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EP4446007B1 - Trousse chromatographique de test rapide pour l'analyse d'un echantillon vis-a-vis de molecules pathogenes, de biomolecules, de biomarqueurs et de substances chimiques - Google Patents

Trousse chromatographique de test rapide pour l'analyse d'un echantillon vis-a-vis de molecules pathogenes, de biomolecules, de biomarqueurs et de substances chimiques

Info

Publication number
EP4446007B1
EP4446007B1 EP23167713.9A EP23167713A EP4446007B1 EP 4446007 B1 EP4446007 B1 EP 4446007B1 EP 23167713 A EP23167713 A EP 23167713A EP 4446007 B1 EP4446007 B1 EP 4446007B1
Authority
EP
European Patent Office
Prior art keywords
test
sample
sample receiving
area
kit according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP23167713.9A
Other languages
German (de)
English (en)
Other versions
EP4446007C0 (fr
EP4446007A1 (fr
Inventor
Hans Hermann SÖFFING
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vellap Diagnostics GmbH
Original Assignee
Vellap Diagnostics GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vellap Diagnostics GmbH filed Critical Vellap Diagnostics GmbH
Priority to EP23167713.9A priority Critical patent/EP4446007B1/fr
Priority to PCT/EP2024/060055 priority patent/WO2024213753A1/fr
Publication of EP4446007A1 publication Critical patent/EP4446007A1/fr
Application granted granted Critical
Publication of EP4446007C0 publication Critical patent/EP4446007C0/fr
Publication of EP4446007B1 publication Critical patent/EP4446007B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces

