FR3121515A1 - Device for the rapid analysis of a biological sample, for example a salivary biological sample - Google Patents
Device for the rapid analysis of a biological sample, for example a salivary biological sample Download PDFInfo
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- FR3121515A1 FR3121515A1 FR2108249A FR2108249A FR3121515A1 FR 3121515 A1 FR3121515 A1 FR 3121515A1 FR 2108249 A FR2108249 A FR 2108249A FR 2108249 A FR2108249 A FR 2108249A FR 3121515 A1 FR3121515 A1 FR 3121515A1
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- 239000012472 biological sample Substances 0.000 title claims abstract description 45
- 238000005070 sampling Methods 0.000 claims abstract description 25
- 239000002250 absorbent Substances 0.000 claims abstract description 24
- 230000002745 absorbent Effects 0.000 claims abstract description 24
- 239000012491 analyte Substances 0.000 claims abstract description 8
- 230000006835 compression Effects 0.000 claims abstract description 4
- 238000007906 compression Methods 0.000 claims abstract description 4
- 238000001514 detection method Methods 0.000 claims abstract description 4
- 239000003153 chemical reaction reagent Substances 0.000 claims description 8
- 239000000523 sample Substances 0.000 claims description 5
- 230000000295 complement effect Effects 0.000 claims description 4
- 238000000605 extraction Methods 0.000 claims description 4
- 230000001900 immune effect Effects 0.000 claims description 4
- 238000013508 migration Methods 0.000 claims description 4
- 230000005012 migration Effects 0.000 claims description 4
- 239000000126 substance Substances 0.000 claims description 4
- 238000004891 communication Methods 0.000 claims description 2
- 239000012530 fluid Substances 0.000 claims description 2
- 238000013519 translation Methods 0.000 claims description 2
- 238000011144 upstream manufacturing Methods 0.000 claims description 2
- 210000003296 saliva Anatomy 0.000 claims 1
- 238000007789 sealing Methods 0.000 claims 1
- 238000012360 testing method Methods 0.000 description 3
- 238000011109 contamination Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 238000013459 approach Methods 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000003317 immunochromatography Methods 0.000 description 1
- 238000012125 lateral flow test Methods 0.000 description 1
- 238000012124 rapid diagnostic test Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
-
- 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
- B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
- B01L3/50273—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the means or forces applied to move the fluids
-
- 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
- B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B2010/0003—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person
- A61B2010/0006—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person involving a colour change
-
- 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
- B01L2200/027—Fluid interfacing between devices or objects, e.g. connectors, inlet details for microfluidic devices
-
- 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
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/069—Absorbents; Gels to retain a fluid
-
- 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54386—Analytical elements
- G01N33/54387—Immunochromatographic test strips
- G01N33/54388—Immunochromatographic test strips based on lateral flow
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Analytical Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Clinical Laboratory Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Pathology (AREA)
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- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Dispersion Chemistry (AREA)
- Medical Informatics (AREA)
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- Investigating Or Analysing Biological Materials (AREA)
Abstract
La présente invention concerne un dispositif pour l’analyse rapide d’un échantillon biologique, par exemple un échantillon biologique salivaire, destiné à la détection de la présence d’au moins un analyte dans ledit échantillon biologique. Le dispositif d’analyse rapide (1) comprend : - un organe de prélèvement (2), destiné au prélèvement dudit échantillon biologique, et - un boîtier (3) qui comporte un emplacement (31) destiné à recevoir une bandelette chromatographique (7) et une interface (32), adaptée à recevoir ledit organe de prélèvement (2) dans une configuration finale assemblée. L’organe de prélèvement (2) et l’interface (32) comportent des moyens d’assemblage étanche (5) comprenant des moyens de guidage (6) qui sont structurés pour guider un mouvement relatif entre ledit organe de prélèvement (2) et ladite interface (32) depuis une configuration initiale de positionnement jusqu’à la configuration finale assemblée, ledit mouvement relatif comprenant deux mouvements : - un mouvement de translation relatif, prévu pour appliquer une compression audit bloc absorbant (21), et - un mouvement de rotation relatif, prévu pour appliquer une torsion audit bloc absorbant (21). Figure pour l’abrégé : 1The present invention relates to a device for the rapid analysis of a biological sample, for example a salivary biological sample, intended for the detection of the presence of at least one analyte in said biological sample. The rapid analysis device (1) comprises: - a sampling device (2), intended for the sampling of said biological sample, and - a housing (3) which comprises a location (31) intended to receive a chromatographic strip (7) and an interface (32), adapted to receive said sampling member (2) in a final assembled configuration. The pick-up member (2) and the interface (32) comprise leaktight assembly means (5) comprising guide means (6) which are structured to guide relative movement between said pick-up member (2) and said interface (32) from an initial positioning configuration to the final assembled configuration, said relative movement comprising two movements: - a relative translational movement, intended to apply compression to said absorbent block (21), and - a movement of relative rotation, intended to apply a twist to said absorbent block (21). Figure for abstract: 1
Description
Domaine technique de l'inventionTechnical field of the invention
La présente invention concerne le domaine technique des dispositifs pour l’analyse rapide d’un échantillon biologique, par exemple un échantillon biologique salivaire.The present invention relates to the technical field of devices for the rapid analysis of a biological sample, for example a salivary biological sample.
