Sampling device

Abstract

An apparatus (100) for separating a biological sample into solid and liquid components. The apparatus (100) includes a front cover (1) and a back cover (2) connected at a hinge portion (11) to allow the apparatus (100) to operate between an open and a closed position. A separation membrane (6) is arranged to hold the solid component and allow the liquid component to pass through it, and an absorbent membrane (7) is arranged to hold the liquid component. The separation membrane and the absorbent membrane (6, 7) are arranged in a layered structure between the front cover and the back cover (1, 2). Opening the apparatus (100) from the closed position to the open position causes the separation membrane and the absorbent membrane (6, 7) to bend, thereby applying a compressive force to the membranes (6, 7).

Description

Technical Field

[0001] This invention relates to an apparatus for separating biological samples into cellular and liquid components, the apparatus being used, for example, in medical diagnostics, clinical analysis, and / or biobanks. Specifically, but not exclusively, the apparatus can be used to separate blood into blood cells and plasma. Background Technology

[0002] It is important to discover new and improved methods for collecting biological samples, such as blood, for use in intermediate testing or in biobanks to monitor an individual's health and / or disease. A biobank is the form of a repository of biological samples used for medical research, diagnostics, and clinical analysis. Generally, a large, anticipated biobank of samples will need to be collected prior to the clinical initiation of a disease in order to use the samples to identify and validate prognostic biomarkers for early detection of the disease. Additionally, targeted therapies working only within a subset of patients require frequent testing to monitor treatment response in drug development and clinical practice, necessitating extensive and continuous sample collection.

[0003] In recent years, there has been a growing interest in 'health,' with individuals wishing to monitor their general health in order to lead a healthy lifestyle. Even those without any specific conditions may wish to monitor their general health to determine, for example, whether they should change certain aspects of their lifestyle. Monitoring health over a period of time allows for the early detection of changes in an individual's health. Samples of biological material can be obtained from the individual over a period of time to detect such changes.

[0004] Recent improvements in sample testing have reduced the amount of sample required (i.e., physical volume), thereby allowing for less invasive sampling procedures, such as finger pricks. Analyses used to analyze samples have also become more comprehensive, leading to lower costs and significantly expanding the preparation and scale of biobank materials. Furthermore, the rapidly growing insights into medically relevant molecular markers greatly increase the medical value of such analyses, stimulating another demand for efficient components for the collection, transport, and storage of biological samples.

[0005] Generally, it may be necessary to provide components that separate the solid and liquid components of a biological sample, such as cells. Pre-separation of the solid and liquid components of a biological sample reduces the complexity of these two sample modalities, thereby aiding downstream analysis. For example, if the biological sample is blood, then it may be necessary to separate the cellular components of blood and plasma. This allows for the separate analysis of cellular and plasma components, as performed in routine medical testing. For instance, diagnostically important components of blood cells can be studied by measuring the levels of characteristic transcripts or proteins in cellular components, while protein levels can be measured in plasma components. Different types of blood cells act as well-established biomarkers under a wide range of conditions, such as AIDS, anemia, bacterial and viral infections, allergies, etc.

[0006] The applicant understands that another motivation for separating blood cells and plasma is that certain types of analysis targeting plasma proteins may involve the addition of reagents that produce colored or fluorescent products in proportion to the target molecules present in the sample. Such analyses are generally preventable with red blood cells but work well in plasma. Therefore, the ability to separate plasma from blood cells advantageously allows for the performance of such analyses.

[0007] When isolating and collecting biological samples, it is also necessary to provide components for capturing the biological sample of interest. One method known in the art, for example with blood samples, is to collect and maintain the sample by drying it on a specialized membrane surface. This can be used to stabilize the sample by reducing enzyme activity in the dried state for short-term or long-term storage, thereby simplifying the standardization of sampling. The drying process can also be used to remove well-known variables that lead to inconsistent handling of blood samples (e.g., hemolysis) and other forms of cell death, whereby cell lysis can cause the release of cellular contents into the plasma components of the blood.

[0008] Other well-known variables associated with inconsistent sample handling may include degradation of the nucleic acid components of the sample or post-translational modifications of the protein components; these variables may also be removed due to sample drying.

[0009] Popular separation methods known in the art include filtration or centrifugation. However, each of these methods has its own associated problems. For example, filtration of a sample via a membrane requires a driving force, such as capillary suction or gravity, to achieve flow of the sample through the filter material. Efficient filtration via membranes is difficult to achieve, especially in portable separation devices. Common solutions involve stacking filter membranes on one or more layers, with the layer beneath the membranes used to pull the fluid sample by capillary suction. However, generating the required pressure on the membrane to achieve efficient sample filtration and collection is difficult to achieve, and there is a lack of effective ways to overcome this problem in the prior art.

[0010] The applicant understands that there will be a need for facilities that can collect biological samples using simple, portable devices that allow for individual sampling potentially without the assistance of healthcare professionals. Therefore, the objective of this invention is to provide an inexpensive, portable device that enables efficient separation and drying of cells and fluids in biological samples supplied in relatively small quantities, while being suitable for the efficient transport, storage, and identification of individual samples. Summary of the Invention

[0011] According to a first aspect, embodiments of the present invention provide an apparatus for separating a biological sample into solid and liquid components, wherein the apparatus comprises:

[0012] (i) A front cover and a back cover, which are connected at a hinge portion so that the device can be operated between an open position and a closed position;

[0013] (ii) a separation membrane arranged to retain the solid component and allow the liquid component to pass through it;

[0014] (iii) An absorbent membrane arranged to retain the liquid components;

[0015] The separation membrane and the absorption membrane are arranged in a layered structure between the front cover and the back cover; and

[0016] Opening the device from the closed position to the open position causes the separation membrane and the absorption membrane to bend, thereby applying a compressive force to the membrane.

[0017] Therefore, it should be understood that embodiments of the present invention advantageously provide an apparatus in which, when the apparatus is opened, the separation membrane and the absorption membrane are pressed against each other, thereby facilitating the separation of solid and liquid components of a biological sample. Solid components, which may be cellular components, are captured and stored on the separation membrane, while liquid components can pass through the separation membrane and are subsequently captured and stored on or in the absorption membrane.

[0018] The applicant understands that providing a tight and temporary juxtaposition of a separation membrane and an absorption membrane can advantageously lead to efficient separation and collection of biological samples. This tight and temporary juxtaposition is achieved by pressing the membranes together. Temporary but uniform pressure is applied to the membranes by layering the separation and absorption membranes in a stacked structure. The stacking of the separation and absorption membranes serves to fluidly communicate the two membranes with each other. In a preferred embodiment, the separation layer is arranged above the absorption layer. It should be understood that the term 'above' herein means that, in use, the separation layer is physically closer to the contact point that will be formed with the biological sample after its deposition.

