Method for operating in-vitro diagnosis examination room control software module by simulated in-vitro diagnosis examination room instrument and the like

Abstract

To provide a method for simulating an in-vitro diagnosis IVD examination room system including an IVD examination room instrument and an IVD examination room control software module.SOLUTION: A method for simulating includes the steps of: simulating sample processing within an IVD examination instrument using a virtual IVD examination room instrument (5), using sample processing data (SPD) to be provided by an IVD examination room control software module (3); operating the IVD examination room control software module just like being in action in an IVD examination room system, that is, operating the IVD examination room control software module in which the sample processing data (SPD) intended to be exchanged between the IVD examination room control software module and the IVD examination room instrument is, instead, exchanged between the IVD examination room control software module and the virtual IVD examination room instrument.SELECTED DRAWING: Figure 7

Description

Technical Field

[0001] The present invention relates to the field of in vitro diagnostic ("IVD") laboratory systems for processing biological samples.

Background Art

[0002] IVD tests have a major impact on medical decisions and provide extremely important information to physicians. IVD tests are often performed by a special IVD laboratory system equipped with one or more IVD laboratory instruments for processing biological samples. Within the IVD laboratory instruments, the samples typically undergo complex sample processing, for example, a number of individual processing steps are performed on individual samples by a plurality of IVD laboratory instruments. The design of IVD laboratory instruments is a complex problem that must consider a number of parameters, and it is a complex task to provide a design of IVD laboratory instruments that can not only meet the desired requirements but also operate efficiently.

[0003] In many IVD laboratory systems, an IVD laboratory control software module is used to control sample processing within the IVD laboratory instruments by, for example, indicating when, in what order, and by which IVD laboratory instruments which tests should be performed. Such IVD laboratory control software modules are highly specialized and usually need to be complexly adapted to the needs of individual IVD laboratory systems. The installation (including configuration, adaptation to the IVD laboratory instruments, and / or verification) of the IVD laboratory control software module at the installation site of the IVD laboratory instruments often requires a significant amount of time, for example, several months, during which the IVD laboratory instruments cannot be used for IVD tests (or at least cannot be fully used), resulting in commercial losses and in some cases even leading to a shortage of IVD capabilities.

Summary of the Invention

[0004] The object of the present invention is to provide methods and systems that extend current state-of-the-art technology. To this end, methods and systems according to the independent claims are proposed, and specific embodiments of the present invention are described in the dependent claims.

[0005] A method for simulating an in vitro diagnostic IVD laboratory system for processing biological samples, wherein the IVD laboratory system is An IVD laboratory apparatus comprising one or more IVD laboratory instruments for processing samples, An IVD laboratory control software module controls sample processing within IVD laboratory equipment and exchanges sample processing data between the IVD laboratory control software module and the IVD laboratory equipment. Equipped with, The IVD laboratory system Designed for sample processing within IVD laboratory equipment using sample processing data provided by the IVD laboratory control software module, The method is The steps include: simulating sample processing within IVD laboratory equipment using virtual IVD laboratory equipment that uses sample processing data provided by an IVD laboratory control software module; A step of operating an IVD laboratory control software module as if it were operating within an IVD laboratory system, wherein sample processing data intended to be exchanged between the IVD laboratory control software module and IVD laboratory equipment is instead exchanged between the IVD laboratory control software module and virtual IVD laboratory equipment. A method including this is proposed.

[0006] According to some embodiments, the sample processing data includes test orders, processing queries, processing orders, test results, transport queries, transport orders, equipment status, workflow instructions, and / or positioning information.

[0007] According to some embodiments, this method Receiving a virtual sample and receiving a test order for the virtual sample, To simulate virtual IVD laboratory equipment or the receipt of virtual samples by such virtual IVD laboratory equipment, Sending processing queries for virtual samples from virtual IVD laboratory equipment or said virtual IVD laboratory equipment to the IVD laboratory control software module, For example, after receiving a processing query, the IVD laboratory control software module sends a processing order for the virtual sample generated using the test order for this virtual sample to the virtual IVD laboratory equipment or the virtual IVD laboratory equipment. For example, by transmitting the created and / or received test results from virtual IVD laboratory equipment or the virtual IVD laboratory equipment to the IVD laboratory control software module, sample processing is simulated in the form of a sample test according to the test order of the virtual IVD laboratory equipment or the virtual IVD laboratory equipment, For example, the test results are transmitted with a time gap from the start of the sample test simulation, and the time gap indicates the time required for the IVD laboratory equipment or the IVD laboratory equipment to perform this sample test, simulating sample processing. The received test results are evaluated by the IVD laboratory control software module, Sending transport queries for virtual samples from virtual IVD laboratory equipment or the virtual IVD laboratory equipment to the IVD laboratory control software module, For example, after receiving a transport query, a transport order for a virtual sample is sent from the IVD laboratory control software module to the virtual IVD laboratory equipment or to the virtual IVD laboratory equipment. For example, simulating the transport of virtual samples within virtual IVD laboratory equipment according to transport orders, and / or Transmitting positioning information from virtual IVD laboratory equipment or said virtual IVD laboratory equipment to an IVD laboratory control software module, wherein the positioning information transmitted relates to the current simulated position of the virtual IVD laboratory equipment or a virtual sample within said virtual IVD laboratory equipment. Includes.

[0008] According to some embodiments, the method includes exchanging quality control data between an IVD laboratory control software module and virtual IVD laboratory equipment.

[0009] According to some embodiments, the method includes simulating sample processing by staff within an IVD laboratory system.

[0010] According to some embodiments, the virtual IVD laboratory equipment comprises exactly one virtual IVD laboratory equipment for each IVD laboratory equipment in the IVD laboratory system to be simulated.

[0011] According to some specific embodiments, each virtual IVD laboratory device simulates the operational behavior of the respective IVD laboratory device. According to some specific embodiments, each virtual IVD laboratory device simulates the communication behavior of the respective IVD laboratory device.

[0012] According to some embodiments, the method includes simulating a sample processed as a virtual sample in an IVD laboratory system.

[0013] According to some embodiments, the method includes displaying a visualization of virtual samples along with a visualization of virtual IVD laboratory equipment.

[0014] According to some embodiments, virtual IVD laboratory equipment is displayed as a schematic representation corresponding to the IVD laboratory equipment to be simulated.

[0015] According to some embodiments, each virtual sample is displayed at a position within a schematic representation corresponding to the position of the corresponding sample to be simulated at that time.

[0016] According to some embodiments, the design of the virtual IVD laboratory equipment is created using a design file.

[0017] According to some embodiments, the design of the virtual IVD laboratory equipment is created using a list of IVD laboratory equipment defined in an IVD laboratory control software module.

[0018] According to some embodiments, the design of the virtual IVD laboratory equipment is created using a graphical user interface.

[0019] According to some specific embodiments, the method includes using a graphical user interface including a schematic representation of the visualization of the details of the design of the virtual IVD laboratory equipment.

[0020] According to some embodiments, simulating sample processing within the IVD laboratory equipment, and operating the IVD laboratory control software module are both executed in real time.

[0021] According to some embodiments, the method simulates sample processing within the IVD laboratory equipment at the simulation time, operates the IVD laboratory control software module in real time, compares the time elapsed at the simulation time with real time, and: if the simulation time is behind real time, increasing the speed of the simulation time, If the simulation time is ahead of real time, you can either slow down the simulation time or Maintain the speed of the simulation time if the simulation time is at least quasi-identical to real time. Includes.

[0022] According to some embodiments, the IVD laboratory control software module is connected to a data management system for exchanging sample-related information with the IVD laboratory control software module. The method is, To exchange sample-related information between the IVD laboratory control software module and the data management system. Includes.

[0023] According to some embodiments, this method To simulate a virtual data management system configured to exchange sample-related information with an IVD laboratory control software module, Exchange of sample-related information between the IVD laboratory control software module and the virtual data management system. Includes.

[0024] According to some specific embodiments, this method The IVD laboratory control software module receives first data from a virtual data management system or virtual IVD laboratory equipment, wherein the first data includes an instruction that a sample has arrived at the IVD laboratory equipment, thereby receiving a virtual sample. The IVD laboratory control software module receives second data from a virtual data management system, the second data includes a test order for a sample, and thereby receives a test order for a virtual sample; To simulate sample processing of this virtual sample according to the test order using virtual IVD laboratory equipment and Includes.

[0025] A method for designing an IVD laboratory control software module using one of the proposed simulation methods, wherein the design method is as follows: Step 0: A step of providing the design of the IVD laboratory control software module, Step 1: Steps to execute the method for simulation, Step 2: The step of changing one or more parameters of the IVD laboratory control software module design, Step 3: The steps to perform Step 1, Step 4: Optionally, repeat Steps 2 and 3. A method including this is proposed.

[0026] A method for designing IVD laboratory equipment using one of the proposed simulation methods, wherein the design method is performed in the following order: Step 0: A step of providing the design of IVD laboratory equipment, Step 1: Steps to execute the method for simulation, Step 2: The step of changing one or more parameters of the design of IVD laboratory equipment, Step 3: The steps to perform Step 1, Step 4: Optionally, repeat Steps 2 and 3. A method including this is proposed.

[0027] A method for designing an IVD laboratory system using one of the proposed simulation methods, wherein the design method is performed in the following order: Step 0: A step of providing the design of the IVD laboratory control software module and the design of the IVD laboratory equipment, Step 1: Steps to execute the method for simulation, Step 2: A step of modifying one or more parameters of the design of the IVD laboratory control software module and / or the design of the IVD laboratory equipment, Step 3: The steps to perform Step 1, Step 4: Optionally, repeat Steps 2 and 3. A method including this is proposed.

[0028] According to some embodiments, step 1 of the proposed method having step 1 may include benchmarking the performance of an IVD laboratory control software module or IVD laboratory equipment.

[0029] A method is proposed for testing the IVD laboratory control software module using one of the proposed simulation methods.

[0030] A method for testing IVD laboratory equipment is proposed using one of the proposed simulation methods.

[0031] A method is proposed for testing an IVD laboratory system using one of the proposed simulation methods.

[0032] A method is proposed to test the operation of an IVD laboratory system by staff using one of the proposed simulation methods.

[0033] A method is proposed for training staff to work in an IVD laboratory system using one of the proposed simulation methods.

[0034] A method for designing virtual IVD laboratory equipment to simulate IVD laboratory equipment for one of the proposed simulation methods, Recording and / or defining data files received and / or transmitted by IVD laboratory equipment, and / or Recording and / or defining the time gap between receiving and / or transmitting data files by IVD laboratory equipment, To create content and / or to define the timing of data file transmission by virtual IVD laboratory equipment, recorded or defined data files and / or recorded or defined time gaps are used. A method including this is proposed.

[0035] A system for simulating an IVD laboratory system for processing biological samples, IVD laboratory equipment comprising one or more IVD laboratory devices for processing biological samples, An IVD laboratory control software module controls sample processing within IVD laboratory equipment and exchanges sample processing data between the IVD laboratory control software module and the IVD laboratory equipment. Equipped with, The IVD laboratory system Designed for sample processing within IVD laboratory equipment using sample processing data provided by the IVD laboratory control software module, The system IVD laboratory control software module, A simulation software module equipped with virtual IVD laboratory equipment for simulating sample processing within IVD laboratory equipment, and Equipped with, The system The IVD laboratory control software module is operated as if it were operating within an IVD laboratory system, and the IVD laboratory control software module is configured to operate in such a way that sample processing data intended to be exchanged between the IVD laboratory control software module and IVD laboratory equipment is instead exchanged between the IVD laboratory control software module and virtual IVD laboratory equipment. Virtual IVD laboratory equipment, A system is proposed that is configured to simulate sample processing within IVD laboratory equipment using sample processing data provided by an IVD laboratory control software module.

[0036] According to some embodiments, the IVD laboratory control software module includes a first communication module having at least one driver for converting the data format of data files.

[0037] According to some embodiments, the simulation software module includes a second communication module which has at least one driver for converting the data format of the data file.

[0038] According to some embodiments, the first communication module and the second communication module each include at least one joint driver.

[0039] According to some embodiments, the operation of a first communication module is mirrored by a second communication module. [Brief explanation of the drawing]

[0040] Specific embodiments of the present invention are described below with reference to the drawings, and are intended to illustrate, and not limit, specific embodiments of the present invention. In the drawings,

[0041] [Figure 1] This shows the IVD laboratory system. [Figure 2] This shows the operating scheme of the IVD laboratory system. [Figure 3] This shows the operating scheme of the IVD laboratory system. [Figure 4] This shows the operational scheme of the IVD laboratory system simulation. [Figure 5] This shows the operational scheme of the IVD laboratory system simulation. [Figure 6] This shows the operational scheme of the IVD laboratory system simulation. [Figure 7] This shows the operational scheme of the IVD laboratory system simulation. [Figure 8] This shows the operational scheme of the IVD laboratory system simulation. [Figure 9] This shows the operational scheme of the IVD laboratory system simulation. [Figure 10] This shows the operational scheme of the IVD laboratory system simulation. [Figure 11] This shows the operational scheme of the IVD laboratory system simulation. [Figure 12] This shows a scheme for exchanging sample processing data in an IVD laboratory system. [Figure 13] This shows a scheme for exchanging sample processing data in a simulation of an IVD laboratory system. [Figure 14a] This shows a visualization of a simulated IVD laboratory. [Figure 14b] This shows a visualization of a simulated IVD laboratory. [Figure 15] This shows possible use cases for the proposed method / system. [Modes for carrying out the invention]

[0042] Figure 1 shows an example of in vitro diagnostics of laboratory system 10, abbreviated herein as "IVD," for processing biological samples.

