Assay system device, system and method

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]

[0001] The present invention relates to an in vitro diagnostic IVD device. [Background technology]

[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 more than $15.5 billion by 2024. The penetration of personalized medicine, the increasing need for chronic diseases, and new markets in emerging countries are the main drivers. Longer diagnostic times increase mortality rates and, moreover, the estimated medical costs of undiagnosed or misdiagnosed patients. Delays in disease diagnosis have led to the development of several solutions for testing in a short time. Such existing solutions have important drawbacks, since rapid and simple tests have low sensitivity and predictive value, and the gold standard methods must be performed in the hospital using benchtop equipment. Current immunological diagnostic tests can be divided into three categories: The first category includes quantitative tests based on immunoassays such as ELISA, which are performed in specialized clinical laboratories and provide feedback of results within a few days. The second category includes qualitative tests, which are rapid diagnostic tests (RDTs) based on immunochromatographic techniques that have very low sensitivity and results are subjective as they are subject to the physician's interpretation. Furthermore, the results of qualitative tests must be confirmed by quantitative laboratory tests. The third category includes analytical clinical testing services, which are companies that specialize in diagnostic testing services, ranging from routine blood tests to genetic and molecular tests.

[0003] There is a need to reduce the time for in vitro diagnosis to avoid resource constraints at the time of need. 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; A first cover, a chamber having a first opening for adding magnetic particles and a liquid into the chamber; a chamber including a second opening for contacting the magnetic particles and the liquid with an electrode disposed within the device adjacent to the chamber; a first cover including a sealing element; a second cover adapted to fit over the first cover, the second cover including a liquid absorbent pad adjacent the chamber; a liquid outlet for draining liquid from the chamber; and an opening assembly for shifting the device between a closed position and an open position, the opening assembly comprising: a first cooperating mechanism and a second cooperating mechanism, the first cover including the first cooperating mechanism and the second cover including the second cooperating mechanism; the sealing element is for sealing the liquid outlet, and the liquid absorbent pad faces at least a portion of the liquid outlet of the chamber in the open position of the device; In the closed position, a sealing element covers the liquid outlet to prevent liquid from exiting the chamber through the liquid outlet, and in the open position At least a portion of the liquid outlet is not covered by the sealing element; The device includes a fluid pathway between the chamber and the liquid absorbent pad through an uncovered portion of the liquid outlet.

[0005] The device or cartridge according to the present disclosure is suitable for performing an assay or in vitro test. The device, also referred to as a cartridge, includes a chamber for receiving a sample, which may include a fluid clinical sample containing a biomarker of a disease or condition, such as blood, serum, plasma, or other samples in liquid form, including food, beverage, and environmental samples containing pollutants. Any application may be utilized in food safety, including micro-contaminants (pesticides, antibiotics, additives, allergens) and pathogens, as well as clinical applications including detection of biomarkers such as malaria, celiac disease, mycobacteria, AIDS, etc., among others. Such samples may further include magnetic particles bound to desired molecules or biological receptors, i.e. peptides, antibodies, DNA, oligonucleotides, or other molecules that can specifically react with or attach to the biomarkers or targets in the sample. One advantage of the device of the present disclosure is that the opening assembly allows the chamber to be used as a container in which liquid can be retained for reaction or removed by capillary action, for example, by an absorbent pad for washing, depending on the position of the opening assembly. In the closed position, a sealing element, which may include a waterproof O-ring or a sealing gasket, which may include a membrane or gasket, seals or seals the liquid outlet, thereby preventing the flow of liquid from the chamber. The liquid outlet may be understood as an orifice or slot, or as a permeable surface suitable for the liquid in the chamber to flow towards the absorbent pad. In the open position, the sealing element exposes at least a portion of the liquid outlet, thereby forming a fluid path between the chamber and the liquid absorbent pad, which removes or drains the liquid in the chamber by capillary action. Such an absorbent pad may be configured with a predetermined pore size or may be any type of absorbent paper or sponge available commercially. The size of the absorbent pad may be suitable for absorbing any predetermined amount of liquid, which may include the liquid sample and / or the wash buffer. The absorbent pad is disposed adjacent to the chamber, which means that the absorbent pad may be in close proximity to the chamber so as to form a fluid path.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 disposed across the liquid outlet.

[0006] An advantage of the device of the present disclosure is that no pipetting is required to remove excess liquid, as compared to, for example, ELISA systems, or microplate immunoassays.

[0007] The device is comprised of two cooperating parts that move relative to one another via an opening assembly formed by a first cooperating feature and a second cooperating feature.