Etat de la techniqueState of the art
Un test de diagnostic rapide, dit « test de dépistage rapide », est un test qui permet d'établir rapidement (en quelques minutes) la présence d’au moins un analyte d’intérêt dans un échantillon biologique.A rapid diagnostic test, known as a "rapid screening test", is a test that quickly establishes (in a few minutes) the presence of at least one analyte of interest in a biological sample.
Cette approche utilise classiquement les phénomènes de réactions chimiques par immunochromatographie sur bandelettes (dit encore «lateral flow test») qui font apparaître une coloration particulière permettant d'interpréter immédiatement le résultat.This approach conventionally uses the phenomena of chemical reactions by immunochromatography on strips (also called “ lateral flow test ”) which reveal a particular coloration allowing the result to be interpreted immediately.
Cette technique a l’intérêt d’être simple, rapide et peu coûteuse. De tels tests sont en plus utilisables au cabinet du médecin mais aussi au chevet du patient ou sur le terrain.This technique has the advantage of being simple, fast and inexpensive. Such tests can also be used in the doctor's office, but also at the patient's bedside or in the field.
Certaines techniques de prélèvement obligent plusieurs manipulations pour transférer l’échantillon biologique depuis un dispositif de prélèvement jusqu’à la bandelette. C’est par exemple le cas des échantillons biologiques salivaires.Some sampling techniques require several manipulations to transfer the biological sample from a sampling device to the strip. This is for example the case of salivary biological samples.
Or, il est toujours intéressant de proposer des solutions qui permettent l’analyse d’un échantillon biologique directement depuis le dispositif de prélèvement, notamment afin de limiter les manipulations et les risque de contamination.However, it is always interesting to offer solutions that allow the analysis of a biological sample directly from the sampling device, in particular in order to limit handling and the risk of contamination.
Présentation de l'inventionPresentation of the invention
Afin de remédier à l’inconvénient précité de l’état de la technique, la présente invention propose un dispositif pour l’analyse rapide d’un échantillon biologique, par exemple un échantillon biologique salivaire, destiné à la détection de la présence d’au moins un analyte dans ledit échantillon biologique.In order to remedy the aforementioned drawback of the state of the art, the present invention proposes a device for the rapid analysis of a biological sample, for example a salivary biological sample, intended for the detection of the presence of least one analyte in said biological sample.
