WO2023067288A1

WO2023067288A1 - System for detecting a target substance in a sample

Info

Publication number: WO2023067288A1
Application number: PCT/FR2022/051999
Authority: WO
Inventors: Jean-Michel Godart; Cécile NAUD; Edouard BERT
Original assignee: Elimaje
Priority date: 2021-10-21
Filing date: 2022-10-21
Publication date: 2023-04-27
Also published as: FR3128363A1

Abstract

The present invention relates to a system for collecting and analysing (1) a solid sample, comprising: - collecting tweezers (10) comprising two legs (12) connected by a handle (13), a distal end of the legs (12) each comprising a through-cavity (14) extending transversely to the legs (12) and opening onto the inner (12a) and outer (12b) surfaces of the legs (12); - a vessel (20) designed to accommodate a resuspension liquid; - a wiper seal (30) mounted on the proximal coupling (21) of the vessel (20) and comprising a wiper port (31) designed to accommodate the distal end of the legs (12), the wiper port (31) being dimensioned so as to wipe the outer surface (12b) of the legs (12) as they are inserted into the wiper seal (30); and - an analysis system (40) designed to be mounted on the distal port (22) of the vessel (20).

Description

DESCRIPTION

TITLE: System for the detection of a target substance in a sample

FIELD OF THE INVENTION

The present invention relates to a system for the detection of a target substance in a solid sample, in particular for the detection of blood in the stools of a patient. More specifically, the invention relates to a device for detecting blood in the stool allowing the patient to carry out the test himself at home.

The invention is particularly applicable for carrying out screening tests for colorectal cancer. The invention may also be applicable in other fields, medical or not, requiring the detection of a target substance in a sample. The invention can for example be used to detect bacteria or fungi in a sludge sample, or even pollutants in soil.

STATE OF THE ART

The detection of blood in the stool is a well-known method for the detection of pathologies affecting the digestive system of a patient. Thus, for example, colorectal cancer can be detected in a patient by a screening test which consists in highlighting the presence of blood in the patient's stools.

Currently, colorectal cancer screening tests are performed using a faecal matter collection kit generally comprising a bottle filled with a liquid and a cap configured to close the bottle. The stopper has a rod 12 ribbed or grooved at its end which is immersed in the liquid when the stopper is placed on the bottle. The patient should then collect a stool sample by scraping the stool with the end of the rod 12, so that the ridges/grooves of the rod 12 collect faecal matter. Once the sample has been taken, the rod 12 is immersed in the bottle. The bottle is finally closed with the cap and sent by post to an analysis laboratory accompanied by an administrative form duly completed by the patient in order to indicate the date on which the sample was taken for the correct interpretation of the result of the laboratory test. However, if the patient forgets to indicate the date of the sample or his name, this sample cannot be analyzed by the laboratory and it is necessary to repeat the operation. The patient must also send the bottle containing the sample to the laboratory by post within 24 hours, which is binding. Finally, stool analysis by a laboratory is expensive and means that the patient has to wait for the results, which is anxiety-provoking.

Devices have therefore been proposed allowing a patient to take and analyze a sample, without necessarily requiring the sample to be sent to an external laboratory. However, calibrating the amount of sample taken can be difficult for the patient to do, which can adversely affect the results of the analysis. The proposed devices can also be complex to handle, have limited ergonomics and have a high cost.

DISCLOSURE OF THE INVENTION

A general object of the invention is to further improve the sampling and analysis systems of the prior art, in particular for the sampling and analysis of stools for the detection of blood, by proposing a system that is less cumbersome and more ergonomic for a more reasonable cost and can also be used by the patient directly at the place of collection.

The object of the invention is in particular to allow the patient to naturally take a stool sample and to proceed easily and quickly to the detection of blood in his stools at home, in a reliable, simple and ergonomic manner, without the need for Send the sample to an analysis laboratory.

For this purpose, according to a first aspect of the invention, a system for taking and analyzing a solid sample, for example faeces, comprising:

- a collection forceps comprising two rods connected by a handle, each rod having an external face and an internal face, a distal end of the rods each comprising a through-cavity extending transversely to the rods, the through-cavity of each rod opening onto the internal face and the external face of the corresponding rod;

- a reservoir configured to receive a re-suspension liquid, the reservoir comprising a proximal connector configured to receive the rods of the collection forceps, and a distal connector opposite the proximal part;

- a scraper seal mounted on the proximal connection of the reservoir and comprising a scraper orifice configured to receive the distal end of the rods, the scraper orifice being dimensioned so as to scrape the external face of the rods during their insertion into the seal scraper ; And

- an analysis system configured to be mounted on the distal connection of the reservoir.

The sampling and analysis system according to this first aspect thus allows the patient to easily and accurately calibrate the sample to be analyzed. The system is also ergonomic, thanks to the configuration of the gripper which allows easy gripping of the sample while remaining at a distance from it.

