Calibration management for in vitro diagnostic systems

Abstract

A computer-implemented method of automatically managing calibration of an in vitro diagnostic (IVD) system, the computer-implemented method comprising performing a calibration cycle / procedure, the calibration cycle / procedure comprising using a calibration solution, using the calibration solution comprises a first step of delivering the calibration solution to a measurement unit and a second step of measuring the calibration solution by the measurement unit. For each calibration cycle, the method comprises: starting a repetition of the calibration procedure earliest at the beginning of a buffer time period prior to expiration of a respective calibration valid period; interrupting the calibration procedure upon receiving a command to perform a sample IVD test; and resuming or resuming the calibration procedure after performing the sample IVD test as long as repetition of the calibration procedure can be resumed or resumed within the buffer time period. Interrupting the calibration protocol comprises different steps according to the following: the command to perform a sample IVD test is received during the use of a first calibration solution or a subsequent calibration solution of a series of calibration solutions, and the command is received during either the first step of delivering the first calibration solution or subsequent calibration solution to the measurement unit or the second step of measuring the first calibration solution or subsequent calibration solution. The invention also discloses an IVD system for performing operations associated with the method for automatically managing calibration.

Description

Technical Field

[0001] The present disclosure relates to a computer-implemented method for automatically managing the calibration of an in vitro diagnostic system and to an in vitro diagnostic system performing operations associated with the method for automatically managing calibration. Background Art

[0002] Medically, a doctor's diagnosis and a patient's treatment often rely on the measurement of the concentration of an analyte or other parameters in a patient sample by performing an in vitro diagnostic (IVD) test. These measurements are typically performed by an in vitro diagnostic system, which can be configured to analyze a particular type of sample and use various detection techniques to detect a particular type of analyte. Since a patient's life may depend on the accuracy and reliability of such measurements, it is very important that the system operates correctly.

[0003] A general requirement for in vitro diagnostic systems is to implement a set of quality control (QC) procedures to check whether they are operating correctly continuously.

[0004] One of these procedures is calibration. In most cases, calibration is performed using a standard solution of known concentration. In this way, the measured signal can be correlated with a quantitative result. Depending on the system and other variable factors that may affect performance, calibration should be performed more or less frequently. One of these factors may be the aging of the reagents and / or other solutions used, resulting in the expiration of the reagents and / or other solutions after a predetermined time when they have been exposed to environmental conditions. The signal stability of the measurement unit, especially for some types of measurement units (including, for example, biosensors), may be another factor. In particular, some detectors and sensors used to measure the concentration of an analyte may be disturbed (e.g., due to the presence of interfering substances and / or high concentrations in a particular test sample) and may suffer at least temporary signal instability. In particular, some sensors may experience signal drift, which may not be noticed in some cases. This may lead to measurement errors and may therefore require more frequent calibration and so-called QC measurements between successive calibrations by measuring one or more reference samples (also called QC samples) in the same way as measuring a test sample, where the value of the analyte or parameter of interest is known, to further check whether the calibrated instrument is actually within the specifications or tolerance range. Thus, generally speaking, there is a time limit to the validity of calibration.

[0005] Typically, during a calibration procedure, the analyzer or its components are not available, for example, not available for receiving new samples. Thus, the effective throughput and availability, as well as the cost of operating an in vitro diagnostic system, may be affected by the fact that a significant amount of time may have to be dedicated to performing and repeating the calibration procedure. In addition, the operator may be in a situation where he or she has to wait for the analyzer to become available again, for example, until the calibration procedure is completed before being able to input a new sample into the analyzer. Especially in a point-of-care setting, such as in an emergency situation, in an intensive care unit, etc., it may be crucial to obtain equally reliable results quickly, and any delay may be life-threatening. Moreover, for some IVD tests, including determining blood gas parameters, such as pO2, it is important to process the sample immediately after it is drawn from the patient, otherwise the reliability of the IVD test will be affected due to exposure to environmental conditions. Additionally, the time of the operator that could be utilized more effectively in other ways may be wasted. If the operator is unable to wait due to other more urgent ongoing activities, he or she will usually make a second attempt at a later time, and the analyzer may become available earlier during this period, so there is no need to necessarily delay the sample analysis. Summary of the Invention

[0006] A computer-implemented method for automatically managing the calibration of an in vitro diagnostic (IVD) system and an IVD system including a calibration management system that runs a computer-readable program, the computer-readable program being set with instructions to perform operations associated with a method of managing calibration that ensure the analytical performance of the IVD system, i.e., the reliability of the IVD test results, while ensuring that the IVD system is always available to process samples and provide IVD test results as soon as possible. Another advantage is the increased efficiency of the laboratory workflow obtained by preventing unnecessary waste of the operator's time and / or preventing additional stress in already highly demanding situations, such as having to search for another available IVD system or having to wait until the IVD system becomes available.

[0007] In particular, the method includes performing a calibration cycle, the calibration cycle including: performing a calibration protocol to determine test-specific calibration parameters for use in evaluating sample IVD test results; and repeating the calibration protocol to update the test-specific calibration parameters before the expiration of the corresponding calibration validity period, wherein different calibration protocols / cycles may have different calibration validity periods respectively, and wherein performing different calibration protocols / cycles includes using different series of calibration solutions respectively, the series including at least two different calibration solutions, and wherein using the calibration solution includes a first step of delivering the calibration solution to the measurement unit and a second step of measuring the calibration solution by the measurement unit. For each calibration cycle, the method further includes: starting the repetition of the calibration protocol at the beginning of a buffer time period earliest before the expiration of the corresponding calibration validity period; interrupting the calibration protocol upon receipt of a command to perform a sample IVD test; and restarting or resuming the calibration protocol after performing the sample IVD test, provided that the repetition of the calibration protocol can be restarted or resumed within the buffer time period. In particular, interrupting the calibration protocol includes different steps depending on: whether the command to perform the sample IVD test is received during the first calibration solution or a subsequent calibration solution in the series of calibration solutions used, and whether the command is received during the first step of delivering the first calibration solution or a subsequent calibration solution to the measurement unit or the second step of measuring the first calibration solution or a subsequent calibration solution.

