Collecting, transporting and storing device

Abstract

The present invention relates to a device for collecting, transporting, and storing biomolecules from a biological sample, such as feces.

Description

[0001] COLLECTING, TRANSPORTING AND STORING DEVICE

[0002] The present invention relates to a device for collecting, transporting, and storing biomolecules from a biological sample, such as feces.

[0003] BACKGROUND OF THE INVENTION

[0004] The collection, transport ,and storing of biomolecules from a biological sample, such as feces, is often associated with diverse problems concerning the stability, durability, and reproducibility of the material.

[0005] For example, stool collection involves gathering fecal samples for medical analysis, research, or fecal microbiota transplantation (FMT). In clinical settings, stool samples are collected to diagnose gastrointestinal conditions, detect infections, or analyze gut microbiota.

[0006] Microbiome-derived biomarkers usually measured in fecal samples are constantly gaining importance in clinical research. Stool samples should ideally be collected by the patients at their home, and the samples should be stabilized until they are delivered to the research facility by post, or at a scheduled appointment.

[0007] When performing diagnostic tests or clinical trials to modulate the gut microbiome, the quality of microbiome samples is crucial for valid results. Upon removal of specimens from the body, undesirable growth or decline of certain microorganisms and degradation and fragmentation of proteins or nucleic acids such as DNA or RNA can occur without rapid specimen stabilization by microbiome stabilizers. Therefore, the use of stabilizers such as nucleic acid stabilizers like DNA or RNA stabilizers or protein stabilizers can be very useful when focusing on the bacterial biomass. However, nucleic acid stabilizers inhibit the measurement of other biomarkers from the same stool sample, such as proteins, metabolites etc. which could contain valuable information. In reverse, protein or metabolite stabilizers have a detrimental effect on nucleic acids. While commercially available stabilizers are optimized to conserve DNA and RNA for microbiome analysis, they cannot preserve proteins or metabolites equally efficiently.

[0008] Therefore, there is a need for an optimized stool donation / sampling device which deals with the above problem.

[0009] The present inventors have designed a stool donation / sampling device which allows to collect several stool samples in diverse types of preservation reagents to adequately measuremicrobiome composition, metabolome, proteome, or any other stool-based biomarkers pertinent to a clinical study or diagnostic analysis.

[0010] In addition, the unpleasant aspects of the stool (particularly the odour and the possibility of transmission of infectious organisms) frequently result in a reluctance or an inability to handle the sample. Some patients might develop an aversion to it, if the procedure is too complicated or laborious. Even in the context of early diagnosis of life-threatening diseases such as colorectal cancer, participation in stool donation can be quite low, especially if complex steps are required.

[0011] Thus, there is a further need for an optimized stool donation / sampling device which deals with the above problem.

[0012] The present inventors have developed a stool donation / sampling device which simplifies stool removal and reduces the amount of time the patient or clinical staff is in contact with the stool. The present inventors have specifically designed a multi-compartment stool donation device, in which multiple samples can be taken from the same stool portion and can be preserved in different conditions without the need of repeated sampling.

[0013] SUMMARY OF THE INVENTION

[0014] In a first aspect, the present invention relates to sampling probe handling unit, the sampling probe handling unit comprising a sampling probe support, wherein the sampling probe support is configured to support a plurality of sampling probes or supports a plurality of sampling probes, the respective sampling probe being a sampling probe of the fourth aspect.

[0015] In a second aspect, the present invention relates to a sample carrier for carrying a plurality of sample containers according to the fifth aspect.

[0016] In a third aspect, the present invention relates to a sampling device or sampling kit for simultaneously obtaining a plurality of stool samples from a material, comprising:

[0017] - the sample carrier of the second aspect equipped with a plurality of sample containers, - a sampling probe handling unit of the first aspect with a plurality of sampling probes.

[0018] In a fourth aspect, the present invention relates to a sampling probe for obtaining a sample, e.g. a fecal sample or stool sample, the sampling probe comprising:

[0019] - a sample portion arranged to contact a material from which the sample should be taken and configured to retain the sample taken from the material when the sampling probe is removed from the material,- an interface portion, wherein the interface portion is provided in an end portion of the sampling probe remote from the sampling portion and / or wherein the interface portion is arranged to protrude from a sample container when the sample portion with the sample has been inserted into the sample container.

[0020] In a fifth aspect, the present invention relates to a sample container for receiving a sample, e.g. a fecal sample or stool sample, wherein the sample container comprises a body defining a sample receiving volume, the sample receiving volume being configured to receive the sample, wherein, in the sample receiving volume, a substance is contained to contact the sample when the sample is received in the volume.

[0021] In a sixth aspect, the present invention relates to the use of

[0022] - the sampling probe of the fourth aspect, and / or

[0023] - the sample container of the fifth aspect, and / or

[0024] - the sample carrier of the second aspect, and / or

[0025] - the sampling probe handling unit of the first aspect, and / or

[0026] - the sampling device or sampling kit of the third aspect

[0027] for obtaining, receiving, and / or transporting a stool sample.

[0028] In a seventh aspect, the present invention relates to a method comprising using

[0029] - the sampling probe of the fourth aspect, and / or

[0030] - the sample container of the fifth aspect, and / or

[0031] - the sample carrier of the second aspect, and / or

[0032] - the sampling probe handling unit of the first aspect, and / or

[0033] - the sampling device or sampling kit of the third aspect

[0034] for obtaining, receiving, and / or transporting a stool sample.

[0035] In a eights aspect, the present invention related to a set of sample containers, the set comprising a plurality of sample containers of the fifth aspect.

[0036] This summary of the invention does not necessarily describe all features of the present invention. Other embodiments will become apparent from a review of the ensuing detailed description.

[0037] DETAILED DESCRIPTION OF THE INVENTION

[0038] Definitions

[0039] Before the present invention is described in detail below, it is to be understood that this invention is not limited to the particular methodology, protocols and reagents described hereinas these may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0040] Preferably, the terms used herein are defined as described in “A multilingual glossary of biotechnological terms: (IUPAC Recommendations)”, Leuenberger, H.G.W, Nagel, B. and Kolbl, H. eds. (1995), Helvetica Chimica Acta, CH-4010 Basel, Switzerland).

[0041] Several documents are cited throughout the text of this specification. Each of the documents cited herein (including all patents, patent applications, scientific publications, manufacturer's specifications, instructions, GenBank Accession Number sequence submissions etc.), whether supra or infra, is hereby incorporated by reference in its entirety. Nothing herein is to be construed as an admission that the invention is not entitled to antedate such disclosure by virtue of prior invention. In the event of a conflict between the definitions or teachings of such incorporated references and definitions or teachings recited in the present specification, the text of the present specification takes precedence.

[0042] The term “comprise” or variations such as “comprises” or “comprising” according to the present invention means the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers. The term “consisting essentially of’ according to the present invention means the inclusion of a stated integer or group of integers, while excluding modifications or other integers which would materially affect or alter the stated integer. The term “consisting of’ or variations such as “consists of’ according to the present invention means the inclusion of a stated integer or group of integers and the exclusion of any other integer or group of integers.

[0043] The terms “a” and “an” and “the” and similar reference used in the context of describing the invention (especially in the context of the claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context.

[0044] The present invention relates a device for collecting, transporting and storing biomolecules from a biological sample, such as feces.

[0045] The term “biomolecule”, as used herein, includes biological molecules and may include molecules such as nucleic acids (like DNA or RNA), proteins, or metabolites, for example.

[0046] The term “biological sample”, as used herein, refers to any specimen potentially containing a biomolecule of interest, in particular a nucleic acid (like DNA or RNA), a protein, a metabolite, or other biomolecules of interest. Preferably, the sample is a stool or fecal sample.The term “sampling device”, as used herein, refers to a device which allows sampling of a biomolecule of interest. The sampling device of the present invention does not only allow the collection, but also the storage and transport of the biomolecule of interest contained in the sample.

[0047] The term “stool or fecal sample device”, as used herein, refers to a device which allows sampling of stool or feces. The stool or fecal sampling device of the present invention does not only allow the collection, but also the storage and transport of the biomolecule of interest contained in the stool or feces. The terms “stool” and “feces” are used interchangeable herein. To collect feces or stool samples, various devices are known in the art. These devices include: Stool Collection Kits: These typically include a sterile collection container (such as a plastic or screw-top vial) and tools like a spatula or scoop. Some kits contain preservatives to stabilize the sample for transport to a lab. Instructions ensure the sample is handled correctly to prevent contamination.

[0048] Disposable Collection Trays: These are designed to fit over the toilet seat, providing a hygienic way to collect stool without it coming into contact with water. After use, the tray is discarded, leaving the sample in the provided container.

[0049] Fecal Occult Blood Test (FOBT) Cards: These are used for detecting blood in stool samples. The patient smears a small amount of stool onto a special card, which is then tested for hidden blood, often used for colorectal cancer screening.

[0050] Automated Collection Devices: Emerging technology includes automated stool collection devices that are designed to gather stool samples in a controlled, sterile environment. These devices may be used in hospitals or specialized clinics to improve sample integrity.

[0051] Refrigeration and Storage Devices: Some stool collection devices come with built-in storage solutions, such as refrigeration packs or containers with preservatives, to maintain the sample’s viability until it can be analyzed or processed.

[0052] These devices help streamline the stool collection process, ensuring that samples are collected in a sanitary, effective manner while maintaining their quality for diagnostic or therapeutic purposes.

[0053] However, these devices have the disadvantage, that they do not allow a fully comprehensive examination of the fecal or stool sample in a safe, fast, and hygienically way. The present inventors have developed a stool donation / sampling device which simplifies stool removal and reduces the amount of time the patient or clinical staff is in contact with the stool. This stool donation / sampling device further allows to collect several stool samples in diverse types ofpreservation reagents to adequately measure microbiome composition, metabolome, proteome, or any other stool-based biomarkers pertinent to a clinical study or diagnostic analysis.

[0054] As used herein, a “fecal sample” refers to an excrement from the digestive tract of a human or animal, expelled through the anus or cloaca during defecation. In the case of human feces, the feces can be represented by one of the seven feces types on the Bristol feces scale.

[0055] The term “Bristol stool scale”, as used herein, refers to a diagnostic medical tool designed to classify the form of human feces into seven categories. It is used in both clinical and experimental fields.

[0056] The seven types of stool are:

[0057] Type 1: Separate hard lumps, like nuts (difficult to pass)

[0058] Type 2: Sausage-shaped, but lumpy

[0059] Type 3: Like a sausage but with cracks on its surface

[0060] Type 4: Like a sausage or snake, smooth and soft (average stool)

[0061] Type 5: Soft blobs with clear cut edges

[0062] Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea)

[0063] Type 7: Watery, no solid pieces, entirely liquid (diarrhea)

[0064] Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, and 6 and 7 indicate diarrhea.

[0065] The term “microorganism”, as used herein, includes one or more species or strains of microscopic agents such as bacteria, viruses, or fungi. As used herein, a group of microorganisms or population of microorganisms is collectively referred to as a “microbiome”.

[0066] The term “microbiome”, as used herein, refers to a community of microorganisms (such as fungi, bacteria and viruses) that exists in a particular environment. In mammals such as humans, the term is often used to describe the microorganisms that live in or on a particular part of the body, such as the skin or gastrointestinal tract. These groups of microorganisms are dynamic and change in response to a host of environmental factors, such as exercise, diet, medication and other exposures.

[0067] The term “intestinal microbiome”, as used herein, refers to the entirety of all microorganisms that colonize the intestine. A balanced ratio of intestinal bacteria is essential for human health. This is because, as numerous studies have shown, an imbalance in the gut microbiome is associated with various diseases. These include metabolic syndrome, diabetes, inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, irritable bowel syndrome, calcium oxalate urinary stones, cardiovascular diseases, rheumatoid arthritis and neurological disorders.Molecular biological methods such as next-generation sequencing can be used for detecting dysbiosis. Next-generation sequencing, for example, involves the molecular genetic analysis of the entire bacterial intestinal microbiome and has revolutionized diagnostics, as conventional stool diagnostics were previously only able to identify a limited range of the intestinal microbes present. Furthermore, the effects of the individual, highly complex microbiota on colonization resistance, digestive processes, absorption of nutrients and vitamins as well as on immunity can be assessed more precisely.

[0068] The molecular genetic examination includes, but is not limited to,

[0069] analysis of the biodiversity of the intestinal microbiome (diversity),

[0070] statement about the bacterial dysbiosis,

[0071] determination of the enterotype,

[0072] frequency distribution of the most important bacterial strains,

[0073] determination of the Firmicutes / Bacteroidetes ratio,

[0074] assessment of the mucosaprotective flora, and

[0075] analysis of risk factors for dysbiosis-associated diseases.