Certain preferred but non-limiting characteristics of the sampling and analysis system according to the first aspect are the following, taken individually or in combination :

- the cavities of the rods extend in line with each other;

- the scraping orifice is closed by a sealing element, the sealing element comprising at least one of the following elements: a lid configured to be opened by the distal end of the rods during their passage through the scraper port, a dolly configured to be pushed into the reservoir by the distal end of the rods as they pass through the scraper port, a cap configured to be removed by the patient;

- A distal end of the rods is configured to break when the rods are inserted into the reservoir so as to open the cavity on the distal face of the rods;

- the system further comprises a striker housed in the reservoir, the distal end of the rods being configured to bear against and break against the striker when the rods of the collecting forceps are inserted into the reservoir;

- the analysis system comprises a support configured to be mounted on the distal connection of the reservoir; and a strip configured to be mounted in the holder;

- the reservoir further comprises an obturator configured to seal the distal connection of the reservoir before mounting of the support on the distal connection;

- the support is movable relative to the reservoir between a first position, in which the support is at a distance from the shutter and a second position in which the support places the resuspension fluid in fluid communication with a distal end of the strip ;

- the shutter comprises a cap and the support is movable in translation relative to the reservoir between a first position in which the support is at a distance from the cap and a second position in which the support pierces the cap and puts in fluid communication the resuspension fluid and a distal end of the strip;

- the system further comprises a removable stopper mounted between the support and the reservoir, said stopper being configured to hold the support in the first position; and or

- the system further comprises a seal mounted on the support and configured to prevent fluid communication between a distal end and a proximal end of the strip.

According to a second aspect, the invention proposes a sampling kit comprising a sampling and analysis system according to the first aspect and a sheet for collecting a solid sample. DESCRIPTION OF FIGURES

Other characteristics, objects and advantages of the invention will emerge from the description which follows, which is purely illustrative and not limiting, and which must be read in conjunction with the appended drawings in which:

FIG. 1 illustrates a sampling and analysis system in accordance with one embodiment of the invention, the analysis system being in the dry position;

Figure 2 shows the collection clamp of the sampling and analysis system of Figure 1;

Figure 3 is a partial cross-sectional view of the collection forceps of Figure 2, in which a rod has been omitted;

FIG. 4 illustrates an exemplary embodiment of an analysis system in accordance with one embodiment of the invention;

Figure 5 illustrates an insert and strip of the assay system of Figure 4; And

Figure 6 is an exploded view of the reservoir and wiper seal of the sampling and analysis system of Figure 1.

In all the figures, similar elements bear identical references.

DETAILED DESCRIPTION OF THE INVENTION

A system for taking 1 and analyzing a solid sample, for example faeces, in accordance with the invention comprises:

- a collection clamp 10 configured to collect a solid sample;

- a reservoir 20 configured to receive a resuspension liquid, the reservoir 20 comprising a proximal connector 21 configured to receive the free end 11 of the collection forceps 10, and a distal connector 22 opposite the proximal connector 21;

- a scraper seal 30 mounted on the proximal part of the reservoir 20 and comprising a scraping orifice 31 configured to calibrate the solid sample during the insertion of the free end 11 of the clamp 10 into the reservoir 20; And

- an analysis system 40 configured to be mounted on the tank 20 and analyze the calibrated solid sample.

In what follows, the terms "proximal" and "distal" will be used in reference to the use of the sampling system 1 during the sampling phase, "proximal" meaning that a part or an end is close to the patient and "distal" meaning the part or end is away from the patient. For example, the collection clamp 10 is in the figures on the proximal side of the system while the analysis system 40 is on the distal side of the latter, even if during the analysis phase, the user is brought manipulate the analysis system 40. Furthermore, the term “longitudinal axis” will denote the axis of extension of the gripper 10. This longitudinal axis corresponds substantially to an axis of symmetry of the gripper 10. A direction transverse to this axis then corresponds to a direction along an axis perpendicular to the longitudinal axis.

Collection forceps 10

The collection clamp 10 comprises two rods 12 connected by a handle 13.

Each rod 12 has an outer face 12b and an inner face 12a, the inner faces of the rods 12 being placed opposite one another. When the collection forceps 10 are pinched by a patient, the internal faces of the rods 12 therefore approach each other until they come into contact, at least in their distal part, in order to prevent a part of the sample does not accumulate between the rods 12. The inner face 12a of the rods 12 can be substantially flat over all or part of its length. Their external face 12b can be curved (convex) in order to facilitate their scraping.

Each rod 12 is connected to the handle 13 in the proximal part and includes a free end in the distal part. A cavity 14 extending transversely to the rods 12 is formed in the distal part of the rods 12, close to their free end. The cavities 14 are through, that is to say they are open and open onto the internal face 12a and the external face 12b of the corresponding rod 12. The cavities 14 each form a reservoir intended to receive a portion of sample to be analyzed. Preferably, the cavities 14 therefore do not open onto the distal face 12c (end) of the free end of the rods 12.

In practice, a patient can simply grasp the collection forceps 10 by the handle 13, press the free end of the rods 12 onto the surface of the sample (for example faecal matter) and close the forceps 10. This movement has for the purpose of filling the cavities 14 from the inside of the clamp 10. The cavities 14 being open on the external face 12b of the rods 12, their filling is more effective since air is not likely to be trapped there. The patient can also visually check that the cavities 14 are indeed filled and, if necessary, repeat the filling operation by pinching the surface of the sample again with the free ends of the rods 12 of the clamp 10. The area of the clamp 10 (distal end 11) being located opposite the gripping zone of the clamp 10 (handle 13), handling is also easier for the patient since he remains at a distance at all times faecal matter.

The cavities 14 for collecting the sample being placed at the level of the distal end 11 of the clamp 10 and being open transversely with respect to the orientation of the clamp 10 during sampling, the sampling of the sample is carried out at the surface and not at depth, as may be the case when the sample is taken by going to through the sample by coring. The invention is therefore of very particular interest (although not limited) to the sampling of fecal matter with a view to screening for colorectal cancer.

