WO2022207890A1

WO2022207890A1 - Device for rapid analysis of a biological sample, for example a salivary biological sample

Info

Publication number: WO2022207890A1
Application number: PCT/EP2022/058725
Authority: WO
Inventors: Milovan Stankov; Milovan STANKOV-PUGES
Original assignee: Ng Biotech
Priority date: 2021-04-02
Filing date: 2022-03-31
Publication date: 2022-10-06

Abstract

The present invention relates to a device for rapid analysis of a biological sample, for example a salivary biological sample, intended for detecting the presence of at least one analyte in the biological sample. The rapid analysis device (1) comprises: a sampling member (2) for collecting the biological sample; and a housing (3) which comprises a location (31) for receiving a chromatographic strip (7) and an interface (32), adapted to receive the sampling member (2) in an assembled final configuration. The sampling member (2) and the interface (32) comprise sealed-assembly means (5) comprising guide means (6) which are structured to guide a relative movement of the sampling member (2) in relation to the interface (32) from an initial positioning configuration to the assembled final configuration, the relative movement comprising two movements: a relative translation movement, intended to apply compression to the absorbent block (21); and a relative rotational movement, intended to apply torsion to the absorbent block (21).

Description

Device for the rapid analysis of a biological sample, for example a salivary biological sample

Technical field of the invention

The present invention relates to the technical field of devices for the rapid analysis of a biological sample, for example a salivary biological sample.

State of the art

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.

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.

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.

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.

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.

Presentation of the invention

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.

The rapid analysis device includes:

(i) a sampling device, intended for the collection of said biological sample, which sampling device comprises:

- a gripping part, suitable for handling said sampling member, and

- a collection part, intended to carry an absorbent block suitable for collecting said biological sample, and

(ii) a box that includes: - 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,

- an interface, adapted to receive said sampling member in a final assembled configuration, 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, which at least one housing comprises:

- an access opening, through which said absorbent block is intended to be introduced into said housing, and

- an outlet opening, in fluid communication with said housing location, through which said extracted biological sample is intended to flow.

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.

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:

- a relative translational movement, intended to apply compression to said absorbent block, and

- a relative rotational movement, advantageously provided to apply a torsion to said absorbent block.

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.

It also has the advantage of enclosing this absorbent block in a chamber during extraction, which ensures optimal user safety against any contamination.

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:

- 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; - 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;

- 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;

- 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;

- 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;

- 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;

- 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;

- 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, emerging through said upper wall; - 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;

- the interface is one-piece with at least part of said location;

- the location has a reading window;

- the sampling device comprises said absorbent block and the housing comprises said chromatographic strip;

- 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 pl_, which intermediate reservoir comprises ducts evacuation to evacuate the excess of biological sample;

- the collection part includes a collar coming, in the final assembled configuration, to bear at the level of the access opening of the interface;

- 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.

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.

The rapid analysis system includes:

- said analysis device according to the invention, 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.

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.

Detailed description of the invention

In addition, various other characteristics of the invention emerge from the appended description made with reference to the drawings which illustrate non-limiting forms of embodiment of the invention and where:

[Fig. 1] is a general view in perspective of the rapid analysis device according to the invention, of which the sampling member and the housing (whose cover is shown partially and in thin lines) are in a final assembled configuration; [Fig. 2] is a cross-sectional view of the rapid analysis device according to FIG. 1, along a cross-sectional plane passing through the general plane of the location and through an added chromatographic strip, in which the sampling device and the housing are in an initial positioning configuration;

[Fig. 3] represents the harvesting organ in isolation, side view (FIG. 3A) and front view (FIG. 3B);

[Fig. 4] is a perspective and isolated view of the box, the location of which (intended to receive a chromatographic strip) does not have its lid;

[Fig. 5] is a perspective view of the box, illustrating the structure of the housing fitted to its interface;

[Fig. 6] is a sectional view of the rapid analysis device according to FIG. 1, along a section plane perpendicular to the general plane of the location and to the general plane of the chromatographic strip, in which the sampling device and the housing are in the initial positioning configuration;

[Fig. 7] is a view of the rapid analysis device according to FIG. 6, in which the sampling member and the housing are now in the final assembled configuration;

[Fig. 8] is a general view in perspective of a variant of the rapid analysis device according to the invention, of which the sampling member and the housing are in a dissociated configuration;

[Fig. 9] is a schematic view, according to a vertical sectional plane, of the case constituting the rapid analysis device according to FIG. 8;

[Fig. 10] is a general and perspective view of a variant of the rapid analysis device according to the invention, in which the housing comprises a cassette, comprising said at least one location, and an accessory, attached to said cassette and comprising said interface;

[Fig. 11] is a general view, according to a vertical sectional plane, of the case constituting the rapid analysis device according to figure 10.

