Face mask

Abstract

Disclosed herein is a face mask (1) for sampling pathogens, the face mask (1) comprising: a mask body (2) being configured to cover at least the mouth and / or the nose of a human subject with an inner side (3) of the mask body (2) being oppositely arranged to an outer side (4) of the mask body (2); a collection sheet (5) being releasably mounted to the inner side (3) of the mask body (2), the collection sheet (5) comprising a substrate (6) and a fiber material (7), in particular a non-woven fiber material.

Description

[0001] Face Mask

[0002] Field of disclosure

[0003] The present disclosure lies in the field of respiratory pathogen collection and their analysis and relates in particular to a face mask for sampling pathogens, a kit of parts comprising such a face mask, a method for analyzing a sample, a method for obtaining a sample and a method for obtaining and analyzing a sample.

[0004] Background, prior art

[0005] Collection of aerosols, in particular pathogens, from the breath of human subjects to test the subjects for the presence of pathogens causing a respiratory disease represents a superior method for collection of such pathogens, as it does not require invasive collection techniques. Furthermore, if devices can be provided which collect pathogens from the breath of a subject, the subject merely has to exhale into the device and thus excessive medical training for the personnel collecting the samples may not be required. This is different to other invasive techniques such as blood tests, bronchoalveolar lavage or even swab tests and represents a major advantage. Many respiratory diseases such as tuberculosis are prevalent in countries with low GDP and therefore it would be desirable to provide collection devices which are low cost and easy to manufacture. Many collection devices are complex and expensive to produce and therefore not suitable for mass sampling and / or testing in many geographic areas.

[0006] Furthermore, another problem is the sample collection and preparation itself. It must be ensured that enough pathogens are collected in order to avoid false negative results. Additionally, the collected pathogens must be provided in a form which is suited for analysis, such as PCR. However, handling such samples is dangerous as the samples are often highly contagious and the sample should further not be contaminated to avoid any crosscontamination to avoid false positive results. Many known methods and devices require handling, and in particular contacting, elements of the device containing the contagious pathogens. Additionally, obtaining such samples is not straightforward and requires at least a basic medical laboratory training.

[0007] Summary of disclosure

[0008] It is the general object of the present disclosure to advance the state of the art in the field of aerosol collection, in particular respiratory pathogen collection and their analysis and in particular to overcome the problems of the prior art fully or at least partly. In advantageous embodiments, a safe and operationally simple sample collection is achieved. In further advantageous embodiments, the collection prevents fully or at least partly contamination of the sample and / or addresses the biohazards risks for medical personnel and the environment. In further advantageous embodiments, a sufficient amount of pathogens can be collected within a short collection time interval.

[0009] The general object is achieved by the subject-matter of the independent claims. Further advantageous embodiments follow from the dependent claims and the overall disclosure.

[0010] A first aspect of the disclosure relates to a face mask for sampling of the respiratory tract, in particular for sampling pathogens. A second aspect of the disclosure relates to a kit of parts comprising such a face mask. A third aspect of the invention relates to a method for analyzing a sample. A fourth aspect of the invention relates to a method for obtaining a sample from a human subject and a fifth aspect of the invention relates to a method for obtaining a sample and analyzing the sample.

[0011] The face mask for sampling pathogens may in some embodiments comprise a mask body. Such a mask body may comprise an inner side and a thereto oppositely arranged outer side. It is understood that the terms “inner” and “outer” refer to the side of the face mask which are in the operative state facing towards a subject’s face (i.e. the inner side) and away from the subject’s face (i.e. the outer side). The operative state or worn state represents the state in which the face mask is mounted onto the subject’s face. It may thus also be possible to refer to the inner side as a first side and to the outer side as a second side. The mask body may in some embodiments be configured to cover at least the mouth and / or the nose of a human subject with the inner side of the mask body, which is oppositely arranged to the outer side of the mask body.

[0012] The face mask may further comprise a collection sheet. In some embodiments, the face mask may comprise exactly one collection sheet. The collection sheet may for example be mounted, in particular releasably mounted, to the inner side of the mask body. The collection sheet may further comprise a substrate and a fiber material. In certain embodiments, the fiber material may be a non-woven fiber material and / or an electrospun fiber material. In some embodiments, the fiber material may be spun-bond, e.g. a spun-bond material. Thus, the fiber material may be spun-bonded on the substrate.

[0013] The term “releasably mounted” as used herein particularly means that the collection sheet can be removed from the mask body without destroying the collection sheet and the mask body and / or their structural integrity. Typically, releasing does not require to dissolve a material or exercising strong forces. For example, the collection sheet is in the mounted state during sample collection mounted to the inner side of the mask body and released during sample processing.

[0014] It is generally understood herein that the term “comprising” is interpreted as meaning that it includes those features following this term, but that it does not exclude the presence of other features, as long as they do not render the claim unworkable. On the other hand, if the wording "consist of" is used, then no further features are present in the corresponding subject-matter apart from the ones following said wording.

[0015] In some embodiments, the substrate and the fiber material are connected by a form-locking connection. In particular, the fiber material may be laminated and / or pressed, in particular calendered, onto the substrate. In certain embodiments, the collection sheet is devoid of an adhesive and / or the connection between the fiber material and the substrate may be devoid of a material bonded connection. The substrate may be considered as a support layer and / or protection layer onto which the fiber material is arranged.

[0016] The collection sheet may be configured such that the breath of a subject flows through the collection sheet and thereby pathogens and / or other breath exhalate content are collected by the fiber material. Since the collection sheet is releasably mounted to the mask body, it can be readily removed therefrom for further analysis.

[0017] The collection sheet may be configured such that the collection sheet is exposed to the breath of the subject and thereby pathogens and / or other breath exhalate content are collected by the fiber material. Exposure may include exhalation onto and / or through the collection material.

[0018] In some embodiments, the substrate comprises a polymer material, in particular a polyolefin, such as polypropylene or polyethylene. Other suitable polymer materials may be poly lactic acid, or polyester.

[0019] In some embodiments, the substrate comprises a hydrophilic material. The hydrophilic material may in particular embodiments be an additional material to the polymer material. Typical examples for such a hydrophilic material may be Si-containing compounds, glycosides, carboxylic acid containing oligomers and polymers, carbonates, metal oxides, such as TiC>2, and the like. A hydrophilic material as used herein may have a water contact angle of smaller than 90°.

