Platform for performing in vitro diagnostics

Abstract

The present disclosure relates to a method of making a platform for performing a test. The method comprises the steps of providing a chassis for the platform, providing a plurality of components based upon the test to be performed, arranging the components on the chassis, and providing a cartridge for use with the platform in performing the test.

Description

PLATFORM FOR PERFORMING IN VITRO DIAGNOSTICSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of the filing date of United States Provisional Patent Application No. 63 / 528,129 filed July 21, 2023, the disclosure of which is hereby incorporated herein by reference.BACKGROUND OF THE INVENTION

[0002] The present disclosure relates to a platform and method for performing various in vitro diagnostics (IVD) assays or other tests on samples.

[0003] Many different testing devices are known for performing IVD assays and other tests on samples. These are often designed for a specific type of test on a specific type of sample. Thus, each device may only have a single particular use and designing and manufacturing such machines can be cumbersome and time consuming.

[0004] There exists a need for a customizable platform that can be quickly and easily configured for different types of testing and other uses.BRIEF SUMMARY OF THE INVENTION

[0005] The present disclosure relates to an apparatus, or platform, for performing different types of tests on different types of samples. The platform includes a cartridge containing the sample, and other fluids, and an instrument for receiving the cartridge and preparing and testing the sample. Both the cartridge and the instrument are designed to be customizable for the test and sample desired to be tested by a user of the platform. Specifically, the cartridge is designed to be customized for the specific sample to be tested. Similarly, the instrument includes different, modular components that are designed to be added, removed, or replaced within the platform for the desired test. Additionally, the platform of the present disclosure includes different embodiments of the cartridge and the instrument, and each embodiment of cartridge is designed to be compatible with each embodiment of the instrument, or a specific embodiment of the cartridge is designed to be compatible with only a specific embodiment of the instrument. Further, the present disclosure relates towards methods of making the platform and performing tests with the platform.

[0006] In a first example of a first aspect, the present disclosure relates to a method of making a platform for performing a test. The method comprises the steps of providing a chassis for the platform, providing a plurality of components based upon the test to be performed, arranging the components on the chassis, and providing a cartridge for use with the platform in performing the test.

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

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

[0009] In an eight example, the seventh example of the first aspect is further defined wherein the step of providing the plurality of components further comprises providing a pneumatic system connected to the fluid controller to provide a vacuum to aspirate the fluid and a pressure to dispense the fluid. In a ninth example, the seventh example of the first aspect is further defined wherein the step of providing the plurality of components further comprises providing a magnet configured to alter properties of the fluid aspirated by the fluid controller. In a tenth example, the ninth example of the first aspect is further defined wherein the step of providing the plurality of components includes the fluid controller provided being configured to connect with a pipette tip which includes a plurality of magnetic beads disposed therein, and the magnet is configured to move the plurality of magnetic beads to a side of the pipette tip.

[0010] In an eleventh example, the first example of the first aspect is further defined wherein the step of providing the plurality of components includes providing a heater configured to alter the temperature of a fluid contained within the cartridge. In a twelfth example, the eleventh example of the first aspect is further defined wherein the step of providing the plurality of components includes providing the heater positioned on the chassis below the cartridge. In a thirteenth example, the eleventh example of the first aspect is further defined wherein the step of providing the plurality of components includes providing the heater being a constant temperature heater or a resistive electric heater. In a fourteenth example, the eleventh example of the first aspect is further defined wherein the step of providing the plurality of components includes providing a detection thermal subsystem positioned on the chassis adjacent to the heater and cartridge, and the detection thermal subsystem is configured to further alter the temperature the fluid contained within the cartridge. In a fifteenth example, the fourteenth example of the first aspect is further defined wherein the step of providing the plurality of components includes providing a detection thermal subsystem being a Peltier-based heater or a Peltier-based cooler.

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

[0012] In a first example of a second aspect, the present disclosure relates to a method of performing a desired test on a sample. The method comprises the step of modifying components of a platform for the desired test, wherein the platform includes a cartridge and an instrument. The method further comprises the step of inserting the cartridge into the instrument, wherein a sample is within a sample container of the cartridge. The method further comprises the step of selecting the desired test to be performed by the platform, wherein selecting the desired test causes: (i) a motion system of the instrument to move and connect a fluid controller of the instrument with a pipette tip located within a pipette tip container of the cartridge, (ii) the motion system to move the pipette tip connected to the fluid controller to be positioned over the sample container to aspirate the sample, (iii) the motion system to move the fluid controller and pipette tip adjacent to a magnet to retain magnetic beads in the pipette tip while the sample is dispensed into a vessel according to the desired test, (iv) thermal systems of the instrument to prepare the temperature of the sample according to the desired test, and (v) a detection system of the instrument to take a reading of the sample according to the desired test. The method further comprises the step of displaying the final reading of the sample from the desired test.

