Assay cartridge for molecular diagnostics

Abstract

This application provides a test kit for use in a PCR-based molecular diagnostic device. In one embodiment, the test kit includes: (1) an elongated body having a proximal end, a distal end, and a plurality of compartments arranged between the proximal and distal ends, the plurality of compartments including at least a first pipette tip holder near the proximal end and a second pipette tip holder near the distal end; and (2) a sealing assembly covering the elongated body, including a rigid frame and an elastic top, the rigid frame mating with the top periphery of the elongated body, the elastic top being mounted on the rigid frame, the elastic top including a first sub-part near the proximal end and a second sub-part near the distal end, the first sub-part including a first annular structure mating with the first pipette tip holder, and the second sub-part including a second annular structure mating with the second pipette tip holder.

Description

Technical Field

[0001] This application relates primarily to devices and systems for molecular diagnostics. Background Technology

[0002] Many nucleic acid sequences have been used to diagnose and monitor diseases, detect risks, and determine which treatment is best suited for an individual patient. For example, the presence of a nucleic acid sequence associated with an infectious organism can indicate infection with that organism. Alterations in nucleic acid sequences in a patient sample can indicate activation or inactivation of pathways associated with the disease or condition.

[0003] Detecting clinically relevant nucleic acid sequences in samples primarily involves isolating nucleic acids from the sample and amplifying specific nucleic acid sequences, followed by the detection of the amplified products. However, the complexity of the multi-step process for isolating nucleic acids limits processing flexibility and reduces reproducibility. For example, DNA and RNA have different chemical properties and stability, requiring different processing conditions for their preparation. Furthermore, samples from different source organisms may require different steps for nucleic acid isolation. For instance, isolating DNA from bacteria may require more stringent conditions (e.g., higher temperatures, higher detergent concentrations, etc.) compared to releasing DNA from relatively unstable mammalian cells. Therefore, an analytical system is needed that provides flexible and adjustable operability to meet the diverse needs of clinical diagnostics. Moreover, while amplification increases the sensitivity of the assay by providing sufficient copies of the specific nucleic acid sequence, it carries the risk of erroneous results due to contamination. Therefore, an analytical system is also needed that allows for minimal user involvement throughout the process, thereby reducing contamination. Summary of the Invention

[0004] Embodiments of this application relate to apparatus and systems for processing and analyzing samples used for molecular diagnostics. Embodiments of this application include a kit for use in an automated random access system, the kit being used to determine specific nucleic acid sequences in a sample.

[0005] In one aspect, this application provides a test kit for a molecular diagnostic device. In one embodiment, the test kit includes (1) an elongated body having a proximal end, a distal end, and a plurality of compartments disposed between the proximal end and the distal end, the plurality of compartments including at least a first pipette tip holder and a second pipette tip holder, wherein the first pipette tip holder is adjacent to the proximal end and the second pipette tip holder is adjacent to the distal end; and (2) a sealing assembly covering the elongated body, the sealing assembly including a rigid frame and a resilient top, the rigid frame being fitted to the top periphery of the elongated body, the resilient top being mounted on the rigid frame, the resilient top including a first sub-part and a second sub-part, the first sub-part being adjacent to the proximal end and including a first annular structure fitting to the first pipette tip holder, the second sub-part being adjacent to the distal end and including a second annular structure fitting to the second pipette tip holder.

[0006] In some embodiments, the plurality of compartments further include sample loading ports located near the proximal end. In some embodiments, the sample loading ports are removable from the elongated body.

[0007] In some embodiments, the plurality of compartments further include purification wells. In some embodiments, the purification wells include magnetic microparticles capable of binding to nucleic acids.

[0008] In some embodiments, the plurality of compartments includes at least one PCR reaction well located near the distal end. In some embodiments, the test kit further includes a sliding cap that movably covers the PCR reaction well.

[0009] In some embodiments, the elastic top is made of latex. In some embodiments, the first sub-portion and / or the second sub-portion of the elastic top has a circular corrugated structure.

[0010] In some embodiments, the sealing assembly includes an opening for loading a volatile reagent into a compartment of the elongated body. In some embodiments, the volatile reagent is isopropanol.

