Quality control method for biological in vitro samples and computer storage medium

Abstract

The present application discloses a quality inspection control method for biological in vitro samples and a computer storage medium. The method mainly transfers the carrier of the biological in vitro sample between the transportation area and multiple work areas of the quality inspection workbench according to the detection process through a transfer step to perform a first diversion treatment on it; detects the sample through the quality inspection step to generate quality inspection data, and transmits the quality inspection data to the quality inspection management system, and performs a second diversion treatment on the carrier; transports the carrier of the completed quality inspection sample out of the quality inspection workbench or transports the empty carrier located in the screening area out of the quality inspection workbench for standby use; the method of the present application determines the detection process of the biological in vitro sample and the determination of the verification results during the detection through information interaction with the quality inspection management system, which can effectively improve the detection accuracy and applicable scenarios, and the devices in the quality inspection workbench work together to form a standardized processing process for the sample, thereby improving the processing efficiency.

Description

Technical Field

[0001] The present application relates to the field of biological sample processing, and in particular to a quality inspection and control method for biological in vitro samples and a computer storage medium. Background Art

[0002] In medical testing, the sample-based testing process includes pre-analysis, analysis, and post-analysis; among them, testing accidents caused by errors in the pre-analysis stage account for about 68% of the total testing accidents. Testing errors may lead to improper examination or improper treatment of patients. Therefore, how to reduce the error rate of sample processing in the pre-analysis stage is of great significance to sample-based medical testing.

[0003] Generally, the current sample pre-analysis process is implemented through manual participation, especially in the detection process of mixed samples. A large number of samples require different test items, and the corresponding sample pre-analysis processes and standards are also different. The process is cumbersome and manual processing relies heavily on experience. For example, whether the quality of blood samples to be tested is qualified is based on manual evaluation. In many process transfers, samples need to be manually loaded onto instruments. In this process, in addition to the above-mentioned problem of easy detection errors, there is also the problem of low efficiency. The pre-analysis process of the sample takes too long, which inevitably leads to an increase in the cycle of the entire inspection process, and consumes a lot of time and labor costs. Summary of the invention

[0004] In view of the shortcomings of the related technologies mentioned above, the purpose of the present application is to provide a quality inspection control method and computer storage medium for biological in vitro samples that do not rely on human participation, so as to solve the problems of high failure rate and low efficiency of sample pre-analysis processing in the prior art.

[0005] To achieve the above-mentioned purpose and other related purposes, the present application discloses a quality inspection control method for biological in vitro samples, comprising the following steps: a conveying step, transporting a carrier containing the biological in vitro sample to a quality inspection workbench; a transfer step, transferring the carrier containing the biological in vitro sample between a transport area and multiple work areas of the quality inspection workbench according to a detection process; wherein the detection process includes: identifying the order information of the transferred biological in vitro sample to transmit it to a quality inspection management system, and subjecting the carrier containing the biological in vitro sample to a first diversion process based on feedback from the quality inspection management system; a quality inspection step, detecting the biological in vitro sample located in the quality inspection work area to generate quality inspection data, transmitting the quality inspection data to the quality inspection management system, and subjecting the carrier containing the biological in vitro sample to a second diversion process; conveying the carrier of the biological in vitro sample that has completed quality inspection out of the quality inspection workbench or conveying the empty carrier located in the screening area out of the quality inspection workbench for standby use.

[0006] The present application also discloses a computer-readable storage medium, comprising a stored computer program, wherein when the computer program is executed by a processor of a computer, the computer is controlled to execute and implement the quality inspection control method for biological in vitro samples.

[0007] In summary, the quality inspection and control method of biological in vitro samples of the present application can be implemented based on the information provided by the quality inspection management system, the determined detection rules, or the determined detection process; by associating the sample processing process with the quality inspection management system, it can be determined based on the quality inspection management system how to adjust the processing process, such as increasing or decreasing the processing steps or adjusting the sequence, and the information provided by the quality inspection management system can assist in determining the detection method, detection results or transportation method of the samples in each processing step. While realizing automated processing of samples to improve sample processing efficiency and reduce sample detection error rate, the quality inspection control equipment associated with the quality inspection management system can further improve the detection accuracy of automated processing of samples; furthermore, the present application provides the structural composition, functions and positional relationships between the structures of the quality inspection control equipment to realize automated processing of samples under a preset sample processing process, thereby improving processing efficiency by forming a standardized processing process for samples. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The specific features of the invention involved in this application are shown in the attached claims. The features and advantages of the invention involved in this application can be better understood by referring to the exemplary embodiments and drawings described in detail below. The drawings are briefly described as follows:

[0009] Figure 1 A schematic diagram showing the framework of the quality inspection control device and the quality inspection management system of the present application in one embodiment.

