Method for controlling the functions of an analysis system

Abstract

A method for controlling the functions of the analysis system (110) is disclosed. The method comprises: a. providing at least one container (114) containing at least one control fluid, wherein the container (114) has at least one identifier (124), the identifier (124) includes at least one identification number of the container (114); b. reading the identifier (124) of the container (114) by using at least one reading device (113) of an analysis system (110); and c. performing a database query in the database (116) of the analysis system (110), wherein the database (116) includes database entries (130) for a plurality of known containers (114), each database entry (130) including the identification number of the known container (114) and the assigned expiration date information for each known container (114), and the database query includes performing a database query that checks whether the container (114) already has a database entry (130) in the database (116). Furthermore, an analytical system (110) is disclosed, comprising at least one analytical device (112) for determining the concentration of an analyte in a body fluid sample.

Description

Technical Field

[0001] The present invention relates to a method for controlling functions of an analysis system. Furthermore, the present invention relates to an analysis system, as well as a computer program and a computer-readable storage medium for executing the method according to the present invention. The method, the analysis system, the computer program and the storage medium are for example used for qualitatively and / or quantitatively determining one or more parameters of a patient, specifically one or more parameters of a patient's body fluid, for example, for detecting glucose in blood and / or interstitial fluid or other parameters further outlined below, in order to qualitatively and / or quantitatively determine the concentration of one or more analytes in one or more body fluids, and can be used in medical diagnosis. However, other fields of application are also feasible for the present invention.

Background Art

[0002] In the field of medical diagnosis, one or more parameters of a patient are often measured. For example, one or more analytes must be detected in a sample of a body fluid, such as blood, interstitial fluid, urine, saliva, or other types of body fluid. Examples of analytes to be detected are glucose, triglycerides, lactates, cholesterol, cardiac parameters (e.g., troponin T, NT-proBNP, and / or D-dimer), sepsis parameters (e.g., PCT), and / or traumatic brain injury parameters, and / or other types of analytes that are typically present in these body fluids. Depending on the concentration and / or presence of the analytes, appropriate treatment may be selected as needed. As an example, and without limiting the scope, the present invention may be described specifically in relation to blood glucose measurement. However, all features and / or embodiments may be explicitly applied to the measurement principles of other parameters (specifically, but not limited to, triglycerides, lactates, cholesterol, cardiac parameters (e.g., troponin T, NT-proBNP, and / or D-dimer), sepsis parameters (e.g., PCT), and / or traumatic brain injury parameters). Therefore, the present invention may also be used in the context of other types of analytical measurements that use analytes and / or test elements.

[0003] Generally, devices and methods known to those skilled in the art utilize a test element comprising one or more test chemicals capable of performing one or more detectable detection reactions in the presence of an analyte to be detected.

[0004] U.S. Patent Application Publication No. 2011 / 0244558 describes a sample analyzer and a method for writing information to a recording medium attached to a reagent container. The sample analyzer comprises a reagent container setting unit for setting a reagent container, a reader / writer for reading information from a recording medium attached to a reagent container set in the reagent container setting unit and writing the information to the recording medium, a write command unit configured to issue a command to write the information to the recording medium, and a controller for controlling the reader / writer to write the information to the recording medium attached to the reagent container set in the reagent container setting unit when the type information read from the recording medium indicates a specific reagent and the write command unit issues a write command.

[0005] To verify the functionality of analytical devices and systems, a control fluid may be used to perform a control measurement. The control fluid has predetermined characteristics, such as a known concentration of the control analyte to be detected, and can therefore be used to perform a control measurement.

[0006] One technical challenge with respect to these analytical control measurements lies in monitoring the control fluid. For example, the date of the first use of the control fluid is not monitored by the analytical system. This implies the risk of using a control fluid whose stability has expired during use. To date, users of control fluids typically record the date of first use, such as the opening date, by hand on a small label on the container of the control fluid.

[0007] Manually recording important information presents several technical challenges. Specifically, manual methods are often cumbersome to use, and the writing may not be wipe-resistant. The main challenge lies in the fact that there is no guarantee that users will pay attention to the recorded date or write the date on the label. Therefore, a more reliable recording method is needed. [Overview of the project]

[0008] Therefore, it is desirable to provide methods and devices that address the aforementioned technical challenges regarding the control of the functionality of analytical systems using control fluids. Specifically, methods and devices are proposed to overcome the need for manual recording of important information, such as the expiration date information of the control fluid.

[0009] This problem is addressed by a method for controlling the functionality of an analysis system having the features of an independent claim. Advantageous embodiments that can be realized individually or in any combination are described in the dependent claims.

[0010] When used below, the terms "has...", "companies...", or "includes...", or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms can refer to both situations in which the entity described in this context has no further features other than those introduced by these terms, and situations in which one or more further features exist. For example, the expressions "A has B", "A is equipped with B", and "A includes B" can both refer to situations in which A has no other elements other than B (i.e., A consists solely and exclusively of B), and situations in which entity A has one or more further elements other than B, such as element C, elements C and D, or further elements.

[0011] Furthermore, note that the terms "at least one" or "one or more," or similar expressions indicating that a feature or element may appear more than once, are typically used only once when introducing each feature or element. In most cases below, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, despite the fact that each feature or element may appear more than once.

[0012] Furthermore, when used below, the terms “preferably,” “more preferably,” “in detail,” “more specifically,” “specifically,” “more specifically,” or similar terms are used with optional features without limiting the possibility of alternatives. Thus, the features introduced by these terms are optional features and are not intended in any way to limit the scope of the claims. The present invention can be carried out by using alternative features, as those skilled in the art will recognize. Similarly, features introduced by “in embodiments of the present invention” or similar expressions are intended to be optional features without any limitation with respect to alternative embodiments of the present invention, without any limitation with respect to the technical scope of the present invention, and without any limitation with respect to the possibility of combining such features with other optional or non-optional features of the present invention.

[0013] In a first aspect of the present invention, a method for controlling the function of an analytical system is disclosed, the analytical system comprising at least one analytical device for determining the concentration of an analyte in a sample of a body fluid. The method includes, as an example, the following steps, which may be performed in a given order. However, it should be noted that different orders are also possible. Furthermore, one or more method steps may be performed only once or repeatedly. Furthermore, two or more method steps may be performed simultaneously or in overlapping time. The method may include further method steps not listed.

[0014] This method, a. To provide at least one container for containing at least one control fluid, wherein the container comprises at least one identifier, the identifier including at least one identification number of the container, b. Reading the container identifier by using at least one reading device of the analysis system, c. Performing a database query in the database of the analysis system, wherein the database includes database entries for multiple known containers, each containing an identification number for a known container and information on the expiration date assigned to each known container, and the database query includes checking whether a container already has a database entry in the database. It also includes.

[0015] The method may be carried out at least semi-automated, or fully automated. The automated steps may be carried out and / or initiated by a processor, machine, and / or controller. As used herein, the term “semi-automated” is a broad term and should be given its usual customary meaning to those skilled in the art, and not limited to any special or customized meaning. Specifically, the term may refer to a process or method comprising several steps or actions, some but not all of which are carried out, supported, and / or initiated by a processor, machine, and / or controller. As used herein, the term “fully automated,” also referred to as “automatically,” is a broad term and should be given its usual customary meaning to those skilled in the art, and not limited to any special or customized meaning. Specifically, the term may refer to a process or method comprising several steps or actions, some but not all of which are carried out, supported, and / or initiated by a processor, machine, and / or controller. Regarding step a, the container may be provided by the user, for example, or alternatively, the container may be transported to the analysis system by a machine or conveyor such as a conveyor belt, and thus this can be considered an automated step. Method steps b and / or c may be performed automatically. More specifically, the container may be automatically positioned at a spot where the container identifier can be read by a reading device. The reading device may then be triggered by a processor to read the identifier. The information, including the identification number retrieved by reading the identifier, may then be automatically linked to one or more database entries when performing a database query.

