EP3936233A1 - Set with a flat sample carrier and box - Google Patents

Abstract

A set is proposed that has a flat sample carrier with an absorbent membrane layer which is suitable for absorbing liquid blood components and in which at least some of the blood components can dry in the membrane layer, the sample carrier also being provided with an optically readable code on the outside having a closable, cuboid box with a base area, which has a rectangular base area and which also has a first opening, further having a flat receiving element with a base area which corresponds to the base area of the bottom area, wherein the receiving element has a second opening and a holding device , which are designed together so that when the sample carrier is fastened in the holding device and the receiving element is then inserted into the box on the bottom surface of the box, the optical code passes through the first opening in the bottom nfläche and is also visible through the second opening of the receiving element.

Description

The invention relates to a set with a flat sample carrier with an absorbent membrane layer and a box.

Sample carriers are known from the prior art, which have an absorbent membrane layer, which in turn is suitable for absorbing liquid blood components, so that such blood components can dry in the membrane layer. Such sample carriers are sometimes also called "dried blood spot (DBS) cards". Such sample carriers are usually used so that blood, in particular capillary blood, can be taken from a patient and the blood can dry as a patient sample on the membrane layer of the sample carrier. Such a dried blood sample or such dried blood components can then be sent from the sampling location to a diagnostic laboratory by means of the sample carrier, preferably by means of a shipping bag or a shipping envelope. In the laboratory, those partial areas of the membrane layer that contain the blood components are then separated from the entire membrane layer and then subjected to an in-vitro diagnostic method. The detached piece of carrier with dried blood is often referred to as a "Dried Blood Spot" or "DBS". The main advantage of using sample carriers with membrane layers for absorbing or drying blood components in the membrane layer and then sending them is that no liquid blood sample of larger volume, for example from a vein, has to be taken from the patient before sending you only have to wait until the blood components in the membrane layer have dried, so that the sample carrier can then be sent to the laboratory by post. So no safety measures need to be taken for the transport of a liquid blood sample.

For many qualitative determinations in the field of analytics and specifically laboratory diagnostics, it is only important that the presence or absence of an analyte can be correctly determined, but not the concentration in which it is present in a patient's blood. This is the case, for example, when the blood sample is tested to determine whether the patient has a metabolic disease that is associated with a defective gene. The blood sample must then only be examined to determine whether such a gene is present, but not how much of the genetic material comprising the gene is contained in the sample.

In the case of other analytes, the concentration of the analyte in the blood must be determined because a diagnostic reference concentration range is known. If the concentration of the analyte is in this range, this indicates that the patient is healthy. For such semi-quantitative or even purely quantitative determinations, it is therefore important that the amount or concentration of the analyte is determined correctly.

For the measurement of concentrations of certain analytes in the blood of patients, venous blood is usually taken from the patient, followed by processing the blood into serum. Apart from the fact that this invasive procedure is uncomfortable for the patient and even poses health risks to a small extent, such as nausea or fainting, blood sampling can only be carried out by a qualified specialist such as a doctor or at least a nurse or an experienced laboratory technician. The patient must visit a doctor's office or a hospital.

The collection of capillary blood, on the other hand, is much easier and gentler. After pricking the patient's fingertip or earlobe with a pointed object such as a lancet, a few drops of capillary blood emerge and are placed on an absorbent sample carrier. As soon as the blood has dried on the carrier, possibly completely after a few hours at room temperature, the carrier can be transported without further processing, very easily even by post. A visit to a laboratory or a doctor's office is therefore no longer necessary. Due to the dried blood sample or the dried blood component, the sample carrier with the sample on it is no longer considered dangerous goods. A piece of support with blood can be detached from a support with dried blood, preferably capillary blood. This can, for example, with a device as in the US14/900,360 is described, or can be achieved by punching.

A carrier mentioned here can be provided, for example, by a membrane layer which can absorb the blood or blood components in a liquid aggregate state and on which the blood or blood components then dry before the carrier is transported in the form of the absorbent membrane.

The blood component taken up by the membrane can be whole blood, in particular capillary blood. Alternatively, it is blood serum or blood plasma.

Usually, the membrane of the sample carrier is placed on a support device or a support area and then the membrane is mechanically acted on from above by means of a punching device or a punching knife in such a way that a membrane element is cut out of the membrane. that the membrane element then falls into a vessel positioned below the sample carrier or below the membrane due to gravity. This vessel can then later be used for a biochemical analysis.

In the context of this application, the term “quantitative determination” is understood to mean a determination that allows a statement to be made about the absolute concentration of the analyte, more preferably with a numerical value. Alternatively, it can be a semi-quantitative determination, in which the concentration can be assigned to a range from at least three, if possible four, concentration ranges, e.g. negative, weakly positive and positive, or a relative concentration determination. In particular, the concentration is determined using calibrators, which are preferably two or more, preferably four units, preferably solutions or solid analytes coated on a diagnostically useful carrier, each containing a known amount of the analyte, the two or more units each comprise a different known amount.

Quantitation is preferably performed by a method selected from the group consisting of immunodiffusion, immunoelectrophoresis, light scattering, agglutination, and labeled immunoassay - such as those from the group consisting of radiolabeled immunoassay, enzymatic label immunoassay, more preferably ELISA, chemiluminescence labeling, preferably electrochemiluminescent labeling and with immunofluorescent labeling, preferably indirect immunofluorescent labeling - preferably with ELISA.

