Eco-friendly analytic fluid device and method of producing an in vitro diagnostic fluid device

Abstract

Analytic fluid device (1) comprising: a substrate (2); a channel negative layer (3) printed onto the substrate (2) and forming at least partially a capillary channel (4) that is configured to guide a fluid (9) along a path (5) that is at least partially defined by the capillary channel (4); and at least one porous fluid reservoir (6) coupled to the capillary channel (4) and configured to receive at least a portion of the fluid (9) after being guided along the path (5) and / or provide at least a portion of the fluid (9) before being guided along the path (5).

Description

[0001] P39624-EP

[0002] Eco-friendly analytic fluid device and method of producing an In Vitro diagnostic fluid device

[0003] Field of the Invention

[0004] The present invention relates to an analytic fluid device, specifically an in vitro diagnostic (IVD) fluid device and a method of producing an analytic fluid device for general analytics and specifically for medical and / or biomedical diagnostics. The present invention may substantially reduce the amount of material required to realize an analytic fluid device, such as a test strip system and / or may allow to increase production efficiency and / or may reduce tremendously the production cost. Therefore, the present invention provides a strong improvement in view of production efficiency and / or eco-friendliness.

[0005] Background of the Invention

[0006] Fluid systems and devices are an integral part of analytic applications as they play a crucial role in sample handling, processing, and analysis. Such systems are used to transport, manipulate, and control fluids throughout the diagnostic workflow. In the following, a couple of applications for fluid systems in analytic applications are described:

[0007] Sample Collection and Preparation: Fluid systems and devices are used to collect patient samples, such as blood, urine, or saliva, and transport them to the laboratory for analysis. They can also be used to prepare the samples by diluting, mixing, or separating different components.

[0008] Reagent Dispensing: Fluid systems and devices are employed to accurately dispense reagents or chemicals required for diagnostic testing. This ensures that the right amount of reagent is added to the sample, maintaining the integrity of the test and avoiding any errors.

[0009] Sample Processing: Fluid systems and devices are used to process samples through various steps like filtration, centrifugation, or purification. These processes help in isolating specific analytes or removing unwanted substances, allowing for accurate and reliable test results.

[0010] Fluidic Control: Fluid systems enable precise control of fluid flow, pressure, and timing. This control is vital for ensuring that samples and reagents are directed to the correct locations within the diagnostic instrument or device. It also helps in automating the testing process, improving efficiency, and reducing human error.

[0011] Waste Management: Fluid systems are responsible for managing waste generated during the diagnostic process. They help in the safe disposal of used reagents, samples, or other biohazardous materials, adhering to proper disposal protocols and ensuring the safety of laboratory personnel and the environment.

[0012] A specific form of fluidic systems are microfluidic systems, which involve the manipulation of very small volumes of fluids, and which are increasingly used in analytic applications for their numerous advantages. Specifically in cases, in which very small sample volumes are used, such as capillary blood tests, microfluidic systems are used. In the following, a couple of applications for microfluidic systems in analytic are described:

[0013] Miniaturization: Microfluidic systems allow for the miniaturization of analytic specifically diagnostic tests, enabling the analysis of small sample volumes. This reduces the amount of sample and reagents required, making testing more cost- effective and suitable for point-of-care or portable diagnostics.

[0014] Sample Handling: Microfluidic systems facilitate precise manipulation of samples, including mixing, separation, and concentration of analytes. These systems can integrate various sample preparation steps, such as cell lysis, nucleic acid extraction, or protein purification, into a single device, streamlining the diagnostic process.

[0015] Assay Integration: Microfluidic systems enable the integration of multiple assay steps onto a single chip, cartridge or device. This integration allows for complex diagnostic workflows, such as immunoassays, PCR amplification, or DNA sequencing, to be performed rapidly and efficiently.

[0016] High Throughput Screening: Microfluidic systems can be designed to handle multiple samples simultaneously, enabling high throughput screening. This is especially valuable in applications such as drug discovery, genetic testing, or infectious disease screening, where large numbers of samples need to be processed quickly.

[0017] Point-of-Care Testing: Microfluidic systems are well-suited for point-of-care testing due to their portability, ease of use, and rapid turnaround time. These systems enable diagnostics to be performed at the patient's bedside, in remote locations, or resourcelimited settings, providing timely results for immediate decision-making.

[0018] Single Cell Analysis: Microfluidic systems enable the isolation and analysis of individual cells, allowing for a deeper understanding of cellular heterogeneity and disease mechanisms. This capability is crucial in fields like cancer research, where studying single cells can provide valuable insights into tumor progression, drug resistance, and personalized medicine.

[0019] Fluidic systems and specifically microfluidic systems, which are used in analytic applications, diagnostics and / or biomedical applications often rely on single-use concepts and / or require a large amount of plastic materials, which may be expensive in production and / or generate large amounts of waste. Further, the production of such systems may be difficult and / or cumbersome. For example, microfluidic cartridges may comprise plastic housings, which may be produced by injection molding and / or techniques including the kiss-cut method and / or punching and gluing. With the kisscut method, a spacer is glued to a hydrophilic film and peeled off to produce a channel structure.

[0020] It is therefore cumbersome to spontaneously change the design of the microfluidic cartridge, as the molds need to be adjusted each time. It may be required, for example in view of personalized diagnostics, to produce a small volume of tests comprising the fluidic systems. This may not be possible if the production is not versatile enough to be adjusted easily. Further, in exceptional situations as a global pandemic, the production volume of such analytic systems (specifically diagnostic such as IVD) needs to be up-scaled and / or adjusted to new requirements quickly, which is not always easy for complex production procedures of analytic systems. In addition, fluidic systems may be costly for users due to the production and / or materials. If a high number of single-use fluidic systems are required, the cost burden for patients, medical institutions and / or medical insurances, which comes at the expense of the patient’s health.

[0021] Summary of the Invention

[0022] It is therefore desirable to provide analytic fluid devices and / or concepts of producing the same, which may reduce the production cost and / or the materials, which are required to realize the analytic fluid devices, specifically IVD devices. Further, it is desirable to reduce the amount of waste generated by using analytic fluid devices in analytics and / or diagnostics and / or by producing the same. Moreover, it is desirable to provide versatile and / or simple concepts of producing analytic fluid devices, such that the design of the analytic fluid devices can be quickly and / or spontaneously adjusted and / or adjusted for a small volume of test (personalized diagnostics / medicine) and / or the production volume can be easily and / or quickly up-scaled. Ultimately, the costs for end consumers should be reduced, which is important to provide the patients in different regions of the world with the required diagnostics and consequently with the best possible medication.

[0023] At least one of these objects is overcome by the subject matter of the independent claims. Further embodiments with optional features are subjected to the dependent claims. The invention according to aspects and related embodiments thereof are described as follows, in more detail.

[0024] According to a first aspect, an analytic fluid device, specifically an IVD fluid device comprises: a substrate acting at least partially as a support of the analytic fluid device; a channel negative layer printed onto the substrate and forming at least partially a capillary channel (and / or a channel structure that comprises a capillary channel) that is configured to guide a fluid along a path that is at least partially defined by the capillary channel; and at least one porous fluid reservoir coupled to the capillary channel and configured to receive and / or provide at least a portion of the fluid, specifically configured to receive at least a portion of the fluid after being guided along the path and / or provide at least a portion of the fluid before being guided along the path. The analytic fluid device with the printed channel negative layer may reduce the production cost and / or the materials, which are required to realize an analytic fluid device, since the printing of the structure is cheap and the printed material required to define the capillary channel and / or a channel structure that comprises the capillary channel is tremendously reduced compared to injection molded systems and / or devices. Therefore, also the amount of material used and / or the waste generated by analytic fluid devices and / or concepts of producing the same can be reduced tremendously compared to injection molded systems and / or devices. The analytic fluid devices may be much more compact as compared to already existing analytic fluid devices. Therefore, the shipping and / or storing of a high volume of such analytic fluid devices may be very efficient, specifically cost- and / or space saving. It is not absolutely required to provide an additional housing for the analytic fluid device, which further helps reducing costs, waste and / or structural and process / production-related complexity. In this case, it may be advantageous to provide a more rigid substrate, for example comprising a rigid polymer and / or a metal, specifically in the form of a sheet.

[0025] Moreover, the production of the analytic fluid device is versatile and / or simple and / or the design of the analytic fluid device can be quickly and / or spontaneously adjusted and / or adjusted for a small volume of test (personalized diagnostics / medicine) and / or the production volume can be easily and / or quickly up- scaled, which is mainly due to the channel negative layer that is realized by printing it the onto the substrate configured for defining the capillary channel and not by injection molding.

[0026] Ultimately, the costs for end consumers can be reduced tremendously, which is important to provide patients in different regions of the world with the required high- quality diagnostics and consequently with the best possible and / or suitable medication and / or therapy to treat the diagnosed conditions.

[0027] Based on the printing technique of this disclosure, the complexity of the capillary channel and / or a channel structure that comprises the capillary channel may be increased and may be realized on a small area to obtain a compact analytic fluid device while at the same time keeping the production costs low and reducing the waste. As an example of a complex channel structure, it may be possible to apply a plurality of fluids and / or to mix different fluids on the analytic fluid device and / or time / pre-determine the arrival of a fluid in a certain portion of the channel structure by determining the length of the flow path of a fluid. Further, a complex channel structure, which may be realized by the printing technique according to this disclosure, may allow processing a fluid in the analytic fluid device (being one single entity) that is formed with a test strip and / or a lateral flow test, namely an analytic fluid device according to an embodiment of this disclosure. For example, a chamber and / or a pad may be provided that is in fluid connection with the capillary channel and that contains reagents that may react with substances, which may be contained in the sample fluid. The chamber may be a portion, component and / or element of the channel structure.

[0028] The substrate may comprise a deformable, bendable, resilient, hard, soft and / or flexible substrate. The substrate may comprise a sheet, a layer, a plate, a board and / or a slide. The substrate may specifically correspond to a thin sheet having a thickness of approx. 50pm to 5mm. The substrate may comprise a polymer, a thermoplast, a fiber material, a hydrophobic material and / or coating, a hydrophilic material and / or coating. The function of the substrate is mainly to support, fix and / or hold the printed channel negative layer during the printing and specifically after being completely realized and / or formed by printing. Further, the substrate may constitute a bottom wall of the capillary channel. The substrate may have the form of a strip, having a long side and a short side, specifically in a rectangular shape and more specifically wherein the long side has a length that corresponds at least 1,5 times length of the short side. Alternatively, the substrate may have a form that is not rectangular but round, oval or otherwise polygonal.

[0029] The analytic fluid device may comprise and / or correspond to an IVD fluid device and / or a diagnostic test element. The analytic fluid device may comprise, correspond to and / or have a test strip structure and / or device, a cartridge, specifically a fluidic and / or microfluidic cartridge, a flow cell and / or channel, a path and / or channel of an analytic device, a PoC device, a lab-on-a-chip device (loc device), a handheld analytic device. The analytic fluid device may correspond to an analytical test element used herein in a broad sense and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may specifically refer, without limitation, to an element or device configured for determining a presence and / or a concentration of at least one analyte in a liquid sample. The analytic fluid device may specifically be an analytical test strip, such as by having a strip-shaped form, as will be outlined in further detail below. The analytical test strip may comprise at least one component, which changes at least one detectable property, specifically at least one of an optically detectable property and an electrochemically detectable property, when the analyte is present in the liquid sample and / or according to a concentration of the analyte in the liquid sample. The analytic fluid device may comprise at least one lateral flow assay, which may correspond to the porous fluid reservoir. The analytic fluid device may be configured for an in-vitro measurement. The analytic fluid device may be and / or comprise an electrochemical test strip. The analytic fluid device may comprise one or more electrodes, such as an electrode structure configured for electrically connecting the analytical test element to a meter, e.g. a blood glucose meter. The analytic fluid device may be configured for determining a presence and / or a concentration of at least one analyte in a bodily fluid, specifically in a sample of a bodily fluid.