[0019] Once a sample has been collected, the device can then return to the closed position. The device, along with the collected sample, is advantageously suited for transport via regular mail, which is used for intermediate testing for sample, biobank storage, and / or health monitoring purposes. Thus, individuals interested in analyzing samples for biomarkers of health and nutritional status, (automatic) immune status, signs of ongoing or previous infections, etc., can simply prick their finger and send the sample via mail for analysis, with recommendations on overall health, diet, and exercise.

[0020] The apparatus according to the invention also advantageously allows for the collection of samples from a very large number of donors with many consecutive samples collected from individuals at an affordable price. Furthermore, samples from individuals that would otherwise be difficult to sample (e.g., young children or animals) can be collected using the apparatus of the invention by collecting smaller but sufficient dried blood samples. The portability of the tests achieved by the apparatus of the invention also means that it is valuable for poor resource settings, where cold chains for transporting the collected samples can be difficult to maintain.

[0021] As outlined above, the front cover and back cover of the device are connected by a hinge portion, which allows the device to operate between an open position and a closed position. As described herein, the term 'hinge portion' refers to a component, such as a joint, that allows the device to rotate or pivot about a point. Although the hinge portion may include mechanical hinges, such as butt hinges, barrel hinges, long-feather hinges, etc. (i.e., 'standard' type hinges, for example, used for mounting a door to a door frame), in some embodiments, the hinge portion is a folding element between the front cover and the back cover. Thus, according to these embodiments, the front cover and back cover may have an integral construction (i.e., a single structure) divided into a 'front cover' or a 'back cover' by the folding element.

[0022] Therefore, it will be understood that a device with a hinge portion between the front cover and the back cover produces a 'book-like' or 'wallet-like' structure, thereby providing the device for opening and closing.

[0023] Additionally, the separating membrane and the absorbent membrane may be fixed to or near the hinge portion of the device on one side of the front cover and the back cover, wherein the other ends of the separating membrane and the absorbent membrane are not fixed to the device. Therefore, in some embodiments, the separating membrane includes a first fixed end and a first free end, and the absorbent membrane includes a second fixed end and a second free end, wherein the first and second fixed ends are fixed to the front cover or back cover at or near the hinge portion of the device, and the first and second free ends are fixed together and can move freely laterally relative to the first and second fixed ends when the device moves between an open position and a closed position. Therefore, in some embodiments, opening the device pulls the free ends of the separating membrane and the absorbent membrane toward the fixed ends.

[0024] As used herein, the term 'free end' refers to the end of a specified membrane that is not fixed to the device, i.e., it can move laterally across the device. The term 'fixed end' refers to the end of a specified membrane that is fixed or 'anchored' to the device, i.e., it cannot move laterally across the device.

[0025] In some of these embodiments, the first fixing end and the second fixing end are fixed to the front cover or the back cover.

[0026] In some potentially overlapping embodiments, the separating membrane and the absorbent membrane are secured by anchors, such as elongated anchors, which extend substantially across the width of the device and preferably across its entire width. In some such embodiments, the anchors secure the separating membrane and the absorbent membrane to a front cover or a back cover. In a preferred embodiment, the free ends of the separating membrane and the absorbent membrane are secured to each other.

[0027] In some embodiments, the device may further include a strain portion. The strain portion may be rigid to impart strain to the separation membrane and the absorption membrane. The strain portion is secured at one end to one side of the front or back cover, and at the other end to the free end of the absorption membrane and / or the separation membrane. In some such embodiments, the strain portion is positioned below the absorption membrane in a layered structure. In a preferred set of potentially overlapping embodiments, the strain portion is secured to the free end of the absorption membrane.

[0028] The device can be appropriately sized for easy storage and transport. However, in some embodiments, the front and back covers are between approximately 2 cm and 25 cm in length, for example, between approximately 4.5 cm and 11.5 cm in length, and in some embodiments, they may be approximately 7 cm in length. In some potentially overlapping embodiments, the separation membrane and the absorption membrane are between approximately 2 cm and 8 cm in length, for example, between 3 cm and 7 cm in length, and in some embodiments, they may be approximately 5 cm in length.

[0029] In a set of embodiments that provide potentially overlapping strain portions, the strain portions may be between approximately 5 cm and 10 cm in length, and in some embodiments may be approximately 8.75 cm in length.

[0030] Therefore, in some embodiments, the opening of the device pulls the free ends of the separation section, absorption section, and strain section toward the fixed end. The rigid strain section thus imparts compressive force to the separation and absorption membranes, thereby inducing bending of the absorption and separation membranes, resulting in enhanced 'strain' of the biological sample to aid in the separation of cellular and liquid components. In this way, liquid in the sample applied to the separation membrane is efficiently drawn to the underlying absorption membrane by capillary force, leaving the non-liquid components of the biological sample on the separation membrane.

[0031] In some embodiments, the front and back covers of the device of the present invention may comprise paper-based materials, such as paper, cardboard, corrugated cardboard, cardboard, carton paper, corrugated paper, or fiberboard. In a set of preferred embodiments, the front and back covers are made of cardboard. In a set of embodiments where the strain portions potentially overlap, the strain portions are preferably made of paper.

[0032] The term 'biological sample' may include, but is not limited to, blood, cerebrospinal fluid, urine, saliva, tears, lymph, tissue fluid, bronchoalveolar lavage fluid (BAL), ascites, etc. A biological sample may consist of, for example, a cellular component comprising the cells that make up the sample and a fluid component comprising the fluid component of the sample. The fluid component may further include soluble substances such as proteins, genetic material (DNA or RNA), hormones, gases, glucose and other metabolites, electrolytes, etc. In a set of preferred embodiments, the biological sample includes blood. In this example, the cellular component may include cells such as leukocytes, erythrocytes, and / or platelets. Although the fluid component, i.e., plasma, will include soluble substances such as blood proteins, clotting factors, electrolytes, glucose, etc.

[0033] In some embodiments, the liquid components of the sample pass through a separation membrane and are absorbed onto an absorption membrane under gravity. However, the liquid components of the sample pass through a separation membrane and are absorbed onto an absorption membrane via capillary action. The terms “capillary action,” “capillary suction,” and “wicking” are used interchangeably to refer to the ability of a liquid to flow in a narrow space without the aid of gravity, and in some cases, against gravity.

[0034] Separation membranes comprise filter paper that filters the liquid components of a biological sample while trapping solids, such as cells or other components. Some suitable filter papers known in the art contain, for example... 3MM, GF / CM30, GF / QA30, S&S903, GB002, GB003, GB004 or Vivid plasma separation membrane. In some embodiments, the separation membrane is formed of Vivid plasma separation membrane filter paper. In some potentially overlapping embodiments, the separation membrane may be GF, GX, or GR grade Vivid plasma separation membrane filter paper. In at least some preferred embodiments, the separation membrane is GR grade Vivid plasma separation membrane filter paper.

