Platform for performing in vitro diagnostics

Abstract

The present disclosure relates to a method of manufacturing a platform for performing a test. The method includes the steps of providing a chassis for the platform, providing a plurality of components based on a test to be performed, arranging the components on the chassis, and providing a cartridge for use with the platform when the test is performed.

Description

Cross-references to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 528,129, filed July 21, 2023, the disclosure of which is incorporated herein by reference. Background Technology

[0002] This disclosure relates to platforms and methods for performing various in vitro diagnostic (IVD) assays or other tests on samples.

[0003] Many different testing devices are known for performing IVD and other tests on samples. These are typically designed for specific types of tests on specific types of samples. Therefore, each device may have only a single specific purpose, and designing and manufacturing such a machine can be troublesome and time-consuming.

[0004] There is a need for a customizable platform that can be quickly and easily configured for different types of testing and other purposes. Summary of the Invention

[0005] This disclosure relates to an apparatus or platform for performing different types of tests on different types of samples. The platform includes a cartridge containing samples and other fluids, and instruments for receiving the cartridge and preparing and testing the samples. Both the cartridge and the instruments are designed to be customized to the tests desired by the user of the platform and the samples to be tested. Specifically, the cartridge is designed to be customized for the specific sample to be tested. Similarly, the instruments include various modular components designed to be added, removed, or replaced within the platform to perform the desired tests. Furthermore, the platform of this disclosure includes different embodiments of the cartridge and the instruments, and each embodiment of the cartridge is designed to be compatible with each embodiment of the instruments, or a particular embodiment of the cartridge is designed to be compatible only with a particular embodiment of the instruments. Additionally, this disclosure relates to manufacturing the platform and methods for performing tests using the platform.

[0006] In a first example of the first aspect, this disclosure relates to a method for manufacturing a platform for performing tests. The method includes the steps of: providing a chassis for the platform, providing a plurality of components based on the tests to be performed, arranging the components on the chassis, and providing a box for use with the platform during the performance of the tests.

[0007] In the second example, the first example of the first aspect is further defined, wherein the test performed is an in vitro diagnostic (IVD) assay. In the third example, the first example of the first aspect is further defined, wherein the step of providing multiple components includes providing a moving system and a fluid controller, and the fluid controller is configured to interact with the cartridge.

[0008] In the fourth example, the third example of the first aspect is further defined, wherein the step of providing multiple components includes: the provided moving system is a motor and pulley system configured to move the fluid controller. In the fifth example, the third example of the first aspect is further defined, wherein the step of providing multiple components includes: the provided moving system is configured to move the fluid controller in any direction along the X, Y, and Z axes. In the sixth example, the third example of the first aspect is further defined, wherein the step of providing multiple components includes: the provided fluid controller is configured to connect to a pipette tip located within a pocket of the cartridge. In the seventh example, the third example of the first aspect is further defined, wherein the step of providing multiple components includes: the provided fluid controller is configured to aspirate and dispense fluid contained within the cartridge.

[0009] In the eighth example, the seventh example of the first aspect is further defined, wherein the step of providing multiple components further includes: providing a pneumatic system connected to a fluid controller to provide a vacuum, thereby drawing in fluid and pressure, and thus dispensing the fluid. In the ninth example, the seventh example of the first aspect is further defined, wherein the step of providing multiple components further includes providing a magnet configured to change the properties of the fluid drawn in by the fluid controller. In the tenth example, the ninth example of the first aspect is further defined, wherein the step of providing multiple components includes: the provided fluid controller being configured to connect to a pipette tip including multiple magnetic beads disposed therein, and the magnet being configured to move the multiple magnetic beads to one side of the pipette tip.

[0010] In the eleventh example, the first example of the first aspect is further defined, wherein the step of providing multiple components includes: providing a heater configured to change the temperature of a fluid contained within the container. In the twelfth example, the eleventh example of the first aspect is further defined, wherein the step of providing multiple components includes: providing a heater positioned on a chassis below the container. In the thirteenth example, the eleventh example of the first aspect is further defined, wherein the step of providing multiple components includes: providing a heater that is a thermostatic heater or a resistance electric heater. In the fourteenth example, the eleventh example of the first aspect is further defined, wherein the step of providing multiple components includes: providing a detection thermal subsystem positioned on the chassis adjacent to the heater and the container, and the detection thermal subsystem being configured to further change the temperature of the fluid contained within the container. In the fifteenth example, the fourteenth example of the first aspect is further defined, wherein the step of providing multiple components includes: the provided detection thermal subsystem is a Peltier-based heater or a Peltier-based cooler.