[0016] Where used herein, the term “controlling the function of an analytical system” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to one or more of checking, evaluating, verifying, maintaining, or setting at least one function of an analytical system. The term “function” is also a broad term, as understood by those skilled in the art, and may specifically refer to the degree of the system’s ability and / or possibility to perform at least one function. Thus, as an example, the at least one function may be, or include, an analytical function such as the ability to measure at least one medical parameter of a patient and / or the ability to qualitatively or quantitatively determine at least one analyte in a body fluid. Thus, as an example, the term “controlling the function of an analytical system” may refer to a method by which the ability of an analytical system to perform at least an analytical function is qualitatively or quantitatively determined, and / or a method by which the ability of an analytical system to perform at least an analytical function is set or maintained, such as by calibrating the analytical system. Specifically, the term “controlling the function of an analytical system” may refer to a method of evaluating the usefulness of a control fluid, by which the control fluid may be used to verify the function of the analytical system. Other options are also feasible.

[0017] As used herein, the term “analytical device” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to any device configured for the analytical testing of a sample, but is not limited thereto. Specifically, an analytical device may be configured to perform at least one analytical measurement, such as determining at least one analytical parameter to qualitatively and / or quantitatively determine the concentration of at least one analyte in a sample, such as a body fluid sample. Thus, an analytical device may specifically be, or include, at least one measuring device for measuring at least one parameter, such as a blood glucose measuring device. Other options are also feasible. As an example, an analytical device may be a handheld device configured for mobile analytical measurement. However, alternatively, an analytical device may be, or include, a laboratory device. An analytical device may further comprise a display and / or screen, in particular a touchscreen, configured to interact with the user of the analytical device. For example, the display of the analytical device may be configured to display the results of an analytical measurement.

[0018] As used herein, the term “determining the concentration of an analyte in a sample in a body fluid,” also referred to as “analytical measurement,” is a broad term and should be given its usual, customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to the quantitative and / or qualitative determination of at least one analyte in an aliquot of any sample or body fluid, without limitation. For example, the body fluid may include one or more of blood, interstitial fluid, urine, saliva, or other types of body fluids. The result of the concentration determination may, for example, be the concentration of an analyte and / or the presence or absence of the analyte being determined. Specifically, for example, the analytical measurement may be a blood glucose measurement, and therefore the result of the analytical measurement may be, for example, a blood glucose concentration. In particular, the analytical measurement may determine an analytical measurement result value. As used herein, the term “analytical measurement result value,” also referred to as “analyte concentration value,” is a broad term and should be given its usual, customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a numerical representation of the concentration of an analyte in a sample, without limitation. As an example, at least one analyte may be one or more specific chemical compounds and / or other parameters, or may include them. The analyte may be one or more of glucose, triglycerides, lactates, cholesterol, cardiac parameters such as troponin T, NT-proBNP and / or D-dimer, sepsis parameters such as PCT, and / or traumatic brain injury parameters, or may include them. As an example, one or more analytes involved in metabolism, such as blood glucose, may be determined. Additionally or alternatively, other types of analytes or parameters, such as pH values, may be determined.

[0019] As used herein, the term “container” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. The term may, but not specifically, refer to any enclosure for holding at least one material, such as one or more of liquid, solid, or gaseous materials. A container may, for example, comprise at least one container wall and optionally at least one opening for removing at least a portion of the contents from inside the container. The opening may, for example, be sealed by at least one closure means, such as a cap, stopper, or breakable seal, or may be sealable. For example, a container may include at least one of a vial, bottle, blister, flask, pouch, syringe, bottle, tube, capillary container, needle, glass container, or plastic container. In general, in one particular embodiment, a container may be formed and / or filled by blow molding techniques. Specifically, a container may be configured to store at least one fluid, such as a control fluid, for example, a control fluid having a well-defined concentration of at least one analyte. Furthermore, the container may be configured to be reversibly closed, thereby protecting the fluid stored inside the vial from the external environment. The container may also be configured to release the fluid stored inside the container in the form of droplets, for example, in volumes of 1 ml or less.

[0020] As used herein, the term “control fluid” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a liquid containing, but not limited to, at least one analyte, e.g., a control analyte, e.g., one or more of the following: a solution of the analyte, a dispersion of the analyte, a reconstituted lyophilized product, and / or an emulsion of the analyte, e.g., a liquid containing at least one solvent, the liquid having one or more predetermined properties, e.g., a predetermined concentration of at least one analyte. For example, a control fluid for blood glucose measurement may contain glucose as a control analyte dissolved in a buffered aqueous solution. The concentration of glucose may be set to a predetermined level. Thus, the control fluid may have a known predetermined concentration of glucose. The control fluid may further contain additional components such as one or more of the following: buffers, biological salts, preservatives, and / or other non-reactive components. The control fluid may be used to verify the functionality of an analytical system. In this context, one or more control fluids may be used to verify the functionality of an analytical system.

[0021] As used herein, the term “identifier” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to an element or combination of elements configured to store one or more information items that identify a container and / or at least one of the contents of a container, for example, in a readable format, particularly in a machine-readable format. An identifier may include at least one of optical identifiers, electronic identifiers, magnetic identifiers such as RFID tags, and / or mechanical identifiers. For example, an identifier, specifically an optical identifier, may be or comprise at least one of a one-dimensional or two-dimensional code and / or a readable information tag, such as a barcode, specifically one-dimensional or two-dimensional barcode, a QR code, or one or more of other types of codes, attached directly to the container and / or attached to the container via at least one label or tag. Further embodiments or options of identifiers are described in detail below. Information stored in an identifier can be read using a suitable reading device.

[0022] At least one information item stored by an identifier may identify one or more of the container or its contents. A variety of options are feasible for identifying the container and / or its contents, as is generally known to those skilled in the art. Therefore, as an example, the at least one information item may specifically include at least one identification number for the container and / or its contents, such as a control fluid. Where used herein, the term “identification number” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to one or more arrays or sequences of numbers and / or letters that encode identification information for a particular container. An identification number may be unique to a particular container. Therefore, it may be possible to identify a particular container according to its respective identification number. The identifier may specifically encode, for example, an identification number for identifying a container, or any other information relating to the contents of the container or the container itself, such as the volume of the container and / or the date the container was opened.

[0023] As used herein, the term “containing at least one identifier, wherein the identifier contains at least one identification number” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. The term may, but not exclusively, refer to a situation in which an identifier is contained in at least one device or object, and the at least one identifier encodes at least one identification number on the object or device.

[0024] As used herein, the term “read” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to the process of obtaining at least one information item stored in an identifier, such as at least one information item in an electronic format. Reading may be specifically performed electronically. The reading process may depend on the type of identifier. Thus, if the identifier includes an optical identifier such as a barcode and / or QR code, reading may include optical reading, for example, by optical scanning. If the identifier includes an electronic identifier such as an RFID code, reading may include electronic reading, such as reading by near-field communication (NFC). Other options are also feasible. Reading may specifically include retrieving encoded information and capturing and decoding optical information, in particular for identifying a container. Specifically, reading the container identifier using at least one reading device of the analysis system may include decoding the container identifier using at least one reading device and / or at least one decoding device of the analysis system.

[0025] As used herein, the term “reading device” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. The term may particularly refer to a device configured to perform a reading process as defined above, such as a device configured to read information stored by an identifier. Specifically, a reading device may be, or include, at least one of a one-dimensional or two-dimensional scanner, a camera, and / or an NFC reader, which are radio frequency reading devices. The reading device may be integrated into the analysis device. Alternatively or additionally, the reading device may be a separate device independent of the analysis device. The reading device may be further configured to communicate with an analysis system. Specifically, the reading device may be configured to transfer the identification number of a container to an analysis system, for example, a processor in the analysis system. The reading device may comprise an optical unit configured to capture an optical code and a processor for processing, in particular, decoding, the captured optical code, in particular its image. Alternatively or additionally, the reading device may be connectable to, or connected to, such a processor for processing the captured optical code.

