DE102020133734A1 - Collection device for sampling, and method for performing sampling of biological material - Google Patents

Abstract

Collection device for sampling, handling means for a collection device, use of a collection device, and method and for performing sampling of biological material. The present invention provides a collection device (1) for sampling of material, a method for performing sampling as well a use of the collection device (1). The collection device (1) has a hollow-cylindrical body (7) made of a porous and capillary-active sintered material. A first outer surface OA1 (3) of the hollow-cylindrical body (7) is designed as a lateral surface of the hollow-cylindrical body (7) and at least the lateral surface has an abrasive surface finish OB1 (33). At least the lateral surface OA1 (3) can have a hydrophilic coating or a hydrophilic impregnation with a food additive, food preservative, emulsifier, surfactant. In addition, the hollow-cylindrical body (7) can have a color indicator. Furthermore, handling means can be provided for the collecting device (1) for carrying out the sampling.

Description

The present invention relates to a collection device for sampling biological material, as well as a handling means for the collection device. Furthermore, the present invention relates to a method for carrying out and using the collecting device for taking a sample in the nose of a living being. A collection device according to the invention is designed to be used when sampling biological material or body fluid. Body fluids, for example blood, lymph fluid, liquor, semen, secretions from the mouth, nose and throat, in particular secretions from the front or lower nose area, for example from areas of the nasal vestibule or the nasal conchae, are used as biological material samples for an application of the collection device according to the invention under consideration. Furthermore, parts or particles of the body surface of a living being, such as skin, skin particles, mucous membrane particles, skin cells or parts of skin cells from the front or lower nasal area, for example from areas of the nasal vestibule or the nasal conchae, are used as biological material samples for an application of the collection device according to the invention consideration. Samples of saliva, secretions, urine or blood are taken from test subjects for a variety of medical diagnoses. Samples of saliva or secretions are usually taken by a user (operator) in the oral cavity or nasal cavity of persons to be examined, the test subjects, as well as patients.

That's how she describes it DE 10 328 984 B4 a device for receiving and dispensing a sample liquid with a sample collector with a porous and dimensionally stable sampling tip for receiving the sample liquid in the sampling tip in connection with a device for generating an overpressure in the pores of the sampling tip for dispensing the sample liquid from the sampling tip.

the DE10 2013 000 922 B4 shows a hollow-cylindrical, dimensionally stable sampling body with a handle. The sampling body is open-pored and capillary-active.

the GB 2 440 353 B2 shows a collection device for collecting liquids in the mouth area of a person.

the EP 2 741 675 B1 describes a method for taking biological samples using a test tube. In order to determine the presence of bacteria, the bacteria contained in the biological sample are multiplied by means of a culture or nutrient solution.

In the field of diagnosis of diseases, samples of secretions are also taken from the pharynx and the nasal cavity, or the nasal/pharyngeal cavity, by means of a collection device or sampling device for a reliable collection of materials or substances to be detected.

It is important to ensure that the collection device and the manner in which the collection device is used during and through sampling make it as unlikely as possible that the test subject will be endangered or injured, ie the aim is to keep the risk of injury as low as possible.
In addition, the sampling should be as uncomplicated, easy to handle, quick and safe as possible for the user.

In addition, it is important to ensure that the material composition of the device used for sampling meets the biocompatibility requirements in order to largely rule out any adverse health effects on the test subject as a result of and during the sampling process.

With knowledge of the prior art mentioned above, the present invention is dedicated to the task of providing a collection device for taking samples in the nasal area that is easy to handle and safe to use.

Another object of the present invention is to provide a collection device in a biocompatible design.

Another object of the present invention is to provide a handling element for a collection device

A further object of the present invention is to specify a method for carrying out sampling in the nose with a collection device.

A further object of the present invention is to specify a use of a collection device for sampling biological material in the nose.

A further object of the present invention is to specify further uses of a collection device for sampling in the nose.

These and other objects are solved by the independent patent claims.

The task of providing a safe and easy-to-handle collection device is achieved with the features of independent claim 1.

The task of providing a collection device in a biocompatible design is solved with the features of independent claim 12.

The task of providing a handling element for a collecting device is achieved with the features of patent claim 15.

The task of providing a method for carrying out sampling with a collection device in the nose is achieved with the features of patent claim 23.

The task of providing a use of a collection device for sampling biological material in the nose is solved with the features of patent claim 27 and with the features of independent patent claim 28.

The tasks for providing further uses of a collection device for sampling in the nose are solved with the features of patent claims 39 to 41.

Advantageous embodiments of the invention result from the dependent claims and are explained in more detail in the following description with partial reference to the figures. Alternatively, the collection device can also be referred to as a "sampling device" or as a "sampler", "sampling device". “, “collecting unit” common.

The described embodiments, both individually and in combination with one another, represent special configurations of the collecting device according to the invention. Advantages resulting from the combination or combinations of several embodiments and further embodiments are nevertheless also covered by the idea of the invention, even if not all possible combinations of embodiments are explained in detail in each case .

According to a first aspect of the invention, a collection device that is easy to handle and safe to use and has a hollow-cylindrical body for sampling in the nasal area is provided. Taking a sample with a collection device in the front or lower nose area or on the front or lower inner sides of the nostrils or on the nasal vestibule, for example, involves a significantly lower risk of injury than taking a sample in the rear area of the nose or nose/pharynx. The shape of the collecting device according to the invention takes this idea into account and therefore takes into account the inner contour of the human nose in the type of design and ensures sampling.

The collecting device according to the invention is designed to be suitable and adapted for taking samples of biological material in the front or lower area of a person's nose. This suitable design is achieved in that the collection device is adapted in size and with a shape of a hollow-cylindrical body for introduction into the front or lower area of the nose of a person, the nasal vestibule.

Investigations into the transmission and spread of viruses in the human body with access through the nose, in particular spread of SARS-CoV-2 in the nasal area, have shown that in certain epithelial cells, in particular goblet cells and cilia cells in the front or lower nasal area the physiological conditions for the entry of SARS-CoV-2 viruses are particularly favorable.

From this it is possible to also conclude that sampling in the form of a nasal swab of skin, skin cells, epithelial tissue, epithelial cells from the front or lower area of the nose, in particular from the inside of the nostrils or from areas of the nasal vestibule, is particularly well suited for subsequent detection analysis. On the basis of such a sampling of biological material from the front or lower area of the nose, for example, a PCR test (PCR = polymerase chain reaction) or an antigen test or an antigen rapid test (point of - Care-Test (POCT)) an analysis for the detection of the virus can be carried out. Antigen tests can be designed as fluorescence or chemiluminescence-based test systems and require an evaluation device. The phenomenon known as “chemiluminescence” is a process in which a chemical reaction emits electromagnetic or optical radiation in the ultraviolet and visible light ranges.

Chemiluminescence can be used to determine low concentrations or even the smallest traces down to individual molecules of hormones, enzymes, proteins, medicines, antibodies and receptors in body fluids such as blood, urine, secretion, saliva. Binding assays and immunoassays can be used. Bioluminescence is a special case of chemiluminescence in biological systems. In contrast to this, fluorescence is understood to mean a spontaneous emission of light after a material has been excited by light. PCR tests can be designed as fluorescence-based test systems and require an evaluation device.

In contrast to this, rapid antigen tests in the form of so-called lateral flow tests can enable immediate visual evaluation on site. Such antigen test systems can provide immunochemical detection (preliminary test, screening test) of virus proteins (e.g. nucleocapsid protein) of SARS-CoV-2 based on a nasal swab in the form of a test kit. The test results provide orientation information, e.g. with regard to a possible SARS-CoV-2 infection.

As a scientific publication on the background of testing for a possible SARS-CoV-2 infection, an article from "NATURE MEDICINE", VOL 26, May 2020, pages 681 to 687, title: "SARS-CoV-2 entry factors are highly expressed in nasal epithelial cells together with innate immune genes". The authors are: Waradon Sungnak, Ni Huang, Christophe Becavin, Marijn Berg, Rachel Queen, Monika Litvinukova, Carlos Talavera-Löpez, Henrike Maatz, Daniel Reichart, Fotios Sampaziotis, Kaylee B. Worlock, Masahiro Yoshida, Josephine L. Barnes.

Another publication on the evaluation of sampling in the front nose compared to the classic nasopharyngeal sampling from an article in the European Respiratory Journal, J. 2020 Dec 10 should also be mentioned, title: "Head-to-head comparison of SARS-Co V-2 antigen -detecting rapid test with self-collected anterior nasal swab versus professional-collected nasopharyngeal swab". The authors are: Andreas K Lindner, Olga Nikolai, Franka Kausch, Mia Wintel, Franziska Hommes, Maximilian Gertler, Lisa J Krüger, Mary Gaeddert, Frank Tobian, Federica Lainati, Lisa Köppel, Joachim Seybold, Victor M Corman, Christian Drosten, Jörg Hofmann, Jilian A Sacks, Frank P Mockenhaupt, Claudia M Denkinger.

The collection device according to the invention is suitably adapted with the design of the outer surfaces of the hollow-cylindrical body in such a way that a sample of biological material such as cell tissue, skin particles or mucous membrane from the inside of the nose and nasal secretion can be effectively removed in a common sample. The hollow-cylindrical body consists of an open-pored or porous and capillary-active material, which is preferably designed to be largely incompressible. Suitable open-pored or porous and capillary-active materials are, for example, pressed cellulose, a cellulose derivative, cotton or plastics. Instead of a homogeneous material or composite material, it is alternatively possible to manufacture the mouthpiece as a non-compressible screen body in the sense of a framework with a porous, absorbent and spongy content inside.

• - einen hohlzylindrischen Körper aus einem porösen und kapillaraktiven Material
• - mit einem frei durchlässigen inneren Durchmesser D_i in einem Bereich von D_i= 3,0 mm bis D_i= 7,5 mm,
• - mit einem äußerem Durchmesser D_a in einem Bereich von D_a= 5,0 mm bis D_a= 10,0 mm,
• - mit einer Länge L in einem Bereich von L= 10,0 mm bis L= 25,0 mm

auf.A collection device according to the invention for sampling biological material samples

• - A hollow-cylindrical body made of a porous and capillary-active material
• - with a freely permeable inner diameter D _i in a range from D _i = 3.0 mm to D _i = 7.5 mm,
• - with an outer diameter D _a in a range from D _a = 5.0 mm to D _a = 10.0 mm,
• - with a length L in a range from L= 10.0 mm to L= 25.0 mm

on.

A first outer surface OA1 of the hollow-cylindrical body is designed as a lateral surface of the hollow-cylindrical body. The first outer surface OA1 of the hollow-cylindrical body has a first surface finish OB1. A further outer surface OA2 of the hollow-cylindrical body is designed as an end face of the hollow-cylindrical body. This additional outer surface OA2 of the hollow-cylindrical body has a surface finish OB2.