[0008] In some embodiments, the first and second cooperating mechanisms are movable relative to one another such that the second cover can move toward and away from the first cover to shift between closed and open positions. The cooperating mechanism may be, for example, a rail and a wheel that rolls across the rail, or a groove and a protrusion that slides through or along the groove, or a mechanism that includes a hinge for opening and closing the device.

[0009] In some embodiments, the first cooperating mechanism can form a threaded connection with the second cooperating mechanism such that the second cover can be threaded onto and unthreaded from the first cover to shift between the closed and open positions.

[0010] The configuration of the cooperating mechanism may depend on the requirements of use, with each configuration providing different advantages to the end user and may also provide advantages during manufacturing. In this embodiment, a second cover is provided that is configured to be screwed onto the first cover. The screw coupling may include a helical groove and a protrusion. Further embodiments may include, for example, a flange that slides through or along a groove, or a protrusion, which may be easier to manufacture than a screw coupling. For example, a screw thread allows the end user to control the opening and closing of the device compared to a protrusion-and-groove mechanism, thus avoiding undesired movement of the sample contained within the chamber.

[0011] In some embodiments, the device may include an electrode receiving slot adjacent to the chamber in 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 a position below the chamber when the device is in an upright or vertical position. In such embodiments, the upright or vertical position may be understood as a position in which, considering a reference plane XZ for placing 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 the electrode receiving slot is below the chamber, such that in use, when the device is placed in an upright position and a sample or liquid is inserted into the chamber, the sample or liquid falls or is discharged toward the electrode receiving slot under the force of gravity.

[0012] The electrode receiving slot allows the electrodes to be fixedly positioned in the device so that the sample to be analyzed can be brought into contact with the electrodes. The electrode receiving slot therefore allows for correct positioning of the electrodes for use in the device or cartridge of the present disclosure. The electrode receiving slot may be provided with a fixing means, such as a flap or adhesive, to provide stability to the electrodes. This is advantageous in avoiding the electrodes being dislodged from the device when they are inserted into or removed from a reading device. The advantage compared to qualitative or rapid diagnostic tests (RDTs) based on immunochromatography is that the electrodes are inserted into a reading device capable of providing a quantitative result, allowing for non-visual interpretation.

[0013] In some embodiments, the device may include a magnet slot adjacent to the chamber in a position that allows the magnetic particles to move toward the magnet through the second opening under a magnetic field generated by the magnet when the chamber contains magnetic particles and the magnet is disposed in the magnet slot. The magnet slot allows for 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 may be used for magnetically driven assays. In some embodiments, where the device is used with, for example, an electrode disposed in the electrode slot and further with a magnet disposed in the magnet slot, the electrode may be between the magnet and the magnetic particles such that the magnetic particles contact and are fixed to the electrode while being attracted toward the magnet. With continued reference to the plane XZ, the magnet slot may be below the electrode receiving slot in an axis Y perpendicular to the plane XZ, such that in use, under the force of gravity, the liquid falls or flows toward the electrode receiving slot, and then the particles in the liquid are attracted toward the magnet disposed in the magnet receiving slot. This configuration has the advantage that even if the liquid portion of the sample is absorbed by the liquid absorbent pad in the open position of the device, the particles are retained on the electrodes located in the electrode receiving slots.

[0014] The magnetically driven assay can be carried out by adding magnetic particles to the sample. Thus, the device or cartridge of the present disclosure is suitable for use in a method for detecting any kind of target or biomarker in a sample, once a specific molecule or biological receptor, i.e., peptide, antibody, DNA, oligonucleotide, or other molecule capable of specifically reacting with or attaching to the biomarker or target, is immobilized on the magnetic particle. For example, a simple and rapid method for detecting a virus or bacteria may include immobilizing an antibody specific for the bacteria or virus on a magnetic particle or magnetic nanoparticle. The magnetic particle with the immobilized antibody can be added to the chamber of the device or cartridge. A sample containing an analyte or target, e.g., a blood sample, can also be added to the chamber so that the molecules or biological receptors attached to the particles can interact with the analyte or target by affinity reaction. A magnet in or adjacent to the device or cartridge can attract the magnetic particles attached to the analyte or target of interest towards the electrode through the second opening. In such position, while the magnetic particles are held or immobilized in contact with at least the surface of the electrodes, the device or cartridge can be shifted to an open position so that excess liquid of the sample can be drained and thereby absorbed into the absorbent pad. Once the excess liquid has been absorbed, a wash step can 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 a closed position and a readout reagent can bind to the magnetic particles attracted in the closed position. The electrodes can be inserted into a transducer or reader that allows a measurement to be performed.

