Devices, systems, and methods for assay systems

Abstract

A device for implementing an assay system is provided, the device including a chamber, the chamber including a first opening and a second opening, a liquid outlet, a liquid absorbent pad adjacent the chamber, an opening assembly for shifting the device between a closed position and an open position, and a sealing element; In the closed position, a sealing element covers the liquid outlet to prevent liquid from exiting the chamber; In the open position, at least a portion of the liquid outlet is uncovered by the sealing element and the device includes a fluid pathway between the chamber and the liquid absorbent pad through the uncovered portion of the liquid outlet. Additionally, an assay system and a method for performing the assay are provided.

Description

Technical Field

[0004] , ,

[0001] The present invention relates to in vitro diagnostic IVD devices.

Background Art

[0002] Currently, in vitro diagnostic IVD devices are being developed on a large scale and account for 13.4% of the global medical technology market. In particular, the European IVD market is expected to reach over $15.5 billion by 2024. The penetration of personalized medicine, the increasing needs for chronic diseases, and new markets in emerging countries are the main driving forces. A long diagnostic time increases mortality and, furthermore, the estimated medical costs for undiagnosed or misdiagnosed patients. Due to the delay in disease diagnosis, the development of several solutions for rapid testing has been progressing. Rapid and simple tests have low sensitivity and predictive values, and moreover, the gold standard methods have to be performed using bench-top equipment in hospitals, so such existing solutions have significant drawbacks. Current immunological diagnostic tests can be classified into the following three categories. The first category includes quantitative tests based on immunoassay methods such as ELISA, which are performed in specialized clinical laboratories and the results are fed back in a few days. The second category includes qualitative tests, which are rapid diagnostic tests (RDTs) based on immunochromatography methods, with very low sensitivity and the results are subject to the interpretation of physicians, so they are subjective. Furthermore, the results of qualitative tests have to be confirmed by quantitative laboratory tests. The third category includes analytical clinical testing services, which are companies specialized in diagnostic testing services ranging from ordinary blood tests to genetic tests and molecular tests.

[0003] It is necessary to shorten the time for in vitro diagnosis and avoid situations where resources are restricted at the required time.

Summary of the Invention

[0004] In a first aspect of the present disclosure, a device for performing an assay is provided, the device comprising an electrode, and The first cover, A chamber comprising a first opening for adding magnetic particles and liquid into the chamber, A chamber including a second opening adjacent to this chamber for bringing magnetic particles and liquid into contact with electrodes located within the device, A first cover including a sealing element, A second cover that fits the first cover, the second cover includes a liquid absorbent pad adjacent to the chamber, A liquid outlet for draining liquid from the chamber, The device includes an opening assembly for shifting the device between a closed position and an open position, and this opening assembly is Including the First Collaborative Organization and the Second Collaborative Organization, the First Cover includes the First Collaborative Organization, and the Second Cover includes the Second Collaborative Organization. The sealing element is for sealing the liquid outlet, and the liquid absorption pad faces at least a portion of the liquid outlet of the chamber when the device is in the open position. In the closed position, the sealing element covers the liquid outlet to prevent the liquid from flowing out of the chamber through the liquid outlet, and in the open position, At least a portion of the liquid outlet is not covered by a sealing element. The device includes a fluid path between the chamber and the liquid absorption pad, passing through the uncovered portion of the liquid outlet.

[0005] The device or cartridge relating to this disclosure is suitable for conducting assays or in vitro tests. Also referred to as a cartridge, this device includes a chamber for containing a sample, which may include fluid clinical samples containing biomarkers of a disease or condition, such as blood, serum, plasma, or other samples in liquid form, including environmental samples containing food, beverages, or contaminants. In particular, it can be utilized in a wide range of applications in food safety, including the detection of biomarkers such as malaria, celiac disease, mycobacterium, and AIDS, as well as microcontaminants (insecticides, antibiotics, additives, allergens) and pathogens. Such samples may further include magnetic particles bound to desired molecules or biological receptors, i.e., peptides, antibodies, DNA, oligonucleotides, or biomarkers in the sample, or other molecules that specifically react with or adhere to the target. One advantage of the device relating to this disclosure is that the chamber can be used as a container, depending on the position of the opening assembly, allowing the liquid to be retained for reaction or removed by capillary action, for example, by an absorbent pad for cleaning. In the closed position, a sealing element, which may include a waterproof O-ring or a sealing gasket that may include a membrane or gasket, seals or defaces the liquid outlet, thereby preventing the flow of liquid from the chamber. The liquid outlet can be understood as an orifice or slot, or as a permeable surface suitable for the liquid in the chamber to flow toward the absorbent pad. In the open position, the sealing element exposes at least a portion of the liquid outlet, forming a fluid path between the chamber and the liquid absorbent pad, which removes or discharges the liquid in the chamber by capillary action. Such an absorbent pad may be composed of a predetermined pore size, or it may be any type of commercially available absorbent paper or sponge. The size of the absorbent pad may be suitable for absorbing any predetermined amount of liquid, including a liquid sample and / or a cleaning buffer. The absorbent pad is positioned adjacent to the chamber, meaning that it may be close to the chamber so that a fluid path can be formed.In some embodiments, the absorbent pad surrounds or covers at least a portion of the liquid outlet; in some embodiments, the absorbent pad faces the liquid outlet; and in some embodiments, the absorbent pad is positioned across the liquid outlet.

[0006] An advantage of the device of this disclosure is that, compared to, for example, ELISA systems or microplate immunoassays, pipetting to remove excess liquid is unnecessary.

