AUTHENTICABLE SAMPLE COLLECTION KIT FOR PLANT SAMPLE COLLECTION AND ITS APPLICATION

Description

[0001] The invention relates to a sample collection kit designed for collecting plant samples, in particular algae samples for biomedical applications. The invention further relates to an authentication arrangement and a method for checking the condition of the sample collection kit. Applications of the invention include sample collection for obtaining plant extracts, especially for biomedical applications, e.g., for producing alginate granules.

[0002] The extraction of alginate from natural algae samples is well-established. Alginate has numerous biomedical applications, such as in the production of implants or in cell biology. For these applications in particular, a high degree of alginate purity and a reproducible process chain are required, from the collection of algae in the wild to the extraction and processing of alginate in the laboratory.

[0003] In EP 3 257 586 A1 and the associated International Patent Application WO2017 / 215939 A1 ("Sample Collection Kit and Method for Collecting Plant Samples, in particular Algal Samples"), a sample collection kit is described that can be used throughout the entire process chain, from the collection of algae in nature to processing in the laboratory. The sample collection kit is used in all phases of the process chain and therefore ensures reproducibility.

[0004] However, practical experience shows that alginates, even when collected and processed using the sample collection kit according to EP 3 257 586 A1, can still exhibit undesirable variations in biofunctionality. It has been found that despite checking the sample collection kits before use and strictly adhering to harvesting and transport conditions, requirements for the approval of plant products for medicinal applications, particularly guidelines for quality assurance of production processes and the environment (e.g., GMP, "Good Manufacturing Practice"), cannot always be reliably met.

[0005] The problems mentioned above occur not only in the collection of algae and the extraction of alginate, but also in the collection of other plant samples, e.g. for the production of active ingredients.

[0006] The object of the invention is to provide an improved sample collection kit for collecting plant samples, in particular algal samples, and an improved device or method for testing the condition of a sample collection kit, thereby avoiding the disadvantages of conventional techniques. The sample collection kit and the testing of its condition are intended, in particular, to enable the use of sample collection kits and / or the production of alginate with increased reliability and reproducibility in the collection and processing of the algae. Furthermore, the invention aims to further improve compliance with quality assurance standards, such as GMP standards.

[0007] This problem is solved by a sample collection kit, an authentication arrangement, and a method for checking the condition of the sample collection kit, respectively, having the features of the independent claims. Advantageous embodiments and applications of the invention are described in the dependent claims.

[0008] According to a first general aspect of the invention, the above-mentioned problem is solved by a sample collection kit designed for collecting plant samples, in particular algae samples for biomedical applications.The sample collection kit comprises at least one sample container configured to receive plant samples, a sensor array with multiple sensors for acquiring sample data, a data recording device configured to record the sample data, a tool array with collection tools configured for harvesting the plant samples and with processing tools configured for processing the plant samples, a container configured to house the tool array and the equipment array in an environment-isolated state, and identification tags containing identification data to which at least one sample container, the collection tools, and the processing tools are attached. Optionally, an equipment array with auxiliary devices for use in collecting, transporting, and processing the plant samples may also be provided.The identification markings include, for example, barcodes, QR codes, wirelessly readable storage devices, in particular transponders and / or strings of numbers and / or letters, preferably in waterproof form, which contain the identification data.

[0009] According to the invention, the sample collection kit further comprises an authentication device containing an electronically readable data carrier (data storage) with authentication data representing a state of the sample collection kit, wherein the authentication device is attached to at least one of the container assembly, the at least one sample container, the collection tools, and the processing tools. Preferably, the data carrier is coupled with an interface for reading the authentication data. The interface can be part of the authentication device or another component of the sample collection kit. The sample collection kit can contain one or more authentication devices.

[0010] According to a second general aspect of the invention, the above-mentioned problem is solved by an authentication arrangement which is configured to check a state of the sample collection kit according to the first general aspect of the invention or an embodiment of the sample collection kit and which comprises the sample collection kit containing the authentication device and a test device configured to read the authentication data and to authenticate the sample collection kit.