The dried blood component is eluted from the punched-out membrane element by contacting the punched-out membrane element with a liquid suitable for picking up the analyte from the dried blood component. Aqueous buffers with a suitable pH and Salt content in question, for example PBS. The precise composition of the liquid and the conditions and duration of the contacting can be found by routine experimentation to stabilize and optimize for as complete as possible incorporation of the analyte into the liquid and depends on the nature of the analyte. If possible, the liquid is also selected in such a way that it is compatible with the method used subsequently for detecting the analyte. The analyte of interest is then detected in the liquid. It is determined whether the analyte is present or absent or is present in a concentration above the detection limit of the detection method used. The analyte is preferably detected semi-quantitatively or quantitatively. Various options for carrying out the method are described in the prior art, e.g Grüner, N., Stambouli, O. and Ross, RS (2015) Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques, J. Vis. Exp97, 52619 .

The object of the present invention is to provide a set which can be handled particularly easily and also particularly safely for the purpose of collecting and drying blood components on a membrane layer of a sample carrier.

The object of the invention is achieved by a set according to claim 1.

The set has a flat sample carrier with an absorbent membrane layer which is suitable for absorbing liquid blood components, with at least some of the blood components being able to dry in the membrane layer. The sample carrier is provided with an optically readable code on the outside. The set also has a closable, cuboid box with a bottom surface, which has a rectangular base surface and which also has a first opening. Furthermore, the set has a flat receiving element with a base area which corresponds to the base area of the bottom area of the box. The receiving element has a second opening and a holding device, which are designed together in such a way that when the sample carrier is fastened in the holding device and the receiving element is then placed in the box on the bottom surface of the box, the optical code passes through the first opening in the bottom surface and also through the second opening of the receiving element is visible through.

The membrane layer is preferably a fleece. The membrane layer does not necessarily have to be a membrane in the sense of a filter membrane, but it is sufficient if the membrane has the properties that liquid blood components can be absorbed in the membrane layer and that at least some of these blood components can dry in the membrane layer.

One or more advantages of the set according to the invention will now be explained in more detail by presenting various aspects.

In order to enable a sample carrier and the blood sample located on its membrane layer to be assigned to a specific patient data record of a specific patient in the laboratory, the sample carrier is provided with a unique optical code on the outside. Such an optical code is preferably a barcode; alternatively, the code can be a so-called QR code or an optical code made up of readable numbers and/or letters.

Before a sample carrier with an individual optical code is sent to a patient in a laboratory or handed to him or, for example, the sample carrier is sent to a doctor, it is usually necessary that the sample carrier with its unique optical code is already in the laboratory before it is sent to the patient a corresponding patient data record, which clearly indicates the patient and is assigned in terms of data technology. After sending back the sample carrier with the blood sample on it from the patient to the laboratory and after receiving the sample carrier in the laboratory, the sample carrier can then be uniquely assigned to the patient or the aforementioned patient data record using the code. Such a flat sample carrier is usually sent from the laboratory to the patient by packing the sample carrier in a box and sending the box to the patient. Other objects, such as at least one lancet or a mailing bag for sending the sample carrier back, as well as plasters or alcohol swabs, for example, are preferably enclosed with the sample carrier in the box, since such other objects are used to take the blood sample or blood components from the patient. If, in a laboratory operation, the sample carrier were first picked up by a laboratory worker to be sent to the patient, then the optical code was read using an optical reading device and then the code was assigned to a patient data record in terms of data technology, the laboratory worker would then have to put the sample carrier in a box and then close the box and then send it.

Since in a laboratory not only individual sample carriers often have to be sent to patients or users such as doctors on individual days or at individual times, but this can be necessary more frequently in larger laboratories, the invention or the set according to the invention has special advantages . The box together with the sample carrier and also preferably other objects can be prefabricated at a point in time long before it is sent to the patient, by placing the sample carrier in the receiving element or attaching it to the holding device of the receiving element, and then placing the receiving element on the bottom surface of the box is inserted, so that a configuration then automatically results, in which the optical code is visible through the first opening of the bottom surface and also through the second opening of the receiving element. The box can then be closed in the course of pre-assembly and initially stored at a storage location for a certain period of time until there is a need at a later point in time for a sample carrier to be sent or handed over to a patient. It is then possible, preferably, for several such boxes to be prefabricated and sealed with the respective sample carriers and kept in storage. If there is a need to send a sample carrier to a patient or a user such as a doctor, the laboratory worker can then simply remove such a prefabricated box from the storage facility and, due to the corresponding openings in the bottom surface of the box and the receiving element, through this Scan or read the optical code of the sample carrier through both openings and then immediately and directly assign a data record or patient data record by means of an EDP system, which clearly indicates the patient in question. Such a patient data record is usually made available or transmitted by the patient himself or by a doctor treating the laboratory beforehand via telecommunication means, or is generated and stored on the basis of written documents in an EDP system in the laboratory. The laboratory worker does not have to remove the sample carrier from the box to read the code, and the laboratory worker does not have to preassemble the box with its components himself or enclose other preferred objects such as a lancet or mailing bag in the box. The handling effort for the laboratory worker is therefore minimized by the invention. At the same time, it is also guaranteed that the sample carrier is uniquely identifiable, since the optical code is located directly on the It is located on the outside of the sample carrier and can be read or scanned through the openings. The code is usually not necessarily reprinted on an outside of the box. If the code were printed on the outside of the box or provided as a peelable sticker on the box, there could be possible mix-ups of sample carriers and their codes when the entire set was handled by the patient or by a doctor, which should be avoided. This is ruled out by the fact that the preferably only code is provided or printed as an optical code directly and immediately on the outside of the sample carrier. Furthermore, after scanning the code through the two openings, the laboratory worker can then simply place the box or set in a shipping carton in a time-saving manner in order to send the set, or preferably hand it over directly to a patient or a user such as a doctor.

