FR3111430A1 - 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 - Google Patents

Abstract

The present invention relates to a system for the rapid analysis of a biological sample (E), intended for the detection of the presence of at least one analyte (A) in said biological sample (E). The rapid analysis system comprises: - at least one sampling device (2), suitable for sampling said biological sample (E), - at least one chromatographic strip (3), designed to detect the presence of said at least one analyte ( A), - a buffer solution (4), for the implementation of the chromatographic technique, and - at least one interface device (5), adapted to receive said at least one chromatographic strip (3) for the implementation implementation of said chromatographic technique, which interface device (5) comprises at least two housings (51, 52) in fluid communication with at least a first housing (51) intended to receive at least said buffer solution (4) and at least a second housing (52) designed to introduce at least the deposit zone (311) of said at least one chromatographic strip (3), said second housing (52) being intended to receive said buffer solution (4), optionally mixed with said sample biological tillage (E), flowing from said at least one first housing (51). Figure for abstract: 9

Description

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

Technical field of the invention

The present invention relates to the technical field of systems for the rapid analysis of biological samples, intended for the detection of the presence of at least one analyte in said 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.

In practice, the strip is conventionally implanted in a casing which is adapted to receive only biological samples in liquid form.

Some sampling techniques then require several manipulations to transfer the biological sample to the strip.

This is, for example, the case of biological samples obtained with swab-type sampling devices used for the collection of biological samples from the upper respiratory tract, or even from an environmental surface to be analyzed.

However, it would also be interesting to propose a versatile solution that would allow the analysis of a liquid biological sample, but also the analysis of a biological sample directly from the sampling device.

Presentation of the invention

In order to remedy the aforementioned drawback of the state of the art, the present invention proposes a 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.

The rapid analysis system includes:

- at least one sampling device, suitable for taking said biological sample (possibly from an individual), for example a biological sample from the upper respiratory tract or a capillary blood sample,

- at least one chromatographic strip, advantageously an immunochromatographic strip, designed to detect the presence of said at least one analyte, which at least one chromatographic strip comprises a deposit zone intended to receive said biological sample,

- a buffer solution, for implementing the chromatographic technique, and

- at least one interface device, adapted to receive said at least one chromatographic strip for the implementation of said chromatographic technique.

The interface device comprises at least two housings in fluid communication (preferably only two housings), advantageously in the form of a well, with:

- at least a first housing intended to receive at least said buffer solution, optionally mixed with said biological sample, and

- at least one second housing designed to introduce at least said deposit zone of said at least one chromatographic strip, said second housing being intended to receive said buffer solution, optionally mixed with said biological sample, flowing from said at least one first accommodation.

Such a system is thus particularly interesting in that it offers a versatile solution that allows:

- the analysis of a liquid biological sample, but also

- the analysis of a biological sample present on a collection part of a sampling device.

Such a device also avoids accidental projection of buffer solution and/or biological sample onto an area of the chromatographic strip other than the deposit area.

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 at least two housings each comprise an access opening and a bottom, which funds of said at least two housings are in fluid communication;

- said at least two housings are in fluid communication via a conduit adapted to a flow of the buffer solution, optionally mixed with said biological sample, from said first housing to said second housing; the conduit advantageously has a lower face with a downward slope from said first housing to said second housing, to promote the flow of the buffer solution, optionally mixed with said biological sample from said first housing to said second housing;

- said at least one first housing comprises a side wall which has a decreasing section from an access opening towards a bottom, for example a frustoconical portion preferably followed by a cylindrical final portion;

- said at least one second housing is shaped to guide the introduction of said at least one chromatographic strip;

- the length of the chromatographic strip is greater than the depth of said at least one second housing, so as to give said chromatographic strip a configuration erected on either side of an access opening;

- said at least one interface device comprises a bottom face, adapted to rest on a receiving surface, and an opposite top face, and said at least two housings of said at least one interface device are in the form of wells juxtaposed, advantageously parallel, and opening at said top face;

- said at least one sampling device comprises a collection part suitable for collecting said biological sample; said at least one first housing is suitable for the introduction of said collection part of said at least one sampling device so that the buffer solution ensures the transfer of said biological sample from said at least one first housing to said at least one second housing ; preferably, said at least one first housing comprises a side wall provided with a compression part whose section is identical to, or smaller than, the collection part, which compression part is preferably cylindrical and located on the bottom side;

- said at least one sampling device is chosen from saliva sampling swabs or nasal sampling swabs, or lancets, suitable for generating a drop of capillary blood;

