Automated method for handling in-vitro diagnostic container in in-vitro diagnostic laboratory

An automated method for handling IVD containers by measuring and storing physical quantities in a data carrier to specify handling steps addresses the fragility and contamination risks, enhancing safety and efficiency in IVD processes.

JP2022189820A5Pending Publication Date: 2026-06-25F HOFFMANN LA ROCHE & CO AG

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
F HOFFMANN LA ROCHE & CO AG
Filing Date
2022-06-10
Publication Date
2026-06-25

AI Technical Summary

Technical Problem

Handling of in vitro diagnostic (IVD) containers, such as sample tubes or reagent cartridges, is challenging due to their fragility and the risk of cross-contamination, particularly during automated handling in pre-analytical, analytical, and post-analytical processes.

Method used

An automated method for handling IVD containers involves measuring physical quantities, storing them in a read-and-write data carrier, and specifying handling steps based on these quantities to ensure safe and precise manipulation, including gripping force and position adjustments.

Benefits of technology

The method enhances the safety and efficiency of IVD container handling by reducing the risk of contamination and improving the accuracy of handling operations, ensuring reliable transfer and analysis.

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Abstract

To provide a method for handling an in-vitro diagnostic (IVD) container, such as sample tubes or reagent cartridges, in a laboratory.SOLUTION: An automated method for handling an in-vitro diagnostic IVD container (30) in an IVD laboratory (1) is proposed. The method comprises at least steps of measuring at least one physical quantity of an IVD container (30), storing the at least one physical quantity in a read-writable data carrier (50) attached to the IVD container (30), and retrieving the at least one physical quantity from the read-writable data carrier (50) attached to the IVD container (30).SELECTED DRAWING: Figure 2
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Description

Technical Field

[0001] The present invention relates to the handling of in vitro diagnostic (IVD) containers such as sample tubes or reagent cartridges in IVD. Laboratory Specifically, it relates to the handling of in vitro diagnostic (IVD) containers such as sample tubes or reagent cartridges in IVD.

Background Art

[0002] IVD tests have a significant impact on medical decisions and provide extremely important information to physicians. IVD tests are usually carried out in an IVD which can typically have a fairly large number of IVD test instruments. In IVD, it is necessary to handle a plurality of IVD containers, particularly automatically. Typically, a plurality of IVD containers are each handled by a plurality of IVD devices, for example, first by a pre - analytical IVD, then by an analytical IVD, and later possibly by a post - analytical IVD. IVD containers are often fragile, and any error in handling them can have undesirable or dangerous effects such as cross - contamination, so the handling of IVD containers should be carried out with particular care. Laboratory In IVD Laboratory Inspection equipment Inspection equipment Inspection equipment

[0003]

Summary of the Invention

[0003] The object of the present invention is to provide a method and an apparatus for extending the current state - of - the - art. An automated method for handling IVD containers for in vitro diagnosis, a method for gripping IVD containers in IVD, an IVD designed to analyze biological samples and handle IVD containers, and an IVD container holder for use in an IVD according to the independent claims are proposed. Specific embodiments that can be realized alone or in any combination are described in the dependent claims as well as throughout the specification. Laboratory Laboratory Laboratory Laboratory Laboratory

[0004] Where used below, the terms “have,” “equip,” or “include,” or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms may refer to both situations in which the entity described in this context has no further features beyond those introduced by these terms, and situations in which one or more additional features exist. For example, the expressions “A has B,” “A equips B,” and “A includes B” may all refer to situations in which A has no other elements besides B (i.e., A consists solely and exclusively of B), and situations in which entity A has one or more additional elements besides B, such as element C, elements C and D, or even further elements.

[0005] Furthermore, it should be noted that the terms “at least one,” “one or more,” or similar expressions indicating that a feature or element can exist one or more times are usually used only once when introducing each feature or element. In most cases below, when referring to each feature or element, the expressions “at least one” or “one or more” may not be repeated, despite the fact that each feature or element can exist one or more times.

[0006] Furthermore, where used below, the terms “particularly,” “more particularly,” “specifically,” “more specifically,” or similar terms are used in conjunction with options without limiting the possibility of alternatives. Thus, the features introduced by these terms are optional and are not in any way intended to limit the scope of the claims. The present invention may be implemented by using alternative features as those skilled in the art will recognize. Similarly, features introduced by “in embodiments of the present invention” or similar expressions are intended to be any features without limitation on alternative embodiments of the present invention, without limitation on the scope of the present invention, and without limitation on the possibility of combining such introduced features with other any or non-any features of the present invention.

[0007] IVD Laboratory An automated method for handling IVD containers for in vitro diagnostics has been proposed, and the method comprises at least, - A step of measuring at least one physical quantity of the IVD container, - A step of storing at least one physical quantity in a read-and-write data carrier attached to an IVD container, The process includes the step of obtaining at least one physical quantity from a read-and-write data carrier attached to an IVD container.

[0008] According to some embodiments, the step of measuring is performed by first IVD Inspection equipment It is executed in - The step to obtain is the second IVD Inspection equipment It is executed in [location].

[0009] According to some embodiments, - First IVD Inspection equipment However, IVD before analysis Inspection equipment And, - Second IVD Inspection equipment However, analysis IVD Inspection equipment and / or post-analysis IVD Inspection equipment That is the case.

[0010] According to some embodiments, this method - Includes the step of specifying a container handling step related to the handling of the IVD container based on at least one physical quantity obtained.

[0011] According to some embodiments, the step of specifying a container handling step related to the handling of an IVD container based on at least one physical quantity obtained includes selecting a container handling step.

[0012] According to some embodiments, the step of specifying a container processing step related to handling an IVD container based on at least one physical quantity obtained includes selecting processing parameters for the container processing step.

[0013] According to some embodiments, the step of specifying a container processing step related to the handling of an IVD container based on at least one acquired physical quantity includes specifying the gripping force by which a gripper grips the IVD container.

[0014] According to some embodiments, the step of specifying a container processing step related to the handling of an IVD container based on at least one acquired physical quantity - includes specifying an IVD container holder for holding the IVD container, - specifying a position within the IVD container holder for holding the IVD container, - specifying to transfer the IVD container from a first IVD container holder to a second IVD container holder, and / or - specifying to transfer the IVD container from a first position within an IVD container holder having two or more positions for holding the IVD container to a second position within the container holder.

[0015] According to some embodiments, the method - includes executing the specified container processing steps related to the handling of the IVD container.

[0016] According to some embodiments, the IVD container is a sample container.

[0017] According to some embodiments, the IVD container is a reagent container.

[0018] According to some embodiments, the readable and writable data carrier is attached to the IVD container directly in that it is attached to the IVD container.

[0019] According to some embodiments, the readable and writable data carrier is attached to the IVD container in that it is attached to an IVD container holder for holding the IVD container.

[0020] According to some embodiments, at least one physical quantity includes at least one dimension of at least a portion of the IVD container.

[0021] According to some embodiments, at least one physical quantity is - Wall thickness of IVD container, - External 3D shape of IVD container, - 3D shape of IVD container, - Angle of the IVD container, - The curvature of the IVD container, including one or more of the following.

[0022] According to some embodiments, at least one physical quantity is - Outer diameter of IVD container, - Inner diameter of IVD container, - Height of IVD container, - Volume of the IVD container, and / or - The mass of the IVD container, including one or more of the following.

[0023] IVD Laboratory A method for grasping an IVD container is further proposed, comprising an automated method according to any of the above proposals, and the following steps: - A step of specifying the gripper force with which the gripper grips the IVD container.

[0024] Furthermore, IVDs designed for analyzing biological samples and handling IVD containers. Laboratory and one or more IVDs Inspection equipment IVD equipped Laboratory , and IVD designed to perform one of the methods proposed above Laboratory This is proposed.

[0025] According to some embodiments, IVD Laboratory teeth, - A measuring unit designed to measure at least one physical quantity of an IVD vessel, - A storage unit designed to store at least one physical quantity in a read-and-write data carrier mounted on an IVD container, - comprising an acquisition unit designed to acquire at least one physical quantity from a read-and-write data carrier mounted in an IVD container.

[0026] According to some embodiments, the measurement unit is pre-analysis IVD Inspection equipment The acquired unit is included in the analysis IVD. Inspection equipment and / or post-analysis IVD Inspection equipment It is included in.

[0027] According to some embodiments, the measurement unit is pre-analysis IVD Inspection equipment and / or Analysis IVD Inspection equipment The recovery unit is included in the pre-analysis IVD Inspection equipment and / or Analysis IVD Inspection equipment and / or post-analysis IVD Inspection equipment It is included in.

[0028] According to some embodiments, - One or more IVDs Inspection equipment At least one of them is equipped with a gripper designed to grasp an IVD container, - IVD Laboratory It is designed to specify the gripper force with which the gripper grips the IVD container based on at least one physical quantity.

[0029] According to some embodiments, the measuring unit is - Camera, - reflector, - Luminous body, - Photodetector, - Laser, - Lidar system, - Mass sensor, and / or - Equipped with one or more artificial intelligence units.

[0030] According to some embodiments, IVD Laboratory It comprises multiple IVD container holders, each designed to hold one or more IVD containers and each having a read and writeable data carrier, - The memory unit is designed to store the physical quantities of the IVD container within a read-and-write data carrier contained in the IVD container holder. - The acquisition unit is designed to acquire physical quantities of the IVD vessel from a read-and-write data carrier contained within the IVD vessel holder.

[0031] According to some embodiments, IVD Laboratory It is equipped with multiple IVD containers, - Each IVD container is fitted with a read-and-write data carrier. - The memory unit is designed to store the physical quantities of the IVD container within a read-and-write data carrier attached to the IVD container. - The acquisition unit is for acquiring physical quantities of the IVD container from a read-and-write data carrier attached to the IVD container.

[0032] According to some embodiments, IVD Laboratory It comprises at least one control unit, and the control unit comprises at least one IVD Inspection equipment It is designed to control at least partially.

[0033] For example, the IVD proposed herein Laboratory IVD Laboratory An IVD container holder for use in the following has been proposed: - The IVD container holder is designed to hold IVD containers. - The IVD container holder is o A container detection sensor designed to detect whether an IVD container is being held by an IVD container holder, o comprising a read-and-write data carrier designed to store physical quantities associated with an IVD container, - The IVD container holder is designed to erase the physical quantities associated with the IVD container from the read and writeable data carrier when the container detection sensor detects that the IVD container is no longer held by the IVD container holder.

[0034] According to some embodiments, the container detection sensor includes a spring mechanism, and a spring load greater than a threshold indicates that the IVD container is being held by the IVD container holder.

[0035] According to some embodiments, - The IVD container holder has multiple positions for holding the IVD container, - The container detection sensor is designed to detect the position in which the IVD container is held. - The read-and-write data carrier is designed to store physical quantities associated with the IVD container, along with information indicating the position in which the IVD container is held. [Brief explanation of the drawing]

[0036] Further optional features and embodiments are disclosed in more detail in subsequent descriptions of embodiments, for example, in conjunction with dependent claims. Therein, each optional feature may be implemented independently and in any viable combination, as will be understood by those skilled in the art. The scope is not limited by the illustrated embodiments. Embodiments are schematically shown in the figures, where the same reference numerals in these figures generally refer to identical or functionally equivalent elements.

[0037] The diagram is as follows.