[0076] The collection, transport, and storing of stool or feces samples is often associated with diverse problems concerning the stability, durability, and reproducibility of the material and the biomolecules comprised therein. For example, stool collection involves gathering fecal samples for medical analysis, research, or fecal microbiota transplantation (FMT). In clinical settings, stool samples are collected to diagnose gastrointestinal conditions, detect infections, or analyze gut microbiota.

[0077] When performing diagnostic tests or clinical trials to modulate the gut microbiome, the quality of microbiome samples is crucial for valid results. Upon removal of specimens from the body undesirable growth or decline of certain microorganisms and degradation and fragmentation of proteins or nucleic acids such as DNA or RNA can occur without rapid specimen stabilization by microbiome stabilizers. Therefore the use of stabilizers such as nucleic acid stabilizers like DNA or RNA stabilizers or protein stabilizers can be very useful when focusing on the bacterial biomass.

[0078] The term “substance”, as used herein, refers to a reagent which comes into contact with the sample such as fecal or stool sample as described herein. It is, for example, part of the sample container for receiving a sample such as a fecal or stool sample. The reagent inactivates all infectious agents and / or protects the genetic integrity and microbiome profile of the fecal or stool sample. In addition, the reagent is provided to stunt the growth or inactivate bacteria and other types of microbes, lyse cells or fix cells, denature or preserve proteins, preservemetabolites, preserve nucleic acids, and / or dilute the sample. Preferably, the substance is a biomolecule preserving reagent.

[0079] As used herein, the term “biomolecule preserving regent” refers to any substance suitable for preserving and stabilizing a biomolecule (e.g. a nucleic acid or protein) in a sample, such as a fecal or stool sample.

[0080] The reagent preferably stabilizes the microbial material comprised in the sample such as fecal or stool sample. More preferably, the stabilizer is a nucleic acid stabilizer, protein stabilizer, and / or metabolite stabilizer.

[0081] The term “nucleic acid stabilizers”, as used herein, refers to molecules or compounds that help maintain the structural integrity and biological function of nucleic acids, such as DNA and RNA, in various experimental or storage conditions. Stabilizers are important to protect nucleic acids from degradation, such as hydrolysis, oxidation, or enzymatic activity.

[0082] Exemplarily nucleic acid stabilizers are selected from the group consisting of EDTA (Ethylenediaminetetraacetic acid), TE Buffer (Tris-EDTA), formamide, RNase inhibitors, guanidine thiocyanate, cryoprotectants (e.g. Glycerol, DMSO), sugars (e.g. Sucrose and Trehalose), BSA (Bovine Serum Albumin), DNA or RNA Aptamers, magnesium (Mg2+) Ions, antioxidants (e.g., DTT, P-Mercaptoethanol), ethanol, X, Y, and Z.

[0083] These stabilizers help ensure the integrity of DNA and RNA for long-term storage, experimental procedures, and applications like PCR, sequencing, and gene expression analysis.

[0084] The different nucleic acid stabilizers are further described below:

[0085] EDTA (Ethylenedi aminetetraacetic acid) chelates divalent metal ions like Mg2+and Ca2+, which are essential cofactors for nucleases (enzymes that degrade nucleic acids). By binding these ions, EDTA inhibits the activity of nucleases and prevents the degradation of DNA and RNA. It’s a component in many nucleic acid storage buffers like TE buffer (Tris-EDTA), commonly used to store both DNA and RNA.

[0086] TE Buffer (Tris-EDTA) includes Tris (tris(hydroxymethyl)aminomethane) and EDTA. Tris helps maintain a stable pH (usually around pH 7.5-8.0) to prevent acid or base-induced hydrolysis, while EDTA chelates metal ions that might activate nucleases. It is widely used as a buffer for storing DNA and RNA.

[0087] Formamide destabilizes hydrogen bonds between nucleic acid strands, reducing secondary structures in RNA and preventing degradation at low temperatures.

[0088] RNase Inhibitors are proteins inhibiting ribonuclease (RNase) activity, which degrades RNA. RNases are ubiquitous and very stable, so inhibitors are crucial in maintaining RNAintegrity, especially in laboratory settings. RNaseOUT or similar products are frequently used in RT-PCR, RNA extraction, and storage of RNA samples.

[0089] Guanidine thiocyanate denatures proteins, including nucleases, which helps to stabilize nucleic acids during extraction. It also helps disrupt cell membranes and inactivate ribonucleases, protecting RNA. Guanidine thiocyanate is a common component of RNA extraction solutions, such as in TRIzol and similar reagents, for stabilizing RNA during the lysis of cells.

[0090] Cryoprotectants (e.g. Glycerol, DMSO (dimethyl sulfoxide)) reduce the formation of ice crystals during freezing, which can physically shear nucleic acids. They also help in stabilizing nucleic acids during long-term storage by preventing degradation. Often used for long-term storage of plasmid DNA or RNA samples at -20°C or -80°C.

[0091] Sucrose and Trehalose are sugars that stabilize nucleic acids by acting as a protective layer and preventing water-mediated hydrolysis. They are often used to create a dehydrated environment around the nucleic acid, which reduces chemical and enzymatic activity.

[0092] BSA (Bovine Serum Albumin) acts as a "carrier protein" that binds and sequesters potentially harmful molecules like nucleases, preventing them from degrading nucleic acids. BSA is often used in molecular biology reactions (e.g. PCR) to stabilize DNA by preventing adhesion to reaction tubes or inhibiting nucleases.

[0093] DNA or RNA Aptamers are synthetic oligonucleotides that can bind specific proteins, like nucleases, inhibiting their activity and preventing the degradation of DNA or RNA. Aptamers are used in advanced research settings where highly specific and targeted stabilization is needed.

[0094] Magnesium (Mg2+) ions can activate nucleases, in some cases, they also help stabilize the structure of DNA or RNA by neutralizing the negative charge on the phosphate backbone of the nucleic acids. Mg2+is a crucial cofactor in many enzymatic reactions involving nucleic acids, such as PCR, but it must be balanced with nuclease inhibitors like EDTA.

[0095] Antioxidants (e.g. dithiothreitol (DTT), P-Mercaptoethanol) are reducing agents which prevent the oxidation of nucleic acids, particularly RNA, which is highly susceptible to oxidative damage. They are commonly added to reaction buffers in RNA research to protect RNA from oxidation during purification and storage.

[0096] The term “protein stabilizers”, as used herein, refers to substances or molecules used to maintain the structural integrity, solubility, and functionality of proteins under various conditions (e.g., during storage, purification, or experimental procedures). Proteins are sensitiveto environmental factors like temperature, pH, and ionic strength, so stabilizers are critical to preventing denaturation, aggregation, or degradation.

[0097] Exemplarily protein stabilizers are selected from the group consisting of glycerol, sugars (e.g. sucrose, trehalose, glucose), BSA, polyols (e.g. sorbitol, mannitol), reducing agents (e.g. DTT, P-Mercaptoethanol), protease inhibitors, detergents (e.g. Triton X-100, Tween-20, SDS), arginine, calcium (Ca2+) and magnesium (Mg2+) ions, imidazole, polyethylene glycol (PEG), salts (e.g., NaCl, KC1, ammonium sulfate), histidine, amino acids (e.g., Glycine, Glutamate), TMAO (Trimethylamine N-oxide), ammonium sulfate, X, Y, andZ.

[0098] These stabilizers help maintain the functional conformation of proteins during various steps of handling, from extraction and purification to storage and usage in experiments or therapeutic applications.

[0099] The different protein stabilizers are further described below:

[0100] Glycerol helps proteins retain their structure by reducing the hydrophobic interactions that can lead to aggregation. It also prevents protein freezing damage by lowering the freezing point. It is widely used in protein storage solutions and enzyme stabilization, particularly for enzymes stored at -20°C or -80°C.

[0101] Sugars (e.g. Sucrose, Trehalose, Glucose) stabilize proteins by forming a protective "hydration shell" around them, reducing water-mediated interactions that could lead to unfolding or aggregation. They also help maintain protein structure during freeze-drying (lyophilization).

[0102] BSA (Bovine Serum Albumin) acts as a protective "carrier" protein that prevents surface adsorption of target proteins to containers and also inhibits aggregation and degradation by binding to harmful molecules (e.g., proteases). It is frequently added to enzyme storage buffers, PCR reactions, or other sensitive protein assays to stabilize the target protein or enzyme.

[0103] Polyols (e.g. Sorbitol, Mannitol) stabilize proteins by enhancing hydration and preventing aggregation or precipitation. They can also help stabilize proteins during freeze-drying.

[0104] Reducing agents (e.g. DTT (Dithiothreitol), P-Mercaptoethanol) prevent the oxidation of cysteine residues in proteins, thus maintaining disulfide bonds in their reduced (functional) state. This helps prevent unwanted oxidation, which can lead to misfolding or aggregation. Commonly used in buffers for enzyme assays, protein purification, and storage to maintain proteins in their reduced and active form.

[0105] Protease Inhibitors prevent the degradation of proteins by inhibiting the activity of proteases (enzymes that break down proteins). This helps protect proteins from enzymaticcleavage during extraction, purification, or storage. Often included in lysis buffers or protein storage solutions to protect sensitive proteins from degradation. Examples of protease inhibitors include:PMSF (Phenylmethylsulfonyl fluoride), EDTA (inhibits metalloproteases by chelating metal ions) or Leupeptin, Pepstatin A, and Aprotinin (specific protease inhibitors).

[0106] Detergents (e.g. Triton X-100, Tween-20, SDS) help to solubilize membrane proteins and prevent aggregation by interacting with hydrophobic regions. Mild detergents (e.g., Triton X-100, Tween-20) stabilize protein conformation without denaturation. Often used in membrane protein purification, protein assays, and storage of proteins prone to aggregation.

[0107] Arginine reduces protein aggregation by interacting with protein surface regions and minimizing hydrophobic interactions that drive aggregation. Frequently used in protein refolding protocols and in the stabilization of antibodies and therapeutic proteins.

[0108] Calcium (Ca2+) and Magnesium (Mg2+) Ions as divalent metal ions stabilize proteins by maintaining the structural integrity of proteins with metal ion-binding sites. They can also help prevent protease activity (e.g., Ca2+stabilizes many proteases). They are added to buffers for stabilizing metalloproteins and certain enzymes (e.g., DNA polymerases or proteases).

[0109] Imidazole stabilizes histidine residues and prevents the premature binding of proteins to metal-chelating columns (e.g., in His-tagged protein purification) while helping maintain the protein’s activity.

[0110] Polyethylene Glycol (PEG) stabilizes proteins by crowding the environment, which promotes protein folding and prevents denaturation. It also helps protect proteins from freezethaw damage and stabilizes them during lyophilization. Used in protein crystallization, storage buffers, and in drug formulations for PEGylated proteins to enhance their stability and solubility.

[0111] Salts (e.g., NaCl, KC1, Ammonium Sulfate) stabilize proteins by shielding their surface charges, which prevents aggregation due to electrostatic interactions. At high concentrations, salts like ammonium sulfate can precipitate proteins in a process called "salting out," which is used for protein purification. Salts are frequently added to buffers for protein purification, crystallization, and long-term storage to enhance protein stability.

[0112] Histidine acts as a buffering agent, stabilizing the pH and reducing the formation of aggregates in protein solutions, especially for therapeutic proteins.

[0113] Amino Acids (e.g., Glycine, Glutamate) stabilize proteins by interacting with the protein’s surface, reducing aggregation, and protecting against denaturation during freezing or lyophilization. Added to protein storage and freeze-drying buffers, as well as formulations for therapeutic proteins and vaccines.TMAO (Trimethylamine N-oxide) is an osmolyte that stabilizes proteins by increasing the thermodynamic stability of their folded conformation, preventing unfolding or aggregation.

[0114] The term “metabolite stabilizers”, as used herein, refers to compounds or conditions used to preserve the chemical integrity and functionality of metabolites in biological samples during processing, storage, or analysis. Metabolites, such as amino acids, lipids, sugars, and other small molecules, can degrade, oxidize, or metabolize further if not properly stabilized, which can affect downstream applications like metabolomics studies or biochemical assays. Here are some common examples of metabolite stabilizers:

[0115] Exemplarily metabolite stabilizers are selected from the group consisting of EDTA (Ethylenediaminetetraacetic acid), methanol, trichloroacetic acid (TCA), acetonitrile, formic acid, oxidation inhibitors (e.g. BHT (Butylated Hydroxytoluene), ascorbic acid), sodium fluoride, Phosphoric acid,.

