WO2018167261A1

WO2018167261A1 - Device and method for rapid testing of a liquid sample

Info

Publication number: WO2018167261A1
Application number: PCT/EP2018/056646
Authority: WO
Inventors: Isabelle Conesa; Joaquim Da Silva
Original assignee: Porcher Industries
Priority date: 2017-03-17
Filing date: 2018-03-16
Publication date: 2018-09-20
Also published as: FR3063918A1; FR3063918B1

Abstract

This rapid testing device (1) comprises: - a one-piece woven fabric (5) with longitudinal and transverse threads, the fabric (5) comprising an application area (7) for applying a liquid sample (3) to be tested and an impregnation area (11) for impregnation by the liquid sample (3), that extends from the application area (7), the impregnation area (11) being configured to be impregnated by the liquid sample (3) by applying said liquid sample (3) on the application area (7); and - rapid testing means (15, 16) for testing the liquid sample (3) arranged in the impregnation area (11). According to the invention, at least in the impregnation area (11), in order to direct the impregnation of the fabric (5) by the liquid sample (3) along the longitudinal threads: - the majority of the longitudinal threads of the fabric (5) are hydrophilic, and - more than the majority of the transverse threads of the fabric (5) are hydrophobic.

Description

Device and method for rapid testing of a liquid sample

The present invention relates to a rapid test device for a liquid sample, as well as a rapid test method for a liquid sample, implemented using such a device.

More particularly, the invention relates to the field of rapid test devices, including immunochromatography (or "lateral flow" in English), for detecting the possible presence of one or more predetermined elements in a liquid sample, for example of physiological origin, of the blood, plasma, serum, urine or food-borne type, by depositing this liquid sample on a deposition zone of the device. This type of device is generally designed to rapidly indicate or quantify the presence of a predetermined element in the liquid sample, using an indicator, especially a visual indicator, after diffusion of the liquid sample on and / or in the support. To ensure this diffusion, the device generally comprises a strip of nitrocellulose.

WO-2005/098439 A1 discloses a test strip for the detection of an analyte present in a liquid sample applied to the strip. The strip comprises a single hydrophilic matrix, including a fiber network and a series of zones, namely a sample application zone; a conjugation zone including a labeled binding reagent, which is capable of binding specifically to the desired analyte and advancing along the strip when binding is made; and a capture reagent capable of binding to the desired analyte or labeled binding reagent.

FR-2 781 056 A1 discloses a wipe test strip for the detection of substances, comprising similar means. In particular, this test strip comprises a wiping sample collection zone constituted in all types of fibrous and / or porous materials, such as glass, polyester or cellulose fibers. FR-2 781 056 provides in particular that this zone can be made of polyester fiber fabric.

However, in these known strips impregnation takes place omnidirectionally, so that a portion of the liquid sample is propagated in regions of the strip which are not necessarily useful for analysis.

US-2010/0172798 A1 discloses a test pad including a polymer fabric, wherein the impregnation of a liquid sample is performed perpendicularly to the plane of the tissue for the analysis of body fluids. Fabric includes rendered regions hydrophobic irradiation to delimit and guide the propagation of the liquid sample in the tissue.

On the other hand, the methods for rendering hydrophobic fabrics may prove to be relatively expensive and difficult to implement for certain particular applications, especially in the case where the fabric comprises glass threads.

US 2013/095506 A1 discloses a diagnostic device, including a hydrophobic wire composition. On a local area of this composition, it is intended to relate a hydrophilic yarn composition, carrying a reagent of the genus antigen or antibody, by intertissage with the hydrophobic yarn composition, in particular by a double-warp and double-weave weaving method. . In this zone, the device therefore comprises hydrophilic threads while only hydrophobic threads are provided outside this zone. The interwoven zone serves as an area for receiving an aqueous sample, comprising an analyte to be analyzed. Due to the hydrophilic nature of the son of the zone and hydrophobic son out of the area, the sample progresses along this area without extending out of this area. For this known device, even within the inter-woven zone, the liquid sample progresses in all directions without the privilege of a particular direction.

WO 2012/150487 A1 discloses a hydrophilic tissue matrix, made entirely of hydrophilic yarns and containing yarns of two different materials to obtain a differentiated flow in different regions of the hydrophilic matrix. Nevertheless, the efficiency of the flow differentiation could be greatly improved.

