Packaging tray and multifunctional microfluidic assembly with packaging tray

Abstract

Packaging trays, tray assemblies, support packs, and other devices for use in centrifugal microfluidic technology are disclosed. The tray includes stepped supports for stacking multiple disk assemblies. The tray also includes retaining members to prevent undesirable movement of the disk assemblies when they are placed on the tray.

Description

Technical Field

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

[0002] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 498,228, filed on April 25, 2023, which is hereby incorporated by reference in its entirety.

Background Art

[0003] Currently, 70% of medical decisions rely on laboratory - based diagnoses, but the diagnostic process is out of sync with the delivery of healthcare. In primary healthcare systems, patients need to travel to external blood collection facilities to have their blood drawn, and that blood is sent to a central laboratory via a transporter and processed overnight. This means that test results reach healthcare providers long after the patient has left. These discrepancies in healthcare delivery and disease management lead to significant waste in the healthcare system as follows. a. Patients often delay getting tested or do not follow test and subsequent medical recommendations. b. Gaps in the diagnostic process lead to missed tests, missed diagnoses, lack of intervention, and ultimately poor prognosis. c. Healthcare providers waste time matching test orders with patient medical records. When intervention is required, even more time is wasted contacting the patient and advancing subsequent steps in the patient's treatment pathway.

[0004] These problems are even more acute when caring for local residents and patients belonging to groups disadvantaged by social determinants of health, and there are many challenges to ensuring the successful follow - up of patients from their first medical visit.

[0005] Several companies have developed point-of-care devices to bridge this gap. However, these devices are limited to a single type of test and cannot fully meet the workflow needs of primary care providers for a single system that produces simple, comprehensive, and rapid test results. A product is currently under development to meet these needs. This product achieves this through a highly automated workflow enabled by the use of centrifugal microfluidic disks.

[0006] Therefore, improvements in devices and methods in centrifugal microfluidics technology are desired. [Overview of the Initiative]

[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 microfluidic technology.

[0008] In one embodiment, the disclosure provides a tray comprising a first compartment configured for stacking a plurality of disk assemblies. The first compartment is substantially circular and includes a stepped support. The stepped support comprises a plurality of steps along the axial direction of the first compartment and is configured to accommodate corresponding disk assemblies in a plurality of disk assemblies characterized by corresponding diameters within a plurality of diameters. In some embodiments, the tray includes at least one axial retaining member formed in each of the steps in the plurality of steps or adjacent to each step, configured to prevent undesirable axial movement of corresponding disk assemblies in the plurality of disk assemblies when the corresponding disk assemblies in the plurality of disk assemblies are placed in the first compartment. In some embodiments, the tray includes at least one angular retaining member formed in each of the steps in the plurality of steps or adjacent to each step, configured to prevent undesirable rotation of corresponding disk assemblies in the plurality of disk assemblies around the axis of the first compartment when the corresponding disk assemblies in the plurality of disk assemblies are placed in the first compartment.

[0009] In some embodiments, the rows are configured such that adjacent disk assemblies within the multiple disk assemblies are spaced apart from each other along the axial direction of the first compartment when they are placed within the first compartment.

[0010] In some embodiments, the multiple stages include two, three, four, five, or more stages.

[0011] In some embodiments, the plurality of stages includes a first stage located at a first level and configured to accommodate a first disk assembly, and a second stage located at a second level higher than the first level and configured to accommodate a second disk assembly larger than the first disk assembly. In some such embodiments, the plurality of stages further includes a third stage located at a third level higher than the second level and configured to accommodate a third disk assembly larger than the second disk assembly.

[0012] In some embodiments, the disk assemblies include disk assemblies configured to perform hematological tests, disk assemblies configured to perform clinical chemistry tests, disk assemblies configured to perform immunoassay tests, or any combination thereof. In some such embodiments, the disk assemblies configured to perform immunoassay tests are larger than the disk assemblies configured to perform clinical chemistry tests, and the disk assemblies configured to perform clinical chemistry tests are larger than the disk assemblies configured to perform hematological tests.

[0013] In some embodiments, at least one axial retaining member formed in different stages of a plurality of stages or adjacent to different stages is arranged alternately in the circumferential direction with respect to each other.

[0014] In some embodiments, at least one axial retaining member formed in each of the multiple steps includes two, three, four or more axial retaining members spaced apart from each other in the circumferential direction.

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

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

[0017] In some embodiments, the first compartment includes a bottom wall and a central positioning mechanism formed in the bottom wall of the first compartment and configured to engage with the positioning mechanism of the equipment when the tray is placed in the equipment to prevent lateral and angular movement of the tray. In some such embodiments, the central positioning mechanism has a substantially triangular cross-section.

[0018] In some embodiments, the support mechanism is formed in the bottom wall of the first compartment and is at the same height as the central positioning mechanism and the bottom wall of the second compartment, facilitating the placement of trays on the surface.

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

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

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

[0022] In some embodiments, the tray further includes a flange formed by a first compartment, a second compartment, and / or a third compartment, configured to engage with the rails of the equipment. In some such embodiments, the flange includes a chamfered edge to prevent the flange from shifting within the equipment.

[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 film; 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 flange and / or stepped support portion of the first compartment and configured to increase 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 regarding the placement of the tray; and a fourth compartment for accommodating reagent packs, pipette packs, or both, or a combination thereof.

[0024] In some embodiments, the disclosure provides a reagent pack comprising a plurality of wells. Each well in the plurality of wells comprises a corresponding opening, a corresponding closed bottom, and a corresponding circumferential side wall between the corresponding opening and the closed bottom, and is formed into a corresponding predefined profile. The angle of the corresponding predefined profile with respect to the axis of each well increases from the corresponding opening to the corresponding closed bottom of each well.

[0025] In another embodiment, there is a tray including a first compartment configured for stacking a plurality of disk assemblies, the first compartment being substantially circular and comprising a stepped support configured to accommodate corresponding disk assemblies within a plurality of disk assemblies characterized by corresponding diameters within a plurality of diameters, with a plurality of tiers along the axial direction of the first compartment. The first compartment further includes at least one axial retaining member formed in each of the tiers or adjacent to each tier, configured to prevent corresponding disk assemblies within a plurality of disk assemblies from moving axially when they are placed in the first compartment. The first compartment also includes at least one angular retaining member formed in each of the tiers or adjacent to each tier, configured to prevent corresponding disk assemblies within a plurality of disk assemblies from rotating about the axis of the first compartment when they are placed in the first compartment. The tray further comprises a second compartment configured to contain a desiccant, a third compartment configured to contain vials for one or more external processes from a plurality of disk assemblies, and a reagent pack comprising a plurality of wells, wherein each well in the plurality of wells comprises a corresponding opening, a corresponding closed bottom, and a corresponding circumferential side wall formed between the corresponding opening and the closed bottom in a corresponding predefined profile, wherein the angle of the corresponding predefined profile with respect to the axis of each well increases from the corresponding opening to the corresponding closed bottom of each well. The tray further comprises a fourth compartment for containing reagent packs, pipette packs, or both, or any combination thereof, and one or more test strips comprising reaction pads for performing colorimetric assays on samples such as urine, whole blood, plasma, serum, or other processed samples.

[0026] The devices, systems, and methods of the present disclosure will be apparent from the accompanying drawings incorporated herein and the following detailed description or will be set forth in other features and advantages which are more particularly set forth, and the accompanying drawings and detailed description together serve to explain certain specific principles of the exemplary embodiments of the present disclosure.

[0027] The accompanying drawings are incorporated herein and form a part thereof, illustrate one or more exemplary embodiments of the present disclosure, and together with the detailed description, serve to explain the principles and implementations of the exemplary embodiments of the present invention. The accompanying drawings are not necessarily to scale. For example, certain design features of the present invention disclosed herein, including specific dimensions, orientations, locations, and shapes, are determined in part by the particular intended use and operating environment. Further, the components illustrated in the drawings can be combined in any useful number and combination.

[0028] The drawings show the following.

