Test strip holder

Abstract

The present invention relates to a test strip holder, which comprises a housing having a front side and a back side, the housing comprising at least one test strip receiving channel, at least one fluid receiving channel, at least one fluid reservoir and optionally at least one ventilation channel. The present invention also relates to the use, method and kit comprising the test strip holder.

Description

Field of the Invention

[0001] The present invention relates to a test strip holder which consists of a housing having a front side and a back side, wherein the housing includes at least one test strip receiving channel, at least one fluid receiving channel and at least one fluid reservoir, wherein the at least one test strip receiving channel and the at least one fluid receiving channel are in fluid connection with the at least one fluid reservoir, and wherein the front side is made of solid material and includes at least one inspection window. The present invention also relates to the use of the test strip holder and a kit including the test strip holder. Background Art

[0002] In many different fields, rapid and reliable detection of analytes is a crucial requirement. Lateral flow immunoassays - also known as lateral flow immunochromatographic assays or lateral flow tests - are an easy-to-use tool for assessing the presence or absence of a target analyte in a sample and, in some cases, also for assessing the amount of the target analyte.

[0003] The basic principle of lateral flow testing is well known in the art. Generally, a lateral flow test strip is a membrane-based carrier which includes at least a sample loading zone, a conjugate pad and a detection zone. The conjugate pad contains a labeled binder - usually a labeled antibody - which can specifically bind to the target analyte. The detection zone contains an immobilized unlabeled binder which can also specifically bind to the target analyte. When the sample fluid contacts the sample loading zone of the lateral flow test strip, the sample fluid traverses the test strip by capillary flow. First, the sample fluid migrates to the conjugate pad. If the sample fluid contains the target analyte, the analyte is bound by the labeled binder. The sample fluid further migrates to the detection zone, where the analyte bound by the labeled binder on the conjugate pad is bound by the immobilized unlabeled binder. Thereby, the analyte provides a connection between the labeled binder and the immobilized unlabeled binder, thus promoting the accumulation of the label in the detection zone. A lateral flow test strip typically also includes a control zone which contains an immobilized unlabeled binder which can bind to the labeled binder. Thereby, the excess labeled binder that is not bound in the detection zone from the conjugate pad is bound in the control zone, thus providing a positive control for the successful immobilization and functionality of the labeled binder. By detecting the label in the detection zone, a conclusion can be drawn as to whether the analyte is present in the sample fluid. Examples of lateral flow testing are disclosed, for example, by Koczula and Gallotta in Essays Biochem 60(1):111 - 20 of June 30, 2016 or by Krska and Molinelli Anal Bioanal Chem 393(1):67 - 71 of January 2009.

[0004] The binder of a lateral flow test strip can be adapted to specifically bind a large number of different analytes. Thereby, lateral flow testing offers a very broad applicability and is routinely used in many fields - such as environmental testing; assessment and analysis of human, animal, and plant health; food and feed testing, etc. Lateral flow testing is performed not only by technical professionals in laboratory use but also by untrained personnel and individuals, for example, in home testing, point-of-care testing, etc.

[0005] In its simplest form, a lateral flow test can be performed using only the test strip and the sample fluid. However, to improve handling, optimize assay conditions, or exclude user errors or accidental operations, more advanced lateral flow test devices can be provided. Especially in cases where the intended users are untrained personnel, such as in pregnancy testing, the test strip holder or test strip housing can provide convenience features such as protecting the test strip or the sample and providing operation guidelines for the target users.

[0006] To obtain maximum reproducibility and comparability between two or more lateral flow test results, testing needs to be performed under comparable - ideally identical - conditions. However, since lateral flow testing is performed not only in temperature-controlled laboratories but also frequently on-site or in non-standard locations around the world, temperature differences can have a significant adverse impact on reproducibility and comparability.

[0007] Another factor to consider in terms of reproducibility is human error or equipment inadequacy. In particular, for untrained users and / or those lacking laboratory equipment such as precision pipettes, it can be challenging to apply the sample in the optimal volume at the correct section of the lateral flow test strip. Thereby, either too little sample is loaded onto the test strip, resulting in a lack of liquid as the mobile phase in the chromatographic assay. Or too much sample is loaded onto the test strip, causing the test strip to be submerged and, in the case of a typical test strip holder, causing the test strip holder to overflow. Additionally, different sample volumes applied to the test strip further negatively affect reproducibility and comparability. Therefore, a solution is needed to facilitate the reproducible application of the sample fluid to the lateral flow test strip while avoiding test strip submersion or holder overflow.

[0008] Examples of test strip holders can be found in the literature, for example in the form of the cassette assembly described in WO 2018 / 125271 A1. The cassette assembly disclosed in WO 2018 / 125271 A1 includes at least a base and a removably connected lid portion, wherein the flange of the base must be disposed in the lid portion to allow the formation of a fluid flow channel. In such a cassette assembly, fluid can be introduced into the base and is further directed to the lid portion via the fluid flow channel of the lid flange and an optional additional fluid filter structure to ultimately reach a fluid receiving void on the lid portion where the fluid can contact the test strip for detection. Although it can be expected that such a cassette assembly arrangement is well-suited for certain assays and can even be moved, for example, into an incubator to achieve a controlled temperature, the specific arrangement of the various components required for the disclosed cassette assembly will make it impossible to transfer heat quickly, effectively, and uniformly from an external temperature source to the test strip and sample fluid within the cassette assembly. Moreover, the cassette assembly of WO 2018 / 125271 A1 lacks a solution to address the incorrect addition of an excessive amount of fluid. Other examples can be in the form of an insertion cassette for an assay reader as described in WO 2009 / 038798, or as a modular part of a reader device as described in US 9,008,373 B2.

[0009] Test strip holders are described in EP 1 102 066 A2, US 2004 / 0115832 A1, and WO 02 / 093169, wherein the test strip is enclosed in a receiving chamber within a plastic test strip holder housing or cassette composed of a top element and a bottom element that cooperate to form the housing. Sample fluid can be applied to such an enclosed test strip through an application port. To achieve temperature transfer from the outside to the enclosed test strip, a rod or plate element is described for contacting the test strip, which is made of a material different from the plastic test strip holder housing or cassette. In particular, the described rod or plate element is made of a metal such as copper, gold, silver, aluminum, or a metal alloy. Such a test strip holder is designed for single use only and cannot be reused since the test strip is irreversibly enclosed within the housing.

[0010] In summary, although there are some types and embodiments of test strip holders, there is still a need for a technical solution suitable for improving the reproducibility and comparability of lateral flow assays. Accordingly, the present invention aims to provide a test strip holder that allows lateral flow assays to be performed in a reproducible and comparable manner by providing a solution for non-standard ambient temperatures. Summary of the Invention

[0011] To solve this purpose, the main feature of the test strip holder according to the present invention is that the back surface of the housing is a substantially flat surface; wherein, the back surface of the housing is thermally conductive. This embodiment allows for lateral flow assays at an operator-defined temperature through the substantially flat back surface of the housing, where the back surface of the housing can be in contact with a thermal element, i.e., a heating or cooling device that determines the temperature during the assay. By providing a test strip holder having a back surface (where the outer surface of the back surface is arranged to be in close contact with the thermal element and rapidly transfer heat from the thermal element into the test strip holder), it is possible to maintain or hold not only one test strip holder at a defined temperature over time but also multiple test strip holders at a defined temperature over time, which can alleviate or even eliminate poor reproducibility, reliability, or comparability of lateral flow assay results due to temperature variations. Even in the case where such a test strip holder is not in direct contact with the thermal element but is, for example, only transferred to an incubator, the substantially flat and thermally conductive back surface ensures uniform and rapid transfer of the external temperature to the assay test strip within the test strip holder.