[0010] Figure 2 Shown is a schematic diagram of the device layout of a quality inspection control device in one embodiment of the present application.

[0011] Figure 3 Shown is a schematic flow chart of a quality control method for an in vitro biological sample of the present application in one embodiment.

[0012] Figure 4 Shown is a schematic flow chart of another embodiment of the biological in vitro sample quality control method of the present application.

[0013] Figure 5 Shown is a schematic diagram of the device layout of the quality inspection control equipment of the present application in another embodiment.

[0014] Figure 6a Shown is a schematic diagram of a label style in one embodiment of the present application.

[0015] Figure 6bShown is a schematic diagram of another label style in one embodiment of the present application.

[0016] Figure 6c Shown is a schematic diagram of a test tube with a label attached in one embodiment of the present application.

[0017] Figure 7 Shown is a schematic diagram of a collection area in a quality inspection and control device of the present application in one embodiment.

[0018] Figure 8a It is a schematic diagram showing that a carrier in a collection area of ​​the quality inspection control device of the present application can be moved out in one embodiment.

[0019] Figure 8b It is a schematic diagram showing that a carrier in a collection area of ​​the quality inspection control device of the present application can be moved out in one embodiment.

[0020] Fig. 9 Shown is a schematic diagram of a transfer device according to an embodiment of the present application.

[0021] Fig.10 Shown is a schematic structural diagram of a carrier of the present application in one embodiment.

[0022] Fig.11 Shown is a schematic structural diagram of a conveying device of the quality inspection and control equipment of the present application in one embodiment.

[0023] Fig.12 Shown is a schematic structural diagram of a conveying robot of a conveying device in the present application in one embodiment.

[0024] Fig.13 It is a schematic diagram showing the quality control device of the present application taking samples from the screening area in one embodiment.

[0025] Fig.14 Shown is a schematic diagram of a quality inspection and control device of the present application identifying a sample in one embodiment.

[0026] Fig.15 Shown is a schematic diagram of placing a sample in a quality inspection work area in one embodiment of the quality inspection control device of the present application.

[0027] Fig.16 Shown is a schematic diagram of placing a sample in a collection area in one embodiment of the quality control device of the present application.

[0028] Fig.17 It is a schematic diagram showing the quality inspection control device of the present application in one embodiment where a sample is placed on a marking device.

[0029] Fig.18 It is a schematic diagram showing the quality inspection control device of the present application in one embodiment where a sample is placed in a qualified product placement area.

[0030] Fig.19 Shown is a schematic diagram of placing samples in a transit temporary storage area in one embodiment of the quality inspection control device of the present application. DETAILED DESCRIPTION

[0031] The following is an explanation of the implementation of the present application by means of specific embodiments. People familiar with the art can easily understand other advantages and effects of the present application from the contents disclosed in this specification.

[0032] In the following description, with reference to the accompanying drawings, several embodiments of the present application are described. It should be understood that other embodiments may also be used, and mechanical composition, structure, electrical and operational changes may be made without departing from the spirit and scope of the present disclosure. The following detailed description should not be considered restrictive, and the scope of the embodiments of the present application is limited only by the claims of the published patents. The terms used here are only to describe specific embodiments and are not intended to limit the present application. Spatially related terms, such as "upper", "lower", "left", "right", "below", "below", "lower", "above", "upper", etc., may be used in the text to facilitate the description of the relationship between an element or feature shown in the figure and another element or feature.

[0033] Although the term first, second etc. is used to describe various elements or parameters in this article in some instances, these elements or parameters should not be limited by these terms.These terms are only used to distinguish an element or parameter from another element or parameter.For example, the first qualified product placement area can be referred to as the second qualified product placement area, and similarly, the second qualified product placement area can be referred to as the first qualified product placement area, without departing from the scope of the various described embodiments.The first qualified product placement area and the second qualified product placement area are both describing a qualified product placement area, but unless the context clearly indicates otherwise, they are not the same qualified product placement area.