[0043] A biological sample may include, for example, biological material taken from the human or animal body. A biological sample may also include body fluids, such as blood, interstitial fluid, urine, saliva, or other types of body fluids. For simplicity, in this specification, a biological sample will typically be referred to simply as a “sample.”

[0044] A sample may potentially contain at least one analyte of interest, such as a molecule, ion, protein, metabolite, or pathogen. Typically, detecting the presence and / or concentration of one or more analytes in a sample is one of the tasks of an IVD test. More generally, an IVD test can refer to determining the biological characteristics of a sample. An IVD test may include performing at least one analytical test on the sample, which may allow conclusions to be drawn regarding the biological characteristics of the sample. The analytical test may include, for example, the addition of a reagent to the sample, a possible detectable reaction between the sample and the reagent, and / or the detection or non-detection of this reaction. Detection of a reaction may include measuring physical values ​​of the sample (or a complex obtained by using the sample, such as a sample-reagent mixture), such as the spectrum and / or intensity of radiation reflected by and / or transmitted through the sample (or a complex obtained by using the sample).

[0045] Processing a sample may include, for example, transporting the sample (typically in an IVD container such as an IVD tube; the IVD container may be held in an IVD container holder such as an IVD tube rack), performing pre-analysis steps on the sample (e.g., preparation steps such as centrifugation), performing analysis steps on the sample (e.g., adding reagents to the sample and measuring the reaction between the sample and the reagents), and / or performing post-analysis steps on the sample (e.g., storing the sample in a refrigerator for later use).

[0046] IVD laboratory equipment 2 comprises one or more IVD laboratory instruments 20 designed to process a sample, for example, by performing one or more steps of an intended workflow on the sample. Sample processing may include one or more physical processing steps (e.g., transfer, mixing, heating, etc.). IVD laboratory equipment 20 may include instrument hardware for processing the sample (e.g., grippers, reagent storage units, pipetting devices, heating elements, etc.), as well as instrument software designed to operate the instrument hardware. IVD laboratory equipment 20 may include a control unit designed to control, in particular, the operation of the instrument hardware, and the instrument software may be designed to run using the control unit.

[0047] IVD laboratory instruments 20 are typically classified according to the different types of sample processing steps they can perform. Transport IVD laboratory instruments 20trans are designed to transport samples (or IVD containers and / or their respective holders) from one IVD laboratory instrument to another. Pre-analysis IVD laboratory instruments 20pre are designed to perform pre-analysis steps on samples. Analytical IVD laboratory instruments 20ana are designed to perform analytical steps (such as analytical tests) on samples. Analytical IVD laboratory instruments 20ana may include digital analytical IVD laboratory instruments designed to perform analytical calculation steps (e.g., medical algorithms). Post-analysis IVD laboratory instruments 20post are designed to perform post-analysis steps on samples. Some IVD laboratory instruments 20 can perform multiple types of sample processing steps, such as pre-analysis steps and analytical steps. In the example shown in Figure 1, the IVD laboratory equipment 2 comprises two pre-analysis IVD laboratory devices 20pre, five analysis IVD laboratory devices 20ana, one post-analysis IVD laboratory device 20post, and one transport IVD laboratory device 20trans. The IVD laboratory equipment 2 shown in Figure 1 is designed so that one transport IVD laboratory device 20trans interconnects all the other IVD laboratory devices 20. The IVD laboratory system 10 may further include an IVD laboratory control software module 3 designed to control sample processing within the IVD laboratory equipment 2, for example, The IVD laboratory control software module 3 is designed to exchange sample processing data (SPD) between the IVD laboratory control software module 3 and the IVD laboratory equipment 2. The IVD laboratory system 10 is designed to process samples within the IVD laboratory equipment 2 using sample processing data SPD provided by the IVD laboratory control software module 3.

[0048] Controlling sample processing may include guiding sample processing (e.g., commanding a workflow for sample processing or each step of a workflow) and / or monitoring sample processing (e.g., receiving and processing data related to sample processing). Monitoring may influence guidance (e.g., if IVD laboratory control software module 3 determines that an analytical test is invalid, IVD laboratory control software module 3 may initiate a re-execution of the test).

[0049] Controlling sample processing within IVD laboratory equipment 2 may include, for example, issuing commands to IVD laboratory equipment 2, managing the status of IVD laboratory equipment 2, tracking the (current) location of the sample, tracking the processing steps (currently) applied to the sample, and receiving and, if applicable, verifying test results. Sample processing data (SPD) can be used to control sample processing within IVD laboratory equipment 2, for example, by enabling communication between IVD laboratory control software module 3 and IVD laboratory equipment 2 using the sample processing data (SPD), and / or by using the sample processing data (SPD) to determine parameters used for adjustment, such as states and / or values ​​used for verification.

[0050] According to some embodiments, the IVD laboratory control software module 3 is designed to make decisions in the context of sample processing, such as which processing steps should be performed by which IVD laboratory equipment 20, and / or whether the test results are considered valid.

[0051] According to some embodiments, the IVD laboratory control software module 3 is designed to guide sample processing within the IVD laboratory equipment 2 by transmitting sample processing data SPDs to the IVD laboratory equipment 2, which can, for example, indicate the sample workflow and / or indicate which processing steps of the sample the IVD laboratory equipment 20 should perform.

[0052] According to some embodiments, the IVD laboratory control software module 3 is designed to monitor sample processing within the IVD laboratory equipment 2 by receiving sample processing data SPD from the IVD laboratory equipment 2, which can indicate, for example, the location of a specific sample within the IVD laboratory equipment 2 and / or the results of an analytical test performed by the analytical IVD laboratory equipment 20ana.

[0053] According to some embodiments, the IVD laboratory control software module 3 is designed to control sample processing between IVD laboratory instruments 20, for example, so that a particular analytical IVD laboratory instrument 20ana performs a particular analytical test, and each IVD laboratory instrument 20 is designed to control the details of sample processing within the IVD laboratory instrument 20 itself, for example, the individual workflow steps of an analytical test within an analytical IVD laboratory instrument 20ana are managed by the analytical IVD laboratory instrument 20ana itself.

[0054] According to some embodiments, the IVD laboratory control software module 3 is designed to control the processing of one or more samples based on test orders for the samples. Test orders can be received by the IVD laboratory control software module 3, for example, from a data management unit 6 or via input using a user interface. The IVD laboratory control software module 3 may include, for example, a communication module that can be designed to receive test orders corresponding to samples. Test orders may indicate processing steps (such as analytical measurements) to be performed for each sample.

[0055] According to some embodiments, the IVD laboratory system 10 may include a data management unit 6 such as a laboratory information system ("LIS") or hospital information system ("HIS"). The data management unit 6 may be designed to input, store, organize, and / or access data, sample-related information SRI such as test orders, test results, and / or patient data. The data management unit 6 may include one or more interfaces for interacting with data consumers, data creators, and / or IVD laboratory control software modules 3. According to some embodiments, the data management unit 6 is provided for the hospital and / or laboratory It is intended to be accessed by staff and is used to manage medically relevant data in the hospital or laboratory. The data management unit 6 may be connected to the IVD laboratory control software module 3 (for example, via a communication network 7 as shown in the example in Figure 1) to exchange sample-related information (SRI), for example. The data management unit 6 may be designed to transmit test orders and / or personal data relating to samples being processed to the IVD laboratory control software module 3. The IVD laboratory control software module 3 may be designed to transmit test results relating to test orders to the data management unit 6.

[0056] According to some embodiments, (e.g., hospital and / or laboratory) staff (e.g., nurses, doctors, etc.) can use a data management unit 6 for managing medically relevant data, including sample-related information (SRI). Staff can input sample-related information (SRI), such as test orders, into the data management unit 6. The data management unit 6 can be connected to an IVD laboratory control software module 3 and can transmit sample-related information (SRI), such as test orders, to the IVD laboratory control software module 3. The IVD laboratory control software module 3 can guide IVD laboratory equipment 2 to execute test orders by using sample processing data (SPD), part of which can be created using sample-related information (SRI), for example. The IVD laboratory control software module 3 can receive test results related to test orders from the IVD laboratory equipment 2. The IVD laboratory control software module 3 can transmit sample-related information (SRI), such as test results, to the data management unit 6, and / or staff can access the test results via the data management unit 6.

[0057] According to some embodiments, the IVD laboratory control software module 3 is designed to function as an intermediate between a data management unit 6, such as an HIS and / or LIS, on one side and IVD laboratory equipment 2 on the other side. In this case, the IVD laboratory control software module 3 is sometimes referred to as IVD laboratory middleware.

[0058] According to some embodiments, the IVD laboratory control software module 3 is designed to be executed by a control unit, for example, a control unit of the IVD laboratory system 10 (e.g., a control unit for its individual IVD laboratory equipment 20). The control unit can be implemented using, for example, a PC, a server, and / or a cloud solution. An example in Figure 1 shows the IVD laboratory control software module 3 included in the control unit 32 of the IVD laboratory system 10.

[0059] According to some embodiments, the IVD laboratory control software module 3 includes one or more computer programs designed to be executed by one or more processing units (e.g., control units).

[0060] According to some embodiments, the IVD laboratory control software module 3 can be embodied as a programmable logic controller that executes a computer-readable program containing instructions for performing actions.

[0061] IVD laboratory control software module 3 is typically a highly specialized and complex software product, such as Roche Diagnostics' cobas® infinity laboratory solution, available as of October 1, 2021.

[0062] Figure 2 shows a possible schema for operating the IVD laboratory system 10. The IVD laboratory control software module 3 communicates with the IVD laboratory equipment 2 by exchanging sample processing data SPD, thereby controlling sample processing within the IVD laboratory equipment 2. The IVD laboratory equipment 2 may comprise, for example, multiple IVD laboratory devices 20 of various types for performing various steps of sample processing based on the sample processing data SPD provided by the IVD laboratory control software module 3. The IVD laboratory control software module 3 may, for example, provide the IVD laboratory equipment 2 with sample processing data SPD indicating which sample processing step should be performed for which sample, and the IVD laboratory equipment 2 may perform the sample processing step accordingly. The IVD laboratory equipment 2 may, for example, provide the IVD laboratory control software module 3 with sample processing data SPD showing queries, status reports, and test results created by the IVD laboratory equipment 2 (for example, by its individual IVD laboratory devices 20). The IVD laboratory control software module 3 can respond to received test results by, for example, sending sample processing data SPD indicating commands to the IVD laboratory equipment 2, updating a dashboard showing the status of the IVD laboratory equipment 2, receiving status reports, and managing test results (e.g., verification of test results).

[0063] Sample Processing Data (SPD) refers to data relating to the processing of samples within the IVD laboratory system 10. The IVD laboratory control software module 3 can use Sample Processing Data (SPD) to control sample processing within the IVD laboratory equipment 2. Sample Processing Data (SPD) may include, for example, test orders, processing queries, processing orders, test results, transport queries, transport orders, equipment status, workflow instructions, and / or positioning information. Sample Processing Data (SPD) may include, for example, workflow instructions from the IVD laboratory control software module 3 to the IVD laboratory equipment 2 regarding how the sample should be processed (e.g., which analytical tests should be performed by which IVD laboratory equipment 20). Sample Processing Data (SPD) may include, for example, queries or information sent from the IVD laboratory equipment 2 to the IVD laboratory control software module 3 (e.g., processing queries regarding what to do next, such as information about the sample or the test results of an analytical test). For example, after receiving a sample and its respective test order within the IVD laboratory system 10, the IVD laboratory control software module 3 plans the processing of the sample according to the test order and sends sample processing data SPD to the IVD laboratory equipment 2 instructing it on how to process the sample. The IVD laboratory equipment 2 processes the sample based on these instructions. During sample processing, the IVD laboratory equipment 2 sends sample processing data SPD, including a status report, to the IVD laboratory control software module 3 so that the IVD laboratory control software module 3 can monitor the status of sample processing. After the measurement steps performed by the IVD laboratory equipment 2, the IVD laboratory equipment 2 sends sample processing data SPD, including the measurement results (e.g., the results of the analytical test), to the IVD laboratory control software module 3 so that the IVD laboratory control software module 3 can manage the measurement results. The sample processing data SPD can be implemented using a data structure compliant with, for example, the Health Level Seven standard (also known as "HL7") or the ASTM standard, which is available as of October 1, 2021.

[0064] According to some embodiments, controlling sample processing within the IVD laboratory equipment 2 includes giving instructions on how to perform sample processing within the IVD laboratory equipment 2.

[0065] According to some embodiments, controlling sample processing within the IVD laboratory equipment 2 includes monitoring sample processing within the IVD laboratory equipment 2.

[0066] According to some embodiments, exchanging sample processing data (SPD) between the IVD laboratory control software module 3 and the IVD laboratory equipment 2 includes sending the sample processing data (SPD) from the IVD laboratory control software module 3 to the IVD laboratory equipment 2 (for example, to a specific IVD laboratory equipment 20 of the IVD laboratory equipment 2), such as test orders, processing orders, transport orders, and / or workflow commands.