[0020] Substrates with a hydrophilic material have a specific advantage further downstream in the analysis process. To analyze the collected pathogens, the collection sheet is released after collection from the mask body and inserted into a test tube, such as a PCR test tube. Therein, the collection sheet is contacted with an aqueous solution. It has been found that a hydrophilic material prevents the formation of air bubbles and improves to detach the collected respiratory sample with the pathogens from the collection sheet and generate the analysis mixture. In some embodiments, the polymer material is filled with the hydrophilic material. That is, during production of the polymer material, the hydrophilic material is blended into the polymer material. It may for example be possible that the monomer composition is mixed with the hydrophilic material. Thus, the hydrophilic material is not a mere coating of the polymer material, but the polymer material is filled with the hydrophilic material. It is not necessary that the hydrophilic material is covalently bound to the polymer material. It may additionally or alternatively also be possible that the polymer material and the hydrophilic material form together a composite. Such a composite is not a mere coating of the polymer material, but the hydrophilic material and the polymer material are mixed with each other. The prevention of bubbles and bringing the pathogens into the analysis solution has been found to be even further improved for such embodiments, as compared to polymer material being merely coated with the hydrophilic material. It has been found that polymer material being merely coated with the hydrophilic material may release said hydrophilic material which leads to interferences during analyte detection, whereas this is not the case if the hydrophilic material is blended into the polymer material.

[0021] In some embodiments, the fiber material is a polyamide, preferably PA-6, polyvinylchloride, or polyacrylonitrile. It may also be possible to that the fiber material is a cellulose acetate, polyvinyl alcohol, polyethylene oxide, poly(meth)acrylate, polyvinylpyrrolidone or chitosan In particular, such a fiber material may be an electrospun material. Polyamide and in particular PA-6 has the advantage that is does not have the tendency to become brittle and can be electrospun with low toxicity solvents.

[0022] In some embodiments, the fiber material comprises fibers. In particular embodiments, the fibers may be nanofibers, i.e. fibers having a diameter of less than 1000 nm, in particular having a diameter of 1 to 1000 nm, more particular 10 to 1000 nm. Such fibers typically have a circular cross-section. The diameter may refer to the longest straight line of opposing peripheries of the cross-section through the center of the cross-section. Nanofibers are advantageous as they provide for a significantly increased surface area being available for collecting pathogens. The pathogens typically are collected by the fiber material and may accumulate at the surface of the fibers. Thus, such fibers reach a high aerosol filter efficiency at a high air permeability and thus low breathing resistance which is important for breath sample collection for diagnosis of respiratory infections in people who may have difficulties breathing.

[0023] In some embodiments the substrate may have an area density of less than 50 g / m2, in particular 20 g / m2or less, more particular 15 g / m2. In some embodiments the fiber material has an area density of less than 5 g / m2, in particular 0.5 g / m2or less, more particular 0.08 g / m2.

[0024] In some embodiments, the fiber material, in particular the fiber layer, is thinner than the substrate, in particular the substrate layer (such as the first and second substrate layer). For example, the thickness of the fiber material, in particular the fiber layer, may be 0.15x or less, in particular 0.1 Ox or less, more particular 0.015x or less, than the thickness of the substrate, in particular the substrate layer.

[0025] In some embodiments, the collection sheet has an air permeability (at 200 Pa) of more than 100 L / (m2-s), in particular between 200 and 1500 L / (m2-s), more particular between 300 and 600 L / (m2-s).

[0026] In some embodiments, the collection sheet has an aerosol filter efficiency for oil particles with a diameter of 0.29 to 0.45 pm of more than 80%, in particular between 80 and 99%, more particular between 85 and 99%. The filter efficiency can be determined according to DIN EN 13274-7:2019-09 and / or DIN EN 149:2009-08. As an oil for the oil particles, di- ethyl-hexyl-sebacate (dioctyl sebacate, CAS 122-62-3) is used.

[0027] In some embodiments, the collection sheet has an air permeability (at 200 Pa) between 300 and 600 L / ( m2-s) and an aerosol filter efficiency (for oil particles with a diameter of 0.29 to 0.45 pm) between 80 and 99%, more particular between 85 and 99%. Such a combination is particularly advantageous, because it strikes a well suited balance between breathing resistance and filter efficiency. In some embodiments, the collection sheet may be a laminate. The laminate may for example comprise a first substrate layer as the substrate and a fiber layer being arranged on the substrate layer. The fiber layer may be made of, e.g. consists of, the fiber material.

[0028] In certain embodiments, the laminate may comprise a second substrate layer. Such as second substrate layer may be different from the first substrate layer. In particular embodiments, the fiber layer may be arranged between the first substrate layer and the second substrate layer. In other words, the fiber layer may in such embodiments be sandwiched between the first and second substrate layer. It may be possible that the fiber layer is connected with the first and second substrate layer by a form-locking connection. In particular, the fiber material may be pressed, in particular calendered, onto the first and second substrate layer. Calendering may for example be performed under ambient conditions (20°C) or above. In certain embodiments the fiber layer and the first and second substrate layer may be devoid of a material bonded connection. Instead, the fiber layer and the first and second substrate layer may be connected by a form-locking connection. Such a sandwiched configuration improves the structural integrity of the collection sheet and protects the fiber material. Furthermore, it prevents that fibers of the fiber material stick or intermingle with the base body or contact the subject’s face which may cause an uncomfortable feeling. In some embodiments, it may also be possible that the fiber layer and the first and second substrate layer are material bonded, e.g. by an adhesive. In some embodiments, the fiber layer consists of a plurality of fiber material portions being sandwiched between the two substrate portions.

[0029] In some embodiments, the laminate is made from two or more, in particular two, separate pieces. A first piece may comprise or consist of the first substrate layer and a first fiber portion being arranged on the first substrate layer. Furthermore, a second piece may comprise or consist of a second substrate layer and a second fiber portion. In certain embodiments, the first fiber portion may be in contact, i.e. in direct contact, with the second fiber portion such that the first fiber portion and the second fiber portion together form the fiber layer which is arranged between the first substrate layer and the second substrate layer. In some embodiments, the mask body may comprise, respectively delimit, a first opening. This first opening may extend from the inner side to the outer side. Thus, the first opening is penetrating through the mask body. In particular embodiments, the first opening may be covered by the collection sheet. The collection sheet may therefore cover the first opening from the inner side of the mask body. Such a first opening allows to release and remove the collection sheet in a particular reliable manner and avoids contamination of the collection sheet and the environment. This is because, as illustrated further below, a rod or stick may be guided from the outer side of the mask body through the first opening. When the rod or stick contacts the collection sheet covering the first opening from the inner side, it can be pushed further, thereby releasing the collection sheet from the mask body. A corresponding test tube may be positioned such that the released collection sheet can directly be pushed into the test tube.

