Stool collection and extraction system for analysis of faecal specimens on infectious diseases

Abstract

An innovative stool sampling system allows the collection of a stool sample ranging from 100 to 400 milligrams and its immediate immersion in a preservation and conversation buffer of only 2 to 3 millilitres tailored for subsequent analysis. The sampling system provides the advantage that the stool analyte undergoes only a modest dilution, which is perfect for highly sensitive immunoanalytical assays. The device presented gives way to a refined protocol for direct immunological testing and identification of a wide range of proteinaceous analytes in faeces, including those associated with infectious agents such as s such as H. pylori, viruses, bacteria, and various parasitic infestations.

Description

[0001] STOOL COLLECTION AND EXTRACTION SYSTEM FOR ANALYSIS OF FAECAL SPECIMENS ON INFECTIOUS DISEASES

[0002] FIELD OF THE INVENTION

[0003]

[0001] The invention relates to a stool sampling device for collecting a faecal specimen for immunological detection and characterization of an infectious disease. In particular, the invention relates to a faecal specimen collection system for analyzing stool for Helicobacter pylori antigens.

[0004] BACKGROUND OF THE INVENTION

[0005]

[0002] Numerous devices for sampling and transporting pasty faecal material, such as spatulas, scoops, ladles, spoons, slot samplers, lancer samplers, or dippers. Sampling systems for occult blood testing typically consist of a screw cap attached to a grooved stick with moulded recesses and a tube prefilled with a preservative buffer. To collect a faecal sample, the stick is pierced into the faecal material and then inserted through a fitting hole into the chamber containing the extraction and preservative buffer (see, e.g., EP 1 384 442, US 5,246,669, US 5,514,341 , US 7,780,915, DE 10 2008 057866, DE 10 2012 109457, EP 3 629 017, US 11 ,293,839).

[0006]

[0003] EP 1 366 715 discloses a sampling device comprising a buffer-filled tubular container that is open at the top end and wherein a top closure member is provided with a threaded rod, and when the closure is fitted into the top end, the rod projects in the axial direction into the interior of the tubular container. The tubular container has a partition at an intermediate position, which divides the container into a proximal compartment and a distal chamber. The partition is provided with an aperture that allows an axial passage of the threaded rod, and any sample contained in its recesses but retains any excess stool in the upper chamber. This sampling device does not allow the detection of Helicobacter pylori antigens by immunological methods. There would always be an increased risk of an incorrect or small sample size. In addition, such a conventional faecal sampling tube or device cannot be used with high throughput analysers.

[0007]

[0004] WO 2013 / 107893 discloses a tube for mixing, diluting, and preserving a sample, comprising a transport pin and a hollow first container with a through-hole for the transport pin. The transport pin is movable between an initial position, in which a recess is positioned at least partially on the outer side of the first container, and an end position, in which the recess is positioned at least partially on the inner side of the first container. The transport pin and / or the through-hole comprises a latch that prohibits unforced movement of the transport pin in its initial position and / or its end position. In particular, in the end position, the latch may lock the movement of the pin completely, i.e., against a higher pushing force. This secures the tube against accidental leaking of the diluted sample or the introduction of unwanted particles. However, while the latches protect against unintentional opening of the tube, intentional opening remains possible.

[0008]

[0005] DE 10 2012 109457 discloses an odor-proof stool sampling device. However, the user may easily remove the sampling rod after collecting and inserting a stool sample into the device. This situation may occur, for example, if the user wrongly considers that an insufficient amount of sample has been introduced into the reagent vessel and proceeds to repeat the procedure of sample collection.

[0009]

[0006] EP 1 366 715 A1 , EP 1 384 442 A1 , JP 06 148177 A, JP 06 207935 A, JP 10 300642 A, JP 10 300643 A, JP 11 316222 A, US 5,246,669 A, US 5,514,341 A teach stool sample devices which are not prefilled and do not provide for extraction of the analyte in a liquid reagent. DE 196 24 687 A1 teaches a device for holding complicated samples. The state of the art represents a problem. There is a lack of a stool sample device that allows a quantity of stool in the range of 100 to 400 mg to be easily solubilized into a liquid reagent, in which leakage of the liquid reagent is reliably prevented during transportation and after sampling and which can be easily opened in the laboratory without causing contamination problems.

