Rack for sample tubes

Abstract

To provide a device for holding a sample tube for sample preparation.SOLUTION: The apparatus includes a sample tube holder having an opening for receiving a sample tube. The apparatus comprises a hinge assembly having a hinge plate and a hinge support, wherein the hinge plate is movable relative to the hinge support. In one example, the hinge plate pivots in two rotational directions and slides in two translational directions relative to the hinge support. The hinge plate limits vertical movement of the sample tube within the sample tube holder. In one aspect, a method includes inserting a sample tube into an opening of a sample tube holder and pivoting and sliding a hinge plate relative to a hinge support, wherein the hinge plate restricts vertical movement of the sample tube within the sample tube holder.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 779,926, filed December 14, 2018, and U.S. Provisional Patent Application No. 62 / 892,263, filed August 27, 2019, both of which are hereby incorporated by reference in their entireties.

[0002] The technology described herein generally relates to racks for holding samples and various reagents. More specifically, the technology relates to sample tube holders that receive and hold complementary sample tubes, each containing a sample for performing a predetermined processing operation with one or more reagents, such as preparing a biological sample for amplification and detection of polynucleotides extracted from the sample. [Background technology]

[0003] The medical diagnostics industry is a critical component of today's healthcare infrastructure. However, today, diagnostic analyses, no matter how routine, represent a bottleneck in patient care. There are several reasons for this. First, many diagnostic analyses can only be performed using highly specialized equipment, which is expensive and can only be operated by skilled clinicians. Such equipment is found in only a few locations, often as few as one within any given metropolitan area. This means that most hospitals are required to ship samples to these locations for analysis, thereby incurring shipping costs and transport delays, and potentially even sample loss or mishandling. Second, such equipment is typically not available "on demand" but instead runs in batches, thereby slowing processing times for many samples as they must wait for the machine to be filled before they can process them.

[0004] Understanding that sample flow is divided into several key steps, it would be desirable to devise methods to automate as many of these as possible. For example, once extracted from a patient, a biological sample must be placed in a form suitable for a processing regime that typically involves using amplification methods, including but not limited to polymerase chain reaction (PCR), TMA, SDA, NASBA, LCR, and rolling circle amplification, to amplify the vector of interest. Once amplified, the presence of the nucleotide of interest from the sample must be unambiguously determined. Preparing the sample for PCR is currently a time-consuming and labor-intensive step, but it does not require specialized skill and could be usefully automated. In contrast, steps such as PCR and nucleotide detection are typically limited to the professional domain of specially trained individuals with access to specialized equipment.

[0005] Sample preparation is labor-intensive due in part to the number of reagents required and the need for multiple liquid transfer (e.g., pipetting) operations. Furthermore, the required reagents are sufficiently diverse that they typically require different handling from one another and are available from different vendors. As explained in U.S. patent application Ser. No. 12 / 218,416, filed July 14, 2008 (and entitled "Reagent Tube, Reagent Holder, and Kits Containing Same" in the names of Wilson et al.), which is incorporated herein by reference, even if reagents can be collected together in a single holder and await use, it would be beneficial to be able to prepare several sample tubes and reagent holders for use in a batch and make them available to a liquid dispensing tool that can operate in parallel on the sample tubes and reagent holders. U.S. Patent Application No. 15 / 017977, entitled "Rack for Sample Tubes and Reagent Holders," filed February 8, 2016 in the name of Duffy et al., is also incorporated in its entirety.

[0006] The discussion of background art herein is included to explain the relevance of the technology described herein and should not be construed as an admission that any of the referenced material was published, publicly known, or part of the common general knowledge as of the priority date of any of these claims.

[0007] Throughout the description and claims of this specification, the words "comprise" and variations thereof, such as "comprising" and "comrises," are not intended to exclude other additions, elements, wholes, or steps. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent Application Serial No. 12 / 218,416 [Patent Document 2] U.S. Patent Application No. 15 / 017977 Summary of the Invention [Means for solving the problem]

[0009] In some embodiments, an apparatus for holding a sample tube is provided. The apparatus can include a sample tube holder including an opening configured to receive a sample tube. The apparatus can include a hinge assembly including a hinge plate and a hinge support. In some embodiments, the hinge plate is configured to slide and pivot relative to the hinge support between a first configuration and a second configuration. In some embodiments, the hinge plate is positioned in the first configuration to allow insertion of the sample tube at the opening. In some embodiments, the hinge plate is positioned in the second configuration to limit vertical movement of the sample tube within the sample tube holder.

[0010] In some embodiments, the device may include a slide lock coupled to the hinge plate. In some embodiments, the slide lock is configured to slide and pivot relative to a hinge pin, the hinge pin being coupled to the hinge support. In some embodiments, the device may include a spring configured to bias the slide lock against an inner surface of the hinge support. In some embodiments, the device may include a reagent housing. In some embodiments, the sample tube holder and the reagent housing are coupled. In some embodiments, the hinge support and the reagent housing are coupled. In some embodiments, the sample tube holder includes a plurality of openings configured to receive a plurality of sample tubes. In some embodiments, the sample tube holder includes two openings configured to receive sample tubes. In some embodiments, the openings horizontally constrain the sample tubes when the sample tubes are received in the sample tube holder. In some embodiments, the hinge plate is configured to limit vertical movement of the sample tubes within the sample tube holder. In some embodiments, the hinge plate includes a small recess along an edge of the hinge plate, the small recess configured to overlie a cap of a sample tube. In some embodiments, the hinge plate includes a large recess along an edge of the hinge plate, the large recess configured to allow a sample tube to be removed from or inserted into the sample tube holder. In some embodiments, the device can include a sample tube. In some embodiments, the device can include a self-locking tab positioned relative to the hinge plate.

[0011] In some embodiments, a method is provided that can include pivoting a hinge plate relative to a hinge support. The method can include sliding the hinge plate relative to the hinge support in a pivoted state, the hinge plate configured to limit vertical movement of a sample tube within the sample tube holder.

[0012] In some embodiments, the hinge plate slides under the biasing force of a spring. In some embodiments, the top surface of the hinge plate is rotated away from the vertical axis of the sample tube when the sample tube is inserted, and the hinge plate is pivoted to be approximately perpendicular to the vertical axis of the sample tube. The method can include inserting a pipette tip into the sample tube when the sample tube is in the sample tube holder and the hinge plate pivots and slides. The method can include removing the pipette tip from the sample tube when the sample tube is in the sample tube holder and the hinge plate pivots and slides.

[0013] In some embodiments, an apparatus for holding a sample tube is provided. The apparatus can include a sample tube holder including an opening configured to receive a sample tube. The apparatus can include a hinge assembly including a hinge plate and a hinge support. In some embodiments, the hinge plate is configured to slide and pivot relative to the hinge support between a first configuration and a second configuration. In some embodiments, the hinge plate is positioned in the first configuration to allow insertion of the sample tube at the opening. In some embodiments, the hinge plate is positioned in the second configuration to limit vertical movement of the sample tube within the sample tube holder.

[0014] In some embodiments, the device can include a reagent housing including a slot configured to receive the reagent holder. In some embodiments, the opening is positioned to align with the slot. In some embodiments, the sample tube holder and the reagent housing are coupled. In some embodiments, the hinge support and the reagent housing are coupled. In some embodiments, the sample tube holder includes a plurality of openings configured to receive a plurality of sample tubes. In some embodiments, the sample tube holder includes two openings configured to receive sample tubes. In some embodiments, the openings horizontally constrain the sample tubes when the sample tubes are received in the sample tube holder. In some embodiments, the hinge plate is configured to apply a force to limit vertical movement of the sample tubes within the sample tube holder. In some embodiments, the device is configured to be received in a receiving compartment including a partition, and the hinge plate is pivoted by the partition when the device is received in the receiving compartment. In some embodiments, the hinge plate includes a recess along an edge of the hinge plate, the recess being configured to abut against a cap of a sample tube. In some embodiments, the hinge plate is pivoted when the device is inserted into a diagnostic device. In some embodiments, the device can include a sample tube.

[0015] In some embodiments, a method is provided that can include inserting a sample tube into an opening in a sample tube holder. The method can include pivoting a hinge plate relative to a hinge support, the hinge plate configured to limit vertical movement of the sample tube within the sample tube holder.

[0016] In some embodiments, pivoting the hinge plate further comprises inserting the sample tube holder into the diagnostic device. In some embodiments, pivoting the hinge plate further comprises contacting the hinge plate with a partition in a receiving compartment of the diagnostic device. In some embodiments, the method can include inserting a pipette tip into the sample tube while the sample tube is in the sample tube holder. In some embodiments, the method can include removing a pipette tip from the sample tube while the sample tube is in the sample tube holder. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 is a front perspective view of a first embodiment of a rack for sample tubes and reagent holders. [Figure 2] FIG. 2 is a rear perspective view of the rack of FIG. 1. [Figure 3] FIG. 2 is a top view of the rack of FIG. 1. [Figure 4] FIG. 2 is a side view of the rack of FIG. 1. [Figure 5] FIG. 2 is a front view of the rack of FIG. 1. [Figure 6] FIG. 2 is a rear view of the rack of FIG. 1. [Figure 7] 2 is a first front perspective view of a sample tube holder of the rack of FIG. 1. [Figure 8] FIG. 8 is a rear perspective view of the sample tube holder of FIG. 7. [Figure 9] FIG. 2 is a front perspective view of a hinge assembly of the rack of FIG. 1. [Figure 10A] FIG. 10 is a rear perspective view of the hinge assembly of FIG. [Figure 10B] FIG. 10 is a rear exploded view of the hinge assembly of FIG. [Figure 11A] FIG. 10 is a first side view of the hinge assembly of FIG. [Figure 11B] FIG. 10 is a first side view of the hinge assembly of FIG. [Figure 12] FIG. 10 is a top view of the hinge assembly of FIG. 9. [Figure 13] FIG. 10 is an exploded front perspective view of a portion of the hinge assembly of FIG. [Figure 14] FIG. 10 is an exploded front perspective view of the hinge assembly of FIG. [Figure 15A] FIG. 2 is a diagram of the sample tube holder of the rack of FIG. 1. [Figure 15B] FIG. 2 is a diagram of the sample tube holder of the rack of FIG. 1. [Figure 15C] FIG. 2 is a diagram of the sample tube holder of the rack of FIG. 1. [Figure 16A] FIG. 2 is a diagram of the sample tube holder of the rack of FIG. 1. [Figure 16B] FIG. 2 is a diagram of the sample tube holder of the rack of FIG. 1. [Figure 17] FIG. 2 is a front perspective view of the diagnostic device and rack of FIG. 1. [Figure 18] FIG. 2 is a front perspective view of the diagnostic device. [Figure 19A] FIG. 10 is a front perspective view of a second embodiment of a rack for sample tubes and reagent holders. [Figure 19B] FIG. 10 is a front perspective view of a second embodiment of a rack for sample tubes and reagent holders. [Figure 20A] FIG. 19B is a rear perspective view of the rack of FIG. 19A. [Figure 20B] FIG. 19B is a rear perspective view of the rack of FIG. 19A. [Figure 21] FIG. 19B is a top view of the rack of FIG. 19A. [Figure 22] FIG. 19B is a side view of the rack of FIG. 19A. [Figure 23] FIG. 19B is a front view of the rack of FIG. 19A. [Figure 24] FIG. 19B is a rear view of the rack of FIG. 19A. [Figure 25] FIG. 19B is a front perspective view of the sample tube holder of the rack of FIG. 19A. [Figure 26] FIG. 26 is a rear perspective view of the sample tube holder of FIG. 25. [Figure 27] FIG. 19B is a front perspective view of the hinge assembly of the rack of FIG. 19A. [Figure 28]FIG. 28 is a rear perspective view of the hinge assembly of FIG. 27. [Figure 29] FIG. 28 is a front exploded view of the hinge assembly of FIG. 27. [Figure 30A] FIG. 28 is a front view of the hinge assembly of FIG. 27. [Figure 30B] FIG. 28 is a front view of the hinge assembly of FIG. 27. [Figure 31] FIG. 28 is a top view of the hinge assembly of FIG. 27. [Figure 32] FIG. 28 is a front perspective view of a portion of the hinge assembly of FIG. 27. [Figure 33] FIG. 28 is a front perspective view of a portion of the hinge assembly of FIG. 27. [Figure 34] FIG. 28 is a top perspective view of a portion of the hinge assembly of FIG. 27. [Figure 35] FIG. 19B is a top view of the self-locking tabs of the rack of FIG. 19A. [Figure 36] FIG. 36 is a bottom view of the self-locking tab of FIG. 35. [Figure 37] FIG. 36 is a perspective view of the self-locking tab of FIG. 35; [Figure 38] FIG. 36 is a side view of the self-locking tab of FIG. 35. [Figure 39] FIG. 36 is a rear view of the self-locking tab of FIG. 35. [Figure 40A] FIG. 19B is a view of the sample tube holder of the rack of FIG. 19A. [Figure 40B] FIG. 19B is a view of the sample tube holder of the rack of FIG. 19A. [Figure 40C] FIG. 19B is a view of the sample tube holder of the rack of FIG. 19A. [Figure 40D] FIG. 19B is a view of the sample tube holder of the rack of FIG. 19A. [Figure 41A] FIG. 19B is a view of the sample tube holder of the rack of FIG. 19A. [Figure 41B] FIG. 19B is a view of the sample tube holder of the rack of FIG. 19A. DETAILED DESCRIPTION OF THE INVENTION

[0018] Described herein are hinge assemblies designed to prevent vertical movement or lifting of sample tubes from a sample tube holder during a pipetting operation. The hinge assembly can include a hinge support coupled to a movable hinge plate. The hinge support can remain stationary, and in some embodiments, remains coupled to the reagent housing of the rack during movement of the hinge plate, e.g., pivoting and sliding of the hinge plate relative to the reagent housing of the rack. The hinge assembly can include one or more hinge pins, and the hinge plate is configured to pivot relative to the hinge support through the one or more hinge pins. In some methods of use, a force is applied to the hinge plate to rotate it into contact with one or more sample tubes. In some embodiments, a partition within the receiving compartment that receives the rack can apply the force. For example, this force can be applied when the rack is inserted into the receiving compartment and the partition physically engages with a feature within the receiving compartment.

[0019] The hinge assembly securely restrains one or more sample tubes within the sample tube holder. A single motion caused by an actuation force can pivot and slide the hinge assembly, thereby locking the sample tubes in place. The hinge plate can be designed to simultaneously contact multiple sample tubes as it pivots and slides into position, thereby securing each sample tube held by the sample tube holder. As it pivots and slides, the hinge assembly can prevent sample tubes from undergoing vertical lift during pipetting operations, thereby increasing pipetting efficiency. As described in more detail herein, the sample tubes are securely and consistently restrained vertically in a single motion by the hinge assembly.

[0020] In some embodiments, the act of placing the rack into the receiving compartment simultaneously pivots and slides the hinge plate to lock the sample tubes in place, thereby preventing movement of the sample tubes during subsequent pipetting operations performed on the rack. Sample tubes can be easily loaded into the sample tube holder before the rack is lowered into the receiving compartment. The hinge plate pivots and slides to contact and restrain multiple sample tubes within the sample tube holder. The hinge plate applies a consistent and reproducible force to each sample tube in the sample tube holder. The hinge plate allows for easy loading and unloading of sample tubes, thereby minimizing user error and the time it takes to load and unload the rack.

[0021] Described herein are racks for supporting, carrying, and transporting reagents and samples for various purposes, particularly related to sample preparation in clinical settings. The racks allow for the placement and retention of one or more sample tubes. The racks allow for the placement of one or more corresponding reagent holders. The sample tubes and reagent holders can be arranged to perform liquid dispensing processes related to sample preparation, such as polynucleotide amplification. This rack arrangement can minimize sample-to-sample contamination and allow for multiple sample preparations to be performed in series or in parallel from multiple clinical samples.

[0022] In some embodiments, the sample in the sample tube is obtained from a source, including an environmental source or a biological source. In some embodiments, the sample is suspected of containing one or more analytes of interest. Biological samples can be obtained from animals (including humans) and encompass fluids, solids, tissues, and gases. Biological samples include urine, saliva, and blood products such as plasma and serum. The sample tube can accept gaseous, liquid, or solid samples. The sample can be provided as a blood sample, a tissue sample (e.g., a swab specimen such as nasal, buccal, anal, or vaginal tissue), a biopsy aspirate, a lysate, a fungus, or a bacterium. The polynucleotide to be amplified may be contained within a particle (e.g., a cell such as a white blood cell or red blood cell), a tissue fragment, a bacterium (e.g., a gram-positive or gram-negative bacterium), a fungus, or a spore. One or more liquids (e.g., water, buffer, blood, plasma, saliva, urine, cerebrospinal fluid (CSF), or an organic solvent) may be part of the sample and / or added to the sample during processing. The sample tubes can accept any biological or environmental sample, however, such examples should not be construed as limiting the sample types applicable to the present disclosure.

[0023] The rack is configured to be insertable into and removable from a diagnostic instrument. The rack is configured for use with a diagnostic instrument that performs automated sample preparation, for example, for multiple samples separately or simultaneously. The diagnostic instrument can perform sample preparation for multiple reagents separately or simultaneously. The racks described herein can be used to analyze any nucleic acid-containing sample for any purpose, including, but not limited to, genetic testing and clinical testing for various human infectious diseases.

[0024] It will be understood that the system embodiments described herein are not limited to racks that are insertable into and removable from diagnostic devices, nor to racks used to analyze nucleic acids. Hinge assembly embodiments according to the present disclosure can be implemented in any suitable rack that accepts sample tubes.

[0025] In one non-limiting example, preparing the amplification-ready sample can include one or both of the following steps: contacting the neutralized polynucleotide sample with an amplification reagent mixture comprising a polymerase enzyme and a plurality of nucleotides, and optionally a positive control plasmid and a fluorogenic hybridization probe selective for at least a portion of the plasmid, and / or reconstituting the lyophilized pellet with a liquid to produce an amplification reagent mixture solution. In some embodiments, the reagent holder provides all of the reagents needed to prepare the amplification-ready sample. It will be understood that the reagent holders and sample tubes described herein are provided by way of example and are not intended to limit the present disclosure. Embodiments of the present disclosure can be practiced using other suitable reagent holders and sample tubes.

[0026] First Exemplary Rack According to the Present Disclosure 1-6 illustrate a rack 100 according to a first embodiment of the present disclosure. FIG. 1 illustrates a front perspective view of the rack 100. FIG. 2 illustrates a rear perspective view of the rack 100. FIG. 3 illustrates a top view of the rack 100. FIG. 4 illustrates a side view of the rack 100. FIG. 5 illustrates a front view of the rack 100. FIG. 6 illustrates a rear view of the rack 100. The rack 100 is configured to receive a plurality of sample tubes 102 and a plurality of reagent holders 104. The rack 100 receives these components such that the sample tubes 102 and the reagent holders 104 are loaded separately and independently of one another. In this non-limiting embodiment, the sample tubes 102 correspond one-to-one to the reagent holders 104. Other configurations are contemplated, such as two sample tubes 102 per reagent holder 104 or one sample tube 102 per two reagent holders 104.