It should be noted that, in these figures, the structural and/or functional elements common to the different variants may have the same references.

According to the invention, the device 1 for the rapid analysis of a biological sample, also called "rapid analysis device 1", is intended for the detection of the presence of at least one analyte in said biological sample.

By "detection" is thus advantageously meant the qualitative determination (advantageously the presence or absence), or even quantitative, of one or more analytes in a biological sample.

By “analyte”, is meant any chemical, biochemical or biological entity that it is desired to detect in a biological sample. This chemical entity advantageously consists of an entity originating from the living world, preferably from the plant world or from the animal world, preferably still present in human beings.

Among the analytes detected by the system and the method according to the present invention, mention will be made in particular of proteins, peptides, antibodies, hormones, steroids, antigens derived from infectious agents or tumor cells, infectious agents such as bacteria, viruses or parasites, nucleic acids (DNA or RNA), therapeutic compounds, drugs or antibiotics.

The term “infectious agent” preferably means:

- viruses, in particular the viruses responsible for pneumopathies, advantageously the Coronaviridae, more preferably Orthocoronavirinae or coronavirus,

- Parasites, for example parasites of the genus Plasmodium.

By “coronavirus”, we mean SARS-CoV, MERS-CoV or SARS-CoV-2.

By “biological sample”, is advantageously meant any sample taken from an individual (human or animal in particular) and in which the analyte is sought.

This biological sample can in particular be any biological or bodily fluid, and preferably a biological salivary sample or salivary sample (saliva is a biological liquid secreted by the salivary glands, inside the mouth).

The term "biological sample" also encompasses surface samples, etc. for the detection of biomarkers (bacteria, viruses, DNA, RNA, proteins, chemical / biochemical substances, etc.).

The liquid sample may also have been obtained directly, or indirectly, from a biological or bodily fluid.

The sample can also be a liquid extract of a solid sample, for example faeces, food products, tissue and organ samples, biopsy samples, etc.

For this, as illustrated in the figures, the rapid analysis device 1 according to the invention comprises:

- a sampling member 2, intended for the sampling (also called "collection") of the biological sample by means of an absorbent block 21 adapted to absorb / release this biological sample, and

- a housing 3 intended, on the one hand, to receive a chromatographic strip (described later) designed to detect the presence of said at least one analyte and, on the other hand, to receive the sampling device 2 carrying the biological sample to be analyzed.

The rapid analysis device 1 advantageously defines a longitudinal axis 1'.

The sampling member 2 and the housing 3 advantageously consist of two parts made of plastic material. As developed subsequently, the sampling member 2 and the casing 3 comprise sealed assembly means 5 which are adapted to obtain a final assembled configuration (FIGS. 1 and 7).

In this final assembled configuration (FIG. 7), the sampling device 2 and the housing 3 together define a chamber 4 suitable for the extraction of the biological sample from the absorbent block 21 and for its flow to the chromatographic strip. .

According to the invention, as developed subsequently, the sealed assembly means 5 allow, between the sampling member 2 and the housing 3, a degree of freedom in translation and a degree of freedom in rotation.

And the sealed assembly means 5 comprise guide means 6 which are structured to guide the relative movement between the sampling member 2 and the housing 3 from an initial positioning configuration (FIG. 6) to a final assembled configuration (figure 7).

This relative movement is in particular intended to ensure optimal extraction of the biological sample from the absorbent block 21.

Sampling organ

The sampler 2 is illustrated in particular in Figure 3, in isolation and without its absorbent block 21. The sampler 2 is also illustrated in Figure 8, in isolation and provided with its absorbent block 21.

The sampling device 2 has two parts:

- a gripping part 22, suitable for handling this sampling member 2, and

- A collection part 23, intended to carry the aforementioned absorbent block 21.

The gripping part 22 is particularly useful when collecting the sample or when assembling the sampling device 2 / housing 3 couple.

The gripping part 22 here consists of a plate or a pad, here in the form of a disc. This gripping part 22 could take any other shape suitable for handling it.