Le dispositif d’analyse rapide comprend :The rapid analysis device includes:
(i) un organe de prélèvement, destiné au prélèvement dudit échantillon biologique,(i) a sampler, intended for the collection of said biological sample,
lequel organe de prélèvement comporte :which sampling device comprises:
- une partie de préhension, adaptée à la manipulation dudit organe de prélèvement, et- a gripping part, suitable for handling said sampling member, and
- une partie de collecte, destinée à porter un bloc absorbant adapté à recueillir ledit échantillon biologique,- a collection part, intended to carry an absorbent block suitable for collecting said biological sample,
etand
(ii) un boîtier qui comporte :(ii) a box that includes:
- au moins un emplacement destiné à recevoir une bandelette chromatographique conçue pour détecter la présence dudit au moins un analyte, avantageusement une bandelette immunochromatographique,- at least one location intended to receive a chromatographic strip designed to detect the presence of said at least one analyte, advantageously an immunochromatographic strip,
- une interface, adaptée à recevoir ledit organe de prélèvement dans une configuration finale assemblée,- an interface, adapted to receive said sampling device in a final assembled configuration,
laquelle interface comporte un logement qui est conçu pour recevoir ledit bloc absorbant dudit organe de prélèvement et qui forme, avec ledit organe de prélèvement dans la configuration finale assemblée, une chambre pour l’extraction dudit échantillon biologique depuis ledit bloc absorbant,which interface comprises a housing which is designed to receive said absorbent block of said sampling member and which forms, with said sampling member in the final assembled configuration, a chamber for the extraction of said biological sample from said absorbent block,
lequel au moins un logement comporte :which at least one housing comprises:
- une ouverture d’accès, au travers de laquelle ledit bloc absorbant est destiné à être introduit dans ledit logement, et- an access opening, through which said absorbent block is intended to be introduced into said housing, and
- une ouverture de sortie, en communication fluidique avec ledit emplacement du boîtier, au travers de laquelle ledit échantillon biologique extrait est destiné à s’écouler.- an outlet opening, in fluid communication with said housing location, through which said extracted biological sample is intended to flow.
Et selon l’invention, ledit organe de prélèvement et ladite interface comportent des moyens d’assemblage étanche qui autorisent, entre eux, un degré de liberté en translation et un degré de liberté en rotation.And according to the invention, said sampling member and said interface comprise sealed assembly means which allow, between them, a degree of freedom in translation and a degree of freedom in rotation.
Les moyens d’assemblage étanche comprennent des moyens de guidage qui sont structurés pour guider un mouvement relatif entre ledit organe de prélèvement et ladite interface depuis une configuration initiale de positionnement jusqu’à la configuration finale assemblée, ledit mouvement relatif comprenant deux mouvements :The sealed assembly means comprise guide means which are structured to guide a relative movement between said sampling member and said interface from an initial positioning configuration to the final assembled configuration, said relative movement comprising two movements:
- un mouvement de translation relatif, prévu pour appliquer une compression audit bloc absorbant, et- a relative translational movement, intended to apply compression to said absorbent block, and
- un mouvement de rotation relatif, avantageusement prévu pour appliquer une torsion audit bloc absorbant.- a relative rotational movement, advantageously provided to apply a torsion to said absorbent block.
Le dispositif d’analyse selon l’invention permet ainsi une extraction optimale de l’échantillon biologique depuis le bloc absorbant, par compression et voire en torsion.The analysis device according to the invention thus allows optimal extraction of the biological sample from the absorbent block, by compression and even by twisting.
Il présente également l’avantage d’enfermer ce bloc absorbant dans une chambre lors de l’extraction, ce qui assure une sécurité optimale de l’utilisateur à l’encontre de toute contamination.It also has the advantage of enclosing this absorbent block in a chamber during extraction, which ensures optimal user safety against any contamination.