[0030] The term “fluid” may comprise and / or refer to liquids, such as buffers, washing solutions, water, aqueous solutions, solvents and test liquids / fluids, also denoted sample fluid and / or sample liquid. The test fluid may comprise at least one bodily fluid. Bodily fluids are liquids / fluids that are produced by a body and which play important roles in various physiological functions. Some examples of bodily fluids include blood, whole blood and / or components thereof such as a serum and / or plasma, further urine, saliva, sweat, tears and the like. These fluids contain a variety of substances such as water, electrolytes, hormones, enzymes, antibodies, and waste products. Medical conditions and / or diseases may be diagnosed based on the composition and / or components of the bodily fluid. Specifically, the analyte to be detected may be or may comprise at least one of an antigenic protein of a virus, such as an antigenic protein of SARS-CoV-2 coronavirus, Influenza virus A, Influenza virus B, HIV or other viruses, and an analyte involved in metabolism, such as glucose, triglycerides, lactate, cholesterol or any other analyte. The bodily fluid may be or may comprise saliva, nasal swab, throat swab, blood, interstitial fluid, urine, salvia, sweat, serum or any other type of bodily fluid. In general, the term “fluid may refer to only a portion of the applied fluid. The fluid that is applied to the analytic fluid device may therefore not completely follow and / or pass the path and / or arrive at another component of the analytic fluid device, such as a fluid transfer portion and / or or a porous fluid reservoir or the like. It may be that only a portion thereof follows and / or passes the path and / or arrives at another component of the analytic fluid device, such as a fluid transfer portion and / or or a porous fluid reservoir or the like.

[0031] The channel negative layer, which is printed onto the substrate may be considered the structure that confines and / or defines the capillary channel. In other words, the channel negative layer is the negative structure of the capillary channel and it comprises the material, that is printed onto the substrate. The printed material may comprise at least one of: ink material, UV and / or thermally curing / hardening material. The channel negative layer is printed onto the substrate and may therefore be considered as being produced by additive manufacturing and / or 3-D printing. The layers may be printed one over the other leaving out the space for the capillary channel and not printing over that region. In general, additive manufacturing comprising 3D printing, allows for the creation of complex geometries and intricate structures. The intrinsic structural features of additive manufactured elements can vary depending on the specific materials and techniques used. In general, 3D printed structures may have the following common intrinsic structural features among many other possible not listed:

[0032] Layered Structure: Additive manufacturing builds objects layer by layer, resulting in a distinct layered structure. Each layer is typically thin and may be seen upon close inspection. This may specifically apply to the analytic fluid device.

[0033] Material Integrity: Additive manufacturing allows for the use of various materials during one and / or several prints. A structural integrity of the layers may and / or the printed structure with the substrate may result from the properties of the material(s) and the printing process parameters. Surface Finish: The surface finish of additive manufactured elements can vary depending on factors such as the printing technology and post-processing techniques. The final layer, which may comprise the surface, may comprise a polish and / or a material, which has certain features such as hydrophilic or hydrophobic properties. In addition, certain layers and / or regions of a printed structure may have varying properties such as hydrophilic or hydrophobic features.

[0034] Overall, the channel negative layer, which is printed onto the substrate, therefore shows intrinsic features due to the printing process such that the channel negative layer can be distinguished from structures, which are produced otherwise as by injection molding for example. Therefore, the production technique of printing manifests in the structural features of the channel negative layer.

[0035] The channel negative layer which is printed onto the substrate may form and / or define a channel structure that comprises the capillary channel, wherein the channel structure and specifically the capillary channel which may be comprised by the channel structure is configured to guide the fluid along at least a portion of the path that is at least partially defined by the channel structure and specifically by the capillary channel.

[0036] A channel structure may for example - without limitation - comprise besides the capillary channel, a sample application portion, a reaction chamber, a fluid receiving portion and / or a fluid transfer portion or the like, wherein the capillary channel or several capillary channels may fluidically connect(s) the sample application portion with other portions, such as the fluid transfer portion. The fluid may be passively transported and / or guided along a path from the sample application portion, via the capillary channel to the fluid transfer portion. The capillary channel exhibits capillary properties, i.e. capillary forces driving the flow of the fluid, which may be considered a passive transport of the fluid. The sample application portion and / or the fluid transfer portion may or may not have capillary features / properties. The channel structure may, besides having at least a capillary channel and optionally a sample application portion and / or a fluid transfer portion, comprise other elements such as a washing fluid application portion that may be fluidically connected with the capillary channel and / or other portion for providing, guiding, processing and / or receiving a fluid. All portions and / or elements of the channel structure may be configured to guide a sample liquid and / or other types of fluids / liquids, such as washing fluids. A sample application portion may be configured as a portion onto which a sample liquid may be applied but may also be configured as a portion onto which a washing fluid / liquid may be applied for example to wash off remaining portions of the sample liquid.

[0037] The capillary channel is at least confined by walls, including the walls, i.e. the side walls, formed by the channel negative layer and the wall, i.e. the bottom wall, constituted by the substrate or a layer supported by the substrate. In the latter case, that layer might be printed onto the substrate and / or applied otherwise, e.g. based on a coating technique and / or an adhesive technique (using for example an adhesive film / foil). Having only these walls and the upper side not being covered, the capillary channel may be considered an open capillary channel that is open to an upper side. In that case, the sandwich structure of the substrate with the channel negative layer and the open capillary channel from low to high plane in the region of the capillary channel is as follows: substrate (1. plane) - channel negative layer and capillary channel (2. plane) - air or potentially the porous fluid reservoir.

[0038] The capillary channel may be closed in some cases, namely when the upper side (side opposite the substrate) of the capillary channel is closed, confined and / or covered by a cover element. In that case, the sandwich structure of the substrate with the channel negative layer and the closed capillary channel from low to high plane (near or in the region of the capillary channel) is as follows: substrate (1. plane) - channel negative layer and capillary channel (2. plane) - cover element (3. plane) - air or potentially the porous fluid reservoir.

[0039] The at least one porous fluid reservoir may be coupled directly or indirectly to the capillary channel. The coupling refers to a fluidic connection between the capillary channel and the porous fluid reservoir. The at least one porous fluid reservoir may be coupled directly to the capillary channel by directly covering and / or contacting the capillary channel. The at least one porous fluid reservoir may be coupled indirectly to the capillary channel by covering an element and / or a chamber that is in fluidic connection / contact with the capillary channel, while the element and / or chamber is not necessarily considered a capillary channel itself. A fluidic connection, regardless of being considered a direct or indirect connection, between a first element and a second element refers to a state in which a fluid can travel from the first element to the second element and / or vice versa without the need to open a gate, an opening, and / or remove some type of barrier.

[0040] The concept described herein may specifically allow using a printer (including UV printers) to print capillaries and / or channel structures and / or fluid structures (specifically microfluidics) on a hydrophilic film. The final height and / or depth of the capillary can be determined by printing a pre-determined number of layers, i.e. scanning over the surface multiple times. Using such a process, manufacturing a cartridge may be considerably simplified. In addition, the manufacturing process may be adapted to process a substrate sheet which comprises multiple substrates from a roll and / or a to roll-to-roll process. The inventive concept may be applied to different types of test strips and other disposables having channel structures.

[0041] The channel negative layer may be directly printed onto the substrate; and / or the channel negative layer may form a bond, specifically an adhesive and / or chemical bond, with the substrate that is free of an additional element between the channel negative layer and the substrate, specifically free of an additional element comprising a layer, an adhesive layer, a bonding agent and / or a layer and / or a sheet comprising a bonding agent.

[0042] The bonding properties may be considered as an intrinsic structural feature of the analytic fluid device, which is realized by printing the channel negative layer instead of producing the channel negative layer otherwise and bonding the channel negative layer with the substrate by an additional layer and / or another bonding agent. This optional feature is dependent from the material bonding properties of the substrate and the printing material. The channel negative layer is therefore directly printed onto the substrate without previously adding a layer and / or component that has a specific function of bonding, such as an adhesive layer and / or a glue. Instead of adding an adhesive layer, the substrate may however be prepared and / or functionalized - this may be considered an intrinsic feature, whereas an adhesive layer would not be considered an intrinsic feature. Further, the substrate and / or the printed material may comprise an agent and / or a substance that improves allows and / or the bonding performance. For example, an adhesive agent may be added to the substrate and / or the printed material as a component thereof instead of a layer on its surface. The substrate and / or the printed material may comprise one or more thermoplast materials, which fuse when heated. If heat is applied during the printing, the materials of the substrate and the printed material can fuse, specifically when the first layer is printed onto the substrate.

[0043] The effect of a bond between the substrate and the printed material of the channel negative layer is a permanent bonding between them, such that the channel negative layer cannot be removed and / or peeled of (easily), specifically not without destruction of at least one of both elements. The channel negative layer and the substrate therefore form one single piece, i.e. one unit, while however, the substrate and the channel negative layer are not produced at the same time and in different production steps. In other words, if the channel negative layer is bonded with the substrate through the printing, they may form a unit and may not be separable from each other without destroying the unit and / or the full function thereof.

[0044] In a conventional case of prior art techniques (for comparison), in which the channel negative layer is produced in an isolated production step, the substrate and the channel negative layer are coupled in an extra step by using an adhesive agent and / or layer. The production and the coupling steps are separated steps whereas the present disclosure shows that the coupling between the channel negative layer and the substrate may be performed during the production of the channel negative layer or at least both steps, the bonding and the printing of the channel negative structure may have a temporal overlap.

[0045] In another conventional case of prior art techniques (for comparison), a channel negative layer is produced together with the substrate and / or with an element or a portion, which has the function of a substrate, by injection molding. In other words, the channel negative layer is produced together with the substrate or the like in a single step and therefore, no coupling is required. On the contrary, the disclosure of the present application shows the production of both elements, the substrate and the channel negative structure, to have no temporal overlap and a coupling to take place during at least a portion of the time of the production (printing process) of the channel negative layer.

[0046] The at least one porous fluid reservoir may comprise: a capillary reservoir structure having capillary properties; and / or the at least one porous fluid reservoir may comprise at least one of: a soft, resilient and / or flexible foam, vlies, fabric and / or sponge or a hard foam and / or sponge, fibrous structures, specifically comprising at least one of: cellulose, nitrocellulose, paper, synthetic, biological and / or natural fibers and / or wherein the analytic fluid device comprises and / or corresponds to and / or consists of a test strip which comprises the porous fluid reservoir and / or which is coupled to the porous fluid reservoir with the porous fluid reservoir. The porous fluid reservoir may comprise a membrane, a sample pad, a conjugate pad, a reaction zone, and / or a result pad, specifically as a component of an immunoassay. A pad may in some cases correspond to and / or comprise a mat of fibers.

[0047] The porous fluid reservoir may have the capacity to absorb and / or hold and / or provide a liquid volume of about 500 pL to 0,05 pL.