Definitions

  • the invention relates to a chromatographic rapid test kit for examining a sample, such as blood, using the so-called lateral flow assay principle.
  • Lateral flow assay also called lateral flow test
  • lateral flow test is a long-established laboratory procedure 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 8,399,261 B2 or US 6,372,516 B1 .
  • This type of immunochromatography is a variant of affinity chromatography based on antigen-antibody reactions.
  • Photo-based methods have been established for detection, for example by simple reading.
  • a disposable cuvette 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 surface of the matrix, and the analysis is performed by quantitatively detecting the transmitted light.
  • test kits widely used rapid coronavirus test kits feature a test cassette with a field for applying a sample solution. Often, too much solution is applied to the test strip, which, in the worst case, floods the planar test strip from all sides. This means that the test can no longer be used for reliable determination and must be discarded unused, or it may produce erroneous results. Furthermore, air bubbles are often trapped in the applied liquid, which also leads to incorrect tests. Applying too small a sample volume also leads to inaccurate results and reduced analytical performance.
  • 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.
  • the printed matter WO 00/72012 A2 Describes a device with 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 so that the sample can only flow out and wet a test strip in the test cassette when the sample container is screwed in.
  • test device with a porous but non-absorbent test substrate is known from EP 296 724 A2 known.
  • connection systems 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.
  • a Luer-Lock connector for connecting an elongated sample collector with a flexible sponge at the lower end.
  • the sample collector has a handle at one end and, at the other, lower end, a sponge 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 out the The sponge is removed by rotating the elongated sample collector.
  • the disadvantage is that the test device must be held firmly, or a holder is required. 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 carefully dropping the rinsing solution into the opening of the test device is not suitable for use by laypersons.
  • US 2005/0180882 A1 describes the sample application by wringing out a sample applicator to apply the solution to a planar test strip.
  • a downward flowing test device is also known, for example from US 2011/0256638 A1 .
  • the object of the invention is to overcome the disadvantages mentioned in the prior art.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • the test strip is pressed down by the plug connection (which acts as a holder for the sample intake device).
  • 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 prongs).
  • 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 typical runtime, the result can be read.
  • the plug-in connection between the sample collection device and the test cassette ensures a clean transfer of the liquids from the sample collection device into the test cassette, whereby the invention ensures that a constant volume is always applied. It is advantageously excluded that the solutions do not reach the The test strip can be used to target the intended area. Patients can operate the test strip themselves.
  • test cassette can be placed on a table and does not necessarily have to be lifted for reading.
  • the device can easily accommodate slight horizontal movements and does not need to be held in place.
  • 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.
  • process fluids/rinsing fluids such as a running buffer or lysis buffer
  • 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.
  • test strip cannot become “flooded”.
  • 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, i.e. when the sample collection device and test cassette are plugged together).
  • 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.
  • the sample to be examined is a biological sample selected from blood, urine, sweat and a stool sample, particularly preferably blood.
  • the opening in the filling area of the sample collection device is preferably one with a diameter of 5-10 mm.
  • 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.
  • 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.
  • 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°.
  • Versions with an oval opening are particularly preferred.
  • the set according to the invention (or already the test cassette) comprises a test strip which has the bend according to the invention and is therefore 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 bending is determined by the first, high support in the test area and the second, low support in the sample receiving area.
  • 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, i.e. there is a positive contact, whereby rotation along the longitudinal axis of the sample collection device remains possible).
  • female connector in the sense of the invention means a receptacle (e.g., a bulge) pointing inward (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 permanently 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.
  • both correspond to the Luer-Lock system, i.e. both the plug connection of the test cassette and the counterpart on the sample collection device are designed as a Luer-Lock plug connection.
  • 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.
  • both connectors male and female
  • locking means such as a spiral and a beaded edge on the counterpart in the case of Luer-Lock.
  • 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.
  • 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, low 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 prevent flooding of the test strip from all sides when the interior of the test cassette is flooded, while at the same time still allowing the sample to flow smoothly upwards in the test strip by ensuring that the capillary forces are just sufficient.
  • the thickness of the test cassette is still practical and easy to handle on an industrial scale with this selected range.
  • a reservoir with outwardly tapered side walls is present next to the plug connection.
  • This has the advantage 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 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 action created by the conical taper.
  • An angle of 92-105°, particularly preferably 94-100°, and in particular 96 ⁇ 2°, between the two outwardly tapered side walls and the adjacent longitudinal wall (the two longer sides of a rectangle) of the housing is particularly advantageous.
  • 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.
  • 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.
  • the sample collection device is an injection-molded part, i.e., it is cast in one piece (only a frit or film can be made of a different material).
  • 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.
  • 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.
  • 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.
  • a capillary is suitable for samples with a small amount of liquid, such as a drop of blood, which is drawn into the sample collection device from below 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.
  • 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.
  • 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.
  • the film would seal the sample collection device at the bottom.
  • the tabs protrude outwards and downwards.
  • 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.
  • a frit i.e. a filter material
  • a frit allows large volumes of liquid to be drawn 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 during sample collection is that slow and therefore bubble-free aspiration is possible. 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).
  • state-of-the-art sample aspiration devices also called sampling tools
  • uncontrolled flow behavior inevitably occurs with larger volumes (from approximately 100 ⁇ L), which means that a constant volume does not reach the test strip.
  • the frit advantageously absorbs itself.
  • the materials suitable for such a frit are known to the expert
  • the capillary has an internal volume of 1-15 ⁇ L, i.e. samples of this volume can be taken.
  • 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 ⁇ L.
  • this has a volume of 50-100 ⁇ L.
  • the tabs are preferably protruding 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 (preferably made of plastic or aluminum foil) above them, allowing a liquid located above them to pass through downwards. It is possible to provide predetermined breaking points on the tabs to enable controlled folding. 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, so that the subsequent liquid passage can take place in a controlled and reproducible amount.
  • the sample collection device has slots that are adapted to the shape of the tabs so that when bent, the tabs only pierce the film in the area of the slots.
  • the destroyed film area is always reproducible and consistent, thus ensuring consistent and reproducible discharge behavior.
  • this is made of plastic and/or in the case of a frit, this is made of sintered polyethylene (PE), preferably hydrophilized PE frits.
  • PE sintered polyethylene
  • 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).
  • 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.
  • 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.
  • 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.
  • the sample collection device has a minimum length of 3 cm, in particular it can preferably be 3-5 cm long.
  • the sample receiving device is tubular.
  • the sample collection device and/or the test cassette is made of ABS plastic (acrylonitrile butadiene styrene).
  • 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.
  • 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.
  • the Fig. 3a - 3c show (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.
  • Fig. 4 shows schematically the set according to the invention in a preferred embodiment with filling area with opening on the sample receiving device-
  • 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).
  • Fig. 6 shows (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.
  • FIG. 7 A preferred version of the sample collection device with capillary is in Fig. 7 shown.
  • FIG. 2 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.
  • FIG. 3a - 3c 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 - 3c
  • This design also has a reservoir with outwardly tapered side walls on the reservoir to absorb excess fluid through capillary action.
  • All examples have a filling area on the sample holder with an opening, such as in Fig. 4 shown.
  • Fig. 5 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.
  • both the test cassette and the sample collection device are made of ABS (acrylonitrile butadiene styrene).
  • 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.
  • the test strip is made of nitrocellulose.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Claims (12)