The collection part 23 advantageously comprises a barrel (designated by the same reference 23 for the sake of efficiency), intended to receive a portion of the absorbent block 21.

The barrel 23 advantageously comprises a bottom wall 231 (advantageously a disc) extended by a tubular skirt 232 (advantageously cylindrical).

The gripping part 22 is here secured to the bottom wall 231 of the collection part 23, here forming a single piece.

The tubular skirt 232 comprises in particular two opposite surfaces:

- an inner surface 232a, facing the absorbent block 21, and

- An outer surface 232b, opposite. As represented in FIG. 3B, the bottom wall 231 and/or the tubular skirt 232 comprise ribs 2311, 2321 which advantageously cooperate with the absorbent block 21 in order in particular to participate in the locking in rotation between the sampling member 2 and the absorbent block 2.

In this case, the barrel 23 advantageously comprises radial ribs 2311 on the bottom wall 231 and/or longitudinal ribs 2321 on the inner surface 232a of the tubular skirt 232.

Furthermore, the tubular skirt 232 advantageously comprises a through orifice 2325 (FIG. 3A) which is adapted to receive a reagent intended to soak the absorbent block 21.

The reagent, advantageously conventional in itself, is for example chosen from a migration buffer or a complementary reagent for the treatment of the sample or a specific chemical/biochemical or immunological functionality.

Still moreover, the collection part 23 advantageously includes a flange 237 coming, in the final assembled configuration, to bear at the level of an access opening of an interface of the casing 3 to participate in a guiding in rotation.

In this case, the flange 237 extends in the general plane of the bottom wall 231.

In general, the absorbent block 21 is for example made of a material chosen from sponges of natural or synthetic origin (cotton, silicone, rubber, cellulose, etc.).

The absorbent block 21 consists of an inert, relatively elastic, compressible absorbent material, for example a wadding or foam made of cellulose fibers.

In the state at rest, the absorbent block 21 has a capacity to absorb any liquid brought into contact with it. And, in a constrained state (compression and/or torsion), this absorbent block 21 has the capacity to restore at least part of the previously absorbed liquid.

The absorbent block 21 advantageously has a length, at rest, which is greater than the length of the tubular skirt 232 of the shaft 23 (FIG. 2).

Before the final assembled configuration (Figure 2 in particular), the absorbent block 21 then advantageously has two portions:

- an inner portion 211, housed in the barrel 23 for assembly between the sampling member 2 and the absorbent block 21, and

- an outer portion 212, protruding, intended to come into contact with the sample during sampling.

Housing

The box 3 mainly comprises two parts:

- at least one location 31 intended to receive a chromatographic strip 7, described later, designed to detect the presence of said at least one analyte, and - An interface 32, adapted to receive the sampling member 2 in the final assembled configuration (Figure 1 in particular).

In general, according to a first embodiment shown in Figures 1 and 4, the location 31 advantageously comprises 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.

The rear wall 311 comprises in particular support structures 3111 (FIG. 4), adapted to carry the chromatographic strip 7 at a distance from this rear wall 311 so as to optimize the continuous capillary diffusion.

The rear wall 311 also comprises a holding structure 3112, on the side and at the exit of the interface 32 (here two facing partitions), which is provided to receive an absorbent block intended to regulate the supply of the sample on a zone for depositing the chromatographic strip 7.

The front wall 312 advantageously comprises a reading window 3121 opposite which a capture zone of the chromatographic strip 7 is intended to be positioned.

According to a second embodiment shown in Figures 8 and 9, the housing 3 advantageously comprises:

- a bottom wall 34 defining an underside adapted to rest on a receiving surface (for example a work surface),

- an upper wall 35 defining an opposite top face, and

- an outer wall 36, connecting these lower 34 and upper 35 walls.

Said at least one location 31 and the interface 32 are advantageously in the form of a well, emerging through the upper wall 35.

In particular, said at least one location 31 (advantageously a single location 31 or at least two locations 31) is designed to introduce at least the deposit zone of a chromatographic strip (here its lower part).

In this case, said at least one location 31 comprises, along a general axis 31', two ends:

- an access opening 311, here upper, formed through the upper wall 35, and

- a bottom 312, here lower, provided on the side of the lower wall 34.

It is here the bottoms of said at least one location 31 and the interface 32 which are in fluid communication. In this case, said at least one location 31 and the interface 32 are in fluid communication via at least one conduit 38 adapted to a flow of the biological sample, from the interface 32 to the said at least a slot 31.