[0011] In some embodiments, the test kit may be loaded into a cartridge carrier. In some embodiments, the cartridge carrier includes a cavity configured to receive the test kit when it is loaded into the cartridge carrier. In some embodiments, the PCR reaction wells of the test kit are not loaded into the cavity. In some embodiments, the cartridge carrier includes a control component that controls the position of the test kit when it is inserted into the PCR-based molecular diagnostic device. In some embodiments, the control component includes: a control button; a circular plate connected to the control button via an axis, wherein the circular plate includes an eccentric arc groove; and a guide connected to the circular plate via a pin, wherein the pin is inserted into the eccentric arc groove.

[0012] These and other features, aspects and advantages of this application will be better understood by referring to the following description, the appended claims and the accompanying drawings. Attached Figure Description

[0013] Figure 1 A top perspective view of a test kit according to one embodiment of this application is shown.

[0014] Figure 2 A top perspective view of the body of a test kit according to one embodiment of this application is shown.

[0015] Figure 3 A bottom perspective view of a test kit according to one embodiment of this application is shown.

[0016] Figure 4 A perspective view of a sealing assembly separate from the body of a test kit according to one embodiment of this application is shown.

[0017] Figure 5A A top perspective view of a sliding cover according to one embodiment of this application is shown.

[0018] Figure 5B A bottom perspective view of a sliding cover according to one embodiment of this application is shown.

[0019] Figure 6A A top perspective view of a test kit loaded into a cartridge carrier according to one embodiment of this application is shown.

[0020] Figure 6B A top perspective view of a test kit loaded into a cartridge carrier according to one embodiment of this application is shown.

[0021] Figure 7A A perspective view of a cartridge carrier according to one embodiment of this application is shown.

[0022] Figure 7B A perspective view of a cartridge carrier according to one embodiment of this application is shown.

[0023] Figure 8 A perspective view of a cartridge carrier according to one embodiment of this application is shown, in which a test kit is loaded and control components are exposed.

[0024] Figure 9 An enlarged perspective view of the control components of a cartridge carrier according to one embodiment of this application is shown.

[0025] Figure 10 A perspective view of a circular plate connected to a guide member according to one embodiment of this application is shown. Detailed Implementation

[0026] In the foregoing description, the following detailed description, the claims, and the accompanying drawings, specific features (including method steps) of this application have been referenced. It should be understood that the disclosure of this application in this specification includes all possible combinations of these specific features. For example, a specific feature disclosed in the context of a particular aspect / embodiment of this application or in a particular claim may also be used or combined with other specific aspects / embodiments of this application to the extent possible, and may also be universally applicable to this application to the extent possible.

[0027] Unless otherwise defined, all technical terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. While any methods and materials similar to or equivalent to those described and used in this application may also be used in the practice or experimentation of this application, preferred methods and materials are now described.

[0028] All publications and patents cited in this specification are incorporated herein by reference, which is equivalent to each individual publication or patent being specifically and individually indicated as incorporated by reference, and which is incorporated herein by reference to disclose and describe methods and / or materials relating to the cited publication. Any publications cited were published prior to the filing date of this application and should not be construed as an admission that this application is not eligible to precede those publications by virtue of prior publication. Furthermore, the publication date provided may differ from the actual publication date, which may require separate confirmation.

[0029] The term “comprising” and its grammatical equivalents are used in this document to indicate the optional presence of other components, ingredients, steps, etc. For example, the statement “comprising” (or “it includes”) components A, B, and C can mean that it consists of components A, B, and C (i.e., contains only them), or it can mean that it contains not only components A, B, and C, but also one or more other components.

[0030] When referring to a method that includes two or more defined steps in this document, the defined steps may be performed in any order or simultaneously (unless the context precludes this possibility), and the method may include one or more other steps that may be performed before any defined steps, between two defined steps, or after all defined steps (unless the context precludes this possibility).

[0031] Where a range of values ​​is provided, it should be understood that all intermediate values ​​between the upper and lower limits of the range, any specified intermediate values, and intermediate values ​​within the specified range are included in the scope of this application, unless otherwise expressly agreed and explicitly excluded. Where the specified range includes one or two limits, the exclusion of ranges including one or two limits is also included in the scope of this application.

[0032] It should be understood that, for the sake of simplicity and clarity in the illustrations, the same reference numerals are used in different figures where appropriate to indicate corresponding or similar elements. Furthermore, numerous specific details are set forth to provide a clearer and more thorough understanding of the embodiments described herein. However, the embodiments described herein can be practiced without specific details. In other instances, methods, processes, and components have not been described in detail to avoid obscuring the related functions described. Moreover, the relevant descriptions should not be considered as limiting the scope of the embodiments described herein. It will be understood that, unless otherwise indicated, the descriptions and features of the embodiments set forth herein should not be considered mutually exclusive.

