IVA test cell, test kit comprising IVA test cell, and method for producing same

Abstract

An IVA test cell (1) comprising: a test strip (2) for detecting an analyte wherein the test strip comprises at least an application function, a test reaction function and a test detection function; and a housing (3) for storing the test strip (2), where the housing (3) comprises an insertion tray (4) and an insertion hole (5) for inserting the test strip (2) into the insertion tray (4), characterized in that the housing (3) is formed as a single piece.

Description

Technical Field

[0001] This invention relates to an in vitro assay (IVA) test unit in the field of in vitro diagnostics (IVD), specifically a lateral flow assay (LFA) test unit and its manufacturing method, as well as a test kit including the IVA test unit. Background Technology

[0002] In diagnostic applications, conventional LFAs, such as LFA strips or dipstick tests, are commonly used. Test membranes that can be used in such tests can specifically include, but are not limited to, nitrocellulose membranes. Typically, a specific strip is applied to a membrane containing a specific chemical trapping reagent or compound designed to react and bind with a predetermined analyte, specifically a biomarker that may be present in the test sample liquid (such as, but not limited to, sputum, urine, blood, water, liquefied food samples, and surface swab samples). A specific example of an LFA is a rapid antigen test strip used to detect the presence of an analyte (such as viral fragments of an infectious disease) in a biological sample. Generally, LFA test units are often used in the form of test strips (such as, for example, pregnancy test strips, drug test strips, influenza and / or Covid-19 tests, and / or rapid allergen tests).

[0003] When the sample liquid is applied to the application area of ​​the LFA test strip, the sample liquid is drawn in by capillary forces along the longitudinal axis of the membrane (also known as the membrane analyte assay strip). The presence of a predetermined analyte is typically indicated when enzymes, target proteins, and / or biomarkers corresponding to these analytes migrate along the membrane and interact with chemically trapped reagents in the strips of the membrane, thereby producing a measurable and detectable signal / change in one or more analyte assay test areas. The resulting detectable and measurable signal at the stripe area can be, but is not limited to, caused by binding to: colloidal gold, charcoal beads, latex-stained beads, magnetic or paramagnetic beads, and / or agents or particles capable of emitting fluorescence, autofluorescence, cryoluminescence, phosphorescence, or chemiluminescence.

[0004] Test kits / test repositories based on this type of test unit, specifically the LFA test unit, consist of several individual components, each with a different function, and their production and assembly are complex, difficult, and / or time-consuming. Therefore, increasing production capacity requires significant effort in terms of machine performance. Furthermore, this necessitates multiple assembly steps to provide packaged and ship-ready assembled test kits. Typically, the volume and shape of the packaging do not allow for easy stacking of multiple kits and require considerable space.

[0005] Figure 1 illustrates the components of a typical LFA kit 200 (i.e., an LFA rapid antigen test kit for detecting the presence of Covid-19 in biological samples). The included LFA rapid antigen test pieces typically correspond to single-use tests, meaning they are disposed of after the test is performed; therefore, the test kit is considered disposable. The LFA rapid antigen test piece includes a test strip, specifically an LFA core strip 202, and a plastic housing 201, which consists of at least two parts: an upper part (cover) and a lower part (support). Further, the LFA kit 200 includes a swab (not shown) for collecting biological samples, a desiccant / dehumidifier 204, and a water vapor-impermeable aluminum pouch 203 into which the LFA rapid antigen test piece, swab, and desiccant 204 are inserted, packaged, and sealed. LFA rapid antigen test kits are typically assembled using a pick-and-place procedure, in which the LFA core 202 is positioned on the lower part of the plastic housing 201, followed by the assembly and clamping of the upper part of the plastic housing 201 onto the lower part to form an LFA unit (in this case, an LFA rapid antigen test kit). Production can be time-intensive and, in some cases, inefficient. Furthermore, the transport of such LFA rapid antigen test kit kits can often be inefficient. In addition, the production and / or transport costs of such LFA rapid antigen test kit kits can be high. Summary of the Invention

[0006] Therefore, a simplified, rapid, and / or efficient method for producing IVA test units is desired. In the context of a pandemic, a method for producing large quantities of IVA test units in a short period is particularly needed. This dynamic situation often requires simple and / or rapid scaling up and / or scaling down of production capacity to cope with the possibility of increasing and / or decreasing infections. Thus, providers can increase agility and respond quickly to changing pandemic situations. Pandemic situations also typically require the efficient and / or rapid delivery of large quantities of test kits / reagents to points of care and / or outbreak sites. Therefore, it is also desirable to provide IVA test units and / or test kits that are particularly improved in terms of logistics, appearance, and / or functionality, and / or are more compact.

[0007] At least one of the described problems is addressed accordingly by the IVA test unit, test kit, and method of producing the IVA test unit as described in the independent claims. Advantageous embodiments are covered by the dependent claims.

[0008] According to one aspect that can be considered a first aspect of this disclosure, an IVA test unit includes a test strip for detecting an analyte in a sample liquid, wherein the test strip includes at least an application function, a test reaction function, and a test detection function; and wherein the IVA test unit includes a housing for storing the test strip, and wherein the housing includes an insertion tray and an insertion hole for inserting the test strip into the insertion tray, characterized in that the housing is formed as a single piece. In other words, the IVA test unit comprises a single-piece housing.

[0009] IVA test units can be, but are not limited to, part of a test kit. According to the first aspect, IVA test units have a simplified and compact structure because the housing is formed from a single piece, and therefore the number of components can be reduced, making assembly of the IVA test units easier. In particular, production steps can be simplified and / or the number of production steps can be reduced. For example, during complex pick-and-place procedures, it is not necessary to assemble two or more components of the housing. Furthermore, it is not necessary to bond components to the housing, as the housing consists of only a single component. The test strip can be easily positioned inside the housing by inserting (specifically pushing) the test strip into the insertion tray through an insertion hole that substantially corresponds to a slit, which reduces production complexity, production time, and / or cost. Therefore, adjusting and / or increasing the production capacity of IVA test units is both simple and inexpensive. Thus, in the context of a pandemic, productivity can be easily scaled up (increased) and / or scaled down (reduced) to cope with increased and / or decreased infection rates, and therefore, manufacturers and / or suppliers of test kits and / or test solutions can easily and quickly respond to sudden changes in the pandemic situation. On the one hand, the possibility of rapid and efficient scaling up could allow for the rapid provision of numerous test kits in the event of a sharp rise in infection rates. On the other hand, the possibility of rapid and efficient scaling down could allow for a rapid response to a sudden drop in infection rates (potentially due to the establishment of herd immunity) and avoid the overproduction of test kits that are no longer needed.

[0010] A single-piece housing eliminates the risk of disassembly of the individual components, as it consists of only one piece. Furthermore, a single-piece housing does not include connecting mechanisms for linking the housing's components together, and therefore no connecting mechanisms can be damaged or lead to erroneous disassembly.

[0011] Furthermore, the one-piece housing provides high stability and therefore high protection for the test strip. Specifically, the one-piece housing does not easily twist.

[0012] In addition to improvements in effectiveness and functionality, IVA test units can also be perceived as high-quality products by users. IVA test units can also demonstrate improvements in aesthetics.

[0013] The housing is formed as a single piece. Specifically, the housing can be formed as a single piece through injection molding and / or additive manufacturing. All areas / parts of the housing produced together through injection molding and / or additive manufacturing can be considered as a single piece. A single piece is characterized in that all elements, areas, and parts of the single piece cannot be reversibly disassembled and reassembled to obtain the single piece again without damage. The elements of a single-piece housing will lose their functionality when attempted to be disassembled from each other.

[0014] An IVA test unit may correspond to, but is not limited to, an LFA unit, which includes a test strip corresponding to an LFA core strip. The LFA core strip may include, but is not limited to, a separate dedicated area for a specific function. Such functions may correspond to, but are not limited to, an application function, a test reaction function, and a test detection function. The area including the sample pad typically has an application function. The area including the conjugate pad typically has a test reaction function, at which binding between the molecule and the conjugate occurs. The area including the membrane can be used as a test detection area and may include a test line and a control line to detect the presence of the target analyte in the sample. Other test strips may also be used. Therefore, an IVA test unit may include another type of IVA test unit, such as, for example, but not limited to, a urine test. Such an alternative test may, for example, have a zone and / or a pad that includes all three functions—the application function, the test reaction function, and the test detection function—in one location. Test membranes that can be used for such tests may include, but are not limited to, nitrocellulose, silicone, plastics, glass, glass fiber, polyvinylidene fluoride, optionally charge-modified nylon, polyethersulfone, aluminum foil, paper, and / or other porous cellulose and rayon composites with hydrophilic or hydrophobic properties. The membrane may further contain an immobilization binder for a specific analyte. This binder can be any molecule or biomolecule with which the target biomolecular analyte interacts to obtain a binder-analyte / ligand complex immobilized on the membrane. Examples of such binders include antibodies, antigens, proteins, enzymes or portions thereof, substrates or portions thereof, peptides, DNA, or RNA.

[0015] The insertion hole may, but is not limited to, be located on the short side of the housing, wherein the housing has a longitudinal axis along its length, which is associated with a side longer than the short side. The insertion hole may, but is not limited to, be centrally located on the surface of the short side and / or positioned relative to the central longitudinal axis, or may be positioned off-center. Alternatively, (but not preferably) the insertion hole may be located on or on the long side of the housing.

[0016] The analyte may include, but is not limited to, at least one of the following: a virus or a fragment of a virus, such as a spike protein; a bacterial complex; a hormone; a molecule produced by the body; or a molecule produced by a foreign organism. The IVA test unit may include, but is not limited to, at least one of the following: a pregnancy test strip; a drug test strip; an influenza and / or Covid-19 test; and / or a rapid allergen test. The IVA test unit may be specific to one or more analytes in a combination test.

[0017] The housing may include a first wall (such as an upper wall) and a second wall (such as a lower wall) adjacent to the first wall, wherein the first wall and the second wall form and / or define an insertion tray at least partially as a gap between the first wall and the second wall. The first wall and the second wall are formed as a single piece, and therefore can be considered as a single wall in some cases. In such cases, the first wall can be considered as a first part of the wall, and the second wall can be considered as a second part of the same wall.

[0018] The first and / or second walls do not need to be “closed” walls, i.e., completely surrounding the insertion tray. Instead, one or both walls may include one or more recesses and / or through-holes. For example, the first wall may include an applied recess and / or a recess in the control area. In this case, both walls, specifically the remaining portions of both walls, can still define the insertion tray.

[0019] A housing can generally be understood as an element having two opposing walls and / or sides, between which a test strip can be positioned at least partially. In other words, the housing may have an upper portion corresponding to a first wall facing downwards, and a lower portion corresponding to a second wall of the housing, thus forming a gap between the two portions for inserting the test strip. The test strip can therefore be at least partially surrounded by the housing. Generally, if a box-shaped housing is provided, the housing may include three to six walls. The walls of the housing are formed as a single piece. In many cases, the housing comprises essentially six walls, specifically six walls arranged perpendicularly to each other. If all the walls on all sides are considered as a single wall and / or envelope, then each side can be considered as part of a wall and / or envelope. In certain embodiments, the housing may enclose the test strip to approximately 51% to 99%, preferably approximately 65% ​​to 95%, and even more preferably approximately 70% to 90%, such that most of the test strip is surrounded by the housing, with only portions of the test strip at the application recess, the control area, and / or the insertion hole of the housing being uncovered, unenclosed, and / or unenclosed. Very high coverage, such as approximately 90% to 98%, is achieved, for example, by applying an open space in a transparent housing that allows the user to read test results and closing the control area. The housing should not be construed as an element that substantially forms a substrate on which the test strip is positioned and a cover plate is positioned to enclose and / or secure the test strip. In this case, the substrate and cover plate would form the housing and therefore would not correspond to the single piece required by the present invention.

[0020] The housing can be further understood as a protective element for the test strip, wherein the housing has higher stability than the test strip to mechanically support and / or protect the test strip. As previously described, the housing should be understood as a single element whose first side and opposite second side form a gap for the insertion tray. If one side is recessed, a cover element can be used to cover the recess, but since the housing is a single piece, the cover element is not considered part of the housing herein. Generally, other elements (such as caps, insert plugs, cover plates, foils, and / or films) are not considered elements of the housing herein unless explicitly formed as a single piece with the housing. However, specifically, caps, insert plugs, and / or cover plates can be formed as a single piece with the remainder of the housing, which is connected to the housing by flexible, bendable, and / or thin bridging elements and / or straps and / or another flexible connecting element that are also formed as a single piece with the main part of the housing and the caps, insert plugs, and / or cover plates. In other words, such components (caps, insert plugs, and / or covers) can be formed as a single piece with the entire housing, and therefore no assembly step is required to attach them to the housing. In this case, the caps, insert plugs, and / or covers can be considered part of the housing. Flexible bridging and / or connecting elements allow the caps, insert plugs, and / or covers to be removed from the recess and the housing opened, while the connection is maintained and the caps, insert plugs, and / or covers are not lost.

[0021] Typically, in a standard test kit, the test strip housing comprises at least two elements, such as a bottom element and a top element with a coupling mechanism, wherein the at least two elements can be clamped together in the middle by the coupling mechanism during a pick-and-place procedure after the test strip is positioned on or in one of these elements. Housings produced using this conventional method allow the test strip to be secured and / or fastened inside the housing, as the housing is assembled after the test strip has been placed on or inside one of the at least two elements. IVA test units allow for easy securing of the test strip, as outlined below for different embodiments.