The invention therefore aims to remedy these drawbacks by proposing a new rapid test device which, while being inexpensive, easy to manufacture, and adaptable to multiple applications, makes it possible to carry out a rapid test efficiently.

Preferably, the invention also aims to obtain a new rapid test device for a liquid sample, in which a particularly efficient differentiation of the liquid sample flow is obtained.

The subject of the invention is a device for rapid testing of a liquid sample, the device comprising:

an integral woven fabric with longitudinal threads and transverse threads, the fabric comprising an application zone of the liquid sample to be tested and an impregnation zone of the liquid sample, which extends to from the application zone, the impregnation zone being configured to be impregnated by the liquid sample by applying said liquid sample to the application zone; and rapid test means for the liquid sample arranged in the impregnation zone.

According to the invention, at least in the impregnation zone, to direct the impregnation of the tissue by the liquid sample along the longitudinal threads:

more than the majority, preferably all, of the longitudinal yarns of the fabric are hydrophilic, and

more than the majority, preferably all, of the transverse threads of the fabric are hydrophobic.

Thanks to the invention, the impregnation of the tissue by the liquid sample is performed mainly, or only, in the direction of the longitudinal son of the fabric. Nevertheless, the fabric is relatively easy to manufacture, insofar as the individually hydrophobic or hydrophilic nature of the threads used is sufficient to direct, that is to say channel, the impregnation of the tissue with the liquid sample, advantageously without recourse to additional treatments of the tissue, of the irradiation kind.

The invention advantageously makes it possible to obtain a strong directional differentiation of the impregnation of the tissue by the liquid sample, this impregnation taking place essentially along the direction of the longitudinal threads. This differentiation is preferentially more marked and more effective than in the prior art.

Other advantageous features of the invention, taken alone or in combination:

At least in the impregnation zone: the hydrophilic longitudinal yarns are yarns of which at least the outer surface is of inorganic material, of the glass type, and the hydrophobic transverse yarns are yarns of which at least the outer surface is made of organic material; , of the plastic kind.

The inorganic material is glass and the organic material is a plastic material, comprising for example at least one of the following polymers: polyamide, polyester, polyvinyl chloride or polypropylene. The area of application corresponds to a part of the tissue located at one end of the fabric, in consideration of a longitudinal direction of the fabric defined by the longitudinal threads;

- The impregnation zone extends to a second end of the fabric, in consideration of the longitudinal direction; - At least in the impregnation zone, the fabric has a density of transverse yarns lower than the density of longitudinal yarns, the density of transverse yarns being measured in a longitudinal direction of the fabric defined by the longitudinal yarns, and the density of yarns. longitudinals being measured in a transverse direction of the tissue defined by the transverse threads.

At least in the impregnation zone, the density of transverse yarns is at least two times smaller than the density of longitudinal yarns.

- At least in the impregnation zone, the density of transverse yarns is less than 10 yarns / cm, preferably about 3 yarns / cm, and the density of longitudinal yarns is more than 10 yarns / cm, preferably more than 30 yarns / cm. son / cm.

The rapid test means comprise at least one reagent immobilized on and / or in the tissue, in the impregnation zone, this immobilized reagent being, for example, an antibody, an antigen, or a protein.

- The rapid test means are designed to react with the contact of the liquid sample, when the liquid sample comprises a predetermined analyte, so as to detect that the analyte is actually present in the liquid sample.

- The device comprises a rigid support on or in which the fabric is disposed.

The invention also relates to a method for rapid testing of a liquid sample, the method comprising:

a step of applying a liquid sample to the zone of application of a device according to the foregoing, and

a step of impregnation, by the liquid sample, of the fabric of the device, a step in which the liquid sample is propagated along the impregnation zone while being directed along the longitudinal threads, so as to reach the means Quick test device.

The invention will be better understood with the aid of the description which follows, given solely by way of illustration and without limitation, and referring to the appended FIG. 1, being a schematic perspective view of a rapid test device conforming to FIG. 'invention.