In other words, the box can be pre-assembled and then stored until a patient or the user is to receive the entire set. If a set is required, the set can be removed from the storage location and the barcode can be scanned and assigned to a patient data record in terms of data technology or EDP technology. The handling is therefore particularly advantageous because the sample carrier does not have to be removed from the box again, but can remain in the box after packaging for the storage time until it is removed from the storage location. The patient or the user, such as a doctor, can then later remove the sample carrier from the box and drip his blood or the patient's blood onto the sample carrier and send it back to the laboratory after the blood components have dried on the membrane layer. Since the sample carrier is provided with the optical code, the blood sample or the blood components located on it can be uniquely assigned to the previously provided patient data in the laboratory by scanning the code again, so that sample mix-ups are avoided. The proposed set is also advantageous because the base of the receiving element and the base of the bottom surface correspond to one another, so that the sample carrier does not have to be correctly positioned and fixed directly on the bottom surface of the box in order to later scan the code through the opening in the bottom surface of the box to be able to Rather, the sample carrier only has to be placed outside the box in the holding device of the receiving element or positioned or attached to it, so that the flat receiving element can then be placed in the open box on the bottom surface of the box in a particularly simple manner during the packaging process, so that because of each other corresponding openings of the receiving element and the bottom surface of the box, the optical code is automatically positioned in such a way that it is visible through these two openings and can later be properly scanned.

If packaging were to be provided in a different way, in which the sample carrier had to be attached directly to the bottom surface of the box or carton by means of an adhesive process, for example two adhesive dots, a person would have to put their hands into the interior of the box during the packaging process Reach into the box or carton and position the sample carrier correctly in the spatially limited interior space. Because the set according to the invention provides a separate receiving element with a separate holding device for the sample carrier, a user can act outside the interior of the box or outside of the carton during the packaging process and insert the sample carrier into the holding device or attach it to it, for which he then has more handling space available than in the case in which he would have to attach the sample carrier directly to the bottom surface of the box in the interior of the box. Due to the fact that the base area of the receiving element corresponds to the base area of the bottom surface of the box or carton, when the sample carrier is fastened in or on the receiving element and when the receiving element is placed in the box on its bottom surface, there is automatically no correct alignment of the sample carrier only in relation to the opening of the receiving element, but also in relation to the opening of the bottom surface of the box. These base areas are preferably of the same geometry and, in particular, these base areas have the same surface dimensions apart from a deviation of at most 10%, preferably at most 5%. During the assembly process, when the receiving element is already in the holding device, the receiving element then only has to be inserted into the box, whereby the user can rely on gravity, since this then pulls the receiving element down to the bottom surface of the box or carton. This enables the set to be assembled in a time-saving and less complex manner than in an application in which the sample carrier has to be fastened directly to the bottom surface of the box or carton.

Advantageous embodiments of the invention are the subject matter of the dependent claims and are explained in more detail in the following description with partial reference to the figures.

Preferably, the cuboid box is formed by a cuboid carton and a sleeve or lid, the cuboid carton being open at the top and the cuboid carton being closable by the sleeve or lid.

Preferably, the box is a slide-in box, which is given by a slide-in carton and a slide-in sleeve, the slide-in sleeve having a third opening which corresponds to the first opening and to the second opening such that when the sample carrier is fastened in the holding device, it is then inserted of the receiving element into the slide-in carton on its bottom surface and subsequent insertion of the slide-in carton into the slide-in sleeve, the optical code is visible through the first opening of the bottom surface, through the second opening of the receiving element and through the third opening of the slide-in sleeve.

The sample carrier preferably has a base body, the membrane layer being attached to the base body and the base body also being provided with the optically readable code on an outside.

The membrane layer is preferably a flat membrane layer, with the base body being a flat base body which can be folded in such a way that the membrane layer is covered by the folded base body.

The holding device preferably allows a mechanically reversible attachment of the sample carrier in the holding device, so that the sample carrier can be removed from the holding device again without mechanical damage.

The sample carrier preferably has a rectangular base area, with the holding device being provided by at least two punched-out portions in the receiving element, into which respective opposite corners of the sample carrier can be clamped.

The first opening is preferably arranged symmetrically to a center point of the base area of the base area, in particular a geometric center point, with the second opening being arranged point symmetrically to a center point of the base area of the receiving element, in particular a geometric center point, and the base area of the base area and the base area of the Recording element are each rectangular but not square.

The set preferably also has at least one lancet and at least one mailing bag for shipping the sample carrier.

Preferably, the set also has a shipping carton or shipping box, preferably in the form of a hinged box, into which the aforementioned box can be placed.

Preferably, the shipping carton has a fourth opening at its bottom or its top, which corresponds to the first and the second opening as well as preferably the third opening. The code is preferably positioned in the center of the base area of the sample carrier or of the folded sample carrier, in particular a geometric center.

Also proposed is a set according to the invention, in which the sample carrier is placed in the receiving element or attached to it, the receiving element is also placed in the box, the box is closed and the box preferably contains at least one lancet and in particular at least has a shipping bag. The set is preferably packed in a shipping carton, which in turn is preferably closed.