[0022] The insertion tray may correspond to the internal volume of the housing. The insertion tray may provide a volume for accommodating the test strip, which is approximately 1.2 to 20 times or more the volume of the test strip. Specifically, the height of the housing may be approximately 1.2 to 20 times or more the height of the test strip. The same applies to the width. It is advantageous to provide a wider and / or taller insertion hole and / or insertion tray to facilitate insertion of the test strip into the insertion tray. The insertion tray may, but is not limited to, have a tapered (and / or conical) insertion hole, which makes insertion of the test strip easier and / or more reliable, while reducing the risk of the test strip falling out of the insertion tray. This may be particularly advantageous in cases where insertion is performed manually by a user but also by a robot or machine. Alternatively, in some embodiments, the insertion tray and / or insertion hole are not tapered and / or conical.

[0023] The insertion tray may have a surface that is approximately the area (length x width) of the test strip (or slightly larger).

[0024] The insertion tray may have a lower surface positioned below the insertion hole. In other words, the insertion tray is positioned further back and / or lower than the lowest point of the insertion hole, or at least the lower surface defined by the insertion hole, to extend further into the lower wall of the housing. Similarly, in other words, the lower wall of the housing defining the lower surface of the insertion tray may be recessed into the interior volume to receive the test strip below the insertion hole. Thus, the test strip can be inserted into the insertion tray via the insertion hole and fall downwards into the insertion tray under the force of gravity, such that the test strip is supported by the lower surface of the insertion tray. Unrestrictedly, the distance between the recess, i.e., the lowest point of the insertion hole, and the lower surface of the insertion tray may be approximately 0.1 cm to 1 cm, specifically approximately 0.2 cm to 0.7 cm, and preferably approximately 0.3 cm to 0.5 cm. This can help secure the test strip within the insertion tray, preventing it from easily falling out.

[0025] Alternatively or additionally, the insertion hole, substantially corresponding to the slit, may be inclined relative to a plane parallel to a substantially parallel (horizontal) plane defined by the upper and lower walls of the housing. Thus, when the test strip is inserted into the insertion tray, the test strip and / or the housing may be slightly inclined relative to each other (and / or relative to the horizontal plane). Without limitation, the slit axis of the insertion hole may be inclined at an angle α of approximately 3° to 45°, specifically approximately 5° to 30°, and preferably approximately 7° to 15°, relative to a plane parallel to the substantially parallel (horizontal) plane defined by the upper and lower walls of the housing. Therefore, the angle between the height axis of the housing (which is perpendicular to the substantially parallel and horizontal plane defined by the upper and lower walls of the housing) and the slit axis of the insertion hole may deviate slightly from 90° (90° + / - approximately 3° to 45°, specifically approximately 90° + / - 5° to 30°, and preferably approximately 90° + / - 7° to 15°). The angled insertion hole allows for easy securing of the test strip inside the insertion tray, as the probability of it falling out of the tray via the angled insertion hole is very low. This is because there is no surface supporting the test strip at that angle, and therefore the test strip will not easily fall out.

[0026] Alternatively or additionally, the insertion hole may be only slightly larger than the test strip in its cross-section, making it less likely for the test strip to be precisely aligned with the insertion hole, thus reducing the risk of detachment. The insertion hole may be tapered toward the insertion tray. Specifically, the insertion hole, i.e., the narrow slit, may be only slightly larger than the test strip on the inner side of the insertion hole (i.e., the side closest to the insertion tray). Without limitation, the cross-sectional area of ​​the insertion hole may be approximately 1.05 to 5 times, specifically approximately 1.1 to 2 times, and preferably approximately 1.2 to 1.7 times, the cross-sectional area of ​​the test strip. If the insertion hole is tapered toward the insertion tray, this allows for easy insertion, and the insertion tray guides the test strip in its tapered form toward the insertion tray. However, once the test strip is inserted, it will not easily detach through the insertion hole because the insertion hole corresponds to a narrow slit, which may be positioned above the insertion tray, may be inclined relative to the upper and lower walls of the housing, and / or may be only slightly larger than the test strip itself.

[0027] Optionally or additionally, the insertion hole may be (slightly) curved, and therefore inserting the test strip may require the test strip to be (slightly) bent to conform to the shape of the insertion hole opening. Bending can be achieved and / or supported by an additional support placed above and / or below the test strip, forcing the test strip into the desired shape for insertion via the curved insertion hole. Alternatively or additionally, the insertion hole may be curved from the outer surface to the inner surface, with a smaller or substantially unbent slit towards the inner surface, and tapered in such a way that the test strip is forced into a (slightly) bent and / or curved shape by the insertion process, specifically by a pushing movement that allows the test strip to enter the insertion tray. Since most test strips are flexible in shape and return to their flat shape once inserted, they will not fall out of the insertion tray because they do not spontaneously assume a curved shape.

[0028] Alternatively or additionally, the insertion hole may include a flexible lip inside the insertion tray that bends toward the insertion tray when the test strip is inserted, and covers or even seals the insertion hole from the inside of the insertion tray. The flexible lip functionally corresponds to a valve. The test strip is then secured inside the insertion tray by the flexible lip and will not fall off through the insertion hole because the flexible lip is configured to bend in only one direction. The flexible lip also protects the insertion tray from contamination, water, and / or water vapor.

[0029] All of these features can be achieved in a relatively simple way through the manufacturing methods (injection molding and / or additive manufacturing), and thus can effectively help secure the test strip inside the housing.

[0030] Therefore, continuing from the above, the IVA test unit may include at least one of the following features to reduce the risk of test strips falling out of the insertion tray: The lower surface of the insertion tray (i.e., the upper surface of the second lower wall of the first wall adjacent to the inner side of the housing) can be positioned below the lowest point of the inner side of the insertion hole. Specifically, the lower surface of the insertion tray is about 0.1 cm to 1 cm deep relative to the lowest point of the inner side of the insertion hole, specifically about 0.2 cm to 0.7 cm, and preferably about 0.3 cm to 0.5 cm. The insertion hole can be tapered from the outside of the insertion hole toward the inside of the insertion hole, specifically such that the cross-sectional area defined by the outside of the insertion hole is greater than the cross-sectional area defined by the inside of the insertion hole, and the sidewall of the insertion hole is tapered from the outside of the insertion hole toward the inside of the insertion hole; The insertion hole, specifically, the inner side of the insertion hole may be inclined at an angle α relative to a plane parallel to the first and second walls of the housing. Specifically, the insertion hole may define a slit having a slit axis (i.e., the length axis of the insertion hole specifically on the inner side), and the slit axis may be inclined relative to a plane parallel to the first and second walls of the housing and form an angle deviating from the height axis of the insertion hole by 90° (i.e., 90° + / - α). The inside of the insertion hole can be formed into a bent shape and / or can be configured to bend the test strip when it is inserted into the insertion tray. Specifically, the outside of the insertion hole can be tapered toward the inside of the insertion hole so that the test strip further becomes a bent shape that matches the shape of the inside of the insertion hole when it is inserted. The IVA test unit may include a flexible and / or resilient flap configured to cover the insertion hole from the inside, so as to bend inward when the test strip is inserted and to snap backward and cover the insertion hole when the test strip is fully inserted, and to prevent the test strip from falling out through the insertion hole.

[0031] The housing may be, but is not limited to, at least partially transparent. Specifically, the housing may be completely transparent. If the housing is at least partially transparent, specifically at least partially transparent in the control area, the user can inspect the state of the test strip inside the housing and / or read the test results through one of the transparent walls. The housing may subsequently function to enclose the test strip while simultaneously providing a view of the test strip, specifically the test detection area, allowing the user to read the test results from the test lines of the test strip.

[0032] The housing may include, but is not limited to, an application recess for allowing sample liquid to be applied onto the test strip. Alternatively or additionally, the housing may include, but is not limited to, a control area for reading test results from the test strip.

[0033] The application recess allows the user to apply sample liquid onto the test strip via the application recess. The application recess may correspond to, but is not limited to, a through-hole to allow the tip of a pipette and / or syringe and / or applicator to extend into the insertion tray to introduce sample liquid onto the test strip. The user may use, but is not limited to, syringes, pipettes, applicators, vials, tubes, etc., to apply the sample liquid. Syringes, pipettes, applicators, tubes, and / or vials may be supplied with, but is not limited to, test kits. The application recess may be covered, for example, by a membrane and / or cap to seal the interior of the housing. The membrane may then be punctured by the needle of the syringe or pipette before applying the sample liquid. The cap can be simply removed to extend into the test strip.

[0034] In one embodiment, the control area may correspond to, but is not limited to, a through-hole that allows a user to read test results from the test lines of the test strip. In this case, the housing does not completely (100%) surround the test strip in the control area. The width of the housing may be, but is not limited to, approximately 1.5 to 20 times the width of the through-hole in the control area. The length of the housing may be, but is not limited to, approximately 1.3 to 15 times the length of the through-hole in the control area.

[0035] Alternatively, the control area may correspond to, but is not limited to, a transparent area of ​​the housing that allows the user to read test results from the test lines of the test strip. Alternatively, or further, the control area may correspond to, but is not limited to, an area comprising at least one sensor, at least one channel and / or recess for the sensor, and / or at least one receiving position for the sensor. The sensor may specifically include an optical sensor. The sensor may include, but is not limited to, a camera. The sensor may record and / or read out test results from the test strip. In other respects, if optically accessible to the user, the user can read the test results from the test strip. Typically, in simple disposable items used as home testing units (tested by a private user in the home) and / or point-of-care units, it is useful that the test results can be read visually by the user or another person who does not need to be a professional healthcare worker. However, alternatively, or further, in a laboratory setting, the IVA testing unit may be read out in an automated manner, such as by a machine. This allows for the automated reading of large numbers of test results and / or the automated input of test results into a database. In this case, when the IVA test unit is used as a disposable item, the machine used to read the results can be used, but is not limited to, for a long period of time.

[0036] The IVA test unit may include, but is not limited to, one or more of the following sealing elements: an insertion plug configured to be inserted into the insertion hole to seal the insertion hole and / or secure the test strip to prevent it from falling out of the insertion tray; and a cap configured to be clamped to the housing in and / or over the insertion hole.

[0037] Closing elements such as insert plugs and / or caps are configured to open and / or close the insert orifice once and / or repeatedly. The closure element can seal the insert tray. In this case, there is no exchange of air and / or water vapor between the outside and the insert tray. The insert plug can engage with the insert orifice and can be inserted into the insert orifice so that the insert plug extends into the insert tray. The cap, instead, can substantially cover the insert orifice without extending into the insert tray. A combination of both possible closure elements can be achieved by having a cap that incorporates an insert plug, such that the insert orifice is covered and sealed with high reliability.

[0038] The insert plug and / or cap may be integrally formed with the housing, i.e., formed as a single piece with the housing. In this case, the insert plug and / or cap are formed together with a flexible, bendable, and / or thin bridging element that connects the insert plug and / or cap to the housing to form a single piece.

[0039] The sealing element may alternatively include a foil, specifically a water vapor-impermeable foil, and / or another element attached to the housing, for example, glued, welded, and / or laminated to the housing, and covering the insertion hole and / or extending into the insertion hole and / or covering another recess. In one embodiment, specifically in a single-use IVA test unit, one and / or more foils may be removed before use and may not be configured to seal the interior of the housing once removed. This allows for a simple and / or effective method of sealing the interior of the housing against water vapor, water, gases, and / or contaminants using a small amount of material. Generally, the internal volume of the housing may be filled with a gas, specifically an inert gas and / or a dry gas, to prevent premature degradation of the test strip.

[0040] The housing may include, but is not limited to, a retaining mechanism configured to retain one, several, or all of the components of the test kit / reagent, such as swabs and / or vials. Vials may include, but are not limited to, including, storing, and / or containing a liquid, such as a buffer solution, in which samples collected by the swab can be eluted. The retaining mechanism may include, but is not limited to, clamps, holding elements, and / or recessed elements to utilize the buffer solution to retain and / or secure the swabs and / or vials. At least one retaining mechanism may be integrally formed with the housing. In other words, at least one retaining mechanism may be formed as a single piece together with the housing. The retaining mechanism may include, but is not limited to, a break point allowing a user to break and / or disassemble the retaining mechanism to remove the swabs and / or vials from the housing along with the retaining mechanism. Alternatively or additionally, the housing may include, but is not limited to, one or more recesses and / or holes to receive and / or secure the vials and / or swabs. In the latter case, the recess may conform to the shape of the vials and / or swabs such that the vials and / or swabs do not exceed the shape of the housing. By attaching vials and / or swabs to the housing, a very compact test kit can be provided. The test kits can be bound together, and shipping becomes highly efficient. The test kits can be tightly packaged using water-impermeable and specifically water vapor-impermeable foil and / or covered using a water vapor-impermeable film. Swabs and / or swab heads can be, but are not limited to, individually packaged to provide clinical purity.

[0041] The IVA test unit may include, but is not limited to, at least one cover plate, specifically a transparent or partially transparent cover plate, configured to cover and / or enclose the control area and / or apply recesses and / or other recesses. As previously mentioned, the cover plate may be formed as a single piece with the remainder of the housing, connected to the housing by a flexible, bendable, and / or thin bridging element and / or band and / or another flexible connecting element, also formed as a single piece with the main part of the housing and the cover plate. In this case, the cover plate can be considered part of the housing.

