Cartridge and analysis system for testing a sample

A cartridge, an analysis system, a method and a computer program product for testing a sample, such as, environmental, food or biological sample, wherein the cartridge has two memory means that are different and/or can be read out by different methods and which correspond to the cartridge or to the batch thereof.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to a cartridge, an analysis system and a method for testing a sample as well as to a computer program product.

Preferably, the present invention deals with analyzing and testing a sample, in particular from a human or animal, particularly preferably for analytics and diagnostics, for example, with regard to the presence of diseases and/or pathogens and/or for determining blood counts, antibodies, hormones, steroids or the like. Therefore, the present invention is in particular within the field of bioanalytics. A food sample, environmental sample or another sample may optionally also be tested, in particular for environmental analytics or food safety and/or for detecting other substances.

Preferably, by means of the present invention, at least one analyte (target analyte) of a sample can be determined, identified or detected. In particular, the sample can be tested for qualitatively or quantitatively determining at least one analyte, for example, in order for it to be possible to detect or identify a disease and/or pathogen.

Within the meaning of the present invention, analytes are in particular nucleic-acid sequences, in particular DNA sequences and/or RNA sequences, and/or proteins, in particular antigens and/or antibodies. In particular, by means of the present invention, nucleic-acid sequences can be determined, identified or detected as analytes of a sample, and/or proteins can be determined, identified or detected as analytes of the sample. More particularly preferably, the present invention deals with systems, devices and other apparatus for carrying out a nucleic-acid assay for detecting or identifying a nucleic-acid sequence and/or a protein assay for detecting or identifying a protein.

The present invention deals in particular with what are known as point-of-care systems, i.e., in particular, with mobile systems, devices and other apparatus, and deals with methods for carrying out tests on a sample at the sampling site and/or independently and/or away from a central laboratory or the like. Preferably, point-of-care systems can be operated autonomously and/or independently of a mains network for supplying electrical power.

Description of Related Art

U.S. Pat. No. 5,096,669 discloses a point-of-care system for testing a biological sample, in particular a blood sample. The system comprises a single-use cartridge and an analysis device. Once the sample has been received, the cartridge is inserted into the analysis device in order to carry out the test. The cartridge comprises a microfluidic system and a sensor apparatus comprising electrodes, which apparatus is calibrated by means of a calibration liquid and is then used to test the sample.

Furthermore, International Patent Application Publication WO 2006/125767 A1 and corresponding U.S. Pat. No. 9,110,044 disclose a point-of-care system for integrated and automated DNA or protein analysis, comprising a single-use cartridge and an analysis device for fully automatically processing and evaluating molecular-diagnostic analyses using the single-use cartridge. The cartridge is designed to receive a sample, in particular blood, and in particular allows cell disruption, PCR and detection of PCR amplification products, which are bonded to capture molecules and provided with a label enzyme, in order for it to be possible to detect bonded PCR amplification products or nucleic sequences as target analytes in what is known as a redox cycling process.

U.S. Patent Application Publication 2014/0030800 A1 discloses methods and compositions for a multipurpose, lab-on-chip device. The device provides on-the-spot testing for micro- and nanoscale (molecular) analysis of a sample. The device can be USB-based and also may include a Bluetooth microchip, an RFID microchip, a wireless microchip and related chip-driver software, which allows data generated by the analytical processing of a sample to be packaged as e-mail or other data-packaging format and sent to a remote recipient.

U.S. Pat. No. 8,383,043 discloses an analyzer system having a sample analyzer which may be a portable sample analyzer that includes a disposable fluidic cartridge. A barcode for identifying the cartridge may be affixed to the cartridge. The sample analyzer may include a bar or other code reader, and, once the cartridge is properly inserted into the analyzer, may read the barcode, and determine if the reagents are the proper reagents for the desired sample analysis, and so on. In addition, an RFID tag may be provided and the analyzer may include a mechanism for reading the RFID tag. The RFID tag can include similar information as the barcode.

U.S. Pat. No. 9,387,476 discloses micro devices and biosensor cartridges for biological or chemical analysis and systems and methods for the same. A workstation including a receptacle for receiving and establishing electrical and fluidic couplings with a biosensor cartridge is provided. The biosensor cartridge may include an identification component to provide identification information of the biosensor cartridge. The system receptacle may automatically scan the identification component when the biosensor cartridge is inserted into the system receptacle. The work station may then communicate information to the user that relates to the biosensor cartridge.

SUMMARY OF THE INVENTION

Point-of-care systems are often designed very specifically for analysing a particular sample in a specific manner, for example, for a blood sugar test or the like. Systems of this kind cannot be used universally.

The problem addressed by the present invention is to provide a cartridge, an analysis system, a method and a computer program product for testing an in particular biological sample, it being possible to implement the analysis system more universally and to perform the test in a more efficient, individual and/or flexible manner.

The above problem is solved by a cartridge, an analysis system, a method and a computer program as described herein.

One aspect of the present invention relates to a cartridge for an analysis system for testing an in particular biological sample.

The cartridge is preferably designed to test the sample. Channels in which the sample can be conveyed and/or treated are in particular provided in said cartridge. This makes it possible for the sample to be pre-treated on the cartridge and/or for the sample to be evaluated by means of a sensor apparatus, which is preferably also located on the cartridge.

The cartridge is preferably designed to receive the sample. Furthermore, the analysis device is preferably designed to receive the cartridge and/or to connect said cartridge electrically, thermally and/or pneumatically.

The analysis system preferably comprises an analysis device and the cartridge. The analysis device is preferably designed to receive and/or connect the cartridge and to subsequently carry out the test using the received cartridge. For this purpose, the cartridge can be inserted or loaded into the analysis device, whereupon the analysis device can act on the cartridge in order to carry out the test.

In one aspect of the present invention, the cartridge comprises two memory means that can be read out by different methods and which each comprise a cartridge identifier, the cartridge identifiers corresponding to the cartridge or to a batch of cartridges.

The different memory means preferably make it possible for the cartridge to be identified by different instruments and/or to be assigned to a batch. This is a particularly significant advantage in the context of analysis systems in which different instruments identify or assign the cartridge, respectively. In this case, for example, a first apparatus can be designed to read out a first of the memory means and a second apparatus of the analysis system can be designed to read out another, second memory means. In particular, the analysis device can be controlled by a smartphone or the like, the smartphone being able to read out one of the memory means and the analysis device being able to read out another of the memory means.

According to another aspect of the present invention, which can also be implemented independently, the cartridge comprises two different cartridge identifiers. In particular, one of the cartridge identifiers identifies the cartridge and/or one, in particular another, of the cartridge identifiers identifies a batch of cartridges with which the cartridge is associated. This provides the advantage that on the one hand cartridge-specific steps and on the other hand batch-specific steps can be carried out. A particular advantage is that the number of different batches is smaller than the number of cartridges. Therefore, the memory and/or the memory capacity for the cartridge identifier that identifies the batch can be smaller than the memory that uniquely identifies the cartridge.

Preferably, one of the memory means is a memory means that can be read out wirelessly, in particular optically or by radio, in particular a barcode, an RFID tag and/or an NFC apparatus. Alternatively or additionally, one of the memory means is a memory means that can be read out electronically, in particular in a wired manner. This provides the advantage that for example, an operating instrument such as a smartphone of the analysis system can first wirelessly read out the cartridge identifier in order to thereby determine or retrieve control and/or evaluation information for carrying out the test. The cartridge can be uniquely identified by the other cartridge identifier.

The memory means that can be read out electronically can preferably be read out or transmitted via the same interface, in particular via contacts, of the cartridge as that via which also measurement results can be read out or transmitted from the cartridge. Consequently, the cartridge identifier can be read out without separate or special tools.

The memory means that can be read out electronically is preferably formed by a sensor apparatus of the cartridge, corresponds to the sensor apparatus and/or uniquely identifies the sensor apparatus. In this case, one or more sensor fields of the sensor apparatus can be formed on or by a semiconductor component, and the memory means that can be read out electronically can be formed on or by the same semiconductor component. As a result, the cartridge identifier can be stored without the need for additional components.

At least one of the memory means, preferably both the memory means, is/are preferably connected to the cartridge and/or formed by the cartridge. This makes it possible for the memory means, and therefore the cartridge identifiers, to be directly physically assigned to the cartridge, in order to prevent confusion and/or in order to ensure that the cartridge is uniquely identified or identifiable.

The cartridge identifier is preferably an identification code or comprises an identification code that uniquely identifies the cartridge and/or a batch with which the cartridge is associated.

Particularly preferably, the memory means that can be read out electronically in a wired manner comprises the cartridge identifier which identifies the cartridge, and the other memory means which can be read out wirelessly comprises the other cartridge identifier which identifies a batch of cartridges with which the cartridge is associated.

Since there are, naturally, fewer batches than cartridges, the cartridge identifier that identifies the batch requires less memory space. Therefore, it is advantageous to store said identifier in a memory means that can be read out wirelessly and thus more easily and more cost-effectively, for example, by means of a barcode or the like. In this case, the storage means can be compact and can therefore be arranged without difficulty on the cartridge or can be formed by the cartridge.

On the other hand, the cartridge identifier which identifies the cartridge requires more memory space and can thus be stored advantageously in a memory means that can be read out electronically in a wired manner, in particular formed on or by the same semiconductor component as the sensor apparatus, as explained above.

Another aspect of the present invention, which can also be implemented independently, relates to an analysis system comprising a proposed cartridge, the analysis system comprising an operating instrument by means of which one of the memory means can be read out, preferably wirelessly, in particular optically. As a result, the cartridge identifier can be read out by the operating instrument, in particular a smartphone, tablet or the like, in a simple manner and without electrical or galvanic contact being established. In particular, the operating instrument determines control information for controlling the test, or evaluation information for evaluating test results using the cartridge identifier.

The analysis system preferably comprises an analysis device by means of which one of the memory means can be read out, preferably electronically, in particular in a wired manner. In this way, the cartridge or control information or evaluation information provided for the test can be identified and/or verified using the cartridge identifier before the start of the test.

In addition, it is preferable for one memory means to be able to be read out by the operating instrument, in particular only by said operating instrument, and/or for the other memory means to be able to be read out by the analysis device, in particular only by said analysis device. In particular, the operating instrument and the analysis device comprise different interfaces, and the cartridge takes account of this, with the result that the cartridge identifier or the cartridge identifiers can be read out without it being necessary for the operating instrument and the analysis device to comprise interfaces for the same memory means.

The analysis system is preferably designed to determine or retrieve control information and/or evaluation information for carrying out the test using a cartridge identifier, in particular the cartridge identifier that can be read out wirelessly.

The analysis system may comprise a database that comprises control information and/or evaluation information for carrying out a test using the cartridge. The database can be controllable or controlled by the cartridge identifier, the control information and/or evaluation information being identifiable, identified, retrievable and/or retrieved from the database by means of the cartridge identifier.

The control information and/or evaluation information can be verified and/or the test can be enabled, unlocked or started using another cartridge identifier, preferably the cartridge identifier that can be read out electronically.

One of the cartridge identifiers, in particular the cartridge identifier that identifies the batch, is thus preferably used for determining and/or retrieving the control information and/or evaluation information, even if the cartridge has not yet been loaded into the analysis device. When a cartridge is inserted into the analysis device, the other cartridge identifier, in particular the cartridge identifier that uniquely identifies the cartridge, can verify whether the control information and/or evaluation information corresponds to the inserted cartridge.

Another aspect of the present invention, which can also be implemented independently, relates to a method for carrying out a test on an in particular biological sample using a cartridge that can be inserted into an analysis device for carrying out the test, a cartridge identifier being read out from a first memory means of the cartridge, and a cartridge identifier being read out from a second memory means of the cartridge that is different from the first memory means, the cartridge identifiers each corresponding to the cartridge and/or to a batch of cartridges. As a result, corresponding advantages and properties can be achieved, as already explained above.

Alternatively, or additionally, a first cartridge identifier and a second cartridge identifier that is different from the first cartridge identifier is/are determined and/or read out, the cartridge identifiers each corresponding to the cartridge and/or to a batch of cartridges.

The cartridge identifier of the first memory means preferably determines or retrieves control information and/or evaluation information for carrying out the test. Furthermore, it is preferable for the cartridge identifier of the second memory means to verify the control information and/or evaluation information, in particular to verify that said information corresponds to the cartridge. As a result, when a cartridge is loaded into the analysis device, it is possible to ensure that the control information and/or evaluation information correspond to the loaded cartridge.

Another aspect of the present invention, which can also be implemented independently, relates to a computer program product comprising program code means which, when executed, in particular by one or more processors or controllers of the analysis system, cause the method steps of the proposed method to be carried out. The computer program product preferably is a non-transitory computer-readable media.

The term “analysis device” is preferably understood to mean an instrument which is in particular mobile and/or can be used on site, and/or which is designed to chemically, biologically and/or physically test and/or analyze a sample or a component thereof, preferably in and/or by means of a cartridge. In particular, the analysis device controls the pretreatment and/or testing of the sample in the cartridge. For this purpose, the analysis device can act on the cartridge, in particular such that the sample is conveyed, temperature-controlled and/or measured in the cartridge.

The term “cartridge” is preferably understood to mean a structural apparatus or unit designed to receive, to store, to physically, chemically and/or biologically treat and/or prepare and/or to measure a sample, preferably in order to make it possible to detect, identify or determine at least one analyte, in particular a protein and/or a nucleic-acid sequence, of the sample.

A cartridge within the meaning of the present invention preferably comprises a fluid system having a plurality of channels, cavities and/or valves for controlling the flow through the channels and/or cavities.

In particular, within the meaning of the present invention, a cartridge is designed to be at least substantially planar, flat and/or card-like, in particular is designed as a (micro)fluidic card and/or is designed as a main body or container that can preferably be closed and/or said cartridge can be inserted and/or plugged into a proposed analysis device when it contains the sample.

The term “operating instrument” is preferably understood to mean an apparatus by means of which the analysis device can be controlled, control information can be transmitted to the analysis device, and/or measurement results can be received from the analysis device and/or measurement results can be evaluated. Preferably, the operating instrument is or forms a user interface for controlling the test and/or the evaluation or outputting of measurement results.

The operating instrument preferably comprises an input apparatus for controlling the analysis device, for controlling data transmission and/or for controlling the evaluation of measurement results. Alternatively, or additionally, the operating instrument comprises an output apparatus for outputting, in particular displaying, information, in particular status information, operating elements and/or results. The operating instrument preferably comprises a processor, microcontroller and/or memory for executing a computer program product for data transmission, for control and/or for evaluating measurement results.

Particularly preferably, the operating instrument is a mobile terminal device, in particular for a radio and/or mobile network, such as a smartphone, tablet computer, mobile telephone or the like. The operating instrument can preferably be operated independently from a power network, using a power storage means, in particular a (rechargeable) battery, and in a mobile manner, autonomously of and/or independently from further components of the analysis system, in particular the analysis device. The operating instrument preferably comprises one or more interfaces for wireless data communications, in particular a WPAN communication interface, a WLAN communication interface, a near-field communication interface, an optical communication interface such as a camera, and/or a mobile radio interface.

