This application is a 35 U.S.C. § 371 National Stage Application of PCT/EP2017/077451, filed on Oct. 26, 2017, which claims the benefit of priority to Serial No. DE 10 2016 222 075.6, filed on Nov. 10, 2016 in Germany, the disclosures of which are incorporated herein by reference in their entirety.

BACKGROUND

When performing tests and analyses of samples in the clinical laboratory, samples are usually processed together with personal data, in particular patient data. In this context it is of particular interest to ensure that no accidental confusion of samples, patient information or results occurs.

Particularly in the case of automated analysis systems, such as lab-on-a-chip systems for in vitro diagnostics, high demands are placed on the correct sequence of the test or the analysis. To provide unambiguous identification of the sample, this usually involves human- and/or machine-readable information being supplied with the sample.

A lab-on-a-chip cartridge with integrated RFID for transmitting information relevant to the sample is known, for example, from EP 2611042 B1, US 20150056099 A1 and US 20140030800 A1.

SUMMARY

The disclosure relates to a method for processing a cartridge, in particular a microfluidic cartridge, and a biological sample with a processing unit, which is received into the cartridge. In a first step, sample data is entered or read into the processing unit, before the sample is inserted into the cartridge and before the cartridge is received into the processing unit. In a second step, initial cartridge data is entered or input into the processing unit. Alternatively, the entry or reading of the initial cartridge data can be carried out even before the entry or reading of the sample data. The input of the sample data and/or the first cartridge data can be carried out manually by a user via an input device of the processing unit, for example using a keypad or a touch screen of the processing unit. Alternatively, the sample data and/or the first cartridge data can be read in, for example, via an optical reader of the processing unit, such as a code scanner. In a third step a comparison of the sample data with the first cartridge data for compatibility of the sample with the cartridge is performed by the processing unit, wherein the comparison is carried out, for example, in a dedicated computing unit, also called a processor, of the processing unit. In a fourth step a first error message is issued by the processing unit, if no compatibility of the sample with the cartridge can be detected by the processing unit. The message can be issued, for example, optically via a display of the processing unit or acoustically via a speaker of the processing unit. If no first error message appears, in a fifth step the sample is inserted into the cartridge and the cartridge is received into the processing unit for further processing.

The processing unit may be understood to mean, in particular, an analysis unit for analyzing the biological sample received in the cartridge, in particular a microfluidic processing unit. The biological sample can be, in particular, a blood sample, a urine sample, a saliva sample or a sample taken from a swab. A processing of the sample can be understood, in particular, to mean the performance of a test with the sample, using the cartridge into which the sample is received. For example, the test can take the form of an assay, in particular a molecular-biological assay, for example for detecting a particular substance or specific pathogens such as viruses, bacteria or fungi in the sample. Typically, a cartridge is designed for one or more tests or analysis procedures with one or more specified samples. This means in particular that one or more predefined test steps for a test can be performed by actuating the cartridge using the processing unit. For example, the cartridge can be designed to carry out an assay for one of the biological samples referred to above in conjunction with the processing unit. A compatibility of the sample with the cartridge can be understood to mean, in particular, that the sample is suitable for the test that can be performed using the cartridge, such as a blood sample with a cartridge designed for detecting pathogens in blood.

Furthermore, the compatibility of the sample with the cartridge can preferably be understood to mean that an expiration date of the sample and/or the cartridge has not yet been exceeded, since after the expiry of the shelf life, reliable tests can no longer be carried out with the sample and thus the cartridge is not or no longer compatible with the sample.

The processing unit can be configured to load a processing procedure which is compatible with the first cartridge, from a memory of the processing unit. Specific processing procedures compatible with different cartridge types, in particular different molecular biological assays, are preferably stored in the memory.