[0035] A single separation membrane may be present for collecting the solid components of a biological sample; however, in some embodiments, multiple separation membranes may be present, each arranged to capture different solid components of the biological sample, such as different cellular components and / or other types of solid components. For example, one separation membrane may capture white blood cells and red blood cells, while another separation membrane may capture blood platelets, and plasma is transferred to an absorption membrane.

[0036] Absorbent membranes may comprise absorbent paper that captures the liquid components of biological samples. Several classes of sample collection materials capable of serving as absorbent membranes are known per se in the art. For example, S&S 903 cellulose (which may be derived from logs or cotton) and / or Sample collection card. In some embodiments, the absorbent membrane may include Whatman 903 and / or Whatman Grade 1 paper. In a preferred embodiment, the absorbent membrane includes Whatman Grade 1 paper.

[0037] In some embodiments, the separation membrane and / or filter membrane may have an active agent impregnated therein. The active agent can influence biological processes. For example, in some embodiments, the active agent can inhibit biological processes. In other embodiments, the active agent can preserve the sample. In a preferred embodiment, the active agent is an inhibitor that protects the biological sample by preventing its degradation. Such active agents may include, but are not limited to, chemically or protein-based ribonuclease inhibitors, deoxyribonuclease inhibitors, or protease inhibitors. In a collection of embodiments in which the apparatus includes multiple separation membranes as outlined above, some or all of the separation membranes may be impregnated with, for example, those active agents listed above. In some embodiments, the separation membrane may further be provided with a solid carrier for subsequent detection and analysis. For example, in a specific embodiment, a fixed capture antibody may be used to capture specific viruses present in the biological sample. Such viruses, specifically viruses identified by the fixed antibody, will be captured on the separation membrane, and the presence of a specific virus in a blood sample can subsequently be determined.

[0038] Viewed from a second aspect, the present invention provides a method for separating a biological sample into solid and liquid components using an apparatus according to an embodiment of a first aspect of the present invention, the method comprising:

[0039] Open the device;

[0040] Provide samples from the subject;

[0041] The sample was applied to a layered structure;

[0042] To ensure that the biological sample on the layered structure is essentially dried; and

[0043] Closing device.

[0044] As used herein, the term 'subject' includes any human or non-human animal subject, including any human or non-human mammal, bird, fish, reptile, amphibian, etc. However, in a preferred embodiment, the subject is a human mammal, such as a human patient. In other embodiments, the sample may be derived from an industrial process, such as biotechnology.

[0045] In some embodiments, the sample is provided by the subject via an invasive method. In other embodiments, the sample is provided by the subject via a non-invasive method. Preferably, the sample is provided in a non-invasive manner. For example, the sample can be provided non-invasively, such as by pricking a finger, and the biological sample is blood. In some additional embodiments, the device of the present invention can be part of a reagent kit equipped with a needle, thereby providing the subject with a component for obtaining a blood sample.

[0046] In one embodiment, after the sample has dried, a separating leaflet may optionally be provided, for example in a component kit, to interleave the separating membrane and the absorption membrane. Thus, the method may include inserting the separating leaflet between the separating membrane and the absorption membrane after the sample has been applied to the layered structure, and optionally after the biological sample on the layered structure has been substantially dried. In some embodiments, this separating leaflet may be impermeable to both the cellular and liquid components of the biological sample. This separating leaflet prevents 'back-transport' of components, for example, preventing liquid components from 'leaking' back onto the separating membrane.

[0047] In some embodiments, the method may further include removing the sample collected on the separation membrane and the absorption membrane. In one embodiment, the separation membrane and the absorption membrane may be non-cancellously removable from each other. In such embodiments, the separation membrane and the absorption membrane allow for the separate isolation of the sample captured thereon. In other embodiments, the retrieval of dried cell and liquid samples may be achieved using mechanical means, such as a perforator. For example, a portion of the sample may be punched out without containing any material higher or lower than that of the separation membrane and the absorption membrane. In other words, the separation membrane and the absorption membrane may be retrieved separately by punching out a portion of these membranes after the sample has been supplied and dried.

[0048] Alternatively, in other embodiments, the sample can be punched out by stamping through the front and / or back covers of the device. This removal method allows for a simple and economical way, for example, to obtain separated samples captured on separation and absorption membranes.

[0049] Therefore, in some embodiments, the front and back covers may be made of a perforable material. Those skilled in the art will understand that this means a material suitable for a substantially circular 'core' to be removed by a bladed punching component, which is typically substantially cylindrical. This punching operation removes a cross-sectional core of the device comprising sections of a separation membrane and an absorption membrane, respectively containing cellular and liquid components of a biological sample, wherein portions of the front and / or back covers can be discarded by punching. This method allows for the direct mechanized removal of samples for subsequent analysis.

[0050] The applicant understands that additional components can be provided to apply compressive forces to the layered separation and absorption membranes. Therefore, in some embodiments, the apparatus includes manually operable actuating components arranged to further bend the separation and absorption membranes, thereby applying further compressive forces to the membranes. In some such embodiments, the manually operable actuating components include a drawstring, wherein pulling the drawstring causes the separation and absorption membranes to bend, thereby applying further compressive forces to the membranes.

[0051] This arrangement is novel and inventive on its own right side, and thus, when viewed from a third aspect, the present invention provides an apparatus for separating a biological sample into solid and liquid components, the apparatus comprising:

[0052] (i) A front cover and a back cover, which are connected at a hinge portion so that the device can be operated between an open position and a closed position;

[0053] (ii) a separation membrane arranged to retain the solid component and allow the liquid component to pass through it;

[0054] (iii) an absorbent membrane arranged to retain the liquid component; and

[0055] (iv) Manually operable actuators;

[0056] The separation membrane and the absorption membrane are arranged in a layered structure between the front cover and the back cover; and

[0057] The manually operable actuating component is arranged such that, when operated, the actuating component causes the separating membrane and the absorbing membrane to bend, thereby applying a compressive force to the membrane.

[0058] In some embodiments, the manually operable actuation component includes a pull wire, wherein pulling the pull wire causes the separating membrane and the absorbing membrane to bend, thereby applying a compressive force to the membrane.

[0059] Therefore, it will be understood that this third aspect provides a device that can use additional or alternative components to induce bending of the functional membranes, namely the separating membrane and the absorbing membrane. In this specific aspect of the invention, the bending of the functional membrane may not necessarily occur due to the opening mechanism of the device. Specifically, in such embodiments included in the third aspect, opening the device and subsequently pulling the cord induces bending of the functional membrane, thereby applying a compressive force to the functional membrane. Of course, in the set of embodiments, opening the device may also cause bending of the membrane, and thereby result in a compressive force on the membrane, as outlined above.

[0060] The applicant also understands that it may be very important to be able to attribute collected samples to the correct subject. For example, in a biobank system, samples can be collected from thousands of different subjects, and knowing which sample came from which patient is extremely important. When the devices outlined above are supplied to subjects, these devices may be given some form of identifier (e.g., a serial number) to provide a relatively inexpensive way to track which sample belongs to which subject. Alternatively, some form of identification hardware, such as a radio frequency identification (RFID) chip, may be embedded in or attached to the device.