[0008] As used herein, the term "calibration protocol" refers to the process of checking whether an IVD system is working accurately by comparing known standards with the measurement results delivered by the IVD system. This enables determination of a valid relationship between the measured value and the actual concentration of the analyte in the sample under actual measurement conditions. Depending on the type of signal, and especially depending on the linearity or non-linearity of the signal at different concentrations (which may vary according to a particular sample IVD test, e.g., according to a particular sample, according to one or more specific target analytes in the sample, according to a particular workflow and measurement conditions), the calibration protocol may include measuring one or more calibration levels corresponding to different concentration ranges of calibration materials or standards that fall within the detection range (dynamic range) of the IVD system and / or within the typical concentration range of the analyte visible in the sample. When measuring only one calibration level, the calibration protocol is a single-point calibration protocol. When measuring two calibration levels, the calibration protocol is a two-point calibration protocol, and so on. A "multi-point calibration protocol" is a calibration protocol that includes measuring multiple calibration levels (i.e., at least two and typically three or more), and in particular includes measuring the corresponding calibration levels of each of the multiple calibration points to obtain multiple corresponding calibration points.

[0009] According to other embodiments, a "calibration protocol" can also be a protocol that enables the correlation of a measured sample signal with a qualitative result (i.e., the mere presence or absence of an analyte). In this case, criteria are typically defined (which, for example, separate normal healthy samples from abnormal pathogenic samples), such as thresholds or cut-off points. For qualitative calibration, two calibrators are typically used: one that is free of the analyte (negative calibrator), and another that has a detectable amount of the analyte (positive calibrator).

[0010] Depending on the specific sample IVD test, different calibration protocols may have to be performed, each of which may include a different one or more calibrators and ultimately different calibrator levels and / or different numbers of levels.

[0011] The calibration protocol can include calculating a calibration result, i.e., the process of constructing a line or curve or mathematical function that best fits the measured calibration points, and includes regression analysis that takes into account statistical inference by calculating the amount of variation or dispersion (standard deviation) of the measured calibration points, such as measurement errors due to unknown and / or random errors occurring during the process, and how much uncertainty exists in the constructed line or curve. The process can include comparing the constructed line or curve with a reference line or curve or a previously constructed line or curve and / or comparing individual calibration points with reference values or previously measured values under the same conditions. In particular, the calibration protocol includes determining test-specific calibration parameters used in evaluating the results of the sample IVD test. Test-specific calibration parameters can be, for example, the slope, linearity, zero point, offset, inflection point, etc. of the calibration line or curve.

[0012] A "calibrator" is a calibration solution containing one or more calibration materials or standards of known value for calibration and measured under the same conditions as the sample. Calibrators can be provided at different levels, which correspond to different concentration ranges of the calibration material, including zero concentration, i.e., a blank solution. Typically, in the case of a linear response to analyte concentration, one or more levels of the same calibrator are used for single-point calibration or two-point calibration. If the calibration curve is non-linear, three or more calibrator levels can be used, for example, up to five, six, or more levels.

[0013] A "calibration material" can be such an analyte (whose concentration or value is known) that is the same as the analyte of interest, or generates an analyte (whose concentration or value is known) that is the same as the analyte of interest through reaction or derivatization (e.g., through fragmentation), or it can be any other equivalent substance or standard that is similar to the analyte of interest or can otherwise be related to a specific analyte of interest or sample parameter.

[0014] "Calibration validity period" is a time window of a predefined time length starting from the time when a calibration procedure has been successfully completed by determining the required test-specific calibration parameters, within which the determined test-specific calibration parameters are considered valid, i.e., applicable to evaluating the results of an IVD test on a sample. Thus, the calibration validity period is set to expire after a predefined time, which can be as short as or as long as, for example, 1 or 2 hours, 6 hours, 12 hours, 24 hours or longer, and can vary respectively for different calibration procedures, but some different calibration procedures can have the same length of calibration validity period.

[0015] In particular, it is important to repeat the calibration procedure before the expiration of the corresponding calibration time period of the calibration procedure in order to update the test-specific calibration parameters before they become invalid and to ensure the continuous analytical performance of the IVD system and the reliability of the IVD test results.

[0016] Thus, as used herein, the term "calibration cycle" refers to the recurrence of a calibration procedure at regular predefined intervals (i.e., at a predefined frequency) with the aim of updating the test-specific calibration parameters before the expiration of the corresponding calibration validity period. In particular, the time between a successfully completed calibration procedure and a subsequent successful completion of the same calibration procedure and any actions or procedures (including replacing previously determined test-specific calibration parameters with newly determined test-specific calibration parameters) are referred to as a calibration cycle.

[0017] In particular, for each calibration cycle, the method includes: starting the repetition of the calibration procedure at the beginning of a buffer time period that is at least as early as before the expiration of the corresponding calibration validity period; interrupting the calibration procedure upon receipt of a command to perform an IVD test on a sample; and restarting or resuming the calibration procedure after performing the IVD test on the sample, provided that the repetition of the calibration procedure can be restarted or resumed within the buffer time period.

[0018] As used herein, the term "buffer time period" refers to the time period within the calibration validity period that is closest to the end or expiration of the calibration validity period, which allows sufficient flexibility in terms of starting and interrupting, restarting or resuming (if needed) the repetition of the calibration procedure, wherein if a command for a sample IVD test is received after starting the repetition of the calibration procedure, there is sufficient time to perform at least one sample IVD test during the interruption. The repetition of the calibration procedure does not necessarily have to be completed before the expiration of the calibration validity period, as long as the calibration procedure can be restarted or resumed within the buffer time period before the expiration of the calibration validity period. The interruption can occur more than once as long as there is still sufficient time to complete the sample IVD test and restart or resume the repetition of the calibration procedure. To avoid continuous interruption, according to one embodiment, the method includes waiting for a predefined time after performing the sample IVD test before restarting or resuming the calibration procedure, as long as the repetition of the calibration procedure can be restarted or resumed within the buffer time period. This is because the operator may bring more than one sample close to the IVD system to perform more than one sample IVD test in a consecutive order.

[0019] The series of calibration solutions for performing the calibration procedure can include two or more calibration solutions that must be delivered to the measuring unit of the IVD system in a specific order and must be measured therein.

[0020] In particular, interrupting the calibration procedure includes different steps depending on whether the command to perform the sample IVD test is received during the use of the first calibration solution or a subsequent calibration solution in the series of calibration solutions, and whether the command is received during the first step of delivering the first calibration solution or a subsequent calibration solution to the measuring unit or the second step of measuring the first calibration solution or a subsequent calibration solution.

[0021] According to one embodiment, the series of calibration solutions includes a single pair or multiple pairs of calibration solutions, each pair including a common calibration solution as the first calibration solution and any other different calibration solution as the subsequent calibration solution.