D’autres caractéristiques non limitatives et avantageuses du produit conforme à l’invention, prises individuellement ou selon toutes les combinaisons techniquement possibles, sont les suivantes :Other non-limiting and advantageous characteristics of the product in accordance with the invention, taken individually or in all technically possible combinations, are the following:
- lesdits moyens de guidage sont structurés pour guider ledit mouvement relatif selon deux mouvements relatifs successifs comprenant ledit mouvement de translation relatif puis ledit mouvement de rotation relatif ;- said guide means are structured to guide said relative movement according to two successive relative movements comprising said relative translational movement and then said relative rotational movement;
- les moyens de guidage comprennent au moins un couple rainure / ergot, avantageusement au moins deux couples rainure / ergot, pour guider ledit mouvement relatif ; le logement de l’interface comporte avantageusement un axe longitudinal, et la rainure comporte avantageusement deux tronçons : un tronçon amont, longitudinal, s’étendant parallèlement audit axe longitudinal du logement, et un tronçon aval, transversal, s’étendant dans un plan perpendiculaire audit axe longitudinal du logement ;- the guide means comprise at least one groove/lug pair, advantageously at least two groove/lug pairs, to guide said relative movement; the housing of the interface advantageously comprises a longitudinal axis, and the groove advantageously comprises two sections: an upstream, longitudinal section, extending parallel to said longitudinal axis of the housing, and a downstream, transverse section, extending in a perpendicular plane to said longitudinal axis of the housing;
- le logement de l’interface comporte une paroi de fond, avantageusement munie de ladite ouverture de sortie, laquelle paroi de fond est munie de munie de nervures et/ou de rainures, avantageusement orientées de manière radiale ;- the housing of the interface comprises a bottom wall, advantageously provided with said outlet opening, which bottom wall is provided with provided with ribs and/or grooves, advantageously oriented radially;
- la partie de collecte comporte un fût, destiné à recevoir une portion du bloc absorbant, lequel fût comporte une paroi de fond prolongée par une jupe tubulaire, laquelle paroi de fond et/ou laquelle jupe tubulaire comportent des nervures, avantageusement des nervures radiales sur la paroi de fond et/ou des nervures longitudinales sur une face intérieure de ladite jupe tubulaire ;- the collection part comprises a barrel, intended to receive a portion of the absorbent block, which barrel comprises a bottom wall extended by a tubular skirt, which bottom wall and/or which tubular skirt comprise ribs, advantageously radial ribs on the bottom wall and/or longitudinal ribs on an inner face of said tubular skirt;
- la partie de collecte comporte un fût comportant une jupe tubulaire, destiné à recevoir une portion du bloc absorbant, et la jupe tubulaire comporte un orifice traversant destiné à recevoir un réactif, par exemple un tampon de migration ou un réactif complémentaire pour le traitement de l’échantillon ou une fonctionnalité spécifique chimique / biochimique ou immunologique ;- the collection part comprises a barrel comprising a tubular skirt, intended to receive a portion of the absorbent block, and the tubular skirt comprises a through orifice intended to receive a reagent, for example a migration buffer or a complementary reagent for the treatment of the sample or a specific chemical/biochemical or immunological functionality;
- la partie de collecte comporte un fût comportant une jupe tubulaire, destiné à recevoir une portion du bloc absorbant, lequel logement comporte une paroi latérale de forme tubulaire, laquelle jupe tubulaire forme soit une partie mâle destinée à être introduite au sein du logement dont la paroi latérale forme une partie femelle, soit une partie femelle destinée à être introduite autour du logement dont la paroi latérale forme une partie mâle ; les surfaces complémentaires de la jupe tubulaire et/ou de la paroi latérale du logement comportent au moins une nervure annulaire ;- the collection part comprises a barrel comprising a tubular skirt, intended to receive a portion of the absorbent block, which housing comprises a side wall of tubular shape, which tubular skirt forms either a male part intended to be introduced within the housing whose side wall forms a female part, or a female part intended to be introduced around the housing, the side wall of which forms a male part; the complementary surfaces of the tubular skirt and/or of the side wall of the housing comprise at least one annular rib;
- l’emplacement et le logement de l’interface comporte des axes longitudinaux respectifs, lesquelles axes longitudinaux sont parallèles l’un par rapport à l’autre ; lequel emplacement comporte avantageusement deux parois : une paroi arrière, recevant la bandelette chromatographique, et une paroi avant, formant avantageusement un couvercle mobile adapté à ouvrir / fermer l’emplacement ;- the location and housing of the interface has respective longitudinal axes, which longitudinal axes are parallel to each other; which location advantageously comprises two walls: a rear wall, receiving the chromatographic strip, and a front wall, advantageously forming a movable lid adapted to open / close the location;