- said at least a first housing comprises a side wall in which is formed at least one groove, for example of spiral or helical shape, extending towards a bottom to promote the flow of the buffer solution, if necessary mixed with said biological sample, towards said bottom;

- at least one of the housings comprises a side wall provided with an annular slot in fluid communication with an internal chamber, said annular slot being advantageously located between a free edge of said side wall and a bottom, to avoid or at least limit a liquid outlet through said housings in the event of tilting of said interface device;

- said at least one interface device is made of a plastic material, advantageously in two assembled parts;

- said at least one chromatographic strip comprises different successive zones, in the direction of capillary migration upstream to downstream, namely at least said deposit zone, intended to receive the buffer solution/biological sample mixture, a release zone which comprises at least a detection reagent conjugated with a visible and/or measurable marker, said detection reagent being able to move as a consequence of the migration of the buffer solution along the chromatographic strip, and at least one capture zone which comprises at least a capture reagent, immobilized on the chromatographic strip;

- said at least one chromatographic strip consists of a chromatographic strip designed to detect the presence of said at least one analyte chosen from antigens, or serological antibodies, specific for an infectious agent, preferably viruses, in particular the viruses responsible for pneumopathies , advantageously Coronaviridae , more preferably Orthocoronavirinae or coronavirus ;

- the buffer solution is packaged in a container which includes a dropper;

- the rapid analysis system comprises a batch [sampling device / chromatographic strip / interface device], for an individual analysis, or several batches [sampling device / chromatographic strip / interface device], for a collective analysis ;

- Said at least one strip is packaged in collective packaging, and said at least one sampling device is packaged in individual packaging.

The present invention also relates to an interface device for a rapid analysis system according to the invention.

The interface device comprises at least two housings in fluid communication (preferably only two housings), preferably in the shape of a well, with:

- at least a first housing, intended to receive at least one buffer solution, optionally mixed with a biological sample, and

- at least a second housing designed for the introduction of a zone for depositing a chromatographic strip.

The present invention also relates to a method for the rapid analysis of a biological sample, using a rapid analysis system according to the invention.

This process includes:

- a step of inserting said at least one chromatographic strip into said second housing,

- a step of adding the buffer solution in said first housing, for the implementation of the chromatographic technique, and

- reading said at least one chromatographic strip positioned in said second housing, after migration of the buffer solution, to detect the presence of said at least one analyte in said biological sample.

In a first preferred mode, the biological sample is deposited directly on the deposit zone of the chromatographic strip, before said insertion step.

In a second preferred mode:

- the insertion step also comprises inserting the collection part of said at least one sampling device into said first housing,

- the step of adding the buffer solution leads to bringing said buffer solution into contact with said collection part of said at least one sampling device positioned in said first housing (advantageously with a movement of said at least one sampling device to promote the flow of the buffer solution/biological sample mixture), to ensure the transfer of said biological sample from said at least one sampling device to said at least one chromatographic strip.

The biological sample is preferably chosen from biological samples from the upper respiratory tract, for example a nasopharyngeal or salivary sample or a capillary blood sample.

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:

is a general and perspective view of a rapid analysis system according to the invention, preferably in an “antigen” approach;

is a general and perspective view of an interface device for the rapid analysis system according to the invention;

is a general side view of the interface device according to FIG. 2;

is a sectional view of the interface device according to FIG. 2, along a sectional plane passing through the first housing;

is an exploded perspective view of the interface device according to FIG. 2;

is another perspective and exploded view of the interface device according to FIG. 2;

is a perspective view of the interface device which shows the insertion of the collection part of the sampling device into the first housing and the insertion of the chromatography strip into the second housing;

is a perspective view of the interface device according to FIG. 7, showing the addition of the buffer solution to the first housing for the implementation of the chromatographic technique;

is a sectional view of Figure 8, the section plane of which passes through the two housings;

is a perspective view illustrating the manipulation of the sampling device in the first housing;

is a general and perspective view of a rapid analysis system according to the invention, advantageously in a “serological” approach;

is a perspective view showing the insertion of the chromatographic strip into the second housing of the interface device, after depositing the biological sample on this chromatographic strip;

is a perspective view showing the addition of the buffer solution to the first housing of the interface device according to FIG. 12, for the implementation of the chromatographic technique.

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

The systems 1 according to the invention, described below in relation to the figures, are suitable for the rapid analysis of a biological sample E with a view to detecting the presence of at least one analyte A in said biological sample. E.