[0022] Thus, the term "first calibration solution" can refer to the first calibration solution in a series of two or more calibration solutions, or if the series includes multiple pairs of calibration solutions, to the first calibration solution in each pair of calibration solutions.

[0023] The first calibration solution can particularly be a solution that has a predefined level of calibration material (e.g., having a lowest or zero level of at least some calibration material and / or having a most suitable level of at least some calibration material related to testing specific calibration parameters that require more frequent updates), and is thus measured more frequently than any other calibration solution.

[0024] Similarly, the term "subsequent calibration solution" can refer to the second calibration solution, third calibration solution, fourth calibration solution, etc. in a series of two or more calibration solutions, or, if the series includes multiple pairs of calibration solutions, to the second calibration solution in each pair of calibration solutions.

[0025] According to one embodiment, when the command to perform a sample IVD test is received during the first step of delivering the first calibration solution in the series and / or the first calibration solution in a pair to the measurement unit, interrupting the calibration procedure includes completing the first step of delivering the first calibration solution to the measurement unit and performing the measurement step of the first calibration solution with a reduced measurement time and aborting any subsequent steps of the calibration procedure in order to perform the sample IVD test.

[0026] As used herein, the term "with a reduced measurement time" is a relative term and is intended to indicate that the time taken to measure the first calibration solution is a predefined time that is shorter than the conventional time taken to measure the same calibration solution when the calibration procedure is not interrupted, e.g., about half or less of that time.

[0027] According to one embodiment, when the command to perform a sample IVD test is received during the second step of measuring the first calibration solution in the series and / or the first calibration solution in a pair, interrupting the calibration procedure includes completing the second step of measuring the first calibration solution and aborting any subsequent steps of the calibration procedure in order to perform the sample IVD test.

[0028] According to one embodiment, when the command to perform a sample IVD test is received during the first step of delivering the subsequent calibration solution in the series and / or the subsequent calibration solution in a pair to the measurement unit, interrupting the calibration procedure includes aborting the first step of delivering the subsequent calibration solution to the measurement unit and any subsequent steps of the calibration procedure in order to perform the sample IVD test.

[0029] According to one embodiment, when the command to perform a sample IVD test is received during the second step of measuring the subsequent calibration solution in the series and / or the subsequent calibration solution in a pair, interrupting the calibration procedure includes completing the second step of measuring the subsequent calibration solution and aborting any subsequent steps of the calibration procedure in order to perform the sample IVD test.

[0030] According to one embodiment, the method includes performing a washing step using the first calibration solution before performing the sample IVD test. By doing so, the same conditions before sample measurement can be ensured while providing an opportunity to measure the first calibration solution again in order to obtain the most up-to-date test-specific calibration parameters that can be determined by measuring the first calibration solution.

[0031] According to one embodiment, the method includes updating at least a portion of the test-specific calibration parameters after a measurement of a first calibration solution or after a completed measurement of a pair of calibration solutions. By doing so, although the calibration procedure may not be complete and / or may still be interrupted, it can be ensured that once any test-specific calibration parameters can be determined based on one or more calibration solutions that have been measured, those test-specific calibration parameters will be updated as well, such that if the calibration procedure is interrupted, those test-specific calibration parameters may have been used to evaluate the next sample IVD test result.

[0032] According to one embodiment, after the calibration procedure is interrupted and after a sample IVD test is performed, the method includes, for a calibration procedure using a single pair of calibration solutions, restarting the calibration procedure, and for a calibration procedure using multiple pairs of calibration solutions, resuming the interrupted calibration procedure starting from the pair of calibration solutions where the measurement was interrupted or aborted. Thus, if the measurement of one or more pairs of calibration solutions in a series including multiple calibration solutions has been completed, there is no need to repeat the measurement of that one or more pairs of calibration solutions before interrupting the calibration procedure, and the test-specific calibration parameters can be updated when they are determined.

[0033] According to one embodiment, the method includes combining different calibration procedures into a single calibration cycle by adding the respective calibration solutions and / or pairs of calibration solutions to the same series if the different calibration procedures share the same or similar calibration validity periods and / or if the respective validity periods have the same expiration time.

[0034] The term "sample" refers to a biological material that may contain one or more analytes of interest and whose detection or analysis, qualitative and / or quantitative measurement may be associated with a clinical condition. Samples can be from any biological source, such as physiological fluids, including blood, saliva, aqueous humor, cerebrospinal fluid, sweat, urine, milk, ascites, mucus, synovial fluid, peritoneal fluid, amniotic fluid, tissue, cells, etc. Test samples can be pre-treated before use, such as preparing plasma or serum from blood, diluting viscous fluids, lysis, etc.; the treatment methods can involve filtration, centrifugation, distillation, concentration, inactivation of interfering components, and addition of reagents. In some cases, the sample can be used directly as obtained from the source or can follow a pre-treatment and / or sample preparation workflow to modify the characteristics of the sample (e.g., after adding an internal standard, after diluting with another solution, or after mixing with a reagent) to, for example: enable one or more in vitro diagnostic tests, or for enrichment (extraction / separation / concentration) of the analyte of interest and / or removal of matrix components that may interfere with the detection of the analyte of interest.

[0035] According to one aspect, the sample is blood or a blood derivative, such as plasma or serum.

[0036] According to certain aspects, the target analytes are hemoglobin, hemoglobin derivatives that are typically measured in an optical detection unit, such as deoxyhemoglobin (HHb), oxyhemoglobin (O2Hb), carboxyhemoglobin (COHb), methemoglobin (MetHb), bilirubin, urea, creatinine. In turn, additional sample parameters can be derived based on previous measurements, such as oxygen saturation (SO2 = O2Hb / (O2Hb + HHb)) and total hemoglobin (tHb = the sum of all hemoglobins). Other target analytes are gases that are typically measured in a flow-through sensor path, such as pO2 and pCO2; blood electrolytes, such as sodium (Na + ), potassium (K + ), chloride (Cl - ), calcium (Ca ++ ), protons (H + ); metabolites, such as glucose and lactate, etc. However, this list is not exhaustive.

[0037] Also disclosed herein is an in vitro diagnostic (IVD) system for performing an IVD test on a patient sample, the IVD system comprising at least one measurement unit, a fluid system for delivering at least a calibration solution and a sample to the at least one measurement unit, and a controller that runs a computer-readable program that is set with instructions to perform operations associated with a method of managing calibration according to any one of the disclosed embodiments.

