Certifiable sample collection kit for collecting plant samples and its use

Abstract

A sample collection kit (100) for collecting plant samples, particularly algae samples for biomedical applications, includes at least one sample container (10) adapted to receive the plant sample, a sensor arrangement (20) having a plurality of sensors that can be used to capture sample data, a data recording device (30) adapted to record the sample data, an equipment arrangement (40, 50) having collection implements adapted to harvest the plant sample and processing implements adapted to process the plant sample, a container device (70) adapted to receive the equipment arrangement and device arrangement while isolated from the surrounding environment, and identification markings (80) containing identification data and attached to at least one of the sample container, the collection implement, and the processing implement. An authentication device (90) is provided, the authentication device (90) including an electronically readable data carrier containing authentication data representative of the status of the sample collection kit (100), and the authentication device (90) is attached to at least one of the container device (70), the at least one sample container, the collection implement, and the processing implement. An authentication arrangement (300) and method for checking the status of the sample collection kit are also described.

Description

[Technical Field]

[0001] The present invention relates to a sample collection kit suitable for collecting plant samples, in particular for collecting algae samples for biomedical applications. Furthermore, the present invention relates to an authentication arrangement and a method for checking the condition of the sample collection kit. The present invention can be used in the collection of samples for obtaining plant extracts, in particular for biomedical applications, e.g. for obtaining alginate granules. [Background technology]

[0002] It is generally known to obtain alginate from natural algae samples. Alginate has many biomedical applications, such as in the manufacture of implants or in cell biology. In particular, these applications require a specific purity of the alginate and a reproducible process chain from the outdoor collection of algae to obtaining and processing the alginate in the laboratory.

[0003] EP 3257586 A1 ("Probe collection kit and collection kit for algae samples from field collection, insbesondere of algae samples") describes a sample collection kit that can be applied throughout the complete process chain, from field collection of algae to processing in the laboratory. The sample collection kit is used at all stages of the process chain and therefore makes it possible to follow the process chain reproducibly.

[0004] However, practical experience has shown that alginate may still exhibit undesirable variations in biofunctionality, even when collected and processed with a sample collection kit according to EP 3257586. It should be noted that, despite checking the sample collection kit before its use and strict compliance with the collection and transport conditions, it is not always possible to reliably meet the requirements for the approval of plant products for medical use, in particular the guidelines for quality assurance of the production flow and the surrounding environment (e.g. GMP, "Good Manufacturing Practices").

[0005] The above-mentioned problems arise not only in the collection of algae and the obtaining of alginates, but also in the collection of other plant samples, for example for the production of active ingredients. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] European Patent Application Publication No. 3257586 Summary of the Invention [Problem to be solved by the invention]

[0007] The object of the present invention is to provide an improved sample collection kit for collecting plant samples, in particular algal samples, as well as an improved device and method for checking the condition of the sample collection kit, respectively, so that the drawbacks of the prior art can be avoided. In particular, the sample collection kit and the checking of its condition should enable the use of the sample collection kit and / or the obtaining of alginate with improved reliability and reproducibility of the collection and processing of algae. Furthermore, compliance with standards for quality assurance, such as GMP standards, should be further improved.

[0008] This object is achieved by a sample collection kit and an authentication arrangement and method for checking the status of a sample collection kit, respectively, having the features of the independent claims. Advantageous embodiments and applications of the invention result from the dependent claims. [Means for solving the problem]

[0009] According to a first general aspect of the present invention, the above-mentioned object is achieved by a sample collection kit adapted for collecting plant samples, particularly algae samples for biomedical applications. The sample collection kit comprises at least one sample container adapted to receive a plant sample; a sensor arrangement having a plurality of sensors that can be used to capture sample data; a data recording device adapted to record the sample data; an equipment arrangement having a collection instrument adapted to harvest the plant sample and a processing instrument adapted to process the plant sample; a container device adapted to receive the equipment arrangement and the device arrangement in an isolated environment; and identification markings containing identification data and attached to the at least one sample container, the collection instrument, and the processing instrument. Optionally, a device arrangement may further be provided having auxiliary devices that can be used for collecting, transporting, and processing the plant sample. The identification markings may, for example, comprise a barcode, preferably in waterproof form, a QR code, a radio-frequency readable memory, particularly a transponder, and / or numbers and / or characters containing the identification data.

