them.

[0112] Clause C1. A method for manufacturing a pallet assembly, the method comprising: A) Obtain a pallet as described in any one of clauses A1 to A20; B) Optionally, one or more detection strips may be placed on the bottom wall of the first compartment of the tray; C) Optionally, the vial may be placed in the third compartment of the tray; D) Optionally, the desiccant may be placed in the second compartment of the tray; E) Place at least one tray assembly into the first compartment of the tray; F) Use a sealing film that engages with the tray to seal the first compartment, the second compartment, and / or the third compartment; G) Optionally, add codes and / or identifiers to the tray; and H) Optionally, the tray may be placed in a bag.

[0113] Clause C2. The method as described in Clause C1, wherein the placement (E) comprises placing two or more tray assemblies into the first compartment of the tray.

[0114] Clause C3. The method as described in Clause C1, wherein the placement (E) comprises placing each of the plurality of tray assemblies into the first compartment of the tray.

[0115] Clause D1. A pallet assembly comprising: Multiple disk assemblies, each disk assembly characterized by a corresponding diameter among a plurality of diameters; and The tray includes a first compartment configured for stacking the plurality of tray assemblies, wherein the first compartment is generally circular and includes a stepped support, and the stepped support includes a plurality of steps along the axial direction of the first compartment, each step being configured to receive a corresponding tray assembly among the plurality of tray assemblies.

[0116] Clause E1. A pallet assembly comprising: At least one disk assembly, each disk assembly including a notch formed at the outer periphery of the disk assembly; and The tray includes a first compartment configured to receive the at least one tray assembly, wherein the first compartment is generally circular and includes circumferential sidewalls, and the circumferential sidewalls of the first compartment include at least one angular retaining member, each angular retaining member engaging with a notch of a corresponding tray assembly in the at least one tray assembly to prevent the corresponding tray assembly from rotating about an axis of the first compartment.

[0117] Clause E2. A tray assembly as described in Clause E1, wherein the at least one tray assembly comprises a single tray assembly.

[0118] Clause E3. A tray assembly as described in Clause E1, wherein the at least one tray assembly comprises two or more tray assemblies.

[0119] Clause E4. The pallet assembly as described in any one of Clauses D1 to E3, wherein the pallet further comprises: The second compartment is configured to contain a desiccant; A passageway connecting the second compartment to the first compartment; A third compartment, which is configured to accommodate vials for one or more external processes; A fourth compartment, configured to accommodate a support package assembly; or Any combination of them.

[0120] Clause E5. The pallet assembly as described in Clause E4, wherein the pallet assembly further comprises: A desiccant, wherein the desiccant is disposed in the second compartment; vials, which are disposed in the third compartment and configured for one or more external processes from the plurality of disk assemblies; Support package assembly, the support package assembly being disposed in the fourth compartment; or Any combination of them.

[0121] Clause F1. A reagent kit comprising: A plurality of holes, each of the plurality of holes comprising: Corresponding openings; Corresponding to the closed bottom; and A corresponding circumferential sidewall is located between the corresponding opening and the corresponding closed bottom and is formed with a corresponding predefined profile, wherein the angle of the corresponding predefined profile relative to the axis of the corresponding hole increases from the corresponding opening to the corresponding closed bottom of the corresponding hole.

[0122] Clause F2. A reagent package as described in Clause F1, wherein the corresponding predefined profile is configured to assist injection molding of the reagent package, assist filling, storing and removing reagents from the corresponding orifice, assist minimizing unwanted air bubbles in the corresponding orifice, or any combination thereof.

[0123] Clause F3. A reagent kit as described in any one of Clauses F1 to F2, wherein the plurality of wells comprises at least two wells having substantially the same predefined profile.

[0124] Clause F4. A reagent kit as described in any one of Clauses F1 to F3, wherein the plurality of wells comprises at least two wells having different predefined profiles.

[0125] Clause F5. The reagent kit as described in any one of Clauses F1 to F4, wherein the plurality of wells comprises a plurality of sets of wells, each set of wells comprising one or more wells.

[0126] Clause F6. The reagent package as described in any one of Clauses F1 to F5, wherein the inner surface of each of the plurality of holes is polished to reduce bubbling during transport.

[0127] Clause F7. The reagent kit as described in any one of Clauses F1 to F6, the reagent kit further comprising: Multiple ribs, each rib surrounding the opening of a hole in the plurality of holes to facilitate sealing of the holes; At least one gripping component to facilitate easy gripping of the reagent pack; At least one guiding member to facilitate indicating the proper orientation of the reagent package; At least one engaging member to facilitate assembly with the suction head package; or Any combination of them.