[0007] This device consists of two cooperative parts that move relative to each other, formed by an opening assembly consisting of a first cooperative mechanism and a second cooperative mechanism.

[0008] In some embodiments, the first and second cooperating mechanisms are movable relative to each other so that the second cover can move toward and away from the first cover in order to shift between a closed position and an open position. The cooperating mechanism may be, for example, a rail and a wheel that rotates across the rail, or a groove and a projection that passes through or slides along the groove, or a mechanism including a hinge for opening and closing the device.

[0009] In some embodiments, the first cooperative mechanism can form a screw-in connection with the second cooperative mechanism such that the second cover is screwed into the first cover and unscrewed from the first cover, shifting between a closed position and an open position.

[0010] The configuration of the cooperative mechanism may depend on the requirements of use, and each configuration may offer various advantages to the end user, as well as advantages during manufacturing. In this embodiment, a second cover is provided that is configured to screw into a first cover. The screw-in connection may include a helical groove and projections. Further embodiments may include, for example, flanges or projections that slide through or along the grooves, which may be easier to manufacture than the screw-in connection. For example, the screw threads allow the end user to control the opening and closing of the device compared to a projection / groove mechanism, thereby avoiding unwanted movement of the specimen housed in the chamber.

[0011] In some embodiments, the device may include an electrode receiving slot adjacent to the chamber at a position that allows the sample or liquid to flow through the second opening toward the electrode receiving slot under the force of gravity when the chamber contains a sample or liquid. In some embodiments, the position that allows the sample or liquid to flow through the second opening toward the electrode receiving slot under the force of gravity when the chamber contains a sample or liquid may be located below the chamber when the device is in an upright or vertical position. In such embodiments, the upright or vertical position can be understood as a position where, considering a reference plane XZ for positioning the device, the first opening is higher than the second opening on an axis Y perpendicular to the plane XZ, and the second opening is higher than the electrode receiving slot on an axis Y perpendicular to the plane XZ, in which case the electrode receiving slot is located below the chamber, so that when the device is positioned in an upright position during use and a sample or liquid is inserted into the chamber, the sample or liquid will fall toward or be discharged toward the electrode receiving slot under the force of gravity.

[0012] The electrode receiving slot allows for the fixed positioning of the electrode within the device so that the sample to be analyzed can be brought into contact with the electrode. Thus, the electrode receiving slot enables the correct positioning of the electrode for use with the device or cartridge of this disclosure. The electrode receiving slot may be provided with fixing means such as a flap or adhesive to provide stability to the electrode. This is convenient in preventing the electrode from becoming detached from the device when inserting or removing the electrode from the reader. An advantage over qualitative or rapid diagnostic tests (RDTs) based on immunochromatography is that the electrode is inserted into a reader capable of providing quantitative results, thus providing non-visual interpretation.

[0013] In some embodiments, the device may include a magnet slot adjacent to the chamber, such that, when the chamber contains magnetic particles and the magnet is positioned in the magnet slot, the magnetic particles are able to move toward the magnet through a second opening under the magnetic field generated by the magnet. The magnet slot allows for the correct positioning of the magnet for use with the device or cartridge of the present disclosure. Thus, the device or cartridge of the present disclosure can be used for magnetically driven assays. In some embodiments in which the device is used, for example, with electrodes positioned in electrode slots and further with magnets positioned in magnet slots, the electrodes may be located between the magnets and the magnetic particles so that the magnetic particles are attracted toward the magnets and come into contact with the electrodes, and are fixed toward the electrodes. Continuing to refer to plane XZ, the magnet slots may be located below the electrode receiving slots on axis Y perpendicular to plane XZ, so that, during use, the liquid falls or flows toward the electrode receiving slots under the force of gravity, and the particles in the liquid are then attracted toward the magnets provided in the magnet receiving slots. This configuration offers the advantage that even if the liquid portion of the sample is absorbed by the liquid absorption pad when the device is in the open position, the particles are retained on the electrodes provided in the electrode receiving slots.

[0014] Magnetically driven assays can be performed by adding magnetic particles to a sample. Therefore, the devices or cartridges of this disclosure are suitable for use in methods for detecting any type of target or biomarker in a sample, when specific molecules or biological receptors, i.e., peptides, antibodies, DNA, oligonucleotides, or other molecules capable of specifically reacting with or adhering to biomarkers or targets, are immobilized on magnetic particles. For example, a simple and rapid method for detecting viruses or bacteria may involve immobilizing antibodies specific to bacteria or viruses onto magnetic particles or magnetic nanoparticles. The antibody-immobilized magnetic particles can be added to the chamber of the device or cartridge. Samples containing specimens or targets, such as blood samples, can also be added to the chamber so that the molecules or biological receptors attached to the particles can interact with the specimen or target by affinity reactions. Magnets within or adjacent to the device or cartridge can attract magnetic particles attached to the specimen or target of interest toward electrodes through a second opening. In this position, while the magnetic particles are in contact with and held or fixed to at least the surface of the electrode, excess liquid from the sample can be drained, thereby shifting the device or cartridge to the open position so that it can be absorbed by the absorption pad. Once the excess liquid has been absorbed, a washing step may also be included while the cartridge is in the open position. In either case, once the liquid has been adsorbed, the device or cartridge can be shifted to the closed position, allowing the readout reagent to bind with the magnetic particles attracted in the closed position. The electrode can then be inserted into a transducer or readout device that enables the measurement to be performed.