• Figur 1a eine Aufsicht auf eine bevorzugte Ausführungsform eines Probenträgers,
• Figur 1b eine rückwärtige Ansicht des Probenträgers aus Figur 1a mit einem optischen Code,
• Figur 1c den Probenträger aus Figur 1a in einer aufgeklappten Konfiguration bzw. aufgefalteten Konfiguration,
• Figur 2a eine bevorzugte Ausführungsform einer Schachtel gegeben durch einen Karton und eine Hülle,
• Figur 2b die Schachtel aus Figur 2a in einem weiteren Konfigurationszustand,
• Figur 2c eine Aufsicht auf den Karton aus Figur 2a,
• Figur 2d eine Schrägansicht der Hülle aus Figur 2a,
• Figur 3a eine Aufsicht auf eine Ausführungsform eines Aufnahmeelementes,
• Figur 3b einen in das Aufnahmeelement aus Figur 3a eingelegten Probenträger,
• Figur 3c das Aufnahmeelement aus Figur 3a bei eingelegtem bzw. befestigtem Probenträger von einer rückwärtigen Ansicht,
• Figur 4a das in die Schachtel bzw. den Karton eingelegte Aufnahmeelement aus Figur 3a ohne Probenträger,
• Figur 4b einen Handhabungsvorgang, bei welchem das Aufnahmeelement aus Figur 3a mit einem daran befestigten Probenträger in die Schachtel bzw. den Karton eingelegt wird,
• Figur 4c eine Konfiguration, bei welcher das Aufnahmeelement aus Figur 3a in den Karton bzw. die Schachtel mit an dem Aufnahmeelement befestigten Probenträger eingelegt ist,
• Figur 4d eine rückwärtige Ansicht des Kartons bzw. der Schachtel bei in den Karton bzw. der Schachtel eingelegtem Aufnahmeelement mit daran befindlichem Probenträger und sichtbarem Code durch die Öffnung des Aufnahmeelementes und der Bodenfläche der Schachtel bzw. des Kartons hindurch,
• Figur 5a verschiedene Objekte, welche ferner zusätzlich einer Schachtel beigelegt werden können,
• Figur 5b eine Konfiguration mit einem in die Schachtel eingelegten Aufnahmeelement und daran befestigtem Probenträger als auch weiterer Objekte,
• Figur 5c eine Konfiguration bzw. einen Handhabungsvorgang, bei welchem der Karton der Schachtel mit darin eingelegten Objekte und darin eingelegtem Aufnahmeelement der Karton in eine Hülle der Schachtel eingeschoben wird,
• Figur 5d eine rückwärtige Ansicht der Schachtel in einem Konfigurationszustand, in welchem der Probenträger an dem Aufnahmeelement befestigt ist und in welchem sich das Aufnahmeelement in der Schachtel befindet, sodass der Code durch die Öffnung des Aufnahmeelementes, durch die Öffnung der Bodenfläche des Kartons als auch durch die Öffnung der Hülle bzw. der Schachtel hindurch sichtbar bzw. lesbar ist,
• Figur 6a einen Versandkarton,
• Figur 6b eine in den Versandkarton eingelegte Schachtel,
• Figur 7a einen Versandkarton mit einer weiteren Öffnung und eine Schachtel,
• Figur 7b der Versandkarton mit der weiteren Öffnung und darin eingelegter Schachtel,
• Figur 7c die weitere Öffnung des Versandkartons aus Figur 7a mit darüber positionierter transparenter Folie,
• Figur 7d eine rückwärtige Ansicht des Versandkartons bei eingelegter Schachtel und durch die Folie hindurch sichtbarem Code,
• Figur 8a ein Ausführungsbeispiel der Schachtel als eine Stülpschachtel sowie
• Figur 8b ein Ausführungsbeispiel der Schachtel als eine Klappschachtel.

The invention is explained in more detail below using specific embodiments without restricting the general inventive concept using the figures. show:

• Figure 1a a top view of a preferred embodiment of a sample carrier,
• Figure 1b a rear view of the sample carrier Figure 1a with an optical code,
• Figure 1c the sample carrier Figure 1a in an unfolded configuration or unfolded configuration,
• Figure 2a a preferred embodiment of a box given by a carton and a sleeve,
• Figure 2b the box out Figure 2a in another configuration state,
• Figure 2c a top view of the box Figure 2a ,
• Figure 2d an oblique view of the shell Figure 2a ,
• Figure 3a a top view of an embodiment of a receiving element,
• Figure 3b one in the receiving element Figure 3a inserted sample carrier,
• Figure 3c the recording element Figure 3a with the sample carrier inserted or attached from a rear view,
• Figure 4a the receiving element inserted in the box or carton Figure 3a without sample carrier,
• Figure 4b a handling process in which the receiving element Figure 3a is placed in the box or carton with a sample carrier attached,
• Figure 4c a configuration in which the receiving element Figure 3a is inserted into the carton or the box with the sample carrier attached to the receiving element,
• Figure 4d a rear view of the carton or box with the receiving element inserted into the carton or box with the sample carrier located thereon and the code visible through the opening of the receiving element and the bottom surface of the box or carton,
• Figure 5a various objects, which can also be added to a box,
• Figure 5b a configuration with a receiving element placed in the box and a sample carrier attached to it as well as other objects,
• Figure 5c a configuration or a handling process in which the carton of the box with objects inserted therein and the receiving element of the carton inserted therein is pushed into a sleeve of the box,
• Figure 5d a rear view of the box in a configuration state in which the sample carrier is attached to the receiving element and in which the receiving element is in the box, so that the code passes through the opening of the receiving element, through the opening of the bottom surface of the carton, and through the opening is visible or legible through the sleeve or box,
• Figure 6a a shipping carton,
• Figure 6b a box inserted in the shipping carton,
• Figure 7a a shipping carton with another opening and a box,
• Figure 7b the shipping carton with the wider opening and the box inserted in it,
• Figure 7c further opening of the shipping carton Figure 7a with a transparent film positioned above it,
• Figure 7d a rear view of the shipping carton with the box inserted and the code visible through the foil,
• Figure 8a an embodiment of the box as a slip-on box and
• Figure 8b an embodiment of the box as a hinged box.