The method according to the disclosure has the advantage that the processing unit detects and informs the user as to whether a sample is in principle compatible with a cartridge. As mentioned above, it is advantageously detected by the processing unit whether the test is suitable for the test that can be performed by the cartridge. This advantageously reduces the risk that samples might be rendered unusable by being received into a cartridge which is unsuitable for the given sample. This is particularly advantageous when the samples are biological samples from human beings, especially patients, since in addition to the high costs of obtaining such samples, the procedure is typically associated with a physical and mental stress on the part of the human sample donors. The method according to the disclosure thus advantageously reduces the risk that samples become unusable due to incorrect processing. As described above, the unsuitable cartridge might be, for example, the wrong cartridge for a test to be carried out or a cartridge which has exceeded its expiry date. The early warning given to the user in the processing procedure advantageously reduces the risk that a sample will become unusable by insertion into an unsuitable cartridge, or conversely by inserting an unsuitable sample into a cartridge the cartridge becomes unusable.

In a particularly advantageous extension of the method according to the disclosure, in a sixth step second cartridge data is read into the processing unit from the cartridge, the reading being carried out after the cartridge has been received into the processing unit. In a seventh step a comparison of the first cartridge data with the second cartridge data is performed by the processing unit to check for an identical identification data set, the comparison process being carried out, for example, by a dedicated calculation unit of the processing unit. If the first cartridge data and the second cartridge data do not include the identical identification data set, in an eighth step a second error message is issued by the processing unit. The identification data set can be, for example, an alphanumeric character string, by means of which the cartridge can be uniquely identified.

This extension of the method according to the disclosure has the advantage that prior to the start of the further processing of the cartridge received in the processing unit, a check is made to ensure that the received cartridge is the same cartridge whose first cartridge data was entered or read into the processing unit. This can be advantageously used in the event of several cartridges being used in parallel, in particular identical cartridges with different samples, and/or processing units, to prevent the wrong cartridge units from being processed by the processing unit and, in particular, thereby processing the wrong sample. This extension of the method according disclosure thus advantageously further reduces the risk that samples or cartridges become unusable due to incorrect processing.

In an advantageous design of the disclosure the first cartridge data and the second cartridge data are the same cartridge data, which can be read in or entered multiple times. This has the advantage that two different data records do not need to be kept.

In accordance with an advantageous design of the disclosure, the scanning of the first and/or second cartridge data is performed via a transponder, in particular an RFID chip, of the cartridge, wherein the transponder is arranged in particular in an area inaccessible to a user, preferably an interior of the cartridge. An area inaccessible to the user may be understood, in particular, to mean an area of the cartridge to which the user can only gain access by at least partially destroying the cartridge. This has the advantage that the possibility of manipulation of the transponder is made more difficult.

Preferably, the transponder is irreversibly connected to a part of the cartridge, for example, a cover of the cartridge, in an irreversible way, such as via a snap-in connection. An irreversible connection in this case is understood to mean a connection that can only be released in particular by at least the partial destruction of the transponder or of the part that is connected to the transponder. As a result of this irreversible connection, the risk of unwanted manipulation of the cartridge can be further reduced.

According to a further advantageous design of the disclosure, the first cartridge data is read in via an optical scanning of the first cartridge data applied to an outer side of the cartridge, wherein the first cartridge data is applied, in particular, in the form of a one- or two-dimensional code. This has the advantage that the first cartridge data can be scanned in a simple manner via an optical reader of the processing unit. If the reader of the processing unit is configured to allow a readout of the first cartridge data outside of the cartridge, the further advantage exists that due to the application of the first cartridge data on the outside of the cartridge the user is prevented from inserting the cartridge in the processing unit before the first cartridge data is read in.

In a particularly advantageous extension of the disclosure, an expiry date of the cartridge included in the first or second cartridge data is compared with a current date by the processing unit, and if the current date exceeds the expiry date an error message is issued by the processing unit.

In a further advantageous extension of the disclosure, after completion of the processing, information about the completed use of the cartridge is deposited in a memory of the cartridge, for example in a memory of the transponder. This information then preferably forms part of the first or second cartridge data. This has the advantage that in the event of a mistaken intention to re-use the same cartridge, a previously completed usage can be detected by the processing unit. If the first cartridge data and the second cartridge data are not the same cartridge data, it is preferred that the information about the non-usability forms part of the first cartridge data. This has the advantage that a non-usability can be detected before the sample is inserted into the cartridge.