[0010] According to the present invention, the sample collection kit further comprises an authentication device including an electronically readable data carrier (data memory) containing authentication data representative of the status of the sample collection kit, the authentication device being attached to at least one of the container device, the at least one sample container, the collection instrument and the processing instrument. Preferably, the data carrier is connected to an interface for reading out the authentication data. The interface may be part of the authentication device or may be a different component of the sample collection kit. The sample collection kit may include a single or multiple authentication devices.

[0011] According to a second general aspect of the present invention, the above object is achieved by an authentication arrangement comprising a sample collection kit adapted to test the status of a sample collection kit or an embodiment of said sample collection kit according to the first general aspect of the present invention and including an authentication device, and a test device adapted to read out the authentication data and authenticate the sample collection kit.

[0012] According to a third general aspect of the present invention, the above object is achieved by a method for testing the status of a sample collection kit or an embodiment of said sample collection kit according to the first general aspect of the present invention, the method comprising the steps of reading authentication data and authenticating the sample collection kit with a testing device, and generating a control signal in response to authentication based on the authentication data, for activating at least one of an alarm system, a mechanical shut-off device and an electronic shut-off device. The method for testing the status of the sample collection kit may be performed once before use begins, or as needed during use, or multiple times at different stages of use of the sample collection kit, or continuously during use of the sample collection kit.

[0013] Authentication involves verifying the authenticity and usability of the sample collection kit by means of authentication data. Preferably, the authentication data is compared with reference data of genuine (originally manufactured) ready-to-use sample collection kits. Authentication preferably results in the generation of a control signal. The control signal may be generated as a blocking signal only in the case of a negative result. Alternatively, the control signal may be generated in both cases, i.e., as an enabling signal in the case of a positive result and as a blocking signal in the case of a negative result.

[0014] Research by the inventors has shown that in actual applications, users may use conventional sample collection kits, for example, according to EP 3257586 A1, beyond the specified validity period at the collection site. Furthermore, the inventors have found that the use of kits that have exceeded their validity period, particularly their instruments and / or chemical treatments, may have a negative impact on the acquisition of plant samples. It should also be noted that sample collection kits may be fraudulently reassembled from parts of used kits and / or tampered parts, which may be confused with the original sample collection kits that were manufactured. Outdated and / or fraudulently assembled sample collection kits may compromise the entire system, resulting in plant samples, particularly alginates, being produced under irreproducible conditions and, in the most undesirable cases, even being contaminated.

[0015] By providing a sample collection kit with an authentication device according to the invention, the process chain from collecting the plant to obtaining and processing the plant sample from the plant can be advantageously protected against tampering or user error. The authentication device advantageously allows for the reading of authentication data and authentication of the sample collection kit by a testing device. A particular advantage of authentication is that the use of tampered and / or outdated sample collection kits is excluded.

[0016] In conventional sample collection kits, identification markings are already provided that allow for the identification of each component of the sample collection kit. This identification allows for correlation of the components in the sample collection kit with the actual plant sample obtained. However, in contrast to the additionally provided authentication device of the present invention, conventional identification markings do not contain information about the overall status of the sample collection kit. The term "status of the sample collection kit" relates to the overall configuration of the sample collection kit as a connection relationship of its components. Information on the identification markings, preferably all of the identification markings, may be included in the authentication data.

[0017] The specimen collection kit acquires new functionality through the authentication device, and depending on the result of the authentication, the use of the specimen collection kit can be enabled (or continued) or disabled (or stopped).

[0018] The authentication device is preferably provided in addition to the identification marking. It is particularly preferred that the data carrier of the authentication device is provided separately from the identification marking. If the identification marking also includes an electronically readable data carrier, the authentication device is preferably separated from the identification marking in an electrical and / or software-based manner. The data carrier of the authentication device forms a so-called "secure enclave" data memory. The authentication device is also preferably arranged separately from an optionally provided control device of the sample collection kit in an electrical and / or software-based manner. It is particularly preferred that access of the control device to the authentication device is excluded. The authentication device is preferably a ROM memory.

