Patent Publication Number: US-10773255-B2

Title: Cartridge and method for testing a sample

Description:
BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present invention relates to a cartridge for testing a sample, including a receiving cavity with a connection for receiving the sample, a closure element for fluidically closing the connection, and a packaging enclosing the cartridge in a delivery state, and to a method for testing a sample by means of a cartridge, including receiving the sample in a receiving cavity of the cartridge, and closing a connection of the receiving cavity using a closure element after the cartridge has been filled with the sample, wherein the cartridge is filled with the sample in an open packaging and is removed from the packaging only after the cartridge has been filled with the sample. 
     Preferably, the present invention deals with analysing 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 cartridge, 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, 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, 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 apparatuses for carrying out a nucleic-acid assay for detecting or identifying a nucleic-acid sequence 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 apparatuses, 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 the 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 Publication No. WO 2006/125767 A1 and corresponding U.S. Pat. No. 9,110,044 B2 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-acid sequences as target analytes in what is known as a redox cycling process. 
     US Patent Application Publication No. 2011/0150705 A1 discloses a cartridge with two hinged parts that are folded together to form the cartridge. The cartridge may be packaged in a moisture resilient container forming a primary package which may be fed into a secondary packaging unit for boxing and overpacking. 
     Usually, a sample to be tested is received in the cartridge before the cartridge is inserted into an analysis device. The handling of the sample is not uncritical. 
     SUMMARY OF THE INVENTION 
     The problem addressed by the present invention is to provide a cartridge and a method for testing a sample, preferably by means of which simple and secure handing and/or testing is/are made possible or facilitated. 
     The above problem is solved by a cartridge for testing a sample, the cartridge including a receiving cavity with the connection for receiving the sample, a closure element for fluidically closing the connection, and a packaging closing the cartridge in a delivery state, wherein the packaging includes a support apparatus for supporting the cartridge, and/or a mounting apparatus for mounting the cartridge in at least one of a form-fit, interlocking, clamping and latching manner, and/or a lower part comprising a peripheral edge for receiving and mounting the cartridge, and a removable lid for closing the lower part, such that, when the packaging is open, the cartridge can be filled in the packaging and the connection can be closed in the packaging. The above problem is also solved by a method for testing a sample by means of a cartridge, the method including the steps of receiving the sample in a receiving cavity of the cartridge and closing a connection of the receiving cavity using a closure element after the cartridge has been filled with the sample, wherein the cartridge is filled with the sample in an open packaging and is removed from the packaging only subsequent to the cartridge being filled with the sample. 
     It is proposed that the cartridge is delivered in a packaging, i.e. comprises a packaging in the delivery state. It is proposed that the cartridge and the packaging are designed such that, after the packaging has been opened, the cartridge can be filled in the packaging with a sample to be tested. 
     In particular, a receiving cavity of the cartridge is filled with the sample via a connection. Following the filling process, the connection is closed. This in particular also takes place in the packaging. In principle, however, the connection can also be closed by means of a closure element only after the cartridge has been removed from the packaging. 
     The proposed method allows very simple and reliable handling. In particular, simple filling of the cartridge with the sample to be tested is made possible or facilitated. Furthermore, the risk of undesired contamination can thus be reduced. 
     After the cartridge can been filled with the sample, the sample is preferably tested in the cartridge. Particularly preferably, the cartridge is connected to and/or received by a corresponding analysis device for this purpose. 
     According to one aspect of the present invention, the packaging preferably comprises a mounting apparatus for mounting the cartridge in the packaging, in particular in a form-fit, interlocking, clamped and/or latching manner. This facilitates filling and in particular also closing of the cartridge in the packaging when the packaging is open. 
     According to another aspect of the present invention, the packaging preferably comprises a support apparatus for supporting the cartridge in the packaging. This facilitates filling and in particular also closing of the cartridge in the packaging when the packaging is open. 
     According to another aspect of the present invention, the packaging comprises a lower part and a peripheral edge for receiving and in particular laterally mounting the cartridge, and a removable or pull-off lid for closing the lower part. This facilitates filling and in particular also closing of the cartridge in the packaging when the packaging is open. 
     Particularly preferably, the connection is arranged on a flat side and/or upper face of the cartridge, and the cartridge is received with its opposite flat side and/or its lower face in the lower part of the packaging. This allows particularly simple and/or intuitive handling. 