[0048] A “test strip” may correspond to and / or comprise a “lateral flow test”, which may be considered a “lateral flow assay”, “lateral flow assay test” (LFA test) and / or a “rapid test”. For the sake of simplicity, at least one or all these terms may be meant by using the term “test strip” herein. A test strip may be considered a type of analytic, specifically diagnostic test that is designed to provide quick and simple results with or without using specialized laboratory equipment for reading out the test result. A specific form of a test strip is an immunoassay, specifically a fluorescence immunoassay. A test strip may be based on the principle of capillary action, where a liquid sample, such as blood, saliva, or urine, is applied to one end of a strip or cassette. The test strip may contain different zones, comprising a sample pad, conjugate pad, reaction zone, and a result window. The sample may be applied to the sample pad, and it then flows through the test strip by means of capillary action / capillary forces. As the sample passes through the different zones, it interacts with specific reagents or antibodies that are immobilized on the test strip. If the analyte of interest, i.e. the target substance or the biomarker is present in the sample, it will bind to the reagents on the test strip, forming a readable signal (fluorescent and / or visible) such as a visible line and / or color change in the result window. The readable signal may be configured to be read out by eye and / or by an optical instrument (e.g. in the case of a fluorescence immunoassay). The appearance of a readable signal typically indicates a positive result. If the target substance is not present, no line or color change will appear, typically indicating a negative result. Test strips are commonly used for various purposes, including the detection of infectious diseases, cardiac markers, pregnancy tests, drug testing, and food safety testing. Test strips are often used in point-of-care settings, pharmacies, and home testing kits due to their simplicity, speed, and portability.

[0049] The term “test strip” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element having an elongated shape and a thickness, wherein an extension of the element in a lateral dimension exceeds the thickness of the element, such as by at least a factor of 2, preferably by at least a factor of 5, more preferably by at least a factor of 10 and most preferably by at least a factor of 20 or even at least a factor of 30.

[0050] Embodiments described herein may without limitation refer to test strip designs. Alternatively, the analytic fluid device may have a design / shape, which is provided in a non-strip-like shape, as for example in a round, in an oval, in a star-like or a square shape or the like.

[0051] A volume of the capillary channel may at least partially be confined by the substrate in at least one first dimension; and / or at least two walls formed by the printed channel negative layer in at least one second dimension; and / or a cover element in the at least one first dimension, specifically the cover element comprises at least one of a sheet, a plate, a film, a layer, an inlay, a wire- and / or path-like element. In other words, the substrate may form and / or define the bottom wall of the capillary channel, the printed channel negative layer may form and / or define the side walls of the capillary channel.

[0052] In some cases, without limitation, a cover element may form and / or define the top wall of the capillary channel. A cover element may help preventing the fluid from dissociating and / or from being contaminated from outside. Further, a cover element may have a surface, specifically a hydrophilic surface facing the capillary channel that provides adhesive forces for the fluid that is transported through the capillary channel. Moreover, a cover element may provide stability to the analytic fluid device. The cover element may be at least partially transparent such that the user can observe the flow of the fluid through the capillary channel. Alternatively, the cover element may be opaque. The cover element may be the same material as the substrate. The cover element may be adhered, for example by an adhesive layer and / or an adhesive agent, to the channel negative layer and covering at least a portion of the capillary channel. The cover element may have opening for the application of one or more fluids and / or for the flow of fluids into the capillary channel and / or channel structure and / or for the flow out of the capillary channel and / or channel structure.

[0053] As already indicated previously, in the first dimension, the analytic fluid device may have a sandwich structure: first layer: substrate; second layer: channel negative layer and capillary channel (being filled with air and / or a liquid); third layer: cover element.

[0054] The channel negative layer, which is printed onto the substrate: may have a thickness of about 0,05 pm to 1,5 mm, specifically about 30 pm to 750 pm; and / or may have a height with regard to the substrate surface of about 0,05 pm to 1,5 mm, specifically about 30 pm to 750 pm; and / or may define the capillary channel with a depth of about 0,05 pm to 1,5 mm, specifically about 30 pm to 750 pm.

[0055] As the thickness of the channel negative layer is typically very small, a very small amount of a fluid may be received and / or transported by the capillary channel and therefore, only small samples, e.g. samples of blood may be required which is beneficial to the patient who is not required to provide larger amounts of blood.

[0056] The substrate: may, without limitation, have a thickness of about 1 pm to 5 mm, specifically 50 pm to 1 mm; may comprise a sheet, a plate, a foil and / or a film; the substrate may comprise a hydrophilic material and / or a hydrophilzed surface onto which the channel negative layer is printed. The substrate may be opaque or at least partially transparent to allow observing / monitoring the flow of the fluid through the substrate. Ideally, the substrate is a thin substrate that comprises for example a polymer. The substrate may be flexible and / or bendable or may have stiff properties, i.e. non-flexible and / or non-bendable properties. The substrate may have a surface, specifically a hydrophilic surface that provides adhesive forces for the fluid that is transported through the capillary channel. The substrate may be coated by a film, a layer, specifically a film of printing material and / or may be functionalized.

[0057] The analytic fluid device may further comprise a channel structure that comprises besides the capillary channel other elements such as: a sample application portion for application of the fluid onto the analytic fluid device, wherein the fluid to be applied to the sample application portion comprises and / or consists of a sample fluid, the sample application portion being fluidically coupled to and / or contacted with the capillary channel; and / or a washing fluid application portion for application of the fluid onto the analytic fluid device, wherein the fluid to be applied to the washing fluid application portion comprises and / or consists of a washing fluid, the washing fluid application portion being fluidically coupled to and / or contacted with the capillary channel; and / or a fluid transfer portion for coupling the capillary channel to the porous fluid reservoir via the fluid transfer portion in that the fluid transfer portion is fluidically coupled to and / or contacted with the capillary channel for receiving at least a portion of the sample fluid and / or the washing fluid after being guided through the capillary channel and in that the fluid transfer portion is fluidically coupled to and / or contacted with the porous fluid reservoir for providing / transferring at least a portion of the received sample fluid and / or the washing fluid to the porous fluid reservoir; and / or a fluid receiving portion being fluidically coupled to and / or contacted with the capillary channel and for receiving at least a portion of the sample fluid and / or the washing fluid after being guided through the capillary channel, specifically wherein the capillary channel is configured to guide at least a portion of the sample fluid and / or the washing fluid from the sample application portion and / or the washing fluid application portion along at least a portion of the path, defined at least partially by the capillary channel, to the fluid receiving portion and / or the fluid transfer portion.

[0058] The sample application portion may be a portion of the capillary channel or may be in fluidic connection with the capillary channel. The sample application portion may be considered a portion onto which the fluid is to be applied. The fluid receiving portion and / or the fluid transfer portion may be a portion of the capillary channel or may be in fluidic connection with the capillary channel. The fluid receiving portion and / or the fluid transfer portion may be in fluidic connection with the capillary channel for example opposite the sample application portion. The sample application portion and the fluid receiving portion and / or the fluid transfer portion may be in fluid connection with each other via the capillary channel.

[0059] The capillary channel may be configured to guide the fluid along the path at least partially defined by the capillary channel to the at least one porous fluid reservoir (and / or from the at least one porous fluid reservoir along the path defined at least partially by the capillary channel); and / or the capillary channel may be configured to guide the fluid which may comprise one of: an aqueous solution, a washing fluid, a washing buffer, a sample fluid, a body fluid, specifically whole blood, serum, plasma, urine, saliva, sweat; and / or the capillary channel may comprise a washing fluid portion that is predetermined for guiding the washing fluid; and / or wherein the capillary channel may comprise a sample fluid portion that is predetermined for guiding the sample fluid.

[0060] The analytic fluid device may comprise: at least one heat agent receiving mechanism, specifically a chamber to receive at least one heating element and / or a heating agent that is configured to provide heat to the analytic fluid device and / or the fluid by means of an exothermic reaction; and / or at least one heat agent coupling mechanism, specifically an adhesive and / or a foil, for example a foil with an adhesive, to couple at least one heating element and / or a heating agent, that is configured to provide heat to the analytic fluid device and / or the fluid by means of an exothermic reaction, to the analytic fluid device; and / or at least one heating element and / or a heating agent that is configured to provide heat to the analytic fluid device and / or the fluid by means of an exothermic reaction.

[0061] The at least one heating element and / or the heating agent is thermally contacted with a portion of the analytic fluid device to provide heat to the analytic fluid device and / or the fluid that is transported through the capillary channel. Therefore, the analytic fluid device may have a chamber to receive and / or house the at least one heating element and / or the heating agent. The at least one heating element and / or the heating agent may be coupled and / or attached to the analytic fluid device and covered and / or affixed by a coupling mechanism such as an adhesive foil that is attached to the analytic fluid device and that covers the at least one heating element and / or the heating agent at least partially. Alternatively or in addition, the at least one heating element and / or the heating agent may have an adhesive such that it can be coupled and / or affixed to the analytic fluid device.

[0062] The at least one heating element and / or the heating agent may provide heat upon a trigger that triggers an exothermic reaction.

[0063] The heating element and / or heating agent may comprise one of the following materials: a salt that can release energy by melting, a material that releases energy by crystallization, one or more chemicals that can release energy by an exothermal reaction, an electrical element having a resistance. For example, LiCl may be used a salt without limitation.

[0064] The analytic fluid device may comprise at least one heat limiting element receiving mechanism, specifically a chamber to receive at least one heat limiting element that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device and / or the fluid; and / or at least one heat limiting element coupling mechanism, specifically a foil to couple at least one heat limiting element, that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device and / or the fluid, to the analytic fluid device; and / or at least one heat limiting element that is configured to perform a change in the state of aggregation by absorbing heat from the analytic fluid device and / or the fluid.

[0065] The at least one heat limiting element is thermally contacted with a portion of the analytic fluid device to receive heat from the analytic fluid device and / or the fluid that is transported through the capillary channel. Therefore, the analytic fluid device may have a chamber to receive and / or house the at least one heat limiting element. The at least one heat limiting element may be coupled and / or attached to the analytic fluid device and covered and / or affixed by a coupling mechanism such as an adhesive foil that is attached to the analytic fluid device and that covers the at least one heat limiting element at least partially. Alternatively or in addition, the at least one heat limiting element may have an adhesive such that it can be coupled and / or affixed to the analytic fluid device.

[0066] The at least one heat limiting element may receive heat upon a trigger that triggers a change in the state of aggregation.

[0067] The heat limiting element may comprise one of the following materials: a material, such as a salt like KC1, without limitation, that, upon receiving energy, can melt and absorb energy. Such materials may comprise without limitation at least one of: C4H8O2, C6H12O2, CsHieCh, C10H20O2, C12H24O2, C14H28O2, C16H32O2, C16H36O2.

[0068] The heat flow may be uncontrolled as it may lack an active control, for example a digital instrument control. A heat limiting element that changes its state of aggregation may be provided to receive and / or deflect excess amounts of heat generated by the at least one heating element and / or the heating agent. This may represent a type of heat control however not a digital and / or electronic heat control that is based on a detection / measurement of the temperature. The at least one heating element and / or the heating agent which is based on an exothermic reaction and / or the heat limiting element is / are cheap elements and therefore a heatable analytic fluid device with incorporated heat agents may be provided at low production costs. No infrastructure is needed to operate the heatable analytic fluid device. Therefore, the analytic fluid device may be provided specifically in regions, in which cheap diagnostics are required and little infrastructure is available. The analytic fluid device may be offered at low costs to doctors, pharmacies, (small) hospitals and / or private users.

