Rapid-test chromatographic set for screening a sample for pathogens, biomolecules, biomarkers, and chemical substances

Abstract

The invention relates to a rapid chromatographic test set for examining a sample, such as blood, using the so-called lateral flow assay principle. The set comprises: • a test cassette (1), comprising a test area (100) for chromatography and a sample receiving area (101) for receiving the sample (3), and • a sample receiving device (2), wherein the test cassette (1) has a plug connection (102) in the sample receiving area (101) as a receptacle for the sample receiving device, and this sample receiving device (2) has the counterpart (200) of this plug connection at its lower end, wherein the test area (100) of the test cassette (1) has a first, raised surface (103) and the sample receiving area (101) has a second, lower surface (104) for inserting a test strip (105), the second surface (104) being lower than the first surface (103).so that the inserted test strip (105) is bent and the sample (3) must flow upwards after the sample receiving device (2) is inserted, and wherein the sample receiving device (2) has at its upper end a filling area (201) for receiving a process fluid with an opening of at least 5 mm in diameter. The subject matter also includes the use of such a set for the detection of pathogens, selected from viruses, bacteria, fungi and parasites, of biomolecules, of biomarkers or of chemical substances, each in a sample (3).

Description

[0001] The invention relates to a chromatographic rapid test kit for examining a sample, such as blood, using the so-called lateral flow assay principle.

[0002] Lateral flow assay (also called lateral flow test) is a long-established laboratory method for detecting substances in liquids using labeled antibodies. It is a combination of thin-layer chromatography and immunoassay. This test principle is behind many common rapid tests, such as those in US Pat. Nos. 8,399,261 B2 and 6,372,516 B1.

[0003] This type of immunochromatography is a variant of affinity chromatography based on antigen-antibody reactions.

[0004] It is also known to immobilize antibodies for red blood cells, for example, in the front chromatography section, so that a colorless (biological) sample is created, the color reactions of which are more easily visible in the further course of the chromatography.

[0005] Numerous test kits for rapid chromatographic tests are also known.

[0006] DE 10 2007 025 311 A1, for example, describes an elongated container for a (vertical) chromatographic binding assay with a porous filling material for photometric detection, whereby several such containers can be stacked on top of each other. Simple reading of a horizontally placed test cassette is therefore not possible. The disadvantage is that holders are required to hold the vertically stacked containers. Operation by everyone is hardly possible, especially since the containers must be brought to eye level for reading, which causes vibration to cause the "reading front" to become uneven and wavy.

[0007] Photo-based methods have been established for detection, for example by simple reading.

[0008] DE 10 2004 006 470 A1 describes a disposable cuvette for detection by absorbance. It is filled with a porous matrix with a reflective inner surface. The substance to be determined is embedded in or deposited on the pores or on the surface of the matrix, and the analysis is performed by quantitatively detecting the transmitted light.

[0009] Regarding the test kits, widely used rapid coronavirus test kits feature a test cassette with a drop-in area for adding a sample solution. Often, too much solution is added to the test strip, which, in the worst case, floods the planar test strip from all sides, rendering the test unusable or producing erroneous results. Furthermore, air bubbles are often trapped in the added solution, which also leads to incorrect tests. Adding too little sample volume also leads to inaccurate results and reduced analytical performance.

[0010] EP 1 813 949 A1 discloses a test cassette for use in sample preparation, conditioning, and subsequent automatic analysis of a liquid sample. The test cassette comprises a housing with an inlet opening and a reservoir for receiving a liquid sample. The test cassette further comprises a carrier platform that can be moved horizontally within the housing for securing strip-shaped, capillary-active detection elements. Upon insertion of the carrier platform into the housing, the capillary-active detection elements are deflected from the longitudinal direction of the strip and immersed in the liquid sample in the reservoir.

[0011] The document US 2017 / 0227536 discloses a test device in which an extraction solution to be tested is first absorbed by a capillary-active guide element and transported to a test strip via capillary action.

[0012] Publication WO 00 / 72012 A2 describes a device comprising a test cassette and a sample container that can be screwed into the test cassette and contains a liquid sample to be tested. The test cassette and sample container are designed to work together in such a way that the sample can only flow out and wet a test strip in the test cassette when the sample container is screwed in.

[0013] A test device with a porous but non-absorbent test substrate is known from EP 296 724 A2.

[0014] In the pharmaceutical sector, universally applicable connection systems have now become established; for example, the well-known Luer-Lock system is used to connect syringes to cannulas.