- le boîtier comporte une paroi inférieure définissant une face de dessous adaptée à reposer sur une surface de réception, une paroi supérieure définissant une face de dessus, opposée, et une paroi extérieure, reliant lesdites parois inférieure et supérieure ; et ledit au moins un emplacement et l’interface sont avantageusement en forme de puits, débouchant au travers de ladite paroi supérieure ;- The housing comprises a bottom wall defining a bottom face adapted to rest on a receiving surface, an upper wall defining a top face, opposite, and an outer wall, connecting said lower and upper walls; and said at least one location and the interface are advantageously in the form of a well, opening through said upper wall;
- le boîtier comporte, d’une part, une cassette comportant ledit au moins un emplacement destiné à recevoir une bandelette chromatographique et, d’autre part, un accessoire, rapporté sur ladite cassette, comportant ladite interface adaptée à recevoir ledit organe de prélèvement dans une configuration finale assemblée ;- the housing comprises, on the one hand, a cassette comprising said at least one location intended to receive a chromatographic strip and, on the other hand, an accessory, attached to said cassette, comprising said interface adapted to receive said sampling device in a final assembled configuration;
- l’interface est monobloc avec au moins une partie dudit emplacement ;- the interface is one-piece with at least part of said location;
- l’emplacement comporte une fenêtre de lecture ;- the location has a reading window;
- l’organe de prélèvement comporte ledit bloc absorbant et le boîtier comporte ladite bandelette chromatographique ;- the sampling device comprises said absorbent block and the housing comprises said chromatographic strip;
- l’emplacement du boîtier comporte un réservoir intermédiaire recevant l’échantillon biologique provenant de l’interface et destiné à coopérer avec la bandelette chromatographique, lequel réservoir intermédiaire présente par exemple une capacité volumique de 50 à 500 µL, lequel réservoir intermédiaire comporte des conduits d’évacuation pour évacuer l’excédent d’échantillon biologique ;- the location of the housing comprises an intermediate reservoir receiving the biological sample coming from the interface and intended to cooperate with the chromatographic strip, which intermediate reservoir has for example a volume capacity of 50 to 500 μL, which intermediate reservoir comprises ducts evacuation to evacuate the excess of biological sample;
- la partie de collecte comporte une collerette venant, dans la configuration finale assemblée, prendre appui au niveau de l’ouverture d’accès de l’interface ;- the collection part includes a collar coming, in the final assembled configuration, to bear at the level of the access opening of the interface;
- le bloc absorbant présente une longueur, au repos, qui est supérieure à la longueur s’étendant entre une paroi de fond du logement d’interface et une paroi de fond de la partie de collecte, dans la configuration finale assemblée.- the absorbent block has a length, at rest, which is greater than the length extending between a bottom wall of the interface housing and a bottom wall of the collection part, in the final assembled configuration.
La présente invention concerne encore le système pour l’analyse rapide d’un échantillon biologique, destiné à la détection de la présence d’au moins un analyte dans ledit échantillon biologique, par exemple un échantillon biologique salivaire.The present invention also relates to the system for the rapid analysis of a biological sample, intended for the detection of the presence of at least one analyte in said biological sample, for example a salivary biological sample.
Le système d’analyse rapide comprend :The rapid analysis system includes:
- ledit dispositif d’analyse selon l’invention, et éventuellement- said analysis device according to the invention, and optionally
- un réactif, par exemple un tampon de migration ou un réactif complémentaire pour le traitement de l’échantillon ou une fonctionnalité spécifique chimique / biochimique ou immunologique.- a reagent, for example a migration buffer or an additional reagent for the treatment of the sample or a specific chemical / biochemical or immunological functionality.
Bien entendu, les différentes caractéristiques, variantes et formes de réalisation de l'invention peuvent être associées les unes avec les autres selon diverses combinaisons dans la mesure où elles ne sont pas incompatibles ou exclusives les unes des autres.Of course, the different characteristics, variants and embodiments of the invention can be associated with each other in various combinations insofar as they are not incompatible or exclusive of each other.