Brief Description of the Drawings

[0029] [Figure 1] Shows an exploded view of an exemplary tray assembly according to some exemplary embodiments of the present disclosure. [Figure 2A] Shows a top view of an exemplary tray according to some embodiments of the present disclosure. [Figure 2B] Shows a top view of an exemplary tray according to some embodiments of the present disclosure. [Figure 2C] Shows a top view of an exemplary tray according to some embodiments of the present disclosure. [Figure 2D] Shows a top view of an exemplary tray according to some embodiments of the present disclosure. [Figure 2E] Shows a top view of an exemplary tray according to some embodiments of the present disclosure. [Figure 3A] Summarizes an exemplary process for manufacturing an exemplary tray assembly according to some embodiments of the present disclosure. [Figure 3B]An exemplary process for manufacturing an exemplary tray assembly is summarized according to several embodiments of this disclosure. [Figure 3C] An exemplary process for manufacturing an exemplary tray assembly is summarized according to several embodiments of this disclosure. [Figure 3D] An exemplary process for manufacturing an exemplary tray assembly is summarized according to several embodiments of this disclosure. [Figure 3E] An exemplary process for manufacturing an exemplary tray assembly is summarized according to several embodiments of this disclosure. [Figure 3F] An exemplary process for manufacturing an exemplary tray assembly is summarized according to several embodiments of this disclosure. [Figure 3G] An exemplary process for manufacturing an exemplary tray assembly is summarized according to several embodiments of this disclosure. [Figure 3H] An exemplary process for manufacturing an exemplary tray assembly is summarized according to several embodiments of this disclosure. [Figure 3I] An exemplary process for manufacturing an exemplary tray assembly is summarized according to several embodiments of this disclosure. [Figure 3J] An exemplary process for manufacturing an exemplary tray assembly is summarized according to several embodiments of this disclosure. [Figure 4A] In accordance with some embodiments of this disclosure, perspective views of exemplary open support kit assemblies and exemplary open tray assemblies prepared for insertion into exemplary equipment drawers are shown. [Figure 4B] According to some embodiments of the present disclosure, Figure 4A shows a perspective view of an exemplary open support kit assembly and an exemplary open tray assembly inserted into an exemplary equipment drawer. [Figure 5] A perspective view of the engagement between an exemplary disk assembly and an exemplary tray is shown according to some embodiments of this disclosure. [Figure 6] A perspective view of the transfer of a sample to a test strip on an exemplary tray is shown according to some embodiments of the present disclosure. [Figure 7] In accordance with some embodiments of this disclosure, perspective views of the return of used parts to an exemplary open support kit assembly and an exemplary open tray assembly are shown. [Figure 8] An exploded view of an exemplary support pack assembly is shown according to some embodiments of the present disclosure. [Figure 9A] In accordance with some embodiments of this disclosure, exemplary top, side, and bottom views of a reagent pack are shown. [Figure 9B] An exemplary perspective view of a reagent pack is shown according to some embodiments of this disclosure. [Figure 9C] An exemplary perspective view of a reagent pack is shown according to some embodiments of this disclosure. [Figure 9D] An exemplary perspective view of a reagent pack is shown according to some embodiments of this disclosure. [Figure 9E] An exemplary reagent pack is shown according to some embodiments of this disclosure. [Figure 9F] An exemplary reagent pack is shown according to some embodiments of this disclosure. [Figure 9G] An exemplary reagent pack is shown according to some embodiments of this disclosure. [Figure 9H] An exemplary reagent pack is shown according to some embodiments of this disclosure. [Figure 9I] An exemplary reagent pack is shown according to some embodiments of this disclosure. [Figure 9J] An exemplary reagent pack is shown according to some embodiments of this disclosure. [Figure 10A] An exemplary process for manufacturing an exemplary support pack is described in accordance with several embodiments of this disclosure. [Figure 10B] An exemplary process for manufacturing an exemplary support pack is described in accordance with several embodiments of this disclosure. [Figure 10C]An exemplary process for manufacturing an exemplary support pack is described in accordance with several embodiments of this disclosure. [Figure 10D] An exemplary process for manufacturing an exemplary support pack is described in accordance with several embodiments of this disclosure. [Figure 10E] An exemplary process for manufacturing an exemplary support pack is described in accordance with several embodiments of this disclosure. [Figure 10F] An exemplary process for manufacturing an exemplary support pack is described in accordance with several embodiments of this disclosure. [Figure 10G] An exemplary process for manufacturing an exemplary support pack is described in accordance with several embodiments of this disclosure. [Figure 10H] An exemplary process for manufacturing an exemplary support pack is described in accordance with several embodiments of this disclosure. [Figure 11A] Exploded views of exemplary integrated kits are shown according to some embodiments of the present disclosure. [Figure 11B] Figure 11A shows a perspective view of an exemplary all-in-one kit. [Figure 12A] An exemplary perspective view of an integrated support pack is shown according to some embodiments of the present disclosure. [Figure 12B] According to some embodiments of this disclosure, the folded and unfolded positions of the exemplary support pack shown in Figure 12A are illustrated. [Figure 12C] According to some embodiments of this disclosure, the folded and unfolded positions of the exemplary support pack shown in Figure 12A are illustrated. [Figure 13A] A perspective top view of a second embodiment of the tray is shown according to some aspects of this disclosure. [Figure 13B] Figure 13A shows an exemplary top view of the tray. [Figure 13C] Figure 13A shows a bottom view of an exemplary tray. [Figure 14] A top view of a third embodiment of the tray is shown according to some aspects of this disclosure. [Modes for carrying out the invention]

[0030] Referring next to the drawings, similar reference numerals indicate similar elements throughout. Figure 1 shows an exemplary tray assembly 100 according to several embodiments of the present disclosure. The tray assembly 100 includes a tray 102, a test strip 104, an external vial 106, a desiccant 108, a first capping layer 110, a first lyophilized reagent bead 112, a first disc 114, a second capping layer 116, a second lyophilized reagent bead 118, a second disc 120, a third capping layer 122, a third lyophilized reagent bead 124, a third disc 126, and a tray sealing film 128. In some embodiments, the first capping layer 110, the first lyophilized reagent bead 112, and the first disc 114 are partially assembled to form a first disc assembly 109. In some embodiments, the second capping layer 116, the second lyophilized reagent beads 118, and the first disk 120 are partially assembled to form a second disk assembly 115. In some embodiments, the third capping layer 122, the third lyophilized reagent beads 124, and the third disk 126 are partially assembled to form a third disk assembly 121.

[0031] Figure 1 shows that the tray assembly 100 includes three disk assemblies, but it should be noted that this is illustrative and the invention is not limited thereto. For example, in some embodiments, the tray assembly 100 may include a single disk assembly (e.g., any one of the first disk assembly 109, the second disk assembly 115, and the third disk assembly 121) or two disk assemblies (e.g., any two of the first disk assembly 109, the second disk assembly 115, and the third disk assembly 121). In some embodiments, the tray assembly 100 may be configured to have more than three disk assemblies. Furthermore, even though Figure 1 shows the tray assembly 100 including a test strip 104, an external vial 106, and a desiccant 108, it should be noted that the tray assembly 100 may include, but may not include, the test strip 104, the external vial 106, and the desiccant 108. In other words, the test strip 104, the external vial 106, and the desiccant 108 are optional or additional components. Furthermore, in some embodiments, the tray assembly 100 may include other alternative, optional, or additional components not shown in Figure 1. Moreover, the reagent can take various forms and may be dry or wet. For example, the reagent can take many other forms besides reagent beads. The reagent can be immersed and dried on a disk or on a capping layer.

[0032] As shown in subsequent figures, in some embodiments, one or more test strips 104 are inserted into the tray 102. In some embodiments, an external vial 106 may contain additional lyophilized reagent beads and may be sealed, for example, with foil, which can be perforated while the external vial 106 is filled with liquid and mixed. In some embodiments, a desiccant 108 may be placed inside the tray 102 to dry the test strips 104, the first lyophilized reagent beads 112, the second lyophilized reagent beads 118, the third lyophilized reagent beads 124, and the additional lyophilized reagent beads in the external vial 106. In some embodiments, the first disk assembly 109, the second disk assembly 115, and / or the third disk assembly 121 are clipped to the tray 102 as shown in subsequent figures. After placing one or more test strips 104, an external vial 106, a desiccant 108, a first disk assembly 109, a second disk assembly 115, a third disk assembly 121, and additional lyophilized reagent beads in the tray 102, the tray is sealed with a tray sealing film 128.