[0042] The cover can seal the internal volume, i.e., the insertion tray where the test strip is located, while being placed on and / or over the control area. The transparent cover also provides a viewing channel for the user, allowing them to monitor the status of the test strip (used or unused) and / or read the results. The cover can also be covered and / or sealed with a water vapor-impermeable foil.

[0043] A cover plate configured to cover the control area can be, but is not limited to, fixed, attached, and / or glued to the housing, such that the user cannot remove the cover plate without substantially damaging the IVA test unit. Alternatively, a transparent cover plate can be placed over and on the control area and can be configured for easy and / or reversible removal from the housing. Specifically, in the latter case, the cover plate does not need to be transparent, and therefore it can be opaque, at least partially opaque. The cover plate can also function to seal the internal volume of the housing, such as the insertion tray and the test strip therein, before using the IVA test unit. In this case, foil and / or film can be used to cover and / or seal the control area in addition to or in place of the cover plate. The foil and / or film can be removed shortly before using the IVA test unit.

[0044] A cover plate positioned in and / or above the application recess may, but is not limited to, be configured for removal from the housing, allowing the user to reach the test strip to apply the sample liquid. Alternatively or additionally, the cover plate may have a recess to allow the user to reach the test strip while applying the sample liquid. The cover plate in and / or above the application recess may have, but is not limited to, the following primary functions: sealing the internal volume of the housing, such as the insertion tray and the test strip therein, before using the IVA test unit. In this case, foil and / or film may also be used instead of the cover plate to cover and / or seal the application recess of the housing and / or the recess in the cover plate above the application recess. The foil and / or film may be removed shortly before using the IVA test unit. Generally, the foil and / or film above any recess may be glued, laminated, and / or fused to the housing. If the foil and / or film has not been removed, it allows the user to identify that the IVA test unit is new and has not been opened and / or used.

[0045] The cover plate (transparent or opaque) over the applied recess and the cover plate (specifically a transparent cover plate) over the control area can correspond to isolated, separate, and / or different cover plates that are separate from each other. Alternatively, only one cover plate and / or foil / film can be provided to cover and / or close more than one recess. For example, a single cover plate and / or a single foil can simultaneously cover both the control area (which may be a recess in the housing) and the applied recess.

[0046] Under no circumstances should one or more covers, one or more foils, and / or one or more films be considered as part of the housing and / or an element thereof. One or more covers, one or more foils, and / or one or more films generally do not form a single piece with the housing.

[0047] When the housing is produced using additive manufacturing principles (such as 3D printing), different materials can be used for different parts of the housing. Therefore, a transparent material can be used to form a control area, while another material (e.g., an opaque material) can be used to produce other parts. However, in this specific case, a cover plate is not provided. The cover plate (which is not formed as a single piece with the housing) is characterized by existing as a separate element not part of the housing, and the production of the IVA test unit requires the cover plate to be assembled into / on the housing. All areas and / or parts of the housing produced together through injection molding and / or additive manufacturing can be considered as a single piece.

[0048] The IVA test unit may include, but is not limited to, a desiccant / dehumidifier as part of the housing. The IVA test unit may include, but is not limited to, a desiccant / dehumidifier as part of a sealing element. The IVA test unit may include, but is not limited to, a desiccant / dehumidifier as part of a cover plate. The IVA test unit may include, but is not limited to, a desiccant / dehumidifier placed in or on at least one chamber and / or recess of the housing. The IVA test unit may include, but is not limited to, a desiccant / dehumidifier placed in or on an insert plug. The IVA test unit may include, but is not limited to, a desiccant / dehumidifier placed in or on a cover plate. In other words, the desiccant may be part of the housing. The desiccant may be part of a sealing element. The desiccant may be part of a cover plate. The desiccant may be a component placed in at least one chamber and / or recess of the housing, the desiccant may be a component placed in at least one chamber and / or recess of an insert plug, and / or the desiccant may be a component placed in at least one chamber and / or recess of a cover plate.

[0049] Therefore, at least one element of the IVA test unit can have an integrated drying function, since the desiccant is a part, component, and / or constituent of the material made of the element, and / or because the element provides a volume into which the desiccant can be positioned and / or filled. The desiccant can be in the form of, but is not limited to, powder, pearl, sponge, solid sheet, liquid, etc. Providing such elements in the IVA test unit is advantageous, as these elements already provide a drying function to absorb water vapor and / or water and protect the test strips from degradation. Therefore, the number of elements in the test kit can be reduced because there is no need to add additional packaging with the desiccant to the bag. In other words, there is no need to provide a separate package with the desiccant in the bag in which the test kit is packaged. This reduces the complexity of producing the test kit, potentially requiring fewer assembly steps, generating less waste, requiring a smaller volume per packaged test kit, and allowing for more compact packaged test kits, which increases shipping efficiency because less empty air-filled space can be filled during the binding and transport of the test kits. Furthermore, the IVA test unit is very effective because it inherently provides a (relatively) large number of functions.

[0050] The proper functioning of test strips is typically sensitive to moisture, and therefore the addition of desiccants and / or water vapor-impermeable packaging is advantageous, or even necessary, to ensure proper functioning. Desiccants may include silica gel and / or zeolite. Salts (e.g., CaCl2) and / or calcium oxide may be used to establish chemical bonds.

[0051] The IVA test unit may include, but is not limited to, at least one of the following features to support the drying conditions in the IVA test unit: a water vapor impermeable material, which is included as an integral material of the housing, closure element and / or cover plate; a water vapor impermeable upper layer, which is sprayed and / or coated onto the housing, closure element and / or cover plate; a water vapor impermeable film, preferably wherein the water vapor impermeable film encapsulates the entire IVA test unit.

[0052] In other words, a water vapor-impermeable material can be included as the integral material of the housing, the integral material of the sealing element, and / or the integral material of the cover plate. The water vapor-impermeable upper layer can be sprayed and / or coated onto the housing. The water vapor-impermeable upper layer can be sprayed and / or coated onto the sealing element, and / or the water vapor-impermeable upper layer can be sprayed and / or coated onto the cover plate. A water vapor-impermeable membrane can encapsulate part or all of the IVA test unit, i.e., 100% of the IVA test unit. A water vapor-impermeable membrane can encapsulate part or all of the test kit.

[0053] If a water vapor-impermeable material is used to encapsulate and / or seal the IVA test unit and / or test kit, it may not be necessary to package the IVA test unit and / or test kit in a bag. The IVA test unit may or may not be supplied to the user with other parts of the test kit. However, in most cases, the IVA test unit is supplied to the user with all necessary components of the test kit.

[0054] The housing may include a fixing mechanism configured to fix the test strip in the position of the insertion tray, optionally wherein the fixing mechanism includes at least one of the following: a hook as an element of the housing and a recess as an element of the test strip, the recess being configured to snap into the hook; a spring element configured to fix the test strip by spring force; and an element of the housing configured to fix the test strip by friction.

[0055] Therefore, the retaining mechanism allows the test strip to be secured inside the housing when it is pushed into the insertion tray, specifically without additional movement. Thus, methods for producing IVA test units and / or test kits including IVA test units are highly efficient because the number of production steps can be reduced. Furthermore, the retaining mechanism can include an element formed monolithically with the housing. Therefore, the housing can acquire additional functionality and / or can achieve this functionality without adding additional components, making the housing highly efficient and simultaneously highly reliable because the test strip will not be accidentally released from the housing.

[0056] One element of the fixing mechanism may be located at one end of the insertion tray, for example, at the end opposite the insertion hole. Alternatively, the element of the fixing mechanism may be located near the insertion hole. The opposite element of the fixing mechanism may be located at one end of the test strip.

[0057] In all cases, the casing may contain, but is not limited to, recycled plastics and / or compostable materials. The casing may be disposable or configured for single use. Alternatively, the casing may be configured for reuse. Therefore, the casing may be constructed of materials resistant to aggressive cleaning procedures using, for example, acids, caustic solutions, ozone, and other corrosive agents. Highly resistant materials include, for example, PTFE, but which is more expensive than other polymeric materials such as acrylic materials, and can be used as materials and / or components of, for example, the casing. Therefore, such casings are very environmentally friendly.

[0058] According to another aspect, which can be considered a second aspect of this disclosure, a method for producing an IVA test cell includes the steps of: providing a one-piece housing for storing test strips, wherein the housing includes an insertion tray and an insertion hole for inserting test strips into the insertion tray; and placing the test strips in the housing.

[0059] This method can encompass all the corresponding features, technical effects, and advantages outlined together with the embodiments of the IVA test unit described herein. Specifically, the method is highly efficient in terms of machine capacity, time, and financial investment. The method allows for rapid production. The method further allows for the production of highly efficient products (IVA test units or test kits including IVA test units) that can be efficiently handled, operated, and / or transported. The method can be easily scaled up to increase production volume with low expenditure. The optional features and / or embodiments described below relate to all the corresponding features, technical effects, and advantages outlined together with the IVA test unit and / or test kit and their corresponding embodiments described (above).

[0060] Providing a housing can involve pure provision, without involving a manufacturing process. Alternatively, providing a housing can include producing the housing as a single piece by injection molding and / or by additive manufacturing, specifically by 3D printing.

[0061] Injection molding and / or additive manufacturing, specifically 3D printing, are production principles for forming single-piece components. While additive manufacturing is typically a layer-by-layer application technique, injection molding requires a mold that defines the negative sheet of form / shape. A liquid material forming the shell is filled into the mold, and this liquid material acquires that form / shape upon solidification. Additive manufacturing has the potential to produce any shape, even very complex ones. Injection molding is limited in the shapes that can be formed. If holes, recesses, etc., need to be formed, the injection molding method requires a negative element (form / shape) positioned relative to the mold. Liquid material is then filled into the mold. This produces a shape defined by the negative shape of the mold and the negative element placed within it. Both principles are simple, easily automated, and allow for efficient and low-cost production of single-piece components, while scaling up production volumes is also simple and effective.

[0062] When applying injection molding technology, producing single-piece housings is advantageous because each piece requires only a single mold instead of several. However, depending on the complexity of the housing shape, injection molding may require a complex-shaped molded part to act as the mold. The mold may include a metal molded part that can be assembled before molten, flowing, and hot polymer is filled into it and disassembled after the polymer has cooled. Complex molded parts can be formed by the mold structure both "from the outside" and "from the inside" of the housing shape. In other words, the mold may include a forming cavity defining the outer surface of the housing and elements extending into the cavity and defining the inner surface of the housing (such as insert trays and possible fixing mechanisms). The size of such molds and their structures is in the range of cm, i.e., between about 0.3 cm and about 30 cm, preferably between about 1 cm and 15 cm.

[0063] Placing the test strip in the housing may include a pushing movement that causes the test strip to enter the housing. Further, placing the test strip in the housing may involve the following steps: providing a strip and / or sheet (having multiple connected test strips) preferably from a roll, having a longitudinal strip / sheet axis, wherein the strip / sheet includes test strips among multiple test strips along the longitudinal strip axis; conveying the strip along the longitudinal strip axis, for example, on a conveyor; cutting the strip / sheet perpendicular to the longitudinal strip axis to separate the test strips from the multiple test strips; aligning the housing, wherein the longitudinal housing axis is parallel to or perpendicular to the longitudinal strip axis, and the insertion hole faces the test strip; and inserting the test strip through the insertion hole into an insertion tray.

[0064] The housing can be provided and / or moved via, but is not limited to, a conveyor (e.g., a conveyor belt). This method is highly efficient and eliminates the need for pick-and-place operations. Specifically, it eliminates the need for robots capable of complex movements such as rotation and / or torsion.

[0065] This embodiment of the method can be at least partially automated, specifically fully automated. The step of inserting the test strip into the insertion tray can include, but is not limited to, movement via pistons, hooks, airflow, conveyors, etc., specifically, pushing movement.

[0066] The method may include, but is not limited to, closing the insertion hole by at least one of the following: inserting an insertion plug into the insertion hole; or clamping a cap over the insertion hole to the housing.

[0067] The method may include, but is not limited to, providing a desiccant as at least one of the following: a component of a housing, an insert plug, and / or a cap; an element placed in at least one chamber and / or recess of the housing, the insert plug, and / or the cap.

[0068] The method may include, but is not limited to, at least one of the following: spraying and / or coating a water vapor-impermeable top layer onto the housing; or encapsulating the entire IVA test unit with a water vapor-impermeable membrane.

[0069] Enclosing the insertion hole and / or providing a desiccant, another element, and / or a coating / film as part of the housing allows the proper functioning and reliability of test strips that may be sensitive to water and / or water vapor to be maintained. Furthermore, the number of components required for shipping and / or storing the IVA test unit can be reduced, and thus a very compact and / or efficient IVA test unit can be provided.

[0070] The method may include the following steps: using a fixing mechanism based on, but not limited to, a snap-fit ​​mechanism, spring force, and / or friction to fix the test strip in the insertion tray.

[0071] This method can reduce the number of production steps because fixing can be performed during insertion and may not require further fixing steps. Furthermore, IVA test units can be manufactured in which the test strips are secured to prevent movement, displacement, and / or detachment from the housing, making the IVA test units highly reliable.