[0033] The following definitions are used in this application:

[0034] In this application, the term "at least" is followed by a number to indicate a range starting with that number (depending on the defined variable, the range may have an upper limit or no upper limit). For example, "at least 1" means greater than or equal to 1. The term "at most" is followed by a number to indicate a range ending with that number (depending on the defined variable, the range may have a lower limit of 1 or 0 or no lower limit). For example, "at most 4" means less than or equal to 4, and "at most 40%" means less than or equal to 40%. In this specification, when a range is specified as "(first number) to (second number)" or "(first number) - (second number)", it indicates that its lower limit is the first number and its upper limit is the second number. For example, 25–100 mm indicates a range with a lower limit of 25 mm and an upper limit of 100 mm.

[0035] PCR, or polymerase chain reaction, refers to a method for amplifying DNA by repeated cycles of enzyme replication, followed by denaturation and annealing of the DNA double helix to form new DNA double helixes. The denaturation and annealing of the DNA double helix can be achieved by varying the temperature of the DNA amplification reaction mixture. Reverse transcriptase PCR (RT-PCR) refers to a PCR process that includes the steps of transcribing RNA (e.g., mRNA) into cDNA and then amplifying the cDNA. Real-time PCR refers to a PCR process in which a signal related to the amount of DNA amplified during the reaction is monitored during amplification. This signal is typically fluorescence. However, other detection methods are also feasible. In one exemplary embodiment, the PCR subsystem uses a prepared, sealed reaction vessel and performs a complete real-time polymerase chain reaction analysis, subjecting the sample to multiple thermal cycles and reporting the fluorescence intensity emitted in each cycle.

[0036] test kit

[0037] In one aspect, this application provides a test kit for use in a fully automated random access device for determining a specific nucleic acid sequence in a sample. An example of such a fully automated random access system is disclosed in US Patent No. 1042716 to Lei et al., the disclosure of which is incorporated herein by reference. The system can combine two main functions: sample preparation in the form of isolating nucleic acids from a sample, and detection of a specific sequence within the isolated nucleic acids. For this purpose, the test kit used in the system has at least two distinct functional modules: one for processing the sample to isolate nucleic acids, and another for nucleic acid amplification and detection. In some embodiments, the two functional modules are integrated into a single unit. The system includes an instrument that operates on the test kit to perform the functions. In some embodiments, the instrument is contained in a single enclosed device. The system also includes consumables containing necessary reagents for use with various assay and transfer devices (e.g., pipette tips). In some embodiments, all consumables are contained in the test kit, eliminating the need to store any consumables in the device. The system may also include a sample rack and power and information connectors. These are integrated into a single unit to provide a system that performs the main functions of sample processing, nucleic acid isolation, nucleic acid amplification, and nucleic acid detection, as well as other supporting functions (such as supply and consumable management, information management, and maintenance). In some implementations, the system includes multiple test kits, each of which can be processed independently and simultaneously (i.e., in a random access manner).

[0038] Combining these functionalities into a single, highly automated, standalone device allows for seamless integration of molecular diagnostics into clinical laboratory workflows. Another benefit is the ability to perform all steps of nucleic acid testing to produce clinically acceptable results without user intervention. The device allows users to load available samples and perform assays on them as needed by patients and physicians, without being restricted by the system's order of samples or analytes.

[0039] The test kit disclosed in this application can work with a sealing assembly to provide a sealed space in which sample preparation and target sequence detection can be performed. This arrangement minimizes the risk of cross-contamination.

[0040] In some embodiments, the assay kit includes a sample preparation module and a PCR module. The sample preparation module is used to purify nucleic acids (e.g., chromosomal DNA, total RNA, etc.) from a sample (e.g., FFPE specimen, blood, or saliva). The PCR module is used to amplify target regions in the purified nucleic acids. In some embodiments, the sample preparation module and the PCR module are formed in a single body, wherein the body is functionally divided into the sample preparation module and the PCR module. In some embodiments, the elongated body may be in the form of a monolithic body and may be formed of plastic (or any other suitable material). In some embodiments, the elongated body is manufactured using a plastic injection molding process. Alternatively, the elongated body may also be manufactured by assembling the individual components into a rigid frame.