[0033] Figure 2A shows some additional or optional features of the tray 102 according to some embodiments of the present disclosure. In some embodiments, the tray 102 includes feedback members such as tactile 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 grips 210, identification marks 212, tray chamfers 205, or any combination thereof. In some embodiments, the tactile feedback recesses 204 provide tactile feedback to the user while the tray 102 is being inserted into the device, as shown in subsequent figures. Once the tray 102 is fully inserted, it clicks into place so that the tactile feedback recesses 204 fit into a corresponding recess in the device. In some embodiments, one or more positioning flanges 206 align the tray 102, for example, in the left-right direction when inserting the tray 102 into the device. Sufficient clearance is left on each side to facilitate insertion of the tray 102 into the device. In some embodiments, the tray chamfer 205, guide arrow 208, and / or identification logo 212 indicate the correct insertion direction for the user, and one or more thumb grips 210 provide a gap for removing the tray sealing film 128 as shown above.

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

[0035] For example, in some embodiments, the tray 102 includes one or more sealing ribs 214, eleven or more structural ribs 216, a stepped disc support 218, a desiccant pocket 220, an external vial pocket 222, or any combination thereof. In some embodiments, one or more sealing ribs 214 provide a surface on the tray 102 for bonding to the aforementioned tray sealing film 128. The total surface area of ​​the sealing ribs 214 can be increased or decreased to increase or decrease the bonding strength between the tray 102 and the tray sealing film 128, making it more difficult or easier to remove the tray sealing film 128 from the tray 102. In some embodiments, one or more structural ribs 216 can be added at various positions on the tray 102 to increase the bending strength of the tray 102. In some embodiments, the desiccant pocket 220 accommodates the previously shown desiccant 108 and provides a clear path for moisture to move throughout the tray 102. In some embodiments, the external vial pocket 222 can accommodate the previously illustrated external vial 106. An external vial 106 can accommodate additional lyophilized reagent beads and provides an off-disk means for reconstituting additional lyophilized reagent beads. In some embodiments, the stepped disk support 218 provides a unique position for each disk inserted into the tray 102. When inserted into the tray 102, the first disk assembly 109 is located in the lower section of the stepped disk support 218, the second disk assembly 115 is located in the middle section of the stepped disk support 218, and the third disk assembly 121 is located in the upper section 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 within the tray 102.

[0036] While the stepped disk support 218 is illustrated to include three steps, it should be noted that this is illustrative 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. In some embodiments, the stepped disk support 218 is configured to stack multiple disk assemblies vertically, and adjacent disk assemblies are spaced apart from each other along the axial direction of the first section 215 when placed in the first section 215 (for example, when seated on the steps of the stepped disk support 218). It should be noted that a stepped disk support 218 having multiple steps can, but does not have to, hold multiple disk assemblies. For example, a stepped disk support 218 having multiple steps can be used to hold a single disk assembly.

[0037] Figure 2C shows some additional or optional features of the tray 102 according to some embodiments of the present disclosure. In some embodiments, the tray 102 includes a test strip area 224, a support mechanism 226, a code placement mechanism 228, a central positioning mechanism 230, a test strip positioning mark 232, a desiccant conduit 234, or any combination thereof. In some embodiments, the test strip area 224 provides an area within the tray 102 for arranging one or more test strips 104 as described above. By positioning one or more test strips 104 in the test strip area 224, the first disk assembly 109, the second disk assembly 115, and the third disk assembly 121 become easily accessible after being removed from the tray 102. Samples can be applied to one or more test strips 104, and the color of one or more test strips 104 can be read by imaging means in the instrument. In some embodiments, one or more test strips 104 can be fixed to the test strip area 224 with adhesive or clipped to recesses in the test strip area 224. In some embodiments, the test strip positioning marks 232 can be used in the manufacture of the tray assembly 100 and can also be used by the instrument when inspecting one or more test strips 104. In some embodiments, a support mechanism 226 may be included in the tray 102 to provide balance when the tray 102 is placed on a surface before being inserted into the instrument. For example, in some embodiments, the support mechanism 226 is at the same height as the central positioning mechanism 230 and the bottom of the second compartment to facilitate the placement of the tray on the surface.

[0038] In some embodiments, the code placement mechanism 228 allows machine-readable information such as calibration information, test menus, and expiration dates to be placed on the tray 102. In some embodiments, the central positioning mechanism 230 engages with a pocket in the instrument (e.g., a positioning mechanism 401) to provide precise positioning of the tray 102 within the instrument (e.g., preventing lateral and angular movement of the tray when it is placed in the instrument). In some embodiments, the central positioning mechanism has a substantially triangular cross-section. In some embodiments, the desiccant conduit 234 provides an obvious path between the first disc assembly 109, the second disc assembly 115, the third disc assembly 121, the test strip 104, and the desiccant 108, allowing moisture to be absorbed by the desiccant 108.

[0039] Figure 2D shows some additional or optional features of the tray 102 according to some embodiments of the present disclosure. In some embodiments, the tray 102 includes at least one axial retaining member, such as a first disk retaining mechanism 236, a second disk retaining mechanism 238, or a third disk retaining mechanism 240, which is arranged to be formed in or adjacent to each tier (e.g., a lower tier, a middle tier, or an upper tier) and is configured to prevent undesirable axial movement of the corresponding disk assemblies (e.g., a first disk assembly 109, a second disk assembly 115, or a third disk assembly 121) when the corresponding disk assemblies are placed in the compartments (e.g., when placed on the tiers of the stepped disk support 218). In some embodiments, the at least one axial retaining member formed in or adjacent to different tiers is arranged circumferentially staggered relative to one another. In some embodiments, the at least one axial retaining member formed in each tier includes two, three, four, or more axial retaining members spaced circumferentially apart from one another.

[0040] As a non-limiting example, it is shown that the tray 102 includes one or more first disk retaining mechanisms 236, one or more second disk retaining mechanisms 238, and one or more third disk retaining mechanisms 240. When the first disk assembly 109 is pressed into the tray 102 during assembly, the outer periphery of the first disk assembly 109 contacts one or more first disk retaining mechanisms 236, providing a slight restraint fit that holds the first disk assembly 109 in the tray 102. The restraint fit is not excessive, and as a result, the first disk assembly 109 can be easily removed by the machine in a subsequent stage. When the second disk assembly 115 is pressed into the tray 102 during assembly, the outer periphery of the second disk assembly 115 contacts one or more second disk retaining mechanisms 238, providing a slight restraint fit that holds the second disk assembly 115 in the tray 102. As the third disk assembly 121 is pressed into the tray 102 during assembly, the outer circumference of the third disk assembly 121 contacts one or more third disk holding mechanisms 240, providing a slight interlocking fit that holds the third disk assembly 121 in the tray 102. The first disk assembly 109 has the smallest disk diameter and is inserted into the tray 102 first during manufacturing. The second disk assembly 115 has the next largest diameter and is inserted into the tray 102 after the first disk assembly 109. The third disk assembly 121 has the next largest diameter and is inserted into the tray 102 after the second disk assembly 115. The disk holding mechanisms secure the disks during transport, provide precise positioning within the tray 102, and allow the equipment to remove the disks from the tray 102 at the appropriate time.

[0041] Figure 2E shows some additional or optional features of the tray 102 according to some embodiments of the present disclosure. In some embodiments, the tray 102 includes at least one angular retaining member, e.g., a first angular lock 242, a second angular lock 244, or a third angular lock 246, formed in or adjacent to each tier (e.g., a lower, middle, or upper tier) and configured to prevent undesirable rotation of the corresponding disk assembly (e.g., a first disk assembly 109, a second disk assembly 115, or a third disk assembly 121) around the axis of the compartment when the corresponding disk assembly is placed in the compartment (e.g., when placed on a tier of the stepped disk support 218). In some embodiments, the at least one angular retaining member formed in one or each tier consists of a single angular retaining member.