The operating instrument can alternatively be called operator control instrument. The operating instrument preferably is configured to be operated by an operator (user) for controlling, in particular of the analysis device, the test and/or the evaluation. Thus, the operating instrument is or comprises a user interface for input of commands and transfer of pieces of control information to the analysis device.

The term “test” as used herein preferably means a test procedure and/or performing an assay, in particular one, several or all steps for performing an assay to determine one or more analytes of a sample. The steps are preferably realized by or within the analysis system, analysis device and/or cartridge.

An “assay” according to the present invention is preferably an investigative procedure for qualitatively and/or quantitatively measuring, detecting and/or identifying the presence, amount, and/or functional activity of a target entity or analyte of the sample. The analyte can, e.g., be a drug, a biological, chemical and/or biochemical substance, and/or a cell in an organism or organic sample. In particular, the analyte can be a molecule, a nucleic-acid sequence, a DNA, an RNA and/or a protein.

Preferably, the assay according to the present invention is a nucleic-acid assay for detecting or identifying a nucleic-acid sequence and/or a protein assay for detecting or identifying a protein.

An assay, test or test procedure according to the present invention accordingly preferably covers at least one of: controlling actuators of the analysis device like a pump drive, temperature control apparatus, and valve actuators; acting on the cartridge or sample; treating the sample; preparing the sample; performing one or more mixing processes and/or reactions with the sample; conveying the sample; and measuring one or more properties of the sample, particularly with the sensor apparatus of the cartridge.

An assay, test or test procedure according to the present invention preferably starts or begins with the analysis device acting on and/or controlling processes on the cartridge and/or the sample. In particular, a test starts or begins with actuators acting on the cartridge. For example, a test can start with conveying the sample within the cartridge.

Methods and/or steps performed before insertion or receiving of the cartridge into/by the analysis device and/or before conveying, treating and/or preparing the sample within said cartridge are preferably not part of an assay, test or test procedure according to the present invention.

The “control information”, thus, preferably is configured to carry out such an assay, test or test procedure or to enable the analysis system or the analysis device to carry out such an assay, test or test procedure. Preferably, said control information is configured to control or to define a control sequence or to be used by the analysis device to carry out said assay, test or test procedure. A “control information”, thus, preferably has instructions being configured for controlling the assay, test or test procedure. In particular, the control information is configured to control an assay, test or test procedure by defining steps or parameters of steps including controlling and/or feedback controlling actuators like the pump drive, the temperature control apparatus and valve actuators.

The sensor apparatus or a sensor array thereof preferably comprises multiple sensor fields and/or electrodes for specifically bonding and/or detecting one or more analytes to be detected or measured. Further, the sensor apparatus preferably is configured for electrical or electrochemical detection of analytes of the sample.

Alternatively, or additionally, the sensor apparatus and/or the sensor device can be configured for detecting or measuring other or further analytes compounds, material characteristics, or the like without specific bonding and/or by means of optical measurement, impedance measurement, capacitance measurement, spectrometric measurement, mass spectrometric measurement, or tomography like MRT. In this regard, the sensor apparatus, thus, can be formed by an arrangement enabling such measurement. In particular, the sensor apparatus or cartridge or any other sample carrier of the analysis device or system can comprise or form a cavity having a window for said optical measurement. The optical sensor or the sensor apparatus, such as a spectrometer, can be realized independently of the cartridge and/or can form part of the analysis device.

In the following, the present invention is explained based primarily on the sensor apparatus having multiple sensor fields and/or being or comprising a chip having electrodes for electrochemical detection. However, unless stated or conductible unambiguously to the contrary, it is to be understood that measurement results alternatively or additionally can be achieved by or can be the outcome of one or more of the above mentioned measurement techniques even if not mentioned explicitly.

The above-mentioned aspects and features of the present invention and the aspects and features of the present invention that will become apparent from the claims and the following description can in principle be implemented independently from one another, but also in any combination or order.

Other aspects, advantages, features and properties of the present invention will become apparent from the claims and the following description of a preferred embodiment with reference to the drawings, in which:

DETAILED DESCRIPTION OF THE INVENTION

In the figures, which are only schematic and sometimes not to scale, the same reference signs are used for the same or similar parts and components, corresponding or comparable properties and advantages being achieved even if these are not repeatedly described.

FIG. 1is a highly schematic view of a proposed analysis system1and analysis device200for testing, in particular, a sample P, preferably by means of or in an apparatus or cartridge100.

FIG. 2is a schematic view of a preferred embodiment of the proposed apparatus or cartridge100for testing the sample P. The apparatus or cartridge100in particular forms a handheld unit, and in the following is merely referred to as a cartridge.

The term “sample” is preferably understood to mean the sample material to be tested, which is in particular taken from a human or animal. In particular, within the meaning of the present invention, a sample is a fluid, such as saliva, blood, urine or another liquid, preferably from a human or animal, or a component thereof. Within the meaning of the present invention, a sample may be pretreated or prepared if necessary, or may come directly from a human or animal or the like, for example. A food sample, environmental sample or another sample may optionally also be tested, in particular for environmental analytics, food safety and/or for detecting other substances, preferably natural substances, but also biological or chemical warfare agents, poisons or the like.

Preferably, the analysis system1and/or analysis device200controls the testing of the sample P in particular in or on the cartridge100and/or is used to evaluate the testing and/or to collect, to process and/or to store measured values from the test.

The analysis system1preferably comprises one or more cartridges100for receiving the sample P.

The analysis system1preferably comprises the analysis device200for receiving the cartridge100and subsequently carrying out the test using the received cartridge100.

By means of the proposed analysis system1, analysis device200and/or cartridge100and/or using the proposed method for testing the sample P, preferably an analyte A of the sample P, in particular a (certain) nucleic-acid sequence and/or a (certain) protein, or particularly preferably a plurality of analytes A of the sample P, can be determined, identified or detected. Said analytes A are in particular detected, identified and/or measured not only qualitatively, but particularly preferably also quantitatively.

Therefore, the sample P can in particular be tested for qualitatively or quantitatively determining at least one analyte A, for example, in order for it to be possible to detect a disease and/or pathogen or to determine other values, which are important for diagnostics, for example.

Particularly preferably, a molecular-biological test is made possible by means of the analysis system1and/or analysis device200and/or by means of the cartridge100.

Particularly preferably, a nucleic-acid assay for detecting a nucleic-acid sequence, in particular a DNA sequence and/or RNA sequence, and/or a protein assay for detecting a protein, in particular an antigen and/or antibody, are made possible or are carried out.

Preferably, the sample P or individual components of the sample P or analyte A can be amplified if necessary, in particular by means of PCR, and tested, identified or detected in the analysis system1, analysis device200and/or in the cartridge100, and/or for the purpose of carrying out the nucleic-acid assay. Preferably, amplification products of the analyte A or analytes A are thus produced.

In the following, further details are first given on a preferred construction of the cartridge100, with features of the cartridge100preferably also directly representing features of the analysis system1, in particular even without any further explicit explanation.

The cartridge100preferably comprises an in particular at least substantially planar, flat, plate-shaped and/or card-like main body or support101, the main body or support101in particular being made of and/or injection-molded from plastics material, particularly preferably polypropylene.

The cartridge100preferably comprises at least one film or cover102for covering the main body101and/or cavities and/or channels formed therein at least in part, in particular on the front, and/or for forming valves or the like, as shown by dashed lines inFIG. 2.

The analysis system1or cartridge100or the main body101thereof, in particular together with the cover102, preferably forms and/or comprises a fluidic system103, referred to in the following as the fluid system103.

The cartridge100, the main body101and/or the fluid system103are preferably at least substantially vertically oriented in the operating position and/or during the test, in particular in the analysis device200, as shown schematically inFIG. 1. In particular, the main plane or surface extension of the cartridge100thus extends at least substantially vertically in the operating position.

The cartridge100and/or the fluid system103preferably comprises a plurality of cavities, in particular at least one receiving cavity104, at least one metering cavity105, at least one intermediate cavity106A-G, at least one mixing cavity107, at least one storage cavity108, at least one reaction cavity109A-C, at least one intermediate temperature-control cavity110and/or at least one collection cavity111, as shown inFIG. 1andFIG. 2.

The cartridge100and/or the fluid system103also preferably comprises at least one pump apparatus112and/or at least one sensor arrangement or sensor apparatus113.

Some, most or all of the cavities are preferably formed by chambers and/or channels or other depressions in the cartridge100and/or the main body101, and particularly preferably are covered or closed by the cover102. However, other structural solutions are also possible.

In the example shown, the cartridge100or the fluid system103preferably comprises two metering cavities105, a plurality of intermediate cavities106A to106G, a plurality of storage cavities108A to108E and/or a plurality of reaction cavities109A-C, which can preferably be loaded separately from one another, in particular a first reaction cavity109A, a second reaction cavity109B and an optional third reaction cavity109C, as can be seen inFIG. 2.

The reaction cavity/cavities109A-C is/are used in particular to carry out an amplification reaction, in particular PCR, or several, preferably different, amplification reactions, in particular PCRs. It is preferable to carry out several, preferably different, PCRs, i.e., PCRs having different primer combinations or primer pairs, in parallel and/or independently and/or in different reaction cavities109A-C.

To carry out the nucleic-acid assay, preferably nucleic-acid sequences, as analytes A of the sample P, are amplified in the reaction cavity/cavities109A-C by means of an amplification reaction, in particular in order to produce amplification products for the subsequent detection in the sensor arrangement or sensor apparatus113.

Within the meaning of the present invention, amplification reactions are in particular molecular-biological reactions in which an analyte A, in particular a nucleic-acid sequence, is amplified/copied and/or in which amplification products, in particular nucleic-acid products, of an analyte A are produced. Particularly preferably, PCRs are amplification reactions within the meaning of the present invention.

“PCR” stands for polymerase chain reaction and is a molecular-biological method by means of which certain analytes A, in particular portions of RNA or RNA sequences or DNA or DNA sequences, of a sample P are amplified, preferably in several cycles, using polymerases or enzymes, in particular in order to then test and/or detect the amplification products or nucleic-acid products. If RNA is intended to be tested and/or amplified, before the PCR is carried out, a cDNA is produced starting from the RNA, in particular using reverse transcriptase. The cDNA is used as a template for the subsequent PCR.

Preferably, during a PCR, a sample P is first denatured by the addition of heat in order to separate the strands of DNA or cDNA. Preferably, primers or nucleotides are then deposited on the separated single strands of DNA or cDNA, and a desired DNA or cDNA sequence is replicated by means of polymerase and/or the missing strand is replaced by means of polymerase. This process is preferably repeated in a plurality of cycles until the desired quantity of the DNA or cDNA sequence is available.

For the PCR, marker primers are preferably used, i.e., primers which (additionally) produce a marker or a label, in particular biotin, on the amplified analyte A or amplification product. This allows or facilitates detection. Preferably, the primers used are biotinylated and/or comprise or form in particular covalently bonded biotin as the label.

The amplification products and/or other portions of the sample P produced in the one or more reaction cavities109A-C can be conducted or fed to the connected sensor arrangement or sensor apparatus113, in particular by means of the pump apparatus112.

The sensor apparatus113is used in particular for detecting, particularly preferably qualitatively and/or quantitatively determining, the analyte A or analytes A of the sample P, in this case particularly preferably the nucleic-acid sequences and/or proteins as the analytes A. Alternatively or additionally, however, other values may also be collected or determined.

As already explained at the outset, in particular nucleic-acid sequences, preferably DNA sequences and/or RNA sequences, and/or proteins, in particular antigens and/or antibodies, are preferably qualitatively and/or quantitatively determined as analytes A of the sample P. In the following, however, a distinction is not made between nucleic-acid sequences and proteins, or between the nucleic-acid assay for detecting nucleic-acid sequences and the protein assay for detecting proteins.

In particular, the pump apparatus112comprises or forms a tube-like or bead-like raised portion, in particular by means of the film or cover102, particularly preferably on the back of the cartridge100, as shown schematically inFIG. 1.

The cartridge100, the main body101and/or the fluid system103preferably comprise a plurality of channels114and/or valves115A,115B, as shown inFIG. 2.

By means of the channels114and/or valves115A,115B, the cavities104to111, the pump apparatus112and/or the sensor arrangement and/or sensor apparatus113can be temporarily and/or permanently fluidically interconnected and/or fluidically separated from one another, as required and/or optionally or selectively, in particular such that they are controlled by the analysis system1or the analysis device200.

The cavities104to111are preferably each fluidically linked or interconnected by a plurality of channels114. Particularly preferably, each cavity is linked or connected by at least two associated channels114, in order to make it possible for fluid to fill, flow through and/or drain from the respective cavities as required.

The fluid transport or the fluid system103is preferably not based on capillary forces, or is not exclusively based on said forces, but in particular is essentially based on the effects of gravity and/or pumping forces and/or compressive forces and/or suction forces that arise, which are particularly preferably generated by the pump or pump apparatus112. In this case, the flows of fluid or the fluid transport and the metering are controlled by accordingly opening and closing the valves115A,115B and/or by accordingly operating the pump or pump apparatus112, in particular by means of a pump drive202of the analysis device200.

Preferably, each of the cavities104to110has an inlet at the top and an outlet at the bottom in the operating position. Therefore, if required, only liquid from the respective cavities can be removed via the outlet.

In the operating position, the liquids from the respective cavities are preferably removed, in particular drawn out, via the outlet that is at the bottom in each case, it preferably being possible for gas or air to flow and/or be pumped into the respective cavities via the inlet that is in particular at the top. In particular, relevant vacuums in the cavities can thus be prevented or at least minimised when conveying the liquids.

In particular, the cavities, particularly preferably the storage cavity/cavities108, the mixing cavity107and/or the receiving cavity104, are each dimensioned and/or oriented in the normal operating position such that, when said cavities are filled with liquid, bubbles of gas or air that may potentially form rise upwards in the operating position, such that the liquid collects above the outlet without bubbles. However, other solutions are also possible here.

The receiving cavity104preferably comprises a connection104A for introducing the sample P. In particular, the sample P may for example, be introduced into the receiving cavity104and/or cartridge100via the connection104A by means of a pipette, syringe or other instrument.

The receiving cavity104preferably comprises an inlet104B, an outlet104C and an optional intermediate connection104D, it preferably being possible for the sample P or a portion thereof to be removed and/or conveyed further via the outlet104C and/or the optional intermediate connection104D. Gas, air or another fluid can flow in and/or be pumped in via the inlet104B, as already explained.