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

By “analyte” is meant any chemical, biochemical or biological entity that it is desired to detect in a biological sample E.

This chemical entity advantageously consists of an entity originating from the living world, preferably from the plant world or 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.

Said at least one analyte A is preferably also chosen from:

- specific antigens of an infectious agent, or

- antibodies developed by a human being that demonstrates an immune response to infection by an infectious agent.

The antibodies sought are advantageously chosen from serum IgM antibodies (immunoglobulins M) preferably on an IgM line or “IgM line” and/or IgG (immunoglobulins G) preferably on an IgG line or “IgG line”.

The term “infectious agent” preferably means viruses, in particular the viruses responsible for pneumopathies, advantageously the Coronaviridae , more preferably Orthocoronavirinae or coronavirus.

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 may in particular be any biological or bodily fluid, including:

- a biological sample from the upper respiratory tract, or

- a sample of capillary blood.

By “biological sample from the upper respiratory tract”, is meant a nasopharyngeal sample or a salivary sample.

The biological sample can be a liquid sample in which the desired analyte is in solution or in suspension.

The term "biological sample" also includes excrement, surface samples, etc. for the detection of biomarkers.

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 excrement.

The biological sample can be urine, whole blood, plasma or serum.

By "whole blood" is meant in particular capillary blood obtained advantageously by means of a lancing device at the level of the pulp of the finger, or the heel, of a human individual.

The biological sample can also be present on a collection part of a collection device described below, for example a saliva collection swab or a nasal collection swab.

For this, the rapid analysis system 1 according to the invention comprises:

- at least one sampling device 2, suitable for taking the biological sample E (advantageously from an individual, or even in the environment, for example on a surface),

- at least one chromatographic strip 3 which is designed to detect the presence of said at least one analyte A,

- a buffer solution 4, for implementing the chromatographic technique, and

- at least one interface device 5 provided with at least two housings 51, 52, of which a second housing 52 is adapted to receive said at least one chromatographic strip 3 for the implementation of said chromatographic technique.

The rapid analysis systems 1 shown here include a single lot [collection device 2 / chromatography strip 3 / interface device 5], for individual analysis.

Alternatively, not shown, the rapid analysis system could comprise several batches [sampling device 2/chromatographic strip 3/interface device 5], for collective analysis (for example in the context of mass screening ).

In this case, the strips 3 can be packaged in collective packaging; the sampling device 2 is packaged in individual packaging.

In general, these components of the rapid analysis system 1 are advantageously grouped / packaged in a package to form a kit.

This kit can then also include an instruction manual.

Sampling device

The rapid analysis system 1 therefore comprises at least one sampling device 2 which is suitable for taking the biological sample E, possibly from an individual.

This sampling device 2 is advantageously chosen from the sampling devices 2 suitable for the collection of:

- a biological sample E from the upper respiratory tract (figure 1), for example a nasopharyngeal or salivary sample, or

- a biological sample E of capillary blood (figure 11), or

- a surface sample (not shown).

For a biological sample from the upper respiratory tract, the sampling device 2 advantageously comprises:

- a collection part 21, adapted to collect the biological sample E, for example fibers and/or flocking, and advantageously,

- a gripping part 22, for example a rod terminated by the collection part 21.

Such a sampling device 2 is advantageously chosen from saliva sampling swabs or nasal sampling swabs (FIG. 1 in particular).

Alternatively, for a capillary blood sample, the sampler 2 may be in the form of a conventional flexible pipette per se with:

- a collection part 21, adapted to collect the biological sample E, in the form of a cannula, and advantageously,

- A gripping part 22, for example a rod terminated by the collection part 21, advantageously serving as a pump.

In this case, this sampling device 2 also advantageously comprises a lancet 23, also known as a lancing device, conventional in itself and for single use, suitable for generating a flow of a drop of capillary blood.

Chromatographic strip

The rapid analysis system 1 also comprises said at least one chromatographic strip 3, also called "capillary diffusion means", advantageously an immunochromatographic strip, designed to detect the presence of said at least one analyte A.

These chromatographic strips 3 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 3 here consists of an elongated support along the direction and/or the direction of the capillary diffusion (lateral migration).

The chromatographic strip 3 can 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 3 determines a direction and sense 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 3.

By way of example, the chromatographic strip 3 can be made up of various immunochromatographic supports, for example cellulose, nylon, nitrocellulose, polyethylene or fiberglass.

Still according to the invention, the chromatographic strips 3 are made of a material capable here of remaining erected / erected in the interface device 5 following the migration of the buffer solution 4.