A typical freely permeable inner diameter D _i of the hollow-cylindrical body is, for example, within the range from D _i =3.0 mm to D _i =7.5 mm at approximately D _i =5 mm to D _i =6 mm. A typical outer diameter D _a of the hollow-cylindrical body is within the range from D _a =5.0 mm to D _a =10.0 mm, for example approximately D _a =8 mm. A typical length L of the hollow-cylindrical body within the range from L=10.0 mm to L=25.0 mm is, for example, approximately L=15 mm.

The hollow-cylindrical body is dimensionally stable or at least largely dimensionally stable, ie elastic dimensionally stable, porous, preferably additionally microporous and thin-layered. The hollow-cylindrical body therefore enables the biological material, in particular secretion, skin particles, mucous membrane particles, skin cells in the front or lower area of the nose, to be taken up quickly and supported by capillary effects. At least one of the surfaces OA1, OA2 is designed as an abrasive surface or as a surface with an abrasive surface finish. An abrasive surface or an abrasive surface texture is characterized in that the structure of the surface is formed such that at or in contact with another surface, in the case of the present invention in contact with skin, mucous membrane, skin particles, mucous membrane particles, skin cells or parts of skin cells , epithelial tissue, epithelial cells, to exert a rubbing, abrasive effect on the surface and thereby to have a detaching, abrasive, scraping, scraping, stripping, scraping, cutting, abrading (peeling) effect on the surface, as well as smoothing, cleaning or polishing.

Parts or particles of the surface, for example skin tissue or cell tissue on the inside of the nostrils or nasal vestibules or possibly skin tissue or cell tissue, can be transferred to the surfaces of the hollow-cylindrical body of the collection device and/or into the porous and capillary-active material of the hollow-cylindrical body of the collection device . With the help of the abrasiveness of the surfaces of the hollow-cylindrical body, the collection device is designed to collect a quantity of skin particles, mucous membrane particles, skin cells or parts of skin cells as a sample of biological material on the surfaces and/or in the pores of the porous and capillary-active material of the hollow-cylindrical body. If, during sampling, a rotational movement is applied in the front or lower area of the nose when it is inserted into one nostril or in both nostrils in succession, combined with gentle pressure on the inside of the nostrils, the abrasive surface of the hollow-cylindrical body a mechanical disintegration of the biological material or parts of the biological material and associated improved absorption and collection of the biological material and in the hollow-cylindrical body.

• - der Rotationsbewegung und
• - Ausübung von sanftem Druck (Krafteinwirkung)

zur Unterstützung der abrasiven Wirkung, hervorgerufen durch die abrasive Oberfläche des hohlzylindrischen Körpers, derart vorzugeben, dass bei der Anwendung nahezu zwangsläufig ein Übertrag einer ausreichende Menge an biologischen Material auf und in den hohlzylindrischen Körper erfolgt.For the purposes of the present invention, gentle pressure is understood to mean a pressure in a range of less than 200 kPa, which is exerted on a skin surface, eg the insides of the nostrils, when sampling is carried out with the collection device. The application of the rotational movement with a force effect caused by the gentle pressure on skin tissue, skin particles, mucous membrane, epithelial cells on the inside of the nostrils or in areas of the nasal vestibule represents on the one hand a possibility to design the sampling in the application and the way of the application With

• - the rotational movement and
• - Applying gentle pressure (force)

to support the abrasive effect, caused by the abrasive surface of the hollow-cylindrical body, in such a way that a transfer of a sufficient amount of biological material to and into the hollow-cylindrical body almost inevitably takes place during use.

• - der Rotationsbewegung und
• - Ausübung von sanftem Druck (Krafteinwirkung)

zur Unterstützung der abrasiven Wirkung, hervorgerufen durch die abrasive Oberfläche des hohlzylindrischen Körpers, eine ideale Vorbereitung für eine nachfolgende Nachweisanalytik (PCR- Test, Antigen- Test, wie zuvor bereits im Zusammenhang mit dem Artikel aus „NATURE MEDICINE“ beschrieben) dar. Somit findet mit dem Übertrag eine Anreicherung von Mengen von Hautpartikeln, Schleimhaut, Schleimhautpartikeln, Drüsengewebe, Epithelgewebe, Epithelzellen, Hautzellen oder Teilen von Hautzellen, überwiegend auf die Mantelfläche und/ oder Anreicherung in Poren des hohlzylindrischen Körpers statt. Bei Übertrag und Anreicherung von Mengen von Hautpartikeln, Schleimhautpartikeln, Hautzellen oder Teilen von Hautzellen auf, bzw. in den hohlzylindrischen Körper findet bei der Probenahme in der Nase zugleich auch ein Übertrag und eine Anreicherung von Sekret, Nasensekret flüssiger und/ oder fester Form statt. Würde man versuchen, die Wirkung der Anwendung der abrasiven Oberfläche zu beschreiben, so bietet sich ein Vergleich mit einer Verwendung von Schleifpapier als einfaches erklärendes Modell an. Die Oberflächen des hohlzylindrischen Körpers, insbesondere die Mantelfläche, weisen Rauigkeiten oder Rauheiten auf, welche bei Kontakt die abrasive, mechanisch- reibende, schleifende Wirkung auf oder an Oberflächen von Innenseiten der Nase, Nasenflügel, Nasenvorhof, Nasenmuscheln hervorrufen, welche mit einer Körnung eines Schleifpapiers vergleichbar sind. Auch der Übertrag von biologischem Material auf und/ oder in die Mantelfläche des hohlzylindrischen Körpers ist in diesem Modell vergleichbar mit einem Übertrag von Material eines zu schleifenden Objektes auf das Schleifpapier. Rauigkeiten oder Rauheiten sind beispielsweise durch technische Normen, etwa die ISO 1302 spezifiziert. Das Kürzel Ra für den arithmetischen Mittenrauwert ist nach DIN EN ISO 4287 2010 genormt. Der Mittenrauwert Ra nach der Reihe 2 der DIN EN ISO 4287 2010 umfasst einen Bereich von Ra= 0,025µm (Oberfläche ohne sichtbare Bearbeitungsspuren) bis zu sehr groben Oberflächen mit einem Ra= 50µm. Eine Oberfläche mit einem Ra= 0,5 µm wird zumeist als glatte Oberfläche bezeichnet. Die im Rahmen dieser Erfindung genannten Angaben zum Mittenrauwert Ra sind hinsichtlich von Gestaltung und Struktur der Oberflächen OB1, OB2 in Relation zu dem Ra= 0,5µm einer glatten Oberfläche zu verstehen.On the other hand, the mechanical disintegration of the material as a result of the specified way of use with:

• - the rotational movement and
• - Applying gentle pressure (force)

to support the abrasive effect, caused by the abrasive surface of the hollow-cylindrical body, is an ideal preparation for a subsequent detection analysis (PCR test, antigen test, as already described in connection with the article from "NATURE MEDICINE") with the transfer an accumulation of amounts of skin particles, mucous membrane, mucous membrane particles, glandular tissue, epithelial tissue, epithelial cells, skin cells or parts of skin cells, predominantly on the lateral surface and / or accumulation in pores of the hollow cylindrical body instead. When transferring and accumulating amounts of skin particles, mucous membrane particles, skin cells or parts of skin cells to or into the hollow cylindrical body, a transfer and accumulation of secretion, nasal secretion in liquid and/or solid form also takes place during sampling in the nose. If one tries to describe the effect of using the abrasive surface, a comparison with the use of sandpaper offers a simple explanatory model. The surfaces of the hollow-cylindrical body, in particular the lateral surface, have roughness or roughness which, upon contact, causes the abrasive, mechanically rubbing, grinding effect on or on surfaces of the inside of the nose, nasal ala, nasal vestibule, nasal conchae, which can be sanded with a grain of sandpaper are comparable. In this model, the transfer of biological material to and/or into the lateral surface of the hollow-cylindrical body is comparable to the transfer of material from an object to be ground to the sandpaper. Roughness or roughness is specified, for example, by technical standards such as ISO 1302. The abbreviation Ra for the arithmetic mean roughness value is standardized according to DIN EN ISO 4287 2010. The mean roughness value Ra according to series 2 of DIN EN ISO 4287 2010 covers a range from Ra= 0.025 µm (surface without visible processing marks) to very rough surfaces with a Ra = 50 µm. A surface with an Ra= 0.5 µm is usually referred to as a smooth surface. The data on the mean roughness value Ra given in the context of this invention are to be understood with regard to the design and structure of the surfaces OB1, OB2 in relation to the Ra=0.5 μm of a smooth surface.

The advantages and other design aspects and embodiments, which result from the abrasiveness of the surface in connection with carrying out the sampling in the manner of application with a rotational movement and exercise, or application of gentle pressure (force), are described in the context of the further descriptions the method according to the invention and the uses according to the invention of the collecting device.

The roughness or roughness in the surface quality OB1 of the lateral surface OA1 of the hollow-cylindrical body thus benefits the efficiency of the sampling, in that the amount of sample material collected on the hollow-cylindrical body - in comparison to a fictitious assumed rather smooth surface quality (Ra = approximately 0, 5µm) - can be increased. The collection device according to the invention is therefore adapted with the design of the outer surfaces of the hollow-cylindrical body in such a way that an effective removal of a material sample of biological material, skin tissue, cell tissue from the inside of the nose and a sampling of nasal secretion from the nose in a common sample is made possible.

In a preferred embodiment of the collecting device, the first surface finish OB1 of the lateral surface OA1 of the hollow-cylindrical body has a rough surface structure with a predetermined roughness or roughness in a range from Ra=0.8 μm to Ra=12.5 μm.

In a preferred embodiment of the collecting device, the porous and capillary-active material of the hollow-cylindrical body consists of a sintered material or of a sintered material. The material according to this preferred embodiment of the collection device is preferably a plastic sintered material, for example a plastic from the group of propylene, ethylene or urethane, such as polypropylene, polyethylene or polyurethane, for example configured as HDPE (high-density polyethylene), modified polyethylene, such as e.g., ethylene copolymers.

PVDF (polyvinylidine difluoride) can also be used as a suitable material.

The porous and capillary-active material of the hollow-cylindrical body preferably has an average pore size in a range from 0.2 μm to 500 μm. In a preferred embodiment of the collection device, the pore size is more preferably in the range from 10.0 μm to 300 μm. The sintered material or the sintered material is typically based on a raw material with a particle size in the range from 50 μm to 950 μm, preferably in a range from 200 μm to 500 μm.