[0015] Accordingly, the device or cartridge of this disclosure allows the electrode or magnetic device to perform quantitative reading of the sample, while excess liquid of the sample and assumed reagents can be removed by capillary action in the liquid absorption pad.

[0016] Expert users can obtain the device or cartridge of this disclosure without electrodes, and can insert the necessary electrodes into the device or cartridge as needed, depending on the feasible analysis. Non-expert users can obtain the system of this disclosure, which includes the device or cartridge and electrodes. In such cases, non-expert users only need to add the sample to the device or cartridge without requiring expertise regarding specific electrodes suitable for the analysis to be performed.

[0017] A second aspect of this disclosure provides an assay system comprising a device or cartridge according to a first aspect of the present invention and a reading device. The reading device can provide the signal change of an electrode or electrode cell as a reading.

[0018] In some embodiments, the assay system of the present disclosure further includes a magnet. The magnet is positioned adjacent to the chamber such that, when the device or cartridge is coupled to the reader, the chamber contains a sample containing magnetic particles, and the magnetic particles are able to move toward the magnet through a second opening under the magnetic field generated by the magnet. In such embodiments, either the device or the cartridge may include a magnet, or the reader may include a magnet.

[0019] In some embodiments, the cartridge or device may include a communication interface for communicating with a portable device. The portable device may be a tablet or portable electronic device, or a smartphone or mobile phone configured to receive measurements from a reader or transducer.

[0020] The devices or cartridges and systems of this disclosure may be understood as in vitro diagnostic (IVD) tools that combine the capabilities of magnetic particles with a standard tablet or smartphone via a connection through an interface such as a USB cable or wireless interface.

[0021] The device or cartridge of the present disclosure may be for single use. Further, when detecting a disease, the device may provide a quantitative readout for detecting disease biomarkers in whole blood, serum or plasma. The device of the present disclosure can be used by medical professionals for rapid diagnosis of diseases.

[0022] In a third aspect of the present disclosure, a method of performing an assay or an in vitro test is provided, which method comprises at least the following steps: providing an assay system according to the second aspect of the present disclosure; providing a device or cartridge in a closed position; adding a sample to be analyzed into the chamber through a first opening, wherein at least a part of the sample is in a liquid state; shifting the device or cartridge to an open position, wherein at least a part of the liquid outlet is not covered by a sealing element, and a fluid path is formed between the chamber and a liquid absorption pad through the uncovered part of the liquid outlet; flowing the liquid part of the sample through the fluid path and removing at least a part by the liquid absorption pad; shifting the device to a closed position; adding a readout reagent into the chamber; and reading the obtained sample with an electrode reading device.

[0023] In the method of the present disclosure, the open and closed positions of the cartridge of the present disclosure can be switched to add the sample and the reagent into the chamber for subsequent analysis by a reading device. The method of the present disclosure is advantageous because it provides a simple usage method that allows the user to remove excess liquid from the sample to be analyzed.

[0024] In some embodiments, the method includes the steps of providing a system equipped with a magnet, adding a sample containing magnetic particles, and further flowing the liquid portion of the sample through a fluid pathway such that at least a portion is removed by a liquid absorption pad while the particles are attracted by the magnet. The sample is said to be discharged by the absorption pad. In such embodiments, the method provides a simple method for removing liquid, which may include a washing solution or buffer. While the excess liquid is being absorbed, the target or specimen of interest is attracted towards the magnet and electrodes, preventing it from moving toward the absorption pad. In such embodiments, the electrodes may not contain molecules or biological receptors because they are immobilized on the magnetic particles.

[0025] In some embodiments of this method, a cleaning buffer is added to the chamber after the sample has been added and before the device or cartridge is shifted to the open position. For example, if there is a sample at a concentration that is not suitable for absorption by the absorption pad by capillary action, the cleaning buffer can improve the cleaning of such a sample.

[0026] In the open position, a cleaning step may also be added, in which the liquid portion of the cleaning solution is discharged, the fluid path is allowed to flow, and at least a portion of it is removed by the liquid absorption pad. For example, the cleaning solution can be added to the chamber before shifting the device or cartridge to the closed position, and thus before adding the readout reagent to the chamber.

[0027] Non-limiting embodiments of this disclosure will be described below with reference to the attached drawings. [Brief explanation of the drawing]

[0028] [Figure 1A] This figure shows an example of a device or cartridge according to the present invention. [Figure 1B] This figure shows an example of notation for a part of the device or cartridge according to the present invention in the closed position. [Figure 1C]This figure shows an example of a notation representing a part of the device or cartridge according to the present invention in the open position. [Figure 2] This is a diagram showing a disassembled cartridge chamber. [Figure 3A] This diagram shows an example of a cartridge chamber in the closed and open positions. [Figure 3B] This diagram shows an example of a cartridge chamber in the closed and open positions. [Figure 4A] This diagram shows further example cartridge chambers in the closed and open positions, respectively. [Figure 4B] This diagram shows further example cartridge chambers in the closed and open positions, respectively. [Figure 5] This is a diagram showing an example of a cartridge. [Figure 6] This figure shows a device or chamber in a closed position, containing liquid held within the chamber. [Figure 7A] This figure shows an example of an assay system. [Figure 7B] This shows a plan view of the assay system and a side view of the assay system cut along line AA'. [Figure 8] This figure shows an example of the method disclosed herein. [Figure 9] This figure shows an example of a device or cartridge 90. [Figure 10] This figure shows an example assay system 100. [Modes for carrying out the invention]

[0029] In order to fully understand the present invention, specific details will be explained in the following description.