[0067] According to some embodiments, the exchange of sample processing data (SPD) between the IVD laboratory control software module 3 and the IVD laboratory equipment 2 includes sending sample processing data (SPD) from the IVD laboratory equipment 2 (or a specific IVD laboratory equipment 20 of the IVD laboratory equipment 2) to the IVD laboratory control software module 3, for example, processing queries, test results, transport queries, equipment status, and / or positioning information.

[0068] According to some embodiments, the IVD laboratory control software module 3 comprises a workflow engine 30w designed to plan sample processing within the IVD laboratory equipment 2 to which the IVD laboratory control software module 3 is connected. According to some specific embodiments, the workflow engine 30w has knowledge and capabilities of each IVD laboratory equipment 20 of the IVD laboratory equipment 2 and is designed to plan which sample processing steps should be performed by which IVD laboratory equipment 20. The workflow engine 30w can be designed to plan in order to balance the load among the IVD laboratory equipment 20. The workflow engine 30w can be designed to plan in order to take into account the priority assigned to samples, for example, priority being assigned using the test order for each sample (e.g., a priority value included in the test order, e.g., specified by a physician). The workflow engine 30w can be designed to plan efficient routes through the IVD laboratory equipment 2 to avoid unhelpful movement of samples, for example, which can reduce the risk of cross-contamination. The workflow engine 30w can be designed to plan in order to take aliquots into consideration, for example, which can enable parallel testing. The workflow engine 30w can be designed to plan with parallel testing in mind, for example, two or more parts of a sample being processed in parallel in two or more different IVD laboratory instruments 20. This can reduce the time required to generate test results. The workflow engine 30w can be designed to plan masking or demasking of the IVD laboratory instruments 20, which can reduce reagent waste, for example. The workflow engine 30w can be designed to replan in the event of specific events, such as when a new test order is received, when a test should be rerun (for example, because an error occurred during the first test), when a reflection test should be performed (for example, a follow-up test to be performed for the results of the previous test), and / or when the IVD laboratory instruments 20 should be masked or unmasked.According to some specific embodiments, the IVD laboratory control software module 3 uses the workflow engine 30w's plan to control, and in particular guide, sample processing within the IVD laboratory equipment 2, for example, by sending sample processing data SPD to the IVD laboratory equipment 2, which includes commands to process the samples according to the plan, when executed by the IVD laboratory equipment 2. The IVD laboratory control software module 3 may include an interface for specifying algorithms, parameters, etc., of the workflow engine 30w. The workflow engine 30w may include an optimization module for optimizing the sample processing plan within the IVD laboratory equipment 2. The optimization module may include an artificial intelligence unit.

[0069] According to some embodiments, the IVD laboratory control software module 3 includes a QC module 30q designed to manage quality control ("QC") data provided by the IVD laboratory equipment 2. The QC data may include the results of QC measurements performed by the IVD laboratory equipment 20 of the IVD laboratory equipment 2. Sample processing data SPD transmitted from the IVD laboratory equipment 2 to the IVD laboratory control software module 3 may indicate the QC measurement results.

[0070] According to some embodiments, the IVD laboratory control software module 3 includes a rules engine 30r designed to verify test results. Verification can be technical verification and / or medical verification. Technical verification is, for example, that the QC of the IVD laboratory equipment 2 that generated the test results is acceptable. Medical verification is, for example, that the test results are within an acceptable range, which may depend, for example, on the respective patient data and / or other test results for the same sample. The IVD laboratory control software module 3 may include an interface for specifying algorithms, parameters, etc., of the rules engine 30r.

[0071] According to some embodiments, the IVD laboratory control software module 3 includes a sample tracking module 30s designed to track the location of a sample within the IVD laboratory equipment 2. The sample tracking module 30s may be designed to track the location using sample processing data SPD, which indicates location data (for example, transmitted from the IVD laboratory equipment 2 to the IVD laboratory control software module 3).

[0072] According to some embodiments, the IVD laboratory control software module 3 includes a patient data module 30p for managing patient data of patients whose samples are being processed. Patient data can be provided, for example, by a data management unit 6 and / or entered by a user interface. Patient data can be used, for example, by the IVD laboratory control software module 3 to verify test results and / or by the IVD laboratory control software module 3 to order additional tests in response to specific test results. The patient data module 30p may include a database for storing patient data, such as name, identifier, age, medical history, etc.

[0073] Figure 3 shows a possible schema for operating an IVD laboratory system 10 similar to that in Figure 2, but also shows details of the control components 30 of the IVD laboratory control software module 3. In the illustrated example, the control components 30 include a workflow engine 30w, a rules engine 30r, a QC module 30q, a sample tracking module 30s, and a patient data module 30p.

[0074] According to some embodiments, the IVD laboratory control software module 3 includes, for example, an artificial intelligence unit designed for use in the context of a workflow engine and / or rule engine. The artificial intelligence unit may be included, for example, in one or more of the control components 30.

[0075] According to some embodiments, the IVD laboratory control software module 3 includes a communication module 31 with at least one driver 31d for converting the data format of data files, for example, a data file containing sample processing data SPD, from a first data format to a second data format. This makes it possible, for example, to use the IVD laboratory control software module 3 with IVD laboratory equipment 20 that uses a data format other than that of the IVD laboratory control software module 3. In one example, the sample processing data SPD is created by the control component 30 in a data format that cannot be processed by the IVD laboratory equipment 2, and the communication module is designed to convert the sample processing data SPD to a data format that can be processed by the IVD laboratory equipment 2, and / or vice versa. For example, at least some of the IVD laboratory equipment 20 of the IVD laboratory equipment 2 may use the HL7 data format standard, while the control component 30 may use its own data format that is not compatible with the HL7 standard. In this case, the communication module 31 can make it possible to convert files from HL7 to the proprietary data format, and vice versa. According to some specific embodiments, the communication module comprises a driver 30d for each IVD laboratory equipment 20 of the IVD laboratory equipment 2. The communication module 31 can communicate with the control components 30 of the IVD laboratory control software module 3 for the internal communication unit IC in the IVD laboratory control software module 3. An example of the IVD laboratory control software module 3 comprising the (first) communication module 31 is shown in Figure 3.

[0076] According to some embodiments, a data management unit 6, such as a LIS or HIS designed for management within a hospital laboratory, is connected to an IVD laboratory control software module 3 to exchange sample-related information (SRI). As shown in the example in Figure 3, the data management unit 6 can be connected to the IVD laboratory control software module 3, for example, via a (first) communication module 31 of the IVD laboratory control software module 3.

[0077] A method is proposed to simulate an IVD laboratory system 10 for processing biological samples.

[0078] The IVD laboratory system 10 to be simulated is: IVD laboratory equipment set 2 comprising one or more IVD laboratory instruments 20 for processing samples, The IVD laboratory control software module 3 controls sample processing within the IVD laboratory equipment 2 and exchanges sample processing data (SPD) between the IVD laboratory control software module 3 and the IVD laboratory equipment 2. Equipped with, The IVD laboratory system 10 to be simulated is: Designed for sample processing within IVD laboratory equipment 2 using sample processing data SPD provided by IVD laboratory control software module 3, The proposed method is, The steps include: simulating sample processing within IVD laboratory equipment 2 using virtual IVD laboratory equipment 5 that uses sample processing data SPD provided by IVD laboratory control software module 3; A step of operating the IVD laboratory control software module 3 as if it were operating within the IVD laboratory system 10, wherein the sample processing data SPD intended to be exchanged between the IVD laboratory control software module 3 and the IVD laboratory equipment 2 is instead exchanged between the IVD laboratory control software module 3 and the virtual IVD laboratory equipment 5. Includes.

[0079] The proposed method allows the IVD laboratory control software module 3 to operate as if it were interacting with real-world IVD laboratory equipment 2, but instead the sample processing data (SPD) is exchanged with virtual IVD laboratory equipment 5, and only sample processing is simulated. The virtual IVD laboratory equipment 5 can be designed, for example, to represent IVD laboratory equipment 2 and can provide the IVD laboratory control software module 3 with the same type of sample processing data (SPD) as the real-world IVD laboratory equipment 2. The proposed method allows the simulation of sample flow and its respective data flow within the IVD laboratory system 10. The proposed method allows testing of IVD laboratory designs similar to (e.g., embodied by) the IVD laboratory control software module 3 and / or virtual IVD laboratory equipment 5.

[0080] The virtual IVD laboratory equipment 5 can be designed to respond to sample processing data SPD in essentially the same way as the real-world IVD laboratory equipment 2, from the perspective of the IVD laboratory control software module 3. According to some embodiments, the virtual IVD laboratory equipment 5 is designed to, for example, in response to receiving a specific type of sample processing data SPD from the IVD laboratory control software module 3, transmit the same type of sample processing data SPD to the IVD laboratory control software module 3 in the same manner as the IVD laboratory equipment 2, which would respond to receiving that specific type of sample processing data SPD from the IVD laboratory control software module 3. For example, the virtual IVD laboratory equipment 5 receives a command to perform a specific analytical test, and in response, the IVD laboratory control software module 3 in real-world operation receives the respective test results from the IVD laboratory equipment 2 in HL7 format. The virtual IVD laboratory equipment 5 then transmits the test results, generated in HL7 format (e.g., randomly generated according to a predetermined distribution), to the IVD laboratory control software module 3. The time lag between receiving an instruction and transmitting the test results by the virtual IVD laboratory equipment 5 can be similar to, for example, the time required to provide test results if the analytical test were performed by the real-world IVD laboratory equipment 2. The time lag can depend on the number and / or type of tests currently being simulated to be processed by the virtual IVD laboratory equipment 5, for example, to be similar to the waiting time caused by a similar workload in the real world. This allows the IVD laboratory control software module 3 to run in essentially the same way as if it were running within the real-world IVD laboratory system 10, and can be tested, for example, by stress testing the IVD laboratory control software module 3 and / or testing its behavior under specific conditions.

[0081] According to some embodiments, simulating sample processing in IVD laboratory equipment 2 using virtual IVD laboratory equipment 5 with sample processing data SPD provided by IVD laboratory control software module 3 includes the virtual IVD laboratory equipment 5 receiving sample processing data SPD from IVD laboratory control software module 3 and, in response to the received sample processing data SPD, sending back each sample processing data SPD to IVD laboratory control software module 3, possibly with a time delay.

[0082] According to some embodiments, the IVD laboratory control software module 3 operates in the proposed manner as if it were operating in the real world, in that it is unaware of the fact that the IVD laboratory control software module 3 is operating in a simulation context. For example, the configuration parameters of the IVD laboratory control software module 3 are not specific to the simulation context itself, so that the IVD laboratory control software module 3 can operate with (appropriate) real-world IVD laboratory equipment 2 using the same configuration.

[0083] The proposed method can be implemented, for example, using one of the Systems 1 schematically illustrated in one of Figures 4 to 11.

[0084] Figure 4 shows a possible schema for implementing the proposed method. The IVD laboratory control software module 3 is connected to a simulation software module 4 used to simulate the operation of the IVD laboratory equipment 2 by operating each virtual IVD laboratory equipment 5. The IVD laboratory control software module 3 communicates with the virtual IVD laboratory equipment 5 by exchanging sample processing data SPD in, for example, HL7 or ASTM format, thereby controlling the simulation of sample processing in the IVD laboratory equipment 2 using the virtual IVD laboratory equipment 5. The IVD laboratory control software module 3 can, for example, provide the virtual IVD laboratory equipment 5 with sample processing data SPD indicating which sample processing steps should be performed and in what order, and the virtual IVD laboratory equipment 5 can simulate the sample processing steps accordingly. The virtual IVD laboratory equipment 5 can provide the IVD laboratory control software module 3 with sample processing data SPDs that show queries, status reports, and / or test results, which are, for example, copies of sample processing data SPDs created by the virtual IVD laboratory equipment 5 (for example, according to certain predetermined rules) or previously created by, for example, the real-world IVD laboratory equipment 20. Similar to real-world situations, the IVD laboratory control software module 3 can respond to received queries by, for example, sending sample processing data SPDs showing commands to the virtual IVD laboratory equipment 5, to received status reports by updating a dashboard showing the status of the claimed IVD laboratory equipment 2, and to received test results by managing the test results (for example, verifying the test results). The IVD laboratory control software module 3 interacts with its simulation in the form of the virtual IVD laboratory equipment 5, but can operate in essentially the same way as if it were interacting with the real-world IVD laboratory equipment 2.The virtual IVD laboratory equipment 5 can be designed to respond to the sample processing data SPD provided by the IVD laboratory control software module 3, for example, by responding to the IVD laboratory control software module 3 with sample processing data SPD of the same type, format, and / or content as the IVD laboratory equipment 2 in the real world (for example, in essentially the same way). The virtual IVD laboratory equipment 5 can be designed to resemble the existing IVD laboratory equipment 2. This makes it possible, for example, to test the performance of the IVD laboratory control software module using the existing IVD laboratory equipment 2. The virtual IVD laboratory equipment 5 can be designed according to the planned design of the IVD laboratory equipment 2. This makes it possible, for example, to test the performance of the design without actually creating the IVD laboratory equipment 2 in the real world.

[0085] According to some embodiments, the virtual IVD laboratory equipment 5 simulates the sample flow within the IVD laboratory equipment 2 according to the sample processing data SPD provided to the virtual IVD laboratory equipment 5 by the IVD laboratory control software module 3. The data flow between the IVD laboratory control software module 3 and the virtual IVD laboratory equipment 5 can be similar to (e.g., identical to) the data flow in the real-world IVD laboratory system 10, for example, in that the IVD laboratory control software module 3 sends and receives the same type of sample processing data SPD as if it were operating in each IVD laboratory system 10.