[0012] Any channel structure that can accommodate a conventional lateral flow assay test strip can be a test strip receiving channel. Any channel structure that allows liquid to flow from one opening of the channel to another opening can be a fluid receiving channel. In this document, the terms "liquid" and "fluid" are used interchangeably. In one embodiment of the present invention, the fluid receiving channel has the same channel structure as the test strip receiving channel. For the avoidance of doubt, the phrase "fluidly connected" as used herein means that fluid can pass from one component to another. For example, when a channel and a reservoir are fluidly connected, fluid can be poured into the reservoir through the channel.

[0013] Any structure that is fluidly connected to the fluid receiving channel and can hold a defined amount of liquid in the test strip holder can be a fluid reservoir. The fluid reservoir can have the same width dimension as the fluid receiving channel or a smaller or larger width dimension than the fluid receiving channel.

[0014] The inspection window mentioned herein is a structure that allows at least one assay test strip inserted in the test strip holder to be observed from the outside, in particular, the assay area and the additional control area (if any) of the assay test strip to be observed. The inspection window can be a notch, cutout, or opening in the housing through which the assay area on the assay test strip inserted into the test strip holder and optionally the control area can be inspected. The inspection window can also be achieved by using a transparent material such as a transparent foil or transparent glass on the test strip holder housing.

[0015] In this document, a surface is considered to be a substantially flat surface when no surface irregularities are observed on a macroscopic scale, i.e., when surface irregularities cannot be observed with the naked eye.

[0016] The heat-conducting back surface mentioned in this article can be defined by its specific heat transfer index. The heat-conducting back surface can be any back surface with a specific heat transfer index of at least 0.0167 s -1 , preferably at least 0.02 s -1 , preferably at least 0.03 s -1 , more preferably at least 0.05 s -1 , more preferably at least 0.075 s -1 , most preferably at least 0.08 s -1 . The specific heat transfer index of the back surface can be experimentally determined by calculating the reciprocal of the time in seconds required to achieve a 10°C temperature transfer from 25°C to 35°C from the outside to the inside of the back surface of the test strip holder housing. Preferably, the thickness of the back surface of the test strip holder is between 0.001 mm and 1.5 mm, more preferably between 0.001 mm and 1.2 mm, even more preferably between 0.01 mm and 1 mm, even more preferably between 0.015 mm and 0.8 mm, and most preferably between 0.03 mm and 0.7 mm. Those skilled in the art are aware of the fact that the specific heat transfer index of the back surface of the test strip holder depends on the material and the thickness of the back surface.

[0017] By way of example only, if a back surface made of a first material with a thickness of 1 mm achieves a temperature transfer from 25°C to 35°C in 5.8 seconds, a back surface made of the same material with a thickness of 2 mm achieves a temperature transfer from 25°C to 35°C in 10 seconds, and a back surface made of a second material with a thickness of 0.2 mm achieves the same temperature transfer from 25°C to 35°C in 4 seconds, then the specific heat transfer indices of these three back surfaces are 1 / 5.8 = 0.172 s -1 , 1 / 10 = 0.100 s -1 and 1 / 4 = 0.250 s -1 .

[0018] In practice, the specific heat transfer index of a particular back surface of a test strip holder should be determined by placing a thermometer within the test strip holder with the back surface to be tested and placing the test strip holder on a heating element. Such a heating element is essentially a surface that can be maintained at a selected temperature, such as a surface from a laboratory hot plate, with the back surface of the test strip holder contacting the hot plate surface. Once the test strip holder is in contact with the hot plate surface, the temperature inside the test strip holder is measured at regular time points. Thereby, data required to calculate the specific heat transfer index can be collected. For this purpose, the temperature of the laboratory hot plate is set to 45 °C, and the test strip holder with the back surface to be tested is brought into contact with the hot plate as described above. Starting from the usual room temperature, the temperature rise inside the test strip holder is tracked and used to calculate the specific heat transfer index as described above, where the usual room temperature is herein defined as any temperature between 18 °C and 25 °C, preferably a temperature between 22 °C and 24 °C. As described above, when conducting the experiment, the specific heat transfer index will be determined by calculating the reciprocal of the time in seconds required to achieve a 10 °C temperature transfer from the outside of the back surface of the test strip holder housing to the inside of the back surface of the test strip holder housing from 25 °C to 35 °C.

[0019] Due to a lack of suitable equipment or technical expertise or simply due to human error, an inappropriate amount of sample liquid may be applied to the assay test strip. As a result, either an insufficient amount of sample and / or buffer may occur, or the test strip may be drowned or the test strip holder may overflow. Accordingly, as an embodiment of the present invention, there is provided a test strip holder comprising a housing having a front face and a back face, wherein the housing includes at least one test strip receiving channel, at least one fluid receiving channel, and at least one fluid reservoir; wherein the at least one test strip receiving channel and the at least one fluid receiving channel are in fluid communication with the at least one fluid reservoir; wherein the front face is made of solid material and includes at least one inspection window; wherein the at least one fluid reservoir is partially separated by at least one test strip support structure, the at least one test strip support structure including at least one dam structure; wherein the at least one test strip support structure is disposed below the at least one test strip receiving channel and the at least one fluid receiving channel; and wherein the at least one test strip support structure is disposed in an orientation orthogonal to the at least one test strip receiving channel and the at least one fluid receiving channel.

[0020] At least one test strip support structure including at least one weir dam structure defines a first sub-reservoir of at least one fluid reservoir that is partially separated. The first sub-reservoir forms a chamber or bin designed to hold a predetermined liquid volume of 50 μL to 5000 μL. More preferably, the first sub-reservoir is designed to hold a liquid volume of 100 μL to 500 μL, even more preferably 100 μL to 300 μL, and most preferably 150 μL to 250 μL. The depth of the liquid contained in the first sub-reservoir is preferably 2 mm to 7 mm. A liquid volume exceeding the maximum volume of the first sub-reservoir can flow through the at least one weir dam structure into a second sub-reservoir of the at least one fluid reservoir that is partially separated. The second sub-reservoir is preferably designed to hold a liquid volume of at least 50 μL, preferably at least 100 μL, more preferably at least 200 μL, and even more preferably at least 250 μL.