[0010]

[0007] There is a need for a stool sample collection device suitable for taking a precise but not too small amount of faecal specimen, preferably in the range of 100 to 400 mg, which can be used in a high-throughput analyzer and does not require repeated sampling by the user. The sampling device should allow one-handed collection and transfer of a precise stool specimen into a tube with about 2 to 3 mL preservation and extraction buffer. A stool sampling with these features is not provided by the prior art.

[0011] SHORT DESCRIPTION OF THE INVENTION

[0012]

[0008] The present application provides a sample preparation device (10), in particular for faecal samples, featuring a closable vessel containing a predetermined volume of liquid reagent or / and solvent, characterised by: a round sampling rod which possesses at its end on its circumferential surface an inwardly hollow barrel-shaped cavity for a received faecal sample so that a faecal sample be formed in the barrel-shaped cavity when the sampling rod is introduced into the vessel (3) through a round insertion opening (17) equipped with a wiping device (74), and an excess faecal sample is wiped off and kept away from the liquid reagent or / and solvent in the vessel chamber, the barrel-shaped cavity (46) and the insertion opening (17) are dimensioned such that after insertion of the sampling rod, a stool sample of 100 to 400 mg, preferably 200 to 300 mg, is inserted into the vessel, and an excess sample is wiped off and kept away from the liquid reagent or / and solvent in the vessel chamber, the barrel-shaped cavity (46) is positioned, and the inner circumference of the vessel are dimensioned such that after insertion of the sampling rod with the inwardly hollow barrel chamber and after setting up of the sample preparation device, the formed faecal sample is wholly immersed in a predetermined liquid reagent or solvent volume of 2 to 3 millilitres.

[0013]

[0009] In certain embodiments, the sample preparation device is characterised in that the hollow barrel cavity and the insertion hole give way for a faecal sample of about 200 milligrams and the volume liquid reagent and / or solvent is about 2 millilitres, such that the sample is diluted 1 : 10 for highly sensitive analysis.

[0014]

[0010] With respect to certain preferred embodiments, the present application provides a sample preparation device comprising a closable container (12) having an access opening and one or more flanges (14) on the outer wall of the access opening; a multi-part stopper comprising an intermediate portion (20) having one or more moulded slotted hooks (24) co-operating with the flanges (14), a conically shaped insertion portion (70) having an outer periphery that cooperates with the inner wall of the access opening of the reagent container (12), and a circular insertion opening (72) that leads into the reagent container (12) when the intermediate piece (20) is seated on the access port; and an end portion (40) having an inwardly hollow barrel chamber (42) formed thereon for receiving a stool sample, wherein the head portion (40) closes the insertion opening (72) in the intermediate piece (20) when the sampling rod (42) is inserted through the insertion opening (72) into the reagent container (12); wherein the intermediate piece (20) has a cylindrical inner wall region with at least one circular bead (34), and in that the head part (40) has a cylindrical outer wall region with at least one circular bead (44), and wherein the cylindrical wall regions interact with the beads (34, 44) in such a way that at least one bead bears radial tension against an opposite wall in a radially sealing manner when the sampling rod (42) is inserted through the round insertion hole (72) into the reagent vessel (12); and wherein the beads (34, 44) are arranged offset in position on the intermediate piece (20) and head part (40) and are designed such that they engage in a particle-tight and sealed snap connection, the sampling rod (42) is inserted through the fitting hole (72) into the reagent vessel (12); and wherein the cylindrical inner wall region of the intermediate piece (20) and the cylindrical outer wall region of the head part (40) are each provided with ramps (50, 60) which cooperate and whose position and dimensions also interact with the beads (34, 44) of the snap connection in such a way that the sealing and closing beads are separated from one another when the head part (40) and the intermediate piece (20) are rotated relative to one another.