[0030] Figure 1A is an illustrative representation of a device or cartridge 10, 10 according to the present invention. Figure 1A shows a chamber 11 including a first opening 111 and a second opening 112.

[0031] Figure 1B is an illustrative representation of a part of the device 10 or cartridge 10 according to the present invention in a closed position. Figure 1B shows the device 10 including a chamber 11 as a cavity 11, which includes a first opening 111 with height and a second opening 112 with no height. Figure 1B also shows a sealing element, sealing gasket, or O-ring 12, an absorbent pad 13, and an opening assembly 14 in a closed position.

[0032] Figure 1C shows an illustrative representation of a part of the device or cartridge according to the present invention in an open position in plane XZ. Figure 1C shows a device 10 comprising a chamber 11 including a first opening 111 and a second opening 112. Furthermore, Figure 1C also shows a sealing element 12, an absorbent pad 13, an open opening assembly 14, and a liquid outlet 15. The liquid outlet 15 is an opening formed between the cover or casing 17, which includes the chamber 11, and the base of the device. The device or cartridge 10 is shown in an upright or vertical position, where, considering a reference plane XZ, the first opening 111 is higher than the second opening 112 on axis Y perpendicular to plane XZ. In use, in the upright position, liquid can be added or inserted through the first opening 111, and the liquid falls into the chamber by gravity and settles at the base of the chamber. In the closed position, the liquid outlet 15 is closed and sealed by the sealing element 12, thereby preventing the liquid from leaving the chamber 11. In the open position, the liquid outlet 15 is open, forming a fluid path 16, and the liquid exits the chamber 11 along the fluid path 16 toward the liquid absorption pad 13.

[0033] As shown in various Figures 1A, 1B, and 1C, the device, or cartridge 10, can be used for an assay system, the device or cartridge including a chamber 11, the chamber 11 including a first opening 111 for adding magnetic particles and liquid into the chamber, and a second opening 112 for bringing the magnetic particles and liquid into contact with an electrode adjacent to the chamber. The device or cartridge includes a liquid outlet 15 suitable for removing liquid from the chamber toward an absorbent pad 13. A sealing gasket 12 is configured to cover at least the liquid outlet 15 of the chamber 11 to prevent liquid flow through the liquid outlet in the closed position. The liquid absorbent pad 13 is positioned adjacent to the chamber. An opening assembly 14 helps to shift the device between a closed position and an open position, and as seen in Figure 1B, in the closed position, the sealing element 12 covers the liquid outlet, thereby closing, locking, or sealing the liquid outlet 15 in Figure 1B. This prevents liquid from flowing out of the chamber 11 in the closed position. As seen in Figure 1C, in the open position, at least a portion of the liquid outlet is not covered by the sealing element, and in particular, Figure 1C shows the liquid outlet 15 which is not completely covered, and the fluid path 16 is formed between the chamber 11 and the liquid absorption pad 13 through the uncovered portion of the liquid outlet 15. In Figures 1A, 1B, and 1C, the absorption pad 13 is shown to have a specific width, but to improve absorption capacity, the absorption pad 13 may completely occupy the empty space 18 shown in Figure 1B. By changing the width or size of the absorption pad, different amounts of liquid can be absorbed by the absorption pad.

[0034] Figure 2 shows a disassembled cartridge or device 20, where the first cover 21 includes the chamber 22, and in Figure 2, the sealing element 23 is shown detached from the first cover. When the cartridge 20 is not disassembled, the first cover 21 fits onto the second cover 24, which includes a liquid absorbent pad 25. When not disassembled, the liquid absorbent pad 25 faces at least a portion of a liquid outlet, which in the embodiment of Figure 2 is an orifice or slot formed in the open position by separating the first cover from the second cover. In the closed position, the sealing element 23 blocks the fluid path between the chamber 22 and the liquid absorbent pad 25, preventing liquid from leaving the chamber. The opening assembly 26 includes a first cooperative mechanism and a second cooperative mechanism (not shown), where the first cover 21 includes the first cooperative mechanism and the second cover 24 includes the second cooperative mechanism.

[0035] Figures 3A and 3B show an exemplary cartridge or device 30 in a closed and open position. In the closed position, the first cover 31 and the second cover 32 are close together, forming a more compact chamber 30 than in the open position. Figure 3 shows that the first cooperating mechanism 33 and the second cooperating mechanism 34 are movable relative to each other so that the cartridge chamber 30 shifts between the closed and open positions when the first cover 31 and the second cover 32 move closer together or further apart. Furthermore, the first cooperating mechanism 33 and the second cooperating mechanism 34 of the cartridge 30 form a screw-in connection or coupling so that either the second cover 32 or the first cover 31 is screwed into the first cover 31 or the second cover 32, and then unscrewed from the first cover 31 or the second cover 32, shifting between the closed and open positions. In particular, the first cooperative mechanism 33 and the second cooperative mechanism 34 of the cartridge or device 30 are movable relative to each other so that the first cover 31 can move toward and away from the second cover 32 in order to shift between a closed position and an open position. In the illustrated cartridge 30, the first cooperative mechanism 33 can form a screw-in with the second cooperative mechanism 34 so that the first cover 31 can screw into and unscrew away from the second cover 32, shifting between a closed position and an open position. In Figure 3, the first cooperative mechanism 33 is a groove 33, and the second cooperative mechanism 34 is a projection 34 that runs along or slides along the groove 33. The cooperative mechanism in Figure 3 may also include a bayonet coupling.