[0038] As used herein, the term "in vitro diagnostic system" refers to an automated or semi-automated analytical device that is configured to analyze in vitro samples to provide information for screening, diagnostic, or therapeutic monitoring purposes. The IVD system can be designed and configured according to the medical application area, the parameter to be determined, and the corresponding laboratory workflow. For example, in a point-of-care testing environment, the IVD system can vary from a handheld device with low throughput, short turnaround time, and a limited number of measurable parameters to a compact benchtop instrument with higher throughput and a higher number of measurable parameters. Such IVD systems are designed to detect specific types of parameters, such as gases, electrolytes, metabolites, clinical chemistry analytes, immunochemistry analytes, coagulation parameters, hematology parameters, etc. Depending on the target parameter, a variety of different sample IVD tests can be applied, including different analytical methods and different detection techniques. For example, in the field of blood gas and electrolyte testing, electrochemical measurement principles and / or conductivity measurement principles and / or optical detection methods are typically used. The IVD system generally includes a plurality of functional units, each functional unit dedicated to a specific task and cooperating with each other to achieve automated sample handling and analysis. Such functional units can include, for example, a sample input interface for receiving samples, a fluid system, at least one measurement unit or detection unit, a fluid supply unit, etc. One or more functional units can be integrated into a larger unit or module to simplify the operation of the IVD system.

[0039] According to one embodiment, at least one measurement unit is an optical detection unit that includes a cuvette disposed between a light source and a light detector such that the intensity of light in a portion of the spectrum transmitted or emitted by a specific substance, such as an analyte or calibration material present in a sample or calibration solution placed therein, can be measured. The optical detection unit can be embodied as a flow-through optical detection unit that includes a flow-through cuvette or a flow-through optical path such that fluids such as samples and calibration solutions and possibly other fluids (including, for example, air) can flow in and out.

[0040] According to one embodiment, the IVD system may alternatively or additionally include a "flow-through sensor path" as a measurement unit, which is a fluid conduit that includes one or more sensors (e.g., arranged in sequence along the path) with which a sample or calibration solution flowing through the sensor path may come into contact, such as sensors for each different parameter / analyte to be detected; and may be embodied in a replaceable cartridge-like structure that includes multiple sensors, which may be distributed across multiple sensor paths. Alternatively, the IVD system may include multiple measurement units, each having a sensor path that includes sensors dedicated to one parameter / analyte, and may or may not be replaceable. Thus, a sample or calibration solution may flow into one or more sensing paths, and different parameters / analytes may be determined by the respective sensors. The term "sensor" is generally used herein to denote a detector configured to detect a sample parameter by generating a related signal output that can be quantified and digitized. The sensor may be, for example, a biosensor, a chemical sensor, or a physical sensor. The sensor may be selective or specific with respect to a target sample parameter, or may be configured to detect and quantify multiple different target sample parameters. Depending on the type of sensor, the sensor may include multiple sensing elements. Thus, the term "sensing element" refers to a part of the sensor (e.g., a working electrode, a reference electrode, a counter electrode) that, in combination with one or more other sensing elements, forms a fully functional sensor. According to one embodiment, the flow-through sensor path includes any one or more of the following: a pO2 sensor, a pCO2 sensor, a pH sensor, one or more ion-selective electrode (ISE) sensors for determining electrolyte values (such as Na + , K + , Ca 2+ and Cl - ), and one or more metabolite sensors for determining parameters (such as lactate and glucose). The sensors may be, for example, based on amperometric principles, potentiometric principles, or conductometric principles, respectively.

[0041] The IVD system may further include at least one pump, such as a peristaltic pump, a syringe pump, a diaphragm pump, or any other suitable pump, for transporting fluids, including samples and calibration solutions, through the fluid system.

[0042] Since at least a part of the measurement unit and the fluid system is the same as at least a part of the measurement unit and the fluid system for transporting and measuring the calibration solution, this is the reason why a sample IVD test cannot be performed when the calibration procedure is being executed.

[0043] An IVD system may include a dedicated sample input interface for introducing a sample into the IVD system. The sample input interface may be arranged at a location accessible to an operator and configured to transfer the sample from a sample container lifted by the operator into the in vitro diagnostic system. The sample input interface may include, for example, a sample input port that includes: an outer input port side configured for coupling, attaching, connecting, positioning, introducing, or inserting a sample container (such as a capillary type or syringe type); and an inner input port side coupled or for coupling to one end of a sample input conduit that is fluidly connected or connectable to a measurement unit. The IVD system may include a fluid supply unit, such as a module or component of the IVD system, that: includes one or more fluid reservoirs that include a calibration solution and possibly other fluids such as quality control (QC) samples; and may also include one or more waste containers in which fluids circulated through the fluid system may be expended at the end of a process.

[0044] The term "controller" encompasses any physical or virtual processing device and, in particular, encompasses a programmable logic computer having a processor that runs a computer-readable program that is set with instructions to perform operations associated with a method of managing calibration according to any one of the disclosed embodiments. The controller may be integrated into the in vitro diagnostic system or be an independent logical entity that communicates with the in vitro diagnostic system. In some embodiments, the controller may be integrated with a data management unit, may consist of a server computer, and / or be distributed / shared across multiple in vitro diagnostic systems / between multiple in vitro diagnostic systems. The controller may also be configured to control the in vitro diagnostic system such that one or more workflows and one or more workflow steps are carried out by the in vitro diagnostic system. In particular, the controller may communicate and / or cooperate with a scheduler and / or a data manager and / or a user input interface and / or a sample input interface in order to consider incoming sample IVD test commands and / or received sample IVD test commands and a plurality of scheduled process operations associated with the execution of the sample IVD test commands in order to plan when to start and when to interrupt the execution of a calibration procedure and when to restart or resume the calibration procedure. In particular, the controller may be configured to perform any method step according to any of the above embodiments.

[0045] Other and further objects, features, and advantages will become apparent from the following description of exemplary embodiments and the accompanying drawings, which are used to explain the principles in more detail. Description of the Drawings

[0046] Figure 1 A table is shown of an arbitrarily selected general calibration solution used in a calibration procedure related to some sample IVD tests.

[0047] Figure 2 shows an example of a calibration cycle that includes performing a calibration procedure to determine test-specific calibration parameters by using different series of calibration solutions selected from Figure 1 among the calibration solutions.