[0015]

[0011] The described stool preparation device described is characterised in certain embodiments in that the ramps (50, 60) are arranged in such a way that when the head part (40) and the intermediate piece (20) are rotated counterclockwise, the head part (40) with the sampling rod (42) is lifted out.

[0016]

[0012] In some other embodiments, the stool preparation device is characterised in that the cylindrical wall region of the head part (40) is formed from an elastic hollow cone (36) and that the cylindrical inner wall of the intermediate piece ends in a stop ring, which cooperates with the hollow cone in such a way that the sealing and closing beads (34, 44) are held against each other after engagement of the snap connection.

[0017]

[0013] In certain preferred embodiments, the stool preparation device is characterized in that the insertion portion (70) has a flat bottom in which the round insertion hole (72) is formed and that the round insertion hole (72) is surrounded by inlet ribs and an optional chamfer, which cooperate with the sample lance so that the latter passes smoothly into the round insertion hole and any hard particles and excess stool on the sampling rod are displaced into the spaces to the side of the insertion ribs so that a barrel-shaped stool sample of defined volume and size is formed.

[0018]

[0014] In certain preferred embodiments, the reagent container (12) includes one or more circular sealing beads (18) in the region of the access opening, which cooperate with the conical outer wall of the insertion portion and provide an additional radial seal.

[0015] In certain embodiments, the stool preparation device is characterized in that, after the snap connection between the head part and the intermediate part has been engaged, the specimen rod (42) with an inwardly hollow chamber cooperates with the insertion hole (72) in such a way that the specimen lance is inserted into the insertion hole in a smoothly sealing manner and with radial tension.

[0019]

[0016] In some preferred embodiments of the stool preparation device the slotted hooks (24) of the intermediate piece (20) may have an offset (26) and audibly snap over the flanges.

[0020]

[0017] In certain most preferred embodiments, the reagent container of the stool preparation device is prefilled with an inert particle-containing reagent for efficient dissolution and dispersion of the barrel-shaped stool sample in the sample buffer when the vessel is vortexed.

[0021]

[0018] The present invention is, however, defined by the scope of the appended claims, which encompass various embodiments, modifications, and adaptations within the spirit and scope of the invention as would be recognized by those skilled in the art. It is understood that the specific embodiments disclosed herein are provided by way of example and are not intended to be limiting.

[0022]

[0019] Furthermore, variations, substitutions, and equivalents that achieve substantially the same function and result, whether explicitly described or not, are considered within the scope of the claims. Modifications may include, but are not limited to, changes in material composition, structural configurations, dimensional adaptations, process variations, and alternative implementations, all of which remain consistent with the principles and objectives of the invention.

[0023]

[0020] Accordingly, any modifications, variations, or equivalent arrangements that fall within the scope of the appended claims, or their legal equivalents as interpreted in light of the disclosure, are intended to be encompassed within the protection conferred by this patent. The essential features of the invention, along with its advantages and benefits, may be summarized as follows:

[0024]

[0021] Barrel Rod for Sample Collection: The container body of the test tube is equipped with a cap with a sampling rod for collecting a faecal specimen of 100 to 400 mg size. This sampling rod protrudes into the container body and is used to collect the sample.

[0025]

[0022] Pass channel with an axial hole and for sizing the collected faecal specimen: The container body includes a partition that creates an upper and lower compartment. The sizing and pass channel has an axial hole to allow the sampling rod to pass through, retaining excess faecal material in the upper compartment and allowing the size sample to enter the lower compartment with the extraction and preservation buffer.

[0026]

[0023] Second end for buffer solution: The container body may have a breaking tip at the bottom end to dispense extraction solution. Alternatively, this end can be sealed with a removable cap, allowing the tube to be used directly on automatic analysers.