[0013] In a first example of a third aspect, the present disclosure relates to a platform for performing a desired test on a sample. The platform comprises a cartridge including a tray and a container, wherein the tray includes a plurality of wells for dispensing the sample and the container includes a pipette tip container and a sample container. The platform further comprises an instrument including a motion system, fluid controller, thermal systems, and a detection system, each removably attached to a chassis, wherein: (i) the motion system is configured to move the fluid controller, (ii) the fluid controller is configured to aspirate and dispense the sample in the cartridge, (iii) the thermal systems are configured to heat or cool reagents, and (iv) the detection system is configured to take a final reading of the sample according to the desired test.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 is a perspective view of a platform according to an embodiment of the present disclosure.

[0015] FIGS. 2A-2B are perspective views of an embodiment of a cartridge of the platform of FIG. 1.

[0016] FIG. 2C is a perspective view of a main body of the cartridge of FIGS. 2A-2B.

[0017] FIG. 2D is a perspective view of a container of the cartridge of FIGS. 2A-2B.

[0018] FIG. 2E is a perspective view of another embodiment of a cartridge of the platform of FIG. 1.

[0019] FIG. 2F is a perspective view of another embodiment of a cartridge of the platform of FIG. 1

[0020] FIG. 3 A is a perspective view of another embodiment of a cartridge of the platform of FIG. 1.

[0021] FIG. 3B is a perspective view of a main body of the cartridge of FIG. 3A.

[0022] FIGS. 3C-3D are perspective views of a container of the cartridge of FIG. 3A.

[0023] FIGS. 3E-3F are perspective views of a detection section of the cartridge of FIG. 3A.

[0024] FIG. 3G is a cross-sectional view of the detection section of FIGS. 3E-3F.

[0025] FIG. 3H is another perspective view of the detection section of FIGS. 3E-3F and a pipette tip of the platform of FIG. 1.

[0026] FIG. 31 is a cross-sectional view of the detection section of FIG. 3H.

[0027] FIGS. 3J-3K are cross-sectional views of a fill port of the detection section of FIG. 3H.

[0028] FIG. 4A is a perspective view of an instrument of the platform of FIG. 1 with covers removed.

[0029] FIG. 4B is an exploded view of a plurality of covers for the instrument of FIG. 4A.

[0030] FIG. 4C is a perspective view of a motion system of the instrument of FIG. 4A.

[0031] FIG. 4D is a perspective view of a fluid controller of the instrument of FIG. 4A.

[0032] FIG. 5A is a perspective view of another embodiment of an instrument of the platform of FIG. 1, with covers removed therefrom.

[0033] FIG. 5B is another perspective view of the instrument of FIG. 5 A.

[0034] FIG. 5C is another perspective view of the instrument of FIG. 5 A.

[0035] FIG. 5D is a top view of the instrument of FIG. 5A.

[0036] FIG. 5E is a perspective view of a motion system of the instrument of FIG. 5A.

[0037] FIG. 5F is another perspective view of a motion system of the instrument of FIG. 5A.

[0038] FIG. 5G is another perspective view of a motion system of the instrument of FIG. 5A.

[0039] FIG. 6 is a diagram for a control system of the platform of FIG. 1.

[0040] FIG. 7 is a flow chart for a method of using the platform of FIG. 1.DETAILED DESCRIPTION

[0041] Particular embodiments of the present disclosure will be described herein with reference to the accompanying drawings. As shown in the drawings and as described throughout the following description, and as is traditional when referring to relative positioning on an object, the term "proximal" should be understood as referring to the portion of a structure that is closer to a clinician during proper use and the term "distal" should be understood as referring to the portion of a structure that is farther from the clinician during proper use. Also, as used herein, the terms “substantially,” “generally,” and “about” are intended to mean that slight deviations from absolute are included within the scope of the term so modified.