[0038] [Figure 1] A flowchart illustrating an embodiment of an automated method for handling in vitro diagnostic containers is shown. [Figure 2] This shows a schematic embodiment of an in vitro diagnostic laboratory. [Figure 3] A flowchart illustrating further embodiments of this method is shown. [Figure 4] This shows an exemplary storage structure of a read-and-write data carrier mounted in an IVD container. [Figure 5] This flowchart shows a method for grasping an IVD container. [Figure 6A1] This illustrates an exemplary embodiment of a pre-analysis IVD testing instrument that measures and stores the physical quantities of an exemplary IVD container. [Figure 6A2] This illustrates an exemplary embodiment of a pre-analysis IVD testing instrument that measures and stores physical quantities of an exemplary IVD container. [Figure 6B] This shows an exemplary embodiment of an analytical IVD testing instrument for analyzing samples in IVD containers. [Figure 6C] This shows the post-analysis IVD testing equipment that accepts IVD containers. [Figure 7A] Further exemplary embodiments of IVD containers within analytical IVD testing equipment are shown. [Figure 7B] Further exemplary embodiments of IVD containers within analytical IVD testing equipment are shown. [Figure 8A] This shows embodiments of the physical quantities of an IVD container. [Figure 8B] This shows embodiments of the physical quantities of an IVD container. [Figure 9] This shows an embodiment of an IVD container holder equipped with a container detection sensor. [Figure 10] This shows an embodiment of one IVD container in an IVD container holder designed to hold three IVD containers. [Figure 11] This shows an embodiment of an IVD container in an IVD container holder equipped with a different type of container detection sensor. [Modes for carrying out the invention]

[0039] The use of specific terms herein, and their formulations, should not be interpreted as being limited by the selected specific terms, but rather as relating to the general concepts behind those terms.

[0040] IVD Laboratory An automated method for handling the in vitro diagnostic (IVD) container 30 in 1 is proposed. This method includes at least, - A step of measuring at least one physical quantity of the IVD container 30 (reference numeral 110), - A step (reference numeral 112) of storing at least one physical quantity in a read-and-write data carrier 50 attached to an IVD container 30, - The step (reference numeral 114) of obtaining at least one physical quantity from a read-and-write data carrier 50 attached to an IVD container 30.

[0041] The method includes, for example, the steps described above, which can be performed in a given order. According to some embodiments, the method may include performing one or more method steps once or repeatedly. For example, measurement and storage may be repeated during the method if an error is acquired, such as a storage error. Furthermore, it is possible to perform two or more method steps simultaneously or in overlapping order. The method may include further method steps not described. An exemplary flowchart embodiment of a method for handling an IVD container 30 is shown, for example, in Figure 1. In the exemplary embodiment of Figure 1, the measurement step 110, the storage step 112, and the reading step 114 may be performed in a given order. Furthermore, as shown as an optional step, the method may include a step 116 that specifies a container handling step related to handling the IVD container 30 based on at least one physical quantity acquired.

[0042] As used herein, the term “automated” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, the method steps described above can be performed without using manual actions and without user interaction. According to some specific embodiments, all steps between the method steps described above can be performed without using manual actions and without user interaction. However, at least some steps between the method steps described above may be performed using manual actions or interactions by the user. For example, after the measuring and storing steps described above have been performed without using manual actions and without user interaction, the IVD container may be interacted with by the user (e.g., different IVDs by the user) Inspection equipment (transported to), thereafter the acquisition steps described above are performed again without using manual action and without user interaction. For example, manual action / user interaction may include one or more of the following: positioning the IVD container holder 40 and / or IVD container 30, selecting the IVD container holder 40 and / or IVD container 30, positioning the measuring unit 20, cleaning, etc. According to a particular embodiment, the method steps are performed without manual action, in particular, for the IVD Laboratory It may be fully executed by 1 (for example, controlled by one or more control units 23).

[0043] According to some embodiments, the method step is IVD Laboratory This may be performed by a measurement unit 20, a storage unit 21, and an acquisition unit 22. - The measuring unit 20 is designed to measure at least one physical quantity of the IVD container 30, - The memory unit 21 is designed to store at least one physical quantity within a read-and-write data carrier 50 attached to the IVD container 30. - The acquisition unit 22 is designed to acquire at least one physical quantity from a read-and-write data carrier 50 attached to the IVD container 30.

[0044] According to some embodiments, the measurement unit 20, the storage unit 21, and the acquisition unit 22 are IVD Inspection equipment It may be included in 10.

[0045] According to some embodiments, the first IVD Inspection equipment 10 comprises a measuring unit 20 and a storage unit 21, and the measurement and storage method step is its first IVD Inspection equipment Executed in 10, the second IVD Inspection equipment 10 comprises an acquisition unit 22, and the acquisition method step is its second IVD Inspection equipment It is performed in 10. According to some specific embodiments, a plurality of second IVDs Inspection equipment Each of the 10 is equipped with an acquisition unit 22, and the acquisition method step is the second IVD Inspection equipment It is executed in each of the 10.

[0046] According to the embodiment, at least one physical quantity of the IVD container 30 is one or more first IVDs Inspection equipment (For example, a single pre-analysis IVD) Inspection equipment such as a single IVD 1 Inspection equipment (by) measured and stored in a read-and-write data carrier 50 attached to the IVD container 30, and at least one physical quantity is measured and stored in multiple downstream IVDs Inspection equipment (For example, multiple downstream IVDs) Inspection equipment All of these were IVD before analysis. Inspection equipment If not, the data is obtained from a read-and-write data carrier 50 attached to the IVD container 30. Thus, once a physical quantity is measured and stored, it is then stored in all downstream IVDs, for example. Inspection equipment This allows it to be used multiple times downstream.

[0047] According to some embodiments, IVD Inspection equipment One or more of the 10 may include at least one control unit 23 designed to control the measurement and storage method steps.

[0048] According to some embodiments, IVD Inspection equipment One or more of the 10 may include at least one control unit 23 designed to control the acquisition method steps.

[0049] According to some embodiments, IVD Laboratory is, IV Laboratory IVD 1 Inspection equipment The system may include a centralized control unit 23 designed to control at least some, for example, all, of the 10 method steps, such as starting and monitoring the measurement, storage, and acquisition process.

[0050] According to some embodiments, the control unit 23 may be designed to initiate and monitor the measurement, storage, and / or acquisition method steps so that the method can be performed automatically, as outlined above. For example, the control unit 23 may be designed to control a measurement unit 20 for performing measurements, a storage unit 21 for performing storage, and / or an acquisition unit 22 for performing acquisitions.

[0051] According to some embodiments, the proposed method is automated in the sense that the measurement, storage, and acquisition method steps are fully controlled by one or more control units 23.

[0052] As used herein, the term “in vitro diagnostic (IVD)” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. In vitro diagnostic may include performing at least one test on a sample, for example, a biological sample taken from a human or animal body. An in vitro diagnostic test may specifically refer to the detection of an analyte of interest in a biological sample and / or another characteristic of the biological sample, but is not limited to that. As used herein, the term “analyte” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. This term may specifically refer to the components of the sample being analyzed, for example, molecules of various sizes, ions, proteins, metabolites, etc. As used herein, the term “detecting an analyte in a biological sample” is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. This term may specifically refer to the quantitative and / or qualitative determination of at least one analyte in a biological sample, but is not limited to that. The result of the decision may, for example, be the concentration of the analyte and / or the presence or absence of the analyte being evaluated.

[0053] In vitro diagnostic tests can help detect diseases or other conditions and can be used to monitor a person's overall health to aid in the treatment, management, or prevention of diseases. In vitro diagnostics can also be used in precision medicine to identify patients who are likely to benefit from a particular treatment or therapy. In vitro diagnostic tests can assist in medical diagnosis and decision-making.

[0054] As used herein, the term “biological sample” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, a biological sample may be, or may contain, at least one biological material which may potentially contain at least one analyte of interest. For example, a biological sample may include body fluids, such as blood, interstitial fluid, urine, saliva, or other types of body fluids. For example, a biological sample may be, or may contain, an aliquot of a substance such as a biological compound. Specifically, a biological sample may be, or may contain, at least one biological sample, such as one or more of blood, serum, plasma, urine, and saliva.

[0055] According to some embodiments, the biological sample may be a liquid sample. For example, the liquid sample may be at least one pure liquid, such as a liquid substance containing a biological substance and / or a solution containing one or more liquid substances, or may include such a liquid sample. In another example, the liquid sample may be a liquid mixture, such as a suspension, emulsion, and / or dispersion of a biological substance, or may include such a mixture. According to some embodiments, the biological sample may be a solid sample, for example, at least one sample of tissue.

[0056] The term "IVD" as used herein Laboratory The term "IVD" is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, IVD Laboratory 1 is designed to perform at least one test on a sample, for example, a biological sample taken from the body of a human or animal (and / or their respective quality control (QC) sample). LaboratoryThis can be done. For example, testing a sample may include applying at least one reagent to the sample and monitoring for a detectable reaction. According to some embodiments, IVD Laboratory 1 is clinical Laboratory It may also be possible. According to some embodiments, IVD Laboratory 1 is medical Laboratory It may also be possible. According to some embodiments, IVD Laboratory 1 is forensic medicine Laboratory Or a blood bank.

[0057] The term "IVD" as used herein Inspection equipment The term "IVD" is a broad term and should be given its usual, customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Inspection equipment The term "pre-analysis IVD" refers to the pre-analysis IVD Inspection equipment 10PRE, post-analysis IVD Inspection equipment 10POST, analysis IVD Inspection equipment It can include 10ANA and the transport system 10TRANS.

[0058] Figure 2 shows IVD Laboratory An example of 1 is shown very simply. IVD in Figure 2. Laboratory 1 is an example of pre-analysis IVD. Inspection equipment 10PRE, two analyses IVD Inspection equipment 10 ANAs and 1 post-analysis IVD Inspection equipment It is equipped with 10POST. Furthermore, it is an IVD in the form of a transfer system 10TRANS. Inspection equipment via pre-analysis IVD Inspection equipment Further IVD from 10PRE Inspection equipment 10ANA and IVD Inspection equipment The IVD container holder 40 is shown to be transferred to 10POST. As shown in Figure 2, the IVD Laboratory The system 1 may include at least one control unit 23 and a data management unit 24.

[0059] As used herein, the term “IVD container” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning.

[0060] According to some embodiments, the IVD container 30 may be, or include, at least one container designed to contain contents contained in a container, such as a sample, for example, a liquid sample, or a reagent, for example, a fluid reagent. According to some embodiments, the IVD container 30 may be, for example, a sample container containing (and / or respective quality control (QC) samples). According to some embodiments, the IVD container 30 may be an IVD container other than a sample container, for example, a reagent container designed to contain at least one reagent.

[0061] According to some embodiments, the IVD container 30 may be or include at least one sample tube. The term “sample tube” as used herein is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, the sample tube may be any individual container for storing and / or processing the contents to be received by the sample tube. According to some embodiments, the sample tube may be a laboratory glass or plastic product optionally having a cap at its upper end. For example, the sample tube may be a glass or plastic tube. According to certain embodiments, the sample tube may be a cylindrical tube, for example, a cylindrical tube having a circular and / or polygonal cross-section. Other types or forms of sample tubes are also possible.

[0062] Figures 2, 6A1 to 6C, 8A, 8B, 9, 10, and 11 show exemplary embodiments of the IVD container 30 designed as a sample tube. Figures 7A and 7B show further exemplary embodiments of the IVD container 30 designed as a cartridge.

[0063] As used herein, the term “handling” an IVD container is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, handling may include performing one or more container handling steps, such as grasping the IVD container 30, moving the IVD container 30 (including rotating it), placing the IVD container 30 into or out of the IVD container holder 40 and / or lifting it, and placing and / or removing the samples contained in the IVD container 30 (each part thereof). According to some embodiments, handling may include simultaneous and / or parallel handling of multiple IVD containers 30.

[0064] As used herein, the term “physical quantity” of the IVD container 30 is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, at least one physical quantity may include at least one dimension of at least a part of the IVD container 30, such as wall thickness, 3D shape, angle, curvature, etc. According to some embodiments, the physical quantity of the IVD container 30 may be the result of a physical measurement determined by at least one measurement, such as a dimensional measurement of the IVD container 30, and / or a calculation using such physical measurement. The measurement may be performed by at least one measuring unit 20, e.g., a pre-analysis IVD in which the IVD container 30 is first handled. Inspection equipment Upstream IVD such as Inspection equipmentThe measurement may be performed using the measurement unit 20. According to some embodiments, the physical quantities of the IVD container 30 may be the physical quantities of the individual IVD containers 30 whose physical quantities have been measured. For example, the physical quantities may differ from one IVD container 30 to another, even if the IVD containers 30 are of the same type, from the same batch, from the same manufacturer, and / or manufactured using the same process and / or the same machine. For example, the inner diameter of a first IVD container 30 may differ from the inner diameter of a second IVD container 30 of the same type. According to certain embodiments, the physical quantities may be actual physical values ​​determined by measurement. For example, the physical quantities may deviate from nominal values ​​such as batch specifications or manufacturer specifications. According to some embodiments, measuring the physical quantities of the IVD container 30 may include determining at least one quantity such as height, diameter, and mass. For example, the physical quantities of the IVD container 30 may be expressed as a combination of numerical values ​​and units, for example, as the wall thickness of a sample tube of 1.5 millimeters. For example, a measurement of at least one physical quantity may include one or more of the following: at least one length measurement, at least one thickness measurement, at least one mass measurement, at least one angle measurement, and at least one curvature measurement.