[0027]

[0024] Direct Use in Automatic Analysers: The test tube can be directly fitted onto a sample-holder plate of an automatic analyzer, with the first end cap facing downwards. After removing the second cap, an automatic analyzer probe can access the buffer solution containing the dispersed faeces sample for analysis.

[0028]

[0025] User-Friendly Design: The design is practical for patients to collect samples and easy for a laboratory technician to use with various automated analysis systems.

[0029] SHORT DESCRIPTION OF THE DRAWINGS

[0030]

[0026] The present invention is further elucidated with reference to the accompanying drawings, wherein:-

[0031] Figure 1 illustrates the extracting and sampling test tube, showing its principal components: the container body, the cap fitted with a collection lance, and the pass channel within the container for the lance.

[0032] Figure 2 provides a detailed depiction of the collection lance, highlighting its integration with the cap and its specific function in collecting a faecal specimen of about 200 mg intended for immunoassays on viral epitopes.

[0033] Figure 3 displays the test container (12) with external latches (14) in an unassembled configuration, demonstrating the method for attaching the collection lance and cap to the container (12) in alignment with the internal bead (18) at the top section.

[0034] Figure 4 details the knurled cap, designed for improved handling, featuring hooks for a bayonet-type connection with the container body and a passage for the sampling lance. Figure 5 presents a sectional view of the top cap, revealing the pass channel for the sampling lance, guidance flanges, and designated spaces for excess faecal specimens.

[0035] Figure 6 illustrates the cap with the pass channel and hooks configured for interaction with the latches.

[0036] Figure 7 depicts the cap featuring latches and an internal lever thread.

[0037] Figure 8 shows the cap when assembled with the sampling lance.

[0038] Figure 9 details the top section of the sampling lance (48) with an internal cap, showcasing its interaction from the side and in a perspective view and how the sampling lance functions as a closure for the pass cap.

[0039] Figure 10 provides a sectional view illustrating the interaction of the cap with the sampling lance.

[0040] Figure 11 focuses on the sealing beads, designed for leak-proof contact between the cap's exterior and the container body's interior wall.

[0041] Figure 12 gives a detailed view of the lever mechanism interfacing the sampling lance and the pass cap.

[0042] Figure 13 elucidates the steps in removing the sampling lance from the assembled storage sampling device.

[0043] Figure 14 offers a top view of the elliptical shape of the interior lever thread.

[0044] Figure 15 shows a top view of the handle of the sampling lance within the elliptically shaped pass part.

[0045] Figure 16 presents a side view of the bottom section of the sampling lance, featuring the barrel-like sample chamber (46), enclosed by a wall (44) and the endface wall.

[0046] Figure 17 shows the sample chamber (46) on the sampling lance (42).

[0047] Figure 18 illustrates rotating the sample chamber (46) to loosen and solubilize the faecal specimen in the preservation buffer.

[0048]

[0027] These figures, taken together, enhance the understanding of the invention by detailing the components, mechanisms, and functionalities of the extracting and sampling test tube. It is to be understood that the above and following description and references to the figures are exemplary embodiments of the present invention and are not intended to limit the scope of the invention as defined by the claims.

[0049] DETAILED DESCRIPTION OF THE INVENTION

[0050]

[0028] Figure 1 illustrates a stool sampling device (10) comprising a reagent vessel (12) and an oval cylindrical intermediate piece (20) featuring knurling (22). Hooks (24), formed at the main vertices of the intermediate piece (20), engage with flanges (14) located on the outer wall of the vessel (12). Also shown is a sampling rod (42) in the form of a barrel rod for taking a faecal sample of 100 to 400 mg, which sample, after insertion of the rod into the sampling device, is completely immersed in a volume of 2 to 3 mL of preservation buffer, if present in the vessel. According to the invention, the reagent vessel (12) and the sampling rod (42) are dimensioned such that, for example, a 200 mg faecal sample in the chamber (46) is surrounded and wetted by a volume of the preservation buffer of 2 to 3 mL in the vessel, i.e. when the sampling rod (42) is inserted.