[0011] In the sixteenth example, a first example of the first aspect is further defined, wherein the step of providing multiple components includes: providing a detection system configured to determine the result of a test. In the seventeenth example, a sixteenth example of the first aspect is further defined, wherein the step of providing multiple components includes: providing a detection system configured to acquire multiple readings of fluid contained within a container. In the eighteenth example, a sixteenth example of the first aspect is further defined, wherein the step of providing multiple components includes: providing a detection system that is a fluorometer, photometer, microscope, spectrophotometer, flow cytometer, or imaging system. In the nineteenth example, a first example of the first aspect is further defined, wherein the step of providing a container includes: positioning the container in a drawer of a platform and moving the drawer such that the container is positioned above a chassis. In the twentieth example, the first example of the first aspect further includes the step of: prior to the step of providing multiple components, removing multiple components arranged on a chassis based on the test to be performed.

[0012] In a first example of the second aspect, this disclosure relates to a method for performing a desired test on a sample. The method includes the step of modifying components of a platform for the desired test, wherein the platform includes a cartridge and an instrument. The method further includes the step of inserting the cartridge into the instrument, wherein the sample is located within a sample container of the cartridge. The method further includes the step of selecting the desired test to be performed by the platform, wherein selecting the desired test causes: (i) a movement system of the instrument to move a fluid controller of the instrument and connect it to a pipette tip located within a pipette tip container of the cartridge; (ii) a movement system causes the pipette tip connected to the fluid controller to move and position it above the sample container to aspirate the sample; (iii) a movement system moves the fluid controller and the pipette tip to the vicinity of a magnet, such that a magnetic bead is retained in the pipette tip when the sample is dispensed into a vessel according to the desired test; (iv) a thermal system of the instrument prepares the sample temperature according to the desired test; and (v) a detection system of the instrument acquires a reading of the sample according to the desired test. The method further includes the step of displaying a final reading of the sample from the desired test.

[0013] In a first example of the third aspect, this disclosure relates to a platform for performing a desired test on a sample. The platform includes a cartridge comprising a tray and a container, wherein the tray includes multiple wells for dispensing the sample, and the container includes a pipette tip container and a sample container. The platform further includes an instrument comprising a movement system, a fluid controller, a thermal system, and a detection system, each removably attached to the chassis, wherein: (i) the movement system is configured to move the fluid controller, (ii) the fluid controller is configured to aspirate and dispense the sample from the cartridge, (iii) the thermal system is configured to heat or cool the reagent, and (iv) the detection system is configured to acquire a final reading of the sample according to the desired test. Attached Figure Description

[0014] Figure 1 This is a perspective view of a platform according to one embodiment of the present disclosure.

[0015] Figures 2A to 2B yes Figure 1 A perspective view of an embodiment of the platform box.

[0016] Figure 2C yes Figures 2A to 2B A three-dimensional view of the main body of the box.

[0017] Figure 2D yes Figures 2A to 2B A three-dimensional representation of a box or container.

[0018] Figure 2E yes Figure 1 A perspective view of another embodiment of the platform box.

[0019] Figure 2F yes Figure 1 A perspective view of another embodiment of the platform box.

[0020] Figure 3A yes Figure 1 A perspective view of another embodiment of the platform box.

[0021] Figure 3B yes Figure 3A A three-dimensional view of the main body of the box.

[0022] Figures 3C to 3D yes Figure 3A A three-dimensional representation of a box or container.

[0023] Figures 3E to 3F yes Figure 3A A 3D view of the detection section of the box.

[0024] Figure 3G yes Figures 3E to 3F A cross-sectional view of the detection section.

[0025] Figure 3H yes Figures 3E to 3F The detection part and Figure 1 Another perspective view of the pipette tip on the platform.

[0026] Figure 3I yes Figure 3H A cross-sectional view of the detection section.

[0027] Figures 3J to 3K yes Figure 3H A cross-sectional view of the filling port of the detection section.

[0028] Figure 4A yes Figure 1 A three-dimensional view of the instrument on the platform, in which the cover has been removed.

[0029] Figure 4B It is used for Figure 4A An exploded view of the instrument's multiple covers.

[0030] Figure 4C yes Figure 4A A three-dimensional diagram of the instrument's moving system.

[0031] Figure 4D yes Figure 4A A three-dimensional view of the fluid controller of the instrument.

[0032] Figure 5A yes Figure 1 A perspective view of another embodiment of the instrument on the platform, in which the cover is removed from it.

[0033] Figure 5B yes Figure 5A Another three-dimensional view of the instrument.

[0034] Figure 5C yes Figure 5A Another three-dimensional view of the instrument.

[0035] Figure 5D yes Figure 5A A top view of the instrument.

[0036] Figure 5E yes Figure 5A A three-dimensional diagram of the instrument's moving system.

[0037] Figure 5F yes Figure 5A Another perspective view of the instrument's moving system.

[0038] Figure 5G yes Figure 5A Another perspective view of the instrument's moving system.

[0039] Figure 6 It is used for Figure 1A simplified diagram of the platform's control system.