[0041] Figure 1 A test kit for a molecular diagnostic device according to one embodiment of this application is shown. Reference Figure 1 The test kit 100 includes an elongated body 110 formed to include multiple compartments for accommodating fluids (e.g., reagents) and devices (e.g., pipette tips) required for handling various samples. Examples of compartments may include one or more sample loading wells, one or more purification wells, one or more reagent storage wells, and one or more pipette tip holders. The test kit 100 further includes a sealing assembly 120 that covers the elongated body and prevents cross-contamination.

[0042] Figure 2 An elongated body of a test kit for a molecular diagnostic device according to one embodiment of this application is shown. Reference Figure 2 The elongated body 110 includes a proximal end 111, a distal end 112, and a plurality of compartments 113 located between the proximal end 111 and the distal end 112 at opposite ends of the elongated body 110. The orientation of the compartments defines the top and bottom of the test kit 100. Typically, the compartments are open at the top, while the bottom and sides are closed.

[0043] In some implementations, multiple compartments can be divided into several sub-regions, each sub-region having a pipette tip holder. (See reference) Figure 2 The elongated body 110 includes a first pipette tip support 114 near the proximal end 111. The elongated body 110 further includes a second pipette tip support 115 near the distal end 112.

[0044] In some implementations, the sub-regions roughly correspond to the sample preparation module located near the proximal end 111 and the PCR module located near the distal end 112, with each sub-region including a compartment for performing the corresponding function of the module. (Reference) Figure 2 The elongated body 110 includes a sample loading orifice 116 located near the proximal end 111 and the first pipette tip support 114. The sample loading orifice 116 is shaped to contain a relatively large reaction volume to allow for efficient mixing of its contents and to allow aspiration with minimal dead volume. In some embodiments, the sample loading orifice 116 is cylindrical with a tapered, narrowed bottom. This shape minimizes dead volume and allows the pipette to collect all or almost all of the contained reagents. In some embodiments, the volume of the sample loading orifice 116 is approximately 1000 to 2000 microliters. In some embodiments, the sample loading orifice 116 is removable from the elongated body 110 (see [link to documentation]). Figure 3 Samples can be added to the sample loading well 116 before attaching it to the test kit and loading it into the molecular diagnostic device. In some embodiments, the sample loading well 116 includes a lysis buffer for efficient sample lysis.

[0045] refer to Figure 2 The elongated body 110 also includes a purification well 117 located near the proximal end 111 and the first pipette tip support 114. In some embodiments, the purification well 117 is cylindrical with a tapered, narrowed bottom. This shape minimizes dead volume and allows the pipette to collect all or almost all of the contained reagents. In some embodiments, the purification well 117 may contain solid particles (e.g., magnetic nanoparticles). In some embodiments, the purification well 117 stores solid particles in a suspension, but dry storage can extend shelf life. In both cases, the solid particles may need to be mixed before use to resuspend particles that precipitated during storage or to disperse the rehydrated suspension.

[0046] When the device is operated primarily from the top over other compartments in the test kit, the purification well 117 can also interact with the magnet via its sides and edges (e.g., the bottom). In some embodiments, when the test kit is loaded into the device and solid-phase particles need to be collected, the magnet is pushed upward to make close contact with the purification well. The magnet can be controlled to establish a magnetic field that collects magnetically responsive particles on the walls of the purification well and causes the magnetically responsive particles to form spheres. The magnet can be turned off (i.e., to remove the magnetic field) when needed, so that the magnetically responsive particles can mix with other contents in the purification well 117 or be collected by a pipette. In some embodiments, the magnet remains in its lower, original position at the bottom when needed to avoid affecting the solid-phase particles in the purification well.

[0047] In one implementation, to isolate DNA or RNA from a sample already lysed in sample loading well 116, an appropriate binding buffer can be added to allow DNA or RNA to bind to magnetically responsive microparticles. A magnet is then pushed upwards to bring it into close contact with purification well 117, thereby applying a magnetic field and collecting microparticles on one side of purification well 117. The liquid is removed using a pipette system. The magnetic field is then removed, and wash buffer is added to the purification well and thoroughly mixed with the microparticles. The magnetic field is applied again to collect the microparticles while removing the wash buffer. Eluent is added to purification well 117 to mix with the microparticles. The purified DNA or RNA is then eluted from the microparticles for downstream applications.