[0026] As used herein, the term "database" is a broad term that is to be given its ordinary and customary meaning as understood by a person skilled in the art, and is not to be limited to a special or customized meaning. Specifically, the term may generally refer to, but is not limited to, an organized collection of data stored and accessed electronically from a computer or computer system. The database may comprise a data storage device, or may be comprised by a data storage device, as outlined in further detail below. The database may comprise at least one database management system comprising software running on a computer or a computer system, wherein the software enables interaction with one or more of a user, an application, or the database itself, for example to capture and analyze data contained in the database. The database management system may further include facilities for managing the database. Accordingly, a database containing data may be configured by a database system that also includes one or more related applications in addition to the data. Specifically, the database may contain information related to the container and / or the contents thereof, such as identification number and / or expiration date information.

[0027] A database may contain multiple database entries. As used herein, the term “database entry” is a broad term and should be given its usual, conventional meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to at least one information item stored in a database in an organized manner, but not limited to this. Thus, for example, each database entry may contain at least one package of information, and multiple packages of information may be related or linked to one another within the database. For example, a database entry may contain its respective identification number and related information linked to its identification number, such as its respective expiration date information linked to the information number of a particular container, as outlined in more detail below.

[0028] Information in a database may be read by performing a database query. As used herein, the term “database query” is a broad term and should be given its usual, conventional meaning to those skilled in the art, and should not be limited to any special or customized meaning. The term may, but not limit, specifically refer to the process of accessing a database, such as performing a search within the database for specific information. For example, a database query may include searching for a specific identification number of a container and / or retrieving further information associated with the identification number of a container within the database.

[0029] As used in the present specification, the term "expiration date information" is a broad term, which shall be given its ordinary and customary meaning to a person skilled in the art, and shall not be limited to any special or customized meaning. Without limitation, this term may specifically refer to a numerical value indicating the maximum allowable use time of a control fluid stored in a container. Specifically, the expiration date information may include an expiration date, such as an absolute date by which the control fluid can be safely used. Additionally or alternatively, the expiration date information may include an in-use stability expiration date, such as a period starting from the first opening date of the container, during which the control fluid stored in the container can be used. Accordingly, the expiration date information may include one or both of absolute expiration date information including an absolute date and / or time, and / or relative expiration date information defined by a time span calculated from a specific date or time, such as from the first opening of the container. Furthermore, the expiration date information may include a combination of both the expiration date of the container and the in-use stability expiration date of the container.

[0030] The method, analysis system, computer program and storage medium can be used, for example, for qualitatively and / or quantitatively determining one or more parameters of a patient, specifically one or more parameters of a patient's body fluid, for example, for detecting glucose in blood and / or interstitial fluid, cardiac parameters such as troponin T, NT-proBNP and / or D-dimer, sepsis parameters such as PCT, and / or traumatic brain injury parameters, or other parameters further outlined below, so as to qualitatively and / or quantitatively determine the concentration of one or more analytes in one or more body fluids, and can thus be used in medical diagnosis.

[0031] As outlined above, the method comprises steps a. and b., using at least one identifier which includes at least one identification number of the container. The identifier may include at least one of a barcode, a QR code, or an RFID tag. Specifically, the identifier may include two or more barcodes, e.g., two, three, or more than three barcodes, two or more QR codes, e.g., two, three, or more QR codes, and / or two or more RFID tags, e.g., two, three, or more RFID tags. The identifier may also include a combination of one or more barcodes, one or more QR codes, and / or one or more RFID tags.

[0032] Furthermore, the identifier may include at least one additional information item in addition to at least one identification number of the container. The at least one additional information item may be selected from the group consisting of a type information item that provides information about the type of control fluid, a kit information item that provides information about a kit comprising at least one analytical test element and a control fluid, level information that provides information about the level of at least one control analyte contained in the control fluid, lot number, shelf life, expiration date, manufacturing date, code content and / or layout version number, kit type, level type, bottle ID, in-use stability period, and target value (lot-specific).

[0033] As used herein, the term “barcode” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to binary optical information such as a binary sequence of optical information, such as a sequence of parallel lines of different widths, or a binary sequence encoding information such as a sequence of digits and / or digits and / or letters. Thus, a barcode may be a sequence of single colored lines having high contrast with respect to the background. Specifically, a barcode may consist of black lines on a white background.

[0034] As used herein, the term “QR code” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a matrix encoding information such as a two-dimensional matrix of binary pixels, or an array of digits and / or characters. The pixels of the two-dimensional matrix may have high contrast with respect to the background. Specifically, the pixels of the matrix may include black squares placed on a white background. Furthermore, a QR code may include orientation notation that enables a QR code reader device to align the matrix.

[0035] As used herein, the term “RFID tag” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a label configured to exchange data information with a reader device by using radio frequency electromagnetic radiation, such as by using the NFC standard. An RFID tag may further comprise an antenna configured to receive and emit radio frequency signals, and an electronic chip such as a microchip configured to store data information. Specifically, an RFID tag may be a flexible substrate having an electronically conductive coil and optionally at least one microchip.

[0036] At least one information item may include, specifically, at least one arbitrary characteristic that describes one or more of the appearance, state, or function of the container and / or its contents, as can be included by an identifier. Specifically, the information item may include at least one item selected from the group consisting of type information items, kit information items, level information, and lot number. The type information item may provide information about the type of control fluid. For example, the type of control fluid may refer to the hypoglycemic or hyperglycemic range in which the control fluid is used. As another example, the information item may provide information about a kit, which may consist of at least one analytical test element and a control fluid. Furthermore, the information item may refer to level information that provides information about the level of at least one analyte contained in the control fluid. The information item may also refer to the lot number of the container, which describes the batch of containers. Thus, a particular container containing a control fluid can be uniquely identified by combining information from at least one identification number with at least one further information item.

[0037] The method according to the present invention may further include an automated step of comparing the current date with expiration information, specifically, performed by a processor, machine, or controller. If the comparison of the current date with the expiration information indicates that the control fluid in the container has expired, the method may include triggering and / or performing at least one expiration response action, such as at least one predefined action for when the control fluid in the container has expired. Furthermore, the expiration response action may include at least one action selected from the group consisting of providing a notification to the user that the control fluid in the container has expired, displaying a warning, providing at least one electronic piece of information indicating that the control fluid in the container has expired, and preventing further use of the control fluid in the container.

[0038] However, if a comparison of the current date with the expiration date information indicates that the control fluid in the container has not expired, the method may include performing at least one confirmation action, such as at least one predefined action for when the control fluid in the container has not expired. The confirmation action may include at least one action selected from the group consisting of providing the user with a notification that the control fluid in the container has not expired, displaying a notification that the control fluid is permitted to be used, providing at least one piece of electronic information indicating that the control fluid in the container has not expired, and permitting further use of the control fluid in the container.

[0039] Furthermore, the expiration response and / or confirmation actions may be provided to the user via an analysis device. The analysis device may be configured to provide information to the user via at least one interface, specifically via at least one display of the analysis device. It should be noted that other options are also feasible. For example, the expiration response and / or confirmation actions may also be additionally or alternatively alerted to the user by other means, such as acoustic and / or tactile means. The method may also include outputting signs, specifically warning signs and / or permission notices, such as visual warnings and / or permission notices, acoustic warnings and / or permission notices, or tactile warnings and / or permission notices.

[0040] If a comparison of the current date with the expiration date information indicates that the control fluid in the container has not expired, the method according to the present invention may further include the following steps. d. Determining the concentration of the analyte in the control fluid contained in the container by using an analytical device.

[0041] Step d. may also be referred to as a control measurement, or may be part of a control measurement. Step d. may be performed automatically. More specifically, step d. may be performed and / or initiated by a processor, controller and / or machine. The control measurement may be used, for example, to adjust the settings of the analysis system and / or analysis device, and / or to interpret the readings of the analysis system and / or analysis device. Additionally or alternatively, the control measurement may also be used for one or more of the following: to calibrate one or both of the analysis system and / or analysis device, and / or to verify the integrity of one or both of the analysis system and / or analysis device and / or the analysis measurement. This analysis measurement of the control fluid may yield an analyte concentration value. The determined analyte concentration value can be further compared with level information of the control fluid. Thus, the comparison can indicate that the analysis system is functioning correctly if the determined analyte concentration value is within a predetermined acceptable range.