Optionally, the distal end 12c of the free end of the rods 12 can be scored, that is to say breakable, in order to break when the rods 12 come into abutment in the reservoir 20. By distal end 12c, it will be understood here the part of the rod 12 is located between the cavity 14 and the distal tip of the rod 12. The rupture of the distal end 12c of the rods 12 in fact makes it possible to open the cavities 14 even further and to facilitate the dispersion and the mixing of the collected sample in the re-suspension liquid. The cavities 14 are then open on the internal face 12a, the external face 12b and the distal face 12c of the rods 12.

The breakable nature of the distal end 12c of the rods 12 can for example be obtained by making the end 12c of the rods 12 in a fragile plastic material or whose thickness is such that the end breaks when it is pushed against a harder surface.

Alternatively, the distal tip 12c of the distal end of the rods 12 may be made of a soluble material and dissolve in the re-suspension fluid to open the cavity 14 on the distal face 12c of the rods 12 when the rod (12) is introduced into the tank (20).

Clamp 10 can for example be made of plastic. The shape of the handle 13 is preferably chosen so as to be easily gripped by a patient, either transversely or in the extension of the rods 12.

Optionally, the proximal part 15 of the rods 12 can have a larger cross-section than their distal part (which includes the cavities 14). This proximal part 15 is configured to penetrate into the wiper seal 30 and improve the sealing of the connection of the clamp 10 with the reservoir 20.

Tank 20

Reservoir 20 is preferably pre-filled with re-suspension fluid to ensure that the analysis volume matches the sample volume calibrated by wiper seal 30.

Alternatively, the reservoir 20 can be filled by the patient before insertion of the collection clamp 10.

Reservoir 20 includes a generally cylindrical rigid shell including proximal connector 21 and distal connector 22. Proximal connector 21 is open at a proximal opening 24 configured to receive rods 12 of clamp 10 and distal connector open at a distal opening 25 located opposite the proximal opening 24. Reservoir 20 further includes chamber 23 configured to receive replacement fluid. suspension. Chamber 23 is preferably located between proximal connector 21 and distal connector 22.

The wiper seal 30 is placed in the proximal connection 21 of the reservoir 20 and plugs the proximal opening 24, preferably in a leaktight manner, in particular when the reservoir 20 is prefilled with the resuspension fluid.

Optionally, the reservoir 20 further comprises a striker 50 fixedly mounted in the chamber 23 and configured to break the distal end 12c of the free end of the rods 12 by contact when the clamp 10 is introduced into the reservoir 20. More specifically, the striker 50 has a proximal surface 51 that is substantially planar, rigid and fixed relative to the reservoir 20, which is positioned so that, when the collection clamp 10 is introduced into the reservoir 20, the distal end 12c of the rods 12 comes into abutment and breaks against the proximal surface of firing pin 50.

The striker 50 is configured so as to allow the circulation of fluid in the chamber 23 of the reservoir 20 in order to allow fluid communication between the proximal connector 21, configured to receive the clamp 10, and the distal connector 22, configured to receive the system analysis 40. The striker 50 can for example be formed integrally and in one piece with the tank 20 and include through passages to allow the flow of fluid between the two connections.

As a variant, the striker 50 can be attached and fixed in the chamber 23 of the reservoir 20. In the embodiment illustrated in the figures, the striker 50 then comprises a base 52 of frustoconical shape whose proximal end, narrower, corresponds to the proximal surface 51. In order to allow the circulation of fluid, the wall connecting the proximal surface 51 and the distal end 54 of the striker 50 is perforated and comprises projecting fins 55 which are configured to come into contact with the surface interior of chamber 23 of tank 20.

Reservoir 20 may further comprise a shutter 27 configured to close its distal opening 25 in leaktight manner. removable plug configured to be inserted into the distal connector 22 to seal the distal opening 25 and to be removed before insertion of the analysis system 40.

Reservoir 20 may be monolithic. As a variant, as illustrated in FIG. 6, the reservoir 20 can comprise several parts, for example a first part comprising the proximal connector 21 and the chamber 23 and a second part comprising the distal connector 22 fixed together in order to facilitate manufacturing operations. . The obturator 27 can then be placed in the distal opening 25 of the distal connector 22 (in particular when it is a plug) or at the interface between the chamber 23 and the distal connector 22 (in particular when it is is an operculum). Wiper seal 30

Wiper seal 30 is mounted on proximal connector 21 of reservoir 20. In one embodiment, wiper seal 30 is mounted in proximal connector 21 and opens into chamber 23.

The wiper seal 30 may comprise a cylindrical proximal part 32 and a distal scraping part 33. The cylindrical proximal part 32 has an outer surface configured to come into surface contact with the inner surface of the proximal connector 21 and an inner surface configured to come into surface contact with the proximal portion 15 of the rods 12. The distal scraper portion 33 extends from the proximal portion 32 and includes the scraper port 31 configured to size the solid sample upon insertion of the distal portion of the rods 12 in the reservoir 20. The scraping part 33 may for example have a generally frustoconical shape whose apex of smaller diameter extends into the chamber 23 of the reservoir 20, in the direction of the distal opening 25. The part of smaller diameter is open and corresponds to the scraping orifice 31 .