[0040] Figure 7 It is for use Figure 1 The flowchart of the platform's method. Detailed Implementation

[0041] This document will describe specific embodiments of the present disclosure with reference to the accompanying drawings. As shown in the drawings and as described throughout the following description, and as is customary when referring to relative positioning on objects, the term "proximal" should be understood to refer to the portion of the structure that is closer to the clinician during proper use, and the term "distal" should be understood to refer to the portion of the structure that is further away from the clinician during proper use. Furthermore, as used herein, the terms "substantially," "generally," and "about" are intended to indicate a slight deviation from the absolute value and are also included within the scope of terms so modified.

[0042] refer to Figure 1 This illustrates a care point of a platform 100 according to one embodiment of the present disclosure. Platform 100 includes boxes 200 and 1200 (in...). Figures 2A to 3K (best shown in the image) and instruments 300, 1300 (in...) Figures 4A to 5G (Best illustrated herein). Platform 100 is designed to perform in vitro diagnostic (IVD) tests or various other tests from bodily samples from patients, which can be human or animal bodily samples or other types of organic samples. While different embodiment cartridges and instruments are disclosed herein, it should be understood that each component can be customized for use with other components. For example, cartridge 200 can be used with instrument 1300. Platform 100 includes multiple detection technologies for various types of tests and various types of samples, while prior art systems include only a single detection technology. In addition, for systems that do include multiple detection technologies, platform 100 reduces the size and cost of instruments 300 and 1300 due to the modularity of its components.

[0043] exist Figures 2A to 3K Different embodiments of cartridges 200 and 1200 are shown. In each embodiment, cartridges 200 and 1200 are modular, disposable, and customizable for use with instruments 300 and 1300 in platform 100. Reference Figures 2A to 2D One embodiment of the box 200 includes a first portion or body 202, which is connected to a second portion or container 204 by a hinge 240. The box 200 can be a single assembly or a plurality of separately stored components, each of which is placed within the instrument 300. For example, the body 202 and the container 204 can each be stored or placed separately within the instrument 300. The body 202 (in...) Figure 2C(Best shown in the diagram) includes a detection portion 210, one or more dish or reagent wells 220, and a foil 230. The detection portion 210 may be an electronic chip or a microfluidic well for polymerase chain reaction (PCR), or another customizable detection device required for a specific assay. The detection portion 210 is positioned at the distal end of the body 202 and the cartridge 200, and in this embodiment, the detection portion 210 is used for PCR detection, comprising a chamber for optical detection designed to maximize the surface area for heat conduction and allow optics to acquire readings. Wells 220 are positioned on the top portion of the body 202 and allow a pipette tip 1280 (discussed further below) to enter for aspiration and dispensing of liquid. Waste containers (not shown) may be located within wells 220 or elsewhere in the body 202 and / or cartridge 204, and each waste container may include a sponge (not shown) for holding waste generated during analysis. The foil 230 is positioned as a puncture-resistant layer on top of the dish 220. Foil 230 includes a container for storing reagents, whether dry (e.g., lyophilized), aqueous, alcoholic, or oily. Foil 230 also includes a pouch 232, also known as a "blister," for reagents that cannot be stored in a plastic container without loss or degradation.

[0044] Box 200, container 204 (in) Figure 2A , 2B (As best shown in 2D) is positioned close to the body 202 and extends downwards. The container 204 includes an outer cover 206, such as... Figure 2A As best shown in the diagram. Container 204 may include one or more pipette tips within a pipette tip container or pocket 250 and one or more glass or sample containers 260 having an opening disposed on the top surface of container 204 and extending downward toward the bottom surface of container 204. Figures 2A to 2B The illustrated embodiment includes eight pipette tip pockets 250 and a sample container 260.

[0045] Box 200 can also be made of different materials and can have different dimensions. For example, container 204 can be made of a transparent material to allow optical inspection of the container and its contents. Container 204 can have a length of 55 mm, a width of 50 mm, and a height of 70 mm. Figures 2E to 2FAs shown, the body 202 and container 204 can be modified to have different sizes and components. Specifically, the body 202 may include various detection chips 210 and vessels 220, and may include foils 230 of different sizes to cover different numbers of vessels 220. Similarly, the container 204 may include different numbers of pipette tip pockets 250 and / or sample containers 260. The body 202 and / or container 204 may be made of non-transparent materials and are not limited to a single material used for the entire box 200. Additionally, as... Figures 2E to 2F As best illustrated, embodiments of box 200 may include box label 270, which is customizable and typically includes a box barcode, graphics for marking, or key user information or security information, as discussed further below.