[0069] Therefore, the analytic fluid device: may be free of an active heat control and / or a coupling mechanism for an active heat control; may be free of an additional energy source and / or a coupling mechanism for an additional energy source; and / or may be configured to be operated at physiologically relevant temperatures. The target temperature and / or temperature range in which the analytic fluid device may be between approximately 20°C and 45°C, specifically between about 35°C and 39°C. This temperature may be reached by making use of the heating element and / or the heating agent and specifically in addition with the heat limiting element. Further, in view of the low costs for the users, the analytic fluid device: may be and / or correspond to a single-use analytic fluid device; may be free of a processor, control and / or machine and / or a coupling mechanism for a processor, control and / or machine; and / or may be free of a liquid flow regulation.

[0070] The analytic fluid device may comprise at least one flow guidance element, which may correspond to a portion of the channel negative layer being printed in one of the elements of the channel structure, such as the sample application portion and / or the fluid transfer portion.

[0071] The analytic fluid device may comprise a transfer portion between the sample application portion and the capillary channel and / or a transfer portion between the capillary channel and the fluid transfer portion. These transfer portions may each have a shape, i.e. an outer contour line that differs from the outer contour lines of the sample application portion, the capillary channel, and / or the fluid transfer portion. At least one transfer portion may for example be diamond-shaped and may specifically have two diamond- shaped structures coupled to each other along their length axis or may have only one diamond-shape. At least one transfer portion may comprise at least one flow guidance element being printed therein and having either the same shape as the outer contour of the transfer portion or a different shape.

[0072] The flow guidance element may specifically have a lengthy form, such as a lengthy oval shape, a bar shape, a lengthy diamond shape or the like. The flow guidance element may have the function to guide the flow of the fluid in a more predetermined and / or controlled and / or laminar (turbulence avoiding) manner. The flow may for example be better distributed along the path from the sample application portion to the fluid transfer portion. Further, the flow guidance element may provide a surface that contributes to the capillary effect on a fluid.

[0073] The washing fluid may already be provided on the analytic fluid device. For example, a blister which contains the washing fluid may be coupled to the analytic fluid device. When needed, the blister may be punched and / or opened otherwise to establish a fluidic connection between the inside of the blister and the capillary channel and / or another element of the channel structure. This makes it very convenient for a user and / or sterilized washing fluid can be provided without the need for the addition / application onto the analytic fluid device.

[0074] According to a second aspect, a method of producing an analytic fluid device comprises: providing a substrate as a supporting structure of the analytic fluid device; printing a channel negative layer onto the substrate and forming at least partially a capillary channel that is configured to guide a fluid along a path that is at least partially defined by the capillary channel; and coupling at least one porous fluid reservoir to the capillary channel wherein the at least one porous fluid reservoir is configured to receive at least a portion of the fluid after being guided along the path and / or provide at least a portion of the fluid before being guided along the path.

[0075] The term “guide” may refer to the situation in which the fluid is confined to flow along the path. It may specifically refer to a passive transport of the fluid that creeps and / or flows along the borders and / or walls provided by the channel negative layer, the substrate and potentially a cover element if present. “Guide” may also mean directing by confinement and passively transporting a fluid along a path for example by means of capillary forces, hydrophilicity and / or van-der-Waals forces.

[0076] The features, advantages and / or technical effects described for the analytic fluid device according to the aspect and / or specific embodiments may apply to the corresponding method.

[0077] The printing of the channel negative layer may comprise: a UV-printing; and / or a layer-by-layer printing. These techniques are typically used to produce a printed element. A printed channel negative structure may comprise and / or correspond to about 1-500 layers, specifically about 20-200 layers and more specifically about 50- 100 layers.

[0078] The method may be performed as a reel-to-reel process, specifically wherein the substrate is a component of a substrate sheet, more specifically wherein the method further comprises a cutting step in which the substrate is cut from the substrate sheet (before or after the printing is completed). A reel-to-reel process allows producing analytic fluid device at a high throughput, i.e. producing large numbers of analytic fluid devices at / in a short time. The process can be adjusted, i.e. up-scaled and / or downscaled, easily depending on the required volume of analytic fluid devices at one point in time. Therefore, the native, i.e. plane and / or unprinted substrate may be provided on a roll. It may be unrolled for the printing process. In some cases, the processed substrate, specifically the printed substrate with the capillary channels may be rolled-up again.

[0079] The term “reel-to-reel process” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process involving at least two turning and / or rotating objects, such as at least two rotating wheels and / or rolls. The reel-to-reel process may specifically comprise transferring at least one element stored on a first roll, such as an element having a sheet form (substrate sheet of this disclosure) and / or tape form, onto a second roll, wherein at least one processing step is performed during the transfer. Thus, as an example, the reel-to-reel process may refer to an arbitrary process starting with a roll of material, e.g. with the first roll, and re-reeling after performing the process, such as into an output roll, e.g. into the second roll. The reel- to-reel-process may also be referred to as roll-to-roll-process. The substrate sheet may be provided on a roll before printing the channel negative layer thereon and / or after printing the channel negative layer thereon.

[0080] The method may comprise at least one cutting process and / or a cutting step, wherein, in the cutting process / step, at least one part of at least one element (e.g. one substrate, one substrate with the printed channel negative layer or one analytic fluid device) is cut, specifically in a longitudinal direction. The at least one element is selected from the group consisting of: a substrate; a substrate with the printed channel negative layer; an analytic fluid device. The term “cutting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may specifically refer, without limitation, to a process of separating at least one object and / or element, wherein a defined and / or controlled edge and / or cutting edge is generated. The cutting may comprise using at least one cutting blade for cutting the at least one element in the cutting process, specifically in a cutting angle a between a surface of the element to be cut and a surface of the cutting blade, in particular at a cutting angle of 20° < a < 40°. The cutting process may specifically be a continuous cutting process. Additionally or alternatively, the method may comprise recycling at least a part of the material cut off during the cutting process, specifically material of the transfer foils.

[0081] The reel-to-reel process may allow introducing small core strips and / or analytic fluid devices, e.g. of sizes smaller than 10 mm in at least one dimension, into disposables or housings exceeding the size of the core strips may generally be envisaged in order to improve the handling of the analytical test element by the user. Manufacturing steps, in which the analytic fluid devices may be transferred or introduced into the disposables by packaging and labelling, e.g. by using pick-and-place methods may be avoided using the reel-to-reel process in which elements are cut off and potentially dropped into the package and / or housing. These steps are generally time- and costintensive and require additional hardware equipment. Thus, a reel-to-reel process may reduce manufacturing time and costs.

[0082] In addition or alternatively, the method may comprise unrolling a substrate sheet, which comprises the substrate besides multiple other substrates.

[0083] The method may further comprise: thermally coupling to the analytic fluid device: at least one heat agent receiving mechanism, specifically a chamber to receive at least one heating element and / or a heating agent that is configured to provide heat to the analytic fluid device and / or the fluid by means of an exothermic reaction; and / or at least one heat agent coupling mechanism, specifically a foil to couple at least one heating element and / or a heating agent, that is configured to provide heat to the analytic fluid device and / or the fluid by means of an exothermic reaction, to the analytic fluid device; and / or at least one heating element and / or a heating agent that is configured to provide heat to the analytic fluid device and / or the fluid by means of an exothermic reaction; and / or at least one heat limiting element receiving mechanism, specifically a chamber to receive at least one heat limiting element that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device and / or the fluid; and / or at least one heat limiting element coupling mechanism, specifically a foil to couple at least one heat limiting element, that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device and / or the fluid, to the analytic fluid device; and / or at least one heat limiting element that is configured to perform a change in the state of aggregation by absorbing heat from the analytic fluid device and / or the fluid.

[0084] According to another aspect, a method of producing multiple analytic fluid devices comprises: providing a substrate sheet that comprises multiple substrates each acting as a supporting structure of one of the multiple analytic fluid device; printing a channel negative layer onto each of the multiple substrates and thereby forming at least partially a capillary channel onto each of the multiple substrates, each capillary channel that is configured to guide a fluid along a path that is at least partially defined by the capillary channel; coupling at least one porous fluid reservoir to the capillary channel of each of the multiple substrates, wherein each of the at least one porous fluid reservoirs is configured to receive at least a portion of the fluid after being guided along the path and / or provide at least a portion of the fluid before being guided along the path; and cutting the substrate sheet according to the multiple substrates to obtain multiple analytic fluid devices. The step of cutting may be performed before or after the step of coupling the at least one porous fluid reservoir to the capillary channel of each of the multiple substrates. In the first case, the porous fluid reservoirs may already be cut and coupled to the cut substrates and in the latter case, the porous fluid reservoirs may already be cut or may correspond to a sheet of porous fluid reservoirs which is required to be cut together with the substrates.

[0085] This method allows manufacturing a plurality of analytic fluid devices and / or analytical test elements, as being described herein according to any one embodiment, at low cost and / or high throughput and, specifically having a reduction in equipment requirements.

[0086] In general, the analytical fluid device and / or analytic test element may correspond to a test element that is not necessarily used in the field of in vitro diagnostics, for example in some embodiments, the analytical fluid device may be used in the field of analytical chemistry, such as a test element involving one or more color-changing indicators. By way of example, such analytical test elements may comprise test elements for determining a presence and / or a concentration of at least one analyte in water, such as analytical test element used for testing water quality of fish tanks, specifically determining a presence and / or a concentration of one or more of pH value, carbonate, nitrate, nitrite, total hardness, total alkalinity and / or other chemical elements or compounds.

[0087] As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.

[0088] Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, nonwithstanding the fact that the respective feature or element may be present once or more than once.

[0089] Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

[0090] The analytical test element, specifically the analytic fluid device may correspond to and / or comprise a core strip used herein as a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one functional element of the analytical test element. Specifically, the core strip may comprise one or more elements being configured for providing alone or in combination with each other the analytical functionality of the analytical test element, such as one or more elements being configured for determining the presence and / or the concentration of the at least one analyte in the liquid sample. The core strip may be the lateral flow assay of the analytical test element. The core strip may comprise, as will be outlined in further detail below, at least one carrier material, such as at least one strip of the carrier foil, and, disposed thereon or therein, the at least one analytical element. The core strip may be a stripshaped element, as defined above. The core strip may be at least partially enclosed by one or more other elements of the analytical test element, e.g. by one or more other elements providing support and / or sealing for the core strip.

[0091] The substrate and / or substrate sheet may correspond to a foil and / or sheet used as a broad term and to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may specifically refer, without limitation, to a thin sheet, plate, strip and / or web of material. The substrate and / or substrate sheet may be referred as thin if a thickness of the substrate and / or substrate sheet does not exceed 1 cm, specifically 5 mm, more specifically 1 mm. The substrate and / or substrate sheet may be provided in continuous form, e.g. on a roll or reel. The substrate and / or substrate sheet may comprise at least one flexible or deformable material, such as at least one flexible or deformable plastic foil. The substrate and / or substrate sheet may comprise at least one plastic material, such as polyester, polyethylene terephthalate, polyethylene or the like and / or a coated sheet comprising a compostable, a biodegradable and / or a fibrous material such as cardboard and / or paper. Additionally or alternatively, the foil may comprise at least one metal, such as aluminum, copper, tin, gold or the like.