[0042] As outlined above, the method may include comparing the current date with the expiration date information of the container. The expiration date information may include at least one of the following: an expiration date indicating the absolute date of expiration of the control fluid; and an in-use stability expiration date indicating the date calculated by determining the end of a predetermined in-use stability period calculated from the initial opening date of the container.

[0043] As used herein, the term “current date” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. The term may, but not exclusively, refer to a numerical value indicating the calendar day on which the container is currently being used. Specifically, the use of a container may be registered by an action of reading the container's identifier.

[0044] As used herein, the term “expiration date” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. The term may, but not specifically, refer to a calendar date indicating the date on which the approved usability of the control fluid stored in the container ends. The expiration date of a control fluid may indicate an absolute date of expiration for the control fluid. Specifically, the stability of the control fluid can only be guaranteed up to the expiration date. After the expiration date, the properties of the control solution may have changed, which could lead to deviations in analyte measurements.

[0045] As used herein, the terms “expired control fluid” and “not expired control fluid” are broad terms, and should be given their usual, customary meanings to those skilled in the art, and not limited to any special or customized meanings. These terms may, but not limited to, refer specifically to the current state of the control fluid, which is the actual or assumed current state, and more specifically to the life of the control fluid and / or the duration of its exposure to ambient air. Specifically, if the current date is after the expiration date, the control fluid may be expired. Furthermore, if the current date is before the expiration date or equal to the expiration date, the control fluid may not be expired. Thus, an expired control fluid may have lost its predetermined properties, or may be assumed to have lost its predetermined properties, particularly a predetermined level of the control analyte, and therefore may not be suitable for use as a control fluid. As a result, a control fluid that is not expired may retain its predetermined properties and is therefore suitable for use as a control fluid.

[0046] As used herein, the term “stable period in use” is a broad term and should be given its usual, customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to the maximum period during which the control fluid can be safely used, starting from the initial opening of the container or, in the case of reconstitution of a reconstitutional freeze-dried product, from the time of reconstitution. Specifically, safe use of the control fluid can be established if the control fluid is stable against changes in its properties.

[0047] As used herein, the term “stable-in-use date” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. The term may, but not exclusively, refer to a numerical value indicating a calendar day on which the stable-in-use period ends. The stable-in-use date may be calculated by determining the end of a predetermined stable-in-use period calculated from the initial opening date of the container. The initial opening date may indicate the current date of the first use of the container and may be recorded in step e. of the method according to the present invention, as described in more detail below.

[0048] As used herein, the term “expiration response action” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to, but not limited to, actions taken by an analytical system, processor, machine, and / or controller associated with an analytical system when, as a result of comparing the current date with expiration information, it is concluded that the control fluid stored in the container has expired. Accordingly, as used herein, the term “confirmation action” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to, but not limited to, actions taken by an analytical system when, as a result of comparing the current date with expiration information, it is concluded that the control fluid stored in the container has not expired.

[0049] As used herein, the term “user” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a person who is not limited to the fact that a person may be in a healthy state or may suffer from one or more diseases. For example, a person may be a patient suffering from diabetes and / or other diseases. However, a user may also be a medically trained person who examines a patient suffering from diabetes and / or other diseases. In particular, a user may be, or include, a healthcare professional, especially in point-of-care applications. However, a user may also be the patient themselves, especially in home care applications. Specifically, a user may be a person who handles one or more of the following: an analytical system, an analytical device, a container, or a control fluid.

[0050] The method according to the present invention may further include the following steps. e. If a container does not already have a database entry in the database, create a new database entry for the container, the new database entry shall include the container's identification number and the container's assigned expiration date information.

[0051] Step e. may be performed and / or initiated automatically by a controller, machine, and / or processor, and therefore may be automated. The expiration information for a new database entry may include at least one of the following: an expiration date indicating the absolute date of expiration of the control fluid; the date of creation of the new database entry; the initial opening date of each container; and an in-use stabilization expiration date indicating the date calculated by determining the end of a predetermined in-use stabilization period calculated from the initial opening date of the container.

[0052] As outlined above, the method involves reading a container identifier by using at least one reading device. The reading device may be selected from a group consisting of a reading device integrated with the analytical device, a reading device separate from the analytical device, and in particular an independent barcode scanner, meaning that the reading device is coupled and / or housed in the housing of the analytical device, particularly in a substantially fixed position. In particular, the reading device may include at least one of a barcode scanner, a QR code scanner, a camera, or an RFID reader. Specifically, in many analytical devices for point-of-care applications, but also in many other analytical devices, the reading device is integrated as a component such as a component of a handheld device. As an example, there may be one or more of an integrated barcode scanner, a QR code scanner, or an NFC reader, or an integrated camera may be used as a reading device for reading barcodes and / or QR codes, etc. If the reading device is separate from the analytical device, it may have a wireless connection with the analytical device. Alternatively, the reading device may be coupled to the analytical device by a cable and / or wire.

[0053] As used herein, the term “barcode scanner” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a device configured to read barcodes, but is not limited to this. Specifically, a barcode scanner may be configured to optically capture a barcode and to determine the information contained in the barcode. As an example, a barcode scanner may comprise at least one light-emitting device and at least one photosensitive detector. The light-emitting device may emit light in the optical and / or infrared range and may be configured to focus the emitted light onto the barcode. The photosensitive detector may be configured to detect reflected light from the barcode and convert the optical signal into an electronic signal. Furthermore, the barcode scanner may be configured to determine the information contained in the barcode from the converted electronic signal.

[0054] As used herein, the term “QR code scanner” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a device configured to read the two-dimensional binary matrix of a QR code, but is not limited thereto. A QR code scanner may be further configured to convert the binary matrix into information stored in the QR code. As an example, a QR code scanner may be a camera.

[0055] As used herein, the term “camera” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a device having at least one image sensor configured to record or capture spatially resolved one-dimensional, two-dimensional, or three-dimensional optical data or information, but is not limited to this. As an example, a camera may comprise at least one camera chip, such as at least one CCD chip and / or at least one CMOS chip, configured to record an image.

[0056] As used herein, the term “image” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to data recorded and / or captured using a camera, such as multiple electronic readouts from an imaging device, such as pixels of a camera chip, but not limited to these. Thus, an image may be, or may contain, an array of at least one information value, such as an array of grayscale values ​​and / or color information values. An image may be a monochrome image, or a multicolor or colored image.

[0057] The camera may comprise at least one camera chip or imaging chip, as well as one or more optical elements, such as one or more lenses. For example, the camera may be a fixed-focus camera having at least one lens fixedly adjusted relative to the camera. Alternatively, however, the camera may comprise one or more variable lenses that can be automatically or manually adjusted. The present invention is specifically applicable to cameras typically used in mobile applications such as notebook computers, tablets, or mobile phones, specifically smartphones. Therefore, specifically, the camera may be part of a mobile device comprising at least one camera, as well as one or more data processing devices, such as one or more data processors. However, other cameras are also achievable.

[0058] As used herein, the term “RFID reader” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a device configured to read RFID tags by using radio frequency electromagnetic radiation, but is not limited to this. Specifically, an RFID reader may be configured to read information stored in an RFID tag by decoding radio frequency signals. An RFID reader may, for example, comprise an NFC standard communication interface or an NFC reader.

[0059] As outlined above, the analytical system according to the present invention comprises at least one analytical device for determining the concentration of an analyte in a sample of a body fluid. The analytical system may further comprise at least one test element, the test element comprising at least one test chemical, in particular at least one test chemical for a diagnostic test and / or at least one test chemical in an immunological test setup. The test chemical may be configured to perform at least one detection reaction in the presence of the analyte, and the analytical device may be configured to determine the concentration of the analyte by using the test element. As an example, the test element may comprise at least one test strip. Thus, the analytical device may comprise at least one test strip port configured to accept a test strip. Alternatively or additionally, the test element may comprise at least one test device, such as at least one test device comprising one or more of a cartridge, a fluid system, a sensor unit, etc. In this example, the analytical device may comprise at least one port of the test device. The display of the analytical device may further comprise providing the user with information regarding the analytical measurement.