The shape and the dimensions of the scraping orifice 31 are chosen in order to allow the passage of the distal ends through the scraping orifice 31 when the collection clamp 10 is closed, that is to say when the internal faces rods 12 are in contact with each other, while scraping the external face 12b of the rods 12 in order to remove the excess material protruding from the external face 12b of the rods 12. Thus, the edge delimiting the orifice scraper 31 is in contact at all times with the outer face 12b of the rods 12 when their free end, and more particularly the cavities 14, pass through the scraper orifice 31.

The scraping part 33 can for example extend in the extension of the proximal cylindrical part 32 . Preferably the cylindrical part 32 and the scraping part 33 are formed integrally and in one piece, typically by molding. The wiper seal 30 can for example be made of silicone or rubber.

In one embodiment, the scraping orifice 31 may be closed by a sealing element before insertion of the clamp 10 into the scraper seal 30. The sealing element may in particular comprise a cover configured to be torn by the distal end 12c of the rods 12 during their insertion into the wiper seal 30. The lid can for example be made of the same material as the wiper seal 30, typically silicone or rubber, and include a single line of weakness or shape of a cross configured to break when the distal tip 12c of the rods 12 is pressed against it.

As a variant, the sealing element of the scraper seal 30 can comprise a diabolo, that is to say a plug retained by the scraping orifice 31 and optionally fixed to the walls delimiting the scraping orifice 31. insertion of the distal end 12c of the rods 12 into the wiper seal 30 then has the effect of pushing the diabolo into the reservoir 20 and opening the scraping orifice

31.

According to yet another variant, the wiper seal 30 may comprise a plug mounted in the proximal cylindrical part of the wiper seal 30 or on the proximal opening 24 of the reservoir 20 so as to prevent the resuspension fluid from exiting the chamber 23 .

In a first embodiment, the analysis system 40 comprises a support 41 configured to be mounted on the distal part of the reservoir 20 and a strip 42 configured to be mounted on the support 41 .

The analysis system 40 is configured so as to put the strip 42 and the resuspension fluid in fluid communication only once the sample has been placed in the reservoir 20. For this, the analysis system 40 is mobile relative to the reservoir 20 between a first position, called the dry position, in which the support 41 is at a distance from the chamber 23, and a second position, called the analysis position, in which the support 41 places the fluid of the re-suspension and a distal end of the strip 42.

It will be understood that in the first position, the support 41 can be mounted on the tank 20, or alternatively distinct and remote from the tank 20.

In a first embodiment, the support 41 is mounted on the tank 20. The support 41 can for example be mounted movable in translation on the tank 20 by means of a sliding connection. To this end, the support 41 and the reservoir 20 comprise at least one rectilinear rib 26 extending substantially along the axis of translation of the support 41, and a complementary groove 43 configured to receive the protuberance. In the example illustrated in the figures, the rib 26 extends from the inner surface of the reservoir 20 near its distal opening 25, the groove 43 being formed on an outer face 12b of the support 41 .

Holder 41 may be held in the dry position by a removable stopper 44 to ensure that the strip 42 does not come into contact with the re-suspension fluid before the patient has placed the sample in the reservoir 20 In a first embodiment, the removable abutment 44 can be placed between the support 41 and the reservoir 20. For example, the removable abutment 44 can comprise a ring configured to bear on the one hand on the distal face 12c of the reservoir 20 and on the other hand on the support 41, for example on a flat flange 45 extending transversely from the support 41. Removing the ring thus releases the support 41 in order to allow its movement towards the analysis position. In this embodiment, the obturator 27 which closes the distal orifice of the reservoir 20 preferably comprises a lid, which can be pierced by the support 41 when the support 41 is moved from the dry position to the analysis position. This configuration in fact makes it possible to limit the number of actions necessary for taking the sample and analyzing it by the patient. Preferably, the thickness of the removable stop 44 is substantially equal to the distance to be traveled by the support 41 to place the proximal part of the strip 42 in the chamber 23 of the reservoir 20. The collar 45 of the support 41 comes in particular bearing against the distal face 12c of the reservoir 20 and prevents the support 41 from sinking further into the reservoir 20.

In a second embodiment, the removable stop 44 can be formed by the shutter 27, when the shutter 27 comprises a plug. Removing the cap then allows the support 41 to move towards the analysis position. Preferably, the support 41 then comprises a stop, such as the collar 45, in order to limit the travel of the support 41 in the reservoir 20 and only position the proximal part of the strip 42 in the reservoir 20.

In a second embodiment, the support 41 is distinct and separate from the reservoir 20. This embodiment makes it possible in particular to keep the support 41 of the strip 42 and the strip 42 in a separate protective envelope from the rest of the sampling system 1 to ensure that strip 42 remains protected from moisture prior to use. In this embodiment, the shutter 27 may comprise a removable plug, which will be removed before insertion of the support 41 in the tank 20, or a cover, for example metallic, which will be crossed by the support 41 when it is connected to the tank 20 .

The support 41 is configured to receive the strip 42 and put it in fluidic contact with the resuspension fluid when the calibrated sample is inserted into the reservoir 20. For this purpose, the support 41 comprises a body comprising a central passage configured to receive the strip 42. The distal part of the body also has an outer surface 12b configured to be manipulated by the patient in order to move the support 41 from the dry position to its analysis position. For this purpose, the distal part of the body may include handling fins extending transversely from its outer surface 12b.