[0021] There is provided a test strip holder which is constituted by a housing having a front face and a back face and is characterized in that: the housing includes at least one test strip receiving channel, at least one fluid receiving channel, and at least one fluid reservoir; wherein, the at least one test strip receiving channel and the at least one fluid receiving channel are in fluid communication with the at least one fluid reservoir; wherein, the front face is made of a solid material and includes at least one inspection window; wherein, the back face of the housing is a substantially flat surface; wherein, the back face of the housing is thermally conductive; wherein, the at least one fluid reservoir is partially separated by at least one test strip support structure which includes at least one weir dam structure, and the at least one weir structure defines a sub-reservoir capable of holding a predetermined fluid volume; wherein, the at least one test strip support structure is disposed below the at least one test strip receiving channel and the at least one fluid receiving channel; and wherein, the at least one test strip support structure is disposed to be orthogonally oriented with respect to the at least one test strip receiving channel and the at least one fluid receiving channel, whereby the test strip holder is arranged to allow lateral flow assays to be performed at an operator-defined temperature and to minimize the risk of applying an inappropriate amount of sample liquid. Such a test strip holder allows lateral flow assays to be performed in a reproducible and comparable manner.

[0022] According to the present invention, there is provided a test strip holder as described herein, wherein the at least one test strip receiving channel and the at least one fluid receiving channel are arranged as separate channels. In particular, there is provided a test strip holder as described herein, wherein the at least one test strip receiving channel and the at least one fluid receiving channel are arranged in parallel orientation to each other. The at least one test strip receiving channel and the at least one fluid receiving channel contained by the test strip holder as described herein are arranged in the following manner, that is, wherein the at least one test strip receiving channel and the at least one fluid receiving channel have an open top. The open top mentioned herein is an opening of the channel opposite to another opening at the fluid reservoir. Thus, the processing of the lateral flow assay can be most conveniently achieved, as long as the detection test strip can be inserted into the test strip holder first, and then the sample liquid can be added in the second step through different fluid receiving channels, thereby avoiding premature contact of the sample with the detection test strip and thus premature initiation of the assay reaction. Moreover, by providing a test strip receiving channel with an open top, the detection test strip can be removed from the test strip holder after the assay is performed and another detection test strip can be inserted into the test strip holder. Thus, the same sample liquid can be tested successively with two different detection test strips. Alternatively, the test strip holder may be rinsed and reused with another test strip and another sample fluid.

[0023] Typical channel structures in test strip holders are designed to occupy as little space as possible to achieve a generally compact and convenient form of the test strip holder. However, when the test strip and sample fluid are applied, the air in the test strip holder accumulates back pressure, resulting in unsatisfactory or malfunctioning liquid flow in the test strip holder. A test strip holder as described herein is provided, wherein the housing also includes a ventilation channel, the ventilation channel including two openings, wherein a first opening is provided at the at least one fluid reservoir, and a second opening is provided at a height above the fluid reservoir, preferably substantially at the height of the insertion opening of the at least one test strip receiving channel, thereby providing a separate escape path for air, the formation of back pressure can be avoided, and the applied sample liquid can flow through the test strip holder in an expected manner without being hindered by the back pressure. Any channel structure that allows air or similar gas to pass unimpeded from one opening of the channel to another opening and allows such gas to be discharged from the inside of the test strip holder to the outside can be a ventilation channel.

[0024] In a preferred embodiment of the present invention, a test strip holder is provided, wherein the ventilation channel is arranged to at least partially surround the at least one fluid reservoir. Thus, the risk of liquid overflowing into the ventilation channel and thus blocking it can be minimized or even completely avoided.

[0025] Currently, many test strip holders are assembled from several independent components. However, the production of multi-piece test strip holders is more complex. Additionally, there is a risk of leakage and instability at each assembly connection point. Therefore, another object of the present invention is to provide a test strip holder composed of as few components as possible. There is provided a test strip holder as described herein, wherein the front face of the housing, at least one test strip receiving channel, at least one fluid receiving channel, at least one fluid reservoir, and at least one ventilation channel are provided as a single piece, whereby a test strip holder with the minimum number of assembly connection points can be obtained. Thereby, production and assembly are less complex, and stability and leak prevention are improved. The front face of the test strip holder housing, at least one test strip receiving channel, at least one fluid receiving channel, at least one fluid reservoir, and at least one ventilation channel can be formed from any material suitable for injection molding.

[0026] The present invention also relates to a test strip holder as described herein, wherein the front face of the housing, at least one test strip receiving channel, at least one fluid receiving channel, at least one fluid reservoir, the back face of the housing, and at least one ventilation channel are provided as a single piece, i.e., provided as an integral body. Such a test strip holder can be made as a single piece, wherein the front face and the back face of the housing are connected on the longer side or the shorter side. Such a single-piece test strip holder can be assembled, for example, by folding the front face and the back face towards each other and connecting and sealing the housing, for example, by gluing, heat sealing, or hot melting. By providing the test strip holder as a single piece, a back face thinner than the front face can be provided. Thereby, sufficient and effective heat transfer from the outside through the back face to the test strip accommodated in such a test strip holder can be achieved without the risk of damaging the back face during production or use.

[0027] According to another embodiment of the present invention, in order to facilitate effective temperature transfer from the outside to the inside of the test strip holder, a test strip holder is provided, wherein the back surface of the housing is made of at least one material selected from the group consisting of aluminum, copper, nickel, tin, silver, gold, polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyester, polycarbonate, acrylonitrile butadiene styrene (ABS) or ABS-like materials, preferably made of at least one material selected from the group consisting of polyethylene, polypropylene, aluminum, acrylonitrile butadiene styrene (ABS) or ABS-like materials. By using these materials, the back surface of the test strip holder housing can be arranged in such a way as to allow the temperature to be transferred from the outside of the test strip holder to the inside of the test strip holder fast enough, thereby generating a uniform temperature distribution and stable measurement conditions, thus improving the comparability. In one embodiment, a test strip holder as described herein is provided, wherein the back surface of the housing is made of at least one material selected from the group consisting of polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyester, polycarbonate, acrylonitrile butadiene styrene copolymer (ABS) or ABS-like materials. In another embodiment, the back surface of the housing is made of at least one material selected from the group consisting of polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyester, polycarbonate, acrylonitrile butadiene styrene copolymer (ABS) or ABS-like materials; and the thickness of the back surface is at most 1 mm, such as at most 0.5 mm, such as at most 0.1 mm, such as at most 40 μm, such as at most 8 μm. In another embodiment, the back surface of such a test strip holder has a specific heat transfer index of at least 0.0167 s -1 , such as at least 0.02 s -1 , such as at least 0.03 s -1 , such as at least 0.05 s -1 , such as at least 0.075 s -1 , such as at least 0.08 s -1 . Despite the common perception and reservations in the prior art that plastics cannot be suitable materials for allowing effective heat transfer from the outside to the test strips contained in the test strip holder, as emphasized, for example, in EP 1 102 066 A2 or in WO 02 / 093169, it has surprisingly been found that a test strip holder as described herein, in which the back surface of the housing is made of the above-mentioned plastic materials, is very suitable for allowing effective heat transfer. Thus, a test strip holder can be provided that is made entirely of the same plastic material and thus does not need to be combined with separate metal elements, thereby saving costs and allowing for rapid production.