     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 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 accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic view of a proposed analysis device and a proposed cartridge received in the analysis device; 
         FIG. 2  is a schematic view of the cartridge; 
         FIG. 3  is a schematic perspective front view of the cartridge; 
         FIG. 4  is a schematic perspective rear view of the cartridge comprising a receiving cavity; 
         FIG. 5  is a schematic plan view of a connection of the receiving cavity; 
         FIG. 6  is a schematic sectional detail of the cartridge while it is being filled with a sample; and 
         FIG. 7  is a schematic perspective view of a packaging of the cartridge. 
     
    
    
     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. 1  is a highly schematic view of a proposed apparatus or cartridge  100  in an analysis device  200  for testing an in particular biological sample P. 
       FIG. 2  is a schematic view of a preferred embodiment of the proposed apparatus or cartridge  100  for testing the sample P. The apparatus or cartridge  100  in particular forms a handheld unit, and in the following is merely referred to as a cartridge  100 . 
     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. 
     A sample within the meaning of the present invention preferably contains one or more analytes, it preferably being possible for the analytes to be identified or detected, in particular qualitatively and/or quantitatively determined. Particularly preferably, within the meaning of the present invention, a sample has target nucleic-acid sequences as the analytes, in particular target DNA sequences and/or target RNA sequences, and/or target proteins as the analytes, in particular target antigens and/or target antibodies. Particularly preferably, at least one disease and/or pathogen can be detected or identified in the sample P by qualitatively and/or quantitatively determining the analytes. 
     Preferably, the analysis device  200  controls the testing of the sample P in particular in or on the cartridge  100  and/or is used to evaluate the testing and/or to collect to process and/or to store measured values from the test. 
     By means of the analysis device  200  and/or by means of the cartridge  100  and/or using the method for testing the sample P, an analyte of the sample P, or particularly preferably a plurality of analytes of the sample P, can be preferably determined, identified or detected. Said analytes are in particular detected 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, for example in order for it to be possible to detect or identify a disease and/or pathogen or to determine other values, which are important for diagnostics, for example. 
     The cartridge  100  is preferably at least substantially planar, flat, plate-shaped and/or card-like. 
     The cartridge  100  preferably comprises an in particular at least substantially planar, flat, plate-shaped and/or card-like main body or support  101 , the main body or support  101  in particular being made of and/or injection-moulded from plastics material, particularly preferably polypropylene. 
     The cartridge  100  preferably comprises at least one film or cover  102  for covering the main body  101  and/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 in  FIG. 2 . 
     The analysis system  1 , cartridge  100  and/or the main body  101  thereof, in particular together with the cover  102 , preferably forms and/or comprises a fluidic system  103 , referred to in the following as the fluid system  103 . 
     The cartridge  100 , the main body  101  and/or the fluid system  103  are preferably at least substantially vertically oriented in the operating position and/or during the test, in particular in the analysis device  200 , as shown schematically in  FIG. 1 . In particular, the main plane or surface extension of the cartridge  100  thus extends at least substantially vertically in the operating position. 
     The cartridge  100  and/or the fluid system  103  preferably comprises a plurality of cavities, in particular at least one receiving cavity  104 , at least one metering cavity  105 , at least one intermediate cavity  106 , at least one mixing cavity  107 , at least one storage cavity  108 , at least one reaction cavity  109 , at least one intermediate temperature-control cavity  110  and/or at least one collection cavity  111 , the cavities preferably being fluidically interconnected by a plurality of channels. 
     Within the meaning of the present invention, channels are preferably elongate forms for conducting a fluid in a main flow direction, the forms preferably being closed transversely, in particular perpendicularly, to the main flow direction and/or longitudinal extension, preferably on all sides. 
     In particular, the main body  101  comprises elongate notches, recesses, depressions or the like, which are closed at the sides by the cover  102  and form channels within the meaning of the present invention. 
     Within the meaning of the present invention, cavities or chambers are preferably formed by recesses, depressions or the like in the cartridge  100  or main body  101 , which are closed or covered by the cover  102 , in particular at the sides. The volume or space enclosed by each cavity is preferably fluidically linked, in particular to the fluid system  103 , by means of channels. 
     In particular, within the meaning of the present invention, a cavity comprises at least two openings for the inflow and/or outflow of fluids. 
     Within the meaning of the present invention, cavities preferably have a larger diameter and/or flow cross section than channels, preferably by at least a factor of 2, 3 or 4. In principle, however, cavities may in some cases also be elongate, in a similar manner to channels. 
     The cartridge  100  and/or the fluid system  103  also preferably comprises at least one pump apparatus  112  and/or at least one sensor arrangement or sensor apparatus  113 . 