Preferably, the sample P or a portion thereof can be removed, optionally and/or depending on the assay to be carried out, via the outlet104C or the optional intermediate connection104D of the receiving cavity104. In particular, a supernatant of the sample P, such as blood plasma or blood serum, can be discharged, conducted away or removed via the optional intermediate connection104D, in particular for carrying out the protein assay.

Preferably, at least one valve115A,115B is assigned to each cavity, the pump apparatus112and/or the sensor apparatus113and/or is arranged upstream of the respective inlets and/or downstream of the respective outlets.

Preferably, the cavities104to111or sequences of cavities104to111, through which fluid flows in series or in succession for example, can be selectively released and/or fluid can selectively flow therethrough by the assigned valves115A,115B being actuated, and/or said cavities can be fluidically connected to the fluid system103and/or to other cavities.

In particular, the valves115A,115B are formed by the main body101and the film or cover102and/or are formed in another manner, for example, by additional layers, depressions or the like.

Particularly preferably, one or more valves115A are provided which are preferably tightly closed initially or in the storage state, particularly preferably in order to seal liquids or liquid reagents F, located in the storage cavities108, and/or the fluid system103from the open receiving cavity104in a storage-stable manner.

Preferably, an initially closed valve115A is arranged upstream and downstream of each storage cavity108. Said valves are preferably only opened, in particular automatically, when the cartridge100is actually being used and/or while inserting the cartridge100into the analysis device200and/or for carrying out the assay.

A plurality of valves115A, in particular three valves in this case, are preferably assigned to the receiving cavity104, in particular if the intermediate connection104D is provided in addition to the inlet104B and the outlet104C. Depending on the use, in addition to the valve115A on the inlet104B, then preferably only the valve115A either at the outlet104C or at the intermediate connection104D is opened.

The valves115A assigned to the receiving cavity104seal the fluid system103and/or the cartridge100in particular fluidically and/or in a gas-tight manner until the sample P is inserted and the receiving cavity104or a connection104A of the receiving cavity104is closed.

As an alternative or in addition to the valves115A (which are initially closed), one or more valves115B are preferably provided which are not closed in a storage-stable manner and/or which are open initially and/or which can be closed by actuation. These valves are used in particular to control the flows of fluid during the test.

The cartridge100is preferably designed as a microfluidic card and/or the fluid system103is preferably designed as a microfluidic system. In the present invention, the term “microfluidic” is preferably understood to mean that the respective volumes of individual cavities, some of the cavities or all of the cavities104to111and/or channels114are, separately or cumulatively, less than 5 ml or 2 ml, particularly preferably less than 1 ml or 800 μl, in particular less than 600 μl or 300 μl, more particularly preferably less than 200 μl or 100 μl.

Particularly preferably, a sample P having a maximum volume of 5 ml, 2 ml or 1 ml can be introduced into the cartridge100and/or the fluid system103, in particular the receiving cavity104.

Reagents and liquids which are preferably introduced or provided before the test in liquid form as liquids or liquid reagents F and/or in dry form as dry reagents S are required for testing the sample P, as shown in the schematic view according toFIG. 2by reference signs F1to F5and S1to S10.

Furthermore, other liquids F, in particular in the form of a wash buffer, solvent for dry reagents S and/or a substrate, for example, in order to form detection molecules and/or a redox system, are also preferably required for the test, the detection process and/or for other purposes, and are in particular provided in the cartridge100, i.e., are likewise introduced before use, in particular before delivery. At some points in the following, a distinction is not made between liquid reagents and other liquids, and therefore the respective explanations are accordingly also mutually applicable.

The analysis system1or the cartridge100preferably contains all the reagents and liquids required for pretreating the sample P and/or for carrying out the test or assay, in particular for carrying out one or more amplification reactions or PCRs, and therefore, particularly preferably, it is only necessary to receive the optionally pretreated sample P.

The cartridge100or the fluid system103preferably comprises a bypass114A that can optionally be used, in order for it to be possible, if necessary, to conduct or convey the sample P or components thereof past the reaction cavities109A-C and/or, by bypassing the optional intermediate temperature-control cavity110, also directly to the sensor apparatus113.

The cartridge100, the fluid system103and/or the channels114preferably comprise sensor portions116or other apparatus for detecting liquid fronts and/or flows of fluid.

It is noted that various components, such as the channels114, the valves115A,115B, in particular the valves115A that are initially closed and the valves115B that are initially open, and the sensor portions116inFIG. 2are, for reasons of clarity, only labelled in some cases, but the same symbols are used inFIG. 2for each of these components.

The collection cavity111is preferably used for receiving excess or used reagents and liquids and volumes of the sample, and/or for providing gas or air in order to empty individual cavities and/or channels.

In particular, the collection cavity111can optionally be connected to individual cavities and channels or other apparatus fluidically in order to remove reagents and liquids from said cavities, channels or other apparatus and/or to replace said reagents and liquids with gas or air. The collection cavity111is preferably given appropriate large dimensions.

Once the sample P has been introduced into the receiving cavity104and the connection104A has been closed, the cartridge100can be inserted into and/or received in the proposed analysis device200in order to test the sample P, as shown inFIG. 1. Alternatively, the sample P could also be fed in later.

FIG. 1shows the analysis system1in a ready-to-use state for carrying out a test or assay on the sample P received in the cartridge100, and/or in the operating position. In this state, the cartridge100is therefore linked to, received by and/or inserted into the analysis device200.

In the following, some features and aspects of the analysis device200are first explained in greater detail, in particular on the basis ofFIG. 1. The features and aspects relating to said device are preferably also directly features and aspects of the proposed analysis system1, in particular even without any further explicit explanation.

The analysis system1or analysis device200preferably comprises a mount or receptacle201for mounting and/or receiving the cartridge100.

Preferably, the cartridge100is fluidically, in particular hydraulically, separated or isolated from the analysis device200. In particular, the cartridge100forms a preferably independent and in particular closed or sealed fluidic or hydraulic system103for the sample P and the reagents and other liquids. In this way, the analysis device200does not come into direct contact with the sample P and can in particular be reused for another test without being disinfected and/or cleaned first.

It is however provided that the analysis device200can be connected or coupled mechanically, electrically, thermally and/or pneumatically to the cartridge100.

In particular, the analysis device200is designed to have a mechanical effect, in particular for actuating the pump apparatus112and/or the valves115A,115B, and/or to have a thermal effect, in particular for temperature-controlling the reaction cavity/cavities109A-C and/or the intermediate temperature-control cavity110.

In addition, the analysis device200can preferably be pneumatically connected to the cartridge100, in particular in order to actuate individual apparatus, and/or can be electrically connected to the cartridge100, in particular in order to collect and/or transmit measured values or measurement results713, for example, from the sensor apparatus113and/or sensor portions116.

The analysis system1or analysis device200preferably comprises a pump drive202, the pump drive202in particular being designed for mechanically actuating the pump apparatus112.

Preferably, a head of the pump drive202can be rotated in order to rotationally axially depress the preferably bead-like raised portion of the pump apparatus112. Particularly preferably, the pump drive202and pump apparatus112together form a pump, in particular in the manner of a hose pump or peristaltic pump and/or a metering pump, for the fluid system103and/or the cartridge100.

Particularly preferably, the pump is constructed as described in German Patent DE 10 2011 015 184 B4 and corresponding U.S. Pat. No. 8,950,424. However, other structural solutions are also possible.

Preferably, the capacity and/or discharge rate of the pump can be controlled and/or the conveying direction of the pump and/or pump drive202can be switched. Preferably, fluid can thus be pumped forwards or backwards as desired.

The analysis system1or analysis device200preferably comprises a connection apparatus203for in particular electrically and/or thermally connecting the cartridge100and/or the sensor arrangement or sensor apparatus113.

As shown inFIG. 1, the connection apparatus203preferably comprises a plurality of electrical contact elements203A, the cartridge100, in particular the sensor arrangement or sensor apparatus113, preferably being electrically connected or connectable to the analysis device200by the contact elements203A.

The analysis system1or analysis device200preferably comprises one or more temperature-control apparatus for temperature-controlling the cartridge100and/or having a thermal effect on the cartridge100, in particular for heating and/or cooling, the temperature-control apparatus(es) (each) preferably comprising or being formed by a heating resistor or a Peltier element.

Individual temperature-control apparatus, some of these apparatus or all of these apparatus can preferably be positioned against or abutted on the cartridge100, the main body101, the cover102, the sensor arrangement, sensor apparatus113and/or individual cavities and/or can be thermally coupled thereto and/or can be integrated therein and/or in particular can be operated or controlled electrically by the analysis device200. In the example shown, in particular the temperature-control apparatus204A-C are provided.

Preferably, the temperature-control apparatus, referred to in the following as the reaction temperature-control apparatus204A, is assigned to one of the reaction cavities109A-C or to a plurality of reaction cavities109A-C, in particular in order for it to be possible to carry out one or more amplification reactions therein.

The reaction cavities109A-C are preferably temperature-controlled simultaneously and/or uniformly, in particular by means of one common reaction temperature-control apparatus204A or two reaction temperature-control apparatus204A.

More particularly preferably, the reaction cavity/cavities109A-C can be temperature-controlled from two different sides and/or by means of two or the reaction temperature-control apparatus204A that are preferably arranged on opposite sides.

The temperature-control apparatus, referred to in the following as the intermediate temperature-control apparatus204B, is preferably assigned to the intermediate temperature-control cavity110and/or is designed to (actively) temperature-control or heat the intermediate temperature-control cavity110and/or a fluid located therein, in particular the amplification products, preferably to a preheat temperature.

The intermediate temperature-control cavity110and/or intermediate temperature-control apparatus204B is preferably arranged upstream of or (immediately) before the sensor arrangement or sensor apparatus113, in particular in order for it to be possible to temperature-control or preheat, in a desired manner, fluids to be fed to the sensor arrangement or sensor apparatus113, in particular analytes A and/or amplification products, particularly preferably immediately before said fluids are fed.

Particularly preferably, the intermediate temperature-control cavity110or intermediate temperature-control apparatus204B is designed or provided to denature the sample P or analytes A and/or the amplification products produced, and/or to divide any double-stranded analytes A or amplification products into single strands and/or to counteract premature bonding or hybridizing of the amplification products, in particular by the addition of heat.

Preferably, the analysis system1, analysis device200and/or the cartridge100and/or one or each temperature-control apparatus comprise/comprises a temperature detector and/or temperature sensor (not shown), in particular in order to make it possible to control and/or regulate temperature.

One or more temperature sensors may for example, be assigned to the sensor portions116and/or to individual channel portions or cavities, i.e., may be thermally coupled thereto.

The temperature-control apparatus204C, referred to in the following as the sensor temperature-control apparatus204C, is in particular assigned to the sensor apparatus113and/or is designed to (actively) temperature-control or heat fluids located in or on the sensor arrangement or sensor apparatus113, in particular analytes A and/or amplification products, reagents or the like, in a desired manner, preferably to a hybridization temperature.

The sensor temperature-control apparatus204C is preferably planar and/or has a contact surface which is preferably rectangular and/or corresponds to the dimensions of the sensor arrangement or sensor apparatus113, the contact surface allowing for heat transfer between the sensor temperature-control apparatus204C and the sensor apparatus113.

Preferably, the analysis device200comprises the sensor temperature-control apparatus204C. However, other structural solutions are also possible in which the sensor temperature-control apparatus204C is integrated in the cartridge100, in particular the sensor arrangement or sensor apparatus113.

Particularly preferably, the connection apparatus203comprises the sensor temperature-control apparatus204C, and/or the connection apparatus203together with the sensor temperature-control apparatus204C can be linked to, in particular pressed against, the cartridge100, in particular the sensor arrangement or sensor apparatus113.

More particularly preferably, the connection apparatus203and the sensor temperature-control apparatus204C (together) can be moved towards and/or relative to the cartridge100, in particular the sensor arrangement or sensor apparatus113, and/or can be positioned against said cartridge, preferably in order to both electrically and thermally couple the analysis device200to the cartridge100, in particular the sensor arrangement or sensor apparatus113or the support thereof.

Preferably, the sensor temperature-control apparatus204C is arranged centrally on the connection apparatus203or a support thereof and/or is arranged between the contact elements203A.

In particular, the contact elements203A are arranged in an edge region of the connection apparatus203or a support thereof or are arranged around the sensor temperature-control apparatus204C, preferably such that the connection apparatus203is connected or connectable to the sensor apparatus113thermally in the centre and electrically on the outside or in the edge region. However, other solutions are also possible here.

The analysis system1or analysis device200preferably comprises one or more valve actuators205A,205B for actuating the valves115A,115B. Particularly preferably, different (types or groups of) valve actuators205A and205B are provided which are assigned to the different (types or groups of) valves115A and115B for actuating each of said valves, respectively.

The analysis system1or analysis device200preferably comprises a control apparatus207for controlling the sequence of a test or assay and/or for collecting, evaluating and/or outputting or providing measured values or measurement results713, in particular from the sensor apparatus113, and/or test results and/or other data or values.

The control apparatus207preferably comprises an internal clock or time base by means of which the sequence of the test is or can be controlled and/or by means of which test steps that follow temporally one another or that extend over time are controlled or can be controlled by the control apparatus207.

The control apparatus207preferably controls or is designed to control actuators of the analysis device200for acting on the cartridge100in order to carry out the test. The actuators are in particular the pump drive202, the temperature-control apparatus and/or the valve actuators205A,205B.

The analysis system1or analysis device200preferably comprises one or more sensors206A-H. In particular, fluid sensors206A are designed or provided to detect liquid fronts and/or flows of fluid in the fluid system103. Particularly preferably, the fluid sensors206A are designed to measure or detect, for example, optically and/or capacitively, a liquid front and/or the presence, the speed, the mass flow rate/volume flow rate, the temperature and/or another value of a fluid in a channel and/or a cavity, in particular in a respectively assigned sensor portion116, which is in particular formed by a planar and/or widened channel portion of the fluid system103.

The fluid sensor206A preferably measures a fluid entering or leaving the sensor portion116and/or a content change or fluid change in the sensor portion116, and in the process generates a measurement result706A that corresponds to the fluid entering, the fluid leaving, the content change and/or the fluid change in the sensor portion116. This measurement result706A from the fluid sensor206A can be retrieved by the control apparatus207and/or transmitted to the control apparatus207. The control apparatus207controls or is designed to control the test and/or the actuators, preferably using or taking into account the measurement result706A from the fluid sensor206A. In particular, when a content change, an entering fluid, a leaving fluid and/or a fluid change is detected in the sensor portion116, in particular when a liquid front is detected, the control apparatus207influences a program sequence. In this case, for example, a check can be carried out or a subsequent step of the test can be controlled, in particular by activating the actuators in a particular and/or differing manner.

Particularly preferably, the sensor portions116are each oriented and/or incorporated in the fluid system103and/or fluid flows against or through the sensor portions116such that, in the operating position of the cartridge100, fluid flows through the sensor portions116in the vertical direction and/or from the bottom to the top, or vice versa, in particular in order to make it possible or easier to accurately detect liquid.