[0116] These stabilizers are employed in various protocols depending on the type of sample (blood, urine, tissue, etc.) and the metabolites of interest. They help ensure that metabolite profiles remain consistent between collection, processing, and analysis, which is critical for accurate results in metabolomics and other biochemical studies.

[0117] The different metabolite stabilizers are further described below:

[0118] EDTA (Ethylenedi aminetetraacetic acid) chelates metal ions such as calcium, magnesium, and iron, which are cofactors for many enzymes that could modify or degrade metabolites.

[0119] Methanol rapidly denatures proteins and enzymes, preventing metabolic reactions from occurring in biological samples. It also helps precipitate proteins, minimizing enzymatic activity. Methanol is particularly useful for stabilizing metabolites in polar metabolomics studies.

[0120] Trichloroacetic Acid (TCA) denatures proteins and enzymes, inhibiting their activity and preventing metabolite degradation. It’s a strong acid that precipitates proteins by breaking hydrogen bonds. Used to precipitate proteins from biological samples (e.g., blood, serum) while stabilizing the metabolites for analysis. It is often used in metabolite extraction protocols.

[0121] Acetonitrile precipitates proteins and disrupts enzyme activity, preventing further metabolism or degradation of metabolites.

[0122] Formic Acid lowers the pH and denatures proteins and enzymes, stopping enzymatic reactions that might degrade metabolites. The low pH also helps in stabilizing certain metabolites, such as organic acids. Commonly used in metabolomics sample preparation,particularly in mass spectrometry analysis to stabilize metabolites and enhance ionization during detection.

[0123] Oxidation inhibitors (e.g. BHT, Ascorbic Acid) prevent oxidative degradation of metabolites, especially lipids and fatty acids.

[0124] Sodium Fluoride inhibits enzymes like enolase in the glycolysis pathway, preventing the conversion of glucose to other metabolites, thereby preserving the metabolite profile in blood samples.

[0125] Phosphoric acid lowers the pH, which denatures enzymes and stops enzymatic reactions, preserving metabolites in their current state. Acidic conditions prevent further metabolic changes, especially in carbohydrate metabolism.

[0126] There are different nucleic acid stabilizing solutions commercial available such as PowerProtect DNA / RNA (Qiagen), DNA / RNA shield (Zymo Research), RNAlater (Invitrogen), or PhoenixProtect DNA / RNA Conservation Solution (Procomcure). These substances also inactivate infectious agents. In addition to that, OMNImet.GUT (DNA Genotek, Inc.) is commercial available. It stabilizes metabolites in stool. Moreover, formalin may be used for the preparation of bacteria for staining or flow cytometry workflows.

[0127] In this respect, is should be noted that nucleic acid stabilizers often inhibit the measurement of other biomarkers from the same stool sample, such as proteins, metabolites etc. which could contain valuable information. In reverse, protein or metabolite stabilizers often have a detrimental effect on nucleic acids. While commercially available stabilizers are optimized to conserve DNA and RNA for microbiome analysis, they cannot preserve proteins or metabolites equally efficiently. For these reasons, the present inventors have designed a stool donation / sampling device which allows to collect several stool samples in diverse types of reagents such as preservation reagents to adequately measure microbiome composition, metabolome, proteome, or any other stool-based biomarkers pertinent to a clinical study or diagnostic analysis.

[0128] When referring to a nucleic acid, “stable” means that at least about 50% of the initial amount of high molecular weight nucleic acid contained in a sample is still present after the sample is stored at room temperature (i.e., 15°C to 25°C) for a particular period of time.

[0129] When referring to a protein, “stable” means that at least about 50% of the initial amount of high molecular weight nucleic acid contained in a sample is still present after the sample is stored at room temperature (i.e., 15°C to 25°C) for a particular period of time.

[0130] The term “nucleic acid”, as used herein, includes DNA or RNA, including mRNA or viral RNA. In one embodiment, the nucleic acid is DNA, which may be of human, viral, ormicrobial origin. In another embodiment, the nucleic acid is RNA, which can be of human, viral, fungal, or bacterial origin.

[0131] As used herein, the terms “analysis” or “analytical techniques” refer to pH measurement, visual inspection, spectral analysis, tonometry, oxygen content, colorimetry, philogenetics, proteomics, metabolomics, mass spectrometry (MS), nuclear magnetic resonance (NMR), chromatography, electrophoresis, immunoassays, protein-protein interactions, fluorescence, flow cytometry, host-microbiome interactions, nucleic acid hybridization, techniques involving mRNA or cDNA transcription analysis and sequencing of nucleic acids, including whole genomes, random fragments, or specific portions such as microbial 16S rRNA, and any combination of the above techniques in parallel or sequentially. Overlaying all or some of these analyses with clinical or phenotypic information provides a comprehensive picture of gastrointestinal physiology, microbiome status in health and disease, and therapeutic safety and efficacy. The ability to combine information about microbial community member identity and diversity obtained from 16S rRNA sequencing, metabolic potential obtained from metagenomic sequence data, and information about gene expression and protein production obtained from metaproteomic data has enabled the intestinal microbiota at multiple molecular levels simultaneously.

[0132] The term “treatment”, in particular “therapeutic treatment”, as used herein, refers to any therapy which improves the health status and / or prolongs (increases) the lifespan of a patient. Said therapy may eliminate the disease in a patient, arrest or slow the development of a disease in a patient, inhibit or slow the development of a disease in a patient, decrease the frequency or severity of symptoms in a patient, and / or decrease the recurrence in a patient who currently has or who previously has had a disease. In the context of the present invention, diseases associated with the gastrointestinal tract are preferably treated.

[0133] The term “disease”, as used herein, refers to an abnormal condition that affects the body of an individual. A disease is often construed as a medical condition associated with specific symptoms and signs. A disease may be caused by factors originally from an external source, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune diseases. In humans, “disease” is often used more broadly to refer to any condition that causes pain, dysfunction, distress, social problems, or death to the individual afflicted, or similar problems for those in contact with the individual. In this broader sense, it sometimes includes injuries, disabilities, disorders, syndromes, infections, isolated symptoms, deviant behaviors, and atypical variations of structure and function, while in other contexts and for other purposes these may be considered distinguishable categories. Diseases usually affect individuals not onlyphysically, but also emotionally, as contracting and living with many diseases can alter one's perspective on life, and one's personality. Preferably, the disease is a disease associated with the gastrointestinal tract.

[0134] The term “infectious disease” (or simply “infection”), as used herein, refers to any disease which can be transmitted from individual to individual or from organism to organism, and is caused by a microbial agent. Infectious diseases are known in the art and include, for example, a viral disease, a bacterial disease, or a parasitic disease. Said diseases are caused by a virus, a bacterium, and a parasite, respectively. In this regard, the infectious disease can be, for example, hepatitis, sexually transmitted diseases (e.g. chlamydia or gonorrhea), tuberculosis, HIV / acquired immune deficiency syndrome (AIDS), diphtheria, hepatitis B, hepatitis C, cholera, severe acute respiratory syndrome (SARS), the bird flu, and influenza. In a preferred embodiment, the infectious disease / infection is a gastrointestinal infection.

[0135] The term “Fecal microbiota transplant (FMT)” (also known as a “stool transplant”), as used herein, is the process of transferring fecal bacteria and other microbes from a healthy individual into another individual. FMT is an effective treatment for Clostridioides difficile infection (CDI). For recurrent CDI, FMT is more effective than vancomycin alone, and may improve the outcome after the first index infection. Side effects may include a risk of infections, therefore the donor should be screened for pathogens. With CDI becoming more common, FMT is gaining increasing prominence, with some experts calling for it to become the first-line therapy for CDI. FMT has been used experimentally to treat other gastrointestinal diseases, including colitis, constipation, irritable bowel syndrome, and neurological conditions, such as multiple sclerosis and Parkinson's. In the United States, human feces has been regulated as an experimental drug since 2013. In the United Kingdom, FMT regulation is under the remit of the Medicines and Healthcare products Regulatory Agency.

[0136] The term “point-of-care testing (POCT)”, as used herein, refers to a medical diagnostic testing at or near the point of care that is the time and place of patient care. This contrasts with the historical pattern in which testing was wholly or mostly confined to the medical laboratory, which entailed sending off specimens away from the point of care and then waiting hours or days to learn the results, during which time care must continue without the desired information. Point-of-care tests are simple medical tests that can be performed at the bedside. The driving notion behind POCT is to bring the test conveniently and immediately to the patient. This increases the likelihood that the patient, physician, and care team will receive the results quicker, which allows for immediate clinical management decisions to be made. POCT is often accomplished through the use of transportable, portable, and handheld instruments and test kits.Small bench analyzers or fixed equipment can also be used when a handheld device is not available - the goal is to collect the specimen and obtain the results in a very short period of time at or near the location of the patient so that the treatment plan can be adjusted as necessary before the patient leaves. The kit or device as claimed herein is suitable for point-of-care testing (POCT).

[0137] The term “patient”, as used herein, encompasses any mammal. A mammal can be, for example, a human, a non-human primate, livestock (such as a cow, goat, or sheep), as well as a dog, cat, horse, etc.

[0138] Embodiments of the invention

[0139] The present invention will now be further described. In the following passages, different aspects of the invention are defined in more detail. Each aspect so defined may be combined with any other aspect or aspects unless clearly indicated to the contrary. In particular, any feature indicated as being preferred or advantageous may be combined with any other feature or features indicated as being preferred or advantageous, unless clearly indicated to the contrary.

[0140] Microbiome-derived biomarkers usually measured in fecal or stool samples are constantly gaining importance in clinical research. Stool samples should ideally be collected by the patients at their home, and the samples should be stabilized until they are delivered to the research facility by post, or at a scheduled appointment.

[0141] The present inventors have designed a stool donation / sampling device which allows to collect several stool samples in diverse types of preservation reagents to adequately measure microbiome composition, metabolome, proteome, or any other stool-based biomarkers pertinent to a clinical study or diagnostic analysis. In addition, the present inventors have developed a stool donation / sampling device which simplifies stool removal and reduces the amount of time the patient or clinical staff is in contact with the stool. The present inventors have specifically designed a multi-compartment stool donation device, in which samples taken from the same stool portion can be preserved in different conditions without the need of repeated sampling.

[0142] Thus, in a first aspect, the present invention relates to a sampling probe handling unit, the sampling probe handling unit may comprise a sampling probe support. The sampling probe support may be configured to support a plurality of sampling probes or may support a plurality of sampling probes. The respective sampling probe may for example be the sampling probe as disclosed in the fourth aspect of this disclosure.The sampling probe may comprise a sample portion arranged to contact a material from which the sample should be taken. The sample portion may be configured to retain the sample taken from the material when the sampling probe is removed from the material. The sampling probe may comprise an interface portion. The interface portion may be provided in an end portion of the sampling probe remote from the sampling portion. Additionally or alternatively, the interface portion may be arranged to protrude from a sample container when the sample portion with the sample has been inserted into the sample container.

[0143] According to at least one embodiment, the sampling probe handling unit may be configured such that a user may perform a sampling procedure to simultaneously obtain a plurality of samples from the material.

[0144] Such an embodiment is useful as it minimizes the effort required by an user, e.g. a patient to obtain a plurality of samples from the material, e.g. from stool. Furthermore, as will become clearer later on, it also give the possibility of simultaneously inserting a plurality of samples into a plurality of sample containers, configured to receiving a sample. The user does not necessarily have to be the patient; in other words a user, e.g. a healthcare professional, may obtain a plurality of samples from the material, e.g. from the stool, of a patient Furthermore, the sampling probe handling unit allows to collect several samples, e.g. several stool samples, and insert them in diverse types of preservation reagents, respectively, to e.g. adequately measure microbiome composition, metabolome, proteome, or any other stool-based biomarkers pertinent to a clinical study or diagnostic analysis.

[0145] According to at least one embodiment, the sampling probe support may have a plurality of probe locations. The sampling probe handling unit, in each probe location, may be configured to cooperate with one sampling probe to support the sampling probe. Each sampling probe location may be configured to cooperate with a single sampling probe.

[0146] According to at least one embodiment, the probe locations may be arranged in a onedimensional linear arrangement along the sampling probe support.

[0147] According to at least one embodiment, the sampling probes may be insertable into and / or removable from the sampling probe support.

[0148] According to at least one embodiment, the sampling probes may be releasably securable to the sampling probe support.