[0061] However, these methods may be unsatisfactory in all applications – the additional hardware can be expensive, and assigning a specific device to a specific subject carries the risk of mixing these devices, for example, if multiple subjects live in the same house and store the devices in the same location (i.e., subject A could accidentally use subject B's device, potentially resulting in subject A's data being stored in subject B's biobank record). Therefore, in some embodiments, optical tags are provided on the device for a user to scan using an external device to associate a biological sample with a subject, optionally including a barcode or, in some preferred embodiments, a quick-response (QR) code. Thus, in some arrangements, each device may have a unique QR code, for example, printed on the front and / or back cover, which can be scanned using a device such as a smartphone or tablet computer that assigns the biological sample to a subject identified by the device. For example, the device may run an application (or 'app') in which details of the subject are captured during sampling or via login credentials; i.e., the subject may need to log in to the app using a username and password that uniquely identify them.

[0062] Therefore, in some embodiments of the second aspect of the invention, the method further includes scanning an optical mark on the device using an application on an external device. In a set of these embodiments, the method further includes logging into the application using user credentials, optionally wherein the application is configured to verify user credentials or to verify user credentials using a remote server. It will be understood that the term 'user credentials' can mean username and password, but also covers other forms of credentials, including, but not limited to, biometric identification (e.g., fingerprint recognition, facial scanning, iris scanning, etc.) or physical tokens (e.g., card readers or hardware authenticators). In some embodiments, a login process may not be necessary, as an authorized session on the external device (e.g., an existing authenticated session on the user's smartphone) can be used to provide user credentials.

[0063] Optical markers (e.g., QR codes or similar) link a specific sample collection event to a device holding the sample. These optical markers are preferably located on the device in a readable position when the device is stored, allowing retrieval of the desired device from the stack (which may be located in a suitable holder), for example, in a refrigerated space, even when many such devices are stacked. Since the sample is divided into two (or more) components upon collection—a solid component and a liquid component (e.g., blood cells and plasma)—these components may need to be identified individually to record when a sample was retrieved from any component of the collected sample. Thus, in a set of preferred embodiments, the optical markers are positioned on the hinges of the device. According to such embodiments, the optical markers are positioned on the 'ridge' of a book-like device.

[0064] In some embodiments, the device may include multiple optical markers. This can be useful, for example, where separate optical markers are needed to individually identify solid and liquid components. It is considered that separate QR codes or other identifiers may be applied to the two functional membranes to ensure proper identification of the sample source retrieved from the membrane (e.g., cells or plasma). Furthermore, it is contemplated that separate QR codes or other identifiers may be applied at any location on the device, for example, on the inside and / or outside of the front and / or back covers, or on the 'ridge' of the device (i.e., on the outer surface of the hinge portion).

[0065] Viewed from a fourth aspect, the present invention provides a method for identifying biological samples obtained using an apparatus according to an embodiment of a first aspect of the present invention, the method comprising:

[0066] Receive user credentials and use the user credentials to retrieve a user identifier;

[0067] Scan the optical markers on the device to retrieve the device identifier; and

[0068] The user identifier and the device identifier are stored as a link pair in the database.

[0069] A fourth aspect of the invention extends to a non-transitory computer-readable medium comprising instructions that, when executed on a processor, cause the processor to perform a method for identifying a biological sample obtained using an apparatus according to an embodiment of a first aspect of the invention, the method comprising:

[0070] Receive user credentials and use the user credentials to retrieve a user identifier;

[0071] Scan the optical markers on the device to retrieve the device identifier; and

[0072] The user identifier and the device identifier are stored as a link pair in the database.

[0073] The step of storing user identifiers and device identifiers as a pair in a database may, at least in some embodiments, include transmitting the user identifiers and device identifiers to a remote server containing the database.

[0074] When analyzing a device, for example, through a biobank, optical markers can be scanned to determine user identifiers and / or device identifiers, so that measurements and conclusions related to the cellular and liquid components of the biological sample can be stored in a database about the correct subject.

[0075] When multiple optical markers are provided, these can provide sample identifiers (in addition to or in place of device identifiers) associated with solid and liquid samples, enabling independent identification of these sample identifiers. These can be stored as linked pairs or groups with corresponding user identifiers in a database, as needed (depending on whether the device identifier is in use, with or without it). These sample identifiers can be processed in the same manner as the device identifiers in the embodiments described herein.

[0076] This app can have a simple and accessible interface that informs the user about the content and provides several simple options depending on the intended use.

[0077] The app may include, for example, short tutorials on how the device should be handled by the user, and the tutorials may also include videos describing how to collect samples to help ensure standardized sample collection.

[0078] This can result in the sample being timestamped, at least in some embodiments, by scanning an optical mark (e.g., a QR code) on the sample collection device. Alternatively, the timestamp can be obtained via a smartwatch connected to an external device and associated with the sample.

[0079] The app may also provide, at least in some embodiments, the opportunity to add information relevant to the sample, for example, by allowing users to populate a 'Notes' field with additional information. This information may be generic or structured depending on the specific study in which the sample will be part of, for example, the evaluation of a new drug, and the app should be constructed so that different versions can be easily prepared depending on the additional information required for a given study. Alternatively or additionally, if samples other than the primary sample of interest are collected (e.g., urine, saliva, CSF, or fine-needle biopsy), these may be recorded by the user.

[0080] For some additional potentially overlapping purposes, this annotation may involve capturing additional images, such as images of healing wounds. Alternatively or concurrently, the recording may be provided via an app that provides audio such as breathing or heart sounds.

[0081] The app can maintain a history of all samples collected by an individual and when those samples were retrieved, and can be arranged to display these samples on a timeline.

[0082] For applications such as clinical research, information about the collected samples can be transmitted to the individual in charge of the study, who may also need to send messages to study participants via an app. Additional functionality may be required to obtain an overview of the sample set from all participants in the study. This document can be combined with information about the analysis results of the samples.

[0083] Whenever a stored sample is retrieved from the card, a QR code scan can also be performed to efficiently link the sample identification to the results of the analysis performed. As outlined above, individual QR codes can be provided for each of the separation and absorption membranes (e.g., on the membrane or elsewhere on the device), allowing for independent identification of the cellular and liquid components of the biological sample. For automated sample retrieval via punching, as outlined above, a camera can capture images (which can be stored) to provide an indication of how many more samples can be collected from the sample device.

[0084] Some or all of the possible results from the analysis of the collected samples can be fed back to the donor via the app. This can increase the donor's willingness to continue providing samples. Alternatively, for some studies, users may receive some form of reward for collecting samples, which can also be provided via the app.

[0085] The app may also include information such as what analyses the sample donor consented to, and what part of one or more studies the sample may be used for. Information regarding ethical licensing and regulations is also available through the app.