[0027] Each of the reagent holders 104 contains reagents for extracting polynucleotides from a sample and rendering them in an amplification-ready form. The reagent holders 104 can be designed to hold and transport reagents for a variety of purposes, including, but not limited to, sample preparation in a clinical setting. The reagent holders 104 can include process tubes 174 used for various mixing and reaction processes performed during sample preparation. For example, cell lysis can occur within the process tubes 174, as well as extraction of nucleic acids, such as patient DNA or RNA and pathogen DNA or RNA. The reagent holders 104 can include one or more reagent tubes 176, which can be integral with or removable from the reagent holders 104. The reagents can be in liquid form or solid form, such as lyophilized form, to perform nucleic acid extraction from the samples associated with the rack 100. Sample preparation can include many different pipetting sequences in which a liquid pipettor pipettes materials into and out of the sample tubes 102 and reagent holders 104 at many different times.

[0028] The rack 100 is configured to accept 12 sample tubes 102 and 12 corresponding reagent holders 104. Although the rack 100 is shown with 12 sample tubes 102, the rack 100 can accept any number of sample tubes 102. Although the rack 100 is shown with 12 reagent holders 104, the rack 100 can accept any number of reagent holders 104. In some embodiments, the rack can accept 1, 2, 4, 6, 8, 10, 12, 16, 20, or 24 sample tubes 102. Each sample can be contained in a separate sample tube 102. In some embodiments, the rack can accept 1, 2, 4, 6, 8, 10, 12, 16, 20, or 24 reagent holders 104. Each reagent holder 104 can contain one or more reagents. 1 configured to receive 12 sample tubes 102 and corresponding 12 reagent holders 104 is exemplary. In some embodiments, the rack 100 is configured such that each of the plurality of sample tubes 102 is maintained at the same height relative to each other. In some embodiments, the rack 100 is configured such that each of the plurality of reagent holders 104 is maintained at the same height relative to each other.

[0029] The rack 100 receives a plurality of sample tubes 102 and a plurality of reagent holders 104 in twelve lanes 106, each having one sample tube 102 and one reagent holder 104. As used herein in connection with the rack 100, a lane 106 is a dedicated area of ​​the rack 100 designed to receive a sample tube 102 and a corresponding reagent holder 104. Although the rack 100 is shown with twelve lanes 106, the rack 100 can include any number of lanes 106.

[0030] The lanes 106 include a first lane and a second lane. The lanes 106 are parallel to one another. This configuration increases pipetting efficiency in some embodiments. Typically, adjacent sample lanes 106 in a pair are separated by 24 mm at their respective midpoints when parallel to one another. Other distances, such as 18 mm or 27 mm spacing, are possible. The distance between these midpoints may depend on the pitch of the nozzles in the liquid dispenser. Keeping the spacing a multiple of 9 mm allows for easy loading from the rack 100 into a 96-well plate, where wells are typically spaced 9 mm apart.

[0031] The rack 100 is configured to receive a number of sample tubes 102 as described in further detail herein. The rack 100 is configured to secure and hold one or more such sample tubes 102. The rack 100 is configured to allow access to samples stored in the sample tubes 102 either on a laboratory benchtop or located in a dedicated area of ​​the diagnostic device. The rack 100 is configured to allow access to the sample tubes 102 that will be utilized by one or more other functions of the diagnostic device, such as automated pipetting.

[0032] Features of a non-limiting exemplary rack that can be implemented in accordance with the present disclosure will now be described with reference to the rack 100 shown in the figures. It will be understood that other suitable racks can be implemented in accordance with the present disclosure, and the features of the rack 100 are not intended to limit the embodiments of the hinge assembly described herein. The rack 100 is configured to receive a given sample tube 102 such that the tube is removably held in a fixed position, thereby remaining stable while the sample is being accessed within the sample tube 102. The rack 100 is configured to receive a given sample tube 102 such that the tube is held while being transported from one location to another. The rack 100 is configured to hold a given sample tube 102 when inserted into a diagnostic device. The rack 100 is configured to receive a given sample tube 102 such that the tube is removably held in a fixed position while a pipette tip enters and exits the given sample tube 102. The rack 100 is configured to receive a given sample tube 102 and prevent vertical movement or lifting during pipetting operations. Other suitable features and configurations of the rack 100 are possible.

[0033] The rack 100 can include two or more subcomponents. The rack 100 includes a sample tube holder 108 configured to receive one or more sample tubes 102. In this non-limiting example, the rack 100 also includes a reagent housing 110 configured to receive one or more reagent holders 104. The sample tube holder 108 and the reagent housing 110 can be coupled to form a unitary structure. To enable assembly and disassembly of the sample tube holder 108 and the reagent housing 110, the sample tube holder 108 and the reagent housing 110 can be removably coupled, for example, by using fasteners. It will be understood in accordance with the present disclosure that the sample tube holder 108 can be coupled to any suitable subcomponent, including, but not limited to, the reagent housing 110.

[0034] The rack 100 can be divided into one or more lanes 106. Each lane 106 of the rack 100 includes a first location 112 configured to receive a sample tube 102 and a second location 114 configured to receive a reagent holder 104. The first location 112 is positioned on a sample tube holder 108. The second location 114 is positioned on a reagent housing 110. Each lane 106 is positioned for processing of samples contained in the sample tubes 102 according to one or more sample processing steps, including mixing the sample with one or more reagents in the corresponding reagent holder.

[0035] In one non-limiting example, the rack 100 includes features for positioning and retaining the reagent holder 104. In the illustrated embodiment, each of the second locations 114 in the respective lanes 106 includes a mechanical key 116 configured to accept the reagent holder 104 in a single orientation. The reagent holder 104 slides horizontally into a slot 120 positioned in the reagent housing 110. The reagent holder 104 can engage with the reagent housing 110 through the mechanical key 116, which holds it in place. For example, the mechanical key 116 can include a raised or recessed portion that, when engaged with a complementary portion of the reagent holder 104, allows the reagent holder 104 to snap into the second location 114. In some embodiments, an edge of the reagent holder 104 engages a complementary groove in an upper portion of the slot 120. In some embodiments, the reagent holder 104 is locked into position in the reagent housing 110 by a locking mechanism. The locking mechanism may be identifiable by an audible or physical cue when locked.

[0036] The reagent housing 110 can be configured to align for proper pipette tip pickup with a liquid dispenser when the reagent holder 104 is placed in the reagent housing 110. Additionally, the second location 114 of each lane 106 can be deep enough to receive one or more pipette tips, such as those included in the pipette tip sheaths described herein. The reagent holder 104, when placed in the reagent housing 110, is configured to be acted upon by one or more components of the diagnostic device described herein.

[0037] The reagent housing 110 can include various features. The reagent housing 110 can have four legs 124 that stabilize it and act as position locators when inserting the rack 100 into a dedicated portion of the device. The reagent housing 110 can include a handle 126. The handle 126 can be attached to the reagent housing 110 anywhere, such as at the midpoint of the reagent housing 110. The portion of the reagent housing 110 that receives the reagent holder 104 can be made of any suitable material, including metal or plastic. The reagent housing 110 can be made of a metal, such as aluminum, that is lightweight yet can be machined to high tolerances. The reagent housing 110 can be made of a material that is sufficiently rigid to ensure that it remains stable when positioned within the diagnostic device. The reagent housing 110 includes one or more alignment members 130. The alignment members 130 include four close-tolerance pegs, one located at each corner of the reagent housing 110. The alignment member 130 fits snugly and tightly into a complementary bore in a receiving area, such as a recessed area, of the diagnostic device, thereby stabilizing the reagent housing 110 within the diagnostic device.

[0038] The reagent housing 110 includes a horizontal member 132 and two vertical members 134 connected thereto. Each of the vertical members 134 includes two legs 124, although other configurations of the vertical members 134 and legs 124 are contemplated. The second location 114 of each respective lane 106 is a recessed portion within the horizontal member 132. The two vertical members 134 are configured to allow the reagent housing 110 to stand upright or maintain stability. The legs 124, which are symmetrically attached to the first and second vertical members 134, provide additional stability to the reagent housing 110 when positioned.

[0039] The rack 100 includes features for positioning and holding sample tubes 102. The rack 100 is configured to receive multiple samples, each received in an individual sample tube 102. The samples received in the sample tubes 102 can be from a common source or from different sources. As described above, each sample tube 102 is mounted adjacent to a corresponding reagent holder 104 in a single lane 106 of the rack 100.

[0040] 7 and 8 illustrate a non-limiting exemplary sample tube holder 108 according to the present disclosure. FIG. 7 illustrates a front perspective view of the sample tube holder 108, and FIG. 8 illustrates a rear perspective view of the sample tube holder 108. One non-limiting example of a sample tube holder 108 including a first portion 142, a second portion 146, a third portion 154, and a fourth portion 160 is described with reference to FIGS. 7 and 8. However, it will be understood that any suitable shape and form of the sample tube holder 108 can be implemented in embodiments of the present disclosure and need not include all or any of the first, second, third, and fourth portions included in the illustrated embodiment.

[0041] The sample tube holder 108 includes a first portion 142. The first portion 142 is planar or substantially planar. The first portion 142 is horizontal or substantially horizontal. The first portion 142 includes a plurality of upper openings 144. The first portion 142 is configured to receive twelve sample tubes 102 through the twelve upper openings 144, respectively. Although the sample tube holder 108 is shown with twelve upper openings 144, the sample tube holder 108 can include any number of upper openings 144. The upper openings 144 can be round or circular, but can have other cross-sectional shapes depending on the characteristics of the sample tubes 102. The number of upper openings 144 can correspond one-to-one to the number of sample tubes 102. The first portion 142 can include one or more rounded edges, such as rounded corners or bends, that connect the first portion 142 to another portion of the sample tube holder 108.

[0042] The sample tube holder 108 includes a second portion 146. The second portion 146 is planar or substantially planar. The second portion 146 is vertical or substantially vertical. The second portion 146 can extend along a portion of the length of the sample tube 102, for example, at least 30% of the length, at least 40% of the length, at least 50% of the length, at least 60% of the length, at least 70% of the length, or any of these values. The second portion 146 includes upper posts 148. The upper posts 148 can extend vertically upward from the first portion 142. Each upper post 148 has an opening 150 configured to receive a fastener therethrough. Any segment of the second portion 146 can include one or more openings 150.

[0043] The sample tube holder 108 is configured to mate with the reagent housing 110 such that the two components of the rack 100 are securely connected. The openings 150 of the sample tube holder 108 are configured to align with corresponding openings in the reagent housing 110. Any suitable fastener (examples include, but are not limited to, screws or pins) can extend through the openings 150 of the sample tube holder 108 and the corresponding openings in the reagent housing 110 to couple the sample tube holder 108 to the reagent housing 110. Although two openings 150 are shown, the sample tube holder 108 can include any number of openings 150.

[0044] The second portion 146 may include one or more rails 152. The rails 152 extend horizontally from the sides of the second portion 146. The rails 152 may extend the entire length of the second portion 146 or a portion thereof. The rails 152 extend in the same direction as the first portion 142.

[0045] The sample tube holder 108 in this non-limiting example includes a third portion 154. It will be understood that other exemplary sample tube holders 108 according to the present disclosure may not include the third portion 154, but may include only the first portion 142, the second portion 146, the fourth portion 160, or any combination of these portions positioned to hold a sample tube 102. In this example, the third portion 154 is oriented obliquely between the second portion 146 and the fourth portion 160. The third portion 154 extends in the same direction as the first portion 142. The first portion 142 and the third portion 154 form an oblique angle. The third portion 154 includes a plurality of lower openings 156. The third portion 154 is configured to receive twelve sample tubes 102, each passing through one of the twelve lower openings 156. Although the sample tube holder 108 is shown with twelve lower openings 156, the sample tube holder 108 can include any number of lower openings 156. The number of lower openings 156 can correspond to the number of sample tubes 102 in a one-to-one correspondence. The lower openings 156 can have any suitable cross-sectional shape, including, but not limited to, oval elongated openings, oval openings, and circular openings. The lower openings 156 are shaped and configured to receive the circumference of the sample tubes 102. The third portion 154 can include one or more rounded edges, such as rounded corners or bends, that connect the third portion 154 to another portion of the sample tube holder 108.

[0046] The sample tube holder 108 includes a fourth portion 160. One or more portions of the fourth portion 160 can be planar or substantially planar. One or more portions of the fourth portion 160 can be horizontal or substantially horizontal. The first portion 142 and a portion of the fourth portion 160 can be parallel. The fourth portion 160 can form a base of the sample tube holder 108. The fourth portion 160 can include one or more rails 164. The rails 164 can extend perpendicularly from the sides of the fourth portion 160. Although three rails 164 are shown, the fourth portion 160 can include any number of rails 164.

[0047] In a method of use according to the present disclosure, each of the multiple sample tubes 102 is inserted into the sample tube holder 108. First, the distal end 166 of the sample tube 102 is inserted into the upper opening 144 of the first section 142. Then, the distal end 166 of the sample tube 102 is threaded vertically parallel to the second section 146. Next, the distal end 166 of the sample tube 102 is inserted into the lower opening 156 of the third section 154. Thereafter, the distal end 166 of the sample tube 102 is threaded vertically until it rests against the surface of the fourth section 160. The proximal end 170 of the sample tube 102 extends above the first section 142 of the sample tube holder 108 when the sample tube 102 is received therein.

[0048] The proximal end 170 of the sample tube 102 may include a cap 172. The cap 172 may be a removable cap attached to the proximal end 170. The cap 172 may include a pierceable seal configured to be pierced by a pipette tip. The pierceable seal may include a metal foil, a plastic layer, an elastomeric membrane, or any combination of these or other suitable sealing structures. The cap 172 may be configured to allow access to a sample held in the sample tube 102 through the proximal end 170. In this non-limiting embodiment, the cap 172 is configured to be penetrated by a pipette tip to allow a liquid dispenser to access the sample in the sample tube 102. The cap 172 extends upward from the first portion 142. In some cases, the cap 172 may abut the first portion 142. The cap 172 may have a diameter greater than the diameter of the upper opening 144. It will be understood that practice of the present disclosure does not require that the sample tube 102 have a cap 172 attached to its proximal end 170. Sample tubes 102 having open (e.g., exposed) proximal ends can be received and held in the sample tube holders according to the present disclosure described herein.

[0049] In the illustrated embodiment, the sample tube 102 is held by an upper opening 144 near the proximal end 170. The upper opening 144 can contact at least one portion of the sample tube 102. The upper opening 144 can contact two opposing portions of the sample tube 102. The upper opening 144 can contact the circumference of the sample tube 102 or a portion thereof. The round shape of the upper opening 144 can fit around the sample tube 102. The sample tube 102 is held by a lower opening 156 near the distal end 166. The lower opening 156 can contact at least one portion of the sample tube 102. The lower opening 156 can contact two opposing portions of the sample tube 102. The lower opening 156 can contact the circumference of the sample tube 102 or a portion thereof. Each of the upper opening 144 and the lower opening 156 can be a ring or an open loop. Each of the upper opening 144 and the lower opening 156 may form a hole in the sample tube holder 108. The sample tube holder 108 may be constructed of any suitable material, such as metal.

[0050] The sample tube 102 can be held at its top and bottom by the sample tube holder 108. The sample tube holder 108 can prevent or limit horizontal movement. The upper opening 144 and lower opening 156 can limit horizontal movement based on the shape of the openings 144, 156 similar to the outer surface of the sample tube 102. The sample tube holder 108 can allow vertical movement of the sample tube 102. The sample tube 102 can be freely inserted into or removed from the sample tube holder 108. The sample tube 102 is moved vertically or substantially vertically to insert it into the sample tube holder 108. The sample tube 102 is moved vertically or substantially vertically to remove it from the sample tube holder 108. This method can be repeated to insert multiple sample tubes 102 vertically into the sample tube holder 108.

[0051] Advantageously, embodiments of the present disclosure allow each portion of the sample tube 102 to be accessible to a sample identification verifier, such as a barcode reader, when placed in the sample tube holder 108. As described herein, the front of each sample tube 102 can be scanned to identify the patient or the sample. A user can rotate the sample tube 102 in the sample tube holder 108 so that the sample identifier faces outward. The sample tube 102 can include an identifier surrounding the sample tube 102.

[0052] 1 is a perspective view of an exemplary hinge assembly according to a first embodiment of the present disclosure; An exemplary hinge assembly 200 according to a first embodiment of the present disclosure is described below with reference to FIGS. 9-14. It will be understood that the hinge assemblies of the present disclosure are not limited to the features of the exemplary hinge assembly 200 and may take other forms, shapes, and dimensions consistent with the present disclosure. FIG. 9 shows a front perspective view of the hinge assembly 200. FIG. 10 shows a rear perspective view of the hinge assembly 200. FIG. 11 shows a side view of the hinge assembly 200. FIG. 12 shows a top view of the hinge assembly 200. FIG. 13 shows an exploded front perspective view of a portion of the hinge assembly 200. FIG. 14 shows an exploded front perspective view of the hinge assembly 200.

[0053] The hinge assembly 200 includes a hinge plate 202. The hinge assembly 200 includes a hinge support 204. The hinge assembly 200 includes one or more hinge pins 206. FIGS. 13 and 14 illustrate the hinge support 204 and the hinge pins 206 in exploded views. The hinge support 204 can be an elongated member. The hinge support 204 has one or more openings 210 configured to receive a fastener therethrough. Any segment of the hinge support 204 can include one or more openings 210. The openings 210 are configured to align with corresponding openings in the reagent housing 110. When a fastener extends through the corresponding opening, the hinge support 204 of the hinge assembly 200 is rigidly coupled to the reagent housing 110. Although three openings 210 are shown, the hinge support 204 can include any number of openings 210 .

[0054] The hinge support 204 may include one or more hubs 212, as shown in Figure 13. The hubs 212 are aligned near the ends of the hinge support 204 with respect to the longitudinal axis L of the hinge support. HS Extending horizontally along the longitudinal axis L of the hinge support 204. In the illustrated non-limiting embodiment, each hub 212 has a hollow cylindrical cross section with an opening 214 extending inward from the end of the hinge support 204. It will be understood that the present disclosure is not limited to hubs 212 and that other shapes and sizes are possible. The opening 214 extends horizontally along the longitudinal axis L of the hinge support 204. HS , extending along the hub 212. Each opening 214 is configured to receive a hinge pin 206. The hub 212 can be a knuckle or hollow portion that creates a hinge joint about which the hinge plate 202 rotates. The hub 212 can be where the hinge pin 206 is set. The hub 212 can be configured as a barrel or hemispherical shape. Other configurations are possible.

[0055] The hinge support 204 can include a back surface 216, as shown in Figure 10. The back surface 216 can be flat so as to abut against a flat surface of the reagent housing 110. The back surface 216 can be any shape that allows for a secure connection between the hinge support 204 and the reagent housing 110 when fastened together.

[0056] The hinge pin 206 may be a generally cylindrical member, and the corresponding opening 214 may be correspondingly cylindrical. It will be understood that any appropriately shaped and sized mating configuration may be implemented in embodiments of the present disclosure. The hinge pin 206 may define a pivot axis about which the hinge assembly 200 may pivot. In other words, the pivot axis or articulation axis of the hinge assembly 200 is the longitudinal axis L of the hinge pin 206. HP 11A , the hinge plate 202 of the hinge assembly 200 can rotate in one dimension, either clockwise or counterclockwise. For example, as shown in FIG. 11A , the hinge support 204 is configured to remain stationary during pivotal movement. In some cases, the hinge pin 206 also remains stationary. The hinge plate 202 is configured to pivot or rotate relative to the stationary hinge support 204. The hinge pin 206 forms the axis of rotation, and all other translations and rotations are prevented or limited. The hinge assembly 200 can have one degree of freedom of movement. For example, as shown in FIG. 11A , the hinge plate 202 of the hinge assembly 200 can rotate in one dimension, either clockwise or counterclockwise.