In other words, a chromatographic strip 3 is advantageously adapted to remain straight / flat during the migration of the buffer solution 4 (at least for the duration of the test).

The chromatographic strip 3 may for this include a stiffening layer (advantageously rear).

This stiffening layer may consist of various materials such as cardboard, plasticized cardboard or more preferably plastic materials. Preferably, the stiffening layer is made of polystyrene.

As shown schematically in Figure 7, the chromatographic strip 3 comprises different successive zones 31, in the direction of capillary migration upstream to downstream, namely at least:

- a deposit zone 311, intended to receive the buffer solution 4/biological sample E mixture,

- a release zone 312 which comprises at least one detection reagent conjugated with a visible and/or measurable label, said detection reagent being able to move as a result of the migration of the buffer solution 4 along the chromatographic strip 3 , And

- at least one capture zone 313 which comprises at least one capture reagent, immobilized on the chromatographic strip 3.

In particular, the deposit zone 311 must here be long enough to be immersed in the biological sample E/buffer solution 4 mixture.

Furthermore, the release 312 and capture 313 zones advantageously consist of a transverse line or strip (extending perpendicular to the direction of migration), having for example a width of between 1 and 2 mm, and an area of between 3 and 5 mm².

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.

Depending on the test format implemented, the complementary binding reagents are intended to form different complexes:

- the binding reagents are able to bind concomitantly to the analyte, to form a test in sandwich format, or

- one of the binding reagents (detection or capture) is able to bind to the analyte but also to the other binding reagent (respectively capture or detection), to form a test in competition format.

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.

By "anti-analyte" is meant any chemical, biochemical or biological entity capable of binding specifically with the analyte, or with the capture reagent in competition with the analyte, for example an antibody, an antigen or a nucleic acid.

The term “suitable analogue of the analyte” is advantageously understood to mean any chemical, biochemical or biological entity capable of binding specifically to the capture reagent or to the detection reagent, as the case may be, in competition with the analyte.

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

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

Thus, if the analyte is an antigen or a hapten, at least one of the binding reagents (the detection reagent and/or the capture reagent) is advantageously an antibody specific for the analyte.

By “analyte-specific antibody” is meant an antibody capable of binding specifically with the analyte in an antigen/antibody type bond.

It is typically a polyclonal antibody or a monoclonal antibody, having a high affinity for the analyte. Preferably, it is a monoclonal antibody.

If the analyte is an antibody, at least one of the binding reagents is advantageously the antigen recognized by the antibody.

If the analyte is a nucleic acid, at least one of the binding reagents is advantageously a complementary DNA probe.

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 313.

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).

To increase the sensitivity, it is possible to use, for example, an antibody labeled according to techniques known to those skilled in the art for indirect detection, such as for example a biotinylated antibody, indirectly allowing detection by the formation of avidin entities -biotin and streptavidin-biotin.

This labeled and biotinylated antibody can also either be deposited directly on a test line, in the capture zone, to increase the sensitivity, or be deposited with the specific detection antibody, to increase the contact time and even the sensitivity in particular, for example, due to the number of binding sites.

For its part, in the capture zone 313, the specific capture reagent for 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.

In the system according to FIG. 1, the detection reagents and the capture reagents are advantageously chosen from reagents suitable for detecting the presence of said at least one analyte chosen from antigens, preferably specific for an infectious agent, preferably viruses, in particular the viruses responsible for pneumopathies, advantageously the Coronaviridae , more preferably Orthocoronavirinae or coronavirus.

In the system according to FIG. 11, the detection reagents and the capture reagents are advantageously chosen from reagents suitable for detecting the presence of said at least one analyte chosen from antibodies, preferably specific for an infectious agent, preferably viruses, in particular the viruses responsible for pneumopathies, advantageously the Coronaviridae , more preferably Orthocoronavirinae or coronavirus.

The reagents are preferably also suitable for analyzing the serology of a biological sample E, preferably for detecting the possible presence of anti-SARS-Cov-2 IgG and/or anti-SARS-Cov-2 IgM antibodies.

The detection reagents and the capture reagents are advantageously chosen, without being limiting in any way, from:

- antibodies, advantageously chosen from anti-IgG antibodies (human) and anti-IgM antibodies (human), preferably directed against SARS-Cov-2,

- specific antigens of a microorganism, advantageously of a virus, preferably SARS-Cov-2, and

- adapted recombinant proteins.

In a preferred embodiment, the capture zone 313 may further comprise a control capture reagent.