[0030] In particular embodiments, the first opening is covered by a first cover, in particular a sticker. Such a first cover may be releasably mounted to the outer side of the mask body. The first cover can be removed directly before a rod is guided through the first opening. Such a sticker may avoid contamination and protect the collection sheet.

[0031] In some embodiments, the mask body comprises, respectively delimits, a second opening. Such a second opening is different from the first opening. It may for example be arranged at a different location than the first opening. The second opening may extend from the inner side to the outer side of the mask body. Thus, the second opening is penetrating through the mask body. Also, the second opening may be covered by the collection sheet, i.e. by the same collection sheet. This has the advantage that the collection sheet can be safely and rapidly removed as described herein further below. The collection sheet may therefore cover the second opening from the inner side of the mask body. A second opening provides an even more improved release and removal of the collection sheet. As will be further illustrated below, the face mask may be folded such that the first and second opening are directly arranged above one another, particularly in flush with each other. In this configuration, the collection sheet is sandwiched between the first and second opening. A rod can then be guided through the first opening from the outer side, which contacts the collection sheet and pushes it from the inner side through the second opening. If a test tube is arranged behind / adjacent to the second opening on the outer side of the mask body, the collection sheet can be directly pushed into the test tube. Since the collection sheet is forced through the second opening, it is compressed / scrunched and therefore is easily guided into the test tube.

[0032] In certain embodiments, the second opening may be covered by the first cover or it may also be possible to cover the second opening by a second cover being different from the first cover. In certain embodiments the first and the second cover may be combined to one cover to reduce the number of processing steps. The second cover may also be a sticker. The second cover may also be releasably mounted to the outer side of the mask body.

[0033] In some embodiments, the first opening and or the second opening define a cross-sectional open area of at least 5 mm2, such as between 5 mm2to 3000 mm2, in particular 30 mm2to 3000 mm2, more particular between 100 mm2to 500 mm2.

[0034] In some embodiments, the first opening and the second opening are arranged such that the mask body can be folded along a folding line, in particular a predetermined folding line, such that the first opening and the second opening are arranged directly on top of each other and in particular flush with each other and / or are coaxially arranged with each other. A predetermined folding line is a folding line about which the mask can be easier folded than along another, non-predetermined folding line. For example, the predetermined folding line may comprise an embossing, a stitch or a perforation.

[0035] In some embodiments, the first opening, the second opening and the collection sheet may be configured such that the collection sheet can be removed from the mask body by a rod being inserted from the outer side through the first opening and thereafter guiding the rod and the collection sheet from the inner side through the second opening. In certain embodiments no additional action is necessary to remove the collection sheet from the mask body. In some embodiments, the collection sheet is releasably mounted to the inner side of the mask body by a form-locking and / or force-locking and / or material-bonding connection, in particular by a form-locking and / or material-bonding connection. For example, the collection sheet may be mounted to the inner side by a hook and loop fastener connection or by means of adhesive surfaces as described below. As noted above, it is generally understood that the inner side of the mask is the side onto which the wearer directly breaths in the operative or worn state, and / or which is facing towards the face of the wearer in the operative or worn state. In embodiments in which the face mask comprises a predetermined fold line, parts of the inner side being arranged on both sides of the fold line are moved closer together during folding and face each other. In some embodiments, the inner side of the mask may form a concave surface, such as a collapsible triangular chamber. In contrast, the oppositely arranged outer side may form a convex surface. As the skilled person understands, the terms “convex” and “concave” refer to the direction to which the surface is curved / angled. While a concave surface forms a chamber and is shaped away from a viewer viewing into the chamber, a convex surface is shaped towards the viewer. The terms “convex” and “concave” do however not necessarily mean that the surfaces must be rounded. Although this may in some embodiments be possible, it may in other embodiments be possible that the convex and / or concave surface is / are angular. For example, a concave surface may in cross section form a part of a concave polygon.

[0036] In some embodiments, the collection sheet may be releasably mounted to the inner side of the mask body by means of one or more adhesive surfaces, in particular adhesive dots, and / or by means of a plurality of hook and loop fastener connections. Such one or more adhesive surfaces may for example cover a total surface area of 2 mm2to 200 mm2, in particular of 15 mm2to 25 mm2. In certain embodiments, each adhesive surface may be smaller than 5%, in particular 0.3% of the total surface area of the side of the collection sheet which faces the mask body. The peel adhesion of the adhesive surface according to ASTM D3330 of the adhesive surface is 2 to 25 N / 25 mm, in particular 7 N / 25 mm. In some embodiments, at least two adhesive surfaces are arranged around the first opening. Additionally or alternatively, at least two adhesive surfaces may be arranged around the second opening.

[0037] In some embodiments, the mask body may comprise or consist of a cloth, such as a textile cloth. For example, the mask body may be a mask body of a surgical mask FFP1 mask or FFP2 mask.

[0038] The kit of parts according to the second aspect of the invention may comprise the face mask according to any of the embodiments described herein, in particular with respect to the first aspect. It may in some embodiments further be possible that the kit also comprises one or more test tubes or test tube assemblies. The test tube(s) may be configured such that the collection sheet can be inserted into and accommodated by the test tube.

[0039] The test tube may comprise a tube body. In particular embodiments, an aqueous solution may be contained in the tube body. The aqueous solution may for example be an aqueous buffer solution. Thus, in such embodiments, the kit comprises a test tube which comprises the tube body and the aqueous solution.

[0040] In some embodiments, the collection sheet has at least a total surface area of 500 mm2, in particular 5500 mm2and the kit comprises less than 5 mL of the aqueous solution, in particular less than 2 mL of the aqueous solution.

[0041] It may also be possible that the aqueous solution is provided separately, e.g. in a separate container. Therefore, the aqueous solution may be a separate part of the kit. The user can then fill the aqueous solution into the test tube before or after the collection sheet has been introduced into the test tube. It may also be possible that the tube body is a sample reservoir from a diagnostic test cartridge, e.g. a PCR cartridge with onboard reagents.