[0015] For example, US 2003 / 0064526 A1 describes a Luer-Lock type connector for connecting an elongated sample collector to a flexible sponge at the lower end. The sample collector has a handle at one end and, for example, a sponge at the other, lower end, for collecting a sample to be analyzed, such as blood or urine. A test device also described is designed for inserting a planar test strip. The sample to be analyzed is transferred from the sponge by wringing the sponge out and rotating the elongated sample collector. A disadvantage is that the test device must be held firmly or a holder is necessary. Another disadvantage is that a significant amount of the sample to be analyzed remains in the sponge and is lost. Rinsing the sponge from the outside and then accurately dripping the rinsing solution into the opening of the test device is not suitable for use by laypersons.

[0016] US 2005 / 0180882 A1 also describes the sample application by wringing out a sample applicator to apply the solution to a planar test strip.

[0017] A downward flowing test device is also known, for example from US 2011 / 0256638 A1.

[0018] The object of the invention is to overcome the disadvantages mentioned in the prior art.

[0019] The invention aims to provide a rapid chromatography test kit that can be operated by the end user. This should eliminate sources of error that would lead to inaccurate or incorrect determination of the result. For example, the chromatography test strip should be prevented from being accidentally flooded with liquid from all sides. Accidental flooding from above, e.g., through the reading opening, should also be prevented. Handling should be simple, i.e., it should not require any holders. One-handed operation is desirable. It should be possible to no longer lift the test kit after the sample to be tested has been applied to the test strip. However, slight movements in the horizontal plane should not affect the invention.

[0020] According to the invention, the object is achieved by the features of the independent main claims. Advantageous embodiments of the invention are specified in the dependent claims.

[0021] The invention relates to a chromatographic rapid test kit for the examination of a sample (e.g. a biological sample such as blood, urine or sweat or an environmental sample), comprising a test cassette comprising a test area for chromatography and a sample receiving area for receiving the sample, and an (elongated) sample receiving device, wherein the test cassette has a plug connection in the sample receiving area as a receptacle for the sample receiving device, and this sample receiving device has the counterpart of this plug connection at the lower end, wherein the test area of ​​the test cassette has a first, high support and the sample receiving area has a second, low support for inserting a test strip, the second support being lower than the first support so that the inserted test strip is bent and the sample must flow upwards after the sample receiving device is inserted, and wherein the sample receiving device has a filling area at the upper end for receiving a process liquid with an opening of at least 5 mm in diameter (in the sense of a minimum opening width), wherein the sample receiving device comprises a capillary or a frit or a film with at least two lugs in the region of the counterpart of the plug connection at the lower end,The tabs protrude outwards and downwards and when the sample collection device and test cassette are plugged together, the tabs break into the interior of the sample collection device and pierce the foil.

[0022] The "opening" within the meaning of the invention provides pressure equalization to the outside during operation (i.e., when plugged together), so that fluids inside the sample collection device can flow downward through the counterpart of the plug connection solely through hydrodynamic pressure. This opening is to be distinguished from, for example, merely hanging openings for threading a thread.

[0023] The diameter described is to be understood as the width of the opening. That is, in the case of a square opening, this corresponds to the side length; in the case of a rectangular opening, it corresponds to the shorter of the two side lengths in terms of width. In the case of an oval opening, such as would be obtained by cutting an oblique section of a tubular sample holder, "diameter" refers to the width of the ellipse, not the length.

[0024] The test cassette according to the invention has a flat, elongated shape, similar to that of currently widely used rapid corona tests, in which a test strip is moistened with a sample inside and, by means of capillary action, the sample "runs" along the test strip and a color reaction can be read in a window opening / reading opening.

[0025] According to the invention, a test strip is bent when inserted and then extends from the area below the plug connection of the test cassette into the test area, where a viewing window (reading opening) is also provided in the lid through which the color reactions can be read.

[0026] The test cassette has a flow opening in the holder for the sample collection device through which the sample to be tested can flow and onto a test strip.

[0027] The "lower end" of the sample collection device refers to the end that is inserted into or on the test cassette when connected to the test cassette. The "upper end" is the correspondingly opposite end. In use, the filling area according to the invention, with an opening of at least 5 mm in diameter, is suitable for filling process fluids (such as running buffer or lysis buffer).