[0042] Referring to FIG. 1, a point of care platform 100 according to one embodiment of the present disclosure is shown. Platform 100 includes a cartridge 200, 1200 (best shown in FIGS. 2A-3K) and an instrument 300, 1300 (best shown in FIG. 4A-5G). Platform 100 is designed to be tailored to perform an in vitro diagnostics (IVD) assay or various other tests of a bodily sample from a patient, which may be a human or animal bodily sample, or other types of organic samples. While different embodiment cartridges and instruments are disclosed herein, it is to be understood that each component may be tailored to be useable with another. For instance, cartridge 200 can be utilized with instrument 1300. Platform 100 includes multiple detection technology for various types of tests and types of samples, while prior art systems include only single detection technology. Additionally, for systems that do include multiple detection technologies, platform 100 reduces instrument 300, 1300 size and costs due to the modularity of its components.

[0043] Different embodiments of cartridge 200, 1200 is shown in FIGS. 2A-3K. In each embodiment, cartridge 200, 1200 is modular, disposable, and customizable for use with instrument 300, 1300 in platform 100. With reference to FIGS. 2A-D, one embodiment of cartridge 200 includes a first section or main body 202 connected to a second section or container 204 by a hinge 240. Cartridge 200 may be a single joined piece or several separately stored components that are each placed into instrument 300. For example, main body 202 and container 204 may each be separately stored or placed into instrument 300. Main body 202 (best shown in FIG. 2C) includes a detection section 210, one or more vessels or regent wells 220, and foil 230. Detection section 210 may be an electronic chip or a microfluidic well for polymerase chain reaction (PCR) or another customizable detection device as required in a particular testing process. Detection section 210 is positioned at a distal end of the main body 202 and cartridge 200, and, in this embodiment, is for PCR detection, containing chambers for optical detection, designed to maximize surface area for thermal conductivity and allowing optics to take a reading. Wells 220 are positioned on a top portion of main body 202 and allows a pipette tip 1280 (discussed further below) access to aspirate and dispense liquids. A waste container (not shown) can be within wells 220 or elsewhere in the main body 202 and / or cartridge 204, and each waste container can include a sponge (not shown) for holding waste generated during the analysis. Foil 230 is positioned as a pierceable layer on top of vessels 220. Foil 230 includes containers for storing reagents, whether dried (e.g., lyophilised), aqueous, alcohols or oil. The foil 230 also includes pouches 232 that are used for reagents that cannot be stored in a plastic container without loss or degradation, also known as “blisters”.

[0044] Container 204 (best shown in FIGS. 2A, 2B and 2D) of cartridge 200 is positioned proximal of main body 202 and extends in a downward manner. Container 204 includes an exterior cover 206, as best shown in FIG. 2A. Container 204 may include one or a plurality of pipette tips within pipette tip containers or pockets 250 and one or a plurality of vessels or sample containers 260 with openings disposed on a top surface of container 204 and extending downward towards a bottom surface of container 204. In the embodiment shown in FIGS. 2A-2B, eight pipette tip pockets 250 and one sample container 260 are included.

[0045] Cartridge 200 may also be comprised of different materials and may have different dimensions. For instance, container 204 may be composed of transparent material to allow optical inspection of the container and its contents. Container 204 may have a length of 55 mm, a width of 50 mm, and a height of 70 mm. As shown in FIGS. 2E-2F, main body 202 and container 204 can be modified to have different dimensions and components. Specifically, main body 202 may include various detection chips 210 and vessels 220 and may include different dimensions of foil 230 to cover differing amounts of vessels 220. Similarly, container 204 may include varying amounts of pipette tip pockets 250 and / or sample containers 260. Main body 202 and / or container 204 may be composed of non-transparent materials and are not limited to a single material for the entire cartridge 200. Additionally, as best shown in FIGS. 2E-2F, embodiments of cartridge 200 may include a cartridge label 270 which is customizable and commonly includes a cartridge barcode, graphics for branding, or key user or safety information, as discussed further below.

[0046] Another embodiment of a cartridge 1200 is shown in FIGS. 3A-3K, with like reference numerals being utilized in connection with similar components to that of cartridge 200, but within the 1200- series of numerals. Cartridge 1200 includes a main body 1202, a pipette tip storage container 1204, and adetection section 1210. Main body 1202 includes a plurality of reagent wells 1220, a foil 1230, a sample container 1260, and a waste container 1270. Each well 1220 extends downward from a top surface of main body 1202 to allow pipette tips 1280 (described below) access to aspirate and dispense liquids. Sample container 1260 also extends downward from the top surface of main body and is designed to receive a sample to be tested by platform 100, as discussed further below. Waste container 1270 also extends downward from the top surface of main body and may include a sponge (not shown) for retaining liquid waste generated during the test execution. In an alternative embodiment, a waste container 1270 may be disposed within at least one of wells 1220, or may be disposed within all of wells 1220.