[0072] According to another aspect which may be considered a third aspect of this disclosure, a test kit may include: an IVA test unit and / or any of the embodiments of the IVA test unit described herein; a swab for collecting biological samples; and a vial containing a liquid for eluting the samples.

[0073] The test kit (also known as a test kit) may further include: a desiccant packaged in a bag for packaging the components of the test kit and / or a water vapor-proof bag; and / or a manual for providing guidance to the user on how to use the test kit.

[0074] The housing may include at least one retainer and / or at least one recess for holding and / or receiving one, several, or all of the components of the test kit. The housing may include a vial retainer and / or a vial recess to receive and / or hold vials. Alternatively or additionally, the housing may include a swab retainer and / or a swab recess to receive and / or hold swabs. The vial retainer and / or the vial recess may be integrally formed with the housing, i.e., formed as a single piece with the housing. This makes it easy to manufacture housings with multiple functions, assemble the basic components of the test kit, and / or hold these basic components together. Furthermore, this can improve the user experience of the test kit, as vials can be placed, for example, upright in the vial recess, and therefore the user does not need to permanently hold the vial once it has been opened. Additionally, the user can find all the components in predetermined positions on the housing, which makes handling easier and increases user satisfaction. In a very compact form, a vial recess and a swab recess are provided in the housing, so that the vial and swab appear as inlays and are therefore flush with the overall surface of the housing.

[0075] Generally, the test kits described herein correspond to a collection of components that can be provided to a user who wishes to perform a test to determine the presence of an analyte in a biological sample. For example, a test kit may include, but is not limited to, an IVA test unit (a housing with test strips and possibly other components associated with the housing and / or test strips, such as a plug for sealing the opening of the housing); a swab for collecting the sample; a liquid, such as a buffer solution, in a vial having application features, such as a nozzle disposed in a cap of the vial; a desiccant; and a bag into which all components are packaged, wherein the bag may be considered part of the kit. The bag functions to maintain dry conditions inside the bag and to prevent degradation of the test strips. In some embodiments, the housing or components associated with and / or connectable to the housing may include a desiccant. In this case, for example, the test kit does not require an additional desiccant provided as a separate component.

[0076] The IVA test unit described herein includes at least a one-piece housing and a test strip that can be placed inside the housing. The test strip can also be delivered to the user or dispenser without being placed inside the housing. The housing and the strip can be supplied as separate components; however, most likely, the IVA test unit is already assembled when supplied to the user, i.e., the test strip is positioned inside the housing.

[0077] Detailed implementation method.

[0078] In the following description, some exemplary embodiments will be described in detail, wherein the invention should not be construed as limited to the described exemplary embodiments. The following examples and drawings are provided to aid in understanding the invention, the true scope of which is set forth in the appended claims. Individual features described in particular embodiments may be combined arbitrarily, provided they are not mutually exclusive. Furthermore, the different features provided together in the exemplary embodiments should not be considered as limiting the invention. Those skilled in the art will understand that the elements in the drawings are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions of some elements in the figures may be enlarged relative to other elements, and other elements may have been omitted or represented by reduced quantities to enhance clarity and improve understanding of aspects of this disclosure. The same reference numerals are used for the same or similar elements or elements having similar or identical effects in different embodiments and examples. Attached Figure Description

[0079] Figure 1 is an image showing several components of a lateral flow determination test kit / reagent according to the prior art; Figure 2 is a schematic diagram showing the assembly steps of an IVA test unit including a housing and test strips according to one embodiment, in a perspective side view; Figure 3 is a schematic diagram illustrating the method steps for producing an IVA test unit according to one embodiment; Figure 4 is a schematic diagram illustrating the method steps of placing a test strip into a housing according to one embodiment; Figure 5 is an image showing an IVA test unit including a transparent housing according to one embodiment, the transparent housing having an application recess; Figure 6 is an image showing an IVA test unit including a transparent housing according to one embodiment, the transparent housing having a cap, an application recess, and a recess in a control area; Figure 7 is an image showing an IVA test unit including a housing packaged in a water vapor impermeable foil according to one embodiment, the housing having an application recess and a recess in a control area; Figure 8 is an image showing an IVA test unit including a housing according to one embodiment, the housing having an application recess and a recess in a control area, wherein the housing is coated with a water vapor impermeable material; Figure 9a is a schematic top view of an IVA test unit including a test strip and a housing according to one embodiment; Figure 9b is a schematic diagram showing a front view of the IVA test unit of Figure 9a along line AA' according to one embodiment; Figure 9c is a schematic top view of a test kit according to one embodiment, the test kit having vials, swabs and an IVA test unit including test strips and a housing; Figure 9d is a schematic diagram showing the cutting of the test kit of Figure 9c according to one embodiment along the cutting line BB'; Figure 9e is a schematic top view of a test kit according to one embodiment, the test kit having vials, swabs, and an IVA test unit including test strips and a housing; Figure 9f is a schematic diagram showing the cut of the test kit of Figure 9e according to one embodiment along the cutting line CC'; Figure 9g is a schematic top view of a test kit according to one embodiment, the test kit having vials, swabs and an IVA test unit including test strips and a housing; Figure 9h is a schematic diagram showing the cutting of the test kit of Figure 9g according to one embodiment along the cutting line DD'; Figure 10a is a schematic top view of a housing with a cap according to one embodiment; Figure 10b is a schematic diagram showing a front view of the housing of Figure 10a along line EE' according to one embodiment; Figure 11a is a schematic diagram of an IVA test unit according to an embodiment in a perspective side view. The IVA test unit has an insertion tray positioned below the insertion hole, while the insertion hole is tapered from the outside to the inside to reduce the risk of losing test strips through the insertion hole. Figure 11b is a schematic diagram of the IVA test unit in Figure 11a in the front view; Figure 12a is a schematic diagram of an IVA test unit according to an embodiment in a perspective side view. The IVA test unit has an insertion hole that is inclined relative to a plane parallel to the upper and lower walls of the housing to reduce the risk of losing test strips through the insertion hole. Figure 12b is a schematic diagram of the IVA test unit in Figure 12a in the front view; Figure 13 is a schematic diagram of an IVA test unit according to an embodiment in a side view, the IVA test unit having a lug in front of the insertion hole to reduce the risk of losing the test strip through the insertion hole; Figure 14 is a schematic diagram of an IVA test unit according to an embodiment in a front view. The IVA test unit has an insertion hole that is curved inward and tapered from the outside to the inside to reduce the risk of losing the test strip through the insertion hole. Figure 15a is a schematic diagram of an IVA test unit according to an embodiment in a perspective side view, the IVA test unit having an insertion tray positioned below the insertion hole, and the lower surface of the insertion tray being inclined relative to the upper wall of the housing; Figure 15b is a schematic diagram of an IVA test unit according to an embodiment in a perspective side view. The IVA test unit has an insertion tray positioned below the insertion hole, and a support structure is provided on the lower surface of the insertion tray; and Figure 15c is a schematic diagram of an IVA test unit according to an embodiment in a perspective side view, the IVA test unit having an insertion tray positioned below the insertion hole, and the upper surface of the insertion tray being inclined relative to the lower wall of the housing.

[0080] Figure 1 is an image illustrating several components of a prior art lateral flow assay (LFA) kit / reagent 200 (denoted as prior art LFA kit 200). Specifically, Figure 1 shows a rapid antigen test piece for detecting the presence of Covid-19 in biological samples. Prior art LFA kit 200 includes: a test strip 202, which is an LFA core strip 202; a housing 201 comprising two parts, namely an upper part 201a and a lower part 201b; packaging with a desiccant 204; a swab (not shown); and a water vapor-impermeable bag / packaging 203. Because the housing comprises two parts 201a, 201b, there is a risk of the housing being erroneously disassembled, for example, when the connecting mechanism linking the upper part 201a and the lower part 201b is damaged and / or when the housing 201 is subjected to an external impact. Typically, prior art LFA kits 200 are assembled using a pick-and-place method, which requires multiple steps and can be time-consuming and / or complex in terms of automated movement. Because prior art LFA kits 200 include multiple components, assembling and packaging the kit can be complex, time-consuming, and / or difficult. Furthermore, the packaged prior art LFA kits 200 are not very compact and employ undefined shapes, making stacking difficult or impossible. In addition, a significant amount of empty air-filled space is packaged. The present invention is made to improve IVA test units and / or test kits overall, especially considering the aforementioned difficulties.

[0081] Figure 2 is a schematic diagram illustrating the assembly steps of an IVA test unit 1, including a housing 3 and test strips 2, according to one embodiment. The housing 3 is a single-piece housing for storing the test strips 2. The housing 3 includes an insertion tray 4 and an insertion hole 5 for inserting the test strips 2 into the insertion tray 4. In this embodiment, the insertion hole 5 corresponds to an opening in the insertion tray 4, and the cross-sectional area of ​​the insertion hole 5 corresponds to the cross-sectional area of ​​the insertion tray 4. Alternatively, the insertion opening 5 may have a smaller cross-sectional area than the insertion tray 4 and may, for example, be positioned slightly above the lower surface of the insertion tray 4.

[0082] The insertion hole 5 is positioned on the short side of the housing 3 at a surface substantially perpendicular to the longitudinal axis A of the housing 3. The housing 3 further includes: a first wall 6, shown as an upper wall in FIG. 2; and a second wall 7, shown as a lower wall in FIG. 2. Overall, in this embodiment, six side surfaces and / or sidewalls are provided in mutually perpendicular planes. The first wall 6 and the second wall 7 face each other, i.e., walls 6 and 7 are adjacent to each other and define the insertion tray 4 at least partially by enclosing it on the upper and lower sides. The first wall 6 includes an applied recess 8, and the second wall 7 is configured to support the test strip 2 from below when positioned in the correct upright orientation. The housing 3 can be produced as a single piece specifically by injection molding or by additive manufacturing, specifically by 3D printing. The housing 3 includes an application recess 8 for allowing the application of sample liquid 23, which can be applied to the test strip 2 via the tip 25 of a needle or pipette when the test strip 2 is positioned inside the insertion tray 4. The sample liquid 23 may include a biological sample collected using a swab eluted in the liquid. The liquid may be an aqueous buffer solution provided in a vial. Furthermore, the housing 3 includes a recessed control area 9 for reading the test result from the test strip 2 when the test strip 2 is positioned inside the insertion tray 4, the sample liquid 23 is applied, and the test is ready to be read.

[0083] According to Figure 2, a belt and / or sheet 18 having a longitudinal belt / sheet axis B is provided and conveyed along the longitudinal belt axis B on a conveyor 122. The belt 18 includes test strips 2 among a plurality of test strips 20 along the longitudinal belt axis B. The longitudinal belt axis B is perpendicular to the longitudinal axis of a single test strip 2 among the plurality of test strips 20. Further details are provided in the form of a belt / sheet. The test strips 20 in the form of belt / sheet 18 already include all elements such as a substrate 15, a sample pad 11, a conjugate pad 12, a membrane 13 such as a nitrocellulose membrane, and an absorbent pad 14. 123 The plurality of test strips 20 of the sheet are cut 123 by a cutter 16 in a direction perpendicular to the longitudinal belt axis B to obtain a single test strip 2. This cutting direction is used if the test strips 20 are connected side-by-side to each other.

[0084] Alternatively, test strips 20 can be arranged one after another adjacently on the short side of the test strip 20 (not shown in the figure). In this case, the longitudinal axis B corresponds to the longitudinal axis of a single test strip 2 among the plurality of test strips 20. In Figure 2, the housing 3 is aligned 124 with the longitudinal housing axis A, which is perpendicular to the longitudinal belt axis B, and with the insertion hole 5 facing the test strip 2. The longitudinal axis of the individual test strip 2 is aligned along the longitudinal housing axis A. After the test strip 2 is cut off from the strip of the test strip 20, the test strip is inserted 125 into the insertion tray 4 of the housing 3 through the insertion hole 5.

[0085] After insertion 125, insert plug 10 and plug 130 are inserted into insertion hole 5. Alternatively, cap 30 can be clamped onto housing 3 above insertion hole 5. Furthermore, IVA test unit 1 is sealed 140 by cover plate 24 inserted into recessed control area 9.

[0086] The final product produced by the method shown in Figure 2 should be an IVA test unit 1, which has a test strip 2 positioned inside the insertion tray 4, wherein the sample pad 11 is substantially aligned with the application recess 8, and the test line 21 and control line 22 of the membrane 13 are aligned with the control area 9. In other words, the sample pad 11 should be located below the application recess 8 so that the user can reach the sample pad 11 through the application recess 8 to apply the sample liquid 23. Furthermore, the test line 21 and control line 22 of the membrane 13 should be visible through the control area 9.

[0087] Figure 3 is a schematic diagram illustrating the method steps of producing IVA test unit 100 according to one embodiment. The method 100 for producing IVA test unit 1 includes the following steps: providing 110 a one-piece housing 3 for storing test strips 2, wherein the housing 3 includes an insertion tray 4 and an insertion hole 5 for inserting the test strips 2 into the insertion tray 4; and placing 120 of the test strips 2 into the insertion tray 4 of the housing 3. In this embodiment, providing the housing 3 includes producing the housing 3 as a single piece by injection molding 110a and / or by additive manufacturing 110b, specifically by 3D printing. Providing the housing 3 may also refer to providing the housing 3 purely to users, suppliers, and / or manufacturers. The housing 3 may be provided as part of IVA test unit 1 or test kit 17.