[0042] As a non-limiting example, the tray 102 is illustrated to include a first angle lock 242, a second angle lock 244, and a third angle lock 246. In some embodiments, the first angle lock 242 is a molded mechanism of the tray 102 that engages with a notch on the side of the first disk assembly 109, providing a precise rotational position of the first disk assembly 109 within the tray 102. As shown in subsequent figures, it is important that the disks are precisely positioned along the x, y, and z axes and rotated to position themselves within the tray 102. In some embodiments, the second angle lock 244 is a molded mechanism of the tray 102 that engages with a notch on the side of the second disk assembly 115, providing a precise rotational position of the second disk assembly 115 within the tray 102. In some embodiments, a third angle lock 246 is a molded mechanism of the tray 102 that engages with a notch on the side of the third disk assembly 121, providing a precise rotational position of the third disk assembly 121 within the tray 102. A key function of the tray 102 is to precisely position the first disk assembly 109, the second disk assembly 115, and the third disk assembly 121 for subsequent processing by the instrument.

[0043] Figures 3A to 3J show the stepwise assembly of the tray assembly 100 according to some embodiments of the present disclosure.

[0044] Figure 3A shows that tray 102 is empty and ready to be loaded with various components.

[0045] In Figure 3B, one or more test strips 104 are arranged in a tray 102 according to some embodiments of the present disclosure. As previously stated, one or more test strips 104 may be bonded to the tray 102 by various methods such as adhesive bonding or clamping bonding, such as clipping into pockets. One or more test strips 104 can perform a wide variety of colorimetric assays on samples such as urine, whole blood, plasma, serum, or other processed samples. Note that arranging one or more test strips 104 in the tray 102 is an optional or additional step. Depending on the application, the tray assembly 100 may or may not include one or more test strips 104.

[0046] In Figure 3C, an external vial 106 is placed in a tray 102 according to some embodiments of the present disclosure. The external vial 106 provides an additional off-disk chamber for processing the sample. The sample and / or diluent can be added to and mixed in the external vial 106. The external vial 106 can contain reagents such as liquids and / or lyophilized reagent beads. Although a single external vial 106 is illustrated in the tray 102, additional external vials can be added elsewhere in the tray 102. The external vial 106 can be sealed with film or foil, which can be punctured using a pipette tip by an instrument. The solution in the external vial 106 can be transferred back into a first disk assembly 109, a second disk assembly 115, and / or a third disk assembly 121 for further processing and analysis. Note that placing the external vial 106 in the tray 102 is an optional or additional step. Depending on the application, the tray assembly 100 may or may not include the external vial 106.

[0047] In Figure 3D, a desiccant 108 is placed in a tray 102 according to some embodiments of the present disclosure. The desiccant 108 controls the humidity level within the tray 102 and may include various desiccant materials such as silica gel and molecular sieves. The desiccant 108 is typically packaged in a water vapor permeable material such as Tyvek. The function of the desiccant 108 is to keep the freeze-dried reagent beads and one or more test strips 104 dry and extend 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.

[0048] In Figure 3E, the first disk assembly 109 is placed in the tray 102 according to some embodiments of the present disclosure. The first disk assembly 109 is inserted into the tray 102 until it rests on the lower step of the stepped disk support 218 and is held in the tray 102 by an interlocking fit with the first disk holding mechanism 236. The interlocking fit with the lower step of the stepped disk support 218 and the first disk holding mechanism 236 provides precise positioning of the first disk assembly 109 within the tray 102 and provides secure packaging for storage and transport.

[0049] In Figure 3F, the second disk assembly 115 is positioned in the tray 102 according to some embodiments of the present disclosure. The second disk assembly 115 is inserted into the tray 102 until it rests on the middle section of the stepped disk support 218 and is held in place within the tray 102 by an interlocking fit with the second disk holding mechanism 238. The interlocking fit with the middle section of the stepped disk support 218 and the second disk holding mechanism 238 provides precise positioning of the second disk assembly 115 within the tray 102 and provides secure packaging for storage and transport.

[0050] In Figure 3G, the third disk assembly 121 is positioned in the tray 102 according to some embodiments of the present disclosure. The third disk assembly 121 is inserted into the tray 102 until it rests on the upper section of the stepped disk support 218 and is held in place within the tray 102 by an interlocking fit with the third disk holding mechanism 240. The interlocking fit with the lower section of the stepped disk support 218 and the third disk holding mechanism 240 provides precise positioning of the third disk assembly 121 within the tray 102 and provides secure packaging for storage and transport.

[0051] Figures 3E-3G show the arrangement of three disks in tray 102, but it should be noted that this is an example and not limiting. In some embodiments, tray assembly 100 is assembled with one disk (e.g., any one of the first disk assembly 109, the second disk assembly 115, and the third disk assembly 121). In some embodiments, tray assembly 100 is assembled with two disks (e.g., any two of the first disk assembly 109, the second disk assembly 115, and the third disk assembly 121).

[0052] In Figure 3H, a tray sealing film 128 is attached to a tray 102, sealing the tray 102 and protecting the contents of the tray 102 from contamination according to some embodiments of the present disclosure. The tray sealing film 128 may be made from a moisture-permeable material such as Tyvek, or it may be a moisture barrier such as a laminate containing 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 102 before use.

[0053] In Figure 3I, the code 300 is printed on the underside of the tray assembly 100 according to some embodiments of the present disclosure. The code 300 may provide machine-readable and / or human-readable information, which may include lot-specific data, calibration information, expiration date, assay type, etc. If the code 300 includes machine-readable data, the code 300 may be imaged by the instrument before or after insertion of the tray assembly 100 into the instrument. Note that printing the code 300 on the tray 102 is an optional or additional step. In some embodiments, the tray assembly 100 may or may not include the code 300 printed on the tray 102.

[0054] In Figure 3J, according to some embodiments of the present disclosure, the tray assembly 100 is placed in a foil pouch 301 and sealed in a tray 102. The foil pouch 301 may be made from a variety of materials such as foil laminate, sputtered film, and / or barrier polymer. The foil pouch 301 provides a barrier against water vapor permeability and light. Materials with low water vapor permeability are particularly desirable. Any moisture moving across the foil pouch 301 is absorbed by the desiccant 108, protecting the first lyophilized reagent beads 112, the second lyophilized reagent beads 118, the third lyophilized reagent beads 124, and any lyophilized reagent beads that may be contained in the external vial 106. It should be noted that placing the tray assembly 100 in the foil pouch 301 is an optional or additional step. In some embodiments, the tray assembly 100 may or may not be placed in the foil pouch 301. In some embodiments, the tray assembly 100 may be placed in an alternative pouch or similar container.

[0055] In Figure 4A, the open support kit assembly 402 and the open tray assembly 404 are prepared for insertion into the equipment drawer 400. Before insertion, the sealing film is removed from the open support kit assembly 402 and the open tray assembly 404, allowing the machine to access the contents of the open support kit assembly 402 and the open tray assembly 404.

[0056] In Figure 4B, the open support kit assembly 402 and the open tray assembly 404 are inserted into the equipment drawer 400 according to some embodiments of the present disclosure. The proximal end regions of the open support kit assembly 402 and the open tray assembly 404 provide a grip for handling the assemblies, and the upper left and right end regions of the assemblies are aligned using guides within the drawer. Once insertion is complete, the mechanisms of the open support kit assembly 402 and the open tray assembly 404 provide tactile feedback indicating that insertion is complete. When the open support kit assembly 402 and the open tray assembly 404 are fully inserted, they are precisely positioned in all directions.

[0057] In some embodiments, each angular holding member formed at each stage (e.g., lower, middle, or upper stage) (e.g., a first angular lock 242, a second angular lock 244, or a third angular lock 246) is configured to engage with a notch formed on the outer circumference of the corresponding disk assembly (e.g., a first disk assembly 109, a second disk assembly 115, or a third disk assembly 121). In a non-limiting embodiment, Figure 5 shows that a third disk notch 502 of the third disk assembly 121 engages with a third angular lock 246, providing a precise angular position of the third disk assembly 121. Precise angular positioning is important in embodiments where the gripper assembly 506 cannot rotate the third disk assembly 121.