[0057] FIG. 11A shows a first side view of the hinge plate 202. FIG. 11B shows a second side view of the hinge plate 202. Features of the hinge plate 202 will now be described with reference to FIG. 11A . The hinge plate 202 includes a first portion 220, a second portion 224, and a third portion 234. The first portion 220 can be planar or substantially planar. In this non-limiting embodiment, as shown in FIG. 11A , when the third portion 234 is positioned parallel to the axis X, the first portion 220 is tilted by an angle alpha (α) from the horizontal. The angle α relative to the axis X can be 0° from the horizontal, such that the first portion 220 is horizontal, or 1° from the horizontal, 2° from the horizontal, 3° from the horizontal, 4° from the horizontal, 5° from the horizontal, 6° from the horizontal, 7° from the horizontal, 8° from the horizontal, 9° from the horizontal, 10° from the horizontal, or any range of these values. It will be understood that other configurations are possible. Referring back to FIG. 10A , the first portion 220 includes a plurality of recesses 222. The first portion 220 is configured to hold twelve sample tubes 102, with twelve recesses 222 each. Although the hinge plate 202 is shown having twelve recesses 222, the hinge plate 202 can include any number of recesses 222. The recesses 222 can be rounded. The recesses 222 can be circular. The recesses 222 can be semicircular or hemispherical. The recesses 222 can be tapered. The number of recesses 222 can correspond one-to-one to the number of upper openings 144 in the sample tube holder 108. The first portion 220 can include one or more rounded edges, such as rounded corners or bends, that connect the first portion 220 to another portion of the hinge plate 202.

[0058] The hinge plate 202 includes a second portion 224. The second portion 224 is planar or substantially planar. In this non-limiting embodiment, as shown in FIG. 11A , when the third portion 234 is positioned perpendicular to the axis Z, the second portion 224 is tilted from the vertical by an angle beta (β). The angle β relative to the axis Z can be 0° from the vertical so that the second portion 224 is vertical, or 2° from the vertical, 4° from the vertical, 6° from the vertical, 8° from the vertical, 10° from the vertical, 12° from the vertical, 14° from the vertical, 16° from the vertical, 18° from the vertical, 20° from the vertical, or a range of any of these values. It will be understood that other configurations are possible. The second portion 224 can extend along a portion of the length of the sample tubes 102 when the rack 100 is assembled, for example, at least 5% of the length, at least 10% of the length, at least 15% of the length, at least 20% of the length, at least 25% of the length, or any of these values. The second portion 146 can extend along at least the length of the caps 172 (if present on the sample tubes) when the rack 100 is assembled.

[0059] The second portion 224 has one or more openings 226 configured to receive a fastener or tool therethrough. Any segment of the second portion 224 can include one or more openings 226. The openings 226 are configured to align with corresponding openings 210 in the hinge support 204. The openings 226 are configured to align with corresponding openings in the reagent housing 110. The openings 226 allow a tool, such as, but not limited to, a screwdriver, to extend therethrough. The tool can install a fastener through the openings 210 in the hinge support 204 and the openings in the reagent housing 110 to rigidly couple the hinge support 204 and the reagent housing 110. Although three openings 226 are shown, the second portion 224 can include any number of openings. The openings 226 can be configured to provide access to the openings 210 in the hinge support 204 to facilitate securing the hinge support 204 to the reagent housing 110.

[0060] The second portion 224 includes flanges 230. The flanges 230 generally extend in a plane defined by the X-axis and Z-axis shown in FIG. 11A. The hubs 230 extend horizontally near the edges of the second portion 224. The hubs 230 extend in the opposite direction from the first portion 220. Each flange 230 includes an opening 232 extending therethrough. The openings 232 may be coaxial. Each opening 232 is configured to receive the hinge pin 206. The pair of flanges 230 are spaced apart to receive the hinge support 204 therebetween. The space between the pair of flanges 230 may be slightly longer than the length of the hinge support 204.

[0061] The hinge plate 202 includes a third portion 234. The third portion 234 can be planar or substantially planar. In this non-limiting embodiment, as shown in FIG. 11A , when the third portion 234 is positioned parallel to the axis X, the first portion 220 is tilted at an angle alpha (α) from horizontal. In other embodiments, the third portion 234 is not parallel to the axis X, but can be tilted relative to the axis X depending on the shape and dimensions of the sample tube holder 108 and rack 100 to which the hinge assembly 200 joins. In one non-limiting implementation, the first portion 220 and the third portion 234 can be parallel or substantially parallel. The third portion 234 can form the base of the hinge plate 202.

[0062] Exemplary Method of Actuating a Hinge Assembly of the First Embodiment of the Present Disclosure 15A-15C show diagrams of operation of the hinge assembly 200 according to a first embodiment of the present disclosure. FIG. 15A is a side view of the sample tube 102 being inserted into the sample tube holder 108. FIG. 15B is a side view of the sample tube 102 fully inserted into the sample tube holder 108. FIG. 15C is a top view of the sample tube 102 and the sample tube holder 108 when the sample tube 102 is fully inserted. In a first configuration, illustrated in FIGS. 15A-15C and referred to herein as the "tube insertion configuration," the hinge assembly 200 is configured to allow the sample tube 102 to be inserted into the sample tube holder 108. The following description describes the hinge assembly 200 in this tube insertion configuration.

[0063] In the tube insertion configuration, the first portion 220 of the hinge plate 202 is positioned near the reagent housing 110. The first portion 220 of the hinge plate 202 is positioned far from the upper opening 144 of the first portion 142 of the sample tube holder 108. The first portion 220 of the hinge plate 202 is rotated away from the upper opening 144 of the sample tube holder 108 (rotated toward the reagent housing 110) to provide clearance for inserting the sample tube 102 into the upper opening 144 of the sample tube holder 108. For example, in the tube insertion configuration, the first portion 220 of the hinge plate 202 is positioned to provide clearance for inserting the sample tube 102 vertically into the sample tube holder 108.

[0064] The third portion 234 of the hinge plate 202 is rotated away from the bottom of the reagent housing 110 in the tube insertion configuration. Rotating the third portion 234 of the hinge plate 202 into the configuration shown in FIGS. 15A-15C provides clearance for inserting the sample tube 102. In this configuration, a portion of the third portion 234 of the hinge plate 202 can extend below the first portion 142 of the sample tube holder 108. In some cases, the third portion 234 of the hinge plate 202 can be disposed at an angle (γ) relative to the first portion 142 of the sample tube holder 108. The angle (γ) can be an acute angle. The angle γ can be 2° from horizontal, 4° from horizontal, 6° from horizontal, 8° from horizontal, 10° from horizontal, 12° from horizontal, 14° from horizontal, 16° from horizontal, 18° from horizontal, 20° from horizontal, or a range of any of these values. The third portion 234 of the hinge plate 202 can abut the first portion 142 of the sample tube holder 108 at location P. When viewed from the perspective of Figures 15A and 15B, the contact between the third portion 234 of the hinge plate 202 and the first portion 142 of the sample tube holder 108 can limit further rotation of the hinge plate 202 in a clockwise direction.

[0065] 15C shows a top view of the tube insertion configuration. As in FIGS. 15A and 15B, the first portion 220 of the hinge plate 202 is rotated toward the reagent housing 110 (out of the first portion 142 of the sample tube holder 108). A recess 222 in the first portion 220 of the hinge plate 202 provides clearance for insertion of the sample tube 102 into the sample tube holder 108 along the vertical axis A of the upper opening 144 in the first portion 142. As shown in FIG. 15C, when viewed from the top of the hinge assembly 200, the recess 222 is laterally offset a distance d from the upper opening 144 of the sample tube holder 108. The lateral offset distance d can be a distance that allows a user to insert the sample tube 102 into the sample tube holder 108 without interference from or contact with the hinge assembly 200.

[0066] Actuation of the hinge assembly 200 according to the present disclosure involves moving the hinge plate 202 from a tube insertion configuration, shown in FIGS. 15A-15C, to a second configuration, illustrated in FIGS. 16A and 16B and referred to herein as the "tube retention configuration." FIG. 16A is a side view of the hinge assembly 200 after actuation. FIG. 16B is a top view of the sample tube 102 and sample tube holder 108 after the hinge assembly 200 has been actuated. As described herein, the hinge plate 202 can pivot relative to the hinge supports 204. During pivotal movement, the hinge supports 204 are configured to remain stationary, and the hinge plate 202 pivots relative to the stationary hinge supports 204. The hinge assembly 200 is configured to allow for vertical retention of the sample tube 102. The following description describes the hinge assembly 200 in the tube retention configuration.

[0067] In this non-limiting embodiment, as shown in FIG. 16A , the first portion 220 of the hinge plate 202 in the tube-holding configuration can be positioned in a horizontal or substantially horizontal orientation. In one non-limiting embodiment, the first portion 220 of the hinge plate 202 can be rotated counterclockwise from the perspective of FIG. 16A . In one non-limiting embodiment, the first portion 220 of the hinge plate 202 can be rotated beyond horizontal. In these exemplary implementations, contact between the hinge plate 202 and the sample tube 102 (or cap 172, if applicable) limits further counterclockwise rotation of the hinge plate 202. The first portion 220 of the hinge plate 202 holds the sample tube 102 within the sample tube holder 108. Compared to FIG. 15B , the first portion 220 of the hinge plate 202 is pivoted to contact a portion of the sample tube 102 or its cap 172. The first portion 220 of the hinge plate 202 rests against the top surface of the cap 172 of the sample tube 102 .

[0068] The recess 222 in the first portion 220 of the hinge plate 202 can be semicircular or hemispherical to allow access to the contents of the sample tube 102. In the tube-holding configuration, the recess 222 in the first portion 220 of the hinge plate 202 does not block a central region or central area C of the top of the sample tube 102. The recess 222 in the first portion 220 of the hinge plate 202 can be semicircular or hemispherical to cover a portion of the cap 172 but not the central area C. The recess 222 can simultaneously hold multiple sample tubes 102 in the sample tube holder 108. Each portion of the first portion 220, including the portion surrounding the recess 222, can simultaneously apply a vertical holding force to all of the sample tubes placed in the sample tube holder 108.

[0069] The second portion 224 of the hinge plate 202 can form an angle delta (δ) with respect to the vertical axis A of the upper opening 144. The angle δ can be 0° from vertical, 2° from vertical, 4° from vertical, 6° from vertical, 8° from vertical, 10° from vertical, 12° from vertical, 14° from vertical, 16° from vertical, 18° from vertical, 20° from vertical, or a range of any of these values. Other configurations are possible. The second portion 224 of the hinge plate 202 is pivoted in a counterclockwise direction compared to the position in FIG. 15B.

[0070] The third portion 234 can be horizontal or substantially horizontal when the hinge assembly 200 is in the tube-holding configuration. The third portion 234 of the hinge plate 202 can be parallel to the horizontal member 132 of the reagent housing 110 when the hinge assembly 200 is in the tube-holding configuration. The third portion 234 of the hinge plate 202 can be parallel to the first portion 142 of the sample tube holder 108 when the hinge assembly 200 is in the tube-holding configuration.

[0071] In embodiments of the present disclosure, an actuation force pivots the hinge plate 202 to move the hinge assembly 200 from the tube insertion configuration to the tube retention configuration. In some embodiments, the same actuation force pivots the hinge plate 202 to move the hinge assembly 200 from the tube retention configuration to the tube insertion configuration. In other embodiments, a second, different actuation force can move the hinge assembly 200 from the tube retention configuration to the tube insertion configuration. In one example, to rotate the hinge assembly 200 between configurations, a user applies an actuation force to a portion of the hinge assembly 200. For example, a user can apply a downward force to the first portion 220 to move the hinge assembly 200 from the tube insertion configuration to the tube retention configuration. Similarly, a user can apply an upward force to the first portion 220 to move the hinge assembly 200 from the tube retention configuration to the tube insertion configuration. In this embodiment, the weight of the first portion 220 of the hinge plate 202 can provide a downward force to prevent vertical movement of the sample tubes 102. In another example, illustrated in FIG. 16A and described in detail below, a structural feature of the receiving compartment that receives the rack 100 exerts an actuation force on the third portion 234 to move the hinge assembly 200 from the tube insertion configuration to the tube retention configuration. The structural feature can maintain this actuation force, thereby locking the hinge plate 202 relative to the sample tubes 102.

[0072] It will be appreciated that any of the first portion 220, second portion 224, and third portion 234 of the hinge plate 202 can be contacted by an actuation force to pivot the hinge assembly 200. For example, the first portion 220 can be pressed downward, the second portion 224 can be pressed horizontally, and / or the third portion 234 of the hinge plate 202 can be pressed upward to move the hinge plate 202 into engagement with the sample tube 102. Compared to FIG. 15B, the third portion 234 of the hinge plate 202 has been actuated to change the position of the hinge assembly 200. When viewed from the perspective of FIGS. 15A and 16A, the third portion 234 of the hinge plate 202 is actuated to rotate the hinge assembly 200 in a counterclockwise direction. The third portion 234 of the hinge plate 202 can be a lever arm that allows the hinge plate 202 to pivot.

[0073] An embodiment of the hinge assembly 200 can be actuated to move from the tube insertion configuration to the tube retention configuration by a divider 250 in the receiving compartment that receives the rack 100. The divider 250 can include a surface, wall, shelf, enclosure, or any other suitable structure shaped and sized to actuate the hinge assembly 200 when the rack 100 is inserted into the receiving compartment. For example, in one non-limiting example, the divider 250 can include one or more pegs, rods, or bars positioned in the receiving compartment to interact with the hinge assembly 200 when the rack 100 is inserted into the receiving compartment. The divider 250 is shaped and sized to divide the receiving compartment into two sections, a first section and a second section. When the rack 100 is received in the receiving compartment, the reagent housing 110 is positioned in the first section and the sample tube holder 108 is positioned in the second section. The divider 250 is positioned between the reagent housing 110 and the sample tube holder 108 when the rack 100 is positioned in the receiving compartment.

[0074] The divider 250 acts on the hinge assembly 200 when the rack 100 is inserted into the receiving compartment. When the hinge assembly 200 is transitioning from the tube insertion configuration shown in FIG. 15A to the tube retention configuration shown in FIG. 16A , the divider 250 contacts the third portion 234 of the hinge plate 202. The divider 250 applies a counterclockwise force to the third portion 234 of the hinge plate 202. The interaction of the divider 250 with the third portion 234 thus causes the hinge plate 202 to rotate about the hinge support 204, transitioning the hinge assembly 200 from the tube insertion configuration to the tube retention configuration.

[0075] The hinge assembly 200 has advantages over other alternative systems designed to hold sample tubes 102 within the sample tube holder 108 during pipetting operations. One alternative system uses an array of spring clips to apply a horizontal force to each cap 172 of a sample tube 102 placed in the sample tube holder 108. The spring clips can be arranged in a horizontal array disposed between the upper posts 148 of the second portion 146 of the sample tube holder 108. The arms of the spring clips contact one side of the cap 172 of a sample tube 102 placed in the sample tube holder 108 and apply a horizontal force thereto. This force, along with a counter force applied to the body of the sample tube 102 by the upper opening 144 of the sample tube holder 108, can restrain the sample tube 102 from moving horizontally out of the sample tube holder 108. The distal end of the sample tube 102 can contact the fourth portion 160 of the sample tube holder 108. The force applied by the spring clip, the force applied by the upper opening 144, and the friction within the contact area at the bottom of the sample tube 102 can prevent the sample tube 102 from being lifted vertically out of the sample tube holder 108.

[0076] In some cases, variations in the dimensions of the sample tubes 102 and caps 172 may prevent the spring clip system from consistently restraining the sample tubes 102 from moving vertically. In some cases, variations in the spring force exerted by the arms of the spring clips (due to manufacturing variations, material variations, or wear of the spring clips over time) may prevent the spring clip system from consistently restraining the sample tubes 102 from moving vertically. In such cases, one or more sample tubes 102 may lift vertically out of the sample tube holder 108 when the pipette tip moves vertically upward and out of the cap 172, applying enough vertical force to the sample tubes 102 to vertically displace the sample tubes 102.

[0077] Thus, in some conventional designs, the sample tube 102 may lift during liquid dispensing. In some cases, the sample tube 102 may be held onto the pipette tip of the liquid dispenser due to, for example, friction between the pipette tip and the cap 172. The spring clip may not consistently hold the sample tube 102 within the sample tube holder 108, and sometimes up to 25% of the sample tubes 102 may be subjected to some degree of vertical lifting by the liquid dispenser. Any degree of vertical lifting of the sample tube 102 may interfere with the pipetting operation and cause the liquid dispenser to malfunction or operate at less than optimal speed and accuracy. In some extreme cases, the pipette tip may be unable to separate from a sample tube 102 that is not sufficiently restrained within the sample tube holder 108, potentially causing system disruption and failure. To ensure reliability and maximum yield, it is desirable for the number of sample tubes 102 that experience vertical lift to be zero or close to zero.

[0078] Advantageously, embodiments of the present disclosure securely restrain sample tubes 102 within the sample tube holder 108, reducing the number of tubes subject to vertical lifting to zero. Embodiments of the rack 100 including the hinge assembly 200 according to the present disclosure securely hold sample tubes 102 during instrument workflow. The upper opening 144 of the sample tube holder 108 can restrain the sample tubes 102 from moving horizontally. In some cases, the force applied to the sample tubes 102 by the hinge assembly 200 can restrain the sample tubes 102 from moving horizontally. The fourth portion 160 of the sample tube holder 108 and the hinge assembly 200 together restrain the sample tubes 102 vertically. The divider 250 can lock the hinge plate 202 in the tube-retaining configuration, thereby locking the sample tubes 102 in place and preventing vertical lifting of the sample tubes 102. Advantageously, the shape, size, and position of the hinge assembly 200 can be adjusted to adjust the maximum holding force required to hold the sample tube 102 .

[0079] Advantageously, embodiments of the present disclosure can reliably and consistently lock sample tubes with a single motion. The hinge plate 202 of the hinge assembly is pivoted by the actuation force of the partition 250 when the partition contacts the hinge plate 202. In some embodiments, lowering the rack 100 relative to the partition 250 is the motion that pivots the hinge plate 202, thereby locking the sample tubes 102. The partition 250 applies an upward force to the hinge plate 202, thereby pivoting the hinge plate 202 into place. The hinge plate 202 is free to pivot before lowering the rack 100 so that sample tubes 102 can be easily loaded into the sample tube holders 108. The hinge plate 202 consistently contacts multiple sample tubes 102 so that all of the sample tubes 102 can be simultaneously restrained within the sample tube holders 108. The unitary construction of the hinge plate 202 allows for consistent force application to each sample tube 102. Furthermore, the pivotal movement of the hinge plate 202 is repeatable such that the same actuation force results in the same pivotal movement of the hinge plate. Advantageously, the hinge plate is easily moved between configurations for easy loading and unloading of batches of sample tubes during a series of diagnostic tests performed sequentially using the same rack, thereby minimizing user error and the time it takes to load and unload the rack, and increasing pipetting efficiency.