[0011] According to a third general aspect of the invention, the aforementioned problem is solved by a method for checking the condition of the sample collection kit according to the first general aspect of the invention or an embodiment of the sample collection kit, comprising the steps of reading the authentication data and authenticating the sample collection kit with a test device and generating a control signal with which at least one of an alarm device, a mechanical blocking device, and an electronic blocking device can be activated, depending on authentication based on the authentication data. The method for checking the condition of the sample collection kit can be performed once before the start of the application or as needed during the application, or multiple times in different phases of the application of the sample collection kit, or continuously during the application of the sample collection kit.

[0012] Authentication comprises verifying the authenticity and usability of the sample collection kit based on the authentication data. Preferably, the authentication data is compared with reference data from a genuine (originally manufactured), usable sample collection kit. The result of the authentication preferably generates the control signal. It can be provided that the control signal is generated only as a blocking signal if the result is negative. Alternatively, it can be provided that the control signal is generated in all cases: as a release signal if the result is positive and as a blocking signal if the result is negative.

[0013] Investigations by the inventors have revealed that, in practical application, a conventional sample collection kit, e.g., according to EP 3 257 586 A1, can be used by the user at the collection site beyond its specified shelf life. Furthermore, the inventors have determined that using a kit, particularly its tools and / or chemical treatments, beyond its shelf life can adversely affect the collection of plant samples. It has also been found that an unauthorized sample collection kit can be reassembled from parts of used kits and / or counterfeit parts, and this reassembled kit can be mistaken for an original, manufactured sample collection kit.Outdated and / or unauthorized sample collection kits can compromise the overall system, as they lead to plant samples, especially alginate, being produced under non-reproducible conditions, or in the worst case, even contaminated.

[0014] By equipping a sample collection kit with an authentication device according to the invention, the process chain from plant collection to the extraction and processing of plant samples can advantageously be secured against falsification or user error. The authentication device advantageously enables the reading of the authentication data and the authentication of the sample collection kit with the test device. A particular advantage of the authentication is that the use of counterfeit and / or expired sample collection kits is prevented.

[0015] Conventional sample collection kits already include identification markers that allow for the identification of individual components within the kit. This identification enables the components of the sample collection kit to be linked to the specific plant samples obtained. However, unlike the authentication device additionally provided according to the invention, conventional identification markers do not contain any information about the overall condition of the sample collection kit. The term "condition of the sample collection kit" refers to the overall configuration of the kit as a combination of its components. The information contained in the identification markers, preferably all of them, can be included in the authentication data.

[0016] The authentication device adds a new functionality to the sample collection kit. Depending on the authentication result, the use of the sample collection kit can be enabled (or continued) or blocked (or aborted).

[0017] According to the invention, the authentication device is provided in addition to the identification marks. Furthermore, according to the invention, the data carrier of the authentication device is provided separately from the identification marks. If the identification marks also include electronically readable data carriers, the authentication device is preferably separated from the identification marks electrically and / or by software. The data carrier of the authentication device forms a so-called "secure enclave" data storage device. Preferably, the authentication device is also arranged electrically and / or by software separately from an optionally provided control unit of the sample collection kit. Access from the control unit to the authentication device is particularly preferably excluded. Preferably, the authentication device is a ROM memory.

[0018] According to a preferred embodiment of the invention, the authentication data of the electronically readable data carrier of the authentication device represents at least one original configuration of the sample collection kit and an expiration date of the sample collection kit. This authentication data advantageously allows verification of whether the original components in the sample collection kit are compatible with an original configuration and / or whether a predetermined usage period of the sample collection kit has been exceeded. Advantageously, this enables the monitoring and elimination of the most important user errors.