In a further configuration variant of this preferred embodiment with configuration of the porous and capillary-active material of the hollow-cylindrical body from a sintered material or from a sintered material, parts of the sintered material or parts of the sintered material can be at least partially added with a dye. The dye can be designed in such a way that when it comes into contact with liquids, in particular when it comes into contact with nasal secretions, there is a color change which is visually visible on or on the hollow-cylindrical body. A color change can be designed both as an at least partial coloring of parts or partial areas of a previously essentially white or transparent hollow-cylindrical body. However, a color change can also be designed as an at least partially partial discoloration of previously colored parts or partial areas of the hollow-cylindrical body. This means that the discolouration or discoloration on contact with liquid, in particular nasal secretion, can be used as a color indicator for correct implementation and quality of sampling, for example with regard to the length of time the collection device remains in one nostril or both nostrils and also with regard to the quality of the contact formation between surfaces OB1, OB2 of the hollow-cylindrical body with insides of the nostrils and/or the nostrils are used. Features and details that are described with regard to the duration of the sampling in connection with the method according to the invention for carrying out a sampling in the nose, of course also in connection and with regard to the design of the collecting device and/or the hollow cylindrical body for the design of the attachment an appropriately measured amount of colorant to the sintered material or sintered material. The amount of dye to the expected amount of nasal secretion in the range of approx. 20 mg to 100 mg when taking a sample, as well as the maximum amount of nasal secretion that can be collected in the hollow cylindrical body of around 200 mg, as well as a minimum amount of nasal secretion required for analysis of around 10 mg appropriately adjusted. Dyes suitable for a color indicator must be harmless to health, for example food dyes such as Patent Blue V are suitable for this purpose, so that the end of sampling can be indicated by a blue color change of the color indicator on the collection device.

In a further embodiment of the collection device, the hollow-cylindrical body consists of a chemically modified sintered polyethylene, preferably a chemically modified sintered polyethylene with an average pore diameter distribution of 10 μm to 300 μm, preferably 50 μm to 200 μm.

In such a configuration, the collection device in the hollow cylindrical body and/or on the surface of the hollow cylindrical body can, for example, absorb a total of approximately 155 mg to 250 mg in the pores of the hollow cylindrical body.

In a preferred embodiment of the collection device, the material of the hollow-cylindrical body is based on a porous and capillary-active sintered material or porous and capillary-active sintered material, the sintered material or the sintered material of the hollow-cylindrical body being based on a plastic starting material with an average particle size in the range from 10 μm to 950 µm, preferably in a range from 200 µm to 500 µm.

In a preferred embodiment of the collecting device, the end face of the hollow-cylindrical body or the surface of the head piece of the guide element of the handling element can have less roughness or roughness in the surface finish OB2 than the surface finish OB1 of the lateral surface OA1 of the hollow-cylindrical body. This offers the advantage in the application when introducing the collection device into one nostril or both nostrils that even in introduction situations in the application in which the collection device or the hollow cylindrical body is inserted slightly crooked or transverse to the nostril, there are bumps in the Forehead OA2 on the inside of the nostrils or the nasal vestibule, the risk of injury can be assessed as particularly low. This results in the advantage that, also and in particular when the collection device is used by medical laypersons, possible operating errors and injury situations for the test subject can be avoided as far as possible. In such an embodiment of the collecting device, the first surface finish OB1 of the lateral surface OA1 of the hollow-cylindrical body is designed with a rough surface structure with a predetermined roughness or roughness in a range from Ra=0.8 μm to Ra=12.5 μm, in contrast to this is the surface finish OB2 of the end face OA2 of the hollow-cylindrical body is formed with a rather smooth surface structure with a predetermined roughness or roughness in a range from Ra=0.3 μm to Ra=1.6 μm.

In a further preferred embodiment of the collecting device, the first surface quality OB1 of the lateral surface OA1 of the hollow-cylindrical body is designed with a rough surface structure with a predetermined roughness or roughness in a range from Ra=0.8 μm to Ra=12.5 μm.

In contrast to this, the surface finish of a head piece of a guide element, which acts as part of a handling element, can be designed with a surface finish that differs from the surface finish OB1 of the lateral surface OA1 of the hollow-cylindrical body.

The surface quality of the head piece of the guide element can have a rather smooth surface structure with a predetermined roughness or roughness in a range from Ra=0.3 μm to Ra=1.6 μm. In such an embodiment, the collecting device can preferably be designed as a combination of a handling element with a guide element.

The outer diameter of the guide element is dimensioned to match the inner diameter D _i of the hollow-cylindrical body in such a way that when the handling element, guide element and the hollow-cylindrical body are assembled, the hollow-cylindrical body can be slid onto the guide element with a precise fit and, in the assembled state, preferably and, for example, the guide element with the head piece is essentially flush with the end face OA2 of the hollow-cylindrical body or forms an essentially common area.

In a preferred embodiment of the collecting device, the end face OA2 of the hollow-cylindrical body can be designed as a substantially flat end face OA2. The flat end face OA2 is preferably in the Substantially designed in a tolerance range of ± 5% perpendicular to the lateral surface OA1 of the hollow cylindrical body.

In a further preferred embodiment of the collecting device
For example, the end face OA2 of the hollow-cylindrical body and/or the hollow-cylindrical body itself can be formed in a beveled, rounded or conical shape on the end face OA2, which is intended for insertion into a nostril.

The beveled or rounded shape of the end face OA2 can be formed by a bevel, phase on the end face OA2 or as a hemisphere, as a cone or truncated cone, for example in a way that an enveloping contour forms a hemisphere at the end or the end face OA2 of the hollow-cylindrical body formed as a substantially round or slanted shaped tip as a sampling tip. A round or rounded end face can be designed, for example, in the form of a hemispherical rounding or with a phase or bevel in an angular range of 105° to 155° in a tolerance range of ±5% to the lateral surface OA1 of the hollow-cylindrical body.

Furthermore, the hollow-cylindrical body itself can be designed to taper conically from the end face OA2 to the lateral surface, the diameter of the hollow-cylindrical body in the area of the end face OA2 being smaller than the diameter in the remaining area of the length of the hollow-cylindrical body. In other words, viewed from a handling element which accommodates the hollow-cylindrical body on one side for carrying out the sampling, the result is a conical narrowing of the circumference of the hollow-cylindrical body towards the end face OA2 of the hollow-cylindrical body. The taper is designed in such a way that the outer diameter in the area of the end face OA2 is in a range from D _a =5.0 mm to D _a =10.0 mm and the outer diameter towards the area of the handling element, for example on a D _a2 = 15.0 mm to D _a = 30.0 mm. This results in a thickening with the effect of a stop or stopper for the hollow-cylindrical body in the area of the handling element. This stop can ensure that the collection device with the hollow cylindrical body can only come into contact with the nose in the front or lower area of the nose or areas of the nasal vestibule and not too far in the rear areas of the nose, for example in the direction of the main nasal cavity or in can be pushed into the nose/pharynx. This has the advantage that the collection device is less susceptible to incorrect use by a user and in this way, particularly in connection with an embodiment of an end face OA2 of the hollow-cylindrical body designed with a beveled or rounded shape, there is a possible risk of injury for the subject during the prevent sampling. These embodiments offer the advantage that, when using the collection device, the feeding of the collection device into the nostril by the user is simplified and the comfort of use is increased for both the user and test persons.

In a further embodiment of the collecting device, it is additionally or alternatively provided that the wall thickness of the hollow-cylindrical body is less than 50% of the radius of the hollow-cylindrical body, in particular not greater than 1.5 millimeters to 3.0 millimeters. During practical testing of the hollow-cylindrical body, these dimensions have proven to be sufficient and advantageous in terms of stability and/or flexibility. Such dimensioning takes into account the knowledge that an open-pored or an open-cell capillarity of the hollow-cylindrical body ensures that its pore volume is filled via the exposed outer sides the faster the thinner the wall of the hollow-cylindrical body is.

In a preferred embodiment of the collecting device, the first outer surface OA1 of the lateral surface of the hollow-cylindrical body and/or the second outer surface OA2 of the end face of the cylindrical hollow body have a coating.

In a further preferred embodiment of the collecting device, at least the lateral surface OA1 of the hollow-cylindrical body is provided with a coating or with an impregnation.

• Zitronensäure, Ascorbinsäure, Milchsäure, Apfelsäure, Sorbinsäure, Kaliumsorbat, Calciumsorbat, Benzoesäure, Natriumbenzoat, Kaliumbenzoat, Kalziumsulfid, Calciumbenzoat, Natriumsulfit, Natriumhydrogensulfit, Natriumdisulfit, Kaliumdisulfit, Calciumsulfit, Calciumhydrogensulfit, Kaliumhydrogensulfit, Propionsäure, Ascorbylpalmitat, Ascorbylstearat, Natriumascorbat, Isoascorbinsäure, Natriumisoascorbat, Lecithin, Natriumlactat, Kaliumlactat, Calciumlactat, Citronensäure, Ammoniumcitrat, Mononatriumcitrat, Dinatriumcitrat, Trinatriumcitrat, Monokaliumcitrat, Trikaliumcitrat, Monocalciumcitrat, Dicalciumcitrat, Tricalciumcitrat, Weinsäure, Calciumtartrat, Malate, sowie polare Fettsäureester, Salze von Speisefettsäuren, Mono- und Diglyceride von Speisefettsäuren, Ester von Mono- and Diglyceriden, Zuckerester von Speisefettsäuren, Zuckerglyceride, Polyglycerin- Ester von Speisefettsäuren, Polyglycerin-Polyricinoleat, Propyleneglycol- Ester von Speisefettsäuren, Mixturen aus Glycerol-/ Propyleneglycol- Ester und/ oder Milch- und Fettsäuren.

In a preferred embodiment of the collection device, the lateral surface OA1 of the hollow-cylindrical body and/or the end face OA2 of the hollow-cylindrical body are coated with at least one substance from a group of substances or a combination of substances from the group of substances or a combination of substances from the group of substances with at least one other substance. The group of substances includes a large number of substances which can also be used as food additives, food preservatives, emulsifiers or surfactants. According to this preferred embodiment, the group of substances includes, for example, ionic surfactants, non-ionic surfactants, Acids and their salts, and acids, alcohols and their esters, fatty acid esters, fatty acid sugar esters, alcohol esters. The group of substances includes, for example, substances that are listed on a list of substances to which the European Food Safety Authority (EFSA) has assigned an international code in the form of a so-called "E number". These include, for example, the following substances:

• Citric acid, ascorbic acid, lactic acid, malic acid, sorbic acid, potassium sorbate, calcium sorbate, benzoic acid, sodium benzoate, potassium benzoate, calcium sulfide, calcium benzoate, sodium sulfite, sodium hydrogen sulfite, sodium metabisulfite, potassium metabisulfite, calcium sulfite, calcium hydrogen sulfite, potassium hydrogen sulfite, propionic acid, ascorbyl palmitate, ascorbyl stearate, sodium ascorbate, isoascorbic acid, sodium isoascorbate, Lecithin, sodium lactate, potassium lactate, calcium lactate, citric acid, ammonium citrate, monosodium citrate, disodium citrate, trisodium citrate, monopotassium citrate, tripotassium citrate, monocalcium citrate, dicalcium citrate, tricalcium citrate, tartaric acid, calcium tartrate, malate, and polar fatty acid esters, salts of fatty acids, mono- and diglycerides of fatty acids, esters of mono- and diglycerides, sugar esters of fatty acids, sugar glycerides, polyglycerol esters of fatty acids, polyglycerol polyricinoleate, propylene glycol esters of fatty acids, mixtures of glycerol/propy leneglycol ester and/or lactic and fatty acids.