[0065] According to some embodiments, the measurement may include spectral measurement. The results of the spectral measurement can be used, for example, to calculate physical quantities in the form of dimensions of the IVD container 30.

[0066] According to some embodiments, at least one physical quantity is - Wall thickness of IVD container 30 - External 3D shape of IVD container 30, - 3D shape of IVD container 30, - Angle of IVD container 30, - The curvature of the IVD container 30, including one or more of the following.

[0067] Figures 8A and 8B show an exemplary IVD container 30 and its physical quantities. In Figure 8A, the IVD container 30 is shown in a cross-sectional view along A, and in Figure 8B, the IVD container 30 is shown in a cross-sectional view along an axis perpendicular to A. The physical quantities can be measured, for example, using a LIDAR system in combination with an artificial intelligence unit, which is trained using data including, for example, the results of measurements using the LIDAR system, as well as target values ​​for the physical quantities to be measured.

[0068] The angle of the IVD container 30 can be determined, for example, using the angle between two edges of each surface. The curvature of the IVD container 40 can be determined, for example, using the reciprocal of the radius. The radius can be determined, for example, using half the value of the diameter. The diameter can be determined, for example, using the distance between two points on the IVD container 30.

[0069] The wall thickness T of the IVD container 30 is, for example, the inner diameter D of the IVD container 30. in It can be determined using the difference between and the outer diameter Dout, and / or using the distance between a first point on the first (e.g., outside) side of the wall and a specific second point on the second (e.g., inside) side of the wall.

[0070] The IVD container 30 may have an inner and outer side separated by a surface. The surface may have an outer side facing outwards and an inner side facing inwards. According to some embodiments, the surface may be curved. For example, the surface may be cylindrical with a circular and / or polygonal cross-section, a circular and / or polygonal open end, and a closed curved end. The cross-section may be uniform along the height of the IVD container 30, or may vary along the height of the IVD container 30. According to some embodiments, the outer 3D shape of the IVD container 30 may be a course on the outer side of the IVD container 30 along the height of the IVD container 30. According to some embodiments, the 3D shape of the IVD container 30 may be a course on the outer and inner sides of the IVD container 30 along the height of the IVD container 30.

[0071] The external 3D shape of the IVD container 30 is defined by the height H, the length of the cylindrical portion of the IVD container 30, the curvature s of the (e.g., outer) curved portion of the IVD container 30, and the outer diameter D. out , outer radius R out The 3D shape of the IVD container 30 can be determined using one or more of the (e.g., outer) angle of the IVD container 30 and the deviation of the IVD container 30 from its nominal value. in , inner diameter R in The IVD container 30 can be further defined using one or more of the curvature s of the (e.g., internal) curved portion, the (e.g., internal) angle of the IVD container 30, and the deviation of the IVD container 30 from its nominal value.

[0072] According to some embodiments, at least one physical quantity includes one or more of the outer diameter of the IVD container 30, the inner diameter of the IVD container 30, the height of the IVD container 30, the volume of the IVD container 30, and / or the mass of the IVD container 30.

[0073] The physical quantities may differ from the so-called tube identification information that can be assigned to the IVD container 30, as they belong to a specific tube type or batch of the IVD container 30. The physical quantities may also differ from the nominal data relating to the IVD container 30.

[0074] According to some embodiments, physical quantities of multiple sections of the IVD container 30 may be measured, and at least one physical quantity to be stored / acquired may be, for example, multiple measured physical quantities (e.g., wall thickness in different sections), the average of the measured physical quantities, the minimum value of the measured physical quantities, the maximum value of the measured physical quantities, and / or a value calculated using the measured physical quantities. The minimum wall thickness of the IVD container 30 can be used, for example, to specify the gripping force of a gripper that grips the IVD container in that area.

[0075] As used herein, the term “read-and-write data carrier” is a broad term and should be given its usual customary meaning to those skilled in the art, and not limited to any special or customized meaning. The read-and-write data carrier 50 may be a read-and-write data carrier. The read-and-write data carrier 50 may be, or comprise, a memory device designed to store data. According to some embodiments, the read-and-write data carrier 50 is an electronic, magnetic, and / or mechanical memory device. According to some embodiments, the read-and-write data carrier 50 may be further designed to store data in an organized manner, such as within a database, more specifically within at least one table. According to some embodiments, the read-and-write data carrier 50 may be designed to enable access to and / or retrieve data stored in the read-and-write data carrier 50 and / or store data in the read-and-write data carrier 50. According to some embodiments, the read-and-write data carrier 50 is designed for wireless storage and / or wireless retrieval of data within the read-and-write data carrier 50 by using radio frequency electromagnetic radiation, for example, by using the NFC standard.

[0076] According to some embodiments, the read-and-write data carrier 50 may be at least one RFID chip, which may also be called an RFID tag. The term “RFID chip” as used herein is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, the RFID chip may comprise an electronic chip, such as a microchip, for storing data. According to some embodiments, the RFID chip may comprise a coil or antenna and a circuit designed to transmit and receive signals with the coil or antenna. For example, the RFID chip may be designed as an RFID assembly as described in U.S. Patent Application Publication No. 2010 / 0021352, the full contents of which are included by reference.

[0077] According to some embodiments, the read-and-write data carrier 50, for example, an RFID chip, may be a tag designed to exchange data with a write and / or acquire device by using radio frequency electromagnetic radiation, such as by using the NFC standard.

[0078] According to some embodiments, the readable and writable data carrier 50, for example, an RFID chip, may be a tag designed to be powered by a passive tag, for example, an RFID reader (for example, using induction via the coil of the passive tag).

[0079] According to some embodiments, the readable and writable data carrier 50, for example, an RFID chip, may be an active tag designed to be powered, for example, by a built-in energy storage device.

[0080] According to some embodiments, a read-and-write data carrier 50, such as an RFID chip, may comprise an antenna designed to receive and radiate radio frequency signals, and an electronic chip such as a microchip designed to store data in one or more memories.

[0081] Storing a physical quantity may include storing a measured physical quantity in a read-and-write data carrier 50 for subsequent acquisition. According to some embodiments, storing a measured physical quantity may include writing the measured physical quantity to at least one memory of the read-and-write data carrier 50. According to some embodiments, the read-and-write data carrier 50 may comprise multiple memories, such as system memory and user memory, the user memory may provide a read-and-write data storage device. According to some embodiments, the read-and-write data carrier 50 may comprise a system memory having a unique identifier for each read-and-write data carrier 50, and a user memory having one or more of a sample identifier, sample status data, and sample container data, for example, at least one measured physical quantity being stored as sample container data. According to some embodiments, the unique identifier may be an element or combination of elements designed to store one or more information items that identify the read-and-write data carrier 50 in a readable format, specifically a machine-readable format, etc. According to some embodiments, the sample identifier may be an element or combination of elements designed to store one or more information items that identify the sample and / or IVD container 30. According to some embodiments, the information stored in a unique identifier and / or sample identifier can be read using a suitable reading device. For example, the unique identifier and / or sample identifier may include an identification number. For example, the identification number may be one or more sequences or arrays of numbers and / or characters that encode the identification information. According to some embodiments, the identification number may be unique to a particular IVD container 30. This makes it possible to identify a particular IVD container 30 according to its respective identification number. According to some embodiments, the reading of physical quantities by the acquisition unit 22 may be performed in connection with the reading of an identification number, which may be useful, for example, when handling multiple IVD containers 30.

[0082] Figure 4 shows a schematic diagram of an exemplary storage pattern of a read-and-write data carrier 50, which comprises a system memory having a unique identifier for the data storage device, a user memory having a sample identifier, sample status data, and sample container data. In this embodiment, physical quantities may be stored in the user memory, for example, as sample container data.

[0083] As used herein, the term “mounted in an IVD container” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, a read-and-write data carrier 50 is mounted in an IVD container 30. directly For example, a readable and writable data carrier 50 is attached in contact with the IVD container 30 and attached to the IV container 30, at least typically, Laboratory It can be attached to the IVD container 30 in such a way that it is attached so as not to be removed during normal handling of the IVD container 30.

[0084] According to some embodiments, the read-and-write data carrier 50 may be attached to the IVD container 30 in such a way that the IVD container 30 includes the read-and-write data carrier 50.

[0085] According to some embodiments, the read-and-write data carrier 50 may be attached to the IVD container 30 in such a way that the read-and-write data carrier 50 is attached to the IVD container 30. According to some embodiments, the IVD container 30 may be a sample tube, and the read-and-write data carrier 50 may be bonded to the surface of the sample tube via an adhesive.

[0086] According to some embodiments, the read-and-write data carrier 50 can be attached to the IVD container 30 in such a way that it is attached to an IVD container holder 40 for holding the IVD container 30.

[0087] According to some embodiments, the read-and-write data carrier 50 may be linked to, for example, a separable or inseparable IVD container 30. For example, the link between the writable data carrier 50 and the IVD container 30 may be a spatial link.

[0088] According to some embodiments, the read-and-write data carrier 50 may be attached to the IVD container 30 in such a way that the read-and-write data carrier 50 is a local data carrier that moves with the IVD container 30. For example, the read-and-write data carrier 50 may be in the vicinity of the IVD container 30 during the storage and / or retrieval steps of the IVD container 30. According to some specific embodiments, the read-and-write data carrier 50 is attached to the IVD container 30 such that it remains in the nearby IVD container 30 between the storage and retrieval steps. For example, the read-and-write data carrier 50 may be located at a distance of 0.05 meters or less, for example 0.01 meters or less, specifically 0.001 meters or less, from the IVD container 30.

[0089] According to some embodiments, the read-and-write data carrier 50 may be applied to the IVD container 30 and / or IVD container holder 40 by using a material closure, such as bonding the read-and-write data carrier 50 to the IVD container 30 and / or IVD container holder 40.

[0090] According to some embodiments, the read-and-write data carrier 50 may be attached to the IVD container 30 by a self-adhesive surface of the read-and-write data carrier 50.

[0091] Figures 6A1 to 6C, 7A, 7B, and 9, 10, and 11 show different options for mounting the read-and-write data carrier 50 to the IVD container. Specifically, Figures 6A1 to 6C, 7A, and 7B show different options for mounting the IVD container 30 to the IVD container 30. directly The mounted read-and-write data carrier 50 is shown. In this case, as shown in Figures 6A1 to 6C, the read-and-write data carrier 50 is positioned, for example, above the barcode and / or name field (indicated by “Test” in Figures 6A1 to 6C). In Figures 9, 10, and 11, the read-and-write data carrier 50 is shown mounted on the IVD container 30 via an IVD container holder 40. In this case, the read-and-write data carrier may be located on the side of the IVD container holder 40.

[0092] According to some embodiments, a single read-and-write data carrier 50 is used to store at least one physical quantity in a single IVD container 30. According to the embodiment, the single read-and-write data carrier 50 is used in a single IVD container 30, for example as shown in Figures 6A1 to 6C, 7A and 7B. directly It is attached, for example, by being glued.

[0093] According to some embodiments, a single read-and-write data carrier 50 is used to store at least one physical quantity of one or more IVD containers 30 held in a single IVD container holder 40. According to embodiments, a single read-and-write data carrier 50 is used in a single IVD container holder 40 that can hold one or more IVD containers 30. directly It can be installed. Examples are shown in Figures 9 to 11.