     In the example shown, the cartridge  100  or the fluid system  103  preferably comprises two metering cavities  105 A and  105 B, a plurality of intermediate cavities  106 A to  106 G, a plurality of storage cavities  108 A to  108 E and/or a plurality of reaction cavities  109 , which can preferably be loaded separately from one another, in particular a first reaction cavity  109 A, a second reaction cavity  109 B and an optional third reaction cavity  109 C, as can be seen in  FIG. 2 . 
     The metering cavities  105  are preferably designed to receive, to temporarily store and/or to meter the sample, and/or to pass on said sample in a metered manner Particularly preferably, the metering cavities  105  have a diameter which is larger than that of the (adjacent) channels. 
     In the initial state of the cartridge or when at the factory, the storage cavities  108  are preferably filled at least in part, in particular with a liquid such as a reagent, solvent or wash buffer. 
     The collection cavity  111  is preferably designed to receive larger quantities of fluids that are in particular used for the test, such as sample residues or the like. Preferably, in the initial state or when at the factory, the collection cavity  111  is empty or filled with gas, in particular air. The volume of the collection cavity  111  corresponds to or exceeds preferably the (cumulative) volume of the storage cavity/cavities  108  or the liquid content thereof and/or the volume of the receiving cavity  104  or the sample P received. 
     The reaction cavity/cavities  109  is/are preferably designed to allow a substance located in the reaction cavity  109  to react when an assay is being carried out, for example by being linked or coupled to apparatuses or modules of the analysis device  200 . 
     The reaction cavity/cavities  109  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 cavities  109 . 
     “PCR” stands for polymerase chain reaction and is a molecular-biological method by means of which certain analytes, 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. 
     The amplification products, target nucleic-acid sequences and/or other portions of the sample P produced in the one or more reaction cavities  109  can be conducted or fed to the connected sensor arrangement or sensor apparatus  113 , in particular by means of the pump apparatus  112 . 
     The sensor arrangement or sensor apparatus  113  is used in particular for detecting, particularly preferably qualitatively and/or quantitatively determining, the analyte or analytes of the sample P, in this case particularly preferably the target nucleic-acid sequences and/or target proteins as the analytes. Alternatively or additionally, however, other values may also be collected or determined. 
     The cartridge  100 , the main body  101  and/or the fluid system  103  preferably comprise a plurality of channels  114  and/or valves  115 , as shown in  FIG. 2 . 
     By means of the channels  114  and/or valves  115 , the cavities  104  to  111 , the pump apparatus  112  and/or the sensor arrangement or sensor apparatus  113  can 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 device  200 . 
     The cavities  104  to  111  are preferably each fluidically linked or interconnected by a plurality of channels  114 . Particularly preferably, each cavity is linked or connected by at least two associated channels  114 , 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 system  103  is 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 apparatus  112 . In this case, the flows of fluid or the fluid transport and the metering are controlled by accordingly opening and closing the valves  115  and/or by accordingly operating the pump or pump apparatus  112 , in particular by means of a pump drive  202  of the analysis device  200 . 
     Preferably, each of the cavities  104  to  110  has 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/cavities  108 , the mixing cavity  107  and/or the receiving cavity  104 , 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 cavity  104  preferably comprises a connection  104 A for introducing the sample P. In particular, the sample P may for example be introduced into the receiving cavity  104  and/or cartridge  100  via the connection  104 A by means of a pipette, syringe or other instrument. 
     The receiving cavity  104  preferably comprises an inlet  104 B, an outlet  104 C and an optional intermediate connection  104 D, it preferably being possible for the sample P or a portion thereof to be removed and/or conveyed further via the outlet  104 C and/or the optional intermediate connection  104 D. Gas, air or another fluid can flow in and/or be pumped in via the inlet  104 B, 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 outlet  104 C or the optional intermediate connection  104 D of the receiving cavity  104 . In particular, a supernatant of the sample P, such as blood plasma or blood serum, can be conducted away or removed via the optional intermediate connection  104 D, in particular for carrying out the protein assay. 
     Preferably, at least one valve  115  is assigned to each cavity, the pump apparatus  112  and/or the sensor apparatus  113  and/or is arranged upstream of the respective inlets and/or downstream of the respective outlets. 
     Preferably, the cavities  104  to  111  or sequences of cavities  104  to  111 , 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 valves  115  being actuated, and/or said cavities can be fluidically connected to the fluid system  103  and/or to other cavities. 