[0034] Furthermore, as used in this article, the singular forms "one", "an" and "the" are intended to include plural forms as well, unless there is an indication to the contrary in the context. It should be further understood that the terms "comprise", "include" indicate the presence of the described features, steps, operations, elements, components, projects, kinds, and / or groups, but do not exclude the presence, occurrence or addition of one or more other features, steps, operations, elements, components, projects, kinds, and / or groups. The terms "or" and "and / or" used herein are interpreted as inclusive, or mean any one or any combination. Therefore, "A, B or C" or "A, B and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B and C". Exceptions to this definition will only occur when the combination of elements, functions, steps or operations is inherently mutually exclusive in some way.

[0035] In medical scenarios, collecting patient samples and analyzing them to determine the treatment plan for the patient is a common process for many types of diagnosis. As described in the background technology, the processing process can be divided into pre-analysis, analysis, and post-analysis. In current sample-based medical tests, the pre-analysis stage of the sample requires manual participation, and this stage is also the stage where detection errors are most likely to occur. Detection errors may lead to improper examinations or improper treatments of patients. In order to avoid the above accidents, it is of great significance to improve the accuracy of sample analysis before analysis.

[0036] Pre-analysis work of samples usually involves multiple complicated processes. In the existing sample pre-processing solutions, the transportation between the various processes or specific links in them need to be implemented manually, which may lead to detection errors, and manual participation also consumes a lot of time and cost.

[0037] In the embodiments provided in the present application, "ex vivo" refers to the separation of in vivo components such as tissues or cells from an animal or human body into an in vitro environment, such as separation by surgery or sampling.

[0038] "Biological samples" may refer to samples of biological macromolecules, cells, tissues and organs of healthy and diseased organisms (including humans, animals, plants, and microorganisms) (for example, human organ tissues, whole blood, plasma, serum, body fluids (urine, saliva, cerebrospinal fluid, etc.) and their derivatives (including DNA, RNA, protein, etc.). For example, the "biological ex vivo sample" may be whole blood, separated blood such as whole blood, serum, plasma, pleural effusion, ascites, pericardial effusion, sweat, tears, ear fluid, sputum, lymph, bone marrow suspension, lymph, urine, saliva, semen, vaginal fluid, feces, transcervical lavage, cerebrospinal fluid, brain fluid, breast milk, vitreous humor, aqueous humor, sebum, endolymph, peritoneal fluid, pleural fluid, cerumen, epicardial fluid, and secretions of the respiratory tract, intestinal tract, and urogenital tract; the biological ex vivo sample may also be a sample obtained by reprocessing blood or tissue directly obtained from an organism, such as a protein, antibody, nucleic acid sample, etc.

[0039] In some embodiments, the biological in vitro sample is used for molecular diagnosis. The quality inspection and control equipment is used to implement pre-analysis processing of the sample. For biological in vitro samples used to implement different analyses, the specific detection process and detection method of the biological in vitro sample before analysis may be different. In some embodiments, the biological in vitro sample processed by the quality inspection and control equipment of the present application may be a biological in vitro sample used for molecular diagnosis. Among them, molecular diagnostic technology refers to a technology that uses DNA and RNA as diagnostic materials and uses molecular biology technology to detect the presence, defects or abnormal expression of genes to diagnose human conditions and diseases. Correspondingly, the biological in vitro sample is usually a sample that can be used to obtain DNA or RNA diagnostic materials.

[0040] In the embodiments provided in the present application, the biological in vitro sample is also referred to as a "sample" for short. Unless otherwise specified, the term "sample" in the embodiments refers to the "biological in vitro sample" in the present application.

[0041] In the embodiments provided in the present application, the term "biological ex vivo sample carrier" or "carrier", unless otherwise specified, refers to the carrier containing the biological ex vivo sample rather than the carrier itself as a container.

[0042] The carrier of the biological sample is a container for holding the biological sample. In different application scenarios, the specific form of the carrier may be different. When the conveying device conveys the carrier of the biological sample, it usually drives the carrier of the carrier to move so that the carrier of the biological sample moves together with its carrier. Accordingly, a limiting structure adapted to the carrier form may be provided in the carrier to ensure that the carrier of the biological sample is smoothly transported when the conveying device is running.