Figure 1 illustrates a quick test device 1 of a liquid sample 3. Device 1 is used to determine whether sample 3 contains an element, i.e., a particular predetermined analyte. Preferably, the device 1 is designed for testing a predetermined type of sample 3. The sample 3 to be tested is for example a body fluid, of the blood, urine, saliva, or other kind. Alternatively, the sample 3 to be tested is any liquid substance, body or not, in which it is desired to detect the possible presence of an analyte. For example, sample 3 may be a food substance. Depending on the application, it may be chosen that the analyte detected by the device 1 is for example of the bacterium, virus, protein, antigen, antibody, enzyme, drug, pollutant type, contained in the sample 3.

The device 1 comprises a fabric 5, which is woven integrally with longitudinal threads, defining a longitudinal direction X of the fabric 5, and transverse threads, defining a transverse direction Y of the fabric 5. By "fabric", it is It is intended that the longitudinal and transverse yarns are interwoven in a weave, obtained for example by means of a loom. By "one piece" is meant that the fabric is formed in a single weaving step. The X and Y directions are preferably perpendicular and extend in the plane of the fabric 5. The longitudinal son are preferably warp son, while the transverse son are preferably weft son. However, it is possible for the longitudinal threads to be weft threads and for the transverse threads to be warp threads.

It also defines a direction of thickness Z of the fabric 5, directed perpendicularly to the X and Y directions, that is to say in the direction of the thickness of the fabric 5.

In the present example, the fabric 5 has an elongated shape in the X direction. More specifically, the fabric 5 is rectangular, with a large length in the X direction, and a smaller width in the Y direction.

As illustrated in FIG. 1, the fabric 5 comprises an application zone 7 of the sample 3 symbolically delimited symbolically by a dashed line 10 in FIG. 5. This zone 7 corresponds to a part of the fabric 5 situated at one end 9 of the fabric 5, in consideration of the direction X. In other words, the zone 7 is preferably a part of the fabric 5 which extends to the end 9. This zone 7 is dedicated to the This application is for example made by depositing a drop of the sample 3 on one side 8 of the fabric, at the level of the zone 7. The fabric 5 may, however, be provided for other methods of application, such as wiping or soaking the zone 7 of the fabric 5 on or in the sample 3. It is also possible to have at the top of the zone 7, a sample buffer porous or filter material, on which the sample will be deposited before the cross to reach the underlying tissue. The fabric 5 also comprises an impregnation zone 11 of the sample 3, which can also be called diffusion zone. This zone 11 is adjacent to the zone 7, that is to say it extends from the zone 7. The zone 11 extends from the discontinuous line 10. Preferably, the zone 1 1 extends to one end 13 of the fabric 5, opposite the end 9, in consideration of the direction X.

Since the fabric 5 has a porous structure, preferably in the zones 7 and 11, the liquid sample 3 deposited on the fabric 5 at the zone 7 impregnates the fabric 5, that is to say it propagates in the tissue 5 along the zone 1 1.

In this zone 11, a sufficient number of hydrophilic longitudinal yarns and hydrophobic transverse yarns are provided to direct the impregnation of the fabric by the liquid sample in the X direction. By "hydrophilic yarn" and "hydrophobic yarn" is meant hydrophobicity and individual hydrophilicity of each wire concerned. Thus, the zone 11 of the fabric 5 is rather hydrophilic in the longitudinal direction X, and rather hydrophobic in the transverse direction Y, by arrangement of individually hydrophilic threads and individually hydrophobic threads distributed along these directions X and Y.

Therefore, the individually hydrophilic or hydrophobic nature of the yarns of the fabric 5 serves to direct, i.e., channel, the impregnation of the tissue by the sample 3 in the X direction rather than the Y direction. , the liquid sample has a tendency to impregnate itself as a priority along the hydrophilic longitudinal wires, without spreading too much along the hydrophobic cross-wires. The sample having been applied in zone 7 and reaching zone 11, at line 10, then propagates in zone 11, mainly, or even totally, in direction X. Sample 3 propagates little, or not, in the Y direction, or in a direction opposite to the Y direction. It does not matter whether the sample 3 is propagating or not in the Z direction.

It is advantageously provided that, in zone 11, all the longitudinal threads of the fabric 5 are hydrophilic while all the transverse threads of the fabric 5 are hydrophobic.

It can be expected that in zone 1 1, the longitudinal son have, with respect to each other, a different degree of hydrophilicity. It can be expected that in the zone 1 1, the transverse son have, with respect to each other, a different degree of hydrophobicity.