[0019] According to a preferred embodiment of the present invention, the authentication data of the electronically readable data carrier of the authentication device represents at least one of the original configuration of the sample collection kit and the expiration date of the sample collection kit. The authentication data makes it possible to advantageously check whether the original components in the sample collection kit match their original configuration and / or whether a predetermined useful life of the sample collection kit has been exceeded. This allows the most important usage errors by users to be monitored and eliminated in an advantageous manner.

[0020] The authentication data on the electronically readable data carrier of the authentication device particularly preferably 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 of the present invention, authentication of the sample collection kit can include a two-stage authentication with a first check of at least one of the original condition of the sample collection kit and the expiration date of the sample collection kit, and a second check of the identity of the components of the sample collection kit. The authentication configuration inspection device is preferably adapted for two-stage authentication. The first check preferably compares the stored information of the information marking with the data of the original components. The second check preferably compares all of the data of the original components with a predetermined original configuration and its service life. In the event of a negative test result, the authentication result is negative.

[0021] According to a further preferred embodiment of the invention, the authentication device is adapted to store encrypted authentication data. The encryption advantageously precludes fraudulent circumvention of the monitoring of the sample collection kit by the user. The authentication data cannot be tampered with or changed by the user. It is particularly preferred to provide a cryptographic encryption of the authentication data.

[0022] The test device in the authentication configuration is preferably adapted to decrypt the authentication data, and advantageously the test device can immediately perform a decryption between the reading of the authentication data and the authentication of the sample collection kit.

[0023] The authentication device may be adapted for wired access to the authentication data, particularly advantageously for wired readout of the authentication data. In this case, the data carrier of the authentication device is provided with a conductor interface, for example a plug connection, for providing a connection to a checking device and for analyzing the stored authentication data. Unauthorized wireless access to the data carrier is thus advantageously excluded.

[0024] Alternatively or additionally, the authentication device may be adapted for wireless access to the authentication data, in particular for wireless readout of the authentication data, in which case advantages are offered by the possibility of rapid testing of the sample collection kit and / or parallel testing of several sample collection kits.

[0025] A further advantage of the present invention is that different types of authentication devices are applicable. According to a preferred variant, the authentication device comprises at least one of at least one RFID beacon, at least one mobile radio SIM card, at least one WLAN transceiver unit, a satellite telephone unit and at least one Bluetooth beacon. These types of authentication devices have particular advantages with regard to wireless readout of authentication data by using available, robust and optionally inexpensive technology.

[0026] According to a particularly preferred embodiment of the present invention, the authentication device is concealed and invisible when the sample collection kit is in use. The authentication device is preferably mounted within the sample collection kit, in particular within at least one member of its components, such that the authentication device is completely or almost completely covered by the member, apart from an optionally provided connector interface. The authentication device may, for example, be embedded in a plastic member of a kit component. This makes the authentication device unrecognizable to the user and / or advantageously protected against unauthorized removal or replacement.

[0027] Alternatively or additionally, the authentication device may be attached to the sample collection kit such that the authentication device cannot be separated from the sample collection kit without mechanically damaging the sample collection kit.

[0028] According to a further preferred embodiment of the present invention, the specimen collection kit comprises a control device connected to the authentication device and adapted to control at least one of an alarm system, a mechanical cut-off device and an electronic cut-off device in response to authentication based on the authentication data, whereby the function of the authentication device can be more easily and optionally automated in an advantageous manner.

[0029] Controlling at least one of the alarm system, mechanical shut-off device and electronic shut-off device preferably includes changing the operational state of the specimen collection kit, for example shutting down at least one of its functions.

[0030] According to a preferred embodiment of the authentication arrangement, the test device is adapted to generate a control signal by means of which at least one of an alarm system, a mechanical shut-off device and an electronic shut-off device can be activated in response to authentication based on the authentication data. A control device of the specimen collection kit can particularly preferably be connected to the test device for receiving the control signal.