[0015] Thus, the device or cartridge of the present disclosure allows the electrodes or magnetic device to provide a quantitative readout of the sample, while excess liquid of the sample and potential reagents can be removed by capillary action with the liquid absorbent pad.

[0016] A professional user can obtain a device or cartridge of the present disclosure without electrodes, so that the professional user can insert the necessary electrodes into the device or cartridge depending on the analysis to be performed. A non-professional user can obtain a system of the present disclosure that includes a device or cartridge of the present disclosure and electrodes. In such a case, the non-professional user need only add a sample to the device or cartridge without the need for specialized knowledge regarding the particular electrodes appropriate for the analysis to be performed.

[0017] In a second aspect of the present disclosure there is provided an assay system comprising a device or cartridge according to the first aspect of the invention and a reader capable of providing a readout in the form of a signal change of the electrode or electrode cell.

[0018] In some embodiments, the assay system of the present disclosure further comprises a magnet. The magnet is positioned such that when the device or cartridge is coupled to a reader, if the chamber contains a sample containing magnetic particles, the magnet is positioned adjacent to the chamber in a position such that the magnetic particles are movable toward the magnet through the second opening under a magnetic field generated by the magnet. In such embodiments, either the device or cartridge may comprise the magnet, or alternatively, the reader may comprise the magnet.

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

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

[0021] The disclosed device or cartridge may be single use, and further, if disease is detected, the device may provide a quantitative readout to detect disease biomarkers in whole blood, serum or plasma. The disclosed device may be used by medical professionals for rapid diagnosis of disease.

[0022] In a third aspect of the present disclosure, there is provided a method of carrying out an assay or in vitro test, the method comprising at least the steps of: 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, the sample being at least partially in a liquid state; shifting the device or cartridge to an open position, wherein at least a portion of the liquid outlet is not covered by the sealing element and a fluid pathway is formed between the chamber and the liquid absorbent pad through the uncovered portion of the liquid outlet; flowing a liquid portion of the sample through a fluid path and removing at least a portion by a liquid absorbent pad; shifting the device to a closed position; adding a readout reagent into the chamber; and reading the resulting sample with an electrode reader.

[0023] In the disclosed method, the cartridge of the present disclosure can be switched between open and closed positions to add sample and reagents to the chamber for subsequent analysis by a reader. The disclosed method is advantageous because it provides an easy to use method that allows a user to remove excess liquid from the sample to be analyzed.

[0024] In some embodiments, the method includes providing a system with a magnet, adding a sample containing magnetic particles, and flowing a liquid portion of the sample through a fluid path such that at least a portion is removed by a liquid absorbent pad while the particles are attracted by the magnet. The sample is said to be drained by the absorbent pad. In such embodiments, the method provides a simple way to remove liquid, which may include a wash or buffer. While the excess liquid is absorbed, the target or analyte of interest is attracted towards the magnet and the electrodes and prevented from moving towards the absorbent pad. In such embodiments, the electrodes may not include molecules or biological receptors since they are immobilized on the magnetic particles.

[0025] In some embodiments of the method, after adding the sample and before shifting the device or cartridge to the open position, a wash buffer is added into the chamber to wash the sample, for example, if the sample has a concentration that is not adequate for the absorbent pad to absorb by capillary action, the wash buffer can improve washing of such sample.

[0026] In the open position, a washing step may also be added, allowing the liquid portion of the washing fluid to drain, flow through the fluid path, and be at least partially removed by a liquid-absorbing pad. For example, a washing fluid can be added to the chamber before shifting the device or cartridge to the closed position, and thus before adding a readout reagent to the chamber.

[0027] Non-limiting examples of the present disclosure are described below with reference to the accompanying drawings. [Brief description of the drawings]

[0028] [Figure 1A] FIG. 1 is a diagram illustrating an example of a device or cartridge according to the present invention. [Figure 1B] FIG. 2 shows an exemplary representation of a portion of a device or cartridge according to the present invention in a closed position. [Figure 1C]FIG. 2 shows an exemplary representation of a portion of a device or cartridge according to the present invention in an open position. [Diagram 2] FIG. 13 depicts an exploded view of the cartridge chamber. [Figure 3A] 1A-1C illustrate an exemplary cartridge chamber in a closed and open position. [Figure 3B] 1A-1C illustrate an exemplary cartridge chamber in a closed and open position. [Figure 4A] 13A-13C show a further exemplary cartridge chamber in closed and open positions, respectively. [Figure 4B] 13A-13C show a further exemplary cartridge chamber in closed and open positions, respectively. [Diagram 5] FIG. 2 illustrates an example of a cartridge. [Figure 6] FIG. 1 illustrates a device or chamber in a closed position with a liquid held within the chamber. [Figure 7A] FIG. 1 illustrates an exemplary assay system. [Figure 7B] 2A shows a plan view of the assay system and a side view of the assay system taken along line AA'. [Figure 8] FIG. 1 illustrates an example of a method of the present disclosure. [Figure 9] FIG. 1 illustrates an exemplary device or cartridge 90. [Figure 10] FIG. 1 illustrates an exemplary assay system 100. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] In the following description, specific details are set forth in order to provide a thorough understanding of the present invention.