[0086] The proposed method can be implemented as a computer implementation method. According to some embodiments, the method involves running the IVD laboratory control software module 3 and a virtual machine on the same and / or different computing entities (e.g., a computer, a cloud environment), where the virtual IVD laboratory equipment 5 is simulated using the virtual machine, and data, in particular sample processing data SPD, is exchanged between the IVD laboratory control software module 3 and the virtual machine.

[0087] According to some embodiments, the IVD laboratory control software module 3 is connected to a data management system 6 designed to exchange sample-related information SRI with the IVD laboratory control software module 3, and the proposed simulation method is as follows: This includes exchanging sample-related information (SRI) between the IVD laboratory control software module 3 and the data management system 6.

[0088] Connecting the IVD laboratory control software module 3 to the data management system 6 allows for testing the IVD laboratory control software module 3 and / or its specific configuration in a practical manner. An example of a real-world data management unit 6 connected to the IVD laboratory control software module 3 connected to virtual IVD laboratory equipment 5 is shown in Figures 4, 6, and 8.

[0089] According to some embodiments, this method To simulate a virtual data management system 56 configured to exchange sample-related information SRI with the IVD laboratory control software module 3, The exchange of sample-related information (SRI) between the IVD laboratory control software module 3 and the virtual data management system 56. Includes.

[0090] The schemas in Figures 5, 7, and 9 each illustrate an example in which the data management unit 6 is simulated as a virtual data management system 56 as part of the simulation software module 4. Using the virtual data management system 56 allows testing of the data management system-related functions of the IVD laboratory control software module 3 without connecting to the real-world data management system 6. The virtual data management system 56 can be designed to simulate the operational behavior of the data management unit 6, particularly its communication behavior. The virtual data management system 56 can be created, for example, by using recordings of the communication behavior of a real-world data management system, or by using an artificial intelligence unit trained using such recordings.

[0091] According to some specific embodiments, this method The IVD laboratory control software module 3 receives first data from the virtual data management system 56 or from the virtual IVD laboratory equipment 5, wherein the first data includes an instruction that a sample has arrived at the IVD laboratory equipment 2, thereby receiving the virtual sample. The IVD laboratory control software module 3 receives second data from the virtual data management system 56, wherein the second data includes a test order for a sample, and thereby the test order for a virtual sample is received. The IVD laboratory control software module 3 simulates sample processing of virtual samples according to the test order using virtual IVD laboratory equipment 5 from the virtual data management system 56. Includes.

[0092] The time at which the first and second data are transmitted from the virtual data management system 56 or the virtual IVD laboratory equipment 5 can be selected or randomized, which allows for the simulation of the behavior of the IVD laboratory system when a sample arrives at the IVD laboratory equipment 2 earlier than the respective test order in the IVD laboratory control software module 3, or vice versa. The first data can be received by the IVD laboratory control software module 3 from the virtual data management system 56 via the virtual IVD laboratory equipment 5, which allows the virtual data management system 56 to be used as a source for both the indication that a sample has arrived and the test order.

[0093] According to some embodiments, the input file is used to provide the simulation with information on which samples should be simulated to be received and the respective test orders. For example, the input file for each sample is: The IVD laboratory control software module 3 receives the sample reception time from the virtual data management system 56. The IVD laboratory control software module 3 receives test orders for samples from the virtual data management system 56. The IVD laboratory control software module 3 receives the test order from the virtual data management system 56, The IVD laboratory control software module 3 retrieves the sample volume from the virtual data management system 56, and The IVD laboratory control software module 3 retrieves the test results of the test order from the virtual data management system 56. It includes at least one of the following.

[0094] The simulation software module 4 may be designed to receive input files using a virtual data management system 56, for example, the virtual data management system 56 being the only software entity of the simulation software module 4 that has direct access to the information in the input files. The virtual data management system 56 may also be designed to provide the IVD laboratory control software module 3 with data created using the input files (optionally at least some of the information via the virtual IVD laboratory equipment 5). For example, the virtual data management system 56 transmits the test order and the time of receipt of the test order to the IVD laboratory control software module 3. The virtual data management system 56 causes the virtual IVD laboratory equipment 5 (e.g., its virtual pre-analysis IVD laboratory equipment 50pre) to transmit an instruction to the IVD laboratory control software module 3 that each sample has arrived at the IVD laboratory equipment 2 upon receipt of each sample. The virtual data management system 56 provides the virtual IVD laboratory equipment 5 with the volume of the sample and / or test results regarding the test order for the sample. The virtual IVD laboratory equipment 5, in some cases, in response to the respective commands from the IVD laboratory control software module 3, transmits sample processing data SPD to the IVD laboratory control software module 3. The sample processing data SPD is created / selected using the test results regarding the volume of the sample and / or the test order for the sample.

[0095] According to some embodiments, the virtual IVD laboratory equipment 5 comprises a virtual IVD laboratory equipment 50 designed to simulate the IVD laboratory equipment 20, for example, by simulating its operational behavior. Simulating operational behavior may include, in particular, simulating receiving samples, processing samples, and / or receiving / creating / transmitting sample processing data (SPD).

[0096] Simulating operational behavior can include, in particular, simulating communication behavior, such as the interaction of IVD laboratory equipment 20 at its communication interface. A virtual IVD laboratory equipment 50 can be designed to simulate the communication behavior of IVD laboratory equipment 20 in such a way that it is designed to respond to sample processing data SPD received from the IVD laboratory control software module 3 in the same manner as each IVD laboratory equipment 20, for example, in essentially the same way. According to some embodiments, the virtual IVD laboratory equipment 50 is designed to transmit the same type of sample processing data SPD in the same data format as each IVD laboratory equipment 20. The virtual IVD laboratory equipment 50 can be further designed to create sample processing data SPD, for example, by using an algorithm for creating the content of the data and / or by copying the sample processing data SPD stored in the virtual IVD laboratory equipment 50. The time difference between receiving specific sample processing data SPD from the IVD laboratory control software module 3 and responding to this sample processing data SPD by sending a response sample processing data SPD can be similar to the time difference that would occur for the IVD laboratory equipment 20 in the same situation, which can be achieved, for example, by recording the communication timing of the actual IVD laboratory equipment 20 and then using this recording to design the response timing of the virtual IVD laboratory equipment 50.

[0097] The type of response of the virtual IVD laboratory equipment 50 to the same type of sample processing data SPD can vary from response to response. For example, a response to a command to perform a specific test may, in some cases, be the result of that test, and in other cases, be an indication of various types of errors (e.g., those that occurred while performing this test on each standard IVD laboratory equipment 20). The timing of the error indication may depend, for example, on the type of error, such as a fast response to errors that typically occur early in the test workflow and a slow response to errors that typically occur later in the test workflow. In general, the timing of when the virtual IVD laboratory equipment 50 transmits the sample processing data SPD to the IVD laboratory control software module 3 can be variated using a statistical distribution that can, for example, allow for the simulation of realistic timing.

[0098] Each virtual IVD laboratory equipment 50 can be implemented as an independent software entity, and the operational behavior of each virtual IVD laboratory equipment 50 is calculated independently of other virtual IVD laboratory equipment 50. For example, with the exception of possible sample processing data SPD exchanged via the IVD laboratory control software module 3, the parameters of the operational behavior of the first virtual IVD laboratory equipment 50 are not used to calculate the operational behavior of the second virtual IVD laboratory equipment 50. If the simulation includes visualization (e.g., a graphical representation of the schema of the simulated IVD laboratory equipment 2, which may include, in some cases, a graphical representation showing the sample currently being processed according to the simulation), each virtual IVD laboratory equipment 50 can be displayed in the visualization.

[0099] A method for designing a virtual IVD laboratory equipment 20 for simulating an IVD laboratory equipment 50 for use in a simulation method (for example, as proposed herein), wherein the design method is To record and / or define (e.g., create) data files, such as sample processing data SPD files, that are received and / or transmitted by the IVD laboratory equipment 20, and / or Recording and / or defining (e.g., creating) the time gap between receiving and / or transmitting data files, such as sample processing data SPD files, by the IVD laboratory equipment 20, and To create content and / or to define the transmission timing of data files, such as sample processing data SPD files, by the virtual IVD laboratory equipment 50, recorded or defined data files and / or recorded or defined time gaps are used. A method including this is proposed.

[0100] This design method may, in particular, include recording all communication inputs and outputs and their respective timings of the real-world IVD laboratory equipment 20, which can be used to design each virtual IVD laboratory equipment 50. Recording data files can make it possible to create a virtual IVD laboratory equipment 20 that simulates the typical behavior of the IVD laboratory equipment 50. Defining data files can make it possible to simulate behavior in special cases, for example, to test the behavior of the IVD laboratory control software module 3 in special cases. Creating the virtual IVD laboratory equipment 50, in particular its communication behavior, may include using an artificial intelligence module trained using recorded data files or time intervals. Creating the virtual IVD laboratory equipment 50 may take into account the type of test to be simulated by the virtual IVD laboratory equipment 50, the type of IVD laboratory equipment 20 to be simulated by the virtual IVD laboratory equipment 50, and / or specific workflow parameters (e.g., those typically or ideally used by the IVD laboratory equipment 20 to be simulated by the virtual IVD laboratory equipment 50).

[0101] According to some embodiments, the virtual IVD laboratory equipment 5 may comprise multiple virtual IVD laboratory equipment 50 of various types for simulating various steps of sample processing based on sample processing data SPD provided by, for example, the IVD laboratory control software module 3.

[0102] The virtual IVD laboratory equipment set 5 may comprise one or more virtual IVD laboratory equipment 50. According to some embodiments, the virtual IVD laboratory equipment set 5 comprises exactly one virtual IVD laboratory equipment 20 for each IVD laboratory equipment 50 of the IVD laboratory equipment 2 to be simulated, for example, an existing IVD laboratory equipment set 2 or a planned IVD laboratory equipment set 2.

[0103] According to some specific embodiments, each virtual IVD laboratory device 50 simulates the operational behavior, particularly the communication behavior, of its respective IVD laboratory device 20. For example, a virtual IVD laboratory device 50 simulating a particular pre-analysis IVD laboratory device 20pre can be designed to simulate the operational behavior of this particular pre-analysis IVD laboratory device 20pre.

[0104] As shown in the examples in Figures 6 to 9 and Figure 11, the virtual IVD laboratory equipment 5 is: A virtual pre-analysis IVD laboratory instrument 50pre is designed to simulate the pre-analysis IVD laboratory instrument 20pre (for example, its operational behavior). A virtual analytical IVD laboratory instrument 50ana designed to simulate the analytical IVD laboratory instrument 20ana (for example, its operating behavior), A virtual post-analysis IVD laboratory instrument 50post designed to simulate post-analysis IVD laboratory instrument 20post (e.g., its operational behavior), and / or A virtual transport IVD laboratory equipment 50trans designed to simulate transport IVD laboratory equipment 20trans (e.g., its operational behavior) It is equipped with.

[0105] According to some embodiments, the virtual IVD laboratory equipment 5 is designed to simulate the operational, for example, communication behavior of the IVD laboratory equipment 2. According to some embodiments, the virtual IVD laboratory equipment 5 is designed to simulate the communication behavior of such IVD laboratory equipment 2, and the simulation can be based on an artificial intelligence module trained using the overall communication inputs and outputs of the IVD laboratory equipment 2 to and from the IVD laboratory control software module 3. According to some embodiments, the virtual IVD laboratory equipment 5 is designed to simulate the communication behavior of each IVD laboratory equipment 50 of the IVD laboratory equipment 2 by using each virtual IVD laboratory equipment 20, and the creation of each virtual IVD laboratory equipment 50 can be based on an artificial intelligence module trained using the communication inputs and outputs of each IVD laboratory equipment 20 to and from the IVD laboratory control software module 3, and the communication inputs and outputs of the virtual IVD laboratory equipment 5 to and from the IVD laboratory control software module 3 can be, for example, a collection of all the communication inputs and outputs of each virtual IVD laboratory equipment 50 to and from the IVD laboratory control software module 3.

[0106] According to some embodiments, the IVD laboratory control software module 3 may be included in a data management unit 6, for example, which is designed to control sample processing within the laboratory. Examples of the IVD laboratory control software module 3 included in the data management unit 6 are shown in Figure 10 (real world) and Figure 11 (simulation).

[0107] System 1 is proposed to simulate an IVD laboratory system 10 for processing biological samples.

[0108] The IVD laboratory system 10 to be simulated is: IVD laboratory equipment set 2 comprises one or more IVD laboratory instruments 20 designed for processing biological samples, The IVD laboratory control software module 3 is designed to control sample processing within the IVD laboratory equipment 2 and to exchange sample processing data (SPD) between the IVD laboratory control software module 3 and the IVD laboratory equipment 2. Equipped with, The IVD laboratory system 10 to be simulated is: Designed for sample processing within IVD laboratory equipment 2 using sample processing data SPD provided by IVD laboratory control software module 3, The proposed system 1 is, IVD laboratory control software module 3, A simulation software module 4 equipped with virtual IVD laboratory equipment 5 for simulating sample processing within IVD laboratory equipment 2, and Equipped with, System 1 is The IVD laboratory control software module 3 is operated as if it were operating within the IVD laboratory system 10, and the IVD laboratory control software module 3 is operated such that the sample processing data SPD, which was intended to be exchanged between the IVD laboratory control software module 3 and the IVD laboratory equipment 2, is instead exchanged between the IVD laboratory control software module 3 and the virtual IVD laboratory equipment 5. Virtual IVD laboratory equipment 5 is, The system is configured to simulate sample processing within the IVD laboratory equipment 2 using sample processing data (SPD) provided by the IVD laboratory control software module 3.