[0086] In some embodiments, the sample may additionally or alternatively be derived from biotechnology. The applicant understands that the invention is extendable to other applications comprising non-biological samples including liquid and solid (e.g., particulate) substances to be separated by filtration, followed by drying. Therefore, when viewed from a fifth aspect, the invention provides an apparatus for separating a sample into solid and liquid components, the sample comprising solid and liquid components, wherein the apparatus includes:

[0087] (i) A front cover and a back cover, which are connected at a hinge portion so that the device can be operated between an open position and a closed position;

[0088] (ii) a separation membrane arranged to retain the solid component and allow the liquid component to pass through it;

[0089] (iii) An absorbent membrane arranged to retain the liquid components;

[0090] The separation membrane and the absorption membrane are arranged in a layered structure between the front cover and the back cover; and

[0091] Opening the device from the closed position to the open position causes the separation membrane and the absorption membrane to bend, thereby applying a compressive force to the membrane.

[0092] Regarding the fifth aspect, the term 'sample' is intended to cover both biological and non-biological samples, which contain both liquid and solid components.

[0093] It will be understood that any and all optional features described in the embodiments of any given aspect of the invention are equally applicable to any and all other aspects of the invention as needed. Attached Figure Description

[0094] Some embodiments of the present invention will now be described with reference to the accompanying drawings, in which:

[0095] Figure 1 A schematic diagram providing a perspective view of an apparatus according to an embodiment of the present invention when in the open position;

[0096] Figure 2 A schematic diagram providing a perspective view of the device in a partially open position;

[0097] Figure 3 A schematic diagram providing a perspective view of the device in its closed position;

[0098] Figure 4 A schematic diagram illustrating the transition of the device from the closed position to the open position;

[0099] Figure 5 A schematic diagram providing a view of the functional membrane of the present invention arranged in a stacked structure;

[0100] Figure 6 A schematic diagram providing a view showing different degrees and distances of bending between either end of a functional membrane;

[0101] Figure 7 A schematic diagram showing a side view of a closed device to illustrate some exemplary measurements;

[0102] Figure 8 This is a schematic diagram showing a simplified side view of half the strain distance;

[0103] Figure 9 A schematic diagram illustrating the strain distance, providing a simplified side view of the opening device;

[0104] Figure 10 A schematic diagram providing a view of the optical markings on the device;

[0105] Figures 11A to 11C This is a schematic diagram illustrating the change in the mechanism by which the functional membrane bends when the display device of the present invention is opened;

[0106] Figure 12 A schematic diagram illustrating an embodiment of the invention including a pull wire. Detailed Implementation

[0107] Figures 1 to 3 These schematic diagrams illustrate an apparatus 100 according to an embodiment of the present invention. Specifically, these schematic diagrams are respectively shown in... Figure 1 , Figure 2 and Figure 3 The device 100 is shown in three different configurations: open, partially open, and closed.

[0108] Specifically Figure 1 and Figure 2 The present invention is illustrated by a device 100 comprising a front cover 1 and a back cover 2 connected by a hinge portion 11. The front cover 1 and the back cover 2 are secured to each other at the hinge portion 11. This securing can be achieved in various ways, such as by using an adhesive, for example, glue or tape, and the hinge portion 11 may include a standard hinge, such as a door hinge. However, in this particular embodiment, the hinge portion 11 is provided by a folding member between the front cover 1 and the back cover 2, the folding member having an integral construction and, in this embodiment, being made from the same piece of cardboard.

[0109] As from Figure 1 As can be clearly seen, the device 100 further includes functional membranes: a separation membrane 6 and an absorption membrane 7 arranged in a stacked or layered structure. Figure 1 In the specific embodiment depicted, the separation membrane 6 and the absorbent membrane 7 below it are curved and side-by-side to compress the membranes tightly against each other. The separation membrane 6 may be, for example, 3MM, GF / CM30, GF / QA30, S&S 903, GB002, GB003, GB004 or Vivid plasma separation membrane. The absorbent membrane 7 can be, for example, S&S 903 cellulose (from logs or cotton) or... Sample collection cards, such as Waterman 903 or Waterman Grade 1 paper.

[0110] Figure 1 and Figure 2 The free ends 8 of membranes 6 and 7 are also depicted, which in this embodiment are not fixed to the back cover 2 of device 100. The free ends 8 of the separating membrane 6 and the absorbing membrane 7 are connected to each other by, for example, an adhesive material or by sewing the separating membrane 6 and the absorbing membrane 7 together, as shown in the figure. Figure 5 As shown in [the image / document]. Figure 1As can be seen, the fixed ends 9 of the separation membrane 6 and the absorption membrane 7 are fixed to the back cover 2 by the elongated anchor 4, which allows the strain portion 5 to slide laterally across the back cover 4 under the 'tunnel' formed by the elongated anchor 4.

[0111] The strain section also has a free end 13, which can be attached to the free ends 8 of the separation membrane 6 and the absorption membrane 7 by means of, for example, adhesive or by means of sew pins, as described below. Figure 5 As described. The function of this strain section 5 is to pull the free ends of the separation membrane 6 and the absorption membrane 7 13 closer to the hinge section 11. This will have the effect of bending the two membranes 6, 7 and forcing them into close contact with each other in the process to ensure efficient wicking of liquid from the biological sample deposited on the separation membrane 6 to the absorption membrane 7. The fixed end 14 of the strain section 5 can be attached to the front cover 1 of the device via the backing part fixing member 3. The strain section 5 also includes a strain section folding member 10, which allows the strain section 5 to fold when the device 100 is closed.

[0112] Figure 3 The device 100 is shown when fully closed. It is thus readily apparent that the device 100 allows for easy storage and transport (including transport via regular mail). Furthermore, multiple individual devices, such as... Figure 3 The device 100 depicted can be easily stacked and stored, similar to stacking bookshelves containing books.

[0113] Figure 4 Showing from Figure 3 The closed position shown in the figure is as follows Figure 1 The transition of the opening device shown in the figure (via Figure 2 (Partially open position). This diagram clearly shows that the hinge portion 11 allows the device to pivot around the folding element, thereby allowing the front cover 1 to move away from the back cover 2.

[0114] like Figure 1 and Figure 2 As shown in, and again in Figure 4 As shown, the free ends 8 of membranes 6 and 7 are pulled toward the separation membrane and absorbent membrane fixing member 9 and the strain portion fixing member 3. The strain portion 5 provides a relatively rigid actuator for pulling the free ends 8 toward the hinge portion 11, thereby causing membranes 6 and 7 to bend upward and thereby imparting a compressive 'strain' force to the separation membrane 6 and absorbent membrane 7, that is, they are squeezed together upward as stacked layers 6 and 7, while the strain portion 5 remains flat.