[0028] Another obstacle in terms of reproducibility is to detect the exact position of the test strip within the test strip holder after inserting the test strip for detection. On the one hand, the test strip receiving channel needs to be wide enough to allow the test strip for detection to be smoothly inserted into the test strip holder. On the other hand, the test strip receiving channel needs to provide sufficient support for the inserted test strip for detection to limit the free movement range of the test strip for detection and hold the test strip for detection in a fixed position after insertion. To achieve this purpose, a test strip holder is provided, wherein the test strip receiving channel further includes at least one wedge element, and the at least one wedge element is arranged inside the front of the test strip holder housing. Therefore, due to the presence of the wedge element, the cross-section of the test strip receiving channel is partially reduced, thus reducing the risk that the operator inserts the test strip for detection in the wrong orientation. When the sample loading area is located in the liquid reservoir and the detection area of the lateral flow assay test strip is visible through the inspection window, the test strip is inserted in the correct orientation. Moreover, the inserted test strip for detection is pressed against the inner side of the back of the housing, thereby locking the test strip for detection in a fixed position and reducing the thermal isolation air gap between the back of the housing and the test strip for detection.

[0029] The most reproducible and convenient evaluation of lateral flow assay data can be achieved by imaging the detection area and optionally the control area on the test strip using, for example, a camera mounted on the reader device. To allow this method to be used, the test strip for detection inserted into the test strip holder must be visible to the camera, for example, through the inspection window. By providing a test strip holder as described herein, wherein the side walls of the inspection window of the at least one test strip receiving channel are beveled, the imaging quality can be optimized because these side walls do not cast shadows on the test strip for detection and do not reflect light onto the camera, while their imaging is minimized or even completely avoided.

[0030] To achieve this effect, the bevel is arranged in such a way that the inspection window widens from the inside to the outside of the test strip holder housing. The side walls of the inspection window are inclined at an angle of at least between 1 degree and 75 degrees, preferably between 15 degrees and 75 degrees, more preferably between 35 degrees and 55 degrees, and most preferably between 40 degrees and 50 degrees.

[0031] Another risk that negatively affects the handling convenience may be the lack of a suitable structure to allow the sample fluid to fill into the fluid receiving channel. By providing a test strip holder as described above, wherein the at least one fluid receiving channel is further provided with at least one funnel portion at the opening of the at least one fluid receiving channel opposite to the opening of the fluid reservoir to facilitate the convenient transfer of the sample fluid into the test strip holder. In other words, the at least one funnel portion is arranged as an extension of the opening top end of the at least one fluid receiving channel.

[0032] By optimizing the structure of the funnel portion, this object can be achieved in a more efficient manner. Thus, in a preferred embodiment of the present invention, a test strip holder is provided, wherein at least two different beveled inner surfaces are provided on the at least one funnel portion. Thereby, the sample fluid flow can be directed into the fluid receiving channel independently of the exact location where the sample fluid is transferred into the funnel portion.

[0033] To optimize the overall process of lateral flow assays and minimize the need for manual input, the structure of the present test strip holder can be designed to fit into a reader or evaluation device. However, when designing the test strip holder to fit into the corresponding reader device, the aim is to provide the test strip holder in a manner that allows for easy addition of the sample fluid and also to avoid the test strip holder being inserted too deeply into the reader device. To solve this problem, a test strip holder is provided herein, wherein the outer surface of at least one funnel portion is inclined at an angle different from the outer surface of the back of the housing, and wherein the outer surface of the at least one funnel portion defines a stop portion that limits the insertion depth of the test strip holder into the evaluation device. Thereby, even if the test strip holder has been inserted into the reader device, the fluid can be easily transferred into the test strip holder.

[0034] The present invention further relates to the use of a test strip holder for performing lateral flow assays at an operator-defined temperature in an evaluation device comprising a heating and / or cooling module, wherein the heating and / or cooling module is set to the temperature at which the lateral flow assay should be performed; inserting a lateral flow detection test strip into the test strip holder as described herein; inserting the test strip holder into the evaluation device, wherein the back side of the test strip holder is brought into contact with the heating and / or cooling module; optionally, incubating the test strip holder for a predetermined time, preferably for at least 5 seconds; adding a fluid containing the analyte to be detected to the test strip holder; and wherein the test strip holder containing the lateral flow detection test strip and the fluid is incubated for a predetermined time, preferably for at least one second, more preferably for at least three seconds, most preferably for at least five seconds. It will be apparent to those skilled in the art that the steps of the use described herein need not be performed in the specific order described above for carrying out the present invention. For example, the step of adding the fluid containing the analyte to be detected to the test strip holder can be performed before inserting the test strip holder into the evaluation device. Those skilled in the art can contemplate the order of the steps described herein that allow for the lateral flow assay of the present invention. Preferably, the use relates to the use of a test strip holder for performing lateral flow assays at an operator-defined temperature in an evaluation device, wherein the evaluation device comprises a heating and / or cooling module, and wherein the lateral flow assay comprises the following steps: 1.) setting the heating and / or cooling module to the temperature at which the lateral flow assay should be performed; 2.) inserting a lateral flow detection test strip into the test strip holder as described herein; 3.) inserting the test strip holder into the evaluation device, wherein the back side of the test strip holder is brought into contact with the heating and / or cooling module; 5.) adding a fluid containing the analyte to be detected to the test strip holder; 6.) incubating the test strip holder containing the lateral flow detection test strip and the fluid for a predetermined time, preferably for at least one second, more preferably for at least three seconds, most preferably for at least five seconds; and wherein the steps are performed in ascending order from 1.) to 6.). In a particularly preferred embodiment, the lateral flow assay further comprises an additional step 4.) incubating the test strip holder for a predetermined time, preferably for at least 5 seconds. By using the test strip holder as described above, comparable and reproducible lateral flow assay results can be obtained at a temperature that can be defined by the operator and is independent of external temperature conditions.

[0035] Another aspect of the present invention relates to a method for performing a lateral flow assay at an operator-defined temperature in an evaluation device comprising a heating and / or cooling module, wherein the heating and / or cooling module is set to the temperature at which the lateral flow assay should be carried out; a lateral flow test strip is inserted into a test strip holder as described herein; the test strip holder is inserted into the evaluation device, wherein the back surface of the test strip holder is brought into contact with the heating and / or cooling module; optionally, the test strip holder is incubated for a predetermined time, preferably for at least 5 seconds; a fluid containing the analyte to be detected is added to the test strip holder; and wherein the test strip holder containing the lateral flow test strip and the fluid is incubated for a predetermined time, preferably for at least one second, more preferably for at least three seconds, and most preferably for at least five seconds. Preferably, the present invention relates to a method for performing a lateral flow assay at an operator-defined temperature in an evaluation device, wherein the evaluation device comprises a heating and / or cooling module, and wherein the lateral flow assay comprises the steps of: 1.) setting the heating and / or cooling module to the temperature at which the lateral flow assay should be carried out; 2.) inserting a lateral flow test strip into a test strip holder as described herein; 3.) inserting the test strip holder into the evaluation device, wherein the back surface of the test strip holder is brought into contact with the heating and / or cooling module; 4.) optionally, incubating the test strip holder for a predetermined time, preferably for at least 5 seconds; 5.) adding a fluid containing the analyte to be detected to the test strip holder; 6.) incubating the test strip holder containing the lateral flow test strip and the fluid for a predetermined time, preferably for at least one second, more preferably for at least three seconds, and most preferably for at least five seconds; and wherein the steps are performed in ascending order from 1.) to 6.).