In the following description of the accompanying figures, which only show a few exemplary embodiments, the same reference symbols can designate the same or comparable components. Furthermore, summarizing reference signs can be used for components and objects that appear multiple times in an exemplary embodiment or in a drawing, but are described together with regard to one or more features. Components or objects that are described with the same or collective reference symbols can be identical with regard to individual, several or all features, for example their dimensions, but may also be different, unless something else is explicitly or implicitly stated in the description. Optional components are shown in the figures with dashed lines or arrows.

Although example embodiments can be modified and altered in various ways, example embodiments are illustrated in the figures and are described in detail herein. It should be understood, however, that example embodiments are not intended to be limited to the precise forms disclosed, but rather that example embodiments are intended to cover all functional and/or structural modifications, equivalents, and alternatives falling within the scope of the invention. The same reference symbols denote the same or similar elements throughout the description of the figures.

Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meanings as those of ordinary skill in the art to which the exemplary embodiments pertain. Further, it is understood that terms, such as those defined in commonly used dictionaries, are to be interpreted as having the meaning consistent with their meaning in the context of the relevant art, and not in an idealized or overly formal sense are to be interpreted unless expressly defined herein.

the Figure 1a shows a flat sample carrier PT, which has a base area GFPT and opposite corners E1, E2. The base GFPT has a center point MPT, which is indicated by a cross. The base area GFPT of the sample carrier PT is preferably rectangular but not square.

Figure 1b shows the sample carrier PT from its rear side A, which can also be referred to as the outer side A. On the outside A the sample carrier PT is provided with an optically readable code C or this code C is printed on the outside A.

Figure 1c shows the sample carrier PT in an unfolded configuration, it being seen that the sample carrier PT has a base body GK to which a membrane layer M is attached. From a synopsis of Figure 1c and the Figure 1b it can be seen that the base body GK as part of the sample carrier PT is preferably provided with the optically readable code C on its outside A. The advantage of such a sample carrier consisting of a base body GK and also a membrane layer M, which is attached to the base body GK, is that the base body GK as part of the sample carrier PT in a holding device of a receiving element can be pinched and that this does not require the membrane layer M to be mechanically stressed.

In particular, the membrane layer M is a flat membrane layer, with the base body GK being a flat base body which can be folded in such a way that the membrane layer M is covered by the folded base body GK when the sample carrier PT is in the folded state. This is advantageous because when the base body GK is fastened in a holding device of a receiving element, the membrane layer M is not damaged or mechanically stressed and also because there is no friction or other mechanical influences due to moving parts in the set or in the box the membrane layer M is mechanically influenced. This prevents the membrane from being affected in terms of its absorptive and analytical properties due to mechanical action. The membrane layer is supposed to later absorb a blood sample or blood components in dried form. Here, for example, abrasion of the surface of the membrane layer M by objects moving on the membrane layer M would possibly counteract the standardized properties of the membrane layer and later possible analytical properties of the membrane layer and thus falsify analytical results in the course of a diagnostic method. This is avoided by providing the base body and in particular by providing a foldable base body GK, so that the membrane layer M is covered by the folded base body.

the Figure 3a shows a receiving element AN with a base area GF2. The receiving element AN has an opening O2. The receiving element AN also has a holding device H, which is preferably provided by two punched-out sections Z1, Z2 of the receiving element AN. On the mounting device or holding device H, a sample carrier PT, as in the Figure 3b shown to be attached. In particular, the holding device H allows a mechanically reversible fastening of the sample carrier PT in the holding device H, so that the sample carrier PT can be removed from the holding device H again without mechanical damage. For this purpose, the sample carrier PT can preferably be attached to the receiving element AN in such a way that a corner E1 of the sample carrier is in a punched-out Z1, see FIG Figure 1a , is introduced, then the receiving element AN is slightly bent and then another corner E2 is inserted into a further punched-out Z2 of the holding device H and then the receiving element AN is bent back again. The receiving element AN is preferably mechanically flexibly bendable.

This is particularly advantageous because in the event that a patient or a user such as a doctor wants to remove the sample carrier from the box or the receiving element later, he can then do this in such a way that the sample carrier is not mechanically damaged, but that in particular only the receiving element is mechanically flexibly bent and the corners of the sample carrier are pulled out of the holding device or the punched-out areas. If the sample carrier had to be glued or glued in or on the receiving element, the sample carrier could tear off or tear when removed from the receiving element or from the holding device and thereby be damaged in an undesired manner, which is avoided according to the invention.

The fact that the sample carrier PT with its rectangular base GFPT, see Figure 1a , into the holding device H, see Figure 3b , or can be inserted or fastened in respective punched-out sections Z1, Z2 of the receiving element AN, this can be done by means of respective opposite corners E1, E2 of the sample carrier PT, since these are then clamped in the holding device H or in the punched-out sections Z1, Z2 be able.

It can be stated that, as in the Figure 1a shown, the corners E1, E2 are arranged opposite one another, in particular symmetrically to a center point MPT of the base area GFPT of the sample carrier PT.