[0019] Preferably, the authentication data of the electronically readable data carrier of the authentication device includes information about both the original configuration of the sample collection kit and the expiration date of the sample collection kit. According to a preferred embodiment of the method according to the invention, the authentication of the sample collection kit can comprise a two-stage authentication process with a first test of the original state of the at least one sample collection kit and its expiration date, and a second test of the compatibility of the parts of the sample collection kit. Preferably, the test device of the authentication arrangement is configured for the two-stage authentication. In the first test, the stored information of the information markers is preferably compared with data from original components.In the second test, the entirety of the data from the original components is preferably compared with a predefined original configuration and its durability. If the test results are negative, the authentication result is negative.

[0020] According to a further preferred embodiment of the invention, the authentication device is configured for storing encrypted authentication data. The encryption advantageously prevents unauthorized circumvention of the monitoring of the sample collection kit by users. The authentication data cannot be forged or altered by users. Cryptographic encryption of the authentication data is particularly preferred.

[0021] Preferably, the test device of the authentication arrangement is configured to decrypt the authentication data. Advantageously, the test device can perform the decryption directly between reading the authentication data and authenticating the sample collection kit.

[0022] Advantageously, the authentication device can be configured for wired access to the authentication data, particularly for wired retrieval of the authentication data. In this case, the authentication device's data carrier is equipped with a wired interface, such as a connector, to establish a connection with a test device and analyze the stored authentication data. This advantageously prevents unauthorized wireless access to the data carrier.

[0023] Alternatively or additionally, the authentication device can be configured for wireless access to the authentication data, in particular for wireless retrieval of the authentication data. In this case, advantages arise from a rapid verification of the sample collection kit and / or the possibility of parallelizing the verification of a large number of sample collection kits.

[0024] A further advantage of the invention is that various types of authentication devices can be used. According to preferred embodiments, the authentication device comprises at least one RFID beacon, at least one mobile SIM card, at least one WLAN transceiver, one satellite phone unit, and at least one Bluetooth beacon. These types of authentication devices offer particular advantages with regard to the wireless reading of authentication data using readily available, robust, and potentially cost-effective technology.

[0025] According to a particularly preferred embodiment of the invention, the authentication device is concealed and invisible during use of the sample collection kit. Preferably, the authentication device is integrated into the sample collection kit, particularly into the material of at least one of its components, such that the authentication device is completely or, apart from the optionally provided wiring interface, almost completely covered by the material. The authentication device can, for example, be embedded in the plastic material of a kit component. Advantageously, this makes the authentication device undetectable by the user and / or protects it against unauthorized removal or replacement.

[0026] Alternatively or additionally, the authentication device can be attached to the sample collection kit in such a way that the authentication device cannot be separated from the sample collection kit without causing mechanical damage to the kit.

[0027] According to a further preferred embodiment of the invention, the sample collection kit includes a control unit that is connected to the authentication device and is configured to control at least one alarm device, one mechanical blocking device, and one electronic blocking device, depending on authentication based on the authentication data. Advantageously, this makes the function of the authentication device easier to monitor and, if necessary, to automate.

[0028] Preferably, the control of at least one of the alarm device, the mechanical blocking device and the electronic blocking device comprises a change in the operating state of the sample collection kit, such as blocking at least one of its functions.

[0029] According to a preferred embodiment of the authentication arrangement, the test device is configured to generate a control signal with which at least one of an alarm device, a mechanical blocking device, and an electronic blocking device can be activated, depending on authentication based on the authentication data. Particularly preferably, the control unit of the sample collection kit can be coupled to the test device for receiving the control signal.

[0030] The alarm device is configured, for example, to trigger an audible and / or visual alarm at the sample collection kit and / or remotely. The alarm device may be configured to send a signal to a central monitoring unit. The mechanical blocking device is designed to prevent mechanical access to the sample collection kit. The mechanical blocking device includes, for example, a mechanical latch that blocks the sample collection kit in the event of a negative authentication result, e.g., by closing the container. The electronic blocking device is similarly configured to block electrically operated components of the sample collection kit. In the event of a negative authentication result, the electronic blocking device can deactivate electrically operated components, such as the data recording device.