In a further preferred embodiment of the collecting device, at least the lateral surface OA1 of the hollow-cylindrical body is provided with a hydrophilic coating or with a hydrophilic impregnation. The hydrophilic coating or hydrophilic impregnation of surfaces causes liquids, biological material in the sense of the present invention, in particular nasal secretion, to be attracted to the surface and thus the nasal secretion can easily transfer to the surfaces OA1, OA2 on contact with the hollow cylindrical body and from the Pores of the hollow cylindrical body can be added and collected there.

In a further preferred embodiment of the collection device, the hydrophilic coating of the lateral surface OA1 of the hollow-cylindrical body or the front surface OA2 of the hollow-cylindrical body is carried out with at least one substance from a group of substances suitable for a hydrophilic coating or impregnation or a combination of substances from this group of Substances or combination of substances from this group of substances with at least one other substance. According to this preferred embodiment, the group of substances suitable for a hydrophilic coating or impregnation includes, for example, emulsifiers, ionic surfactants, nonionic surfactants, acids and their salts, and also acids and their esters. The group of substances suitable for a hydrophilic coating or impregnation includes, for example, substances that are listed on a list of substances to which the European Food Safety Authority (EFSA) has assigned an international code in the form of a so-called "E number". is.

• polare Fettsäureester, Salze von Speisefettsäuren, Mono- und Diglyceride von Speisefettsäuren, Ester von Mono- and Diglyceriden, Zuckerester von Speisefettsäuren, Fettsäureester, Fettsäurezuckerester, Zuckerglyceride, Polyglycerin- Ester von Speisefettsäuren, Polyglycerin-Polyricinoleat, Propyleneglycol- Ester von Speisefettsäuren, Mixturen aus Glycerol-/ Propyleneglycol- Ester und/ oder Milch- und Fettsäuren.

According to a preferred embodiment, the group of substances suitable for a hydrophilic coating or impregnation includes:

• polar fatty acid esters, salts of fatty acids, mono- and diglycerides of fatty acids, esters of mono- and diglycerides, sugar esters of fatty acids, fatty acid esters, fatty acid sugar esters, sugar glycerides, polyglycerol esters of fatty acids, polyglycerol polyricinoleate, propylene glycol esters of fatty acids, mixtures of glycerol -/ propylene glycol esters and/ or lactic and fatty acids.

In a further preferred embodiment of the collection device, the hydrophilic coating or impregnation of the cylindrical hollow body and/or the first outer surface OA1 and/or the second outer surface OA2 of the cylindrical hollow body can be effected on the basis of a plasma treatment method.

The foregoing has provided a collection device according to a first aspect of the invention. According to a further aspect of the invention, a collection device in a biocompatible design for sampling in the nasal area is provided below.

For a biocompatible design of a collection device, it is important that the materials used and/or used, as well as coatings, are designed to be biocompatible. In the field of medicine, the term biocompatibility refers to the property of materials or substances in direct contact with living tissue, such as skin, skin cells or mucous membranes, not having any negative effects on their metabolism and function. Certification of the biocompatibility of medical materials and products is described, for example, by the ISO 10993 1-12 standard. A collection device according to the invention in a biocompatible design consists of a hollow-cylindrical body made of a porous Material with an end face OA2 and with an outer surface OA1. The hollow-cylindrical body of the collection device in a biocompatible design is made of sintered polyethylene. Sintered polyethylene can be produced or manufactured in the composition defined in such a way that it is medically harmless with regard to contact with skin or mucous membranes. In addition, at least the lateral surface OA1 is provided with a hydrophilic coating. The hydrophilic coating can be designed as a coating or impregnation that is medically safe in terms of contact with skin or mucous membranes. The overall arrangement of the collection device in a biocompatible embodiment with material and hydrophilic coating can thus be assigned the property of biocompatibility. Incidentally, features and details that are described in connection with the collection device for the first aspect of the invention also apply, of course, in connection and also with regard to the collection device in a biocompatible design, so that the disclosure of the individual aspects of the invention relates to the collection device is, or can be, referred to in accordance with the first aspect of the invention.

Therefore, for the collection device according to the invention in a biocompatible embodiment, the configurations described for the collection device according to the invention in embodiments with regard to shape, design, dimensions, length, base area, diameters such as L, D _i , D _a , OA1, OA2, OB1, OB2, Structure and / or roughness or roughness of the surfaces, pore sizes of the hollow cylindrical body are also used. For the collection device according to the invention in a biocompatible embodiment, the group of substances listed for the collection device according to the invention in embodiments for the design of a hydrophilic coating or impregnation, preferably food additives, preservatives for food, emulsifiers or surfactants for coating or impregnating the hollow cylindrical body can be used. The hydrophilic coating of the lateral surface OA1 takes place with a food additive or food preservative, emulsifier, surfactant, for example with a polar fatty acid ester, in particular with a fatty acid sugar ester, which is also known as a food additive with the designation E473. The lateral surface OA1 is formed with an abrasive surface structure OB1, the roughness or roughness of the lateral surface OA1 is in a range from Ra=0.8 μm to Ra=12.5 μm.

In a preferred embodiment, a hydrophilic coating or hydrophilic impregnation with only a polar fatty acid ester, for example and preferably with a fatty acid sugar ester, is sufficient. Fatty acid sugar esters are also known by code E number E473. This is made possible because during the nasal swab or sampling in the front or lower area of the nose, a rotational movement with gentle pressure in combination with the abrasive lateral surface OA1, OB1 causes a mechanical rubbing effect on the inside of the nostrils, which leads to a Transfer of nasal secretion in liquid and/or solid form as well as skin particles, epithelial tissue, epithelial cells on the inside of the nose or into the hollow-cylindrical body takes place, no additional stimulation of the salivary flow is required. It is therefore not always necessary to coat the hollow-cylindrical body or the surfaces of the hollow-cylindrical body with a substance that is particularly suitable for stimulating the flow of saliva or secretion. Stimulating the flow of saliva or secretion is advantageous, for example, when taking a sample or swab in the mouth/throat area, which is why the surfaces of such sampling devices - mostly used in the mouth/throat area - are usually coated with an acidic substance, for example with Citric acid.

However, stimulating the flow of secretion can also be advantageous, for example, when taking a nose sample or when taking a swab in the nose/pharynx, so coating the surfaces of sampling devices used in the nose/pharynx with an acidic substance, for example citric acid, can also be advantageous .

In a particularly preferred embodiment of the collection device, a handling element, for example a handle with a gripping element, is detachably or non-detachably arranged on the collection device or connected to the collection device or attachable to the collection device or the hollow-cylindrical body. The arrangement, connection, joining or attachment can be designed, for example, as a screw connection, plug-in connection, latching connection, threaded connection, clamping connection or a conically fixing connection.

The connection can be detachable or non-detachable.

Above, the invention was provided according to a first aspect of the invention, a collection device or collection device in a biocompatible embodiment. Below will according to a further aspect of the invention, a handling element for a collection device is provided. Features and details that are described in connection with the handling element according to the invention naturally also apply in connection and with regard to the collection device or collection device in a biocompatible design and vice versa, so that the disclosure of the individual aspects of the invention is always the same mutual reference is or can be made. According to this further aspect of the invention, a handling element for the collection device, or use of the collection device for sampling, is provided. For the handling element according to the invention, the configurations described for the collecting device according to the invention in embodiments with regard to shape, design, dimensions, length, base area, diameter, such as L, D _i , D _a , of the hollow-cylindrical body can be used as a basis for dimensioning. The handling element is suitably adapted to the dimensions of the hollow-cylindrical body for connection to the hollow-cylindrical body.

For connection to the hollow-cylindrical body, the handling element is suitably adapted to the dimensions of the hollow-cylindrical body, ie, for example, to a length L of the hollow-cylindrical body in a range of 10.0 mm to 25.0 mm.

The adjustment is such, for example, that an outer circular circumference of the hollow-cylindrical body of the collecting device, which is defined by an outer diameter d _a in a range of 5.0 mm to 10.0 mm, encompasses the handling element or a receiving element of the handling element, so that it can be picked up and kept.

The adjustment is such, for example, that an inner circular circumference of the hollow-cylindrical body of the collecting device, which is defined by an inner diameter d _i in a range of 3.0 mm to 7.5 mm, is pushed onto the handling element or a guide element of the handling element, so that it can be picked up and kept.

The handling element is designed for a detachable or non-detachable connection or joint with a hollow-cylindrical body of the collecting device. Connections or joints for connecting the handling element to the hollow-cylindrical body can be designed in particular as a plug-in connection, adhesive connection, snap-in connection, screw connection, threaded connection, clamp connection or a conically fixing connection.

In a preferred embodiment of the handling element for a collection device, the connection to a hollow-cylindrical body is designed as a detachable plug-in connection, snap-in connection, conical connection, joint connection, screw connection.

In a further preferred embodiment of the handling element for a collection device, the releasable connection is designed as a connection that can be releasable without tools. In this preferred embodiment of the handling element, the connection between the handling element and the hollow-cylindrical body can be released by the user without the use of tools after the sampling has been completed. The collection device with the hollow-cylindrical body can thus preferably subsequently be placed ready for analysis, for example in a laboratory, also separately from the handling element in a test station, a test cassette, in a transport cassette or a storage system ready for subsequent analysis.

In a preferred embodiment of the handling element for a collection device, the handling element is designed to extend the hollow-cylindrical body over a length section in a range from 10% to 70%, preferably in a range from 20% to 60%, more preferably in a range from 25% to To include 35% of the length L of the hollow cylindrical body. The handling element receives the hollow-cylindrical body in such a way that the hollow-cylindrical body is held firmly in the handling element. Optionally, a receiving element can be provided on the handling element for receiving the hollow-cylindrical body and can be arranged on the handling element.

In a preferred embodiment of the handling element for a collection device, the handling element is designed by means of a guide element—preferably tubular or rod-shaped—connected or connectable to the handling element, into the hollow-cylindrical body over a length section in a range from 10% to 70%, preferably in inserted, inserted or snapped in a range of 20% to 60%, more preferably in a range of 25% to 35% of the length L of the hollow-cylindrical body. The hollow-cylindrical body accommodates the guide element in such a way that the hollow-cylindrical body can be held on the handling element and the hollow-cylindrical body is thus connected to the handling element.

In a preferred embodiment of the handling element for a collection device, the connection to a hollow-cylindrical body is designed as a non-detachable joint connection, adhesive connection, welded connection, screw connection.

In a preferred embodiment of the collecting device, the at least one additional, outer surface OA2 of the end face of the hollow-cylindrical body and/or a head piece of the guide element of the handling element have a
surface texture OB2 different from the first surface texture OB1 of the first surface OA1.

In a preferred embodiment of the collecting device, the structure of the end face OA2 of the hollow-cylindrical body and/or the structure of the head piece of the guide element have a rather smooth surface structure with a predetermined roughness in a range from Ra=0.3 μm to Ra=1.6 μm .