[0080] In some embodiments, the hinge assembly 200 contacts the sample tube 102, for example, contacts the cap 172 of the sample tube 102. In some embodiments, the hinge assembly 200 applies a downward force to the sample tube 102. In some embodiments, the hinge assembly 200 prevents all vertical movement of the sample tube 102 within the sample tube holder 108 in the tube holding configuration. In some embodiments, the hinge assembly 200 allows partial vertical movement of the sample tube 102 within the sample tube holder 108 in the tube holding configuration. In some embodiments, one or more sample tubes may lift vertically a small distance during a pipetting operation, but the presence of the hinge plate 202 prevents the sample tubes from moving vertically enough to affect the performance of the pipetting system. In some embodiments, the hinge assembly 200 applies a compressive force to the sample tube 102. In some embodiments, the hinge plate 202 of the hinge assembly 200 is positioned laterally above and in some cases covers a portion of the sample tube 102 to prevent upward movement. In some embodiments, the hinge assembly 200 is positioned laterally above and in some cases covers a portion of the circumference of the cap 172 of the sample tube 102 without blocking area C of the cap 172 against the pipette tip.

[0081] Advantageously, the hinged plate 202 according to the present disclosure can prevent or limit vertical movement of the sample tube 102 within the sample tube holder 108. In one example, the hinged plate 202 prevents or limits vertical lifting of the sample tube 102 when the contents of the sample tube 102 are accessed by a liquid dispenser. In another example, the hinged plate 202 prevents or limits vertical movement of the sample tube 102 within the sample tube holder 108 during fluid processing operations. In yet another example, the hinged plate 202 prevents or limits vertical lifting of the sample tube 102 by a pipette tip.

[0082] The hinge assembly 200 may include several advantages. The hinge assembly 200 may be easy and intuitive to use. The hinge assembly 200 may be automatically activated, such as by the simple action of inserting the rack 100 into a diagnostic device described herein. Using the hinge assembly 200 may be a simple self-learning process. The hinge support 204 may span the reagent housing 110 or a portion thereof along the front surface of the reagent housing 110. The first portion 220 of the hinge plate 202 may be considered a locking member. The hinge mechanism 200 may be fabricated from any suitable material, including metal plate.

[0083] Advantageously, the disclosed embodiments of the present invention reliably and consistently unlock the sample tubes with a single motion. The hinge plate 202 of the hinge assembly 200 can be held in place by the partition 250 of the receiving compartment that receives the rack 100. To relieve the force of the partition 250, the rack 100 can be lifted relative to the partition 250. Thus, the hinge plate 202 is free to pivot relative to the hinge support 204. A single motion to raise the rack 100 relative to the receiving compartment can unlock the sample tubes 102. After raising the rack 100, the hinge plate 202 is free to pivot so that the first sample tube 102 can be easily unloaded from the sample tube holder 108 and the second sample tube 102 can be loaded. The hinge plate can be pivoted by a user from a tube-holding configuration to a tube-insertion configuration. The hinge plate 202 can be moved away from the sample tube holder 108 to easily load the next sample tube.

[0084] The hinge assembly 200 does not interfere with loading and unloading operations. Advantageously, the hinge assembly 200 allows a user to easily load and unload the sample tubes 102 into and out of the rack 100. The hinge assembly 200 allows the sample tubes 102 to be locked in place when the rack 100 is placed in a diagnostic instrument. The hinge assembly 200 is a locking mechanism that holds the sample tubes 102 in the rack 100 after the rack 100 is received in the receiving compartment. The hinge assembly 200 can facilitate complete retention of the sample tubes 102 in the sample tube holders 108. The hinge assembly 200 can lock the sample tubes 102 in place when the rack 100 is placed in a diagnostic instrument. The hinge assembly 200 can act as a cover over each sample tube 102. In the illustrated embodiment, all of the sample tubes 102 in the sample tube holder 108 are constrained under one physical part, the hinge plate 202 .

[0085] Embodiments of the hinge assembly according to the present disclosure include additional advantages. The hinge assembly according to the present disclosure can be used with any design of sample tube 102. The hinge assembly according to the present disclosure can be used with any design of cap 172. The hinge assembly can be backward compatible, such that racks without the hinge assembly can be advantageously retrofitted to include the hinge assembly. As one non-limiting example, racks with spring clip systems can be retrofitted. In some embodiments, the spring clip system is removed without disconnecting the sample tube holder from the reagent housing. In some embodiments, the hinge assembly is installed without disconnecting the sample tube holder from the reagent housing.

[0086] The hinge assembly 200 can be directly incorporated into the rack 100, such as by fastening fasteners as described herein. The hinge assembly 200 can be easily installed between the sample tube holder 108 and the reagent housing 110. The sample tube holder 108, hinge support 204, and reagent housing 110 can form a unitary structure that is inserted into and removed from the receiving compartment in one fluid motion. The hinge plate 202 is designed to pivot relative to this unitary structure. The hinge assembly 200 can be easily introduced into a manufacturing supply chain or installed by the user at the point of use of the rack.

[0087] FIG. 17 illustrates an exemplary diagnostic instrument 300 according to the present disclosure. The rack 100 can be designed to allow for easy insertion and removal into and from the diagnostic instrument 300. The reagent housing 110 can include one or more alignment members 130, shown in FIGS. 2 and 3, that facilitate positioning of the rack 100. The alignment members 130 are configured to ensure that the rack 100 can only be placed in a single orientation within the diagnostic instrument 300. Furthermore, the alignment members 130 can ensure that the rack 100 is inserted in the correct orientation to be actuated by the partition 250. It may be desirable to properly position the rack 100 within the diagnostic instrument 300 and to limit subsequent movement so as not to impair the movement of the liquid dispenser during liquid handling operations. For example, the alignment members 130 can limit movement of the rack 100 in two directions, such as left-right and front-to-back. Vertical movement can be limited based on the weight of the rack 100, allowing a user to lift the rack 100 off the diagnostic device 300. The alignment members 130 can provide stability to the rack 100 when placed on the diagnostic device 300.

[0088] In some embodiments, the rack 100 or the diagnostic instrument 300 may include a sensor configured to indicate proper placement of the rack 100 within the diagnostic instrument 300. The sensor may be in communication with the processor to provide a warning to the user, such as an audible or visual warning communicated through an interface, if the rack 100 is not properly seated. The sensor may be configured to prevent a sample preparation process from starting or continuing if a seating error of the rack 100 is detected. In some embodiments, the rack 100 provides positive feedback to the user, for example, audibly or physically, that it is properly positioned. Positive feedback indicating that the rack 100 is properly positioned within the diagnostic instrument 300 may indicate to the user that the hinge assembly 200 has transitioned to the tube-holding configuration and the sample tubes 102 have locked into place within the sample tube holder 108.

[0089] It will be apparent that the embodiments of the hinge assembly of the present disclosure can be actuated in many different ways. For example, in one non-limiting embodiment, the divider 250 is stationary and the rack 100 interacts with the divider 250 as it is lowered into the diagnostic device 300, thereby actuating the hinge assembly 200. In another non-limiting embodiment, the divider 250 moves vertically from a stowed position to an engaged position in contact with the hinge assembly 200 after the rack 100 is received within the diagnostic device 300, thereby applying a force to actuate the hinge assembly 200.

[0090] The dividers 250 are shaped and sized to contact the hinge plates 202 of the hinge assemblies 200 to lock one or more sample tubes 102 in place when the rack 100 is placed in the diagnostic instrument 300. Advantageously, the sample tubes 102 are horizontally constrained within the rack 100 and the diagnostic instrument 300 by at least the upper openings 144 of the sample tube holders 108, and further vertically constrained by at least the hinge assemblies 200.

[0091] The rack 100 can be designed so that it can be easily removed and reinserted into and out of the diagnostic instrument 300. After removal from the diagnostic instrument 300, the dividers 250 no longer exert a force against the hinge plates 202 of the hinge assembly 200. One or more sample tubes 102 can be easily removed by sliding one or more sample tubes 102 vertically upward. New sample tubes 102 can be easily inserted by sliding one or more sample tubes 102 vertically downward. The rack 100 can be reinserted into the diagnostic instrument 300. The action of insertion can actuate the hinge assembly 200 to hold a new set of sample tubes 102. Thus, actuation of one or more dividers 250 can be automatic and requires no further action by the user. The act of engaging the hinge assembly 200 with the dividers 250 can be the same act as inserting the rack 100 into the diagnostic instrument 300.

[0092] It will be appreciated that embodiments of the hinge assembly according to the present disclosure can be received in a receiving compartment that does not include a divider 250. In such cases, the hinge assembly 200 can be locked in place by any suitable mechanism, including, but not limited to, a pin, linkage, lever, wedge, cam, or sliding bar that engages the hinge assembly 200 to pivot the hinge plate 202. In some embodiments, this mechanism also serves to lock the hinge plate 202 in the tube-retaining configuration. In some embodiments, the rack 100 can be loaded with one or more sample tubes 102 only before insertion into the diagnostic device 300, such as by using a receiving compartment with a divider 250. In some embodiments, the rack 100 can be loaded with one or more sample tubes 102 before and after insertion into the diagnostic device 300, such as by using a receiving compartment with another suitable mechanism.

[0093] FIG. 18 illustrates another example of a diagnostic device 300 according to the present disclosure. The diagnostic device 300 includes a receiving compartment 301 configured to receive a rack 100 or a portion thereof according to an embodiment of the present disclosure. In the non-limiting embodiment illustrated in FIG. 18, the receiving compartment 301 is shown surrounded by a dashed line. In this example, the receiving compartment 301 includes a first portion 303 configured to receive the reagent housing 110 of the rack 100. The receiving compartment 301 can include a second portion 304 separate from and adjacent to the first portion 303. The second portion 304 can include an open volume, well, or compartment separate from and adjacent to the first portion 303. The rack 100 can be designed to allow it to be easily inserted into and removed from the diagnostic device 300; for example, the reagent housing 110 can be inserted into the first portion 303 of the receiving compartment 301, and the sample tube holder 108 can be inserted into the second portion 304 of the receiving compartment 301. As described herein, the reagent housing 110 can include one or more alignment members 130 that facilitate positioning the rack 100 within one or more recesses 306 within the diagnostic instrument 300. The alignment members 130 are configured to ensure that the rack 100 can only be placed within the diagnostic instrument 300 in a single orientation such that the first portion 303 receives the reagent housing 110.

[0094] 18 , the receiving compartment 301 can include a divider 250, shown enclosed in dashed lines. The divider 250 is positioned between a first portion 303 of the receiving compartment 301 and a second portion 304 of the receiving compartment 301. The divider 250 can be stationary within the receiving compartment 301, e.g., an integral wall portion of the receiving compartment 301. The rack 100 interacts with the divider 250 when lowered into the receiving compartment 301 of the diagnostic device 300, e.g., when the reagent housing 110 is inserted into the first portion 303 and the sample tube holder 108 is inserted into the second portion 304. The divider 250 actuates the hinge assembly 200 as described herein.

[0095] Exemplary Sample Tube and Reagent Holder Loading Procedure An exemplary sample tube and reagent holder loading procedure according to the first embodiment of the present disclosure will now be described below. In some embodiments, one or more sample tubes 102 are loaded into a rack 100 on a benchtop surface. As shown in FIGS. 15A-15C , the rack 100 can be designed to allow one or more sample tubes 102 to be easily loaded therein. Loading the sample tubes 102 can be intuitive because the sample tubes 102 are inserted vertically into the vertically aligned openings 144, 156. The hinge plate 202 is pivoted away from the openings 144, 156 to allow the sample tubes 102 to be loaded.

[0096] The sample tube holder 108 can include aligned upper and lower openings 144, 156 that permit insertion of the sample tube 102. The upper and lower openings 144, 156 can be aligned along a vertical axis to permit insertion of the sample tube 102 along vertical axis A shown in FIG. 15A. The upper opening 144 can support and guide the sample tube 102 during further insertion. The lower opening 156 can support and guide the sample tube 102 during further insertion.

[0097] In some embodiments, one or more reagent holders 104 are loaded into the reagent housing 110 of the rack 100 before insertion into the diagnostic device 300. In some embodiments, one or more reagent holders 104 are loaded into the rack 100 on a benchtop surface.

[0098] In some embodiments, the rack 100, which is loaded with one or more sample tubes 102 and one or more reagent holders 104, is designed to be stable on a horizontal surface, such as a benchtop surface. The rack 100 does not easily tip over during transport, and for this purpose has one or more legs 124 symmetrically attached to first and second vertical members 134 of the reagent housing 110. In certain embodiments, the rack has a handle 126 for easy lifting and movement, and in some embodiments, the handle 126 can be locked in a vertical position. In some embodiments, the handle 126 is positioned about an axis that is offset from an axis passing through the center of gravity of the rack 100 when loaded. The handle 126 is designed to fit flush with the upper horizontal member 132 of the reagent housing 110.

[0099] The sample tube 102 may include additional features to facilitate the sample preparation process. The sample tube 102 is designed to hold and transport samples for a variety of purposes. In one non-limiting embodiment, the sample tube 102 is used for sample preparation in a clinical setting. The sample tube 102 may be of any suitable shape and size.

[0100] Exemplary Sample Tubes and Sample Tube Holders Exemplary sample tube and sample tube holder features for use with embodiments of the present disclosure are now described below. It will be understood that the following exemplary sample tubes are non-limiting and that any suitable sample tubes can be used with embodiments of the present disclosure. In some cases, all of the sample tubes 102 loaded into the sample tube holder 108 are the same. In some cases, two or more sample tubes 102 loaded into the sample tube holder 108 are of the same size, shape, or configuration. In other cases, two or more sample tubes 102 loaded into the sample tube holder 108 are of different sizes, shapes, or configurations. The diameters and lengths of the sample tubes 102 can be different. For example, two or more sample tubes 102 loaded into the sample tube holder 108 can have the same diameter. As another example, two or more sample tubes 102 loaded into the sample tube holder 108 can have different lengths. Sample tubes having various characteristics that can be received within the rack 100 can interact differently with the sample tube holder 108 and hinge assembly 200. For example, one sample tube 102 can contact the fourth surface 160 of the sample tube holder 108, and one sample tube 102 cannot. In some embodiments, the sample tube holder 108 is designed to hold multiple identical sample tubes 102. In some embodiments, a second sample tube holder 108 is designed to hold multiple identical sample tubes 102 of a different size, shape, or configuration than the first sample tube holder 108. In some embodiments, the sample tube holder 108 can be swapped or replaced with a second sample tube holder 108 in the rack 100. In some embodiments, the sample tube holder 108 is coupled to the rack 100, and the second sample tube holder 108 is coupled to the second rack 100.

[0101] The sample tube 102 is a self-contained container that can prevent fluid leakage and minimize cross-sample contamination. The sample tube 102 can include a sealing cap that allows it to be transported. The sealing cap prevents any liquid from spilling by providing a liquid-tight seal. The sealing cap can be attached to the sample tube 102 by the manufacturer or by a healthcare provider after the sample has been added to the sample tube 102. In some embodiments, the proximal end 170 of the sample tube 102 includes a threaded surface. The sealing cap can engage this threaded surface to removably attach it to the sample tube 102. The sample tube 102 and sealing cap can be any commercially available sample tube system.

[0102] The sample tube 102 can include a cap 172 that allows the sample tube 102 to be penetrated by a fluid transfer device, such as a pipette tip. In some embodiments, the cap 172 may not provide a fluid-tight seal. The cap 172 can be coupled to the sample tube 102 at the location where sample preparation is performed, for example, at the location of the diagnostic device 300. In some embodiments, the proximal end 170 of the sample tube 102 includes a threaded surface. The cap 172 can engage this threaded surface to removably couple it to the sample tube 102.

[0103] The cap 172 can allow access to the sample by a liquid dispenser. In some embodiments, the cap 172 includes a threaded outer portion designed to engage the sample tube 102. In some embodiments, the cap 172 includes a pierceable septum designed to receive a pipette tip therethrough. The septum can include features to substantially limit inadvertent fluid transfer, evaporation, or leakage. The septum can include features for wiping the pipette tip during withdrawal. The cap 172 can allow access to the sample to allow preparation of one or more amplification-ready samples from the sample. The sample tube 102 with the cap 172 is designed for use in a diagnostic device 300 that can perform sample preparation on samples in more than one sample tube 102 simultaneously.

[0104] The sample tubes 102 for use with the rack 100 can be made of any suitable material, including, but not limited to, plastic. The sample tubes 102 can be sufficiently rigid so that the sample tubes 102 do not easily deform during routine handling and shipping. The tubular portion of the sample tubes 102 can be manufactured from a single piece, such as a unitary or monolithic construction, and the caps 172 are manufactured from a separate construction. The sample tubes 102 can be translucent. The sample tubes 102 can be disposable for single use, after which the sample tubes 102 are discarded.

[0105] Exemplary Liquid Dispenser The sample tubes 102 and reagent holders 104, when received by the rack 100, are configured to accept pipetting operations both performed manually by an operator and performed by a liquid dispenser 302. The liquid dispenser 302 controls fluid handling operations for any fluid, including fluid samples, particularly multiple biological samples. The liquid dispenser 302 performs various aspiration and dispensing operations on the sample tubes 102 and reagent holders 104. The liquid dispenser 302 can include pipette tips sized to penetrate the caps 172 of the sample tubes 102.

[0106] Exemplary, non-limiting features of a liquid dispenser 302 suitable for operating on sample tubes 102 and reagent holders 104 according to the present disclosure include at least the ability to pick up pipette tips and return them after use, the ability to detach and discard pipette tips from the liquid dispenser 302 after use or when an abnormality is encountered, and the ability to precisely move pipette tips from one location to another in a given rack 100. During a sample preparation procedure, for example, a sample from a sample tube 102 can be mixed with one or more reagents, liquid reagents can be added to solid reagents to prepare solutions, and various liquid reagents and samples can be mixed with each other. The liquid dispenser 302 can operate separately or simultaneously on two or more sample tubes 102 when received by the rack 100. The liquid dispenser 302 can operate separately or simultaneously on two or more reagent holders 104 when received by the rack 100. The liquid dispenser 302 can operate separately or simultaneously on two or more lanes 106. The liquid dispenser 302 can perform certain operations in parallel. The liquid dispenser 302 can perform certain operations in series. The liquid dispenser 302 can move in multiple degrees of freedom, such as at least three degrees of freedom.

[0107] The diagnostic device 300 can be designed to perform automated sample preparation according to the steps illustrated herein on multiple samples contained in sample tubes 102. The geometric arrangement of the components of the diagnostic device 300 is schematic and not intended to be limiting. Disclosed embodiments of the present invention can be implemented in any suitable diagnostic device in which sample tubes are received in a sample tube holder. The diagnostic device 300 can further include a microfluidic cartridge 308 within the cartridge-receiving compartment 305. The microfluidic cartridge 308 can be configured to amplify the sample and detect the presence of amplified polynucleotides within the microfluidic cartridge 308. The liquid dispenser 302 can be configured to obtain an aliquot of fluid containing an analyte of interest, such as, but not limited to, nucleic acids extracted from one or more samples, and direct it to another area of ​​the diagnostic device, such as, but not limited to, a storage area.

[0108] The diagnostic device 300 may include a processor 310, such as a microprocessor, configured to control the functions of its various components and, therefore, in communication with each such component requiring control. The liquid dispenser 302 may be controlled by the processor 310. The liquid dispenser 302 is configured to perform various aspiration and dispensing operations on the samples, fluids, and reagents in the sample tubes 102 and reagent holders 104, respectively. The liquid dispenser 302 may perform such operations on multiple sample tubes 102 and reagent holders 104 simultaneously. The diagnostic device 300 may process multiple samples in parallel, with each lane 106 undergoing a separate or independent step or process. Furthermore, the order in which the various functions are described below does not limit the order in which the processor 310 executes instructions when the diagnostic device 300 is operating.