[0036] The evaluation device mentioned herein can be any device or apparatus suitable for supporting the steps involved in a lateral flow assay, including, for example, imaging or recording and analyzing the data obtained in the assay. The heating and / or cooling module mentioned herein comprises at least one substantially flat surface of its own, which can contact the substantially flat surface of the back of the test strip holder housing. When in contact, an attempt is made to minimize the air gap between the heating and / or cooling module and the back of the test strip holder to allow for rapid and uniform heat transfer. The steps of analyzing the lateral flow assay involve at least imaging the test strip. Optionally, further automatic data evaluation by analyzing and interpreting the recorded images can additionally be performed.

[0037] Optimal lateral flow assay results can be obtained when the individual components are designed in a mutually compatible manner and structural obstacles are avoided. Accordingly, the present invention also relates to a kit comprising at least one test strip holder as described above, at least one lateral flow analysis test strip, and an evaluation device, wherein the evaluation device is capable of accommodating the at least one test strip holder, and wherein the evaluation device includes a temperature control element. By providing the necessary components as a kit as described herein, an optimal match and complementarity between the components can be ensured, and thus optimized assay conditions and assay reproducibility can be achieved. The temperature control element can be, for example, a heating or cooling element. Preferably, the temperature control element is arranged in the evaluation device in such a way as to allow close contact with the at least one test strip holder. Accordingly, one aspect of the present invention relates to an evaluation device, wherein the evaluation device is capable of accommodating at least one test strip holder as described herein, and wherein the evaluation device includes a temperature control element. In a preferred aspect of the present invention, the evaluation device includes at least one slot for accommodating at least one test strip holder as described herein, wherein the temperature control element is arranged to contact at least 20%, preferably at least 30%, more preferably at least 40% of the back of the at least one test strip holder once the at least one test strip holder is inserted into the at least one slot. Thereby, the heat transfer from the temperature control element to the test strip holder according to the present invention can be achieved most effectively. More preferably, the evaluation device further includes a camera, wherein the camera is arranged to allow imaging of the detection test strip within the test strip holder through an inspection window. Even more preferably, the evaluation device further includes a transparent plane, preferably a glass plane, which separates the camera from the at least one test strip holder. Thereby, the risk of splashing onto the camera can be minimized while still allowing imaging of the lateral flow detection test strip. Even more preferably, the evaluation device further includes a code reader slot. The code reader slot mentioned herein can be a slot for inserting any kind of code-carrying device, such as: a card carrying a matrix bar code or a linear bar code. Preferably, the code reader slot is provided to allow the camera of the evaluation device to read the code. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Hereinafter, the solution of the present invention will be further described by way of drawings and examples.

[0039] Figure 1 is a graph showing the relationship between the volume of liquid retained in the sub-reservoir in the test strip holder and the volume of liquid added to the test strip holder.

[0040] Figure 2 is a graph showing the heat transfer curves of the test strip holder in three different back cases.

[0041] Figure 3Is a front view cross-sectional view of a lateral flow test strip in a test strip holder including a test strip receiving channel, a fluid receiving channel, and a fluid reservoir.

[0042] Figure 4 Is a front view cross-sectional view of a test strip holder including a test strip support structure with a weir structure.

[0043] Figure 5 Is a front view cross-sectional view of an alternative embodiment of a test strip support structure having two weir structures.

[0044] Figure 6 Is a front view cross-sectional view of a test strip holder including a test strip receiving channel, a fluid receiving channel, and a test strip support structure with a weir structure.

[0045] Figure 7 Is a front view cross-sectional view of a test strip holder including a ventilation channel.

[0046] Figure 8 Is a front view cross-sectional view of a test strip holder including two test strip receiving channels, two separate fluid receiving channels, and two test strip support structures with weir structures.

[0047] Figure 9 Is a front view cross-sectional view of a test strip holder including a ventilation channel, wherein the ventilation channel partially surrounds the fluid reservoir.

[0048] Figure 10 Is a front view cross-sectional view of a test strip holder including a funnel portion.

[0049] Figure 11 Is a side view cross-sectional view of a test strip holder having an inspection window on the front side and including a wedge element, a test strip support structure, and a weir structure on the back side.

[0050] Figure 12 Is a cross-sectional view of a test strip holder taken laterally, the front side of which has an inspection window with a beveled sidewall.

[0051] Figure 13 Is a side view of a test strip holder having a funnel portion. Detailed Description

[0052] Figure 1It is a diagram showing the functions provided by the sub - memory, which is defined by a test strip support structure including a weir structure within a fluid reservoir of a test strip holder. In this diagram, the x - axis shows the volume in μL introduced into the test strip holder, and the y - axis shows the volume in μL retained in the sub - memory. The nominal geometric volume defined by the sub - memory defined by the test strip support structure including the weir structure is 250 μL. Due to water surface tension, volumes above the nominal geometric volume of the first sub - memory are also retained. However, these volumes do not cause the test strip to be submerged. Volumes above 350 μL flow over the weir structure into the fluid memory below the sub - memory, thus avoiding test strip submergence and overflow of the test strip holder. Thereby, test strip submergence due to adding an excessive volume can be avoided while still retaining an appropriate volume that allows for reliable lateral flow assays.

[0053] Figure 2 It is a diagram showing the heat transfer behavior on the back of different exemplary test strip holders. The x - axis shows the time in seconds, and the y - axis shows the measured temperature in °C. The dotted line represents the data recorded when using a test strip holder with back A (a 50 - μm polyolefin film with a 50 - μm silicone adhesive with an inert encapsulation). The dashed line represents the data recorded when using a test strip holder with back B (a 38 - μm impermeable soft aluminum foil). The solid line represents the data recorded when using a test strip holder with back C (a 0.5 - mm acrylonitrile - butadiene - styrene - like plastic foil). The specific heat transfer index for all the tested back materials is greater than 0.08 s -1 and is thus found to be suitable for allowing effective heat transfer from an external heating / cooling source to the test strip holder. Thereby, independence from the ambient temperature can be achieved, and lateral flow assays can be performed at an operator - defined temperature and thus in a more reproducible and reliable manner.

[0054] Hereinafter, exemplary embodiments of the test strip holder according to the present invention are described in detail. These embodiments are only used as illustrative examples and should not be construed as restrictive embodiments of the present invention. In Figures 3 to 12 them, reference numerals are consistently used for the indicated features. For example, the feature "test strip receiving channel" is indicated by reference numeral 2. Thus, in Figures 3 to 12 them, reference numeral 2 always indicates the feature "test strip receiving channel". In Figures 3 to 12 them, the shown test strip receiving channel 2 or fluid receiving channel 3 has an open end substantially at the top of the test strip holder. In particular, these channels are arranged in a way that allows a test strip or fluid to be inserted into the test strip receiving channel 2 or fluid receiving channel 3 respectively from the top end of the test strip holder 100.