[0047] Foil 1230 is designed to be positioned on the top surface of main body 1202 as a pierceable layer above each respective opening for wells 1220, forming cavities that can be used for reagent storage or processing steps during test execution, as discussed further below. In an alternative design, foil 1230 may be used to form both the top and bottom surfaces of a “blister pack” (not shown) which has the primary benefit of low vapor transmission rates and extending the cartridge shelf life. A combination of these reagent storage approaches is suitable for many different reagent types, including dried (e.g., lyophilised), aqueous, alcohols or oils.

[0048] Pipette tip storage container 1204 (best shown in FIGS. 3A, 3C, and 3D) of cartridge 1200 is releasably received within a pair of arms 1240 extending laterally from a side of main body 1202. When connected with main body 1202, and in use with platform 100 as described further below, container 1204 extends in a vertically downward manner from cartridge 1200. In alternative embodiments, container 1204 may initially extend horizontally from cartridge 1200 prior to being articulated or rotated into the vertical position as shown and described above. Container 1204 includes a plurality of pipette tips 1280 positioned within pipette tip containers or pockets 1250. In the depicted embodiment, container 1204 has a length of 55 mm, a width of 50 mm, and a height of 70 mm. However, main body 1202 and container 1204 may be modified to various dimensions and additional components. Specifically, main body 1202 may include numerous detection sections 1210 and wells 1220 and may include different dimensions of foil 1230 to cover differing amounts of wells 1220. Additionally, container 1204 may include varying amounts of pipette tip pockets 1250, and container 1204 may additionally include wells 1220, sample containers 1260, and / or waste containers 1270.

[0049] Container 1204 includes a pipette tip cover 1252 designed to selectively contain or encapsulate pipette tips 1280 positioned within pipette tip pockets 1250, as best shown in FIGS. 3C and 3D. Cover 1252 is hinged to a bottom portion of container 1204 such that cover 1252 is designed to laterally move or flex away from container 1204 to create an opening that exposes pipette tips 1280. For example, when not in use with platform 100, cover 1252 fully encapsulates pipette tips 1280 in container 1204 which prevents contamination of the pipette tips 1280 by the user and prevents displacement of pipette tips 1280 from container 1204. However, when in use with platform 100, instrument 300 includes a feature, such as a pin, (not shown) designed to contact cover 1252, which causes cover 1252to actuate and pipette tips 1280 to become exposed through an opening of the top portion of container 1204, as discussed further below. The actuation of the cover 1252 when in use with platform 100 is an improvement over commonly known andused methods of transferring pipette tips 1280 to an instrument 300, as this simplifies the design of instrument 300 and reduces the amount of required components and cost of manufacturing.

[0050] Detection section 1210 (best shown in FIGS. 3E-3K) includes a plurality of detection chambers 1211, a fill port 1212, and a plurality of air chambers 1218. In one embodiment, depicted in FIGS. 3F-3K, detection section 1210 includes eight detection chambers 1211 and is designed for PCR thermal cycling and optical readings. In other embodiments, the number of detection chambers 1211 may vary. For example, as shown in FIG. 3E, detection section 1210 includes four detection chambers 1211. Each detection chamber 1211 contains dried reagents that mix with the liquid reagent injected via fill port 1212. Additionally, detection section 1210 includes an air chamber 1218 for each detection chamber 1211, respectfully, configured to manage cartridge 1200 pressurization while in use with platform 100. Detection section 1210 may include a plurality of wells 1220 and foil 1230, as described above, at the point of connection with main body 1202, as best shown in FIG. 3E. Alternatively, detection section 1210 may not include any wells 1220 or foil 1230, and all wells 1220 and foil 1230 may be included only in main body 1202, as best shown in FIGS. 3F-3I.