[0115] Therefore, when the device is opened, the free end of the strain section 13 slides along the back cover 2, thereby pulling the free ends 8 of the membranes 6 and 7 closer to the hinge section 11 of the device 100. This pulling of 13 causes the free ends 8 of the membranes 6 and 7 to bend. This forces the membranes 6 and 7 into close contact and compresses them, keeping them tightly held together. Thus, when the device 100 opens with the compressive force applied to the membranes 6 and 7, a relatively uniform pressure is applied to them. This ensures that liquid is efficiently wicked from the biological sample deposited on the separation membrane 6 to the absorption membrane 7. It can be clearly seen from the accompanying drawings how the separation membrane 6 and the absorption membrane 7 become tightly pressed against each other when bent.

[0116] When device 100 is in such a state Figure 1 When the configuration shown is open, a biological sample—which may be, for example, blood—is applied to the apex of the layered structure formed by the separation membrane 6 and the absorption membrane 7. As described above, the separation membrane 6 includes a filter that filters the liquid components of the biological sample while capturing the solid cellular components, which in this example are blood cells. The absorption membrane 7 includes absorbent paper that captures the liquid components of the biological sample, which in this example are plasma.

[0117] The liquid component of the biological sample, i.e., plasma in this example, will be drawn through separation membrane 6 and collected on absorption membrane 7. This is driven by capillary action, whereby the absorption of the liquid component onto absorption membrane 7 drives the flow of the liquid component through separation membrane 6. For effective separation of the biological sample, it is advantageous to provide a uniform pressure applied across the separation membrane 6 and absorption membrane 7. Figure 1 The bending of the separation membrane 6 and the absorption membrane 7 depicted in the figure serves as an effective component for applying substantially uniform pressure to the separation membrane 6 and the absorption membrane 7.

[0118] It will be understood that the device opens by bending the separation membrane 6 and the absorption membrane 7 in a manner similar to a so-called 'pop-up book', as the action of opening the book to a new pair of pages pulls the paper fixed to the page, thereby causing the paper to rise from its previously flattened page.

[0119] Once the biological sample is applied to the apex of the layered structure formed by the separation membrane 6 and the absorption membrane 7, sufficient time should be given for the sample to separate into cellular components, and then returned to the apparatus 100 as follows: Figure 3 The device is essentially dry before being closed as shown in the diagram. The amount of time required for drying will vary depending on the type of sample and material selected – however, instructions can be easily provided to the user regarding how long they should open the device 100 for drying, depending on the intended application.

[0120] Separating and drying biological samples on individual membranes 6 and 7 is an attractive method for collecting and maintaining samples. This can be used, for example, to stabilize samples by reducing enzyme activity in the dried state for short- or long-term storage, thereby simplifying the standardization of sampling. The drying process can also be used to remove well-known variables that produce inconsistent treatments, such as those attributed to hemolysis or other forms of cell death, nucleic acid or protein degradation, or other alterations, such as post-translational modifications of proteins. Material obtained from, for example, a single drop of dried blood is sufficient for many different types of analysis. Several smaller samples of the same dried blood sample can be used for analysis of, for example, nucleic acids, proteins, or metabolites.

[0121] When the device 100 is closed, the free ends 8 of membranes 6 and 7 will move away from the separation and absorption membrane fixing members 9 and the strain portion fixing member 3. Therefore, the separation membrane 6 and the absorption membrane 7 will no longer be compressed and will return to their flat positions; thus allowing the front cover 1 and the back cover 2 to close above the separation membrane 6, the absorption membrane 7 and the strain portion 5.

[0122] Figure 5 A closer view is provided of the functional membranes 6, 7 of the present invention arranged in a stacked structure. It will be understood that... Figure 5 Like other diagrams, this is a schematic illustration and is not drawn to scale.

[0123] As outlined above, the separation membrane 6 and the absorption membrane 7 are arranged in a stacked or layered structure. Biological samples, such as blood, can be applied to the separation membrane 6. Figure 5 In the specific embodiment depicted, the separating membrane 6 and the absorbent membrane 7 are held together by a pin 12. This pin 12 is used to anchor the free ends 8 of the separating membrane 6 and the absorbent membrane 7 to each other. An elongated anchor 4 at the fixed end 9 anchors the separating membrane 6 and the absorbent membrane 7 to the back cover 2, such that the membranes 6, 7 and the strain portion 5 slide under the 'tunnel' formed by the anchor 4 in the direction indicated by arrow 17.

[0124] Figure 6 The demonstration showcases several different curvatures of a stacked separation membrane 6 and absorption membrane 7, tested to determine suitable curvatures for efficiently wicking liquid components of biological samples onto the absorption membrane 7. Separation membrane 6 and absorption membrane 7 are shown as follows: Figure 5 The arrangement depicted is such that the separation membrane 6 is on top of the absorption membrane 7.

[0125] In this specific experimental setup, Vivid grade paper is used as the filter paper for separation membrane 6, and Waterman grade 1 paper is used as the absorption membrane 7. In this specific embodiment, when laid flat, i.e., when membranes 6 and 7 are not subjected to any kind of bending, membranes 6 and 7 are 5 cm long.

[0126] When the application Figure 6When various curvatures were shown, more efficient wicking was observed for shorter settings. Specifically, more efficient wicking was observed for settings of 0.5cm, 1.4cm, and 2.3cm than for settings of 5cm (flat) and 3.2cm, but the optimal size may actually depend on the specific membrane used.

[0127] Figure 7 The device 100 of the present invention in a closed configuration is depicted and a cross-sectional view is provided so that some exemplary dimensions of the device 100 can be seen. In this specific embodiment, the front cover 1 and the back cover 2 are 10 cm long, the strain portion 5 is 8.75 cm long, and the separation membrane 6 and the absorption membrane 7 are 5 cm long. However, it will be understood that other lengths may be used alternatively.

[0128] Figure 8 and Figure 9 The simplified form of the display device 100 omits the separation membrane 6 and the absorption membrane 7 used for illustrative purposes in both the closed and open configurations. Figure 8 The half-strain distance of strain section 5 is further demonstrated. Figure 9 The full strain distance of strain section 5 is shown. As discussed above, strain section 5 is essentially 'rigid' and restricted to sliding along 2 in order to apply tension to separation membrane 6 and absorption membrane 7, and to impart an 'upward' compressive strain force to these membranes 6 and 7 when the device 100 is opened.

[0129] As previously outlined, pulling the free ends 8 of membranes 6 and 7 toward the fixed ends 9 of the strain portion retainer 3 allows the rigid strain portion 5 to apply force to the separation membrane 6 and the absorption membrane 7. This forces the separation membrane 6 and the absorption membrane 7 to bend and compress these membranes 6 and 7, causing them to become tightly held together. In this specific embodiment, the strain distance is as follows: Figure 9 The value shown is 2.5 cm; however, other values ​​can be readily used, depending on the choice of membrane used for the separation and absorption of sample components.