[0092] The substrate may, without limitation, refer to at least one foil providing a base for at least one other element, specifically a support foil and / or a carrier foil, which may provide a base and / or support for the analytical test element, specifically the analytic fluid device or multiple analytic fluid devices. The support foil and / or carrier foil may be configured for receiving the printed structure, i.e. the channel negative layer. The support foil may be part of the manufactured plurality of analytical test elements. The support foil may be configured for at least partially enclosing the core strip, e.g. by providing, alone or in combination with one or more further elements, sealing for the manufactured plurality of analytical test elements.

[0093] The method comprises “providing a substrate as a supporting structure of the analytic fluid device”. The term “providing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of supplying and / or making available. Specifically, the providing may comprise making the substrate available for further processing. The providing may comprise supplying the substrate to a manufacturing device and / or producing the substrate from one or more base products.

[0094] It is to be understood that the present invention is not limited to the particular embodiments and examples described herein as these may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0095] Detailed Description of the Invention

[0096] In the following, some embodiments will be described in detail, wherein the invention should not be understood to be limited to the embodiments described. The following embodiments and figures are provided to aid the understanding of the present invention, the true scope of which is set forth in the appended claims. Single features being described in a particular embodiment may be arbitrarily combined, given that they are not excluding each other. In addition, different features, which are provided together in the example embodiments, are not to be considered restrictive to the invention.

[0097] Skilled artisans appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements whereas other elements may have been left out or represented in a reduced number in order to enhance clarity and improve understanding of the aspects of the present disclosure.

[0098] The same reference numerals are used among different embodiments and examples for the same or similar elements or elements that have similar or the same effects.

[0099] Fig. la and Fig. lb are schematic top views of a substrate in the process of printing a channel negative layer thereon, according to an embodiment;

[0100] Fig. 1c is a schematic cut view of the substrate in the process of printing the channel negative layer thereon along the cutline AA’ of Fig. lb;

[0101] Fig. Id is a schematic cut view of the substrate in the process of printing the channel negative layer thereon along the cutline BB’ of Fig. lb;

[0102] Fig. 2a is a schematic top view of the substrate after the process of printing the channel negative layer thereon is completed, according to an embodiment;

[0103] Fig. 2b is a schematic cut view of the substrate after the process of printing the channel negative layer thereon is completed along the cutline AA’ of Fig. 2a;

[0104] Fig. 2c is a schematic cut view of the substrate after the process of printing the channel negative layer thereon is completed along the cutline BB’ of Fig. 2a;

[0105] Fig- 3 is a flow chart illustrating the steps of the method of producing an analytic fluid device, according to an embodiment; Fig. 4a is a schematic top view of an analytic fluid device, according to an embodiment;

[0106] Fig. 4b is a schematic cut view of the analytic fluid device along the cutline AA’ of Fig. 4a;

[0107] Fig. 5a is a schematic top view of an analytic fluid device, according to a further embodiment;

[0108] Fig. 5b is a schematic cut view of the analytic fluid device along the cutline AA’ of Fig. 5a;

[0109] Fig. 6a is a schematic top view of an analytic fluid device, according to a further embodiment;

[0110] Fig. 6b is a schematic cut view of the analytic fluid device along the cutline AA’ of Fig. 6a;

[0111] Fig. 7a is a schematic top view of an analytic fluid device, according to a further embodiment;

[0112] Fig. 7b is a schematic cut view of the analytic fluid device along the cutline AA’ of Fig. 7a;

[0113] Fig. 8a and Fig. 8b are schematic cut views of analytic fluid devices with heating element according to two embodiments (corresponding to the cutline AA’ of Fig. 4a, Fig. 5a, Fig. 6a, or Fig. 7a) and implementable into the analytic fluid devices of Fig. 4a, Fig. 5a, Fig. 6a, or Fig. 7a;

[0114] Fig. 9a and Fig. 9b are schematic cut views of analytic fluid devices with heating element and heat limiting element according to two embodiments (corresponding to the cutline AA’ of Fig. 4a, Fig. 5a, Fig. 6a, or Fig. 7a) and implementable into the analytic fluid devices of Fig. 4a, Fig. 5a, Fig. 6a, or Fig. 7a;

[0115] Fig. 10a is a schematic top view of an analytic fluid device, according to a further embodiment;

[0116] Fig. 10b and Fig. 10c are schematic detail views of the analytic fluid device of Fig. 10a; Fig. 11 is a schematic top view of an analytic fluid device, according to a further embodiment;

[0117] Fig. 12a is a photographic top view of an analytic fluid device, according to a further embodiment;

[0118] Fig. 12b is a photographic top view of the substrate with the channel negative layer printed thereon of the analytic fluid device of Fig. 12a;

[0119] Fig. 13 is a schematic top view of an substrate sheet in the process of printing a channel negative layer thereon, according to an embodiment of a reel-to-reel process;

[0120] Fig. 14 is a schematic top view of the substrate sheet of Fig. 13 after the process of printing the channel negative layer thereon is completed, according to the embodiment of the reel-to-reel process; and

[0121] Fig. 15 is a schematic top view of an analytic fluid device having an oval shape, according to a further embodiment.

[0122] The embodiments discussed together with Fig. la to Fig. 9b are embodiments of strongly simplified structures and analytic fluid devices in order to describe and illustrate the basic concept of the invention, embodiments thereof and the disclosure. For specific applications, the structures may be much more complex, having for example complex channel structures and / or a complex channel structure system. Such embodiments that are more complex, are shown in Fig. 10a to Fig. 12b, for example.

[0123] Fig. la and Fig. lb are schematic top views of a substrate 2 in the process of printing a channel negative layer 3 (typically indicated as black areas herein) thereon to produce an analytic fluid device 1, according to an embodiment. The portion of the channel negative structure 3 that has been printed on the substrate 2 is indicated in both figures by the trace of the scanning line, leaving out portions of the channel structure, specifically the microfluidic channel / capillary channel 4. The shown process may correspond to the printing of a first layer of several layers to print the channel negative structure 3, for example, it may correspond to the first layer of 50 layers. Fig. la shows the printed channel negative layer 3 in an early stage and Fig. lb shows the printed channel negative layer 3 in a slightly later stage. In Fig. la, a portion of a fluid transfer portion 8 (dotted area) is indicated as being excluded and / or left out from the printed layer, i.e. the printed channel negative structure 3. In other words, the printed channel negative structure 3 is printed onto the substrate 2 leaving out gaps in which no channel negative structure 3 is printed, such as the fluid transfer portion 8 and the capillary channel 4 (see Fig. lb). In Fig. lb, the entire fluid transfer portion 8 and a portion of the capillary channel 4 is indicated as being defined by the printed channel negative structure 3 and as being excluded and / or left out from the printed layer, i.e. the printed channel negative structure 3.

[0124] Fig. 1c is a schematic cut view of the substrate 2 in the process of printing the channel negative layer 3 thereon along the cutline AA’ (which corresponds to the central length axis CLA of the analytic fluid device 1) of Fig. lb, which is a cutline along the central longitudinal axis / central length axis CLA of the substrate 2. Fig. Id is a schematic cut view of the substrate 2 in the process of printing the channel negative layer 3 thereon along the cutline BB’ of Fig. lb, which is a cutline that is off-center parallel to the central longitudinal axis of the substrate 2. In Fig. 1c, a portion of the first layer of the channel negative structure 3, which is printed onto the substrate 2, is indicated (black structure). Further, portions, which are left out from the printed channel negative structure 3, are indicated, namely the entire fluid transfer portion 8 (dotted structure) and the portion of the capillary channel 4 (empty box with dotted outline - the capillary channel 4 is indicated in several figures using dotted contour lines which does explicitly not indicate a closed space, instead the capillary channel 4 may correspond to a space that is open on the upper side is some embodiments in which no cover element is provided). In Fig. Id, the portion of the first layer of the channel negative layer 3, which is printed onto the substrate 2 is indicated. In a completed state according to an embodiment, this layer will cover the substrate 2 over the entire length along the cutline BB’ as indicated in Fig. 2c.

[0125] Fig. 2a is a schematic top view of the substrate 2 after the process of printing the channel negative layer 3 thereon is completed, according to an embodiment. Fig. 2b is a schematic cut view of the substrate 2 after the process of printing the channel negative layer 3 thereon is completed along the cutline AA’ of Fig. 2a. Fig. 2c is a schematic cut view of the substrate 2 after the process of printing the channel negative layer 3 thereon is completed along the cutline BB’ of Fig. 2a.

[0126] In the embodiment of Fig. 2a n layers of the printing material were printed onto the substrate 2 to produce the channel negative layer 3 with a thickness or height of dl measured from the surface of the substrate 2 perpendicularly to the cutline AA’, i.e. perpendicularly to the surface of the substrate 2 and the longitudinal axis of the substrate 2 (see Fig. 2b and Fig. 2c). As can be seen in Fig. 2a and Fig. 2b, the channel structure, i.e. the portions being left out from the printed channel negative layer 3 and being filled with air and / or a fluid, comprise in this particular embodiment a sample application portion 7, a fluid transfer portion 8 and a capillary channel 4 that fluidically connects the sample application portion 7 with the fluid transfer portion 8. The channel structure and all portions thereof 4, 7, 8 have a depth that corresponds to the thickness dl of the printed channel negative layer 3. The substrate 2 may have a thickness d2 that may be larger than dl or may be similar to dl . Typically, the substrate 2 provides support and specifically rigidity to the analytic fluid device 1. Further, the substrate 2 provides a bottom surface to the channel structure, specifically to the capillary channel 6. The substrate 2 may be composed of a single sheet and / or layer (as shown in the embodiments of the figures) or may have a lower sheet that provides the support and a second sheet (an upper sheet) that provides the surface and / or bottom of the capillary channel and / or the channel structure.

[0127] Fig- 3 is a flow chart illustrating the steps 101-103 and 104 of the method 100 of producing an analytic fluid device 1, according to an embodiment. The method 100 is described with the previously described and the following figures. Fig. 4a is a schematic top view of an analytic fluid device 1, according to an embodiment. Fig. 4b is a schematic cut view of the analytic fluid device 1 along the cutline AA’ of Fig. 4a. Fig. 5a is a schematic top view of an analytic fluid device 1, according to a further embodiment. Fig. 5b is a schematic cut view of the analytic fluid device 1 along the cutline AA’ of Fig. 5a. Fig. 6a is a schematic top view of an analytic fluid device 1, according to a further embodiment. Fig. 6b is a schematic cut view of the analytic fluid device 1 along the cutline AA’ of Fig. 6a. Fig. 7a is a schematic top view of an analytic fluid device 1, according to a further embodiment. Fig. 7b is a schematic cut view of the analytic fluid device 1 along the cutline AA’ of Fig. 7a.

[0128] The analytic fluid devices 1 of Fig. 4a, Fig. 5a, Fig. 6a, and Fig. 7a may be produced by applying the method according to Fig. 3. The analytic fluid devices 1 of Fig. 4a, Fig. 5a, Fig. 6a, and Fig. 7a may comprise the substrate 2 of Fig. 2a after the process of printing the channel negative layer 3 thereon is completed.

