Diagnostic device for detecting and / or identifying a target analyte from a liquid sample

Abstract

The present invention relates to a diagnostic device (D) for detecting and / or identifying a target analyte from a liquid sample, comprising: • a support (1) having an upper face (2) and a lower face (3), and • at least one reagent strip (4) contained within said support (1) between said upper face (2) and said lower face (3), said at least one reagent strip (4) comprising a test zone (5) and reagents for detecting and / or identifying said target analyte, said upper face (2) of said support (1) comprising: - at least one opening (6) arranged to provide access to a deposition zone (7) of said liquid sample, said deposition zone (7) being in fluidic communication with said test zone (5) of said at least one reagent strip (4),and - a reading window (F) opening onto said test area (5) of said at least one test strip (4) where the detection and / or identification of said target analyte takes place, said support (1) having at least one breakaway area (8) designed to give a user access to a free end (4') of said at least one test strip (4).

Description

[0001] The present invention relates to a diagnostic device for detecting and / or identifying a target analyte from a liquid sample. In particular, the present invention relates to a pregnancy test based on the detection of the hormone hCG.

[0002] A device according to the present invention can allow the detection and / or identification of any type of analyte, often called an analyte of interest or target analyte. For example, a device according to the present invention can allow the detection and / or identification of an analyte of interest being a toxin, an organic compound, a protein, a peptide, a microorganism, a bacterium, a virus, an amino acid, a nucleic acid, a carbohydrate, a hormone, a steroid, a vitamin, a drug, a pollutant, a pesticide, an antigenic substance, a hapten or even an antibody.

[0003] Many diagnostic devices are available, some of which consist of a plastic shell (or holder) containing a synthetic test strip (or detection strip) made of a plastic material, typically nitrocellulose. A more environmentally friendly approach to significantly reduce the plastic waste generated by the use of such diagnostic devices has led to the development of diagnostic devices consisting of a paper or cardboard shell (or holder) containing a test strip (or detection strip) made of a plastic material, typically nitrocellulose. Nitrocellulose membranes or strips are synthetic and non-biodegradable.

[0004] When it comes to pregnancy tests, these devices are usually based on a biochemical immunoassay, testing for the presence of high levels of the hormone human chorionic gonadotropin (hCG) in bodily fluids, such as urine. The hCG hormone is generated early in pregnancy and is therefore a very useful indicator analyte. The immunoassay is usually based on the use of anti-hCG antibodies and antigens suitable for coupling to such antibodies, at binding sites on the antibody.

[0005] Conventionally, pregnancy test devices rely on the use of a urine sample that seeps by capillary action along a test strip. A reservoir of anti-hCG antibodies bound to a colored particulate material is encountered first. If hCG is present, the antibodies couple to it, forming a complex that is carried along the test strip. Further along the test strip is a transverse linear zone with an anchored reagent to which the hCG / antibody complex will bind. Also, if hCG is present in the urine, the hCG / antibody complex and associated colored material will accumulate in this zone, forming a visible colored line on the test strip.

[0006] Unfortunately, current diagnostic devices, for example current pregnancy tests, remain not very environmentally friendly. In this sense, even if they have a shell (or support) made of paper or cardboard, current pregnancy tests still constitute waste that is not easily recycled since they include on the one hand a test strip made of a plastic material and on the other hand a shell (or support) made of paper or cardboard. After using such devices, the user is faced with waste comprising two materials that cannot be recycled / treated / disposed of in the same way since plastic materials and paper or cardboard materials follow very different recycling, treatment or disposal channels.

[0007] To meet the expectations of consumers who are increasingly demanding ecological products (green products) and / or to reduce environmental pollution and / or to meet regulatory obligations, there is therefore today a real need to provide diagnostic devices whose recycling, treatment or disposal is possible and easy.

[0008] To solve these problems, the invention provides a diagnostic device for detecting and / or identifying a target analyte from a liquid sample, comprising: a support having an upper face and a lower face, and at least one test strip enclosed inside said support between said upper face and said lower face, said at least one test strip comprising a test zone and reagents making it possible to detect and / or identify said target analyte, said upper face of said support comprising: at least one opening arranged to provide access to a deposit area of ​​said liquid sample, said deposit area being in fluid communication with said test area of ​​said at least one reactive strip, and a reading window opening onto said test area of ​​said at least one reactive strip where the detection and / or identification of said target analyte takes place, said diagnostic device being characterized in that said support has at least one rupture area designed to provide access to a user to a free end of said at least one reactive strip.