[0058] In Figure 6, the sample is transferred onto the test strip 104 by the instrument according to some embodiments of the present disclosure. The test strip 104 is exposed after the first disk assembly 109, the second disk assembly 115, and the third disk assembly 121 are removed from the tray 102 by the instrument. At this point, the robotic pipette 600 can dispense a fixed amount of the sample onto the reaction pad 602, one pad at a time. Small amounts of sample, on the order of microliters in volume, can be dispensed onto each pad. In a non-limiting embodiment, 14 individual reaction pads are illustrated in Figure 6, each capable of performing a different assay. The volume is controlled so that the sample remains within each individual reaction pad. After waiting for a predetermined time, the reaction pad 602 can be imaged by the instrument, correlating the color with the concentration of the analyte. In this way, additional assays and additional 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.

[0059] In some embodiments, upon completion of the test, the used components are returned to the open support kit assembly 402 and the open tray assembly 404, as shown in Figure 7. The open support kit assembly 402 and the open tray assembly 404 may become biological hazards after use and can be properly disposed of. The open support kit assembly 402 contains unused reagent solutions and used pipette tips. If biologically hazardous samples have been processed, the open support kit assembly 402 becomes a biological hazard. The open tray assembly 404 contains used test strips 104 and used first disk assembly 109, second disk assembly 115, third disk assembly 121, and / or external vial 106. If biologically hazardous samples have been processed, the open support kit assembly 404 is a biological hazard. Disposal of biologically hazardous components is made easier by containing them within the open tray assembly 404 and the open tray assembly 404. Even though there are many components, the user only needs to operate on two components: the open support kit assembly 402 and the open tray assembly 404.

[0060] Figure 8 shows an exploded view of an exemplary support pack assembly 800 according to several 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 subsequent drawings and, in some embodiments, is injection molded from polyolefin or a similar material. It contains various reagent wells. In some embodiments, it also includes ribs for sealing, various alignment mechanisms, snaps, or any combination thereof. The reagent pack seal 804 is a punctureable sealing film that provides an airtight seal around the reagent wells and can be punctured by an instrument when necessary. The tip pack 806 is also injection molded using polyolefin or a similar material and provides housing for the pipette tip 808. The pipette tip 808 can be removed from the tip pack 806 by an instrument as needed. The tip pack seal 810 provides temporary cover and prevents the pipette tip 808 from being removed from the tip pack 806 until needed. The tip pack seal 810 is typically removed from the tip pack 806 before inserting the support pack assembly 800 into the instrument.

[0061] Figure 9A shows a reagent pack 802 according to some embodiments of the present disclosure. 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 capacity, and the second reagent well 902, third reagent well 904, and fourth reagent well 906 have progressively larger capacities depending on the requirements of the support pack assembly 800. The number and size of the reagent wells can be varied in different embodiments, and the configuration illustrated in Figure 9A is a non-limiting example. During manufacturing, the reagent wells are filled with liquid reagents, which are used by the instrument at various points in the assay.

[0062] Figure 9B shows some additional or optional features of the reagent pack 802 according to some embodiments of the present disclosure. In some embodiments, there is a sealing rib 908 around each of the reagent wells. The sealing rib 908 provides a specific area around each reagent well where heat sealing of the reagent pack seal 804 can be performed, providing an airtight seal to each reagent well.

[0063] Figure 9C shows some additional or optional features of the reagent pack 802 according to some embodiments of the present disclosure. In some embodiments, the reagent pack 802 includes a thumb grip 910 and / or one or more positioning pins 912. The thumb grip 910 provides a recess from which the user can grasp the reagent pack 802 when inserting it into and removing it from the instrument. One or more positioning pins 912 provide means for aligning the reagent pack 802 when it is secured to the tip pack 806. One or more positioning pins 912 provide precise positioning of the reagent pack 802 relative to the tip pack 806.

[0064] Figure 9D shows some additional or optional features of a reagent pack 802 according to some embodiments of the present disclosure. In some embodiments, the reagent pack 802 includes one or more snap mechanism notches 914. The one or more snap mechanism notches 914 provide means for attaching the reagent pack 802 to the tip pack 806. The one or more snap mechanism notches 914 provide precise positioning of the reagent pack 802 relative to the tip pack 806 and prevent them from separating.

[0065] Figure 9E shows some additional or optional features of a reagent pack 802 according to some embodiments of the present disclosure. Sectional view AA shows various reagent well shapes. As shown in sectional view AA, the reagent well includes an opening, a closed bottom, and a circumferential side wall between the opening and the closed bottom. The circumferential side wall has a variable draft angle 916 with respect to the axis of the reagent well. In some embodiments, the reagent well is formed with a predefined contour such that the draft angle 916 increases from the opening to the closed bottom of the reagent well. The variable draft angle 916 can assist in the injection molding of the reagent pack 802 and can also assist in filling, storing, and removing reagents from the reagent well. The variable draft angle 916 can help minimize unwanted air bubbles in the reagent well.

[0066] In some embodiments, the reagent pack 802 includes multiple wells. In some embodiments, the multiple wells include at least two wells having substantially the same predefined profile. In some embodiments, the multiple wells include at least two wells having different predefined profiles. In some embodiments, the multiple wells include a set of multiple wells, each set containing one or more wells. In some embodiments, the inner surface of each well in the multiple wells is polished to reduce air bubbles during transport.

[0067] Figure 9F shows exemplary top, side, and bottom views of a tip pack 806 according to some embodiments of the present disclosure. In some embodiments, the tip pack 806 includes various pipette tip nests 918, each capable of housing pipette tips. Pipette tips are loaded into the tip pack 806 during manufacturing, can be removed by the instrument during assays, and can be returned to the tip pack 806 for disposal after use.

[0068] Figure 9G shows some additional or optional features of the tip pack 806 in top, side, and bottom views according to some embodiments of the present disclosure. In some embodiments, the tip pack 806 includes one or more snap mechanisms 920 used to attach the tip pack 806 to the reagent pack 802 during manufacturing. The one or more snap mechanisms 920 provide precise positioning of the tip pack 806 and the reagent pack 802, which is important when inserting the support pack assembly 800 into the instrument.

[0069] Figure 9H shows some additional or optional features of the tip pack 806 in top, side, and bottom views according to some embodiments of the present disclosure. In some embodiments, the tip pack 806 includes one or more tip pack positioning holes 922 that engage with one or more positioning pins 912 on the reagent pack 802 to ensure accurate positioning between the tip pack 806 and the reagent pack 802. Accurate 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 9I shows some additional or optional features of the tip pack 806 according to some embodiments of the present disclosure. In some embodiments, the tip pack 806 includes one or more tip pack notches 924 that engage with one or more snap mechanism notches 914 on the reagent pack 802 to ensure precise positioning between the tip pack 806 and the reagent pack 802. As previously mentioned, 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.

[0071] Figure 9J shows some additional or optional features of the tip pack 806 in top, side, and bottom views, according to some embodiments of the present disclosure. In some embodiments, the tip pack 806 includes a tip interface 926. The tip interface 926 provides precise positioning of the pipette tip within the instrument while allowing the pipette tip to be freely removed from and returned to the tip pack 806. Precise positioning of the pipette tip is particularly important when it is picked up by the pipette mechanism within the instrument, as the tip needs to move slightly to be engaged by the instrument, but the movement should not be excessive.

[0072] Figures 10A to 10H show exemplary support pack assemblies according to some exemplary embodiments of the present disclosure.

[0073] The assembly process begins with an empty reagent pack 802, as illustrated in Figure 10A.

[0074] Figure 10B shows a reagent pack 802 according to some embodiments of the present disclosure. 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.

[0075] As shown in Figure 10C, after filling the first reagent well 900, the second reagent well 902, the third reagent well 904, and the fourth reagent well 906 with reagents, the reagent pack 802 is sealed with the reagent pack seal 804 to obtain a sealed reagent pack 1000. As previously stated, the reagent pack seal 804 is sealed to the reagent pack 802 using heat sealing, but in alternative embodiments, the reagent pack seal 804 may be sealed to the reagent pack 802 using adhesive or induction sealing. It is important that the reagent pack seal 804 is completely bonded to the reagent pack 802 to prevent leakage or cross-contamination of reagents.

[0076] Figure 10D shows an empty tip pack 806. In a preferred embodiment, the tip pack 806 is injection molded using polyolefin or a similar material.

[0077] In Figure 10E, the pipette tip 808 is inserted into the tip pack 806, resulting in a filled tip pack 1002. Although the pipette tip 808 is precisely positioned within the tip pack 806, it can be freely removed and replaced by the instrument. As previously mentioned, in a preferred embodiment, the pipette tip 808 is injection molded using polyolefin or a similar material.