[0129] The method 100 of producing an analytic fluid device 1 comprises: providing 101 a substrate 2 as a supporting structure of the analytic fluid device 1; printing 102 a channel negative layer 3 onto the substrate 2 and forming at least partially a capillary channel 4 that is configured to guide a fluid 9 along a path 5 that is at least partially defined by the capillary channel 4; and coupling 103 at least one porous fluid reservoir 6 to the capillary channel 4, wherein the at least one porous fluid reservoir 6 is configured to receive at least a portion of the fluid 9 after being guided along the path 5 and / or provide at least a portion of the fluid 9 before being guided along the path 5.

[0130] For realizing the embodiment of Fig. 4a, the printing 102 of the channel negative layer 3 onto the substrate 2 leads to forming the sample application portion 7, the fluid transfer portion 8 and the capillary channel 4. The printing 102 of the channel negative layer 3 may comprise a UV-printing and / or a layer-by-layer printing, the layer-by-layer printing being indicated for the embodiment shown in Fig. la to Fig. Id

[0131] The at least one porous fluid reservoir 6 may be coupled to the capillary channel 4 via the fluid transfer portion 8 as shown for the embodiments of Fig. 4a, Fig. 6a and Fig. 7a. Therefore, the at least one porous fluid reservoir 6 is positioned to cover at least a portion of the fluid transfer portion 8.

[0132] Alternatively or in addition, the at least one porous fluid reservoir 6 may be coupled to the capillary channel 4 via the sample application portion 7 as shown for the embodiments of Fig. 5a and Fig. 6a. Therefore, the at least one porous fluid reservoir 6 is positioned to cover at least a portion of the sample application portion 7. In the embodiments of Fig. 4a and Fig. 7a, the at least one porous fluid reservoir 6 is fluidically connected and / or coupled to the fluid transfer portion 8. The embodiments of Fig. 4a and Fig. 7a differ in that a cover element 11 is provided over at least a portion of the capillary channel 4 of the embodiment of Fig. 7a and Fig. 7b specifically to separate the capillary channel 4 from the porous fluid reservoir 6, whereas in the embodiment of Fig. 4a and Fig. 4b, there is no cover element 11 provided. In other words, in the embodiment of Fig. 7a and Fig. 7b, a cover element is positioned between at least a portion of the capillary channel 4 and the at least one porous fluid reservoir 6. The cover element 11, indicated in Fig. 7a and Fig. 7b as finely hatched area may cover all areas of the channel negative layer 3 plus at least a portion of the capillary channel 4. In other words, the cover element 11 may only leave open areas which must be approached and / or which are required to be open for a fluid transfer and / or a fluidic connection such as the fluid transfer from the fluid transfer portion 8 to the porous fluid reservoir 6. The cover element 11 confines the space of the capillary channel 4 at least partially. The upper side of the capillary channel 4 is closed by the cover element 11 and therefore, the path of the fluid is in this case at least partially defined by the capillary channel 11 to the sides, the substrate 2 on the bottom and the cover element 11 on the top.

[0133] In some embodiments, the cover element 11 may have a removable portion, for example a pre-cut segment of the cover element 11, that may for example cover the sample application portion 7 before usage of the analytic fluid device 1 to prevent it from contamination. When using the analytic fluid device 1, the user may remove that portion of the cover element 11.

[0134] Other than the provided cover element 11, the embodiments of Fig. 4a and Fig. 7a are identical.

[0135] In Fig. 4a and Fig. 7a, the porous fluid reservoir 6 corresponds to a test strip TS and may be based on an immunoassay for testing a parameter, a component and / or a substance in the sample fluid 9. The sample fluid 9 is applied to the sample application portion 7 as indicated in Fig. 4b and Fig. 7b (in fact as indicated in Fig. 4b, 5b, 6b, 7b, 8a, 8b, 9a, 9b) The sample fluid 9, or at least a portion thereof is then passively transported by the capillary channel 4, i.e. by the capillary forces of the capillary channel 4 along the path 5 that is at least partially defined by the capillary channel 4.

[0136] The path 5 leads towards the fluid transfer portion 8, where the sample fluid 9 is collected to be transferred to the test strip TS. The test strip TS may be composed of cellulose, nitrocellulose and / or another type of porous material, for example a sponge-like and / or capillary-like material. The sample fluid 9, or at least a portion thereof is then passively transported by the porous fluid reservoir 6 along the test strip TS, i.e. by the capillary forces of the porous fluid reservoir 6. Test lines may be provided on the test strip at which a reaction of a component of the sample fluid 9 and an agent in the test line may take place, such as an antibody-antigen binding reaction. The path 5 that is substantially taken and / or followed by the sample fluid 9 is indicated in the figures by the arrow.

[0137] The cover element 11 shown in Fig. 7a and Fig. 7b, prevents the sample fluid 9 from travelling into the test strip TS directly from the capillary channel 4. The cover element 11 may in another embodiment also cover at least partially the sample application portion 7, wherein the cover element 11 may leave a small hole open through which the sample fluid 9 may be applied onto the sample application portion 7.

[0138] Fig. 7b shows a sandwich structure of the substrate with the channel negative layer and the closed capillary channel from low to high plane is as follows: substrate 2 (1. plane) - channel negative layer 3 and capillary channel 4 (2. plane) - cover element 11 (3. plane) - porous fluid reservoir 6 which may overlap with the 3. Plane defined by the cover element 11. In general, the term “plane” refers to a range, i.e. a plane having a certain thickness, for example the 2. plane defined by the channel negative layer and the capillary channel (and the entire channel structure) has a thickness dl indicated in Fig. 2b and 2c. For example, the 1. plane defined by the cover element 11 has a thickness d2 as indicated in Fig. 2b and 2c. Therefore, the term plane does not refer to an infinitely thin plane but a layer that has a physical thickness defined by the thickness of the elements that define that plane.

[0139] The sample application portion 7 and / or the fluid transfer portion 8 may vary in size and shape. The size and shape indicated in the Figures are just examples. Shapes may be round, oval, polygonal, star-like, random in shape, partially filled (having a printed structure therein) or completely empty (with no printed structure therein). The shapes of the sample application portion 7 and / or the fluid transfer portion 8 may have printed structures within that may have capillary properties to distribute the sample fluid 9 and / or a washing fluid effectively within the sample application portion 7 and / or the fluid transfer portion 8, also denoted as flow guidance elements herein.

[0140] In the embodiment of Fig. 5a and Fig. 5b, the fluid transfer portion 8 corresponds to a fluid receiving portion 8’ not (yet) coupled to a porous fluid reservoir 6. At least a portion of the fluid that is guided by the capillary channel 4 is received by the fluid receiving portion 8’. In the embodiment of Fig. 5a and Fig. 5b the porous fluid reservoir 6 is fluidically coupled to the capillary channel 4 via the sample application portion 7. The porous fluid reservoir 6 may correspond to a separation pad that is configured for separating and / or holding back components of the sample. For example, if whole blood is applied to the separation pad, some components of the whole blood may be held back from entering the capillary channel 4 by the separation pad. For example, in an immunoassay, a separation pad may correspond to a component that helps to separate unbound substances from the target analyte. It is often used in solid-phase immunoassays such as ELISA (enzyme-linked immunosorbent assay) and other similar techniques. The separation pad may assist in removing any unbound molecules or particles, allowing only the specific target analyte and its associated detection reagents to proceed for measurement. This separation step may in some cases be critical for the accuracy and reliability of the immunoassay results.

[0141] Not only the sample fluid 9 but also a washing fluid and / or other fluid may be applied to the porous fluid reservoir 6 that covers the sample application portion 7. The sample fluid 9 and / or the washing fluid is then soaked by the porous fluid reservoir 6. Excess amounts of the sample fluid 9 and / or the washing fluid, and / or predetermined components thereof may enter the capillary channel 4 and / or may be passively transported and / or dragged in by the capillary channel 4. The fluid receiving portion 8’ may then for example have the function of collecting at least a portion of these components and / or excess amounts. The embodiment of Fig. 6a and Fig. 6b, is a combination or similar to a combination of the embodiments of Fig. 4a and Fig. 4b with Fig. 5a and Fig. 5b. In this embodiment, two porous fluid reservoirs 6i, 62 are fluidically coupled to the capillary channel 4, namely a first porous fluid reservoir 61 (which may correspond to a test strip) being coupled to the fluid transfer portion 8 and a second porous fluid reservoir 62 (which may correspond to a separation pad) being coupled to the sample application portion 7. The sample fluid 9 may be applied to the second porous fluid reservoir 62 being coupled to the sample application portion 7 and excess amounts of the sample fluid 9 which cannot be held by the second porous fluid reservoir 62 travel along the capillary channel 4 towards the fluid transfer portion 8 fluidically coupled to the first porous fluid reservoir 61. One or both of the porous fluid reservoir 61, 62 may correspond to a test strip and / or an element thereof.

[0142] The method 100 as indicated in Fig. 3 may further comprise: thermally coupling 104 to the analytic fluid device 1 : at least one heat agent receiving mechanism 13, specifically a chamber to receive at least one heating element 10 and / or a heating agent that is configured to provide heat to the analytic fluid device 1 and / or the fluid 9 by means of an exothermic reaction (see embodiments shown in Fig. 8b and Fig. 9b); and / or at least one heat agent coupling mechanism 12, specifically a foil to couple at least one heating element 10 and / or a heating agent, that is configured to provide heat to the analytic fluid device 1 and / or the fluid 9 by means of an exothermic reaction, to the analytic fluid device 1 (see embodiments shown in Fig. 8a and Fig. 9a); and / or at least one heating element 10 and / or a heating agent that is configured to provide heat to the analytic fluid device 1 and / or the fluid 9 by means of an exothermic reaction (see embodiments shown in Fig. 8a and 8b and Fig. 9a and 9b); and / or at least one heat limiting element receiving mechanism 15, specifically a chamber to receive at least one heat limiting element 16 that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device 1 and / or the fluid 9 (see embodiment shown in Fig. 9b); and / or at least one heat limiting element coupling mechanism 14, specifically a foil to couple at least one heat limiting element 16, that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device 1 and / or the fluid 9, to the analytic fluid device 1 (see embodiment shown in Fig. 9a); and / or at least one heat limiting element 16 that is configured to perform a change in the state of aggregation by absorbing heat from the analytic fluid device 1 and / or the fluid 9 (see embodiment shown in Fig. 9a and Fig. 9b).

[0143] Fig. 10a is a schematic top view of an analytic fluid device 1, according to a further embodiment. Fig. 10b and Fig. 10c are schematic detail views of the analytic fluid device 1 of Fig. 10a. Fig. 10b shows the fluid transfer portion 8 together with a transfer portion 4’ between the capillary channel 4 and the fluid transfer portion 8, in more detail. Fig. 10c shows the sample application portion 7 together with a transfer portion 7’ between the sample application portion 7 and capillary channel 4, in more detail.

[0144] The analytic fluid device 1 of Fig. 10a comprises a substrate 2 (not visible), a channel negative layer 3 (black portion), and a channel structure (white portions) comprising a sample application portion 7, a capillary channel 4, a fluid transfer portion 8 and a porous fluid reservoir 6 being fludically coupled to / connected with the capillary channel 4 via the fluid transfer portion 8.