[0051] Fill port 1212 (best shown in FIGS. 3F-3K) includes a plunger 1213, inlet ports 1214, seals 1215, a window 1216, and outlet ports 1217. Fill port 1212, as discussed further below when in use with instrument 300 and platform 100, is designed to transfer and seal reagents at different internal positions within cartridge 1200. In the depicted embodiment, fill port 1212 is connected to each detection chamber 1211 by internal channels (not shown) extending through detection section 1210. Reagent that is transferred into internal channels by fill port 1211 is unable to escape detection section 1210 of cartridge 1200, which is particularly beneficial when reagent is amplified in PCR and is essential that no amplified reagent contaminates the environment of platform 100.

[0052] Instrument 300 (best shown in FIGS. 4A-4D) includes a motion system 310, a fluid controller 320, a detection system 330, a detection thermal system 340, a heater 350, printed circuit boards 360, a pneumatic system 370, and a chassis 380. All components of instrument 300 are all positioned on a top surface of chassis 380, and all of the components are configured to be added, removed, modified, or rearranged on chassis 380 for numerous different designs and to be compatible with various configurations of cartridge 200, 1200 and of detection system 330. Additionally, a plurality of covers 302 may be customized for each specific design of instrument 300 and platform 100, one of which is shown in FIG. 4B.

[0053] Motion system 310 is shown both in FIG. 4 A and in more detail in FIG. 4C. Motion system 310 includes three independent motors and two pulley systems. Two of the motors are configured to move fluid controller 320 along a single toothed belt arranged between two pulleys. Motion system 310 is comprised of sheet metal and in an “H” design pattern. Motion system 310 is capable of moving fluid controller 320 in any direction along the X-, Y- and Z- axis.

[0054] Fluid controller 320 is shown both in FIGS. 4A-4B and in more detail in FIG. 4D. Fluid controller 320 is positioned along motion system 310 and includes a mandrel 324. Mandrel 324 of fluid controller 320 is configured to connect with disposable pipette tips located in the pipette tip pockets 250. Fluid controller 320 includes an internal valve that connects mandrel 324 with pneumatic system 380 that provides vacuum or pressure to aspirate and dispense fluid. Fluid controller 320 can monitor air flow rate in the systemto determine the volume of fluid the pipette tip aspirates and dispenses. The monitoring also allows fluid controller 320 and platform 100 to determine error conditions, such as, no pipette tip, bubbles or blockages in the fluid aspirate, aspiration of air rather than fluid, etc. Magnet 322 is best shown in FIG. 4A. Magnet 322 is positioned above cartridge 200, 1200 and adjacent to the pipette tip connected to mandrel 324 of fluid controller 320.

[0055] FIG. 6 is a diagram of a control system 102 according to one embodiment of platform 100.Control system 102 is designed for high flexibility for seamless use by a large range of tests or projects. Components of control system 102 include, but are not limited to, an optional user interface of a single board computer (SBC) or a lower instrument cost involving a phone or tablet that can connect via Bluetooth, onedimensional (ID) or two-dimensional (2D) barcoding for sample tracking, and status lights indicating when a user should interact with platform 100 coming in a range of color options. Additionally, control system 102 and platform 100 may be operated by various types of interchangeable software. Software examples include, but are not limited to, thermal control algorithms, optics signal processing, motion control algorithms, pipetting monitoring, engineering development tools, graphical user interface (GUI), automatic alignment and calibration tools, health monitoring, motion system 310 and fluid controller 320 coordination for liquid level following (LLF) in arbitrary well geometry to minimize pipette tip submersion.

[0056] Another embodiment of an instrument 1300 is shown in FIGS. 5A-5G, with like reference numerals being utilized in connection with similar components to that of instrument 300, but within the 1300- series of numerals. Instrument 1300 includes a motion system 1310, a fluid controller 1320, an optical detection system 1330, a detection thermal system 1340, a heater 1350, printed circuit board 1360, a pneumatic system 1370, and a chassis 1380. Similar to instrument 300, all components of instrument 1300 are all positioned on a top surface of chassis 1380, and all of the components are configured to be added, removed, modified, or rearranged on chassis 1380 for numerous different designs and to be compatible with various configurations of cartridge 200, 1200 and of detection system 1330. Further, a plurality of covers (not shown) may be customized for each specific design of instrument 1300 and platform 100.