[0046] exist Figures 3A to 3K Another embodiment of cartridge 1200 is shown, wherein similar components to cartridge 200 are referred to using the same reference numerals, but with a 1200-series reference numerals. Cartridge 1200 includes a body 1202, a pipette tip storage container 1204, and a detection section 1210. Body 1202 includes a plurality of reagent orifices 1220, a foil 1230, a sample container 1260, and a waste container 1270. Each orifice 1220 extends downward from the top surface of body 1202 to allow pipette tips 1280 (described below) to enter for aspiration and dispensing of liquid. Sample container 1260 also extends downward from the top surface of body and is designed to receive samples to be tested by platform 100, as discussed further below. Waste container 1270 also extends downward from the top surface of body and may include a sponge (not shown) for retaining liquid waste generated during test execution. In an alternative embodiment, the waste container 1270 may be disposed within at least one of the holes 1220, or may be disposed within all of the holes 1220.

[0047] The foil 1230 is designed to be positioned on the top surface of the body 1202 as a punctureable layer above each corresponding opening of the orifice 1220, forming a cavity that can be used for reagent storage or handling steps during test execution, as discussed further below. In alternative designs, the foil 1230 can be used to form both the top and bottom surfaces of a blister pack (not shown), which offers the primary benefits of low vapor transfer rates and extended shelf life. Combinations of these reagent storage methods are suitable for many different reagent types, including dry (e.g., lyophilized), aqueous, alcoholic, or oily reagents.

[0048] The pipette tip storage container 1204 of box 1200 (in Figure 3A , Figure 3C and Figure 3D(Best shown in the diagram) The container 1204 is releasably received within a pair of arms 1240 extending laterally from one side of the body 1202. When connected to the body 1202 and used with the platform 100 as further described below, the container 1204 extends vertically downward from the cassette 1200. In an alternative embodiment, the container 1204 may initially extend horizontally from the cassette 1200 before being connected or rotated to the vertical position shown and described above. The container 1204 includes a plurality of pipette tips 1280 positioned within a pipette tip container or pocket 1250. In the depicted embodiment, the container 1204 has a length of 55 mm, a width of 50 mm, and a height of 70 mm. However, the body 1202 and the container 1204 can be modified to have various sizes and additional components. Specifically, the body 1202 may include several detection portions 1210 and orifices 1220, and may include foils 1230 of different sizes to cover different numbers of orifices 1220. Additionally, the container 1204 may include different numbers of pipette tip pockets 1250, and the container 1204 may further include orifices 1220, a sample container 1260, and / or a waste container 1270.

[0049] Container 1204 includes a pipette tip cap 1252, which is designed to selectively receive or seal a pipette tip 1280, the pipette tip 1280 being positioned within the pipette tip pocket 1250, such as... Figure 3C and Figure 3D As best shown in the diagram. The cap 1252 is hinged to the bottom portion of the container 1204 such that the cap 1252 is designed to move laterally or bend away from the container 1204 to form an opening that exposes the pipette tip 1280. For example, when not used with the platform 100, the cap 1252 completely encloses the pipette tip 1280 within the container 1204, preventing contamination of the pipette tip 1280 by the user and preventing displacement of the pipette tip 1280 from the container 1204. However, when used with the platform 100, the instrument 300 includes features (e.g., a pin (not shown)) designed to contact the cap 1252, which actuates the cap 1252 and exposes the pipette tip 1280 through an opening in the top portion of the container 1204, as discussed further below. When used with platform 100, the actuation of cap 1252 is an improvement on the commonly known and used method of transferring pipette tip 1280 to instrument 300, as this simplifies the design of instrument 300 and reduces the number of required parts and manufacturing costs.

[0050] Detection section 1210 (in) Figures 3E to 3K (Best shown in the image) includes multiple detection chambers 1211, a filling port 1212, and multiple air chambers 1218. In one embodiment, as... Figures 3F to 3K As shown, the detection section 1210 includes eight detection chambers 1211 and is designed for PCR thermal cycling and optical reading. In other embodiments, the number of detection chambers 1211 can be varied. For example, as Figure 3E As shown, the detection section 1210 includes four detection chambers 1211. Each detection chamber 1211 contains dried reagent, which is mixed with liquid reagent injected via the filling port 1212. Additionally, the detection section 1210 includes an air chamber 1218 for each detection chamber 1211, configured to manage pressurization of the cartridge 1200 when used with the platform 100. As described above, the detection section 1210 may include a plurality of holes 1220 and foils 1230 at the connection point with the body 1202, such as... Figure 3E As best shown in the diagram. Alternatively, the detection section 1210 may not include any holes 1220 or foils 1230, and all holes 1220 and foils 1230 may be included only in the body 1202, as shown in the diagram. Figures 3F to 3I The best example shown is...