Above, according to a first aspect of the invention, a collecting device was provided and according to a further inventive aspect, a handling element was provided. According to a further aspect of the invention, a method according to the invention for carrying out sampling in the nose is provided below. Features that are described in connection with the method according to the invention also apply, of course, with regard to the collecting device and the handling element and vice versa, so that with regard to the disclosure of the individual aspects of the invention, reference is or can always be made to one another.

According to this further inventive aspect, a method for sampling with a collection device in the nasal region is provided.

1. a. in einem ersten Schritt durch eine Einbringung der Sammelvorrichtung mit einer Rotationsbewegung oder einer kreisenden Bewegung der hohlzylindrische Körper in mindestens einem der beiden Nasenlöcher mit der Stirnfläche OA2 und/ oder der Mantelfläche OA1 in einen Kontakt mit einer Innenseite des mindestens eines der Nasenlöcher und/ oder Innenseite mindestens eines Nasenflügels gebracht und
2. b. in einem zweiten Schritt der Probenahme durch einen Verbleib der Sammelvorrichtung in dem Nasenloch für eine vorbestimmte Zeitdauer von 10 Sekunden bis 60 Sekunden eine Menge an biologischem Material an mindestens einer der Oberflächen OA1, OA2 des hohlzylindrischen Körpers gesammelt und/ oder aufgenommen.

A method according to the invention for taking a sample with a collecting device is designed as a process with a sequence of steps. During the sampling of biological material in a subject's nose

1. a. in a first step, by introducing the collection device with a rotational movement or a circular movement, the hollow-cylindrical body in at least one of the two nostrils with the end face OA2 and/or the lateral surface OA1 in contact with an inside of at least one of the nostrils and/or inside brought at least one nostril and
2. b. in a second sampling step, a quantity of biological material is collected and/or taken up on at least one of the surfaces OA1, OA2 of the hollow-cylindrical body by leaving the collection device in the nostril for a predetermined period of 10 seconds to 60 seconds.

In a preferred embodiment of the method, the first and second step in carrying out the sampling in one nostril is also carried out for the second nostril and thus a quantity of biological material from both nostrils on at least one of the surfaces OA1, OA2 of the hollow cylindrical Body collected and / or recorded.

In a preferred embodiment of the method, the color of a color indicator, which is arranged in or on the collecting device or in or on the hollow cylindrical body and is fluidically connected to the hollow cylindrical body, changes color—usually after the predetermined period of time has elapsed.

The color change occurs when a sufficient amount of biological material has been taken up by the collection device or the hollow-cylindrical body. In a preferred embodiment of the method, in the first and/or second step when carrying out the sampling, the biological material is processed by the abrasive surface structure OB1 of the lateral surface OA1 of the hollow-cylindrical body, by a force or force acting on the inside of the nostril. This force or force is caused by the introduction of the hollow cylindrical body in connection with the rotational movement of the hollow cylindrical body. The force or force is applied using gentle pressure on the inside of the nostril and/or the nasal vestibule.

In a preferred embodiment of the method, the collecting device and the handling element and/or the guide element can be joined or connected in the first and/or second step.

This embodiment of the method enables the handling element and collecting device, or handling element and the hollow-cylindrical body, to be assembled on site. Thus, on the one hand, a possibility can be created for different sized nostrils of Babies, small children, school children, adolescents, adults to provide the user with a kind of assembly kit in order to be able to assemble hollow-cylindrical bodies with a handling element that are adapted to the test subject in each case in terms of dimensions (length L, D _i =D _a ). Furthermore, this offers the possibility of enabling disassembly after the sampling has been carried out and of being able to handle the collecting device without a handling element during the subsequent analysis.

Above, according to aspects of the invention, the invention was provided a collecting device, a handling element and a method for carrying out sampling with the collecting device. According to a further aspect of the invention, a use for carrying out sampling in the nose is provided below. Features and details that are described in connection with the use according to the invention also apply, of course, in connection and with regard to the collecting device, the handling element and the method for carrying out sampling and vice versa, so that with regard to the disclosure of the individual aspects of Invention is always referred to mutually, or can be.

According to these aspects, a collection device is used for sampling material, in particular biological material in the nose. To this end, uses of a collection device for a nasal swab or sampling in the nasal area are provided.

The embodiments of uses described for this purpose represent particular configurations of the collecting device according to the invention, both individually and in combination with one another. Advantages resulting from a combination or combinations of several embodiments and further embodiments are nevertheless also covered by the idea of the invention, even if not all possible combinations of embodiments are detailed in detail are each executed.

When a collection device is used according to the invention for taking a sample from the inside of the nostrils of a subject, a quantity of material is transferred from at least one of the insides of the nostrils or the nasal vestibule to at least one of the surfaces OB1, OB2 of the hollow-cylindrical body. The transfer of a quantity of material from at least one of the insides of the nostrils or the nasal vestibule to at least one of the surfaces OB1, OB2 of the hollow-cylindrical body is carried out by introducing the collection device with a rotational movement or a circular movement of the hollow-cylindrical body using gentle pressure on at least an inside of the nostrils or on the nasal vestibule of the subject. The transfer of the quantity of material occurs by leaving the collection device in the nostril for a predetermined period of time of 2 seconds to 10 seconds. After the predetermined period of time has elapsed, the collection device is made available for further analysis.

• - mit einem frei durchlässigen inneren Durchmesser D_i in einem Bereich von D_i= 3,0 mm bis D_i= 7,5 mm,
• - mit einem äußerem Durchmesser D_a in einem Bereich von D_a= 5,0 mm bis D_a= 10,0 mm,
• - mit einer Länge L in einem Bereich von L= 10,0 mm bis L= 25,0 mm, mit einer Mantelfläche OA1, mit einer Stirnfläche OA1

aufweist.A collection device, preferably a collection device in a biocompatible design, is used for sampling biological material samples with a collection device which has a hollow-cylindrical body made of a porous sintered material or sintered material made of polypropylene, polyethylene or polyurethane,

• - with a freely permeable inner diameter D _i in a range from D _i = 3.0 mm to D _i = 7.5 mm,
• - with an outer diameter D _a in a range from D _a = 5.0 mm to D _a = 10.0 mm,
• - with a length L in a range from L= 10.0 mm to L= 25.0 mm, with a lateral surface OA1, with a front surface OA1

having.

The lateral surface OA1 of the collecting device is designed with an abrasive surface structure (OB1) with a roughness in a range from Ra=0.8 μm to Ra=12.5 μm. At least the lateral surface OA1 of the collection device has a hydrophilic coating or hydrophilic impregnation with a food additive or with a food preservative. When used, a quantity of biological material is transferred from at least one inside of the nostrils or the nasal vestibule to at least one of the surfaces OB1, OB2 of the hollow-cylindrical body of the collection device.

The amount of biological material is transferred to at least one of the surfaces OB1, OB2 of the hollow-cylindrical body by introducing the collection device into a nostril with a rotational movement or a circular movement of the hollow-cylindrical body while applying gentle pressure to the at least one inner side of the nostrils or on the subject's nasal vestibule. The amount of biological material is transferred by leaving the collection device in place for a predetermined period of time of 2 seconds to 10 seconds in the nostril. After the predetermined period of time has elapsed, the collection device is made available for further analysis.

In a preferred embodiment of use, the color of a color indicator which is arranged in or on the collecting device or in or on the hollow-cylindrical body and is fluidically connected to the hollow-cylindrical body changes color—usually after the predetermined period of time has elapsed. The color change occurs when a sufficient amount of biological material has been taken up by the collection device or the hollow-cylindrical body.

In a preferred embodiment of the use, before the sampling is carried out on the subject, the subject blows out the nose or parts of the nose. For the sampling and the subsequent analysis, it is important that the subject transfers amounts of nasal secretion from the middle area of the nose to the front area of the nose by blowing it out, which is then accessible for sampling. When you snort, nasal secretion accumulates in the front or lower area of the nose.

In a preferred embodiment of the use, after the sampling has been carried out, the collection device is positioned or deposited in a test station or in a test cassette in order to be ready for an analysis to be carried out immediately after the sampling. Such a test cassette or test station is part of a test system, often referred to as a “test kit”, for a rapid antigen test, in which a reservoir, container or tank is arranged, which is designed and provided for storing a quantity of liquid. Such a system is also referred to as an antigen rapid test, point-of-care test (POCT)) and mostly functions as a lateral flow test with a direct visual result display. When positioning, the user inserts it into an opening in the test station or test cassette. By actively shaking the test system for a period of 20 seconds to 90 seconds, quantities of this liquid from the reservoir come into fluidic contact with the hollow-cylindrical body. The material collected on the surfaces of the hollow-cylindrical body and/or in the pores of the hollow-cylindrical body is dissolved out or flushed out and brought into contact with a test strip. Substances are present in the test strip which, in a reaction with the collected material, cause a color change at a marking on the test strip. A rapid antigen test is based on the principle of a sandwich immunoassay. Virus proteins present in the collected material are bound both by monoclonal capture antibodies and by colored monoclonal detection antibodies. Such sandwich complexes are caught at a mark on the test strip. Depending on the virus concentration, a colored line is visible on the marker as a test line. In addition, there is another line on the test strip as a control line, which indicates the correct execution of the sampling, use of the collection device and the course of the test.

In a preferred embodiment of the use, after the sampling has been carried out, the collection device is deposited in a transport cassette or in a storage system in order to be made available for transport for subsequent analysis.

In a preferred embodiment of the use, after the sampling has been carried out, before and/or during the analysis, the material or the biological material is processed by adding a reagent in solid and thus soluble form or in liquid form. Solubilization means increasing the solubility of a substance.

In a preferred embodiment of the use, after the sampling has been carried out, before and/or during the analysis, the material or the biological material is processed with a subsequent qualitative and/or quantitative analysis of the biological material. The processing can include tempering the material or the biological material and/or shaking the material or the biological material.

In a preferred embodiment of the use, a rapid antigen test, for example in the form of a lateral flow test (POCT), an antigen laboratory analysis or a PCR laboratory analysis (PCR = Polymerase Chain Reaction) are used.

In a preferred embodiment of the use, after the sampling has been carried out, the quantitative and/or qualitative analysis of the material or the biological material is used to determine whether a virus type from the group of corona viruses is present. These include, for example, the so-called called SARS viruses, SARS CoV-2 viruses, MERS viruses.

In a preferred embodiment of the use, an analysis device is used for carrying out the antigen test method, which uses methods of fluorescence or chemiluminescence detection when carrying out the analysis. An analysis result of the antigen test method is provided by the analyzer.

In a further preferred embodiment of the use, an analysis device is used for carrying out the PCR test method, which uses methods of fluorescence detection when carrying out the analysis. An analysis result of the PCR test procedure is provided by the analyzer.

Further embodiments show further uses or possible uses of the collection device for sampling in the front or lower area of the nose, in particular in the area of the nasal vestibule.

In one embodiment of a further use of the collection device, substances, particles or substances that are hazardous to health in the air we breathe or in the environment can be detected by taking samples from an inside of the nostrils.