     In particular, the valves  115  are formed by the main body  101  and the film or cover  102  and/or are formed therewith and/or are formed in another manner, for example by or having additional layers, depressions or the like. 
     Particularly preferably, one or more valves  115 A are provided which are preferably tightly closed initially or when in storage, particularly preferably in order to seal liquids or liquid reagents F, located in the storage cavities  108 , and/or the fluid system  103  from the open receiving cavity  104  in a storage-stable manner. 
     Preferably, an initially closed valve  115 A is arranged upstream and downstream of each storage cavity  108 . Said valves are preferably only opened, in particular automatically, when the cartridge  100  is actually being used and/or during or after inserting the cartridge  100  into the analysis device  200  and/or for carrying out the assay. 
     A plurality of valves  115 A, in particular three valves in this case, are preferably assigned to the receiving cavity  104 , in particular if the intermediate connection  104 D is provided in addition to the inlet  104 B and the outlet  104 C. Depending on the use, in addition to the valve  115 A on the inlet  104 B, then preferably only the valve  115 A either at the outlet  104 C or at the intermediate connection  104 D is opened. 
     The valves  115 A assigned to the receiving cavity  104  seal the fluid system  103  and/or the cartridge  100  in particular fluidically and/or in a gas-tight manner, preferably until the sample P is inserted and/or the receiving cavity  104  or the connection  104 A of the receiving cavity  104  is closed. 
     As an alternative or in addition to the valves  115 A (which are initially closed), one or more valves  115 B are preferably provided which are not closed in a storage-stable manner and/or which are open initially or in an inoperative position, in an initial state or when the cartridge  100  is not inserted into the analysis device  200 , and/or which can be closed by actuation. These valves  115 B are used in particular to control the flows of fluid during the test. 
     The cartridge  100  is preferably designed as a microfluidic card and/or the fluid system  103  is 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 cavities  104  to  111  and/or channels  114  are, 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 cartridge  100  and/or the fluid system  103 , in particular the receiving cavity  104 . 
     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 to  FIG. 2  by reference signs F 1  to F 5  and S 1  to S 10 . 
     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 D 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 cartridge  100 , 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 cartridge  100  preferably 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 cartridge  100  or the fluid system  103  preferably comprises a bypass  114 A 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 cavities  109  and/or, by bypassing the optional intermediate temperature-control cavity  110 , also directly to the sensor apparatus  113 . 
     The cartridge  100 , the fluid system  103  and/or the channels  114  preferably comprise sensor portions  116  or other apparatuses for detecting liquid fronts and/or flows of fluid. 
     It is noted that various components, such as the channels  114 , the valves  115 , in particular the valves  115 A that are initially closed and the valves  115 B that are initially open, and the sensor portions  116  in  FIG. 2  are, for reasons of clarity, only labelled in some cases, but the same symbols are used in  FIG. 2  for each of these components. 
     The collection cavity  111  is 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 the initial state, the collection cavity  111  is preferably filled solely with gas, in particular air. 
     In particular, the collection cavity  111  can optionally be connected to individual cavities and channels  114  or other apparatuses fluidically in order to remove reagents and liquids from said cavities, channels or other apparatuses and/or to replace said reagents and liquids with gas or air. The collection cavity  111  is preferably given appropriate large dimensions. 
       FIG. 3  is a perspective front view of the cartridge  100  and  FIG. 4  is a perspective rear view thereof, i.e. of the back  100 B thereof. 
     The cartridge  100  and/or the main body  101  preferably comprises a reinforced or angled edge  121  and/or a reinforcing rib  122 , particularly preferably on the back  100 B, as shown schematically in  FIG. 4 . 
     The cartridge  100  and/or the main body  101  preferably comprises a grip portion  123  in order for it to be possible to optimally grip and/or hold the cartridge  100  by hand. The grip portion  123  is in particular arranged and/or formed or integrally moulded on a longitudinal side. 
     Particularly preferably, the grip portion  123  extends in the main plane or plate plane of the cartridge  100  or main body  101 . In the example shown, the grip portion  123  is particularly preferably substantially trapezoidal. However, other shapes are also possible. 
     The edge  121  and/or the reinforcing rib  122  preferably projects/project transversely from the main plane or plate plane and/or the back  100 B of the cartridge  100  or main body  101 . 
     In the example shown, the edge  121  preferably extends along the two narrow sides and/or along a longitudinal side and/or the grip portion  123  of the cartridge  100  or main body  101 , substantially on the outside. 