[0009] By the terms "said support has at least one rupture zone designed to give access to a user to a free end of said at least one test strip", it is understood within the meaning of the present invention that the support comprises one or more means allowing it to be broken and / or ruptured at least partially. In particular, according to the present invention, the "rupture zone" can allow the upper face of the support or the lower face of the support or both the upper face and the lower face of the support to be broken and / or ruptured, so as to give access to a user to a free end of at least one test strip. Said support according to the present invention therefore has at least one rupture zone arranged to give access to a user to a free end of at least one test strip

[0010] By the term "free end of said at least one test strip", is meant, within the meaning of the present invention, an end of at least one test strip which is not fixed to the support and which is directly accessible to a user following a rupture of the rupture zone, i.e. when the rupture zone has been used in order to break and / or rupture the support. According to the invention, the free end of at least one test strip is therefore not fixed / attached / attached to the support by any means. The free end is also not blocked in the support such that it can be easily grasped to be separated therefrom.

[0011] With such a diagnostic device according to the invention having a rupture zone designed to / arranged to give a user access to a free end of said at least one test strip, it is easy to separate at least one test strip (for example made of a plastic material) from the support (for example made of paper or cardboard). Consequently, a user can easily direct separately, to the appropriate recycling / treatment / disposal channel, at least one test strip made of a plastic material and the support made of paper or cardboard. This makes it possible, among other things, to avoid incineration of the diagnostic device. A diagnostic device according to the invention is therefore ecological, meets consumer expectations in terms of reducing the ecological footprint and is in line with current and future regulatory obligations.All this allows for recycling and waste management, as each component can be individually treated appropriately.

[0012] For the purposes of the present invention, the term "sample" refers to anything that may contain an analyte for which analyte detection and / or identification is desired. The sample may be a biological sample, such as a biological fluid sample. Examples of biological fluids include urine, blood, plasma, serum, saliva, semen, stool, sputum, cerebrospinal fluid, tears, mucus, amniotic fluid, or the like. Such samples may be human, animal, or human-made samples.

[0013] For the purposes of the present invention, the terms "fluid sample" or "liquid sample" refer to a material suspected of containing the analyte of interest, which material has sufficient fluidity to flow through a diagnostic device according to the invention.

[0014] The fluid sample or liquid sample may be used as obtained directly from the source or following pretreatment so as to modify its character. Possible pretreatment of the sample may involve the preparation of plasma from blood, dilution of viscous fluids, filtration, distillation, separation, concentration, inactivation of interfering components and the addition of reagents.

[0015] Typically, the sample is an aqueous solution or biological fluid. The liquid sample can come from any source, such as a physiological fluid, including blood, serum, plasma, saliva, sputum, ocular lens fluid, sweat, urine, milk, ascitic fluid, mucus, synovial fluid, peritoneal fluid, transdermal exudates, pharyngeal exudates, bronchoalveolar lavage, tracheal aspirates, cerebrospinal fluid, semen, cervical mucus, vaginal or urethral secretions, or amniotic fluid.

[0016] A solid material suspected of containing the analyte can be used as a sample after modification to form a liquid medium or to release the analyte.

[0017] For the purposes of the present invention, the term "biodegradable" refers to a material that is capable of being decomposed by bacteria or other living organisms, natural processes or other biological agents or means. For example, for the purposes of the present invention, cardboard and paper may be considered biodegradable materials.

[0018] For the purposes of the present invention, the term "fluid communication" refers to the arrangement or arrangement of one or more materials such that fluid is capable of flowing through the material or flowing between the materials by capillary action, absorptive flow, or axial flow. A material may be in "fluid communication" with another material regardless of the presence of fluid if it provides the capability to allow fluid flow between materials when a fluid is present.

[0019] For the purposes of the present invention, the terms "test strip" or "detection tab" refer to a part / component of the diagnostic device comprising reagents and a test area in fluid communication with a sample deposition area / receiving area.

[0020] For the purposes of the present invention, the term "sample deposition area" (also referred to as "sample area") refers to an area where a sample is brought into contact with the diagnostic device. According to one embodiment of the invention, the sample deposition area is provided to receive a fluid sample (or liquid sample) which may contain an analyte of interest. In another embodiment, the sample deposition area is immersed in a fluid sample (or liquid sample).

[0021] According to the invention, reagents capable of binding to the analyte of interest, in particular marker reagents capable of binding to the analyte of interest, may be positioned downstream of the sample deposition zone or may be positioned within the sample deposition zone. Furthermore, the test zone is disposed downstream of the sample zone and contains test and control zones or lines. The test zone contains a reagent or adaptation that allows the analyte of interest to be retained in the test zone. In particular, the reagent or adaptation included in the test zone comprises an immobilized capture reagent that binds to the analyte of interest. Therefore, when the liquid sample flows along the test strip, the analyte of interest first binds with a marker reagent and is then retained in the test zone.