[0043] In some embodiments, the carrier of the biological in vitro sample is a test tube type container. The test tube type container is usually composed of a test tube as a container and a test tube plug or a test tube cap. The outer wall of the test tube can be used to attach the information carrier of the aforementioned order information or a label of identity information. In one embodiment, the test tube is, for example, a blood collection tube. More specifically, the test tube is, for example, a Streck blood collection tube with a height of 105 mm and a bottle diameter of 15.5 mm. Of course, in some other embodiments, the sample carrier is also, for example, a urine collection tube or a container / dish for other case specimens.

[0044] In the embodiments provided in the present application, the term "carrier" refers to the bearing structure of the carrier used to load the biological sample in vitro in the quality inspection workbench and during the transportation process of the conveying device. Generally, the carrier has a certain limiting effect on the carrier of the biological sample in vitro so that the area where the biological sample is located can be determined or moved by determining or moving the position of the carrier. In some embodiments provided in the present application, the carrier is a carrier plate, a well plate, or a well rack for holding a test tube. In the embodiment where the carrier is a test tube container, the carrier of the carrier can be set as a well plate, and the well plate can be a bearing plate with a preset number of limiting holes, and the limiting holes are used to hold the test tube container. The well plate is also provided with a clamping hole structure for fixing the loaded test tube container, and the clamping hole structure is, for example, a clamping claw provided in the limiting hole. When the test tube container is placed in the limiting hole, the clamping claw is pressed against the outside of the test tube container to limit the displacement of the test tube container in the limiting hole, such as tilting, shaking, etc.

[0045] In some embodiments, the carrier is provided with a buffer layer for contacting the test tube container of the biological sample; in some examples, the material of the test tube container has a certain degree of hardness and brittleness, and in order to protect the test tube container from being damaged during the transfer process, the carrier may also be provided with a buffer layer at least in the portion for contacting the test tube container. The buffer layer is, for example, elastic rubber, silicone, or other materials with elastic deformation, damping properties, or buffering properties.

[0046] To this end, the present application provides a quality inspection control device for biological in vitro samples, the quality inspection control device is communicatively connected to a quality inspection management system, the quality inspection control device includes: a quality inspection workbench, a transfer device, an identification device, a quality inspection device, a conveying device, and a communication device, wherein the quality inspection workbench is provided with a transport area and multiple work areas; the transfer device is adjacent to the transport area and the multiple work areas, and is used to transfer the carrier containing the biological in vitro sample between the transport area or multiple work areas; the identification device is used to identify the order information of the biological in vitro sample transferred by the transfer device; the quality inspection device is used to detect the biological in vitro sample located in the quality inspection work area to generate a quality inspection result; the conveying device is used to convey the carrier of the biological in vitro sample to be inspected to the quality inspection workbench, or to convey the carrier of the biological in vitro sample that has completed quality inspection out of the quality inspection workbench; the communication device is used to communicate with a quality inspection management system to send and receive information, and the information sent includes the order information and quality inspection data.

[0047] The communication device of the quality inspection control device provided in the present application is connected to a quality inspection management system, and the communication device can be connected to the quality inspection management system to send and receive information, and the information sent includes the order information and quality inspection data, so that the sample processing process performed by the quality inspection control device can be based on the information provided by the quality inspection management system, the determined detection rules, or the determined detection process. By associating the sample processing process with the quality inspection management system, the quality inspection control device can determine how to adjust the processing process, such as the increase or decrease adjustment or sequence adjustment of the processing process, through the quality inspection management system in some embodiments of realizing automated sample processing, and the information provided by the quality inspection management system can assist in determining the detection method, detection result or transportation or delivery method of the sample in each processing process, while realizing automated processing of samples to improve sample processing efficiency and reduce sample detection error rate, the quality inspection control device associated with the quality inspection management system can further improve the detection accuracy of automated processing samples; furthermore, the present application provides the structural composition, function and positional relationship between the structures of the quality inspection control device, so as to realize the automated processing of samples under the preset sample processing process, and improve the processing efficiency by forming a standardized processing process for samples.

[0048] In an embodiment, the communication connection of the communication device to the quality inspection management system is a connection method for establishing a connection between different devices based on a certain communication protocol or other matching rules and realizing data transmission and information exchange, including a connection between a remote terminal and a target object terminal established by matching identification information. The communication protocol determines the rules to be followed for communication or service between devices. The protocol defines the format of the data unit, the connection method of the information unit, and the timing of sending and receiving information to ensure that the information is identified and transmitted between devices; the communication protocol includes TCP / IP, NETBEUI and IPX / SPX. The identification information is used to determine the properties of different terminal devices, such as a unique device identification code, to determine that the connection terminal is correctly corresponding, and then to realize the subsequent data transmission between terminal devices.