Alternatively, or additionally, the analysis device200preferably comprises one or more (different, other and/or further) sensors206B.

Preferably, the other sensor206B is or comprises a pressure sensor for determining the (relative) air pressure. The other sensor206B can generate a measurement result706B, which corresponds in particular to the air pressure. This measurement result706B can be retrieved by the control apparatus207and/or transmitted to the control apparatus207. The control apparatus207controls or is designed to control the test and/or the actuators, preferably using or taking into account the measurement result706B from the other sensor206B.

Alternatively or additionally, one or more temperature sensors206C are provided for detecting the internal temperature and/or the temperature in the interior space212A of the analysis device200, in particular the temperature of an atmosphere in the interior space212A. Alternatively or additionally, one or more temperature sensors206C are provided for detecting the ambient temperature and/or the temperature of an atmosphere surrounding the analysis device200and/or the temperature of one or more of the temperature apparatus.

The temperature sensor206C preferably measures a temperature, in particular of the interior space212A of the analysis device200, and in the process generates a measurement result706C that corresponds to the temperature, in particular of the interior space212A and/or atmosphere of or parts of the interior space212A. This measurement result706C from the temperature sensor206C can be retrieved by the control apparatus207and/or transmitted to the control apparatus207. The control apparatus207controls or is designed to control the test and/or the actuators, preferably using or taking into account the measurement result706C from the temperature sensor206C.

The analysis device200preferably comprises a tilt sensor206D for detecting the inclination and/or orientation of the analysis device200and/or of the cartridge100. The inclination sensor206D is in particular designed and set up to determine the inclination of the analysis device200and/or of the cartridge100that differs from that in an operating position.

The inclination sensor206D preferably measures the inclination, and in the process generates a measurement result706D that corresponds to the inclination of the analysis device200and/or of the cartridge100. This measurement result706D from the tilt sensor206D can be retrieved by the control apparatus207and/or transmitted to the control apparatus207. The control apparatus207controls or is designed to control the test and/or the actuators, preferably using or taking into account the measurement result706D from the tilt sensor206D. In particular, if the inclination is too great, the test is prevented, blocked or interrupted, and/or an error is identified, processed, transmitted and/or signaled.

The analysis device200may comprise an acceleration sensor206E. The acceleration sensor206E is preferably designed to determine an acceleration of the analysis device200, in particular an acceleration in the vertical and/or horizontal direction with respect to the operating position.

The acceleration sensor206E preferably measures the acceleration, and in the process generates a measurement result706E that corresponds to the acceleration of the analysis device200and/or of the cartridge100. This measurement result706E from the acceleration sensor206E can be retrieved by the control apparatus207and/or transmitted to the control apparatus207. The control apparatus207controls or is designed to control the test and/or the actuators, preferably using or taking into account the measurement result706E from the acceleration sensor206E. In particular, if the acceleration is too great, the test is prevented, blocked or interrupted, and/or an error is identified, processed, transmitted and/or signaled.

The analysis device200may comprise a humidity sensor206F for determining the (relative) atmospheric humidity and/or the dew point of the atmosphere inside or in the interior space212A and/or outside the analysis device200.

The humidity sensor206F preferably measures the (relative) atmospheric humidity and/or the dew point, and in the process generates a measurement result706F that corresponds to the (relative) atmospheric humidity and/or the dew point of the atmosphere in the analysis device200and/or the surroundings of the analysis device200. This measurement result706F from the humidity sensor206F can be retrieved by the control apparatus207and/or transmitted to the control apparatus207. The control apparatus207controls or is designed to control the test and/or the actuators, preferably using or taking into account the measurement result706F from the humidity sensor206F. In particular, if the (relative) atmospheric humidity is too high and/or if the dew point is approached or reached, the test is prevented, blocked or interrupted, and/or an error is identified, processed, transmitted and/or signaled.

The analysis device200may comprise a position sensor206G for determining the position or location, for example, by means of a GPS sensor. The position sensor206G is preferably designed to determine the location of the analysis device200in space, in particular on the Earth's surface, and/or to output the geographical position, the location and/or the coordinates of the analysis device200.

The position sensor206G preferably measures the position, in particular the geographical position, of the analysis device200, and in the process generates a measurement result706G that corresponds to the position or geographical position. This measurement result706G from the position sensor206G can be retrieved by the control apparatus207and/or transmitted to the control apparatus207. The control apparatus207controls or is designed to control the test and/or the actuators, preferably using or taking into account the measurement result706G from the position sensor206G.

The analysis device200may comprise a cartridge sensor206H for determining or checking the position or alignment of the cartridge100in or with respect to the analysis device200. In particular, the cartridge sensor206H is designed to detect an incorrect position of the cartridge100in the analysis device200. Alternatively, or additionally, the cartridge sensor206H is designed to detect and/or verify the correct and/or operating position of the cartridge100in the analysis device200.

The cartridge sensor206H preferably measures the position of the cartridge100in the analysis device200, and in the process generates a measurement result706H that corresponds to the position or alignment of the cartridge100in the analysis device200. This measurement result706H from the cartridge sensor206H can be retrieved by the control apparatus207and/or transmitted to the control apparatus207. The control apparatus207controls or is designed to control the test and/or the actuators, preferably using or taking into account the measurement result706H from the cartridge sensor206H. In particular, if the cartridge100is incorrectly positioned in the analysis device200, the test is prevented or blocked and/or the cartridge100is automatically ejected from the analysis device200or the like. Alternatively, or additionally, the test is enabled if it is detected that the cartridge100is in the correct operating position in the analysis device200.

The control apparatus207preferably controls or regulates the pump drive202, the temperature-control apparatus204and/or the valve actuators205, in particular taking into account or depending on the desired test and/or measured values from the sensor arrangement or sensor apparatus113and/or sensors206A-H.

The flows of fluid are controlled in particular by accordingly activating the pump or pump apparatus112and actuating the valves115A,115B.

Particularly preferably, the pump drive202comprises a stepper motor, or a drive calibrated in another way, such that desired metering can be achieved, at least in principle, by means of appropriate activation.

Additionally, or alternatively, the fluid sensors206A are used to detect liquid fronts or flows of fluid, in particular in cooperation with the assigned sensor portions116, in order to achieve the desired fluidic sequence and the desired metering by accordingly controlling the pump or pump apparatus112and accordingly activating the valves115A,115B.

Optionally, the analysis system1or analysis device200comprises an input apparatus208, such as a keyboard, a touch screen or the like, and/or a display apparatus209, such as a screen.

The analysis system1or analysis device200preferably comprises at least one interface210, for example, for controlling, for communicating and/or for outputting measured data or test results and/or for linking to other devices, such as a printer, an external power supply or the like. This may in particular be a wired or wireless interface210.

The analysis system1or analysis device200preferably comprises a power supply211, preferably a battery or an accumulator, which is in particular integrated and/or externally connected or connectable.

Preferably, an integrated accumulator is provided as a power supply211and can be (re)charged by an external charging device (not shown) via a connection211A and/or is interchangeable.

The analysis system1or analysis device200preferably comprises a housing212, all the components and/or some or all of the apparatus preferably being integrated in the housing212. Particularly preferably, the cartridge100can be inserted or slid into the housing212, and/or can be received by the analysis device200, through an opening213which can in particular be closed, such as a slot or the like.

The analysis system1or analysis device200is preferably portable or mobile. Particularly preferably, the analysis device200weighs less than 25 kg or 20 kg, particularly preferably less than 15 kg or 10 kg, in particular less than 9 kg or 6 kg.

The fluidic, in particular pneumatic, coupling between the cartridge100and the analysis device200will be explained in greater detail in the following, it being possible for the following aspects to be implemented independently from the preceding aspects.

As already explained, the analysis device200can preferably be pneumatically linked to the cartridge100, in particular to the sensor arrangement or sensor apparatus113and/or to the pump apparatus112.

Particularly preferably, the analysis device200is designed to supply the cartridge100, in particular the sensor arrangement or sensor apparatus113and/or the pump apparatus112, with a working medium, in particular gas or air.

Preferably, the working medium can be compressed and/or pressurized in the analysis device200or by means of the analysis device200.

Preferably, the analysis device200comprises a pressurized gas supply214for this purpose, in particular a pressure generator or compressor, preferably in order to compress and/or pressurize the working medium.

The pressurized gas supply214is preferably integrated in the analysis device200or the housing212and/or can be controlled or regulated by means of the control apparatus207. The pressurized gas supply214can also, at least in part, be faulted on or by the cartridge100.

Preferably, the pressurized gas supply214is electrically operated or can be operated by electrical power. In particular, the pressurized gas supply214can be supplied with electrical power by means of the power supply211.

The analysis device200or pressurized gas supply214is preferably designed to compress the working medium to a pressure of more than 100 kPa, particularly preferably more than 150 kPa or 250 kPa, in particular more than 300 kPa or 350 kPa, and/or of less than 1 MPa, particularly preferably less than 900 kPa or 800 kPa, in particular less than 700 kPa and/or to feed said medium to the cartridge100at said pressure.

Preferably, air can be drawn in, in particular from the surroundings, as the working medium by means of the analysis device200or pressurized gas supply214. In particular, the analysis device200or pressurized gas supply214is designed to use the surroundings as a reservoir for the working medium or the air. However, other solutions are also possible here, in particular those in which the analysis device200or pressurized gas supply214comprises a preferably closed or delimited reservoir, such as a tank or container, comprising the working medium, and/or is connected or connectable thereto.

Preferably, the analysis device200or pressurized gas supply214comprises an inlet, the working medium in particular being able to be drawn in and/or conducted in the pressurized gas supply214via the inlet.

Preferably, the analysis device200or pressurized gas supply214comprises a filter, the filter preferably being integrated in the inlet and/or it preferably being possible for the working medium to be filtered by means of the filter and/or it preferably being possible for particles to be separated from the working medium by means of the filter.

The filter is preferably designed as a micro filter or as a fine particulate air filter. Preferably, particles having a particle diameter of more than 10 μm, particularly preferably more than 8 μm or 9 μm, in particular more than 6 μm or 7 μm, more particularly preferably more than 4 μm or 5 μm, can be separated by means of the filter, the particle diameter preferably being the maximum or average diameter of the respective particles. This ensures that the channels or lines in the cartridge that convey the working medium do not become contaminated or clogged and/or that no undesired pressure loss occurs.

The analysis device200or pressurized gas supply214preferably comprises a connection element214A, in particular in order to pneumatically connect the analysis device200and/or pressurized gas supply214to the cartridge100.

FIG. 3is a schematic view of the proposed analysis system1for testing an in particular biological sample P, comprising the analysis device200for receiving the cartridge100and subsequently carrying out the test using the received cartridge100, and an operating instrument400for the analysis device200.

The operating instrument400is preferably designed to control the analysis device200. Alternatively, or additionally, the operating instrument400can receive or retrieve information, in particular (measurement) results such as measured values, from the analysis device200. In particular, the operating instrument400is a mobile terminal device such as a smartphone, a tablet or the like.

The operating instrument400is preferably implemented or provided so as to be physically separated from the analysis device200. The operating instrument400can preferably be separated and/or disconnected from the analysis device200physically and/or with respect to a data connection.

The operating instrument400can preferably be wirelessly connected to the analysis device200. A data connection DVA can thus be established between the analysis device200and the operating instrument400. However, the data connection DVA can in principle also be established in another manner, for example, wired.

It is preferable for the operating instrument400to also be operational when separated or disconnected from the analysis device200, in particular for carrying out evaluations or for other purposes. Alternatively, or additionally, the analysis device200is also operational when separated or disconnected from the operating instrument400, in particular for continuing a test.

The interface430and/or the operating instrument400in particular comprises what is referred to as an analysis device interface431that is designed to establish the preferably wireless data connection DVA to the analysis device200. This can, for example, be a radio interface, WPAN interface, Bluetooth interface and/or a Bluetooth module or the like.

The interface210of the analysis device200preferably corresponds to the interface430and/or the analysis device interface431of the operating instrument400, in particular such that the data connection DVA between the operating instrument400and the analysis device200can be established. The interface210of the analysis device200and the analysis device interface431preferably support the same data transmission method and/or radio transmission method or radio standard, in particular WLAN or WPAN methods such as Bluetooth, NFC, Zigbee or the like.

Particularly preferably, the interface210of the analysis device200and the analysis device interface431make possible or facilitate what is known as an ad-hoc connection. In this case, the data connection DVA is established preferably automatically when the devices, i.e., the operating instrument400and the analysis device200, are within range of one another. In other words, the operating instrument400and the analysis device200each comprise a wireless data interface430,210, respectively, which are designed to jointly establish an ad-hoc data connection between the operating instrument400and the analysis device200, preferably such that, when the operating instrument400and the analysis device200approach one another in space, the data connection DVA therebetween is automatically established and is preferably displayed by means of the operating instrument400.

The data connection DVA is preferably a point-to-point connection. The data connection DVA connects the analysis device200to the operating instrument400preferably directly and/or without any interposed networks. It is possible for the operating instrument400to establish data connections DVA to different analysis devices200simultaneously or in succession. Alternatively or additionally, it is possible for one analysis device200to establish data connections DVA to a plurality of operating instruments400simultaneously or in succession.

In order to control the test, it is preferable for precisely one data connection DVA to be provided between the analysis device200to be controlled and the operating instrument400controlling the analysis device200, and/or for control information510to be received and/or accepted or to be acceptable and/or receivable and/or for measurement results713to be transmitted or to be transmittable only via precisely one data connection DVA between the analysis device200to be controlled and the operating instrument400controlling the analysis device200.

The analysis device200preferably comprises a receiver210A for, preferably wirelessly, receiving the control information510from the operating instrument400. Preferably, the interface210comprises the receiver210A, via which signals, in particular control information510, are or can be received from the operating instrument400.

Alternatively, or additionally, the analysis device200and/or the interface210comprises a transmitter210B, via which data, in particular results such as measurement results713from the sensor apparatus113, are or can be sent, particularly preferably to the operating instrument400.

The interfaces210,431preferably correspond to one another such that they support the same data transmission standard and/or radio standard, in particular Bluetooth, WLAN or the like. These interfaces are particularly preferably interfaces210,431which make possible what is known as an ad-hoc connection, the data connection DVA preferably being established automatically when the devices, i.e., the operating instrument400and the analysis device200, are within range of one another.

The analysis system1preferably further comprises a database500or the database500is assigned to the analysis system1. The database500is preferably an external database500that is implemented or provided so as to be physically separated from the operating instrument400and/or from the analysis device200. In principle, however, it is not impossible for the database500to be provided or implemented such that it can be directly linked, in particular to the operating instrument400, or to be provided or implemented by the operating instrument400.