Such evidence can be used for early detection and possible prophylaxis of diseases, for example lung and respiratory diseases, cardiovascular diseases or diseases that can be caused by exposure to toxic substances or particles that enter the air through the nose . In the skin tissue, skin particles, mucous membrane, epithelial cells of the nose, as well as in the nasal secretion, amounts or components of the substances, particles or substances are present after exposure to substances, particles or substances from the environment and/or breathing air. Some substances, particles or substances in the environment, air, breathing air are named here as examples: Dust particles, flour, paint particles, fine dust, metal dust, asbestos fiber dust, fertilizer dust, quartz dust, crystalline silicon dioxide, dust from fabrics and textile fibers, soot, asphalt and tar residues, plastic abrasion , rubber abrasion, tar residues, soot and combustion gases from combustion engines, engines, turbines, power plants, polycyclic aromatic hydrocarbons, especially in connection with asbestos fiber dust, sanding dust from the wood or metal processing industry and trade, traces of smoke. Some possible sources with the release of the above-mentioned materials, particles or substances are mentioned here as examples: Mining of ores, hard coal and lignite, power plants, coking plants, coal smelting, steel works, chemical processes, petrochemical processes, cement production, wood processing and metal processing industry and trade, road traffic (cars, trucks), ship traffic, air traffic.

In one embodiment of a further use of the collection device, the presence of substances consumed by inhalation through the nose can be detected by taking a sample from an inside of the nostrils. Examples of substances consumed through inhalation through the nose include substances that expand consciousness, such as medicines or drugs such as cocaine.

In one embodiment of a further use of the collection device, a sample can be taken from the inside of the nostrils to detect, determine or detect the presence of hormones, biomarkers such as stress or tumor markers in the nasal secretion. Cortisol is an example of a stress marker.

By using the collection device, components of the above-mentioned materials, particles or substances can be collected in the front or lower area of the nose and thus used for subsequent analysis in the laboratory (antigen test system, PCR test system) or directly on site (point of - Care test (POCT)) are made available.

The present invention will now be explained in more detail with the aid of the following figures and the associated descriptions of the figures without restricting the general inventive concept.

• die 1A eine schematische Darstellung eine Sammelvorrichtung,
• die 1B eine schematische Darstellung einer seitlichen Ansicht nach der 1A,
• die 1C eine schematische Darstellung einer Draufsicht nach der 1A,
• die 2 eine schematische Darstellung eines menschlichen Kopfes,
• die 3 eine Darstellung einer Sammeleinrichtung in der Anwendung,
• die 4 verschiedene Ausgestaltungsvarianten der Sammelvorrichtung,
• die 5 eine Montagesituation von hohlzylindrischem Körper und Handhabungselement,
• die 6 eine schematische Darstellung von Ansichten von Verbindungen des hohlzylindrischen Körpers mit dem Handhabungselement,
• die 7 eine weitere Ansicht einer Montagesituation von hohlzylindrischem Körper und Handhabungselement.

Show it:

• the 1A a schematic representation of a collection device,
• the 1B a schematic representation of a side view according to FIG 1A ,
• the 1C a schematic representation of a plan view according to 1A ,
• the 2 a schematic representation of a human head,
• the 3 a representation of a collection facility in use,
• the 4 different design variants of the collection device,
• the 5 an assembly situation of hollow cylindrical body and handling element,
• the 6 a schematic representation of views of connections of the hollow cylindrical body with the handling element,
• the 7 another view of an assembly situation of hollow cylindrical body and handling element.

the 1A , 1B , 1C are described in more detail below using mutual reference in a coherent description of the figures. Same elements in the 1A , 1B , 1C are in 1A , 1B , 1C denoted by the same reference numerals. the 1A shows a collecting device 1 in a perspective view, which extends as a hollow cylindrical body 7, preferably with a substantially round or circular base over a length L 65. The tall cylindrical body 7 has a lateral surface OA1 3 and an end face OA2 5 . The area of the end face OA2 5 of the hollow cylindrical body 7 is formed with an inner diameter D _i 61 and an outer diameter D _a 63.

The lateral surface OA1 3 and the front surface OA2 5 have surface finishes OB1 33 ( 1B) and OB2 55 ( 1C ), which can be designed differently in terms of smoothness or roughness or roughness in the design of the surface structure. The lateral surface OA1 3 has a surface structure OB1 33 and the end face OA2 5 has a surface structure OB2 55 . the 1A shows the configuration of a collecting device 1 with a cylindrical body 7 reduced to the essentials.

the 1B shows a detailed view of the 1A in a side view the hollow cylindrical body 7 after 1A . the 1C shows a detailed view of the 1A in a plan view of the hollow cylindrical body 7 after 1A .
The side view after the 1B shows schematically the surface structure OB1 33, the plan view after the 1C shows schematically the surface structure OB2 55. In this 1B is shown by way of example that the surface structure OB1 33 compared to the surface structure OB2 55 of 1C has greater roughness or roughness and/or greater porosity, resulting in an increased effective surface area for the lateral surface OA1 3 for absorbing liquid, in particular body fluid, such as nasal secretion, as well as saliva, and for sampling nasal secretion in the nose a particularly good absorption capacity for secretions on and in the surface structure OB1 33 of the lateral surface OA1 3 can be provided by the collection device 1 when using sampling.

the 2 shows a schematic representation of a side view of a head 100 of a human being or of a subject 100 for sampling. Same elements in the 2 , such as 1A , 1B , 1C are in 1A , 1B , 1C , 2 denoted by the same reference numerals. The region of the nose is essential in this schematic representation of the head of a subject 100 . Other body parts such as the mouth, eyes, ears, brain, larynx, lips, jaws, teeth, tongue, esophagus, trachea, tonsils, etc. are not shown in this illustration 100 as they are used for nasal sampling and explanations of the Collection device 1, as well as descriptions of a collection device 1 for its use for sampling in the nose are not required. The schematic representation 100 in a side view of a human head shows nostrils 12, nasal vestibule 21, inner sides 31 of the nostrils, nasal conchae 23, 25, 27. The collecting device 1 is designed and constructed for sampling secretion in the nose on the inner sides 31 of the Nose 12 and / or the front or lower nasal concha 23 and / or the middle nasal concha 25, as well as to be used on the nasal vestibule 21.

the 2 also shows the nose/pharynx 29 and the main nasal cavity 28. At the 2 It is clearly evident that sampling in the area of the nasal projection 21 and the insides 31 of the nostrils 12, as well as on the nasal conchae, 23, 25, 27 in the application for the subject (100) involves significantly lower risks of injury than sampling in the nose -/pharynx 29 or in the main nasal cavity 28. Due to the design of the collecting device 1 in size with a length of 65 ( 1A) of the hollow-cylindrical body 7, as well as the circumference of the lateral surface OA1 3 of the hollow-cylindrical body 7, there is the structural advantage that the collection device 1 can be inserted into the main nasal cavity 28 or rear areas of the nasal/pharyngeal cavity 29, as well as the esophagus or trachea are largely made impossible. This largely avoids incorrect operation of the collection device 1 by the user. In connection with the handling element 11 ( 3 ) The safety in operation and application is further increased, since the design of the handling element 11 with a size in width and circumference ensures that the handling element 11 can be inserted into the nose 12, 25, 23, 27, 28, 29 and so that the collection device 1 in the main nasal cavity 28 or rear areas of the nose / throat 29, as well as the esophagus or trachea is not possible.

the 3 shows a schematic representation 100 in a side view of the head 100 of a human according to FIG 2 an application of the collecting device 1. Same elements in the 3 and in the 2 , such as 1A , 1B , 1C are in 1A , 1B , 1C , 2 , 3 denoted by the same reference numerals. The collection device 1 with the hollow cylindrical body 7 is shown in a position in relation to the head 100 of the human. The collection device 1 has a handling element 11 for use in sampling, which is attached to the hollow-cylindrical body 7 by means of a connection 9, for example designed as an adhesive connection, plug-in connection, joint connection, screw connection, or similar, or can be attached to the hollow-cylindrical body 7. The one in the 3 The representation of the collection device 1 shown shows the spatial position and situation when the collection device 1 is inserted from below the nose through one of the nostrils to the nasal vestibule 21 to the inner sides 31 of the nostrils 12 when used in sampling when used for sampling of secretions in the nose. When using the collection device 1 for sampling secretion in the nose, the handling element 11 enables the collection device 1 to be fed in from underneath the nose through a nostril into the nose.

The insertion takes place so far into the nose that the collection device 1 is inserted into the interior of the nose with approximately 1/3 to 2/3 of the length L of the hollow cylindrical body 7, so that the collection device 1 is inserted at least with one of the inner sides 31 of the nostrils 12 touches or has contact.

When the contact is introduced and formed - due to the roughness or roughness in the surface quality OB1 33 of the lateral surface OA1 3 and the porous material of the hollow cylindrical body 7 - there is a slight scraping or rubbing contact with the skin on at least one of the inner sides 31 the nostril 12. The collection device 1 in the nostril collects both nasal secretion in liquid and/or solid form as a sample material as well as skin particles, mucous membrane, glandular tissue, epithelial tissue, epithelial cells on the inside of the nose, which are removed in an abrasive manner from the skin surface of the inner sides 31 of the nostrils 12 is transferred to the outer surface OA1 3 of the hollow-cylindrical body 7 . The roughness or roughness in the surface quality OB1 33 of the lateral surface OA1 3 therefore benefits the efficiency of the sampling, in that the amount of sample material collected on the hollow-cylindrical body can be increased - compared to a fictitious assumed smooth surface quality. The end face OA2 5 of the hollow cylindrical body 7 - or a surface of a guide element 8 ( 5 ) or a head piece 88 of a guide element 8 ( 5 ) of a handling element 11 ( 3 , 5 ) can have a surface finish OB2 55 that differs from the first surface finish OB1 33, which is designed with less roughness or roughness than the surface finish OB1 33 of the lateral surface OA1 3 of the hollow-cylindrical body 7. This offers the advantage when introducing the collection device 1 into one nostril or both nostrils that even in introduction situations in the application in which the collection device 1 or the hollow cylindrical body 7 is inserted slightly crookedly or transversely to the nostril Impacts of the end face OA2 5 on the inner sides 31 of the nostrils 12 or the nasal vestibule 21 is a possible risk of injury to be assessed as particularly low. The absorption of sample material is supported by a hydrophilic coating or impregnation of the lateral surface OA1 3 of the hollow-cylindrical body 7.

Food additives or preservatives, for example, are suitable for such a coating, as a result of which, together with a suitably selected material for the hollow-cylindrical body 7, a collection device 1 can be designed in a biocompatible embodiment.

The collection of sample material can also be supported by the manner in which the collection device 1 is used on humans. Thus, a slight twisting or rotational movement of the collection device 1 during insertion from below into the nostril, as it were in a manner of turning in as if one wanted to screw in a screw, supports the sampling and increases the amount of sample material collected on the collection device 1.