This control capture reagent makes it possible to have a positive control in order to ensure the effective capillary diffusion of the liquid sample from the deposit zone 311 to the capture zone 313.

This control capture reagent is permanently immobilized downstream of the “analyte” capture reagents (“Control line” or control line).

It may for example be an antibody binding to the detection reagent(s).

Alternatively, this control capture reagent is independent of analyte A and simply makes it possible to check the diffusion of the liquid sample along the chromatographic strip 3 (for example by capturing a labeled control reagent).

In general, the chromatographic strip 3 is intended to be inserted into a second housing 52 of the interface device 5, here in an erected position with respect to this second housing 52.

For this, the chromatographic strips 3 have dimensions adapted to allow this individual insertion in this second housing 52.

By “insertion”, as illustrated by FIG. 9, is meant in particular an introduction of a lower part 35 of the length of a chromatographic strip 3 into the second housing 52; this lower part 35 (at the level of a transverse border 351) is advantageously intended to rest on a bottom of the second housing 52 (see in particular FIG. 9).

This lower part 35 can be:

- free, in particular in the case of a second housing without a guide, or

- guided, in the presence of a conformation adapted to the guidance (figures 8 and 9).

And an upper part 36 of the length of this chromatographic strip 3 then advantageously protrudes with respect to this second housing 52, from its upper access opening (see in particular FIGS. 8 and 9).

The lower part 35 advantageously comprises the deposit zone 311 (and preferably the release zone 312 which is advantageously located above the mixture contained in the second housing 52); the upper part 36 comprises the capture zone 313.

To allow this insertion, the chromatographic strip 3 has a width L1 which is less than the width P1 of the second housing 52 (at least at its lower part 35).

In practice, as illustrated in connection with FIG. 7, the chromatographic strips 3 have a rectangular outline with:

- two longitudinal borders 38 defining its width L1, and

- Two transverse borders 39 defining its length L2.

For example, a chromatographic strip 5 has the following dimensions:

- the width L1 is 2 to 6 mm, preferably 3 to 5 mm, and

- the length L2 is 5 to 10 cm, preferably 6 to 8 cm.

Buffer solution

The buffer solution 4 is intended to be brought into a first housing 51 of the interface device 5 and to be mixed with the biological sample E.

This buffer solution 4 is chosen from buffer solutions adapted to the implementation of chromatographic technique: it is in particular intended to migrate along a chromatographic strip 3 so as to cause, or at least to facilitate, the migration of the biological sample E (and in particular said at least one analyte A).

The buffer solution 4 is for example chosen from diluents composed of a buffered saline solution. It can also comprise a detergent or any other component necessary in particular for the migration or the reactions on the chromatographic strips 3.

To control the reported quantity of this buffer solution 4, the buffer solution 4 is packaged in a container which includes a dropper.

Interface device

The interface device 5 according to the invention comprises housings 51, 52 (here only two housings) which are in fluid communication.

In general, this interface device 5 advantageously comprises:

- a bottom wall 54 defining an underside 541 adapted to rest on a receiving surface (for example a work surface),

- an upper wall 55 defining a top face 551, opposite, and

- an outer wall 56, connecting these faces below 541 and above 551.

These walls 54, 55, 56 here together define an internal chamber 57.

According to the invention, the housings 51, 52, advantageously in the shape of a well, comprise:

- a first housing 51 intended to receive at least said buffer solution 4, optionally mixed with said biological sample E, and

- A second housing 52 designed to introduce at least the deposit zone 311 of the chromatographic strip 3 (here its lower part 35).

The second housing 52 is intended to receive the buffer solution 4, possibly mixed with the biological sample E, by flow from the first housing 51.

The two housings 51, 52 of this interface device 5 are then advantageously in the form of juxtaposed wells, advantageously parallel, and opening at the level of the top face 551.

In this case, the two housings 51, 52 each have a side wall 511, 521, defining a general axis 51', 52', which is delimited by:

- an access opening 512, 522, here upper, made through the top face 551, and

- a bottom 513, 523, here lower, made on the side of the bottom face 541.

It is here the bottoms 513, 523 of these two housings 51, 52 which are in fluid communication.

In this case, the two housings 51, 52 are in fluid communication via a conduit 58 adapted to a flow of the buffer solution 4, optionally mixed with the biological sample E, from the first housing 51 to the second housing 52.

The duct 58, here in the form of a channel or gutter, advantageously has for this a lower face 581 presenting a downward slope from the first housing 51 towards the second housing 52.