[0051] Fill port 1212 (in Figures 3F to 3K (Best shown in the diagram) includes a plunger 1213, an inlet port 1214, a seal 1215, a window 1216, and an outlet port 1217. As discussed further below, when used with instrument 300 and platform 100, the fill port 1212 is designed to transfer and seal reagents at different internal locations within cartridge 1200. In the depicted embodiment, the fill port 1212 is connected to each detection chamber 1211 by extending an internal channel (not shown) through the detection portion 1210. Reagents transferred into the internal channel by the fill port 1211 are not allowed to escape from the detection portion 1210 of cartridge 1200, which is particularly beneficial when reagents are amplified in PCR and is crucial to ensuring that amplified reagents do not contaminate the environment of platform 100.

[0052] Instrument 300 (in) Figures 4A to 4D (Best shown in the diagram) includes a movement system 310, a fluid controller 320, a detection system 330, a detection thermal system 340, a heater 350, a printed circuit board 360, a pneumatic system 370, and a chassis 380. All components of the instrument 300 are positioned on the top surface of the chassis 380, and all components are configured to be added, removed, modified, or rearranged on the chassis 380 for many different designs and to be compatible with various configurations of the housings 200 and 1200 and various configurations of the detection system 330. Additionally, multiple covers 302 can be customized for each specific design of the instrument 300 and platform 100, one of which is in… Figure 4B As shown in the image.

[0053] Mobile System 310 Figure 4A As shown in, and in Figure 4C The following is shown in more detail. The moving system 310 includes three independent motors and two pulley systems. Two of the motors are configured to move the fluid controller 320 along a single toothed belt arranged between the two pulleys. The moving system 310 is constructed of metal plates and has an "H" shaped design. The moving system 310 enables the fluid controller 320 to move in any direction along the X, Y, and Z axes.

[0054] Fluid controller 320 in Figures 4A to 4B As shown in, and in Figure 4D The fluid controller 320 is positioned along the moving system 310 and includes a spindle 324. The spindle 324 of the fluid controller 320 is configured to connect to a disposable pipette tip located in a pipette tip pocket 250. The fluid controller 320 includes an internal valve that connects the spindle 324 to a pneumatic system 380 that provides vacuum or pressure to aspirate and dispense fluid. The fluid controller 320 can monitor the airflow rate in the system to determine the volume of fluid aspirated and dispensed by the pipette tip. Monitoring also allows the fluid controller 320 and platform 100 to identify malfunctions (e.g., no pipette tip, air bubbles or blockage in the aspirated fluid, air being aspirated instead of liquid, etc.). A magnet 322 is best shown in... Figure 4A In the middle. The magnet 322 is positioned above the boxes 200 and 1200 and adjacent to the pipette tip of the mandrel 324 connected to the fluid controller 320.

[0055] Figure 6 This is a simplified diagram of a control system 102 according to one embodiment of platform 100. Control system 102 is designed to be highly flexible for seamless use in a wide range of tests or projects. Components of control system 102 include, but are not limited to, a selectable user interface for a single-board computer (SBC), or for lower instrumentation costs involving Bluetooth-connected phones or tablets, one-dimensional (1D) or two-dimensional (2D) barcodes for sample tracking, and status lights (offering a range of color options) indicating when the user should interact with platform 100. Additionally, control system 102 and platform 100 can be operated by various types of interchangeable software. Examples of software include, but are not limited to: thermal control algorithms, optical signal processing, motion control algorithms, pipetting monitoring, engineering development tools, graphical user interface (GUI), automatic alignment and calibration tools, health monitoring, coordination of a motion system 310 and a fluid controller 320 for level following (LLF) in arbitrary orifice geometries to minimize pipette tip immersion.

[0056] exist Figures 5A to 5GAnother embodiment of instrument 1300 is shown, wherein similar components to those of instrument 300 are referred to using the same reference numerals, but with a 1300-series reference numerals. Instrument 1300 includes a movement system 1310, a fluid controller 1320, an optical detection system 1330, a detection thermal system 1340, a heater 1350, a printed circuit board 1360, a pneumatic system 1370, and a chassis 1380. Similar to instrument 300, all components of instrument 1300 are positioned on the top surface of chassis 1380, and all components are configured to be added, removed, modified, or rearranged on chassis 1380 for many different designs and compatible with various configurations of housings 200 and 1200 and various configurations of detection system 1330. Furthermore, multiple covers (not shown) can be customized for each specific design of instrument 1300 and platform 100.