[0130] Figure 10 This is a schematic diagram providing a view of the optical mark 15 on the device 100. Specifically, Figure 10The provision of QR codes 15 on the front cover 1 and back cover 2 of device 100 is described. In this embodiment, each device 100 has a unique QR code 15 printed on both the front cover 1 and back cover 2. However, it will be understood that these QR codes 15 may be printed elsewhere on device 100 or added to device 100 via some other component (e.g., adhesive sticker). For example, it may be advantageous to print the QR code 15 on the 'ridge' of the device, i.e., on the exterior of a portion of hinge 11, so that the QR code 15 can be easily scanned when device 100 is in a stack, thereby allowing easy identification of the sample associated with the device. Furthermore, it may also be advantageous to read the same QR code in the open state, for example, when taking pictures after stamping out a sample specimen.

[0131] These QR codes 15 are used to identify which samples come from which subjects when, for example, the collection device 100 is used, through a biobank. When the device 100, as outlined above, is supplied to a subject (e.g., a human patient), a user can scan the QR codes 15 using an external device to associate the biological sample with the subject, wherein this 'external device' can be a device such as a smartphone or tablet computer having a camera suitable for scanning QR codes 15 in components known in the art itself. In another example, a separate QR code or other identifier may be applied to both membranes to ensure that the source of the sample retrieved from the membrane, such as cells or plasma, can be correctly identified. However, it will be understood that a separate QR code or other identifier may be applied at any location on the device.

[0132] For example, the device can run an application (or 'app') that captures details of the subject. Specifically, in this embodiment, the user must provide login credentials; that is, the user (who could be the subject themselves or another person assisting in the sampling of the subject, such as a friend, family member, caregiver, nurse, doctor, clinician, etc.) must log in to the app using a username and password that uniquely identify them or the subject. User credentials can be verified, for example, locally or via a remote server, and result in the appropriate selection of the correct user identifier associated with the subject or user.

[0133] Once logged into the application, one or more QR codes 15 can be scanned to 'bind' a device identifier associated with device 100 to a user identifier associated with a subject or user. The user identifier and device identifier can be stored together as a linked pair in a database, either locally or remotely as needed, ensuring that samples collected on device 100, as outlined above, are properly attributed to the correct subject. Generally, the linked user identifier and device identifier pair will be transmitted to a remote server containing the database, for example, to a biobank that collected device 100.

[0134] At the biobank itself, one or more QR codes15 can be scanned to identify the user identifier and device identifier, so that measurements and conclusions related to the cellular and liquid components of the biological sample can be stored in a database about the correct subject.

[0135] Sample identifiers may be provided in addition to or in place of the device identifier. These sample identifiers may relate to specific solid and liquid samples (i.e., corresponding to membranes 6 and 7 themselves), and these identifiers may be stored in a database and linked to the correct user identifier.

[0136] Figure 11 is a schematic diagram showing a variation of the design of the device 100. Components with apostrophe (') correspond to the apostrophe used above to indicate similar components without apostrophe, meaning that their form and function are essentially the same. Figures 11A to 11C The difference in the design of the device 100 shown is in the back cover 2', which has an additional fold or flap 16. This additional flap 16 is found at the end of the back cover 2' opposite to the hinge portion 11' and is attached to the free ends 8' of the separation membrane 6' and the absorption membrane 7'.

[0137] The transition of device 100 from the closed position to the open position can be referenced. Figures 11A to 11C Understanding, of which: Figure 11A Show the closed position; Figure 11B The display section opens at the following location; and Figure 11C The open position is shown. In this particular set of embodiments, the free end 13' of the strain portion 5' attached to the additional flap slides along the back cover 2' toward the hinge portion 11', and in doing so, pulls the flap of the back cover 2'. This movement pulls the flap of the back cover 2', causing it to fold, as... Figure 11C As depicted in the description. The folding of the additional flap 16 of the back cover 2' acts as a substitute member, through which the strain portion 5' pulls the separation membrane 6' and the absorption membrane 7' to induce bending of these membranes and thereby cause compressive forces thereon as previously outlined.

[0138] Figure 12 The schematic diagram illustrates another embodiment of the invention, wherein the device 200 includes a manually operable actuating component. Elements with reference numerals bearing a double apostrophe (“) correspond to reference numerals used above to indicate similar components without the apostrophe, i.e., their form and function are substantially equivalent.

[0139] Specifically, the manually operable actuating component of the device 200 includes a pull wire 18. Pulling the pull wire 18 in the direction indicated by arrow 19 causes the separating membrane 6 and the absorbent membrane 7 to bend, thereby applying a further compressive force to the membranes.

[0140] In this specific embodiment, the strain section 10” pull wire 18 arrangement can be combined with any of the methods outlined above, wherein the method of fixing the membrane to the cover of the device can be combined such that opening the device applies a first compressive force to the membrane, and pulling the pull wire applies an additional compressive force to the membrane.

[0141] The apparatus according to embodiments of the invention can readily provide suitable separation and collection of biological samples obtained, for example, by finger puncture. Cellular and liquid components, with donor approval, can be readily fragmented into samples to be processed in a clinical chemistry laboratory. This will enable diagnostic testing of the samples for medical and health purposes and will allow for the collection, transportation, accumulation, and long-term storage of large biobanks at minimal cost, facilitating subsequent work with reference to earlier samples. Similar biological sample collection will also be valuable, for example, in veterinary medicine.

[0142] The device of the present invention will be significant for, for example, anticipated sample collection and collection related to disease, treatment, or health. The device described herein allows for the affordable collection of samples from a very large number of donors and potentially the collection of numerous samples from individuals. As described above, there is an increasing concern among individuals regarding the supply of biological samples (e.g., blood) for health purposes. The demand for biological samples for individuals with analyses regarding, for example, general health examinations and nutritional status, (autoimmune) status, signs of infection, etc. The device of the present invention provides a user-friendly component by which a healthy, conscious individual can simply prick their finger and send samples for analysis via regular mail. Such devices also provide patients undergoing treatment with the opportunity to obtain routine follow-up samples at their own homes and send these samples for analysis. Furthermore, sample donors participating in, for example, research programs or clinical trials can be monitored through biological samples obtained by individuals at their homes. It is also readily apparent that a low-cost, anticipated, and disease-specific biobank can be collected and maintained using the device described herein. The device of the present invention with the collected material can also be easily stored in large quantities, whether stored, for example, at room temperature or in a freezer.

[0143] The apparatus of the present invention can also be used to allow the detection and analysis of genetic material, such as DNA or RNA, in the cellular and liquid components of biological samples. It is well known in the art, per se, that genetic material can be analyzed in dried biological samples. In the case of blood samples, even after perfect separation of the liquid and cellular components, DNA or RNA will be present in the cellular component and cell-free DNA or RNA will be present in the liquid component. By separating and collecting the dried cellular and liquid components, the apparatus of the present invention provides an efficient method for analyzing both cellular-based DNA and cell-free DNA, as well as cellular-based RNA and cell-free RNA.