Claims (13)
lequel dispositif d’analyse rapide (1) comprend :
(i) un organe de prélèvement (2), destiné au prélèvement dudit échantillon biologique,
lequel organe de prélèvement (2) comporte :
- une partie de préhension (22), adaptée à la manipulation dudit organe de prélèvement (2), et
- une partie de collecte (23), destinée à porter un bloc absorbant (21) adapté à recueillir ledit échantillon biologique,
et
(ii) un boîtier (3) qui comporte :
- au moins un emplacement (31) destiné à recevoir une bandelette chromatographique (7) conçue pour détecter la présence dudit au moins un analyte, avantageusement une bandelette immunochromatographique,
- une interface (32), adaptée à recevoir ledit organe de prélèvement (2) dans une configuration finale assemblée,
laquelle interface (32) comporte un logement (321) qui est conçu pour recevoir ledit bloc absorbant (21) dudit organe de prélèvement (2) et qui forme, avec ledit organe de prélèvement (2) dans la configuration finale assemblée, une chambre (4) pour l’extraction dudit échantillon biologique depuis ledit bloc absorbant (21),
lequel au moins un logement (321) comporte :
- une ouverture d’accès (3211), au travers de laquelle ledit bloc absorbant (21) est destiné à être introduit dans ledit logement (321), et
- une ouverture de sortie (3212), en communication fluidique avec ledit emplacement (31) du boîtier (3), au travers de laquelle ledit échantillon biologique extrait est destiné à s’écouler,
caractérisé en ce que ledit organe de prélèvement (2) et ladite interface (32) comportent des moyens d’assemblage étanche (5) qui autorisent, entre eux, un degré de liberté en translation et un degré de liberté en rotation,
lesquels moyens d’assemblage étanche (5) comprennent des moyens de guidage (6) qui sont structurés pour guider un mouvement relatif entre ledit organe de prélèvement (2) et ladite interface (32) depuis une configuration initiale de positionnement jusqu’à la configuration finale assemblée, ledit mouvement relatif comprenant deux mouvements :
- un mouvement de translation relatif, prévu pour appliquer une compression audit bloc absorbant (21), et
- un mouvement de rotation relatif, avantageusement prévu pour appliquer une torsion audit bloc absorbant (21).Device for the rapid analysis of a biological sample, for example a salivary biological sample, intended for the detection of the presence of at least one analyte in said biological sample,
which rapid analysis device (1) comprises:
(i) a sampling device (2), intended for the sampling of said biological sample,
which sampling member (2) comprises:
- a gripping part (22), suitable for handling said sampling member (2), and
- a collection part (23), intended to carry an absorbent block (21) suitable for collecting said biological sample,
and
(ii) a housing (3) which comprises:
- at least one location (31) intended to receive a chromatographic strip (7) designed to detect the presence of said at least one analyte, advantageously an immunochromatographic strip,
- an interface (32), adapted to receive said sampling member (2) in a final assembled configuration,
which interface (32) comprises a housing (321) which is designed to receive said absorbent block (21) of said sampling member (2) and which forms, with said sampling member (2) in the final assembled configuration, a chamber ( 4) for the extraction of said biological sample from said absorbent block (21),
which at least one housing (321) comprises:
- an access opening (3211), through which said absorbent block (21) is intended to be introduced into said housing (321), and
- an outlet opening (3212), in fluid communication with said location (31) of the housing (3), through which said extracted biological sample is intended to flow,
characterized in that said sampling member (2) and said interface (32) comprise sealed assembly means (5) which allow, between them, a degree of freedom in translation and a degree of freedom in rotation,
which sealing means (5) comprise guide means (6) which are structured to guide a relative movement between said sampling member (2) and said interface (32) from an initial positioning configuration to the configuration final assembly, said relative movement comprising two movements:
- a relative translational movement, intended to apply a compression to said absorbent block (21), and
- a relative rotational movement, advantageously provided to apply a torsion to said absorbent block (21).
et en ce que la rainure (61) comporte deux tronçons :
- un tronçon amont (611), longitudinal, s’étendant parallèlement audit axe longitudinal (321’) du logement (321), et
- un tronçon aval (612), transversal, s’étendant dans un plan perpendiculaire audit axe longitudinal (321’) du logement (321).Device for the rapid analysis of a biological sample, according to claim 3, characterized in that the housing (321) of the interface (32) comprises a longitudinal axis (321'),
and in that the groove (61) has two sections:
- an upstream section (611), longitudinal, extending parallel to said longitudinal axis (321') of the housing (321), and
- a downstream section (612), transverse, extending in a plane perpendicular to said longitudinal axis (321') of the housing (321).