[0048] like Figure 2 As shown, the compartments near the proximal end 111 and the first pipette tip holder 114 can be arranged in a radial pattern, such that the pipette tip mounted in the pipette tip holder 114 can be easily accessed by the operation of a dispensing system in the molecular diagnostic device, wherein the dispensing system includes pipettes for transferring reagents between compartments (see, for example, U.S. Patent No. 1042716, the disclosure of which is incorporated herein by reference). Some compartments are reagent storage wells that can contain discrete components used in the extraction and purification process, including cell lysis buffer, washing buffer, and elution buffer. Reagent storage wells can have various sizes and shapes. In some embodiments, some reagent storage wells are shallower than the purification well 117 to facilitate operation of a magnet that works in conjunction with the purification well 117.

[0049] like Figure 2 As shown, the elongated body 110 further includes a PCR well 118 and a mixing well 119 near the distal end 112 and the second pipette tip holder 115, which are used to store PCR reagents and mix purified nucleic acids with PCR reagents.

[0050] In some embodiments, the individual compartments within the elongated body 110 do not share a common wall to prevent fluid creep between compartments. This reduces the likelihood of contamination between compartments. In some embodiments, the outer contour of each compartment closely follows the inner contour of the cavity, meaning the compartment walls can have a relatively constant thickness and can be thinner relative to the compartment's dimensions. One advantage of this design is reduced material usage, thereby lowering the module's manufacturing cost.

[0051] Sealing components

[0052] In some embodiments, the test kit described herein includes a sealing assembly that covers the elongated body and prevents cross-contamination. As described in detail below, the sealing assembly is designed to allow the test kit to be used with a dispensing system in a molecular diagnostic device, wherein the molecular diagnostic device includes a pipette for transferring reagents between compartments within the elongated body (see, for example, U.S. Patent No. 1042716, the disclosure of which is incorporated herein by reference).

[0053] Figure 4 A top perspective view of a sealing assembly according to one embodiment of this application is shown. Reference Figure 4 The sealing assembly 120 includes a rigid frame 121 that matches the top periphery of the elongated body and has a proximal end 122 and a distal end 123. The sealing assembly 120 further includes a resilient top 124 mounted on the rigid frame 121. The resilient top 124 includes a flexible membrane that can be stretched in various directions. The flexible membrane can be made of any elastic material. In some embodiments, the flexible membrane is made of latex.

[0054] In some implementations, the resilient top 124 includes multiple sub-sections. (See reference...) Figure 4 The resilient top 124 includes a first sub-section 125 near the proximal end 122 and a second sub-section 126 near the distal end 123. The first and second sub-sections are generally circular in shape. In some embodiments, each of the first and second sub-sections has a circular corrugated structure. The first sub-section 125 includes a first annular structure 127 at the center of the circular corrugations, which mates with a first pipette tip holder 114 in the elongated body when the sealing assembly covers the elongated body. The second sub-section 126 includes a second annular structure 128 at the center of the circular corrugations, which mates with a second pipette tip holder 115 in the elongated body when the sealing assembly covers the elongated body. This design allows the pipette and dispensing system of the molecular diagnostic device to manipulate the pipette tip through the annular structure. The flexibility of the membrane allows the pipette tip to move between the individual compartments of the test kit without opening the sealed space.

[0055] In some embodiments, the sealing assembly 120 further includes an opening 129 for loading a volatile reagent into a compartment of the elongated body. In some embodiments, the volatile reagent includes ethanol or isopropanol.

[0056] Dividing the test kit and sealing assembly into multiple sub-regions allows automated random access devices to process samples and perform tests within the sealed space using pipette tips mounted in a pipette tip holder. In short, the sealing assembly has a flexible membrane that covers the top of the test kit. The sealing assembly further includes an annular structure within the flexible membrane that allows the pipette and dispensing systems of automated molecular diagnostic devices to access and manipulate pipette tips (see US Patent No. 1042716 for details on examples of pipettes and dispensers). The elasticity and flexibility of the membrane allow the pipette tips to move within the sealed space without removing the sealing assembly from the test kit.

[0057] Sliding cover

[0058] In one embodiment, the kit also includes a sliding cap that can cover the PCR reaction wells after the reagents for the PCR reaction are mixed and added.