The according to Figures 3a and 3b The solution described is particularly cost-effective since only two punched-out areas Z1, Z2 are required in the receiving element AN in order to form the holding device H. The corresponding corners E1, E2 of the sample carrier PT can be inserted at these punched-out areas Z1, Z2, so that the sample carrier PT is sufficiently fixed in its position without the need for additional materials such as adhesives to fix the sample carrier. The perforations Z1, Z2 are preferably in the form of a segment of a circle, so that the corners E1, E2 of the sample carrier PT can be inserted particularly easily into these perforations Z1, Z2, since the perforations Z1, Z2 in the form of a segment of a circle form corresponding tabs LA1, LA2, which are preferably reversible are bendable or mechanically bendable in a reversible manner. Such tabs LA1, LA2 as parts of the receiving element AN can then be flexibly bent in order to attach the sample carrier PT to the receiving element AN.

the Figure 3c shows the receiving element AN from its rear side with a sample carrier inserted therein, so that the sample carrier is in its position due to the holding device H with the preferably provided punched-out sections Z1, Z2 Position is fixed that the optical code C is visible through the opening O2 of the receiving element.

How from the Figure 3a As can be seen, the opening O2 of the receiving element is arranged point-symmetrically to a center point M2, indicated by a cross, of the base area GF2 of the receiving element AN. This base area GF2 is preferably rectangular but not square.

the Figure 2a shows a preferred embodiment of a box S in the form of a slide-in box ES, given by a box K in the form of a slide-in box EK and by a sleeve HU in the form of a slide-in sleeve EHU. the Figure 2b shows how a slide-in box EK can be inserted into a slide-in sleeve EHU.

Alternatively, the box S is a slip-on box STS shown in FIG Figure 8a , having a lid SD and a bottom box K2. The opening O1 is then in the carton K3.

Alternatively, the box S is a hinged box KLS, shown in Figure 8b , having a carton or base carton K3 and a hinged lid KD located thereon. The opening O1 is then in the carton K3.

The box K or the slide-in box EK from the Figure 2a is open to its top OS. The box S is therefore a cuboid box with a cuboid carton K, EK and an envelope HU, EHU, the envelope being able to be alternatively replaced by a lid, not shown here.

The carton K is preferably a folding carton. The carton K is preferably a four-point folding carton open at the top or a four-point box open at the top.

The box S and its components of the carton K, EK and also the cover HU, EHU or a lid is/are preferably made of paper, cardboard or cardboard.

the Figure 2c shows the carton K, EK, which is open at the top, with its base area BF, which has a base area GF1. As already explained, the carton K, EK is open towards its upper side OS. The base GF1 is rectangular and has an opening O1. The bottom surface BF of the carton K, EK can be regarded as the bottom surface of the cuboid box S.

the Figure 2d shows the slide-in sleeve EHU as an embodiment of a sleeve HU, the slide-in sleeve EHU having an opening O3, which is preferably arranged point-symmetrically to a center M3, in particular a geometric center M3, a base area GF3, an outside SEHU of the sleeve HU, EHU.

The base GF2 of the receiving element AN from the Figure 3a corresponds in particular with regard to its dimensioning to the base area GF1 of the bottom area BF of the box S or of the carton K, EK from FIG Figure 2c .

The base GF2 of the receiving element AN from the Figure 3a is preferably rectangular.

How from the Figure 2c As can be seen, the opening O1 of the box S or of the carton K, EK is arranged point-symmetrically to the center point M1 of the base area GF1 of the base area BF. Both the base GF1 and the base GF2 from the Figure 3a are each preferably rectangular but not square.

the Figure 4a shows the carton K, EK with an inserted receiving element AN, which rests on the bottom surface BF of the carton K or the box S. The openings O1 and O2 are designed to substantially overlap. The openings O1, O2 are preferably of the same size.

the Figure 4b shows the step of inserting the receiving element AN into the box S or the carton K, EK on the bottom surface BF of the box S or the carton K, EK, the sample carrier PT being fastened in the holding device H of the receiving element AN. If, for example, the receiving element AN is then inserted into the box S or the carton K, EK by manual insertion with one hand HA, the result is a configuration as shown in FIG Figure 4c shown.

the Figure 4d shows the entirety of the elements from the Figure 4c from another view, from which it can be seen that when attaching the sample carrier PT to the holding device H and then inserting the receiving element AN into the box S or onto the bottom surface BF of the box S, the optical code C then passes through the first opening O1 is visible in the bottom surface BF and also through the second opening O2 in the receiving element AN, so that the code C can be detected and read without any problems.

Because the box S is provided at least by a separate carton K, EK, which is open at the top, and a separate closure in the form of a sleeve HU, EHU or a lid that is not shown in detail, the receiving element AN with the Sample carrier PT are provided or the sample carrier PT are first attached to the receiving element AN and then simply the receiving element AN, as in FIG Figure 4b set out in the box S or the carton K, EK are inserted, so that the advantageous configuration from the Figure 4d is brought about. Such a box S with a part of a carton K, EK and a sleeve HU, EHU or a lid is advantageous because other parts can then also be included in the box.

the Figure 5a shows further parts or further objects such as one or more lancets L1, L2 as well as a mailing bag VT. Also shown as further objects are a plaster PF, a gauze bandage MB, as well as alcohol swabs AT or operating instructions BA. One or more such objects from the Figure 5a are usually shipped in a box together with a sample carrier and can therefore accompany the sample carrier. Such parts or objects from the Figure 5a are necessary for sampling capillary blood in the patient and are then used by the patient himself or by a user such as a doctor for sampling.

Figure 5b shows, with a receiving element AN inserted in the carton K, EK, that further parts such as a lancet L or a mailing bag VT can also be inserted in the box. Because the box S, ES has a carton K, EK that is open at the top, at least one lancet L and at least one mailing bag VT can also be enclosed with this carton K, EK, with these other parts L, VT also being closed by closing the Cartons K, EK remain inside the box S, ES by means of a cover HU, EHU or a lid.

the Figure 5c shows the slide-in box EK being pushed into the slide-in sleeve EHU, with the other parts such as a lancet L or a mailing bag VT then also being packed inside the box.