[0109] The diagnostic device 300 is configured to operate in conjunction with a complementary rack 100. In some embodiments, the diagnostic device 300 can be capable of receiving multiple racks 100. FIG. 17 illustrates two racks 100 within the diagnostic device 300. The racks 100 are configured to receive several biological samples in sample tubes 102 and prepare these samples in a form suitable for workup and diagnostic analysis. The racks 100 are configured to receive several reagents in reagent holders 104, which may optionally be equipped with various components including processing tubes 174, reagent tubes 176, and receptacles 180 having containers. The racks 100 are configured so that during sample workup, the samples are processed in the respective reagent holders 104 within the respective lanes 106 of sample tubes 102. In some embodiments, this processing includes mixing, heating, cooling, and / or magnetic separation.

[0110] The diagnostic device 300 may be self-contained and operates in conjunction with sample tubes 102 and reagent holders 104 inserted into the diagnostic device 300 through racks 100. The diagnostic device 300 may be configured for multiple sample analysis and / or analysis of multiple sample batches, with a single rack 100 holding a single sample batch. Thus, each component of the diagnostic device 300 may be present as many times as there are sample batches, although the various components may be configured within a common housing.

[0111] Second Exemplary Rack According to the Present Disclosure 19-24 illustrate a rack 400 according to a second embodiment of the present disclosure. FIG. 19A illustrates a front perspective view of the rack 400. FIG. 19B illustrates an exploded front perspective view of the rack 400. FIGS. 20A-20B illustrate rear perspective views of the rack 400. FIG. 21 illustrates a top view of the rack 400. FIG. 22 illustrates a side view of the rack 400. FIG. 23 illustrates a front view of the rack 400. FIG. 24 illustrates a rear view of the rack 400. The rack 400 is configured to receive multiple sample tubes 102 and multiple reagent holders 104. The rack 400 receives these components such that the sample tubes 102 and the reagent holders 104 are loaded separately and independently of each other. In this non-limiting embodiment, the sample tubes 102 correspond one-to-one to the reagent holders 104. The rack 400 is configured to accept 12 sample tubes 102 and 12 corresponding reagent holders 104. In some embodiments, the rack 400 can accept 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48, 60, or 72 sample tubes 102 and, therefore, 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48, 60, or 72 corresponding reagent holders 104. In some embodiments, the rack 400 can accept any suitable number of samples. In some embodiments, the rack 400 can accept any suitable number of reagent holders. The rack 400 can include any of the features of the rack 100 described herein.

[0112] The rack 400 can include two or more subcomponents. The rack 400 includes a sample tube holder 408 configured to receive one or more sample tubes 102. See FIGS. 1-3 for non-limiting embodiments of the sample tubes 102. In this non-limiting example, the rack 400 also includes a reagent housing 410 configured to receive one or more reagent holders 104. See FIGS. 1-3 for non-limiting embodiments of the reagent holders 104. The sample tube holder 408 and the reagent housing 410 can be joined to form a unitary structure. The sample tube holder 408 can include any of the features of the sample tube holder 108 described herein. The reagent housing 410 can include any of the features of the reagent housing 110 described herein. The rack 400 can be divided into one or more lanes 406. The lanes 406 can have any of the features of the lanes 106 described herein.

[0113] The reagent housing 410 includes a horizontal member 432 and two vertical members 434 connected thereto. Each of the vertical members 434 includes two legs 424, although other configurations of the vertical members 434 and legs 424 are contemplated. Any suitable arrangement of the horizontal and vertical members can be implemented. The two vertical members 434 are configured to allow the reagent housing 410 to stand upright or maintain stability. The reagent housing 410 can include a handle 426.

[0114] The reagent housing 410 includes a reagent housing edge 436. The reagent housing edge 436 is where a horizontal portion 436a and a vertical portion 436b of the reagent housing 410 meet. The reagent housing edge 436 can be a 90-degree or right-angle edge. The reagent housing edge 436 can be an edge of the horizontal member 432.

[0115] The reagent housing edge 436 is positioned to face the sample tube holder 408 described herein. The reagent housing 410 includes a first set of openings 438. The first set of openings 438 can include one or more openings. In the illustrated embodiment, the first set of openings 438 includes two openings. The first set of openings 438 is designed to mate with the sample tube holder 408 described herein.

[0116] The reagent housing 410 includes a second set of openings 440, shown in FIG. 19B. The second set of openings 440 can include one or more openings. In the illustrated embodiment, the second set of openings 440 includes three openings. The second set of openings 440 is designed to mate with a hinge assembly described herein. The first set of openings 438 can be near two vertical members 434. The second set of openings 440 can be located between the first set of openings 438.

[0117] 25 and 26 illustrate a non-limiting exemplary sample tube holder 408 according to the present disclosure. The sample tube holder 408 includes features for positioning and holding the sample tubes 102. The rack 400 is configured to receive multiple samples, each received within an individual sample tube 102. FIG. 25 illustrates a front perspective view of the sample tube holder 408, and FIG. 26 illustrates a rear perspective view of the sample tube holder 408. The sample tube holder 408 can have any of the features of the sample tube holder 108 described herein.

[0118] The sample tube holder 408 includes a first portion 442, a second portion 446, a third portion 454, and a fourth portion 460. The first portion 442 is planar or substantially planar. The first portion 442 includes a plurality of upper openings 444. The upper openings 444 can be round or circular, but can have other cross-sectional shapes depending on the characteristics of the sample tubes 102.

[0119] The sample tube holder 408 includes a second portion 446. The second portion 446 is vertical or substantially vertical. The second portion 446 includes upper posts 448. The upper posts 448 can extend vertically upward from the first portion 442. Each upper post 448 has an opening 450 configured to receive a fastener 412 therethrough. Any segment of the second portion 446 can include one or more rails 452.

[0120] The sample tube holder 408 is configured to mate with the reagent housing 410 such that the two components of the rack 400 are securely connected. The openings 450 of the sample tube holder 408 are configured to align with the first set of openings 438 in the reagent housing 410. To couple the sample tube holder 408 to the reagent housing 410, any suitable fastener 412 can extend through the openings 450 of the sample tube holder 408 and the corresponding openings in the reagent housing 410. An example of this fastener 412 is shown in FIG.

[0121] The sample tube holder 408 includes a third portion 454. In this example, the third portion 454 is oriented obliquely between the second portion 446 and the fourth portion 460. The third portion 454 includes a plurality of lower openings 456. The lower openings 456 can have any suitable cross-sectional shape, including, but not limited to, oval elongated openings, oval openings, and circular openings. The lower openings 456 are shaped and configured to receive the circumference of the sample tubes 102.

[0122] The sample tube holder 408 includes a fourth portion 460. One or more portions of the fourth portion 460 can be horizontal or substantially horizontal. The fourth portion 460 can form a base of the sample tube holder 408. The fourth portion 460 can include one or more rails 464.

[0123] In a method of use according to the present disclosure, each of the multiple sample tubes 102 is inserted into the sample tube holder 408. First, the distal end 166 of the sample tube 102 is inserted into the upper opening 444 of the first portion 442. Then, the distal end 166 of the sample tube 102 is threaded vertically parallel to the second portion 446. Next, the distal end 166 of the sample tube 102 is inserted into the lower opening 456 of the third portion 454. Thereafter, the distal end 166 of the sample tube 102 is threaded vertically until it rests against the surface of the fourth portion 460. The proximal end 170 of the sample tube 102 extends upward from the first portion 442 of the sample tube holder 408 when the sample tube 102 is received in the sample tube holder 408. The proximal end 170 of the sample tube 102 may include a cap 172. The cap 172 extends upward from the first portion 442. See FIG. 7 for an embodiment of a sample tube 102 including a distal end 166, a proximal end 170, and a cap 172.

[0124] The upper opening 444 and the lower opening 456 can limit horizontal movement based on the shape of the openings 444, 456 similar to the exterior surface of the sample tube 102. Advantageously, embodiments of the present disclosure allow portions of the sample tube 102 to be accessible to a sample identity verifier, such as a barcode reader, when placed within the sample tube holder 408.

[0125] 1. An exemplary hinge assembly according to a second embodiment of the present disclosure. An exemplary hinge assembly 500 according to a second embodiment of the present disclosure will now be described with reference to FIGS. 27-34. It will be understood that the hinge assembly of the present disclosure is not limited to the features of the exemplary hinge assembly 500 and may take other forms, shapes, and dimensions consistent with the present disclosure. FIG. 27 shows a front perspective view of the hinge assembly 500. FIG. 28 shows a rear perspective view of the hinge assembly 500. FIG. 29 shows a front exploded view of the hinge assembly 500. FIGS. 30A-30B show a front view of the hinge assembly 500. FIG. 31 shows a top view of the hinge assembly 500. FIG. 32 shows a partial view of the hinge assembly 500. FIG. 33 shows a partial view of the hinge assembly 500. FIG. 34 shows a partial view of the hinge assembly 500.

[0126] The hinge assembly 500 includes a tube insertion configuration. In the tube insertion configuration, the hinge assembly 500 can allow vertical movement of the sample tube 102 within the sample tube holder 408. The sample tube 102 can be freely inserted into or removed from the sample tube holder 408. The sample tube 102 is moved vertically or substantially vertically to insert it into the sample tube holder 408. This method can be repeated to insert multiple sample tubes 102 vertically into the sample tube holder 408. In some methods of use, the sample tube 102 is moved vertically or substantially vertically to remove it from the sample tube holder 408. In some methods of use, the rack is inverted to remove the sample tube 102 from the sample tube holder 408.

[0127] The hinge assembly 500 includes a tube retention configuration. In the tube retention configuration, the hinge assembly 500 can prevent or limit vertical movement of the sample tube 102 within the sample tube holder 408. In some embodiments, the hinge assembly 500 can prevent or limit the sample tube 102 from undergoing vertical lift during a pipetting operation, thereby increasing pipetting efficiency. In some cases, there is some amount of vertical lift of the sample tube 102 during pipetting, for example, during withdrawal of the pipette tip from the sample tube 102. In these cases, the hinge assembly 500, in the tube retention configuration, stops the sample tube 102 at a particular point during its vertical progression, specifically when the sample tube 102 comes into physical contact with the hinge assembly 500 and is thereby physically restrained against further vertical lift. In these cases, the hinge assembly 500 can prevent the sample tube 102 from lifting vertically to such an extent that a malfunction of the liquid dispenser would hinder or completely stop the pipetting operation. The sample tube 102 is advantageously restrained vertically by the hinge assembly 500.

[0128] The hinge assembly 500 includes a hinge support 502. The hinge support 502 is a horizontal slide mount. The hinge support 502 is an elongated member. In the illustrated embodiment, the hinge support 502 is generally rectangular in shape. The hinge support 502 includes a front surface 504, a rear surface 506, and a side surface 508. The front surface 504 faces the sample tube 102 in use. The rear surface 506 faces the reagent housing 410 in use. The rear surface 506 can be a flat surface that abuts the vertical portion 436b of the reagent housing 410. The rear surface 506 can be any shape that allows for a secure connection between the hinge support 502 and the reagent housing 410 when fastened together. The hinge support 502 can be made of any material, including, but not limited to, metal and plastic.

[0129] The hinge support 502 has one or more openings 510 configured to receive the fasteners 414. The one or more openings 510 extend from the front surface 504 to the rear surface 506. Although three openings 510 are shown, the hinge support 502 can include any number of openings 510. Any segment of the hinge support 502 can include one or more openings 510. The openings 510 are configured to align with a second set of openings 440 in the reagent housing 410. When the fasteners 414 extend through the corresponding openings 510, 440, the hinge support 502 of the hinge assembly 500 is rigidly coupled to the reagent housing 410. The center fastener 414 can be coupled to a self-locking tab as described herein. FIG. 23 illustrates the fasteners 414. FIG. 19B illustrates the fasteners of the rack 400.

[0130] The hinge support 502 includes a cutout 512. Although two cutouts 512 are shown, the hinge support 502 can include any number of cutouts 512. The cutout 512 includes an upper portion. The upper portion of the cutout 512 includes an upper opening 514. The upper opening 514 can be a generally rectangular opening in the cutout 512. The upper opening 514 extends from the front surface 504 to the rear surface 506. The upper opening 514 extends through the hinge support 502. In other embodiments, the upper opening 514 extends through a portion of the hinge support 502.

[0131] The cutout 512 includes a lower portion. The lower portion of the cutout 512 includes a lower opening 516. The lower opening 516 may be a generally rectangular opening. The lower opening 516 may be smaller than the upper opening 514. The lower opening 516 may be centered relative to the upper opening 514. The lower opening 516 may extend from the front surface 504 through a portion of the hinge support 502. In some embodiments, the lower opening 516 in the lower portion of the cutout 512 does not extend to the rear surface 506. In some embodiments, the lower opening 516 extends through only a portion of the hinge support 502. In other embodiments, the lower opening 516 extends through the hinge support 502.

[0132] A lower portion of the cutout 512 includes a channel 518. The channel 518 may be a generally rectangular channel. The channel 518 may be smaller than the upper opening 514. The channel 518 may be to the right of the lower opening 516 when viewed from the front of the hinge assembly 500 as shown in FIG. 27 . The channel 518 is disposed between the front face 504 and the rear face 506. In some embodiments, the channel 518 does not extend to the front face 504. In some embodiments, the channel 518 does not extend to the rear face 506. The channel 518 may form a catch, which will be described in more detail below.

[0133] The hinge support 502 can include one or more bores 520. The one or more bores 520 can be coaxial. Although two bores 520 are shown, the hinge support 502 can include any number of bores 520. The bores 520 extend horizontally through the hinge support 502. The bores 520 extend inward from the side surfaces 508 toward the center of the hinge support 502. The bores 520 terminate at the upper opening 514 and then continue beyond the upper opening 514 toward the center of the hinge support 502. In the illustrated example, each side surface 508 of the hinge support 502 can include a bore 520. In other examples, the hinge support 502 includes a single bore 520 extending between its side surfaces 508.

[0134] The hinge assembly 500 includes one or more hinge pins 522. The one or more hinge pins 522 can be coaxial. Although two hinge pins 522 are shown, the hinge assembly 500 can include any number of hinge pins 522. The number of hinge pins 522 can correspond to the number of bores 520. In some embodiments, the hinge assembly 500 can include a single bore 520 and a single hinge pin 522. In some embodiments, the hinge assembly 500 can include several hinge pins 522 and a corresponding number of bores 520. In the illustrated embodiment, each bore 520 is configured to receive a hinge pin 522. The hinge pins 522 can be generally cylindrical members, and the corresponding bores 520 can be cylindrical. The hinge pin 522 can provide a pivot axis about which the components of the hinge assembly 500 can pivot. The hinge pin 522 can be located within the upper opening 514. The hinge pin 522 can be centered relative to the upper opening 514. The hinge pin 522 can be any material, including stainless steel.

[0135] The hinge assembly 500 includes one or more springs 524. The one or more springs 524 can be coaxial. Although two springs 524 are shown, the hinge assembly 500 can include any number of springs 524. The number of springs 524 can correspond one-to-one to the number of notches 512. The number of springs 524 can correspond one-to-one to the number of hinge pins 522. Any suitable spring 524 can be implemented in embodiments of the present disclosure. The spring 524 can be a compression spring. The spring 524 can be designed to apply a biasing force to restore a neutral configuration. The spring 524 can be any material, including stainless steel. The spring 524 can be a 0.218" outer diameter spring. The spring can be 1" long. The hinge assembly 500 can include one or more washers 526. The washers 526 can distribute the force of the springs 524. The number of washers 526 can correspond one-to-one to the number of springs 524. The hinge assembly 500 can include one or more caps 528. The caps 528 can retain the hinge pins 522 within the bores 520. The number of caps 528 can correspond one-to-one to the number of hinge pins 522.

[0136] The hinge assembly 500 includes a slide lock 530. Features of a non-limiting example of the slide lock 530 are then described below, although it will be understood that the present disclosure is not limited to this example and that any suitable slide lock can be implemented in accordance with the present disclosure. The slide lock 530 includes a front surface 532, a rear surface 534, and a side surface 536. The front surface 532 faces the sample tube 102 in use. The rear surface 534 faces the reagent housing 410 in use. The slide lock 530 can include a top surface 538 and a bottom surface 540. The slide lock 530 can be made of any material, including plastic.

[0137] The top surface 538 of the slide lock 530 can form a shelf. The top surface 538 can form a right-angled shelf. The top surface 538 can include an upwardly extending lip 542. The lip 542 can form a portion of the rear surface 534. The lip 542 can be a generally rectangular block. The top surface 538 has one or more openings 544 configured to receive fasteners. The one or more openings 544 extend from the top surface 538 toward the bottom surface 540. Although two openings 544 are shown, the slide lock 530 can include any number of openings 544.

[0138] The slide lock 530 includes one or more bores 546. Although one bore 546 is shown, the slide lock 530 can include any number of bores 546. The bore 546 extends horizontally through the slide lock 530. The bore 546 extends to the side surfaces 536. In the illustrated example, the slide lock 530 includes a single bore 546 extending between its side surfaces 536. The bore 546 can extend along a central portion of the slide lock 530. The axis of the bore 546 can transverse the axis of the opening 544. In some embodiments, the bore 546 and the opening 544 intersect. In some embodiments, the bore 546 and the opening 544 do not intersect. The bore 546 can extend along a center of rotation of the slide lock 530. The bore 546 is configured to receive the hinge pin 522 therethrough.

[0139] The rear surface 534 of the slide lock 530 can form a shelf. The rear surface 534 can form a right-angle shelf. The rear surface 534 can include an inwardly extending notch 548. The notch 548 can form a portion of the rear surface 534. The notch 548 can be a generally rectangular notch. In some embodiments, the notch 548 and the lip 542 have the same or similar thickness. The notch 548 can extend parallel to the bore 546. The notch 548 can extend along a central portion of the slide lock 530. The notch 548 can act as a stop to hold the hinge assembly 500 in the tube insertion configuration described herein. The rear surface 534 can be shaped to slide linearly relative to the reagent housing 410. The rear surface 534 can be generally planar. The rear surface 534 can slide relative to a flat surface of the reagent housing 410.

[0140] The slide lock 530 includes a flange 550. The flange 550 can be offset inward from the front face 532. The flange 550 can be offset inward from the rear face 534. The flange 550 can be centered between the front face 532 and the rear face 534. The flange 550 can be offset inward from the side faces 536. The flange 550 can be centered between the side faces 536. The flange 550 can form a bottom face 540 of the slide lock 530. The flange 550 can be a generally rectangular block. The flange 550 can include one or more rounded edges.

[0141] The slide lock 530 can be assembled relative to the hinge pin 522 and the hinge support 502. The hinge pin 522 can be inserted into the bore 520 of the hinge support 502 near the side surface 508. The spring 524 can be disposed in the upper opening 514. The hinge pin 522 can be inserted through the spring 524. The washer 526 can be disposed in the upper opening 514. The hinge pin 522 can be inserted through the washer 526. The slide lock 530 can be disposed in the notch 512. The flange 550 can be disposed in a lower portion of the notch 512. The flange 550 can be disposed in the lower opening 516 and / or the channel 518. The hinge pin 522 can be inserted through the slide lock 530. The hinge pin 522 can be inserted into the hinge support 502. The hinge pin 522 can be secured to a cap 528. Another hinge pin 522 can be inserted in a similar manner near the other side 508 and through a second slide lock 530 into the bore 520 of the hinge support 502.