This slight rotational movement causes the hollow-cylindrical body 7 with the lateral surface OA1 3 to nestle against a large number of surface segments on the surfaces of the inner sides 31 of the nostrils 12 and in this way a very good contact between the inner sides 31 of the nostrils 12 and the entire lateral surface OA1 3 of the hollow cylindrical body 7 comes about. In addition, an abrasive surface finish causes OB1 33 ( 1B) of the hollow-cylindrical body 7 a rubbing, mechanical rubbing, grinding effect on or on the surfaces of the insides of the nose, nostrils 12, nasal vestibule 21 an application and a mechanical unlocking of Skin cells or parts of skin cells, epithelial tissue, epithelial cells in the nose, nostrils 12, nasal vestibule 21.

Alternative design variants of the collecting device 1 and the hollow-cylindrical body 7, also in connection with the handling element 11, are described in the 4 , 5 , 7 shown and described. Alternative variants of the handling element 11 are in the 5 , 6 , 7 shown and described.

the 4 shows schematically different embodiment variants 41, 42, 41', 42', 41", 42" of the collecting device with the hollow-cylindrical body 7 according to FIG 1A , 1B , 1C , 3 . Same elements in the 4 and in the 3 , such as 1A , 1B , 1C are in 1A , 1B , 1C , 3 , 4 denoted by the same reference numerals. The design variants 41, 41', 41", 42, 42', 42" show different possible shapes of the hollow-cylindrical body 7 with regard to the design of the end face OA2 5. Thus, embodiment variant 41 shows a perspective view of a hollow-cylindrical body with a planar end face OA2 5 with a surface structure 55 and with a lateral surface OA1 3 with a surface structure 33 corresponding to FIG 1A , 1C . In a view 41', the embodiment variant 41 is shown in a sectional representation. In a view 41″, the embodiment variant 41 is shown in a variant with a bevel 56 of the end face OA2 5 in a sectional view.

A hollow-cylindrical body 7 with a round shape or shape 58 of the planar end face OA2 5 with a surface structure 55 and with a lateral surface OA1 3 with a surface structure 33 is shown in a perspective view as an embodiment variant 42 . The shape 58 of the end face OA2 5 has a substantially round shape formed as a hemispherical or spherical shape. In a view 42', the embodiment variant 42 is shown in a sectional illustration. In a view 42″, a variation of the embodiment variant 42 is shown in a sectional view, in which the end face OA2 5 has a shape of a rounded tip or a cone. Beveled shapes 56 or round shapes 58 of the end face OA2 5 are for use in the implementation advantageous for sampling, since the comfort for the test person is increased during the introduction into the nostril and a possible risk of injury for the test person during the introduction into the nostril can be reduced.

the 5 shows a view of an assembly situation 43 with a hollow-cylindrical body 7 with a connection 9 to a handling element 11 with an ergonomically shaped grip element 110. The connection 9 is produced by means of a guide element 8. The guide element 8 is pushed, inserted or snapped into the hollow-cylindrical body 7, as well as pushed, inserted or snapped into the handling element 11, in this way the connection 9 is established. In the views 44, 45, 46 variants of different options for the arrangement and connection 9 of the guide element 8 in the hollow-cylindrical body 7 are shown. The view 46 shows a variant in which the guide element 8 is almost completely in the hollow-cylindrical body 7, which - as in 4 shown in the embodiment variants 42, 42', 42" - has a round end face OA2 5. View 44 shows a variant in which the guide element 8 is not completely in the hollow-cylindrical body 7, which - as in 4 shown in the embodiment variant 41 "- has a bevel 56 of the end face OA2 5. View 45 shows a guide element 8 with a head piece 88, which is designed for a connection 9 with the hollow-cylindrical body 7 and hollow-cylindrical body 7 on the Guide element fixed in a defined position.The same elements in the 3 , 4 , 5 , such as 1A , 1B , 1C are in 1A , 1B , 1C , 3 , 4 and 5 denoted by the same reference numerals.

the 6 shows views 47, 48 of connections or joints 9 of the hollow cylindrical body 7 with the handling element 11.

Same elements in the 3 , 4 , 5 , 6 such as 1A , 1B , 1C are in 1A , 1B , 1C , 3 , 4 , 5 and 6 denoted by the same reference numerals. In view 48 , the hollow-cylindrical body 7 is connected to the handling element 11 by means of a receiving element 99 . The receiving element 99 can have a bevel 96 .

In the view 47 the hollow-cylindrical body 7 is connected directly to the handling element 11 .

The handling element 11 can have a bevel 96 . The handling element 11 can have an ergonomic grip element 110 .

the 7 shows an assembly situation from a collecting device 1 with a hollow cylindrical body 7, handling element 11 and Füh tion element 8 in a variant based on the in the 4 , 5 , 6 shown embodiments or variants. Same elements in the 3 , 4 , 5 , 6 , 7 such as 1A , 1B , 1C are in 1A , 1B , 1C , 3 , 4 , 5 , 6 and 7 denoted by the same reference numerals. The hollow-cylindrical body 7 has a conical shape 59 , for example as a truncated cone with a conical tip, and is connected to the handling element 11 by means of a guide element 8 .

Reference List

1

collection device

3

Lateral surface OA1

5

Face OA2

7

hollow cylindrical body

8th

guide element

9

connection

11

handling element

12

nostrils

21

nasal vestibule

23

Inferior nasal concha

25

Middle nasal concha

27

nasal concha

28

main nasal cavity

29

nose/pharynx

31

Inside nostrils

33

Surface structure OB1 of the lateral surface

41, 42, 41', 42', 41", 42"

design variants

43

Assembly situation, joint view

44, 45, 46, 47, 48

views, joining views

55

Surface structure OB2 of the end face

56

Shaping, beveling, phase of the face

58

Shaping/contour of the end face of the hollow-cylindrical body 7 in hemispherical shape, conical shape, pointed shape

59

Conical shape of the hollow cylindrical body 7

61

Diameter Di (inside) of the hollow cylindrical body 7

63

Diameter Da (outside) of the hollow cylindrical body 7

65

Length L of the hollow cylindrical body 7

88

Head piece of the guide element 8

96

Shape, Bevel, Phase

99

receiving element

100

Schematic representation of a head

110

grip element

QUOTES INCLUDED IN DESCRIPTION

This list of documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• DE 10328984 B4 [0002]
• DE 102013000922 B4 [0003]
• GB 2440353 B2 [0004]
• EP 2741675 B1 [0005]

Claims (41)