[0042] In some embodiments, the kit further comprises a rod. The rod may in particular be configured such that it can be guided through the first and optionally the second opening. In some embodiments, the rod may be mounted to a cap. The cap and the test tube may in particular be configured to form a sealing engagement such that the test tube is closed by the cap. For example, the cap and the test tube may form together a thread connection. Such embodiments have the advantage that the rod does not have to be packed in a separate sterile packing but is maintained inside the test tube until it is being used. Further, the rod itself needs not to be touched which avoids contaminations.

[0043] In some embodiments, the kit of parts comprises a face mask according to any of the embodiments described herein, in particular with respect to the first aspect and a test tube assembly.

[0044] A test tube assembly may comprise, or consist of, a test tube as described for example herein above and a cap as also described herein above. The cap and the test tube may in particular be configured to form a sealing engagement such that the test tube is closed by the cap. Furthermore, a rod may either be a separate part of the kit or the rod may be mounted to the cap, e.g. as described herein above. The test tube may comprise a tube body. In particular embodiments, an aqueous solution may be contained in the tube body. The aqueous solution may for example be an aqueous buffer solution. Thus, in such embodiments, the kit comprises a test tube which comprises the tube body and the aqueous solution.

[0045] The third aspect of the present disclosure relates to a method for analyzing a sample. Such a method may comprise the step of providing a face mask as described in any of the embodiments herein, in particular with respect to the first aspect.

[0046] The method may in some embodiments further comprise the step of releasing and / or removing the collection sheet from the mask body to separate the collection sheet from the mask body. Thereby, a separated collection sheet may be provided.

[0047] The method may further comprise the step of introducing the separated collection sheet into a test tube and suspending the separated collection sheet in the test tube in an aqueous solution, in particular an aqueous buffer solution, to provide an analyte mixture. The analyte mixture may comprise, or consist of, the aqueous solution as well as collected aerosols and / or breath exhalate, in particular pathogens, having been attached to the collection sheet

[0048] In some embodiments, the collection sheet has at least a total surface area of 500 mm2, in particular 5500 mm2and is fully submerged and / or suspended in less than 5 mL of the aqueous solution, in particular 2 mL of the aqueous solution.

[0049] In some embodiments, the method may further comprise the step of analyzing the analyte mixture. In certain embodiments, analyzing the analyte mixture may comprise a nucleic acid amplification test (NAAT), PCR analysis, sequencing, DNA hybridization assay, CRISPR- based analysis, immunoassay, antigen assays, biochemical assays, molecular detection methods, mass spectrometry, chemical, cytometry, flow cytometry, or growth-based microbiology methods. In particular embodiments, the step of analyzing the analyte mixture comprises or consists of PCR analysis.

[0050] In some embodiments, the method may further comprise determining a diagnosis, and / or the presence of a pathogen. This may in certain embodiments be done by comparing an analysis result, such as a nucleic acid sequence, amplification curve or melt curve or the like with a database that associates this analysis result with a pathogen and / or with a disease. For example, upon determining the presence of a specific pathogen, a disease may be diagnosed by associating the determined pathogen with a disease.

[0051] In some embodiments, removing the collection sheet from the mask body comprises inserting a rod from the outer side of the mask body through the first opening of the mask body. Thereby the collection sheet may at least partially or completely be released from the inner side of the mask body. In certain embodiments, the first and optionally the second cover may be removed from the mask body, e.g. from the outer side of the mask body.

[0052] In certain embodiments, after inserting the rod through the first opening, the rod and the collection sheet are guided through the second opening of the mask body. For example, this may be done such that the collection sheet completely passes through the second opening and is thereby completely separated and / or released from the mask body.

[0053] In some embodiments, an opening of a test tube is arranged or held adjacent to the outer side of the mask body in front of the second opening. The collection sheet may be directly introduced into the test tube, e.g. through the opening of the test tube, after passing the second opening.

[0054] In some embodiments, the second opening is held above an opening of a test tube and the collection sheet may be directly introduced into the test tube after passing the second opening.

[0055] In some embodiments, the face mask is folded along a folding line, for example a predetermined folding line as described herein, such that the first opening and the second opening are arranged above each other and above the opening of the test tube before the rod is inserted into the first opening. Typically, parts of the inner side may face towards each other during and / or after folding. Furthermore, the second opening may in some embodiments be arranged between the first opening and the opening of the test tube. Thus, as explained above, the collection sheet may be directly released and pushed into the test tube in a straightforward and efficient manner which avoids any undesired contamination of the collection sheet and the medical environment. After folding the face mask along the folding line, the rod is guided through the first opening and contacts the collection sheet. The rod is then further guided from the inner side of the mask body through the second opening and into the test tube. Thereby the collection sheet is released and guided together with the rod through the second opening into the test tube.

[0056] In some embodiments, the face mask is folded, e.g. along the fold line, such that the first opening and the second opening flush with each other, i.e. are aligned with each other.

[0057] The fourth aspect of the present disclosure relates to a method for obtaining a sample from a human subject. Such a method may be considered as a use of the face mask as described herein, in particular with respect to the first aspect, for obtaining a sample from a human subject. The method may comprise the step of mounting a face mask according to any of the embodiments described herein, in particular with respect to the first aspect, on the human subject’s face. The face mask may be mounted such on the human subject’s face that the mouth and / or nose of the subject are covered and such that the human subject exhales directly onto the collection sheet which is releasably mounted to the inner side of the mask body.

[0058] Mounting may for example be achieved by a head band, such as an elastic wire or strap. This head band may be part of the face mask and may particularly be mounted to the mask body.

[0059] The method may further comprise that the human subject exhales onto, and in particular through, the collection sheet and also through the face mask for a sampling interval. The sampling interval may be predefined.

[0060] In some embodiments, the sampling interval may be at least 10 min, in particular at least 20 min, more particular at least 30 min, even more particular at least 50 min. In some embodiments, the sampling interval may be at most 3 h, in particular at most 2.5 h, more particular at most 2 h, even more particular at most 1 h.

[0061] A test tube or test tube assembly as described herein may be used in such a method.