[0028] The supports for a test strip can also be multiple supports each, or for example an edge etc. or a rectangular, closed, upward-facing edge onto which the test strip is placed (and expediently otherwise snapped or clamped into place). According to the invention, there are one or more first, high supports and one or more second, deep supports so that the test strip gets its curvature. To prevent the test strip from escaping upwards due to the tension, the lid is pressed onto the first support, for example by means of pins, edges or other counter-pressure devices, and held in this curved shape. In the sample intake area, the test strip is pressed down by the plug connection (which acts as a holder for the sample intake device).

[0029] The invention also relates to the use of the chromatographic rapid test kit according to the invention for the detection of pathogens selected from viruses, bacteria, fungi, and parasites, biomolecules, biomarkers, or chemical substances, each in a sample. The sample to be tested is preferably filled into the sample collection device (aspirated from below in the case of a capillary or frit, or inserted from above in the case of a film with two tabs). The sample collection device is inserted (using the counterpart of the plug connection) into or onto the test cassette (the plug connection serves as a receptacle for the sample collection device). A process fluid can then be added from above through the inventive filling area of ​​the sample collection device with opening. This fluid flushes the sample to be tested out of the sample collection device. The sample or the resulting mixture reaches the test strip.After a normal running time, the result can be read.

[0030] The plug-in connection between the sample collection device and the test cassette advantageously ensures a clean transfer of the liquids from the sample collection device to the test cassette, while the invention ensures that a constant volume is always applied. It advantageously prevents the solutions from missing the intended target site on the test strip. Patient operation is possible.

[0031] In this regard, no support is required, neither for the test cassette nor for the elongated sample collection device. The test cassette can be placed on a table and does not necessarily have to be lifted for reading. However, the device can easily accommodate slight horizontal movements and does not need to be held in place.

[0032] The opening in the filling area at the top of the sample collection device also advantageously ensures that no holder is required during use. This is because process fluids / rinsing fluids (such as a running buffer or lysis buffer) can be poured directly into the attached sample collection device (i.e., attached to the test cassette) from above into the opening. Even with relatively strong shaking movements by the user, no holder is necessary.

[0033] One-handed operation is possible.

[0034] This is because the process fluid can be accurately filled from standard ampoules, for example. Due to the opening facing the ambient pressure (meaning the opening in the sample intake device's filling area), the process fluid can flush the sample that has accumulated in the frit downwards solely due to hydrodynamic pressure. The opening is advantageously designed so that the head of an ampoule can be easily guided into the opening (in the sense of "hooking" along the edge on the head into the opening in the sample intake device's filling area). Above all, it is easy and reliable for the user to recognize when the ampoule can be pressed so that the process fluid drips into the sample intake device's filling area, and when it does not. Accidental spillage is prevented.

[0035] Another advantage is that the test strip cannot become “flooded”.

[0036] On the one hand, the above-mentioned opening with the specified minimum opening width prevents process fluids from accidentally running past the outside of the sample collection device, which would flood the test cassette from above, for example through the reading opening (as could happen when filling process fluids during operation, ie when the sample collection device and test cassette are plugged together).

[0037] On the other hand, no liquid can flow from below inside the test cassette along the surface of the test strip without having properly passed through the test strip material. This is because an inserted test strip inevitably has a curved shape (as in the Fig. 3a and Fig. 3c visible), such that the liquid must rise upwards in the direction of travel of the test strip by means of capillary forces.

[0038] The opening advantageously allows the sample (possibly together with a process fluid) to drain automatically downwards into the test cassette when the sample collection device is opened upwards. Wringing or pressing the sample collection device (to build up pressure) is unnecessary. Displacement using the positive displacement principle (e.g., as with a syringe) is also unnecessary. The sample can be flushed downwards by an added process fluid, using only hydrodynamic pressure. Preferred embodiments

[0039] Preferably, the sample to be examined is a biological sample selected from blood, urine, sweat and a stool sample, particularly preferably blood.

[0040] The opening in the filling area of ​​the sample collection device is preferably one with a diameter of 5-10 mm.

[0041] Particularly preferably, the opening has a maximum extension of 7 mm diameter in the case of the circular opening and a maximum width of 7 mm in the case of the oval opening.

[0042] The oval opening is most preferably designed to form a tab, allowing the user to easily hold the sample collection device. The tab is the area (on the sample collection device from bottom to top (as viewed from the direction inserted into the cassette), starting with the lower edge where the opening begins, up to the upper edge on the opposite side, which represents the upper end of the tab for holding. The ampoule can, for example, be placed on the lower edge of the opening.