[0078] In Figure 10F, the tip pack seal 810 is sealed onto the filled tip pack 1002, resulting in a sealed tip pack 1004. The tip pack seal 810 protects the pipette tip 808 from fragments and prevents the pipette tip from falling out of the tip pack 806 during transport. Since the barrier properties of the 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 tip pack seal 810. The tip pack seal 810 can be attached to the filled tip pack 1002 using heat sealing, adhesive bonding, or induction sealing, among other means.

[0079] In Figure 10G, the sealed tip pack 1004 is attached to the sealed reagent pack 1000 by the snap mechanism notch 914 and snap mechanism 920 (shown in Figure 9G), resulting in a sealed support pack 1006. When it is time to insert the support pack into the instrument, the reagent pack seal 804 and tip pack seal 810 can be removed before insertion.

[0080] In Figure 10H, the sealed support pack 1006 is packaged in a support pack pouch 1008 for storage. The support pack pouch 1008 can be made from a variety of materials, with materials having a low water vapor permeability being particularly desirable. Such materials minimize the evaporation of liquid from the sealed support pack 1006 during long-term storage.

[0081] Figure 11A shows an exemplary integrated kit 1100 according to several exemplary embodiments of the present disclosure. In some embodiments, the tray 1102 includes a desiccant 1104, a first disk assembly 1106, a second disk assembly 1108, a third disk assembly 1110, a pipette tip 1111, a tip pack 1112, a reagent pack seal 1114, a reagent pack 1116, or any combination thereof. In some embodiments, the space and / or mechanism on the tray 1102 for accommodating the pipette tip 1111, the tip pack 1112, the reagent pack seal 1114, the reagent pack 1116, or any combination thereof is referred to herein as a fourth compartment 1117. Instead of inserting the open support kit assembly 402 and the open tray assembly 404 into the instrument drawer 400 (as shown in Figures 4A and 4B), the integrated kit 1100 is instead inserted into the instrument.

[0082] As shown in Figure 11B, when manufacturing the integrated kit 1100, the tray sealing film 1118 can be sealed over the tray 1102. The tray sealing film 1118 protects the contents of the integrated kit 1100 from contamination and can be removed before inserting the integrated kit 1100 into the equipment.

[0083] Figure 12A shows alternative embodiments of the support pack according to some embodiments of the present disclosure. In some embodiments, the unibody support pack 1200 includes a reagent pack portion 1202, a tip pack portion 1204, and an integrated hinge 1206. Instead of having separate reagent and tip packs connected during manufacturing, as shown in the previous figure, the unibody support pack 1200 features reagent and tip packs connected during the molding process and thus features a unibody structure. The reagent pack portion 1202 and the tip pack portion 1204 are connected by the integrated hinge 1206 during injection molding. As shown in Figure 12B, the reagent pack portion 1202 and the tip pack portion 1204 can pivot around an axis created by the integrated hinge 1206, providing a lower profile assembly with a lower profile for subsequent packaging operations. As described in the previous embodiment, the reagent pack portion 1202 may be filled with liquid reagents during manufacturing and sealed with foil, while the tip pack portion 1204 may be filled with pipette tips and sealed with a removable film. The integrated hinge 1206 is typically not covered with foil or film.

[0084] Figure 12B shows the unibody support pack 1200 in both its unfolded and folded states. After filling the reagent pack portion 1202 with liquid reagents and sealing it with foil, and after placing pipette tips in the tip pack portion 1204 and sealing it with film, the unibody support pack 1200 is folded along the integrated hinge 1206 as shown in Figure 12B. In the folded state, the unibody support pack 1200 has a lower profile, which may be advantageous for packaging and transport.

[0085] Before use, the unibody support pack 1200 is removed from its packaging (not shown) as shown in Figure 12C. In the unfolded state, the sealing film is removed from the tip pack portion 1204, and the unibody support pack 1200 can be inserted into the device for further processing.

[0086] Figures 13A–13C show a second embodiment of a tray, generally referred to as 202, according to several aspects of the present disclosure. Tray 202 is similar to the first embodiment of tray 102, except that tray 202 includes a stacking mechanism 1304, a knurled surface 1306, a curved edge 1307, and ribs 1309 on a central positioning mechanism. One or more stacking mechanisms 1304 can be added at various positions on the tray to protect the tray when stacked during transport. The knurled surface 1306 and curved edge 1307 provide the user with a better grip and improved comfort when placing and picking up the tray in the equipment. The ribs 1309 function as structural supports for the central positioning mechanism and engage with a sensor button on the equipment to alert the equipment that the tray has been placed.

[0087] Figure 14 shows a third embodiment of a tray generally referred to as 302, according to several aspects of the present disclosure. Tray 302 is similar to the second embodiment of tray 202, except that tray 302 has a straight edge 1404.

[0088] The devices 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 WO2018 / 119437, WO2018 / 140719, WO2022 / 029731, and WO2022 / 029732, the contents of which are incorporated herein by reference in their entirety. The devices and methods disclosed herein may 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.

[0089] Several embodiments or designs will be described in relation to the following provisions.

[0090] Clause A1. It is a tray, It comprises a first compartment configured to stack multiple disk assemblies, the first compartment being substantially circular, (i) A stepped support comprising a plurality of steps along the axial direction of the first compartment and configured to accommodate corresponding disk assemblies within the plurality of disk assemblies characterized by corresponding diameters within a plurality of diameters, (ii) at least one axial retaining member formed in each of the plurality of stages or adjacent to each stage, configured to prevent the corresponding disk assembly in the plurality of disk assemblies from moving in the axial direction when the corresponding disk assembly in the plurality of disk assemblies is positioned in the first compartment, (iii) at least one angular directional retaining member formed in each of the plurality of stages or adjacent to each stage, configured to prevent the corresponding disk assembly in the plurality of disk assemblies from rotating about the axis of the first compartment when the corresponding disk assembly in the plurality of disk assemblies is placed in the first compartment, The aforementioned tray.

[0091] Clause A2. The tray according to clause A1, wherein the plurality of tiers are configured such that adjacent disk assemblies within the plurality of disk assemblies are spaced apart from each other along the axial direction of the first compartment when they are placed within the first compartment.

[0092] Clause A3. The tray as described in any of the preceding clauses, wherein the plurality of tiers includes two, three, four, or five or more tiers.

[0093] Clause A4. The aforementioned multiple stages, A first stage in a first level configured to house a first disk assembly, A second stage in a second level higher than the first level, configured to accommodate a second disk assembly larger than the first disk assembly, The trays described in any of the preceding clauses, including the trays described in any of the preceding clauses.

[0094] Clause A5. The tray according to Clause 4, wherein the plurality of tiers include a third tier at a third level higher than the second level, configured to accommodate a third disk assembly larger than the second disk assembly.

[0095] Clause A6. The aforementioned plurality of disk assemblies A disk assembly configured to perform hematological tests, A disk assembly configured to perform clinical scientific tests, A disk assembly configured to perform immunoassay testing. Or any combination thereof, The trays described in any of the preceding clauses, including the trays described in any of the preceding clauses.

[0096] Clause A7. The tray according to Clause A6, wherein the disk assembly configured to perform the immunoassay test is larger than the disk assembly configured to perform the clinical chemistry test, and the disk assembly configured to perform the clinical chemistry test is larger than the disk assembly configured to perform the hematological test.

[0097] Clause A8. The tray according to any of the preceding clauses, wherein the at least one axial retaining member formed in different stages of the plurality of stages or adjacent to different stages is arranged alternately in the circumferential direction with respect to each other.

[0098] Clause A9. The tray according to any of the preceding clauses, wherein the at least one axial retaining member formed in each of the plurality of steps includes two, three, four or more axial retaining members spaced apart from each other in the circumferential direction.

[0099] Clause A10. The tray according to any of the preceding clauses, wherein each of the at least one angular retaining members formed in each of the plurality of stages, or adjacent to each of the plurality of stages, is configured to engage with a notch formed on the outer periphery of the corresponding disk assembly in the plurality of disk assemblies.

[0100] Clause A11. The tray according to any of the preceding clauses, wherein the at least one angular retaining member formed in each of the plurality of steps, or formed adjacent to each of the steps, consists of a single angular retaining member.