[0062] The fifth aspect of the invention relates to a method for obtaining a sample from a human subject and for analyzing the obtained sample. Such a method may be considered as a use of a face mask as described herein, in particular with respect to the first aspect, for obtaining a sample from a human subject and for analyzing the obtained sample. This method may comprise one or more of the steps of the method described with respect to the fourth aspect of the disclosure. In some embodiments, the method according to the fifth aspect may comprise the step of mounting a face mask according to any of the embodiments described herein, in particular with respect to the first aspect, on the human subject’s face. The face mask may be mounted such on the human subject’s face that the mouth and / or nose of the subject are covered and such that the human subject exhales directly onto the collection sheet which is releasably mounted to the inner side of the mask body.

[0063] Mounting may for example be achieved by a head band as already described above, such as an elastic wire or strap.

[0064] The method may further comprise that the human subject exhales onto, and in particular through, the collection sheet and also through the face mask for a sampling interval. The sampling interval may be predefined.

[0065] The method may further comprise one or more of the steps described herein with respect to the method of the third aspect.

[0066] The method of the fifth aspect may for example further comprise the step of removing the mask from the human subject and removing the collection sheet from the mask body to separate the collection sheet from the mask body.

[0067] The method may also comprise the step of introducing the separated collection sheet into a test tube and suspending the separated collection sheet in the test tube in an aqueous solution, in particular an aqueous buffer solution to provide an analyte mixture.

[0068] The method may further comprise the step of analyzing the analyte mixture, in particular as it has been described herein above, for example with respect to the third aspect of the disclosure.

[0069] A test tube or test tube assembly as described herein may be used in such a method.

[0070] In the following, non-limiting examples of the present disclosure are provided: A 1 . example relates to a face mask for sampling pathogens, the face mask comprising: a. a mask body being configured to cover at least the mouth and / or the nose of a human subject with an inner side of the mask body being oppositely arranged to an outer side of the mask body; b. a collection sheet being releasably mounted to the inner side of the mask body, the collection sheet comprising a substrate and a fiber material, in particular an electrospun fiber material.

[0071] A 2. example relates to the face mask according to the 1. example, wherein the substrate comprises a polymer material, in particular a polyolefin, such as polypropylene or polyethylene, or poly lactic acid, or polyester.

[0072] A 3. example relates to the face mask according to the 1. or 2. example, wherein the substrate comprises a hydrophilic material.

[0073] A 4. example relates to the face mask according to the 2. and 3. example, wherein the polymer material is filled with the hydrophilic material and / or wherein the polymer material and the hydrophilic material form together a composite.

[0074] A 5. example relates to the face mask according to any of the previous examples, wherein the fiber material is a polyamide, preferably PA-6, polyvinylchloride, polyacrylonitrile, cellulose acetate, polyvinyl alcohol, polyethylene oxide, poly(meth)acrylate, polyvinylpyrrolidone or chitosan, in particular polyamide, such as PA-6, or polyvinylchloride, polyacrylonitrile.

[0075] A 6. example relates to the face mask according to any of the previous examples, wherein the collection sheet is a laminate comprising a first substrate layer as the substrate and a fiber layer being arranged on the substrate layer and being made of the fiber material. A 7. example relates to the face mask according to the 6. example, wherein the laminate comprises a second substrate layer and wherein the fiber layer is arranged between the first substrate layer and the second substrate layer.

[0076] A 8. example relates to the face mask according to the 7. example, wherein the laminate is made from two separate pieces, wherein a first piece consists of the first substrate layer and a first fiber portion arranged on the first substrate layer, and wherein a second piece consists of a second substrate layer and a second fiber portion arranged on the second substrate layer.

[0077] A 9. example relates to the face mask according to the 8. example, wherein the first fiber portion contacts the second fiber portion such that the first fiber portion and the second fiber portion together form the fiber layer being arranged between the first substrate layer and the second substrate layer.

[0078] A 10. example relates to the face mask according to any of the previous examples, wherein the mask body comprises a first opening extending from the inner side to the outer side, wherein the first opening is covered by the collection sheet.

[0079] A 11 . example relates to the face mask according to the 10. example, wherein the first opening is covered by a first cover, in particular a sticker, being releasably mounted to the outer side of the mask body.

[0080] A 12. example relates to the face mask according to the 10. or 11. example, wherein the mask body comprises a second opening extending from the inner side to the outer side , wherein the second opening is covered by the collection sheet.

[0081] A 13. example relates to the face mask according to the 12. example, wherein the second opening is covered by the first cover or wherein the second opening is covered by a second cover being particularly different from the first cover, in particular a sticker, being releasably mounted to the outer side of the mask body. A 14. example relates to the face mask according to the 12. or 13. example, wherein the first opening and the second opening are arranged such that the mask body can be folded along a folding line, in particular a predetermined folding line, such that the first opening and the second opening are arranged directly on top of each other and in particular flush with each other.

[0082] A 15. example relates to the face mask according to any of the 12. to 14. examples, wherein the first opening, the second opening and the collection sheet are configured such that the collection sheet can be removed from the mask body by a rod being inserted from the outer side through the first opening and thereafter guiding the rod and the collection sheet from the inner side through the second opening.

[0083] A 16. example relates to the face mask according to any of the previous examples, wherein the collection sheet is releasably mounted to the inner side of the mask body by a formlocking and / or force-locking and / or material-bonding connection.

[0084] A 17. example relates to the face mask according to any of the previous examples, wherein the collection sheet is releasably mounted to the inner side of the mask body by means of one or more adhesive surfaces , in particular adhesive dots, and / or by means of a plurality of hook and loop connections.

[0085] A 18. example relates to the face mask according to the 17. example, wherein at least two adhesive surfaces are arranged around the first opening and / or second opening.

[0086] A 19. example relates to the face mask according to any of the previous examples, wherein the mask body comprises, or consists of, a cloth, in particular a textile cloth.

[0087] A 20. example relate to a kit of parts comprising the face mask according to any of the previous examples and a test tube and optionally a rod.

[0088] A 21 . example relates to the kit according to the 20. example, wherein the kit comprises a test tube assembly which comprises the test tube and optionally a cap wherein the cap and the test tube are configured to form a sealing engagement such that the test tube is closed by the cap.

[0089] A 22. example relates to the kit according to the 21 . example wherein the rod is mounted to the cap.