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

[0031] Figure IB is an exemplary representation of a portion of a device 10 or cartridge 10 according to the present invention in a closed position. Figure IB shows the device 10 including a chamber 11 as a cavity 11, which includes a first opening 111 with a height and a second opening 112 with no height. Figure IB 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] FIG. 1C shows an exemplary representation of a part of a device or cartridge according to the invention in an open position in a plane XZ. FIG. 1C shows a device 10 with a chamber 11, including a first opening 111 and a second opening 112. In addition, FIG. 1C also shows a sealing element 12, an absorbent pad 13, an opening assembly 14 in an open position, and a liquid outlet 15. The liquid outlet 15 is an opening formed between a cover or casing 17, including the chamber 11, and a base of the device. The device or cartridge 10 is shown in an upright or vertical position, in which, considering a reference plane XZ, the first opening 111 is higher than the second opening 112 in an axis Y perpendicular to the plane XZ. In use, the upright position allows liquid to be admitted or inserted through the first opening 111, which falls by gravity into the chamber and rests at the base of the chamber. In the closed position, the liquid outlet 15 is closed and sealed by the sealing element 12, which prevents liquid from exiting the chamber 11, and in the open position, the liquid outlet 15 is open, forming a fluid path 16 through which liquid exits the chamber 11 along the fluid path 16 towards the liquid absorbent pad 13.

[0033] As shown by various figures 1A, 1B and 1C, a device or cartridge 10 can be used for an assay system, the device or cartridge comprising a chamber 11, the chamber 11 comprising 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 comprises a liquid outlet 15 suitable for removing liquid from the chamber towards an absorbent pad 13. A sealing gasket 12 is configured to cover at least the liquid outlet 15 of the chamber 11 so as to prevent liquid flow through the liquid outlet in the closed position. The liquid absorbent pad 13 is disposed adjacent to the chamber. The opening assembly 14 serves to shift the device between the closed and open positions, and in the closed position, as seen in figure 1B, the sealing element 12 covers the liquid outlet, thereby closing or locking or sealing the liquid outlet 15 in figure 1B. In this way, liquid is prevented from flowing out of the chamber 11 in the closed position. As can be 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 a completely uncovered liquid outlet 15, with a fluid path 16 being formed between the chamber 11 and the liquid absorbent pad 13 through the uncovered portion of the liquid outlet 15. Although Figures 1A, 1B and 1C show the absorbent pad 13 as having a particular width, to improve the absorption capacity, the absorbent pad 13 may completely occupy the free space 18 shown in Figure 1B. Varying the width, or size, of the absorbent pad allows different amounts of liquid to be absorbed by the absorbent pad.

[0034] FIG. 2 shows the cartridge or device 20 disassembled, with the first cover 21 including the chamber 22, and in FIG. 2 the sealing element 23 is shown separated 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-absorbing pad 25. When not disassembled, the liquid-absorbing pad 25 faces at least a portion of the liquid outlet, which in the embodiment of FIG. 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-absorbing pad 25, preventing liquid from exiting the chamber. The opening assembly 26 includes a first cooperating mechanism and a second cooperating mechanism (not shown), with the first cover 21 including the first cooperating mechanism and the second cover 24 including the second cooperating mechanism.

[0035] 3A and 3B show an exemplary cartridge or device 30 in a closed position and an open position. In the closed position, the first cover 31 and the second cover 32 are brought closer together to form a more compact chamber 30 than in the open position. FIG. 3 shows that the first cooperating mechanism 33 and the second cooperating mechanism 34 are movable relative to each other such that the cartridge chamber 30 shifts between the closed and open positions when the first cover 31 and the second cover 32 are brought closer together or apart. Furthermore, the first cooperating mechanism 33 and the second cooperating mechanism 34 of the cartridge 30 form a threaded connection or coupling such that one of the second cover 32 or the first cover 31 is threaded into and unthreaded from the first cover 31 or the second cover 32 to shift between the closed and open positions. In particular, the first cooperating feature 33 and the second cooperating feature 34 of the cartridge or device 30 are movable relative to one another such that the first cover 31 can move towards and away from the second cover 32 to shift between closed and open positions. In the exemplary cartridge 30, the first cooperating feature 33 can form a threaded engagement with the second cooperating feature 34 such that the first cover 31 can be threaded into and unthreaded from the second cover 32 to shift between closed and open positions. In FIG. 3, the first cooperating feature 33 is a groove 33 and the second cooperating feature 34 is a protrusion 34 that runs or slides along the groove 33. The cooperating feature of FIG. 3 can also include a bayonet coupling.