[0036] Figures 4A and 4B show further illustrative cartridge chambers 40 in a closed and open position, respectively. The cartridge 40 comprises a first cover 41 which includes a chamber 411 and a sealing element 412. The first cover 41 fits into a second cover 42. The second cover 42 includes a liquid absorbent pad 421 which faces a liquid outlet 43 (shown in an unsealed state in Figure 4B). In this example, the liquid outlet 43 is a hole or cavity 43 formed between the first cover 41 and the second cover 42 in the open position. The liquid outlet 43 is covered by the sealing element 412 in the closed position and exposed in the open position, leaving a fluid path 44 between the chamber and the absorbent pad 421. In addition, in the closed position, the sealing element 412 blocks the fluid path 44 between the chamber 411 and the liquid absorbent pad 421, preventing liquid from leaving the chamber. As shown in the figures, in the closed position of Figure 4A, the liquid 45 is held in the chamber 411, and in the open position of Figure 4B, the liquid 45 flows along the fluid path 44 and is absorbed by the absorption pad 421. Furthermore, the opening assembly 46 includes a first cooperating mechanism 461 and a second cooperating mechanism 462, with the first cover 41 including the first cooperating mechanism 461 and the second cover 42 including the second cooperating mechanism 462. The first cooperating mechanism 461 and the second cooperating mechanism 462 of the cartridge or device 40 are movable relative to each other so that the first cover 41 and the second cover 42 can move relative to each other in order to shift between the closed and open positions. In particular, the cooperating mechanisms of the cartridge or device 40 are the first locking tab 461 and the second locking tab 462. The user can lift the first cover 41 away from the second cover 42 and position the first locking tab 461 on the second locking tab 462 at point 47 to lock the first cover 41 in the open position. Furthermore, the user can lower the first cover 41 toward the second cover 42 and position the first locking tab 461 below the second locking tab 462 at point 48 to lock the first cover 41 in the closed position.

[0037] Figure 5 shows an illustrative embodiment of the cartridge 50. The cartridge or device 50 includes a first cover 51 and a second cover 52. Figure 5 shows the first cover and the second cover removed. The first cover 51 includes a chamber 54 defined within an inner cavity of a funnel, partitioned by a first opening (not shown) and a second opening 512, as in previous embodiments. As shown in Figure 5, the first cooperating mechanism 511 and the second cooperating mechanism 521 form a screw-in connection or joint so that the first cover 51 can be screwed into the second cover 52. The first cooperating mechanism 511 and the second cooperating mechanism 521 are two helical projections. The cartridge 50 ultimately includes an electrode receiving slot 53 adjacent to the chamber 54 when the first cover 51 and the second cover 52 are attached or screwed in. The electrode receiving slot 53 is positioned such that, in operation with the second cover 52 functioning as a base, when the chamber 54 contains liquid in the closed position, gravity forces the liquid to flow towards the electrode receiving slot in the closed position through the second opening. When the electrode is placed in the electrode receiving slot 53, the electrode can interact with the liquid and, furthermore, the electrode can be read to determine the composition of the liquid or to detect its components. Once the electrode has been analyzed, the cartridge or device 50 can be shifted to the open position so that the liquid is absorbed by a liquid absorption pad (not shown in Figure 5) contained within the cartridge 50.

[0038] As seen in the specific embodiment in Figure 5, when the chamber contains a sample or liquid, the position that allows the sample or liquid to flow through the second opening toward the electrode receiving slot due to the force of gravity is a position below the chamber 54 when the device is in the upright or vertical position. In such an embodiment, the upright or vertical position is a position where, considering a reference plane XZ for positioning the device, the first opening is higher than the second opening 512 on axis Y perpendicular to plane XZ, and the second opening 512 is higher than the electrode receiving slot 53 on axis Y perpendicular to plane XZ, in which case the electrode receiving slot 53 is below the chamber 54, and when the device is positioned in the upright position and a sample or liquid is inserted into the chamber 54, the sample or liquid falls toward the electrode receiving slot 53 due to the force of gravity.

[0039] In one embodiment, the cartridge or device may include a magnet slot adjacent to the chamber, in a position that allows the magnetic particles to move toward the magnet through a second opening under the magnetic field generated by the magnet, when the chamber contains magnetic particles and the magnet is positioned in the magnet slot. In the above embodiment, in the cartridge or device 10, the magnet may be included in a magnet slot (not shown) adjacent to or near the chamber 11, below the second opening 112, in a position that allows the magnetic particles to move toward the magnet through the second opening 112 under the magnetic field generated by the magnet, when the chamber contains magnetic particles in a liquid and the magnet is positioned in the magnet slot. In the cartridge or device 20, the magnet slot may be located in the second cover 24. In the cartridge or device 30, the base of the second cover 32 may have a magnet slot on the side opposite to the side facing the chamber. In the cartridge or device 40, the magnet slot may be included in the second cover 42 below the surface facing the chamber. In the cartridge or device 50, a magnet is provided in the magnet slot, and when the chamber 54 is in the closed position and contains liquid, magnetic particles in the liquid are attracted to the magnet, and an electrode provided in the electrode receiving slot may be located in the second cover 52 below the electrode receiving slot 53 so that it can be brought into contact with a specimen or target of interest attached to the magnetic particles. Figure 6 shows the cartridge or device 60 in the closed position, containing liquid 61 held in the chamber. The cartridge or device 60 includes the magnet slot 63. If the liquid 61 contains magnetic particles and the magnet slot contains a magnet, the particles are attracted under the magnetic field generated by the magnet and come into contact with the surface between the second opening and the magnet. If the cartridge or device has an electrode in the electrode receiving slot 62, the electrode can be brought into contact with the magnetic particles through the second opening 64, and the electrode can be used to read a specimen or target attached to the particles.