     The reinforcing rib  122  preferably extends between the grip portion  123  and the remaining, particularly preferably substantially rectangular, part of the cartridge  100  or main body  101 . 
     The reinforcing rib  122  thus extends at least substantially along a longitudinal side of the preferably at least substantially rectangular basic shape of the cartridge  100 . 
     The edge  121 , the reinforcing rib  122  and/or the grip portion  123  is/are preferably formed in one piece with the main body  101 , in particular integrally moulded thereon. 
     The cartridge  100  preferably comprises an in particular optically readable identifier, such as a barcode  124 , in this case in particular on the back  100 B and/or on the collection cavity  111  and/or adhesively bonded. 
     The connection  104 A of the receiving cavity  104  can be closed after the sample P has been received. The cartridge  100  preferably comprises a closure element  130  for this purpose. 
     In particular, the connection  104 A can be closed in a liquid-tight and particularly preferably also gas-tight manner by the closure element  130 . In particular, a closed fluid circuit can thus be formed, with the receiving cavity  104  being included. In particular, once the assigned valves  115 A at the inlet  104 B, outlet  104 C and/or intermediate connection  104 D have been opened, the receiving cavity  104  thus forms part of the fluid system  103  of the cartridge  100 , wherein the fluid system is preferably closed or can be closed by the closure element  130 . 
     The closure element  130  or the closure part  132  thereof closes the receiving cavity  104  or the connection  104 A thereof preferably in a permanent manner, i.e. it preferably cannot be released again. The connection  104 A therefore preferably cannot be reopened after it has been closed. 
     In the example shown, the closure element  130  preferably comprises a base part  131  and a closure part  132 , the closure part  132  being movably and/or pivotally connected to the base part  131  in particular by means of a connecting part  133  that is preferably formed bar-like in this case. 
     Particularly preferably, the base part  131  is fastened to the main body  101  in a form-fit or interlocking manner. 
     In the example shown, the base part  131  is preferably latched onto the cartridge  100 , the main body  101  and/or the receiving cavity  104 , or otherwise connected thereto in a form-fit, interlocking or bonded manner, for example by welding, heat staking, adhesion or the like. 
     Preferably, in the closed state, the closure element  130  or the closure part  132  thereof is sealingly held on or positioned against the connection  104 A in a latching or form-fit or interlocking manner, in this case in particular by means of one or more latching or retaining arms or elements  134 , as shown in  FIG. 3 . However, other structural solutions are also possible. 
     In the example shown, these retaining arms or elements  134  can encompass or extend over a peripheral edge or projection of the closure part  132  when the closure part  132  is sealingly placed on the connection  104 A. However, other structural solutions are also possible. 
       FIG. 5  is a schematic plan view of the connection  104 A of the receiving cavity  104 . Preferably, the connection  104 A, which is in particular substantially designed as a so-called Luer connection or Luer port or as a conical receiving opening, comprises an integrated vent  104 E which is in particular formed by corresponding axial grooves in the inner wall of the connection  104  or by axially extending ridges or by inwardly protruding projections  104 F, as shown in  FIG. 5 . 
       FIG. 6  is a highly schematic sectional detail of the cartridge  100  or the receiving cavity  104  being filled, by means of a transfer apparatus  320 , with the sample P to be tested. The transfer apparatus  320  is preferably formed in the manner of a syringe. However, other structural solutions are also possible. 
     The transfer apparatus  320  is preferably connected to and/or plugged into the connection  104 A by means of a connection  323 , in particular a connecting tip, particularly preferably in such a way that the vent  104 E or the grooves formed thereby remain open so that, when the receiving cavity  104  is filled (in part) with the sample P, gas or air can escape from the receiving cavity  104  to the outside through the vent  104 E. In this regard it is noted that, in the delivery state, the valves  115 A assigned to the receiving cavity  104  are all closed, and the fluid system  103  is thus closed off from the receiving cavity  104  such that displaced air can escape only through the connection  104 A and/or the vent  104 E that is particularly preferably provided. However, other structural solutions are in principle also possible. 
     For reasons of simplicity, the closure element  130  is not shown in the sectional view according to  FIG. 6 . 
       FIG. 6  shows the cartridge  100  together with the connected transfer apparatus  320 , but before the receiving cavity  104  is actually filled with the sample P or before said sample is actually fed to said cavity. 
     A packaging  140  is shown by dashed lines in  FIG. 6 . In the following, a preferred construction of the packaging  140  is explained in more detail with reference to the schematic perspective view from  FIG. 7 . 