[0048] Figure 3 shows a schematic example of performing a calibration cycle, where the repetition of the calibration procedure has been completed, and thus all test-specific calibration parameters used to evaluate glucose test results in this example can be updated.

[0049] Figure 4 is Figure 3 a variant of, where the repetition (solid line) of the calibration procedure has been interrupted, and thus only the glucose-specific calibration parameters can be partially updated.

[0050] Figure 5 shows another schematic example of performing a calibration cycle, where the repetition of the calibration procedure has been completed, and thus all test-specific calibration parameters used to evaluate Ca ++ test results in this example can be updated.

[0051] Figure 6 is Figure 5 a variant of, where the repetition of the calibration procedure has been interrupted, and thus only the Ca ++ -specific calibration parameters can be partially updated.

[0052] Figure 7 schematically shows sub-steps during the execution of a calibration procedure using a series of calibration solutions.

[0053] Figure 8 schematically shows a more comprehensive computer-implemented method for automatically managing the calibration of an IVD system, which includes Figures 1 to 7 aspects of.

[0054] Figure 9 schematically shows an IVD system for performing sample IVD tests, the IVD system including a controller configured to execute a method for managing calibration according to Figure 8 of.

[0055] Those skilled in the art should understand that the elements in the figures are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions of some elements in the figures may be enlarged relative to other elements, while other elements may have been omitted or shown in reduced numbers to enhance clarity and improve the understanding of aspects of the present disclosure. Detailed Description

[0056] Figure 1Shows a table for an arbitrarily selected general calibration solution, which includes calibration materials or standards with known values corresponding to different levels (usually indicated as "high", "medium", "low") of the analyte of interest that may be present in the sample, and can be used in one or more calibration procedures to determine test-specific calibration parameters for evaluating sample IVD test results, such as for determining the presence and quantity of the corresponding analyte in the sample. In this example, the analyte of interest or sample parameter related to the corresponding sample IVD test is an electrolyte that can be detected by an ion-selective electrode (ISE), such as Na + , K + , Cl - and Ca ++ ; and metabolites that can be detected by the corresponding metabolite sensor (MSS), such as glucose and lactate. The calibration solution may alternatively or additionally include other calibration materials or standards related to other analytes of interest or sample parameters, and depending on one or more specific sample IVD tests, the corresponding measurement principle, and the IVD system, including, for example, the dynamic range, sensitivity, etc., fewer or more calibration solutions may be used. Therefore, no specific values are given in this example.

[0057] ISE sensors typically operate according to the potentiometric measurement principle. They differ only due to different membrane materials that are sensitive to the corresponding electrolyte.

[0058] Glucose sensors typically use glucose oxidase, and glucose is oxidized by glucose oxidase with oxygen from the air to gluconolactone. The H2O2 formed in this process is measured amperometrically by a manganese dioxide / carbon electrode. Since the sensor replenishes the oxygen required for glucose oxidation in the enzymatic reaction, the measurement of the glucose value is independent of the oxygen concentration in the test sample.

[0059] Lactate sensors typically use lactate oxidase, and lactate is oxidized by this lactate oxidase with oxygen from the air to pyruvate. The H2O2 formed in this process is determined amperometrically in a manner similar to that of the glucose sensor.

[0060] Calibration solution A listed in the table is typically used and measured more frequently than other calibration solutions, for example, always as the first calibration solution and / or between different calibration solutions, and can also be used as a washing solution, for example, before and / or after introducing the sample.

[0061] Figure 2Shows examples of calibration cycles 10, 20, 30, which include performing calibration procedures 11, 21, 31 respectively to determine test-specific calibration parameters 12, 22, 32 for use in evaluating sample IVD test results, and repeating calibration procedures 11, 21, 31 to update test-specific calibration parameters 12, 22, 32 before the expiration of the corresponding calibration validity period, i.e., before starting new cycles 10, 20, 30, where different calibration procedures 11, 21, 31 have different calibration validity periods respectively, and where performing different calibration procedures 11, 21, 31 / cycles 10, 20, 30 includes using different series of calibration solutions selected from, for example Figure 1 different series of calibration solutions of the calibration solutions, the series including at least two different calibration solutions, such as 2, 4, and possibly more, such as 6 (not shown) or more. In particular, in this example, the series of calibration solutions includes a single pair A-B or multiple pairs A-B-A-C, A-B-A-D calibration solutions A, B, C, D, each pair A-B, A-C, A-D including a common calibration solution A as the first calibration solution and any other different calibration solutions B, C, D as the second or subsequent calibration solutions. Other combinations (not shown) are also possible, such as A-C, A-D, A-B-A-C-A-D, etc., and in general, depending on one or more specific sample IVD tests and the content of the calibration solutions, any combination with any number of calibration solutions is possible, not necessarily in pairs.

[0062] According to the specific calibration procedures 11, 21, 31 used and the corresponding series A-B, A-B-A-C, A-B-A-D of calibration solutions, the corresponding test-specific calibration parameters 12, 22, 32 can be determined. Exemplary test-specific calibration parameters 12, 22, 32 that can be determined with reference to the target analyte or sample parameters as indicated, for example, in Figure 1 and relative to the corresponding calibration lines or curves include slope (SL), offset (OS), linearity (LN), zero point (ZP) explained in more detail by way of example in Figures 3 to 6 . Each calibration parameter is indicated together with a subscript next to it, which refers to the corresponding target analyte or sample parameter. For simplicity, electrolytes Na + , K + , Cl - and Ca ++ are usually indicated under the same group of ISE. Metabolites glucose and lactate are usually indicated under the same group of MSS respectively. If not specified, the abbreviation CK (check) can refer to the calibration parameter OS or SL. It can also be noted that after using each calibration solution, a subset of the test-specific calibration parameters 12, 22, 32 can be determined.