[0036] 4A and 4B show a further exemplary cartridge chamber 40 in closed and open positions, respectively. The cartridge 40 comprises a first cover 41, which includes a chamber 411 and a sealing element 412. The first cover 41 fits over a second cover 42, which includes a liquid absorbent pad 421, which faces a liquid outlet 43 (shown unsealed in FIG. 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. Otherwise, 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 exiting the chamber. As shown, in the closed position of FIG. 4A, the liquid 45 is retained in the chamber 411, and in the open position of FIG. 4B, the liquid 45 flows along the fluid path 44 and is absorbed by the absorbent pad 421. Furthermore, the opening assembly 46 includes a first cooperating mechanism 461 and a second cooperating mechanism 462, the first cover 41 includes the first cooperating mechanism 461, and the second cover 42 includes 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, such that the first cover 41 and the second cover 42 can move relative to each other to shift between the closed position and the open position. Among other things, the cooperating mechanisms of the cartridge or device 40 are a first locking tab 461 and a second locking tab 462. The user can lift the first cover 41 from the second cover 42 and position the first locking tab 461 against the second locking tab 462 at point 47 to secure the first cover 41 in the open position, and further the user can lower the first cover 41 towards the second cover 42 and position the first locking tab 461 under the second locking tab 462 at point 48 to secure the first cover 41 in the closed position.

[0037] FIG. 5 illustrates an exemplary embodiment of a cartridge 50. The cartridge or device 50 includes a first cover 51 and a second cover 52. FIG. 5 shows the first and second covers removed. The first cover 51 includes a chamber 54 defined within an inner cavity of a funnel bounded by a first opening (not shown) and a second opening 512, as in the previous embodiments. As shown in FIG. 5, a first cooperating feature 511 and a second cooperating feature 521 form a threaded connection or coupling so that the first cover 51 can be threaded onto the second cover 52. The first cooperating feature 511 and the second cooperating feature 521 are two helical protrusions. The cartridge 50 includes an electrode receiving slot 53 that is ultimately adjacent to the chamber 54 when the first cover 51 and the second cover 52 are attached or threaded. The electrode receiving slot 53 is in a position that, in operation when the second cover 52 functions as a base, allows liquid to flow under the force of gravity through the second opening towards the electrode receiving slot in the closed position if the chamber 54 contains liquid. When an electrode is placed in the electrode receiving slot 53, the electrode can interact with the liquid and can be read to determine the composition of the liquid or detect its components. Once the electrode has been analyzed, the cartridge or device 50 can be shifted to an open position so that the liquid can be absorbed by a liquid absorbing pad (not shown in FIG. 5) contained within the cartridge 50.

[0038] 5, when the chamber contains a sample or liquid, the position that allows the sample or liquid to flow through the second opening towards the electrode receiving slot under the force of gravity is the position below the chamber 54 when the device is in an upright or vertical position. In such an embodiment, the upright or vertical position is the position in which, considering a reference plane XZ for placing the device, the first opening is higher than the second opening 512 on an axis Y perpendicular to the plane XZ, and the second opening 512 is higher than the electrode receiving slot 53 on an axis Y perpendicular to the plane XZ, in which the electrode receiving slot 53 is below the chamber 54, such that in use, when the device is placed in the upright position and a sample or liquid is inserted into the chamber 54, the sample or liquid falls towards the electrode receiving slot 53 under the force of gravity.