[0094] According to some embodiments, a single read-and-write data carrier 50 is used to store at least one physical quantity of a plurality of IVD containers 30. According to the embodiment, the single read-and-write data carrier 50 is used in a single IVD container holder 40 that can hold a matrix of a plurality of, for example, IVD containers 30. directly It can be attached. An example is shown in Figure 10.

[0095] According to some embodiments, the physical quantities may further be stored in a centralized database for storing the physical quantities of multiple IVD containers. The centralized database may be stored on a server, for example, a cloud server. Storing in a centralized database allows, for example, backing up the physical quantities, providing the physical quantities to instruments that cannot read a single read-and-write data carrier 50, and / or collecting the physical quantities for statistical and / or QC-related purposes.

[0096] As used herein, the term “IVD container holder” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, the IVD container holder 40 can be a device designed to receive at least one IVD container 30. According to some embodiments, the IVD container holder 40 is designed to enclose and hold the IVD container 30 at least partially. According to some embodiments, the IVD container holder 40 comprises at least one section designed to be negative with respect to at least a portion of the IVD container 30 to be accommodated, for example, its lower part. The IVD container 30 held within the IVD container holder 40 is, for example, an IVD container in the sense that the IVD container holder 40 is moved. Laboratory It may be moved by a transport system 10TRANS.

[0097] According to some embodiments, the IVD container holder 40 may be designed to accept a plurality of IVD containers 30. In some embodiments, the IVD container holder 40 may be a rack designed to hold a plurality of IVD containers 30. According to some specific embodiments, the IVD container holder 40 may have a plurality of convex openings that can open upward, for example. Figure 10 shows an exemplary embodiment of such an IVD container holder 40, which is embodied here as a rack. The illustrated IVD container holder 40 is designed to hold up to three IVD containers 30, and in Figure 10, one IVD container 30 held within the IVD container holder 40 is shown exemplary. In the embodiment shown in Figure 10, a read-and-write data carrier 50 is attached to the IVD container 30 in that it is attached to the IVD container holder 40.

[0098] According to some embodiments, the IVD container holder 40 may include a matrix shape pattern of the opening.

[0099] According to some embodiments, the IVD container holder 40 may be a container holder designed to accept at most one IVD container 30. An example of this is shown, for example, in Figures 6A1 to 6C. For example, the IVD container holder 40 may be designed as a pack that can have a tube receiving opening designed to accept the IVD container 30.

[0100] According to some embodiments, acquiring at least one physical quantity from the read-and-write data carrier 50 may include reading at least one physical quantity from the read-and-write data carrier 50. According to some embodiments, acquiring at least one physical quantity from the read-and-write data carrier 50 may include at least one process of acquiring at least one physical quantity from the read-and-write data carrier 50. According to some embodiments, the acquisition may be initiated by an acquisition unit 22 or another entity (e.g., a control unit 23).

[0101] According to some embodiments, at least one physical quantity may be acquired through one or more interfaces, such as a data interface. The interface can form a boundary configured to transfer data. The interface can provide means for exchanging data. According to some embodiments, the interface can provide a data transfer connection such as Bluetooth®, NFC, or inductive coupling.

[0102] According to some embodiments, acquiring at least one physical quantity may be performed by using an acquisition unit 22 comprising at least one RFID reader. The RFID reader may be designed to read the RFID chip by using radio frequency electromagnetic radiation. Specifically, the RFID reader may be designed to read information stored in the RFID chip by decoding radio frequency signals. The RFID reader may comprise, for example, an NFC standard communication interface or an NFC reader.

[0103] According to some embodiments, obtaining physical quantities may include obtaining one or more of the following: the wall thickness of the IVD container 30, the outer 3D shape of the IVD container 30, the 3D shape of the IVD container 30, the angle of the IVD container 30, and the curvature of the IVD container 30.

[0104] According to some embodiments, the step of measuring is performed by first IVD Inspection equipment This may be performed in step 10, and the step to obtain is the second IVD Inspection equipment Executed in 10. First IVD Inspection equipment 10 and the second Inspection equipment 10 is, for example, pre-analysis IVD Inspection equipment 10PRE, analytical IVD Inspection equipment 10ANA and / or post-analysis IVD Inspection equipment It can be set to 10 POST.

[0105] According to some specific embodiments, the first IVD Inspection equipment 10 is the IVD before analysis. Inspection equipment It may also be 10PRE, the second IVD Inspection equipment 10 is Analysis IVD Inspection equipment 10ANA and / or IVD after analysis Inspection equipment 10 POST is also acceptable.

[0106] According to some embodiments, IVD Inspection equipment 10 may be any apparatus or apparatus component or apparatus section designed to perform at least one container processing step of one or more IVD containers 30 containing samples and / or reagents. For example, pre-analytical IVD Inspection equipment 10PRE may include one or more instrument sections for different processes of sample preparation, etc. According to some embodiments, IVD Inspection equipment At least one of the 10 may be designed to perform one or more container processing steps, such as centrifugation, aliquoting, pipetting, mixing, dispensing, and sample analysis.

[0107] According to some embodiments, pre-analysis IVD Inspection equipment 10PRE may be one or more devices for performing one or more pre-analytical container processing steps on one or more IVD containers 30, such as samples contained in IVD containers 30, or may include such devices.

[0108] According to some embodiments, pre-analysis IVD Inspection equipment 10PRE can be designed to prepare IVD containers 30, particularly samples contained in IVD containers 30, for one or more subsequent analytical tests. For example, pre-analytical container preparation steps may include centrifugation, capping, decapping or re-capping, aliquoting, adding buffer to the sample, and so on.

[0109] According to some embodiments, pre-analysis IVD Inspection equipment 10PRE can be designed to pre-treat biological samples before use, such as centrifugation of plasma from blood, dilution of viscous fluids, and dissolution. According to some embodiments, pre-treatment may include filtration, distillation, concentration, inactivation of interfering components, and addition of reagents. According to some embodiments, pre-analytical IVD Inspection equipment 10PRE is designed to render solid or semi-solid biological sample liquids by first dissolving or suspending them in a suitable liquid medium.

[0110] According to some embodiments, post-analysis IVD Inspection equipment 10POST may be designed to perform at least one post-analysis container processing step. According to some embodiments, post-analysis IVD Inspection equipment 10POST can be designed to automatically process, store, and / or place one or more samples. For example, the post-analysis container processing step may include a capping or re-capping step, a step to retrieve the sample from the IVD container 30, or a step to transfer the IVD container 30 to a storage unit or a unit for collecting biological waste.

[0111] According to some embodiments, analysis IVD Inspection equipment 10ANA may be designed to obtain at least one measurement of a sample, for example, a component of the sample. According to some embodiments, analytical IVD Inspection equipment10ANA can be made operational to determine measurements of a sample or its components through various chemical, biological, physical, optical, or other technical procedures. For example, analytical IVD Inspection equipment 10ANA can be made operable to measure a measurement of a sample (e.g., at least one of its analytes) and return the measured measurement.

[0112] According to some embodiments, analysis IVD Inspection equipment The list of possible measurements returned by ANA may include, but is not limited to, the concentration of the analyte in the sample, a digital (yes or no) result indicating the presence of the analyte in the sample (corresponding to concentrations above the detection level), optical parameters, DNA or RNA sequences, data obtained from mass spectrometry of proteins or metabolites, and various types of physical or chemical parameters.

[0113] According to some embodiments, the analysis of a biological sample may include detecting at least one analyte of interest in the biological sample. According to some embodiments, detecting an analyte in a biological sample may be a quantitative and / or qualitative determination of at least one analyte in the biological sample. For example, the result of the analytical measurement may be the concentration of the analyte and / or the presence or absence of the analyte to be determined. Examples of analytes in a biological sample may be molecules of various sizes, ions, proteins, metabolites, etc.

[0114] According to some embodiments, analysis IVD Inspection equipment The 10ANA may comprise at least one unit designed to assist in the pipetting, administration, and / or mixing of samples and / or reagents.

[0115] According to some embodiments, analysis IVD Inspection equipmentThe 10ANA may include a reagent holding unit for holding reagents to perform an assay, for example, the reagent holding unit may be implemented as an IVD container 30 or contained within it. For example, the reagents may be contained in an IVD container 30 or multiple IVD containers 30, each containing an individual reagent or a group of reagents, and for example, the IVD containers 30 may be arranged in at least one IVD container holder 40.

[0116] According to some embodiments, analysis IVD Inspection equipment 10ANA may be equipped with a consumables supply unit.

[0117] According to some embodiments, analysis IVD Inspection equipment 10ANA can feature processes and detection systems whose workflows are optimized for specific types of analysis.

[0118] According to some embodiments, analysis IVD Inspection equipment 10ANA may be a clinical chemistry analyzer, a coagulation chemistry analyzer, an immunochemistry analyzer, a urine analyzer, a nucleic acid analyzer, a morphological staining agent, or a tissue analyzer and histochemical strainer.

[0119] According to some embodiments, analysis IVD Inspection equipment 10ANA can be designed to detect the outcome of a chemical or biological reaction, or to monitor the progress of a chemical or biological reaction.

[0120] The distinction between pre-analysis, analysis, post-analysis, and transport is, for example, different IVDs. Inspection equipment Alternatively, it can refer to different sections of a single device. For example, a single IVD. Inspection equipment It may be designed for one or more of the following functions: pre-analysis function, analysis function, post-analysis function, and transport function.

[0121] According to some embodiments, the method may include a step of specifying a container processing step related to handling the IVD container 30 based on at least one physical quantity obtained. The term “container processing step” as used herein is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, the container processing step may include performing at least one workflow step of at least one workflow on the IVD container 30. For example, a workflow may define a sequence in which the container processing step is performed. According to some embodiments, the container processing step may be at least one activity belonging to a workflow. For example, an activity may be of a basic or complex nature and typically one or more IVDs Inspection equipment This activity may be performed in or by the IVD container 30. For example, this activity may include grasping the IVD container 30, transferring the IVD container 30 from the first IVD container holder 40 to the second IVD container holder 40, positioning the IVD container 30 (e.g., within the IVD container holder 40), performing at least one test on the sample stored in the IVD container 30, and / or positioning the IVD container 30.

[0122] According to some embodiments, the step of specifying a container processing step related to handling the IVD container 30 based on at least one physical quantity obtained may include selecting a container processing step. According to some embodiments, the step of specifying a container processing step related to handling the IVD container 30 based on at least one physical quantity obtained may include selecting processing parameters for the container processing step. According to some specific embodiments, the step of specifying a container processing step related to handling the IVD container 30 based on at least one physical quantity obtained may include specifying a gripping force for which the gripper 13 grips the IVD container 30, for example, a gripping force suitable for a particular wall thickness of the IVD container 30.

[0123] According to some embodiments, the step of specifying a container handling step related to handling the IVD container 30 based on at least one physical quantity obtained may include specifying an IVD container holder 40 for holding the IVD container 30, for example, an IVD container holder 40 designed to hold IVD containers 30 of a particular diameter and / or a particular shape.

[0124] According to some embodiments, the step of specifying a container handling step related to handling the IVD container 30 based on at least one physical quantity obtained may include specifying a position within the IVD container holder 40 for holding the IVD container 30, for example, a position designed to hold an IVD container 30 of a particular diameter and / or a particular shape.

[0125] According to some embodiments, the step of specifying a container handling step related to handling the IVD container 30 based on at least one physical quantity obtained may include specifying that the IVD container 30 be transferred from a first IVD container holder 40 to a second IVD container holder 40, for example, a second IVD container holder 40 designed to hold IVD containers 30 of a particular diameter and / or a particular shape.

[0126] According to some embodiments, the step of specifying a container handling step related to handling the IVD container 30 based on at least one physical quantity obtained may include specifying that the IVD container 30 be transferred from a first position in the IVD container holder 40, which includes two or more positions for holding the IVD container 30, to a second position in the IVD container holder 40, for example, a second position designed to hold an IVD container 30 of a particular diameter and / or a particular shape.

[0127] According to some embodiments, the method may include the step of performing a specified container processing step related to the processing of the IVD container 30 (for example, moving the IVD container 30 accordingly).