[0043] Preferably, the cutting plane (for producing this oval opening) has an inclination to the longitudinal axis of rotation of the sample receiving device of 25-65°, particularly preferably 30-60°, in particular 35-45°.

[0044] Versions with an oval opening are particularly preferred.

[0045] In a likewise preferred embodiment of the invention, the set according to the invention (or even the test cassette) comprises a test strip that has the bend according to the invention and is thus held in the test cassette while being bent in such a way that it lies lower in the sample receiving area below the receptacle in the test cassette than in the test area. The decisive factors for the bend are the first, high support in the test area and the second, low support in the sample receiving area.

[0046] In a preferred embodiment of the invention, the plug connection of the test cassette is designed as a female plug connection and the counterpart on the sample collection device is designed as a male plug connection (the male plug connection fits exactly into the female one, ie there is a positive contact, whereby rotation along the longitudinal axis of the sample collection device remains possible).

[0047] "Female connector" within the meaning of the invention means a receptacle (e.g., a bulge) pointing inwards (i.e., toward the interior of the test cassette (downward during use). Accordingly, "male connector" means a protrusion of the sample collection device, whereby, during use, this protrusion can be positively but detachably or irremovably inserted into the female receptacle. Non-detachable includes, for example, a design in which clips prevent spontaneous detachment. This is practical in the present case, since the set according to the invention is suitable for single use.

[0048] In a preferred embodiment of the invention, both correspond to the Luer-Lock system, ie both the plug connection of the test cassette and the counterpart on the sample collection device are designed as a Luer-Lock plug connection.

[0049] The Luer-Lock system is a standardized, state-of-the-art connection system for infusions and injections in the medical field. The seal is achieved by a precisely fitting, truncated cone-shaped design of both connecting parts, which are designed to fit tightly together. The truncated cone shape is referred to as the Luer cone.

[0050] Preferably, both connectors (male and female) have locking means, such as a spiral and a beaded edge on the counterpart in the case of Luer-Lock.

[0051] Particularly preferably, the female plug connection has an inner diameter of >4mm so that the test strip in a common dimension is completely covered by the opening which the female plug connection opens up.

[0052] In a likewise preferred embodiment of the invention, the first, high support for the test strip in the test area is 2-5 mm (particularly preferably 3-4 mm, or even 4-5 mm) higher than the second, deep support in the sample receiving area (or more precisely the upper end points of the supports that touch the test strip from below). The resulting degree of bending of the test strip is particularly well suited to, on the one hand, preventing flooding of the test strip from all sides when the interior of the test cassette is flooded, but on the other hand, also allowing the sample to flow upwards in the test strip without any problems, as the capillary forces are just sufficient. The thickness of the test cassette with this selected range is still practical and easy to handle on an industrial scale.

[0053] It is also preferred if, in the sample intake area of ​​the test cassette, a reservoir with outwardly tapered side walls is present next to the plug connection. The advantage of this is that as soon as an inserted test strip is completely wetted with liquid (i.e., so that the intake area of ​​the test strip is saturated), excess liquid can enter the reservoir. The capillary effect created by the conical shape of the reservoir (compared to, for example, a rectangular reservoir) ensures that excess liquid does not spread uncontrollably anywhere in the test cassette, but is drawn into the reservoir in a targeted manner due to the capillary effect created by the conical taper.Particularly advantageous is an angle of 92-105°, particularly preferably 94-100°, in particular also 96±2°, between the two outwardly conically tapering side walls and the adjacent longitudinal wall (these are the two longer sides of a rectangle) of the housing.

[0054] In any case, the reservoir sensibly has access to the interior of the test cassette so that liquid from the interior (especially from the sample collection area) can be drawn into the reservoir by means of capillary forces.

[0055] The reservoir preferably extends across the entire width of the test cassette. The side walls of the reservoir are preferably made of the same material as the test cassette.

[0056] In a likewise preferred embodiment of the invention, the sample collection device is an injection-molded part, i.e., it is cast in one piece (only a frit or film may be made of a different material). This means that in this embodiment, the sample collection device is a single piece and can therefore be easily manufactured. A capillary, which may be present, is particularly preferably made of the same material as the sample collection device itself, so that it can also be manufactured with the capillary by injection molding.

[0057] According to the invention, the sample receiving device comprises a capillary or a frit or a foil with at least two lugs at the lower end in the region of the counterpart of the plug connection.