[0060] The term “analytical test element,” also known as “test element” as used herein, is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to any device capable of detecting an analyte in a sample or determining parameters of a sample, but not limited to these. Specifically, a test element may be a strip-shaped test element. As used herein, the term “strip-shaped” refers to an element having an elongated shape and thickness, where the extension of the element in the lateral dimension is, for example, at least twice, preferably at least five times, more preferably at least ten times, most preferably at least twenty times, and even more preferably at least thirty times, the thickness of the element. Thus, a test element may also be referred to as a “test strip.”

[0061] The term “test chemical,” often also called “test chemical,” as used herein is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term can refer to any material or composition of materials adapted to alter at least one detectable property in the presence of an analyte. Generally, this property may be selected from electrochemically detectable properties and / or optically detectable properties such as changes in color and / or changes in reflectivity. Specifically, the test chemical may be a highly selective test chemical that alters its property only when an analyte is present in a sample of a bodily fluid applied to a test element, but does not alter it when the analyte is not present. More preferably, the degree or alteration of the property may depend on the concentration of the analyte in the bodily fluid to enable quantitative detection of the analyte. The alteration of the property of the test chemical in the presence of an analyte is sometimes referred to as a “detection reaction.” For example, the test chemical may be, or include, at least one test chemical in a diagnostic test, such as a blood glucose test. Alternatively or additionally, the test chemical may be, or may include, at least one test chemical in an immunological test setup, such as a urine test, allergy test, or pregnancy test.

[0062] The analysis system may further include at least one backbone server, which is configured to exchange information with the analysis devices. The backbone server may also be configured to store a database. Furthermore, the analysis system may include multiple analysis devices.

[0063] As used herein, the term “backbone server” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to a device, in particular a server device, that can perform one or more operations with respect to data to be processed, but is not limited to this. Specifically, a server may comprise at least one processor that can be programmed by appropriate software to perform one or more operations with respect to the data to be processed. Furthermore, a backbone server may be configured to exchange information with analytical devices in particular for data exchange. A backbone server may also be configured to store data. As an example, a backbone server may be configured to store a database. A backbone server may comprise at least one data interface for exchanging one or both data or commands with at least one analytical device and / or further devices. The at least one data interface may be, or include, at least one of wired or wireless interfaces. A backbone server may also be embodied, in whole or in part, as a cloud server device.

[0064] As already stated above, the method according to the present invention may be at least partially automated and / or computer-implemented, specifically steps b., c. and optionally steps d. and e., as described in more detail below, may be at least partially automated and / or computer-implemented. In a further embodiment of the present invention, an analytical system is disclosed. The analytical system is A. At least one analytical device for determining the concentration of an analyte in a body fluid sample, B. At least one reading device configured to read at least one identifier of a container containing at least one control fluid, wherein the identifier includes at least one identification number of the container, C. At least one database containing database entries for multiple known containers, wherein each database entry contains an identification number for a known container and assigned expiration date information for each known container. D. At least one processor configured to execute at least one database query, the database query including checking whether a container already has a database entry in the database and It is equipped with.

[0065] The analysis system may further comprise at least one container containing at least one control fluid, or may be configured to be used with at least one container. Specifically, the analysis system may be configured to carry out and / or to be used in the method according to the present invention. For definitions of the features of the analysis system and any features of the analysis system, one or more embodiments of the method disclosed above or the method disclosed in more detail below may be referenced.

[0066] As used herein, the term “system” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to any set of interacting or interdependent component parts that form a whole, but not limited to any specific set of components. Specifically, the components may interact with each other to perform at least one common function. At least two components may be treated independently, or they may be combined or connectable. Thus, the term “analytical system” generally refers to a group of at least two elements or components that can interact with any test element to perform at least one analytical measurement, specifically at least one analytical measurement of at least one analyte of a sample. Analytical systems may also be commonly referred to as test element analytical systems, analytical kits, sensor systems, or measurement systems. Specifically, an analytical system may be a device comprising at least two components.

[0067] The term “processor” as used herein is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer to any logic circuit configured to perform the basic operations of a computer or system, and / or, more generally, to a device configured to perform calculations or logical operations. In particular, a processor may be configured to process basic instructions that drive a computer or system. For example, a processor may comprise at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a numerical coprocessor or numerical coprocessor, a number of registers, specifically registers configured to supply operands to the ALU and store the results of calculations, and memory such as L1 and L2 cache memories. In particular, a processor may be a multi-core processor. Specifically, a processor may be a central processing unit (CPU) or comprise a CPU. In addition to or instead of this, a processor may be a microprocessor or include one, and therefore specifically, the elements of a processor may be contained in a single integrated circuit (IC) chip. Additionally or alternatively, the processor may be, or include, one or more application-specific integrated circuits (ASICs) and / or one or more field-programmable gate arrays (FPGAs). Specifically, the processor may be configured to perform one or more evaluation operations, for example, by software programming.

[0068] In a further embodiment of the present invention, a computer program is disclosed that includes instructions, which, when the program is executed by an analysis system according to the present invention, such as an analysis system according to any one of the embodiments of the above disclosure and / or an analysis system according to any one of the embodiments further disclosed below, cause the analysis system to perform at least steps b. and c. and optionally step e. of a method according to the present invention, such as an analysis method according to any one of the embodiments of the above disclosure and / or an analysis method according to any one of the embodiments further disclosed below. Where a step is not computer-implemented or cannot be computer-implemented, the computer program may mean prompting a user to perform a particular action or triggering an element of the analysis system to perform and / or start these steps. Thus, as an example, the computer program may, when executed, include instructions prompting a user to perform one or more of the following: provide at least one container, i.e., perform step a. of the method. Additionally or alternatively, the computer program may, when executed, include instructions prompting a user to read a container identifier by using at least one reading device of the analysis system, such as by scanning a barcode and / or QR code. For example, the prompting described above may be done by other means, such as visually displaying the command on the display of the analysis device and / or providing an audible command. However, step c. and optionally step e. of the Method may be fully computer-implemented by a computer program. The computer program may, when the program is executed by the analysis system according to the present invention, include instructions that prompt the analysis system to prompt the user to perform step a., optionally prompt the user to assist in performing step b., and further, to automatically read an identifier and to automatically perform at least step c.

[0069] Similarly, a computer-readable storage medium containing instructions is disclosed, and when the instructions are executed by an analysis system according to the present invention, such as an analysis system according to any one embodiment of the above disclosure and / or an analysis system according to any one embodiment further disclosed below, the analysis system causes the analysis system to perform at least steps b. and c., and optionally step e., of a method according to the present invention, such as an analysis method according to any one embodiment of the above disclosure and / or an analysis method according to any one embodiment further disclosed below. For options that prompt a user to assist with some of the method steps, in particular step a., see the description of the computer program.

[0070] As used herein, the term “computer-readable storage medium” may specifically refer to non-temporary data storage means such as hardware storage media storing computer executable instructions. The computer-readable data carrier or storage medium may specifically be, or include, storage media such as random-access memory (RAM) and / or read-only memory (ROM).

[0071] Computer programs can also be embodied as computer program products. As used herein, a computer program product may refer to a program as a tradable product. Products can generally exist in any format, such as paper format, or on computer-readable data carriers and / or computer-readable storage media. Specifically, computer program products can be delivered over data networks.

[0072] The methods and devices according to the present invention may offer many advantages over similar methods and devices known in the art. Specifically, the methods and devices described herein can enhance the usefulness of the control fluid. Thus, the methods according to the present invention enable the analytical system to recognize and / or identify individual containers of the control fluid on the first day of use by reading an identifier. This allows the analytical system, in particular the analytical device, to monitor the permitted usage period of each individual control fluid after each container has been opened.

[0073] Furthermore, the method and device according to the present invention enable automatic recording of the date of first use of the control fluid. Therefore, there is no need to manually record the date of first use. The risk of information written on the container being wiped off is also avoided. Thus, the loss of this information is prevented by using the method according to the present invention.

[0074] Furthermore, the method described herein ensures that the date of first use of the control fluid is accurately recorded. In addition, the status of the control fluid is automatically provided to the user via at least one interface of the analytical device, so the user's attention is drawn to the status of the control fluid. Thus, there is no longer any possibility of using a control fluid whose stability has expired during use.