It can be expected that in the zone 1 1, some longitudinal son are hydrophobic. In this case, it is expected that the proportion of hydrophilic longitudinal yarns with respect to the number of hydrophobic longitudinal yarns is sufficiently high to confer a relatively hydrophilic character on all the longitudinal yarns of the zone 11. It is expected that most of the longitudinal threads are hydrophilic in the zone 1 1. It can be expected that in zone 1 1, some longitudinal son are hydrophilic. In this case, it is expected that the proportion of hydrophobic transverse yarns with respect to the number of hydrophilic transverse yarns is sufficiently high to confer a relatively hydrophobic character on all the transverse yarns of the zone 11. It is expected that more than the majority of transverse yarns are hydrophobic in zone 11.

It is also possible to provide, in the same fabric, one or more blocking zones in which the impregnation of the liquid sample is not allowed, or is limited, by providing hydrophobic longitudinal threads and hydrophobic transverse threads, while in another zone of the tissue, called "channel zone", the longitudinal threads are hydrophilic to promote and guide the propagation along the longitudinal direction. In particular, it is possible to form a plurality of parallel channel zones, in each of which the longitudinal threads are hydrophilic, the adjacent channel zones being separated by a blocking zone, in which the longitudinal threads are hydrophobic, in order to prevent propagation of the liquid sample transversely from the first channel zone to the second adjacent channel zone. In order to improve this effect, it is possible to predict that the density of longitudinal wires is greater in the blocking zone than in the channel zone.

In order to obtain a different degree of hydrophobicity or hydrophilicity between the longitudinal and transverse yarns, the material constituting the yarns is preferably adapted. In other words, the chemical nature of the wire is one of the parameters that may determine its hydrophilic or hydrophobic character. In this case, a hydrophilic material is chosen for the hydrophilic longitudinal yarns, and hydrophobic for the hydrophobic transverse yarns. Preferably, it is expected that the hydrophilic longitudinal son are son made of inorganic material, such as glass, rather hydrophilic, while the hydrophobic cross son are son made of organic material, such as plastic, rather hydrophobic . Preferably, the above-mentioned plastics material comprises one or more of the following polymers: polyamide, polyester, polyvinyl chloride or polypropylene.

Alternatively, this type of material can be provided only on the outer surface of the wire, that is to say for the skin of the wire, while the core of the wire is made of a different material. Indeed, the hydrophilic or hydrophobic nature of the son depends in particular on the properties of their outer surface. For example, in the case of longitudinal son may be provided son whose outer surface comprises a hydrophilic sheath, including an inorganic material, while these son comprise a material organic at heart. For example, in the case of transverse son may be provided son whose outer surface comprises a hydrophobic sheath, including an organic material, while these son include a core inorganic material, such as glass. Thus, at least the outer surface of each longitudinal wire is hydrophilic material, and at least the outer surface of each transverse wire is hydrophobic material, at least in the area 1 1.

Alternatively or in addition, other characteristics specific to the son can be modified in order to confer a hydrophilic or hydrophobic character to the wire. For example, it can be expected to modify the number of constituent filaments of the yarn concerned to vary its degree of hydrophilicity or hydrophobicity.

It is also possible to perform a surface treatment on each yarn, prior to weaving, of the corona, plasma or supercritical C0 _{2 type} , in order to make it hydrophilic or hydrophobic.

Provisions concerning the presence of hydrophilic and hydrophobic threads applicable to the tissue in zone 11 may be applied in the rest of the fabric 5, especially in zone 7.

By "transverse yarn density" is meant the number of transverse yarns of the fabric counted per unit length, over a distance measured in the X direction. By "density of longitudinal yarns" is meant the number of longitudinal yarns of the fabric. 5 counted per unit length, over a distance measured along the Y direction.

In general, it is expected that the zone 1 1 of the fabric 5 has a density of transverse son less than the density of longitudinal son. Preferably, in zone 11, the density of transverse yarns is at least two times smaller than the density of longitudinal yarns. This difference in yarn density makes it possible to direct the sample 3 even more efficiently along the X direction. Indeed, a reduced quantity of transverse yarns oppose the impregnation of the fabric 5 in the X direction. a reduced quantity of transverse threads is capable of guiding the impregnation of the fabric 5 in the direction Y, so that the impregnation is totally, or almost completely, in the direction X.