In particular, in the presence of at least two slots 31, the slots 31 and the interface 32 are advantageously in fluid communication via a single conduit 38, adapted to a flow of the biological sample, from the interface 32 to said locations 31.

The duct 38, here in the form of a channel or gutter, advantageously has for this an underside presenting a downward slope from the interface 32 towards at least one location 31.

This embodiment thus promotes the flow of the biological sample, from the bottom of the interface 32 to the bottom 312 of at least one location 31.

This conduit 38 comprises in this case two parts:

- a first part 382, forming the bottom of the interface 32, on a downward slope, and

- a second part 383, terminating the first sloping part 382 and forming the bottom 312 of at least one location 31, in the general shape of a cup to collect and maintain the liquids flowing from the interface 32.

According to a third embodiment (illustrated by FIGS. 10 and 11), the box 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.

The cassette 8, containing the chromatographic strip 7, is advantageously conventional in itself.

This cassette 8 has a generally parallelepipedal shape.

This cassette 8 comprises a set of walls:

- a front wall 81,

- a rear wall 82, and

- a side wall 83, forming a peripheral belt and connecting the front wall 81 and the rear wall 82.

The front wall 81 of the cassette 8 advantageously comprises different windows:

- a deposition window 81a, arranged opposite the deposition zone 71 of the chromatographic strip 7 (FIG. 11), and

- a reading window 81b, arranged opposite the capture zone 73 of the chromatographic strip 7. The accessory 9 is attached to this cassette 8, advantageously by interlocking, so as to cover at least the deposit window 81a of the front wall 81 of the cassette 8.

In this case, accessory 9 includes:

- a bottom wall 91, optional, defining a bottom face adapted to rest on a receiving surface (for example a work surface) and to partially cover the rear wall 82 of the cassette 8,

- an upper wall 92 defining an opposite top face, and

- an outer wall 93, connecting these lower 91 and upper 92 walls.

The interface 32 is advantageously in the form of a well which opens through the upper wall 92 and which is surrounded by the outer wall 93.

In this case, said at least one location 31 and the interface 32 are in fluid communication via the deposition window 81a, adapted to a flow of the biological sample from the interface 32 towards the said at least one location 31.

In general, the location 31 of the housing 3 also advantageously comprises an intermediate reservoir 315 receiving the biological sample coming from the interface 32 and intended to cooperate with the chromatographic strip 7 (FIGS. 2 or 9).

The intermediate tank 315 is thus located between the location 31 and the interface 32.

This intermediate reservoir 315 has, for example, a volume capacity of 50 to 500 μL.

According to the first embodiment illustrated in FIGS. 1 and 4, the intermediate tank 315 advantageously comprises evacuation ducts (not shown), to evacuate the excess biological sample.

In the second embodiment, the intermediate tank 315 is advantageously formed by the bottom of said at least one location 31.

According to the second embodiment illustrated in Figure 9, the excess biological sample is advantageously evacuated by overflow into a secondary reservoir 316, surrounding the pipe 38.

In general, the interface 32 forms, with the sampling member 2 in the final assembled configuration, the chamber 4 for the extraction of the biological sample from the absorbent block 21.

For this, this interface 32 includes a housing 321 which is designed to receive the absorbent block 21 of the sampling device 2.

To this end, the housing 321 comprises:

- an access opening 3211, through which the absorbent block 21 is intended to be introduced into the housing 321, and - an outlet opening 3212, in fluid communication with the location 31 of the housing 3 (here via the intermediate reservoir 315), through which the extracted biological sample is intended to flow.

In this case, the housing 321 is advantageously delimited by two walls:

- a side wall 3215, of which a front edge 3215a delimits the access opening 3211, and

- A bottom wall 3216, connected to a rear edge 3215b of the side wall 3215 and in which the outlet opening 3212 is formed.

The front edge 3215a of the side wall 3215 is here in the form of a flange intended to cooperate with the flange 237 of the collection part 23 to participate in guiding in rotation during assembly.

As illustrated in Figures 5, 9 or 11, the bottom wall 3216 is provided with ribs 3216a and / or grooves 3216b, advantageously oriented radially (also called "star") starting from the outlet opening 3212.

In particular, the ribs 3216a advantageously cooperate with the absorbent block 21 (in particular its free end) to promote its twisting during the relative rotational movement; the grooves 3216b are for their part useful for promoting/authorizing the flow of the biological sample extracted through the outlet opening 3212.