In the case of a slide-in box ES, the box ES is given by a slide-in carton EK open at the top, into which the receiving element AN can be inserted and which is then closed as part of the box S by sliding it into the slide-in sleeve EHU. As a result, other parts such as a mailing bag VT or a lancet L are advantageously held and packaged within the slide-in carton or box. The embodiment of the box S as a slide-in box ES is particularly advantageous, since the slide-in box EK can simply be pushed into the slide-in sleeve EHU during assembly, and further parts such as a lancet L or mailing bag VT then remain in the slide-in box EK, even if these parts L, VT are in a loose state inside the box ESH, since such parts L, VT are then held inside the box ES by the slide-in sleeve EHU. Parts, such as one in the Figure 5b illustrated alcohol wipes AT, which at an earlier packing stage from the Figure 5b possibly on the top OS of the box K, EKU would protrude upwards, then just in an advantageous manner by the slide-in sleeve EHU, as in the Figure 5c shown, pushed down into the interior of the slide-in box. In other words: the slide-in box ES is securely closed in that the slide-in box ES is automatically closed simply by inserting the slide-in box EK into the slide-in sleeve EHU. In the case of the box as a slip-on box or as a hinged box, further closure elements would have to be provided and actuated for a secure closing of the box, such as a hinged lid or a slip-on lid to be mechanically fastened or hooked to a box. The embodiment of the box as a slide-in box ES is therefore particularly advantageous since simple and quick handling in the course of assembling the set with further parts such as a lancet L and a mailing bag VT is particularly simple, safe and time-saving. The set preferably has at least one lancet L and one mailing bag VT. A set with all the components is also disclosed.

There is also another advantage in the embodiment of the box S as a slide-in box ES, since then, for example, in the course of packaging in a first step, as in the Figure 5b set out, first parts such as the receiving element AN with the sample carrier PT and other parts L, VT can simply be inserted into the box or slide-in box EK and then instead of inserting the slide-in box EK into the slide-in sleeve EHU, as in FIG Figure 5c set out in an alternative packaging step of the box EK from the Figure 5b thereby with the slide-in cover EHU can be provided that the slide-in carton EK is wrapped by a cardboard element, which is glued on one side, so that the wrapping cardboard element forms the slide-in sleeve EHU. Here, too, it can then be ensured in a particularly advantageous manner that parts, such as an alcohol swab AT or a mailing bag VT from the Figure 5b , which can protrude upwards over the top OS of the box EK, are pressed into the inner area of the box EK and are held securely there.

the Figure 5d shows the box S, ES in the preferred embodiment of a slide-in box ES in a configuration in which the box S, ES is closed by inserting the slide-in carton EK into the slide-in sleeve EHU, the receiving element AN with the sample carrier PT attached to it also being placed in the box S , ES or in the carton K, EK. It can be seen that when the sample carrier PT is fixed in the holding device H of the receiving element AN and the receiving element AN is inserted in the box S, ES or the box K, EK on the bottom surface and the box S, ES is then closed due to a correspondence of the opening O3 the slide-in sleeve EHU, as in Figure 2d explained, then there is a configuration according to which the optical code C is visible through the opening O1 of the bottom surface BF, through the opening O2 of the receiving element AN and through the opening O3 of the slide-in case EHU.

As already mentioned above, the opening O1 of the box S, ES or the carton K, EK is preferably arranged point-symmetrically to the center M1 of the base area GF1 of the bottom surface BF of the box S, ES or the carton K, EK, with the Opening O2 is arranged point-symmetrically to the center point M2 of the base area GF2 of the receiving element AN and the base areas GF1 and GF2 are each rectangular but not square. This is particularly advantageous because when the sample carrier PT is inserted or attached in or on the receiving element AN, the code C can always be read when the receiving element AN is inserted in the box S, ES or in the carton K, EK, since the rectangular but not square bases GF1, GF2 result in only two possible insertion configurations of the receiving element AN, which are in particular rotated by 180° to one another, but in both of these configurations the code C of the sample carrier PT can always be read through the openings O1 and O2. In the exemplary embodiment of the box S in a slide-in box ES, this is further ensured in that the slide-in sleeve EHU has an opening O3 which is point-symmetrical to the center point M3 of the base area GF3 of that side SEHU, the slide-in sleeve EHU, which has the opening O3, see Figure 2d . So that's it then Also in the exemplary embodiment of the box as a slide-in box, there is a 180° interchangeability of the configuration arrangement of the slide-in sleeve EHR relative to the slide-in box EK and also in particular relative to the receiving element AN, with each of the possible configuration arrangements of the slide-in sleeve EHR relative to the slide-in box EK and in particular relative to the receiving element AN the code can be read through the openings O1, O2, O3 when the box is closed. This avoids incorrect configurations when the slide-in box EK and the slide-in sleeve EHU, and in particular also the receiving element AN, are joined together.

the Figure 6a also shows a shipping carton VK or a shipping box, preferably in the form of a folding box, into which the box S can be inserted. The set preferably also has such a shipping carton VK. This is advantageous because the shipping carton then provides mechanical protection and/or dirt protection for the sample carrier PT and its membrane layer M as well as for the barcode C.

the Figure 6b shows a box S inserted in the shipping carton VK.

Figure 7a shows a preferred embodiment of the shipping carton VK1, which has an opening O4 on its underside VKU or its upper side VKO, which preferably corresponds to the first and the second opening O1, O2 and preferably to the third opening O3. the Figure 7b shows the carton VK1 from its underside VKU, with the code C being readable through the openings O1, O2, O3, O4.