Preferably, if the cartridge is identified as unusable when processing the first or second cartridge data, information about the non-usability is stored in a memory of the cartridge, for example, in a memory of the transponder. This information then preferably forms part of the first or second cartridge data. This has the advantage that in the event of a mistaken intention to re-use the same cartridge, the non-usability of the cartridge can be detected by the processing unit. If the first cartridge data and the second cartridge data are not the same cartridge data, it is preferable that the information about the non-usability forms part of the first cartridge data. This has the advantage that a non-usability can be detected before the sample is inserted into the cartridge.

Preferably, an error message is issued by the processing unit if either the non-usability of the cartridge or the information about the already completed use of the cartridge is detected during processing of the first or second cartridge data. The error message in this case can be issued, for example, optically via a display of the processing unit or acoustically via a loudspeaker of the processing unit. This advantageously enables the user to be informed about an unusable cartridge.

In a particularly preferred extension of the disclosure in the transponder, in particular in a memory of the transponder of the cartridge, a kill-switch for an irreversible destruction of the transponder is set if an expiry date of the cartridge is detected by the processing unit as being exceeded. A kill-switch here can be understood to mean, in particular, an electrical destruction, for example, using a high current, wherein in particular the memory is irreversibly destroyed, so that in the event of a repeated attempted readout of the memory no cartridge data can be read out completely. In addition, the kill-switch can preferably be set if an already completed prior use of the cartridge is detected by the processing unit. Alternatively, the first and/or second cartridge data in a memory of the cartridge can be deleted if the exceedance of the expiry date and/or the previously completed use of the cartridge has been detected by the processing unit.

The subject matter of the disclosure also relates to a processing unit for processing a cartridge, in particular a microfluidic cartridge, and a biological sample which is received into the cartridge. The processing unit has a calculation unit, wherein the calculation unit is configured to compare entered or scanned sample data with entered or scanned first cartridge data for the compatibility of the sample with the cartridge and to issue a first error message if no compatibility of the sample with the cartridge can be determined by the processing unit. In relation to the advantages and definitions of the processing unit according to the disclosure and the following extensions, reference is made to the above comments.

In a particularly preferred extension of the disclosure the calculation unit is additionally configured to compare entered or scanned first cartridge data with second cartridge data read in by the cartridge for an identical identification data set and to issue a second error message if the first cartridge data and the second cartridge data do not include the identical identification data set.

The processing unit, in particular the calculation unit of the processing unit, can preferably be configured in such a way that an opening in a bay of the processing unit for receiving the cartridge is only carried out after the scanning or entry of the first cartridge data, in particular only after a positive comparison of the first cartridge data with a procedure for processing the cartridge stored in a memory of the processing unit. This has the advantage that no cartridges can be accepted into the processing unit that cannot be processed.

The subject matter of the disclosure is also a cartridge, in particular a microfluidic cartridge, for processing a biological sample received into the cartridge. The cartridge comprises first cartridge data applied to an outer side of the cartridge. The cartridge also comprises a transponder, in particular an RFID chip, wherein the transponder comprises a memory for second cartridge data to be deposited or already deposited therein, wherein the first cartridge data and the second cartridge data comprise an identical identification data set. In relation to the advantages and definitions of the cartridge according to the disclosure and the following extensions and designs, reference is made to the above comments.

According to a particularly advantageous design of the disclosure the transponder is arranged in an area inaccessible to a user, preferably an internal region of the cartridge.

The transponder is preferably arranged on an inner side of a part of a cover of the cartridge, wherein the part cannot be non-destructively separated from the cartridge.

Preferably, the first cartridge data is applied to the outer side of the cartridge in the form of a one- or two-dimensional code, in particular in the form of a barcode or a matrix code, such as a QR Code® or DataMatrix™ Code (DMC for short). This has the advantage that the first cartridge data can be scanned in a simple manner using an optical reader of the processing unit. A further advantage is that the application of the first cartridge data to the outside of the cartridge prevents the user from inserting the cartridge in the processing unit before the first cartridge data is read in, if the reader is configured for scanning outside the cartridge.

The subject matter of the disclosure also relates to a processing system comprising a processing unit according to the disclosure and a cartridge according to the disclosure.