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

[0040] FIG. 7A shows an assay system 70 comprising a device or cartridge 71 including all or any of the exemplary features described in this disclosure. The assay system includes an electrode 72, a reader 73 configured to read the electrode 72, and a magnet 733 included in the reader. The cartridge or device 71 includes an electrode receiving slot (not shown) into which the electrode 72 is seen to be inserted. As shown, a portion 721 of the electrode including the contacts of the electrode 72 can be inserted and fixed under the second opening 711 in such a way that when a liquid is vertically placed in the chamber through the first opening of the cartridge or device, the liquid contacts the portion 721 of the electrode through the second opening. In one example, the electrode can be a screen printed electrode, which is suitable for processing microvolumes or for immersion in a solution. Such an electrode can work well for developing distributed assays or electrochemically readout biosensors. The electrochemical cell can include a working electrode and an auxiliary electrode, the working electrode can be made of carbon, and the auxiliary electrode can be made of silver or silver chloride. The electrodes can be constructed on ceramic or plastic substrates. The electrodes may include other transducer mechanisms other than electrochemical, such as optical, electronic, piezoelectric, gravimetric, pyroelectric, magnetic, among others. The cartridge or device 71 may be disposable. The cartridge or device 71 does not include a magnet slot or magnet, thus reducing the weight and cost of the disposable cartridge or device 71. The reader 73 may include a screen or display, for example, to display the measured potential, the current range obtained during the measurement, the acquisition time, and the stabilization time. The reader 73 may further include a communication interface with the device, for example a wireless interface for communication with a smartphone. Furthermore, the reader 73 may include a cartridge or device receiving slot 731, a control button 732, and a magnet slot with a magnet 733, as at least one of the following functions. The reader may include a communication interface (not shown) for communicating with the device. FIG. 7B shows a top view of the assay system 70 and a side view of the assay system 70 cut along line AA′.

[0041] A method of performing an assay or in vitro test can be carried out using any of the cartridges or devices described in this disclosure. An example of a method is shown in Figure 8, where the following steps are represented in different diagrams from left to right: This method is Providing an assay system 80; Providing a device or cartridge 81 in a closed position; Adding a sample 82 to be analyzed into a chamber 84 through a first opening 83, said sample being at least partially in a liquid state; Shifting 85 the device or cartridge 81 to an open position, where at least a portion of the liquid outlet 86 is not covered by the sealing element and a fluid path is formed between the chamber and a liquid absorbent pad 87 through the uncovered portion of the liquid outlet; flowing a liquid portion of the sample through a fluid path and removing at least a portion by a liquid absorbent pad; 88 steps to shift the device to a closed position; adding a readout reagent 88' into the chamber; and reading the resulting sample with an electrode reader 89 .

[0042] In some embodiments, the sample includes magnetic particles, and the step of flowing a liquid portion of the sample through the fluid path to be at least partially removed by the liquid absorbent pad is performed while the magnetic particles are attracted by the magnet 801. In some embodiments, after adding the sample 82, a wash buffer is added to wash the sample in the chamber before shifting 85 the device or cartridge to an open position.

[0043] 9 illustrates an exemplary device or cartridge 90 that includes all or any of the exemplary features described in this disclosure. This figure shows the cartridge 90 with an electrode 92 inserted into the electrode receiving slot. The electrode insertion is visible through the second opening 912 of the chamber 91. A liquid can be inserted into the chamber 91 through the first opening 911 and allowed to fall by gravity to the second opening 912 in a vertical position where the liquid contacts the electrode 92. A magnet (not shown) positioned below the electrode can attract the magnetic particles and hold them in an open position so that the liquid is absorbed into an absorbent pad (not shown).

[0044] FIG. 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 103 being insertable into an electrode slot 104 provided in the reader 103.

[0045] In some embodiments, the electrodes may be permanently incorporated within the device or cartridge adjacent the chamber, such that in use, when a sample or liquid is inserted into the chamber, the sample or liquid falls towards the electrodes under the force of gravity. For example, the electrodes may be attached with an adhesive or the like, or screen printed electrodes may be used. In such cases, the device or cartridge may be disposable.

[0046] In such cases, the electrodes may contain any immobilized molecules or biological receptors, i.e. peptides, antibodies, DNA, oligonucleotides, or other molecules capable of specifically reacting with or attaching to the biomarkers or targets in the sample. In such cases, the addition of the sample into the chamber is performed with the device or cartridge in the closed position. After a certain time, the molecular or biological receptors on the electrodes will attach or react with the analyte or target, allowing the compound of interest to flow towards the absorbent pad without risk of being absorbed therein, allowing the device or cartridge to be opened for washing and removal of excess reagents.