[0088] Figure 4 is a schematic diagram illustrating the steps of a method for placing a test strip 2 into a housing 3 according to one embodiment. Placing the test strip 2 into the housing 3 includes: providing 121 a strip / sheet 18 preferably from a roll having a longitudinal strip axis B, wherein the strip / sheet 18 includes test strip 2 among a plurality of test strips 20 along the longitudinal strip axis B; conveying 122 the strip / sheet 18 along the longitudinal strip axis B on a conveyor; cutting 123 the strip / sheet 18 perpendicular to the longitudinal strip axis B to separate the test strip 2 from the plurality of test strips 20; aligning 124 the housing 3 with the longitudinal housing axis A (aligned with the longitudinal strip axis B (when the strip axis B is aligned with the housing axis A), parallel or perpendicular (when the strip axis B is perpendicular to the housing axis A, as shown in Figure 2)) and with an insertion hole 5 facing the test strip 2; and inserting 125 the test strip 2 into an insertion tray 4 through the insertion hole 5. In all cases, when the test strip 2 is inserted into the insertion tray 4, the housing axis A should be substantially aligned with the longitudinal axis of the individual test strip 2.

[0089] Figure 5 is an image showing an IVA test unit 1 according to one embodiment, including a transparent housing 3 with an application recess 8 and a recess in a control area 9. In this particular embodiment, the transparent housing 3 includes a recess in the control area 9. However, since the housing 3 is transparent, the user can read the test results without the recess in the control area 9. Even without the recess in the control area 9, the test strip 2, which is an LFA core strip, is still visible through the transparent housing 3, making it easy for the user to read the test results from the test strip 2. Sample liquid can be applied to the sample pad 11 of the test strip 2 through the application recess 8.

[0090] The proper functioning of test strip 2 typically requires sensitivity to moisture / water vapor and / or water, and therefore necessitates the addition of a desiccant. In this particular embodiment of Figure 5, housing 3 does not include a desiccant as part of housing 3. It may be necessary to add a bag containing a desiccant to IVA test unit 1 to maintain dry conditions. Alternatively, housing 3 may include a desiccant. Therefore, it may not be necessary to add a package / bag containing a desiccant to a larger package / bag along with IVA test unit 1. Instead of providing a bag, or in addition to providing a bag, the depressions in the application depression 8 and / or control area 9 can be covered, particularly sealed, by a cover and / or foil. At least one foil / film can be glued, welded, and / or laminated to the housing to cover one or both depressions. In this case, the cover and / or foil / film may include a desiccant to absorb moisture in the internal volume (specifically, the insertion tray 4 of housing 3) and protect the function of test strip 2.

[0091] Figure 6 is an image illustrating an IVA test unit 1 according to one embodiment, including a transparent housing 3 having a cap 30 containing a desiccant, an application recess 8, and a recess in a control area 9. The housing 3 may have the same features as the housing 3 of the embodiment shown in Figure 5. Furthermore, the IVA test unit 1 of Figure 6 includes a coupling mechanism that allows the cap 30 to be coupled, secured, and / or attached to the housing 3. Therefore, the housing 3 of Figure 6 includes a component of the coupling mechanism 38, and the cap 30 includes opposing elements of the coupling mechanism 38. More specifically, the cap 30 includes two extension elements (nose) facing the housing 3 when the cap 30 is about to be coupled to the housing 3. The extension elements engage with two corresponding recesses in the housing 3 (not visible in this figure). The extension elements on the cap 30 and the corresponding recesses in the housing form the coupling mechanism 38. The cap 30 may not be considered part of the housing 3. The cap 30 has a slit aligned with the insertion tray 4 of the housing to receive one end of the test strip 2. The cap 30 covers and thereby closes the insertion hole 5 of the housing 3. The cap 30 contains the entire desiccant. Alternatively or additionally, the cap 30 may have an internal volume that can contain the desiccant, wherein the internal volume can be connected to the insertion tray 4 when the cap 30 is attached to the housing 3. Generally, the recesses in the application recess 8 and / or control area 9 can be covered, particularly sealed, by a cover plate and / or foil.

[0092] Figure 7 is an image showing an IVA test unit 1, including a housing 3, packaged in a transparent, water vapor-impermeable foil 26 according to one embodiment. The housing has an applied recess 8 and a recess in a control area 9. The transparent, water vapor-impermeable foil 26 allows a user to view and / or inspect the condition of the IVA test unit 1. Simultaneously, the transparent, water vapor-impermeable foil 26 protects the IVA test unit 1 from moisture, water, and / or water vapor. In this embodiment, the IVA test unit 1 is tightly packaged in the transparent, water vapor-impermeable foil 26.

[0093] Figure 8 is an image showing an IVA test unit 1 including a housing 3 according to one embodiment, the housing having an application recess 8 and a recess in a control area 9, wherein the housing 3 is coated with a water vapor impermeable material.

[0094] In the embodiments shown in Figures 5, 8, and 9, all recesses and insertion holes 5 are open; therefore, it may be advantageous to provide a cap 30 or an insertion plug 10 (possibly coupled to the housing 3 with a coupling mechanism) to close and / or seal the insertion holes 5, and it may be advantageous to provide a cover plate and / or foil to cover and / or seal the recesses in the applied recess 8 and / or the control area 9. At least one foil / film may be glued, welded, and / or laminated to the housing to cover one or both recesses 8 and 9. The cover plate and / or foil may be water vapor impermeable and / or transparent. Generally, the cover plate, foil, and / or film may include a desiccant and / or a chamber / internal volume for containing the desiccant.

[0095] Figure 9a is a schematic top view of an IVA test unit 1 including a test strip 2 and a housing 3 according to one embodiment. Figure 9b is a schematic front view of the IVA test unit 1 of Figure 9a along line AA', indicating the front of the housing 3.

[0096] In both figures, the test strip 2 (which is an LFA core strip) is shown separately on the left. On the right, a housing 3 is shown, in which the LFA core strip 2 is inserted into the insertion tray 4. In this embodiment, the insertion hole 5 and the insertion tray 4 have the same cross-sectional area and are aligned with each other; in other words, the insertion hole 5 is the opening of the insertion tray 4.

[0097] Test strip 2 is a typical LFA core strip and, as previously mentioned, includes a substrate 15 to which several elements are positioned. Sample pad 11 is positioned on one side of substrate 15 to receive the sample liquid, which is typically applied via an application recess 8 in housing 3 when the LFA core strip 2 is properly inserted into housing 3. Sample pad 11 contacts conjugate pad 12. Typically, conjugate pad 12 contains the detection reagent, i.e., the conjugate. As the sample liquid flows through the conjugate pad, the conjugate is released into the sample liquid and binds to the target molecule (if present in the sample liquid). Conjugate pad 12 contacts membrane 13, such as a nitrocellulose membrane. As the sample liquid / fluid passes through membrane 13, the result is visualized on membrane 13 via control line 22 and test line 21 in the presence of the target molecule. In other words, if the target molecule is not present in the sample liquid, test line 21 remains invisible or absent. If the target molecule is present in the sample liquid, test line 21 becomes visible or present. In all cases, once the sample liquid has passed through the membrane, control line 22 will be visible.

[0098] When fully and correctly inserted into the insertion tray 4, the test strip 2, together with the sample pad 11, is positioned below the application recess 8. The application recess 8 is located in / at a location within the housing 3 in an area away from the insertion hole 5. For example, the insertion hole 5 may be located in the front of the housing 3, and the application recess 8 may be located in the back of the housing 3. The control area 9 is located between the insertion hole 5 and the application recess 8.

[0099] However, the situation can also be reversed, and the insertion hole 5 can be located in the front of the housing 3, and the application recess 8 can also be located in the front of the housing 3. Therefore, in an alternative embodiment, the application recess 8 can be located in / at the housing 3 in a region near the insertion hole, and the control region 9 can subsequently be located in / at the housing 3 in a region away from / away from the insertion hole 5. In the latter case, compared to the first case where the application recess 8 is located in / at the housing 3 in a region away from / away from the insertion hole 5, the LFA core bar needs to be inserted in the opposite direction.

[0100] In the following text, dimensions of some features of the housing 3 and the test strip 2 are specified. These dimensions should be understood as exemplary embodiments to better understand the invention, and should not be construed as necessary limitations.

[0101] Test strip 2 has a length "e", a width "a", and a height "b". The length "e" may be, but is not limited to, between approximately 3 cm and 15 cm, specifically between approximately 4 cm and 10 cm, and more specifically between approximately 5 cm and 8 cm. The width "a" may be, but is not limited to, between approximately 0.5 cm and 3 cm, specifically between approximately 0.8 cm and 2 cm, and more specifically between approximately 0.9 cm and 1.5 cm. The height "b" may be, but is not limited to, between approximately 0.5 mm and 3 mm, specifically between approximately 0.8 mm and 2.5 mm, and more specifically between approximately 0.9 mm and 2 mm.

[0102] The housing 3 is shown on the right in Figures 9a and 9b, with the test strip 2 placed in the insertion tray 4, as seen in Figure 9b. In Figure 9a, the housing 3 is schematically shown from a top view. This figure shows details such as the application recess 8, the control area 9, and the structure of the housing 3. The control area 9 may, but is not limited to, be implemented as a recess in the housing 3. Alternatively, the control area 9 may, but is not limited to, be implemented as a transparent portion, window, foil, and / or film of the housing 3. Furthermore, or alternatively, the application recess 8 and / or the control area 9 may, but is not limited to, be covered and / or closed by a cover plate, film, and / or foil, specifically to seal the internal volume of the housing 3. Further, the insertion hole 5 may, but is not limited to, be covered, sealed, and / or closed by inserting a plug 10, a cap 30, a film, and / or foil.

[0103] The housing 3 has a length “f”, a width “c”, and a height “d”. The length “f” may be, but is not limited to, between approximately 4 cm and 20 cm, specifically between approximately 5 cm and 15 cm, and more specifically between approximately 6 cm and 10 cm.

[0104] Insert tray 4 has a length "l", a width "k", and a height "n". The length "f" may be, but is not limited to, between approximately 3.9 cm and 19.9 cm, specifically between approximately 4.9 cm and 14.9 cm, and more specifically between approximately 5.9 cm and 9.9 cm.

[0105] The housing 3 may, but is not limited to, have a length "f" longer than "e". In some other cases, specifically when a cap 30 is provided that also houses a portion of the test strip 2, the length "f" of the housing 3 may be the same as or shorter than the length "e" of the test strip 2. In such cases, the length "f" of the housing 3 may, but is not limited to, be approximately 0 cm to 5 cm shorter than the length "e" of the test strip 2, specifically approximately 0.4 cm to 2 cm shorter, and more specifically approximately 0.5 cm to 1.5 cm shorter. Alternatively, the length "f" of the housing may, but is not limited to, be approximately 0.3 cm to 5 cm longer than the length "e" of the test strip 2, specifically approximately 1 cm to 2 cm longer, and more specifically approximately 1.2 cm to 1.5 cm longer.

[0106] The insertion tray 4 may, but is not limited to, have a length "l" longer than the length "e" of the test strip. In some other cases, specifically when a cap 30 is provided that also accommodates a portion of the test strip 2, the length "l" of the insertion tray 4 may be the same as or shorter than the length "e" of the test strip 2. In such cases, the length "l" of the insertion tray 4 may, but is not limited to, be approximately 0 cm to 5 cm shorter than the length "e" of the test strip 2, specifically approximately 0.4 cm to 2 cm shorter, and more specifically approximately 0.5 cm to 1.5 cm shorter. Alternatively, the length "l" of the insertion tray 4 may, but is not limited to, be approximately 0.3 cm to 5 cm longer than the length "e" of the test strip 2, specifically approximately 1 cm to 2 cm longer, and more specifically approximately 1.2 cm to 1.5 cm longer.

[0107] The width “c” of the housing 3 may be, but is not limited to, between approximately 0.8 cm and 5 cm, specifically between approximately 0.9 cm and 3 cm, and more specifically between approximately 1 cm and 2.5 cm. The height “d” of the housing 3 may be, but is not limited to, between approximately 0.8 cm and 3 cm, specifically between approximately 1 cm and 2.5 cm, and more specifically between approximately 1.3 cm and 2 cm.

[0108] The width "k" of the insertion tray 4 may, but is not limited to, be between approximately 0.51 cm and 3.1 cm, specifically between approximately 0.81 cm and 2.1 cm, and more specifically between approximately 0.91 cm and 1.51 cm. The height "n" of the insertion tray 4 may, but is not limited to, be between approximately 0.7 cm and 2.9 cm, specifically between approximately 0.9 cm and 2.4 cm, and more specifically between approximately 1.2 cm and 1.9 cm. In other words, the insertion tray 4 may, but is not limited to, have a length "l", a width "k", and a height "n", depending on the thickness of the walls of the housing 3. Therefore, the dimensions of the insertion tray 4 may, but are not limited to, correspond to the corresponding dimensions of the housing 3 minus the thickness of the housing wall at a certain location. The thickness of the shell wall may be, but is not limited to, between about 0.05 cm and 2 cm, specifically between about 0.2 cm and 1 cm, and more specifically between about 0.25 cm and 0.4 cm.