[0058] A set according to the invention with at least two such differently designed sample collection devices is also advantageous, so that this set can be used universally. Capillary:

[0059] A capillary is suitable for samples with a small amount of liquid, such as a drop of blood, which is collected from below into the sample collection device via the capillary. This drop is later significantly diluted during use, i.e., when the liquid from the upper part of the sample collection device passes through the filled capillary. Frit:

[0060] A "frit" in the sense of the invention is a porous or filamentous material in which capillary forces can act on a liquid and absorb the liquid spontaneously due to capillary forces. It is preferably a material that is less than 65 vol% compressible, particularly preferably less than 60 vol%; in particular even less than 10 vol%, such as glass, plastic, or ceramic ("less than 65 vol% compressible" means that the so-called "void volume" is less than 65 vol%). It is also possible for the material to be 40-65 vol% compressible. A frit is suitable for larger volumes than a capillary. Advantageously, a reactant for the sample can already be contained or immobilized in the frit. For example, the pH of the sample can also be adjusted or changed in this way. By functionalizing the frit, it is possible to filter out individual substances (e.g. red blood cells) from the sample.Functionalization of the frit to make it hydrophilic is also possible. Foil with at least two noses:

[0061] In the initial state in the set according to the invention, in this preferred embodiment, the film would seal the sample collection device at the bottom. The tabs protrude outwards and downwards. When the sample collection device and test cassette are put together, the tabs break into the interior of the sample collection device and pierce the film. The liquid inside the sample collection device can then escape to the outside and flow downwards into the test cassette. This embodiment with film and tabs is suitable for SWAP tests, in which a swab is first filled into the sample collection device, then a process liquid is added from above, and only then, after homogeneous mixing, is the resulting mixture allowed to reach the test strip in the test cassette.

[0062] The advantage of designs with a frit or capillary is that it only absorbs a specific and constant volume (when the sample is taken up via the frit or capillary by placing or dipping the end with the frit / capillary onto the sample). Any further sample absorption does not occur, as absorption occurs solely through capillary forces within the frit / capillary. Therefore, a design with a frit or capillary is particularly preferred.

[0063] A further advantage of a frit, i.e. a filter material, is that it allows large volumes of liquid to be sucked up homogeneously and bubble-free from below into the sample aspiration device and then applied downwards onto the test cassette. The advantage of the lack of negative pressure inside the sample aspiration device when taking in the sample is that it allows slow and therefore bubble-free aspiration. This slow and controlled aspiration is made possible by the capillary forces with the inventive opening of the sample aspiration device at the top (pressure equalization). With state-of-the-art sample aspiration devices (also called sampling tools), uncontrolled flow behavior inevitably occurs with larger volumes (from approx. 100 µL), which means that a constant volume does not reach the test strip.

[0064] In particular, when the application is interrupted (by applying pressure to the test strip), uncontrolled flow behavior inevitably occurs.

[0065] The frit advantageously absorbs itself. Materials suitable for such a frit are known to those skilled in the art. In a particularly preferred variant of the capillary design, the capillary has an internal volume of 1-15µL, meaning it can accommodate samples of this volume.

[0066] The frit is preferably 5 mm high (±1 mm, preferably ±0.3 mm) and has a 5 mm diameter (±1 mm, preferably ±0.3 mm). This most preferably corresponds to a volume of 0.098 cm3, i.e., 98 µL.

[0067] In a likewise preferred variant of an embodiment with a frit, this has a volume of 50-100µL.

[0068] In a preferred variant of the design with foil and tabs (the tabs are preferably protruding outwards), there are 3 or even 5 tabs. The tabs are designed in such a way that when inserted into the test cassette they bend inwards and upwards so that they pierce a sensitive base above them (preferably made of plastic or aluminum foil), allowing any liquid above them to pass through downwards. It is possible to provide predetermined breaking points on the tabs to enable controlled buckling. This is because the bent tabs can, for example, push through slits above or below (preferably above) the foil, so that the area of ​​the foil pierced by the tabs is always the same, allowing the subsequent passage of liquid in a controlled manner and in a reproducible amount.This means that slits are preferably located above the tabs and above the film in the wall material of the sample collection device. These slits are adapted to the shape of the tabs so that when bent, the tabs only pierce the film in the area of ​​the slits. Advantageously, the destroyed film area is always reproducibly consistent, and thus the leakage behavior is reproducible and consistent.