The operating instrument400can access the database500via a data connection DVD. For this purpose, the operating instrument400and/or the interface430can comprise a database interface432by means of which the database500can be accessed, in particular via a network N. The network N may be the Internet or another data network. It is also preferable for the operating instrument400to be able to establish the data connection DVD to the database500via a wireless interface, in particular WLAN, WPAN, mobile communications or the like. However, in principle, other solutions are also possible here.

Particularly preferably, the operating instrument400comprises different interfaces430that are independent of one another for establishing data connections DVA, DVD to the analysis device200and to the database500, the analysis device200(as a peripheral device of the operating instrument400) being designed to communicate exclusively with or via the operating instrument400.

The analysis system1, in particular, the database500, preferably comprises control information510by means of which the analysis device200can be controlled in order to carry out a test.

The control information510preferably defines the actuation of the actuators of the analysis device200in a particular manner, such that the sample P is tested in the cartridge100. In particular, actuators for carrying out the test can be or are controlled using the control information510such that said actuators act on the cartridge100and/or the sample P. These actuators are in particular the pump drive202and/or one or more temperature-control apparatus204and/or one or more valve actuators205. The control information510preferably comprises parameters and/or instructions for carrying out one or more steps of the method for testing the sample P explained above.

Preferably, the analysis system1comprises calibration information520that can be stored in the database500and/or can be retrieved from the database500. The calibration information520is preferably capable of influencing the test of the sample P, in particular depending on the specific cartridge100, on a cartridge batch of the specific cartridge100and/or on the specific test.

Calibration information520can be used in addition to control information510for carrying out the test, the calibration information520preferably influencing or specifying the control information510. The calibration information520can be or can form part of the control information510, even if this is not explicitly mentioned in the following.

The analysis device200can be calibrated and/or configured by calibration information520that can form part of the control information510or can be provided separately. For this purpose, the calibration information520can be determined, retrieved and/or transmitted to the analysis device200by means of the operating instrument400.

In one example, fluid sensor calibration information521is provided which influences setting and/or evaluation of the fluid sensor206A. The fluid sensor calibration information521is preferably dependent on the test to be carried out, the phase of the test and/or expected effects of a content change in a sensor portion116during the test sequence, and/or contains various specifications which are dependent thereon.

Alternatively, or additionally, tilt sensor calibration information524can be provided, preferably comprising one or more threshold values525, in particular a start threshold value526for blocking the start of a test if said threshold value is exceeded, and/or an interruption threshold value527for interrupting the test and/or for processing errors if said threshold is exceeded.

Alternatively, or additionally, sensor arrangement calibration information528can be provided, by means of which properties of the sensor apparatus113are or can be set. In particular, it is provided that the sensor arrangement calibration information528is transmitted or can be transmitted to the sensor arrangement113by the analysis device200, and that the sensor arrangement113carries out or is designed to carry out a measurement taking into account the sensor arrangement calibration information528.

The proposed analysis system1preferably comprises evaluation information530which is stored in the database500and/or is retrievable or can be retrieved from the database500. The evaluation information530is preferably designed to be able to interpret measurement results713that originate from the cartridge100, in particular from the sensor apparatus113.

The control information510and/or the evaluation information530particularly preferably comprises instructions, preferably in the form of an algorithm and/or for controlling a process on or using a processor or controller. The instructions preferably form a module that can be or is implemented by the analysis device200and/or the operating instrument400, as a result of which the behavior of the analysis device200and/or the operating instrument400can be or is changed.

The instructions are in particular commands, machine code, pre-compiled source code or source code. The instructions preferably form a module-like software component, in particular a plugin. The instructions can be designed to form and/or to replace a module of the operating instrument400and/or of the analysis device200. For this purpose, the control information510and/or the evaluation information530can comprise a (software) interface for coupling or implementation by the control apparatus207and/or an evaluation module440of the operating instrument400.

The control information510particularly preferably comprises or forms a module of the control apparatus207that can be exchanged, preferably in terms of software. This module preferably contains instructions such as logic commands, loops and the like for controlling the test, in particular in the form of a computer program or computer program product to be executed by the analysis device200and/or the control apparatus207. The control information510can be or form, in particular as a plugin, an exchangeable part of the control apparatus207.

An evaluation module440is preferably formed by the operating instrument400or the operating instrument400comprises the evaluation module440. By means of the evaluation module440, measurement results713read out from the sensor apparatus113are evaluated preferably using the evaluation information530retrieved from the database500and/or the evaluation module440is designed for this purpose.

The evaluation information530particularly preferably comprises or forms a module of the evaluation apparatus440that can be exchanged, preferably in terms of software. This module preferably contains instructions such as logic commands, loops and the like for controlling the evaluation of measurement results713, in particular in the form of a computer program or computer program product to be executed by the operating instrument400and/or the evaluation module440. The evaluation information530can be or form, in particular as a plugin, an exchangeable part of the evaluation module440.

Alternatively, or additionally, the instructions can comprise parameters for configuring the control apparatus207and/or the evaluation module440. These parameters are preferably provided in addition to the instructions, for example, for the analysis device200in the form of or comprising the calibration information520. Alternatively, the control information510and/or evaluation information530can however also merely comprise parameters and/or other information for the control and/or evaluation.

The database500preferably comprises a results memory550in which results can be stored and/or saved.

Within the meaning of the present invention, the term “database” should preferably be understood in a broad sense and also incorporates multi-part databases in particular. Therefore, in principle, the database500can be provided in different physical units or at different locations and/or can be composed of a plurality of sub-databases.

The operating instrument400can preferably be separated and/or disconnected from the analysis device200with respect to a data connection and/or physically. For this purpose, the analysis device200can initially be connected to the operating instrument400by the data connection DVA being established.

In order to control the test and/or the analysis device200, the operating instrument400can retrieve control information510from the database500and transmit said information to the analysis device200in unaltered or altered form.

The operating instrument400is preferably designed to evaluate measurement results713which can preferably be generated by the sensor apparatus113of the cartridge100while the sample P is being tested. For this purpose, it is provided that measurement results713, which can originate from a sensor apparatus113of the cartridge100and/or which can be transmitted from the analysis device200to the operating instrument400, are or can be evaluated in the operating instrument400. For this purpose, the operating instrument400can retrieve or receive the evaluation information530from the database500and, using this evaluation information530, evaluate the measurement results713, in particular in the evaluation module440of the operating instrument400.

The operating instrument400preferably comprises a memory450. The memory450can be used to store, at least temporarily, control information510, calibration information520and/or evaluation information530, or the operating instrument400and the memory450can be designed for this purpose. Alternatively or additionally, evaluation results740, that have been or can be generated from the measurement results713by means of the operating instrument400, can be stored in the memory450.

In one example, the operating instrument400comprises an output apparatus410, preferably an in particular touch-sensitive screen or display411and/or a speaker412. Alternatively, or additionally, the operating instrument400comprises an input apparatus420, in particular a camera421, a touchpad422, a microphone423and/or a keyboard424.

The operating instrument400is preferably designed to display an operating interface or a user interface via the output apparatus410, in particular the screen or display411, or to provide in another way operating elements for controlling the test and/or the analysis device200, and/or to output a status or other information relating to the test. Alternatively or additionally, commands can be received via the input apparatus420, by means of which the operating instrument400starts, configures and/or controls the test of the sample P in a manner corresponding to the commands.

Preferably, the transmission of commands and/or information to the analysis device200is triggered via the input apparatus420or can be triggered by the input apparatus420.

In particular, transmission of the control information510from the operating instrument400to the analysis device200can be initiated or controlled via the input apparatus420. Alternatively, or additionally, the analysis device200can be controlled in order to receive the cartridge100and/or to start the test, preferably using the control information510and/or a command received via the input apparatus420. The operating instrument400is therefore preferably designed to transmit to the analysis device200control information510for receiving or ejecting the cartridge100. In this case, a cartridge100can in particular be inserted only when the operating instrument400is connected to the analysis device200, whereupon the operating instrument400can verify the cartridge100and can eject said cartridge or block a test if an error, such as incompatibility, is detected.

Alternatively, or additionally, the operating instrument400is designed to transmit control information510for starting the test to the analysis device200. The test is thus preferably started only by a command originating from the operating instrument400. The analysis device200itself preferably does not comprise a user interface for generating a start command or for causing the test to start. This task is preferably reserved for the operating instrument400.

The cartridge100preferably comprises at least one cartridge identifier100C which corresponds to the cartridge100and/or to a batch with which the cartridge100is associated.

The cartridge identifier100C is in particular a piece of information that is specific to the relevant cartridge100, is in particular unique and/or is designed to uniquely identify the cartridge100, such as an identification code which is assigned to the relevant cartridge100and makes it possible for said cartridge to be identified in a preferably unique manner.

Alternatively, or additionally, the cartridge identifier100C makes it possible to assign the cartridge100to a production cycle and/or to a batch of particular cartridges100. A batch is preferably characterized in that cartridges100are produced in the same continuous production cycle and/or are produced having the same components, in particular having the same sensor apparatus113and/or the same reagents and the like. There is preferably a plurality of batches which can differ from one another with regard to production periods, batches of starting materials used and the like, for example.

The cartridge identifier100C can be stored and/or saved in a memory means100D of the cartridge100. The memory means100D can be a barcode124, an NFC tag and/or a memory which is provided in the sensor apparatus113, is connected to the sensor apparatus113or is assigned to the sensor apparatus113, or another apparatus for storing code or the like.

The cartridge identifiers100C are preferably assigned to the respective cartridges100. In particular, the cartridge identifier100C is formed by the cartridge100, connected thereto and/or arranged thereon.

The analysis system1can comprise a plurality of cartridges100which can each preferably be distinguished from one another by means of at least one cartridge identifier100C and/or which are assigned to a batch.

Another aspect of the present invention, which can also be implemented independently, relates to a cartridge100having at least two cartridge identifiers100C that each correspond to the cartridge100. The cartridge identifiers100C can preferably be read out by different read-out methods, in particular optically, by radio, by a wired connection or the like.

The respective cartridges100can comprise two different memory means100D having the same or corresponding cartridge identifiers100C. The memory means100D are preferably independent of one another and/or separated from one another physically. The memory means100D can preferably be read out in different ways, in particular electronically and/or by an electronic connection on the one hand, and wirelessly, in particular optically and/or by radio on the other hand.

One of the memory means100D is preferably read out wirelessly, in particular optically or by radio, or can be read out accordingly. This memory means is preferably the barcode124, an RFID tag and/or an NFC apparatus. This allows for the cartridge identifier100C to be read out in a convenient manner, since it is read out contactless, preferably by means of the operating instrument400, in particular a smartphone, using the camera421or the like.

One of the memory means100D can preferably be read out electronically, in particular in a wired manner, or is read out electronically, in particular in a wired manner, preferably by means of the analysis device200. The memory means100D that can be read out electronically can be read out or transmitted via the same interface, in particular via contacts, of the cartridge100, as the interface via which also measurement results713can be read out or transmitted from the cartridge100, or said memory means100D can be read out by the analysis device200or transmitted to the analysis device200by the same means via which measurement results713can be read out or transmitted. This memory means100D can preferably be contacted and read out by the analysis device200without additional hardware. There is therefore no need for an additional interface such as a wireless interface for reading out the other memory means100D.

The memory means100D that can be read out electronically is preferably formed by the sensor apparatus113of the cartridge100, corresponds to the sensor apparatus113and/or identifies the sensor apparatus113, preferably uniquely.

The cartridge identifier100C that uniquely identifies the cartridge100can therefore be an identifier that uniquely identifies the sensor apparatus113and thus indirectly the cartridge100that comprises the sensor apparatus113. This identifier, also referred to as a sensor ID or chip ID, can be used to verify the control information510, calibration information520and/or evaluation information530.

Alternatively, or additionally, measurement results713are preferably (uniquely) assigned to the cartridge100by means of the identifier and/or the cartridge identifier100C. In particular, the cartridge100and/or the analysis device200allocates the measurement results713to the cartridge identifier100C and/or the operating instrument400, following evaluation, allocates the evaluation results740to said cartridge identifier100C, which (uniquely) identifies the cartridge100and/or the sensor apparatus113. This facilitates documentation, handling of possible errors and/or evaluation of measurement results713while taking account of the sensor apparatus113, the cartridge100and/or the batch.

As already mentioned above, the sensor apparatus113preferably comprises one or more sensor fields113B. These sensor fields113B are preferably formed on what is known as a chip, i.e., on or by a semiconductor component. The memory means100D that can be read out electronically is preferably formed on or by the same semiconductor component. This makes it possible to prevent outlay for additional memory means. The memory means100D that can be read out electronically is in particular a PROM, EPROM or another programmable memory.

Preferably at least one of the memory means100D, in particular both the memory means100D, is/are connected to the cartridge100and/or formed by the cartridge100. The physical connection of the memory means100D to the cartridge100makes it possible to ensure that the cartridge100is correctly identified. In principle, however, at least the memory means100D that can be read out wirelessly can alternatively or additionally be provided on a packaging or can be assigned to the cartridge100in another manner.

The cartridge identifier100C is preferably an identification code or comprises an identification code that preferably uniquely identifies the cartridge100and/or the batch with which the cartridge100is associated.

The cartridge100preferably forms a part of the analysis system1, the operating instrument400being designed to read out one of the memory means100D, preferably wirelessly, in particular optically. In a corresponding method, the operating instrument400reads out, preferably wirelessly, the cartridge identifier100C, in particular the cartridge identifier that corresponds to the batch and/or that can be read out wirelessly.

The operating instrument400is preferably first physically separated and/or separable from the analysis device200, although it is also possible in particular in this aspect for the operating instrument400to be part of the analysis device200or to be formed by the analysis device200or to be connected to the analysis device200.

The analysis device200preferably reads out the cartridge identifier100C, in particular the cartridge identifier that uniquely identifies the cartridge100, and/or the cartridge identifier from a or the memory means100D that can be read out electronically, i.e., by means of a wired or galvanic connection, preferably electronically, in particular in a wired manner, or the analysis device200is designed for this purpose.

One of the memory means100D can preferably be read out, in particular can only be read out, by the operating instrument400, and/or the other memory means100D can be read out, in particular can only be read out, by the analysis device200.

In the example shown, cartridge identifiers100C that correspond to one another are stored, saved or recorded both in a memory means100D that can be read out electronically, in particular the sensor apparatus113, and in a memory means100D that can be read out wirelessly, by radio or optically, in particular the barcode124. This makes it possible for the cartridge identifier100C or cartridge identifiers100C corresponding to the same cartridge100to be read out in different ways.

This advantageously makes it possible to retrieve control information510, calibration information520and/or evaluation information530from the database500independently or separately or disconnected from the analysis device200, preferably by optically reading out the cartridge identifier100C from the cartridge100. Alternatively, or additionally, a memory means100D of the cartridge100that can be read out electronically makes it possible for the cartridge identifier100C to be read out without there being an optical connection to or visual contact with the cartridge100, for example, when said cartridge is inserted in the analysis device200.