[0145] Further, the analytic fluid device 1 comprises a transfer portion 7’ between the sample application portion 7 and the capillary channel 4 and a transfer portion 4’ between the capillary channel 4 and the fluid transfer portion 8. These transfer portions 4’, 7’ have a shape, i.e. an outer contour line which differs from the outer contour lines of the sample application portion 7 (having a round shape), the capillary channel 4 (having a straight shape), and the fluid transfer portion 8 (having a rectangular shape). The transfer portion 7’ between the sample application portion 7 and capillary channel 4 is diamond-shaped having two diamond-shaped structures coupled and / or connected to each other along their length axis. The transfer portion 4’ between the capillary channel 4 and the fluid transfer portion 8 is also diamondshaped but having only one diamond-shape. Moreover, the sample application portion 7, the transfer portion 7’ between the sample application portion 7 and the capillary channel 4, and the transfer portion 4’ between the capillary channel 4 and the fluid transfer portion 8 each comprises a flow guidance element 18, namely a printed structure being printed therein with the function to guide the flow of the fluid in a more predetermined, laminar, non- turbulent, directed and / or controlled manner. The flow may be better distributed along the path from the sample application portion 7 to the fluid transfer portion 8. Further, the flow guidance element 18 may provide a surface, specifically in the form of the side walls, that contributes to the capillary effect on a fluid.

[0146] As shown in Fig. 10b, which is a detail view of Fig. 10a, the transfer portion 4’ between the capillary channel 4 and the fluid transfer portion 8, which has a single diamond-shaped outer contour defined by the channel negative layer 3, has a diamond-shaped inner flow guidance element 18, also being defined by the channel negative layer 3. The resulting well-distributed flow of a fluid is indicated in the fluid transfer portion 8 by grey lines, which diverge concentrically from the tip of the diamond-shaped inner flow guidance element 18. All regions of the fluid transfer portion 8 may be reached well by the fluid, due to the improved distribution.

[0147] As shown in Fig. 10c, which is another detail view of Fig. 10a, the sample application portion 7, which has a round outer contour defined by the channel negative layer 3, has a lengthy inner flow guidance element 18 (long stretched oval shape), also being defined by the channel negative layer 3. The transfer portion 7’ between the sample application portion 7 and the capillary channel 4, which has a double diamond-shaped outer contour defined by the channel negative layer 3, has a lengthy inner flow guidance element 18 (bar / bridge shape), also being defined by the channel negative layer 3. Both flow guidance elements 18 shown in this figure have the function of better directing the flow of the fluid towards the capillary channel 4 by adding adhesion forces contributing to a capillary effect and by representing an obstacle for the fluid that is bypassed in a main direction. The flow guidance element 18 of the sample application portion 7 directs the fluid towards the transfer portion 7’ and the flow guidance element 18 of the transfer portion 7’ directs the flow towards the capillary channel 4. Fig. 11 is a schematic top view of an analytic fluid device 1, according to a further embodiment. The analytic fluid device 1 comprises a substrate 2 (not visible in this figure) and a channel negative layer 3 printed thereon defining a channel structure as follows: a sample application portion 7 with a round contour is provided to apply a sample fluid. The sample application portion 7 has a flow guidance element 18 printed therein in a lengthy slightly oval shape. The sample application portion 7 is fluidically connected with a fluid transfer portion 8 via a transfer portion 7’ having the contour / shape of three diamonds with a bar-like flow guidance element 18 in the first two diamond-shaped elements and a diamond shape printed in the third diamond-shaped element. The transfer portion 7’ may be considered a capillary channel (this may apply to some or all transfer portions 4’, 7’ of some or all embodiments described herein). The fluid transfer portion 8 is configured to transfer the sample fluid to a reactive pad 22, which is a porous fluid reservoir 6.

[0148] The reactive pad 22 may be considered a conjugate pad, also known as a reagent pad, which is often used in lateral flow assays and immunoassays. It is responsible for holding the conjugate, which consists of a labeled antibody or other binding agent that is specific to the target analyte. The conjugate pad facilitates the controlled release of the labeled reagent as the sample flows through the test, allowing it to interact with the target analyte, if present. This interaction forms the basis for the detection and visualization of the analyte within the assay.

[0149] The sample fluid may migrate across the reactive pad 22 and enter a double diamondshaped channel structure (comprising a bar-like flow guidance element 18) that is overlapped by the reactive pad 22. The reactive pad 22 bridges and as such fluidically connects the fluid transfer portion 8 with the double diamond-shaped channel structure. From there, the sample fluid enters a capillary channel 4 that leads towards a mixing area / chamber 19 having a round outer contour and a round flow guidance element 18 printed therein. The mixing area / chamber 19 is fluidically connected with a fluid receiving portion 8’ via two capillary channels 4 wherein the right capillary channel 4 serves as an air supply portion 19’ of mixing area / chamber.

[0150] In experiments, it was shown that at least a portion of the sample fluid creeps along the left capillary channel 4 towards the fluid transfer portion 8 where it is at least partially transferred to the above laying test strip TS that covers the fluid transfer portion 8.

[0151] A washing fluid may be applied onto the mixing area / chamber 19 after the sample fluid has passed the test strip TS. The washing fluid has shown to creep along the right capillary channel 4, in experiments. Before entering the fluid transfer portion 8, the washing fluid enters a round element that serves as a flow-stopping element. It completely fills with the washing fluid before the washing fluid enters the fluid transfer portion 8 and before the washing fluid is transferred to the test strip TS. The washing fluid flows across the test strip TS in order to wash off unspecifically -bound components for a more accurate test result.

[0152] The washing fluid may in some cases of the embodiments shown herein already be provided on the analytic fluid device 1. For example, a blister containing the washing fluid may be coupled to the analytic fluid device 1. When needed, the blister may be punched and / or opened otherwise to establish a fluidic connection between the inside of the blister and the capillary channel 4 and / or another element of the channel structure. This makes it very convenient for a user and / or sterilized washing fluid can be provided without the need for the addition / application onto the analytic fluid device 1.

[0153] Fig. 12a is a photographic top view of an analytic fluid device 1, according to a further embodiment. Fig. 12b is a photographic top view of the substrate 2 with the channel negative layer 3 printed thereon of the analytic fluid device 1 of Fig. 12a.

[0154] Fig. 12b shows a channel structure comprising a washing fluid application portion 26 having a lengthy (oval-shaped) flow guidance element 18 and a round outer contour defined by the channel negative layer 3. The washing fluid application portion 26 is fluidically connected to a first capillary channel 4i via a transfer portion 26’ between the washing fluid application portion 26 and the capillary channel 4. The transfer portion 26’ has a double-diamond outline / contour shape and a bar-like flow guidance element 18. When applying a washing fluid / liquid, it follows the FD (indicated by the right arrow) along the capillary channel 4 to a fluid transfer portion 8. The channel structure of Fig. 12b also comprises a sample application portion 7, which is located slightly above the washing fluid application portion 26 in the plane / layer of the channel negative layer 3. The sample application portion 7 has an outer contour in the shape of a double diamond if the edges are considered sharp or two droplet-like shapes if the edges are considered round. The sample application portion 7 comprises a bar-like flow guidance element 18 being printed therein. The sample application portion 7 is fluidically connected to a second capillary channel 42 that guides the sample fluid when applied to the sample application portion 7 towards the fluid transfer portion 8. The second capillary channel 42 is fluidically connected to the fluid transfer portion 8 via a transfer portion 4’ between the second capillary channel 42 and the fluid transfer portion 8, having a bar-like flow guidance element 18. The flow direction FD of the sample fluid is indicated by the left arrow.

[0155] As can be seen in these embodiments, complex channel structures can be provided efficiently on a small space.

[0156] In Fig. 12a, the layers of the analytic fluid device 1 on top of the channel negative layer 3 are shown. Most of the channel negative layer 3 and the channel structure is covered by a cover element 11, which may be an adhesive foil that may have a hydrophilic surface directed towards the channels structure. The cover element 11 leaves holes open in the region of the washing fluid application portion 26, the sample application portion 7 and the fluid transfer portion 8. Other portions of the channel structure are covered and / or closed by the cover element 11 to form a closed capillary leaving only a gap for applying fluids and transferring the fluids onto a porous fluid reservoir 6. In this embodiment with a closed capillary channel, an additional wall / surface is provided that may contribute to the capillary effect, i.e. the adhesive forces of the walls onto the fluid. Further, evaporation into the open space and / or (cross) contamination may be avoided in that case.

[0157] When the fluids arrive at the fluid transfer portion 8, they are transferred to a transfer pad 21 (which is a porous fluid reservoir 6 and may be considered a transfer mat of fibers) provided in a plane above the fluid transfer portion 8. In this elevated plane, i.e. the plane above the substrate 2, the channel negative layer 3 and the channel structure comprising the capillary channel 4 and the cover element 11, the fluids change the direction of flow FD as indicated by the arrow on the left. At least some portions of the fluids (sample fluid and washing fluid) flow from the transfer pad 21 via a reactive pad 22, a separation pad 23, and a membrane 24 to a waste pad 25. All these pads 21-25 may be considered porous fluid reservoirs 6. These pads 21-25 may each have the function as when used in test strips and / or lateral flow tests and / or immunoassay tests and may therefore be considered the core element of a test strip.

[0158] The components of a lateral flow test and / or a test strip typically include a sample pad (which may correspond to the transfer pad 21), a conjugate pad (which may correspond to the reactive pad 22), a nitrocellulose membrane (which may correspond to the membrane 24), an absorbent pad (which may correspond to the waste pad 25), and a backing card. The sample pad is where the sample (e.g. blood, urine, or saliva) is applied, the conjugate pad contains labeled antibodies or antigens, the nitrocellulose membrane captures the target analyte, and the absorbent pad wicks the sample through the test. These components work together to produce a visible result, such as the appearance of colored lines, indicating the presence or absence of the target analyte.

[0159] More specifically, the transfer pad 21 may facilitate the movement of the sample from the sample application area (here specifically the fluid transfer portion 8) to the rest of the test. The reactive pad 22 may contain reagents, such as labeled antibodies or antigens that react with the target analyte in the sample. The separation pad 23 may help to separate any interfering substances from the sample, allowing the target analyte to move through the test unaffected. The membrane 24 may capture the target analyte and may allow for the formation of visible lines or signals to indicate the presence or absence of the analyte. Finally, the waste pad 25 may absorb excess fluids for example comprising sample fluid, washing fluid and / or reagents, preventing them from interfering with the test result.

[0160] The analytic fluid device 1 therefore has a sandwich structure from the lowest plane to the highest plane in the following order: substrate 2 substantially forming a first plane - channel negative layer 3 and channel structure comprising the capillary channel 4 substantially forming together a second plane - cover element 11 substantially forming a third plane - pads 21-25, 6 (which may overlap each other at least partially) substantially forming together a fourth plane or forming several planes which overlap each other and / or are stacked.

[0161] By the design of the channel structure, the time / the moment when two fluids flow across the test strip (portions) may be pre-determined and / or controlled. For example, the sample fluid and the washing fluid may be applied at the same time. By the difference in the distance from the respective application portion 7 and 26, the sample fluid may arrive at the transfer pad 21 prior to the washing fluid.

[0162] The Method 100 may be performed as a reel-to-reel process, as indicated in Fig. 13 and Fig. 14. Fig. 13 is a schematic top view of a substrate sheet 20 in the process of printing 102 a channel negative layer 3 thereon, according to an embodiment of a reel-to-reel process and Fig. 14 is a schematic top view of the substrate sheet 20 of Fig. 13 after the process of printing 102 the channel negative layer 3 thereon is completed, according to the embodiment of the reel-to-reel process. The substrate sheet 20 comprises multiple single substrates as a component thereof. In Fig. 13, eight substrates 2 are shown as an example and in Fig. 14, six substrates 2 are shown as an example. However, a substrate sheet 20 may comprise hundreds or even thousands of single substrates 2 for a high volume production of analytic fluid devices. The channel negative layer 3 may be printed in one process on the multiple substrates 2 as indicated in Fig. 13. The finished printed channel negative layer 3 on six substrates 2 of the substrate sheet 20 is shown in Fig. 14 For the sake of simplicity, one printed channel negative layer 3 on one substrate is identical with the printed channel negative layer 3 of embodiment of Fig. 2a, Fig. 2b and Fig. 2c.