[0049] In some embodiments provided in the present application, the quality inspection control device is used to implement a series of detection operations in the pre-analysis stage of the sample, and the detection operations are, for example, quality inspection of the sample and information detection of the sample; wherein, the quality inspection is used to achieve quality control or quality assurance of the sample. The sample is a biological in vitro sample. Accordingly, the quality inspection control device of the present application is usually associated with medical applications such as assisting in forming a diagnosis opinion, treatment plan or biological-related medical research such as pharmaceutical development or scientific research for the patient. In some scenarios, the quality inspection control device is also an instrument system for implementing sample pre-processing audit quality inspection.

[0050] In the embodiments provided in the present application, the quality inspection management system to which the communication device of the quality inspection control device is connected may be a system used in different scenarios, such as testing laboratories or hospitals. The quality inspection management system includes but is not limited to electronic devices, servers, server clusters, cloud server systems, etc. The quality inspection management system may also be a combination of software and hardware; the quality inspection control device and the quality inspection management system are connected in communication by, for example, a network connection.

[0051] In a first aspect, the present application provides a quality inspection control device. Figure 1 , showing a schematic diagram of the framework of the quality inspection control device of the present application and the quality inspection management system in communication connection therewith in one embodiment. As shown in the figure, the quality inspection control device 1 is connected to the quality inspection management system 2 through a network, and the network can be the Internet, a mobile network, a local area network (LAN), a wide area network (WLAN), a storage area network (SAN), or one or more intranets, or a suitable combination thereof. In the embodiments provided in the present application, there is no limitation on the types of the client and the server, or the types or protocols of the communication networks between the publisher terminal and the server, or between the responder terminal and the server.

[0052] The quality inspection and control device 1 needs to communicate with the quality inspection and management system 2 to realize the interaction of information or instructions in order to realize the automated processing of samples. Accordingly, the quality inspection and management system 2 can be configured with functional modules adapted to the operation needs of the quality inspection and control device 1. The functional modules are collaboratively implemented by, for example, various types of devices (such as terminal devices, servers, server clusters, or cloud server systems), or computing resources such as processors, and communication resources (such as for supporting various modes of communication such as optical cables and wireless communications). In some examples, each functional module in the quality inspection and management system 2 can be embedded in the software system of the electronic device, and the software system of the electronic device can obtain the order information or quality inspection rules from the electronic device storage medium or other devices, servers, etc. that communicate with the electronic device network. In an embodiment, the quality inspection and management system 2 includes a communication module 20, a storage module 21, a verification module 22, and a quality inspection module 23.

[0053] In an embodiment, the storage module 21 can be used to store the order information of the biological ex vivo sample and the identity information corresponding to the order information. In this way, after the quality inspection control device 1 transmits the order information of the biological ex vivo sample obtained by the identification device to the quality inspection management system 2, the verification module 22 obtains the pre-stored order information from the storage module, and compares the pre-stored order information with the received order information identified by the quality inspection control device 1 to generate a verification result of the order information. The quality inspection control device 1 receives the order information verification result and can determine the subsequent transportation or detection action of the biological ex vivo sample based on it.

[0054] For example, at least one quality inspection rule may also be provided in the storage module 21, and the quality inspection device of the quality inspection control device 1 may perform quality inspection on the biological ex vivo sample based on the at least one quality inspection rule, and the quality inspection result may be generated by comparing the quality inspection data obtained by the quality inspection device with the qualified standard determined by the quality inspection rule. The quality inspection rule may be, for example, a parameter to be inspected (to be tested) for detecting the biological ex vivo sample and a corresponding quality inspection means. It should be understood that when the parameters to be tested for the sample are different, the corresponding device, equipment, or detection step for obtaining the measurement value is different.

[0055] The quality inspection module 23 in the quality inspection management system 2 can be used to perform the comparison between the aforementioned quality inspection data and the quality inspection qualified standard to determine the quality inspection result (for example, the judgment result of whether the biological ex vivo sample is qualified for quality inspection), or, based on the determined quality inspection result, generate diversion information to control the subsequent transportation or detection action of the biological ex vivo sample by the quality inspection control device 1. In some embodiments, the quality inspection module can also be configured to associate the quality inspection data with a piece of identity information.