[0031] The alarm system is designed, for example, for an acoustically and / or visually perceptible alarm at the sample collection kit and / or at a remote location of the kit. The alarm system may be adapted to transmit a signal to a central monitoring device. The mechanical shut-off device is adapted to prevent mechanical access to the sample collection kit. The mechanical shut-off device may, for example, comprise a mechanical latch that shuts off the sample collection kit when, for example, closing the container device, in the event of a negative authentication result. The electronic shut-off device is correspondingly adapted to shut off electrically operated components of the sample collection kit. In the event of a negative authentication result, the electronic shut-off device may switch off electrically operated components, such as, for example, a data recording device.

[0032] Further details and advantages of the invention will be explained below with reference to the accompanying drawings. [Brief explanation of the drawings]

[0033] [Figure 1] FIG. 1 is a block diagram of a sample collection kit having features according to a preferred embodiment of the present invention. [Figure 2] 1 is a flow chart of a method for testing the condition of a specimen collection kit having features according to a preferred embodiment of the present invention. [Figure 3] FIG. 1 is a perspective view of a specimen collection kit having a stack of multiple container modules. DETAILED DESCRIPTION OF THE INVENTION

[0034] In the following, features of preferred embodiments of the present invention will be described with exemplary reference to a sample collection kit for collecting algae samples for the production of alginate, as known from EP 3257586. EP 3257586 is fully incorporated by reference into the present disclosure, in particular with regard to the sample collection kit and its uses, such as the provision of the components of the sample collection kit and their properties.

[0035] As described in EP-A-3257586, the algae sample is preferably obtained from macroalgae, particularly the Laminaria algae species. However, the implementation of the present invention is not limited to the sample collection kit from EP-A-3257586 or its use in collecting algae, but can also be applied to other sample collection kits with different configurations and / or different uses, e.g., without the modular structure described in EP-A-3257586. The working materials for collecting algae samples included in the sample collection kit are mentioned in an exemplary manner. In particular, the implementation of the present invention is not limited to the use of the actually mentioned instruments and auxiliary devices, but may be realized using modified processing materials adapted to the actual application. Details of the collection and processing of algae samples and the selection of suitable algae species are not discussed below, as they are well known and common.

[0036] 1 is a schematic diagram of a sample collection kit 100 and a test device 200 having features of a preferred embodiment of the present invention. The sample collection kit 100 and the test device 200 together represent one embodiment of an authentication arrangement 300 according to the present invention. The test device 200 optionally includes a computer having a display, which may be connected to the sample collection kit 100 via wires or wirelessly.

[0037] In a preferred application of the present invention, the test device 200 is positioned at a specific distance from the sample collection kit 100. For example, a single test device 200 may be positioned to authenticate one or more sample collection kits 100.

[0038] Alternatively, the testing device 200 may be incorporated into the sample collection kit 100. In this case, the authentication arrangement 300 includes the testing device 200 integrated with the sample collection kit 100. The testing device 200 may be provided, for example, by a control device 95 that is optionally included in the sample collection kit 100.

[0039] The control device 95 comprises a control circuit, for example a computer circuit, in which data of the components of the sample collection kit 100 and / or control signals of the testing device 200 are received and control signals are generated, in particular for the control of the alarm system 96 and / or the mechanical and / or electronic shut-off device 97.

[0040] The sample collection kit 100 includes a plurality of sample containers 10, such as storage bags and / or storage bottles, within a container device 70. Prior to use of the sample collection kit 100, the sample containers 10 are included either empty or pre-filled with treatment solution and ready to be received by the sample collection kit 100. After collecting the plant sample, the containers 10 filled with the plant sample are included in the sample collection kit 100 or in a separate collection container.

[0041] Furthermore, the sample collection kit 100 comprises a sensor device 20 in the container device 70, the sensor device 20 being adapted to detect external conditions, in particular during the collection, transport and / or processing of plant samples, and comprising at least one sensor. For example, the temperature of the sample collection kit 100, the humidity of the air, the salt content, the CO2 content and / or mechanical acceleration in the external medium and / or the sample container can be detected using the sensor device 20. The sensor device 20 is connected to a data recording device 30 and / or an optionally provided control device 95.