laquelle paroi de fond (3216) est munie de nervures (3216a) et/ou de rainures (3216b), avantageusement orientées de manière radiale.Device for the rapid analysis of a biological sample, according to any one of Claims 1 to 4, characterized in that the housing (321) of the interface (32) comprises a bottom wall (3216), advantageously provided of said outlet opening (3212),
which bottom wall (3216) is provided with ribs (3216a) and/or grooves (3216b), advantageously oriented radially.
lequel fût (23) comporte une paroi de fond (231) prolongée par une jupe tubulaire (232),
laquelle paroi de fond (231) et/ou laquelle jupe tubulaire (232) comportent des nervures (2311, 2321), avantageusement des nervures radiales (2311) sur la paroi de fond (231) et/ou des nervures longitudinales (2321) sur une face intérieure de ladite jupe tubulaire (232).Device for the rapid analysis of a biological sample, according to any one of Claims 1 to 5, characterized in that the collection part (23) comprises a barrel (23), intended to receive a portion (211) of the absorbent block (21),
which shaft (23) comprises a bottom wall (231) extended by a tubular skirt (232),
which bottom wall (231) and/or which tubular skirt (232) comprise ribs (2311, 2321), advantageously radial ribs (2311) on the bottom wall (231) and/or longitudinal ribs (2321) on an inner face of said tubular skirt (232).
et en ce que la jupe tubulaire (232) comporte un orifice traversant (2325) destiné à recevoir un réactif, par exemple un tampon de migration ou un réactif complémentaire pour le traitement de l’échantillon ou une fonctionnalité spécifique chimique / biochimique ou immunologique.Device for the rapid analysis of a biological sample, according to any one of Claims 1 to 6, characterized in that the collection part (23) comprises a barrel (23) comprising a tubular skirt (232), intended to receiving a portion of the absorbent block (21),
and in that the tubular skirt (232) comprises a through orifice (2325) intended to receive a reagent, for example a migration buffer or a complementary reagent for the treatment of the sample or a specific chemical/biochemical or immunological functionality.
lequel logement (321) comporte une paroi latérale (3215) de forme tubulaire,
laquelle jupe tubulaire (232) forme :
- une partie mâle destinée à être introduite au sein du logement (321) dont la paroi latérale (3215) forme une partie femelle, ou
- une partie femelle destinée à être introduite autour du logement (321) dont la paroi latérale (3215) forme une partie mâle.Device for the rapid analysis of a biological sample, according to any one of Claims 1 to 7, characterized in that the collection part (23) comprises a barrel (23) comprising a tubular skirt (232), intended to receiving a portion of the absorbent block (21),
which housing (321) comprises a side wall (3215) of tubular shape,
which tubular skirt (232) forms:
- a male part intended to be introduced into the housing (321) whose side wall (3215) forms a female part, or
- a female part intended to be introduced around the housing (321) whose side wall (3215) forms a male part.
lequel emplacement (31) comporte deux parois :
- une paroi arrière (311), recevant la bandelette chromatographique (7), et
- une paroi avant (312), formant avantageusement un couvercle mobile adapté à ouvrir / fermer l’emplacement (31).Device for the rapid analysis of a biological sample, according to any one of Claims 1 to 9, characterized in that the location (31) and the housing (321) of the interface (32) comprise longitudinal axes (31', 321') respectively, which longitudinal axes (31', 321') are parallel to each other,
which location (31) has two walls:
- a rear wall (311), receiving the chromatographic strip (7), and
- a front wall (312), advantageously forming a mobile cover suitable for opening/closing the slot (31).
- une paroi inférieure (34) définissant une face de dessous adaptée à reposer sur une surface de réception,
- une paroi supérieure (35) définissant une face de dessus, opposée, et
- une paroi extérieure (36), reliant lesdites parois inférieure (34) et supérieure (35),
et en ce que ledit au moins un emplacement (31) et l’interface (32) sont avantageusement en forme de puits, débouchant au travers de ladite paroi supérieure (35).Device for the rapid analysis of a biological sample, according to any one of Claims 1 to 9, characterized in that the housing (3) comprises:
- a bottom wall (34) defining an underside adapted to rest on a receiving surface,
- an upper wall (35) defining an opposite top face, and
- an outer wall (36), connecting said lower (34) and upper (35) walls,
and in that said at least one location (31) and the interface (32) are advantageously in the form of a well, emerging through said upper wall (35).