The central passage is open on the proximal end of the support 41 in order to allow the fluidic communication of the strip 42 with the chamber 23 which contains the re-suspension fluid. If necessary, the central passage can also be opened on the distal end of the support 41, for example to facilitate the manufacture of the support 41 and/or the insertion of the strip 42.

The strip 42 can be inserted directly into the central passage. As a variant, the support 41 can comprise an insert 46 distinct from the body and configured to receive the strip 42. The insert 46 may for example comprise a channel comprising a flat bottom 47 and raised edges 48 (on either side of the strip 42 and where appropriate at its distal end) configured to hold in position the strip 42 with respect to the insert 46. Alternatively, the insert 46 may comprise a sheath comprising an elongated body in which is formed a central slot configured to receive the strip 42 with adjustment in order to block it with respect to the sheath. The central slot is then opened on the proximal end of the insert in order to allow part of the strip to protrude from the sheath via this proximal end and to come into fluid contact with the resuspension liquid. The sheath can for example comprise two half-shells, which can each comprise a chute, and are configured to be assembled in order to together delimit the central slot and the body of the insert 46.

The strip 42 is then housed in the insert 46, the insert 46 then being inserted into the central passage of the support 41. This configuration (with chute or sheath) simplifies the introduction of the strip 42, which is flexible, into the central passage while ensuring that it is held in position in the support 41 . Thus, the strip 42 is not likely to move during manipulations, which guarantees its fluidic communication with the chamber 23 when the support 41 is in the analysis position.

Preferably, the shape of the central passage corresponds substantially to the shape of the insert 46 in order to guide the insert 46 and prevent any play between the insert 46 and the support 41 during manipulations of the sampling system 1 by the patient. . If necessary, the internal wall which delimits the central passage and the insert 46 can comprise complementary means for guiding and locking the insert 46 in the central passage, such as one or more ribs 26/grooves 43 formed in the internal wall and/or the insert 46.

Optionally, the support 41 further comprises a sealing element 28 mounted on the support 41 and configured to prevent fluid communication between a distal end and a proximal end of the strip 42. The sealing element 28 can for example be placed at a distance from the proximal end of the strip 42 of between 10% and 25% of the total length of the strip 42 in order to allow the impregnation of the proximal end of the strip 42 while maintaining the rest of the strip 42 dry. The sealing element 28 may comprise a seal (see FIG. 6) housed in the central passage of the support 41 or, if necessary, in the central slot of the insert 46. Alternatively, the sealing element 28 can be formed by the cooperation between the internal wall of the support 41 which delimits the central passage and the insert 46. The internal wall can in fact be configured to pinch the insert 46 and/or the strip 42 in a zone distant from the proximal end of the strip 42 so as to prevent the passage of the re-suspension fluid towards its distal end. Optionally, when the obturator 27 of the distal opening 25 of the reservoir 20 comprises a cover, the proximal end of the support 41 further comprises a perforator 48 configured to perforate the cover when the support 41 is brought into its position of analysis. Punch 48 may extend from the proximal end of holder body 41 and be monolithic with the body. The perforator 48 can then comprise one or more points protruding from the distal end, near the strip 42. Alternatively, the perforator 48 can extend from the proximal end of the insert 46. The insert 46 then comprises a convergent proximal end 48a, for example pointed, which protrudes in the proximal part of the central passage of the body of the support 41 .

The strip 42 is a substantially flat strip, which can be rectangular, and comprises several solid parts allowing the migration of a liquid sample. The solid parts can for example comprise successively: a sampling part configured to be immersed in the sample and serves as a filter. The sampling part is configured to extend near the proximal end of the support 41 in order to come into contact with the resuspension liquid; a detection part on which detection antibodies are impregnated and dried. These antibodies can be coupled to colored markers to be visible to the naked eye when grouped with sufficient density; a nitrocellulose membrane which may include one or more test lines composed of capture antibodies, for example two test lines. During the passage of the sample, the antibodies of the detection part mix with the sample and migrate with the sample to the nitrocellulose membrane. If predetermined biomarkers (corresponding to the biomarkers revealing a pathology that one seeks to identify) are present in the sample, these biomarkers are captured by the capture antibodies and revealed by the detection antibodies which will have migrated from the part detection; and a control line configured to attest to the migration of the liquid. The control line is visible whether the sample contains the biomarkers or not. an absorbent part, configured to store the detection antibodies when the sample does not contain biomarkers (because they are not captured by the capture antibodies).

Such strips are known to those skilled in the art. Examples of commercial strips that can be used for example in colorectal cancer screening are marketed by BIOHIT Healthcare in the ColonView Quick Test device, or by EIKEN CHEMICAL CO. ltd. in the OC-Light™ S device. These two devices in fact each comprise at least one strip configured to reveal a predetermined biomarker of colorectal cancer. In a second embodiment, the analysis system 40 comprises a microfluidic chip configured to detect the target substance to be identified in the sample, such as blood for example. The microfluidic chip for this purpose includes reaction chambers in which reagents are located that react with the target substance. The reagents can for example be proteins or antibodies.

For the detection of blood, the microfluidic chip can for example be a blood detection chip by immunoagglutination. Detection of blood by immunoagglutination is a known method. Antibodies are placed in the reaction chambers, and react with hemoglobin molecules to form aggregates. The microfluidic chip can in particular be configured to perform passive immunoagglutination, or active immunoagglutination based on magnetic activation.

Reference may be made to document FR3073291 for more details on this type of chip.