[0042] As described in EP 3257586 A1, further components may be included in the container device 70 of the sample collection kit 100, such as a data recording device 30, an instrument arrangement 40, 50, a device arrangement 60 with auxiliary devices, an energy storage device such as a rechargeable battery, and an identification marking 80. The data recording device 30 is connected to a control device 95. Optionally, the electrically driven or electronic parts of the components 40, 50, 60, and 80 may also be connected to the control device 95.

[0043] The container device 70 may comprise one single container that together houses all components of the sample collection kit 100. Preferably, the container device 70 according to Figure 3 comprises a number of container modules 71, 72, 73 and 74, inside which the components of the sample collection kit 100 according to Figure 1 are housed. In such a case, which is also described in EP 3257586 A1, the sample collection kit 100 forms a case, which may be carried by a handle 75 or may be transported manually to the sample collection site.

[0044] In accordance with the present invention, the specimen collection kit 100 includes at least one authentication device 90. The authentication device 90 is included as part of the specimen collection kit 100 within the container device 70, and is preferably concealed and embedded in a member of the container device 70, for example, by casting in a plastic member of the container device 70. Alternatively or additionally, at least one authentication device 90 is provided in one or more components of the specimen collection kit 100. The authentication device 90 is shown schematically in FIG. 3, where the dashed line indicates that the authentication device 90 is not visible to a user of the specimen collection kit 100.

[0045] As shown schematically in FIG. 1 , the authentication device 90 comprises an electronic data carrier 91 and a wireless interface 92 and / or a wired interface 93. The authentication device 90 is supplied with electrical energy by an energy storage device (not shown) of the sample collection kit 100 or an internal rechargeable battery. The energy supply may be wired or inductive. The data carrier 91 is an electronic storage device, such as a mobile wireless SIM card, that contains authentication data. The stored authentication data may include, for example, a list with multiple data characteristics relative to the initial state of the sample collection kit 100. These preferably include, for example, the service life of the sample collection kit 100 and / or a list of components included in the sample collection kit 100, each of which includes respective identification data. Alternatively or additionally, further authentication data may be stored in the authentication device 90. The authentication data may be stored in the authentication device 90 in an encrypted manner.

[0046] 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 may be provided by an optical connection, in which case the wireless interface 91 is formed by a light source. The details of the wireless interface 91 are selected depending on the actual technical configuration. For example, a mobile radio antenna or a Bluetooth antenna is provided. The wired interface 92 comprises, for example, a USB port for connecting the inspection device 200 to the authentication device 90.

[0047] An implementation of a method for testing the status of a sample collection kit 100 is shown schematically in Figure 2. First, authentication data is read from the authentication device 90 (step S1). Reading involves transferring the authentication data to the testing device 200 via a wireless interface 91 and / or a wired interface 92.

[0048] Subsequently, the sample collection kit 100 is authenticated by the test device 200, using the received authentication data (step S2). Authentication optionally includes decoding 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 case of a positive authentication, an enable signal may be generated as a control signal, which is designed, for example, to release a blocking device and / or to generate an optically and / or acoustically perceptible signal that the sample collection kit 100 is enabled.

[0049] If a deviation of the authentication data from the reference data is detected, a shut-off signal is preferably generated as a control signal to activate an alarm system 96 and / or shut-off device 97 to preclude further use of the sample collection kit 100 (step S3).

[0050] If the inspection device 200 is connected to or included in the control device 95, the control signal may be generated by the control device 95. Contrary to the illustration according to Figure 1, the inspection device 200 may also be directly connected to the alarm system 96 and / or the shut-off device 97 in order to directly transmit the control signal.

[0051] In summary, the present invention provides a sample collection kit with electronic authentication capabilities. For example, an RFID beacon or similar readable data carrier is used to verify the authenticity of the sample collection kit. A check of the kit's integrity can be performed in two stages. A first check can determine whether it is the original kit and whether its expiration date has not been exceeded. A second check checks whether the kit's components match, i.e., whether they are the original components of the original kit. If authentication fails, a shutdown of the kit or a control device contained in the kit can be performed. Furthermore, a warning message can be generated.

[0052] The features of the invention disclosed in the above description, in the drawings, and in the claims may be used both singly and in combination or subcombination to realize the invention in its different embodiments.