In the present example, in the impregnation zone 11, the density of transverse yarns of the fabric 5 is less than 10 threads / cm (threads per centimeter), preferably about 3 threads / cm. The density of longitudinal threads is higher and is more than 10 threads / cm, preferably more than 30 threads / cm. Experience shows that the density values of the present example are particularly suitable for guiding the impregnation of a sample 3 formed by blood or plasma. The provisions concerning the density of hydrophilic and hydrophobic yarns applicable to the fabric in zone 11 can be applied in the rest of the fabric 5, especially in zone 7.

The device 1 advantageously comprises a rigid support, not shown, on or in which the fabric 5 is disposed. The rigid support may have the function of giving the fabric 5 a certain rigidity. For example, the device may be stretched between two elements of the support, the rest of the tissue not being in contact with the support, or only at remote contact points one another. The rigid support may also have the function of protecting the fabric 5. For example, the rigid support further forms a housing in which the fabric 5 is enclosed or stretched.

The device 1 comprises rapid test means arranged in the area 1 1. These means are arranged to be reached by the sample 3 during its impregnation in the zone 1 1. The rapid test means is designed to react in a certain way in contact with the sample 3, when the sample 3 comprises a predetermined analyte, so as to make it possible to detect that the analyte is indeed present in the sample 3 In the absence of analyte, it is expected that the rapid test means react differently, or do not react.

The rapid test means are known as such. However, their application to a tissue such as tissue is not known. These rapid test means are, for example, immunochromatography means, or immunoprecipitation means. The means are chosen according to the analyte that it is desired to detect in the sample 3.

The rapid test means comprise at least one reagent immobilized on and / or in the tissue in an area 16 extending across the zone 11, in the direction Y, from one edge to the other of the fabric 5. The zone 16 advantageously has the shape of a line or transverse band. Any immobilized reagent commonly used in rapid tests, such as an antibody, antigen, protein, etc., may be used. The immobilization is also done by the usual means in the field.

For carrying out the test, it will be possible to use, as is usual, a labeled or detectable synthetic or biological detection conjugate, such as a labeled antibody, a labeled antigen, an enzyme, a labeled protein, etc. use any conventional marking, for example particulate, colored latex or colloidal gold particles, for example.

Unless the selected rapid test means are concentrated in a single continuous zone, the means are distributed in the zone 1 1, in the direction X, so as to be reached successively by the sample 3 during its impregnation in the zone 1 1. In the present example, there is shown a zone 15, in the form of a transverse band, located between the zone 7 and the zone 16, and on which the conjugate is disposed, for example an antibody.

The antibodies in zone 15 are of a first type, and are capable of binding, preferably specifically, to the analyte to be detected. The antibodies carry gold nanoparticles, or any usual detection reagent. The analyte, if it is present in Sample 3, migrating along the T1 area, passes through the area 15 where it binds with the labeled antibodies to form a complex. These antibodies are deposited on the tissue 5 so as to be carried by the sample 3, during impregnation of the latter in the tissue 5, that these antibodies are bound or not to analytes of the sample 3.

On the second band 16, there is an immobilized reagent, for example analyte-specific antigens or analyte-specific antibodies. They are attached to the fabric 5 so as not to be carried by the sample 3 during its impregnation. The immobilized reagents are selected to capture the complexes formed by labeled antibody-bound analytes from zone 15 when sample 3 reaches band 16 by impregnation. This capture advantageously produces a distinctive color of the tissue 5, linked to the presence of gold nanoparticles or other colored or detectable staining (fluorescence, enzymatic reaction, as is known).

Of course, the device 1 may comprise different rapid test means depending on the desired application, as defined above.

It is understood that the device 1 makes it possible to implement a rapid test of a liquid sample 3. This rapid test includes a step of applying the sample 3 to the zone 7 of the device 1, which follows by a step impregnating, with the sample 3, the fabric 5, in which step the sample 3 is propagated along the impregnation zone while being directed along the longitudinal threads. During the impregnation step, the sample 3 successively reaches the rapid test means located in zones 15 and 16.

It is also possible to provide at the end 13, as is done in conventional rapid tests, a pad of highly absorbent material intended to facilitate the migration of the sample from the zone 7 and through the strips 15 and 16, then to accumulate in this buffer. However, the choice of the constituent yarns of the fabric according to the invention can make it possible to dispense with such a buffer while ensuring adequate propagation of the sample. Various tests have been carried out:

The 18μΙ drop is a liquid sample comprising methanol and a dye.