  1. Kit de test rapide chromatographique pour l'analyse d'un échantillon, comprenant
    • une cartouche de test (1) comprenant une zone de test (100) pour la chromatographie et une zone de réception d'échantillon (101) pour la réception de l'échantillon (3), et
    • un appareil de réception d'échantillon (2) comportant une extrémité supérieure et une extrémité inférieure,
    dans lequel la cartouche de test (1) présente dans la zone de réception d'échantillon (101) un connecteur à fiche (102) sous forme de logement pour l'appareil de réception d'échantillon et ledit appareil de réception d'échantillon (2) présente, au niveau de l'extrémité inférieure, la contre-pièce (200) dudit connecteur à fiche,
    dans lequel, dans la cartouche de test (1), la zone de test (100) possède un premier appui haut (103) et la zone de réception d'échantillon (101) possède un second appui bas (104) pour l'insertion d'une bande de test (105), dans lequel le second appui (104) est plus bas que le premier appui (103), de sorte que la bande de test (105) insérée est courbée et que l'échantillon (3) doit s'écouler vers le haut après l'enfichage de l'appareil de réception d'échantillon (2), et
    dans lequel l'appareil de réception d'échantillon (2) présente au niveau de l'extrémité supérieure une zone de remplissage (201) pour la réception d'un liquide de processus comportant une ouverture d'au moins 5 mm de diamètre, caractérisé en ce que l'appareil de réception d'échantillon (2) comprend, au niveau de l'extrémité inférieure, dans la zone de la contre-pièce (200) du connecteur à fiche, un capillaire (202) ou une fritte (203) ou une feuille comportant au moins deux ergots (205), dans lequel les ergots font saillie vers l'extérieur et vers le bas et, lors de l'enfichage commun de l'appareil de réception d'échantillon et de la cartouche de test (1), les ergots se brisent à l'intérieur de l'appareil de réception d'échantillon (2) et percent ainsi la feuille.
  2. Kit selon la revendication 1, comprenant une bande de test (105) qui est maintenue pliée dans la cartouche de test de sorte qu'elle se trouve plus bas dans la zone de réception d'échantillon (101) en dessous du logement dans la cartouche de test (1) que dans la zone de test (100).
  3. Kit selon l'une des revendications 1 ou 2, dans lequel le connecteur à fiche (102) de la cartouche de test est conçu sous forme de connecteur à fiche femelle et la contre-pièce (200) sur l'appareil de réception d'échantillon est conçue sous forme de connecteur à fiche mâle.
  4. Kit selon l'une des revendications 1 à 3, dans lequel le connecteur à fiche (102) de la cartouche de test et la contre-pièce (200) sur l'appareil de réception d'échantillon sont conçus sous forme de raccords Luer Lock.
  5. Kit selon l'une des revendications 1 à 4, dans lequel le premier appui haut (103) pour la bande de test (105) dans la zone de test est situé 3 à 4 mm plus haut que le second appui bas (104) dans la zone de réception d'échantillon.
  6. Kit selon l'une des revendications 1 à 5, dans lequel est présent, dans la zone de réception d'échantillon (101) de la cartouche de test, outre le connecteur à fiche (102), un réservoir (106) comportant des parois latérales (107) se rétrécissant vers l'extérieur de manière conique.
  7. Kit selon l'une des revendications 1 à 6, dans lequel l'appareil de réception d'échantillon (2) est une pièce moulée par injection.
  8. Kit selon l'une des revendications 1 à 7, dans lequel, dans le cas du capillaire (202), celui-ci est en matière plastique et/ou, dans le cas de la fritte (203), celle-ci est en polyéthylène fritté.
  9. Kit selon l'une des revendications 1 à 8, dans lequel, dans le cas de la fritte (203), un fond (206) est présent immédiatement au-dessus de la fritte, lequel fond présente sur le côté inférieur une cavité (207) en forme de spirale ou d'étoile comportant au moins un trou (208) au centre de la spirale ou de l'étoile.
  10. Kit selon l'une des revendications 1 à 9, dans lequel la cartouche de test (1) présente dans la zone de test (100), sur les côtés supérieur et inférieur opposés, respectivement une ouverture de lecture (108) qui permet une détection automatique au moyen d'une mesure de lumière transmise.
  11. Kit selon l'une des revendications 1 à 10, dans lequel la cartouche de test (1) présente un boîtier fermé vers les deux plus petites surfaces (109).
  12. Utilisation d'un kit de test rapide chromatographique selon l'une des revendications 1 à 11 pour la détection d'agents pathogènes choisis parmi virus, bactéries, champignons et parasites, de biomolécules, de biomarqueurs ou de substances chimiques, respectivement dans un échantillon (3).
EP23167713.9A 2023-04-13 2023-04-13 Trousse chromatographique de test rapide pour l'analyse d'un echantillon vis-a-vis de molecules pathogenes, de biomolecules, de biomarqueurs et de substances chimiques Active EP4446007B1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP23167713.9A EP4446007B1 (fr) 2023-04-13 2023-04-13 Trousse chromatographique de test rapide pour l'analyse d'un echantillon vis-a-vis de molecules pathogenes, de biomolecules, de biomarqueurs et de substances chimiques
PCT/EP2024/060055 WO2024213753A1 (fr) 2023-04-13 2024-04-12 Ensemble de test rapide chromatographique pour analyser un échantillon à la recherche d'agents pathogènes, de biomolécules, de biomarqueurs et de substances chimiques