[0149] According to at least one embodiment, in the respective probe location, a sampling probe may be configured to be mounted, e.g. releasably mounted, to or may be mounted, e.g. releasably mounted, to the sampling probe support.According to at least one embodiment, for supporting the sampling probe in the probe location, a surface of the interface portion of the sampling probe may be arranged to abut a surface of the sampling probe support to support the respective sampling probe.

[0150] According to at least one embodiment, for supporting the sampling probe in the probe location, the surface of the interface portion faces towards the sample portion.

[0151] According to at least one embodiment, in order to remove the sampling probes, a flexible portion of the sampling probes may be deflected so as to reduce the width of the sampling probe in a region to allow the sampling probe support to be moved past the interface portion.

[0152] According to at least one embodiment, in the respective probe location, a sampling probe can be inserted into the sampling probe support from a first side of the support such that the sample portion of the sampling probe may protrude from the side of the support which faces away from the first side.

[0153] According to at least one embodiment, in the respective probe location, an opening may be provided which extends through the sampling probe support from the first side of the sampling probe support to the second side of the sampling probe support. The opening may be configured to receive the sampling probe.

[0154] According to at least one embodiment, the opening may have a first section which receives the interface portion of the sampling probe. The opening may have a second section which receives a different portion of the sampling probe.

[0155] According to at least one embodiment, the first section and the second section may have different widths, e.g. radial widths.

[0156] According to at least one embodiment, the width of the first section may be greater than the width of the second section.

[0157] According to at least one embodiment, the width of the first section may be greater than or equal to the width of the flexible portion and / or the width of the interface portion.

[0158] According to at least one embodiment, the width of the second section may be smaller than the width of the interface portion and / or the flexible portion.

[0159] According to at least one embodiment, when the sampling probe is supported by the sampling probe support, the interface portion may be arranged on or accessible from the first side of the sampling probe support. The sample portion may be arranged on the second side of the sampling probe support. The sampling probe support may abut the interface portion of the sampling probe.

[0160] According to at least one embodiment, the sampling probe handling unit may comprise a further member, which is securable or secured to the sampling probe support.According to at least one embodiment, the further member may be releasably connected to the sampling probe support.

[0161] According to at least one embodiment, the further member may be a handling member. The handling member may be configured to provide a user interface for the user for performing a sampling procedure.

[0162] According to at least one embodiment, the further member may extend along all of the sampling probes and / or probe locations.

[0163] According to at least one embodiment, the further member may cover all of the interface portions of the sampling probes supported or supportable by the sampling probe support.

[0164] According to at least one embodiment, the further member may be rigidly connected to the sampling probe support.

[0165] According to at least one embodiment, the further member may be arranged to abut the interface portion of one, of more of, or of all of the sampling probes, e.g. to react a force transferred to the probes during the sampling procedure, in order to secure the sampling probes in their position relative to the sampling probe support, e.g. during the sampling procedure.

[0166] According to at least one embodiment, the sampling probe support and / or the further member may be autoclavable.

[0167] According to at least one embodiment, the sampling probe support and / or the further member may be a reusable component.

[0168] According to at least one embodiment, the sampling probe handling unit may comprise at least one unit connection feature configured to cooperate with at least one carrier connection feature to connect, e.g. releasably, the sampling probe handling unit to the sample carrier.

[0169] According to at least one embodiment, the unit connection feature may comprise a snap feature, e.g. a flexible arm and / or a protrusion.

[0170] In a second aspect, the present invention relates to a sample carrier for carrying a plurality of sample containers, e.g. the sampling container according to the fifth aspect, e.g. a sample container for receiving a sample, e.g. a fecal sample or stool sample. The sample container may comprise a body defining a sample receiving volume. The sample receiving volume may be configured to receive the sample. In the sample receiving volume, a substance may be contained to contact the sample when the sample is received in the volume.

[0171] According to at least one embodiment, the sample containers may be releasably fixable or releasably fixed to the sample carrier in different container positions defined on the sample carrier.According to at least one embodiment, the respective sample container, when fixed to the sample carrier, may be fixed against axial movement away from the carrier.

[0172] According to at least one embodiment, the sample carrier may comprise a carrier fixing feature which is configured to cooperate with a container fixing feature of a sample container to fix the sample container to the sample carrier in a container position.

[0173] According to at least one embodiment, the carrier fixing feature may be or may comprise a thread.

[0174] According to at least one embodiment, the sampling probes may be removed from the sampling probe carrier, e.g. by moving the carrier relative to the sampling probes in a direction away from a sample portion of the sampling probes, e.g. when the sampling probes are arranged in the sample containers.

[0175] According to at least one embodiment, the sample carrier may comprise a carrier main body with a plurality of container receiving portions. One container receiving portion may be provided per container position. The respective container receiving portion may be configured to receive at least a section of a sample container.

[0176] According to at least one embodiment, the respective container receiving portion may be configured to receive more than 50% of the total length of the body of the sample container, e.g. more than one of the following: 60%, 70%, 80%, 90%.

[0177] According to at least one embodiment, the respective container receiving portion may be configured to receive less than 50% of the total length of the body of the sample container, e.g. less than one of the following: 40%, 30%, 20%, 10%.

[0178] According to at least one embodiment, the respective container receiving portion may be configured to receive the entire body of the sample container or the entire sample container.

[0179] According to at least one embodiment, a section of the container may protrude from the container receiving portion, e.g. from an introduction opening thereof, when the container is received in the container receiving portion.

[0180] According to at least one embodiment, a color coding may be visible in the protruding section.

[0181] According to at least one embodiment, the section may be less than or equal to a percentage X of the total length of the container, wherein X is one of: 10%, 20%, 30%, 40%.

[0182] According to at least one embodiment, at least one carrier fixing feature may be associated with each container position.

[0183] According to at least one embodiment, the carrier fixing feature may be or may comprise a thread.According to at least one embodiment, the at least one carrier fixing feature may be provided in an end region of the container receiving portion remote from an opening of the container receiving portion through which the sample container is introducible into the container receiving portion.

[0184] According to at least one embodiment, the sample carrier may be configured such that the same sample container can be fixed in different container positions to the sample carrier.

[0185] According to at least one embodiment, the sample container may be configured such that the same sample container cannot be secured to the sample carrier in different container positions.

[0186] According to at least one embodiment, the sample carrier may be autoclavable.

[0187] According to at least one embodiment, the sample carrier may be a reusable component and / or the sample containers may be disposable components.

[0188] According to at least one embodiment, the sample carrier may be configured to be, e.g. releasably, secured to a sampling probe handling unit with a plurality of sampling probes.

[0189] According to at least one embodiment, the sample carrier may comprise at least one carrier securing feature. The securing feature may be configured to cooperate with at least one unit securing feature of the sampling probe handling unit to secure the sample carrier to the sampling probe handling unit, e.g. releasably.

[0190] According to at least one embodiment, the carrier securing feature may be or may comprise a snap feature, such as a recess or cut-out.

[0191] In a third aspect, the present invention relates to a sampling device or sampling kit for simultaneously obtaining a plurality of stool samples from a material, comprising:

[0192] - the sample carrier of the second aspect equipped with a plurality of sample containers, - a sampling probe handling unit of the first aspect with a plurality of sampling probes.

[0193] According to at least one embodiment, the sample carrier may be connected to the sampling probe handling unit, e.g. after a sampling procedure with samples arranged in the sample containers and / or with broken or pierced seals.

[0194] According to at least one embodiment, the sample carrier may be disconnected from the sampling probe handling unit, e.g. before a sampling procedure without samples in the sample containers and with intact seals.

[0195] According to at least one embodiment, the sample carrier may be provided in a sterile packaging before a sampling procedure is commenced.According to at least one embodiment, the sampling probe handling unit may be provided in a sterile packaging before a sampling procedure is commenced.

[0196] According to at least one embodiment, the sampling probe handling unit and the sample carrier may be provided in the same sterile packaging or different sterile packagings.

[0197] According to at least one embodiment, the further member may be connected to the sampling probe support.

[0198] In a fourth aspect, the present invention relates to a sampling probe for obtaining a sample, e.g. a fecal sample or stool sample. The sampling probe may comprise a sample portion. The sample portion may be arranged to contact a material from which the sample should be taken. The sample portion may be configured to retain the sample taken from the material when the sampling probe is removed from the material. The sampling probe may comprise an interface portion. The interface portion may be provided in an end portion of the sampling probe remote from the sampling portion. Additionally or alternatively, The interface portion may be arranged to protrude from a sample container when the sample portion with the sample has been inserted into the sample container.

[0199] According to at least one embodiment, the interface portion may be or may comprise a flexible portion.

[0200] According to at least one embodiment, the interface portion may be arranged to be contacted by a user when handling the sampling probe, e.g. for connecting the sampling probe to a sampling probe handling unit and / or to contact one or more elements of a sampling probe handling unit when the sampling probe is connected to the sampling probe handling unit.

[0201] According to at least one embodiment, the sampling probe may comprise a sealing portion. The sealing portion may be arranged between the sample portion and the interface portion, e.g. as seen along a main axis of the sampling probe extending from the sample portion to the interface portion.

[0202] According to at least one embodiment, the sealing portion may be arranged to contact an inner wall of a sample container to seal the sample within the sample container when the sample portion of the sampling probe has been inserted into the sample container.

[0203] According to at least one embodiment, the sealing portion may have one or a plurality of sealing lips. According to at least one embodiment, the respective sealing lip may be radially oriented. According to at least one embodiment, the sealing lips may be axially separated from one another.According to at least one embodiment, the sealing portion may be elastically deformable.

[0204] According to at least one embodiment, the respective sealing lip may be elastically deformable.

[0205] According to at least one embodiment, the flexible portion may protrude outwardly and / or radially with respect to the sealing portion.

[0206] According to at least one embodiment, a radial width of the sealing portion is smaller than a radial width of the interface portion.

[0207] According to at least one embodiment, the flexible portion may extend along the entire circumference of the sampling probe.

[0208] According to at least one embodiment, a probe portion may extend away from the sealing portion. The sample portion may be arranged at the end of the probe portion remote from the sealing portion.

[0209] According to at least one embodiment, a radial width of the probe portion may be smaller than a radial width of the sealing portion.

[0210] According to at least one embodiment, the flexible portion may be configured to be deflected in the direction axially away from the sample portion to reduce a radial width of the sampling probe in the region of the flexible portion, e.g. to allow removal of a sampling probe support from the sampling probe by moving an opening of the sampling probe support away from the sample portion of the sampling probe optionally thereby deflecting the flexible portion by interaction of the flexible portion and the sampling probe support.

[0211] According to at least one embodiment, the reduced radial width or the reduced outer diameter may be less than or equal to the radial width of the opening in the sampling probe support, e.g. to allow the interface portion to pass through the opening.

[0212] According to at least one embodiment, the radial width of the sampling probe in the region of the flexible portion with a non-deflected flexible portion may be greater than or equal to the radial width of the opening in the sampling probe support.

[0213] According to at least one embodiment, the sampling probe may be a disposable component.

[0214] In a fifth aspect, the present invention relates to a sample container for receiving a sample, e.g. a fecal sample or stool sample, wherein the sample container comprises a body defining a sample receiving volume, the sample receiving volume being configured to receivethe sample, wherein, in the sample receiving volume, a substance is contained to contact the sample when the sample is received in the volume.

[0215] According to at least one embodiment, the sample container comprises a seal sealing the sample receiving volume with the substance before a sample is received in the container.

[0216] According to at least one embodiment, the seal is breakable for insertion of the sample into the sample receiving volume through the seal.

[0217] According to at least one embodiment, the seal is configured to break or be pierced when the sampling probe is inserted into the sample container. According to at least one embodiment, the seal is a foil.

[0218] According to at least one embodiment, the seal is connected to an inner side wall of the body.

[0219] According to at least one embodiment, the seal is spaced apart from an opening of the body, and wherein the sample container is configured such that the sample is or can be introduced into the sample container via the opening.

[0220] According to at least one embodiment, a distance by which the seal is spaced apart from the opening of the body is greater than or equal to any one of the following: 3 mm, 5 mm, 10 mm, 15 mm.

[0221] According to at least one embodiment, the container is coded, e.g. color coded, to specify the substance contained in the sample receiving volume and / or a container position in which the sample container should be fixed to a sample carrier.