[0051]

[0029] Figure 2 depicts the assembly of the intermediate piece (20) and head part (40) post-detachment from the reagent vessel (12). The head part (40) is inserted with a sampling rod (42) through a fitting hole (72) in the insertion cone (70) of the intermediate piece (20). The head part (40) comprises a flag (48) serving as a handle and a sampling rod (42) with an enlarged barrel chamber (46) for collecting the stool sample. A predefined stool volume is transferred into the extraction reagent for diagnostic analysis via the chamber (46).

[0052]

[0030] Figure 3 displays the reagent vessel (12) containing a predetermined amount of liquid reagent (not shown) for sample preparation or analyte extraction from the stool sample. Flanges (14) are located on the outer wall of the vessel opening while sealing beads (18) are formed on the inner wall near the edge to engage with the insertion cone (70). The vessel wall, preferably made of non-elastic material like transparent polypropylene or clear polystyrene, ensures a tight radial connection between the insertion cone (70) and sealing beads (18).

[0053]

[0031] Figure 4 shows the - more - oval-cylindrical intermediate piece (20) from an oblique top view. Details include the slotted hook (24) with an offset (26), the position of the sleeve ramp (60), and the sealing and closing bead (34) of the snap closure. The oval-cylindrical intermediate piece must correspond to the thicker sampling rod (42) with the barrel-shaped sampling chamber (46).

[0032] Figure 5 illustrates a sectional view of the intermediate piece (20), where the sealing and closing bead (34) are located below the ramp (60). The inner wall tapers into a conical stop ring (62), with guide ribs (76) leading radially to a fitting hole (72) and ending seamlessly in a chamfer (74). Spaces (78) between the guide ribs can accommodate excess faecal sample retained by the insertion hole (72).

[0054]

[0033] Figure 6 portrays the intermediate piece (20) with the round fitting hole (72) viewed from below, and Figure 7 shows the same from the side. In both, slotted hooks (24) with offsets (26) interact with vessel flanges (14).

[0055]

[0034] Figure 8 reveals how the intermediate piece (20) sits on the circular rim of the reagent vessel (12). The sleeve-like section of the intermediate piece (20) is closed internally by a round section of the head part (40). The flag (48) at the handle end has two gripping surfaces. Thickening flanges (14) on the vessel's upper smooth edge (16) interact with the slotted hooks (24). The hooks (24) snap over the flanges (14) when rotated clockwise, indicating secure seating on the vessel's upper edge (16). Optional sealing rings may be provided for enhanced seal integrity.

[0056]

[0035] Figure 9 shows the head part (40) with a sampling rod (42), flag (48), gripping surfaces, and a shield-shaped circular cover. The head shield (40) transitions into a hollow cone (36) with sealing and closing bead (44), which snaps into a corresponding bead (34) of the intermediate piece (20) to form a secure connection.

[0057]

[0036] Figure 10 displays a sectional view through the intermediate piece (20) with the head part (40) inserted, detailing the sealing interactions and tension mechanism.

[0058]

[0037] Figure 11 and Figure 12 focus on the sealing and closing beads (34, 44) of the head part (40) and intermediate piece (20), illustrating the insertion direction and the snug fit achieved.

[0059]

[0038] Figure 13 and Figure 14 describe the rotational mechanism for disengaging the head part (40) from the intermediate piece (20), and the subsequent release of the bayonet coupling.

[0060]

[0039] Figure 15 offers a top view of the intermediate piece (20), highlighting the play and rotation limits within the snap connection for easy opening.

[0061]

[0040] Figure 16 and Figure 17 detail the sampling rod (42), emphasizing the barrel chamber arrangement for efficient sample collection and removal, especially in varying stool consistencies.

[0041] Figure 18 illustrates a schematic of the sampling rod with multiple open sample wells, demonstrating the design for effective sample collection and interaction with preservation liquid or reagents.