[0109] The recess 8 can be, but is not limited to, any shape viewed from a top view. In this embodiment, the recess 8 is rectangular, specifically square. Alternatively, the recess 8 can be, but is not limited to, circular, elliptical, or polygonal. The sidewall of the housing 3 extending downward from the recess 8 to the insertion tray can be, but is not limited to, tapered, or can extend vertically from the upper surface of the housing 3. The recess 8 has a length “h”, a width “g”, and a depth (not indicated). The depth typically corresponds to the thickness of the housing wall. The length “h” can be between approximately 0.3 cm and 4 cm, specifically between approximately 0.5 cm and 3 cm, and more specifically between approximately 0.8 cm and 2 cm. The width “g” can be between approximately 0.3 cm and 3.5 cm, specifically between approximately 0.5 cm and 2.8 cm, and more specifically between approximately 0.8 cm and 1.5 cm.

[0110] The reference area 9, which may correspond to the recess in the housing 3, may have any shape as viewed from the top view. In this embodiment, the reference area 9 is rectangular. Alternatively, the reference area 9 may be, but is not limited to, elliptical or polygonal. In the case of a recess in the reference area 9, the sidewall of the housing 3 extending downward from the reference area 9 to the insertion tray may be, but is not limited to, tapered, or may extend vertically from the upper surface of the housing 3.

[0111] The reference area 9 has a length "i", a width "j", and may have a depth if a recess is provided in the housing 3. The depth typically corresponds to the thickness of the wall of the housing 3 at that location. The length "i" may be, but is not limited to, between approximately 1 cm and 10 cm, specifically between approximately 2 cm and 8 cm, and more specifically between approximately 3 cm and 6 cm. The width "j" may be, but is not limited to, between approximately 0.3 cm and 3.5 cm, specifically between approximately 0.5 cm and 2.8 cm, and more specifically between approximately 0.8 cm and 1.5 cm. The width "j" of the reference area 9 may be, but is not limited to, the same as the width "g" of the recess 8. Further, the width "j" of the reference area 9 and the width "g" of the recess 8 may be the same as or less than the width of the insertion tray 4.

[0112] The width “p” and / or height “o” (also referred to as “slit size”) of the insertion hole 5 may, but is not limited to, correspond to the width “k” and / or height “n” of the insertion tray 4, respectively. Alternatively, for example, when the insertion hole 5 is tapered toward the insertion tray 4, the width “p” and / or height “o” of the insertion hole 5 may be greater than or less than the width and / or height of the insertion tray 4, respectively. Further, but without limitation, the width “p” of the insertion hole 5 and / or the width “k” of the insertion tray 4 may correspond to the width “j” of the control area 9 and / or the width “g” of the applied recess 8 (see, for example, Figures 9a and 9b). Alternatively, the width “p” of the insertion hole 5 and / or the width “k” of the insertion tray 4 may be less than the width “j” of the control area 9 and / or the width “g” of the applied recess 8 (see, for example, Figures 9c to 9h).

[0113] As shown in some embodiments of the accompanying drawings, the applied recess 8 and the control area 9 correspond to two isolated recesses in the housing 3. Alternatively, the applied recess 8 and the control area 9 may correspond to a single recess in the housing 3 (not shown in any embodiment).

[0114] In Figure 9b, a first wall 6 and a second wall 7 are shown. The first wall 6 corresponds to the upper wall of the housing 3, and the second wall 7 corresponds to the lower wall of the housing 3. The first wall 6 and the second wall 7 face each other and at least partially enclose the insertion tray 4. In the cross-section shown here along AA', the first wall 6 and the second wall 7 enclose the insertion tray 4 together with the sidewalls. Slightly above, in the region of the recess in the control region 9 or in the region where the recess 8 is applied, the upper wall is not closed and recessed, as can be seen in Figures 9d, 9f, and 9h below, where the recess in the control region 9 is visible. The recess is not indicated to be tapered in the illustrated embodiment, but may be tapered in other embodiments.

[0115] The specifications mentioned for the embodiments shown in Figures 9a and 9b can be applied to other embodiments described herein.

[0116] Figure 9c is a top view schematic diagram showing a test kit / test kit 17, i.e., an IVA test unit 1, according to one embodiment. The test kit / test kit includes a test strip 2, a housing 3, a vial holder 27, a vial 19, a swab holder 28, and a swab 29. The swab has a rod 34 and a head 33, the head being wrapped and / or packaged in a package 35. Figure 9d is a schematic diagram showing a cut along the cutting line BB' of the test kit / test kit 1 of Figure 9c. The central portion of the housing 3 shown in this embodiment may have the features shown in Figure 9a and... Figure 9b The dimensions of the housing 3 shown may be similar to those of the housing 3 shown in Figures 9a and 9b.

[0117] The vial holder 27 and / or swab holder 28 may be formed as a single piece with the central portion of the housing 3. Alternatively, the vial holder 27 and / or swab holder 28 may be formed as one or more separate pieces attached to the housing 3.

[0118] The vial holder 27 of this embodiment has a square outer shape and a circular recess for receiving a vial 19, which has a circular shape in its cross-section. The outer contour / shape of the vial holder 27 is square. Generally, the outer contour / shape and / or the shape of the recess of the vial holder 27 may differ from the shape shown. Both shapes may include polygons, ellipses, circles, squares, or other shapes.

[0119] The swab holder 28 of this embodiment has a trapezoidal shape when viewed from a top view, and has a recess configured to receive and hold the swab 29. The swab holder 28 may alternatively have different shapes, such as polygonal, circular, elliptical, and / or square. When the swab holder 28 of this embodiment becomes visible in a cut view (FIG. 9d), it extends taperedly from the housing 3. The recess configured to receive and hold the swab 29 may correspond to the shape of the rod 34 of the swab 29. For example, the cross-section of the rod 34 of the swab 29 may be circular or polygonal, and therefore, the recess configured to receive and hold the swab 29 may correspond to such a circular or polygonal shape of the rod 34. The swab holder 28 may be flexible and / or elastic, such that force is pressed onto the rod 34 to hold and / or fix the swab 29 to a certain extent. However, since the force applied to the rod 34 by the swab holder 28 is not too great, the swab 29 can be released from the swab holder 28. Therefore, when shipping the test kit / test kit 17, the swab 29 and vial 19 can be attached to their respective holders 27, 28. When using the test kit / test kit 17, the swab 29 and / or vial 19 can be removed from their holders 27, 28. Specifically, the swab 29 can be removed to collect biological samples. However, the vial 19 can remain in the vial holder 27, and only the vial cap 19' can be removed to open the vial 19 so that the (flexible porous) head 33 of the swab 29 can be immersed in the liquid stored in the vial 27.

[0120] Similar to Figure 9c, Figure 9e is a schematic top view of a test kit / test kit 17, i.e., an IVA test unit 1, according to one embodiment. The test kit / test kit includes a test strip 2, a housing 3, a vial holder 27, a vial 19, a swab holder 28, and a swab 29. The swab has a rod 34 and a head 33, the head being wrapped and / or packaged in a package 35. In this embodiment, the vial holder 27 and the swab holder 28 are connected and / or coupled to the housing 3 via a bridging member 31 for the vial holder 27 and a bridging member 32 for the swab holder 28, respectively. Similar to Figure 9d, Figure 9f is a schematic diagram showing a cut along the cutting line CC' of the test kit / test kit 17 of Figure 9e. The vial holder 27, the bridging member 31 for the vial holder 27, the swab holder 28, and / or the bridging member 32 for the swab holder 28 may be formed as a single piece with the housing 3. Alternatively, the bridging member 31 for the vial holder 27, the swab holder 28, and / or the bridging member 32 for the swab holder 28 may be formed as one or more separate pieces coupled to the housing 3. At least one of the bridging members 31, 32 may be configured to be broken and / or disassembled by the user to release the vial holder 27 and / or the swab holder 28 from the housing 3. If one of the bridging members 31, 32 can be broken, this means that the corresponding holder 27, 28 can be irreversibly disassembled from the housing 3. Therefore, the corresponding bridging members 31, 32 may have a break point that allows for easy breaking of the bridging members 31, 32. If one of the bridging elements 31 and 32 can be reversibly detached from the housing 3, the connecting mechanism can be provided with one element located at or in the housing 3 and an opposing element located at or in the bridging elements 31 and 32. If the bridging elements 31 and 32 are not provided, as in the embodiment of FIG. 9c, the vial holder 27 and / or swab holder 28 can also be detachable from the housing 3, and therefore, the connecting mechanism can be provided with one element located at or in the housing 3 and an opposing element located at or in the respective holder 27 or 28.

[0121] At least one of the bridging elements 31 and 32 may be flexible so that the vial holder 27 and / or swab holder 28 can be twisted. If the bridging element 31 for the vial holder 27 can be reversibly or irreversibly removed, the vial holder 27 may include an edge for placing the vial 19 together with the vial holder 27 in an upright position on the ground plane.

[0122] In the embodiments of Figures 9c and 9e, the housing 3 is composed of a block structure, wherein the vial holder 27 and the swab holder 28 are attached to the side of the housing 3 or integrally formed with the housing 3, but always extend from the block structure of the housing 3. Figure 9g shows different structures of the housing 3.

[0123] Figure 9g is a schematic top view of a test kit / test kit 17, i.e., an IVA test unit 1, according to one embodiment. The test kit / test kit includes a test strip 2, a housing 3, a vial holder 27, a vial 19, a swab holder 28, and a swab 29. The swab has a rod 34 and a head 33, the head being wrapped and / or packaged in a package 35. In this embodiment, the vial holder 27 corresponds in fact to a vial recess in the housing 3, and the swab holder 28 also corresponds to a swab recess in the housing 3. The housing 3 is substantially formed as a block, with all recesses and / or holders integrated within it. Figure 9h is a schematic diagram showing a cut of the test kit / test kit 17 of Figure 9g along the cut line DD'. The vial recess 27 and the swab recess 28 are integrated into the housing 3 and are respectively and substantially matched in size and shape to the vial 19 and the swab 29. The vial 19 and swab 29 can be removed from their holders for use during testing. The vial recess 27 and / or swab recess 28 can be specifically sized such that the vial 19 and swab 29 do not extend beyond the surface of the housing 3. As can be seen from the figure, the cap 19' of the vial 19 and the upper surface of the swab 29 are flush with the upper surface of the housing 3. This has the advantage of allowing multiple test kits 1 to be bundled, thus optimizing transport efficiency.

[0124] In the embodiment of Figure 9g, as an example, the application recess 8 has a circular shape; however, the shape of the application recess 8 can be different, such as square, oval, or polygonal, and the sidewalls extending toward the insertion tray 4 can be rectangular or conical. Generally, the conical sidewalls provide a larger application recess 8 on the upper side, allowing the user to easily apply the sample liquid without spilling it, where liquid may flow down the wall toward the test strip 2 if the user does not precisely align the lower opening closest to the test strip 2.

[0125] The advantage of providing a housing 3 that integrates holders 27, 28 for other components of the test kit 17 (such as at least one vial 19 and / or at least one swab 29) is that the test kit 17 has a compact structure and the components are less likely to be lost.

[0126] Generally, the corresponding housing 3 of the embodiments described herein can be used for single purposes only. In this case, housing 3 is already equipped with test strip 2, as described, for example, according to one of the methods described herein. Alternatively, at least housing 3, as a component of test kit 17, can be reused. In this case, other elements, such as test strip 2, vial 19, and / or swab 28, can be provided as single-use elements / consumables. The user can equip housing 2 with consumables themselves or submit the housing to a provider responsible for the cleaning and / or equipping of housing 3. Specifically, Figures 9g and Figure 9h The shell 3 is reusable because it is composed of a large sheet and / or block of material. To reduce the weight of the shell, a recessed structure can be provided on the underside of the shell 3, so that material can be saved, the shell 3 becomes lighter, and stability is maintained.

[0127] In all applicable embodiments of test kit 17, vial 19 may include an applicator, specifically an applicator disposed at or on cap 19'. The applicator may be permanently disposed thereon or may be coupled to the vial once it is opened. The applicator may be configured to securely transfer and / or dispense liquid onto test strip 2. If the applicator is not permanently coupled and / or connected to vial 19, housing 3 may also provide a retainer and / or recess for receiving and / or storing the applicator. Alternatively, liquid may be transferred from vial 19 to test strip 2 using a pipette and / or syringe. Housing 3 may then provide a retainer and / or recess for receiving and / or storing the pipette and / or syringe.

[0128] Generally, the recess 8 can include a connecting mechanism that engages with a counterpart located at a vial, syringe, or other container. This facilitates the transfer of sample liquid from the container to the test strip 2 without spillage. The connecting mechanism can be based on a threaded system, a bayonet coupling, or another component that mates with its counterpart.

[0129] Figure 10a is a schematic top view of a housing 3 having an insert plug 10 according to one embodiment. Figure 10b is a schematic front view of the housing 3 of Figure 10a along line EE'. The insert plug 10 is connected to the housing 3 via a flexible bridging portion 10'. This ensures that the insert plug 10 is not lost when removed from the insertion hole 5. The housing 3 may be formed as a single piece with the flexible bridging portion 10' and the insert plug 10. Alternatively, the flexible bridging portion 10' may be coupled to the housing 3 and formed as a single piece. The flexible bridging portion 10' may be formed as a single piece together with the insert plug 10, or coupled separately to the insert plug 10. The flexible bridging portion 10' may, for example, correspond to a flexible band or cord. In alternative embodiments, these features apply to the cap 30 rather than the insert plug 10.