[0128] According to some embodiments, this method - (Reference numeral 118) A step of determining at least one characteristic of the IVD container 30 using at least one physical quantity, - (Reference numeral 120) The step of storing at least one characteristic of the IVD container 30 on a read-and-write data carrier 50 attached to the IVD container 30.

[0129] According to some embodiments, the method may further include obtaining at least one characteristic from a read-and-write data carrier 50 attached to an IVD container 30. Figure 3 shows an exemplary flowchart similar to Figure 1, including steps 118 and 120 in addition to the steps shown in Figure 1.

[0130] According to some embodiments, the characteristics of the IVD container 30 can be information assigned to the IVD container 30. According to some specific embodiments, the characteristics of the IVD container 30 may be assigned to the IVD container 30 using physical quantities, for example, various physical characteristics in the form of dimensions, which are used to assign a specific type of characteristic, such as a characteristic of a type that matches dimensions, to the IVD container 30. According to some embodiments, the characteristics of the IVD container 30 may be a function assigned to the IVD container 30 by using at least one lookup table, for example, a lookup table of dimensions for a specific type of IVD container 30.

[0131] According to some embodiments, the characteristics may be stored on a read-and-write data carrier 50 with respect to a lookup table, for example, the type of IVD container is encoded with respect to the lookup table.

[0132] According to some embodiments, at least one physical quantity may be used, for example, to determine, at least one of the following: - Damage to IVD container 30, - Presence or absence of a swab in IVD container 30, - Number of swabs in IVD container 30, - Fluid filling level in IVD container 30, - The filling volume of the fluid in the IVD container 30, - Lower and / or upper levels of the phase in the IVD container 30, - Volume of the phase in the IVD container 30, - IVD container type 30, - The presence of separation gel in the IVD container 30, and / or - Presence of stabilizing powder on the wall of IVD container 30.

[0133] According to some embodiments, damage to the IVD container 30 can be determined using at least one physical quantity. For example, damage determination can be made using the physical quantity of the outer 3D shape and / or 3D shape determined by exploring, for example, scanning, the outer 3D shape or 3D shape of the IVD container 30, for example, by using a LIDAR system 66.

[0134] According to some embodiments, the presence or absence of a swab in the IVD container 30 can be determined using at least one physical quantity. For example, the determination of the presence or absence of a swab can be made using a physical quantity such as mass, which is determined by mass and / or gravimetric measurement.

[0135] According to some embodiments, the number of swabs in the IVD container 30 can be determined using at least one physical quantity. For example, the physical quantity mass can be used to determine the number of swabs.

[0136] According to some embodiments, the level of fluid filling in the IVD container 30 can be determined using at least one physical quantity. For example, the determination of the filling level can be done by using the wall thickness of the IVD container 30, for example, to correct / refine the optical filling level measurement using the wall thickness.

[0137] According to some embodiments, the filling volume of the fluid in the IVD container 30 can be determined using at least one physical quantity. For example, the determination of the filling volume can be done using the physical quantities of the IVD container 30, namely its internal diameter and / or 3D shape (e.g., measured using a LiDAR system 66). The calculation of the filling volume may, in some cases, further utilize knowledge of the fluid filling level in the IVD container 30.

[0138] According to some embodiments, the lower and / or upper levels of the phase within the IVD vessel 30 can be determined using at least one physical quantity. For example, the determination of the lower and / or upper levels of the phase can be done by using the wall thickness of the IVD vessel 30, for example, to correct / refine the optical measurements using the wall thickness.

[0139] According to some embodiments, the volume of the phase in the IVD vessel 30 can be determined using at least one physical quantity. For example, the determination of the phase volume can be done using the physical quantities of the IVD vessel 30, namely its internal diameter and / or 3D shape (e.g., measured using a LiDAR system 66). The calculation of the phase volume may, in some cases, further utilize lower-level and / or upper-level knowledge of the phase in the IVD vessel 30.

[0140] According to some embodiments, the type of IVD container 30 can be determined using at least one physical quantity. For example, the type of IVD container 30 can be determined using the physical quantity of the IVD container 30, the outer 3D shape and / or 3D shape (determined, for example, by scanning the outer 3D shape or 3D shape of the IVD container 30).

[0141] According to some embodiments, the presence of the separation gel in the IVD container 30 can be determined using at least one physical quantity. For example, the determination of the presence of the separation gel in the IVD container 30 can be made by using the wall thickness of the IVD container 30, for example, to correct / refine the optical measurement using the wall thickness.

[0142] According to some embodiments, the presence of stabilizing powder in the walls of the IVD container 30 can be determined using at least one physical quantity. For example, the determination of the presence of stabilizing powder in the walls of the IVD container 30 can be made by using the physical quantity of the wall thickness of the IVD container 30, for example, to correct / refine optical measurements using the wall thickness.

[0143] An automated method for handling an IVD container 30 according to some embodiments described herein, including the following steps: Laboratory A further method for gripping the IVD container 30 within 1 is proposed: - A step of specifying the gripper force for the gripper 13 to grip the IVD container 30.

[0144] As shown in Figure 5, IVD Laboratory The proposed method for gripping the IVD container 30 in 1 includes, in addition to - the steps of measuring at least one physical quantity of the IVD container 30, storing at least one physical quantity in a read-and-write data carrier 50 attached to the IVD container 30, and obtaining at least one physical quantity from the read-and-write data carrier 50 attached to the IVD container 30, - a step of specifying a container handling step relating to the handling of the IVD container 30 based on the obtained at least one physical quantity, in the form of specifying a gripping force for which the gripper 13 grips the IVD container 30. According to the embodiment, the gripping force is specified using a physical quantity value relating to the measured wall thickness in the section of the IVD container 30 that will be gripped. The gripping force is specified, for example, not to be so strong as to endanger the integrity of the IVD container 30.

[0145] As used herein, the term “gripper” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. According to some embodiments, a gripper can be designed to perform at least one gripping function, such as gripping and / or moving and / or handling and / or transporting and / or positioning an IVD container 30. According to some embodiments, a gripper 13 may comprise at least one gripper body and at least one gripper finger. According to some embodiments, the gripper body may comprise further elements, in particular mounting elements designed so that at least one gripper finger of the gripper can be mounted on the gripper body. For example, a gripper 13 may comprise two gripper fingers designed so that the gripper 13 exerts a gripping force to grip the IVD container 30. The gripper 13 may be connected to at least one control unit 23 so that the control unit 23 can control the gripper 13, in particular the gripper body and / or the gripper finger. According to some embodiments, the specification of the gripper force can be based on at least one physical quantity obtained, such as wall thickness and / or diameter.

[0146] Furthermore, an IVD designed for analyzing biological samples and for handling the IVD container 30 Laboratory 1 is proposed. IVD Laboratory 1 is one or more IVDs Inspection equipment It has 10. IVD Laboratory 1 is a method for handling an IVD container 30 according to some embodiments described herein and / or an IVD according to some embodiments described herein. Laboratory Designed to perform a method for grasping the IVD container 30 within 1. Laboratory An exemplary embodiment of the first example is shown in Figure 2.

[0147] According to some embodiments, IVD Laboratory 1 is, - A measuring unit 20 designed to measure at least one physical quantity of the IVD container 30, - A storage unit 21 designed to store at least one physical quantity within a read-and-write data carrier 50 attached to an IVD container 30, - The system may include an acquisition unit 22 designed to acquire at least one physical quantity from a read-and-write data carrier 50 attached to an IVD container 30.

[0148] According to some embodiments, the acquisition unit 22 can be designed to read physical quantities stored in the read-and-write data carrier 50 from the read-and-write data carrier 50. According to some specific embodiments, the acquisition unit 22 may include at least one RFID reader.

[0149] According to some embodiments, the measuring unit 20 is - Camera 61, - reflector 62, - Light-emitting body 63, - Photodetector 64, - Laser 65, - LiDAR system 66, - Mass sensor 67, and / or - It may be equipped with one or more of the artificial intelligence units 68.

[0150] Exemplary embodiments of the measurement unit 20 are shown in Figures 6A1 and 6A2. Figure 6A1 shows an embodiment having one or more of the following: a camera 61, a reflector 62, a light emitter 63, a photodetector 64, a laser, a LiDAR system 65, and an artificial intelligence unit 68. Figure 6A2 shows an embodiment using a mass sensor 67.

[0151] According to some embodiments, the measurement unit 20 may include a camera 61. The camera 61 may be designed to capture at least one image of the IVD container 30. As shown in Figure 6A1, the IVD container 30 may be rotated so that the camera 61 can capture images from different sides, and the artificial intelligence unit 68 may be designed to evaluate one or more images of the IVD container 30 and determine at least one physical quantity from one or more images, such as dimensions, 3D shape, and outer 3D shape.

[0152] According to some embodiments, the processor may include an artificial intelligence unit 68 designed for, for example, object detection. The artificial intelligence unit 68 may be designed to apply, for example, at least one trained machine learning model to an image, and the trained machine learning model is trained on, for example, at least one training dataset including image data and target values ​​of physical quantities to be measured. According to one embodiment, the trained machine learning model was pre-trained to recognize IVD containers 30 in an image.

[0153] According to some embodiments, the measurement unit 20 may comprise at least one light emitter 63 and at least one photodetector 64. The light emitter 63 may be designed to generate at least one light beam to illuminate the IVD container 30. The photodetector 64 may be designed to detect at least one light beam generated, for example, by reflection, transmission, or absorption, in response to illumination by the IVD container 30 and / or a sample stored in the IVD container 30. In some embodiments, the measurement unit 20 may comprise at least one reflector 62 designed to guide the light beam generated in response to illumination to the photodetector 64. The measurement unit 20 may further comprise at least one processor designed to evaluate the detected light beam and determine at least one physical quantity from the detected light beam (for example, from its intensity).

[0154] The determination of physical quantities can be performed, for example, at different locations along the height of the IVD container 30 to measure the profile of the wall thickness along the height.

[0155] According to some embodiments, the measurement unit 20 may include a LiDAR (Light Detection and Ranging) system 66. The LiDAR system 66 may be designed to explore the IVD vessel 30. The LiDAR system 66 may include at least one laser 65 designed to generate at least one light beam for exploring the IVD vessel 30. The LiDAR system 66 may include at least one photodetector 64 designed to detect at least one light beam generated by the IVD vessel 30 in response to illumination and generate at least one LiDAR signal. The measurement unit 20 may further include at least one processor designed to evaluate the signal from the LiDAR system 66 and determine at least one physical quantity from the image, such as dimensions, 3D shape, or outer 3D shape.

[0156] According to some embodiments, the measuring unit 20 may include a mass sensor 67. The mass sensor 67 may be designed for measuring mass or weight.

[0157] According to some embodiments, IVD Laboratory 1 may comprise a plurality of IVD container holders 40, each designed to hold one or more IVD containers 30, and each having a read and writeable data carrier 50. - The memory unit 21 is designed to store the physical quantities of the IVD container 30 within a read-and-write data carrier 50 contained in the IVD container holder 40. - The acquisition unit 22 is designed to acquire physical quantities of the IVD container 30 from a read-and-write data carrier 50 contained in the IVD container holder 40.

[0158] According to the examples, IVD Laboratory The transport system may include a transport system that uses multiple IVD container holders 40 (for example, in the form of a single holder pack that can move in two dimensions), and the IVD container 30 is transported by using the IVD container holders 40. Inspection equipment The IVD container holder 40 is transported between at least some of the 10, and each of the IVD container holders 40 is equipped with a readable and writable data carrier 50 (e.g., in the form of an RFID chip) and the first IVD Inspection equipment In step 10, at least one physical quantity of the IVD container 30 is measured and stored in a read-and-write data carrier 50 of the first IVD container holder 40 to which the IVD container 30 is first transported, and later, at least one physical quantity of the IVD container 30 is stored in the second IVD Inspection equipment Data is acquired by 10 from the read-and-write data carrier 50 of the first IVD container holder 40 and the second IVD Inspection equipment In 10, the IVD container 30 is used to handle the IVD container 30. Inspection equipment (by 10) the IVD container is placed in the second IVD container holder 40 and transported, and at least one physical quantity of the IVD container 30 (for example, the second IVD Inspection equipment It is also possible that the data is stored in the read-and-write data carrier 50 of the second IVD container holder 40 (by 10 storage units). In such a case, at least one physical quantity of the IVD container 30 may be erased from the read-and-write data carrier 50 of the first IVD container holder 40. According to the embodiment, at least one physical quantity of the IVD container 30 is stored only in the read-and-write data carrier 50 of the particular IVD container holder 40 that currently holds the IVD container 30, and is erased from the read-and-write data carrier 50 of the particular IVD container holder 40 after the IVD container 30 has been removed from that particular IVD container holder 40.