[0090] A 23. example relates to a method for analyzing a sample, the method comprising the steps: a. Providing a face mask according to any of the 1 . to 19. example; b. Removing the collection sheet from the mask body to separate the collection sheet from the mask body; c. Introducing the separated collection sheet into a test tube and suspending the separated collection sheet in the test tube in an aqueous solution, in particular an aqueous buffer solution to provide an analyte mixture; d. Analyzing the analyte mixture.

[0091] A 24. example relates to the method according to the 23. example, wherein step d. includes a nucleic acid amplification test (NAAT), PCR analysis, sequencing, DNA hybridization assay, CRISPR-based analysis, immunoassay, antigen assays, biochemical assays, molecular detection methods, mass spectrometry, chemical, cytometry, flow cytometry, or growth-based microbiology methods to detect the analyte, in particular nucleic acid amplification tests (NAAT) such as PCR analysis or sequencing..

[0092] A 25. example relates to the method according to the 23. or 24. example, wherein step b. comprises inserting a rod from the outer side of the mask body through the first opening of the mask body, thereby at least partially releasing the collection sheet from the inner side of the mask body. A 26. example relates to the method according to the 25. example, wherein after inserting the rod through the first opening, the rod and the collection sheet are guided through the second opening of the mask body, in particular such that the collection sheet completely passes through the second opening and is thereby completely released from the mask body

[0093] A 27. example relates to the method according to the 26. example, wherein an opening of a test tube is held adjacent to the outer side of the mask body in front of the second opening and wherein the collection sheet is directly introduced into the test tube upon passing the second opening.

[0094] A 28. example relates to the method according to the 27. examples wherein the face mask is folded along a folding line such that the first opening and the second opening are arranged above each other and above the opening of the test tube before the rod is inserted into the first opening, wherein the second opening is arranged between the first opening and the opening of the test tube.

[0095] A 29. example relates to a method for obtaining a sample from a human subject, the method comprising the steps: a. Mounting a face mask according to any of the 1. to 19. examples on the human subject’s face, such that the mouth and / or nose of the subject are covered and such that the human subject exhales directly onto the collection sheet being releasably mounted to the inner side of the mask body; b. Letting the human subject exhale onto the collection sheet and through the face mask for a sampling interval.

[0096] A 30. example relates to the method according to the 29. example, wherein the sampling interval is at least 10 min, in particular at least 20 min, more particular at least 30 min, even more particular at least 50 min. A 31. example relates to a method for obtaining a sample from a human subject and analyzing the sample, the method comprising the steps: a. Mounting a face mask according to any of the 1. to 19. examples on the human subject’s face, such that the mouth and / or nose of the subject are covered and such that the human subject exhales directly onto the collection sheet being releasably mounted to the inner side of the mask body; b. Letting the human subject exhale onto the collection sheet for a sampling interval; c. Removing the face mask from the human subject and removing the collection sheet from the mask body to separate the collection sheet from the mask body; d. Introducing the separated collection sheet into a test tube and suspending the separated collection sheet in the test tube in an aqueous solution, in particular an aqueous buffer solution to provide an analyte mixture; e. Analyzing the analyte mixture.

[0097] Brief description of the figures

[0098] The herein described invention will be more fully understood from the detailed description given herein below and the accompanying drawings which should not be considered limiting to the invention described in the appended claims. The drawings are showing:

[0099] Fig. 1 a schematic perspective view of a face mask according to an embodiment of the disclosure;

[0100] Fig. 2 a schematic view of a folded face mask onto the outer side of a face mask according to another embodiment of the disclosure; Fig. 3 a schematic view of a test tube as it can be used in some embodiments of the disclosure;

[0101] Fig. 4 a schematic view of how a collection sheet can be separated from a mask body of a face mask according to an embodiment of the disclosure;

[0102] Fig. 5a, b schematic cross-sectional views of collection sheets as they can be used in some embodiments of the disclosure;

[0103] Fig. 6 a microscopic image of a collection sheet as it can be used in some embodiments of the disclosure.

[0104] Exemplary embodiments

[0105] Fig. 1 shows a schematic view of a face mask onto the inner side 3 of mask body 2. Inner side 3 may also be considered as the inside of the face mask, respectively the mask body. It can be seen that the inner side 3 forms a concave surface, such as a collapsible triangular chamber. Besides mask body 2, face mask 1 comprises collection sheet 5 which is arranged such that when the face mask is mounted onto the face of a human subject, the human subject exhales onto collection sheet 5. Mask body 2 delimits first opening 8 and second opening 10. The collection sheet 5 shown may be transparent such that first opening 8 and second opening 10 are visible also from the inner side 3, even though they are both covered by collection sheet 5. Collection sheet 5 is releasably mounted to mask body 2 by means of adhesive surfaces 13 (only one of the 6 shown adhesive surfaces is referenced for clarity purposes). Mask body 2 further comprises a fold line 1 1 along which the face mask can be folded as shown for example in Fig. 2.

[0106] Fig. 2 shows a schematic view of another embodiment of a face mask 1 . Face mask 1 may in some embodiments be foldable in half along a fold line. As can be seen, a releasable cover 9, such as a sticker, covers first opening 8. Cover 9 is mounted to outer side 4 of mask body 2. Also, the mask body may be transparent such that adhesive surfaces 13 may be visible from the outer side. Upon folding, the parts of the inner side are facing each other.

[0107] Fig. 3 shows a test tube assembly 18 comprising test tube 14 as it can be used in some embodiments of the disclosure, in particular in the methods according to the fourth or fifth aspect. Test tube 14 may in this or any other embodiment described herein comprise tube body 16. Furthermore, test tube assembly 18 may comprise cap 15. Cap 15 can be configured such that it seal i n g ly closes test tube 14, respectively tube body 16. For example, cap 15 may comprise a thread and tube body 16 may comprise a corresponding thread such that the two threads can engage with each other to form a form-locking connection. Test tube assembly 18 further comprises rod 12 which is mounted to cap 15 and arranged inside tube body 16. Furthermore, an aqueous solution 17 is accommodated inside tube body 16. T ube body 16 may in this or any other embodiment described herein have a tubular shape, respectively the shape of a blind hole.