[0059] Figure 5A A top perspective view of a sliding cover 130 according to one embodiment of this application is shown. (Reference) Figure 5A The sliding cover 130 includes a plate 131 having a proximal end 132 and a distal end 133. The plate 131 has a groove 134 near the proximal end 132.

[0060] Figure 5B A bottom perspective view of a sliding cover 130 according to one embodiment is shown. (Reference) Figure 5B The sliding cover 130 has a convex element 135 near its distal end 133, which is resiliently attached to the plate 131. The convex element 135 has a spherical surface capable of covering the PCR reaction wells of the test kit. In some embodiments, the convex element has a height of 0.3-1.5 mm (e.g., about 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, or 1.5 mm).

[0061] In some embodiments, plate 131 has at least a pair of ridges 136 on its side surface, which mate with a pair of grooves in the elongated body of the test kit (see [link]). Figure 2 (137) and allows the sliding cover 130 to slide along the groove.

[0062] In some embodiments, the test kit includes a wedge-shaped structure for controlling the position of the sliding cover. When the plate 131 is inserted into the recess 137, the wedge-shaped structure is adjacent to the recess 134. The wedge-shaped structure can be pushed down towards the underside of the test kit and is configured to push the sliding cover 130 toward a distal end when the wedge-shaped structure is pushed down.

[0063] In some embodiments, when the sliding cover 130 is installed into the test kit, the bottom of the plate 131 is approximately 0-0.5 mm from the top surface of the PCR module. This prevents the convex element from extending downwards through the top surface of the PCR module. When the sliding cover 130 is pushed to the far end of the test kit and slid to the closed position, the resilient convex element 135 extends downwards into the PCR reaction wells and seals them.

[0064] Carrier

[0065] In order to work within an automated system, the test kit described herein can be loaded into a kit carrier (described below) before being inserted into an automated molecular diagnostic device. Figure 6A and Figure 6B Top perspective views of a cartridge carrier according to an embodiment of this application are shown, wherein a test kit is loaded in the cartridge carrier. Reference Figure 6A and Figure 6B The cartridge carrier 200 includes an elongated body having a proximal end 201, a distal end 202, and a pair of sidewalls 203 that together define a cavity configured to accommodate the test kit 100 when loaded into the cartridge carrier. In one embodiment, the PCR reaction wells of the test kit are not loaded into the cavity. This design allows the PCR reaction wells to be accommodated within the container of a thermal cycling module of a molecular diagnostic device.

[0066] The test kit carrier 200 includes a control component with a control button 204 that controls the position of the test kit 100 when the test kit is inserted into the automated system. Figure 7A and Figure 7B Perspective views of a cartridge carrier according to an embodiment of this application are shown, wherein sidewall 203 is removed to disassemble the control assembly. Reference Figure 7A and 7B The control assembly includes a rotatable and actuable control button 204. The control button 204 is connected to a circular plate 208 via an axis. Rotation of the circular plate 208 raises or lowers a pair of levers 206, which slide into a pair of recesses 207 in the elongated body of the test kit (see [link]). Figure 1 ).

[0067] Figure 8A perspective view of a cartridge carrier according to one embodiment of this application is shown, in which a test kit is loaded and control components are exposed. Reference Figure 8 After the test kit 100 is loaded onto the carrier via a pair of levers 206, a locking button 205 can lock the test kit 100 in the carrier. The control assembly includes a control button 204 that controls the rotation of a circular plate 208 via an axis 210. Rotation of the circular plate 208 raises or lowers a guide 209, which in turn raises or lowers the pair of levers 206.

[0068] Figure 9 An enlarged perspective view of the control components of a cartridge carrier according to one embodiment of this application is shown, in which control button 204, axis 210 and circular plate 208 are shown.

[0069] Figure 10 A perspective view of a circular plate connected to a guide member according to an embodiment of this application is shown. Reference Figure 10 A circular plate 208 is connected to a control button (not shown) via an axis 210. The circular plate 208 has an eccentric arcuate groove 211 into which a pin 212 is inserted. The pin 212 is linked to a guide 209, which is connected to a pair of rods 206 (not shown). Movement of the pin 212 in the eccentric arcuate groove 211 causes the guide 209 to rise (when the circular plate 208 rotates counterclockwise) or fall (when the circular plate 208 rotates clockwise), thereby raising or lowering the rods 206.