[0159] According to some embodiments, at least one physical quantity is stored in a first read-and-write data carrier 50 attached to the IVD container 30, retrieved from the first read-and-write data carrier 50 attached to the IVD container 30, and stored in a second read-and-write data carrier 50 attached to the IVD container 30. According to some specific embodiments, between the time at least one physical quantity is retrieved from the first read-and-write data carrier 50 and the time at least one physical quantity is stored in the second read-and-write data carrier 50, for example, both of the first read-and-write data carrier 50 and the second read-and-write data carrier 50 are not in close proximity to (or at least not always) the IVD container 30, for example, the IVD container 30 during that time. Inspection equipment Handled by 10, the first read-and-write data carrier 50 and the second read-and-write data carrier 50 are respectively IVD Inspection equipment During at least part of the processing of the IVD container 30 by 10 Inspection equipment It is included in the IVD container holder 40 which does not hold 10.

[0160] According to some embodiments, IVD Laboratory 1 can be equipped with multiple IVD containers 30, - Each of the IVD containers 30a is fitted with a read-and-write data carrier 50 (for example, readily fitted), - The memory unit 21 is designed to store the physical quantities of the IVD container 30 within a read-and-write data carrier 50 attached to the IVD container 30. - The acquisition unit 22 is for acquiring physical quantities of the IVD container 30 from a read-and-write data carrier 50 attached to the IVD container 30.

[0161] According to an embodiment of such an example, the physical quantity of a particular IVD container 30 is attached to that particular IVD container 30 (e.g., immediately attached) and subsequently handled by at least one (e.g., each) IVD container 30. Inspection equipment It is stored in a readable and writable data carrier 50 obtained from there by 10.

[0162] According to some embodiments, the measurement unit 20 is used for pre-analysis IVD Inspection equipment 10PRE and / or Analysis IVD Inspection equipment It may be included in 10ANA, and the acquired unit 22 is pre-analysis IVD. Inspection equipment 10PRE and / or Analysis IVD Inspection equipment 10ANA and / or post-analysis IVD Inspection equipment It may be included in 10POST.

[0163] According to some embodiments, the measurement unit 20 is used for pre-analysis IVD Inspection equipment It may be included in 10PRE, and acquisition unit 22 is analysis IVD Inspection equipment 10ANA and / or post-analysis IVD Inspection equipment 10POST may be included. Furthermore, according to some specific embodiments, the storage unit 21 is pre-analysis IVD Inspection equipment May also be included in 10PRE. Pre-analysis IVD Inspection equipment Measuring and storing physical quantities in 10PRE is, for example, equivalent to at least one analytical IVD. Inspection equipment 10ANA and / or IVD after at least one analysis Inspection equipment IVD, such as 10POST, then handles IVD container 30. Inspection equipment This makes it possible to use physical quantities in this context.

[0164] Measurement unit 20 is pre-analysis IVD Inspection equipment An exemplary embodiment that may be included in 10PRE is shown in Figure 2. The measured physical quantities relating to a particular IVD container 30 are shown in the illustrated pre-analysis IVD Inspection equipmentThe data can be stored in a read-and-write data carrier 50 attached to the IVD container 30 using the 10PRE storage unit 21. Inspection equipment Measuring physical quantities using 10PRE can make those quantities available for subsequent container processing steps.

[0165] According to some embodiments, IVD Laboratory 1 is designed to be measured at the start of the workflow. At the start of the workflow, especially large IVD Laboratory Measuring a physical quantity in step 1 and storing it in a read-and-write data carrier 50 so that it is available in subsequent workflow steps can significantly reduce the effort required for subsequent tasks that require, or at least can utilize, this information on the IVD container 30. This advantage is particularly beneficial for large IVDs where the same type of task (e.g., gripping the IVD container 30) can be repeated many times. Laboratory This could be particularly important for 1.

[0166] According to some embodiments, IVD Laboratory Each analysis IVD in 1 Inspection equipment 10ANA and IVD Laboratory IVD after each analysis in step 1 Inspection equipment 10POST includes an acquisition unit 22 as shown in Figure 2. This unit is used for each analysis IVD. Inspection equipment 10ANA and post-analysis IVD Inspection equipment 10POST is, for example, each IVD Inspection equipment For one or more container processing steps in the process, it is possible to obtain and use at least one physical quantity.

[0167] According to some embodiments, the acquisition unit 22 is - Analysis IVD Inspection equipment At the entrance of 10ANA (each in the transport system 10TRANS, the acquisition unit 22 is an analysis IVD Inspection equipment (Located adjacent to the entrance of 10ANA), and / or - Post-analysis IVD Inspection equipment At the entrance of 10POST (for example, in the transfer system 10TRANS, the acquisition unit 22 performs IVD analysis), Inspection equipment It is placed (near the entrance to POST 10).

[0168] Figures 6A to 6C show IVD Laboratory This shows an exemplary sequence of container processing steps for an exemplary IVD container 30 handled in 1. For example, as shown in Figures 6A1 and 6A2, the measurement of physical quantities is performed on the IVD before analysis. Inspection equipment This can be performed by 10PRE. As shown in Figure 6A1, the memory of physical quantities is the same pre-analysis IVD. Inspection equipment It may be performed by 10PRE. However, as shown in Figure 6A2, the memory of physical quantities is the same pre-analysis IVD. Inspection equipment In 10PRE (or, for example, in a transfer system (not shown in Figure 6A2), pre-analysis IVD where physical quantities were measured, for example) Inspection equipment (In some parts of the transport system adjacent to 10PRE) This may not be performed. Pre-analysis IVD Inspection equipment The 10PRE may include a measurement unit 20 comprising one or more of the following: a camera 61, a reflector 62, a light emitter 63, a photodetector 64, a laser 65, a LiDAR system 66, a mass sensor 67, and / or an artificial intelligence unit 68, schematically shown in Figures 6A1 and 6A2, respectively. To perform measurements, the position of the IVD container 30 may be changed for weighing and / or exploration, etc. For example, as shown in Figure 6A1, the IVD container 30 may be rotated around an axis. As further shown in Figure 6A1, the storage unit 21 may be configured to store the measured physical quantities in a read-and-write data carrier 50, for example, wirelessly. The IVD container 30 is then used, for example, for analysis of the IVD Inspection equipment You may be transferred to 10ANA.

[0169] Figure 6B shows an analytical IVD analyzing a sample transferred within an IVD container 30. Inspection equipmentAn exemplary embodiment of 10ANA is shown. Subsequently, the IVD container 30 is used for analysis. Inspection equipment It can be transferred to 10POST. Figure 6C shows the post-analysis IVD receiving IVD container 30. Inspection equipment This shows an embodiment of 10POST. Analysis IVD Inspection equipment 10ANA and / or post-analysis IVD Inspection equipment Each of the 10POSTs may comprise at least one acquisition unit 22 designed to acquire a physical quantity from a read-and-write data carrier 50. For example, one or more IVDs. Inspection equipment 10. For example, analysis IVD Inspection equipment 10ANA and / or post-analysis IVD Inspection equipment At least one of the 10POSTs may be equipped with a gripper 13 designed to grip the IVD container 30, and the gripper force with which the gripper 13 grips the IVD container 30 may be specified using at least one physical quantity (for example, using the wall thickness). Figure 6B shows an analytical IVD Inspection equipment Figure 6B shows an example in which the 10ANA may include at least one acquisition unit 22 that acquires physical quantities from a read-and-write data carrier 50. Inspection equipment The gripper 13 of 10ANA is further shown, and the gripper force with which the gripper 13 grips the IVD container 30 can be specified using at least one physical quantity. Figure 6C shows the IVD after analysis. Inspection equipment Figure 6C shows an example in which 10POST may include at least one acquisition unit 22 that acquires physical quantities from a read-and-write data carrier 50. Post-analysis IVD designed to grip the IVD container 30 Inspection equipment A 10-POST gripper 13 is further shown, and the gripper force with which the gripper 13 grips the IVD container 30 can be specified using at least one physical quantity.

[0170] Figures 7A and 7B show, respectively, cartridges (e.g., analytical IVD). Inspection equipmentFigure 7A and Figure 7B respectively show an exemplary embodiment of an IVD container 30 designed for use in storing reagents used to analyze a sample in 10ANA, and the IVD container 30 is equipped with a gripper 13 designed to grip the IVD container 30. Inspection equipment It is located within 10ANA. The gripper force with which the gripper 13 grips the IVD container 30 may be specified based on at least one physical quantity.

[0171] According to some embodiments, for example, IVD Laboratory In the sense that 1 is designed to perform automated handling of at least one IVD container 30, Laboratory 1 can be automated.

[0172] According to some embodiments, IVD Laboratory 1 may be designed to automatically perform at least one container processing step. According to some embodiments, IVD Laboratory 1 may include at least one control unit 23.

[0173] According to some embodiments, the control unit 23 may comprise and / or be connected to at least one processing unit.

[0174] According to some embodiments, the control unit 23 is at least partially at least one IVD Inspection equipment 10 may be designed to control the IVD. For example, the control unit 23 may perform, for example, pre-analysis, post-analysis, analysis container, and / or transfer processing steps. Laboratory It may be designed to control one or a particular device.

[0175] According to some embodiments, the control unit 23 can receive information from the data management unit 24 regarding which container processing steps should be performed by a particular IVD container 30. The data management unit 24 is designed to coordinate the processing of the IVD container 30 (with respect to the sample contained therein), for example, middleware. Laboratory It can be equipped with / running adjustment software modules. Laboratory An example of a tuning software module is cobas® infinity, which was released commercially on June 1, 2021. Laboratory It is a solution.

[0176] According to some embodiments, the control unit 23 may be designed to be integrated with the data management unit 24, and / or may be comprised of a server computer, and / or may be part of a single instrument, and / or IVD Laboratory Multiple IVDs Inspection equipment It may be distributed over 10. According to some embodiments, the control unit 23 may be embodied as a programmable logic controller that executes a computer-readable program having instructions for performing a specified operation.

[0177] According to some embodiments, the IVD is in the form of a transfer system 10TRANS. Inspection equipment Automated IVD Laboratory It may be part of 1. According to some specific embodiments, Laboratory 1 comprises at least one transfer system 10TRANS.

[0178] According to some embodiments, the transfer system 10TRANS transports the IVD container 30 to the IVD Laboratory It can be designed to transport to at least one target destination within 1. For example, the transport system 10TRANS transports the IVD container 30 to the IVD Inspection equipment 10. For example, at least one pre-analysis IVD Inspection equipment 10PRE, at least one analysis IVD Inspection equipment10 ANA and / or at least one post - analysis IVD Inspection equipment It can be designed to transfer to 10 POST.

[0179] According to some embodiments, the transfer system 10 TRANS can transfer the IVD container 30 from a first IVD Inspection equipment to a second IVD Inspection equipment , for example, from a pre - analysis IVD Inspection equipment 10 PRE to an analysis IVD Inspection equipment 10 ANA, from a first analysis IVD Inspection equipment 10 ANA to a second analysis IVD Inspection equipment 10 ANA, and / or from an analysis IVD Inspection equipment 10 ANA to a post - analysis IVD Inspection equipment 10 POST. It may be designed to transfer.

[0180] According to some embodiments, the transfer system 10 TRANS can include at least one transfer surface. According to some embodiments, the transfer system 10 TRANS may be designed to support the IVD container 30.