     The packaging  140  preferably comprises a lower part  141  and a lid  142 . The lid  142  is not shown in  FIG. 7 , but rather just the opened lower part  141 . 
     The packaging  140  is shown by dashed lines in  FIG. 6 , specifically in the open state, the lid  142  being shown pulled off or folded back in part. 
     Particularly preferably, the cartridge  100  is delivered in the closed packaging  140 . The packaging encloses the cartridge  100  preferably in a liquid-tight manner and in particular in a gas-tight manner. 
     The packaging  140  and/or the lower part  141  is preferably designed as a blister. 
     Particularly preferably, the lower part  141  is designed as a plastics moulded part and/or is transparent in part. 
     The lid  142  is preferably formed by a film, in particular laminated onto the lower part  141 , or the like. 
     The lid  142  is preferably fastened to a peripheral connection region  143 , in particular on the upper face, of the lower part  141 . However, other structural solutions are also possible. 
     The atmosphere in the packaging  140  is preferably conditioned, particularly preferably set to a desired relative humidity, for example of between 30 and 40%. 
     The packaging  140  preferably comprises a desiccant  144  that is particularly preferably received packaged in a bag  145 , as shown schematically in  FIG. 6 . 
     Particularly preferably, the packaging  140  and/or the lower part  141  comprises at least one receiving compartment  146  for the desiccant  144  and/or the bag  145 . 
     The desiccant  144  and/or the receiving compartment  146  is preferably arranged below the cartridge  100  and/or at the flat side of the cartridge  100  remote from the lid  142 . 
     Preferably, the packaging  140  and/or the lower part  141  comprises a plurality of receiving compartments  146  that are separated from one another. 
     Preferably, the packaging  140  and/or the lower part  141  comprises a support apparatus  147  that is formed in particular in the base of the lower part  141  and/or by corresponding raised portions and/or reinforcements in order to support the cartridge  100  on its lower face and/or front  100 A. Specifically, the smooth flat side and/or the front  100 A and/or cover  102  of the cartridge  100  is preferably oriented downwards and/or towards the lower part  141  in the packaged state. 
     The packaging  140  and/or the lower part  141  preferably comprises a peripheral edge  148  for mounting and/or encompassing the cartridge  100 , in particular laterally. The inner contour of the lower part  141  and/or the edge  148  is in particular adapted to the outer contour of the cartridge  100  in a plan view of the flat side. 
     The packaging  140  and/or the lower part  141  preferably comprises a mounting apparatus  149  for mounting the cartridge  100  in the lower part  141 , in particular in a latching form-fit, interlocking and/or clamped manner, also when the lid  142  is removed and/or open. 
     The mounting apparatus  149  preferably comprises one or more projections  149 A which are in particular formed by the edge  148  of the lower part  141  and/or protrude inwards and/or extend over the cartridge  100  and/or main body  101  and/or the edge  121  in the received state, as shown by way of example on the left-hand side of  FIG. 6 . Preferably, the cartridge  100  is in particular thus held in the packaging  140  and/or in the lower part  141  preferably in a form-fit, interlocking and/or latching manner, also when the lid  142  is removed and/or open. 
     The projections  149 A particularly preferably form detents or locking pins. However, other structural solutions are also possible. 
     As already mentioned, the cartridge  100  is preferably delivered to the customer, for example a veterinary practitioner, packaged in the mentioned packaging  140 . The cartridge  100  and the packaging  140  thus in particular form a sales unit. The cartridge  100  preferably comprises the packaging  140 . 
     The packaging  140  is preferably opened by pulling off or folding open the lid  142 . 
     The cartridge  100  and/or packaging  140  is preferably designed such that, when the packaging  140  is open, the cartridge  100  can be or is filled with the sample P while the cartridge  100  is (still) received in the packaging  140  and/or in the lower part  141 . 
     In particular, the connection  104 A is arranged on a flat side and/or on the side of the cartridge  100  that is oriented upwards and/or towards the lid  142  in the packaging  140 . 
     In particular, the connection  104 A of the cartridge  100  is open towards the lid  142 . 
     When the lid  142  is removed and/or open, the connection  104 A of the cartridge  100  can be accessed preferably directly or, if necessary, after an additional protective cap or cover or the like has been removed. 
     The packaging  140  and/or the lower part  141  holds or supports the cartridge  100 , in particular by means of the support apparatus  147 , the edge  148  and/or the mounting apparatus  149 , in such a way that the cartridge  100  can be or is easily and reliably filled with the sample P in the opened packaging  140  and/or in the open lower part  141 , as shown schematically in  FIG. 6 . 