[0130] Figure 11a is a perspective side view of a schematic diagram of an IVA test unit 1 according to one embodiment. The IVA test unit has an insertion tray 4 positioned below the insertion hole 5 (the lowest position 5c of the insertion hole), while the insertion hole 5 tapers from the outer side 5a to the inner side 5b to reduce the risk of losing the test strip 2 via the insertion hole 5. Figure 11b is a front view of the schematic diagram of the IVA test unit 1 of Figure 11a.

[0131] Figure 12a is a perspective side view of a schematic diagram of an IVA test unit 1 according to one embodiment. The IVA test unit has an insertion hole 5 inclined relative to a plane parallel to the height axis D of the housing 3 (specifically, a plane 37 parallel to the upper wall 6 and / or lower wall 7 of the housing 3) to reduce the risk of losing the test strip 2 via the insertion hole 5. Figure 12b is a front view of the schematic diagram of the IVA test unit 1 of Figure 12a.

[0132] Figure 13 is a side view of a schematic diagram of an IVA test unit 1 according to one embodiment, which has a lug 36 in front of the insertion hole 5 to reduce the risk of losing the test strip 2 through the insertion hole 5.

[0133] Figure 14 is a front view of a schematic diagram of an IVA test unit 1 according to one embodiment, wherein the inner side 5b of the insertion hole 5 is curved, and the insertion hole 5 is tapered from the outer side 5a to the inner side 5b (in a non-linear manner) to reduce the risk of losing the test strip 2 through the insertion hole 5.

[0134] In Figures 11a to 14, the insertion tray 4 inside the housing 3 is indicated by a dashed line. The test strip 2, located inside the insertion tray 4, is also indicated by a dashed line. As can be seen from both figures, the outer side 5a of the insertion hole 5 tapers towards the inner side 5b of the insertion hole 5.

[0135] Generally, the insertion tray 4 can be considered, in some cases, as the internal volume of the housing 3. The insertion tray 4 can provide a volume for accommodating the test strip 2, which is approximately 1.1 to 20 times or more the volume of, but not limited to, the test strip 2 itself. Specifically, the height n of the insertion tray 4 can be approximately 1.1 to 20 times or more the height b of, but not limited to, the test strip 2 (see Figure 12a). The width k of the insertion tray 4 can be approximately 1.01 to 1.5 times the width a of, but not limited to, the test strip 2 (see Figures 11b and 12b). The length l of the insertion tray 4 can be approximately 1.01 to 1.5 times the length e of, but not limited to, the test strip 2 (see Figure 13). The insertion tray 4 can have a lower surface 4a that is approximately (or slightly larger) corresponding to the area (length x width) of the test strip 2. By selecting a lower surface 4a of the insertion tray 4 that is only slightly larger (length x width) than the area of ​​the test strip 2, the test strip can be well positioned inside the housing 3 without the test strip 2 having any freedom of wobbling and / or movement in a plane parallel to the area of ​​the insertion tray 4. In other words, the insertion tray 4 well defines the position of the test strip 2 such that the test strip 2 is substantially fixed, at least in the direction along the plane (i.e., the lower surface 4a of the insertion tray 4).

[0136] The lower surface 4a of the insertion tray 4 can lie in a plane defined by the length l and width k of the insertion tray 4 and is considered to be the upper surface of the second wall 7 (i.e., the lower wall of the housing 3). Therefore, the lower surface 4a of the insertion tray 4 faces the lower side of the upper wall 6 of the housing 3.

[0137] The lower surface 4a of the insertion tray 4 can be in the same plane as the lowest point of the insertion opening 5. Alternatively, and as shown in Figures 11a to 14, the lower surface 4a of the insertion tray 4 is positioned deeper than the lowest point 5c of the insertion hole 5 (see corresponding reference numerals in, for example, Figures 11b, 12a, 12b, and 14). Therefore, the lower surface 4a of the insertion tray 4 can be positioned below the insertion hole 5. In other words, the insertion tray 4 is set back and / or lowered relative to the lowest point 5c of the insertion hole 5 into the lower wall 7 of the housing 3. Specifically, the lower wall 7 of the housing 3 defining the lower surface 4a of the insertion tray can be recessed into the interior volume to receive the test strip 2 in a position positioned below the lowest point of the insertion hole 5. In this way, the test strip 2 can be inserted into the insertion tray 4 via the insertion hole 5, and the test strip 2 can then fall onto the lower surface 4a of the insertion tray 4 under the influence of gravity. Unrestricted, the recess corresponding to the depth and / or distance from the lowest point 5c of the insertion hole 5 to the lower surface 4a of the insertion tray 4 can be approximately 0.1 cm to 1 cm, specifically approximately 0.2 cm to 0.7 cm, and preferably approximately 0.3 cm to 0.5 cm. The distance between the lowest point 5c of the insertion hole 5 and the lower surface 4a of the insertion tray 4 can be approximately 1.5 to 20 times or more larger than the size of the test strip 2. The distance between the lowest point 5c of the insertion hole 5 and the lower surface 4a of the insertion tray 4 can be approximately 1.5 to 20 times or more larger than the slit size o on the inner side 5b of the insertion hole 5. This may help to secure the test strip 2 firmly inside the insertion tray 4, making the test strip less likely to fall off.

[0138] As shown in Figures 11a, 11b, and 14, the insertion hole 5 tapers from the outer side 5a towards the inner side 5b. This feature is compatible with other embodiments described herein, such as those in Figures 2, 5 to 10b, 12a, 12b, and 13. The insertion hole 5 includes a slit with a slit size “o” (mentioned above as the height of the insertion hole). In most cases, the slit size “o” can be measured in a direction perpendicular to the length axis C of the insertion hole 5. The slit size “o” can be, but is not limited to, approximately 1.01 to 2 times the height “b” of the test strip 2, such that the test strip 2 is only slightly thinner than the slit size “o”. The width “p” of the insertion hole 5, measured in most cases along the length axis C, can substantially correspond to the width “k” of the insertion tray 4 and / or the width “a” of the test strip 2. The width "p" of the insertion hole 5 may be slightly less than or slightly greater than the width "k" of the insertion tray 4 and / or slightly greater than the width "a" of the test strip 2. The width "p" of the insertion hole 5 may, but is not limited to, be approximately 1.01 to 2 times the width "a" of the test strip 2, such that the test strip 2 is only slightly smaller than the insertion hole 5 in width. In other words, the insertion hole 5, which may be tapered toward the insertion tray 4, may be only slightly larger than the test strip 2 in cross-section, making it less likely that the test strip 2 will align precisely with the insertion hole 5 from the inside of the housing 3 when fully inserted, thus reducing the risk of dislodgement. The insertion hole 4, i.e., the narrow slit, may specifically be only slightly larger than the test strip 2 on the inner side 5b of the insertion hole 5 (i.e., the side closest to the insertion tray 4). Without limitation, the cross-sectional area of ​​the insertion hole 5 may be approximately 1.05 to 5 times, specifically approximately 1.1 to 2 times, and preferably approximately 1.2 to 1.7 times, the cross-sectional area of ​​the test strip 2. If the insertion hole 5 is tapered toward the insertion tray 4, this allows for easy insertion of the test strip 2, and the insertion hole 5 guides the test strip 2 in its tapered form toward the insertion tray 4.

[0139] It is advantageous to provide an insertion hole 5 and / or insertion tray 4 that are slightly wider and / or taller than the size of the test strip 2 so that the test strip 2 can be inserted into the insertion tray 4. As described above, the insertion tray 4 may have, but is not limited to, a tapered and / or conical insertion hole 5, which makes insertion of the test strip 2 even easier and / or more reliable, while reducing the risk that the test strip 2 will fall out of the insertion tray 4 once it is fully inserted. This can be particularly advantageous in cases where insertion is performed manually by a user. It is also advantageous in cases where insertion is performed by a robot or machine. Alternatively, in some embodiments, it is not necessary for the insertion tray 4 and / or insertion hole 5 to be tapered and / or conical.

[0140] As shown in Figures 12a and 12b, the insertion hole 5, which substantially corresponds to the slit, can be inclined at an angle α relative to a plane that is parallel to a substantially parallel (horizontal) plane defined by the upper wall 6 and lower wall 7 of the housing 3. Without limitation, the slit axis of the insertion hole can be inclined at an angle α of approximately 3° to 45°, specifically approximately 5° to 30°, and preferably approximately 7° to 15° relative to the plane that is parallel to the substantially parallel (horizontal) plane defined by the upper wall 6 and lower wall 7 of the housing. Therefore, the angle between the height axis of the housing (which is perpendicular to the substantially parallel and horizontal plane defined by the upper and lower walls of the housing) and the slit axis C of the insertion hole 5 can deviate slightly from 90° (90° + / - approximately 3° to 45°, specifically approximately 90° + / - 5° to 30°, and preferably approximately 90° + / - 7° to 15°). Therefore, when the test strip 2 is inserted into the insertion tray 4, the test strip 2 and / or the housing 3 can be slightly tilted relative to each other (and / or relative to the horizontal plane). The tilted insertion hole 5 allows the test strip 2 to be secured inside the insertion tray 4 in a simple manner, because the probability of the test strip 2 falling out of the insertion tray 4 via the tilted insertion hole 5 is very low, due to the absence of a surface supporting the test strip 2 at that angle α, and therefore the test strip will not easily fall out.

[0141] As shown in Figure 14, the insertion hole 5 may be (slightly) curved, and therefore inserting the test strip 2 may require the test strip 2 to be (slightly) bent to conform to the shape of the opening of the insertion hole 5. Bending can be achieved by an additional support placed above and / or below the test strip 2, forcing the test strip 2 into the desired shape for insertion via the curved insertion hole 5. Alternatively or additionally, the insertion hole 5 may be tapered from the outer side 5a toward the inner side 5b (possibly from the unbent slit on the outer side) toward the curved slit on the inner side, so that by the insertion process, specifically by a pushing movement that propels the test strip 2 into the insertion tray, the test strip 2 is forced into a (slightly) bent and / or curved shape. Since most test strips 2 are elastic in shape and return to their flat shape once inserted, they will not fall out of the insertion tray 4 because they do not spontaneously assume a curved shape.

[0142] As shown in Figure 13, the insertion hole 5 and / or housing 3 may include a flexible lip 36 inside the insertion tray 4. This flexible lip bends toward the insertion tray 4 when the test strip 2 is inserted, and covers or even seals the insertion hole 5 from the inside of the insertion tray 4. The flexible lip 36 functionally corresponds to a valve and is configured to allow the test strip 2 to pass through only in one direction (i.e., the insertion direction from the outside toward the inside of the housing 3 / insertion tray 4). The test strip 2 is then secured inside the insertion tray 4 and will not fall off through the insertion hole 5 because the flexible lip 36 is configured to bend in only one direction.

[0143] Therefore, continuing from the above, the IVA test unit 1 may include at least one of the following characteristics: the risk of the test strip 2 detaching from the insertion tray 4: The lower surface 4a of the insertion tray 4 (i.e., the upper surface of the second lower wall 7, which is adjacent to the lower surface of the first wall 6 on the inner side of the housing 3) can be positioned below the lowest point 5c of the inner side 5b of the insertion hole 5. Specifically, the lower surface 4a of the insertion tray 4 is about 0.1 cm to 1 cm deep relative to the lowest point 5c of the inner side 5b of the insertion hole 5, specifically about 0.2 cm to 0.7 cm, and preferably about 0.3 cm to 0.5 cm (see Figures 11a, 11b, 12a, 12b, 13 and 14).

[0144] The insertion hole 5 may taper from its outer side 5a toward its inner side 5b, specifically such that the cross-sectional area defined by the outer side 5a of the insertion hole 5 is greater than the cross-sectional area defined by the inner side 5b of the insertion hole 5, and the sidewall of the insertion hole tapers from its outer side 5a toward its inner side 5b (see [link to relevant documentation]). Figure 11a , 11b and 14).

[0145] The insertion hole 5, specifically, the inner side 5b of the insertion hole 5, can be inclined at an angle α relative to the plane 37 parallel to the first wall 6 and the second wall 7 of the housing 3. Specifically, the insertion hole 5 can define a slit with a slit axis C (i.e., the length axis of the insertion hole 5 specifically on the inner side 5b), and the slit axis C can be inclined relative to the plane 37 parallel to the first wall 6 and the second wall 7 of the housing 3, and form an angle deviating from 90° (i.e., 90° + / - α) with the height axis D of the insertion hole 5 (see Figures 12a, 12b).

[0146] The inner side 5b of the insertion hole 5 may be formed into a bent shape and / or may be configured to shape / bend the test strip 2 when it is inserted into the insertion tray 4. Specifically, the outer side 5a of the insertion hole 5 may be tapered toward the inner side 5b of the insertion hole 5 so that the test strip 2 may further become a bent shape that matches the shape of the inner side 5b of the insertion hole 5 when it is inserted (see Figure 14).

[0147] The IVA test unit 1 may include a flexible and / or resilient lug 36, which is configured to cover the insertion hole 5 from the inside 5b of the insertion hole 5, so as to bend inward when the test strip 2 is inserted and to snap backward and cover the insertion hole 5 when the test strip 2 is fully inserted, and to prevent the test strip 2 from falling out through the insertion hole 5 (see Figure 13).