[0057] exist Figure 5E and Figure 5F The moving system 1310 is shown in more detail below. The moving system 1310 includes a first pulley system 1311 and a second pulley system 1312. The first pulley system 1311 includes two drive pulleys 1313, six idler pulleys 1314, and two motors 1315. The first pulley system 1311 is configured to cause the fluid controller 1320 to move along a single toothed belt between the idler pulleys 1314 in a first and second direction, or along a first and second axis, due to actuation of the drive pulleys 1313 from the respective motors 1315. Furthermore, the first pulley system 1311 is assembled on the sidewall of the moving system 1310 in an "H"-shaped design pattern. The second pulley system 1312 includes one drive pulley 1313, one idler pulley 1314, and one motor 1315. The second pulley system 1312 is configured to cause the fluid controller 1320 to move along a single toothed belt between idler pulleys 1314 in a third-order upward or third-axis direction due to actuation of a single drive pulley 1313 from a corresponding motor 1315. The moving system 1310 consists of a metal plate. The moving system 1310 enables the fluid controller 1320 to move in any direction along the X, Y, and Z axes. The moving system 1310 provides greater flexibility in the workflow performed by the instrument 1300, particularly for different steps taken to perform the desired IVD assays. Furthermore, the moving system 1310 allows for more direct and faster translation of the workflow, reducing the need to change reagent formulations, reagent and sample volumes, and processing steps.

[0058] Figure 7This is a flowchart illustrating method 1 for performing in vitro diagnostic (IVD) tests using platform 100. Examples of steps taken to perform the desired IVD test (performed in method 1 using platform 100) include, but are not limited to: sample measurement, reagent addition and mixing, rehydration of lyophilized reagents, lysis by heating, washing using magnetic bead separation, purification, and detection. It should be understood that the following operations need not be performed in the exact order described below, and are not exhaustive of all operations that can be performed during IVD testing. Additionally, it should be understood that the following operations can be performed in different orders or simultaneously. Furthermore, control system 102 can be used to perform any of the functions described in method 1 below.

[0059] In step 10, the user (not shown) customizes and modifies the cartridges 200 and 1200 and instruments 300 and 1300 of platform 100 to match specific testing needs. Method 1 refers to the use of cartridge 200 below, but cartridges 200 and 1200 are interchangeable for use with instruments 300, 1300, and platform 100, and the use of cartridges 200 and 1200 differs from that of instruments 300, 1300, and platform 100 only as described below. Similarly, Method 1 refers to the use of instrument 300 below, but instruments 300 and 1300 are interchangeable for use with cartridges 200, 1200, and platform 100, and the use of instruments 300 and 1300 differs from that of cartridges 200, 1200, and platform 100 only as described below. Specifically, platform 100 is modified to perform the desired tests or IVD assays on samples from a specific patient (not shown). This step may include adding or removing components from cartridge 200 and / or instrument 300 as needed for the desired sample testing. Instrument 300 is compatible with various configurations of cartridge 200 to perform the desired tests, and components of instrument 300 are configured to be altered and / or rearranged to perform numerous other tests on additional configurations of cartridge 200 or additional types of samples. The user may be the person who modifies platform 100 and / or uses the platform to perform the desired tests. Alternatively, a first user may modify only platform 100, while a second user may use only platform 100 to perform the desired tests. In step 11, the user inserts the sample into sample container 260 of cartridge 200.

[0060] In step 12, the user scans the box label 270 and inserts the box 200 into the instrument 300 of the platform 100. For example, when using the box 1200, the body 1202 of the box 1200 is positioned or loaded into the drawer (not shown) of the instrument 300 without the container 1204. After the body 1202 is correctly positioned, the container 1204, in a closed configuration, is positioned within the arm 1240 and attached to the body 1202. The user then closes the drawer of the instrument 300, which causes the instrument's pin to actuate the cap 1252 of the container 1204 into an open configuration, exposing the pipette tip 1280.

[0061] In step 13, the user determines what tests the instrument 300 will perform on the sample within the cartridge 200. The instrument 300 may display one or more tests that can be performed on the sample based on the readings of the cartridge label 270. The user can determine the test to be performed by selecting the test on a touchscreen display located on the surface of the platform 100. The user can also select the test to be performed in other ways (e.g., via Bluetooth on a smartphone or tablet). In an alternative example, the instrument 300 may not require the user to select the test to be performed, and the instrument 300 may automatically perform the test corresponding to the readings of the cartridge label 270 of the inserted cartridge 200.

[0062] In step 14, the instrument 300 begins to perform the desired test on the sample contained in the sample container 260 of the cartridge 200. The movement system 310 moves the fluid controller 320 to properly position it above the pipette tip pocket 250 within the cartridge 200. The mandrel 324 of the fluid controller 320 is connected to the pipette tip 1280 selected by the user for the desired test. The mandrel 324 can be connected to any pipette tip 1280 by moving the movement system 310 into the pipette tip 1280 and forming a press-fit connection.

[0063] In step 15, the moving system 310 then causes the pipette tip 1280, which is connected to the mandrel 324 of the fluid controller 320, to move so as to properly position it above the sample container 260 of the cartridge 200. The fluid controller 320 uses an internal valve connected to the mandrel 324 and the pipette tip 1280 to aspirate the sample contained within the sample container 260.