[0055] Figure 3FIG. 0 is a front cross-sectional view of a test strip holder 100 that includes a channel serving as a test strip receiving channel 2 and a second channel serving as a fluid receiving channel 3, wherein the test strip receiving channel 2 and the fluid receiving channel 3 are arranged parallel to each other. Figure 3 The cross-section shown also depicts a lateral flow detection test strip 1 in contact with a fluid 101 contained in a fluid reservoir 4. The channels and the fluid reservoir are formed by a wall structure 21 that connects the front face 9 of the test strip holder to the back face 11. When the test strip holder 100 has a substantially flat thermally conductive back face 11 according to the present invention as Figure 3 shown, such a test strip holder can be brought into contact with a heating / cooling element to effect an efficient temperature transfer from the heating / cooling element via the back face 11 to the contents of the test strip holder 100, thereby allowing the detection of an analyte at an operator-controlled temperature.

[0056] Figure 4 FIG. 8 is a front cross-sectional view of another embodiment of a test strip holder 100 that includes a test strip receiving channel 2 that also serves as a fluid receiving channel, and further includes a test strip support structure 5 having a weir structure 6. The test strip support structure 5 having the weir structure 6 can be attached, for example, to one of the wall structures 21 of the fluid reservoir 4. A sub-reservoir 17 formed by the test strip support structure 5 having the weir structure 6 partially divides the fluid reservoir 4 and defines a first sub-reservoir 17 within the fluid reservoir 4. Below the first sub-reservoir 17 is a second sub-reservoir 18. Figure 5 FIG. 10 is a front cross-sectional view of a test strip holder in which a test strip support structure 5 having two weir structures 6 is not attached to one of the wall structures 21 of the fluid reservoir 4, but rather is attached to the front face 9 and the back face 11 of the test strip holder 100. A test strip holder 100 that includes a test strip support structure 5 having a weir structure 6 can be used to avoid submerging the test strip due to the accidental addition of an excessive amount of liquid. The added liquid will first fill the first sub-reservoir 17 formed by the test strip support structure 5 having at least one weir structure 6, and only when the maximum volume of the first sub-reservoir 17 is reached will the excess liquid overflow over the weir structure and enter the second sub-reservoir 18, thus avoiding submerging the lateral flow detection test strip 1 standing in the first sub-reservoir 17.

[0057] Referring to Figures 4 to 5 the view shown, the test strip receiving channel 2 and the fluid receiving channel are implemented by the same channel. In such an embodiment, the liquid to be analyzed is introduced into the test strip holder 100 via the same channel 2 used to introduce the lateral flow detection test strip 1 into the test strip holder 100.

[0058] Referring to Figure 3 and 6-10, the test strip receiving channel 2 and the fluid receiving channel 3 are separate channels. By separately arranging the test strip receiving channel 2 and the fluid receiving channel 3, the risk of premature wetting of the lateral flow detection test strip 1 can be avoided, and the measurement process can be more conveniently performed.

[0059] Referring to Figure 7 , 9 -10, an additional ventilation channel 7 is shown. In Figures 9 to 10 , the ventilation channel 7 partially surrounds the fluid reservoir 4. The presence of the ventilation channel makes it possible to avoid the accumulation of back pressure in the test strip holder 100. By providing the ventilation channel 7 in a manner that at least partially surrounds the fluid reservoir 4, the risk of blocking the ventilation channel 7 due to liquid overflowing into the ventilation channel 7 can be reduced.

[0060] Figure 8 is a front cross-sectional view of an embodiment of a test strip holder 100 according to the present invention, wherein two lateral flow assay test strips 1 can be used in the same test strip holder 100. Those skilled in the art will appreciate that multiple test strip holders can also be provided, which allow the handling of three or even more lateral flow assay test strips. Such multiple test strip holders are also within the scope of the present invention. Figure 8 's view shows a test strip holder including two test strip receiving channels 2, two fluid receiving channels 3, and two separate test strip support structures 5 having a weir structure 6. Instead of having two separate test strip support structures 5 with a weir structure 6, a single test strip support structure having at least one weir structure can also be provided, which supports two or more lateral flow detection test strips.

[0061] Figure 10 is a front cross-sectional view showing a test strip holder 100 including a funnel portion 8. Thus, the most convenient introduction of fluid into the test strip holder 100 can be achieved through this funnel portion 8. As Figure 10 shown, by providing at least two different beveled inner surfaces 14, 15, and 16 to the funnel portion 8, the liquid introduced into the funnel portion 8 can be guided to the fluid receiving channel 3 regardless of the position where the liquid is introduced into the funnel portion 8.

[0062] Figure 11It is a side cross-sectional view of the test strip holder 100, which includes a back surface 11 and a front surface 9 having an inspection window 10, and includes a wedge element 12, a test strip support structure 5, and a weir structure 6. The inspection window 10 is represented by a dashed line. The wedge element 12, on the one hand, prevents a lateral flow detection test strip from being inserted into the test strip holder 100 in the wrong orientation, and applies pressure to the correctly inserted lateral flow detection test strip to push the test strip against the back surface 11 of the test strip holder 100. Thereby, the temperature isolation air gap between the detection test strip and the back surface 11 is minimized, thus achieving an ideal temperature transfer from an external heating / cooling element via the back surface 11 of the test strip holder 100 to the detection test strip.

[0063] Figure 12 It is a horizontal cross-sectional view of the test strip holder 100, which has a back surface 11 and a front surface 9, and the front surface 9 has an inspection window 10, wherein the side wall 13 of the inspection window 10 is beveled. By providing the inspection window 10 with a beveled side wall 13, the imaging quality can be maximized by avoiding the non-beveled side wall from casting a shadow on the lateral flow test strip. As Figure 12 shown, the back surface 11 can be made of the same material as other components of the test strip holder (such as the front surface 9). However, it should be understood that the back surface 11 can also be made of a material different from one or more of the other components or structural elements of the test strip holder, as disclosed herein.

[0064] Figure 13 It is a side view of the test strip holder 100 having a rear surface 11, a front surface 9, and a funnel portion 8, wherein the outer surface 19 of the funnel portion is inclined at an angle different from that of the outer surface of the rear surface 11. In this example, the angle 20 between the outer surface 19 of the funnel portion and the outer surface of the back surface 11 is about 33°. By providing such a test strip holder, the angle formed by the outer surface 19 of the funnel portion and the outer surface of the back surface 11 defines a stop portion, which limits the insertion depth of the test strip holder in the evaluation device.