[0070] The preceding description provides only exemplary embodiments and is not intended to limit the scope, applicability, or configuration of this application. Rather, the prior description of exemplary embodiments will provide those skilled in the art with a description for implementing one or more exemplary embodiments. It should be understood that various changes can be made to the function and arrangement of elements without departing from the spirit and scope of this application. Several embodiments have been described herein, and although various features are attributed to different embodiments, it should be understood that features described with respect to one embodiment may also be incorporated into other embodiments. However, for the same reason, one or more features of any described embodiment should not be considered necessary for every embodiment of this application, as these features may be omitted in other embodiments of this application.

[0071] Specific details have been set forth in the preceding description to provide a thorough understanding of the implementation methods. However, those skilled in the art will understand that various implementation methods can be practiced without these specific details. For example, circuits, systems, networks, processes, and other elements in this application may be shown as components in block diagram form to avoid obscuring the implementation methods with unnecessary details. In other instances, well-known circuits, processes, algorithms, structures, and techniques may be shown while omitting unnecessary details to avoid obscuring the implementation methods.

[0072] While a detailed description of one or more embodiments has been given above, various alternatives, modifications, and equivalents will be apparent to those skilled in the art without departing from the spirit of this application. Furthermore, unless explicitly inappropriate or otherwise clearly indicated, it should be assumed that features, devices, and / or components of different embodiments can be substituted and / or combined. Therefore, the above description should not be considered as limiting the scope of this application. Finally, without departing from the scope of this application, one or more elements of one or more embodiments may be combined with one or more elements of one or more other embodiments.

Claims

1. A cartridge carrier for use in a PCR-based molecular diagnostic device, characterized in that, The test kit includes: An elongated body having a proximal end, a distal end, and a plurality of compartments arranged between the proximal end and the distal end, the plurality of compartments comprising at least one... A first pipette tip holder, the first pipette tip holder being close to the proximal end, and A second pipette tip holder, the second pipette tip holder being proximal to the distal end; and A sealing assembly covering the elongated body, the sealing assembly comprising... A rigid frame that matches the top periphery of the elongated body, and The resilient top, mounted on the rigid frame, includes... The first sub-part, located near the proximal end, includes a first annular structure that mates with the first pipette tip support. The second sub-part is located near the distal end and includes a second annular structure that matches the second pipette tip support. The plurality of compartments include at least one PCR reaction well, the PCR reaction well being located near the distal end, and the test kit further includes a sliding cover that movably covers the PCR reaction well. The cartridge carrier includes: A cavity configured to accommodate the test kit, wherein the PCR reaction wells of the test kit are not loaded into the cavity; A control component that controls the position of the test kit when the test kit, loaded in the kit carrier, is inserted into the PCR-based molecular diagnostic device, and the control component includes: Control buttons; A circular plate, the circular plate being connected to the control button via a shaft, wherein the circular plate includes an eccentric arc groove; and A guide member is connected to the circular plate by a pin, the pin being inserted into the eccentric arc groove, and the guide member is connected to a pair of rods that are slidably inserted into a pair of grooves in the elongated body of the test kit; Wherein, when the test kit, loaded in the cartridge, is inserted into the PCR-based molecular diagnostic device, the control component controls the position of the test kit by including: The control button controls the rotation of the circular plate via the shaft, thereby causing the pin to move in the eccentric arc groove. The movement of the pin in the eccentric arc groove causes the guide to rise or fall, thereby raising or lowering the pair of rods and the test box.

2. The carrier material containing the test kit according to claim 1, characterized in that, The plurality of compartments include sample loading ports located near the proximal end.

3. The carrier material containing the test kit according to claim 2, characterized in that, The sample loading hole can be removed from the elongated body.

4. The carrier material containing the test kit according to claim 1, characterized in that, The multiple compartments include purification wells.

5. The carrier material containing the test kit according to claim 4, characterized in that, The purification well includes magnetic microparticles capable of binding to nucleic acids.

6. The carrier containing the test kit according to claim 1, characterized in that, The elastic top is made of latex.

7. The carrier material containing the test kit according to claim 1, characterized in that, The first sub-part and / or the second sub-part of the elastic top have a circular corrugated structure.

8. The carrier material containing the test kit according to claim 1, characterized in that, The sealing assembly includes an opening for loading volatile reagents into the compartments of the elongated body.

9. The carrier material containing the test kit according to claim 8, characterized in that, The volatile reagents include ethanol or isopropanol.

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