In general, the housing 321 advantageously comprises a longitudinal axis 32T, concentric with the access opening 3211, the outlet opening 3212 and the side wall 3215.

Still generally, according to the first embodiment shown in Figure 4, the slot 31, of elongated shape, here has two ends:

- a first end 31a, free and remote from the interface 32, and

- a second end 31b, connected to the interface 32 and at which the outlet opening 3212 emerges from its housing 321 (via the intermediate tank 315).

Still generally, slot 31 and housing 321 of interface 32 have respective longitudinal axes 3T, 32T.

According to the first embodiment, these longitudinal axes 3T, 32T are advantageously parallel to each other.

Still generally, according to the first embodiment of Figure 4, the interface 32 is advantageously made in one piece with at least part of the slot 31.

In this case, according to the first embodiment, the interface 32 is made in one piece with at least the rear wall 311 of the location 31.

According to the second embodiment, said at least one slot 31 and the interface 32 are made in one piece. According to the third embodiment, the cassette 8 and the accessory 9 consist of two parts assembled, advantageously in a sealed manner (or at least able to limit the passage of liquids).

In this embodiment, the housing 321 comprises:

- said access opening 3211, formed in the upper wall 92, and

- said outlet opening 3212, in fluid communication with the location 31 of the box 3, opening opposite the deposit window 81a of the cassette 8.

The outlet opening 3212 advantageously marries the deposit window 81a of the cassette 8 to ensure liquid tightness.

Again according to this third embodiment, the longitudinal axes 31', 321' are advantageously perpendicular to each other:

- the longitudinal axis 31' of the location 31 is intended to advantageously extend horizontally, and

- the longitudinal axis 321' of the housing 321 of the interface 32 is intended to advantageously extend vertically.

Still in this third embodiment, the outer wall 93 envelops the housing 321.

The outer wall 93 is advantageously made in one piece with the upper wall 92 and with the housing 321.

The outer wall 93 advantageously comprises a lower band 931 marrying a part of the side wall 83 of the cassette 8 and receiving, by interlocking, the lower wall 91.

Cassette 8 is thus advantageously sandwiched between outer wall 93 and lower wall 91.

Means of waterproof assembly

The sampling member 2 (here its collection part 23) and the housing 3 (here its interface 32) comprise the sealed assembly means 5 which allow, between them, the degree of freedom in translation and the degree of freedom in rotation during assembly.

The degree of freedom in translation and the degree of freedom in rotation are advantageously defined according to the same guide axis A which is advantageously coaxial with the longitudinal axis 32T of the housing 321 of the interface 32 in the first, second and third modes of realization, or even also to the longitudinal axis 3T of the location 31 in the first embodiment).

In this case, the degree of freedom in translation D1 corresponds to a relative translational clearance between the sampling member 2 and the housing 3 which is defined by a translation axis coaxial with this guide axis A (FIG. 6). And the degree of freedom in rotation D2 corresponds to a relative rotational clearance between the sampling member 2 and the housing 3 which is defined by an axis of rotation coaxial with this guide axis A (FIG. 7).

To this end, the sampling member 2 (here its collection part 23) and the housing 3 (here its interface 32) advantageously cooperate with each other by means of complementary tubular structures intended to fit together the one inside the other (to the nearest game), namely:

- the collection part 23 of the sampling member 2 here comprises the tubular skirt 232 which is intended to receive a portion of the absorbent block 21, and

- The side wall 3215 of the housing 321 has a tubular shape.

The tubular skirt 232 of the collection part 23 forms the male part intended to be introduced/fitted into the housing 321, the side wall 3215 of which forms a female part (FIG. 7).

The length of the tubular skirt 232 of the collection part 23 is then advantageously equal to, or less than, the length of the side wall 3215 of the housing 321.

Alternatively, not shown, the tubular skirt 232 of the collection part 23 here forms a female part intended to be fitted around the housing 321 whose side wall 3215 forms a male part.

Preferably, the complementary surfaces of the tubular skirt 232 of the collection part 23 and/or of the side wall 3215 of the housing 321 comprise at least one annular rib 2326 (FIGS. 3 and 8).

Said at least one annular rib 2326 allows firm clamping of the absorbent block 21, good sealing and avoids the rise of the sample in the opposite direction to the chromatographic strip 7 (between the tubular skirt 232 of the collection part 23 and the side wall 3215 of the housing 321).