[0109] The system can be implemented, in particular, as a software system, and its components can be implemented, for example, by one or more processing units.

[0110] The simulation software module 4 can be equipped with virtual IVD laboratory equipment 5, in that the simulation software module 4 includes one or more virtual IVD laboratory equipment 50.

[0111] The simulation software module 4 can be created using a simulation framework for simulating discrete events, such as Simio Simulation Software from Simio LLC, available as of October 1, 2021. Within such a simulation framework, virtual IVD laboratory equipment 50 of a type can be created, each representing a type of IVD laboratory equipment 20. Each type of virtual IVD laboratory equipment 50 can be implemented using, for example, a module of the simulation framework, the properties of which are configured to represent (e.g., mimic) the properties of each type of IVD laboratory equipment 20, the properties of which may relate, for example, the type of input and / or output of the sample processing data SPD (e.g., to mimic the time required for a particular process within this type of IVD laboratory equipment 20), and the relative timing of each sample processing data SPD. A graphical user interface can be used to create virtual IVD equipment 5 by placing visual representations of the virtual IVD laboratory equipment 50 in a virtual IVD laboratory (e.g., by drag and drop). A virtual transport IVD laboratory equipment 50trans can be used to represent connections for transporting IVD containers. The virtual length and / or geometric shape can be used, for example, to calculate the relative timing of each sample processing data SPD representing the transport time between IVD laboratory equipment 20. The communication interface and details between the simulation software module 4 and the IVD laboratory control software module 3 can be implemented within the simulation framework using, for example, program code (written in C# or a similar coding language). The simulation software module 4 can be designed in particular to process incoming sample processing data SPD and / or to create outgoing sample processing data SPD using the program code within the simulation framework.In particular, the details of the communication behavior of IVD laboratory equipment can be taught to the simulation software module 4, for example, by configuring functions provided by the simulation framework or program code (for example, in the interface provided by the simulation framework). Steps to be performed for a specific test order for a sample can be implemented, for example, using a logical flowchart within the simulation framework, and the simulation framework can, during execution, call the respective program code to trigger the appropriate communication behavior for each step.

[0112] According to some embodiments, the IVD laboratory control software module 3 comprises a first communication module 31 having at least one driver 31d designed to convert the data format of data files (e.g., data files containing sample processing data SPD). Some examples of such embodiments can be seen in Figures 6 to 9. The driver 31d may be designed to convert the data format of sample processing data SPD exchanged between the IVD laboratory control software module 3 on one side and each of the individual virtual IVD laboratory equipment units 50 on the other side. The driver 31d of the communication module 31 used in the proposed simulation may be the same driver used by the communication module 31 to interact with real-world IVD laboratory equipment units 2 that are simulated using the virtual IVD laboratory equipment units 5. This may allow, for example, testing of the driver used with such IVD laboratory equipment units 2. When the virtual IVD laboratory equipment 50 simulates a specific IVD laboratory equipment 20, the driver 31d used for communication between the IVD laboratory control software module 3 and the virtual IVD laboratory equipment 50 can be, for example, the same driver used for communication between the IVD laboratory control software module 3 and the specific IVD laboratory equipment 20.

[0113] According to some embodiments, a first communication module 31 for each virtual IVD laboratory device 50 includes at least one driver for converting a data format compatible with the virtual IVD laboratory device 50 to and from a data format compatible with the IVD laboratory control software module 3. This can, for example, enable the IVD laboratory control software module 3 to communicate with each virtual IVD laboratory device 50 of the virtual IVD laboratory devices 5.

[0114] According to some embodiments, the simulation software module 4 includes a second communication module 51 having at least one driver 51d for converting the data format of a data file (e.g., a data file containing sample processing data SPD). Examples of such embodiments are shown in Figures 8 and 9. For example, the IVD laboratory control software module 3 provides the virtual IVD laboratory equipment 5 with sample processing data SPD in one or more data formats that at least some of the virtual IVD laboratory equipment 50 cannot process. Using a suitable driver 51d can enable the IVD laboratory control software module 3 to communicate with these virtual IVD laboratory equipment 50 in the intended manner. This can enable, for example, the use of a uniform data format, e.g., the same data format used internally by the IVD laboratory control software module 3, thereby reducing the complexity of various virtual IVD laboratory equipment 50.

[0115] According to some embodiments, the first communication module 31 and the second communication module 51 each include at least one joint driver 31d, 51d, for example, the joint drivers 31d, 51d are bidirectional, i.e., capable of converting from a first data format to a second data format and vice versa. According to some specific embodiments, the operation of the first communication module 31 is reflected by the second communication module 51, for example, the data format in which the first communication module 31 receives data files from the control component 30 is the same as the data format in which the second communication module 51 provides data files to the virtual IVD laboratory equipment 50. In particular, the drivers of the first communication module 31 and the second communication module 51 can be joint drivers 31d, 51d used by both communication modules 31, 51. This allows the virtual IVD laboratory equipment 50 to use the same data format that the IVD laboratory control software module 3 uses for its internal communication IC. As a result, for a given IVD laboratory control software module 3, only virtual IVD laboratory equipment 50 that uses that data format must be created, although it is still possible to simulate the behavior of the IVD laboratory control software module 3 using IVD laboratory equipment 20 that uses other data formats.

[0116] According to some embodiments, the sample processing data (SPD) indicates instructions regarding test orders, e.g., which analytical tests should be performed on individual samples (e.g., including). The IVD laboratory control software module 3 may be designed to determine at least some of the sample processing steps for performing a test order, for example, by using a data bank in which its entries link test orders to their respective sample processing steps. The IVD laboratory control software module 3, in particular the workflow engine 30w of the IVD laboratory control software module 3, may include an optimization module designed to optimize in what order and by which IVD laboratory instrument 20 the sample processing steps for multiple test orders of multiple samples should be performed. Optionally, the test order may further include an indication of the urgency of the sample. The IVD laboratory control software module 3 may be designed to prioritize the sample processing steps performed on a sample according to the urgency of the sample, for example, by taking the urgency of the sample into consideration for optimizing the sample processing steps for multiple test orders of multiple samples.

[0117] According to some embodiments, the sample processing data SPD indicates to the IVD laboratory control software module 3 a processing query, for example, that a particular IVD laboratory instrument 20 has received a particular sample and is requesting instructions on how the particular IVD laboratory instrument 20 should process this particular sample (e.g., including).

[0118] According to some embodiments, the sample processing data (SPD) indicates a processing order, such as instructions from the IVD laboratory control software module 3 to the IVD laboratory equipment 2 on how a particular sample should be processed (e.g., which analytical tests should be performed on this sample). The processing order can be transmitted in response to a processing query.

[0119] According to some embodiments, the sample processing data (SPD) shows test results, for example, the results of analytical tests performed on one or more analytical IVD laboratory instruments 20ana (e.g., including). The test results may be quantitative results (e.g., glucose concentration in the sample) or qualitative results (e.g., an indication that a particular virus type is present in the sample).

[0120] According to some embodiments, the sample processing data SPD indicates transport queries, for example, queries from the IVD laboratory equipment 20 to the IVD laboratory control software module 3 regarding where a sample currently located in the IVD laboratory equipment 20 should be transported next (including, for example, the following).

[0121] According to some embodiments, the sample processing data SPD indicates a transport order, such as instructions from the IVD laboratory control software module 3 to the IVD laboratory equipment 20 regarding where the sample currently located in the IVD laboratory equipment 20 should be transported next (e.g., including). The transport order can be sent in response to a transport query.

[0122] According to some embodiments, the sample processing data SPD indicates the status of the equipment, such as whether a particular IVD laboratory equipment 20 is powered on and operating, or whether a particular IVD laboratory equipment 20 is masked (e.g., including).

[0123] According to some embodiments, the sample processing data SPD indicates workflow instructions, for example, instructions relating to a specific workflow within the IVD laboratory equipment 2 (e.g., including).

[0124] According to some embodiments, the sample processing data SPD indicates the current location of the sample within the IVD laboratory equipment 2, such as positioning information, for example, which IVD laboratory equipment 20 or which submodule / section of IVD laboratory equipment 20 the sample is currently located in (e.g., including).

[0125] Figure 12 shows the possible exchange scheme for sample processing data (SPD) in the IVD laboratory system 10:

[0126] Step A: IVD laboratory equipment 2 creates a processing query for a specific sample and sends the processing query to the IVD laboratory control software module 3.

[0127] Step B: The processing query is received by the communication module 31 and converted from the first data format, in this example "HL7", to a second data format, in this example "XML", file, using a specific data structure that can be processed by the control component 30. The converted processing query is then sent to the control component 30 and processed by the control component. In response to the processing query, the control component 30 creates a processing order in XML and sends this processing order to the communication module 31, where the processing order is converted to HL7.

[0128] Step C: Next, the processing order in HL7 is sent to IVD laboratory equipment 2.

[0129] Step D: In the illustrated example, the processing order indicates a specific analytical test to be performed on this particular sample, and after this specific analytical test is performed on this particular sample, the HL7 test results are created and sent from IVD laboratory equipment 2 to IVD laboratory control software module 3.

[0130] Step E: The communication module 31 receives the test results, converts them to XML, and transmits these converted test results to the control component 30. The control component 30 can then, for example, verify the test results and transmit them to the data management unit 6 (not shown).

[0131] Figure 13 shows a scheme for the possible exchange of sample processing data SPDs using one of the proposed methods for simulation. The example depicted is similar to the example in Figure 12:

[0132] Step A: Within the simulation software module 4, the virtual IVD laboratory equipment 5 creates a processing query for a specific virtual sample. In the illustration, the processing query is initially created in XML. In the illustrated example, the control component 30 can process the XML file, but the real IVD laboratory control software module 3 is designed to receive sample processing data SPD in HL7. To realistically simulate data exchange with the IVD laboratory control software module 3, the processing order is sent to the virtual communication module 51 of the simulation software module 4, where the processing query is converted to HL7. The converted processing query is then sent to the IVD laboratory control software module 3.

[0133] Step B: The processing query is received by the communication module 31, as in the example in Figure 12, and converted from HL7 to XML. The converted processing query in HL7 is then sent to the control component 30, where it is processed. In response to the processing query, the control component 30 creates a processing order in XML, sends this processing order to the communication module 31, and the processing order is converted back to HL7.

[0134] Step C: Next, the processing order in HL7 is sent to the simulation software module 4 and received by the virtual communication module 51, where it is converted to XML. The virtual communication module 51 can simply reflect the operation of the communication module 31 so that the processing order is now identical (or at least very similar) to the processing order initially created by the control component 30. The processing order in XML is then sent to the virtual IVD laboratory equipment 5.

[0135] Step D: Similar to the example in Figure 12, the processing order in this example also indicates a specific analytical test to be performed on this particular virtual sample. In response to the processing order, the virtual IVD laboratory equipment 5 creates the test results in XML (for example, using a database of test results obtained by each real-world IVD laboratory equipment 2 for the same type of processing order) and sends it to the virtual communication module 51, where the text results are converted to HL7 and sent to the IVD laboratory control software module 3.

[0136] Step E: As shown in the example in Figure 12, the communication module 31 receives the test results, converts them to XML, and transmits these converted test results to the control component 30. The control component 30 can then, for example, verify the test results and transmit them to the data management unit 6 or the virtual data management system 56 (not shown).

[0137] As can be seen by comparing steps B and E described above for the examples in Figures 12 and 13, the IVD laboratory control software module 3 operates in exactly the same way in both examples. In this sense, the IVD laboratory control software module 3 does not know whether it interacts with real-world IVD laboratory equipment 2 or virtual IVD laboratory equipment 5.

[0138] According to some embodiments, the method includes simulating a sample processed as a virtual sample 52 in an IVD laboratory system 10. Simulating sample processing at the level of individual virtual samples can enable a high degree of realism in the simulation.

[0139] According to some specific embodiments, the method includes displaying a visualization of a virtual sample 52 along with a visualization of virtual IVD laboratory equipment 5, for example, as or as part of a virtual IVD container, and / or as or as part of a virtual IVD container holder.

[0140] According to some specific embodiments, the virtual IVD laboratory equipment 5 is displayed as a schematic representation corresponding to the IVD laboratory equipment 2 to be simulated. According to some specific embodiments, the virtual sample 52 is displayed, for example, as a virtual IVD container or as part of a virtual IVD container, and / or as a virtual IVD container holder or as part of a virtual IVD container holder, in a position within the schematic representation corresponding to the position of the corresponding sample being simulated at that time.

[0141] According to some embodiments, a schematic diagram visualizing the design details of the virtual IVD laboratory equipment 5 is graphically displayed, for example, as part of a graphical user interface 9.