[0075] Therefore, the analytical system can avoid using expired control materials, which cannot be guaranteed to fulfill their purpose in light of the analytical system's control functions. Results obtained from controls performed using expired control materials are not acceptable to the analytical system, and only results obtained from controls performed using control materials within a qualified range (e.g., by shelf-life studies) may be acceptable for use by the analytical system.

[0076] In summary, without precluding further possible embodiments, the following embodiments may be conceivable.

[0077] Embodiment 1: A method for controlling the function of an analytical system, wherein the analytical system comprises at least one analytical device for determining the concentration of an analyte in a body fluid sample, and the method is a. To provide at least one container for containing at least one control fluid, wherein the container comprises at least one identifier, the identifier including at least one identification number of the container, b. Reading the container identifier by using at least one reading device of the analysis system, c. Performing a database query in the database of the analysis system, wherein the database contains database entries for multiple known containers, each database entry contains an identification number for the known container and assigned expiration date information for each known container, and the database query includes checking whether the container already has a database entry in the database. Methods that include...

[0078] Embodiment 2: The method according to Embodiment 1, wherein the identifier includes at least one of a barcode, a QR code, or an RFID tag.

[0079] Embodiment 3: The method according to any one of Embodiments 1 to 2, wherein the identifier includes at least one identification number of the container, plus at least one additional information item, the at least one additional information item being selected from the group consisting of a type information item providing information about the type of control fluid, a kit information item providing information about a kit comprising at least one analytical test element and a control fluid, level information providing information about the level of at least one control analyte contained in the control fluid, lot number, shelf life, expiration date, manufacturing date, code content and / or layout version number, kit type, level type, bottle ID, in-use stability period, and target value (lot-specific).

[0080] Embodiment 4: The method according to any one of Embodiments 1 to 3, further comprising an automated step of comparing the current date with expiration information, specifically, performed by a processor, machine, or controller.

[0081] Embodiment 5: The method according to Embodiment 4, wherein if a comparison of the current date with expiration information indicates that the control fluid in the container has expired, the method further includes triggering and / or performing at least one expiration response action.

[0082] Embodiment 6: The method according to Embodiment 5, wherein the expiration response action includes at least one action selected from the group consisting of providing the user with a notification that the control fluid in the container has expired, displaying a warning, providing at least one piece of electronic information indicating that the control fluid in the container has expired, and preventing further use of the control fluid in the container.

[0083] Embodiment 7: The method according to Embodiment 6, wherein a comparison of the current date with expiration date information indicates that the control fluid in the container has not expired, and at least one verification operation is performed.

[0084] Embodiment 8: The method according to Embodiment 7, wherein the confirmation operation includes at least one operation selected from the group consisting of providing a notification to the user that the control fluid in the container has not expired, displaying a notification that the control fluid is permitted to be used, providing at least one piece of electronic information indicating that the control fluid in the container has not expired, and permitting further use of the control fluid in the container.

[0085] Embodiment 9: d. Determining the analyte concentration of the control fluid contained in the container by using an analytical device. The method according to any one of embodiments 7 to 8, further including the method described above.

[0086] Embodiment 10: The method according to any one of Embodiments 1 to 9, wherein the expiration date information includes at least one of an expiration date indicating an absolute date of expiration of the control fluid, and an in-use stabilization expiration date indicating a date calculated by determining the end of a predetermined in-use stabilization period calculated from the initial opening date of the container.

[0087] Embodiment 11: The method according to any one of Embodiments 1 to 10, wherein the analysis device is configured to provide information to the user via at least one interface, specifically via at least one display of the analysis device.

[0088] Embodiment 12: e. If a container does not yet have a database entry in the database, create a new database entry for the container, the new database entry shall include the container's identification number and the container's assigned expiration date information. The method according to any one of embodiments 1 to 11, further comprising:

[0089] Embodiment 13: The method according to Embodiment 12, wherein the expiration information of a new database entry includes at least one of the following: an expiration date indicating an absolute date of expiration of the control fluid; a date of creation of the new database entry; the initial opening date of each container; and an in-use stabilization expiration date indicating a date calculated by determining the end of a predetermined in-use stabilization period calculated from the initial opening date of the container.

[0090] Embodiment 14: The method according to any one of Embodiments 1 to 13, wherein the reading device is selected from the group consisting of a reading device integrated into the analysis device, a reading device separate from the analysis device, and specifically an independent barcode scanner.

[0091] Embodiment 15: The method according to Embodiment 14, wherein the reading device includes at least one of a barcode scanner, a QR code scanner, a camera, or an RFID reader.

[0092] Embodiment 16: The method according to any one of Embodiments 1 to 15, wherein the analytical system further comprises at least one test element, the test element comprising at least one test chemical, specifically at least one test chemical in a diagnostic test and / or at least one test chemical in an immunological test setup, the test chemical being configured to carry out at least one detection reaction in the presence of an analyte, and the analytical device being configured to determine the concentration of the analyte using the test element.

[0093] Embodiment 17: The method according to Embodiment 16, wherein the test element includes at least one test strip and / or at least one test device, for example, one or more of a cartridge, a fluid system, a sensor unit, etc., and the analysis device has at least one test strip port and / or at least one port of the test device configured to accept a test strip.

[0094] Embodiment 18: The method according to any one of Embodiments 1 to 17, wherein the analysis system further comprises at least one backbone server, the backbone server configured to exchange information with the analysis device, and the backbone server configured to store a database.

[0095] Embodiment 19: The analysis system is a method according to any one of Embodiments 1 to 18, comprising a plurality of analysis devices.

[0096] Embodiment 20: The method according to any one of Embodiments 1 to 19, wherein steps b., c., and optionally steps d. and e., are carried out at least partially by a computer.

[0097] Embodiment 21: An analysis system, A. At least one analytical device for determining the concentration of an analyte in a body fluid sample, B. At least one reading device configured to read at least one identifier of a container containing at least one control fluid, wherein the identifier includes at least one identification number of the container, C. At least one database containing database entries for multiple known containers, wherein each database entry contains an identification number for a known container and assigned expiration date information for each known container. D. At least one processor configured to execute at least one database query, the database query including checking whether a container already has a database entry in the database and An analytical system equipped with the following features.

[0098] Embodiment 22: The analysis system according to Embodiment 21, wherein the analysis system is configured to carry out the method described in any one of Embodiments 1 to 20, which references the method.

[0099] Embodiment 23: A computer program comprising instructions, wherein when the program is executed by an analysis system as described in any one of Embodiments 21 or 22 which references an analysis system, the computer program causes the analysis system to perform at least steps b. and c., and optionally steps d. and / or e., of the method described in any one of Embodiments 1 to 20 which references a method.

[0100] Embodiment 24: A computer-readable storage medium including instructions, wherein when a program is executed by an analysis system as described in any one of Embodiments 21 or 22, which references an analysis system, the instructions cause the analysis system to perform at least steps b. and c., and optionally steps d. and / or e., of the method described in any one of Embodiments 1 to 20, which references a method. [Brief explanation of the drawing]

[0101] Further optional features and embodiments are disclosed in more detail in subsequent descriptions of embodiments, preferably in conjunction with dependent claims. Each of these optional features may be implemented in an independent manner or in any viable combination, as will be understood by those skilled in the art. The scope of the present invention is not limited by preferred embodiments. Embodiments are schematically shown in the figures, where the same reference numerals in these figures refer to the same or functionally equivalent elements.

[0102] [Figure 1] A schematic diagram showing embodiments of an analytical system, analytical device, and container. [Figure 2] A flowchart of one embodiment of a method for controlling the functionality of an analysis system. [Modes for carrying out the invention]

[0103] Figure 1 shows a schematic diagram of an embodiment of the analysis system 110, an analysis device 112, and a container 114. The analysis system 110 comprises at least one analysis device 112 configured to determine the concentration of an analyte in a body fluid sample. The analysis system 110 further comprises at least one reading device 113 configured to read at least one identifier 124 of a container 114 containing at least one control fluid. The container 114 may also form part of the analysis system 110. The analysis system 110 further comprises at least one database 116 containing database entries 130 of a plurality of known containers 114, the database entries 130 containing the identification number of the known container 114 and the expiration date information assigned to each known container 114. Furthermore, the analysis system 110 comprises at least one processor 117 configured to perform at least one database query, the database query including checking whether the container 114 already has a database entry 130 in the database 116. The components of the analysis device 112 and their functions are described below.