It is observed that, for fabric A, the propagation takes place on the same distance in the direction parallel to the warp and parallel to the weft.

For fabrics B to E, whose warp yarns are hydrophilic and the hydrophobic weft yarns, it is observed that the propagation is greater in the direction parallel to the warp than in the direction parallel to the weft. It is noted that this effect is more marked for fabrics C and E, in which the density of weft yarns is reduced compared with fabrics B and D.

The characteristics of each variant defined above can be implemented in the other variants described, as far as technically possible.

Claims

1. - Device (1) for rapid testing of a liquid sample (3), the device (1) comprising:

a fabric (5) woven in one piece with longitudinal threads and transverse threads, the fabric (5) comprising an application zone (7) of the liquid sample (3) to be tested and an area of impregnating (1 1) the liquid sample (3), which extends from the application zone (7), the impregnation zone (1 1) being configured to be impregnated by the liquid sample ( 3) applying said liquid sample (3) to the application zone (7); and

rapid test means (15, 16) for the liquid sample (3) arranged in the impregnation zone (1 1),

the device (1) being characterized in that, at least in the impregnation zone (1 1), to direct the impregnation of the fabric (5) by the liquid sample (3) along the longitudinal threads:

more than the majority, preferably all, of the longitudinal yarns of the fabric (5) are hydrophilic, and

more than the majority, preferably all, of the transverse threads of the fabric (5) are hydrophobic.

2. - Device (1) according to claim 1, characterized in that, at least in the impregnation zone (1 1):

the hydrophilic longitudinal yarns are yarns whose at least the outer surface is made of inorganic material, such as glass, and

the hydrophobic transverse yarns are yarns of which at least the external surface is made of organic material, such as plastics material.

3. - Device (1) according to claim 2, characterized in that the inorganic material is glass and in that the organic material is a plastic material, comprising for example at least one of the following polymers: polyamide, polyester, polyvinyl chloride or polypropylene.

4.- Device (1) according to any one of the preceding claims, characterized in that: - the application zone (7) corresponds to a part of the tissue located at a first end (9) of the fabric (5), in consideration of a longitudinal direction (X) of the fabric (5) defined by the longitudinal son; and

- The impregnation zone (1 1) extends to a second end (13) of the fabric (5), in consideration of the longitudinal direction (X).

5. - Device (1) according to claim 4, characterized in that, at least in the impregnation zone (1 1), the fabric (5) has a density of transverse son less than the density of longitudinal son, the density of transverse yarns being measured in the longitudinal direction (X) of the fabric (5) defined by the longitudinal yarns, and the density of longitudinal yarns being measured in a transverse direction (Y) of the fabric (5) defined by the transverse yarns.

6. - Device (1) according to claim 5, characterized in that, at least in the impregnation zone (1 1), the density of transverse son is at least two times smaller than the density of longitudinal son.

7. - Device (1) according to claim 6, characterized in that, at least in the impregnation zone (1 1), the density of transverse son is less than 10 son / cm, preferably about 3 son / cm and in that the density of longitudinal threads is more than 10 threads / cm, preferably more than 30 threads / cm.

8. - Device (1) according to any one of the preceding claims, characterized in that the rapid test means (15, 16) comprise at least one immobilized reagent on and / or in the tissue (5), in the zone impregnation (1 1), this immobilized reagent being for example an antibody, an antigen, or a protein.

9. - Device (1) according to any one of the preceding claims, characterized in that the rapid test means (15, 16) are designed to react with the contact of the liquid sample (3), when the liquid sample (3) comprises a predetermined analyte, so as to detect that the analyte is actually present in the liquid sample (3).

10.- Device (1) according to any one of the preceding claims, characterized in that the device (1) comprises a rigid support on or in which the fabric (5) is disposed.

1 1 .- A rapid test method of a liquid sample (3), the method comprising:

a step of applying a liquid sample (3) to the application zone (7) of a device (1) according to any one of the preceding claims, and

a step of impregnation, by the liquid sample (3), of the fabric (5) of the device (1), a step in which the liquid sample (3) is propagated along the impregnation zone (1 1 ) being directed along the longitudinal threads, so as to reach the quick test means (15, 16) of the device (1).