[0064] In step 16, the moving system 310 then moves the pipette tip 1280, which is connected to the mandrel 324 of the fluid controller 320 adjacent to the magnet 322. The magnet 322 pulls the magnetic beads located within the pipette tip 1280 to one side of the pipette tip 1280. The fluid controller 320 then dispenses the reagent into the appropriate well 220. The magnetic beads can separate DNA / RNA of interest from the sample and then clean or alter the chemical properties of the sample. After dispensing the sample, the moving system 310 can then move the pipette tip 1280 connected to the mandrel 324 away from the magnet 322 to aspirate another sample and repeat the process in this step. In an alternative embodiment, beads are collected within each corresponding well 220 by placing the magnet 322 on the outer surface of each well 220 before the fluid controller removes fluid from the well 220, leaving the magnetic beads. In such an embodiment, the magnet 322 can move toward and away from the well 220 to capture or release the magnetic beads.

[0065] In step 16.5, particularly for cartridge 1200, the moving system 310 moves the fluid controller 320 and the pipette tip 1280 on the detection section 1210. In the first position, the plunger 1213 of the filling port 1212 is positioned close to the top surface of the filling port 1212, wherein the top seal 1215 engages with the window 1216, which holds the plunger 1213 within the desired first position during storage and transport of cartridge 1200. Furthermore, in the first position, the top surface of the plunger 1213 is positioned below the top surface of the filling port 1212 to prevent accidental actuation of the plunger 1213 by the user before inserting cartridge 1200 into the instrument 300 of platform 100. While the plunger 1213 is still in the first position, the moving system 310 moves the pipette tip 1280 into the inlet port 1214 of the filling port 1212 on the side adjacent to the plunger 1213. Then, the pipette tip 1280 dispenses the sample near the plunger 1213 and into the internal chamber of the filling port 1212, as shown. Figure 3I As best illustrated. The pipette tip 1280 can dispense a sample into either inlet port 1214 of the filling port 1212, while the inlet port 1214 not engaged by the pipette tip 1280 provides ventilation to the internal chamber of the filling port 1212 during sample dispensing, such as... Figures 3H to 3I The best example shown is...

[0066] Continuing with step 16.5, after all samples have been dispensed, the moving system 310 next moves the pipette tip 1280 into the internal opening of the plunger 1213 and actuates the plunger 1213 in a downward direction through the filling port 1212. As the plunger 1213 is actuated in a downward direction through the filling port 1212, the bottom surface of the plunger 1213 forces the sample in the internal chamber of the filling port 1212 through the outlet port 1217 and into the internal channel of the detection section 1210. The plunger 1213 will continue to be actuated by the pipette tip 1280 until all samples have been dispensed, and the plunger 1213 is positioned in a second position within the filling port 1212, as shown below. Figure 3K As best shown in the diagram. In the second position, the bottom seal 1215 is positioned close to the bottom surface of the outlet port 1217 and the filling port 1212. Furthermore, in the second position, the bottom surface of the plunger 1213 seals the outlet port 1217, preventing sample from escaping from the internal channel of the detection section 1210 and flowing back into the filling port 1212. Additionally, in the second position, sealing the outlet port 1217 prevents crosstalk between detection chambers 1211 connected to different outlet ports 1217.

[0067] In step 17, as part of the testing process, heater 350 is positioned below cartridge 200 and heats orifice 220 to maintain the target liquid temperature. Heater 350 can be used in tests requiring sample temperature control above ambient temperature (e.g., during cell lysis). Heater 350 can be a thermostatic heater or a resistive electric heater, along with a temperature sensor, which heats the reaction vessel within cartridge 200 to maintain the target liquid temperature. Additionally, heater 350 can be coupled to orifice 220 to maximize surface area, improving heat conduction, thereby increasing temperature accuracy and reducing the time it takes for the sample or reagent to reach the target temperature. Heater 350 and any accompanying sensors can be paired with electronics that can set the temperature and remove power under fault conditions to meet individual fault condition requirements.

[0068] In step 18, prior to or during the detection step 19 discussed below, the detection thermal system 340 further prepares the sample by heating or cooling it according to the desired test. As shown, the thermal system 340 is positioned adjacent to the body 202 of the container 200 and the heater 350. The thermal system 340 is modular and can consist of heaters and cooling elements designed to maintain a constant temperature or perform ramps (ascent or descent). For example, the thermal system 340 can be a Peltier-based heater / cooler designed to rapidly heat and cool the sample through a series of setpoints in the qPCR (formation of copies of target DNA) process (e.g., for PCR). Different chemical reactions require different temperatures, and reagents also need to be at specific / reproducible temperatures when optical measurements are performed. Alternatively, the detection thermal system 340 can consist of Peltier-based heating / cooling elements that can maintain high or low reagent temperatures, or allow the temperature to increase or decrease steadily.