[0101] Clause A12. The first section mentioned above is The bottom wall and, A central positioning mechanism is formed in the bottom wall of the first compartment and is configured to engage with the positioning mechanism of the equipment when the tray is placed in the equipment, thereby preventing the tray from moving laterally and angularly. The trays described in any of the preceding clauses, including the trays described in any of the preceding clauses.

[0102] Clause A13. The central positioning mechanism is the tray according to A12, having a substantially triangular cross-section.

[0103] Clause A14. A tray according to any one of the clauses A12 to A13, wherein the support mechanism is formed in the bottom wall of the first compartment and is at the same height as the central positioning mechanism and the bottom wall of the second compartment, facilitating the placement of the tray on the surface.

[0104] Clause A15. The tray according to any one of clauses A12 to A14, wherein the first compartment includes a designated area on the inner surface of the bottom wall for arranging one or more test strips.

[0105] Clause A16. A second compartment configured to contain a desiccant, A conduit connecting the second section to the first section, A tray further comprising any of the preceding clauses.

[0106] Clause A17. The tray according to any of the preceding clauses, further comprising a third compartment configured to accommodate vials for one or more external processes from the plurality of disk assemblies.

[0107] Clause A18. A tray according to any of the preceding clauses, further comprising a flange formed together with the first compartment, the second compartment, and / or the third compartment, and configured to engage with the rails of the equipment.

[0108] Clause A19. The tray according to clause A18, wherein the flange has a chamfered edge to prevent the flange from shifting within the equipment.

[0109] Clause A20. A plurality of sealing ribs are formed on the upper surface of the flange and configured to engage with the sealing film, At least one gripping member formed on the flange and configured to facilitate easy gripping of the tray, A plurality of structural ribs are formed on the flange and / or the stepped support portion of the first section and configured to increase 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 regarding the arrangement of the tray, A fourth compartment for accommodating reagent packs, pipette packs, or both. Or any combination thereof, A tray further comprising any one of clauses A18 to A19.

[0110] Clause B1. The tray described in any of the preceding clauses, At least one disk assembly disposed in the first compartment of the tray, A sealing film that engages with the tray to seal the at least one disk assembly within the first compartment of the tray, A tray assembly comprising:

[0111] Clause B2. The tray assembly according to clause B1, wherein the at least one disk assembly comprises two or more disk assemblies within the plurality of disk assemblies.

[0112] Clause B3. The tray assembly according to clause B1, wherein the at least one disk assembly comprises each of the plurality of disk assemblies.

[0113] Clause B4. A desiccant placed in the second compartment of the tray, A vial placed in the third compartment of the tray, One or more test strips are placed on the bottom wall of the first compartment of the tray, Or any combination thereof, A tray assembly further comprising any one of clauses B1 to B3.

[0114] Clause C1. A) Obtaining a tray as described in any one of clauses A1 to A20, B) Optionally, one or more test strips are placed on the bottom wall of the first compartment of the tray, C) Optionally, the vial is placed in the third compartment of the tray, D) Optionally, place the desiccant in the second compartment of the tray, E) Placing at least one disk assembly within the first compartment of the tray, F) Sealing the first compartment, the second compartment, and / or the third compartment using a sealing film that engages with the tray, G) Optionally, add the code and / or logo to the tray. H) A method for manufacturing a tray assembly, comprising optionally placing the tray inside a pouch.

[0115] Clause C2. The method according to clause C1, wherein arrangement E) includes arranging two or more disk assemblies within the first compartment of the tray.

[0116] Clause C3. The method according to clause C1, wherein arrangement E) includes arranging each of the plurality of disk assemblies within the first compartment of the tray.

[0117] Clause D1. It is a tray assembly, Multiple disk assemblies, each characterized by a corresponding diameter within a plurality of diameters, A tray assembly comprising: a tray including a first compartment configured for stacking the plurality of disk assemblies, wherein the first compartment is substantially circular and includes a stepped support, the stepped support including a plurality of steps along the axial direction of the first compartment, each configured to accommodate a corresponding disk assembly in the plurality of disk assemblies.

[0118] Clause E1. It is a tray assembly, At least one disk assembly, each having a notch formed on the outer circumference of the disk assembly, A tray assembly comprising: a tray including a first compartment configured to accommodate at least one disk assembly, wherein the first compartment is substantially circular and includes a circumferential side wall, the circumferential side wall of the first compartment includes at least one angular retaining member, each engaging with the notch of the corresponding disk assembly in the at least one disk assembly to prevent the corresponding disk assembly from rotating about the axis of the first compartment.

[0119] Clause E2. The tray assembly described in clause E1, wherein the at least one disk assembly consists of a single disk assembly.

[0120] Clause E3. The tray assembly according to clause E1, wherein the at least one disk assembly comprises two or more disk assemblies.

[0121] Clause E4. The aforementioned tray A second compartment configured to contain a desiccant, A conduit connecting the second section to the first section, A third compartment configured to accommodate vials for one or more external processes, A fourth compartment configured to house the support pack assembly, Or any combination thereof, A tray assembly further comprising any one of clauses D1 to E3.

[0122] Clause E5. A desiccant placed in the second compartment, A vial located within the third compartment and configured for one or more external processes from the plurality of disk assemblies, A support pack assembly located within the fourth compartment, Or any combination thereof, The tray assembly described in Clause E4 further includes the following:

[0123] Clause F1. It is a reagent pack, It comprises multiple wells, and each of the multiple wells is Corresponding openings, Corresponding closed bottom, The reagent pack comprises a corresponding circumferential side wall formed in a corresponding predefined profile between the corresponding opening and the closed bottom, wherein the angle of the corresponding predefined profile with respect to the axis of each well increases from the corresponding opening to the corresponding closed bottom of each well.

[0124] Clause F2. The reagent pack according to clause F1, wherein the corresponding predefined profile is configured to assist in the injection molding of the reagent pack, filling, storing, and removing reagents from each of the wells, minimizing unwanted air bubbles in each of the wells, or any combination thereof.

[0125] Clause F3. The reagent pack according to any one of the clauses F1 to F2, wherein the plurality of wells include at least two wells having substantially the same predefined profile.

[0126] Clause F4. The reagent pack according to any one of the clauses F1 to F3, wherein the plurality of wells include at least two wells having different predefined profiles.

[0127] Clause F5. The reagent pack according to any one of the clauses F1 to F4, wherein the plurality of wells comprises a set of a plurality of wells, each set comprising one or more wells.

[0128] Clause F6. The reagent pack according to any one of the clauses F1 to F5, wherein the inner surface of each well in the plurality of wells is polished to reduce air bubbles during transport.

[0129] Clause F7. Multiple ribs, each surrounding the well opening within the multiple wells to facilitate sealing of the wells, At least one gripping member for facilitating easy gripping of the reagent pack, A guide member that indicates the proper orientation of the reagent pack, At least one engaging member to facilitate assembly with the tip pack, Or a combination of those, A reagent pack further comprising any one of clauses F1 to F6.

[0130] Clause G1. It is a tip pack, A tip pack comprising multiple pipette tip nests, each formed by a tip interface, wherein the corresponding pipette tip within the multiple pipette tips is positioned on the tip interface, thereby facilitating accurate pickup of the corresponding pipette tip with minimal movement.

[0131] Clause G2. The tip pack according to clause G1, further comprising at least one engaging member and / or at least one positioning member for facilitating assembly with a reagent pack.

[0132] Clause H1. A support pack assembly comprising a reagent pack according to any one of clauses F1 to F7, coupled with a tip pack according to any one of clauses G1 to G2.

[0133] Terminology and cited references The terms used herein are intended solely to describe specific embodiments and are not intended to limit the scope of the claims. In the descriptions of embodiments and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural form unless the context clearly indicates otherwise. Terms such as “left” or “right,” “top” or “bottom,” “bottom” or “top,” “inside” or “outside,” and “inside” or “outside” are used to describe features of exemplary embodiments by reference to the location of features as shown in the figures. While terms such as “first” and “second” may be used herein to describe various elements, it should be understood that these elements should not be limited by these terms. These terms are used merely to distinguish one element from another. For example, “first element” and “second element” may be referred to as the second element, and similarly, the second element may be referred to as the first element, without changing the meaning of the description, provided that the terms are consistently renamed accordingly.