[0142] Figure 14a shows a possible example of a graphical display, such as a graphical user interface 9, for visualizing virtual IVD laboratory equipment 5 and virtual samples 52 within it. In the illustrated example, the virtual IVD laboratory equipment 50 is represented by an image similar to each IVD laboratory equipment 20 viewed from above, and each virtual sample 52 is visualized by a circle to represent the shape of the sample tube viewed from above. Of course, other viewpoints are also possible. The visualization shows virtual sample container holders 53, each capable of holding up to five sample tubes. The virtual sample container holders 53 are indexed by a number that allows the viewer to distinguish and track individual virtual sample container holders 53. In Figure 14a, the following three virtual sample container holders 53 are shown: Virtual sample container holder No. 708304 holds five samples 52 and is being transported via virtual transport IVD laboratory equipment 50trans; Virtual sample container holder No. 708319 holds five samples 52 and is located at the entrance of the virtual analysis IVD laboratory instrument 50ana (only the portion visible within the cutout shown in Figure 14a); and Virtual sample container holder No. 708324 holds one sample 52 and is located inside virtual pre-analysis IVD laboratory equipment 50pre, with four samples 52 displayed next to it.

[0143] The visualization can be designed to fluidly adapt to the situation within the virtual IVD laboratory equipment 5 currently being simulated. Figure 14b shows a possible example of a second graphical display of Figure 14a. Virtual sample container holder No. 708304 has been moved to the left and rotated 90°; Virtual sample container holder No. 708319 is no longer visible in the illustrated notch (for example, because it has been moved to a part of the virtual analytical IVD laboratory equipment 50ana outside the illustrated notch); and Virtual sample container holder No. 708324 is still located within the virtual pre-analysis IVD laboratory instrument 50pre, but here it holds three samples 52, and two more samples 52 are displayed next to them (for example, indicating that an additional sample has been loaded into virtual sample container holder No. 708324 between the two).

[0144] Such visualizations can enable viewers to monitor simulated sample processing within the virtual IVD laboratory equipment 5, which in turn can enable them to analyze, for example, the effectiveness and / or weaknesses of the design of the IVD laboratory equipment 2 simulated by the virtual IVD laboratory equipment 5, and / or train personnel to work in the IVD laboratory system 10. The visualizations may further include visualizations of personnel operations within the virtual IVD laboratory equipment 5, for example, representing a staff member walking to the first IVD laboratory equipment 20, withdrawing a sample from the IVD laboratory equipment 2, and then, possibly, reinserting the sample into the IVD laboratory equipment 2 in the second IVD laboratory equipment 20. This can enable, for example, testing personnel operations within the IVD laboratory system 10.

[0145] According to some embodiments, the method includes receiving a virtual sample, for example, by simulating the receipt of a sample. This can be achieved, for example, by having a simulation of virtual IVD laboratory equipment 5, each IVD laboratory equipment 2, create data indicating the virtual sample (for example, based on an input file), and send sample processing data SPD indicating that the sample has been received to the IVD laboratory control software module 3, thereby informing the IVD laboratory control software module 3 that the sample has been received by the IVD laboratory equipment 2 that the IVD laboratory control software module 3 considers to be connected to. According to some specific embodiments, the method may further include receiving a test order for the virtual sample. This can be achieved, for example, by sending a test order to the IVD laboratory control software module 3 by a data management system 6 communicating with the IVD laboratory control software module 3, or by a virtual data management system 56 communicating with the IVD laboratory control software module 3 (which can be simulated, for example, as part of the virtual IVD laboratory equipment 5, or can be simulated independently of the virtual IVD laboratory equipment 5). For example, the IVD laboratory control software module 3, which is communicating with the virtual IVD laboratory equipment 5, receives a test order and instructions (simulated by the virtual IVD laboratory equipment 5) that each sample has been received by the IVD laboratory equipment 2. The virtual IVD laboratory equipment 5 then sends sample processing data SPD based on the test order to the virtual IVD laboratory equipment 5, as if it were the (real-world) IVD laboratory equipment 2. The sample processing data SPD is designed to cause the IVD laboratory equipment 2 to process the samples according to the test order.

[0146] According to some embodiments, the method includes simulating the receipt of a virtual sample by virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50.

[0147] According to some embodiments, the method includes sending processing queries for virtual samples from virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50 to the IVD laboratory control software module 3.

[0148] According to some embodiments, the method includes, for example, sending a processing order for a virtual sample generated using a test order for the virtual sample, after receiving a processing query, from the IVD laboratory control software module 3 to the virtual IVD laboratory equipment 5 or its virtual IVD laboratory equipment 50.

[0149] According to some embodiments, the method includes simulating sample processing in the form of the virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50 according to a test order, for example, by transmitting test results (e.g., created and / or received) from, for example, the virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50 to the IVD laboratory control software module 3. The test results may be transmitted with a time gap relative to the start of the sample test simulation, where the time gap indicates the time required for this sample test in the IVD laboratory equipment 2 or the IVD laboratory equipment 20.

[0150] According to some embodiments, the method includes evaluating, for example, verifying, the test results received by the IVD laboratory control software module 3.

[0151] According to some embodiments, the method includes sending transport queries for virtual samples from virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50 to the IVD laboratory control software module 3.

[0152] According to some embodiments, the method includes, for example, sending a transport order for a virtual sample from the IVD laboratory control software module 3 to the virtual IVD laboratory equipment 5 or its virtual IVD laboratory equipment 50 after receiving a transport query.

[0153] According to some embodiments, the method includes, for example, simulating the transport of virtual samples within virtual IVD laboratory equipment 5 according to a transport order.

[0154] According to some embodiments, the method involves transmitting positioning information from virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50 to an IVD laboratory control software module 3, wherein the positioning information relates to the currently simulated position of a virtual sample 52 within the virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50.

[0155] According to some embodiments, the method includes exchanging quality control ("QC") data between an IVD laboratory control software module 3 and virtual IVD laboratory equipment 5, for example, the QC data is intended to be exchanged between the IVD laboratory software 3 and IVD laboratory equipment 2 within the IVD laboratory system 10. According to some specific embodiments, the method includes transmitting QC data from the virtual IVD laboratory equipment 5 to the IVD laboratory control software module 3. For example, the QC data includes data identical or similar to test results, as well as information classifying this data as a QC result. The IVD laboratory control software module 3 can be configured to process QC results different from test results, for example, by using information classifying data identical or similar to test results as QC results. According to some embodiments, the simulation includes creating QC data according to, for example, predefined rules. The format of the created QC data can be selected to be identical to the format used for QC data within the IVD laboratory system 10 to be simulated.

[0156] According to some embodiments, the method includes simulating sample handling by staff in an IVD laboratory system 10, which may include, for example, the following: To simulate manual workflows such as placing samples into IVD laboratory equipment and / or removing samples from IVD laboratory equipment. Simulating the walking routes of staff members, and / or Schedule breaks for staff members from their work.

[0157] According to some embodiments, the design of the virtual IVD laboratory equipment 5 is created using a design file. The design file can be a file that can be used to plan the layout of the IVD laboratory equipment 2. For example, the design file is Definition of IVD laboratory equipment 20 in IVD laboratory equipment 2, and Details of the arrangement of IVD laboratory equipment 20 and / or connections between IVD laboratory equipment 20 in IVD laboratory equipment 2 Includes.

[0158] The design file may be, for example, a Visio file (.VSD) or may contain one. According to some specific embodiments, the design details of the virtual IVD laboratory equipment 5 are automatically created using the design file, for example, by applying a set of rules to the information contained in the design file.

[0159] According to some embodiments, the design of the virtual IVD laboratory equipment 5 is created using a list of IVD laboratory equipment 20 defined in the IVD laboratory control software module 3. According to some specific embodiments, the details of the design of the virtual IVD laboratory equipment 5 are created automatically using the list of IVD laboratory equipment 20 defined in the IVD laboratory control software module 3, for example, by applying a set of rules to the list. For example, the design is created such that the IVD laboratory equipment 20 in the list are placed in the design and connected to each other according to specific rules.

[0160] According to some embodiments, the design of the virtual IVD laboratory equipment 5 is created using a graphical user interface 9. According to some specific embodiments, the graphical user interface 9 includes a schematic representation of the visualization of the details of the design of the virtual IVD laboratory equipment 5. For example, the graphical user interface 9 includes a drag-and-drop function. The drag-and-drop function can, for example, allow dragging and dropping images representing the IVD laboratory equipment 20 or other parts of the IVD laboratory equipment 2 within the graphical user interface 9. Using the graphical user interface 9 can allow creating a design of the virtual IVD laboratory equipment from scratch, or modifying an existing design, for example, a design created using a design file and / or a list of IVD laboratory equipment 20 defined in the IVD laboratory control software module 3.

[0161] According to some embodiments, To simulate sample processing within IVD laboratory equipment 2, and Activate the IVD laboratory control software module 3. However, both are executed in real time. Typically, simulations run much faster than real time, and as a result, long-term behavior can be tested in a relatively short time. However, running the proposed simulation in real time can make it possible to more realistically simulate the operation of the IVD laboratory system 10, thereby increasing the importance of testing, for example, testing the IVD laboratory control software module 3 and / or its specific configuration.

[0162] According to some embodiments, the simulation is designed to run at various speeds, such as faster than real time (e.g., up to 10 times faster) and / or slower than real time (e.g., at least half the speed).

[0163] According to some embodiments, this method To simulate sample processing within IVD laboratory equipment 2 during the simulation time, To operate the IVD laboratory control software module 3 in real time, Comparing the elapsed time during the simulation with real-time data. and: If the simulation time is behind real-time (for example, a delay of more than 1 second), increase the speed of the simulation time. If the simulation time is ahead of real time (for example, by more than 1 second), the simulation time will be slowed down. Maintaining the speed of the simulation time when the simulation time is at least quasi-identical to real time (for example, when the two times differ by less than 1 second). Includes.

[0164] Comparisons can be performed periodically at specific measurement intervals (e.g., every second). If the simulation time is lagging behind real time, the simulation speed can be increased, for example, in proportion to the observed time gap (or in proportion to the observed time gap divided by the length of the measurement interval). If the simulation time is running ahead, the real-time simulation speed can be decreased, for example, in proportion to the observer's time gap (or in proportion to the observed time gap divided by the length of the measurement interval).

[0165] The proposed method of simulation involves operating the IVD laboratory control software module 3 in relation to the simulated IVD laboratory. Designing IVD laboratory equipment 2, IVD laboratory control software module 3, and / or IVD laboratory system 10, Test (especially benchmark) the IVD laboratory equipment 2, the IVD laboratory control software module 3, and / or the IVD laboratory system 10, To test the operation of the IVD laboratory system 10 by staff, (In particular, training personnel to work in the IVD laboratory system 10 for use with the IVD laboratory control software module 3) This can make it possible to provide support for this.

[0166] A method for designing and configuring IVD laboratory control software module 3 using one of the proposed simulation methods, in the following order: Step 0: A step to provide the design of the IVD laboratory control software module 3, Step 1: Steps to execute the method for simulation, Step 2: The step of changing one or more parameters (e.g., configuration parameters) of the design of the IVD laboratory control software module 3, Step 3: The steps to perform Step 1, Step 4: Optionally, repeat Steps 2 and 3. A method including this is proposed.

[0167] Step 4 is optional and can be omitted, for example, if, based on benchmarks, the method described in Step 3 is deemed successful. Designing the IVD laboratory control software module 3 may include, for example, creating the IVD laboratory control software module 3, adding modules and / or functions to the IVD laboratory control software module 3, and / or configuring the IVD laboratory control software module 3. In practice, configuring the IVD laboratory control software module 3 on installed IVD laboratory equipment 2 can take a considerable amount of time (up to several months) during which the IVD laboratory system 10 may be (at least partially) unusable. Configuring the IVD laboratory control software module 3 using virtual IVD laboratory equipment 5 similar to IVD laboratory equipment 2 can significantly reduce the downtime of IVD laboratory equipment 2 and thus avoid unnecessary waste of testing capacity and other resources.

[0168] A method for designing IVD laboratory equipment 2 using one of the proposed simulation methods, wherein the design method is performed in the following order: Step 0: A step of providing the design for IVD laboratory equipment 2, Step 1: Steps to execute the method for simulation, Step 2: The step of changing one or more parameters of the design of the IVD laboratory equipment (2), Step 3: The steps to perform Step 1, Step 4: Optionally, repeat Steps 2 and 3. A method including this is proposed.

[0169] Step 4 is optional and can be omitted, for example, if, based on benchmarks, the method described in Step 3 is deemed successful. Designing the IVD laboratory equipment 2 can be a complex task. Simulating the IVD laboratory equipment according to the selected design and testing its performance in cooperation with the IVD laboratory control software module 3 can make it possible to determine the feasibility and / or efficiency of the selected design, and thus, in some cases, the design can be improved using the proposed method for simulation.

[0170] A method for designing an IVD laboratory system 10 using one of the proposed methods for simulation, wherein the design method is performed in the following order: Step 0: A step of providing the design of the IVD laboratory control software module 3 and the IVD laboratory equipment 2, Step 1: Steps to execute the method for simulation, Step 2: The step of modifying one or more parameters of the design of the IVD laboratory control software module 3 (e.g., configuration parameters) and / or the design of the IVD laboratory equipment 2 (e.g., the specific type of IVD laboratory equipment 20), Step 3: The steps to perform Step 1, Step 4: Optionally, repeat Steps 2 and 3. A method for designing, including this, is proposed.

[0171] Step 4 is optional and can be omitted, for example, if, based on benchmarks, performing the method described in Step 3 is deemed successful.