In this case, the outer surface 232b of the tubular skirt 232 of the collection part 23 comprises such ribs 2326 (here three in number).

The ribs 2326 are distributed over the length of the tubular skirt 232.

And as also discussed previously, the sealed assembly means 5 comprise the guide means 6 which are structured to guide the relative movement between the sampling member 2 and the housing 3 from the initial positioning configuration (FIG. 6) until to the final assembled configuration (Figure 7).

This relative movement, during assembly, includes two movements:

- a relative translation movement, provided to apply compression to the absorbent block 21, and

- a relative rotational movement, advantageously provided to apply a twist to the absorbent block 21. According to a preferred embodiment, the guide means 6 are structured to guide this relative movement according to two successive relative movements comprising:

- the relative translational movement, to apply the compression to the absorbent block 21 initially, then

- The relative rotational movement, advantageously to apply the torsion to the absorbent block 21 still compressed, in a second time.

For this purpose, the guide means 6 advantageously comprise at least one groove 61/lug 62 couple which is distributed over the sampling member 2 (here its collecting part 23) and over the housing 3 (here its interface 32).

The guide means 6 preferably comprises here at least two groove 61 / lug 62 pairs (or even only two groove 61 / lug 62 pairs) which are distributed around the guide axis A.

In this case, the groove 61 is carried by the interface 32 of the housing 3 and the lug 62 is carried by the collection part 23 of the sampling member 2.

To obtain the two successive relative movements, the groove 61 advantageously comprises two sections:

- an upstream section 611 intervening in the relative guidance in translation, longitudinal and preferably rectilinear, extending parallel to the longitudinal axis 321' of the housing 321, preferably from the front edge 3215a, and

- a downstream section 612 intervening in the relative guidance in rotation, transverse and preferably rectilinear, extending here in a plane perpendicular to the longitudinal axis 321' of the housing 321, preferably at a distance and parallel to the front edge 3215a.

The lug 62 is carried here by the outer surface 232b of the tubular skirt 232 of the collecting part 23 of the sampling member 2.

This lug 62 is sized to run within the groove 61 forming a slide for guiding the lug 62 and, as a corollary, a guide for the relative movement.

The sealed assembly means 5 also advantageously comprise locking means 55, adapted to lock the sampling member 2 and the housing 3 in the final assembled configuration (FIG. 7).

In this case, the locking means 55 here consist of elastic interlocking means (also called "clipping means") which are implemented when the sampling member 2 and the housing 3 reach the final assembled configuration.

In this case, the elastic interlocking means 55 advantageously consist of a couple pin 551 / cup 552.

Preferably, the pin 551 is carried by the collection part 23 of the sampling member 2 (in particular by the outer surface 232b of its tubular skirt 232); the cup 552 is carried by the interface 32 of the housing 3 (in particular by the inner surface of the side wall 3215 of its housing 321).

Chromatographic strip

The chromatographic strip 7, reported in the location 31 of the housing 3 and also called "means of capillary diffusion", advantageously an immunochromatographic strip, is designed to detect the presence of said at least one analyte.

These chromatographic strips 7 are formed of any means constituting or acting as a continuous capillary diffusion unit, by lateral migration (that is to say perpendicular to the thickness of the capillary material or materials used for the capillary diffusion ).

This capillary diffusion means advantageously consists of a porous solid support allowing the migration of a liquid by simple capillary diffusion.

The porosity of this support allows capillary diffusion (or lateral migration) of the sample and/or of the reagents in the liquid or wet state.

Such capillary diffusion means are very widely used, in particular in all the lateral migration immunochromatography techniques.

Such a chromatographic strip 7 here consists of an elongated support along the direction and/or the direction of the capillary diffusion (lateral migration).

The chromatographic strip 7 may consist of:

- one and the same capillary or porous material, or

- several different capillary or porous elements or materials, suitably arranged with respect to each other (for example by overlapping), to obtain a continuity of capillary flow from one element or material to another, according to the direction of capillary diffusion.

Such a chromatographic strip 7 determines a direction and direction of capillary diffusion of any liquid which is received or deposited at an upstream end, and which then moves towards a downstream end of the chromatographic strip 7.

By way of example, the chromatographic strip 7 can be made up of various immunochromatographic supports, for example cellulose, nylon, nitrocellulose, polyethylene or fiberglass.