[0031] Further details and advantages of the invention are described below with reference to the accompanying drawings. These schematically show: Figure 1: a block diagram of a sample collection kit with features according to preferred embodiments of the invention; Figure 2: a flowchart of methods for checking the condition of a sample collection kit with features according to preferred embodiments of the invention; and Figure 3: a perspective view of a sample collection kit with a stack of several container modules.

[0032] Features of preferred embodiments of the invention are described below with exemplary reference to a sample collection kit for collecting algal samples for the production of alginate, as known from EP 3 257 586 A1. EP 3 257 586 A1 is hereby fully incorporated into the present disclosure by reference, in particular with regard to the sample collection kit and its application, such as the provision of the components of the sample collection kit and their properties.

[0033] As described in EP 3 257 586 A1, the algal samples are preferably obtained from macroalgae, in particular from the algal species Laminaria. However, the implementation of the invention is not limited to the sample collection kit from EP 3 257 586 A1 or to its use in algal collection, but can be implemented with other sample collection kits that have a different configuration, e.g., without the modular structure described in EP 3 257 586 A1, and / or a different application. The tools for collecting algal samples included in the sample collection kit are mentioned by way of example. In particular, the implementation of the invention is not limited to the use of the specifically mentioned tools and auxiliary equipment, but can be realized with modified tools adapted to the specific application.Details of the collection and processing of algae samples and the selection of suitable algae species are not explained below, insofar as these are known and commonly used.

[0034] Figure 1 Figure 1 is a schematic overview of a sample collection kit 100 with features of preferred embodiments of the invention and a test device 200. Together, the sample collection kit 100 and the test device 200 represent an embodiment of an authentication arrangement 300 according to the invention. The test device 200 includes a computer, optionally with a display, which can be connected to the sample collection kit 100 via a wired or wireless connection.

[0035] In preferred applications of the invention, the test device 200 is arranged at a distance from the sample collection kit 100. For example, a single test device 200 can be arranged for the authentication of one or more sample collection kits 100.

[0036] Alternatively, the test device 200 can be integrated into the sample collection kit 100. In this case, the authentication arrangement 300 is provided by the sample collection kit 100 with the integrated test device 200. The test device 200 can be provided, for example, by the control unit 95, which is optionally included in the sample collection kit 100.

[0037] The control device 95 comprises a control circuit, such as a computer circuit, in which data from components of the sample collection kit 100 and / or control signals from the test device 200 are received and control signals are generated, in particular for controlling an alarm device 96 and / or a mechanical and / or electronic blocking device 97.

[0038] The sample collection kit 100 comprises a variety of sample containers 10, such as container bags and / or container bottles, housed in a container unit 70. Before use, the empty sample containers 10, or those pre-filled with treatment fluids, are contained within the sample collection kit 100, ready for collection. After plant samples have been collected, the containers 10 filled with the plant samples are contained within the sample collection kit 100 or in a separate collection container.

[0039] Furthermore, the sample collection kit 100 in the container unit 70 includes a sensor unit 20, which is designed to detect environmental conditions, particularly during the collection, transport, and / or processing of plant samples, and contains at least one sensor. The sensor unit 20 can detect, for example, the temperature, humidity, salinity in an ambient medium and / or in a sample container, CO₂ content, and / or mechanical acceleration of the sample collection kit 100. The sensor unit 20 is coupled to a data recording unit 30 and / or to the optionally provided control unit 95.

[0040] Further components, such as the data recording device 30 and a tool arrangement 40, 50, as well as an equipment arrangement 60 with auxiliary devices, an energy storage device, such as a rechargeable battery, and identification markers 80, can be contained in the container arrangement 70 of the sample collection kit 100, as described in EP 3 257 586 A1. The data recording device 30 is coupled to the control unit 95. Optionally, electrically operated or electronic parts of components 40, 50, 60, and 80 can also be coupled to the control unit 95.

[0041] The container arrangement 70 can comprise a single container that holds all components of the sample collection kit 100 together. Preferably, the container arrangement 70 comprises according to Figure 3 several container modules 71, 72, 73 and 74, in which the components of the sample collection kit 100, for example according to Figure 1, are housed. In this case, which is also described in EP 3 257 586 A1, the sample collection kit 100 forms a case portable by 75 handles, which can be transported manually to the sample collection site.