As in Figure 7c shown, the opening O4 is preferably covered with an optically transparent film F, so that the code C can also be read when the box S is placed in the shipping carton VK1, as in Figure 7d shown. A transparent film F at the opening O4 prevents dirt from entering the interior of the shipping carton VK1 and the box S to the sample carrier PT and its membrane layer M. This means that the entire set can be pre-assembled and stored together with the shipping carton VK1, so that then in the If necessary, a laboratory worker in the laboratory can only remove the entire set and scan or read the optical code through the opening O4 of the shipping carton VK1.

In a preferred embodiment, the code C is arranged centrally or point-symmetrically to a center point MPT, in particular a geometric center point MPT, of a base area GFPT of the sample carrier, preferably of the folded one sample carrier PT. In particular, the holding device H is then also arranged symmetrically to the center point M2 of the base area GF2 of the receiving element AND, in particular the punched-out areas Z1, Z2. Here, too, there is the advantage of 180° variability when assembling or fastening the sample carrier PT on the receiving element AN while ensuring that the code can be read through the opening O1 of the receiving element and in particular further openings O2, O3 and/or O4.

Claims (14)

set - Having a flat sample carrier (PT) with an absorbent membrane layer (M), which is suitable for absorbing liquid blood components, and wherein at least some of the blood components can dry in the membrane layer (M), the sample carrier (PT) also on an outside (A) is provided with an optically readable code (C), - further comprising a closable, cuboid box (S, ES) with a base area (BF), which has a rectangular base area (GF1) and which also has a first opening (O1), - further comprising a flat receiving element (AN) with a base area (GF2) which corresponds to the base area (GF1) of the base area (BF), wherein the receiving element (AN) has a second opening (O2) and a holding device (H), which are designed together such that when the sample carrier (PT) is fastened in the holding device (H) and the receiving element (AN) is then inserted into the Box (S, ES) on the bottom surface (BF) of the box, the optical code (C) is visible through the first opening (O1) of the bottom surface (BF) and also through the second opening (O2) of the receiving element (AN). set according to claim 1,
wherein the cuboid box (S, ES) consists of a cuboid carton (K, EK) and a sleeve (HU, EHU) or a lid (SD, KD),
wherein the cuboid carton (K, EK) is open at the top (OS) at the top and the cuboid carton (K, EK) can be closed by the cover (HU, EHU) or the lid (SD, KD). set according to claim 2,
wherein the box (S) is a slide-in box (ES), which is provided by a slide-in carton (EK) and a slide-in sleeve (EHU),
wherein the slide-in sleeve (EHU) has a third opening (O3) corresponding to the first opening (O1) and to the second opening (O2) such that - when attaching the sample carrier (PT) in the holding device (H), - Subsequent insertion of the receiving element (AN) into the slide-in box (EK) on its bottom surface (BF) - and subsequent insertion of the slide-in box (EK) into the slide-in sleeve (EHU) the optical code (C) is visible through the first opening (O1) of the bottom surface (BF), through the second opening (O2) of the receiving element (AN) and through the third opening (O3) of the slide-in case (EHU). Set according to one of the preceding claims
wherein the sample carrier (PT) has a base body (GK),
wherein the membrane layer (M) is attached to the base body (GK),
and wherein the base body (GK) is also provided with the optically readable code (C) on an outside (A). Set according to claim 4
wherein the membrane layer (M) is a flat membrane layer and the base body (GK) is a flat base body which can be folded in such a way
that the membrane layer (M) is covered by the folded base body (GK). set according to claim 1,
wherein the holding device (H) allows a mechanically reversible attachment of the sample carrier (PT) in the holding device (H), so that the sample carrier (PT) without mechanical damage from the holding device (H) can be removed again. set according to claim 1,
wherein the sample carrier (PT) has a rectangular base area (GFPT), the holding device (H) being provided by at least two punched-out portions (Z1, Z2) in the receiving element (AN), into which respective opposite corners (E1, E2) of the sample carrier (PT) can be pinched. set according to claim 1,
wherein the first opening (O1) is arranged point-symmetrically to a center point (M1) of the base area (GF1) of the bottom area (BF),
and wherein the second opening (O2) is arranged point-symmetrically to the center point (M2) of the base area (GF2) of the receiving element (AN).
and wherein the bases (GF1, GF2) are rectangular but not square. set according to claim 1,
further comprising at least one lancet (L) and at least one mailing bag (VT) for mailing the sample carrier (PT). set according to claim 1,
further comprising a shipping carton (VK, VK1) or a shipping box, preferably in the form of a folding box, into which the aforementioned box (S, ES) can be inserted. Set according to claim 10,
wherein the shipping carton (VK1) has a fourth opening (O4) on its underside (VKU) or its upper side (VKO), which corresponds to the first opening (O1) and the second opening (O2). set according to claim 1,
wherein the code (C) is positioned centrally to a center point (MPT) of the base area (GFPT) of the sample carrier (PT). Set according to one of the preceding claims,
wherein the sample carrier (PT) is fixed in the receiving element (AN),
wherein the receiving element (AN) is inserted into the box (S) and wherein the optical code (C) passes through the first opening (O1) of the bottom surface (BF) and also through the second opening (O2) of the receiving element (AN) is visible through. Set according to claim 13,
the box being a slide-in box (ES) given by a slide-in carton (EK) and a slide-in sleeve (EHU),
the slide-in case having a third opening (O3) corresponding to the first opening O1 and the second opening O2,
wherein the slide-in carton (EKU) is inserted into the slide-in sleeve (EHU) and the optical code (C) through the first opening (O1) of the bottom surface (BF),
is visible through the second opening (O2) of the receiving element (AN) and through the third opening (O3).

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