[0128] Clause G1. A suction head pack, said suction head pack comprising: Multiple pipette tip nests, each pipette tip nest forming a tip interface to allow a corresponding pipette tip from the multiple pipette tips to be placed on the tip interface, thereby facilitating accurate pickup of the corresponding pipette tip with minimal movement.

[0129] Clause G2. The suction head kit as described in Clause G1, the suction head kit further comprising: At least one joining member and / or at least one placement member to facilitate assembly with the reagent package.

[0130] Clause H1. A support package assembly, the support package assembly comprising: A reagent kit as described in any one of the terms F1 to F7, which is connected to a pipette tip kit as described in any one of the terms G1 to G2.

[0131] Terminology and References The terminology used herein is for the purpose of describing a particular embodiment only and is not intended to limit the claims. As used in the description of the embodiments and the appended claims, the singular forms “a” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be understood that terms such as “left” or “right,” “top” or “bottom,” “lower” or “upper,” “inner” or “outer,” “inward” or “outward,” etc., are used to describe such features of the exemplary embodiments with reference to the position of the features shown in the figures. It should be understood that although the terms “first,” “second,” etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are merely used to distinguish one element from another. For example, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element, without changing the meaning of the description, provided that “first element” and “second element” are consistently renamed.

[0132] As used herein, the term “and / or” means and covers any and all possible combinations of one or more of the items listed in connection with the description. It should also be understood that the terms “comprising,” “including,” “containing,” and / or “having” as used in this specification specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0133] This document uses the term "about" or "approximately" to provide textual support for precise figures following it, as well as figures following terms of approximation or approximation. In determining whether a figure is close to or approximates a specifically listed figure, an unlisted close or approximate figure may be a figure that provides a substantial equivalence to the specifically listed figure within the context in which it is presented. It should be understood that all numerical values ​​and ranges disclosed herein are approximate values ​​and ranges, whether or not they are used with the term "about". It should also be understood that the term "about," as used herein in conjunction with figures, can refer to a value that is ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive), ±2% (inclusive), ±3% (inclusive), ±5% (inclusive), ±10% (inclusive), or ±15% (inclusive). It should also be understood that when this document discloses a range of numerical values, any numerical values ​​falling within that range are also specifically disclosed.

[0134] Depending on the context, the term "if" as used herein may optionally be interpreted as "when," "at," "in response to determination," "in response to detection," or "according to determination." Similarly, depending on the context, the phrases "if determination" or "if [the stated condition or event] is detected" as used herein may optionally be interpreted as "when determination," "in response to determination," "when [the stated condition or event] is detected," "in response to detection of [the stated condition or event]," or "according to determination that [the stated condition or event] is detected."

[0135] When the reference numerals are assigned "the", i When "unit" is used, the reference numerals refer to general components, groups, or embodiments. For example, "unit". i " refers to the first in multiple units" i Units.

[0136] All references cited herein are incorporated herein in their entirety and for all purposes, to the same extent that each individual publication or patent or patent application is specifically and individually incorporated herein in its entirety and for all purposes.

Claims

1. A tray comprising: a first compartment configured for stacking a plurality of disc assemblies, wherein the first compartment is generally circular and comprises: (i) a stepped support comprising a plurality of steps along an axial direction of the first compartment and configured for accommodating a corresponding disc assembly of the plurality of disc assemblies, the corresponding disc assembly characterized by a corresponding diameter of a plurality of diameters; (ii) at least one axial retention member formed at or adjacent to each respective step of the plurality of steps and configured for preventing an undesired movement of the corresponding disc assembly of the plurality of disc assemblies in the axial direction when the corresponding disc assembly is placed in the first compartment; and (iii) at least one angular retention member formed at or adjacent to each respective step of the plurality of steps and configured for preventing an undesired rotation of the corresponding disc assembly of the plurality of disc assemblies about an axis of the first compartment when the corresponding disc assembly is placed in the first compartment.

2. The tray of claim 1, wherein the plurality of steps are configured such that adjacent disc assemblies of the plurality of disc assemblies are spaced apart from each other along the axial direction of the first compartment when placed in the first compartment.

3. The tray of claim 2, wherein the plurality of steps comprises two, three, four, five or more steps.

4. The tray of claim 3, wherein the plurality of steps comprises: a first step at a first level and configured for accommodating a first disc assembly; and a second step at a second level higher than the first level and configured for accommodating a second disc assembly larger than the first disc assembly.

5. The tray of claim 4, wherein the plurality of steps comprises: a third step at a third level higher than the second level and configured for accommodating a third disc assembly larger than the second disc assembly.

6. The tray of claim 1, wherein the plurality of disc assemblies comprises: a disc assembly configured for performing hematology tests; a disc assembly configured for performing clinical chemistry tests; a disc assembly configured for performing immunochemistry tests; or any combination thereof.