The at least two cartridge identifiers100C can be the same or, in one aspect of the present invention, which can also be implemented independently, said cartridge identifiers100C can be different. In particular, it is possible and preferable for a (first) cartridge identifier100C to be individual or unique to the cartridge100, i.e., designed to uniquely identify the cartridge100. A (different or second) cartridge identifier100C is preferably designed to assign the cartridge100to a batch of cartridges100.

One of the cartridge identifiers100C thus preferably identifies (only) the cartridge100and/or one, in particular another, of the cartridge identifiers100C preferably identifies (only) a batch of cartridges100with which the cartridge100is associated, but not, in particular, the individual cartridge100.

Since there are, naturally, fewer batches than cartridges100, the cartridge identifier100C that identifies the batch requires less memory space and can therefore be stored more easily and more cost-effectively, for example, by means of the barcode124, in particular a QR code, or another memory means100D that can be retrieved wirelessly. In this case, the barcode124can be compact and can therefore be arranged without difficulty on the cartridge100or can be formed by the cartridge100.

In principle, however, it is not impossible that the cartridge identifiers100C may be identical or may both uniquely identify the batch and/or the cartridge100.

The at least two cartridge identifiers100C preferably correspond to one another. In particular, the cartridge identifier100C corresponding to the batch and/or the batch can be identified using the cartridge identifier100C that uniquely identifies the cartridge100. Preferably, both cartridge identifiers100C are read out and used, in particular in order to determine and/or retrieve control information510and/or evaluation information530on the one hand and in order to verify said information on the other hand.

The respective cartridges100are preferably identified at least twice or a cartridge identifier100C is read out and used at least twice, namely preferably once directly by the operating instrument400in order to retrieve control information510and/or calibration information520and/or evaluation information530and a second time by means of or via the analysis device200in order to ensure that the test is carried out using control information510, calibration information520and/or evaluation information530that corresponds to the cartridge100and/or in order to verify that the control information510, calibration information520and/or evaluation information530corresponds to the cartridge100.

The database500is preferably controllable/controlled by the cartridge identifier100C. Alternatively or additionally, the control information510and/or evaluation information530is preferably identifiable/identified and/or retrievable/retrieved from the database500by the cartridge identifier100C, specifically preferably by the cartridge identifier100C that can be read out wirelessly and or corresponds (only) to the batch.

The analysis system1, in particular the operating instrument400, is preferably designed to determine or retrieve the control information510and/or evaluation information530using one of the cartridge identifiers100C, in particular the cartridge identifier100C that can be read out wirelessly, and to verify the control information510and/or evaluation information530and/or to enable or unlock or start the test using another/the other cartridge identifier100C, preferably the cartridge identifier100C that can be read out electronically. In a corresponding method, by means of one of the cartridge identifiers100C, in particular the cartridge identifier100C that can be read out wirelessly, the control information510and/or evaluation information530is determined or retrieved, and by means of another/the other cartridge identifier100C, preferably the cartridge identifier100C that can be read out electronically, the control information510and/or evaluation information530is verified and/or the test is enabled, unlocked or started.

FIG. 4shows a schematic sequence of a preferred method for testing and/or evaluating by means of the proposed analysis system1, in particular in a manner which is dependent on the individual cartridge100. The following aspects and/or method steps can also be implemented and can be advantageous individually or in different combinations, the described order being preferred, but not obligatory, and it being possible for steps to be omitted or added or carried out independently.

As explained above, at least one cartridge identifier100C corresponds to the (respective) cartridge100. This cartridge identifier100C is preferably stored in a memory means100D, in particular the barcode124and/or a memory cell of the sensor apparatus113, on the cartridge100. However, in principle, other storage options are possible here or there is the option of providing other memory means100D. For example, a memory means100D assigned to the cartridge100can be arranged on the packaging of the cartridge100or can form part of said packaging.

Preferably, the cartridge100, in particular the sensor apparatus113, is electrically contacted by the analysis device200. This is preferably achieved by one or more contact elements203A, as shown inFIG. 1by way of example.

If the cartridge identifier100C is stored in the sensor apparatus113or is assigned thereto, said cartridge identifier100C can be read out by the analysis device200via a data connection DVC between the cartridge100and the analysis device200that can be created by means of the contact elements203A. This is symbolised by the arrow601, which represents the data transmission from the cartridge100to the analysis device200. The cartridge identifier100C stored in the sensor apparatus113and/or assigned to the sensor apparatus113identifies the cartridge100preferably uniquely or on a one-to-one basis.

The cartridge identifier100C read out from the cartridge100by the analysis device200can be transmitted to the operating instrument400via the data connection DVA between the analysis device200and the operating instrument400, as indicated inFIG. 4by the arrow602, which represents the data transmission between the analysis device200and the operating instrument400. In addition to the cartridge identifier100C, a device identifier200C can optionally also be transmitted from the analysis device200to the operating instrument400. The device identifier200C preferably corresponds to the specific analysis device200and/or makes it possible for said analysis device200to be identified.

In an alternative, which can also be carried out additionally, the cartridge identifier100C is or can be determined or read out directly by the operating instrument400. Particularly preferably, this is achieved optically and/or using the camera421of the operating instrument400, preferably by reading in a code, in particular the barcode124. It is however also possible for the cartridge identifier100C to be directly and/or wirelessly determined or read out from the relevant cartridge100by the operating instrument400in some other way, for example, by radio, in particular by reading out an RFID tag which is optionally assigned to the cartridge100or arranged on the cartridge100, or an NFC memory apparatus or the like which is assigned to the cartridge100, is arranged on the cartridge100or forms part of the cartridge100in some other way.

As a result, the cartridge identifier100C is therefore particularly preferably transmitted to the operating instrument400either directly by the operating instrument400reading out the memory means100D of the cartridge100, or indirectly by data being correspondingly transferred via the analysis device200, and the operating instrument400thereby receives or determines the cartridge identifier100C.

In one aspect of the present invention, which can also be implemented independently, the operating instrument400receives or determines information, which is preferably cartridge-specific and/or cartridge-batch-specific, by means of the cartridge identifier100C, or the operating instrument400is designed for this purpose.

The operating instrument400retrieves or is designed to retrieve, preferably automatically, the control information510for controlling the analysis device200in order to carry out the test supported by the cartridge100and/or analysis information530for evaluating measurement results713determined during the test, by reading out the cartridge identifier100C of the cartridge100or after said cartridge identifier100C has been read out.

In particular, it is provided that the operating instrument400receives or retrieves control information510on the basis of the cartridge identifier100C, which information is specific to the cartridge100, the batch thereof and/or specific for carrying out the test using the cartridge100. Particularly preferably, the control information510is retrieved from the database500or can be retrieved from the database500.

Preferably, the cartridge identifier100C is transmitted to the database500, as indicated inFIG. 4by the arrow603, which corresponds to the data transmission from the operating instrument400to the database500.

The database500can send back control information510corresponding to the cartridge100and/or to the cartridge identifier100C, i.e., transmit said information to the operating instrument400, as indicated inFIG. 4by the arrow604, which represents the data transmission between the database500and the operating instrument400.

Alternatively, or additionally, calibration information520and/or evaluation information530can also be transmitted to the operating instrument400in a corresponding manner from the database500to the operating instrument400or is or can be retrieved from the database500by the operating instrument400.

In one variant, the information can also be retrieved without the cartridge identifier100C being transmitted to the database500. In a variant of this kind, control information510, calibration information520and/or evaluation information530which is available to the operating instrument400and, for example, has been previously retrieved and/or temporarily stored in the operating instrument400, can be identified by means of the operating instrument400on the basis of the cartridge identifier100C and can be selected for subsequent use.

In another variant, which can be combined with the two previous methods for determining and/or retrieving the control information510, calibration information520and/or evaluation information530, the information is selected and/or retrieved in addition by using and/or transmitting a device identifier200C for identifying the analysis device200and/or an operating instrument identifier400C for identifying the operating instrument400. This makes it possible for the control information510, calibration information520and/or evaluation information530to be specific to or compatible with the analysis device200and/or the operating instrument400and for said information to be selected, transmitted, retrieved and/or sent back in a manner in which it is specific to or compatible with the analysis device200and/or the operating instrument400.

Preferably, control information510is retrieved or determined that corresponds to both the cartridge100and the analysis device200, particularly preferably to the combination of the cartridge100and the analysis device200. As a result, the test can be carried out in a manner which is specific to both the cartridge100and the analysis device200, and this contributes to making tests highly reproducible and reliable.

In one aspect of the present invention, which can also be implemented independently, the cartridge identifier100C, which preferably corresponds only to the batch with which the cartridge100is associated, is first determined by the operating instrument400, in particular is or can be read out from the cartridge100directly by the operating instrument400.

Using the cartridge identifier100C, the control information510and/or evaluation information530is retrieved, in particular by means of the operating instrument400. The retrieved control information510and/or evaluation information530is preferably stored temporarily in the operating instrument400.

The control information510is transmitted by the operating instrument400preferably to the analysis device200or the operating instrument400is designed for this purpose. This is indicated inFIG. 4by the arrow605, which corresponds to data transmission from the operating instrument400to the analysis device200.

Optionally, calibration information520can also be transmitted from the operating instrument400to the analysis device200. Alternatively, or additionally, the operating instrument400can modify the control information510, in particular taking into account the calibration information520. The control information510can however also already comprise or incorporate the calibration information520. It is therefore not obligatory for the calibration information520to be transmitted to the analysis device200.

Preferably, transmission only takes place if the cartridge100, the control information510, and the assignment, association and/or compatibility thereof have been verified. This ensures that the control information510to be transmitted corresponds to the cartridge100which is intended to be used to carry out the test. This is provided for in particular if the control information510and/or evaluation information530has been previously retrieved by the operating instrument400and/or stored temporarily in the operating instrument400.

Verification is achieved particularly preferably by a/the cartridge identifier100C. In particular, for verification, a cartridge identifier100C different from the cartridge identifier for retrieving the control information510and/or evaluation information530is used, and/or a cartridge identifier100C that is read out from another memory means100D of the cartridge100is used.

The cartridge identifier100D provided for verification is preferably read out by means of or via the analysis device200and/or transmitted to the operating instrument400. This takes place if the cartridge100is in direct contact with the analysis device200for carrying out the test, i.e., if the cartridge100is in particular loaded or inserted into the analysis device200. This ensures that the cartridge100which is intended to be used to carry out the test is determined. Verification by means of the cartridge identifier100C of the cartridge100therefore makes it possible to ensure that the test is carried out using the control information510that corresponds to the cartridge100.

Verification can be achieved by checking that the cartridge identifier100D provided for verification is assigned to the control information510and/or by checking that the cartridge identifier100C provided for verification is assigned to the cartridge identifier100C used for determining the control information510. In this respect, it can be checked whether the cartridge identifier100C provided for verification corresponds to the batch of cartridges100to which the control information510corresponds. This can be achieved by an assignment, allocation or mapping, such as a table or database, and/or by verification means which are assigned to or form part of the control information510. For this purpose, the control information510can comprise corresponding assignment means, for example, information relating to cartridge identifier groups. Verification can be carried out by these assignment means.

Other retrieved information, in particular the evaluation information530, can be verified in a corresponding manner.

The control information510can be received by the analysis device200and used for controlling the test. Alternatively or additionally, the control information510can also be verified in the analysis device200.

After the control information510has been transmitted, the test is started, preferably in a manner controlled by the operating instrument400.

InFIG. 4, the testing process on the cartridge100by means of the analysis device200is indicated by the arrow606.

According to one aspect of the present invention, which can also be implemented independently, the analysis device200is designed to carry out the test using the transmitted control information510and independently and/or separately and/or disconnected from the operating instrument400and/or the test is carried out independently and/or separately and/or disconnected from the operating instrument400.

Particularly preferably, the test is carried out independently and/or separately from the operating instrument400. For this purpose, the analysis device200is preferably designed to carry out or continue the test using the transmitted control information510and independently and/or separately and/or disconnected from the operating instrument400and/or when the data connection DVA is disconnected, terminated or broken.

This makes it possible for example, to transmit the control information510to the analysis device200by means of the operating instrument400, to start the test process, and to subsequently disconnect, terminate or break the data connection DVA between the analysis device200and the operating instrument400, such that the analysis device200carries out or can carry out the test self-actingly, automatically and/or autonomously of and independently from the operating instrument400. Therefore, while the test is underway, a user together with the operating instrument400can move away from the analysis device200and/or can use the operating instrument400for other purposes.

In order to carry out the test, the analysis device200preferably acts on the cartridge100such that the sample P is prepared, conveyed and/or analysed inside the cartridge100, or the analysis device200is designed for this purpose. Preferably, the test is or can be controlled by the control apparatus207of the analysis device200.

In order to carry out the test, the analysis device200preferably receives the control information510and, preferably, the calibration information520, particularly preferably via the operating instrument400in each case. For this purpose, the operating instrument400is preferably designed to transmit, and the analysis device200is designed to receive, the control information510and, preferably, the calibration information520.

Using the control information510, the control apparatus207controls apparatus and/or actuators of the analysis device200such that said apparatus and/or actuators act on the cartridge100, or the control apparatus207is designed for this purpose.

The actuators are in particular the pump drive202, the temperature-control apparatus204and/or the (valve) actuators205. By means of the actuators, the sample P can be conveyed within the fluid system103of the cartridge100and/or the temperature of the sample P can be changed and/or the sample P can be mixed with reagents and/or prepared and/or fed to the sensor apparatus113in order to ultimately determine, by means of the sensor apparatus113, measurement results713that correspond to the sample P.

The sample P is preferably conveyed inside the cartridge100to the sensor apparatus113in a manner specified by the control information510and/or the analysis device200is designed to do this, preferably together with the cartridge100.

Valves115A,115B of the cartridge100are preferably opened or closed in a manner specified by the control information510and/or the analysis device200is designed to do this, preferably together with the cartridge100.

One or more temperature-control apparatus204of the analysis device200are preferably controlled such that the sample P and/or sensor apparatus113are temperature-controlled in a manner specified by the control information510and/or the analysis device200is designed to do this, preferably together with the cartridge100.

Control on the basis of the control information510and, preferably, of the calibration information520is preferably carried out, as explained in connection withFIGS. 1 and 2, in particular so as to carry out a nucleic-acid assay for detecting a nucleic-acid sequence and/or a protein assay for detecting a protein. The control information510is therefore preferably designed to, the control information510in particular comprising instructions and/or parameters, in order to carry out a nucleic-acid assay for detecting a nucleic-acid sequence and/or a protein assay for detecting a protein. However, other assays are also possible.

The control information510preferably comprises valve control information510A for actuating one or more valve actuators205in order to open and/or close valves on the cartridge100.