[0047] For the sake of completeness, various aspects of the disclosure are described in the following series of numbered sections. Section 1. A device (10, 20, 30, 40, 50, 60, 71, 81) for performing an assay, the device comprising: A chamber (11, 22, 411, 54, 84), a first opening (111, 83) for adding magnetic particles and liquid (45, 61, 82) into the chamber; a chamber (11, 22, 411, 54, 84) having a second opening (112, 512, 64, 711) for contacting magnetic particles and liquid with an electrode adjacent the chamber; a liquid outlet (15, 43, 86) for allowing liquid to leave the chamber; a liquid absorbent pad (13, 25, 421, 87) adjacent the chamber; an aperture assembly (14, 26, 46) for shifting the device between a closed position and an open position; a sealing element (12, 23, 412) for sealing the liquid outlet (15, 43, 86); In the closed position, the sealing element (12, 23, 412) covers the liquid outlet (15, 43, 86) to prevent liquid from exiting the chamber (11, 22, 411, 54, 84) through the liquid outlet (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 (10, 20, 30, 40, 50, 60, 71, 81) includes a fluid pathway (16, 44) between the chamber (11, 22, 411, 54, 84) and the liquid absorbent pad (13, 25, 421, 87) through an uncovered portion of the liquid outlet (15, 43, 86). Section 2. a first cover (21, 31, 41, 51) including a chamber (11, 22, 411, 54, 84) and a sealing element (12, 23, 412); The first cover fits into the second cover (24, 32, 42, 52), The second cover includes a liquid absorbent pad (13, 25, 421, 87); the liquid absorbent pad faces at least a portion of the liquid outlet (15, 43, 86) of the chamber in the open position; The opening assembly (14, 26, 46) includes a first cooperating feature (33, 461, 511) and a second cooperating feature (34, 452, 521); 2. The device (10, 20, 30, 40, 50, 60, 71, 81) of claim 1, wherein the first cover (21, 31, 41, 51) includes a first cooperating feature (33) and the second cover (18, 32) includes a second cooperating feature (34). Section 3. 3. The device of claim 2, wherein the first cooperating mechanism (33,461,511) and the second cooperating mechanism (34,452,521) are movable relative to one another such that the first cover and the second cover can move relative to one another to shift between a closed position and an open position. Section 4. A device as described in any one of claims 2 or 3, wherein the first cooperating mechanism (33, 461, 511) and the second cooperating mechanism (34, 452, 521) form a threaded connection such that one of the second cover or the first cover is threaded into and unthreaded from the first cover or the second cover to shift between a closed position and an open position. Section 5. A device as described in any one of claims 1 to 4, further comprising an electrode receiving slot (53, 62) adjacent the chamber in a position that allows liquid to flow through the second opening and towards the electrode receiving slot under the force of gravity when the chamber contains liquid. Section 6. 6. The device of any one of claims 1 to 5, further comprising a magnet slot (63) adjacent the chamber in a position that allows the magnetic particles to move through the second opening towards the magnet when the chamber contains magnetic particles and the magnet is disposed in the magnet slot (63) under a magnetic field generated by the magnet. Section 7. An assay system (70, 80), comprising: A device or cartridge according to any one of items 1 to 6, an electrode (72); Assay systems (70, 80). Section 8. 8. The assay system (70, 80) of paragraph 7, further comprising a magnet (733). Section 9. 10. The assay system (70, 80) of any one of paragraphs 7 or 8, further comprising a reading device (73, 801) configured to read the electrodes. Section 10. The assay system (70, 80) according to any one of paragraphs 7 to 9, further comprising a communication interface for communicating with a device. Section 11. A method for carrying out an assay or in vitro test, the method comprising at least the following steps: Providing an assay system (70, 80) according to any one of items 7 to 10; providing a device (10, 20, 30, 40, 50, 60, 71, 81) in a closed position; adding a sample to be analyzed into the chamber through a first opening, the sample being at least partially in a liquid state; shifting the device to an open position, wherein at least a portion of the liquid outlet is not covered by the sealing element and a fluid pathway is formed between the chamber and the liquid absorbent pad through the uncovered portion of the liquid outlet; flowing a liquid portion of the sample through a fluid path and removing at least a portion by a liquid absorbent pad; shifting the device to a closed position; adding a readout reagent into the chamber; and reading the resulting sample with an electrode reader. Section 12. A method according to clause 11, when clause 11 is dependent on clause 8, wherein the sample contains magnetic particles and the step of flowing a liquid portion of the sample through the fluid path so that at least a portion is removed by the liquid absorbent pad is performed while the magnetic particles are attracted by the magnet. Section 13. 12. The method of any one of clauses 10 or 11, further comprising the step of adding a wash buffer to wash the sample in the chamber after adding the sample and before shifting the device to the open position.

[0048] Although only some examples are disclosed herein, other alternatives, modifications, uses and / or equivalents are possible. Moreover, all conceivable combinations of the described examples are also covered. Therefore, the scope of the present disclosure should not be limited by the specific embodiments, but should be determined only by the proper interpretation of the following claims. If reference signs related to the drawings are included in parentheses in the claims, they are merely to aid in the understanding of the claims and should not be interpreted as limiting the scope of the claims.