[0222] According to at least one embodiment, the substance is or comprises one of, more of, or all of the following: preservation fluids for nucleic acids or proteins, ethanol solutions, methanol solutions, ammonium sulfate solutions, formalin, water (among others) According to at least one embodiment, the substance is provided to either stunt the growth or inactivate bacteria and other types of microbes, lyse cells or fix cells, denature or preserve proteins, preserve metabolites, preserve nucleic acids, dilute the sample.

[0223] According to at least one embodiment, the sample container comprises a container fixing feature which is configured to cooperate with a carrier fixing feature to releasably fix the sample container to a sample carrier.

[0224] According to at least one embodiment, the sample container is configured to receive the sampling probe of any one of the preceding claims.

[0225] A set of sample containers, the set comprising a plurality of sample containers may also be provided.

[0226] In a sixth aspect, the present invention relates to the use of- the sampling probe of the fourth aspect, and / or

[0227] - the sample container of the fifth aspect, and / or

[0228] - the sample carrier of the second aspect, and / or

[0229] - the sampling probe handling unit of the first aspect, and / or

[0230] - the sampling device or sampling kit of the third aspect

[0231] for obtaining, receiving, and / or transporting a stool sample.

[0232] In a seventh aspect, the present invention relates to a method comprising using

[0233] - the sampling probe of the fourth aspect, and / or

[0234] - the sample container of the fifth aspect, and / or

[0235] - the sample carrier of the second aspect, and / or

[0236] - the sampling probe handling unit of the first aspect, and / or

[0237] - the sampling device or sampling kit of the third aspect

[0238] for obtaining, receiving, and / or transporting a stool sample.

[0239] We note that features described above and below in conjunction with different embodiments or aspects can be combined with one another, even if such a combination is not explicitly disclosed herein above or below. Also, features described in combination with one another should be considered as being disclosed separately from each other throughout the entire disclosure. Further features, advantages and expediencies of the disclosure will become apparent from the following description of the exemplary embodiments in conjunction with the drawings.

[0240] Various modifications and variations of the invention will be apparent to those skilled in the art without departing from the scope of invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art in the relevant fields are intended to be covered by the present invention.

[0241] BRIEF DESCRIPTION OF THE FIGURES

[0242] The following figures and examples are merely illustrative of the present invention and should not be construed to limit the scope of the invention as indicated by the appended claims in any way.FIGURE 1: shows a schematic cross sectional view of an exemplary embodiment of a sample probe;

[0243] FIGURE 2A: shows a schematic cross sectional view of an exemplary embodiment of a sampling probe handling unit comprising a sample probe, e.g. the sample probe of FIGURE 1;

[0244] FIGURE 2B: shows a plan view from above of the sampling probe handling unit of FIGURE 2A without a sampling probe;

[0245] FIGURE 2C: shows a schematic cross sectional view of an exemplary embodiment of an handling member;

[0246] FIGURE 2D: shows a schematic cross sectional view of the sampling probe handling unit of Figure 2 A comprising a handling member, e.g. the handling member of FIGURE 2C;

[0247] FIGURE 2E: shows a schematic method of removing a sampling probe, e.g. the sampling probe from FIGURE 1 from the sampling probe handling unit of FIGURE 2A;

[0248] FIGURE 3A: shows a schematic cross sectional view of an exemplary embodiment of a sample container;

[0249] FIGURE 3B shows an exemplary embodiment of a container with an exemplary embodiment of a sampling probe connected to it, e.g. the sampling probe 100 of FIGURE 1;

[0250] FIGURE 4A: shows a schematic cross sectional view of an exemplary embodiment of a sample carrier.

[0251] FIGURE 4B: shows a schematic cross sectional view of the narrow side of the sample carrier of Figure 4A.

[0252] FIGURE 4C: shows a schematic cross sectional view of the narrow side of the sample carrier of Figure 4A with a sample container inserted into the sample carrier, e.g. the sample container of FIGURE 3.

[0253] FIGURE 4D: shows a schematic cross sectional view of the exemplary embodiment of the sample carrier of FIGURE 4A with four sample container, e.g. the one shown in FIGURE 3 attached to the carrier.

[0254] FIGURE 5: shows schematic steps of an exemplary embodiment of a method of obtaining multiple samples according to the disclosure.

[0255] EXAMPLES

[0256] The examples given below are for illustrative purposes only and do not limit the invention described above in any way.FIGURE 1 shows a schematic cross sectional view of an exemplary embodiment of a sample probe 100. The sampling probe 100 may be for obtaining a sample, e.g. a fecal sample or stool sample, e.g. of a patient. The sampling probe 100 may comprise a sample portion 110. The sample portion 110 may be arranged to contact a material from which the sample should be taken (in case of a fecal sample, the material may for example be the feces of the animal or patient). The sample portion 110 may be configured to retain the sample taken from the material when the sampling probe is removed from the material. In other words, the sample probe 100 and in particular the sample portion 110 may be inserted into the feces of example a patient and then removed. The sample portion 110 may be configured such that during removal of the sample probe 100 from the feces some material, e.g. some feces are retained, e.g. for later analysis. The sample portion 110 may for example comprises a ridged outer surface to better retain the feces. The sample portion 110 may additionally or alternatively comprise a recess, e.g. a channel, inside the sample portion and extending towards the interface portion. The sample taken from the material may be retained in the recess, e.g. in the channel (not seen in this Figure).

[0257] The sampling probe 100 may comprise an interface portion 120. The interface portion 120 may be provided in an end portion of the sampling probe 100 remote from the sample portion 110. The interface portion 120 may be arranged on an opposite end of the sample portion 110. As will become clear in relation to other figures the interface portion 120 may additionally or alternatively be arranged to protrude from a sample container 300 when the sample portion 110 with the sample has been inserted into the sample container 300 (see e.g.

[0258] FIGURE 3B for an exemplary embodiment of a sample container 300 with a sampling probe connected to the sample container 300).

[0259] The interface portion 120 may be or may comprise a flexible portion 120.

[0260] The interface portion 120 may be arranged to be contacted by a user, e.g. a patient, when handling the sampling probe 100. For example the user may hold the sampling probe 100 at its interface portion 120. The user may for example hold the interface portion 120 of the sampling probe 100 for connecting the sampling probe 100 to a sampling probe handling unit 200 (shown in FIGURE 2A)

[0261] The interface portion 120 may comprise a surface 122 which faces towards the sample portion 110. This surface 122 may be configured to interact with the sampling probe handling unit 200 as explained with respect to FIGURE 2A.

[0262] The sampling probe 100 may comprise a sealing portion 130. The sealing portion may be arranged between the sample portion 110 and the interface portion 120, e.g. as seen along amain axis of the sampling probe 100 extending from the sample portion 110 to the interface portion 120.

[0263] The sealing portion 130 may comprise one or a plurality of sealing lips 132. The sealing lips 132 may be radially orientated and / or axially separated, e.g. spaced, from one another The sealing portion 130 may be elastically deformable. The sealing lips 132 may be elastically deformable.

[0264] As can be seen from the figure the interface portion 120, e.g. the flexible portion 120, may protrude outwardly and / or radially relative to the sealing portion 130. The radial width, RW1, of the interface portion, e.g. of the flexible portion 120, may be greater than the width, e.g. the radial width, RW2, of the sealing portion 130. In other words, a radial width, RW2, of the sealing portion 130 may be smaller than a radial width, RW1, of the interface portion 120, e.g. of the flexible portion 120. .

[0265] The sampling probe 100 may comprise a probe portion 140. The probe portion may extend away from the sealing portion 130 towards the sample portion 110. The sample portion 110 may be arranged at the end of the probe portion 140, e.g. remote from the sealing portion 130. In other words, seen along a main axis of the sampling probe 100 extending from the sample portion 110 to the interface portion 120, the sampling probe 100 may comprise a sample portion 110, a probe portion 140 a sealing portion 130 and an interface portion 120, e.g. a flexible portion 120. As can be seen from the figure a radial width of the probe portion 140 may be smaller than the radial with of the sealing portion 130 and / or of the interface portion 120. The radial width of the probe portion 140 may be equal to the radial width of the sample portion 110

[0266] The flexible portion 120 of the sampling probe 100 may be configured to be deflected in the direction axially away from the sample portion 110. This may reduce a radial width of the flexible portion 120, e.g. of the interface portion 120, and therefore of the sampling probe 100. Such a reduction in width may be advantageous to allow removal of a sampling probe support unit 200 from the sampling probe 100 (as will be explained more in detail in FIGURE 2A).

[0267] The sampling probe 100 may be a disposable component.

[0268] The probe portion and the sample portion may together be less than or equal to 20 mm long, e.g. 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm.

[0269] The probe portion and the sample portion may together be more than or equal to 20 mm long, e.g. 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm.The radial width, RW2 of the sealing portion may be 11 mm. The radial width, RW2 of the sealing portion RW2 may be also less than, or more than, or equal to 11mm, e.g. 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm.

[0270] The radial width RW1 of the interface portion 120 may be less than, or more than, or equal to 0.5 mm, 1 mm, 1.5 mm, 2 mm wider than the radial width RW2 of the sealing portion 130.

[0271] FIGURE 2A shows a schematic cross sectional view of an exemplary embodiment of a sampling probe handling unit 200.

[0272] The sampling probe handling unit 200 may comprise a sampling probe support 210. The sampling probe support 210 may be configured to support a plurality of sampling probes 100 (only one shown on the right side), e.g. of sampling probes 100 as shown and described in relation to FIGURE 1. In this example the sampling probe handling unit 200 and especially the sampling probe support 210 may be configured to support four sampling probes 100, however the disclosure is not limited to four. The sampling probe handling unit 200 and especially the sampling probe support 210 may be configured to support less than four sampling probes 100, for example, two, three or a singular sampling probe. The sampling probe handling unit 200 may be configured to support more than four sampling probes 100, for example, five, six, seven, eight, nine or ten sampling probes.

[0273] The sampling probe support 210 may comprise a plurality of probe locations 240a, 240b, 240c (and 240d shown clearer in FIGURE 2B). The sampling probe handling unit 200 may be configured to cooperate with one sampling probe 100 in each probe location 240a, 240b, 240c, 240d to support the respective sampling probe 100. As the sampling probe handling unit 200 of the exemplary embodiment shown in FIGURE 2A is configured to support four sampling probes, the sampling probe support 210 comprises four probe locations 240a, 240b, 240c, 240d.

[0274] The sampling probes 100 may be insertable into the sampling probe support 210, in particular they may be mounted in the respective probe locations 240a, 240b, 240c (in this figure the sampling probe 100 is inserted into the probe location 240d). The sampling probes 100 may be releasably securable to the sampling probe support 210.

[0275] The sampling probes 100 may additionally or alternatively be removable from the sampling probe support 210, in particular from the respective probe locations 240a, 240b, 240c, 240d.

[0276] For supporting the sampling probe 100 in the probe location 240d, a surface 122 of the interface portion 120 of the sampling probe 100 (see FIGURE 1) is arranged to abut a surface 220 of the sampling probe support 210 to support the respective sampling probe 100. Thesurface 122 of the interface portion 120 of the sampling probe 100 may face towards the sample portion 110 of the sampling probe 100. The surface 220 of the sampling probe support 210 may face towards the interface portion 120. In the respective probe location 240a, 240b, 240c, 240d the sampling probe 100 may be inserted into the sampling probe support 210 from a first side 212 of the support 210. The sample portion 110 of the sampling probe 100 protrudes from the side 214, e.g. a second side 214, of the support 210 which faces away from the first side 212. In the respective probe location, an opening 240a, 240b, 240c, 240d may be provided which extends through the sampling probe support 210 from the first side 212 of the sampling probe support 210 to the second side 214 of the sampling probe support 210. The openings, e.g. each opening may be configured to receive the sampling probe 100.

[0277] In order to remove the sampling probes 100 from the sampling probe handling unit 200 and in particular from the sampling probe support 210, the flexible portion 120 may be deflected so as to reduce the width of the sampling probe 100 in a region, e.g. in the interface portion 120, to allow the sampling probe support 210 to be moved past the interface portion 120. In other words, the flexible region 120, e.g. the interface portion 120, may be squeezed such as to allow the removal of a sampling probe from the sampling probe support 210. The reduced radial width or the reduced outer diameter may be less than or equal to the radial width of the opening in the sampling probe support, e.g. to allow the interface portion 120 to pass through the opening.