[0040] Figure 7A shows an assay system 70 comprising a device or cartridge 71, which includes all or any of the exemplary features described herein. The assay system includes an electrode 72, a reader 73 configured to read the electrode 72, and a magnet 733 provided within the reader. The cartridge or device 71 includes an electrode receiving slot (not shown) into which the electrode 72 appears to be inserted. As shown, when a liquid is introduced vertically into the chamber through a first opening of the cartridge or device, a portion of the electrode 72, including the contacts of the electrode 72, can be inserted and fixed below the second opening 711 such that the liquid comes into contact with a portion of the electrode 721 through a second opening. For example, the electrode may be a screen-printed electrode, which is suitable for processing minute volumes or immersion in a solution. Such electrodes can function well in the development of dispersed assays or electrochemical readout biosensors. The electrochemical cell may include a working electrode and an auxiliary electrode, the working electrode may be made of carbon, and the auxiliary electrode may be made of silver or silver chloride. The electrodes may be constructed on a ceramic or plastic substrate. The electrodes may include, in particular, other non-electrochemical transducer mechanisms such as optical, electronic, piezoelectric, gravimetric, pyroelectric, and magnetic. The cartridge or device 71 may be disposable. Since the cartridge or device 71 does not include a magnet slot or magnet, the weight and cost of the disposable cartridge or device 71 are reduced. The reading device 73 may include a screen or display that shows, for example, the measured potential, the current range obtained during measurement, the acquisition time, and the stabilization time. The reading device 73 may further include a communication interface with the device, for example, a wireless interface for communication with a smartphone. Furthermore, the reading device 73 may include a magnet slot with a cartridge or device receiving slot 731, a control button 732, and a magnet 733 as at least one of the following functions. The reading device may include a communication interface (not shown) for communicating with the device. Figure 7B is a plan view of the assay system 70 and a side view of the assay system 70 cut along line AA'.

[0041] The assay or in vitro test can be performed using any of the cartridges or devices described in this disclosure. Figure 8 is a diagram illustrating an example of the method, in which the following steps are represented from left to right in different diagrams. This delicious, The steps include providing an assay system 80, The steps include providing a device or cartridge 81 in a closed position, The step of adding the sample to be analyzed 82 into the chamber 84 through the first opening 83, wherein at least a portion of the sample is in a liquid state, Step 85 of shifting the device or cartridge 81 to the open position, wherein at least a portion of the liquid outlet 86 is not covered by a sealing element, and the fluid path is formed between the chamber and the liquid absorption pad 87 through the uncovered portion of the liquid outlet. The steps include: flowing the liquid portion of the sample through a fluid path and removing at least a portion of it with a liquid absorption pad; 88 steps to shift the device to the closed position, The steps include adding the readout reagent 88' into the chamber, The procedure includes 89 steps of reading the obtained sample with an electrode reading device.

[0042] In the examples, the sample contains magnetic particles, and the step of flowing the liquid portion of the sample through a fluid path is performed while the magnetic particles are attracted by the magnet 801, so that at least a portion of the sample is removed by the liquid absorption pad. In some examples, after adding the sample 82 and before shifting the device or cartridge to the open position 85, a cleaning buffer is added to clean the sample in the chamber.

[0043] Figure 9 shows an exemplary device or cartridge 90 that includes all or any of the exemplary features described herein. This figure shows the cartridge 90 with an electrode 92 inserted into the electrode receiving slot. The electrode insertion portion can be seen through a second opening 912 of the chamber 91. Liquid can be introduced into the chamber 91 through a first opening 911 and allowed to fall vertically by gravity to the second opening 912, where it can come into contact with the electrode 92. A magnet (not shown) placed beneath the electrode can attract magnetic particles and hold them in an open position so that the liquid is absorbed by an absorbent pad (not shown).

[0044] Figure 10 shows an exemplary assay system 100 comprising a device or cartridge 101 including an electrode 102, the assay system including a reader 103 configured to read the electrode 102, the reader being insertable into an electrode slot 104 provided in the reader 103.

[0045] In some embodiments, the electrodes can be permanently integrated into the device or cartridge adjacent to the chamber, so that when a sample or liquid is inserted into the chamber during use, gravity causes the sample or liquid to fall toward the electrodes. For example, the electrodes can be attached with an adhesive or screen-printed electrodes can be used. In such cases, the device or cartridge may be disposable.

[0046] In such cases, the electrode may contain some immobilized molecule or biological receptor, i.e., a peptide, antibody, DNA, oligonucleotide, or biomarker in the sample, or other molecule that specifically reacts with or adheres to the target. In such cases, the addition of the sample to the chamber is performed with the device or cartridge in the closed position. After a predetermined time, the molecular or biological receptor of the electrode adheres to or reacts with the sample or target, and there is no risk of the compound of interest flowing toward the absorption pad and being absorbed there, and the device or cartridge can be opened to wash and remove excess reagent.