[0062]

[0042] For rigidity and visibility, the reagent vessel is made of transparent plastic material, like clear polystyrene or transparent polypropylene. The insertion cone (70) seals against the vessel's inner wall, secured by a bayonet coupling.

[0063] SYNOPSIS

[0064]

[0043] The stool collection device described here has a critical advantage: it allows the collection of stool samples ranging from one to four hundred milligrams, quickly immersed in a conservation buffer of only two to three millilitres, meticulously tailored for protein analysis. Its effectiveness is further enhanced by the remarkable revelation that the stool analyte undergoes only a modest 1 :10 dilution, which is conducive to subsequent immunoanalytical assays. This refined protocol accelerates the direct immunological testing and identification of a wide range of proteinaceous analytes, including those associated with infectious agents such as H. pylori, viruses, bacteria, and various parasitic infestations.

[0065]

[0044] This innovative stool sampling system heralds the rapid collection of stool samples, followed by their proper treatment with a carefully formulated buffer, facilitating the seamless execution of immunological assays. This allows direct detection of bacteriological pathogens such as H. pylori or elusive gastrointestinal viruses, improving the speed and accuracy of diagnosis and subsequent therapeutic interventions. In addition, the seals and beads integrated into the vessel and its components allow the use of particles such as glass or other rigid particles, facilitating complete dissolution and solubilization of the analyte in the preservation buffer, ensuring efficient preservation and subsequent analysis.

[0066] LIST OF REFERENCE SIGNS

[0067] 10 Stool sampling and preparation device for proteinaceous antigens

[0068] 12 Reagent vessel

[0069] 14 Vessel flange

[0070] 16 Vessel rim

[0071] 18 Sealing bead (inner vessel wall)

[0072] 20 Intermediate piece

[0073] 22 Grip grooves (knurling)

[0074] 24 Slotted hooks

[0075] 26 Cranking

[0076] 27 Ring bead

[0077] 28 Gap between the inner wall and sleeve wall

[0078] 34 Closing and sealing bead (intermediate piece)

[0079] 36 Hollow cone

[0080] 37 Interior wall

[0081] 38 Cone taper

[0082] 40 Head part

[0083] 42 Sampling rod

[0084] 44 Closing and sealing bead (head section)

[0085] 46 Barrel-shaped chamber / cavity

[0086] 48 Head flag and handle

[0087] 50 Head ramp

[0088] 60 Sleeve ramp

[0089] 62 Stop ring

[0090] 64 Main vertex

[0091] 66 Outer sleeve inner wall

[0092] 68 Inner sleeve inner wall

[0093] 70 Insertion cone

[0094] 72 Round insertion hole

[0095] 74 Chamfer (fitting hole)

[0096] 76 Inlet ribs

[0097] 78 Intermediate space

[0098] 80 Connection point

Claims

CLAIMS1. Sample preparation device (10), particularly for stool samples, featuring a closable vessel containing a predetermined volume of liquid reagent or / and solvent, characterised by: a round sampling rod which possesses at its end on its circumferential surface an inwardly hollow barrel-shaped cavity for a received faecal sample so that a faecal sample be formed in the barrel-shaped cavity when the sampling rod is introduced into the vessel (3) through a round insertion opening (17) equipped with a wiping device (74), and an excess faecal sample is wiped off and kept away from the liquid reagent or / and solvent in the vessel chamber, the barrel-shaped cavity (46) and the insertion opening (17) are dimensioned such that after insertion of the sampling rod, a stool sample of 100 to 400 mg is inserted into the vessel, and an excess sample is wiped off and kept away from the liquid reagent or / and solvent in the vessel chamber, the barrel-shaped cavity (46) is positioned, and the inner circumference of the vessel are dimensioned such that after insertion of the sampling rod with the inwardly hollow barrel chamber and after setting up of the sample preparation device, the formed faecal sample is wholly immersed in a predetermined liquid reagent or solvent volume of 2 to 3 millilitres.