Collection device (1) for taking samples of biological material, comprising: a hollow-cylindrical body (7) made of a porous and capillary-active material with a freely permeable inner diameter D _i (61), in a range from D _i = 3.0 mm to D _i = 7.5 mm, with an outer diameter D _a (63), in a range from D _a = 5.0 mm to D _a = 10.0 mm, with a length L (65) in a range from L= 10.0 mm to L= 25.0 mm, a. wherein a first outer surface OA1 (3) of the hollow-cylindrical body (7) is designed as a lateral surface of the hollow-cylindrical body (7) and has a first surface finish OB1 (33), b. wherein at least one further, outer surface OA2 (5) is designed as an end face of the hollow-cylindrical body (7) and c. wherein at least one of the surfaces OA1, OA2 (3, 5) is formed with an abrasive surface finish (33). Collecting device (1) after claim 1 , wherein the first surface finish OB1 (33) is designed as an abrasive or as a rough surface structure with a predetermined roughness or roughness in a range from Ra=0.8 μm to Ra=12.5 μm. Collecting device (1) after claim 1 , wherein the porous and capillary-active material of the hollow-cylindrical body (7) consists of a sintered material or a sintered material. Collecting device (1) after claim 3 wherein parts of the sintered material or parts of the sintered material have at least partially added a dye as a color indicator. Collecting device (1) according to one of Claims 1 until 3 , wherein the first surface finish (33) OB1 of the lateral surface OA1 (3) of the hollow-cylindrical body (7) with a rough surface structure with a predetermined roughness or roughness in a range from Ra = 0.8 µm to Ra = 12.5 µm and the surface finish ( 55) OB2 of the end face (5) of the hollow-cylindrical body (7) is designed with a rather smooth surface structure with a predetermined roughness or roughness in a range from Ra=0.3 μm to Ra=1.6 μm. Collecting device (1) according to one of Claims 1 until 4 , wherein the end face OA2 (5) of the hollow-cylindrical body (7) as a substantially flat end face OA2 (5) or the end face OA2 (5) of the hollow-cylindrical body (7) and/or the hollow-cylindrical body (7) in a bevelled, rounded or conical shape (56, 58, 59) are formed. Collecting device (1) according to one of Claims 1 until 6 , wherein the first outer surface OA1 (3) as the lateral surface of the hollow-cylindrical body (7) and/or the second outer surface OA2 (5) as the end face of the cylindrical hollow body (7) has a coating with a substance from a group of substances, wherein the coating or impregnation is carried out by coating or impregnating with at least one substance from a group of substances or with a combination of substances from the group of substances or with a combination of substances from the group of substances with at least one other substance, the group of substances different food additives, preservatives, emulsifiers, surfactants, ionic surfactants, non-ionic surfactants, acids and their salts, as well as acids, alcohols and their esters, polar fatty acid esters, fatty acid esters, fatty acid sugar esters, alcohol esters from a variety of food additives, preservatives, emulsifiers or Tens ides included. Collecting device (1) after claim 7 , wherein at least the lateral surface OA1 (3) of the hollow cylindrical body (7) has a hydrophilic coating or impregnation. Collecting device (1) after claim 7 or according to 8, wherein the hydrophilic coating or impregnation by a coating or impregnation with at least one substance from a group of substances suitable for a hydrophilic coating or impregnation or a combination of substances from this group of substances or combination of substances from this group of substances with at least one other substance, the group of substances suitable for a hydrophilic coating or impregnation different food additives, preservatives, emulsifiers, surfactants, ionic surfactants, non-ionic surfactants, acids and their salts, and acids, alcohols and their esters, Fatty acid esters, polar fatty acid esters, fatty acid sugar esters, alcohol esters from a variety of food additives, preservatives, emulsifiers or surfactants. Collecting device (1) according to one of Claims 7 until 9 , wherein the group of, to a coating or impregnation of substances includes at least one of the following substances: citric acid, ascorbic acid, lactic acid, malic acid, sorbic acid, potassium sorbate, calcium sorbate, benzoic acid, sodium benzoate, potassium benzoate, Calcium sulfide, calcium benzoate, sodium sulfite, sodium bisulfite, sodium bisulfite, potassium bisulfite, calcium sulfite, calcium bisulfite, potassium bisulfite, propionic acid, ascorbyl palmitate, ascorbyl stearate, sodium ascorbate, isoascorbic acid, sodium isoascorbate, lecithin, sodium lactate, potassium lactate, calcium lactate, ammonium citrate, monosodium citrate, disodium citrate, trisodium citrate, monopotassium citrate, tripotassium citrate, Monocalcium citrate, dicalcium citrate, tricalcium citrate, tartaric acid, calcium tartrate, malates, the group of substances suitable for a hydrophilic coating or impregnation comprising at least one of the following substances: polar fatty acid esters, salts of fatty acids, mono- and diglycerides of fatty acids, esters of mono- and diglycerides, sugar esters of fatty acids, sugar glycerides, polyglycerol esters of fatty acids, polyglycerol polyricinoleate, propylene glycol esters of fatty acids, mixtures of glycerol/propylene glycol es ter and/or lactic and fatty acids. Collecting device (1) after claim 7 or claim 8 , wherein the hydrophilic coating or impregnation of the cylindrical hollow body (7) and/or the first outer surface OA1 (3) and/or the second outer surface OA2 (5) of the cylindrical hollow body (7) is effected on the basis of a plasma treatment method becomes. Collection device (1) in a biocompatible design having a hollow-cylindrical body (7) made of a porous sintered material or a sintered material made of polypropylene, polyethylene or polyurethane, with a freely permeable inner diameter D _i (61), in a range of D _i = 3 .0 mm to D _i = 7.5 mm, with an outer diameter D _a (63), in a range from D _a = 5.0 mm to D _a = 10.0 mm, with a length L (65) in a range from L= 10.0 mm to L= 25.0 mm, with a lateral surface OA1 (3), with an end face OA2 (5), the lateral surface OA1 (3) having an abrasive surface structure (OB1) (33) with a roughness in a range from Ra=0.8 µm to Ra=12.5 µm, at least the lateral surface OA1 (3) having a hydrophilic coating or a hydrophilic impregnation with a food additive, food preservative, emulsifier, surfactant. Collection device (1) with after claim 12 , A polar fatty acid ester, in particular a fatty acid sugar ester, being used for a hydrophilic coating or hydrophilic impregnation. Collecting device (1) according to one of the preceding claims, wherein a handling element (11) can be attached to the collecting device (1) or to the hollow-cylindrical body (7). Handling element (11) for a collecting device (1) according to one of Claims 1 until 13 , wherein the handling element (11) is designed for a detachable or non-detachable connection (9) or joint with the hollow-cylindrical body (7) and wherein the handling element (11) for a connection with the hollow-cylindrical body (7) is suitable to the dimensions of the hollow-cylindrical Body (7) is adjusted. Handling element (11) after claim 15 , wherein the connection (9) is designed as a detachable plug-in connection, latching connection, conical connection, joint connection, screw connection. Handling element (11) after Claim 16 , wherein the detachable connection (9) is designed as a tool-free detachable connection (9). Handling element (11) after claim 15 , wherein the connection (9) is designed as a non-detachable joint connection, adhesive connection, welded connection, screw connection. Handling element (11) after Claim 14 or after one of the Claims 15 until 18 , wherein the handling element (11) is designed to extend the hollow-cylindrical body (7) over a length section in a range from 10% to 70%, preferably in a range from 20% to 60%, more preferably in a range from 25% to 35% % of the length L of the hollow-cylindrical body (7) and wherein the handling element (11) can accommodate the hollow-cylindrical body (7) in such a way that the hollow-cylindrical body (7) can be held firmly on or in the handling element (11) and thus there is a connection (9) of the hollow-cylindrical body (7) with the handling element (11). Handling element (11) after Claim 14 or after one of the Claims 15 until 18 , wherein a guide element (8) that can be connected or is connected to the handling element (11) is provided, in the hollow-cylindrical body (7) over a length section in a range from 10% to 70%, preferably in a range from 20% to 60% , more preferably in a range of 25% to 35% of the length L (65) of the hollow-cylindrical body (7) to be inserted or snapped in and the guide element (8) within the hollow-cylindrical body (7) being at least partially accommodated in this way that the hollow cylindrical body (7) can be held firmly on the handling element (11) by means of the guide element (8) and thus a connection (9) of the hollow cylindrical body (7) to the handling element (11) is provided. Collecting device (1) according to one of Claims 1 until 14 or handling element (11). claim 20 , wherein the at least one further, outer surface OA2 of the end face (5) of the hollow-cylindrical body (7) and/or a head piece (88) of the guide element (8) has one of the first surface properties OB1 (33) of the lateral surface OA1 (3) of the hollow cylindrical body (7) have different surface finishes. Collecting device (1) according to one of Claims 1 until 14 or handling element (11). Claim 21 , wherein the structure of the at least one further, outer surface OA2 of the end face (5) of the hollow-cylindrical body (7) and/or the head piece (88) of the guide element (8) has a rather smooth surface structure with a predetermined roughness or roughness in a range of Ra= 0.3 µm to Ra= 1.6 µm Method for carrying out sampling with a collecting device (1) according to one of Claims 1 until 14 , wherein during the execution of the sampling of biological material in a nose of a subject (100) a. in a first step, by introducing the collection device (1) with a rotational movement or a circular movement, the hollow-cylindrical body (7) in at least one of the two nostrils comes into contact with the end face OA2 (5) and/or the lateral surface OA1 (3). is brought to an inner side (31) of at least one of the nostrils and/or inner side (31) of at least one nostril b. and in a second step of sampling a quantity of biological material on at least one of the surfaces OA1 (3), OA2 (5) of the hollow cylindrical body by leaving the collection device (1) in the nostril for a predetermined period of 10 seconds to 60 seconds (7) collected and/or ingested. procedure after Claim 23 , wherein the first step and the second step of sampling in one nostril is also carried out for the second nostril and thus a quantity of biological material from both nostrils on at least one of the surfaces OA1 (3), OA2 (5) of the hollow cylindrical body (7) collected and/or ingested. procedure after Claim 23 or after Claim 24 , wherein in the first step and/or the second step, the biological material is processed by the abrasive surface structure OB1 (33) of the lateral surface OA1 (3) of the hollow-cylindrical body (7), by an effective on the inside (31) of the nostril Force action or force effect occurs, which is caused by the introduction of the hollow-cylindrical body (7) in connection with the rotational movement of the hollow-cylindrical body (7) inside the nose. Procedure according to one of claims 20 until 22 , wherein in a further step preceding the first step, a joining or connection (9) takes place between the collecting device (1) and the handling element (11) and/or the guide element (8). Use of a collecting device (1) according to one of Claims 1 until 14 and / or with a handling element according to one of Claims 15 until 22 for sampling at least one inner side (31) of the nostrils (12), with a transfer of a quantity of material from the at least one inner side (31) of the nostrils (12) or the nasal vestibule (21) to at least one of the surfaces OB1, OB2 (3.5) of the hollow cylindrical body (7). wherein the transfer of the amount of material to that of the hollow cylindrical body (7) by introducing the collection device (1) into a nostril with a rotary motion or a circular motion of the hollow cylindrical body (7) while applying gentle pressure to the at least one inner side ( 31) the nostril (12) or on the nasal vestibule (21), the collection device (1) remaining in the nostril for a predetermined period of time of 2 seconds to 10 seconds and the collection device being made available after the predetermined period of time has expired (1) for further analysis. Use of a collection device (1) for sampling biological material samples, the collection device (1) having a hollow-cylindrical body (7) made of a porous sintered material or sintered material made of polypropylene, polyethylene or polyurethane, with a freely permeable inner diameter D _i (61) in a range from D _i = 3.0 mm to D _i = 7.5 mm, with an outer diameter D _a (63) in a range from D _a = 5.0 mm to D _a = 10.0 mm, with has a length L (65) in a range from L= 10.0 mm to L= 25.0 mm, with a lateral surface OA1 (3), with an end face OA2 (5), the lateral surface OA1 (3) being the collecting device Device (1) is formed with an abrasive surface structure (OB1) (33) with a roughness in a range from Ra=0.8 μm to Ra=12.5 μm, at least the lateral surface OA1 (3) of the collecting device (1) having a hydrophilic coating or hydrophilic impregnation with a food additive or with a preservative for food, with a transfer of a quantity of biological material from at least one inner side (31) of the nostrils (12) or the nasal vestibule (21) to at least one of the surfaces OB1, OB2 (3.5) of the hollow-cylindrical body (7) of the collection device (1), the amount of biological material being transferred to at least one of the surfaces OB1(33), OB2 (55) of the hollow-cylindrical body (7) by introducing the Collection device (1) with a rotary movement or a circular movement of the hollow cylindrical body (7) into a nostril while applying gentle pressure to the at least one in inner side (31) of the nostrils (12) or on the nasal vestibule (21) of the subject (100), with the transfer of the amount of biological material by remaining in the collection device (1) for a predetermined period of 2 seconds to 10 seconds in which takes place and wherein, after the predetermined period of time has elapsed, the collection device (1) is made available for further analysis. Use of a collecting device (1) according to one of claims 27 until 28 , wherein before the sampling is carried out on the subject (100), nasal secretion is enriched in the front or lower area of the nose (21, 31). Use of a collecting device (1) according to one of claims 27 until 29 , wherein after the sampling has been carried out, the collection device (1) is positioned or deposited in a test station, a test cassette or in a transport cassette or a storage system in order to make it available for an analysis to be carried out immediately afterwards or to make it available for transport for a period of time subsequent analysis is carried out. Use of a collecting device (1) according to one of claims 27 until 30 , wherein the material or the biological material is processed by adding a reagent that is solid, solubilizable, or liquid. Use of a collection device (1) after Claim 30 or Claim 31 , wherein the biological material is processed and the material or the biological material is subsequently analyzed qualitatively and/or quantitatively. Use of a collection device (1) after Claim 32 , wherein during the processing, temperature control and/or shaking of the material or the biological material takes place. Use of a collection device (1) after Claim 32 or Claim 33 , whereby an antigen rapid test, an antigen laboratory analysis or a PCR laboratory analysis is used for the quantitative and/or qualitative analysis of the material or the biological material. Use of a collecting device (1) according to one of Claims 32 until 34 , wherein the quantitative and/or qualitative analysis of the material or the biological material determines the presence of a virus type from the group of corona viruses. Use of a collecting device (1) according to one of Claims 34 until 35 , whereby the qualitative analysis is carried out using an antigen rapid test, with a result being displayed visually immediately after the analysis. Use of a collecting device (1) according to one of Claims 34 until 35 , wherein the quantitative and / or qualitative analysis is carried out by means of an antigen test method, wherein an analysis device is used to carry out the antigen test method, which methods of fluorescence or chemiluminescence detection are used in the analysis and wherein an analysis result of the antigen test method is carried out the analyzer is provided. Use of a collecting device (1) according to one of Claims 34 until 35 , wherein the quantitative and / or qualitative analysis is carried out by means of a PCR test method, wherein an analysis device is used to carry out the antigen test method, which methods of fluorescence detection are used in the analysis, and an analysis result of the PCR test method by the analysis device provided. Use of a collecting device (1) according to one of Claims 32 until 34 , whereby the quantitative and/or qualitative analysis of the material or the biological material determines the presence of substances, particles or substances that are hazardous to health in the air we breathe or in the environment. Use of a collecting device (1) according to one of Claims 32 until 34 , whereby in the quantitative and/or qualitative analysis of the material or of the biological material a determination or a detection of a presence be of substances consumed by inhalation through the nose. Use of a collecting device (1) according to one of Claims 32 until 34 , With the quantitative and/or qualitative analysis of the material or the biological material being a determination or proof of the presence of hormones, biomarkers, tumor markers in the nasal secretion

Images