[0181] According to some embodiments, the transfer system 10 TRANS can be designed for linear (one - dimensional) transfer using, for example, a set of IVD container holders 40 that can move linearly. An exemplary embodiment of the linear transfer system 10 TRANS is shown in FIG. 2.

[0182] According to some embodiments, the transfer system 10 TRANS can be designed for two - dimensional transfer of the IVD container 30 using, for example, a set of IVD container holders 40 that can move in two dimensions.

[0183] According to some embodiments, the transfer system 10TRANS may be designed to move the IVD container holder 40 in at least one direction. For example, the transfer system 10TRANS may include at least one transfer element selected from the group consisting of conveyors such as belt conveyors or chain conveyors, and vehicle systems such as electronic vehicle systems. According to some specific embodiments, the transfer system 10TRANS may be a multi-lane transfer system having a plurality of transfer elements, or may comprise such a system. According to some specific embodiments, the transfer system 10TRANS may be a plurality of parallel transfer elements, or may comprise such a system. For example, the transfer elements may be arranged in a common plane and / or different planes, for example, overlapping each other.

[0184] According to some embodiments, one or more IVDs Inspection equipment At least one of the 10 may include a gripper 13 designed to grip the IVD container 30, Laboratory 1. For example, IVD Laboratory 1 or at least one IVD Inspection equipment A control unit 23 for controlling 10 can be designed to specify the gripper force with which the gripper 13 grips the IVD container based on at least one physical quantity.

[0185] According to some specific embodiments, the determination of gripper force based on at least one physical quantity can be automated, for example, using a predetermined algorithm. Each of these algorithms can be trained using empirical data.

[0186] In this specification, IVD Laboratory An IVD container holder 40 for use in 1 is further proposed. - The IVD container holder 40 is designed to hold the IVD container 30. - The IVD container holder 40 is A container detection sensor 41 designed to detect whether the IVD container 30 is held by the IVD container holder 40, o comprising a read-and-write data carrier 50 designed to store physical quantities associated with the IVD container 30, - The IVD container holder 40 is designed to erase the physical quantity associated with the IVD container 30 from the read-and-write data carrier 50 when the container detection sensor 41 detects that the IVD container 30 is no longer held by the IVD container holder 40.

[0187] The erasure of the physical quantity associated with the IVD container 30 after it has been removed from the IVD container holder 40 may allow for the design of a read-and-write data carrier 50 with limited memory and / or may allow for a reduction in the possibility of errors.

[0188] According to some embodiments, erasing may include erasing all physical quantities such that, at a given time, only physical quantities associated with at most one IVD container 30 are stored in the read-and-write data carrier 50.

[0189] According to some embodiments, erasing may include erasing only a single physical quantity, rather than all physical quantities.

[0190] According to some embodiments, the container detection sensor 41 includes a spring mechanism, and a spring load greater than a threshold, for example, a predetermined threshold (which can be determined empirically, for example), indicates that the IVD container 30 is being held by the IVD container holder 40. An example of an IVD container holder 40 having a container detection sensor 41 with a spring mechanism is shown in Figure 9. For example, Figure 9 shows an IVD container holder 40 having a container detection sensor 41 with a spring mechanism. Further examples are shown in the embodiment of Figure 10, in which the IVD container holder 40 can be equipped with a container detection sensor 41 at each position designed to hold the IVD container 30. Figure 10 shows three positions for holding the IVD container 30, each equipped with a container detection sensor 41.

[0191] According to some embodiments, the container detection sensor 41 may include at least one light barrier. For example, the light barrier may be designed to determine the presence of an IVD container 30 in an IVD container holder 40. The container detection sensor 41 may comprise a light source 42 designed to produce at least one light beam and at least one photodetector 43 designed to detect the light beam illuminating its sensor area. The photodetector 43 may be located on the side of the cavity (for holding the IVD container 30) opposite to the side where the light source 42 is located. Such a container detection sensor 41 may be designed to determine whether an IVD container 30 is held in the cavity based on the amount of light detected by the photodetector 43. The light source 42 may be designed to illuminate the photodetector 43, and interruptions and dips in illumination may indicate that an IVD container 30 is located in the IVD container holder 40 (each in its cavity), and a (complete) resumption of illumination may indicate the absence of an IVD container 30 from the IVD container holder 40 (each in its cavity). Figure 11 shows an example of a container detector sensor equipped with a light barrier.

[0192] According to some embodiments, the container detection sensor 41 may include a force sensor, such as a piezoelectric sensor, for detecting whether the IVD container 30 is held by the IVD container holder 40, for example, the force sensor being located at the bottom and / or side of the cavity designed to hold the IVD container 30.

[0193] According to some embodiments, the IVD container holder 40 may have multiple positions for holding the IVD containers 30, and one or more container detection sensors 41 may be designed to detect which position the IVD container 30 is held in. According to some specific embodiments, a read-and-write data carrier 50 may be designed to store physical quantities associated with the IVD container 30, along with information indicating which position the IVD container 30 is held in. This may allow the IVD acquisition device 10 to assign physical quantities to each IVD container 30 through each position.

[0194] IVD comprising one or more of the proposed IVD container holders 40 Laboratory Further disclosures are made in section 1.

[0195] Further disclosed and proposed herein are, for example, IVD Laboratory 1 at least one IVD Laboratory 1 and / or one or more IVDs Inspection equipment When the program is executed by at least one of the 10 control units 23, it is a computer program that includes computer-executable instructions for performing the methods proposed herein in one or more of the embodiments attached herein. Specifically, the computer program may be stored in a computer-readable data carrier and / or computer-readable storage medium.

[0196] As used herein, the terms "computer-readable data carrier" and "computer-readable storage medium" can specifically refer to non-transitory data storage means such as a hardware storage medium storing computer-executable instructions. The computer-readable data carrier or storage medium can specifically be or comprise a storage medium such as random access memory (RAM) and / or read-only memory (ROM).

[0197] Thus, specifically, one, two or more, or even all of the method steps can be executed, for example, by using a computer program, for example, at least one IVD Laboratory 1 and / or IVD Laboratory 1 of the IVD Inspection equipment by using at least one control unit 23 of the IVD.

[0198] Further disclosed and proposed herein is a computer program product having program code means for executing the method in one or more of the embodiments appended hereto when the program is executed on at least one control unit 23 of, for example, at least one IVD Laboratory 1 and / or IVD Laboratory 1 of the IVD Inspection equipment Specifically, the program code means can be stored in a computer-readable data carrier and / or a computer-readable storage medium.

[0199] Further disclosed and proposed herein is a data carrier storing a data structure that can execute the method according to one or more of the embodiments disclosed herein after being loaded into the working memory or main memory of at least one control unit 23, for example, at least one IVD Laboratory 1 and / or IVD Laboratory 1 of the IVD Inspection equipment 10 of the control units 23.

[0200] Further disclosed and proposed herein are, for example, at least one IVD Laboratory 1 and / or IVD Laboratory IVD Inspection equipment When a program is executed on at least one control unit 23, it is a computer program product having program code means stored on a machine-readable carrier for performing a method according to one or more embodiments disclosed herein. As used herein, a computer program product refers to a program as a tradable product. The product generally exists in any format, such as paper format, or on a computer-readable data carrier and / or computer-readable storage medium. Specifically, a computer program product may be delivered over a data network.

[0201] Finally, modulated data signals including instructions readable by a computer system or computer network for performing methods according to one or more embodiments disclosed herein are further disclosed and proposed herein.

[0202] Referring to the computer implementation, one or more, or even all, of the method steps of the method according to one or more embodiments of the method disclosed herein, for example, at least one IVD of at least one control unit 23 Laboratory 1, and / or IVD Laboratory IVD Inspection equipment This can be performed by using at least one processor. Therefore, generally, any method step involving data provision and / or manipulation can be performed by using a computer or computer network. Generally, these method steps can include any method step except for method steps that require manual work, such as in certain embodiments of providing samples and / or performing actual measurements.

[0203] Specifically, this specification further discloses the following: - A IVD having at least one processor, for example, at least one Laboratory 1 and / or IVD Laboratory IVD 1 Inspection equipment at least one control unit 23 wherein the processor is adapted to perform a method according to one of the embodiments described herein, - For example, IVD Laboratory 1 at least one IVD Laboratory 1 and / or IVD Laboratory IVD 1 Inspection equipment A computer-loadable data structure adapted to perform a method according to one of the embodiments described herein while the data structure is being executed on at least one of the control units 23 of 10, - A computer program, where the program is, for example, IVD Laboratory 1 at least one IVD Laboratory 1 and / or IVD Laboratory IVD 1 Inspection equipment A computer program adapted to perform a method according to one of the embodiments described herein while running on at least one of the 10 control units 23, - For example, IVD Laboratory 1 at least one IVD Laboratory 1 and / or IVD Laboratory IVD 1 Inspection equipment A computer program including programming means for performing a method according to one of the embodiments described herein while the computer program is running on at least one of the 10 control units 23, - A computer program including the programming means according to the above-described embodiment, wherein the programming means is, for example, IVD Laboratory 1 at least one IVD Laboratory 1 and / or IVD Laboratory IVD 1 Inspection equipmentStored in a storage medium readable by at least one of the 10 control units 23, - A storage medium in which a data structure is stored, and the data structure is stored in at least one control unit 23, for example, at least one IVD Laboratory 1 and / or IVD Laboratory IVD 1 Inspection equipment A storage medium, which, after being loaded into 10 main memory and / or working memory, is adapted to perform a method according to one of the embodiments described herein, - A computer program product having program code means, wherein the program code means comprises at least one control unit 23, for example, at least one IVD Laboratory 1 and / or IVD Laboratory IVD 1 Inspection equipment 10. Computer program products that, when executed on a computer or on a computer network, can be stored in a storage medium, or are stored in a storage medium, for performing a method according to one of the embodiments described herein.

[0204] Furthermore, a measurement unit 20, a storage unit 21, an acquisition unit 22, and optionally a control unit 23 are proposed, designed and / or configured to perform any of the proposed methods. The proposed methods can be implemented, at least in part, as computer implementations performed by, for example, a signal processing unit, a computer, a computer network, etc. Further proposals are made for methods embodied by any of the proposed measurement unit 20, storage unit 21, acquisition unit 22, and optionally a control unit 23.

[0205] Proposed IVD Laboratory Further methods are proposed that are embodied by one of the proposed methods. IVD embodies one of the proposed methods. Laboratory Further suggestions are made.

[0206] Furthermore, chemistry (not necessarily IVD) Laboratory ,other Laboratory In and / or other situations / settings / fields, it is suggested that the methods and / or apparatus proposed herein be used.

[0207] It will be understood that many variations can be adopted based on the aforementioned specific structure without departing from the scope defined in the following claims.

[0208] In particular, the following embodiments are proposed: Proposal 1: IVD Laboratory An automated method for handling in vitro diagnostic (IVD) containers in a laboratory, wherein at least, - A step of measuring at least one physical quantity of the IVD container, - A step of storing at least one physical quantity in a read-and-write data carrier attached to an IVD container, - The step of obtaining at least one physical quantity from a read-and-write data carrier attached to an IVD container.

[0209] Proposal 2: - The measurement step is the first IVD Inspection equipment It is executed in - The step to obtain is the second IVD Inspection equipment The method of Proposal 1, as performed in [location].

[0210] Proposal 3: - First IVD Inspection equipment However, IVD before analysis Inspection equipment And, - Second IVD Inspection equipment However, analysis IVD Inspection equipment and / or post-analysis IVD Inspection equipment The method described in Proposal 2.

[0211] Proposal 4: The method is, - The method according to any one of proposals 1 to 3, comprising the step of specifying a container handling step related to the handling of an IVD container based on at least one physical quantity obtained.

[0212] Proposal 5: The method of Proposal 4, wherein the step of specifying a container handling step related to the handling of an IVD container based on at least one physical quantity obtained includes selecting a container handling step.

[0213] Proposal 6: The method according to Proposal 4 or 5, wherein the step of specifying a container processing step related to handling an IVD container based on at least one physical quantity obtained includes selecting processing parameters for the container processing step.