[0047] For the sake of completeness, various aspects of this disclosure are described in the following series of numbered sections. Section 1. A device (10, 20, 30, 40, 50, 60, 71, 81) for performing the assay, and this device is The chamber is (11,22,411,54,84), First openings (111, 83) for adding magnetic particles and liquid (45, 61, 82) into the chamber, A chamber (11, 22, 411, 54, 84) comprising a second opening (112, 512, 64, 711) for bringing magnetic particles and liquid into contact with electrodes adjacent to the chamber, Liquid outlets (15, 43, 86) for draining the liquid from the chamber, Liquid absorbent pads adjacent to the chamber (13, 25, 421, 87), An opening assembly (14, 26, 46) for shifting the device between a closed position and an open position, It includes sealing elements (12, 23, 412) for sealing the liquid outlets (15, 43, 86), In the closed position, the sealing elements (12, 23, 412) cover the liquid outlets (15, 43, 86) to prevent the liquid from flowing out of the chambers (11, 22, 411, 54, 84) through the liquid outlets (15, 43, 86). In the open position, At least a portion of the liquid outlet is not covered by the sealing element (12,23,412), The device includes a fluid path (16, 44) between the chamber (11, 22, 411, 54, 84) and the liquid absorption pad (13, 25, 421, 87), passing through the uncovered portion of the liquid outlet (15, 43, 86), and the device (10, 20, 30, 40, 50, 60, 71, 81). Section 2. The first cover (21, 31, 41, 51) includes chambers (11, 22, 411, 54, 84) and sealing elements (12, 23, 412), The first cover fits the second cover (24, 32, 42, 52), The second cover includes liquid absorbent pads (13, 25, 421, 87), The liquid absorption pad faces at least a portion of the liquid outlets (15, 43, 86) of the chamber when in the open position. The opening assembly (14, 26, 46) includes the first cooperative mechanism (33, 461, 511) and the second cooperative mechanism (34, 452, 521), The devices described in paragraph 1 (10, 20, 30, 40, 50, 60, 71, 81) include the first cooperation mechanism (33) in the first cover (21, 31, 41, 51) and the second cooperation mechanism (34) in the second cover (18, 32). Section 3. The device according to paragraph 2, wherein the first cooperative mechanism (33,461,511) and the second cooperative mechanism (34,452,521) are movable relative to each other so that the first cover and the second cover can move relative to each other in order to shift between a closed position and an open position. Section 4. The device according to either the second or third paragraph, wherein the first cooperating mechanism (33,461,511) and the second cooperating mechanism (34,452,521) form a screw-fit connection so that one of the second cover or the first cover is screwed into the first cover or the second cover and shifts between a closed position and an open position by being screwed out from the first cover or from the second cover. Section 5. The device according to any one of paragraphs 1 to 4, further including electrode receiving slots (53, 62) adjacent to the chamber, which, when the chamber contains liquid, are subject to the force of gravity, allow the liquid to flow through the second opening toward the electrode receiving slots. Section 6. The device according to any one of paragraphs 1 to 5, further including a magnet slot (63) adjacent to the chamber, where the chamber contains magnetic particles and the magnet is positioned in the magnet slot (63), and under the magnetic field generated by the magnet, the magnetic particles are able to move toward the magnet through a second opening. Section 7. Assay system (70,80), A device or cartridge as described in any one of paragraphs 1 to 6, Including electrode (72), Assay system (70, 80). Section 8. The assay system described in paragraph 7 (70, 80), further including magnets (733). Section 9. The assay system according to either paragraph 7 or 8 (70, 80), further including a reading device configured to read electrodes (73, 801). Section 10. The assay system described in any one of paragraphs 7 to 9 (70, 80), further including a communication interface for communicating with a device. Section 11. A method for performing an assay or in vitro test, the method comprising at least the following steps: A step of providing an assay system (70, 80) as described in any one of paragraphs 7 to 10, The steps include providing devices (10, 20, 30, 40, 50, 60, 71, 81) in a closed position, A step of adding the sample to be analyzed into the chamber through a first opening, wherein at least a portion of the sample is in a liquid state, A step of shifting the device to an open position, wherein at least a portion of the liquid outlet is not covered by a sealing element, and a fluid path is formed between the chamber and the liquid absorption pad through the uncovered portion of the liquid outlet. The steps include: flowing the liquid portion of the sample through a fluid path and removing at least a portion of it with a liquid absorption pad; Steps to shift the device to the closed position and The steps include adding the readout reagent into the chamber, A method comprising the step of reading the obtained sample with an electrode reading device. Section 12. If paragraph 11 is dependent on paragraph 8, the method according to paragraph 11, wherein the sample contains magnetic particles, and the step of flowing the liquid portion of the sample through a fluid path is performed while the magnetic particles are attracted by a magnet, such that at least a portion of the sample is removed by a liquid absorption pad. Section 13. The method according to either item 10 or 11, further comprising the step of adding a cleaning buffer for cleaning the sample in the chamber after the sample has been added and before the device has been shifted to the open position.

[0048] While this specification discloses only a few examples, other alternatives, modifications, uses, and / or equivalents are possible. Furthermore, all conceivable combinations of the examples described are also covered. Therefore, the scope of this disclosure should not be limited by any particular embodiment, but shall be determined solely by the correct interpretation of the following claims. Where reference numerals related to the drawings are indicated in parentheses in a claim, they are for the sole purpose of aiding the understanding of the claim and should not be construed as limiting the scope of the claim.