[0057] Motion system 1310 is shown in more detail in FIGS. 5E and 5F. Motion system 1310 includes a first pulley system 1311 and a second pulley system 1312. First pulley system 1311 includes two driver pulleys 1313, six idler pulleys 1314 and two motors 1315. First pulley system 1311 is configured to move fluid controller 1320 in a first and second direction, or first and second axis, along a single toothed belt between idler pulleys 1314 due to actuation of driver pulleys 1313 from respective motors 1315. Further, first pulley system 1311 is assembled in an “H” design pattern on sidewalls of motion system 1310. Second pulley system 1312 includes one driver pulley 1313, one idler pulley 1314, and one motor 1315. Second pulley system 1312 is configured to move fluid controller 1320 in a third direction, or third axis, along a single toothed belt between idler pulleys 1314 due to actuation of the single driver pulley 1313 from the respective motor 1315.Motion system 1310 is comprised of sheet metal. Motion system 1310 is capable of moving fluid controller 1320 in any direction along the X-, Y- and Z- axis. Motion system 1310 provides greater flexibility in the workflow executed by instrument 1300, particularly for the different steps taken to execute the desiredIVD assay. Additionally, motion system 1310 allows for a more direct and faster translation of workflow such that there is a reduced need to change reagent formulations, reagent and sample volumes and processing steps.

[0058] FIG. 7 is a flow chart illustrating a method 1 of using platform 100 to perform an in vitro diagnostics (IVD) assay. Examples of the steps taken to execute the desired IVD assays that are performed in a method 1 of using platform 100 include, but are not limited to, sample metering, reagent addition and mixing, rehydration of lyophilized reagents, lysis through heating, washing using magnetic bead isolation approach, purification, detection. It should be understood that the following operations do not have to be performed in the exact order described below and are not necessarily exhaustive of all of the operations that may be performed during an IVD assay. Additionally, it should be understood that the below operations may be handled in a different order or simultaneously. Further, control system 102 may be used to perform any of the functions as described in the method 1 below.

[0059] In step 10, a user (not shown) customizes and modifies cartridge 200, 1200 and instrument300, 1300 of platform 100 to match a specific testing need. Method 1 refers to the use of cartridge 200 below, but cartridge 200, 1200 are interchangeable for use with instrument 300, 1300 and platform 100, and use of cartridges 200, 1200 with instrument 300, 1300 and platform 100 only differ as mentioned below. Similarly, method 1 refers to use of instrument 300 below, but instrument 300 and instrument 1300 are interchangeable for use with cartridges 200, 1200 and platform 100, and use of instrument 300, 1300 with cartridges 200, 1200 and platform 100 only differ as mentioned below. Specifically, platform 100 is modified to perform a desired test or IVD assay of a sample of the specific patient (not shown). This step may include adding or removing components from cartridge 200 and / or instrument 300 as needed for the desired test of the sample. Instrument 300 is compatible to perform desired tests on various configurations of cartridge 200, and the 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 modifying platform 100 and / or the person performing the desired test with the platform. Alternatively, a first user may only modify platform 100, while a second user may only perform the desired test with platform 100. In step 11, the user inserts the sample into sample container 260 of cartridge 200.

[0060] In step 12, the user scans cartridge label 270 and inserts cartridge 200 into instrument 300 of the platform 100. For example, when using cartridge 1200, main body 1202 of cartridge 1200 is positioned or loaded into a drawer (not shown) of instrument 300 without container 1204. After main body 1202 is properly positioned, container 1204, in a closed configuration, is positioned within arms 1240 and connected to main body 1202. User then closes drawer of instrument 300 which causes pin of instrument to actuate cover 1252 of container 1204 to an open configuration exposing pipette tips 1280.

[0061] In step 13, the user determines what test will be performed by instrument 300 to the sample within cartridge 200. Instrument 300 may display the test or tests able to be performed for the sample based upon the reading of cartridge label 270. The user may determine the test that will be performed by selecting the test on a touch screen display located on the surface of platform 100. The user may also select the test to be performed by other means, such as on a smartphone or tablet via Bluetooth. In alternative examples, theinstrument 300 may not require the user to select the test to be performed, and instrument 300 may automatically perform a test corresponding to a reading of cartridge label 270 of the inserted cartridge 200.

[0062] In step 14, instrument 300 begins to perform the desired test on the sample contained within sample container 260 of cartridge 200. Motion system 310 moves fluid controller 320 to be properly positioned over pipette tip pockets 250 within cartridge 200. Mandrel 324 of fluid controller 320 connects with the required pipette tip 1280 needed for the desired test selected by the user. The mandrel 324 may connect with any of pipette tips 1280 by having motion system 310 move mandrel 324 into pipette tip 1280 and forming a press-fit connection.