[0134] As used herein, the terms “and / or” refer to and encompass any possible combination of one or more of the related enumerated items. Furthermore, as used herein, the terms “include,” “includes,” “including,” “comprise,” “comprises,” and / or “comprising” express the presence of the described features, entities, stages, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, entities, stages, actions, elements, components, and / or groups thereof.

[0135] The terms “approximately” or “about” are used herein to provide a literal justification for a number that is close to or approximately the same as the number that follows, as well as the number itself. When determining whether a number is close to or approximately the same as a specifically described number, undescribed neighboring or approximate values ​​may be substantially equivalent to the specifically described number in the context in which they are presented. It should be understood that all numerical values ​​and ranges disclosed herein, whether “approximately” is used in conjunction with them, are approximate values ​​and ranges. It should also be understood that the term “approximately” as used herein with numerical values ​​may refer to values ​​that are ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive), ±2% (inclusive), ±3% (inclusive), ±5% (inclusive), ±10% (inclusive), or ±15% (inclusive). Furthermore, when a numerical range is disclosed herein, it should be understood that any numerical values ​​that fall within that range are also specifically disclosed.

[0136] As used herein, the term “if” shall be interpreted as “when,” “upon,” “depending on the decision,” “depending on the detection,” or “in accordance with the decision that.” Similarly, as used herein, the expressions “when it is decided that” or “when [the described condition or event] is detected” shall be interpreted as “when it is decided that” or “depending on the decision,” or “when [the described condition or event] is detected,” or “in accordance with the decision that [the described condition or event] has been detected,” or “in accordance with the decision that [the described condition or event] has been detected.”

[0137] When a reference number is given the notation "i-th", that reference number refers to a general component, set, or embodiment. For example, "unit i" refers to the i-th unit of a group of units.

[0138] All references cited herein are incorporated herein by reference in any and all for any and all for any and all for any and all for the same degree as each individual publication or patent or patent application is specifically and individually indicated to be incorporated herein by reference in any and all for

Claims

1. It is a tray, It comprises a first compartment configured to stack multiple disk assemblies, the first compartment being substantially circular, (i) A stepped support comprising a plurality of steps along the axial direction of the first compartment and configured to accommodate corresponding disk assemblies within the plurality of disk assemblies characterized by corresponding diameters within a plurality of diameters, (ii) at least one axial retaining member formed in each of the plurality of stages or adjacent to each stage, configured to prevent undesirable axial movement of the corresponding disk assembly in the plurality of disk assemblies when the corresponding disk assembly in the plurality of disk assemblies is positioned in the first compartment, (iii) comprising at least one angular directional retaining member formed in each of the plurality of stages or adjacent to each stage, configured to prevent undesirable rotation of the corresponding disk assembly in the plurality of disk assemblies about the axis of the first compartment when the corresponding disk assembly in the plurality of disk assemblies is placed in the first compartment, The aforementioned tray.

2. The tray according to claim 1, wherein the plurality of stages are configured such that adjacent disk assemblies within the plurality of disk assemblies are spaced apart from each other along the axial direction of the first compartment when they are placed within the first compartment.

3. The tray according to claim 2, wherein the plurality of tiers includes two, three, four, or five or more tiers.

4. The aforementioned multiple stages, A first stage in a first level configured to house a first disk assembly, A second stage in a second level higher than the first level, configured to accommodate a second disk assembly larger than the first disk assembly, The tray according to claim 3, including the following:

5. The aforementioned multiple stages, The tray according to claim 4, comprising a third tier at a third level higher than the second level, configured to accommodate a third disk assembly larger than the second disk assembly.

6. The aforementioned plurality of disk assemblies A disk assembly configured to perform hematological tests, A disk assembly configured to perform clinical scientific tests, A disk assembly configured to perform immunoassay testing. Or a combination of those, The tray according to claim 1, further comprising:

7. The tray according to claim 6, wherein the disk assembly configured to perform the immunoassay test is larger than the disk assembly configured to perform the clinical chemistry test, and the disk assembly configured to perform the clinical chemistry test is larger than the disk assembly configured to perform the hematological test.

8. The tray according to claim 1, wherein the at least one axial retaining member formed in different stages of the plurality of stages or adjacent to different stages is arranged alternately in the circumferential direction with respect to each other.

9. The tray according to claim 8, wherein the at least one axial holding member formed in each of the plurality of steps includes two, three, four or more axial holding members spaced apart from each other in the circumferential direction.

10. The tray according to claim 1, wherein each of the at least one angular holding member formed in each of the plurality of stages, or adjacent to each of the plurality of stages, is configured to engage with a notch formed on the outer periphery of the corresponding disk assembly in the plurality of disk assemblies.

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

12. The first section is, The bottom wall and, A central positioning mechanism is formed in the bottom wall of the first compartment and is configured to engage with the positioning mechanism of the equipment when the tray is placed in the equipment, thereby preventing the tray from moving laterally and angularly. The tray according to claim 1, further comprising:

13. The tray according to claim 12, wherein the central positioning mechanism has a substantially triangular cross-section.

14. The tray according to claim 12, wherein the support mechanism is formed in the bottom wall of the first compartment and is at the same height as the central positioning mechanism and the bottom wall of the second compartment, facilitating the placement of the tray on the surface.

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

16. A second compartment configured to contain a desiccant, The tray according to claim 1, further comprising a conduit connecting the second compartment to the first compartment.

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

18. The tray according to claim 17, further comprising a flange formed together with the first compartment, the second compartment, and / or the third compartment, and configured to engage with a rail of equipment.

19. The tray according to claim 18, wherein the flange has a chamfered edge to prevent the flange from shifting within the equipment.

20. A plurality of sealing ribs are formed on the upper surface of the flange and configured to engage with the sealing film, At least one gripping member formed on the flange and configured to facilitate easy gripping of the tray, A plurality of structural ribs are formed on the flange and / or the stepped support portion of the first section and configured to increase the strength of the tray, A 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 regarding the arrangement of the tray, A fourth compartment for accommodating reagent packs, pipette packs, or both. The tray according to claim 18, further comprising either or a combination thereof.

21. The aforementioned reagent pack, It comprises multiple wells, and each of the multiple wells is Corresponding openings, Corresponding closed bottom, The tray according to claim 20, further comprising a reagent pack having a corresponding circumferential side wall formed in a corresponding predefined profile between the corresponding opening and the closed bottom, wherein the angle of the corresponding predefined profile with respect to the axis of each well increases from the corresponding opening to the corresponding closed bottom of each well.

22. It is a tray, A first compartment configured to stack multiple disk assemblies, wherein the first compartment is substantially circular. (i) A stepped support comprising a plurality of steps along the axial direction of the first compartment and configured to accommodate corresponding disk assemblies within the plurality of disk assemblies characterized by corresponding diameters within a plurality of diameters, (ii) at least one axial retaining member formed in each of the plurality of stages or adjacent to each stage, configured to prevent the corresponding disk assembly in the plurality of disk assemblies from moving in the axial direction when the corresponding disk assembly in the plurality of disk assemblies is positioned in the first compartment, (iii) The first compartment, comprising: at least one angular directional retaining member formed in each of the plurality of steps or adjacent to each step, configured to prevent the corresponding disk assembly in the plurality of disk assemblies from rotating about the axis of the first compartment when the corresponding disk assembly in the plurality of disk assemblies is placed in the first compartment; A second compartment configured to contain a desiccant, A third compartment configured to accommodate vials for one or more external processes from the plurality of disk assemblies, It is a reagent pack, It comprises multiple wells, and each of the multiple wells is Corresponding openings, Corresponding closed bottom, The reagent pack comprises a corresponding circumferential side wall formed in a corresponding predefined profile between the corresponding opening and the closed bottom, wherein the angle of the corresponding predefined profile with respect to the axis of each well increases from the corresponding opening to the corresponding closed bottom of each well, A fourth compartment for housing the aforementioned reagent pack, pipette pack, or both, or any combination thereof, One or more test strips containing a reaction pad for performing a colorimetric assay on a sample such as urine, whole blood, plasma, serum, or other processed sample, The tray comprising the above.

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