[0069] In a preferred embodiment of the invention, in the case of a previously mentioned variant with a capillary, this is made of plastic and / or in the case of a frit, this is made of sintered polyethylene (PE), preferably hydrophilized PE frits.

[0070] In a further preferred variant of an embodiment with a frit, a base is provided directly above the frit, which is designed on the underside (i.e. between the frit and the base) in such a way that a homogeneous and large-area wetting of the frit is possible, for example by a spiral or star-shaped depression with at least one hole in the middle of the spiral or the star (as exemplified for the spiral shape in Fig. 6 shown).

[0071] The advantage of this is that the liquid from the sample collection device can pass through the hole and then flow along the spiral or star-shaped groove (i.e., an upward-facing depression), wetting the frit as extensively and evenly as possible, creating a virtually bubble-free "running front" at the top of the frit. This advantageously prevents the frit from forming an oblique liquid front with only spot wetting, which would trap air bubbles as it flows.

[0072] Furthermore, this ensures that the sample in the frit is mixed evenly with the process liquid (e.g. buffer) located in the upper part of the sample holder.

[0073] In a likewise preferred embodiment of the invention, the test cassette has a reading opening opposite each other on the top and bottom sides in the test area, which advantageously enables automatic detection by means of transmitted light measurement.

[0074] It is also preferred if the test cassette has a housing that is closed off by its two smallest surfaces. This prevents the test cassette from leaking out of the sides, which would make it cumbersome and complicated to use. The two smallest surfaces within the meaning of the invention refer to the two end faces of the naturally elongated, rectangular test cassette.

[0075] In a preferred embodiment, the sample collection device has a minimum length of 3 cm, in particular it can preferably be 3-5 cm long.

[0076] In a preferred embodiment, the sample receiving device is tubular.

[0077] In a preferred embodiment of the invention, the sample collection device and / or the test cassette is made of ABS plastic (acrylonitrile butadiene styrene).

[0078] Fig. 1 shows a schematic of the chromatographic rapid test set with the sample collection device inserted into the test cassette, whereby process liquids can be added through the filling area of ​​the sample collection device, which rinse the sample downwards into the test cassette.

[0079] Fig. 2 shows a preferred embodiment with a frit at the lower end of the sample collection device, in which the sample is taken up solely by capillary forces, so that squeezing the sample collection device and subsequent suction by means of negative pressure is not necessary - an opening at the upper end is provided.

[0080] The Fig. 3a - 3cshow (in part) a preferred embodiment of the invention, in which the test cassette has two reading openings. The test strip curved according to the invention is visible. This embodiment also has a reservoir with outwardly tapered side walls on the reservoir for absorbing excess fluid through capillary action.

[0081] Fig. 4 shows schematically the set according to the invention in a preferred embodiment with filling area with opening on the sample receiving device-

[0082] The Fig. 5 shows three different designs of the lower end of the sample collection device for holding the sample (left a): frit with base above it, middle b): foil with lugs underneath to break through the foil in use, right c): capillary).

[0083] Fig. 6shows (left: from the side; right: looking from below above the frit) for the preferred version of the sample holder with frit the area above the frit with a spiral-shaped recess and a hole for the homogeneous application of liquids to the frit, e.g. of process liquids to the frit saturated with the sample to be examined.

[0084] A preferred version of the sample collection device with capillary is in Fig. 7 shown.

[0085] The version with foil and noses is in Fig. 8 When the sample collection device and test cassette are connected, the tabs break inward and break through the foil, allowing a liquid inside the sample collection device to flow downward into the test cassette. This design is particularly suitable for SWAP tests.

[0086] For the realization of the invention, it is also expedient to combine the above-described inventive embodiments, embodiments and features of the claims.

[0087] The invention will be explained in more detail below using exemplary embodiments. The exemplary embodiment is intended to describe the invention without limiting it. Examples of implementation

[0088] An example with a frit at the lower end of the sample holder is shown in Fig. 2 The sample is taken up by capillary forces alone, eliminating the need to compress the sample collection device and then suck it up using negative pressure. An opening at the top is provided.

[0089] An example of an embodiment with two reading openings for transmitted light evaluations located on opposite sides of the test cassette is shown (in part) in the Fig. 3a - 3cThis design also has a reservoir with outwardly tapered side walls on the reservoir to absorb excess fluid through capillary action.