[0022] Advantageously, according to the invention, said support is composed of a biodegradable and / or recyclable material, such as for example paper or cardboard.

[0023] Preferably, the diagnostic device according to the invention is a single-use diagnostic device, meaning that the diagnostic device is generally discarded after use.

[0024] Preferably, according to the invention, said at least one reactive strip is designed to detect an analyte comprising chorionic gonadotropin (hCG).

[0025] Advantageously, the diagnostic device according to the invention comprises a housing located on the lower face of said support and being arranged to be able to house at least one reactive strip therein. In particular, such a housing is arranged to receive and keep in a stable position at least one reactive strip during the test, without it being fixed in the housing.

[0026] Preferably, according to the invention, said housing is arranged to accommodate said at least one test strip in order to hold it in place without fixing it to the support. Such holding of said at least one test strip in the housing makes it possible to guarantee the performance of a reliable diagnosis. The housing may for example be in the form of a bowl in which said at least one test strip is immobilized without however being fixed there. For the purposes of the present invention, such a housing may simply be defined between the upper face and the lower face of the support, said at least one test strip then being held between these two faces without however being fixed to the support.

[0027] Preferably, according to the invention, said zone for depositing said liquid sample comprises an absorbent material in fluid communication with said at least one reactive strip.

[0028] According to an embodiment according to the invention, said at least one reactive strip is composed of a plastic material and / or a polymer such as for example nitrocellulose.

[0029] Advantageously, according to the invention, said rupture zone is in the form of perforations or in the form of a predetermined point of weakness or in the form of a reversible fixing system or in the form of a pre-printed rupture line or in the form of a flexible hinge or in the form of an adhesive rupture zone or in the form of an unlocking rupture zone or in the form of an assisted tear rupture zone.

[0030] Advantageously, the diagnostic device according to the invention is manufactured from materials compatible with safety and quality standards for medical devices.

[0031] Preferably, the diagnostic device according to the invention comprises a gripping zone or element located in a plane substantially parallel to the plane of the upper face or the lower face of the support, said gripping zone being connected to the support by a connecting zone or element.

[0032] The present invention also relates to a use of a diagnostic device according to the invention for detecting and / or identifying a target analyte from a liquid sample, in particular for detecting and / or identifying human chorionic gonadotropin (hCG).

[0033] Other characteristics, details and advantages of the invention will emerge from the examples given below, without limitation and with reference to the appended figures. THE figures 1 to 4 illustrate a first embodiment of a diagnostic device according to the invention. The figures 5 to 8illustrate a second embodiment of a diagnostic device according to the invention. The figure 9 illustrates another embodiment of a diagnostic device according to the invention. Examples

[0034] THE figures 1 to 4illustrate a first embodiment of a diagnostic device D according to the invention. According to this first embodiment, the diagnostic device D for detecting and / or identifying a target analyte from a liquid sample comprises a support 1 having an upper face 2 and a lower face 3 and a reactive strip 4 enclosed inside the support 1 between its upper face 2 and its lower face 3. According to this embodiment, the lower face 3 comprises a housing 3' arranged to contain and maintain in a stable position the reactive strip 4, without however fixing the latter to the support 1 or to the housing 3'. The support 1 is composed of a biodegradable material and has at least one rupture zone 8 arranged to give access to a user to a free end 4' of said reactive strip 4. The reactive strip 4 comprises a test zone 5 and reagents making it possible to detect and / or identify said target analyte.The upper face 2 of the support 1 comprises openings 6 arranged to provide access to a deposition zone 7 for the liquid sample, the deposition zone 7 being in fluid communication with the test zone 5 of the reactive strip 4. The upper face 2 of the support 1 also comprises a reading window F opening onto the test zone 5 of the reactive strip 4 where the detection and / or identification of the target analyte takes place. The diagnostic device as illustrated comprises prints 9, 10 allowing the user to interpret the results displayed in the reading window F.

[0035] After using the diagnostic device as described above and illustrated in figures 1 to 4 , the user can exert a movement on a part of the support 1 as indicated by the double arrow at the figure 2This movement will allow the rupture zone 8 to break in such a way that a part of the upper face 2 of the support 1 can be easily lifted as indicated by the arrow in the figure. figure 3 The user then has access to a free end 4' of the test strip 4 contained in the housing 3' and can easily extract the test strip 4 by grasping its free end 4' as indicated by the arrow in the figure 4 so as to separate the support 1 and the test strip 4.