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP23167713.9A EP4446007B1 (fr) 2023-04-13 2023-04-13 Trousse chromatographique de test rapide pour l'analyse d'un echantillon vis-a-vis de molecules pathogenes, de biomolecules, de biomarqueurs et de substances chimiques

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EP4446007C0 EP4446007C0 (fr) 2025-09-10
EP4446007B1 true EP4446007B1 (fr) 2025-09-10

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Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1313616C (fr) * 1987-06-01 1993-02-16 Robert B. Sargeant Protocoles avec membranes non absorbantes a ecoulement lateral
WO2000072012A2 (fr) * 1999-05-24 2000-11-30 Abbott Laboratories Appareil de pretraitement d'un echantillon contenant un analysat
US6372516B1 (en) 2000-09-07 2002-04-16 Sun Biomedical Laboratories, Inc. Lateral flow test device
US7879293B2 (en) 2001-09-28 2011-02-01 Orasure Technologies, Inc. Sample collector and test device
CA2545125A1 (fr) 2003-11-14 2005-06-02 Oakville Hong Kong Co., Limited Dispositif de prelevement et d'analyse rapide d'echantillons et procedes d'utilisation
DE102004006470B4 (de) 2004-02-06 2006-06-01 Senova Gesellschaft für Biowissenschaft und Technik mbH Absorptionsphotometrisches Verfahren zur quantitativen Stoffanalyse
US7888130B2 (en) * 2006-01-03 2011-02-15 Dräger Safety AG & Co. KGaA Test cassette for fluid analyses
DE102007025311A1 (de) 2007-05-30 2008-12-04 Senova Gesellschaft für Biowissenschaft und Technik mbH Quantitativer heterogener schneller Bindungsassay mit breitem dynamischen Bereich und einfacher photometrischer Detektion
CA2690904C (fr) 2007-06-27 2015-11-03 Inbios International, Inc. Systeme d'analyse a flux lateral et procedes pour son utilisation
CA2740902C (fr) 2008-10-17 2016-10-04 Medmira Inc. Dispositif de diagnostic a ecoulement vers le bas ou vertical et analyse
WO2016027782A1 (fr) * 2014-08-20 2016-02-25 株式会社シン・コーポレイション Appareil d'examen

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EP4446007A1 (fr) 2024-10-16
WO2024213753A1 (fr) 2024-10-17

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