[0142] The slide lock 530 can slide relative to the hinge pin 522. The slide lock 530 can slide in two directions generally parallel to the longitudinal axis of the hinge support 502. The upper portion of the slide lock 530 can slide within the upper opening 514 of the cutout 512. The flange 550 can slide within the lower opening 516. The flange 550 can slide within the channel 518. The channel 518 is dimensioned to allow the flange 550 to slide therein. The hinge support 502 is configured to remain stationary during the sliding movement of the slide lock 530. The slide lock 530 is configured to slide relative to the stationary hinge support 502.

[0143] The slide lock 530 can slide in two directions. In a first direction, the slide lock 530 compresses the spring 524 against the inner surface of the upper opening 514. In the exemplary embodiment shown in FIG. 30A , the slide lock 530 compresses the spring when slid to the left. In a second direction, the slide lock 530 expands the spring 524. The spring 524 can bias the spring lock 530 to move in the second direction. In the exemplary embodiment shown in FIG. 30A , the slide lock 530 expands the spring when slid to the right.

[0144] The slide lock 530 can rotate about the hinge pin 522 when the flange 550 is positioned in the lower opening 516. The flange 550 can rotate from a position aligned with the channel 518 to a position forming an oblique angle with the channel 518. The flange 550 can rotate through the lower opening 516. The slide lock 530 can rotate about the hinge pin 522 when the spring 524 is compressed. The slide lock 530 can rotate about the hinge pin 522 when slid to the left. After sliding the slide lock 530 to align the flange 550 with the lower opening 516, the slide lock 530 can rotate about the hinge pin 522. The flange 550 is not positioned in or restrained by the channel 518 in the tube insertion configuration. In the tube insertion configuration, flange 550 is rotated from a position within lower opening 516 (aligned with, but not disposed within, channel 518) to a position where flange 550 passes through a plane containing front surface 504. Figure 30B shows where flange 550 is rotated out of lower opening 516 in the tube insertion configuration.

[0145] To transition to the tube retention configuration, the slide lock 530 can be rotated to align the flange 550 with the channel 518. In some embodiments, the slide lock 530 is slid into the channel 518 by a user. In some embodiments, a spring 524 can bias the flange 550 to slide into the channel 518. The spring 524 can move the slide lock 530 toward the right as viewed in FIG. 30B . The channel 518 can prevent or limit the flange 550 from rotating when the flange 550 is within the channel 518. The channel 518 can prevent or limit the slide lock 530 from rotating. During the sliding movement, the hinge support 502 is configured to remain stationary. The slide lock 530 is configured to slide relative to the stationary hinge support 502.

[0146] The hinge assembly 500 includes a hinge plate 552. The hinge plate 552 can be rigidly coupled to the two slide locks 530 such that, during use, sliding and pivoting movement of the slide locks 530 relative to the hinge supports 502 results in sliding and pivoting movement of the hinge plate 552 relative to the hinge supports 502, as described in more detail below. The hinge plate 552 includes a front surface 554, a rear surface 556, and a side surface 558. The rear surface 556 faces the reagent housing 410 during use. The hinge plate 552 can include a top surface 560 and a bottom surface 562. The hinge plate 552 can be planar or substantially planar. The top surface 560 and the bottom surface 562 can be parallel. The hinge plate 552 can have a constant thickness between the top surface 560 and the bottom surface 562.

[0147] The hinge plate 552 includes one or more openings 564 configured to receive fasteners 566 therethrough. Although four openings 564 are shown, the hinge plate 552 can include any number of openings 564. Any segment of the hinge plate 552 can include one or more openings 564. In the illustrated embodiment, two openings 564 are located near the right side of the hinge plate 552 and two openings 564 are located near the left side of the hinge plate 552. The one or more openings 564 extend from the top surface 560 to the bottom surface 562 of the hinge plate 552.

[0148] As described herein, the top surface 538 of the slide lock 530 has one or more openings 544 configured to receive a fastener. The top surface 538 of the slide lock 530 forms a shelf shaped and sized to receive a portion of the hinge plate 552. The top surface 538 of the slide lock 530 includes an upwardly extending lip 542. The lip 542 is configured to be positioned near a rear surface 556 of the hinge plate 552. The remainder of the top surface 538 of the slide lock 530 extends along a bottom surface 562 of the hinge plate 552. The lip 542 can facilitate alignment between the slide lock 530 and the hinge plate 552. When the hinge plate 552 abuts the lip, the openings 544, 564 align. The one or more openings 564 in the hinge plate 552 can align with the one or more openings 544 in the slide lock 530. Fasteners 566 can connect the hinge plate 552 and the slide lock 530. The hinge plate 552 and the slide lock 530 can form a unitary structure. When the fasteners 566 extend through the corresponding openings 544, 564, the hinge plate 552 is rigidly connected to the slide lock 530. The fasteners 566 can be Torx screws. The fasteners 566 can be 18-8 screws. The fasteners 566 can be made of any material, including stainless steel. In an alternative embodiment, the hinge plate 552 and one or more slide locks 530 are manufactured as a single, unitary piece, for example, injection molded from any suitable plastic.

[0149] The rear surface 556 of the hinge plate 552 can include a flange 568. The flange 568 can provide support to a central portion of the hinge plate 552. The flange 568 can prevent bending of the central portion of the hinge plate 552. The flange 568 can be a surface that is actuated to receive forces and pivot the hinge plate 552, as described in more detail below.

[0150] The front surface 554 of the hinge plate 552 can include a contoured edge. The front surface 554 includes a plurality of concave surfaces. The front surface 554 includes a plurality of small recesses 570. The hinge plate 552 is configured to restrain one or more sample tubes 102 received in the sample tube holder 408 from vertical movement. The one or more sample tubes 102 are restrained using the respective small recesses 570. In this example, the hinge plate 552 is configured to hold twelve sample tubes 102 received in the sample tube holder 408 using twelve small recesses 570 each. See FIG. 21 and FIG. 41B, which is described in more detail below. Although the hinge plate 552 is shown having twelve small recesses 570, the hinge plate 552 can include any number of small recesses 570.

[0151] The recess 570 can be round. The recess 570 can be semicircular or hemispherical. The recess 570 can be a partial circle. The recess 570 can be a partial circle, for example, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, 270°, or a range of any of these values. The recess 570 can be tapered. The recesses 570 can correspond one-to-one to the number of upper openings 444 in the sample tube holder 408. The recess 570 may include one or more rounded edges, such as rounded corners or bends.

[0152] The front surface 554 includes a plurality of large recesses 572. The hinge plate 552 is configured to permit insertion and removal of one or more sample tubes 102 through the upper and lower openings 444, 456 of the sample tube holder 408. Movement of the sample tubes 102 is permitted when the sample tubes are aligned with their respective large recesses 572. See FIG. 40C , which is described in more detail below. The hinge plate 552 is configured to permit reception of 12 sample tubes 102 through the large recesses 572 into the upper and lower openings 444, 456 of the sample tube holder 408. The hinge plate 552 is also configured to release the 12 sample tubes 102 from the sample tube holder 408 when the sample tubes 102 are aligned with the large recesses 572. Although the hinge plate 552 is shown with twelve major recesses 572, the hinge plate 552 can include any number of major recesses 572. Multiple minor recesses 570 can be interspersed between the multiple major recesses 572. Each of the major recesses 572 can be located to the right of the corresponding minor recess 570 when viewed from the perspective of Figures 31 and 32.

[0153] The large recess 572 can be round. The large recess 572 can be semicircular or hemispherical. The large recess 572 can be a partial circle. The large recess 572 can be a partial circle, for example, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, 270°, 280°, 290°, 300°, 310°, 320°, or a range of any of these values. The large recess 572 can be tapered. The large recess 572 can correspond to the number of sample tubes 102 in the sample tube holder 408 in a one-to-one correspondence. The major recess 572 may include one or more rounded edges, such as rounded corners or bends.

[0154] In some embodiments, the small recesses 570 and the large recesses 572 can have different radii of curvature. In some embodiments, the large recesses 572 can have a larger radius of curvature than the small recesses 570. In some embodiments, the small recesses 570 and the large recesses 572 can have the same radius of curvature. In some embodiments, the small recesses 570 and the large recesses 572 can be concave. The hinge plate can include one or more rounded edges, such as rounded corners or bends, connecting the small recesses 570 and the large recesses 572. The small recesses 570 and the large recesses 572 can form a repeating pattern.

[0155] The front surface 554 may include different features near the sides 558 when viewed from the perspective of Figures 31 and 32. In the illustrated embodiment, the smaller recess 570 closest to the left side surface 558 may be a larger partial circle than the other smaller recesses 570. The smaller recess 570 closest to the left side surface 558 may be a partial circle, for example, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, 270°, or a range of any of these values. In the illustrated embodiment, the larger recess 572 closest to the right side surface 558 may be a larger partial circle than the other larger recesses 572. The major recess 572 closest to the right side 558 can be a partial circle, e.g., 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, 270°, 280°, 290°, 300°, 310°, 320°, or a range of any of these values. The side surfaces 558 can be parallel. The side surfaces 558 can include one or more rounded edges. The major recess 572 and the minor recess 570 can be spaced inward from the side surfaces 558.

[0156] The recesses 570 of the hinge plate 552 can be shaped and sized to allow access to the contents of the sample tubes 102 when the hinge plate 552 is in the tube-holding configuration. In the tube-holding configuration, the recesses 570 do not block a central region or area C of the top of the sample tubes 102. The recesses 570 may cover a portion of the cap 172 but not the central area C. Multiple recesses 570 can simultaneously hold multiple sample tubes 102 within the sample tube holder 408. Multiple recesses 570 can simultaneously hold all of the sample tubes 102 placed in the sample tube holder 408 together. The recesses 570 of the hinge plate 552 may or may not contact the sample tubes 102 within the sample tube holder 408. In some embodiments, the recesses 570 of the hinge plate 552 can be in direct physical contact with the cap or proximal end of the sample tube 102. In some embodiments, the recess 570 can be vertically offset from the sample tube 102 in a locking or tube-holding configuration. In such a case, a vertical space exists between the top of the sample tube 102 (or the cap of the sample tube 102) and the bottom of the recess 570 during normal operation, and the sample tube 102 only contacts the recess 570 (and is restrained against further vertical movement by the recess 570) when subjected to vertical movement or lifting during a pipetting operation.

[0157] In the tube insertion configuration, the hinge plate 552 is slid toward the left as viewed from the perspective of Figures 30A and 31. After sliding, the hinge plate 552 is pivoted as shown in Figure 30B. In the tube insertion configuration, the large recess 572 is positioned above the cap 172 of the sample tube 102. The large recess 572 of the hinge plate 552 allows for the insertion or removal of the sample tube 102. In the tube insertion configuration, the large recess 572 does not impede the vertical movement of the sample tube 102. Multiple large recesses 572 can allow for the separation or simultaneous release of multiple sample tubes 102 from the sample tube holder 408.

[0158] Exemplary Self-Locking Tab According to a Second Embodiment of the Present Disclosure Exemplary self-locking tabs for use in the second embodiment of the present disclosure are now described below. It will be understood that examples of the second embodiment do not require self-locking tabs. For example, the self-locking tabs can be omitted from the second embodiment, or different self-locking tabs can be appropriately implemented in the second embodiment. The self-locking tabs allow the hinge plate to mechanically pivot by their upward force. In the pivoted state, the hinge plate can slide from the tube insertion configuration to the tube retention configuration under the influence of the biasing force of spring 524. The self-locking tabs can be actuated by a receiving compartment of diagnostic device 300 to ensure that hinge assembly 500 is in the tube retention configuration during operation within diagnostic device 300.

[0159] FIG. 35 shows a top view of the rack 400 with self-locking tabs 480. FIG. 36 shows a bottom view of the rack 400 with self-locking tabs 480. FIG. 37 shows a side perspective view of the self-locking tab 480. FIG. 38 shows a side view of the self-locking tab 480. FIG. 39 shows a rear view of the self-locking tab 480. The self-locking tab 480 includes a first portion 482, a second portion 484, a third portion 486, and a fourth portion 488. The first portion 482 can be planar or substantially planar. In this non-limiting embodiment, the first portion 482 is vertical. The second portion 484 can be planar or substantially planar. The second portion 484 can be sloped downward between the first portion 482 and the third portion 486, as shown in FIG. 38. The second portion 484 can be at an angle (α) from vertical, as shown in FIG. 38. The angle α relative to the vertical axis can be 40° from vertical, 45° from vertical, 50° from vertical, 55° from vertical, 60° from vertical, 65° from vertical, 70° from vertical, 75° from vertical, 80° from vertical (as shown), 85° from vertical, 90° from vertical (e.g., horizontal), or any range of these values. The transition between the first portion 482 and the second portion 484 can be rounded. The transition between the second portion 484 and the third portion 486 can be rounded. The third portion 486 can be planar or substantially planar. In this non-limiting embodiment, the third portion 486 is vertical. The first portion 482 and the third portion 486 can be parallel.

[0160] The third portion 486 has an opening 490 configured to receive the fastener 414 therethrough. As described herein, the hinge support 502 has one or more openings 510 configured to receive the one or more fasteners 414. The central fastener 414 can be coupled to the self-locking tab 480. A central fastener 414 is shown in FIG. 23 . Any segment of the third portion 486 can include one or more openings 490. The openings 490 are configured to align with corresponding openings 440 in the reagent housing 410 and corresponding openings 510 in the hinge support 502. The openings 490 are configured to align with the central opening 440 in the reagent housing 410 and the central opening 510 in the hinge support 502. The openings 490 are shaped and sized to allow the fastener 414 to move freely therein, yet be restrained thereby. As described in detail below, self-locking tab 480 is configured to move perpendicularly relative to fastener 414. Movement of self-locking tab 480 is constrained by various features, described in detail below. One feature that constrains movement of self-locking tab 480 is the inner surface of opening 490, which is in physical contact with and restrained by fastener 414.

[0161] The fourth portion 488 can be planar or substantially planar. In this non-limiting embodiment, the fourth portion 488 is horizontal. The transition between the third portion 486 and the fourth portion 488 can be rounded. The second portion 484 can be at an oblique angle to the fourth portion 488.

[0162] During use, the self-locking tab 480 is disposed between the reagent housing 410 and the hinge support 502, as shown in FIG. 35 . The third portion 486 is disposed between the reagent housing 410 and the hinge support 502. The third portion 486 extends above and below the horizontal member 432 of the reagent housing 410, as shown in FIG. 35 . The first portion 482, the second portion 484, and at least a portion of the third portion 486 are above the horizontal member 432, as shown in FIG. 35 . The fourth portion 488 is below the horizontal member 432, as shown in FIG. 36 . The first portion 482 and the second portion 484 extend outward from the sample tube holder 408. The fourth portion 488 extends outward from the sample tube holder 408. Referring back to FIG. 33 , the hinge support 502 can include a notch 578 configured to retain the self-locking tab 480. The notch 578 can have a similar lateral dimension as the self-locking tab 480. The notch 578 can allow vertical movement of the self-locking tab 480 relative to the hinge support 502.

[0163] As described above with reference to FIGS. 23 and 27 , the hinge support 502 has one or more openings 510 configured to receive the fasteners 414. The one or more openings 510 extend from the front surface 504 to the rear surface 506. The openings 510 are configured to align with the second set of openings 440 in the reagent housing 410. When the fasteners 414 extend through the corresponding openings 510, 440, 490, the self-locking tabs 480 can slide relative to the reagent housing 410. The openings 490 are sized to be larger than the corresponding fasteners 414. The openings 490 allow the self-locking tabs 480 to slide vertically relative to the reagent housing 410. The openings 490 are vertically oblong. The openings 490 can be any shape that allows vertical movement when the self-locking tabs 480 are coupled to the reagent housing 410.

[0164] The self-locking tab 480 can translate vertically upward until the fourth portion 488 comes into physical contact with the self-locking tab 480 and is restrained by the horizontal member 432 of the reagent housing 410. The self-locking tab 480 can translate vertically downward until the first portion 482 comes into physical contact with the self-locking tab 480 and is restrained by the horizontal member 432 of the reagent housing 410. The self-locking tab 480 can translate vertically until the fasteners 414 abut the upper and lower walls of the opening 510 as they slide.

[0165] Exemplary Method of Actuating the Hinge Assembly of the Second Embodiment of the Present Disclosure 40A-40D show diagrams of operation of the hinge assembly 500 according to the second embodiment. FIG. 40A is a front view of where the sample tube 102 is inserted into the sample tube holder 408. FIG. 40B is a side view of where the sample tube 102 is fully inserted into the sample tube holder 408. FIG. 40C is a top view of the sample tube 102 and sample tube holder 408 when the sample tube 102 is fully inserted. FIG. 40D is a detailed view of FIG. 40B. In a first configuration, illustrated in FIGS. 40A-40D and referred to herein as the "tube insertion configuration," the hinge assembly 500 is configured to allow the sample tube 102 to be inserted into the sample tube holder 408. The following description describes the hinge assembly 500 in this tube insertion configuration.

[0166] In the tube insertion configuration, the slide lock 530 is slid to the left as viewed in FIG. 30A . The slide lock 530 compresses the spring 524 as shown in FIG. 30B . The flange 550 is to the left of the channel 518 as shown in FIG. 30B . The channel 518 does not retain the flange 550. The flange 550 is positioned within the lower opening 516. The flange 550 is rotated out of the lower opening 516. The flange 550 passes through the lower opening 516 in the front of the hinge assembly 500. A portion of the flange 550 abuts the wall 576 of the lower opening 516. The flange 550 forms an angle outward from the lower opening 516. The flange 550 is rotated toward the front as shown in FIG. 30B . The flange 550 is rotated away from the lower opening 516. In some cases, the flange 550 can be disposed at an angle gamma (γ) relative to the vertical axis. The angle γ can be an acute angle. The angle γ can be 2° from vertical, 4° from vertical, 6° from vertical, 8° from vertical, 10° from vertical, 12° from vertical, 14° from vertical, 16° from vertical, 18° from vertical, 20° from vertical, 22° from vertical, 24° from vertical, 26° from vertical, 28° from vertical, 30° from vertical, 32° from vertical, 34° from vertical, 36° from vertical, 38° from vertical, 40° from vertical, or any range of these values. While the views shown in FIGS. 40B and 40D appear to show the flange 550 in physical contact with the sample tube 102, this is a result of the perspective view shown in FIG. 40D. In some embodiments, the flange 550 of the slide lock 530 does extend beyond the cap of the sample tube 102 in side view. In some embodiments, the slide lock 530 is positioned such that within the movement, the slide lock 530 never contacts the sample tubes 102 (eg, is spaced between the sample tubes 102).

[0167] In the tube insertion configuration, the hinge plate 552 forms an oblique angle with respect to the first portion 442 of the sample tube holder 408. The hinge plate 552 is tilted outward from the sample tube 102. For example, the hinge plate 552 is rotated clockwise along the longitudinal axis of the hinge plate 552 as viewed from the perspective of FIG. 40B . The hinge plate 552 is tilted upward. The plurality of large recesses 572 align with the upper opening 444 of the sample tube holder 408. The hinge plate 552 is rotated toward the reagent housing 410. The hinge plate 552 is rotated to provide clearance for the sample tube 102 to pass by the plurality of large recesses 572 and be inserted into the upper opening 444 of the sample tube holder 408. In the tube insertion configuration, the hinge plate 552 is positioned to provide clearance for vertically inserting the sample tube 102 into the sample tube holder 408. The tube insertion configuration also allows for tube removal. The hinge plate 552 is rotated to provide clearance for the sample tube 102 to pass by the plurality of large recesses 572 and be removed from the upper opening 444 of the sample tube holder 408. The hinge plate 552 is positioned to provide clearance for vertically removing the sample tube 102 from the sample tube holder 408.