[0108] Fig. 4 illustrates how collection sheet 5 can be removed, respectively released and / or separated from mask body 2 of face mask 1 . Face mask 1 is folded along folding line 11 such that first opening 8 and second opening 10 are arranged above each other and / or flush with each other. It can be seen that first opening 8 and second opening 10 may generally be coaxially arranged. Further, a test tube 14, respectively a tube body 16, is arranged adjacent to outer side 4 of mask body 2 in front of second opening 10. It is understood that the test tube may either contact outer side 4 of mask body 2 or may be spaced apart from it, respectively in proximity thereto. There may be positioning indicators to aid alignment. Then, a rod 12, which may for example be mounted to a cap 15 of a test tube as described with respect to Fig. 3, can be guided from outer side 4 through first opening 8. The rod then contacts collection sheet 5. Subsequently, rod 12 is guided further from inner side 3 through second opening 10. Thereby, rod 12 forces collection sheet 5 through second opening 10. Due to a pushing force being exerted on rod 12, collection sheet 5 is released from mask body 2, having been connected thereto via adhesive surfaces 13 (only one adhesive surface is referenced for clarity reasons). Since test tube 14 can be directly arranged adjacent to second opening 10, rod 12 can in this or any other embodiment described herein be introduced into test tube 14, respectively into tube body 16. Thereby, collection sheet 5 is forced into test tube 14, respectively into tube body 16. This avoids contamination of the sample and of the environment, because collection sheet 5 containing pathogens (if the subject tested exhales pathogens) does not have to be touched and can be introduced in a fast and straightforward manner into a test tube. It is thus not necessary to train the medical personnel excessively in handling contagious material, since the operative procedure of preparing a sample for testing is fast and straightforward to perform. After collection sheet 5 has been inserted into the test tube, the latter can be sealed by a cap and shaken to provide the analyte mixture comprising or consisting of the aqueous solution 17 and optionally pathogens or other breath analytes (provided the subject exhales these). Thereafter, the analyte mixture may be analyzed, for by nucleic acid amplification tests (NAAT) such as PCR analysis or sequencing.

[0109] Fig. 5a and b show schematically two different embodiments of a collection sheet 5 as they can be used in embodiments of the disclosure. Collection sheet 5 shown in Fig. 5a comprises substrate 6 and fiber material 7 arranged thereon. It can be seen that fiber material 7, which may form a fiber layer, is thinner than substrate 6. Fig. 5b shows an embodiment of collection sheet 5 which is a laminate comprising a first substrate layer 6a and second substrate layer 6b. Further the fiber material in the form of a fiber layer is arranged between first and second substrate layer 6a and 6b. The dashed line schematically indicates a first fiber portion 7a and a second fiber portion 7b. During production, a first piece of the laminate comprising, or even consisting of, first substrate layer 6a and first fiber portion 7a, as well as a second piece of the laminate comprising, or even consisting of, second substrate layer 6b and second fiber portion 7b, are independently and / or separately produced. Then, the two pieces are arranged on top of each other such that the first fiber portion 7a and the second fiber portion 7b contact each other. Substrate 6 may be produced with spun bonding and the fiber material 7, respectively fiber portion 7a / 7b, may be spun onto the substrate 6 with electrospinning or with other methods known by those skilled in the art. It may also be possible to spin one fiber portion 7a / 7b onto the first substrate layer 6a and cover it with substrate layer 6b. Pressing the two pieces and thus the layers together, for example by calendaring, provides then collection sheet 5 as shown for example in Fig. 5b.

[0110] Fig. 6 shows a scanning electron microscope image of a collection sheet 5 of the type shown in Fig. 5b. The image is taken such that the lens views onto first substrate layer 6a. It can be seen that second substrate layer 6b is arranged in the back and that first fiber portion 7a and second fiber portion 7b are sandwiched between first substrate layer 6a and second substrate layer 6b.

[0111] List of designations

[0112] 1 face mask

[0113] 2 mask body

[0114] 3 inner side

[0115] 4 outer side

[0116] 5 collection sheet

[0117] 6 substrate

[0118] 6a first substrate layer

[0119] 6b second substrate layer

[0120] 7 fiber material

[0121] 7a first fiber portion

[0122] 7b second fiber portion

[0123] 8 first opening

[0124] 9 first cover

[0125] 10 second opening

[0126] 1 1 folding line

[0127] 12 rod

[0128] 13 adhesive surface

[0129] 14 test tube

[0130] 15 cap

[0131] 16 tube body 17 aqueous solution

[0132] 18 test tube assembly

Claims

Claims1. A face mask (1 ) for sampling pathogens, the face mask (1 ) comprising: a. a mask body (2) being configured to cover at least the mouth and / or the nose of a human subject with an inner side (3) of the mask body (2) being oppositely arranged to an outer side (4) of the mask body (2); b. a collection sheet (5) being releasably mounted to the inner side (3) of the mask body (2), the collection sheet (5) comprising a substrate (6) and a fiber material (7), in particular a non-woven fiber material.

2. The face mask (1 ) according to claim 1 , wherein the substrate (6) comprises a polymer material, in particular a polyolefin, such as polypropylene or polyethylene, or poly lactic acid, or polyester.

3. The face mask (1 ) according to claim 1 or 2, wherein the substrate (6) comprises a hydrophilic material.

4. The face mask (1 ) according to claim 2 and 3 wherein the polymer material is filled with the hydrophilic material and / or wherein the polymer material and the hydrophilic material form together a composite.

5. The face mask (1 ) according to any of the previous claims, wherein the fiber material (7) is a polyamide, preferably PA-6, polyvinylchloride, polyacrylonitrile, cellulose acetate, polyvinyl alcohol, polyethylene oxide, poly(meth)acrylate, polyvinylpyrrolidone or chitosan.

6. The face mask (1 ) according to any of the previous claims, wherein the collection sheet (5) is a laminate comprising a first substrate layer (6a) as the substrate (6) and a fiber layer being arranged on the substrate layer (6a) and being made of the fiber material (7).

7. The face mask (1 ) according to claim 6, wherein the laminate comprises a second substrate layer (6b) and wherein the fiber layer is arranged between the first substrate layer (6a) and the second substrate layer (6b).

8. The face mask (1 ) according to claim 7, wherein the laminate is made from two or more separate pieces, wherein a first piece consists of the first substrate layer (6a) and a first fiber portion (7a) arranged on the first substrate layer (6a), and wherein a second piece consists of a second substrate layer (6b) and a second fiber portion (7b) arranged on the second substrate layer (6b).