Claims

1. A device (10, 20, 30, 40, 50, 60, 71, 81, 90, 101) for performing an assay, said device comprising: electrodes (72, 92, 102); a first cover (21, 31, 41, 51); a chamber (11, 22, 411, 54, 84, 91); a first opening (111, 83, 911) for adding magnetic particles and a liquid (45, 61, 82) into said chamber (11, 22, 411, 54, 84, 91); a chamber (11, 22, 411, 54, 84, 91) including a second opening (112, 512, 64, 711) for contacting said magnetic particles and liquid with said electrodes (72, 92, 102) disposed within said device adjacent to said chamber (11, 22, 411, 54, 84, 91); a first cover (21, 31, 41, 51) including a sealing element (12, 23, 412); a second cover (24, 32, 42, 52) adapted to said first cover (21, 31, 41, 51), said second cover (24, 32, 42, 52) comprising: a second cover (24, 32, 42, 52) including a liquid absorption pad (13, 25, 421, 87) adjacent to said chamber (11, 22, 411, 54, 84, 91); a liquid outlet (15, 43, 86) for discharging liquid from said chamber (11, 22, 411, 54, 84, 91); an opening assembly (14, 26, 46) for shifting said device between a closed position and an open position, said opening assembly (14, 26, 46) including a first cooperating mechanism (33, 461, 511) and a second cooperating mechanism (34, 462, 521); wherein said first cover (21, 31, 41, 51) includes said first cooperating mechanism (33, 461, 511) and said second cover (24, 32, 42, 52) includes said second cooperating mechanism (34, 462, 521); wherein said sealing element (12, 23, 412) is for sealing said liquid outlet (15, 43, 86); wherein said liquid absorption pad (13, 25, 421, 87) faces at least a portion of said liquid outlet (15, 43, 86) of said chamber (11, 22, 411, 54, 84, 91) in said open position of said device. In the closed position, the sealing element (12, 23, 412) covers the liquid outlet (15, 43, 86) so as to prevent liquid from flowing out of the chamber (11, 22, 411, 54, 84, 91) through the liquid outlet (15, 43, 86). In the open position, at least a part of the liquid outlet (15, 43, 86) is not covered by the sealing element (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). **Claim 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 to shift between the closed position and the open position. **Claim 3** The device according to claim 1 or claim 2, wherein the first cooperating mechanism (33, 461, 511) and the second cooperating mechanism (34, 462, 521) form a screwed 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 unscrewed from the first cover or the second cover to shift between the closed position and the open position. **Claim 4** The device according to claim 1 or claim 2, further including the electrode receiving slot (53, 62) adjacent to the chamber (11, 22, 411, 54, 84, 91) in a position that allows the liquid to flow towards the electrode receiving slot (53, 62) through the second opening (112, 512, 64, 711) under the force of gravity when the chamber contains liquid. **Claim 5** A magnet slot (63), wherein the chamber contains magnetic particles, and when a magnet is disposed in the magnet slot (63), the magnetic particles are movable toward the magnet through the second openings (112, 512, 64, 711) under the magnetic field generated by the magnet, and the magnet slot (63) adjacent to the chamber (11, 22, 411, 54, 84, 91) is further included, the device according to claim 1 or claim 2.

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

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

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

9. A method of performing an assay or an in vitro test, the method comprising at least the following steps: Providing the assay system (70, 80, 100) according to claim 6; Providing the device (10, 20, 30, 40, 50, 60, 71, 81, 90, 101) in the closed position; Adding a sample (82) to be analyzed into the chamber (11, 22, 411, 54, 84, 91) through the first opening (111, 83, 911), wherein at least a part of the sample is in a liquid state; Shifting (85) the device (10, 20, 30, 40, 50, 60, 71, 81, 90, 101) to the open position, wherein at least a part 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 part of the liquid outlet (15, 43, 86). Flowing the liquid portion of the sample through the fluid path (16, 44) and removing at least a part thereof by the liquid absorption pad (13, 25, 421, 87); Shifting (88) the device (10, 20, 30, 40, 50, 60, 71, 81, 90, 101) to the closed position; Adding a read reagent (88') into the chamber (11, 22, 411, 54, 84, 91); A method comprising the step of reading (89) the obtained sample with an electrode reading device (73, 800, 103).

10. The method according to claim 9, wherein the sample contains magnetic particles, and the step of flowing the liquid portion of the sample through the fluid path (16, 44) so that at least a part thereof 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 washing buffer for washing the sample in the chamber (11, 22, 411, 54, 84, 91) after adding the sample and before shifting the device to the open position.

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