[0163] The method 100 may further comprise at least one cutting process, wherein, in the cutting process, at least one substrate, i.e. one single substrate with the printed channel negative layer is cut, specifically in a longitudinal direction of the substrate namely along the separation line / cutline 17.

[0164] Fig. 15 is a schematic top view of an analytic fluid device 1, which may correspond to an IVD fluid device, which has an oval shape, according to a further embodiment. This or a similar analytic fluid device 1 may be used for example in a centrifuge to drive the liquids through the channel system. The sample analytic fluid device 1 has a sample application portion 7 that is fluidically connected to two reaction chambers 27, which may contain one or more reagents via a capillary channel 4. The second reaction chamber 27 is fluidically connected / coupled to a fluid transfer portion 8 via the capillary channel 4 - the capillary channel 4 / capillary channel portions therefore connect the sample application portion 7, the first reaction chambers 27, the second reaction chambers 27 and the fluid transfer portion 8. A test strip 6 (indicated as transparent grey-shaded element) covers at least a portion of the fluid transfer portion 8 and is therefore fluidically connected therewith and with the capillary channel 4. The test strip 6 may correspond to an immunoassay based for example on a fluorescence signal. The analytic fluid device 1 comprises a washing fluid application portion 26 that is fluidically connected via a capillary channel 4 to a dosage chamber 28 and the sample application portion 7. The washing fluid application portion 26 may be connectable and / or comprising a blister that contains the washing fluid. The blister may be opened to establish a fluidic connection between the inside volume of the blister and the washing fluid application portion 26 and / or the capillary channel 4.

[0165] Reference list

[0166] 1 analytic fluid device, specifically IVD fluid device

[0167] 2 substrate

[0168] 3 channel negative layer

[0169] 4 capillary channel

[0170] 4’ transfer portion between capillary channel and fluid transfer portion

[0171] 5 path

[0172] 6 porous fluid reservoir

[0173] 61 first porous fluid reservoir

[0174] 62 second porous fluid reservoir

[0175] 7 sample application portion

[0176] 7’ transfer portion between sample application portion and capillary channel fluid transfer portion ’ fluid receiving portion not coupled to a porous fluid reservoir fluid 0 heating element 1 cover element 2 heat agent coupling mechanism 3 heat agent receiving mechanism 4 heat limiting element coupling mechanism 5 heat limiting element receiving mechanism 6 heat limiting element 7 separation line 8 flow guidance element 9 mixing area / chamber 9’ Air supply portion of mixing area / chamber 0 substrate sheet 1 transfer pad / mat of fibers 2 reactive pad / mat of fibers 3 separation pad / mat of fibers 4 membrane, specifically cellulose membrane 5 waste pad / mat of fibers 6 washing fluid application portion 6’ transfer portion between washing fluid application portion and capillary channel 27 reaction chamber

[0177] 28 dosage chamber

[0178] 100 method of producing an analytic fluid device

[0179] 101-104 steps of method of producing an analytic fluid device

[0180] CL A center length axis of analytic fluid device

[0181] Di first dimension / direction dl thickness of channel negative layer

[0182] D2 second dimension / direction d2 thickness of substrate

[0183] FD flow direction

[0184] TS test strip

[0185] V volume of capillary channel

Claims

1. - 48 -Patent claims1. Analytic fluid device (1) comprising: a substrate (2); a channel negative layer (3) printed onto the substrate (2) and forming at least partially a capillary channel (4) that is configured to guide a fluid (9) along a path (5) that is at least partially defined by the capillary channel (4); and at least one porous fluid reservoir (6) coupled to the capillary channel (4) and configured to receive at least a portion of the fluid (9) after being guided along the path (5) and / or provide at least a portion of the fluid (9) before being guided along the path (5).

2. Analytic fluid device (1) of claim 1, wherein the channel negative layer (3) is directly printed onto the substrate (2); and / or wherein the channel negative layer (3) forms a bond with the substrate (2) that is free of an additional element between the channel negative layer (3) and the substrate (2), specifically free of an additional element comprising a layer, a bonding agent and / or a layer and / or a sheet comprising a bonding agent.

3. Analytic fluid device (1) of claim 1 or 2, wherein the at least one porous fluid reservoir (6) comprises a capillary reservoir structure having capillary properties; and / or wherein the at least one porous fluid reservoir (6) comprises at least one of: a soft, resilient and / or flexible foam and / or sponge or a hard foam and / or sponge, fibrous structures, specifically comprising at least one of: cellulose, nitrocellulose, paper, synthetic, biological and / or natural fibers; and / or wherein the analytic fluid device (1) comprises a test strip (TS) which comprises the porous fluid reservoir (6) and / or which is coupled to the porous fluid reservoir (6).- 49 -4. Analytic fluid device (1) of any one of the preceding claims, wherein a volume (V) of the capillary channel (4) is at least partially confined by the substrate (2) in at least one first dimension (Di); and / or at least two walls formed by the printed channel negative layer (3) in at least one second dimension (D2); and / or a cover element (11) in the at least one first dimension (Di), specifically the cover element comprises (11) at least one of: a sheet, a plate, a film, a layer, an inlay, a wire- and / or path-like element.

5. Analytic fluid device (1) of any one of the preceding claims, wherein the channel negative layer (3) has a thickness (dl) of about 0,05 pm to 1,5 mm.

6. Analytic fluid device (1) of any one of the preceding claims, wherein the substrate (2): has a thickness (d2) of about 1 pm to 5 mm; comprises a sheet, a plate, a foil and / or a film; comprises a hydrophilic material and / or a hydrophilzed surface onto which the channel negative layer (3) is printed.

7. Analytic fluid device (1) of any one of the preceding claims, further comprising: a sample application portion (7) for application of the fluid comprising a sample fluid onto the analytic fluid device (1), the sample application portion (7) being fluidically coupled to the capillary channel (4); and / or a washing fluid application portion for application of the fluid comprising a washing fluid onto the analytic fluid device (1), the washing fluid application portion being fluidically coupled to the capillary channel (4); and a fluid transfer portion (8) for coupling the capillary channel (4) to the porous fluid reservoir (6) via the fluid transfer portion (8) in that the fluid transfer- 50 - portion (8) is fluidically coupled to the capillary channel (4) for receiving at least a portion of the sample fluid and / or the washing fluid after being guided through the capillary channel (4) and in that the fluid transfer portion (8) is fluidically coupled to the porous fluid reservoir (6) for transferring at least a portion of the received sample fluid and / or the washing fluid to the porous fluid reservoir (6); and / or a fluid receiving portion (8’) being fluidically coupled to the capillary channel (4) and for receiving at least a portion of the sample fluid and / or the washing fluid after being guided through the capillary channel (4), specifically wherein the capillary channel (4) is configured to guide at least a portion of the sample fluid and / or the washing fluid from the sample application portion (7) and / or the washing fluid application portion along at least a portion of the path (5) defined at least partially by the capillary channel (4) to the fluid receiving portion (8’) and / or the fluid transfer portion (8).

8. Analytic fluid device of any one of the preceding claims, further comprising: at least one heat agent receiving mechanism (13), specifically a chamber to receive at least one heating element (10) and / or a heating agent that is configured to provide heat to the analytic fluid device (1) and / or the fluid (9) by means of an exothermic reaction; and / or at least one heat agent coupling mechanism (12), specifically a foil to couple at least one heating element (10) and / or a heating agent, that is configured to provide heat to the analytic fluid device (1) and / or the fluid (9) by means of an exothermic reaction, to the analytic fluid device (1); and / or at least one heating element (10) and / or a heating agent that is configured to provide heat to the analytic fluid device (1) and / or the fluid (9) by means of an exothermic reaction.

9. Analytic fluid device (1) of any one of the preceding claims, further comprising:- 51 - at least one heat limiting element receiving mechanism (15), specifically a chamber to receive at least one heat limiting element (16) that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device (1) and / or the fluid (9); and / or at least one heat limiting element coupling mechanism (14), specifically a foil to couple at least one heat limiting element (16), that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device (1) and / or the fluid (9), to the analytic fluid device (1); and / or at least one heat limiting element (16) that is configured to perform a change in the state of aggregation by absorbing heat from the analytic fluid device (1) and / or the fluid (9).

10. Analytic fluid device (1) of claim 8 or 9, wherein the analytic fluid device (1): is free of an active heat control and / or a coupling mechanism for an active heat control; is free of an additional energy source and / or a coupling mechanism for an additional energy source; and / or is configured to be operated at physiologically relevant temperatures.

11. Analytic fluid device (1) of any one of the preceding claims, wherein the analytic fluid device (1): is a single-use analytic fluid device; is free of a processor, control and / or machine and / or a coupling mechanism for a processor, control and / or machine; and / or is free of a liquid flow regulation.

12. Method (100) of producing an analytic fluid device (1) comprising: providing (101) a substrate (2) as a supporting structure of the analytic fluid device (1);printing (102) a channel negative layer onto the substrate (2) and forming at least partially a capillary channel (4) that is configured to guide a fluid (9) along a path (5) that is at least partially defined by the capillary channel (4); and coupling (103) at least one porous fluid reservoir (6) to the capillary channel(4) wherein the at least one porous fluid reservoir (6) is configured to receive at least a portion of the fluid (9) after being guided along the path (5) and / or provide at least a portion of the fluid (9) before being guided along the path(5).

13. Method (100) of claim 12, wherein the printing of the channel negative layer comprises: a UV-printing; and / or a layer-by-layer printing.

14. Method (100) of claim 12 or 13, wherein the method (100) is performed as a reel-to-reel process and / or wherein the method (100) comprises unrolling a substrate sheet which comprises the substrate besides multiple other substrates.

15. Method (100) of any one of claims 12 to 14, further comprising: thermally coupling (104) to the analytic fluid device (1): at least one heat agent receiving mechanism (13), specifically a chamber to receive at least one heating element (10) and / or a heating agent that is configured to provide heat to the analytic fluid device (1) and / or the fluid (9) by means of an exothermic reaction; and / or at least one heat agent coupling mechanism (12), specifically a foil to couple at least one heating element (10) and / or a heating agent, that is configured to provide heat to the analytic fluid device (1) and / or the fluid (9) by means of an exothermic reaction, to the analytic fluid device (1); and / orat least one heating element (10) and / or a heating agent that is configured to provide heat to the analytic fluid device (1) and / or the fluid (9) by means of an exothermic reaction; and / or at least one heat limiting element receiving mechanism (15), specifically a chamber to receive at least one heat limiting element (16) that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device (1) and / or the fluid (9); and / or at least one heat limiting element coupling mechanism (14), specifically a foil to couple at least one heat limiting element (16), that is configured to perform a change in the state of aggregation when absorbing heat from the analytic fluid device (1) and / or the fluid (9), to the analytic fluid device (1); and / or at least one heat limiting element (16) that is configured to perform a change in the state of aggregation by absorbing heat from the analytic fluid device (1) and / or the fluid (9).

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