Alternatively, or additionally, the control information510comprises pump drive control information510B for controlling the pump drive202, which can act, mechanically or otherwise, on the pump apparatus112of the cartridge100in order to convey fluid, in particular the sample P, through the fluid system103of the cartridge100.

Alternatively, or additionally, the control information510comprises temperature-control apparatus control information510C which specifies a temperature or a temperature curve or temperature profile of or for one or more temperature-control apparatus204of the analysis device200, as a result of which the sample P or another substance contained in the fluid system103of the cartridge100can be temperature-controlled, in particular in order to carry out a PCR and/or hybridization.

Alternatively, or additionally, the control information510comprises execution information511for executing the test, in particular the sequence for controlling different actuators. The execution information511can also be separate from the control information510, can be stored in the database500and/or can be transmitted to the analysis device200and/or the operating instrument400.

Execution information511includes in particular delay information511A, looping information511B for repeating certain steps and/or condition information511C for defining conditions, in particular threshold values, for triggering further steps or events.

The control information510can be in the Rhin of a control file. The control information510preferably contains or can be represented as a command sequence which defines the execution of the test, in particular in a sequential or procedural manner. The analysis device200preferably comprises an interpreter for the control information510.

The analysis device200and/or the control apparatus207preferably comprises a memory207A in which the control information510is stored and/or temporarily stored or in which said information can be stored. In particular, it is provided that the analysis device200receives the control information510and, optionally, calibration information520and saves said information in the memory207A. This makes it possible for the control apparatus207to control the analysis device200and/or actuators of the analysis device200independently and/or separately and/or disconnected from the operating instrument400in order to carry out or continue the test of the sample P.

The control apparatus207preferably controls and/or regulates and/or is designed to control and/or regulate apparatus of the analysis device200in order to carry out the test.

The control apparatus207preferably comprises an actuator interface207B by means of which one or more of the actuators can be controlled. In particular, the actuator interface207B makes it possible to supply power to and/or to specify a target value for one or more of the actuators. This makes it possible to specify a target temperature value and/or a target temperature profile or curve for one or more of the temperature-control apparatus204by means of the actuator interface207B. Alternatively or additionally, the pump drive202can be controlled.

The pump drive202preferably comprises a stepper motor, as a drive element, and the actuator interface207B preferably comprises a corresponding stepper motor controller. Owing to this combination, fluid can be conveyed in the fluid system103of the cartridge100in a very accurate manner. In addition, via the actuator interface207B, the analysis device200and/or the control apparatus207can activate and/or supply power to one or more of the valve actuators205, such that valves115A,115B located on the cartridge100can be opened and/or closed.

Alternatively, or additionally, the analysis device200, in particular the control apparatus207, comprises a read-out module207C for reading out measurement results713from the sensor apparatus113. The read-out module207C can be designed to digitalise measurement results713determined in the sensor apparatus113and to store and/or transmit said results in the form of a code or data set. In some cases, at least with regard to the digitalisation of the measurement results, the read-out module207C can also be located in the cartridge100or in the sensor apparatus113, and/or the read-out module207C can read out measurement results713digitalized by the sensor apparatus113.

Alternatively, or additionally, the analysis device200and/or the control apparatus207can comprise an error module207D for identifying errors. In particular, the error module207D is designed to detect errors in the execution of the test. Alternatively, or additionally, the error module207D can detect and document errors in boundary conditions, for example, a temperature, inclination or the like, and/or control the analysis device200according to and/or taking into account the error detection.

The analysis system1, the cartridge100and/or the analysis device200is/are preferably designed to carry out the proposed method and/or the method is preferably controlled by means of the control information510, taking into account the control information510or in a manner specified by the control information510. However, the method described below can also be modified and the invention can also be used and be advantageous for other methods for testing an in particular biological sample.

Within the context of the method, a sample P having at least one analyte A on the basis of a fluid or a liquid from the human or animal body, in particular blood, saliva or urine, is usually first introduced into the receiving cavity104via the connection104A, in order to detect diseases and/or pathogens, it being possible for the sample P to be pretreated, in particular filtered.

Once the sample P has been received, the receiving cavity104and/or the connection104A thereof is fluidically closed, in particular in a liquid-tight and/or gas-tight manner.

Preferably, the cartridge100together with the sample P is then linked or connected to the analysis device200, in particular is inserted or slid into the analysis device200.

The method sequence, in particular the flow and conveying of the fluids, the mixing and the like, is controlled by the analysis device200or the control apparatus207, in particular by accordingly activating and actuating the pump drive202or the pump apparatus112and/or the valve actuators205or valves115A,115B.

During the nucleic-acid assay, a desired volume of the sample P that is mixed and/or pretreated in the mixing cavity107is subsequently preferably fed to one or more reaction cavities109A-C, particularly preferably via (respectively) one of the upstream, optional intermediate cavities106A to106C and/or with different reagents or primers, in this case dry reagents S4to S6, being added or dissolved.

In the reaction cavities109A-C, the amplification reactions or PCRs are carried out to copy/amplify the analytes A. This is carried out in particular by means of the assigned, preferably common, reaction temperature-control apparatus204A and/or preferably simultaneously for all the reaction cavities109A-C, i.e., in particular, using the same cycles and/or temperature (curves/profiles).

During the nucleic-acid assay, a label is in particular produced directly and/or during the amplification reaction(s) (in each case) and/or is attached to the analytes A and/or amplification products. This is in particular achieved by using corresponding, preferably biotinylated, primers. However, the label can also be produced and/or bonded to the analytes A and/or amplification products separately or later, optionally also only in a sensor compartment of the sensor apparatus113and/or after hybridization. In particular, during the protein assay, a label is only bonded to analytes A after hybridization of the analytes A to the capture molecules.

The label is used in particular for detecting bonded analytes A and/or amplification products. In particular, the label can be detected or the label can be identified in a detection process, as explained in greater detail in the following.

After carrying out the amplification reaction(s), corresponding fluid volumes and/or amplification products are conducted out of the reaction cavities109A-C in succession to the sensor arrangement, in particular the sensor apparatus113and/or the sensor compartment, in particular via a group-specific and/or separate intermediate cavity106E,106F or106G (respectively) and/or via the optional (common) intermediate temperature-control cavity110.

After the sample P and/or the analytes A and/or amplification products are fed to the sensor apparatus113, the analytes A and/or amplification products are hybridised to the capture molecules, preferably by (actively) temperature-controlling, in particular heating, the sensor arrangement or sensor apparatus113, in particular by means of the sensor temperature-control apparatus204C.

When carrying out the protein assay, the sample P or the analytes A is/are preferably fed directly from the mixing cavity107to the sensor arrangement or sensor apparatus113and/or is/are guided past the intermediate cavity/cavities106A-G, reaction cavity/cavities109A-C and/or the intermediate temperature-control cavity110via the bypass114A.

Once the sample P, analytes A and/or amplification products are hybridised and/or bonded to the capture molecules, detection follows, in particular by means of the preferably provided label, or in another manner.

In the following, a particularly preferred variant of the detection is described in greater detail, specifically electrochemical detection, but other types of detection, for example, optical detection, capacitive detection or the like, may also be carried out.

Following the (respective) bondings/hybridisations, preferably an optional washing process takes place and/or additional reagents or liquids, in particular from the storage cavities108B to108E, are optionally fed in.

Subsequently and/or after the washing process, in accordance with a preferred variant of the method, detection of the analytes A and/or amplification products bonded to the capture molecules takes place.

If the bonded analytes A or amplification products are still not marked or provided with a label, in particular during the protein assay, the labels are then fed to the sensor arrangement or the sensor compartment, preferably from the storage cavity108E. Optionally, there is then another washing process.

In order to detect the analytes A or amplification products bonded to the capture molecules, a reagent F4and/or detector molecules is/are fed to the sensor apparatus113, preferably from the storage cavity108D. In particular, alkaline phosphatase/streptavidin is an example of a detector molecule suitable for use for this purpose.

Within the meaning of the present invention, the team “detector molecules” is preferably understood to mean molecules that bond specifically to the marker or label of the (bonded) analytes A or amplification products and thus allow the detection thereof.

In particular, the detector molecules may be enzyme conjugates and/or immunoconjugates, which bond specifically to the marker or label, in particular biotin, and comprise a reporter enzyme for converting a substrate.

In the context of the present invention, the detector molecules are preferably based on streptavidin, which has a high affinity for biotin, and/or alkaline phosphatase, which can convert non-reactive phosphate monoesters to electrochemically active molecules and phosphate.

Preferably, a detection system is used, where the label is based on biotin and where the detector molecules are based on streptavidin/alkaline phosphatase. However, other detector molecules can also be used.

The reagents F4or detector molecules can bond to the bonded analytes or amplification products, in particular to the label of the bonded analytes A or amplification products, particularly preferably to the biotin marker.

Optionally, subsequently or after the reagents F4and/or detector molecules have bonded to the analytes A and/or amplification products and/or the labels, an (additional) washing process and/or flushing takes place, preferably by means of the fluid or reagent F3or wash buffer, in particular in order to remove unbonded reagents F4and/or detector molecules from the sensor apparatus113.

Preferably, a reagent S8and/or substrate for the detection, in particular from the storage cavity106D, is lastly fed to the sensor arrangement or sensor apparatus113, preferably together with a fluid or reagent F2(in particular a buffer), which is suitable for the substrate, particularly preferably for dissolving the reagent S8and/or substrate, the fluid or reagent in particular taken from the storage cavity108B.

Preferably, p-aminophenyl phosphate (pAPP) is used as the substrate.

The substrate preferably reacts on and/or with the bonded analytes A or amplification products and/or detector molecules and/or allows these to be electrochemically measured.

Preferably, a first or electrochemically active substance is detected in the sensor apparatus113by electrochemical measurement and/or redox cycling.

The measurement is preferably taken just once and/or for the entire sensor array113A of the sensor apparatus113and/or for all the sensor fields113B of said sensor array, in particular simultaneously or in parallel. In particular, the bonded analytes A or amplification products are detected, identified or determined simultaneously or in parallel in a single or common detection process.

However, in principle, it is also possible to measure a plurality of sample portions in the sensor apparatus113or in a plurality of sensor apparatus113in succession or separately.

The test results or measurement results713are in particular electrically transmitted to the analysis device200or the control apparatus207thereof, preferably by means of the electrical connection apparatus203, and are accordingly prepared, analyzed, evaluated, stored, displayed and/or output, in particular by the display apparatus209and/or interface210.

After the test has been carried out, the cartridge100is disconnected from the analysis device200and/or is released or ejected therefrom, and is in particular disposed of.

The test results or measurement results713that have been determined by means of the testing method described above or by means of another testing method are transmitted, in particular electrically, to the analysis device200and/or the control apparatus207thereof, preferably by means of the electrical connection apparatus203. The measurement results713are transmitted from or via the analysis device200preferably to the operating instrument400, and are prepared, analyzed, evaluated, stored, displayed and/or output by the operating instrument400.

The measurement result(s)713of the sensor apparatus113is/are preferably transmitted from the cartridge100to the analysis device200and/or retrieved by the analysis device200from the cartridge100and/or the sensor apparatus113. For this purpose, the analysis system1is preferably designed to transmit the measurement result713from the sensor apparatus113of the cartridge100, from the analysis device200and/or via the analysis device200to the operating instrument400. This is indicated inFIG. 4by the arrow607, which corresponds to the results retrieval from the cartridge100by the analysis device200.

In one aspect of the present invention, which can also be implemented independently, the measurement result(s)713, i.e., in particular, the result for the test of the sample P using the analysis device200, is/are preferably transmitted to the operating instrument400without any prior evaluation or can be transmitted without any prior evaluation. This is indicated inFIG. 4by the arrow608, which corresponds to the data transmission from the analysis device200to the operating instrument400.

Transmitting the measurement results713without any prior evaluation in the analysis device200makes possible an individual and/or easily adaptable evaluation outside of the analysis device200.

Transmission of the measurement result713without any prior evaluation can also be referred to as the transmission of unprocessed measurement results713. This should be understood to mean that, although it is possible to carry out processing in terms of data transmission, as provided for by transmission protocols, in order to address transmission errors or the like, it is not provided that the measurement results713are interpreted prior to transmission, i.e., the significance of measurement results is not determined or established and, if applicable, conclusions are not made with regard to properties of the sample P. In the present case of a biological sample P, this means in particular that measurement results713are assigned to the presence of certain substances/analytes and/or concentrations and/or diseases or the like not in the analysis device200, but rather externally.

The measurement results713are preferably evaluated in the operating instrument400after the operating instrument400has received the measurement results713from the analysis device200and/or the cartridge100. InFIG. 4, the evaluation process by means of the operating instrument400is indicated by the arrow609.

The evaluation of the measurement results713by means of the operating instrument400can also be carried out independently and/or separately and/or disconnected from the analysis device200.

As mentioned previously, the operating instrument400can determine and/or retrieve, in particular from the database500, evaluation information530on the basis of the cartridge identifier100C and/or the device identifier200C. The evaluation information530is designed or used to evaluate measurement results713determined during the test. The measurement results713can be evaluated by means of the operating instrument400on the basis of or using said evaluation information530. For this purpose, the operating instrument400is preferably designed to retrieve and/or receive measurement results713from the analysis device200.

In one aspect of the present invention, which can also be implemented independently, the operating instrument400evaluates or is designed to evaluate the measurement results713using the evaluation information530and independently and/or separately and/or disconnected from the analysis device200. It is also possible for the data connection DVA between the analysis device200and the operating instrument400to be disconnected, terminated or broken after the measurement results713have been retrieved, and for the evaluation to also be carried out separately and/or disconnected from the analysis device200.

In particular, the evaluation information530comprises instructions, in particular an algorithm, in order to compute or calculate with the measurement results713and to assign said measurement results713to a physical variable, value or property. As a result, the measurement results713can be interpreted.

The evaluation information530is preferably individual, unique and/or specific to a specific cartridge100or batch of cartridges100and/or to a specific analysis device200and/or the combination of a specific cartridge100and an analysis device200. Alternatively or additionally, the evaluation information530is individual, unique and/or specific to a/the operating instrument400, in particular an operating system of the operating instrument400.

The evaluation information530is particularly preferably dependent on the specific sensor apparatus113of the respective cartridges100and can be specific to a specific type of cartridge or a specific batch of cartridges and/or a specific test or evaluation that can be carried out using a type of cartridge or a batch of cartridges.

As mentioned at the outset, the evaluation information530preferably comprises instructions, which preferably form an algorithm and/or a plugin or module. This evaluation information530can form all or part of the evaluation module440of the operating instrument400. For this purpose, the evaluation information530is integrated in the operating instrument400as a component or a module which defines the behaviour of the evaluation module440and/or of the operating instrument400.

The operating instrument400implements the evaluation information530preferably by interpreting the instructions using a processor or controller of the operating instrument400. The instructions are in particular source code, pre-compiled code or machine code for being executed on the operating instrument400.