The microfluidic chip can in particular be mounted in a central passage formed in a support 41 similar to the support 41 of the first embodiment. On the other hand, it is not necessary to fix the microfluidic chip in the support 41 via an insert 46, the chip being substantially more rigid than a strip 42.

Sampling process

Sampling can be performed as follows using the sampling system 1 of the invention. The steps will more particularly be described in the case of the collection of faecal matter. However, the sample is taken in the same way regardless of the sample taken.

During a step E1, the patient places or fixes a sheet of paper (which can be adhesive) on the toilet. The sheet of paper may have a particular folding in order to form a reservoir 20. Such a sheet of paper being conventional, it will not be further detailed here.

The patient can then place a sample of fecal matter in reservoir 20.

During a step E2, the patient grasps the collection forceps 10 by its handle, places its distal end against the surface of the sample and closes the forceps 10 so as to fill the cavities 14. The cavities 14 are filled by inside.

The patient can then visually check that the cavities 14 are full (and do not include a vacuum, for example due to the presence of air in the sample). If necessary, the patient can repeat step E2 until the cavities 14 are full. The external 12b and internal faces of the clamp 10 may, if necessary, be soiled. However, it is not necessary to remove the excess sample, this being done mechanically in the next step when inserting the clamp 10 into the reservoir 20.

Preferably, the patient keeps the collection forceps 10 closed by placing the internal surface 12a of the rods 12 in contact in order to prevent the cavities 14 from emptying from the inside under the effect of gravity. If necessary, the collection forceps 10 may include a closure system in order to hold the rods 12 against each other.

During a step E3, the patient introduces the clamp 10 closed in the scraper seal 30 until the proximal part 15 of the rods 12 comes into abutment against the distal scraping part of the scraper seal 30. When the end distal of the rods 12 passes through the scraping orifice 31, the outer face 12b of the rods 12 slides against the wall of the scraping orifice 31 . The excess fecal matter attached to the outer surface 12b of the rods 12 is then blocked by the scraper seal 30 and only the fecal matter enclosed in the cavities 14 enters the reservoir 20. The sample of fecal matter is then perfectly calibrated according to the volume of re-suspension liquid contained in the reservoir 20.

When the reservoir 20 is not prefilled, the method further comprises a prior step of filling the reservoir 20 and, where appropriate, of closing its proximal connector 21 using the wiper seal 30.

During an optional step E4, the distal end 12c of the rods 12 opens in order to open the cavity 14 on the distal face 12c of the rods 12 and to facilitate the dispersion and mixing of the sample taken from the re-suspension liquid. In one embodiment, the distal tip 12c breaks upon contact with a striker 50 housed in the chamber 23 of the reservoir 20. Alternatively, the distal tip 12c dissolves in the re-suspension liquid.

During a step E5, the patient places the support 41 in the analysis position.

For this, when the support 41 is mounted on the reservoir 20, the patient removes the removable abutment 44 then pushes on the support 41 in the proximal direction to perforate the cap blocking the distal opening 25 and bring the proximal end of the support 41 and strip 42 in fluid contact with the resuspension fluid.

When the support 41 is separated from the reservoir 20, the patient places the support 41 against the distal opening 25, then inserts the distal end of the support 41 and of the strip 42 into the reservoir 20 (after piercing a lid or opening of the cap.

Optionally, the system comprises retaining means 49, 29 of the support 41 on the reservoir 20 when the support 41 is in the analysis position, in order to prevent the removal of the support 41. For example, the retaining means 49, 29 may comprise complementary snap-fastening means, such as a hook 29 mounted on one of the internal face of the tank 20 and the external face of the support 41 and configured to deform when passing a protrusion 49 mounted on the other between the internal face of the tank 20 and the external face of the support 41, the hook 29 then blocking the protuberance by elastic return and thus preventing the output of the support 41 from the tank. The protuberance 49 can for example have the shape of a ramp fixed on the external face of the support 41 (respectively, on the internal face of the reservoir 20) whose thickness increases (respectively, decreases) progressively from the proximal end in the direction from the distal end of the support 41 (respectively, the distal end in the direction of the proximal end of the reservoir) up to a peak then decreases abruptly so as to form an abutment. During the assembly of the support 41 on the reservoir 20, the hook 29 slides on the ramp of the protuberance 49 until it reaches its top and then comes into abutment against the latter by elastic return. The protuberance 49 then blocks the hook 29 and retains the support 41 on the reservoir 20.

EXAMPLES of sampling systems in accordance with the invention:

Example 1: A system for collecting and analyzing a solid sample, for example feces, comprising: a reservoir comprising a chamber configured to receive a re-suspension liquid for a solid sample and a distal connection closed by a obturator to seal the distal connector; a test system comprising a holder configured to be mounted on the distal fitting of the reservoir and a test strip configured to be mounted in the holder; and a perforator mounted on the carrier and configured to open the shutter; the support being movable between a first position, in which the analysis system is at a distance from the obturator, and a second position in which the perforator opens the obturator so as to place the reservoir chamber and the strip in fluid communication .

The sampling system according to Example 1 thus makes it possible to put the analysis system in fluid communication in a simple and rapid manner with the resuspension fluid, after dissolution of the solid sample. The patient can therefore carry out all the steps himself at home, from sampling to analysis, thanks to an ergonomic device that takes up little space. The analysis system can also be stored away from the rest of the sampling system, which guarantees the storage conditions of the strip and its proper functioning during the analysis. Example 2: Sampling and analysis system according to Example 1, in which the support comprises a body in which is formed a central passage configured to receive the strip, the central passage being open at a proximal end of the body.