[0056] Of course, the functional module composition of the quality inspection management system 2 is not limited to this. For example, the quality inspection management system 2 can also be configured with a report generation module 24, and the report generation module 24 can generate a quality inspection report of the biological in vitro sample including the quality inspection results based on the order information and identity information.

[0057] In some embodiments, the quality inspection management system of the present application may also refer to the embodiment provided in the prior patent document of the present applicant, publication number CN104899697B (name: A laboratory process quality control management and reporting automation system and method), that is, the functional modules that may be configured in some embodiments of the quality inspection management system may refer to the functional modules in the laboratory process quality control management and reporting automation system described in the patent disclosure document, such as a sample confirmation module, a sample information entry module, a test application submission module, etc.

[0058] In each embodiment provided in the first aspect of the present application, the quality inspection control equipment includes a quality inspection workbench, a transfer device, an identification device, a quality inspection device, and a conveying device to collaboratively realize the automated detection and transportation of samples. It should be understood that in order to realize the automated processing of samples, it is necessary to deploy devices that realize different functions, and the quality inspection workbench can realize the deployment of different devices, including a transportation area and multiple work areas, wherein the multiple work areas include an identification work area and a quality inspection work area corresponding to the identification device and the quality inspection device, respectively, and the conveying area is an area in the quality inspection workbench associated with the conveying device. The quality inspection workbench can be set to different shapes according to the sample processing requirements, and this application does not impose any restrictions.

[0059] The transfer device transfers the carrier containing the biological in vitro sample between the transportation area or multiple work areas according to the detection process. For example, the carrier of the biological in vitro sample is transferred to the identification work area. The identification device can identify the order information of the biological in vitro sample and transmit it to the quality inspection management system, thereby realizing the association of the biological in vitro sample order information with the information in the quality inspection management system.

[0060] In the quality inspection work area, the quality inspection device detects the biological in vitro sample to generate a quality inspection result. The specific detection parameters of the quality inspection device can be determined based on the quality inspection rules. Accordingly, the quality inspection device can be configured based on the preset quality inspection rules. When the detection process is completed, the conveying device can convey the carrier of the biological in vitro sample out of the quality inspection workbench; or, the conveying device is used to transport the carrier of the biological in vitro sample into the quality inspection workbench.

[0061] The transfer device and the conveying device of the quality inspection control device can cooperate to realize the automatic conveyance of the biological in vitro samples according to the detection process. The quality inspection control device can realize the automatic processing of the biological in vitro samples to improve the processing efficiency and reduce the detection error rate. At the same time, by making the quality inspection control device communicate with the quality inspection management system, information transmission can be realized between the quality inspection control device and the quality inspection management system. Accordingly, the quality inspection control device has higher adaptability to the processing method of the biological in vitro samples. For example, the quality inspection operation is performed based on the quality inspection rules determined by the quality inspection management system. The quality inspection device can implement one or more quality inspection operations corresponding to the quality inspection rules, and the subsequent processing of the biological in vitro samples can be determined based on the quality inspection results. For example, the identification device can identify the order information of the biological in vitro samples and transmit the identification results to the quality inspection management system. In actual applications, the biological in vitro samples often go through multiple transportation processes. By identifying the order information, the detection errors caused by the order information errors can be avoided, or the specific processing flow required for the biological in vitro samples can be clarified by determining the order information, thereby further reducing the detection error rate.

[0062] To facilitate the description of the structure and layout of the quality control equipment of this application, please refer to Figure 2 , which is a schematic diagram of the device layout of the quality inspection control device of the present application in one embodiment. It should be noted that, Figure 2 It is only shown as an achievable method, and the specific structure of the quality inspection and control equipment provided in this application and the positional relationship between the structures are not limited to this.

[0063] like Figure 2 As shown, the quality inspection control device 1 includes a quality inspection workbench 10, and the quality inspection workbench 10 is provided with a transport area 101 and a plurality of work areas 100. The transport area 101 is also an area in the quality inspection workbench 10 associated with the conveying device 14, that is, the conveying area 101 can be a position area where the conveying device 14 conveys the carrier of the biological ex vivo sample to be inspected to the quality inspection workbench 10, or it can be a position area where the conveying device 14 conveys the carrier of the biological ex vivo sample from the quality inspection workbench 10. In the embodiment, the quality inspection workbench 10 of the quality inspection control device 1 is provided with the identification device 12, the quality inspection device 13, and the work area 100 corresponding to the transfer device 11.