[0278] The openings 240a, 240b, 240c, 240d, may have a first section 242. The first section 242 may be configured to receive the interface portion 120 of the sampling probe 100. The openings 240a, 240b, 240c, 240d, may have a second section 244. The second section 244 may be configured to receive a different portion of the sampling probe 100. The different portion may for example be at least the sealing portion 130 of the sampling probe 100. The second section 244 may receive only a portion of the sealing portion 130. It is noted that the figures are schematic and the sizes are shown such as to ameliorate the understanding of the exemplary embodiments. A substantially percentage of the sealing portion may protrude from the openings 240a, 240b, 240c, 240d and in particular from the second section 244. The second section, may for example have a length, LI seen from the first side toward the second side of less than or equal to 10 mm, 15 mm, 20 mm. The section of the sealing portion 130 protruding from the opening, e.g. from the second section (in a direction towards the sample portion), may interact, e.g. interact in a sealing manner, with a sample container (as will be explained further below).

[0279] The section of the sealing portion 130 protruding from the opening, e.g. from the second section 244, may be smaller (e.g. shorter) than the section of the sealing portion 130 notprotruding from the opening, e.g. from the second section 244. In such an embodiment the sampling probe may have a good halt to the sampling probe support 210.

[0280] The section of the sealing portion 130 protruding from the opening, e.g. from the second section 244, may be greater (e.g. longer) than the section of the sealing portion 130 not protruding from the opening, e.g. from the second section 244. In such an embodiment the sampling probe may have a good halt to the sample container.

[0281] The section of the sealing portion 130 protruding from the opening, e.g. from the second section 244, may be equal in length to the section of the sealing portion 130 not protruding from the opening, e.g. from the second section 244. Such an embodiment may have good halt both with the sample container and with the sampling probe support 210.

[0282] The first section 242 and the second section 244 may have different widths, e.g. different radial widths. The width of the first section 242 may be greater than the width of the second section 244. The width of the first section 242 may be greater than or equal to the width of the flexible portion 120 and / or the width of the interface portion 120. The width of the second section 244 may be smaller than the width of the interface portion 120 and / or the flexible portion 120. The difference between the width of the first section 242 and the second section 244 may substantially coincide with the difference in radial width between the interface portion 120 and the sealing portion 130 of the sample probe 100.

[0283] The width of the first section may be equal to or smaller than the radial width of the interface portion 120 and / or of the flexible portion 120. The width of the first section 242 may be 0.1 mm, 0.2 mm , 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm or 1 cm smaller than the radial width of the interface portion 120. The difference between the width of the first section 242 and the radial width of the interface portion 120 may be dependent on the elastic properties of the flexible portion 120.

[0284] When inserting the sampling probe 100 into the opening, e.g. opening 240d, the interface portion 120 of the sampling probe 100 may be configured to contact one or more elements of the sampling probe handling unit 200. When connecting the sampling probe to the sampling probe handling unit 200, e.g. when inserting the sampling probe 100 in the opening 240d, the flexible portion 120 may be configured to deflect, by interaction of the flexible portion 120 and the sampling probe support 210. The width of the first section 242 might be smaller than the width of the interface portion 120, e.g. of the flexible portion 120, and as such the flexible portion might have to deflect in order to connect the sampling probe to the sampling probe unit 200. Because the flexible portion may be elastic, once the sampling probe 100 is connected to the sampling probe unit, the flexible portion would tend to expand and therebyapplies a force on the inner wall of the first section 242 of the opening 240, thereby achieving a better halt of the sampling probe 100 in the sampling probe handling unit 200.

[0285] The width of the second section may be equal to or smaller than the radial width of the sealing portion 130. The width of the second section 244 may be 0.1 mm, 0.2 mm , 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm or 1 cm smaller than the radial width of the sealing portion 130. The difference between the width of the second section 244 and the radial width of the sealing portion 130 may be dependent on the elastic properties of the sealing portion 130.

[0286] The sampling probe 100 may be supported by the sampling probe support 210. The interface portion 120 may be arranged on or may be accessible from the first side 212 of the sampling probe support 210. The sample portion 110 may be arranged on the second side 214 of the sampling probe support 210. The sampling probe support 210 may abut the interface portion 120 of the sampling probe 100, e.g. at its first surface 122.

[0287] As can be seen in FIGURE 2A the sampling probe handling unit 200 may comprise also at least one unit connection feature 250. The unit connection feature 250 may be configured to cooperate with at least one carrier connection feature 460 (see FIGURE 4A and respective description) to connect, e.g. releasably, the sampling probe handling unit 200 to the sample carrier 400, e.g. the one of FIGURE 4A.

[0288] The or each connection feature 250 may comprise a snap feature, such as an arm element 252, e.g. a flexible arm element 252 and / or a protrusion, e.g. a radially extending protrusion 254. The type of connections features is however not limited by these exemplary embodiments and also other types of connections are conceivable. Some example may be different snap-fit connections, e.g. cantilever snap joints or torsion snap joints.

[0289] FIGURE 2B, shows a plan view from above of the sampling probe handling unit of FIGURE 2A without the sampling probe 100 inserted in the opening 240d.

[0290] As can be seen from the figures, the sampling unit support 210 may have a substantially rectangular shape seen from above. The sampling probe handling unit 200 may have a compact perimeter. An advantage of a more compact sampling probe support 210 is its smaller size and therefore e.g. easier storage. As mentioned a user may have to store the probes in the fridge, and a smaller compact sampling support units rendered such a storage easier (also in view of more than one probe sampling units being stored).

[0291] A less compact size, instead may facilitate handling of the sampling probe handling unit 200, therefore being more convenient for example for elderly patients or patients with impaired fine motor skills.In a more compact size, the sampling probe handling unit 200 may comprise a perimeter of less than or equal to 200 mm, e.g. 175 mm, 150 mm, 125 mm, 100 mm. A compact size may e.g. comprise a perimeter of 170 mm. .

[0292] In a less compact size, the sampling probe handling unit 200 may comprise a perimeter of more than or equal to 200 mm, e.g. 225 mm, 250 mm, 275 mm, 300 mm, 400 mm, 500 mm.

[0293] The unit connection feature 250, e.g. the protrusion 254, may extend radially outwardly from the perimeter of the sampling probe support 210.

[0294] As can be seen the probe locations may arranged in a one-dimensional linear arrangement along the sampling probe support 210. The disclosure is however not limited to such an arrangement and the probe locations may for example be arranged in a two dimensional matrix form, e.g. in a quadratic arrangement.

[0295] FIGURE 2C, shows a schematic cross sectional view of an exemplary embodiment of a further member 280 of the sapling probe handling unit 200, e.g. of an handling member 280.

[0296] The sampling probe handling unit 200 may comprise the further member 280. The further member may be securable or secured to the sampling probe support 210. In particular the further member 280 may be releasably connected to the sampling probe support 210. The sampling probe handling unit 200 may comprise at least one further member connection feature 230 (se e.g. FIGURE 2A and 2B) The sampling probe handling unit 200, especially the sampling probe support 210 may be configured to connect to a further member, e.g. via the further member connection feature 230 and a respective connection feature 283 on the further member 280, e.g. the further member 280 shown in FIGURES 2C and 2D. The respective connection feature 283 may be thread and configured to interact with a respective threaded further member connection feature 230. The connection system may however comprise snapping features, e.g. the further member may be connected to the sampling probe support 210 via a snap connection.

[0297] The further member 280 may be a handling member 280, e.g. it might provide a user interface for the user for performing a sampling procedure. The handling member 280 may comprise, e.g. a handle 282 which could be gripped by an user.

[0298] FIGURE 2D, shows a schematic cross sectional view of the sampling probe handling unit of FIGURE 1A comprising a handling member, e.g. the handling member of FIGURE 2D

[0299] In this exemplary embodiment, the further member 280, e.g. the handling member 280, is connected, e.g. releasably connected to the sampling probe handling unit 200. Specifically, the handling member 280 may be connected, e.g. releasably connected to the sampling probehandling unit 20 via the connection between the further member connection feature 230 and the respective connection member 283 of the handling member 280.

[0300] As can be see the further member 280 may extend along all of the sampling probes and / or probe position, (in FIGURE 2D only one sampling probe 100 is shown (see e.g.

[0301] FIGURE 2A))

[0302] The further member 280 may, in particular, cover all of the interface portions 120 of the sampling probes 100 supported or supportable by the sampling probe support 210. The further member 280 may be arranged to abut the interface portion 120 of one, of more of, or of all of the sampling probes 100. Such an abutment may lead to the further member 280 to react a force transferred to the sampling probes 100 during the sampling procedure, e.g. in order to secure the sampling probes 100 in their position relative to the sampling probe support 210, e.g. during the sampling procedure. In other words, the sampling probes 100 may be hindered to move in an axial direction opposite the sample portion 110 of the sampling probe 100, by the abutment of the further member 280 on the interface portion 120 and the connection, e.g. rigid connection of the further member to the sampling probe unit.

[0303] The sampling probe handling unit 200, comprising for example the further member 280, as depicted in FIGURE 2D, may for example be easy to use when collecting a, or multiple, samples of a material. A user may be able to grab the whole sampling probe handling unit 200 by grabbing the handle 282 of the further member 280. The sampling probe handling unit 200 may be configured such that a user can perform a sampling procedure to simultaneously obtain a plurality of samples from the material (see also FIGURE 5 and respective description).

[0304] The sampling probe support 210 and / or the further member 280 may be autoclavable. The sampling probe support 210 and / or the further member 280 may be a reusable component, respectively.

[0305] FIGURE 2E shows a schematic method of removing a sampling probe, e.g. the sampling probe from FIGURE 1 from the sampling probe handling unit of FIGURE 2A.

[0306] To remove the sampling probe 100 from the sampling probe handling unit 200 and especially from the sampling unit support 210, the sampling probe 100 may be pushed toward the second side 214 of the sampling unit support (marked with an arrow Al) and / or the sampling unit support 210 may be pushed towards the first side 212 of the sampling probe unit (e.g. towards the interface feature 120) (marked with arrow A2).

[0307] Such a push may cause the flexible portion 120 to deflect so as to reduce its width, e.g. the width of the sampling probe 100 in a region, e.g. in the interface portion 120, to allow the sampling probe support 210 to be moved past the interface portion 120. In other words, theflexible region 120, e.g. the interface portion 120, may be squeezed such as to allow the removal of a sampling probe from the sampling probe support 210.

[0308] FIGURE 3A shows a schematic cross sectional view of an exemplary embodiment of a sample container 300.

[0309] The sample container may be configured to receive a sample, e.g. a fecal sample or stool sample. The sample container 300 may comprise a body 310. The body 310 may define a sample receiving volume V. The sample receiving volume V may be configured to receive the sample. The sample receiving volume V may comprise a substance S. The substance S may be configured to contact the sample when the sample is received in the volume V.

[0310] The sample container 300 may comprise a seal 320. The seal may be sealing the sample receiving volume V with the substance S before a sample is received in the sample container 300, e.g. in the volume V.

[0311] The seal 320 may be breakable for insertion of the sample into the sample receiving volume through the seal 320. In particular the seal may be configured to break when the sampling probe 100 is inserted into the sample container 300, e.g. when the sample portion 110 is inserted through the seal 320. The seal 320 may for example be a foil. The seal 320 may be connected to an inner side wall 312 of the body 310 of the sample container 300.

[0312] The body 310 may have an opening 312. The opening may be configured to receive the sampling probe 100. In other words The sample may be introduced into the sample container 300 via the opening 312. The seal 320 may be spaced apart from the opening 312 of the body 310 (see e g FIGURE 3B)

[0313] A distance by which the seal is spaced apart from the opening of the body may be greater than or equal to any one of the following: 3 mm, 5 mm, 10 mm, 15 mm. The distance between the seal and the opening may be such that, when a sampling probe is inserted into the sample container 300 via the opening 312, the whole, or at least three quarter of the probe portion 140 passes the seal. In this way it may be assured that the whole sample portion 110 which usually comprises the sample of the material to be analysed, e.g. the feces, has passed the seal 320.

[0314] The sample container 300 may be coded, e.g. may comprise a code 330, e.g. a colour code 330. The code 330 may be arranged anywhere on the body 310 of the sample container 300, for example on a top portion of the body 310, e.g. in the space between the seal 320 and the opening 312 of the body 310. The code may be indicative for the substance S comprised in the sample receiving volume V and / or a container position in which the sample container should be fixed to a sample carrier (see e.g. FIGURE 4A).The substance in the sample receiving volume V may be or may comprise one of, more of, or all of the following: Preservation fluids for nucleic acids or proteins, ethanol solutions, methanol solutions, ammonium sulfate solutions, formalin, water (among others). The substance S may be provided to either stunt the growth or inactivate bacteria and other types of microbes, lyse cells or fix cells, denature or preserve proteins, preserve metabolites, preserve nucleic acids, dilute the sample.