[0065] Example

[0066] Example 1 - Avoiding test strip immersion and test strip holder overflow

[0067] To avoid adverse effects on test strip immersion when adding excessive fluid, the test strip holder was tested. The test strip holder includes a housing having a front face including an inspection window and a back face. The housing includes a test strip receiving channel, a separate fluid receiving channel, a fluid reservoir, and a ventilation channel. The test strip receiving channel and the fluid receiving channel are in fluid communication with the fluid reservoir. The fluid reservoir is partially divided into a first sub-reservoir and a second sub-reservoir by a test strip support structure including a weir structure located below the test strip receiving channel and the fluid receiving channel. Figure 7 ) The test strip support structure is provided to form a first sub-reservoir that defines a nominal geometric volume of 250 μL. The geometric volume is defined by the test strip support structure orthogonal to the test strip receiving channel and the fluid receiving channel, the front and back faces of the housing, the side walls of the housing, and the weir structure. Excess liquid should overflow through the weir structure into the second sub-reservoir below the test strip support structure, thereby avoiding immersion of the test strip standing in the test strip receiving channel on the test strip support structure.

[0068] Different volumes of aqueous liquid were introduced into the fluid reservoir through the fluid receiving channel, first reaching the first sub-reservoir and, in the case of excess volume, overflowing into the second sub-reservoir. The different added volumes and the approximate volumes retained in the first sub-reservoir are shown in Table 1 and illustrated in Figure 1 . It can thus be demonstrated that the described test strip support structure is functional and well-suited to handle excess volumes that may be added erroneously.

[0069] Added volume μL Remaining volume μL Overflow volume μL 100 100 - 150 150 - 200 200 - 250 250 - 300 300 - 350 350 - 400 150 250 500 150 350

[0070] Table 1: Volume added to the test strip holder, volume retained in the first sub-reservoir, overflow volume in the second sub-reservoir.

[0071] Example 2 - Evaluation of the influence of ambient temperature

[0072] To evaluate the influence of uncontrolled ambient temperature, an aqueous solution containing known concentration of 0.50 ppm of fumonisin B1 was measured by standard LFD assay at three different temperatures: the optimal temperature, 5 °C below the optimal temperature, and 5 °C above the optimal temperature. The concentration of fumonisin B1 determined at the optimal temperature was 0.49 ppm, the concentration determined at 5 °C below the optimal temperature was 0.64 ppm, and the concentration determined at 5 °C above the optimal temperature was 0.37 ppm. These results illustrate the importance of controlling the temperature at which the LFD assay is performed to maximize reproducibility and accuracy. When using the test strip holder described herein, such deviation can be completely avoided by allowing control of the temperature at which the assay reaction is performed.

[0073] Example 3 - Determining the Specific Heat Transfer Index

[0074] In order to measure the heat transfer properties of different test strip holder architectures or different test strip holder backs, a common laboratory hot plate (e.g. RCT Basic from IKA) is set to 45°C. The test strip holder to be measured is equipped with a temperature probe (e.g. Traceable Digital Thermometer, VWR) directly in contact with the inside of the back at approximately the same height as the test area where the test strip will be located. The test strip holder is then fixed flat on the hot plate with tape to ensure close contact, while the probe temperature, ambient temperature and incubation time are recorded. Before each new experiment, the temperature probe is allowed to cool to room temperature, i.e. a temperature between 18°C and 25°C.

[0075] As an example, metal foils and plastic foils were tested as the back of the test strip holder with different thicknesses. The thickness of the aluminum foil described is 9 μm, 40 μm, 125 μm, 0.5 mm, 1 mm or 1.5 mm. The thickness of the copper foil and silver foil described is 1 μm, 50 μm or 1 mm. The thickness of the zinc foil described is 35 μm or 0.5 mm. The thickness of the foil made of polyethylene, polyvinyl chloride, polypropylene, polyester, polycarbonate, polystyrene or acrylonitrile butadiene styrene (ABS) described is 8 μm, 40 μm, 0.1 mm, 0.5 mm or 1 mm. The nominal thermal conductivity of aluminum is in the range of about 200 W / (m·K), the nominal thermal conductivity of copper is in the range of about 275 W / (m·K), the nominal thermal conductivity of silver is in the range of about 430 W / (m·K) and the nominal thermal conductivity of zinc is in the range of about 110 W / (m·K). The nominal thermal conductivity of plastics (such as polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyester, polycarbonate, ABS or ABS-like materials) is significantly lower than that of metal foils, about 0.15-0.5 W / (m·K). In detail, data of three different back surfaces A, B and C are shown as examples: Back surface A is a "ThermaSeal RTS TM Sealing film". This polyethylene-based film described is a 50 μm thick polyolefin with 50 μm of inert encapsulating silicone adhesive. The back side B was purchased from Sigma-Aldrich Handels GmbH" II seal". The film described is a 38 μm impermeable soft aluminum foil. The back side C is a 0.5 mm acrylonitrile butadiene styrene (ABS)-like polymer foil. Figure 2 The data recorded for the back sides A, B and C are shown as an example.

[0076] To calculate the specific heat transfer index on the back side of the test strip holder, measure the time (in seconds) required to achieve a 10 °C temperature transfer from 25 °C to 35 °C from the outer side to the inner side of the back side of the test strip holder housing. For the test strip holder with back side A, the time is 6.9 s. For the test strip holder with back side B, the time is 5.7 s. For the test strip holder with back side C, the time is 12 s. The specific heat transfer index is determined by calculating the reciprocal of the measured time. The specific heat transfer index of the test strip holder with back side A is determined to be 0.145 s -1 . The specific heat transfer index of the test strip holder with back side B is determined to be 0.175 s -1 . And, the specific heat transfer index of the test strip holder with back side C is determined to be 0.083 s -1 . Finally, in the case of any of the tested back sides, the time required to achieve a 10 °C temperature transfer from 25 °C to 35 °C from the outer side to the inner side of the back side of the test strip holder housing does not exceed 60 s. In other words, the specific heat transfer index of these test strip holder back sides is at least 0.0167 s -1 . Most surprisingly, it can be seen therefrom that not only materials with a high nominal thermal conductivity such as silver (430 W / (m·K)), but also synthetic materials and plastics with a lower nominal thermal conductivity (0.15 - 0.5 W / (m·K)) can serve as the thermally conductive back side according to the present invention and can thus be suitable for use as the back side of the test strip holder according to the present invention.

Claims

1. A test strip holder (100), said test strip holder being constituted by a housing having a front face (9) and a back face (11), wherein, The housing includes at least one test strip receiving channel (2), at least one fluid receiving channel (3), and at least one fluid reservoir (4); wherein both the at least one test strip receiving channel (2) and the at least one fluid receiving channel (3) are in fluid connection with the at least one fluid reservoir (4); and wherein the front face (9) is made of solid material and includes at least one inspection window (10); characterized in that the back face (11) of the housing is a substantially flat surface; the back face (11) of the housing is thermally conductive; and wherein the back face (11) of the housing is made of at least one material selected from the group consisting of polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyester, polycarbonate, acrylonitrile-butadiene-styrene copolymer ABS or ABS-like materials, characterized in that the at least one fluid reservoir (4) is partially separated by at least one test strip support structure (5), the at least one test strip support structure including at least one weir structure (6), the at least one weir structure defining a sub-memory (17) capable of holding a predetermined fluid volume, wherein the at least one test strip support structure (5) is disposed below the at least one test strip receiving channel (2) and the at least one fluid receiving channel (3); and wherein the at least one test strip support structure (5) is disposed in an orientation orthogonal to the at least one test strip receiving channel (2) and the at least one fluid receiving channel (3).