This embodiment thus promotes the flow of the buffer solution 4, optionally mixed with said biological sample E, from the bottom 513 of the first housing 51 to the bottom 523 of the second housing 52.

This conduit 58 comprises in this case two parts:

- a first part 582, forming the bottom 513 of the first housing 51, with a downward slope, and

- a second part 583, terminating the first sloping part 582 and forming the bottom 523 of the second housing 52, in the general shape of a cup to collect and hold the liquids flowing from the first housing 51.

In general, the first housing 51 advantageously comprises a side wall 511 which has a decreasing section from the access opening 512 towards the bottom 513 (Figure 4 in particular).

This shape is useful to facilitate the addition of the buffer solution 4, or even the insertion of the collection part 22 of the sampling device 2.

In this case, this side wall 511 has the general shape of a funnel.

This side wall 511 here comprises a frustoconical portion preferably followed by a cylindrical final portion.

More specifically, the side wall 511 here comprises:

- a first tapered portion 511a, upper, having a first angle,

- a second tapered portion 511b, intermediate, having a second lower angle with respect to said first angle, and

- a cylindrical portion 511c, lower.

As discussed above, the first housing 51 is advantageously adapted to the introduction of the collection part 21 of the sampling device 2 so that the buffer solution 4 ensures the transfer of the biological sample E from this first housing 51 to the second. housing 52.

In this context, the side wall 511 of this first housing 51 advantageously comprises a compression part 511b, 511c whose section is identical to, or smaller than, the collecting part 21 (see FIG. 9).

The compression part 511b, 511c is preferably cylindrical and located on the side of the bottom 513.

This compression part 511b, 511c is here formed by the second tapered portion 511b and by the cylindrical portion 511c.

The side wall 511 of this first housing 51 also advantageously comprises at least one groove 511e (FIG. 4), here of spiral or helical shape, extending over part of its height.

This groove 551e extends towards the bottom 513 of this first housing 51, to promote the flow of the buffer solution 4, where appropriate mixed with said biological sample E, towards this bottom 513.

Furthermore, the second housing 52 here comprises a conformation suitable for guiding the introduction of the chromatographic strip 3.

In this case, this second housing 52 has a rectangular cross section for maintaining the orientation of the chromatographic strip 3 added.

In particular, this second housing 52 comprises:

- a dimension in width P1 greater than the width L1 of the chromatographic tab 3 (P1 comprises for example from 1 to 10 mm more than L1), and

- a thickness dimension P2 less than the width L1 of the chromatographic strip 3 (P2 is for example from 1 to 3 mm).

As discussed above, the length L2 of the chromatographic strip 3 is greater than the depth P3 of this second housing 52 so as to give this chromatographic strip 3 a configuration erected on either side of the opening of access 522.

In general, the outer wall 56 of the interface device 5 defines, with the top face 551 and the bottom face 541, the internal chamber 57 over the height of which the housings 51, 52 extend.

The side wall 511, 521 of at least one of the housings 51, 52 is then advantageously provided with an annular slot 511f, 521f which is in fluid communication with this internal chamber 57 (FIGS. 4 and 9).

Such an annular slot 511f, 521f is advantageously located between a free edge 511g, 521g of said side wall 511, 521 and the bottom 513, 523.

Such a structure is particularly useful for preventing, or at least limiting, an outflow/outflow of liquid through the housings 51, 52 in the event of the interface device 5 tilting.

Indeed, during such an inclination of the interface device 5, the liquids will tend to flow through the annular opening 511f, 521f, without being able to go up along the side wall 511, 521 of the housing 51 , 52.

Such an annular opening 521f is also useful for evacuating any overflow of buffer solution 4, at the level of the bottom of the second housing 52, which would be likely to immerse the chromatographic strip 3 above its deposit zone 311.

Still generally, the interface device 5 is advantageously made of a plastic material.

Preferably, this interface device 5 is formed of two assembled parts 5a, 5b (FIGS. 5 and 6), in this case:

- a first part 5a forms the outer wall 56 assembled with the side wall 511, 521 of the housings 51, 52, via the upper wall 55, and

- a second part 5b, a first side of which forms the underside 541 and a second side 542 comprises the duct 58 connecting the bottom 513, 523 of the housings 51, 52.

Examples of systems

Figures 1 to 10 illustrate an embodiment suitable in particular for the search for an antigen in a biological sample E advantageously chosen from biological samples from the upper respiratory tract, for example a nasopharyngeal or salivary sample or a capillary blood sample.