[0148] All these features can be achieved in a relatively simple way by the manufacturing methods (injection molding and / or additive manufacturing), and thus effectively help to secure the test strip 2 inside the housing 3 and / or reduce the risk of the test strip 2 falling off.

[0149] Generally, it is advantageous to provide a housing 3 with an insertion tray 4, which allows for close contact between the test strip 2 and the application recess 8. More specifically, it is advantageous for the walls surrounding the application recess 8 to be in close contact with the test strip 2, specifically with the sample pad of the test strip 2, for the flow of liquid applied via the application recess 8. Thus, the flow of the applied liquid can be guided by the application recess toward the sample pad of the test strip 2.

[0150] Figure 15a is a schematic diagram of an IVA test unit 1 according to one embodiment in a perspective side view. The IVA test unit has an insertion tray 4 positioned below the insertion hole 5, and the lower surface 4a of the insertion tray is inclined relative to the upper wall 6 of the housing 3. When the housing 3 is positioned in a proper upright orientation for correct use, the upper and lower surfaces of the upper wall 6 are parallel to each other and lie in a horizontal plane. The inclined lower surface 4a of the insertion tray 4 supports the test strip 2 so as to press the back portion of the test strip 2 against the upper wall 6 of the housing 3, and a tight contact can be established between the wall portion around the applied recess 8 and the test strip 2. The lower wall 7 forming and / or defining the portion of the inclined lower surface 4a can be considered as a support structure of the housing 3 for the test strip 2 and can be formed as a single piece with the entire housing 3. The angle between the inclined surface 4a and the plane parallel to the upper wall can be between approximately 1° and 20°, specifically between approximately 3° and 15°.

[0151] Figure 15b is a schematic diagram of an IVA test unit 1 according to one embodiment in a perspective side view. The IVA test unit has an insertion tray 4 positioned below the insertion hole 5, and a support structure 4b in the form of a semi-domed is provided on the lower surface 4a of the insertion tray 4. The support structure is configured to press the back portion of the test strip 2 against the upper wall 6 of the housing 3, and can establish a tight contact between the wall portion around the application recess 8 and the test strip 2. In this embodiment, the support structure 4b can also be formed as a single piece with the entire housing 3.

[0152] Figure 15c is a schematic diagram of the IVA test unit 1 in a perspective side view. The IVA test unit has an insertion tray 4 positioned below the insertion hole 5, and the lower surface 6a of the upper wall 6 (i.e., the upper surface 6a of the insertion tray 4) is inclined relative to the upper surface 4a of the lower wall 7 of the housing 3 (i.e., the lower surface 4a of the insertion tray 4). Further, the upper surface 6a of the insertion tray 4 is inclined relative to the upper surface 6b of the upper wall 6 of the housing 3. This configuration also allows for close contact between the test strip 2 and the upper wall 6 (specifically, the lower surface 6a of the upper wall 6 in the area where the recess 8 is applied). The angle between the inclined lower surface 6a of the upper wall 6 and the plane parallel to the upper surface 6b of the upper wall can be between approximately 1° and 20°, specifically between approximately 3° and 15°. The depth of the recess 8 corresponds to the thickness of the upper wall 6, and therefore can be changed in this embodiment as the thickness of the upper wall 6 changes.

[0153] Some of the potential advantages of the invention are described again below. A one-piece housing may increase the torsional stiffness and value of the housing. Housing production eliminates the need for a pick-and-place process. The test strip can be inserted into the single-use insertion test item by lifting movement, without the need for bonding. The housing's "internal design" prevents "overflow" / "uncontrolled" spillage of the test strip. In one embodiment, the housing may contain a water vapor-impermeable material, and therefore, packaging the IVA test unit may not require a bag. Alternatively or additionally, the housing may be sprayed with a water vapor barrier, painted or coated by immersion in a bath of a water vapor-impermeable material. In this case, openings in the housing (such as the insertion opening, the application recess (considered the insertion opening), and the recess in the control area (considered the readout window)) may be covered with a water vapor-impermeable foil and / or film to seal the interior of the housing. Such foil may be bonded to the housing and can be peeled off the housing before use of the IVA test unit. A separate foil may be provided for each opening. Alternatively, a single foil may be provided for at least two openings in the housing. In this case, it may not be necessary to provide bags, such as aluminum PE bags.

[0154] The following sections continue to describe some concepts, examples, and embodiments that may be similar to or deviate from the above embodiments: When the test strip is inserted into the housing, the (IVA) test strip may also be referred to as an insertion test. Generally, test strips that can be used with this invention or any embodiment thereof may differ from the test strip shown. For example, if the reaction takes place outside, for example, the test strip may not have a substrate, or may only have a membrane and a sample collection pad, but no sample pad and conjugate pad.

[0155] Insertion test (without desiccant properties) The housings (also referred to as insert disposables in some cases) are filled into the device as “bulk”. These housings are fed into the system in a roller, with the insertion hole at the front, and guided by a conveyor belt to the insertion of the test strip. The test strip is cut, separated, and / or sheared from the laminated roll by, for example, a guillotine cutter.

[0156] Insertion test with desiccant properties (which in one embodiment can be integrated into the housing). The finished product is sealed in a material impermeable to water vapor (such as aluminum-plastic composites or HDPE). To bind moisture, a desiccant (usually a desiccant pouch) is inserted into the packaging. Therefore, a desiccant pouch can be added to the packaging and sealed within it. The insertion tester can be made of plastic with desiccant properties. This eliminates the need to add a desiccant as a separate component, and thus allows for smaller and / or more compact pouches.

[0157] Insertion test with a clip-on cap that has desiccant properties.

[0158] In this particular embodiment, the housing does not have desiccant properties. Similar or identical advantages to those of a housing with desiccant properties can be achieved by attaching an additional cap (attachable and provided with desiccant properties). This embodiment has advantages over insertion tests with a housing having desiccant properties: The insertion opening of the test strip for testing disposable products can be sealed. The test strip is no longer visible through the insertion opening and will not fall off. The plastic material of the casing can be made from inexpensive plastic materials.

[0159] Insertion testing of functionalized disposable surfaces (e.g., coatings impermeable to water vapor). In this particular embodiment, the following options exist: the insertion test is made of water vapor-impermeable injection-molded plastic and / or functionalized with a water vapor-impermeable coating, specifically with a water vapor-impermeable coating. Finally, the insertion test can be glued or sealed, for example, with aluminum foil.

[0160] In the following sections, some general statements are made. When liquid and / or liquid samples are applied to the sample pad of an LFA wick, lateral flow through the wick material can be caused by capillary forces, surface tension, cohesion, adhesion, and wicking. Generally, embodiments utilizing lateral flow may require a large volume of liquid sample to achieve adequate contact between the sample and the test area of ​​the device. Furthermore, some embodiments overcome lateral flow by using a test pad designed to absorb liquid samples, without requiring surface tension, cohesion, adhesion, wicking, and / or capillary action to bring the liquid sample into contact with the test area. Such embodiments are particularly suitable when the volume of the liquid sample is small. Such situations include, but are not limited to, cases where the liquid sample corresponds to or includes capillary blood samples.

[0161] Insertion hole 5 can generally be understood as an insertion opening and / or insertion slit.

[0162] As used herein, the terms “upper” and “lower” refer to the presented drawings, particularly those showing a cross-section of the housing 3, wherein the upper surface is shown as the upper surface in the true sense, and wherein the lower surface is shown as the lower surface in the true sense.

[0163] Based on the above description, modifications and variations to the disclosed aspects are of course possible. Therefore, it should be understood that, within the scope of the appended claims, the invention can be practiced in ways different from the specific designs described in the above examples.

[0164] In particular, it should be understood that at least some of the accompanying drawings or parts are merely illustrative and provided only as examples. Furthermore, the relationships between elements may differ from those shown, and portions irrelevant to the purpose of this disclosure have been omitted.

[0165] Furthermore, throughout this specification, references to "an aspect," "an aspect," "an instance," "an embodiment," or "an embodiment" refer to a specific feature, structure, or characteristic described in connection with that aspect, instance, or embodiment being included in at least one aspect, instance, or embodiment. Therefore, the phrases "in an aspect," "in a aspect," "an instance," "an embodiment," or "an embodiment" appearing throughout this specification do not necessarily refer to the same aspect, instance, or embodiment.

[0166] Furthermore, specific features, structures, or characteristics may be combined in any suitable combination and / or sub-combination in one or more aspects, examples, or embodiments.

[0167] List of reference numerals

Claims

1. An IVA test unit (1), comprising: Test strip (2) for detecting analytes, wherein the test strip includes at least an application function, a test reaction function and a test detection function; as well as A housing (3) for storing the test strip (2), wherein the housing (3) includes an insertion tray (4) and an insertion hole (5) for inserting the test strip (2) into the insertion tray (4), characterized in that the housing (3) is formed as a single piece.

2. The IVA test unit (1) according to claim 1, wherein the housing (3) includes a first wall (6) and a second wall (7) adjacent to the first wall (6), and wherein the first wall (6) and the second wall (7) define the insertion tray (4) between the first wall (6) and the second wall (7).

3. The IVA test unit (1) according to claim 1 or 2, wherein the housing (3) comprises: An indentation (8) is applied to allow sample liquid (23) to be applied onto the test strip (2); and / or The control area (9) is used to read the test results from the test strip (2).

4. The IVA test unit (1) according to any one of the preceding claims, further comprising one of the following enclosure elements: Insert plug (10) is configured to be inserted into the insertion hole (5) to close the insertion hole (5) and / or secure the test strip (2) to prevent it from falling out of the insertion tray (4); A cap (30) is configured to be held over the insertion hole (5) and attached to the housing (3).

5. The IVA test unit (1) according to claim 3 or 4, further comprising at least one transparent cover plate (24) configured to cover (140) and / or close the control area (9) and / or the application recess (8).

6. The IVA test unit (1) according to claim 5, further comprising at least one of the following: A desiccant, which is a compound of the housing (3), the sealing element and / or the cover plate; A desiccant, which is an element placed in at least one chamber and / or recess of the housing (3), the insert plug (10) and / or the cover plate (24) for storing the desiccant.

7. The IVA test unit (1) according to claim 5 or 6, wherein the IVA test unit (1) comprises at least one of the following: A water vapor impermeable material is included as an integral material of the housing (3), the closure element, and / or the cover plate (24); A water vapor impermeable upper layer is sprayed and / or coated onto the housing (3), the sealing element, and / or the cover plate (24); A water vapor impermeable membrane, preferably wherein the water vapor impermeable membrane encapsulates the entire IVA test unit (1).

8. The IVA test unit (1) according to any one of the preceding claims, wherein the housing (3) includes a fixing mechanism configured to fix the test strip (2) in the insertion tray (4), optionally wherein the fixing mechanism includes at least one of the following: The hook, which is an element of the housing (3), and the recess, which is an element of the test strip (2), are configured to snap into the hook; A spring element configured to hold the test bar (2) in place by spring force; The housing (3) is an element configured to fix the test strip (2) by friction.

9. A method (100) for producing an IVA test unit (1), the method comprising the following steps: Provide (110) a one-piece housing (3) for storing test strips (2), wherein the housing (3) includes an insertion tray (4) and an insertion hole (5) for inserting the test strips (2) into the insertion tray (4); The test strip (2) is placed (120) in the housing (3).

10. The method (100) according to claim 9, wherein providing the housing (3) comprises producing the housing (3) as a single piece by injection molding (110a) and / or by additive manufacturing (110b), specifically by 3D printing.

11. The method (100) according to claim 9 or 10, wherein placing the test strip (2) into the housing (3) comprises: Provide (121) a strip (18) preferably from a roll having a longitudinal strip axis (B), wherein the strip (18) includes the test strip (2) among a plurality of test strips (20) along the longitudinal strip axis (B); The belt (18) is conveyed (122) along the longitudinal belt axis (B); Cut (123) the strip (18) perpendicular to the longitudinal strip axis (B) to separate the test strip (2) from the plurality of test strips (20); Align the housing (3) with (124), wherein the longitudinal housing axis (A) is parallel to or perpendicular to the longitudinal belt axis (B), and the insertion hole (5) faces the test strip (2); and The test strip (2) is inserted (125) through the insertion hole (5) into the insertion tray (4).

12. The method (100) according to any one of claims 9 to 11, further comprising closing the insertion hole (5) by at least one of the following: Insert the plug (10) or plug (130) into the insertion hole (5); The cap (30) is clamped onto the housing (3) over the insertion hole (5).

13. The method (100) according to any one of claims 12, further comprising providing a desiccant as at least one of the following: The compound of the housing (3), the insertion plug (10) and / or the cap (30); An element placed in at least one chamber and / or recess of the housing (3), the insertion plug (10), and / or the cap (30).

14. The method (100) according to any one of claims 9 to 13, further comprising at least one of the following: A water vapor-impermeable top layer is sprayed and / or coated onto the housing (3); The entire IVA test unit was encapsulated with a water vapor impermeable membrane (1).

15. The method (100) according to any one of claims 9 to 14, further comprising securing the test strip (2) in the insertion tray (4) using a fixing mechanism based on a snap-fit ​​mechanism, spring force, and / or friction.

16. A test kit (17) comprising: The IVA test unit (1) according to any one of claims 1 to 8; Swabs (29), used to collect biological samples; as well as vials (19) containing a liquid for eluting the sample.

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