Claims

1. A device for performing an assay (10, 20, 30, 40, 50, 60, 71, 81, 90, 101), wherein the device is Electrodes (72, 92, 102) and The first cover (21, 31, 41, 51), The chambers are (11, 22, 411, 54, 84, 91), A first opening (111, 83, 911) for adding magnetic particles and liquid (45, 61, 82) into the chamber (11, 22, 411, 54, 84, 91), A chamber (11, 22, 411, 54, 84, 91) including a second opening (112, 512, 64, 711) for bringing the magnetic particles and liquid into contact with the electrodes (72, 92, 102) arranged in the device adjacent to the chamber (11, 22, 411, 54, 84, 91), A first cover (21, 31, 41, 51) including sealing elements (12, 23, 412), A second cover (24, 32, 42, 52) that fits the first cover (21, 31, 41, 51), wherein the second cover (24, 32, 42, 52) is A second cover (24, 32, 42, 52) including liquid absorbent pads (13, 25, 421, 87) adjacent to the chambers (11, 22, 411, 54, 84, 91), Liquid outlets (15, 43, 86) for discharging liquid from the chambers (11, 22, 411, 54, 84, 91), The device includes an opening assembly (14, 26, 46) for shifting the device between a closed position and an open position, the opening assembly (14, 26, 46) including a first cooperating mechanism (33, 461, 511) and a second cooperating mechanism (34, 462, 521), The first cover (21, 31, 41, 51) includes the first cooperative mechanism (33, 461, 511), and the second cover (24, 32, 42, 52) includes the second cooperative mechanism (34, 462, 521), The sealing elements (12, 23, 412) are for sealing the liquid outlets (15, 43, 86), The liquid absorbent pads (13, 25, 421, 87) face at least a portion of the liquid outlets (15, 43, 86) of the chambers (11, 22, 411, 54, 84, 91) in the open position of the device. In the closed position, the sealing element (12, 23, 412) covers the liquid outlet (15, 43, 86) to prevent the liquid from flowing out of the chamber (11, 22, 411, 54, 84, 91) through the liquid outlet (15, 43, 86), and in the open position, At least a portion of the liquid outlets (15, 43, 86) is not covered by the sealing elements (12, 23, 412), The device (10, 20, 30, 40, 50, 60, 71, 81, 90, 101) includes a fluid path (16, 44) between the chamber (11, 22, 411, 54, 84, 91) and the liquid absorption pad (13, 25, 421, 87) passing through the uncovered portion of the liquid outlet (15, 43, 86).

2. The device according to claim 1, wherein the first cooperating mechanism (33, 461, 511) and the second cooperating mechanism (34, 462, 521) are movable relative to each other so that the first cover (21, 31, 41, 51) and the second cover (24, 32, 42, 52) can move relative to each other in order to shift between the closed position and the open position.

3. The device according to claim 1 or 2, wherein the first cooperating mechanism (33, 461, 511) and the second cooperating mechanism (34, 462, 521) form a screw-in connection such that one of the second cover (24, 32, 42, 52) or the first cover (21, 31, 41, 51) is screwed into the first cover or the second cover and is unscrewed from the first cover or the second cover to shift between a closed position and an open position.

4. The device according to claim 1 or 2, further comprising the electrode receiving slots (53, 62) adjacent to the chamber (11, 22, 411, 54, 84, 91), in a position that, when the chamber contains liquid, allows the liquid to flow through the second openings (112, 512, 64, 711) toward the electrode receiving slots (53, 62) under the force of gravity.

5. The device according to claim 1 or 2, further comprising a magnet slot (63) adjacent to the chamber (11, 22, 411, 54, 84, 91) in a position that allows the magnetic particles to move toward the magnet through the second opening (112, 512, 64, 711) under the magnetic field generated by the magnet when the chamber contains magnetic particles and the magnet is positioned in the magnet slot (63).

6. Assay system (70, 80, 100), Assay system (70, 80, 100) comprising a device (10, 20, 30, 40, 50, 60, 71, 81, 90, 101) according to claim 1 or claim 2, and a reading device (73, 800, 103) configured to read the electrodes (72, 92, 102).

7. The assay system (70, 80, 100) according to claim 6, further comprising magnets (733, 801).

8. The assay system according to claim 6 (70, 80, 100), further comprising a communication interface for communicating with a device.

9. A method for performing an assay or in vitro test, the method comprising at least the following steps: The steps of providing the assay system (70, 80, 100) according to claim 6, The steps include providing the devices (10, 20, 30, 40, 50, 60, 71, 81, 90, 101) in the closed position, A step of adding a sample to be analyzed (82) into the chamber (11, 22, 411, 54, 84, 91) through the first opening (111, 83, 911), wherein at least a portion of the sample is in a liquid state; Step (85) of shifting the device (10, 20, 30, 40, 50, 60, 71, 81, 90, 101) to the open position, wherein at least a portion of the liquid outlet (15, 43, 86) is not covered by the sealing element (12, 23, 412), and a fluid path (16, 44) is formed between the chamber (11, 22, 411, 54, 84, 91) and the liquid absorption pad (13, 25, 421, 87) through the uncovered portion of the liquid outlet (15, 43, 86), The steps include: flowing the liquid portion of the sample through the fluid path (16, 44) and removing at least a portion of it with the liquid absorption pad (13, 25, 421, 87); Step (88) of shifting the devices (10, 20, 30, 40, 50, 60, 71, 81, 90, 101) to the closed position, The steps include adding the readout reagent (88') into the chambers (11, 22, 411, 54, 84, 91), A method comprising the step of reading the sample with an electrode reading device (73, 800, 103) (89).

10. The method according to claim 9, wherein the sample comprises magnetic particles, and the step of flowing the liquid portion of the sample through the fluid path (16, 44) so ​​that at least a portion of it is removed by the liquid absorption pad (13, 25, 421, 87) is performed while the magnetic particles are attracted by a magnet (733, 801).

11. The method according to claim 9, further comprising the step of adding a cleaning buffer for cleaning the sample in the chamber (11, 22, 411, 54, 84, 91) after the sample has been added and before the device has been shifted to the open position.

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