[0063] In this example, performing cycle 10 includes performing calibration procedure 11, which includes using calibration solution AB once every 1.5 hours, meaning that the calibration validity period of calibration procedure 11 is 1.5 hours and a repetition of the calibration procedure must be performed before this calibration validity period expires. Performing calibration cycle 20 includes performing calibration procedure 21, which includes using calibration solution C once every 12 hours, meaning that the calibration validity period of calibration procedure 21 is 12 hours and a repetition of the calibration procedure must be performed before this calibration validity period expires. In particular, calibration procedure 21 includes using a pair of calibration solutions AC in combination with a pair of calibration solutions AB of calibration procedure 11 into a single calibration cycle 20. This is an example of two calibration procedures 11, 21, which have different calibration validity periods of 1.5 hours and 12 hours, respectively (however, they expire at the same time), and are therefore combined by adding the corresponding calibration solutions and / or pairs of calibration solutions to the same series. Similarly, executing calibration cycle 30 includes executing calibration procedure 31, which includes using calibration solution D once every 12 hours, meaning that the calibration validity period of calibration procedure 31 is 12 hours and the repetition of the calibration procedure must be performed before the expiration of this calibration validity period. In particular, calibration procedure 31 includes using a pair of calibration solutions AD in combination with a pair of calibration solutions AB of calibration procedure 11 into a single calibration cycle 30. This is another example of two calibration procedures 11 and 21, which have different calibration validity periods of 1.5 hours and 12 hours respectively (however, they expire at the same time), and are therefore combined by adding the corresponding calibration solutions and / or pairs of calibration solutions to the same series. On the other hand, both calibration procedures 21 and 31 have a calibration validity period of 12 hours, but because the calibration validity periods are staggered by a period of 6 hours, the calibration validity periods expire at different times.

[0064] Figure 3 and Figure 4 1 and 2 show a specific example of calculating the results of a calibration procedure, which is the process of constructing a line or curve or mathematical function that has the best fit to the measured calibration points. In this case, the calibration curve is a calibration curve for evaluating glucose test results, which can be performed by measuring calibration solutions A, B, and C. Figure 2 This is because the glucose calibration curve is a non-linear curve that requires the use of three levels of calibration solutions. Figure 3 and 4 The dashed curve in Figure 2At the start of loop 20 in, the calibration procedure using all three levels of calibration solutions A old, B old, and C old has been completed. The glucose test specific calibration parameters ZP, SL old, and LN old have been determined through this completed calibration procedure and need to be updated by repeating calibration procedure 21 before the calibration validity period expires, in order to determine the new glucose test specific calibration parameters ZP, SL new, and LN new, and update the old glucose test specific calibration parameters ZP, SL old, and LN old. Figure 3 The difference between Figure 4 and Figure 3 is that in Figure 4 , the repetition of calibration procedure 21 (solid curve) has been completed, and thus all three new glucose test specific calibration parameters ZP, SL new, and LN new can be determined. While in

[0065] Figure 5 and Figure 6 together show another specific example of calculating the results of the calibration procedure. In this case, the calibration curve is the calibration curve for evaluating the Ca ++ test results, and this test result can be determined by measuring calibration solutions A and D and performing the calibration procedure 31 in Figure 2 . This is because the Ca ++ calibration curve is linear, and thus using two levels of calibration solutions is sufficient. Figure 5 and 6 The dashed lines in Figure 2 relate to the completed calibration procedure using two levels of calibration solutions A old and D old at the start of loop 30 in ++ . Regarding the Ca ++ test specific calibration parameter OS old (not shown) and SL old for the previous loop 30 have been determined through this completed calibration procedure and need to be updated by repeating calibration procedure 31 before the calibration validity period expires, in order to determine the new Ca ++ test specific calibration parameters OS new and SL new, and update the old Ca Figure 5 The difference between Figure 6 and Figure 5 is that in ++ , the repetition of calibration procedure 31 (solid line) has been completed, and thus two new Ca Figure 6In [description], the repetition (solid line) of calibration procedure 31 has been interrupted after measuring A new, so it is impossible to determine the new slope (SL new) of the new line without measuring D new yet. However, OS new can be determined at least temporarily to update Ca ++ Test at least a part of the specific calibration parameters until the calibration procedure is restarted or resumed. At this time, continue to use SL old.

[0066] Figure 7 Another aspect of performing a calibration procedure for series 40 using calibration solutions is shown. Series 40 includes at least two different calibration solutions A, X, where X can be any calibration solution, such as B, C, D. Using calibration solutions A, X includes a first step of delivering calibration solutions A, X to the measurement unit, t:A, t:X respectively, and a second step of measuring calibration solutions A, X by the measurement unit, m:A, m:X respectively. In particular, each step t:A, t:X, m:A, m:X has the same duration, for example 30 seconds in this example, meaning that delivering and measuring the calibration solutions takes 60 seconds. This is just an example, and this example can be adjusted according to the specific IVD system and calibration solutions used.

[0067] Figure 8 A more comprehensive computer-implemented method for automatically managing the calibration of an IVD system is schematically shown. The method includes performing calibration cycles 10, 20, 30, which include performing calibration procedures 11, 21, 31 to determine test-specific calibration parameters 12, 22, 32 used in evaluating IVD test results (IVD TR) of samples, and repeating the calibration procedures to update the test-specific calibration parameters 12, 22, 32 before the expiration of the corresponding calibration validity periods 50. Different calibration procedures 11, 21, 31 / cycles 10, 20, 30 may have different calibration validity periods respectively, and performing different calibration procedures 11, 21, 31 / cycles 10, 20, 30 includes using different series 40 of calibration solutions A, X respectively. Series 40 includes at least two different calibration solutions A, X, and using calibration solutions A, X includes a first step of delivering the calibration solutions to the measurement unit, t:A, t:X, and a second step of measuring the calibration solutions by the measurement unit, m:A, m:X, as also Figure 7As shown. In particular, for each calibration cycle 10, 20, 30, the method includes: starting 41 the repetition of the calibration procedures 11, 21, 31 at the start 48 of the buffer time period 49, which is at the earliest 50 before the expiration of the corresponding calibration validity period; interrupting 42, 42', 42", 42'" the calibration procedures 11, 21, 31 upon receipt of a command 60 to perform a sample IVD test (spl); and restarting 43 or resuming 44 the calibration procedures 11, 21, 31 after performing the sample IVD test (spl), provided that the repetition of the calibration procedures 11, 21, 31 can be restarted 43 or resumed 44 within the buffer time period 49. Additionally, interrupting 42, 42', 42", 42'" the calibration procedures 11, 21, 31 includes different steps depending on whether the command 60 to perform the sample IVD test (spl) is received during the first calibration solution A or a subsequent calibration solution X in the series 40 using calibration solutions A, X, and whether the command is received during the first step t:A, t:X of delivering the first calibration solution or a subsequent calibration solution A, X to the measuring unit, respectively, or during the second step m:A, m:X of measuring the first calibration solution or a subsequent calibration solution A, X, respectively.