Example 3: Collection and analysis system according to example 2, in which the support further comprises an insert configured to be inserted and housed in the central passage of the body, the insert being configured to receive the strip, the strip being placed in the body of the support via the insert.

Example 4: Sampling and analysis system according to example 3, in which the insert comprises at least one of the following means:

- A chute comprising a bottom and raised edges dimensioned so as to receive the strip;

- a sheath comprising an elongated body in which is formed a central slot configured to receive the strip with adjustment in order to block it with respect to the sheath.

Example 5. Sampling and analysis system according to one of examples 3 or 4, in which the perforator is integral with the insert and protrudes from the body.

Example 6: Sampling and analysis system according to one of Examples 1 to 5, in which the analysis system is mounted on the distal connector, the sampling and analysis system further comprising a removable stop mounted between the distal connector and the bracket to lock the bracket in the first position.

Example 7: Sampling and analysis system according to one of Examples 1 to 6, further comprising means for retaining the support on the distal connector when the support is in the second position.

Example 8: Sampling and analysis system according to one of Examples 1 to 7, in which the shutter comprises a cap, for example metallic, the perforator being configured to pierce the cap when the support is in the second position .

Example 9: Collection and analysis system according to one of examples 1 to 7, in which the obturator comprises a diabolo, the perforator being configured to push the diabolo into the distal connector and release a distal opening of the distal connector when the support is in the second position.

Example 10: Collection and analysis system according to one of Examples 1 to 9, further comprising at least one collection rod comprising a free end configured to collect a solid sample, the reservoir further comprising a proximal connector configured to receive the free end of the collection rod and place it in fluid communication with the chamber.

Example 11 Sampling kit comprising a sampling and analysis system according to one of Examples 1 to 10 and a sheet for collecting a solid sample. Example 12: System for taking and analyzing a solid sample, for example faeces, comprising:

- a reservoir comprising a chamber configured to receive a resuspension liquid for a solid sample and a distal connection;

- an analysis system comprising a support fixed to the distal connector of the reservoir, the support being movable in translation relative to the distal connector between a first position, in which the support is separate and at a distance from the chamber, and a second position , wherein the carrier is in fluid communication with the chamber.

The sampling system according to example 12 is therefore one-piece and includes all the means making it possible to carry out the analysis of the solid sample in situ, by the patient, in an ergonomic, simple and rapid manner.

Example 13: Collection and analysis system according to Example 12, in which the distal connector comprises a distal opening, the collection and analysis system further comprising a shutter configured to seal the distal opening when the support is in the first position.

Example 14: Sampling and analysis system according to one of Examples 12 and 13, in which the shutter comprises a cover configured to be perforated by the support when the support is in the second position, or a diabolo configured to be pushed by the bracket into the tank when the bracket is in the second position.

Example 15: Sampling and analysis system according to one of examples 12 to 14, further comprising a removable stop mounted between the distal connector and the support in order to block the support in the first position.

Example 16: Sampling and analysis system according to one of Examples 12 to 15, in which the support further comprises a strip, the strip being in fluid communication with the chamber when the support is in the second position.

Example 17: Collection and analysis system according to example 16, in which the support comprises a body in which is formed a central passage configured to receive the strip, the central passage being open on a proximal end of the body.

Example 18: Collection and analysis system according to example 17, in which the support further comprises an insert configured to be inserted and housed in the central passage of the body, the strip being placed in the body via insert.

Example 19: Sampling and analysis system according to one of examples 12 to 18, further comprising at least one collection rod configured to collect a solid sample and introduce it into the chamber of the reservoir.

Example 20: Sampling and analysis system according to example 19, in which the collection rod has an external face and an internal face, a free end of the rod comprising a through-cavity extending transversely to the rod, the through-cavity of the rod opening onto the internal face and the external face of the rod.

Example 21: Sampling and analysis system according to one of examples 19 and 20, further comprising means for retaining the collection rod on the proximal connector.

Example 22: Sampling and analysis system according to one of examples 12 to 21, further comprising means for retaining the support on the distal connector when the support is in the second position.

Example 23: Sampling kit comprising a sampling and analysis system according to one of Examples 12 to 22 and a sheet for collecting a solid sample.

Example 24: System for taking and analyzing a solid sample, for example faeces, comprising:

- at least one collection rod having an external face and an internal face, a free end of the rod comprising a through-cavity extending transversely to the rod, the through-cavity of the rod extending at a distance from a distal face of the rod and opening onto the internal face and the external face of the rod;

- a reservoir comprising a chamber configured to receive a resuspension liquid, the reservoir comprising a proximal connector configured to receive the rod and a distal connector opposite the proximal connector; And

- an analysis system configured to be mounted on the distal connection of the reservoir; the distal face of the rod being configured to open when the rod is inserted into the reservoir to open the cavity on the distal face of the rod.

The configuration of the cavity and the rod of the sampling system according to example 24 makes it possible to take samples from the surface of the sample, which makes the sampling system particularly suitable for screening for colorectal cancer. Sample release and dissolution is further improved by opening the free end of the rod. The calibration of the quantity of sample dissolved in the resuspension liquid is therefore more precise.

Example 25: Sampling and analysis system according to Example 24, further comprising a striker housed in the chamber of the reservoir, the free end of the rod being configured to come into abutment against the striker and break when the rod is introduced into the reservoir so as to open the cavity on the distal face.