2. Sample preparation device according to claim 1 , wherein the hollow barrel cavity and the insertion hole give way to a faecal sample of about 200 milligrams and the volume liquid reagent and / or solvent is about 2 millilitres, so that the sample is diluted 1 : 10 for highly sensitive analysis.

3. A sample preparation device comprising a closable vessel (12) having an access opening and one or more flanges (14) on the outer wall of the access opening; a multi-part stopper comprising an intermediate piece (20) having one or more moulded slotted hooks (24) cooperating with the flanges (14), a cone-shaped insertion portion (70) having an outer periphery cooperating with the inner wall of the access opening of the reagent vessel (12), and a round insertion opening (72) leading into the reagent vessel (12) when the intermediate piece (20) is seated on the access opening; and an end portion (40) having an inwardly hollow barrel chamber (42) formedthereon for receiving a stool sample, the head portion (40) closing the insertion opening (72) in the intermediate piece (20) when the sampling rod (42) is inserted through the insertion opening (72) into the reagent vessel (12); the intermediate piece (20) having a cylindrical inner wall region with at least one circular bead (34), and in that the head part (40) has a cylindrical outer wall region with at least one circular bead (44), the cylindrical wall regions cooperating with the beads (34, 44) in such a way that at least one bead bears radial tension against an opposite wall in a radially sealing manner when the sampling rod (42) is inserted through the round insertion hole (72) into the reagent vessel (12); in that the beads (34, 44) are arranged offset in position on the intermediate piece (20) and head part (40) and are designed such that they engage in a particle-proof and tight snap connection, the sampling rod (42) is inserted through the fitting hole (72) into the reagent vessel (12); the cylindrical inner wall region of the intermediate piece (20) and the cylindrical outer wall region of the head part (40) are each provided with ramps (50, 60) which cooperate and whose position and dimensions also cooperate with the beads (34, 44) of the snap connection in such a way that the sealing and closing beads are separated from one another when the head part (40) and the intermediate piece (20) are rotated relative to one another.

4. The stool preparation device according to one of the preceding claims 1 to 3, characterised in that the ramps (50, 60) are arranged in such a way that when the head part (40) and the intermediate piece (20) are turned counterclockwise, the head part (40) with the sampling rod (42) is lifted out.

5. Stool preparation device according to any preceding claim 1 to 4, characterised in that the cylindrical wall region of the head part (40) is formed from an elastic hollow cone (36) and that the cylindrical inner wall of the intermediate piece ends in a stop ring, which cooperates with the hollow cone in such a way that the sealing and closing beads (34, 44) are held against each other after engagement of the snap connection.

6. Stool preparation device according to one of the preceding claims 1 to 5, characterised in that the insertion section (70) has a flat bottom in which the round insertion hole (72) is formed and that the round insertion hole (72) is surroundedby inlet ribs and an optional chamfer, which cooperate with the sample lance so that the latter runs smoothly into the round insertion hole and any hard particles and excess stool on the sampling rod are displaced into the spaces to the side of the insertion ribs so that a barrel-shaped stool sample of defined volume and size is formed.

7. Stool preparation device according to one of the preceding claims 1 to 6, wherein the reagent vessel (12) comprises one or more circular sealing beads (18) in the region of the access opening, which cooperate with the conical outer wall of the insertion portion and provide an additional radial seal.

8. Stool preparation device according to any one of preceding claims 1 to 7, wherein, after the snap connection between the head part and the intermediate piece has engaged, the sampling rod (42) with inwardly hollow chamber cooperates with the insertion hole (72) in such a way that the sample lance is inserted in the insertion hole in a smoothly sealing manner and with radial tension.

9. Stool preparation device according to one of the claims 1 to 8, wherein the slotted hooks (24) of the intermediate piece (20) have an offset (26) and audibly snap over the flanges.

10. Stool preparation device according to any one of claims 1 to 9, wherein the reagent vessel is prefilled with an inert particle-containing reagent for efficient dissolution and dispersion of the barrel-shaped stool sample in the sample buffer when the vessel is vortexed.

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