[0036] THE figures 5 to 8 illustrate a second embodiment of a diagnostic device according to the invention. The diagnostic device D for detecting and / or identifying a target analyte from a liquid sample according to this second embodiment comprises the same elements as those described for the first embodiment, only the rupture zone 8 being substantially in another form.

[0037] After using the diagnostic device D as described above and illustrated in figures 5 to 8 , the user can exert a movement on a part of the support 1 as indicated by the double arrow at the figure 6 This movement will allow the rupture zone 8 to break in such a way that a part of the upper face 2 of the support 1, a part of the lower face 3 of the support 1 and a part of the housing 3' become detached from the rest of the diagnostic device D, for example by simple traction as indicated by the arrow in the figure. figure 7 The user then has access to the free end 4' of the test strip 4 and can easily extract the test strip 4 by grabbing / gripping its free end 4' as indicated by the arrow in the figure. figure 8 so as to separate the support 1 and the test strip 4.

[0038] There figure 9illustrates an embodiment of a diagnostic device according to the invention. According to this embodiment, the diagnostic device comprises a gripping zone or element 11 located in a plane substantially parallel to the plane of the upper face 2 or the lower face 3 of the support 1, the gripping zone 11 being connected to the support 1 by a connecting zone or element 12.

[0039] The present invention has been described in relation to specific embodiments, which are of purely illustrative value and should not be considered as limiting. In general, it will be obvious to those skilled in the art that the present invention is not limited to the examples illustrated and / or described above.

[0040] The use of the verbs "comprendre", "include", "comprendre", or any other variant, as well as their conjugations, cannot in any way exclude the presence of elements other than those mentioned.

[0041] The use of the indefinite article "un", "une", or the definite article "le", "la" or "l'", to introduce an element does not exclude the presence of a plurality of these elements.

Claims

1. Diagnostic device (D) for detecting and / or identifying a target analyte from a liquid sample, comprising: • a support (1) having an upper face (2) and a lower face (3), and • at least one reactive strip (4) enclosed inside said support (1) between said upper face (2) and said lower face (3), said at least one reactive strip (4) comprising a test zone (5) and reagents for detecting and / or identifying said target analyte, said upper face (2) of said support (1) comprising: • at least one opening (6) arranged to provide access to a deposition zone (7) of said liquid sample, said deposition zone (7) being in fluid communication with said test zone (5) of said at least one reactive strip (4), and • a reading window (F) opening onto said test zone (5) of said at least one reactive strip (4) where the detection and / or identification of said target analyte takes place,said diagnostic device (D) being, characterized in that said support (1) has at least one rupture zone (8) designed to give a user access to a free end (4') of said at least one test strip (4).

2. Diagnostic device (D) according to claim 1, characterized in that said support is made of a biodegradable and / or recyclable material.

3. Diagnostic device (D) according to claim 1 or 2, characterized in that that it is single-use.

4. Diagnostic device (D) according to any one of the preceding claims, characterized in that said at least one test strip (4) is adapted to detect an analyte comprising human chorionic gonadotropin (hCG).

5. Diagnostic device (D) according to any one of the preceding claims, characterized in thatit comprises a housing (3') located on the lower face (3) of said support (1) and being arranged to be able to house said at least one reactive strip (4).

6. Diagnostic device (D) according to any one of the preceding claims, characterized in that said deposition zone (7) of said liquid sample comprises an absorbent material in fluid communication with said at least one test strip.

7. Diagnostic device (D) according to any one of the preceding claims, characterized in that said at least one test strip (4) is made of a plastic material and / or a polymer such as for example nitrocellulose.

8. Diagnostic device (D) according to any one of the preceding claims, characterized in thatsaid rupture zone is in the form of perforations or in the form of a predetermined point of weakness or in the form of a reversible fastening system or in the form of a pre-printed rupture line or in the form of a flexible hinge or in the form of an adhesive rupture zone or in the form of an unlocking rupture zone or in the form of an assisted tear rupture zone.

9. Diagnostic device (D) according to any one of the preceding claims, characterized in that It is made from materials compatible with safety and quality standards for medical devices.

10. Diagnostic device (D) according to any one of the preceding claims, characterized in thatit comprises a gripping zone or element (11) located in a plane substantially parallel to the plane of the upper face (2) or the lower face (3) of said support (1), said gripping zone (11) being connected to the support (1) by a connecting zone or element (12).

11. Use of a diagnostic device (D) according to any one of claims 1 to 10 for detecting and / or identifying a target analyte from a liquid sample, in particular for detecting and / or identifying human chorionic gonadotropin (hCG).