     Particularly preferably, the cartridge  100  and/or the connection  104 A is closed by means of the closure element  130  or the closure part  132  before the cartridge  100  is removed, i.e. when still in the packaging  140  and/or in the lower part  141 , and the cartridge  100  is preferably removed from the packaging  140  and/or the lower part  141  only subsequently. 
     For removal of the cartridge  100 , the edge  148  of the lower part  141  is preferably sufficiently flexible to be able to overcome the projections  149 A by means of corresponding deformation. 
     Alternatively, however, the cartridge  100  can also be closed only after it has been removed from the packaging  140  and/or the lower part  141 . 
     The packaging  140  and/or the lid  142  is preferably designed transparent in such a way and/or in part that, when the packaging  140  is in the closed state, the identifier and/or barcode  124 , if provided, can be read. 
     Once the sample P has been introduced into the receiving cavity  104  and the connection  104 A has been closed, the cartridge  100  can be inserted into and/or received in the proposed analysis device  200  in order to test the sample P, as shown in  FIG. 1 . 
     The analysis device  200  preferably comprises a mount or receptacle  201  for mounting and/or receiving the cartridge  100 . 
     Preferably, the cartridge  100  is fluidically, in particular hydraulically, separated or isolated from the analysis device  200 . In particular, the cartridge  100  forms a preferably independent and in particular closed or sealed fluidic or hydraulic system  103  for the sample P and the reagents and other liquids. In this way, the analysis device  200  does 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 device  200  is connected or coupled mechanically, electrically, thermally and/or pneumatically to the cartridge  100 . 
     In particular, the analysis device  200  is designed to have a mechanical effect, in particular for actuating the pump apparatus  112  and/or the valves  115 , and/or to have a thermal effect, in particular for temperature-controlling the reaction cavity/cavities  109  and/or the intermediate temperature-control cavity  110 . 
     In addition, the analysis device  200  can preferably be pneumatically connected to the cartridge  100 , in particular in order to actuate individual apparatuses, and/or can be electrically connected to the cartridge  100 , in particular in order to collect and/or transmit measured values, for example from the sensor apparatus  113  and/or sensor portions  116 . 
     The analysis device  200  preferably comprises a pump drive  202 , the pump drive  202  in particular being designed for mechanically actuating the pump apparatus  112 . 
     The analysis device  200  preferably comprises a connection apparatus  203  for in particular electrically and/or thermally connecting the cartridge  100  and/or the sensor arrangement or sensor apparatus  113 . 
     As shown in  FIG. 1 , the connection apparatus  203  preferably comprises a plurality of electrical contact elements  203 A, the cartridge  100 , in particular the sensor arrangement or sensor apparatus  113 , preferably being electrically connected or connectable to the analysis device  200  by the contact elements  203 A. 
     The analysis device  200  preferably comprises one or more temperature-control apparatuses  204  for temperature-controlling the cartridge  100  and/or having a thermal effect on the cartridge  100 , in particular for heating and/or cooling, the temperature-control apparatus(es)  204  (each) preferably comprising or being formed by a heating resistor or a Peltier element. 
     Preferably, individual temperature-control apparatuses  204 , some of these apparatuses or all of these apparatuses can be positioned against the cartridge  100 , the main body  101 , the cover  102 , the sensor arrangement, sensor apparatus  113  and/or individual cavities and/or can be thermally coupled thereto and/or can be integrated therein and/or can be operated or controlled in particular electrically by the analysis device  200 . In the example shown, in particular the temperature-control apparatuses  204 A,  204 B and/or  204 C are provided. 
     The analysis device  200  preferably comprises one or more actuators  205  for actuating the valves  115 . Particularly preferably, different (types or groups of) actuators  205 A and  205 B are provided which are assigned to the different (types or groups of) valves  115 A and  115 B for actuating each of said valves, respectively. 
     The analysis device  200  preferably comprises one or more sensors  206 . In particular, sensors  206 A are assigned to the sensor portions  116  and/or are designed or intended to detect liquid fronts and/or flows of fluid in the fluid system  103 . 
     Particularly preferably, the sensors  206 A are designed to measure or detect, in particular in a contact-free manner, for example optically and/or capacitively, a liquid front, flow of fluid 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 portion  116 , which is in particular formed by a planar and/or widened channel portion of the fluid system  103 . 