- une cassette (8) comportant ledit au moins un emplacement (31) destiné à recevoir une bandelette chromatographique (7), et
- un accessoire (9), rapporté sur ladite cassette (8), comportant ladite interface (32) adaptée à recevoir ledit organe de prélèvement (2) dans une configuration finale assemblée.Device for the rapid analysis of a biological sample, according to any one of Claims 1 to 9, characterized in that the housing (3) comprises:
- a cassette (8) comprising said at least one location (31) intended to receive a chromatographic strip (7), and
- an accessory (9), attached to said cassette (8), comprising said interface (32) adapted to receive said sampling member (2) in a final assembled configuration.
lequel système d’analyse rapide comprend :
- ledit dispositif d’analyse (1) selon l’une quelconque des revendications 1 à 12, et éventuellement
- un réactif, par exemple un tampon de migration ou un réactif complémentaire pour le traitement de l’échantillon ou une fonctionnalité spécifique chimique / biochimique ou immunologique.System for the rapid analysis of a biological sample, intended for detecting the presence of at least one analyte in said biological sample, for example a biological saliva sample,
which rapid analysis system comprises:
- said analysis device (1) according to any one of claims 1 to 12, and optionally
- a reagent, for example a migration buffer or an additional reagent for the treatment of the sample or a specific chemical/biochemical or immunological functionality.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/EP2022/058725 WO2022207890A1 (en) | 2021-04-02 | 2022-03-31 | Device for rapid analysis of a biological sample, for example a salivary biological sample |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR2103428A FR3121514A1 (en) | 2021-04-02 | 2021-04-02 | Device for the rapid analysis of a biological sample, for example a salivary biological sample |
| FR2103428 | 2021-04-02 | ||
| FR2105705 | 2021-05-31 | ||
| FR2105705A FR3121513A1 (en) | 2021-04-02 | 2021-05-31 | Device for the rapid analysis of a biological sample, for example a salivary biological sample |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| FR3121515A1 true FR3121515A1 (en) | 2022-10-07 |
Family
ID=83459951
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FR2108249A Pending FR3121515A1 (en) | 2021-04-02 | 2021-07-29 | Device for the rapid analysis of a biological sample, for example a salivary biological sample |
Country Status (1)
| Country | Link |
|---|---|
| FR (1) | FR3121515A1 (en) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005050165A2 (en) * | 2003-11-14 | 2005-06-02 | Oakville Hong Kong Co., Limited | Rapid sample analysis and storage devices and methods of use |
| WO2006016051A2 (en) * | 2004-07-13 | 2006-02-16 | Vedalab | Device with removal member for detecting an analyte in a liquid sample |
| US20070239069A1 (en) * | 2006-03-31 | 2007-10-11 | Guirguis Raouf A | Integrated screening and confirmation device |
| DE102009010563A1 (en) * | 2009-02-16 | 2010-08-26 | Matthias W. Engel | Device for the detection of analytes in body fluids |
| CN102379724B (en) * | 2010-09-06 | 2015-05-27 | 艾博生物医药(杭州)有限公司 | Device for collecting fluid samples |
-
2021
- 2021-07-29 FR FR2108249A patent/FR3121515A1/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005050165A2 (en) * | 2003-11-14 | 2005-06-02 | Oakville Hong Kong Co., Limited | Rapid sample analysis and storage devices and methods of use |
| WO2006016051A2 (en) * | 2004-07-13 | 2006-02-16 | Vedalab | Device with removal member for detecting an analyte in a liquid sample |
| US20070239069A1 (en) * | 2006-03-31 | 2007-10-11 | Guirguis Raouf A | Integrated screening and confirmation device |
| DE102009010563A1 (en) * | 2009-02-16 | 2010-08-26 | Matthias W. Engel | Device for the detection of analytes in body fluids |
| CN102379724B (en) * | 2010-09-06 | 2015-05-27 | 艾博生物医药(杭州)有限公司 | Device for collecting fluid samples |
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| HANSEN T.M., IVD TECHNOLOGY, vol. 4, 2003, pages 35 - 40 |
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