[0069] In step 19, the detection system 330 acquires multiple readings of the sample to calculate the test result. During this step, the detection system 330 may acquire only one reading of the sample or may acquire multiple readings of the sample. The detection system 330 is modular and may be a fluorometer, photometer, microscope, spectrophotometer, flow cytometer, imaging system, or any other detection system specific to the test required by the patient. The fluorometer measures the fluorescence generated by the sample and does so by projecting excitation light of an appropriate wavelength into a vessel to generate fluorescence in the presence of any fluorophores. The fluorescence is then detected by the fluorometer's photoelectric device and expressed as a measurement in relative fluorescence units (RFU). The photometer may include a light source, a sample holder, and a detector. The photometer may measure the transmission, absorption, or scattering of light.

[0070] In step 20, platform 100 displays the final reading of the sample to the user based on the selected test. The final reading can be displayed via a touchscreen display on the surface of platform 100 or via other means (e.g., displaying to a mobile phone or tablet via Bluetooth). In step 21, instrument 300 returns pipette tip 1280 to the pipette tip container 204 of cartridge 200. The user can then remove cartridge 200.

[0071] While the invention has been described with respect to specific embodiments, it should be understood that these embodiments are merely illustrative examples of the principles and applications of the invention. Platform 100 can be customized to match specific testing needs, and this includes adding, removing, modifying, or rearranging any or all components of boxes 200, 1200 and / or instruments 300, 1300. Therefore, it should be understood that many modifications can be made to the exemplary embodiments, and other arrangements can be designed, without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A method for manufacturing a platform for performing tests, the method comprising the following steps: Provide a chassis for the platform; Multiple components are provided based on the tests to be performed; The components are arranged on the chassis; as well as A box is provided for use with the platform when performing the test.

2. The method of claim 1, wherein the test performed is an in vitro diagnostic (IVD) test.

3. The method of claim 1, wherein the step of providing the plurality of components comprises: A mobile system and a fluid controller are provided, and the fluid controller is configured to interact with the box.

4. The method of claim 3, wherein the step of providing the plurality of components comprises: The provided mobility system is a motor and pulley system, which are configured to move the fluid controller.

5. The method of claim 3, wherein the step of providing the plurality of components comprises: The provided mobility system is configured to allow the fluid controller to move in any direction along the X, Y, and Z axes.

6. The method of claim 3, wherein the step of providing the plurality of components comprises: The provided fluid controller is configured to connect to a pipette tip located in the pocket of the box.

7. The method of claim 3, wherein the step of providing the plurality of components comprises: The provided fluid controller is configured to draw in and dispense the fluid contained within the cartridge.

8. The method of claim 7, wherein the step of providing the plurality of components further comprises: A pneumatic system is provided, which is connected to the fluid controller to provide a vacuum, thereby drawing in the fluid and applying pressure, and thus distributing the fluid.

9. The method of claim 7, wherein the step of providing the plurality of components further comprises: A magnet is provided, the magnet being configured to alter the properties of the fluid being drawn in by the fluid controller.

10. The method of claim 9, wherein the step of providing the plurality of components comprises: The provided fluid controller is configured to connect to a pipette tip, the pipette tip including a plurality of magnetic beads disposed therein, and the magnet is configured to move the plurality of magnetic beads to one side of the pipette tip.

11. The method of claim 1, wherein the step of providing the plurality of components comprises: A heater is provided, which is configured to change the temperature of the fluid contained within the container.

12. The method of claim 11, wherein the step of providing the plurality of components comprises: The provided heater is positioned on a chassis below the box.

13. The method of claim 11, wherein the step of providing the plurality of components comprises: The provided heater is a thermostatic heater or a resistance electric heater.

14. The method of claim 11, wherein the step of providing the plurality of components comprises: A detection thermal subsystem is provided, which is positioned on a chassis adjacent to the heater and the box, and is configured to further change the temperature of the fluid contained within the box.

15. The method of claim 14, wherein the step of providing the plurality of components comprises: A detection thermal subsystem is provided, which is a Peltier-based heater or a Peltier-based cooler.

16. The method of claim 1, wherein the step of providing the plurality of components comprises: A detection system is provided, which is configured to determine the result of the test.

17. The method of claim 16, wherein the step of providing the plurality of components comprises: The provided detection system is configured to acquire multiple readings of the fluid contained within the cartridge.

18. The method of claim 16, wherein the step of providing the plurality of components comprises: The provided detection system is a fluorometer, photometer, microscope, spectrophotometer, flow cytometer, or imaging system.

19. The method of claim 1, wherein the step of providing the box comprises: Position the box in the drawer of the platform and move the drawer so that the box is positioned above the chassis.

20. The method of claim 1, further comprising the step of removing the plurality of components disposed on the chassis based on a test to be performed prior to the step of providing the plurality of components.

Images