7. The tray of claim 6, wherein the disc assembly configured for performing the immunochemistry tests is larger than the disc assembly configured for performing the clinical chemistry tests, which is larger than the disc assembly configured for performing the hematology tests.

8. The tray of claim 1, wherein the at least one axial retention member formed at or adjacent to different steps of the plurality of steps are circumferentially staggered relative to each other. ​ ​ 9. The tray of claim 8, wherein the at least one axial retention member formed at each respective step of the plurality of steps comprises two, three, four, or more axial retention members circumferentially spaced apart from one another.

10. The tray of claim 1, wherein each of the at least one angular retention member formed at or adjacent to each respective step of the plurality of steps is configured to engage with a notch formed at an outer perimeter of the corresponding disk assembly of the plurality of disk assemblies.

11. The tray of claim 10, wherein the at least one angular retention member formed at or adjacent to each respective step of the plurality of steps consists of a single angular retention member.

12. The tray of claim 1, wherein the first compartment further comprises: a bottom wall; and a centering feature formed at the bottom wall of the first compartment and configured for engagement with a seating feature of an instrument to prevent lateral and angular movement of the tray when placed in the instrument.

13. The tray of claim 12, wherein the centering feature has a generally triangular shaped cross-section.

14. The tray of claim 12, wherein a support feature is formed at the bottom wall of the first compartment and is flush with the centering feature and a bottom wall of a second compartment to facilitate placement of the tray on a surface.

15. The tray of claim 12, wherein the first compartment includes a designated area on an inner surface of the bottom wall for placement of one or more test strips.

16. The tray of claim 1, further comprising: a second compartment configured to house a desiccant; and a passageway connecting the second compartment with the first compartment.

17. The tray of claim 16, further comprising: a third compartment configured to house vials for one or more external processes from the plurality of disk assemblies.

18. The tray of claim 17, further comprising: a flange formed with the first compartment, the second compartment, and / or the third compartment and configured for engagement with a rail of an instrument.

19. The tray of claim 18, wherein the flange includes a chamfered edge to prevent misplacement of the flange in the instrument.

20. The tray of claim 18, further comprising: a plurality of sealing ribs formed at an upper surface of the flange and configured for engagement with a sealing film; at least one gripping member formed at the flange and configured to facilitate easy gripping of the tray; a plurality of structural ribs formed at the flange and / or the stepped supports of the first compartment and configured to enhance the strength of the tray; at least one guiding member formed at the flange and configured to indicate proper orientation of the tray; ​ ​ a feedback member formed at the flange and configured for providing feedback regarding placement of the tray; a fourth compartment for accommodating a reagent pack, a pipette pack, or both; or any combination thereof.

21. The tray of claim 20, further comprising: the reagent pack, the reagent pack comprising: a plurality of wells, each respective well of the plurality of wells comprising: a corresponding opening; a corresponding closed bottom; and a corresponding circumferential sidewall located between the corresponding opening and the corresponding closed bottom and formed with a corresponding predefined profile, wherein an angle of the corresponding predefined profile relative to an axis of the respective well increases from the corresponding opening to the corresponding closed bottom of the respective well.

22. A tray, comprising: a first compartment configured for stacking a plurality of disc assemblies, wherein the first compartment is generally circular and comprises: (i) a stepped support comprising a plurality of steps along an axial direction of the first compartment and configured for accommodating a corresponding disc assembly of the plurality of disc assemblies, the corresponding disc assembly featuring a corresponding diameter of a plurality of diameters; (ii) at least one axial retention member formed at or adjacent to each respective step of the plurality of steps and configured for preventing movement of the corresponding disc assembly of the plurality of disc assemblies in the axial direction when the corresponding disc assembly is placed in the first compartment; and (iii) at least one angular retention member formed at or adjacent to each respective step of the plurality of steps and configured for preventing rotation of the corresponding disc assembly of the plurality of disc assemblies about an axis of the first compartment when the corresponding disc assembly is placed in the first compartment. a second compartment configured for accommodating a desiccant; a third compartment configured for accommodating vials for one or more external processes from the plurality of disc assemblies; a reagent pack comprising: a plurality of wells, each respective well of the plurality of wells comprising: a corresponding opening; a corresponding closed bottom; and a corresponding circumferential sidewall located between the corresponding opening and the corresponding closed bottom and formed with a corresponding predefined profile, wherein an angle of the corresponding predefined profile relative to an axis of the respective well increases from the corresponding opening to the corresponding closed bottom of the respective well. a fourth compartment for accommodating the reagent pack, a pipette pack, or both; or any combination thereof; and one or more test strips comprising a reaction pad that performs a colorimetric assay on a sample such as urine, whole blood, plasma, serum, or other processed samples.

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