[0064] In order to facilitate the description of the workflow and equipment coordination mode, structural composition and layout of the quality control device 1 provided in this application, the following takes the quality control process or quality control method of the quality control device 1 in one embodiment as an example to describe the equipment and working principle for executing each step of the quality control process. It should be understood that in actual scenarios, the quality control process based on which the quality control device 1 pre-processes biological ex vivo samples is not limited to this. Please refer to Figure 3, which is a flow chart of a biological sample quality control method in one embodiment of the present application. As shown in the figure, the quality control method includes the following steps:

[0065] In step S10 , a carrier containing the biological ex vivo sample is transported to a quality inspection workbench by a transport device; in the embodiment, the transfer device 11 obtains the carrier of the biological ex vivo sample transported to the quality inspection workbench 10 by the transport device 14 .

[0066] In step S11, a transfer device is used to transfer the carrier containing the biological ex vivo sample between the transport area and multiple work areas of the quality inspection workbench according to the detection process; wherein the detection process includes: identifying the order information of the biological ex vivo sample transferred by the transfer device through an identification device to transmit it to a quality inspection management system, and performing a first diversion process on the carrier containing the biological ex vivo sample according to the feedback of the quality inspection management system; in an embodiment, the carrier of the biological ex vivo sample is transferred to the work area corresponding to the identification device 12 by the transfer device 11, so that the identification device 12 identifies the order information on the carrier of the biological ex vivo sample, and the order information obtained by the identification device 12 is transmitted to the quality inspection management system 2, so as to determine whether the order information matches the order information pre-stored in the quality inspection management system 2, thereby determining the first diversion information of the biological ex vivo sample. The diversion information is information used to determine whether the biological ex vivo sample is transferred from the identification device 12 to the next work area or placement area.

[0067] The identification device 12 is configured in the identification work area of ​​the quality inspection workbench 10, and is used to identify the order information of the biological in vitro sample transferred by the transfer device 11 for transmission to the quality inspection management system 2. In actual scenarios, such as sample testing conducted within a hospital or sample testing performed by a central laboratory, the biological in vitro samples obtained are all associated with certain order information to ensure that the biological in vitro samples match the corresponding users, such as the sample provider or the patient from whom the sample is collected. In each stage of medical verification before, during, and after analysis, it is necessary to ensure that the sample corresponds to the user in order to perform testing based on user needs and provide the test results to the user. The identification device 12 can be used to identify the order information of the biological in vitro sample and can transmit the identified order information to the quality inspection management system 2, and the quality inspection management system 2 can compare the received order information with the pre-stored order information to determine whether the order information of the biological in vitro sample is correct. The quality inspection management system 2 is communicatively connected with the quality inspection control device 1, and therefore can be respectively set in different occasions or application environments. Accordingly, the quality inspection control device 1 of the present application can verify the order information in different application environments, and the adapted application scenarios are wide and highly adaptable.

[0068] In one implementation scenario, before the carrier of the biological ex vivo sample is transported to the quality inspection workbench 10, it is pre-configured with an information carrier such as a barcode, a QR code or a number field for associating or carrying order information. The identification device 12 identifies the information carrier to obtain the order information associated or carried therein, and matches the order information obtained based on the identification with the information in the order information database pre-stored in the quality inspection management system 2 to determine whether the order information loaded or associated on the carrier of the biological ex vivo sample is correct. Taking the information carrier as a barcode as an example, in some examples, the position of the barcode on the carrier of the biological in vitro sample is not fixed, that is, when the barcode is attached, the barcode does not have to be in a fixed position and attachment direction; or, in other examples, the information carrier on the carrier of the biological in vitro sample can also be set to multiple, and the multiple information carriers are, for example, order information collected in different scenarios such as different hospitals; here, when identifying the information carrier, the identification device 12 can identify each information carrier attached at different positions and directions. When it is determined that at least one of the order information corresponding to all the information carriers on the carrier of the biological in vitro sample matches the order information in the order information database pre-stored in the quality inspection management system 2, it can be determined that the order information of the biological in vitro sample is correct for subsequent detection procedures.