This Rapid Analysis System 1 includes:

- at least one sampling device 2 chosen from saliva sampling swabs or nasal sampling swabs,

- at least one chromatographic strip 3 which is designed to detect the presence of said at least one analyte A of the antigen type,

- a buffer solution 4, for implementing the chromatographic technique, and

- at least one interface device 5 according to the invention.

Figures 11 to 13 illustrate an embodiment suitable in particular for the search for antibodies in a biological sample E advantageously chosen from biological samples of the capillary blood type.

This Rapid Analysis System 1 includes:

- at least one sampling device 2 comprising a flexible pipette 21, 22 and/or a lancet 23,

- at least one chromatographic strip 3 which is designed to detect the presence of said at least one analyte A of the antibody type,

- a buffer solution 4, for implementing the chromatographic technique, and

- at least one interface device 5 according to the invention.

Method for rapid analysis of a biological sample E

The implementation of the rapid analysis system according to the invention is described below according to two distinct modes:

- a first mode adapted to a biological sample E deposited directly on the deposit zone 311 of the chromatographic strip 3 (FIGS. 11 to 13), and

- a second mode adapted to a biological sample E recovered on the collection part 21 of a sampling device 2 (Figures 1 to 10).

The biological sample E is advantageously chosen from biological samples from the upper respiratory tract, for example a nasopharyngeal or salivary sample, or a sample of capillary blood. The biological sample may also consist of a surface sample.

In general, the method advantageously comprises:

- a step of inserting the chromatographic strip 3 into the second housing 52 (Figures 7 or 12),

- a step of adding the buffer solution 4 in the first housing 51, for the implementation of the chromatographic technique (Figures 8 or 13), and

- the reading of the chromatographic strip 3 positioned in the second housing 52, after migration of the buffer solution 4, to detect the presence of said at least one analyte A in the biological sample E.

During the insertion step, the lower part 36 of the strip 3 advantageously rests on the bottom 523 and on the upper access opening 522 (at the level of its rear layer).

Playback can be done directly or through a playback device.

The second embodiment is interesting in particular for a nasopharyngeal or salivary sample.

In the second mode, illustrated in Figures 1 to 10, it is advantageously provided that:

- the insertion step also includes inserting the collection part 21 of the sampling device 2 into the first housing 51 (FIG. 7), and

- the step of adding the buffer solution 4 leads to bringing the buffer solution 4 into contact with the collection part 21 of the sampling device 2 positioned in the first housing 51 (rinsing/extraction phenomenon), to ensure the transfer of the biological sample E from the sampling device 2 to the chromatographic strip 3 (FIGS. 8 and 9).

The flow of the biological sample E/buffer solution 4 mixture, from the collection part 21, is further advantageously favored by the movement of the sampling device 2 (FIG. 10).

The helical groove 511e advantageously ensures a screwing phenomenon when handling the sampling device 2, further promoting the extraction of the biological sample E.

The first embodiment (FIGS. 10 to 13) is particularly interesting for a capillary blood sample.

In this first illustrated mode, the biological sample E is deposited directly on the deposit zone 311 of the chromatographic strip 3, before said insertion step (FIG. 12).

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

Claims (16)