The chromatographic strip 7 comprises different successive zones, in the direction of capillary migration upstream to downstream, namely at least:

- a deposit zone 71, intended to receive the biological sample,

- a release zone 72 which comprises at least one detection reagent conjugated with a visible and/or measurable marker, said detection reagent being able to move as a result of the migration of the sample along the chromatographic strip 7, and - at least one capture zone 73 which comprises at least one capture reagent, immobilized on the chromatographic strip 7.

In this case, according to the first embodiment, the deposit zone 71 is advantageously associated with an interface block 711 intended to regulate the supply of the sample to the deposit zone 71 of the chromatographic strip 7 (figure 6).

In general, the release 72 and capture 73 zones advantageously consist of a transverse line or band (extending perpendicular to the direction of migration), having for example a width between 1 and 2 mm, and a surface between 3 and 5 mm ² .

In general, the "detection reagent" or the "capture reagent" consists of any chemical, biochemical or biological entity, which is capable of binding specifically to form a complex allowing the determination of said analyte in the liquid sample.

The detection reagent and/or the capture reagent also constitute so-called “binding” reagents.

Such binding reagents, allowing the detection of at least one analyte in the liquid sample, are well known and can be chosen for the implementation of the invention.

These binding reagents are advantageously chosen from those which are capable of binding specifically with said analyte and/or of binding specifically with each other.

By "binding" or "binding" is meant any strong bond, for example covalent, but also any weak bond, for example of the antigen/antibody or analyte/anti-analyte type.

The binding reagents are advantageously chosen from antibodies, antigens or nucleic acids.

The analyte and the binding reagent thus typically form a couple capable of binding specifically with each other, such as for example a ligand/anti-ligand couple, an antigen/antibody couple, a DNA/RNA couple or a DNA/DNA couple.

The detection reagent(s) are advantageously conjugated to a visible and/or measurable marker, advantageously a particulate marker.

"Visible and/or measurable marker" means any marking allowing direct or indirect detection with the naked eye, or using a device, due to the emission of a signal at the level of said at least one capture zone 73.

The signal is for example a fluorescence, a coloration, the presence of an isotope or a magnetic signal.

Mention will be made, for example, of colored particulate markers such as colloidal gold, or fluorescent markers, colored latex particles, fluorescent latex particles and particles conjugated with avidin and streptavidin. The particulate markers, colored or fluorescent, thus consist of small particles which are insoluble in water and which therefore form suspensions, dispersions or solutions, in the liquid phase.

Among the markers allowing direct observation with the naked eye, mention will also be made of markers of dextran type (Hansen T.M., IVD Technology 4, 35-40, 2003). The binding reagent is then conjugated to a chain of dextran (polysaccharide derivative) carrying fluorophores.

The markers can also consist of enzymes (alkaline phosphatase or AP, horseradish peroxidase or HRP, in particular), dyes or chemiluminescent compounds (in particular fluorescein isothiocyanate or FITC).

For its part, in the capture zone 73, the specific capture reagent of the analyte is immobilized on the solid support according to techniques known to those skilled in the art.

This capture reagent is immobilized in such a way that it is not mobile when wet.

This immobilization can be carried out for example by absorption or by covalent coupling.

According to the second embodiment, the chromatographic strip 7 is intended to be inserted into said at least one slot 31, here in an erected position relative to this slot 31.

For this, the chromatographic strips 7 have dimensions adapted to allow this individual insertion in a location 31.

By “insertion”, as illustrated by FIG. 9, is meant in particular an introduction of a lower part 75 of the length of a chromatographic strip 7 into the location 31; this lower part 75 is advantageously intended to rest on a bottom of the location 31 (see in particular FIG. 9).

And an upper part 76 of the length of this chromatographic strip 7 then advantageously protrudes with respect to this location 31, from its access opening 311 (see in particular FIGS. 8 and 9).

The lower part 75 advantageously comprises the deposit zone (and preferably the release zone which is advantageously located above the mixture contained in the location 71); the upper part 76 comprises the capture zone.

System for rapid analysis of a biological sample

The rapid analysis system includes:

- the analysis device 1 according to the invention, and optionally - the reagent, for example a migration buffer or an additional reagent for the treatment of the sample or a specific chemical/biochemical or immunological functionality.

Implementation

The implementation of the analysis device 1 according to the invention advantageously comprises the following succession of steps:

- taking the biological sample at the level of the absorbent block 21, by appropriate manipulation of the sampling member 2,

- possibly adding a reagent to the absorbent block 21,

- manipulation of the analysis device 1 so as to obtain the assembly and the relative movement between the sampling member 2 and the housing 3 from the initial positioning configuration (FIG. 6) to the final assembled configuration (FIG. 7).