[0063] In step 15, motion system 310 then moves pipette tip 1280 connected to mandrel 324 of fluid controller 320 to be properly positioned over sample container 260 of cartridge 200. Fluid controller 320 uses an internal valve connected to mandrel 324 and pipette tip 1280 to aspirate the sample contained within sample container 260.

[0064] In step 16, motion system 310 then moves pipette tip 1280 connected to mandrel 324 of fluid controller 320 adj cent to magnet 322. Magnet 322 pulls magnetic beads located within pipette tip 1280 to a side of pipette tip 1280. Fluid controller 320 then dispenses the reagent into an appropriate wells 220. The magnetic beads may isolate DNA / RNA of interest in a sample and then clean or alter the chemical properties of the sample. After dispensing the sample, motion system 310 may then move pipette tip 1280 connected to mandrel 324 away from magnet 322 to aspirate another sample and repeat the process in this step. In an alternative embodiment, beads are collected within wells 220, by placing magnet 322 against an outside surface of each respective well 220 before the fluid controller removes the fluid from the well 220, leaving the magnetic beads behind. In such an embodiment, magnet 322 may move towards and away from the wells 220 to capture or release the magnetic beads.

[0065] In step 16.5, specifically for cartridge 1200, motion system 310 moves fluid controller 320 and pipette tip 1280 over detection section 1210. In a first position, plunger 1213 of fill port 1212 is disposed proximal a top surface of fill port 1212 with top seal 1215 engaging window 1216, which maintains plunger 1213 within this desired first position during storage and transportation of cartridge 1200. Also, in the first position, top surface of plunger 1213 is disposed below top surface of fill port 1212 to prevent accidental actuation of plunger 1213 from a user prior to inserting cartridge 1200 into instrument 300 of platform 100. While plunger 1213 is still within the first position, motion system 310 moves pipette tip 1280 into an inlet port 1214 of fill port 1212 adjacent a side of plunger 1213. Pipette tip 1280 then dispenses the sample adjacent plunger 1213 and into an internal chamber of fill port 1212, as best shown in FIG. 31. Pipette tip 1280 may dispense the sample into either inlet port 1214 of fill port 1212 and the inlet port 1214 not engaged by pipette tip 1280 provides venting of internal chamber of the fill port 1212 during the dispensing of the sample, as best shown in FIGS. 3H-3I.

[0066] Continuing with step 16.5, after dispensing all of the sample, motion system 310 then moves pipette tip 1280 into an internal opening of plunger 1213 and actuates the plunger 1213 in a downward direction through fill port 1212. As plunger 1213 is actuated in the downward direction through fill port 1212, a bottom surface of plunger 1213 forces the sample within the internal chamber of fill port 1212 to be pushedthrough outlet ports 1217 and into internal channels of detection section 1210. Plunger 1213 will continue to be actuated by pipette tip 1280 until all of the sample is dispensed and plunger 1213 is disposed in a second position within fill port 1212, as best shown in FIG. 3K. In the second position the bottom seal 1215 is positioned proximal the outlet ports 1217 and bottom surface of fill port 1212. Also, in the second position, the bottom surface of plunger 1213 seals the outlet ports 1217 preventing the sample from escaping the internal channels of the detection section 1210 and flowing back into fill port 1212. Additionally, in the second position, sealing outlet ports 1217 prevents cross talk between detection chambers 1211 connected to different outlet ports 1217.

[0067] In step 17, heater 350 is positioned under cartridge 200 and heats wells 220 to maintain a target liquid temperature as part of the test process. Heater 350 may be used in tests that require the sample be temperature controlled higher than ambient temperature (for example, in a cell lysis process). Heater 350 may be a constant temperature heater or a resistive electric heater and temperature sensors that heats reaction vessels within cartridge 200 to maintain a target liquid temperature. Additionally, heater 350 may engage with wells 220, aiming to maximize surface area to improve thermal conduction and thereby temperature accuracy, and reducing the time taken for the sample or reagent to reach the target temperature. Heater 350, and any accompanying sensors, may be paired with electronics that can set the temperature as well as remove power under fault conditions to meet a single fault condition requirement.