[0090] All examples have a filling area on the sample holder with an opening, such as in Fig. 4 shown.

[0091] Three different embodiments according to Fig. 5 are described with a frit, a foil with three tabs, or a capillary. The frit embodiment also has a spiral-shaped depression with a hole above it, as in Fig. 6 shown.

[0092] In all examples, both the test cassette and the sample collection device are made of ABS (acrylonitrile butadiene styrene). Only the foil in the example with foil and tabs is aluminum foil, and the frit in the example with frit is made of sintered polyethylene.

[0093] The test strip is made of nitrocellulose. Reference symbol

[0094] 1Test cassette 100Test area (for chromatography) 101Sample area (for receiving the sample) 102Plug connection (as a holder for the sample collection device) 103First, high support (for the test strip) 104Second, low support (for the test strip) 105Test strip 106Reservoir 107Outwardly tapered side walls 108Reading opening (of the test cassette) 109Both smallest surfaces of the housing 2Sample intake device 200Counterpart of the plug connection 201Filling area with one opening 202Capillary 203Frit 204Foil 205Lubricants 206Bottom (above the frit) 207Recess (of the bottom) 208Hole (of the bottom above the frit) 3Sample

Claims

1. Chromatographic rapid test kit for the analysis of a sample, comprising • a test cassette (1) comprising a test area (100) for chromatography and a sample receiving area (101) for receiving the sample (3), and • a sample receiving device (2) with an upper and lower end, wherein the test cassette (1) has a plug connection (102) in the sample receiving area (101) as a receptacle for the sample receiving device and this sample receiving device (2) has the counterpart (200) of this plug connection at the lower end, wherein in the test cassette (1) the test area (100) has a first, high support (103) and the sample receiving area (101) has a second, low support (104) for inserting a test strip (105), the second support (104) being lower than the first support (103) so that the inserted test strip (105) is bent and the sample (3) must flow upwards after insertion of the sample receiving device (2), and wherein the sample receiving device (2) has at the upper end a filling area (201) for receiving a process liquid with an opening of at least 5 mm diameter, characterized in that the sample receiving device (2) comprises at the lower end in the area of the counterpart (200) of the plug connection a capillary (202) or a frit (203) or a foil with at least two lugs (205), wherein the lugs protrude outwardly and downwardly and when the sample receiving device and test cassette (1) are plugged together, the lugs break into the interior of the sample receiving device (2) and pierce the foil.

2. Kit according to claim 1, comprising a test strip (105) which is held in the test cassette under bending such that it lies in the sample receiving area (101) below the receptacle in the test cassette (1) lower than in the test area (100).

3. Kit according to one of the claims 1 or 2, wherein the plug connection (102) of the test cassette is designed as a female plug connection and the counterpart (200) on the sample receiving device is designed as a male plug connection.

4. Kit according to one of the claims 1 to 3, wherein the plug connection (102) of the test cassette and the counterpart (200) on the sample receiving device is designed as a Luer-Lock-plug connection.

5. Kit according to one of the claims 1 to 4, wherein the first, high support (103) for the test strip (105) in the test area is 3-4 mm higher than the second, low support (104) in the sample receiving area.

6. Kit according to one of the claims 1 to 5, wherein in the sample receiving area (101) of the test cassette, next to the plug connection (102), there is a reservoir (106) with outwardly conically tapering side walls (107).

7. Kit according to one of the claims 1 to 6, wherein the sample receiving device (2) is an injection-molded part.

8. Kit according to one of the claims 1 to 7, wherein in the case of the capillary (202) this is made of plastic and / or in the case of the frit (203) this is made of sintered polyethylene.

9. Kit according to one of the claims 1 to 8, wherein in the case of the frit (203), a bottom (206) is provided directly above the frit, which has a spiral-shaped or star-shaped deepening (207) on the bottom with at least one hole (208) in the center of the spiral or star.

10. Kit according to one of the claims 1 to 9, wherein the test cassette (1) in the test area (100) has a reading opening (108) on the top and bottom opposite each other, which enables automatic detection by means of transmitted light measurement.

11. Kit according to one of the claims 1 to 10, wherein the test cassette (1) has a housing, closed at the two smallest surfaces (109).

12. Use of a chromatographic rapid test kit according to one of the claims 1 to 11 for the detection of pathogens selected from viruses, bacteria, fungi and parasites, of biomolecules, of biomarkers or of chemical substances, in each case in a sample (3).

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