In the third embodiment, the manipulation of the analysis device 1 advantageously comprises a preliminary step of assembling the accessory 9 on the cassette 8.

The final assembled configuration is maintained here by the locking means 55.

The relative movement advantageously comprises two components: a relative translational movement and a relative rotational movement.

During the relative translation movement, the length of the chamber 4 (defined between the bottom wall 3216 of the housing 321 of the interface 32 and the bottom wall 231 of the collection part 23) decreases.

Similarly, during the relative rotational movement, the housing 321 of the interface 32 and the collection part 23 undergo a relative rotational movement.

During these relative movements between the sampling member 2 and the housing 3, the absorbent block 21 is thus brought into a constrained state, in compression and advantageously in torsion, which causes the extraction of its contents.

To ensure the phenomenon of compression, the length at rest of the absorbent block 21 is advantageously greater than the length extending, in the final assembled configuration, between the bottom wall 3216 of the housing 321 of the interface 32 and the bottom wall 231 of collection part 23.

The reduction in length of the chamber 4 causes the two ends of the absorbent block 21 to come together and put it into compression.

This particular dimension makes it possible here to apply compression to the absorbent block 21 during the relative translational movement.

To ensure the torsion phenomenon, the inner portion 211 of the absorbent block 21 is advantageously locked in rotation with the collection part 23 and the outer portion 212 of the absorbent block 21 is advantageously locked in rotation with the housing 321 of the interface 32. In this case, the guide means 6 are advantageously structured to guide this relative movement according to the two successive relative movements comprising:

- the relative translational movement, to apply compression to the absorbent block 21 in a first step, then - the relative rotational movement, advantageously to apply the torsion to the absorbent block 21 in a second step.

As it is extracted, the biological sample is evacuated from chamber 4 to location 31 containing chromatographic strip 7.

The sealed assembly means 5 then direct the biological sample through the outlet opening 3212, then here through the intermediate tank 315, before reaching the chromatographic strip 7.

The biological sample then migrates along the length of the chromatographic strip 7.

According to the first embodiment or the third embodiment, the result of the analysis can be read through the reading window 3121, 81b opposite which the capture zone 73 of the chromatographic strip 7 is intended to position.

According to the second embodiment, the result of the analysis can be read at the level of the projecting section of the chromatographic strip 7.

Of course, various other modifications may be made to the invention within the scope of the appended claims.

Claims

Claims [Claim 1] 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 the said biological sample, which rapid analysis device (1 ) understand :

(1) a sampling member (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 organ

(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) comprises sealed assembly means (5) which allow, between them, a degree of freedom in translation and a degree of freedom in rotation, which sealed assembly means (5) comprise 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 a compression to said absorbent block (21), and

- a relative rotational movement, advantageously provided to apply a torsion to said absorbent block (21).

[Claim 2] Device for the rapid analysis of a biological sample, according to claim 1, characterized in that said guide means (6) are structured to guide said relative movement according to two successive relative movements comprising said relative translation movement then said relative rotational movement.

[Claim 3] Device for the rapid analysis of a biological sample, according to any one of claims 1 or 2, characterized in that the guide means (6) comprise at least one groove (61) / lug ( 62), advantageously at least two groove (61)/lug (62) pairs, to guide said relative movement.

[Claim 4] 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).

[Claim 5] 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 with said outlet opening (3212), which bottom wall (3216) is provided with ribs (3216a) and/or grooves (3216b), advantageously oriented radially.

[Claim 6] 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).

[Claim 7] 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 receive 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.

[Claim 8] 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 receive 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.

[Claim 9] Device for the rapid analysis of a biological sample, according to claim 8, characterized in that the complementary surfaces of the tubular skirt (232) and/or of the side wall (3215) of the housing (321) comprise at least one annular rib (2326).

[Claim 10] 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) comprises respective longitudinal axes (31', 321'), which longitudinal axes (31', 321') are parallel to one another, which location (31) comprises 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).

[Claim 11] 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 a bottom face adapted to rest on a receiving surface, - a top 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 of said top wall (35).

[Claim 12] 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. [Claim 13] 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 biological saliva sample, which rapid analysis system comprises:

- said analysis device (1) according to any one of claims 1 to 12, and optionally