[0104] As outlined above, the analysis system 110 comprises at least one database 116. The at least one database 116 may be fully or partially stored in the backbone server 118 of the analysis system 110, such as in at least one data storage device 119 of the backbone server 118. The backbone server 118 may be a standalone backbone server 118, or may comprise multiple backbone servers 118, and / or may be embodied as a cloud server. Additionally or alternatively, the database 116 may also be fully or partially stored in at least one data storage device 121 of at least one analysis device 112.

[0105] The analysis system 110 may comprise a single analysis device 112 or multiple analysis devices 112. In the latter case, the analysis devices 112 may be specifically configured to communicate with each other and / or with the backbone server 118. The analysis devices 112 are configured to determine the concentration of an analyte in a body fluid sample, in particular by using at least one test element 125, such as a test strip 126 and / or a test device, as outlined in more detail below. The analysis devices 112 may specifically be handheld analysis devices 112, which may be portable, for example, in one hand of a user.

[0106] The analysis system 110 comprises at least one reading device 113, as outlined above. The reading device 113 may be a standalone reading device 113 or may include one. Additionally or alternatively, the reading device 113 may also be integrated, all or in part, with at least one other component, such as the analysis device 112. Specifically, the analysis device 112 may comprise at least one integrated reading device 113. Specifically, the reading device 113 may be at least one camera 120 or may include one.

[0107] As outlined above, the analytical device 112 is configured to determine the concentration of an analyte in a body fluid sample. For this purpose, the analytical device 112 may be configured in particular as a portable handheld measuring device. Thus, the analytical device 112 may be configured as an electrochemical and / or optical measuring device configured to use at least one test element 125, such as at least one test strip 126 and / or a test device. The test element 125 may be, or include, at least one of an electrochemical test element or an optical test element. Alternatively or additionally, the test element 125 may include at least one test device, such as at least one test device including one or more of a cartridge, a fluid system, a sensor unit, etc. To interact with the test element 125, specifically to interact with the test strip 126, the analytical device 112 may have, for example, at least one test strip port 122 for receiving at least one test element 125. If the test element 125 may include a test device, the analysis device 112 may have at least one port of the test device. The analysis device 112 may further have at least one user interface, such as a display 123.

[0108] As outlined above, the analysis system 110 may further comprise at least one container 114. The container 114 may contain at least one control fluid, the function of which is outlined in more detail below. The container 114 includes at least one identifier 124, such as a barcode, QR code and / or RFID tag.

[0109] As described above, the test element 125, specifically the test strip 126 and / or test device, may be used for analytical measurement of the analyte concentration in a body fluid sample. The control fluid contained in the container 114 may be used for at least one control measurement by using at least one aliquot of the control fluid instead of the analytical device 112, the test element 125, and the body fluid sample.

[0110] As outlined above, the analysis device 112 includes at least one reading device 113, specifically a camera 120. The reading device 113 is configured to read the identifier 124 of the container 114. Thus, as an example, the camera 120 may be used as a barcode reader and / or QR code reader. The display 123 of the analysis device 112 may be configured to provide information to the user of the analysis device 112.

[0111] The backbone server 118 can connect to the analysis device 112 for one-way or two-way data exchange, such as via at least one wireless interface 128 of the backbone server 118 that communicates with at least one corresponding wireless interface 129 of the analysis device 112, in order to exchange information between the backbone server 118 and the analysis device 112.

[0112] The test element 125, in particular the test strip 126 and / or the test device, may include at least one test chemical, which may be configured to perform at least one detection reaction in the presence of the analyte to be detected. The detection reaction may alter the optically detectable and / or electrochemically detectable properties of the test chemical, specifically at least one test chemical in a diagnostic test and / or at least one test chemical in an immunological test setup. The degree of the property change may depend on the analyte concentration of the analyte in the control fluid. Thus, the analytical device 112 may be configured to determine the analyte concentration in the control fluid stored in the container 114 by detecting the property change of the test chemical on the test strip 126. The results of the analytical measurement may be displayed via the display 123 of the analytical device 112.

[0113] Identifier 124 includes at least one identification number of container 114. Furthermore, identifier 124 may also include at least one additional information item, specifically one or more additional information items as listed below. The additional information item may be selected from the group consisting of a type information item providing information about the type of control fluid, a kit information item providing information about a kit comprising at least one analytical test element 125 and the control fluid, level information providing information about the level of at least one control analyte contained in the control fluid, lot number, shelf life, expiration date, manufacturing date, code content and / or layout version number, kit type, level type, bottle ID, in-use stability period, and target value (lot-specific). A reading device 113, such as a camera 120, may also be configured to read at least one additional information item from identifier 124 in addition to at least one identification number.

[0114] Database 116 contains database entries 130 for a number of known containers 114, as outlined above. Database entries 130 contain the identification number and assigned expiration date information for the known containers 114, as outlined above. The backbone server 118 may be configured to exchange information with the analysis device 112. Thus, the analysis device 112 and the backbone server 118 may be configured to exchange information such as the identification number of the container 114 and / or at least one further information item.

[0115] The analysis system 110 is specifically comprised of software programming to implement a method for controlling the functions of the analysis system 110. Figure 2 shows a flowchart of an exemplary embodiment of the method, which is indicated by reference numeral 132. Method 132 specifically includes the following steps, which can be performed in a given order. Furthermore, different orders may also be possible. It may be possible to perform two or more method steps completely or partially simultaneously. It may be possible to perform one, two or more, or even all, method steps once or repeatedly. Method 132 may include additional method steps that are not enumerated.

[0116] Method 132 is, a. Providing at least one container 114 for containing at least one control fluid (indicated by reference numeral 134), wherein the container 114 comprises at least one identifier 124, the identifier 124 comprising at least one identification number of the container 114, b. The step of reading the identifier 124 of the container 114 by using at least one reading device 113 of the analysis system 110 (indicated by reference numeral 136), c. A step of performing a database query in the database 116 of the analysis system 110 (indicated by reference numeral 138), wherein the database 116 includes database entries 130 for a plurality of known containers 114, each including an identification number for a known container 114 and assigned expiration date information for each known container 114, and the database query includes checking whether a container 114 already has a database entry 130 in the database 116. Includes.

[0117] In step c.138, the database entry 130 includes, in addition to the identification number, the expiration date information assigned to each container 114. The expiration date information may include the expiration date and / or the in-use stability expiration date. Specifically, the expiration date may indicate the absolute date of expiration of the control fluid. Furthermore, the in-use stability expiration date may indicate the maximum usage date, which can be calculated by determining the end of a predetermined in-use stability period calculated from the initial opening date of the container 114. The initial opening date of the container 114 may be registered by the initial reading of the identifier 124 of each container 114.

[0118] Method 132 may further include an automated step of comparing the current date with expiration information stored in database entry 130, specifically performed by a processor, machine, or controller. If the comparison of the current date with the expiration information indicates that the control fluid has expired, Method 132 may include triggering and / or performing at least one expiration response action, such as at least one predefined action for when the control fluid in container 114 has expired. However, if the comparison of the current date with the expiration information indicates that the control fluid in container 114 has not expired, Method 132 may include performing at least one confirmation action, such as at least one predefined action for when the control fluid in container 114 has not expired. Furthermore, the expiration response action and / or confirmation action may be provided to the user via at least one interface of the analysis device 112. Specifically, the interface of the analysis device 112 may be at least one display 123 configured to visually provide the user with information such as the expiration response action, confirmation action, or the results of the analysis measurement. It should be noted that other options are also feasible. Therefore, information may be brought to the user's attention, alternatively and / or additionally, via acoustic and / or tactile means.