[0042] According to the invention, the sample collection kit 100 includes at least one authentication device 90. The authentication device 90 is included as part of the sample collection kit 100 in the container 70 and is preferably embedded in the material of the container 70, e.g., cast into a plastic material of the container 70. Alternatively or additionally, at least one authentication device 90 is provided on one or more components of the sample collection kit 100. The authentication device 90 is in Figure 3shown schematically, with the dashed illustration symbolizing that the authentication device 90 is not recognizable by the user of the sample collection kit 100.

[0043] The authentication device 90 comprises, as shown schematically in Figure 1The authentication device 90 is illustrated with an electronic data carrier 91 and a wireless interface 92 and / or a wired interface 93. The authentication device 90 is powered by the energy storage device (not shown) of the sample collection kit 100 or by an internal accumulator. The power supply can be wired or inductive. The data carrier 91 is an electronic storage device containing the authentication data, such as a mobile phone SIM card. The stored authentication data includes, for example, a list of numerous data characteristic of the original state of the sample collection kit 100. This preferably includes the shelf life of the sample collection kit 100 and / or a list of the components contained in the sample collection kit 100, each with its identification data.Alternatively or additionally, further authentication data can be stored in authentication device 90. The authentication data can be stored in encrypted form in authentication device 90.

[0044] The wireless interface 92 generally comprises an antenna for emitting electromagnetic radiation, typically in the radio frequency range, which is connected to the data carrier via a driver circuit. Alternatively, wireless information transmission can also be provided via an optical connection, in which case the wireless interface 91 is formed by a light source. Details of the wireless interface 91 are selected depending on the specific technical configuration. For example, a mobile phone antenna or a Bluetooth antenna may be provided. The wired interface 92 includes, for example, a USB port for connecting the test device 200 to the authentication device 90.

[0045] The execution of the procedure for checking the condition of sample collection kit 100 is shown schematically in Figure 2This is illustrated. First, the authentication data is read from the authentication device 90 (step S1). This reading process includes transmitting the authentication data via the wireless interface 91 and / or the wired interface 92 to the test device 200.

[0046] The sample collection kit 100 is then authenticated with the test device 200 using the received authentication data (step S2). This authentication optionally includes decryption of the authentication data. The authentication data is then compared with reference data stored in the test device 200. If a match between the authentication data and the reference data is found, the sample collection kit 100 is considered authenticated. In the event of successful authentication, a release signal can be generated as a control signal, which can be used, for example, to release a blocking device and / or to generate a visually and / or audibly perceptible signal indicating the release of the sample collection kit 100.

[0047] If deviations of the authentication data from the reference data are detected, a blocking signal is preferably generated as a control signal to activate the alarm device 96 and / or the blocking device 97 in order to prevent further use of the sample collection kit 100 (step S3).

[0048] If the test device 200 is coupled to or contained within the control unit 95, the control signal can be generated by the control unit 95. This differs from the illustration shown. Figure 1 The test device 200 can be directly coupled to the alarm device 96 and / or blocking device 97 in order to transmit the control signal directly.

[0049] In summary, the invention provides a sample collection kit with an electronic authentication function. For example, RFID beacons or similar readable data carriers are used to verify the authenticity of the sample collection kit. The integrity of the kit can be verified in two stages. In a first stage, it can be determined whether it is an original kit and whether its expiration date has passed. In a second stage, it is checked whether the kit components are compatible, i.e., whether they are original parts of the original kit. If authentication fails, the kit or a control unit contained within it can be blocked. A warning message can also be generated.

[0050] The features of the invention disclosed in the foregoing description, the drawings and the claims may be important for the realization of the invention in its various embodiments, either individually or in combination or in sub-combination.