[0172] According to some embodiments, a method for designing IVD laboratory equipment 2, IVD laboratory control software module 3, and / or IVD laboratory system 10 may include step 1 being benchmarking the performance of the IVD laboratory control software module 3 and / or IVD laboratory equipment 2. Possible parameters for benchmarking are so-called turnaround time ("TAT"), i.e., the time required to process a sample. Possible benchmark parameters may be, for example, the average TAT of all samples and / or the average TAT of specific samples, such as high-priority samples. Benchmarking can enable comparison of designs and enable improvement / optimization of designs.

[0173] A method is proposed for testing the IVD laboratory equipment 2, the IVD laboratory control software module 3, and / or the IVD laboratory system 10 using one of the proposed simulation methods. Such a testing method can, for example, assist in the preparation of documentation and / or the satisfaction of regulatory requirements.

[0174] A method is proposed for testing the operation of the IVD laboratory system 10 by staff using one of the proposed simulation methods. This can assist in staff optimization, staff role definition, staff planning, schedule planning, pause planning, etc.

[0175] A method is proposed for training personnel to work in the IVD laboratory system 10 using one of the proposed methods for simulation. According to some embodiments, the method includes training individuals to use the IVD laboratory control software module 3. This can enable training personnel without the operational IVD laboratory system 10 to avoid problems in the operation of the IVD laboratory system 10 caused by errors made before or during training. In particular, this can enable training personnel to deal with problematic situations without creating such problematic situations for the operational IVD laboratory system 10.

[0176] Figure 15 illustrates a possible use case of the proposed method for the new installation of the IVD laboratory control software module 3 for existing IVD laboratory equipment 2.

[0177] During the preparation phase, customer requirements for the installation of IVD laboratory control software module 3 (e.g., equipment maintenance schedule, tubing types, assay deployment to equipment, etc.) are collected.

[0178] In the simulation phase, a simulation software module 4 is created that includes virtual IVD laboratory equipment 5 similar to the customer's IVD laboratory equipment 2, and is connected to a test IVD laboratory control software module 3, thereby creating a software system 1 that can be used according to the proposed method. This allows the IVD laboratory control software module 3 to be configured according to customer requirements, and the operation of the configured IVD laboratory control software module 3 to be tested by the customer's IVD laboratory equipment 2. This does not require a field service engineer to visit the customer's site, the presence of the customer's intended IVD laboratory equipment 2, and / or the presence of the IVD laboratory control software module 3 at the customer's site. In some cases, the IVD laboratory control software module 3 can be installed at the customer's site in parallel with the simulation phase, thereby creating the customer's IVD laboratory control software module 3.

[0179] During the verification phase, the tested configuration of the IVD laboratory control software module 3 is transferred from the test IVD laboratory control software module to the customer's IVD laboratory control software module and tested by real-world IVD laboratory equipment 2 within the customer's IVD laboratory system 10. After the configuration is verified, the IVD laboratory system 10 can be operational. Using the proposed method for simulating the IVD laboratory system 10 can significantly reduce the overall time required at the customer's site to configure and verify the IVD laboratory control software module 3. This can enable faster installation of the IVD laboratory control software module 3 and / or less downtime for the IVD laboratory system 10, which can, for example, significantly reduce commercial losses and / or reduce wasted IVD capacity.

[0180] During the maintenance phase, the proposed simulation can be used to analyze problems, which can save downtime and / or enable better analysis. Intended changes in the configuration of the IVD laboratory control software module 3 can be tested using simulation before operational changes are made in the customer system, which can similarly save downtime. Overall, using the proposed simulation can enable more efficient and higher-quality customer service.

[0181] The proposed system 1 may be implemented using one or more computer programs, for example, a first computer program for IVD laboratory control software module 3 and a second computer program for simulation software module 4. Each computer program may be executed by one or more processing units, which may be included, for example, in a control unit, server, personal computer, and / or cloud system. Each processing unit may comprise a processor, volatile memory, non-volatile memory, and a bus structure connecting these components.

[0182] The proposed method may be implemented, at least in part, as a computer implementation method performed by one or more processing units that execute each software component.

[0183] A computer program is proposed that includes instructions for causing one or more processing units to perform one or more of the proposed methods. Furthermore, a computer-readable data carrier containing the computer program is also proposed.

[0184] A system 1, in particular a software system, is proposed to be designed to perform one of the proposed methods.

[0185] A method is proposed that can be realized by one of the proposed systems 1.

[0186] In particular, the following proposals are made: Proposal 1: A method for simulating an in vitro diagnostic IVD laboratory system 10 for processing biological samples, wherein the IVD laboratory system 10 is IVD laboratory equipment set 2 comprising one or more IVD laboratory instruments 20 for processing samples, The IVD laboratory control software module 3 controls sample processing within the IVD laboratory equipment 2 and exchanges sample processing data (SPD) between the IVD laboratory control software module 3 and the IVD laboratory equipment 2. Equipped with, The IVD laboratory system 10, Designed for sample processing within IVD laboratory equipment 2 using sample processing data SPD provided by IVD laboratory control software module 3, The method is The steps include: simulating sample processing within IVD laboratory equipment 2 using virtual IVD laboratory equipment 5 that uses sample processing data SPD provided by IVD laboratory control software module 3; A step of operating the IVD laboratory control software module 3 as if it were operating within the IVD laboratory system 10, wherein the sample processing data SPD intended to be exchanged between the IVD laboratory control software module 3 and the IVD laboratory equipment 2 is instead exchanged between the IVD laboratory control software module 3 and the virtual IVD laboratory equipment 5. Methods that include...

[0187] Proposal 2: A method according to any one of the preceding proposals, wherein the sample processing data SPD indicates test orders, processing queries, processing orders, test results, transport queries, transport orders, equipment status, workflow instructions, and / or positioning information.

[0188] Proposal 3: The method is, Receiving a virtual sample and receiving a test order for the virtual sample, To simulate the receipt of a virtual sample by the virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50, The process involves sending processing queries for virtual samples from the virtual IVD laboratory equipment 5 or its virtual IVD laboratory equipment 50 to the IVD laboratory control software module 3, For example, after receiving a processing query, the IVD laboratory control software module 3 transmits a processing order for a virtual sample generated using the test order for this virtual sample to the virtual IVD laboratory equipment 5 or its virtual IVD laboratory equipment 50. For example, by transmitting the created and / or received test results from the virtual IVD laboratory equipment 5 or its virtual IVD laboratory equipment 50 to the IVD laboratory control software module 3, the sample processing is simulated in the form of a sample test according to the test order of the virtual IVD laboratory equipment 5 or its virtual IVD laboratory equipment 50, For example, the test results are transmitted with a time gap from the start of the sample test simulation, and the time gap indicates the time required for this sample test in IVD laboratory equipment 2 or its IVD laboratory equipment 20, simulating sample processing. The received test results are evaluated by the IVD laboratory control software module 3, A transport query for a virtual sample is sent from the virtual IVD laboratory equipment 5 or its virtual IVD laboratory equipment 50 to the IVD laboratory control software module 3, For example, after receiving a transport query, the IVD laboratory control software module 3 sends a transport order for the virtual sample to the virtual IVD laboratory equipment 5 or its virtual IVD laboratory equipment 50. For example, simulating the transport of virtual samples within virtual IVD laboratory equipment 5 according to transport orders, and / or The transmission of positioning information from the virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50 to the IVD laboratory control software module 3, wherein the positioning information transmitted relates to the current simulated position of the virtual sample 52 within the virtual IVD laboratory equipment 5 or the virtual IVD laboratory equipment 50. A method of any one of the prior proposals, including the method described above.

[0189] Proposal 4: A method according to any one of the prior proposals, wherein the method includes exchanging quality control data between an IVD laboratory control software module 3 and virtual IVD laboratory equipment 5.

[0190] Proposal 5: A method according to any one of the preceding proposals, wherein the method includes simulating sample handling by staff within the IVD laboratory system 10.

[0191] Proposal 6: A method according to any one of the preceding proposals, wherein the virtual IVD laboratory equipment 5 comprises exactly one virtual IVD laboratory equipment 20 for each IVD laboratory equipment 50 of the IVD laboratory system 10 to be simulated.

[0192] Proposal 7: A method according to any one of the preceding proposals, wherein each virtual IVD laboratory equipment 50 simulates the operational behavior of its respective IVD laboratory equipment 20.

[0193] Proposal 8: The method according to Proposal 6 or 7, wherein each virtual IVD laboratory equipment 50 simulates the communication behavior of its respective IVD laboratory equipment 20.

[0194] Proposal 9: A method according to any one of the prior proposals, wherein the method includes simulating a sample that will be processed as a virtual sample 52 in an IVD laboratory system 10.

[0195] Proposal 10: A method according to a prior proposal, wherein the method includes displaying a visualization of virtual IVD laboratory equipment 5 along with a visualization of a virtual sample 52.

[0196] Proposal 11: The method of the preceding proposal, wherein the virtual IVD laboratory equipment 5 is displayed as a schematic representation corresponding to the IVD laboratory equipment 2 to be simulated.

[0197] Proposal 12: The method of the preceding proposal, wherein each virtual sample 52 is displayed in a position within the schematic representation corresponding to the position of the corresponding sample to be simulated at that time.

[0198] Proposal 13: A method according to any one of the preceding proposals, wherein the design of virtual IVD laboratory equipment 5 is created using a design file.

[0199] Proposal 14: A method according to any one of the preceding proposals, wherein the design of virtual IVD laboratory equipment 5 is created using a list of IVD laboratory equipment 20 defined in the IVD laboratory control software module 3.

[0200] Proposal 15: A method according to any one of the preceding proposals, wherein the design of virtual IVD laboratory equipment 5 is created using a graphical user interface 9.

[0201] Proposal 16: The method according to any one of the prior proposals, comprising using a graphical user interface 9 that includes a schematic representation of the design details of the virtual IVD laboratory equipment 5, wherein the graphical user interface 9 may be, for example, the graphical user interface of Proposal 15.

[0202] Proposal 17: To simulate sample processing within IVD laboratory equipment 2, and Activate the IVD laboratory control software module 3. However, both methods are executed in real time, according to one of the preceding proposals.

[0203] Proposal 18: The method is, To simulate sample processing within IVD laboratory equipment 2 during the simulation time, To operate the IVD laboratory control software module 3 in real time, Comparing the elapsed time during the simulation with real-time data. and: If the simulation time is behind real time, increase the speed of the simulation time. If the simulation time is ahead of real time, you can either slow down the simulation time or Maintain the speed of the simulation time if the simulation time is at least quasi-identical to real time. A method of any one of the prior proposals, including the method described above.

[0204] Proposal 19: The IVD laboratory control software module 3 is connected to the data management system 6 for exchanging sample-related information (SRI) with the IVD laboratory control software module 3. The method is A method according to any one of the prior proposals, comprising exchanging sample-related information SRI between an IVD laboratory control software module 3 and a data management system 6.

[0205] Proposal 20: The method is, To simulate a virtual data management system 56 configured to exchange sample-related information SRI with the IVD laboratory control software module 3, The exchange of sample-related information (SRI) between the IVD laboratory control software module 3 and the virtual data management system 56. A method of any one of the prior proposals, including the method described above.

[0206] Proposal 21: The method is, The IVD laboratory control software module 3 receives first data from the virtual data management system 56 or from the virtual IVD laboratory equipment 5, wherein the first data includes an instruction that a sample has arrived at the IVD laboratory equipment 2, thereby receiving the virtual sample. The IVD laboratory control software module 3 receives second data from the virtual data management system 56, wherein the second data includes a test order for a sample, and thereby the test order for a virtual sample is received. Using virtual IVD laboratory equipment 5, simulate the sample processing of this virtual sample according to the test order. Methods of prior proposals, including those described above.

[0207] Proposal 22: A method for designing an IVD laboratory control software module 3 using the simulation method described in one of Proposals 1 to 21, wherein the design method is as follows: Step 0: A step to provide the design of the IVD laboratory control software module 3, Step 1: Steps to execute the method for simulation, Step 2: The step of changing one or more parameters of the design of the IVD laboratory control software module 3, Step 3: The steps to perform Step 1, Step 4: Optionally, repeat Steps 2 and 3. Methods that include...

[0208] Proposal 23: A method for designing IVD laboratory equipment 2 using the method described in any one of Proposals 1 to 21, wherein the method for designing is in the following order: Step 0: A step of providing the design for IVD laboratory equipment 2, Step 1: Steps to execute the method for simulation, Step 2: changing one or more parameters of the IVD examination room equipment 2; Step 3: performing Step 1; Step 4: optionally, repeating Step 2 and Step 3 A method comprising the above steps.

[0209] Proposal 24: A method for designing an IVD examination room system 10 using the method described in any one of Proposals 1 to 21, wherein the method for design is in the following order: Step 0: providing the design of the IVD examination room control software module 3 and the design of the IVD examination room equipment 2; Step 1: performing a method for simulation; Step 2: changing one or more parameters of the design of the IVD examination room control software module 3 and / or the IVD examination room equipment 2; Step 3: performing Step 1; Step 4: optionally, repeating Step 2 and Step 3 A method comprising the above steps.

[0210] Proposal 25: The method for design according to any one of Proposals 22 to 24, wherein Step 1 includes benchmarking the performance of the IVD examination room control software module 3 or the IVD examination room equipment 2.