The evaluation information510is preferably specific to a certain group of operating instruments400, in particular specific to a certain operating system or a group of operating systems.

Depending on the operating instrument identifier400C for identifying an operating instrument400or group, class or kind of operating instruments400, in particular having the same operating system, it is possible to provide, make available and/or retrieve different forms of the same or different evaluation information510. In particular, when transmitting the operating instrument identifier400C, the database500sends evaluation information510of such kind back to the operating instrument400, that can be processed, compiled, used and/or executed by the operating instrument400.

The analysis system1, in particular the database500, therefore preferably comprises different items of evaluation information530or is designed to generate and/or provide different items of evaluation information530, the different items of evaluation information530generating or making possible the same or similar functionality on different operating instruments400. Nevertheless, the evaluation information530is preferably specific to a cartridge100or a batch of cartridges100.

As a result, different items of evaluation information530are preferably provided and/or can be retrieved for different cartridges100or batches of cartridges100, and said different items of evaluation information530are each provided and/or can each be retrieved in different versions for different operating instruments400.

The operating instrument400preferably outputs or is designed to output, by means of the output apparatus410, the evaluation results740that are determined, in particular calculated, by evaluating the measurement results713using the evaluation information530. For this purpose, the operating instrument400can display the evaluation results740graphically or otherwise, in particular by means of the screen or display411. Alternatively, or additionally, the operating instrument400sends or is designed to send the evaluation results740to the database500.

The operating instrument400is preferably designed to receive and/or display an operating status of the analysis device200.

In particular, the operating instrument400comprises a graphical user interface which is displayed on the screen or display411. The graphical user interface preferably comprises an interface which graphically symbolizes the possible controls and/or states of the analysis device200. Alternatively, or additionally, the user interface is designed to control interaction with the database500and/or with the analysis device200. For this purpose, the operating instrument400can be designed so as to be touch-sensitive, in particular via a touch-sensitive screen or display411. Alternatively, or additionally, the user interface can however also be controlled via the touchpad422, the microphone423, the keyboard424or some other input apparatus420.

In one aspect of the present invention, the analysis system1comprises a plurality of cartridges100which support the same or different tests. It is therefore possible for there to be a plurality of different types of cartridge for carrying out different tests and/or for the analysis system1to comprise or support said types of cartridge. It is preferable for these cartridges100to be inserted into the same analysis device200and/or for the test using the cartridges100to be carried out or be able to be carried out by means of the same analysis device200.

In another aspect, the proposed analysis system1comprises a plurality of analysis devices200. It is preferable that the analysis devices200can each be coupled to the same operating instrument400. The same operating instrument400can thus be connected to different analysis devices200, the data connection DVA preferably connecting to or being established to just one of the analysis devices200at any one time. Alternatively, the same operating instrument400can however also be connected to a plurality of analysis devices200simultaneously. In this case, it is preferable for the operating instrument400to assist in selecting an analysis device200for configuration and/or control. In particular, an analysis device200can be selected by the operating instrument400via the input apparatus420, such that (only) the selected analysis device200is subsequently controlled.

The analysis system1can comprise or support a plurality of operating instruments400. In particular, a plurality of operating instruments400can be coupled to the same analysis device200alternately, but preferably not simultaneously. By coupling the analysis device200to an operating instrument400, the data connection DVA between the analysis device200and the operating instrument400is preferably established, such that control information510can be transmitted to the analysis device200and/or results can be transmitted to the operating instrument400.

The database500preferably comprises a plurality of different items of control information510for carrying out tests using the different cartridges100and/or different analysis devices200. The control information510can also be formed in multiple parts. In particular, the control information510can comprise parts specific to the cartridge100and parts specific to the analysis device200.

Evaluating the measurement results713preferably comprises assigning measurement results713corresponding to particular sensor fields113B to functions of the respective sensor fields113B. This can be achieved by using different evaluation methods, threshold values or the like for different sensor fields113B.

It is possible for sensor fields113B of the same kind to be evaluated together. In this case, it is preferable that measurement results713corresponding to sensor fields113B of the same kind are tested for considerable deviations, that measurement results713having considerable deviations with respect to other measurement results713for sensor fields113B of the same kind are rejected, and that only similar measurement results713for sensor fields113B of the same kind are evaluated.

During evaluation, it is possible to determine measurement results713for sensor fields113B of the same kind. Alternatively or additionally, the measurement results713, jointly or in a calculated manner, for example, the average value thereof, can be compared with a threshold value or with a plurality of threshold values, or evaluated in some other way. In this case, the one or more threshold values may be values or, alternatively or additionally, specified profile or curve progressions, specified gradients, maximum values thereof or the like.

By evaluating the measurement results713, the evaluation result740is generated, which preferably corresponds to a physical value, variable or property of the sample P, preferably directly. For example, the evaluation result740represents the presence of certain DNA sequences and/or RNA sequences and/or proteins, in particular antigens and/or antibodies.

Alternatively, or additionally, the evaluation result740can however also be or comprise an interpretation derived from the presence of the DNA sequences and/or RNA sequences and/or proteins, in particular antigens and/or antibodies, in particular information on whether or how likely it is that a certain disease and/or pathogen, such as a virus, bacterium or the like, is present in the sample P.

The evaluation result740is preferably output by the output apparatus410of the operating instrument400, or can be output, in particular displayed, by the output apparatus410.

If a disease and/or a pathogen is detected, it can be provided that the operating instrument400automatically outputs or sends a warning and/or message.

Measurement results713and/or evaluation results740are preferably archived. Particularly preferably, these results are saved, or saved temporarily, in the operating instrument400. Alternatively, or additionally, these results are saved and/or archived in the database500, in particular in the results memory550of the database500. For this purpose, the evaluation results740can be transmitted from the operating instrument400to the database500via data transmission610.

Archiving in the database500can be temporally offset with respect to the evaluation results740being generated and/or the measurement results713being retrieved or received. This is in particular the case when the test or evaluation is carried out without there being a data connection DVD between the database500and the operating instrument400. In this case, the measurement results713and/or evaluation results740can be transmitted to the database500in a temporally offset manner and/or at a later point in time, as soon the data connection DVD is restored or can be re-established.

Control information510and/or calibration information520and/or evaluation information530can be retrieved from the database500separately, disconnected and/or independently from the analysis device200. For this purpose, a data connection DVB between the cartridge100and the operating instrument400is preferably used, for example, by the operating instrument400reading in the barcode124and determining the cartridge identifier100C by evaluation. This is also possible when the data connection DVA between the analysis device200and the operating instrument400is disconnected, terminated or broken.

Furthermore, the operating instrument400can also retrieve control information510, calibration information520and/or evaluation information530from the database500independently, disconnected and/or separately from the cartridge100and/or the analysis device200. It is therefore possible for example, for the operating instrument400to firstly determine, read out or receive the cartridge identifier100C. Retrieval from the database500can take place subsequently, also independently from the cartridge100and/or the analysis device200. For this purpose, in particular only the data connection DVD between the operating instrument400and the database500is required. The retrieved data can be stored temporarily in the memory450.

It is preferable for the analysis device200to determine or read out the cartridge identifier100C and send it to the operating instrument400before the test is carried out using a specific cartridge100, even if the operating instrument400has already previously retrieved or received control information510, calibration information520and/or evaluation information530. The cartridge identifier100C transmitted from the analysis device200to the operating instrument400before the test has begun can then be checked by the operating instrument400in order to determine whether control information510, calibration information520and/or evaluation information530that corresponds to the cartridge100and/or the cartridge identifier100C is provided, in particular already stored or temporarily stored in the memory450.

If the operating instrument400identifies control information510and/or calibration information520that already corresponds to the cartridge100or the cartridge identifier100C, this information can be transmitted to the analysis device200and the test using the cartridge100inserted into the analysis device200can be started.

Alternatively, required control information510and/or calibration information520is retrieved from the database500.

In a preferred development of the invention, the analysis system1comprises a plurality of different cartridges100for carrying out preferably different tests, to which different control information510and evaluation information530corresponds.

For the same cartridge100, different control information510and/or evaluation information530can be provided, selected, selectable, retrieved, retrievable, used and/or usable, in particular when different tests can be carried out using the same cartridge100, and the control information510corresponds in each case to one of the tests that can be carried out.

In another aspect of the present invention, which can also be implemented independently, a computer program product is provided that comprises program code means for carrying out the proposed method. This computer program product is in particular an instruction stored on a storage medium, in particular in the form of a smartphone app or the like. The computer program product preferably is a non-transitory computer-readable media.

The instruction is preferably set up to control the operating instrument400, and/or to determine and/or receive the cartridge identifier100C.

Alternatively, or additionally, the instruction is set up to control the operating instrument400, to transmit the cartridge identifier100C to the database500, and to subsequently receive control information510from the database500.

Alternatively, or additionally, the instruction is designed to control the operating instrument400and/or to transmit or forward control information510to the analysis device200.

Alternatively, or additionally, the instruction is designed to control the operating instrument400, and/or to receive, evaluate and/or interpret measurement results713, in particular using retrieved and/or received evaluation information530.

In general, the analysis device200, the cartridge100or in particular the sensor apparatus113may measure, detect or identify the one or more analytes A by means of specific bonding, in particular by means of capture molecules and/or of means of electrochemical detection such as redox cycling, or the like, preferably performed on the cartridge100and/or in the sensor apparatus113. Preferably, the capture molecules are arranged or immobilized on a sensor array or on sensor fields or electrodes of the sensor apparatus113. In particular, an immuno-assay or a protein assay for detecting or identifying a protein and/or a nucleic-assay for detecting or identifying a nucleic-acid sequence can be or is realized.

Alternatively, or additionally, measurements without specific bonding and/or without electrochemical detection can be used or performed, preferably in or by the analysis device200and/or cartridge100. Such measurements can include an optical measurement, impedance measurement, capacitance measurement, spectrometric measurement, mass spectrometric measurement, or the like. For this purpose, the analysis device200or cartridge100may comprise an optical spectrometer and/or allow optical measurements of the treated or untreated sample P. Thus, it is possible to measure, detect or identify other or further analytes A, compounds, material characteristics, or the like of the sample P, e.g. within the cartridge100or any other sample carrier. These alternative or additional measurements can be used or processed and/or evaluated in a similar manner as described or differently.

Individual aspects and features of the present invention and individual method steps and/or variants of the method may be implemented independently from one another, but also in any desired combination and/or order.

In particular, the present invention relates also to any one of the following aspects which can be realized independently or in any combination, also in combination with any aspects described above.1. Cartridge100for an analysis system1for testing an in particular biological sample P, characterizedin that the cartridge100comprises two memory means100D that can be read out by different methods and which each comprise a cartridge identifier100C, the cartridge identifiers100C corresponding to the cartridge100or to a batch of cartridges100; and/orin that the cartridge100comprises two different cartridge identifiers100C.2. Cartridge according to aspect 1, characterized in that one of the cartridge identifiers100C identifies the cartridge100and/or one, in particular another, of the cartridge identifiers100C identifies a batch of cartridges100with which the cartridge100is associated.3. Cartridge according to aspect 1 or 2, characterized in that one of the memory means100D is a memory means100D that can be read out wirelessly, in particular optically or by radio, in particular a barcode124, an RFID tag and/or an NFC apparatus.4. Cartridge according to any one of the preceding aspects, characterised in that one of the memory means100D is a memory means100D that can be read out electronically, in particular in a wired manner.5. Cartridge according to aspect 4, characterized in that the memory means100D that can be read out electronically can be read out or transmitted via the same interface, in particular via contacts, of the cartridge100as that via which also measurement results713can be read out or transmitted from the cartridge100.6. Cartridge according to aspect 4 or 5, characterized in that the memory means100D that can be read out electronically is formed by a sensor apparatus113of the cartridge100, corresponds to the sensor apparatus113and/or uniquely identifies the sensor apparatus113, preferably one or more sensor fields113B being formed on or by a semiconductor component, and the memory means100D that can be read out electronically being formed on or by the same semiconductor component.7. Cartridge according to any one of the preceding aspects, characterized in that at least one of the memory means100D, preferably both the memory means100D, is/are connected to the cartridge100and/or formed by the cartridge100.8. Cartridge according to any one of the preceding aspects, characterized in that the cartridge identifier100C is an identification code or comprises an identification code that uniquely identifies the cartridge100and/or a batch with which the cartridge100is associated.9. Analysis system1comprising a cartridge100according to any one of the preceding aspects, wherein the analysis system1comprises an operating instrument400by means of which one of the memory means100D can be read out, preferably wirelessly, in particular optically.10. Analysis system1comprising a cartridge100according to any one of aspects 1 to 8, in particular according to aspect 8, wherein the analysis system1comprises an analysis device200by means of which one of the memory means100D can be read out, preferably electronically, in particular in a wired manner.11. Analysis system according to aspects 9 and 10, characterized in that a memory means100D can be read out, in particular can only be read out, by the operating instrument400and/or the other memory means100D can be read out, in particular can only be read out, by the analysis device200.12. Analysis system according to any one of aspects 9 to 11, characterized in that the analysis system1comprises a database500that comprises control information510and/or evaluation information530for carrying out a test using the cartridge100, the database500being controllable by the cartridge identifier100C, and/or the control information510and/or evaluation information530being identifiable and/or retrievable from the database500by means of the cartridge identifier100C.13. Analysis system according to any one of aspects 9 to 12, characterized in that the analysis system1is designed to determine or retrieve control information510and/or evaluation information530for carrying out the test using a cartridge identifier100C, in particular the cartridge identifier that can be read out wirelessly, and to verify the control information510and/or evaluation information530and/or to enable or start the test using another cartridge identifier100C, preferably the cartridge identifier that can be read out electronically.14. Method for carrying out a test on an in particular biological sample P using a cartridge100that can be inserted into an analysis device200for carrying out the test,characterizedin that a cartridge identifier100C is read out from a first memory means100D of the cartridge100, and a cartridge identifier100C being read out from a second memory means100D of the cartridge100that is different from the first memory means, the cartridge identifiers100C each corresponding to the cartridge100and/or to a batch of cartridges100; and/orin that a first cartridge identifier100C and a second cartridge identifier100C that is different from the first cartridge identifier100C are determined and/or read out, the cartridge identifiers100C each corresponding to the cartridge100and/or to a batch of cartridges100.15. Method according to aspect 14, characterized in that by means of the cartridge identifier100C of the first memory means100D control information510and/or evaluation information530for carrying out the test is determined or retrieved, by means of the cartridge identifier100C of the second memory means100D the control information510and/or evaluation information530preferably being verified, in particular said information being verified to correspond to the cartridge (100), preferably when a cartridge100is loaded in the analysis device200, in order to ensure that the control information510and/or evaluation information530corresponds to the loaded cartridge100.16. Computer program product comprising program code means which, when executed, cause the method steps of the method according to aspect 14 or 15 to be carried out.