2. A test strip holder (100), said test strip holder being constituted by a housing having a front face (9) and a back face (11), wherein, The housing includes at least one test strip receiving channel (2), at least one fluid receiving channel (3), and at least one fluid reservoir (4), wherein both the at least one test strip receiving channel (2) and the at least one fluid receiving channel (3) are in fluid connection with the at least one fluid reservoir (4); and wherein the front face (9) is made of solid material and includes at least one inspection window (10); characterized in that the at least one fluid reservoir (4) is partially separated by at least one test strip support structure (5), the at least one test strip support structure including at least one weir structure (6), the at least one weir structure defining a sub-memory (17) capable of holding a predetermined fluid volume, wherein the at least one test strip support structure (5) is disposed below the at least one test strip receiving channel (2) and the at least one fluid receiving channel (3); and wherein the at least one test strip support structure (5) is disposed in an orientation orthogonal to the at least one test strip receiving channel (2) and the at least one fluid receiving channel (3).

3. The test strip holder (100) according to claim 2, characterized in that, The back face (11) of the housing is a substantially flat surface; and the back face (11) of the housing is thermally conductive.

4. The test strip holder (100) according to any one of claims 1 to 3, characterized in that, The housing further includes a ventilation channel (7), the ventilation channel (7) including two openings, wherein a first opening is provided at the at least one fluid reservoir (4) and at a height position above the fluid reservoir.

5. The test strip holder (100) according to claim 4, characterized in that, A second opening is provided at the height position of the insertion opening of the at least one test strip receiving channel (2).

6. The test strip holder (100) according to claim 4, characterized in that, The ventilation channel (7) is arranged to at least partially surround the at least one fluid reservoir (4).

7. The test strip holder (100) according to claim 4, characterized in that, The front side (9) of the housing, the at least one test strip receiving channel (2), the at least one fluid receiving channel (3), the at least one fluid reservoir (4) and at least one ventilation channel (7) are provided as a single piece.

8. The test strip holder (100) according to claim 1 or 2, characterized in that, The housing of the test strip holder is provided as a single piece.

9. The test strip holder (100) according to claim 1 or 2, characterized in that, The test strip receiving channel (2) further includes at least one wedge element (12), wherein the at least one wedge element (12) is arranged on the inner side of the front side (9).

10. The test strip holder (100) according to claim 1 or 2, characterized in that, The side wall (13) of the inspection window (10) of the at least one test strip receiving channel (2) is beveled.

11. The test strip holder (100) according to claim 1 or 2, characterized in that, At least one funnel portion (8) pointing outwards is provided at the opening of the at least one fluid receiving channel (3) in the at least one fluid receiving channel (3).

12. The test strip holder (100) according to claim 11, characterized in that, The outer surface of the at least one funnel portion (8) is inclined at an angle different from the outer surface of the back side of the housing, wherein the outer surface of the at least one funnel portion (8) defines the insertion depth of the test strip holder in the evaluation device.

13. Use of a test strip holder (100) in a lateral flow assay, the lateral flow assay being carried out at an operator-defined temperature in an evaluation device, wherein, The evaluation device includes a heating and / or cooling module; and wherein the lateral flow determination includes the following steps: Setting the heating and / or cooling module to the temperature at which the lateral flow determination should be performed; Inserting a lateral flow detection test strip (1) into the test strip holder (100) according to any one of claims 1 to 12; Inserting the test strip holder (100) into the evaluation device, wherein the back side (11) of the test strip holder (100) is brought into contact with the heating and / or cooling module; Adding a fluid (101) containing the analyte to be detected to the test strip holder (100); and Incubating the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) for a predetermined time.

14. Use of a test strip holder (100) in a lateral flow assay, the lateral flow assay being carried out in an assessment device at an operator-defined temperature, wherein, The evaluation device includes a heating and / or cooling module; and wherein the lateral flow determination includes the following steps: Setting the heating and / or cooling module to the temperature at which the lateral flow determination should be performed; Inserting a lateral flow detection test strip (1) into the test strip holder (100) according to any one of claims 1 to 12; Inserting the test strip holder (100) into the evaluation device, wherein the back side (11) of the test strip holder (100) is brought into contact with the heating and / or cooling module; Incubating the test strip holder (100) for a predetermined time; Adding a fluid (101) containing the analyte to be detected to the test strip holder (100); and Incubating the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) for a predetermined time.

15. The use according to claim 14, wherein the test strip holder (100) is incubated for at least 5 seconds.

16. The use according to claim 13 or 14, wherein the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) is incubated for at least one second.

17. The use according to claim 13 or 14, wherein the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) is incubated for at least three seconds.

18. The use according to claim 13 or 14, wherein the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) is incubated for at least five seconds.

19. A method for performing a lateral flow assay at an operator-defined temperature in an evaluation device comprising a heating and / or cooling module, wherein, The lateral flow determination comprises the following steps: Setting the heating and / or cooling module to the temperature at which the lateral flow determination should be performed; Inserting the lateral flow detection test strip (1) into the test strip holder (100) according to any one of claims 1 to 12; Inserting the test strip holder (100) into the evaluation device, wherein the back surface (11) of the test strip holder (100) is brought into contact with the heating and / or cooling module; Adding a fluid (101) containing the analyte to be detected to the test strip holder (100); and Incubating the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) for a predetermined time.

20. A method for performing a lateral flow assay at an operator-defined temperature in an evaluation device comprising a heating and / or cooling module, wherein, The lateral flow determination comprises the following steps: Setting the heating and / or cooling module to the temperature at which the lateral flow determination should be performed; Inserting the lateral flow detection test strip (1) into the test strip holder (100) according to any one of claims 1 to 12; Inserting the test strip holder (100) into the evaluation device, wherein the back surface (11) of the test strip holder (100) is brought into contact with the heating and / or cooling module; Incubating the test strip holder (100) for a predetermined time; Adding a fluid (101) containing the analyte to be detected to the test strip holder (100); and Incubating the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) for a predetermined time.

21. The method according to claim 20, wherein the test strip holder (100) is incubated for at least 5 seconds.

22. The method according to claim 19 or 20, wherein the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) is incubated for at least one second.

23. The method according to claim 19 or 20, wherein the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) is incubated for at least three seconds.

24. The method according to claim 19 or 20, wherein the test strip holder (100) containing the lateral flow detection test strip (1) and the fluid (101) is incubated for at least five seconds.

25. A kit, comprising at least one test strip holder (100), at least one lateral flow assay test strip (1) and an evaluation device, wherein the test strip holder is the test strip holder according to any one of claims 1 to 12, wherein, The evaluation device is capable of receiving the at least one test strip holder (100), and wherein the evaluation device includes a temperature control element.

26. An evaluation device, wherein, The evaluation device is capable of receiving at least one test strip holder (100) according to any one of claims 1 to 12, and wherein the evaluation device includes a temperature control element.

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