[0315] The sample container 300 may further comprise a container fixing feature 340. The container fixing feature may be configured to cooperate with a carrier fixing feature 440 (seen and explained in FIGURE 4A). This may lead to a releasable connection of the sample container 300 to the sample carrier 400.

[0316] The sample container length without the container fixing feature 340 may have a length greater than or equal to 2 cm, e.g. 2.1 cm, 2.2 cm, 2.2 cm, 2.3 cm, 2.4 cm, 2.5 cm, 2.6 cm, 2.7 cm, 2.8 cm, 2.9 cm. The sample container length without the container fixing feature 340 may have a length less than or equal to 3 cm, e.g. 3.1 cm, 3.2 cm, 3.2 cm, 3.3 cm, 3.4 cm, 3.5 cm, 3.6 cm, 3.7 cm, 3.8 cm, 3.9 cm.

[0317] The fixing feature may be e.g. a thread. The thread may be greater than or equal to 5 mm long, e.g. 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 1.1 cm, 1.2 cm, 1.3 cm, 1.4 cm, 1.5 cm.

[0318] The sample container size with the container fixing feature 340 may have a length greater than or equal to 3 cm, e.g. 3.1 cm, 3.2 cm, 3.2 cm, 3.3 cm, 3.4 cm, 3.5 cm, 3.6 cm, 3.7 cm, 3.8 cm, 3.9 cm. The sample container length with the container fixing feature 340 may have a length less than or equal to 4 cm, e.g. 4.1 cm, 4.2 cm, 4.2 cm, 4.3 cm, 4.4 cm, 4.5 cm, 4.6 cm, 4.7 cm, 4.8 cm, 4.9 cm.

[0319] A set comprising a plurality of sample containers may also be provided. Each sample container of the set of sample container may comprise the same substance S. A first sample container and a second sample container of the plurality of sample container may comprise the same substance S.

[0320] Each sample container of the set of sample container may comprise a different substance S. A first sample container and a second sample container of the plurality of sample container may comprise different substances S. With at least two sample containers comprising different substances, it is easier to perform several tests on collected stool samples, e.g. in diverse types of preservation reagents to adequately measure microbiome composition, metabolome, proteome, or any other stool-based biomarkers pertinent to a clinical study or diagnostic analysisSample containers 300 comprising different substances may have different codes 330. The code 330 may be linked to, e.g. may be indicative of the substances S. A first sampling sample container and a second sampling sample container of the plurality of sample containers may be coded differently, e.g. by different color codings. The number of sample container provided may correspond to the number of sampling probes provided in the sampling probe unit.

[0321] FIGURE 3B shows an exemplary embodiment of a sample container with an exemplary embodiment of a sampling probe connected to it, e.g. the sampling probe 100 of FIGURE 1.

[0322] The sealing portion 130 of the sampling probe 100 may be arranged such as to contact an inner wall of the sample container 300, e.g. to seal the sample within the sample container when the sample portion of the sampling probe has been inserted into the sample container. In such a manner the sample container 300 may be sealed. The probe portion and the sample portion (see FIGURE 1) of the sampling probe 100 may be long enough to have at last a section of, or all of, the sample portion inside the substance S, once the sampling probe 100 is connected to the sample container 300.

[0323] When inserting the sampling probe 100 into the sample container 300 the seal may be broken by at least the probe portion and the sample portion of the sampling probe 100.

[0324] FIGURE 4A, shows a schematic cross sectional view of an exemplary embodiment of a sample carrier 400. FIGURE 4B, shows a schematic cross sectional view of the narrow side of the sample carrier of FIGURE 4A. FIGURE 4C, shows a schematic cross sectional view of the narrow side of the sample carrier of FIGURE 4A with a sample container inserted into the sample carrier, e.g. the sample container of FIGURE 3. FIGURE 4D shows a schematic cross sectional view of the exemplary embodiment of the sample carrier 400 of FIGURE 4D with four sample containers connected to the sample carrier. Reference is made to all four drawings if not otherwise specified.

[0325] The sample carrier 400 is configured to carry at least one, e.g. a plurality of sample containers 300, e.g. sample containers 300 similar to the one in FIGURE 3. In FIGURE 4A two sample containers 300 are shown, the sample carrier 400, may however be adapted to receive four sample container as shown in this figure. The number is not limited to four and the carrier 400 may be adapted to carry one, two, three, four, five, six, seven, eight, nine, ten or even more sample containers.

[0326] The sample containers 300 may be releasably fixable or releasably fixed to the sample carrier 400, e.g. in different container positions defined on the sample carrier 400. As mentioned with respect to FIGURE 3, the sample carrier 400 may comprise a carrier fixing feature 440which may be configured to cooperate with a container fixing feature 340 of a sample container 300, e.g. to fix the sample container 300 to the sample carrier 400 in a container position. A carrier 400 adapted to carry four sample containers may comprise four carrier fixing features which may be configured to cooperate with four respective container fixing features 340. Once fixed to the carrier 400, the sample container 300 may be fixed against axial movement away from the carrier 400. The carrier fixing feature 440 may be or may comprise a thread. The thread may be configured to cooperate with a respective thread of the container fixing feature 340.. The disclosure is however not limited to a thread and also other types of connection, e.g. snap-on connections, fit-connections and similar may be conceivable.

[0327] The sample carrier 400 may comprise a carrier main body 410. The carrier main body 410 may comprise a plurality of container receiving portions 450. One container receiving portion 450 may be provided per container position, e.g. per container. The respective container receiving portion 450 may be configured to receive at least a section of a sample container. Each receiving portion may be linked to a carrier fixing feature 440. The sample containers 300 may be wider than the width of the carrier fixing feature 440. This guarantees an axial abutment of the container body 310 with the carrier main body 410 when the container is connected to the carrier.

[0328] The container receiving portion may be defined by the respective carrier fixing features and optionally by respective inner walls of the carrier extending away from the carrier fixing features (not shown). Inner walls may delimit or may indicate where to insert the containers into the carrier. The container receiving portion 450 may be defined by the carrier fixing feature 440 and the side walls o the main body 410 of the carrier 400.

[0329] Each container receiving portion may comprise a code 430, e.g. a colour code 430. The code 430 may correspond to the code 330 of the sample container 300, e.g. to indicate which container should be inserted, e.g. received in which container receiving portion 450. At least one carrier fixing feature may be provided in an end region of the container receiving portion remote from an opening of the container receiving portion through which the sample container 300 is introducible into the container receiving portion. The code 430 may be arranged on the end region of the carrier.

[0330] The container receiving portion may be configured to receive more than 50% of the total length of the body of the sample container 300, e.g. more than one of the following: 60%, 70%, 80%, 90%. A section of the container 300 may protrude from the container receiving portion, e.g. from an opening thereof, when the container is received in the container receiving portion. If the container receiving portion is configured by the side walls 416 of the main body 410 ofthe carrier, a section of the sample container 300 may protrude from the side walls 416 (not shown).

[0331] The coding, e.g. the colour coding, of the container may be visible in the protruding section (as shown in FIGURE 4A). The protruding section may be less than or equal to a percentage X of the total length of the container, wherein X is one of: 10%, 20%, 30%, 40%.

[0332] The container receiving portion may be configured to receive the entire body of the sample container or the entire sample container (as shown in FIGURE 4A for example).

[0333] The inner walls which may delimit the container receiving portion may be of a transparent material. The walls defining the main body 410 of the carrier 400 may comprise or consist of a transparent material. The side walls 416 of the carrier 400 may comprise a transparent material. This may allow a user to see which container are inserted, e.g. connected to the carrier 400, for example even when the entire body of the sample container is received in the container receiving portion.

[0334] The sample carrier may be configured such that the same sample container 3000 can be fixed in different container positions to the sample carrier, e.g. in each container position.

[0335] The sample carrier may be configured to be, e.g. releasably secured, e.g. connected to a sampling probe handling unit 200 (with, with some, or without sampling probes).

[0336] The sample carrier 400 may comprise at least one carrier securing feature 460. The carrier securing features may be configured to cooperate with at least one unit securing feature 250, e.g. with the flexible arm 252 and the protrusion 254, of the sampling probe handling unit 200 to secure the sample carrier 400 to the sampling probe handling unit 200, e.g. releasably.

[0337] The carrier securing feature may be or may comprises a snap feature, such as a recess or cut-out 460. The flexible arm 252 and the protrusion 254 may snap in the recess or curt-out 460.

[0338] The sample carrier 400 may be autoclavable. The sample carrier may be a reusable component and / or the sample containers may be disposable components.

[0339] FIGURE 5 shows three schematic steps of a method for obtaining multiple samples using the elements described in the previous figures, e.g. the sampling probe of Figure 1, he sample container of FIGURE 3, the sample carrier of FIGURES 4A to 4D and the sampling probe handling unit of FIGURES 2A to 2D. Clearly the method, is however not limited to the exact embodiments of the elements as described in the previous figures.

[0340] At first a sampling device or sampling kit for simultaneously obtaining a plurality of stool samples from a material may be provided. The sampling device or sampling kit may comprise a sample carrier, e.g. the one described in FIGURES 4A to 4D, equipped with aplurality of sample containers, e.g. as the one described in relation to FIGURE 3. The sampling device or sampling kit may comprise a sampling probe handling unit, e.g. the one described in relation to FIGURES 2A to 2D, with a plurality of sampling probes, e.g. the one described in relation to FIGURE 1. In FIGURE 5 the sampling probe handling unit may comprise four sampling probes 100 connected to the sampling probe support. The sampling probe handling unit 200 may also comprise the further member 280, e.g. the handling member 280, e.g. the handle 282 connected to the sampling probe support 210.

[0341] The sample carrier 400 and / or the sampling probe handling unit 200 may be provided in a sterile packaging before a sampling procedure is commenced. The sampling probe handling unit and the sample carrier may be provided in the same sterile packaging or different sterile packaging.

[0342] When provided to the user, the sample carrier may be disconnected from the sampling probe handling unit. In other words, before a sampling procedure, the sample carrier may be disconnected from the sampling probe handling unit. In such a case, the container may not comprise the sampling probes in the sample containers and the seals may be intact.

[0343] In a first step SI a user, e.g. a patient would pick the sampling probe handling unit 200, e.g. via the handle. The sampling probe handling unit 200 may for example comprise four sampling probes as in the Figure 5. The user may then push the sample portion of all four sampling probes into a material which samples need to be analyzed, e.g. into the feces. The sampling probes may be pushed into the material until at least a portion of the sample portion is completely inserted into the material. The sampling probes may be pushed into the material until at least the whole sample portions of each sampling probe are completely inserted into the material. The sampling probes may be pushed into the material until at least a portion of the probe portion is inserted into the material.

[0344] The size of the sampling probe handling unit is such that in most cases the material is big enough for all four sampling probes to be inserted into the material. Furthermore the further member, e.g. the handle may be size such that a user may easily insert the probe sections of the sampling probes into the material without a risk of contact between the material and the user, e.g. with the risk of contamination of the user with the material, e.g. with the feces.

[0345] The sampling probes may be configured such that when the sampling probe unit, e.g. the sample portion of the sampling probes, are removed from the material, a sample of the material is attached to each sample portion of the sampling probes (see e.g. step S2).

[0346] As a further step S3, the sample probe unit may be connected to the sample carrier such as to insert at least the sample portion of the sample probes into the volume of the container.This may comprise breaking the seals of the respective containers. The probe unit may be pushed into the carrier until a snap-connection between the carrier and the sample probe unit is achieved.

[0347] At this point the sampling probes may be sealingly connected to the containers such that the substance S with the sample of the material cannot exit the container. At this point the sampling probe handling unit may be removed S4 from the sampling probes (as shown and described in FIGURE 2E) . The carrier with the containers and the sampling probes then remain as a single element. The sampling probe handling unit may be reused in another sapling process.

[0348] As such a method may be provided for obtaining, receiving, and / or transporting a stool sample. The method may comprise using a sample carrier, e.g. the one described in FIGURES 4A to 4D, equipped with a plurality of sample containers, e.g. as the one described in relation to FIGURE 3. The sampling device or sampling kit may comprise a sampling probe handling unit, e.g. the one described in relation to FIGURES 2A to 2D, with a plurality of sampling probes, e.g. the one described in relation to FIGURE 1.

[0349] In the present disclosure the terms "sample container" and "container" may have been used interchangeably. In the present disclosure the terms "sample unit support" and "support" may have been used interchangeably.