[0068] In step 18, detection thermal subsystem 340 further prepares the sample before or during the detection step 19 discussed below, by heating or cooling the sample according to the desired test. As shown, thermal subsystem 340 is positioned adjacent to main body 202 of container 200 and heater 350. Thermal subsystem 340 is modular and may consist of heater and cooling elements intended to hold constant temperatures or to perform a ramp (up or down). For instance, thermal subsystem 340 may be a Peltier-based heater / cooler, designed to rapidly heat and cool a sample, for example for PCR, through a series of setpoints in the process of qPCR (creating copies of the target DNA). Different chemical reactions require different temperatures to occur, and the reagent also needs to be at specific / repeatable temperatures as optical measurements are made. Additionally, detection thermal subsystem 340 may consist of Peltier-based heating / cooling elements which can maintain a high or low reagent temperature or steadily increase or decrease the temperature.

[0069] In step 19, detection system 330 takes multiple readings of the sample to calculate a result of the test. Detection system 330 may take only one reading or may take multiple readings of the sample during this step. Detection system 330 is modular and may be a fluorometer, a photometer, microscopes, spectrophotometers, flow cytometers, imaging systems or any other detection systems specific to the test needed by the patient. The fluorometer measures the fluorescence generated by the sample and does this by projecting excitation light of a suitable wavelength into the vessel to generate fluorescence if any fluorophore is present. The fluorescent light is then detected by the fluorometer optoelectronics and represented as a measurement of Relative Fluorescent Unit (RFU). The photometer may include a light source, sample holder and detector. The photometer may measure transmission, absorption or scatter of light.

[0070] In step 20, platform 100 displays the final reading of the sample according to the selected test for the user. The final reading may be displayed by touch screen display located on the surface of platform 100 or by other means, such as by Bluetooth to a mobile phone or tablet. In step 21, instrument 300 returns pipette tips 1280 into the pipette tip container 204 of cartridge 200. Cartridge 200 may then be removed by the user.

[0071] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. Platform 100 may be customized to match a specific testing need, and that includes adding, removing, modifying, or rearranging any or all components of cartridge 200, 1200 and / or instrument 300, 1300. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

Claims

CLAIMS1. A method of making a platform for performing a test, the method comprising the steps of: providing a chassis for the platform; providing a plurality of components based upon the test to be performed; arranging the components on the chassis; and providing a cartridge for use with the platform in performing the test.

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

3. The method of claim 1, wherein the step of providing the plurality of components includes providing a motion system and a fluid controller, and the fluid controller is configured to interact with the cartridge.

4. The method of claim 3, wherein the step of providing the plurality of components includes the motion system provided being a motor and a pulley system configured to move the fluid controller.

5. The method of claim 3, wherein the step of providing the plurality of components includes the motion system provided being configured to move the fluid controller in any direction along an X-, Y-, and Z- axis.

6. The method of claim 3, wherein the step of providing the plurality of components includes the fluid controller provided being configured to connect with a pipette tip located within a pocket of the cartridge.

7. The method of claim 3, wherein the step of providing the plurality of components includes the fluid controller provided being configured to aspirate and dispense a fluid contained within the cartridge.

8. The method of claim 7, wherein the step of providing the plurality of components further comprises providing a pneumatic system connected to the fluid controller to provide a vacuum to aspirate the fluid and a pressure to dispense the fluid.

9. The method of claim 7, wherein the step of providing the plurality of components further comprises providing a magnet configured to alter properties of the fluid aspirated by the fluid controller.

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

11. The method of claim 1, wherein the step of providing the plurality of components includes providing a heater configured to alter the temperature of a fluid contained within the cartridge.

12. The method of claim 11, wherein the step of providing the plurality of components includes providing the heater positioned on the chassis below the cartridge.

13. The method of claim 11 , wherein the step of providing the plurality of components includes providing the heater being a constant temperature heater or a resistive electric heater.

14. The method of claim 11, wherein the step of providing the plurality of components includes providing a detection thermal subsystem positioned on the chassis adjacent to the heater and cartridge, and the detection thermal subsystem is configured to further alter the temperature the fluid contained within the cartridge.

15. The method of claim 14, wherein the step of providing the plurality of components includes providing a detection thermal subsystem being a Peltier-based heater or a Peltier-based cooler.

16. The method of claim 1, wherein the step of providing the plurality of components includes providing a detection system configured to determine a result of the test.

17. The method of claim 16, wherein the step of providing the plurality of components includes providing the detection system being configured to take multiple readings of a fluid contained within the cartridge.

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

19. The method of claim 1, wherein the step of providing the cartridge includes positioning the cartridge in a drawer of the platform and moving the drawer such that the cartridge is positioned over the chassis.

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

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