[0119] If a comparison of the current date with the expiration date information indicates that the control fluid in container 114 has not expired, method 132 may optionally include an additional step d. (indicated by reference numeral 140). This method step d. is d. This may include determining the analyte concentration of the control fluid contained in the container 114 by using the analytical device 112 (indicated by reference numeral 140).

[0120] Step d. may also be referred to as a control measurement, or may be part of a control measurement. A control measurement may be used, for example, to adjust the settings of the analysis system 110 and / or the analysis device 112, and / or to interpret the readings of the analysis system 110 and / or the analysis device 112. Additionally or alternatively, a control measurement may also be used for one or more of the following: to calibrate one or both of the analysis system 110 and / or the analysis device 112, and / or to verify the integrity of one or both of the analysis system 110 and / or the analysis measurement. This analysis measurement of the control fluid may yield an analyte concentration value. The determined analyte concentration value can be further compared with level information of the control fluid. The comparison can then indicate that the analysis system 110 is functioning correctly if the determined analyte concentration value is within a predetermined acceptable range.

[0121] As outlined above, step c of method 132 includes performing a database query. The database query includes checking whether container 114 already has a database entry 130. Thus, method 132 does not require any additional steps, namely, e. If container 114 (indicated by reference numeral 142) does not already have a database entry 130 in the database 116, the step of creating a new database entry for container 114, the new database entry including an identification number for container 114 and assigned expiration date information for container 114.

[0122] The expiration date information assigned to a new database entry may include at least one of the following: an expiration date indicating the absolute date of the control fluid's expiration; the date of creation of the new database entry; the initial opening date of each container 114; and an in-use stabilization expiration date indicating the date calculated by determining the end of a predetermined in-use stabilization period calculated from the initial opening date of the container 114. Specifically, the operation of creating a new database entry and the initial opening operation of each container 114 may be performed in a timely manner. Therefore, the creation date of the new database entry and the initial opening date of the container 114 may correspond to each other. The initial opening date of the container 114 may be registered by first reading the identifier 124 of the container 114 and assigning the corresponding current date.

[0123] Furthermore, Method 132, in particular at least steps b., c., and optionally e. of Method 132 as described above, may be at least partially automated and / or computer-implemented. Thus, the analysis system 110 comprises at least one processor 117 configured to perform at least one database query, specifically in step c. of Method 132. The at least one processor 117 may be fully or partially included by the analysis device 112 and / or the backbone server 118. The database query may include checking whether container 114 already has a database entry 130 in database 116. For method steps that are not computer-implemented, the analysis system 110 may be configured to prompt the user to assist in performing steps a. and d., in particular by software programming. As an example, the prompting may be done by other means, such as visually displaying instructions on the display 123 of the analysis device 112 and / or providing audible instructions. [Explanation of Symbols]

[0124] List of reference numbers 110 Analysis System 112 Analytical Devices 113 Reading device 114 Container 116 Databases 117 Processors 118 Backbone Servers 119. Data storage devices for backbone servers 120 Cameras 121 Data storage devices for analytical devices 122 Test strip ports 123 displays 124 Identifiers 125 test elements 126 test strips 128 Backbone Server Wireless Interface 129 Wireless Interface for Analytical Devices 130 database entries 132 Control Method 134. Provide at least one container (step a.) 136. Reading the identifier (Step b.) 138. Execute a database query (Step c.) 140. Determine the analyte concentration in the control fluid contained in the container by using an analytical device (step d.). 142. If the container does not yet have a database entry, create a new database entry for the container (step e.).

Claims

1. A method for controlling the function of an analysis system (110), wherein the analysis system (110) comprises at least one analysis device (112) for determining the concentration of an analyte in a body fluid sample, the analysis device (112) being a handheld device configured for mobile analysis measurement, and the method is a. To provide at least one container (114) for containing at least one control fluid, wherein the container (114) comprises at least one identifier (124), and the identifier (124) includes at least one identification number of the container (114), b. Reading the identifier (124) of the container (114) by using at least one reading device (113) of the analysis system (110), c. Performing a database query in the database (116) of the analysis system (110), wherein the database (116) includes database entries (130) for a plurality of known containers (114), each database entry (130) containing an identification number for the known container (114) and assigned expiration date information for each of the known containers (114), and the database query includes performing a database query that checks whether the container (114) already has a database entry (130) in the database (116). Methods that include...

2. The method according to claim 1, wherein the identifier (124) includes at least one of a barcode, a QR code, and an RFID tag.

3. The method according to any one of claims 1 to 2, further comprising comparing the current date with the expiration date information.

4. The method according to claim 3, wherein if the comparison between the current date and the expiration date information indicates that the control fluid in the container (114) has expired, the method further comprises triggering and / or performing at least one expiration response action.

5. The method according to claim 4, wherein the expiration response action includes at least one action selected from the group consisting of providing a user with a notification that the control fluid in the container (114) has expired, displaying a warning, providing at least one piece of electronic information indicating that the control fluid in the container (114) has expired, and preventing further use of the control fluid in the container (114).

6. The method according to claim 5, wherein if the comparison between the current date and the expiration date information indicates that the control fluid in the container (114) has not expired, at least one verification operation is performed.

7. The method according to claim 6, wherein the confirmation operation includes at least one operation selected from the group consisting of providing a user with a notification that the control fluid in the container (114) has not expired, displaying a notification that the control fluid is permitted to be used, providing at least one piece of electronic information indicating that the control fluid in the container (114) has not expired, and permitting further use of the control fluid in the container (114).

8. d. Determining the concentration of the analyte in the control fluid contained in the container (114) by using the analytical device (112). The method according to any one of claims 6 to 7, further comprising:

9. The method according to any one of claims 1 to 8, wherein the expiration date information includes at least one of an expiration date indicating an absolute date of expiration of the control fluid, and an expiration date indicating a date calculated by determining the end of a predetermined in-use stabilization period calculated from the initial opening date of the container (114).

10. e. If the container (114) does not already have a database entry (130) in the database (116), create a new database entry for the container (114), the new database entry including the identification number of the container (114) and the assigned expiration date information for the container (114). The method according to any one of claims 1 to 9, further comprising:

11. The method according to claim 10, wherein the expiration information of the new database entry includes at least one of the following: an expiration date indicating an absolute date of expiration of the control fluid; a date of creation of the new database entry; the initial opening date of each of the containers (114); and an in-use stabilization expiration date indicating a date calculated by determining the end of a predetermined in-use stabilization period calculated from the initial opening date of the containers (114).

12. The method according to any one of claims 1 to 11, wherein the reading device (113) is selected from the group consisting of a reading device (113) integrated with the analysis device (112), a reading device (113) separate from the analysis device (112), and specifically an independent barcode scanner.

13. The method according to any one of claims 1 to 12, wherein the analysis system (110) further comprises at least one backbone server (118), the backbone server (118) is configured to exchange information with the analysis device (112), and the backbone server (118) is configured to store the database (116).

14. An analysis system (110), wherein the analysis system (110) is configured to perform the method described in any one of claims 1 to 13, and the analysis system (110) is A. At least one analytical device (112) for determining the concentration of an analyte in a body fluid sample, B. At least one reading device (113) configured to read at least one identifier (124) of a container (114) containing at least one control fluid, wherein the identifier (124) includes at least one identification number of the container (114), C. At least one database (116) including database entries (130) for a plurality of known containers (114), wherein each database entry (130) includes an identification number of the known container (114) and assigned expiration date information for each of the known containers (114), D. At least one processor (117) configured to perform at least one database query, wherein the database query includes checking whether the container (114) already has a database entry (130) in the database (116) and An analysis system (110) equipped with the following:

15. A computer program comprising instructions, wherein, when the program is executed by the analysis system (110) described in claim 14, the analysis system (110) causes the analysis system (110) to execute at least step b. (136) and step c. (138) and optionally step d. (140) and / or step e. (142) of the method according to any one of claims 1 to 13.

16. A computer-readable storage medium containing instructions, wherein, when executed by the analysis system (110) described in claim 14, the instructions cause the analysis system (110) to execute at least step b. (136) and step c. (138) and optionally step d. (140) and / or step e. (142) of the method according to any one of claims 1 to 13.

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