System for the rapid analysis of a biological sample (E), intended for detecting the presence of at least one analyte (A) in said biological sample (E),
which rapid analysis system comprises:
- at least one sampling device (2), suitable for sampling said biological sample (E), for example a biological sample (E) from the upper respiratory tract or a capillary blood sample,
- at least one chromatographic strip (3), advantageously an immunochromatographic strip, designed to detect the presence of said at least one analyte (A),
which at least one chromatographic strip (3) comprises a deposit zone (311) intended to receive said biological sample (E),
- a buffer solution (4), for implementing the chromatographic technique, and
- at least one interface device (5), adapted to receive said at least one chromatographic strip (3) for the implementation of said chromatographic technique,
which interface device (5) comprises at least two housings (51, 52) in fluid communication, advantageously in the form of a well, with:
- at least a first housing (51) intended to receive at least said buffer solution (4), optionally mixed with said biological sample (E), and
- at least one second housing (52) designed to introduce at least said deposit zone (311) of said at least one chromatographic strip (3), said second housing (52) being intended to receive said buffer solution (4), optionally mixed with said biological sample (E), flowing from said at least one first housing (51). Rapid analysis system, according to Claim 1, characterized in that the said at least two housings (51, 52) each comprise an access opening (512, 522) and a bottom (513, 523),
which bottoms (513, 523) of said at least two housings (51, 52) are in fluid communication. Rapid analysis system, according to any one of Claims 1 or 2, characterized in that the said at least two housings (51, 52) are in fluid communication via a conduit (58) adapted to a flow buffer solution (4), optionally mixed with said biological sample (E), from said first housing (51) to said second housing (52). Rapid analysis system, according to claim 3, characterized in that the duct (58) has a lower face (581) presenting a downward slope from the said first housing (51) towards the said second housing (52), to favor the flow of buffer solution (4), optionally mixed with said biological sample (E) from said first housing (51) to said second housing (52). Rapid analysis system, according to any one of Claims 1 to 4, characterized in that the said at least one first housing (51) comprises a side wall (511) which has a section decreasing from an access opening (512 ) to a bottom (513). Rapid analysis system, according to any one of Claims 1 to 5, characterized in that the said at least one second housing (52) is shaped to guide the introduction of the said at least one chromatographic strip (3). Rapid analysis system, according to any one of Claims 1 to 6, characterized in that the length of the chromatographic strip (3) is greater than the depth of the said at least one second housing (52), so as to give said chromatography strip (3) has an erect configuration on either side of an access opening (512, 522). Rapid analysis system, according to any one of Claims 1 to 7, characterized in that the said at least one interface device (5) comprises:
- a bottom face (541), adapted to rest on a receiving surface, and
- a top face (551), opposite,
and in that said at least two housings (51, 52) of said at least one interface device (5) are in the form of juxtaposed wells, advantageously parallel, and opening at the level of said top face (551). Rapid analysis system, according to any one of Claims 1 to 8, characterized in that the said at least one sampling device (2) comprises a collection part (21) adapted to collect the said biological sample (E),
and in that said at least a first housing (51) is suitable for the introduction of said collection part (21) of said at least one collection device (2) so that the buffer solution (4) ensures the transfer of said biological sample (E) from said at least one first housing (51) to said at least one second housing (52). Rapid analysis system, according to Claim 9, characterized in that the said at least one first housing (51) comprises a side wall (511) provided with a compression part (511b, 511c) whose section is identical, or lower, to the collection part (21). Rapid analysis system, according to any one of Claims 1 to 10, characterized in that the said at least one sampling device (2) is chosen from:
- saliva sample swabs or nasal sample swabs, or
- lancets, suitable for generating a drop of capillary blood. Rapid analysis system, according to any one of Claims 1 to 11, characterized in that the said at least one first housing (51) comprises a side wall (511) in which at least one groove (511e) is provided, for example of a spiral or helical shape, extending towards a bottom (513) to promote the flow of the buffer solution (4), where appropriate mixed with said biological sample (E), towards said bottom (513). Rapid analysis system, according to any one of Claims 1 to 12, characterized in that at least one of the housings (51, 52) comprises a side wall (511, 521) provided with an annular opening (511f , 521f) in fluid communication with an internal chamber (57), to prevent or at least limit liquid outflow through said housings (51, 52) in the event of tilting of said interface device (5). Interface device for a rapid analysis system according to any one of Claims 1 to 13,
which interface device (5) comprises at least two housings (51, 52) in fluid communication, preferably in the form of a well, with:
- at least a first housing (51), intended to receive at least one buffer solution (4), optionally mixed with a biological sample (E), and
- at least a second housing (52) designed for the introduction of a deposit zone (311) of a chromatographic strip (3). Method for the rapid analysis of a biological sample (E), using a rapid analysis system (1) according to any one of Claims 1 to 13,
characterized in that said method comprises:
- a step of inserting said at least one chromatographic strip (3) into said second housing (52),
- a step of adding the buffer solution (4) in said first housing (51), for the implementation of the chromatographic technique, and
- reading said at least one chromatographic strip (3) after migration of the buffer solution (4), to detect the presence of said at least one analyte (A) in said biological sample (E). Rapid analysis method according to Claim 15, characterized in that:
(i) in a first mode:
the biological sample (E) is deposited directly on the deposit zone (311) of the chromatographic strip (3), before said insertion step,
Or
(ii) in a second mode:
- the insertion step also comprises inserting the collection part (21) of said at least one collection device (2) into said first housing (51),
- the step of adding the buffer solution (4) leads to bringing said buffer solution (4) into contact with said collection part (21) of said at least one sampling device (2) positioned in said first housing (51), to ensure the transfer of said biological sample (E) from said at least one sampling device (2) to said at least one chromatographic strip (3).