[0350] For obtaining, receiving, and / or transporting a stool sample

[0351] - the sampling probe as shown in FIGURE 1, and / or

[0352] - the sample container as shown in FIGURE 3A , and / or

[0353] - the sample carrier as shown in FIGURES 4A to 4D, and / or

[0354] - the sampling probe handling unit as shown in FIGURES 2A to 2E,

[0355] may be used.

Claims

1. CLAIMS1. A sampling probe handling unit, the sampling probe handling unit comprising a sampling probe support, wherein the sampling probe support is configured to support a plurality of sampling probes or supports a plurality of sampling probes for obtaining a sample, e.g. a fecal sample or stool sample, the sampling probe comprising:- a sample portion arranged to contact a material from which the sample should be taken and configured to retain the sample taken from the material when the sampling probe is removed from the material,- an interface portion, wherein the interface portion is provided in an end portion of the sampling probe remote from the sampling portion and / or wherein the interface portion is arranged to protrude from a sample container when the sample portion with the sample has been inserted into the sample container.

2. The sampling probe handling unit of claim 1, wherein the sampling probe handling unit is configured such that a user can perform a sampling procedure to simultaneously obtain a plurality of samples from the material.

3. The sampling probe handling unit of any one of the preceding claims, wherein the sampling probes are releasably securable to the sampling probe support.

4. The sampling probe handling unit of claim 1 or 2, wherein the sampling probe support has a plurality of probe locations, and wherein the sampling probe handling unit, in each probe location, is configured to cooperate with one sampling probe to support the sampling probe.

5. The sampling probe handling unit of claim 4, wherein, for supporting the sampling probe in the probe location, a surface of the interface portion of the sampling probe is arranged to abut a surface of the sampling probe support to support the respective sampling probe.

6. The sampling probe handling unit of claim 4 or 5, wherein, in the respective probe location, an opening is provided which extends through the sampling probe support from the first side of the sampling probe support to the second side of the sampling probe support, and wherein the opening is configured to receive the sampling probe.

7. The sampling probe handling unit of claim 6, wherein the opening has a first section which receives the interface portion of the sampling probe and a second section which receives a different portion of the sampling probe.

8. The sampling probe handling unit of claim 7, wherein the first section and the second section have different widths, e.g. radial widths.

9. The sampling probe handling unit of any one of the preceding claims, wherein the sampling probe handling unit comprises a further member, which is securable or secured to the sampling probe support.

10. The sampling probe handling unit of claim 9, wherein the further member is releasably connected to the sampling probe support.

11. The sampling probe handling unit of claim 9 or 10, wherein the further member is a handling member, configured to provide a user interface for the user for performing a sampling procedure.

12. The sampling probe handling unit of any one of claims 9 to 11, wherein the further member covers all of the interface portions of the sampling probes supported or supportable by the sampling probe support.

13. The sampling probe handling unit of any one of claims 9 to 12, wherein the further member is arranged to abut the interface portion of one, of more of, or of all of the sampling probes, e.g. to react a force transferred to the probes during the sampling procedure, in order to secure the sampling probes in their location relative to the sampling probe support, e.g. during the sampling procedure.

14. The sampling probe handling unit of any one of the preceding claims, wherein the sampling probe handling unit comprises at least one unit connection feature configured to cooperate with at least one carrier connection feature of a sample carrier to connect, e.g. releasably, the sampling probe handling unit to the sample carrier.

15. A sample carrier for carrying a plurality of sample containers for receiving a sample, e.g. a fecal sample or stool sample, wherein the sample container comprises a body defining a sample receiving volume, the sample receiving volume being configured to receive the sample, wherein, in the sample receiving volume, a substance is contained to contact the sample when the sample is received in the volume.

16. The sample carrier of claim 15, wherein the sample containers are releasably fixable or releasably fixed to the sample carrier in different container locations defined on the sample carrier.

17. The sample carrier of claim 16, wherein the sample carrier comprises a carrier fixing feature which is configured to cooperate with a container fixing feature of the sample container to fix the sample container to the sample carrier in a container location.

18. The sample carrier of claim 16 or claim 17, wherein the sample carrier comprises a carrier main body with a plurality of container receiving portions, wherein one container receiving portion is provided per container location, the respective container receiving portion being configured to receive at least a section of a sample container.

19. The sample carrier of claim 18, wherein the respective container receiving portion is configured to receive more than 50% of the total length of the body of the sample container, e.g. more than one of the following: 60%, 70%, 80%, 90%.

20. The sample carrier of claim 18 or claim 19, wherein a section of the container protrudes from the container receiving portion, e.g. from an introduction opening thereof, when the container is received in the container receiving portion.

21. The sample carrier of claim 20, wherein a color coding of the sample container is visible in the protruding section.

22. The sample carrier of any one of claims 15 to 21, wherein the sample carrier is configured to be, e.g. releasably, secured to a sampling probe handling unit, e.g. the sampling probe handling unit according to any one of the claims 1 to 14.

23. The sample carrier of claim 22, wherein the sample carrier comprises at least one carrier securing feature which is configured to cooperate with at least one unit securing feature of the sampling probe handling unit to secure the sample carrier to the sampling probe handling unit, e.g. releasably.

24. A sample container for receiving a sample, e.g. a fecal sample or stool sample, wherein the sample container comprises a body defining a sample receiving volume, the sample receiving volume being configured to receive the sample, wherein, in the sample receiving volume, a substance is contained to contact the sample when the sample is received in the volume.

25. The sample container of claim 24, wherein the sample container comprises a seal sealing the sample receiving volume with the substance before a sample is received in the container.

26. The sample container of claim 25, wherein the seal is breakable for insertion of the sample into the sample receiving volume through the seal.

27. The sample container of claim 25 or claim 26, wherein the seal is configured to break when a sampling probe is inserted into the sample container.

28. The sample container of any one of claims 25 to 27, wherein the seal is spaced apart from an opening of the body, and wherein the sample container is configured such that the sample is or can be introduced into the sample container via the opening.

29. The sample container of claim 28, wherein a distance by which the seal is spaced apart from the opening of the body is greater than or equal to any one of the following: 3 mm, 5 mm, 10 mm, 15 mm.

30. The sample container of any one of the claims 24 to 29, wherein the container is coded, e.g. color coded, to specify the substance contained in the sample receiving volume and / or a container location in which the sample container should be fixed to a sample carrier.

31. The sample container of any one of the claims 24 to 30, wherein the substance is or comprises one of, more of, or all of the following: preservation fluids for nucleic acids orproteins, ethanol solutions, methanol solutions, ammonium sulfate solutions, formalin, water (among others)32. The sample container of any one of the claims 24 to 31, wherein the substance is provided to either stunt the growth or inactivate bacteria and other types of microbes, lyse cells or fix cells, denature or preserve proteins, preserve metabolites, preserve nucleic acids, dilute the sample.

33. The sample container of any one of the claims 24 to 32, wherein the sample container comprises a container fixing feature which is configured to cooperate with a carrier fixing feature to releasably fix the sample container to a sample carrier, e.g. the sample carrier of any one of claims 15 to 2334. The sample container of claim 33, wherein the sample container is coded such that the sample container can be fixed in a first container location of a sample carrier but not in a second container location of the sample carrier.

35. A set of sample containers, the set comprising a plurality of sample containers according to any one of the claims 24 to 34.

36. The set of claim 35, wherein a first sample container and a second sample container of the plurality of sample containers comprise different substances.37 The set of claim 35 or of claim 36, wherein a first sample container and a second sample container of the plurality of sample containers comprise the same substance.

38. The set of any one of claims 15 to 27wherein a first sample container and a second sample container of the plurality of sample containers are coded differently e.g. comprise different color codings.

39. A sampling probe for obtaining a sample, e.g. a fecal sample or stool sample, the sampling probe comprising:a sample portion arranged to contact a material from which the sample should be taken and configured to retain the sample taken from the material when the sampling probe is removed from the material,an interface portion, wherein the interface portion is provided in an end portion of the sampling probe remote from the sampling portion and / or wherein the interface portion is arranged to protrude from a sample container when the sample portion with the sample has been inserted into the sample container.

40. The sampling probe of claim 39, wherein the interface portion is or comprises a flexible portion.

41. The sampling probe of claim 39 or claim 40, wherein the interface portion is arranged to be contacted by a user when handling the sampling probe, e.g. for connecting the sampling probe to a sampling probe handling unit, and / or to contact one or more elements of a sampling probe handling unit when the sampling probe is connected to the sampling probe handling unit.

42. The sampling probe of any one of claims 39 to 41, wherein the sampling probe comprises a sealing portion, the sealing portion being arranged between the sample portion and the interface portion, e.g. as seen along a main axis of the sampling probe extending from the sample portion to the interface portion.

43. The sampling probe of claim 42, wherein the sealing portion is arranged to contact an inner wall of a sample container, e.g. the sample container according to any one of claims 24 to 34, to seal the sample within the sample container when the sample portion of the sampling probe has been inserted into the sample container.

44. The sampling probe of claim 42 or claim 43, wherein the sealing portion has one or a plurality of sealing lips.

45. The sampling probe of any one of claims 42 to 44, wherein the sealing portion is elastically deformable.

46. The sampling probe of any one of claims 42 to 45, wherein the interface portion and / or the flexible portion protrudes outwardly and / or radially with respect to the sealing portion.

47. The sampling probe of any one of the claims 42 to 46, wherein a radial width of the sealing portion is smaller than a radial width of the interface portion.

48. The sampling probe of any one of claims 42 to 47, wherein a probe portion extends away from the sealing portion the sample portion being arranged at the end of the probe portion remote from the sealing portion.

49. The sampling probe of any one of claims 42 to 48, wherein a radial width of the probe portion is smaller than a radial width of the sealing portion.

50. The sampling probe of any one of claims 40 to 49, wherein the flexible portion is configured to be deflected in the direction axially away from the sample portion to reduce a radial width of the sampling probe in the region of the flexible portion, e.g. to allow removal of a sampling probe support from the sampling probe by moving an opening of the sampling probe support away from the sample portion of the sampling probe, optionally thereby deflecting the flexible portion by interaction of the flexible portion and the sampling probe support.

51. The sampling probe of claim 50, wherein the reduced radial width or the reduced outer diameter is less than or equal to the radial width of the opening in the sampling probe support, e.g. to allow the interface portion to pass through the opening.

52. The sampling probe of claim 50 or claim 51, wherein the radial width of the sampling probe in the region of the flexible portion with a non-deflected flexible portion is greater than or equal to the radial width of the opening in the sampling probe support.

53. A sampling device or sampling kit for simultaneously obtaining a plurality of stool samples from a material, comprising:the sample carrier of any one claims 15 to 23 equipped with a plurality of sample containers, e.g. the sample containers of any one of claims 25 to 34,a sampling probe handling unit of any one claims 1 to 14 with a plurality of sampling probes, e.g. the sampling probes of any one of claims 39 to 52.

54. The sampling device or sampling kit of claim 53, wherein the sample carrier is connected to the sampling probe handling unit, e.g. after a sampling procedure with samples arranged in the sample containers and / or with broken seals.

55. The sampling device or sampling kit of claim 53 or claim 54, wherein the sample carrier is disconnected from the sampling probe handling unit, e.g. before a sampling procedure without samples in the sample containers and with intact seals.

56. The sampling device or sampling kit of any one of claims 53 to 55, wherein the sample carrier is provided in a sterile packaging before a sampling procedure is commenced.

57. The sampling device or sampling kit of any one of claims 53 to 56, wherein the sampling probe handling unit is provided in a sterile packaging before a sampling procedure is commenced.

58. The sampling device or sampling kit of any one of claims 53 to 57, wherein the sampling probe handling unit and the sample carrier are provided in the same sterile packaging or different sterile packagings.

59. The sampling device or sampling kit of any one of claims 53 to 58, wherein the further member is connected to the sampling probe support.

60. Usingthe sampling probe of any one of claims 39 to 52, and / orthe sample container of any one of claims 24 to 34, and / orthe sample carrier of any one of claims 15 to 23, and / orthe sampling probe handling unit of any one of claims 1 to 14, and / orthe sampling device or sampling kit of any one of claims 53 to 59for obtaining, receiving, and / or transporting a stool sample.

61. A method comprising usingthe sampling probe of any one of claims 39 to 52, and / orthe sample container of any one of claims 24 to 34, and / or the sample carrier of any one of claims 15 to 23, and / orthe sampling probe handling unit of any one of claims 1 to 14, and / or the sampling device or sampling kit of any one of claims 53 to 59 for obtaining, receiving, and / or transporting a stool sample.

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