[0068] According to one embodiment, when the command 60 to perform a sample IVD test (spl) is received during the first step t:A of delivering the first calibration solution A in the series 40 and / or the first calibration solution A in a pair A, X to the measuring unit, interrupting 42 the calibration procedures 11, 21, 31 includes completing the first step t:A of delivering the first calibration solution A to the measuring unit and performing the measurement step m':A of the first calibration solution A with a reduced measurement time and aborting any subsequent steps (marked with a dotted cross) of the calibration procedures 11, 21, 31 in order to perform the sample IVD test (spl).

[0069] According to one embodiment, when the command 60 to perform a sample IVD test (spl) is received during the second step m:A of measuring the first calibration solution A in the series 40 and / or the first calibration solution A in a pair A, X, interrupting 42' the calibration procedures includes completing the second step m:A of measuring the first calibration solution A and aborting any subsequent steps (marked with a dotted cross) of the calibration procedures in order to perform the sample IVD test (spl).

[0070] According to one embodiment, when the command 60 to perform a sample IVD test (spl) is received during the first step t:X of delivering the subsequent calibration solution X in the series 40 and / or the subsequent calibration solution X in the pair A, X to the measuring unit, the interrupted 42” calibration procedures 11, 21, 31 include aborting the first step t:X of delivering the subsequent calibration solution X to the measuring unit and any subsequent steps of the calibration procedures 11, 21, 31 (marked with a dashed cross) in order to perform the sample IVD test (spl). The method further includes performing a washing step (washing) before performing the sample IVD test (spl), the washing step (washing) having a duration shorter than that of any interrupted step. In particular, the method may include performing the washing step (washing) with the first calibration solution A before performing the sample IVD test (spl). The method may further include performing a measurement step m':A of the first calibration solution A with a reduced measurement time before performing the sample IVD test spl.

[0071] According to one embodiment, when the command 60 to perform a sample IVD test (spl) is received during the second step m:X of measuring the subsequent calibration solution X in the series 40 and / or the subsequent calibration solution X in the pair A, X, the interrupted 42”' calibration procedures 11, 21, 31 include completing the second step m:X of measuring the subsequent calibration solution X and aborting any subsequent steps of the calibration procedures 11, 21, 31 (marked with a dashed cross) in order to perform the sample IVD test (spl). The method further includes performing a washing step (washing) before performing the sample IVD test (spl), the washing step (washing) having a duration shorter than that of any interrupted step. In particular, the method may include performing the washing step (washing) with the first calibration solution A before performing the sample IVD test (spl). The method may further include performing a measurement step m':A of the first calibration solution A with a reduced measurement time before performing the sample IVD test spl.

[0072] Continuing to refer to Figure 8 , the method further includes updating at least a part of the test-specific calibration parameters 12, 22, 32 after the measurement of the first calibration solution A or the completed measurement of the pair of calibration solutions A, X.

[0073] In addition, after performing the sample IVD test (spl), the method includes restarting (43) the calibration procedures 11, 21, 31 for the calibration procedures that use a single pair of calibration solutions A, X or that are interrupted 42, 42', 42” during the use of the first pair of calibration solutions A, X, and resuming 44 the interrupted calibration procedures 11, 21, 31 starting from the pair of calibration solutions where the measurement was interrupted or aborted 42”' for the calibration procedures that use multiple pairs of calibration solutions.

[0074] In addition, restarting 43 or resuming 44 the calibration procedures 11, 21, 31 includes waiting for a predefined time 47 after performing a sample IVD test (spl), provided that the restarting 43 or resuming 44 of the calibration procedures can be repeated within a buffer time period 49.

[0075] Figure 9 An IVD system 200 for performing a sample IVD test is schematically shown. The IVD system includes at least one measurement unit 210, a fluid system 213 for delivering at least calibration solutions A, B, C, D and a sample 2 to the at least one measurement unit 210, and a controller 250 that runs a computer-readable program that is set with instructions to perform operations associated with a method of managing calibration according to any of the above embodiments.

[0076] The measurement unit 210 includes a flow-through sensor path 211 that includes a plurality of sensors 212, such as ISE sensors and metabolite sensors. The IVD system 200 further includes a pump 240 (such as a peristaltic pump) located downstream of the fluid system 213, a fluid supply unit 220 that includes a plurality of fluids (including calibration solutions A, B, C, D), and a waste container 224 in which the fluid circulated through the fluid system 213 can be processed by the action of the pump 240. The IVD system 200 further includes a fluid selection valve 230 for selecting between fluids A, B, C, D and / or air 232.

[0077] The IVD system 200 further includes a sample input interface 201 that includes a sample input port 10. The sample input port includes an outer input port side 11 configured to insert an open end of a sample container 1 and an inner input port side 12. The sample input interface 201 further includes a suction needle 30 that includes an upstream end 31 and a downstream end 32. The downstream end 32 of the suction needle 30 is fluidly connected to the fluid system 213, while the upstream end 31 is configured to alternately couple to the inner input port side 12 in order to aspirate a sample 2 from a sample container 1 inserted into the outer input port side 11 and aspirate it into a fluid supply unit port 40 that is fluidly connected to a common outlet port 231 of the fluid selection valve 230. However, the fluid system 213 can be directly connected to the outlet port 231 of the fluid selection valve 230, and the sample can be introduced via, for example, a different fluid line that is separately connected to the fluid selection valve 230.

[0078] Based on the above description, modifications and variations of the disclosed aspects are of course feasible. Therefore, it should be understood that within the scope of the appended claims, the present invention can be practiced in a manner different from that specifically designed in the above examples.

[0079] In particular, it should be understood that at least some of the figures or parts are schematic and are provided only as examples. Additionally, the relationships between elements may be different from those shown, and parts that are not relevant to the purpose of the present disclosure have been omitted.

[0080] Furthermore, throughout this specification, reference to "an aspect", "aspects", "an example" or "examples", "an embodiment" or "embodiments" means that a particular feature, structure, or characteristic described in connection with that aspect or example or embodiment is included in at least one aspect, example, or embodiment. Thus, the phrases "in an aspect", "in an aspect", "an example" or "examples", "an embodiment" or "embodiments" that appear throughout this specification do not necessarily all refer to the same aspect or example or embodiment.

[0081] In addition, particular features, structures, or characteristics may be combined in any suitable combination and / or sub - combination in one or more aspects or examples or embodiments.