[0168] In the tube insertion configuration, the notch 548 in the slide lock 530 can act as a stop to secure or hold the hinge plate 552 in the tube insertion configuration until actuated to switch out of the tube insertion configuration. When held in the tube insertion configuration, the hinge plate 552 can be spring-loaded to actuate and move to the tube retention configuration. The notch 548 can abut against the reagent housing edge 436, as shown in FIG. 40B . The notch 548 can provide an additional point of contact between the hinge assembly 500 and the reagent housing 410. The notch 548 can provide stability to the slide lock 530. The notch 548 can prevent further rotation of the slide lock 530. The notch 548 can abut against the reagent housing edge 436 and prevent further rotational movement in one direction. The notch 548 can prevent further clockwise rotation of the slide lock 530 about the hinge pin 522. 40B, the notch 548 can allow counterclockwise rotation of the slide lock 530 about the hinge pin 522 until it abuts the housing edge 436. The notch 548 of the slide lock 530 can abut the reagent housing edge 436 along its face. Contact between the notch 548 of the slide lock 530 and the reagent housing 410 can limit further rotation of the hinge plate 552 in a clockwise direction as viewed from the perspective of FIGS. 40A and 40B.

[0169] The hinge pin 522 provides an axis of rotation for the rotational movement of the hinge plate 552 and slide lock 530. In the tube insertion configuration, all other translational and rotational movements may be prevented or limited. The hinge plate 552 and slide lock 530 may have one degree of freedom of rotational movement in the tube insertion configuration. For example, as shown in FIG. 40A , the hinge plate 552 and slide lock 530 of the hinge assembly 500 may rotate in a counterclockwise direction. When rotated in the counterclockwise direction, the slide lock 530 may have an additional degree of freedom to allow sliding.

[0170] FIG. 40C shows a top view of the hinge plate 552 in the tube insertion configuration. As in FIGS. 40A and 40B, the hinge plate 552 is rotated toward the reagent housing 410 (out of the first portion 442 of the sample tube holder 408). A large recess 572 in the hinge plate 552 provides clearance for insertion of the sample tube 102 into the sample tube holder 408 along the vertical axis of the upper opening 444 in the first portion 442. As shown in FIG. 40C, the large recess 572 is laterally offset from the upper opening 444 of the sample tube holder 408 when viewed from the top of the hinge assembly 500. The distance of the lateral offset can be a distance that allows a user to insert the sample tube 102 into the sample tube holder 408 without interference from or contact with the hinge plate 552.

[0171] Actuation of the hinge assembly 500 according to the present disclosure involves moving the hinge plate 552 from a tube insertion configuration, as shown in FIGS. 40A-40D, to a second configuration, illustrated in FIGS. 41A and 41B and referred to herein as the "tube retention configuration." FIG. 41A is a side view of the hinge assembly 500 after actuation. FIG. 41B is a top view of the sample tube 102 and sample tube holder 408 after the hinge assembly 500 has been actuated to move from the tube insertion configuration to the tube retention configuration. As described herein, the hinge plate 552 is coupled to two slide locks 530 via fasteners 566. The hinge plate 552 and one or more slide locks 530 rotate as a unitary structure about the hinge pin 522. The hinge plate 552 and one or more slide locks 530 slide as a unitary structure about the hinge pin 522. The hinge plate 552 and one or more slide locks 530 are capable of pivoting and sliding relative to the stationary hinge support 502. The following description describes the hinge assembly 500 in the tube retention configuration.

[0172] In this non-limiting embodiment, the hinge plate 552 in the tube retention configuration is positioned in a horizontal or substantially horizontal orientation as shown in FIG. 41A . The hinge plate 552 and slide lock 530 can be rotated counterclockwise from the perspective of FIG. 40A . The hinge plate 552 and slide lock 530 can be rotated from an oblique orientation to a nearly horizontal orientation. As the hinge plate 552 and slide lock 530 rotate, the flange 550 rotates from abutting against the wall 576 of the lower opening 516 to a position completely within the lower opening 516, with the flange 550 positioned between the front face 504 and the rear face 506 of the hinge support 502. As the hinge plate 552 and slide lock 530 rotate, the flange 550 rotates inward toward the rear face 506. The hinge plate 552 and slide lock 530 can be rotated until the flange 550 is vertical or nearly vertical. Hinge plate 552 and slide lock 530 can be rotated until flange 550 abuts the rear portion of lower opening 516. Hinge plate 552 and slide lock 530 can be rotated until flange 550 aligns with channel 518. In these exemplary implementations, contact between flange 550 and the rear portion of lower opening 516 limits further counterclockwise rotation of hinge plate 552 and slide lock 530.

[0173] In this non-limiting embodiment, the hinge plate 552 and slide lock 530 slide along the hinge pin 522. The spring 524 applies a force to the slide lock 530 and, therefore, to the hinge plate 552 coupled thereto. The spring 524 biases the slide lock 530 in a first direction. The spring 524 biases the slide lock 530 to move in the first direction within the lower opening 516 toward the channel 518. See FIG. 30A . The flange 550 slides within the channel 518 under the influence of the spring 524. The hinge plate 552 is positioned in a horizontal or substantially horizontal orientation when the flange 550 slides within the channel 518. The hinge plate 552 and slide lock 530 can slide until the slide lock 530 contacts the side of the upper opening 514. In these exemplary implementations, contact between slide lock 530 and upper opening 514 limits further sliding of slide lock 530 relative to hinge support 502, and therefore limits further sliding of hinge plate 552 (coupled to slide lock 530) relative to hinge support 502. Upon completion of this pivoting and sliding movement of slide lock 530 and hinge plate 552, hinge plate 552 is in the tube retention configuration shown in FIG.

[0174] When in the tube-holding configuration, the hinge plate 552 holds the sample tube 102 in the sample tube holder 408. Compared to FIG. 40B, the hinge plate 552 is pivoted and slid. The plurality of small recesses 570 in the hinge plate 552 vertically align with the sample tube 102. In some embodiments, the plurality of small recesses 570 in the hinge plate 552 overlie a portion of the sample tube 102 or its cap 172. In some embodiments, the hinge plate 552 is vertically offset from the top surface of the cap 172 of the sample tube 102. In some embodiments, the hinge plate 552 has a small vertical clearance between the hinge plate 552 and the top surface of the cap 172 of the sample tube 102.

[0175] The recess 570 in the hinge plate 552 can be a recess or notch that allows access to the contents of the sample tube 102. In the tube-holding configuration, the recess 570 allows access to a central region or area C of the top of the sample tube 102. In some embodiments, the central region or area C of the top of the sample tube 102 can include a foil cover. In some embodiments, the central region or area C of the top of the sample tube 102 can include a membrane configured to be pierced. In the tube-holding configuration, the recess 570 can be shaped similarly to the outer rim or edge of the cap 172. The recess 570 can simultaneously hold multiple sample tubes 102 in the sample tube holder 408. The recesses 570 can simultaneously apply a vertical holding force to each other when the sample tubes are lifted during a pipetting operation.

[0176] In embodiments of the present disclosure, an actuation force pivots the hinge plate 552 to move the hinge assembly 500 from the tube insertion configuration to the tube retention configuration. In some embodiments, the same actuation force pivots the hinge plate 552 to move the hinge assembly 500 from the tube retention configuration to the tube insertion configuration. In other embodiments, a second, different actuation force can move the hinge assembly 500 from the tube insertion configuration to the tube retention configuration.

[0177] In some embodiments, to move the hinge assembly 500 from the tube insertion configuration to the tube retention configuration, a user applies an actuation force to a portion of the hinge assembly 500 to pivot the hinge plate 552 relative to the hinge support 502. In some embodiments, with the user pivoting the hinge plate 552, the actuation force of the spring 524 slides the hinge plate 552 in a translational direction (right / left as viewed in FIGS. 30A-30B ). In some embodiments, to move the hinge assembly 500 from the tube retention configuration to the tube insertion configuration, a user applies an actuation force to a portion of the hinge assembly 500. In some embodiments, a user applies a force to rotate the hinge plate 552. In some embodiments, a user applies a force to translate the hinge plate 552. In some embodiments, a user can exert a downward force on the hinge plate 552 to rotate it. In some embodiments, once the user has pivoted the hinge plate 552, the actuation force of the spring 524 causes the hinge plate 552 to slide in a translational direction.

[0178] 41A and described in detail below, a structural feature in the receiving compartment that receives the rack 400 exerts an actuation force on the self-locking tab 480 to move the hinge assembly 500 from the tube insertion configuration to the tube retention configuration. The structural feature can maintain this actuation force, thus locking the hinge plate 552 in the tube retention configuration.

[0179] It will be appreciated that an actuation force can be applied to any portion of the self-locking tab 480 to pivot the hinge assembly 500. For example, the first portion 482, the second portion 484, the third portion 486, or the fourth portion 488 can be pushed upward to move the self-locking tab 480 into engagement with the hinge plate 552. The fourth portion 488 can be planar or substantially planar. In this non-limiting embodiment, the fourth portion 488 is horizontal. In some embodiments, an actuation force is applied to the fourth portion 488 of the self-locking tab 480 to pivot the hinge assembly 500. The self-locking tab 480 can be actuated to switch the position of the hinge assembly 500. From the perspective of FIGS. 40A and 41A , the hinge plate 552 is actuated to rotate it counterclockwise. The second portion 484 of the hinge plate 552 can be a lever arm that allows the hinge plate 552 to rotate.

[0180] An embodiment of the hinge assembly 500 can be actuated to move from the tube insertion configuration to the tube retention configuration by a divider 250 in the receiving compartment that receives the rack 400. See FIG. 18 . The divider 250 can include a surface, wall, shelf, enclosure, or any other suitable structure shaped, sized, and positioned in the receiving compartment to activate the self-locking tab 480 when the rack 400 is inserted into the receiving compartment. In the illustrated example, the divider 250 can include one or more shelves or stepped surfaces. For example, in one non-limiting example, the divider 250 can include one or more pegs, rods, or bars positioned in the receiving compartment to interact with the hinge assembly 500 when the rack 400 is inserted into the receiving compartment. The divider 250 is shaped and sized to divide the receiving compartment into two sections: a first section and a second section. When the rack 400 is received in the receiving compartment, the reagent housing 410 is positioned in the first area and the sample tube holder 408 is positioned in the second area. The divider 250 is positioned between the reagent housing 410 and the sample tube holder 408 when the rack 400 is positioned in the receiving compartment.

[0181] The divider 250 acts against the self-locking tab 480 when the rack 400 is inserted into the receiving compartment. The divider 250 contacts the fourth portion 488 of the self-locking tab 480. The divider 250 applies an upward force to the fourth portion 488 of the self-locking tab 480. In this case, the interaction between the divider 250 and the fourth portion 488 causes the self-locking tab 480 to slide upward. The self-locking tab 480 contacts the flange 568 of the hinge plate 552. See FIGS. 35 and 40C. The rear surface 556 of the hinge plate 552 may include the flange 568. The flange 568 may extend outward from the shaped front surface 554. In use, the flange 568 extends over the self-locking tab 480 when the rack 400 is assembled.

[0182] The flange 568 can be actuated to pivot the hinge plate 552. The self-locking tab 480 is pushed upward by the partition 250. The self-locking tab 480 slides against the fastener 414 inserted into its opening 490. The second surface 484 of the self-locking tab 480 forms an oblique angle. See FIG. 38 . When the self-locking tab 480 moves upward, the upward edge of the second surface 484 contacts the flange 568. The upward edge of the second surface 484 is positioned near the interface between the second surface 484 and the first surface 482. The upward edge of the second surface 484 is spaced apart from the third surface 486. The upward edge of the second surface 484 faces the rear edge of the flange 568 to provide more leverage for pivoting the hinge plate 552.

[0183] 18 , the diagnostic device 300 includes a receiving compartment 301 configured to receive the rack 400 or a portion thereof. In this example, the receiving compartment 301 includes a first portion 303 configured to receive the reagent housing 410 of the rack 400. The receiving compartment 301 may include a second portion 304 separate from and adjacent to the first portion 303. The second portion 304 may include an open volume, well, or compartment separate from and adjacent to the first portion 303. The rack 400 may be designed to allow it to be easily inserted into and removed from the diagnostic device 300; for example, the reagent housing 410 may be inserted into the first portion 303 of the receiving compartment 301, and the sample tube holder 408 may be inserted into the second portion 304 of the receiving compartment 301. The receiving compartment 301 may include a divider 250. The divider 250 is positioned between the first portion 303 of the receiving compartment 301 and the second portion 304 of the receiving compartment 301. The divider 250 is stationary within the receiving compartment 301 and may, for example, be an integral wall portion of the receiving compartment 301. The rack 400 interacts with the divider 250 when it is lowered into the receiving compartment 301 of the diagnostic equipment 300. The divider 250 actuates the self-locking tab 480 by providing a stop that pushes the self-locking tab 480 upward. This upwardly moving self-locking tab 480 acts against the hinge plate 552 of the hinge assembly 500.

[0184] The self-locking tabs 480 rotate the hinge plate 552 about the hinge support 502. Upon rotation, the springs 524 slide the hinge plate 552, transitioning the hinge assembly 500 from the tube insertion configuration to the tube retention configuration. In some embodiments, the self-locking tabs 480 pivot the hinge plate 552 to move the hinge assembly 500 from the tube insertion configuration to the tube retention configuration. In some embodiments, a user pivots the hinge plate 552 to move the hinge assembly 500 from the tube insertion configuration to the tube retention configuration prior to insertion into the receiving compartment. In some embodiments, the self-locking tabs 480 or a user imparts this pivoting motion to facilitate transition of the hinge assembly 500 from the tube insertion configuration to the tube retention configuration.

[0185] In some embodiments, a spring 524 slides the hinge plate 552 to facilitate transition of the hinge assembly 500 from the tube insertion configuration to the tube retention configuration. The spring 524 can provide a biasing force to slide the hinge plate 552. In some embodiments, the spring 524 slides the hinge plate 552 after the self-locking tab 480 or a user provides a pivoting motion. In some embodiments, a user pivots and slides the hinge plate 552 to move the hinge assembly 500 from the tube insertion configuration to the tube retention configuration.

[0186] While the rack 400 is within the receiving compartment, the self-locking tabs 480 are pushed upward by the divider 250. The self-locking tabs 480 limit or prevent the hinge plate 552 from pivoting to the tube insertion configuration while the rack 400 is received in the receiving compartment. The self-locking tabs 480 ensure that the hinge assembly 500 is in the tube retention configuration when within the receiving compartment. The self-locking tabs 480 ensure that the hinge plate 552 is always horizontal or near-horizontal when placed in the diagnostic device 300. FIG. 17 illustrates an embodiment of a diagnostic device 300. The diagnostic device 300 can be configured to activate the self-locking tabs 480 as described herein. In the tube retention configuration, the hinge plate 552 can limit vertical movement of the sample tube 102 if the sample tube 102 is lifted during a pipetting operation.

[0187] A user can remove rack 400 from the receiving compartment of diagnostic device 300. Once rack 400 is extracted from the receiving compartment, self-locking tab 480 no longer interacts with divider 250 and can slide downward under the influence of gravity. Second portion 484 of self-locking tab 480 can move downward and away from flange 568. A user can move hinge assembly 500 from the tube retention configuration to the tube insertion configuration when rack 400 is extracted from the receiving compartment. In this case, in some embodiments, a user pivots hinge plate 552 to move hinge assembly 500 from the tube retention configuration to the tube insertion configuration. The force of spring 524 is overcome to move hinge assembly 500 from the tube retention configuration to the tube insertion configuration. In some embodiments, a user provides both sliding and pivoting actuation forces to transition from the tube retention configuration to the tube insertion configuration. A user can apply a sliding force to the hinge plate 552 to move the hinge assembly 500 from the tube-holding configuration to the tube-insertion configuration, and then apply an upward or clockwise force. A side surface 558 of the hinge plate 552 near the right side can be laterally offset from the nearest sample tube 102 in the tube-holding configuration to facilitate gripping. It will be appreciated that an actuation force can be applied to any portion of the hinge plate 552 or any portion of the slide lock 530 when sliding or pivoting the hinge assembly 500. The hinge plate 552 can be gripped near the side surface 558.

[0188] When the rack 400 is extracted from the receiving compartment after being loaded with sample tubes 102, a user can move the hinge assembly 500 from the tube insertion configuration to the tube holding configuration. In this case, in some embodiments, a user slides the hinge plate 552 to move the hinge assembly 500 from the tube holding configuration to the tube insertion configuration. In some embodiments, to move the hinge assembly 500 from the tube holding configuration to the tube insertion configuration, a user pivots the hinge plate 552, and the spring 524 slides the hinge plate 552. In some embodiments, only the pivot actuation force is applied when transitioning from the tube insertion configuration to the tube holding configuration. A user can apply a downward force or a counterclockwise force to the hinge plate 552 to transition the hinge assembly 500. Alternatively or additionally, a self-locking tab 480 can move the hinge assembly 500 from the tube insertion configuration to the tube holding configuration.

[0189] The hinge assembly 500 has advantages over other alternative systems designed to hold sample tubes 102 in sample tube holders during pipetting operations. Advantageously, embodiments of the present disclosure securely hold sample tubes 102 in the sample tube holders, reducing the number of tubes that experience substantial vertical lift. Embodiments of the rack 400 including the hinge assembly 500 according to the present disclosure securely hold sample tubes 102 during instrument workflow. The upper opening 444 of the sample tube holder 408 can restrain the sample tubes 102 from moving horizontally. In some cases, the hinge assembly 500, and particularly the hinge plate 552, can restrain the sample tubes 102 from moving substantially vertically. The sample tubes may have slight vertical movement due to clearance between the cap 172 and the hinge plate 552.

[0190] The divider 250 can lock the hinge plate 552 in the tube-retaining configuration, thereby locking the sample tube 102 in place and limiting vertical lifting of the sample tube 102. The divider 250 and self-locking tab 480 interact to apply a pivoting force to the hinge plate 552. The pivoting force of the self-locking tab 480, in combination with the biasing force of the spring 524, can transition the hinge plate 552 from the tube-insertion configuration to the tube-retaining configuration. In some embodiments, insertion of the rack 400 into the receiving compartment ensures that the self-locking tab 480 is actuated. Advantageously, the shape, size, and position of the hinge assembly 500 can be adjusted to adjust the maximum retention force required to retain the sample tube 102.

[0191] Advantageously, embodiments of the present disclosure can reliably and consistently hold sample tubes 102 in one motion. The hinge plate 552 of the hinge assembly 500 is pivoted by the actuation force of the partition 250 when the partition 250 contacts the self-locking tab 480. In some embodiments, pulling the rack 400 down relative to the partition 250 is a motion that slides the self-locking tab 480, thus pivoting the hinge plate 552. The partition 250 applies an upward force to the self-locking tab 480, thus pivoting the hinge plate 552. In the pivoted state, the biasing force of the spring 524 slides the hinge plate 552. As the hinge plate 552 slides, the small recess 570, instead of the large recess 572, overlies each sample tube 102.

[0192] The small recesses 570 in the hinge plate 552 can contact or be spaced a small vertical distance from multiple sample tubes 102 in the tube-holding configuration. The hinge plate 552 can simultaneously restrain all of the sample tubes 102 within the sample tube holder 408. The unitary structure of the hinge plate 552 allows for a consistent force to be applied to each sample tube 102. Furthermore, the pivoting motion of the hinge plate 552 is repeatable such that the same actuation force results in the same pivoting motion of the hinge plate 552. Advantageously, the hinge plate 552 is easily moved between configurations for easy loading and unloading of batches of sample tubes during a series of diagnostic tests performed sequentially using the same rack, thereby minimizing user error and the time required to load and unload the rack, and increasing pipetting efficiency.