9. The face mask (1 ) according to claim 8, wherein the first fiber portion (7a) contacts the second fiber portion (7b) such that the first fiber portion (7a) and the second fiber portion (7b) together form the fiber layer being arranged between the first substrate layer (6a) and the second substrate layer (6b).

10. The face mask (1 ) according to any of the previous claims, wherein the mask body (2) comprises a first opening (8) extending from the inner side (3) to the outer side (4), wherein the first opening (8) is covered by the collection sheet (5).

11. The face mask (1 ) according to claim 10, wherein the first opening (8) is covered by a first cover (9), in particular a sticker, being releasably mounted to the outer side (4) of the mask body (2).

12. The face mask (1 ) according to claim 10 or 1 1 , wherein the mask body (2) comprises a second opening (10) extending from the inner side (3) to the outer side (4) , wherein the second opening (10) is covered by the collection sheet (5).

13. The face mask (1 ) according to claim 12, wherein the second opening (10) is covered by the first cover (9) or wherein the second opening (10) is covered by a second cover, in particular a sticker, being releasably mounted to the outer side (4) of the mask body14. The face mask (1 ) according to claim 12 or 13, wherein the first opening (8) and the second opening (10) are arranged such that the mask body (2) can be folded along a folding line (11 ), in particular a predetermined folding line, such that the first opening (8) and the second opening (10) are arranged directly on top of each other and in particular flush with each other.

15. The face mask (1 ) according to any of claims 12 to 14, wherein the first opening (8), the second opening (10) and the collection sheet (5) are configured such that the collection sheet (5) can be removed from the mask body (2) by a rod (12) being inserted from the outer side (4) through the first opening (8) and thereafter guiding the rod (12) and the collection sheet (5) from the inner side (3) through the second opening (10).

16. The face mask (1 ) according to any of the previous claims, wherein the collection sheet (5) is releasably mounted to the inner side (3) of the mask body (2) by a formlocking and / or force-locking and / or material-bonding connection.

17. The face mask (1 ) according to any of the previous claims, wherein the collection sheet (5) is releasably mounted to the inner side (3) of the mask body (2) by means of one or more adhesive surfaces (13) , in particular adhesive dots, and / or by means of a plurality of hook and loop connections.

18. The face mask (1 ) according to claim 17, wherein at least two adhesive surfaces (13) are arranged around the first opening (8) and / or second opening (10).

19. The face mask (1 ) according to any of the previous claims, wherein the mask body (2) comprises, or consists of, a cloth, in particular a textile cloth.

20. Kit of parts comprising the face mask (1 ) according to any of the previous claims and a test tube ( 14) and optionally a rod ( 12) .

21. The kit according to claim 20, wherein the kit comprises a test tube assembly which comprises the test tube (14) and optionally a cap (15) wherein the cap (15) and the test tube (14) are configured to form a sealing engagement such that the test tube is closed by the cap.

22. The kit according to claim 21 wherein the rod (12) is mounted to the cap (15).

23. Method for analyzing a sample, the method comprising the steps: a. Providing a face mask (1 ) according to any of the claims 1 -19; b. Removing the collection sheet (5) from the mask body (2) to separate the collection sheet (5) from the mask body (2); c. Introducing the separated collection sheet (5) into a test tube (14) and suspending the separated collection sheet in the test tube (14) in an aqueous solution, in particular an aqueous buffer solution to provide an analyte mixture; d. Analyzing the analyte mixture.

24. The method according to claim 23, wherein step d. includes a nucleic acid amplification test (NAAT), PCR analysis, sequencing, DNA hybridization assay, CRISPR-based analysis, immunoassay, antigen assays, biochemical assays, molecular detection methods, mass spectrometry, chemical, cytometry, flow cytometry, or growth-based microbiology methods, in particular PCR analysis.

25. The method according to claim 23 or 24, wherein step b. comprises inserting a rod (12) from the outer side (4) of the mask body (2) through the first opening (8) of the mask body (2), thereby at least partially releasing the collection sheet (5) from the inner side (3) of the mask body (2).

26. The method according to claim 25, wherein after inserting the rod (12) through the first opening (8), the rod (12) and the collection sheet (5) are guided through the second opening (10) of the mask body (2), in particular such that the collection sheet (5) completely passes through the second opening (10) and is thereby completely released from the mask body (2).

27. The method according to claim 26, wherein an opening of a test tube (14) is held adjacent to the outer side (4) of the mask body (2) in front of the second opening (10) and wherein the collection sheet (5) is directly introduced into the test tube (14) upon passing the second opening (10).

28. The method according to claim 27 wherein the face mask (1 ) is folded along a folding line (11 ) such that the first opening (8) and the second opening (10) are arranged above each other and above the opening of the test tube (14) before the rod (12) is inserted into the first opening (8), wherein the second opening (10) is arranged between the first opening (8) and the opening of the test tube (14).

29. Method for obtaining a sample from a human subject, the method comprising the steps: a. Mounting a face mask (1 ) according to any of claims 1 -19 on the human subject’s face, such that the mouth and / or nose of the subject are covered and such that the human subject exhales directly onto the collection sheet (5) being releasably mounted to the inner side (3) of the mask body (2); b. Letting the human subject exhale onto the collection sheet (5) and through the face mask (2) for a sampling interval.

30. The method according to claim 29, wherein the sampling interval is at least 10 min, in particular at least 20 min, more particular at least 30 min, even more particular at least 50 min.

31. The method according to claim 29 or 30, further comprising the steps of removing the collection sheet from the mask body to separate the collection sheet from the mask body to provide a separated collection sheet and introducing the separated collection sheet into a test tube and optionally suspending the separated collection sheet in the test tube in an aqueous solution.

32. Method for obtaining a sample from a human subject and analyzing the sample, the method comprising the steps: a. Mounting a face mask (1 ) according to any of claims 1 -19 on the human subject’s face, such that the mouth and / or nose of the subject are covered and such that the human subject exhales directly onto the collection sheet (5) being releasably mounted to the inner side (3) of the mask body (2); b. Letting the human subject exhale onto the collection sheet (5) for a sampling interval; c. Removing the face mask (1 ) from the human subject and removing the collection sheet (5) from the mask body (2) to separate the collection sheet (5) from the mask body (2); d. Introducing the separated collection sheet (5) into a test tube (14) and suspending the separated collection sheet in the test tube (14) in an aqueous solution, in particular an aqueous buffer solution to provide an analyte mixture; e. Analyzing the analyte mixture.

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