     Alternatively or additionally, the analysis device  200  preferably comprises (other or additional) sensors  206 B for detecting the ambient temperature, internal temperature, atmospheric humidity, position, and/or alignment, for example by means of a GPS sensor, and/or the orientation and/or inclination of the analysis device  200  and/or the cartridge  100 . 
     The analysis device  200  preferably comprises a control apparatus  207 , in particular comprising an internal clock or time base for controlling the sequence of a test or assay and/or for collecting, evaluating and/or outputting or providing measured values in particular from the sensor apparatus  113 , and/or from test results and/or other data or values. 
     The control apparatus  207  preferably controls or feedback controls the pump drive  202 , the temperature-control apparatuses  204  and/or actuators  205 , in particular taking into account or depending on the desired test and/or measured values from the sensor arrangement or sensor apparatus  113  and/or sensors  206 . 
     Optionally, the analysis device  200  comprises an input apparatus  208 , such as a keyboard, a touch screen or the like, and/or a display apparatus  209 , such as a screen. 
     The analysis device  200  preferably comprises at least one interface  210 , 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 interface  210 . 
     The analysis device  200  preferably comprises a power supply  211  for providing electrical power, 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 supply  211  and is (re)charged by an external charging device (not shown) via a connection  211 A and/or is interchangeable. 
     The analysis device  200  preferably comprises a housing  212 , all the components and/or some or all of the apparatuses preferably being integrated in the housing  212 . Particularly preferably, the cartridge  100  can be inserted or slid into the housing  212 , and/or can be received by the analysis device  200 , through an opening  213  which can in particular be closed, such as a slot or the like. 
     The analysis device  200  is preferably portable or mobile. Particularly preferably, the analysis device  200  weighs 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. 
     As already explained, the analysis device  200  can preferably be pneumatically linked to the cartridge  100 , in particular to the sensor arrangement or sensor apparatus  113  and/or to the pump apparatus  112 . 
     Particularly preferably, the analysis device  200  is designed to supply the cartridge  100 , in particular the sensor arrangement or sensor apparatus  113  and/or the pump apparatus  112 , with a working medium, in particular gas or air. 
     Preferably, the working medium can be compressed and/or pressurised in the analysis device  200  or by means of the analysis device  200 . 
     Preferably, the analysis device  200  comprises a pressurised gas supply  214 , in particular a pressure generator or compressor, preferably in order to compress, condense and/or pressurise the working medium. 
     The pressurised gas supply  214  is preferably integrated in the analysis device  200  or the housing  212  and/or can be controlled or feedback controlled by means of the control apparatus  207 . 
     Preferably, the pressurised gas supply  214  is electrically operated or can be operated by electrical power. In particular, the pressurised gas supply  214  can be supplied with electrical power by means of the power supply  211 . 
     Preferably, air can be drawn in, in particular from the surroundings, as the working medium by means of the analysis device  200  or pressurised gas supply  214 . In particular, the analysis device  200  or pressurised gas supply  214  is 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 device  200  or pressurised gas supply  214  comprises a preferably closed or delimited reservoir, such as a tank or container, comprising the working medium, and/or is connected or connectable thereto. 
     The analysis device  200  or pressurised gas supply  214  preferably comprises a connection element  214 A, in particular in order to pneumatically connect the analysis device  200  or pressurised gas supply  214  to the cartridge  100 . 
     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 or in the claims:
     1. Cartridge  100  for testing an in particular biological sample P, the cartridge  100  comprising a receiving cavity  104  with a connection  104 A for receiving the sample P and a closure element  130  for fluidically closing the connection  104 A, characterized in that the cartridge  100  comprises a packaging  140 , the packaging  140  comprising a support apparatus  147  for supporting the cartridge  100  and/or a mounting apparatus  149  for mounting the cartridge  100  in a form-fit, clamping and/or latching manner, and/or a lower part  141  comprising a peripheral edge  148  for receiving and mounting the cartridge  100 , and a removable or pull-off lid  142  for closing the lower part  141 , such that, when the packaging  140  is open, the cartridge  100  can be filled in the packaging  140  and the connection  104 A can be closed in the packaging  140 .   2. Method for testing an in particular biological sample (P) by means of a cartridge ( 100 ), the cartridge ( 100 ) comprising a receiving cavity ( 104 ) for receiving the sample (P), and a connection ( 104 A) of the receiving cavity ( 104 ) being closed by means of a closure element ( 130 ) after the cartridge has been filled with the sample (P), characterized in that the cartridge ( 100 ) is filled with the sample (P) in the open packaging ( 140 ) and is removed from the packaging ( 140 ) only subsequently.   

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