[0211] Proposal 26: A method for testing the IVD examination room control software module 3 using the method for simulation described in any one of Proposals 1 to 21.

[0212] Proposal 27: A method for testing the IVD examination room equipment 2 using the method described in any one of Proposals 1 to 21.

[0213] Proposal 28: A method for testing the IVD examination room system 10 using the method for simulation described in any one of Proposals 1 to 21.

[0214] Proposal 29: A method for testing the operation of an IVD laboratory system 10 by staff using the simulation method described in any one of Proposals 1 to 21.

[0215] Proposal 30: A method for training staff to work in an IVD laboratory system 10 using the simulation method described in any one of Proposals 1 to 21.

[0216] Proposal 31: A method for designing a virtual IVD laboratory equipment 50 to simulate an IVD laboratory equipment 20 for the simulation method described in any one of Proposals 1 to 21, Recording and / or defining data files received and / or transmitted by IVD laboratory equipment 20, and / or Record and / or define the time gap between receiving and / or transmitting data files by the IVD laboratory equipment 20, To create content and / or to define the timing of data file transmission by the virtual IVD laboratory equipment 50, recorded or defined data files and / or recorded or defined time gaps are used. Methods that include...

[0217] Proposal 32: A system 1 for simulating an IVD laboratory system 10 for processing biological samples, wherein the IVD laboratory system 10 is IVD laboratory equipment set 2 comprising one or more IVD laboratory instruments 20 for processing biological samples, The IVD laboratory control software module 3 controls sample processing within the IVD laboratory equipment 2 and exchanges sample processing data (SPD) between the IVD laboratory control software module 3 and the IVD laboratory equipment 2. Equipped with, The IVD laboratory system 10, Designed for sample processing within IVD laboratory equipment 2 using sample processing data SPD provided by IVD laboratory control software module 3, System 1 is IVD laboratory control software module 3, A simulation software module 4 equipped with virtual IVD laboratory equipment 5 for simulating sample processing within IVD laboratory equipment 2, and Equipped with, System 1 is The IVD laboratory control software module 3 is operated as if it were operating within the IVD laboratory system 10, and the IVD laboratory control software module 3 is operated such that the sample processing data SPD, which was intended to be exchanged between the IVD laboratory control software module 3 and the IVD laboratory equipment 2, is instead exchanged between the IVD laboratory control software module 3 and the virtual IVD laboratory equipment 5. Virtual IVD laboratory equipment 5, A system configured to simulate sample processing within IVD laboratory equipment 2 using sample processing data SPD provided by IVD laboratory control software module 3.

[0218] Proposal 33: System 1 according to Proposal 32, wherein the IVD laboratory control software module 3 comprises a first communication module 31 having at least one driver 31d for converting the data format of data files.

[0219] Proposal 34: System 1 according to Proposal 32 or 33, wherein the simulation software module 4 comprises a second communication module 51 having at least one driver 51d for converting the data format of the data file.

[0220] Proposal 35: The system 1 described in Proposal 34, which is subordinate to Proposal 33, where the first communication module 31 and the second communication module 51 each include at least one joint driver 31d, 51d.

[0221] Proposal 36: The system 1 described in Proposal 34 or Proposal 35, which is subordinate to Proposal 33, where the operation of the first communication module 31 is mirrored by the second communication module 51.

Explanation of Signs

[0222] 1 System 10 IVD Examination Room System 2 IVD Examination Room Equipment 20 IVD Examination Room Equipment 20pre Pre - analysis IVD Examination Room Equipment 20ana Analysis IVD Examination Room Equipment 20post Post - analysis IVD Examination Room Equipment 20trans Transport IVD Examination Room Equipment 3 IVD Examination Room Control Software Module 30 Control Component 30w Workflow Engine 30q Quality Management Module 30r Rule Engine 30s Sample Tracking Module 30p Patient Data Module 31 Communication Module 31d Driver 32 Control Unit 4 Simulation Software Module 5 Virtual IVD Examination Room Equipment 50 Virtual IVD Examination Room Equipment 50pre Virtual Pre - analysis IVD Examination Room Equipment 50ana Virtual Analysis IVD Examination Room Equipment 50post Virtual Post - analysis IVD Examination Room Equipment 50trans Virtual Transport IVD Examination Room Equipment 51 Virtual Communication Module 51d Driver 52 Virtual Samples 53 Virtual sample container holder 56 Virtual Data Management System 6. Data Management Unit 7. Communication Network 9. Graphical User Interface SPD Sample Processing Data SRI Sample-Related Information IC internal communication department

Claims

1. 1. A method for simulating an in vitro diagnostic IVD laboratory system (10) for processing biological samples, the method comprising: IVD laboratory instrumentation (2) comprising one or more IVD laboratory devices (20) for processing samples; an IVD laboratory control software module (3) for controlling sample processing within said IVD laboratory equipment (2) and for exchanging sample processing data (SPD) between said IVD laboratory control software module (3) and said IVD laboratory equipment (2); Equipped with The IVD laboratory system (10) Designed for sample processing within said IVD laboratory instrumentation (2) using sample processing data (SPD) provided by said IVD laboratory control software module (3); The method comprises: simulating sample processing in said IVD laboratory instrumentation (2) using virtual IVD laboratory instrumentation (5) using sample processing data (SPD) provided by said IVD laboratory control software module (3); operating the IVD laboratory control software module (3) as if it were operating within the IVD laboratory system (10), wherein sample processing data (SPD) intended to be exchanged between the IVD laboratory control software module (3) and the IVD laboratory equipment (2) is instead exchanged between the IVD laboratory control software module (3) and the virtual IVD laboratory equipment (5); A method comprising:

2. The method comprises: receiving a virtual sample and receiving a test order for the virtual sample; simulating receipt of the virtual sample by the virtual IVD laboratory instrumentation (5) or its virtual IVD laboratory equipment (50); sending a processing query for a virtual sample from the virtual IVD lab instrumentation (5) or the virtual IVD lab device (50) to the IVD lab control software module (3); sending a processing order for the virtual sample generated using the test order for the virtual sample from the IVD laboratory control software module (3) to the virtual IVD laboratory instrumentation (5) or its virtual IVD laboratory device (50); simulating sample processing in the form of a sample test; evaluating the received test results by said IVD laboratory control software module (3); sending a transport query for a virtual sample from the virtual IVD lab instrumentation (5) or the virtual IVD lab device (50) to the IVD lab control software module (3); Sending a transport order for a virtual sample from the IVD lab control software module (3) to the virtual IVD lab equipment (5) or its virtual IVD lab equipment (50); simulating the transport of the virtual sample within the virtual IVD laboratory instrumentation (5); and / or transmitting positioning information from the virtual IVD lab instruments (5) or the virtual IVD lab equipment (50) to the IVD lab control software module (3), the positioning information relating to a current simulated position of a virtual sample (52) within the virtual IVD lab instruments (5) or the virtual IVD lab equipment (50); The method of claim 1 , comprising:

3. The method, receiving a virtual sample and receiving a test order for the virtual sample; simulating receipt of the virtual sample by the virtual IVD laboratory instrumentation (5) or its virtual IVD laboratory equipment (50); sending a processing query for a virtual sample from the virtual IVD lab instrumentation (5) or the virtual IVD lab device (50) to the IVD lab control software module (3); After receiving the processing query, sending a processing order for the virtual sample generated using the test order for the virtual sample from the IVD laboratory control software module (3) to the virtual IVD laboratory instrumentation (5) or its virtual IVD laboratory device (50); simulating sample processing in the form of sample testing according to test orders of the virtual IVD laboratory equipment (5) or the virtual IVD laboratory equipment (50) by transmitting generated and / or received test results from the virtual IVD laboratory equipment (5) or the virtual IVD laboratory equipment (50) to the IVD laboratory control software module (3); simulating a sample process, wherein the test results are transmitted with a time gap from the start of the simulation of the sample testing, the time gap indicating the time required for the sample testing on the IVD laboratory instrumentation (2) or its IVD laboratory device (20); evaluating the received test results by said IVD laboratory control software module (3); sending a transport query for a virtual sample from the virtual IVD lab instrumentation (5) or the virtual IVD lab device (50) to the IVD lab control software module (3); sending a transport order for the virtual sample from the IVD lab control software module (3) to the virtual IVD lab instruments (5) or the virtual IVD lab instrument (50) after receiving the transport query; simulating the transport of said virtual sample in said virtual IVD laboratory equipment (5) according to a transport order; and / or transmitting positioning information from the virtual IVD lab instruments (5) or the virtual IVD lab equipment (50) to the IVD lab control software module (3), the positioning information relating to a current simulated position of a virtual sample (52) within the virtual IVD lab instruments (5) or the virtual IVD lab equipment (50); The method of claim 1 , comprising:

4. The method of claim 1 , wherein the method includes simulating sample processing by personnel within the IVD laboratory system (10).

5. 2. The method of claim 1, wherein the virtual IVD laboratory equipment (5) comprises exactly one virtual IVD laboratory equipment (50) for each IVD laboratory equipment (20) of the IVD laboratory system (10) to be simulated, each virtual IVD laboratory equipment (50) simulating the communication behavior of a respective one of the IVD laboratory equipment (20).

6. 2. The method of claim 1, wherein the method includes simulating a sample processed in the IVD laboratory system as a virtual sample, and the method includes displaying a visualization of the virtual IVD laboratory equipment along with a visualization of the virtual sample.

7. simulating sample processing within said IVD laboratory instrumentation (2); and Operating the IVD laboratory control software module (3). The method of claim 1 , wherein both are performed in real time.

8. The method comprises: simulating sample processing within said IVD laboratory instrumentation (2) at a simulated time; Operating said IVD laboratory control software module (3) in real time; comparing the time elapsed in the simulation time with the real time; and: increasing the speed of the simulation time if the simulation time lags behind the real time; Slowing down the simulation time if the simulation time is ahead of the real time; or maintaining the speed of the simulation time if the simulation time is at least near the same as the real time; The method of claim 1 , comprising:

9. said IVD laboratory control software module (3) is connected to a data management system (6) for exchanging sample related information (SRI) with said IVD laboratory control software module (3); The method comprises: Exchanging sample related information (SRI) between the IVD laboratory control software module (3) and the data management system (6). The method of claim 1 , comprising:

10. The method comprises: simulating a virtual data management system (56) configured to exchange sample related information (SRI) with said IVD laboratory control software module (3); exchanging sample related information (SRI) between said IVD laboratory control software module (3) and said virtual data management system (56); The method of claim 1 , comprising:

11. 11. A method for designing an IVD laboratory control software module (3) and / or IVD laboratory instrumentation (2) using the method for simulating according to any one of claims 1 to 10, said method for designing comprising the steps of: Step 0: Providing a design for the IVD laboratory control software module (3) and / or IVD laboratory instrumentation (2); Step 1: executing the method for simulating; Step 2: Modifying one or more parameters of the design of the IVD laboratory control software module (3) and / or IVD laboratory instrumentation (2); Step 3: Execute step 1. A method comprising:

12. The method for designing, comprising: Step 4: Repeating steps 2 and 3. The method for designing according to claim 11 , comprising:

13. 12. The method for designing of claim 11, wherein step 1 comprises benchmarking the performance of the IVD laboratory control software module (3) and / or the IVD laboratory instrumentation (2).

14. A method for testing an IVD laboratory control software module (3) and / or an IVD laboratory device (2) using the method for simulating according to any one of claims 1 to 10.

15. A method for testing the operation by personnel of an IVD laboratory system (10) and / or for training personnel to work in an IVD laboratory system (10) using the method for simulating according to any one of claims 1 to 10.

16. A method for designing a virtual IVD laboratory equipment (50) for simulating an IVD laboratory equipment (20) for a method for simulating according to any one of claims 1 to 10, comprising: Recording and / or defining data files being received and / or transmitted by the IVD laboratory device (20); and / or recording and / or defining time gaps between the receipt and / or transmission of said data files by said IVD laboratory device (20); using recorded or defined data files and / or recorded or defined time gaps to create content and / or define the timing of transmission of data files by said virtual IVD lab device (50); A method comprising:

17. A system (1) for simulating an IVD laboratory system (10) for processing biological samples, said IVD laboratory system (10) comprising: IVD laboratory instrumentation (2) comprising one or more IVD laboratory devices (20) for processing biological samples; an IVD laboratory control software module (3) for controlling sample processing within said IVD laboratory equipment (2) and for exchanging sample processing data (SPD) between said IVD laboratory control software module (3) and said IVD laboratory equipment (2); Equipped with The IVD laboratory system (10) Designed for sample processing within said IVD laboratory instrumentation (2) using sample processing data (SPD) provided by said IVD laboratory control software module (3); The system (1), the IVD laboratory control software module (3); a simulation software module (4) comprising virtual IVD laboratory equipment (5) for simulating sample processing within said IVD laboratory equipment (2); Equipped with The system (1), configured to operate the IVD laboratory control software module (3) as if it were operating within the IVD laboratory system (10), wherein sample processing data (SPD) intended to be exchanged between the IVD laboratory control software module (3) and the IVD laboratory equipment (2) is instead exchanged between the IVD laboratory control software module (3) and the virtual IVD laboratory equipment (5); The virtual IVD laboratory equipment (5) configured to simulate sample processing within said IVD laboratory instrumentation (2) using sample processing data (SPD) provided by said IVD laboratory control software module (3); System (1).

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