[0193] In some embodiments, the hinge assembly 500 allows some vertical movement of the sample tubes 102 within the sample tube holder 408 in the tube-holding configuration. In some embodiments, one or more sample tubes may lift vertically a small distance during a pipetting operation, but the presence of the hinge plate 552 prevents the sample tubes from moving vertically to an extent that would affect the performance of the pipetting system. In some embodiments, the hinge assembly 500 contacts the sample tubes 102, for example, contacting the caps 172 of the sample tubes 102 via the small recesses 570. In some embodiments, the hinge assembly 500 only covers the caps 172 of the sample tubes 102 via the small recesses 570. In some embodiments, the hinge assembly 500 prevents substantially all vertical movement of the sample tubes 102 within the sample tube holder 408 in the tube-holding configuration. In some embodiments, the hinge plate 552 is positioned vertically above a portion of the sample tubes 102. In some embodiments, hinge assembly 500, and in particular recess 570, covers a portion of the circumference of cap 172 of sample tube 102 without blocking area C of cap 172 against the pipette tip. Embodiments of hinge assemblies according to the present disclosure include additional advantages. Hinge assembly 500 can be used with any design of sample tube 102. Hinge assembly 500 can be used with any design of cap 172.

[0194] Advantageously, the hinge plate 552 can prevent or limit vertical movement of the sample tube 102 within the sample tube holder 408 in the tube holding configuration. The hinge plate 552 can prevent or limit vertical lifting of the sample tube 102 when the contents of the sample tube 102 are accessed by a liquid dispenser. The hinge plate 552 can prevent or limit vertical movement of the sample tube 102 within the sample tube holder 408 during fluid processing operations. The hinge plate 552 can prevent or limit vertical lifting of the sample tube 102 by a pipette tip. Pipetting operations can be performed within the diagnostic device 300. While within the diagnostic device 300, the hinge assembly 500 is in the tube holding configuration.

[0195] The hinge assembly 500 may include several advantages. The hinge assembly 500 may be easy and intuitive to use. The hinge assembly 500 may be automatically activated, such as by the simple action of inserting the rack 400 into the diagnostic device 300 described herein. Using the hinge assembly 500 may be a simple self-learning process. The hinge support 502 may tension the reagent housing 410 or a portion thereof along the front surface of the reagent housing 410. The hinge assembly may be easily activated by the user, or in some embodiments, may be activated by a self-locking tab 480.

[0196] The hinge assembly 500 can lock the sample tubes 102 in place when the rack 400 is placed in the diagnostic instrument 300. The self-locking tabs 480 are a locking mechanism that locks the hinge plate 552 in a position that retains the sample tubes 102 within the rack 400. The hinge assembly 500 can facilitate complete retention of the sample tubes 102 within the sample tube holder 408. The hinge assembly 500 can act as a cover over each sample tube 102. In the illustrated embodiment, all of the sample tubes 102 within the sample tube holder 408 are restrained under one physical part, the hinge plate 552.

[0197] Advantageously, the disclosed embodiments of the present invention reliably and consistently unlock the sample tubes with a single motion. The hinge plate 552 of the hinge assembly 500 can be held in place by the partition 250 of the receiving compartment that receives the rack 400. To relieve force on the partition 250, the rack 400 can be lifted relative to the partition 250. The self-locking tab 480 can slide vertically away from the hinge plate 552. A user can apply a pivoting or downward force to the hinge plate 552. When the hinge plate 552 is pivoted, it can slide relative to the hinge support 502. Before lowering the rack 400 into the diagnostic instrument 300 or after removing the rack 400 from the diagnostic instrument 300, a user can freely pivot and slide the hinge assembly 500 to the tube insertion configuration.

[0198] In the tube insertion configuration, the hinge plate 552 pivots upwardly away from the sample tube holder 408. The large recess 572 overlies the upper opening 444 of the sample tube holder 408. The sample tubes 102 can be easily inserted without interference from the hinge plate 552. A first sample tube 102 can be easily unloaded from the sample tube holder 408, and then a second sample tube 102 can be loaded. The hinge assembly 500 does not interfere with tube loading and unloading. Advantageously, the hinge assembly 500 allows a user to easily load and unload sample tubes 102 into and out of the rack 400.

[0199] Hinge assembly 500 can be backward compatible so that racks without hinge assembly 500 can be advantageously retrofitted to include hinge assembly 500. In some embodiments, the sample tube holder of the rack being retrofitted can be removed from the reagent housing. As described herein, the sample tube holder is configured to couple and uncouple with the reagent housing through one or more fasteners 412. Openings in the sample tube holder are configured to align with a first set of openings in the reagent housing. Any suitable fasteners 412 can extend through the sample tube holder and the reagent housing to couple the sample tube holder to the reagent housing. The one or more fasteners 412 can decouple the sample tube holder from the reagent housing. Any conventional hinge assembly or retaining member can be removed from the rack being retrofitted. In some embodiments, the sample tube holder remains in place during retrofitting. In some embodiments, the sample tube holder does not need to be decoupled from the reagent housing during the process of providing the hinge assembly to the rack.

[0200] The hinge support 502 has one or more openings 510 configured to receive the fasteners 414. The one or more openings 510 extend from the front surface 504 to the rear surface 506. Although three openings 510 are shown, the hinge support 502 can include any number of openings 510. The openings 510 are configured to align with a second set of openings in the reagent housing to be converted. When the fasteners 414 extend through the corresponding openings, the hinge support 502 of the hinge assembly 500 is rigidly coupled to the reagent housing to be converted.

[0201] The central fastener 414 can be coupled to the self-locking tab 480. When the fastener 414 extends through the hinge assembly 500, the self-locking tab 480, and a corresponding opening in the reagent housing to be converted, the self-locking tab 480 can slide relative to the reagent housing. The opening 490 is sized larger than the corresponding fastener 414. The opening 490 allows the self-locking tab 480 to slide vertically relative to the reagent housing. The opening 490 can be any shape that allows vertical movement when the self-locking tab 480 is coupled to the reagent housing. In embodiments where the sample tube holder is removed for installation of the hinge assembly 500, the sample tube holder can be coupled to the reagent housing. In some embodiments, the hinge assembly 500 is installed without disconnecting the sample tube holder from the reagent housing. In some embodiments, a kit for converting the rack is provided. The kit can include the hinge assembly 500. The kit can include the self-locking tab 480. The kit can include a fastener 412 for coupling the sample tube holder to the reagent housing. The kit can include a fastener 414 for coupling the hinge assembly to the reagent housing. The kit can include a tool, such as a tool for turning the fastener. In some embodiments, the kit can include a 1 / 16 hex screwdriver. In some embodiments, the kit can include a 1 / 16 hex I key wrench. In some embodiments, the kit can include a threadlocker adhesive. In some embodiments, the kit can include Loctite® 242. The kit can include any additional components described herein.

[0202] The hinge assembly 500 can be directly installed into the rack 400, such as by fastening the fasteners 412, 414 as described herein. The hinge assembly 500 and self-locking tabs 480 can be easily installed between the sample tube holder 408 and the reagent housing 410. The hinge assembly 500 can be easily introduced into a manufacturing supply chain or can be installed by a user at the point of use of the rack. The sample tube holder 408, hinge assembly 500, self-locking tabs 480, and reagent housing 410 can form a unitary structure that can be inserted into and removed from the receiving compartment in a single fluid motion.

[0203] The rack 400 can be designed to allow it to be easily inserted and removed from the diagnostic instrument 300 shown in FIGS. 17 and 18 . The reagent housing 410 can include one or more alignment members 430 to facilitate positioning of the rack 400. The alignment members 430 can ensure that the rack 400 is inserted in the proper orientation to be actuated by the partition 250. It is desirable that the rack 400 be properly positioned within the diagnostic instrument 300 and that subsequent movement be limited so as not to impair movement of the liquid dispensers during liquid handling operations. In some embodiments, the rack 400 or the diagnostic instrument 300 can include a sensor configured to indicate proper placement of the rack 400 within the diagnostic instrument 300.

[0204] It will be apparent that the embodiments of the hinge assemblies of the present disclosure can be actuated in many different ways. For example, in one non-limiting embodiment, the dividers 250 are stationary and the rack 400 interacts with the dividers 250 as it is lowered into the diagnostic instrument 300, thereby actuating the hinge assemblies 500. The dividers 250 are shaped and sized to contact the self-locking tabs 480 when the rack 100 is placed into the diagnostic instrument 300. Advantageously, the sample tubes 102 are horizontally constrained within the rack 400 by at least the upper openings 444 of the sample tube holders 408 and vertically constrained by at least the hinge assemblies 500.

[0205] The rack 400 can be designed to allow it to be easily removed and reinserted into and out of the diagnostic instrument 300. After removal from the diagnostic instrument 300, the dividers 250 no longer exert force against the self-locking tabs 480. The hinge plate 552 can remain in the tube-retaining configuration until actuated by a user. A user can pivot and / or slide the hinge plate 552 to easily remove one or more sample tubes 102 by sliding one or more sample tubes 102 vertically upward. New sample tubes 102 can be easily inserted by sliding one or more sample tubes 102 vertically downward. The rack 400 can be reinserted into the diagnostic instrument 300. An insertion actuation can actuate the hinge assembly 500 to retain a new set of sample tubes 102. Actuation of the self-locking tabs 480 can be automatic and requires no further action by the user. The act of engaging the self-locking tabs 480 with the dividers 250 may be the same act as inserting the rack 400 into the diagnostic device 300 .

[0206] It will be appreciated that embodiments of the rack 400 can be received in a receiving compartment that does not include dividers 250. In such cases, the hinge assembly 500 can be transitioned from the tube insertion configuration to the tube retention configuration by actuation of the hinge plates 552 by a user. In some embodiments, the user transitions the hinge plates 552 from the tube insertion configuration to the tube retention configuration regardless of the presence of the self-locking tabs 480. In some embodiments, the self-locking tabs 480 are an added protection to ensure that the hinge assembly 500 has been actuated into the tube retention configuration. In some embodiments, the hinge assembly 500 can be locked by either the user or the self-locking tabs 480. In some embodiments, the rack 400 can be loaded with one or more sample tubes 102 only before insertion into the diagnostic device 300, such as by using a receiving compartment having dividers 250. In some embodiments, the rack 400 can be loaded with one or more sample tubes 102 before and after insertion into the diagnostic device 300, such as by using a receiving compartment without dividers 250.

[0207] The hinge assembly 500 is a mechanical assembly that can slide and pivot for tube loading and unloading when outside the diagnostic device 300. In the tube insertion configuration, the hinge assembly has a stable state that locks into this open or loadable configuration. The hinge assembly 500 is a mechanical assembly that can slide and pivot for tube retention when outside or inside the diagnostic device 300. In the tube retention configuration, the hinge assembly has a stable state that locks into this closed configuration. The hinge assembly 500 utilizes springs and self-closing components to ensure that the hinge assembly 500 is in a closed state when placed within the diagnostic device 300. The sample tube 102 is vertically constrained by covering a minimal area of ​​the top of its cap 172. In some embodiments, the hinge plate 552 of the hinge assembly 500 in the tube retention configuration does not contact the top of the tube 102. The tube retention configuration allows for pipetting operations while preventing escape of the sample tube 102. The hinge assembly 500 can be thought of as a spring-locked tube restraint. The hinge assembly 500 is suitable for sample collection and transport. The hinge assembly 500 is related to mechanics and automation.

[0208] The hinge assembly 500 is the mechanism that applies the vertical restraint. The hinge assembly 500 can replace other designs that include a series of spring fingers as described herein. The hinge assembly 500 has two states when outside the diagnostic device 300: a tube retention configuration in which the sample tubes 102 are secured and cannot escape from the rack 400, and a tube insertion configuration in which the user can insert and / or remove sample tubes 102 from the rack 400. In some embodiments, the hinge assembly 500 only has two possible states when outside the diagnostic device. In some embodiments, the hinge assembly 500 can only be actuated in the tube retention configuration when inside the diagnostic device 300. In some embodiments, the hinge assembly 500 transitions to the tube retention configuration when inserted into the diagnostic device 300.

[0209] The hinge assembly 500 operates by using two springs 524 that allow the slide lock 530, and therefore the hinge plate 552, to slide back and forth along the hinge pin 522 within the hinge support 502. In the tube retention configuration, the slide lock 530 prevents the hinge plate 552 from rotating. The flange 550 of the slide lock 530 is within the channel 518. The channel 518 prevents or limits the rotation of the flange 550 of the slide lock 530, thereby preventing or limiting the rotation of the hinge plate 552 attached to the slide lock 530. In the tube retention configuration, the self-locking tab 480 can be actuated to push the flange 568 upward, for example, when the rack 400 is within the diagnostic instrument 300. In the tube retention configuration, the self-locking tab 480 cannot be actuated when the rack 400 is outside the diagnostic instrument 300, for example. Self-locking tabs 480 are a self-closing mechanism incorporated into this design to ensure that hinge assembly 500 is always in a tube-retaining configuration when placed in diagnostic device 300 .

[0210] In the tube insertion configuration, the slide lock 530 is slid relative to the channel 518. The flange 550 of the slide lock 530 is first positioned within the lower opening 516. The flange 550 of the slide lock 530 is then pivoted outward from the lower opening 516. The slide lock 530 is pivoted relative to the hinge support 502, which causes the hinge plate 552 attached to the slide lock 530 to pivot relative to the hinge support 502. As the spring 524 and slide lock 530 slide so that the flange 550 aligns with the opening in the surface 504, the flange 550 rotates out of the lower opening 516, thereby rotating the hinge plate 552.

[0211] The hinge assembly 500 has advantages over spring finger designs that hold sample tubes in place through contact friction. The spring constants used to create the contact friction have variable spring constants and can easily be compromised, resulting in the escape of the sample tubes 102. The hinge assembly 500 does not rely on friction and springs to restrain the tubes. In the tube retention configuration, the sample tubes 102 do not have a clear path to exit the hinge assembly 500. The sample tubes 102 have a positive stop that prevents them from escaping through interaction with the hinge plate 552. Similarly, the hinge assembly 500 makes it easy for the user to load and remove tubes. When the hinge assembly 500 is in the tube insertion configuration, the user has two hands free to insert and remove sample tubes 102. In some limited circumstances, the rack can be inverted, allowing the sample tubes 102 to be discarded all at once from the rack 400. In some embodiments, rather than requiring 12 individual force applications by the user to load or unload 12 sample tubes 102, only one force application from the user is required.

[0212] The hinge assembly 500 can prevent or limit vertical movement of the sample tube 102. The hinge assembly 500 can prevent or limit escape of the sample tube 102 from the sample tube holder 408. The hinge assembly 500 can prevent or limit escape of the sample tube 102 from the rack 400 during instrument workflow. An escape of a sample tube would disrupt operation and require user intervention.

[0213] The hinge assembly 500 may use a spring for movement. The hinge assembly 500 does not use a motor for movement. The hinge assembly 500 uses only a small area to constrain the sample tube 102. The hinge assembly 500 is used to constrain the tube. The hinge assembly 500 uses a spring for sliding movement to open and close. The hinge assembly 500 uses a sliding hinge plate 552 for tube constraining.

[0214] The hinge plates 552 of the hinge assembly 500 are pivoted by an actuation force. In some embodiments, self-locking tabs 480 are the mechanism that pivots the hinge plates 552, thereby locking the sample tubes 102. The hinge plates 552 can be in a tube insertion configuration so that the sample tubes 102 can be easily loaded into the sample tube holder 408 prior to utilization of the self-locking tabs 480. When in the tube retention configuration, the hinge plates 552 consistently provide vertical restraint for multiple sample tubes 102 so that all of the sample tubes 102 can be simultaneously restrained within the sample tube holder 408. The unitary construction of the hinge plates 552 allows for consistent force application to each sample tube 102. Furthermore, the pivoting motion of the hinge plates 552 is repeatable so that the same actuation force results in the same pivoting and / or sliding motion of the hinge plates 552. Advantageously, the hinge plate 552 is easily moved between configurations for easy loading and unloading of batches of sample tubes 102 during a series of diagnostic tests performed sequentially using the same rack 400, thereby minimizing user error and the time it takes to load and unload the rack, and increasing pipetting efficiency.

[0215] The foregoing description is intended to illustrate various aspects of the present invention. The examples presented herein are not intended to limit the scope of the invention. Now that the technology of the present invention has been fully described, it will be apparent to those skilled in the art that many changes and modifications can be made thereto without departing from the spirit or scope of the appended claims.

Claims

1. 1. A device for holding sample tubes, comprising: a sample tube holder including an opening configured to receive a sample tube; a hinge assembly having a hinge plate and a hinge support, the hinge plate configured for sliding and pivoting movement relative to the hinge support between a first configuration and a second configuration, the hinge plate positioned to allow insertion of the sample tube at the opening in the first configuration, and the hinge plate positioned to limit vertical movement of the sample tube within the sample tube holder in the second configuration; An apparatus comprising:

2. The apparatus of claim 1 further comprising a slide lock coupled to the hinge plate.

3. the slide lock is configured to slide and pivot relative to a hinge pin; the hinge pin is coupled to the hinge support; 3. The apparatus of claim 2.

4. The apparatus of claim 2 , further comprising a spring configured to bias the slide lock against an inner surface of the hinge support.

5. The device of claim 1 further comprising a reagent housing.

6. The device of claim 5 , wherein the sample tube holder and the reagent housing are coupled.

7. The device of claim 5 , wherein the hinge support and the reagent housing are coupled.

8. The apparatus of claim 1 , wherein the sample tube holder comprises a plurality of openings configured to receive a plurality of sample tubes.

9. The apparatus of claim 1 , wherein the sample tube holder comprises two openings configured to receive the sample tubes.

10. The apparatus of claim 1 , wherein the opening horizontally restrains the sample tube when the sample tube is received in the sample tube holder.

11. The apparatus of claim 1 , wherein the hinge plate is configured to limit vertical movement of the sample tube within the sample tube holder.

12. the hinge plate includes a small recess along an edge of the hinge plate; the small recess is configured to overlie the cap of the sample tube; 10. The apparatus of claim 1.

13. the hinge plate includes a large recess along an edge of the hinge plate; the large recess is configured to allow a sample tube to be removed from or inserted into the sample tube holder; 10. The apparatus of claim 1.

14. The apparatus of claim 1 further comprising the sample tube.

15. The device of claim 1 , further comprising a self-locking tab positioned relative to the hinge plate.

16. inserting a sample tube into an opening in a sample tube holder; pivoting the hinge plate relative to the hinge support; sliding the hinge plate relative to the hinge support in a pivoted manner, the hinge plate being configured to limit vertical movement of the sample tube within the sample tube holder; A method having the following.

17. The method of claim 16, wherein the hinge plates slide under the biasing force of a spring.

18. an upper surface of the hinge plate is rotated away from a vertical axis of the sample tube when the sample tube is inserted; the hinge plate is pivoted to be approximately perpendicular to the vertical axis of the sample tube; 17. The method of claim 16.

19. 17. The method of claim 16, further comprising inserting a pipette tip into the sample tube when the sample tube is in the sample tube holder and the hinge plate pivots and slides.

20. 17. The method of claim 16, further comprising ejecting a pipette tip from the sample tube when the sample tube is in the sample tube holder and the hinge plate pivots and slides.

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