Claims

1. at least one sample container (10) adapted to receive a plant sample; a sensor arrangement (20) having a plurality of sensors (21, 22, ...) that can be used to capture sample data; a data recording device (30) adapted to record said sample data; A collection device (41, 42) adapted to collect the plant sample , . . . ) and processing tools (51, 52) adapted to process the plant sample. , . . . ), and a container device (70) adapted to receive said instrument arrangement in isolation from the surrounding environment; and a processing device (51, 52) for processing said at least one sample container, said collection device (41, 42, . . . ), and said processing device (51, 52) and an identification marking (80) attached to the sample collection kit (100), suitable for collecting plant samples, in particular algae samples for biomedical applications, comprising: The sample collection kit (100) further comprises an authentication device (90) including an electronically readable data carrier having authentication data representative of the overall status of the sample collection kit (100); The authentication device (90) is provided in addition to the identification marking (80), The authentication data represents the overall configuration of the sample collection kit (100) as a connection relationship of components; the authentication data is provided to verify the authenticity and usefulness of the sample collection kit; The authentication device (90) is connected to the container device (70), the at least one sample container, the collection devices (41, 42, . . . ) and the processing devices (51, 52). , . . . .) and The authentication device (90) is provided separately from the identification marking (80). Sample collection kit (100).

2. the authentication data on the electronically readable data carrier of the authentication device (90) represents at least one of the original configuration of the sample collection kit (100) and the expiration date of the sample collection kit (100); The sample collection kit of claim 1 .

3. The authentication device (90) is adapted to store encrypted authentication data. The sample collection kit of claim 1 or 2.

4. the authentication device (90) is adapted for wired access to the authentication data; The sample collection kit according to any one of claims 1 to 3.

5. the authentication device (90) is adapted for wireless reading of the authentication data; The sample collection kit according to any one of claims 1 to 4.

6. the authentication device (90) comprises at least one of at least one RFID beacon, at least one mobile radio SIM card, at least one WLAN transceiver unit, a satellite telephone unit, and at least one Bluetooth beacon; The sample collection kit according to any one of claims 1 to 5.

7. The authentication device (90) is covertly positioned and is not visible when the sample collection kit (100) is in use. The sample collection kit according to any one of claims 1 to 6.

8. a control device (95) connected to the authentication device (90) and adapted to control at least one of an alarm system (96), a mechanical shut-off device (97), and an electronic shut-off device (97) in response to authentication based on the authentication data; The sample collection kit according to any one of claims 1 to 7.

9. The authentication device (90) is connected to an interface for reading the authentication data. The sample collection kit according to any one of claims 1 to 8.

10. An authentication arrangement (300) adapted to check the status of a specimen collection kit (100) according to any one of claims 1 to 9, comprising: the sample collection kit (100) including the authentication device (90); a test device (200) adapted to read the authentication data and authenticate the sample collection kit; An authentication arrangement (300) comprising:

11. the testing device (200) is adapted for a two-step authentication comprising a first check of the original condition of at least one sample collection kit and the expiration date of the sample collection kit, and a second check of the identity of components of the sample collection kit; The authentication arrangement of claim 10.

12. The inspection device (200) is adapted to generate a control signal for activating at least one of an alarm system (96), a mechanical shut-off device (96), and an electronic shut-off device (96) in response to authentication based on the authentication data.

12. An authentication arrangement according to claim 10 or 11.

13. the inspection device (200) is adapted to decrypt the authentication data; 13. An authentication arrangement according to any one of claims 10 to 12.

14. 10. A method for testing the condition of a specimen collection kit (100) according to any one of claims 1 to 9, comprising: a testing device (200) reading the authentication data to authenticate the sample collection kit (100); and a control device (95) generating a control signal to activate at least one of an alarm system (96), a mechanical shut-off device (97), and an electronic shut-off device (97) in response to authentication based on the authentication data.

15. The authentication of the sample collection kit (100) comprises a two-step authentication of a first check of the original condition of at least one sample collection kit (100) and the expiration date of the sample collection kit (100), and a second check of the identity of the components of the sample collection kit (100).

15. The method of claim 14.

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