[0144] The availability of collection devices, such as those described herein, for preserving the cellular and liquid components of biological samples facilitates the application of current molecular analytical assays for biological samples and the development of new molecular analytical assays. Those skilled in the art will be well aware of examples of suitable molecular analyses of collected biological samples, such as blood. For example, the number of cells from different hematopoietic lineages, including subsets of, for example, different forms of T cells, can be estimated by measuring the levels of characteristic transcripts or proteins collected from the blood sample. Those skilled in the art will readily recognize several suitable techniques available for protein measurements, such as adjacent ligation assays or multiple adjacent extension assays, enzyme-linked immunosorbent assays (ELISA) (e.g., direct, sandwich, competitive, or reverse ELISA), or mass spectrometry. In the case of nucleic acid analysis, various forms of polymerase chain reaction (PCR) or related amplification methods can be utilized, such as real-time PCR, reverse transcriptase PCR, digital PCR, or loop-mediated isothermal amplification (LAMP) or sequence-dependent amplification (NASBA) assays, such as lock-probe ligation assays. The development of assays for metabolites or other analytes via, for example, mass spectrometry is also of interest.

[0145] Therefore, it will be understood that embodiments of the present invention provide a device that facilitates the separation of cellular and liquid components of biological samples in a small, lightweight, inexpensive, and easily disposable package highly suitable for both storage and transport. As summarized above, this device may have a 'book-like' structure, which allows multiple such devices to be easily stacked in a manner similar to books on a bookshelf.

[0146] Although specific embodiments of the invention have been described in detail, those skilled in the art will understand that the detailed embodiments are not limited to the scope of the invention.

Claims

1. An apparatus for separating a biological sample into solid and liquid components, the apparatus comprising: (i) A front cover and a back cover, which are connected at a hinge portion to enable the device to operate between an open position and a closed position; (ii) a separation membrane arranged to retain the solid component and allow the liquid component to pass through it; as well as (iii) An absorbent membrane arranged to retain the liquid components; The separation membrane and the absorption membrane are arranged in a layered structure between the front cover and the back cover; and Opening the device from the closed position to the open position causes the separation membrane and the absorption membrane to bend, thereby applying a compressive force to the membrane. The separation membrane includes a first fixed end and a first free end, and the absorption membrane includes a second fixed end and a second free end. The first fixed end and the second fixed end are fixed to the front cover or the back cover at or near the hinge portion of the device. The first free end and the second free end are fixed together and can move freely laterally relative to the first fixed end and the second fixed end when the device moves between the open position and the closed position.

2. The apparatus of claim 1, wherein the separating membrane and the absorbing membrane are secured by an elongated anchor extending across the width of the apparatus.

3. The apparatus according to claim 2, wherein, The elongated anchor extends across the entire width of the device.

4. The apparatus according to claim 1, wherein the separation membrane is disposed above the absorption membrane.

5. The apparatus of claim 1, wherein the apparatus further comprises a strain section.

6. The apparatus of claim 5, wherein the strain portion is disposed beneath the absorbent membrane in the layered structure.

7. The apparatus of claim 5, wherein the opening of the apparatus causes the strain portion to apply the compressive force to the separation membrane and the absorption membrane.

8. The apparatus of claim 1, wherein the separating membrane and the absorbing membrane can be retrieved separately by stamping the membrane.

9. The device according to claim 1, wherein the front cover and / or the back cover are made of a perforated material.

10. The apparatus of claim 9, wherein the perforable material comprises cardboard.

11. The apparatus of claim 1, wherein the separation membrane comprises a filter that filters the liquid component of the biological sample while capturing the solid component.

12. The apparatus of claim 1, wherein the separation membrane layer comprises a single separation membrane or multiple separation membranes.

13. The apparatus of claim 1, wherein the absorbent membrane comprises absorbent paper that captures the liquid components of the biological sample.

14. The apparatus of claim 1, wherein the separation membrane or plurality of separation membranes is impregnated with an active agent.

15. A method for separating a biological sample into solid and liquid components using the apparatus according to any one of claims 1 to 14, the method comprising: (i) Open the device; (ii) Provide samples from individuals; (iii) Apply the sample to the layered structure; (iv) Dry the biological sample; as well as (v) Close the device.

16. The method of claim 15, wherein the sample is provided in a non-invasive manner.

17. The method according to claim 16, wherein, The non-invasive method involves pricking a finger and the sample is blood.

18. The method of claim 15, wherein after step (iv), separating leaflets are provided to interleave the separating membrane and the absorption membrane.

19. The method of claim 15, wherein after step (v), the solid component and the liquid component are removed by punching the sample out of the apparatus.

20. The method of claim 15, wherein after step (v), the device can be easily stored and stacked for transport.

21. The method of claim 15, wherein the biological sample is at least one of the following: blood, cerebrospinal fluid, urine, saliva, tears, lymph, tissue fluid, bronchoalveolar lavage fluid (BAL), and ascites.

22. The method of claim 21, wherein the biological sample is blood.

23. The method of claim 15, wherein the separation of the biological sample into solid and liquid components occurs via capillary action.

24. The method of claim 15, wherein the solid component comprises: The cells that make up the sample.

25. An apparatus for separating a biological sample into solid and liquid components, the apparatus comprising: (i) A front cover and a back cover, which are connected at a hinge portion to enable the device to operate between an open position and a closed position; (ii) a separation membrane arranged to retain the solid component and allow the liquid component to pass through it; (iii) An absorbent membrane arranged to retain the liquid components; as well as (iv) Actuating components that can be manually operated; The separation membrane and the absorption membrane are arranged in a layered structure between the front cover and the back cover; and The manually operable actuating component is arranged such that, during operation, the actuating component causes the separating membrane and the absorbent membrane to bend, thereby applying a compressive force to the membrane. The separation membrane includes a first fixed end and a first free end, and the absorption membrane includes a second fixed end and a second free end. The first fixed end and the second fixed end are fixed to the front cover or the back cover at or near the hinge portion of the device. The first free end and the second free end are fixed together and can move freely laterally relative to the first fixed end and the second fixed end when the device moves between the open position and the closed position.

26. The apparatus of claim 25, wherein the manually operable actuating component comprises a pull wire, wherein pulling the pull wire causes the separating membrane and the absorbing membrane to bend, thereby applying the compressive force to the membrane.

27. A method for identifying a biological sample, said biological sample being obtained using the apparatus according to any one of claims 1 to 14 or 25 to 26, said method comprising: Receive user credentials and use the user credentials to retrieve a user identifier; Scan the optical markings on the device to retrieve the device identifier; as well as The user identifier and the device identifier are stored as a link pair in the database.

28. A non-transitory computer-readable medium comprising instructions that, when executed on a processor, cause the processor to perform a method for identifying a biological sample obtained using the apparatus according to any one of claims 1 to 14 or 25 to 26, the method comprising: Receive user credentials and use the user credentials to retrieve a user identifier; Scan the optical markings on the device to retrieve the device identifier; as well as The user identifier and the device identifier are stored as a link pair in the database.

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