Claims

1. A computer-implemented method for automatically managing calibration of an in vitro diagnostic (IVD) system (200), the method comprising: A calibration cycle (10, 20, 30) is performed, the calibration cycle (10, 20, 30) comprising performing a calibration procedure (11, 21, 31) to determine test-specific calibration parameters (12, 22, 32) used in evaluating sample IVD test results, and repeating the calibration procedure (11, 21, 31) to update the test-specific calibration parameters (12, 22, 32) before the corresponding calibration validity period expires (50), wherein different calibration procedures (11, 21, 31) / cycles (10, 20, 30) may have different different calibration validity periods, and wherein performing different calibration procedures (11, 21, 31) / cycles (10, 20, 30) comprises using different series (40) of calibration solutions (A, X), the series comprising at least two different calibration solutions (A, X), and wherein using the calibration solutions (A, X) comprises a first step (t:A, t:X) of conveying the calibration solutions (A, X) to a measuring unit (210) and a second step (m:A, m:X) of measuring the calibration solutions (A, X) by means of the measuring unit (210), wherein for each calibration cycle (10, 20, 30), the method comprises - starting (41) the repetition of the calibration procedure (11, 21, 31) at the earliest at the beginning (48) of a buffer time period (49) before the expiration (50) of the corresponding calibration validity period, - upon receiving a command (60) to perform a sample IVD test (spl), interruption (42, 42', 42", 42"') of the calibration procedure (11, 21, 31), and restarting (43) or resuming (44) the calibration procedure (11, 21, 31) after performing the sample IVD test (spl), as long as the repetition of the calibration procedure (11, 21, 31) can be restarted (43) or resumed (44) within the buffer time period (49), wherein The calibration procedure (11, 21, 31) comprises different steps depending on whether the command (60) to perform a sample IVD test (spl) is received during a first calibration solution (A) or a subsequent calibration solution (X) in a series (40) of using calibration solutions (A, X) and whether the command is received during the first step (t:A, t:X) of delivering the first calibration solution or the subsequent calibration solution (A, X) to the measuring unit (210) or the second step (m:A, m:X) of measuring the first calibration solution or the subsequent calibration solution (A, X).

2. The method according to claim 1, wherein the series (40) of calibration solutions (A, X) comprises a single or multiple pairs of calibration solutions (A, X), each pair comprising a common calibration solution (A) as a first calibration solution and any other different calibration solution (X, B, C, D) as said subsequent calibration solution.

3. The method according to claim 1 or 2, wherein when the command (60) to perform a sample IVD test (spl) is received during the first step (t:A) of delivering the first calibration solution (A) in a series (40) and / or the first calibration solution (A) in a pair to the measuring unit (210), interrupting (42) the calibration procedure (11, 21, 31) comprises completing the first step (t:A) of delivering the first calibration solution (A) to the measuring unit (210) and performing a measurement step (m':A) of the first calibration solution (A) with a reduced measurement time and aborting any subsequent steps of the calibration procedure (11, 21, 31) in order to perform the sample IVD test (spl).

4. The method according to claim 1 or 2, wherein when the command (60) to perform a sample IVD test (spl) is received during the second step (m:A) of measuring the first calibration solution (A) in a series (40) and / or the first calibration solution (A) in a pair, interrupting (42') the calibration procedure (11, 21, 31) comprises completing the second step (m:A) of measuring the first calibration solution (A) and aborting any subsequent steps of the calibration procedure (11, 21, 31) in order to perform the sample IVD test (spl).

5. The method according to claim 1 or 2, wherein when the command (60) to perform a sample IVD test (spl) is received during the first step (t:X) of delivering a subsequent calibration solution (X) in a series (40) and / or the subsequent calibration solution (X) in a pair to the measurement unit (210), interrupting (42") the calibration procedure (11, 21, 31) comprises aborting the first step (t:X) of delivering the subsequent calibration solution (X) to the measurement unit (210) and any subsequent steps of the calibration procedure (11, 21, 31) in order to perform the sample IVD test (spl).

6. A method according to claim 1 or 2, wherein when the command (60) to perform a sample IVD test (spl) is received during the second step (m:X) of measuring a subsequent calibration solution (X) in a series (40) and / or the subsequent calibration solution (X) in a pair, interrupting (42'") the calibration procedure (11, 21, 31) comprises completing the second step (m:X) of measuring the subsequent calibration solution (X) and aborting any subsequent steps of the calibration procedure (11, 21, 31) in order to perform the sample IVD test (spl).

7. The method according to claim 5 or 6, comprising performing a washing step with the first calibration solution (A) before performing the sample IVD test (spl).

8. The method according to claim 7, comprising performing a measurement step (m': A) of the first calibration solution (A) with a reduced measurement time before performing the sample IVD test (spl).

9. Method according to any one of claims 3 to 8, comprising updating at least a part of the test-specific calibration parameters (12, 22, 32) after the measurement of the first calibration solution (A) or a completed measurement of a pair of calibration solutions (A, X).

10. The method according to any one of claims 2 to 9, wherein after performing the sample IVD test (spl), the method comprises, for a calibration procedure (11) using a single pair of calibration solutions (A, X) or interrupted (42, 42', 42") when using a first pair of calibration solutions (A, X), restarting (43) the calibration procedure (11, 21, 31), and for a calibration procedure (21, 31) using multiple pairs of calibration solutions (A, X), resuming (44) an interrupted (42'") calibration procedure (11, 21, 31) starting from the pair of calibration solutions at which the measurement was interrupted or aborted.

11. A method according to any of the preceding claims, wherein restarting (43) or resuming (44) the calibration procedure (11, 21, 31) comprises waiting for a predefined time (47) after performing the sample IVD test, as long as it is possible to restart (43) or resume (44) a repetition of the calibration procedure (11, 21, 31) within the buffer time period (49).

12. Method according to any of the preceding claims, comprising combining different calibration procedures (11, 21, 31) into a single calibration cycle (20, 30) by adding corresponding calibration solutions and / or pairs of calibration solutions to the same series (40), if the different calibration procedures (11, 21, 31) have in common the same or similar calibration validity periods and / or if the respective validity periods have the same expiry time.

13. An in vitro diagnostic (IVD) system (200) for performing a sample IVD test (spl), the IVD system comprising at least one measuring unit (210), a fluid system (213) for conveying at least calibration solutions (A, B, C, D) and a sample (2) to the at least one measuring unit (210), and a controller (250), the controller running a computer readable program provided with instructions for performing operations associated with the method for managing calibration according to any one of claims 1 to 12.

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