Example 26: Sampling and analysis system according to example 25, in which the striker is attached and fixed in the chamber.

Example 27: Sampling and analysis system according to one of Examples 25 and 26, in which the striker comprises a base comprising a proximal surface configured to come into contact with the free end of the rod and an openwork wall extending from the proximal surface allowing fluid circulation between the distal connector and the proximal connector.

Example 28: A collection and analysis system according to Example 27, wherein the striker further comprises fins extending from the wall that are configured to contact an interior surface of the chamber to secure the striker in The reservoir.

Example 29: Collection and analysis system according to example 24, in which the free end of the rod is configured to dissolve in the re-suspension liquid so as to open the cavity on the distal face.

Example 30: Collection and analysis system according to one of Examples 24 to 29, comprising two collection rods connected by a handle so as to form a collection forceps, the proximal connection of the reservoir being configured to receive the two rods .

Example 31: Sampling and analysis system according to one of Examples 24 to 30, further comprising a scraper seal mounted on the proximal connection of the reservoir and comprising a scraping orifice configured to receive the free end of the rod, the scraping orifice being dimensioned so as to scrape the outer face and/or the inner face of the rod during its insertion into the wiper seal.

Example 32: Sampling kit comprising a sampling and analysis system according to one of Examples 24 to 31 and a sheet for collecting a solid sample.

Claims

1. System for taking and analyzing (1) a solid sample, for example faeces, comprising:

- at least one rod (12) having an outer face (12b) and an inner face (12a), a distal end of the rod (12) comprising a through cavity (14) extending transversely to the rod (12), the through cavity (14) of the rod (12) opening onto the internal face (12a) and the external face (12b) of the rod (12);

- a reservoir (20) comprising a chamber (23) configured to receive a resuspension liquid, the reservoir (20) comprising a proximal connection (21) configured to receive the rod (12) and a distal connection (22) opposite at the proximal part; And

- an analysis system (40) configured to be mounted on the distal connector (22) of the reservoir (20), the distal face (12c) of the at least one rod (12) being configured to open when the at least one rod (12) is introduced into the reservoir (20) in order to open the cavity (14) on the distal face (12c) of the rod (12).

2. Sampling and analysis system (1) according to claim 1, comprising two collection rods (12) connected by a handle (13) so as to form a collection clamp (10), the proximal connector (21) of the reservoir (20) being configured to receive the two rods (12) and the distal face (12c) of the two rods (12) being configured to open when the rods (12) are inserted into the reservoir (20) so opening the cavity (14) on the distal face (12c) of the rods (12).

3. Sampling and analysis system (1) according to one of claims 1 and 2, wherein the cavities (14) of the rods (12) extend in the extension of one another.

4. Sampling and analysis system (1) according to one of claims 1 to 3, further comprising a scraper seal (30) mounted on the proximal connector (21) of the reservoir (20) and comprising a scraping orifice (31) configured to receive the free end (11) of the rod (12), the scraping orifice (31) being dimensioned so as to scrape the external face (12b) and/or the internal face (12a) of the rod (12) during its insertion into the wiper seal (30).

5. Sampling and analysis system according to claim 4, in which the scraping orifice (31) is closed by a sealing element, the sealing element comprising at least one of the following elements: a lid configured to be opened by the distal end of the rods (12) during their passage through the scraping orifice (31), a diabolo configured to be pushed into the reservoir (20) by the distal end of the rods (12) as they pass through the scraper port (31), a plug configured to be removed by the patient.

6. Sampling and analysis system (1) according to one of claims 1 to 5, further comprising a striker (50) housed in the reservoir chamber (20), a distal end (12c) of the rod ( 12) being configured to bear and break against the striker (50) when the rod (12) is inserted into the reservoir (20).

7. sampling and analysis system (1) according to claim 6, wherein the striker (50) comprises a base (52) comprising a proximal surface configured to come into contact with the free end (11) of the rod (12) and a perforated wall extending from the proximal surface allowing fluid circulation between the distal connector (22) and the proximal connector (21).

8. sampling and analysis system (1) according to claim 7, wherein the striker (50) further comprises fins (55) extending from the wall which are configured to come into contact with an interior surface of the chamber (23) for fixing the firing pin (50) in the tank (20).

9. Sampling and analysis system (1) according to one of claims 1 to 5, wherein the free end (11) of the rod (12) is configured to dissolve in the re-suspension liquid of so as to open the cavity (14) on the distal face (12c).

10. Sampling and analysis system (1) according to one of claims 1 to 9, wherein the analysis system (40) comprises:

- a support (41) configured to be mounted on the distal connector (22) of the reservoir (20);

- a strip (42) configured to be mounted in the support (41); And

- a lid (27) configured to seal the distal connector (22) of the reservoir (20) before mounting the support (41) on the distal connector (22), the support (41) being movable in translation relative to the reservoir ( 20) between a first position in which the support (41) is at a distance from the lid and a second position in which the support (41) pierces the lid and puts the re-suspension fluid in fluid communication with a distal end of the strip (42).

11 . Sampling and analysis system (1) according to claim 10, further comprising a removable stopper (44) mounted between the support (41) and the reservoir (20), said stopper (44) being configured to hold the support ( 41) in the first position.

12. Sampling kit comprising a sampling and analysis system (1) according to one of claims 1 to 11 and a sheet for collecting a solid sample.