[0214] Proposal 7: The method according to any one of Proposals 4 to 6, wherein the step of specifying a container handling step related to handling an IVD container based on at least one physical quantity obtained includes specifying the gripping force with which the gripper grips the IVD container.

[0215] Proposal 8: A step specifying a container handling step related to the handling of an IVD container based on at least one physical quantity obtained, - Specify an IVD container holder for holding IVD containers. - Specify the position within the IVD container holder for holding the IVD container. - Specify that the IVD container be transferred from the first IVD container holder to the second IVD container holder, and / or - The method according to any one of Proposals 4 to 7, comprising specifying that the IVD container be transferred from a first position in an IVD container holder having two or more positions for holding the IVD container to a second position in the container holder.

[0216] Proposal 9: The method is, - The method according to any one of Proposals 4 to 8, comprising the step of performing a specified container handling step related to the handling of IVD containers.

[0217] Proposal 10: The method according to any one of Proposals 1 to 9, wherein the IVD container is the sample container.

[0218] Proposal 11: The method according to any one of Proposals 1 to 10, wherein the IVD container is a reagent container.

[0219] Proposal 12: A readable and writable data carrier in the IVD container directly The method according to any one of Proposals 1 to 11, wherein the method is attached to an IVD container.

[0220] Proposal 13: The method according to any one of Proposals 1 to 11, wherein a read-and-write data carrier is mounted on an IVD container holder for holding the IVD container.

[0221] Proposal 14: The method according to any one of Proposals 1 to 13, wherein at least one physical quantity includes at least one dimension of at least a portion of the IVD vessel.

[0222] Proposal 15: At least one physical quantity, - Wall thickness of IVD container, - The outer 3D shape of the IVD container, - 3D shape of the IVD container, - The angle of the IVD container, - The method according to any one of Proposals 1 to 14, comprising one or more of the curvature of the IVD container.

[0223] Proposal 16: At least one physical quantity, - Outer diameter of IVD container, - Inner diameter of IVD container, - Height of IVD container, - Volume of the IVD container, and / or - The method according to one of the proposals 1 to 15, comprising one or more of the masses of the IVD container.

[0224] Proposal 17: IVD Laboratory A method for gripping an IVD container, comprising the automated method described in any one of Proposals 1 to 16, A method comprising the steps of: specifying the gripper force with which the gripper grips the IVD container.

[0225] Proposal 18: An IVD designed for analyzing biological samples and for handling IVD containers. Laboratory and one or more IVDs Inspection equipment IVD equipped Laboratory , and IVD designed to perform the method described in any one of Proposals 1 to 17. Laboratory .

[0226] Proposal 19: IVD Laboratory but, - A measuring unit designed to measure at least one physical quantity of an IVD vessel, - A storage unit designed to store at least one physical quantity in a read-and-write data carrier mounted on an IVD container, - An IVD according to proposal 18, comprising: an acquisition unit designed to acquire at least one physical quantity from a read-and-write data carrier mounted on an IVD container. Laboratory .

[0227] Proposal 20: The measurement unit is pre-analysis IVD Inspection equipment Included in the acquired unit, analysis IVD Inspection equipment and / or post-analysis IVD Inspection equipment The IVD described in Proposal 19 is included in this. Laboratory .

[0228] Proposal 21: The measurement unit is pre-analysis IVD Inspection equipment and / or Analysis IVD Inspection equipment It is included in the recovery unit, pre-analysis IVD Inspection equipment and / or Analysis IVD Inspection equipment and / or post-analysis IVD Inspection equipment The IVD described in Proposal 19 is included in this. Laboratory .

[0229] Proposal 22: - One or more IVDs Inspection equipmentAt least one of them is equipped with a gripper designed to grasp an IVD container, - IVD Laboratory The IVD described in any one of the proposals 18 to 21 is designed to specify the gripper force with which the gripper grips the IVD container based on at least one physical quantity. Laboratory .

[0230] Proposal 23: The measuring unit is - Camera, - reflector, - Luminous body, - Photodetector, - Laser, - Lidar system, - Mass sensor, and / or - An IVD according to any one of proposals 18 to 22, comprising one or more artificial intelligence units. Laboratory .

[0231] Proposal 24: IVD Laboratory However, it comprises multiple IVD container holders, each designed to hold one or more IVD containers and each equipped with a read and writeable data carrier, - The memory unit is designed to store the physical quantities of the IVD container in a read-and-write data carrier contained within the IVD container holder. - An IVD according to any one of Proposals 18 to 23, in which the acquisition unit is designed to acquire physical quantities of an IVD container from a read-and-write data carrier contained in the IVD container holder. Laboratory .

[0232] Proposal 25: IVD Laboratory It is equipped with multiple IVD containers, - Each IVD container is fitted with a read-and-write data carrier. - The memory unit is designed to store the physical quantities of the IVD container in a read-and-write data carrier attached to the IVD container. - An IVD according to any one of Proposals 18 to 24, wherein the acquisition unit is for acquiring physical quantities of the IVD container from a read-and-write data carrier attached to the IVD container. Laboratory .

[0233] Proposal 26: IVD Laboratory However, it includes at least one control unit, and the control unit has at least one IVD Inspection equipment An IVD described in any one of Proposals 18 to 25, designed to control at least partially Laboratory .

[0234] Proposal 27: IVD Laboratory For example, the IVD described in proposals 18 to 26. Laboratory An IVD container holder for use in one of the following: - The IVD container holder is designed to hold the IVD container. - The IVD container holder, o A container detection sensor designed to detect whether an IVD container is being held by an IVD container holder, o comprising a read-and-write data carrier designed to store physical quantities associated with an IVD container, - An IVD container holder is designed to erase the physical quantities associated with the IVD container from a readable and writable data carrier when a container detection sensor detects that the IVD container is no longer held by the IVD container holder.

[0235] Proposal 28: An IVD container holder according to Proposal 27, wherein the container detection sensor comprises a spring mechanism, and a spring load greater than a threshold indicates that the IVD container is being held by the IVD container holder.

[0236] Proposal 29: - The IVD container holder has multiple positions for holding the IVD container, - The container detection sensor is designed to detect the position in which the IVD container is held. - An IVD container holder according to proposal 27 or 28, wherein a read-and-write data carrier is designed to store physical quantities associated with the IVD container, along with information indicating the position in which the IVD container is held. [Explanation of Symbols]

[0237] 1 IVD Laboratory 10 IVD Inspection equipment 10PRE pre-analytical IVD Inspection equipment 10ANA Analysis IVD Inspection equipment 10POST IVD after analysis Inspection equipment 10TRANS Transfer System 13 Grippa 20 measuring units 21 Memory Units 22 units acquired 23 Control Unit 24 Data Management Units 30 IVD containers 40 IVD container holder 41 Container detection sensor 42 Light source 43 Photodetector 50 Read and write data carriers 61 Camera 62 Reflector 63 Luminous element 64 Photodetectors 65 lasers 66 LIDAR systems 67 Mass Sensor 68 Artificial Intelligence Units 110 Measure 112 Remember 114 Obtain 116 Specify the container processing step. 118 Determine at least one characteristic of the IVD container. 120 Store at least one characteristic of the IVD container.

Claims

1. An automated method for handling an in vitro diagnostic IVD container (30) in an IVD laboratory (1), wherein the method is A step of measuring at least one physical quantity of the IVD container (30), The steps include storing the at least one physical quantity in a read-and-write data carrier (50) attached to the IVD container (30), The steps include obtaining the at least one physical quantity from the read-and-write data carrier (50) attached to the IVD container (30), It includes at least, The at least one physical quantity includes at least one dimension of at least a part of the IVD container, A method wherein the at least one physical quantity measured in the step of measuring the at least one physical quantity is used in a subsequent container handling step relating to the handling of the IVD container (30).

2. The aforementioned measurement step is performed in the first IVD inspection device (10), The method according to claim 1, wherein the acquisition step is performed in a second IVD inspection device (10).

3. The first IVD testing device (10) is a pre-analysis IVD testing device (10PRE), The second IVD testing equipment (10) is an analytical IVD testing equipment (10ANA) and / or a post-analytical IVD testing equipment (10POST). The method according to claim 2.

4. The method described above is The process includes specifying a container handling step related to the handling of the IVD container (30) based on the at least one physical quantity obtained, The method according to claim 1.

5. The method according to claim 4, wherein the step of specifying a container processing step relating to the handling of the IVD container (30) based on the at least one physical quantity obtained includes selecting a container processing step.

6. The method according to claim 4, wherein the step of specifying a container processing step relating to the handling of the IVD container (30) based on the at least one physical quantity obtained includes selecting processing parameters for the container processing step.

7. The method according to claim 4, wherein the step of specifying a container handling step relating to handling the IVD container (30) based on the at least one physical quantity obtained includes specifying a gripping force for which the gripper (13) grips the IVD container (30).

8. The aforementioned at least one physical quantity is The wall thickness of the aforementioned IVD container (30) and The outer 3D shape of the aforementioned IVD container (30), The 3D shape of the aforementioned IVD container (30), The angle of the aforementioned IVD container (30) and The curvature of the aforementioned IVD container (30) and The method according to claim 1, comprising one or more of the following.

9. An IVD laboratory (1) designed for analyzing biological samples and for handling IVD containers (30), wherein the IVD laboratory (1) comprises one or more IVD testing devices (10), and the IVD laboratory (1) is designed to perform the method according to any one of claims 1 to 8, A measuring unit (20) designed to measure at least one physical quantity of the IVD container (30), A storage unit (21) designed to store the at least one physical quantity within a read-and-write data carrier (50) attached to the IVD container (30), An acquisition unit (22) designed to acquire at least one physical quantity from the read-and-write data carrier (50) attached to the IVD container (30), Equipped with, The at least one physical quantity includes at least one dimension of at least a part of the IVD container, The at least one physical quantity measured in the step of measuring the at least one physical quantity is used in a subsequent container processing step related to the handling of the IVD container (30) in the IVD testing room (1).

10. The IVD testing chamber (1) comprises a plurality of IVD container holders (40), each designed to hold one or more IVD containers (30) and each equipped with a read and writeable data carrier (50), The storage unit (21) is designed to store the physical quantity of the IVD container (30) in the read-and-write data carrier (50) contained within the IVD container holder (40). The acquisition unit (22) is designed to acquire physical quantities of the IVD container (30) from the read-and-write data carrier (50) contained in the IVD container holder (40). The IVD testing room (1) according to claim 9.

11. The aforementioned IVD testing room (1) is equipped with a plurality of IVD containers (30), Each of the aforementioned IVD containers (30) is fitted with a read-and-write data carrier (50). The storage unit (21) is designed to store the physical quantity of the IVD container (30) in the read-and-write data carrier (50) attached to the IVD container (30), The acquisition unit (22) is for acquiring physical quantities of the IVD container (30) from the readable and writable data carrier (50) attached to the IVD container (30). The IVD testing room (1) according to claim 9.

12. An IVD container holder (40) for use in an IVD testing room (1) according to claim 9, The IVD container holder (40) is designed to hold the IVD container (30), The aforementioned IVD container holder (40) A container detection sensor (41) is designed to detect whether the IVD container (30) is being held by the IVD container holder (40), A read-and-write data carrier (50) designed to store physical quantities associated with an IVD container (30) is provided, The IVD container holder (40) is designed to erase the physical quantity associated with the IVD container (30) from the read-and-write data carrier (50) when the container detection sensor (41) detects that the IVD container (30) is no longer held by the IVD container holder (40). IVD container holder (40).

13. The IVD container holder (40) according to claim 12, wherein the container detection sensor (41) is equipped with a spring mechanism, and a spring load greater than a threshold indicates that the IVD container (30) is being held by the IVD container holder (40).

14. The IVD container holder (40) has multiple positions for holding the IVD container (30), The container detection sensor (41) is designed to detect the position in which the IVD container (30) is held. The read-and-write data carrier (50) is designed to store physical quantities associated with the IVD container (30) along with information indicating the position in which the IVD container (30) is held. The IVD container holder (40) according to claim 12.