Claims

1. Sample collection kit (100) configured to collect plant samples, in particular algae samples for biomedical applications, comprising: - at least one sample container (10) configured for accommodating the plant samples, - a sensor arrangement (20) with several sensors (21, 22, ...), with which sample data can be recorded, - a data recording device (30) configured to record the sample data, - a tool arrangement (40, 50) with collecting tools (41, 42, ...) configured for harvesting the plant samples and with processing tools (51, 52, ...) configured for processing the plant samples, - a container device (70) configured for accommodating the tool arrangement and a device arrangement in a state isolated from the environment, and - identification markings (80) which contain identification data and are attached to the at least one sample container, the collecting tools (41, 42, ...) and the processing tools (51, 52, ...), characterized in that - in addition to the Identification markings (80), an authentication device (90) is provided, which contains an electronically readable data carrier with authentication data, which represent a state of the sample collection kit (100) in its entirety, comprising a general configuration of the sample collection kit (100) as a connection of its components and are provided for a proof of authenticity and usability of the sample collection kit (100), wherein - the authentication device (90) is attached to at least one of the container device (70), the at least one sample container, the collecting tools (41, 42, ...) and the processing tools (51, 52, ...), and - the authentication device (90) is provided separately from the identification markings (80).

2. Sample collection kit according to claim 1, wherein - the authentication data of the electronically readable data carrier of the authentication device (90) represents at least one of an original configuration of the sample collection kit (100) and an expiration date of the sample collection kit (100).

3. Sample collection kit according to any one of the preceding claims, wherein - the authentication device (90) is configured for storing encrypted authentication data.

4. Sample collection kit according to any one of the preceding claims, wherein - the authentication device (90) is configured for wired access to the authentication data.

5. Sample collection kit according to any one of the preceding claims, wherein - the authentication device (90) is configured for wireless readout of the authentication data.

6. Sample collection kit according to any one of the preceding claims, wherein - the authentication device (90) comprises at least one of at least one RFID beacon, at least one mobile SIM card, at least one WLAN transceiver unit, a satellite phone unit and at least one Bluetooth beacon.

7. Sample collection kit according to any one of the preceding claims, wherein - the authentication device (90) is hidden and invisible when the sample collection kit (100) is in use.

8. Sample collection kit according to any one of the preceding claims, further comprising - a control device (95) connected to the authentication device (90) and configured for controlling at least one of an alarm device (96), a mechanical blocking device (97) and an electronic blocking device (97) in dependence on an authentication based on the authentication data.

9. Sample collection kit according to any one of the preceding claims, wherein - the authentication device (90) is coupled to an interface for reading out the authentication data.

10. Authentication arrangement (300) configured to check a state of a sample collection kit (100) according to any one of the preceding claims, comprising - the sample collection kit (100) containing the authentication device (90), and - a test device (200) configured to read out the authentication data and to authenticate the sample collection kit.

11. Authentication arrangement according to claim 10, wherein - the test device (200) is configured for a two-step authentication, comprising a first test of the original state of the at least one sample collection kit and a shelf life date of the sample collection kit and a second test of a membership of the parts of the sample collection kit.

12. Authentication arrangement according to any one of claims 10 to 11, wherein - the test device (200) is configured to generate a control signal for activating at least one of an alarm device (96), a mechanical blocking device (96) and an electronic blocking device (96) in response to an authentication based on the authentication data.

13. Authentication arrangement according to any one of claims 10 to 12, wherein - the test device (200) is configured to decrypt the authentication data.

14. Method for testing a state of a sample collection kit (100) according to any one of claims 1 to 9, comprising the steps of - Reading out the authentication data and authenticating the sample collection kit (100) with a test device (200), and - generating a control signal with which at least one of an alarm device (96), a mechanical blocking device (97) and an electronic blocking device (97) can be activated, depending on an authentication based on the authentication data.

15. Method according to claim 14, wherein - the authentication of the sample collection kit (100) comprises a two-step authentication with a first test of the original state of the at least one sample collection kit (100) and a shelf life date of the sample collection kit (100) and a second test of a membership of the parts of the sample collection kit (100).