[0069] In some embodiments, the order information includes the traceability information of the biological sample in vitro, and the traceability information includes at least one of user identification information, communication information, biometric information, and order number information. In an embodiment, the traceability information is used to determine the user information corresponding to the order, such as the user identification information, communication information, biometric information, and order number information of the user, which are usually unique (i.e., non-repetitive). The types of user identification information that can be obtained include the identification number customized by the system, or the identification number customized by a third party, etc., which are de-identified identification information, such as: user code, user code, user identification code, and barcodes, QR codes, etc. based on this; the communication information is, for example, the user's mobile phone number, fixed number, email address, and other communication identification numbers; the biometric information is, for example, the user's portrait information, iris information, and fingerprint information. The specific user corresponding to the order can be determined by the uniqueness of the biometric information; usually, under the predetermined order number rules, the order number is also unique information, and the corresponding order information can be found in the order system based on the order number.

[0070] In some embodiments, the quality inspection management system 2 has an order system. When the identification device 12 identifies the order information on the biological ex vivo sample and transmits it to the quality inspection management system 2, the quality inspection management system 2 uses the traceability information in the received order information as an index to search for a matching pre-stored order in the order system, and can compare the order information of the pre-stored order with the order information identified by the quality inspection control device 1 to determine whether there is an order information error. In some embodiments, the traceability information is also associated with the test item information and sample information of the biological ex vivo sample; wherein the sample information includes at least one of the collection time of the biological ex vivo sample, the amount of collected sample, the sample type, and the number of sample carriers.

[0071] In some scenarios, when an order is generated, the order also includes the user's testing requirements, such as test item information, and sample attribute-related information, such as collection time, sample volume, sample type, and number of sample carriers, etc. The sample volume is the mass or volume of the collected sample, the sample type is, for example, blood or tissue fluid, etc., and the number of sample carriers is the number of carriers containing samples corresponding to the same order.

[0072] The test item information and sample information are associated with the traceability information, for example, the order information pre-stored in the order system of the quality inspection management system 2 includes the associated traceability information, test item information and sample information. In this example, the order information on the biological in vitro sample can be part of the order information, such as the traceability information therein.

[0073] In the embodiments provided in the present application, the order information on the biological in vitro sample can be used to refer to the order information content carried on the carrier, such as the order number presented in the form of digital symbols, and can also be used to refer to the information obtained by reading the information carrier on the carrier, such as the information code, label, coding, etc.

[0074] The order information can be presented in different forms or information carriers attached to the carrier of the biological ex vivo sample. Correspondingly, the identification device 12 can be configured as, for example, an RFID device, an NFC device, or a code scanning device, etc., as long as the identification device 12 can identify and obtain the order information associated with the biological ex vivo sample.

[0075] In some embodiments, the identification device 12 is a code scanning device, which is used to identify the information code on the carrier of the biological sample to obtain the order information, and compare the order information with the information pre-stored in the quality inspection management system 2 to obtain the verification result. Figure 2In the illustrated embodiment, the identification device 12 is a code scanning device, and a corresponding code scanning station is provided in the quality inspection work area. In the embodiment, the code scanning device is, for example, a line scanning camera.

[0076] When the order information is attached to the carrier of the biological sample in vitro with the information code as the information carrier, the identification device 12 can be configured as a code scanning device to obtain the order information associated with the information code by reading the information code on the carrier. The verification result of the order information of the biological sample in vitro can be obtained by comparing the order information obtained by scanning the code with the order information pre-stored in the quality inspection management system 2. When the type of information carrier of the order information is different, the correspondingly configured code scanning device can be different, such as a barcode scanner or a QR code scanner, etc. The specific specifications and product types of the code scanning device are not limited in this application.

[0077] The verification result is the result of judging whether the order information is qualified. In some scenarios, when the order information of the biological sample is determined to be qualified, the transfer device 11 transfers the biological sample to the next work area; or, when the order information of the biological sample is determined to be unqualified, the biological sample is transferred to the corresponding collection area for placing biological samples that do not match the order information. The qualified standard for whether the order information is qualified is, for example, whether the position of the information code is qualified, such as whether the information codes overlap and cover each other when multiple information codes are attached to the carrier, or whether the information codes are covered by other labels and cannot be recognized, etc., and whether the order information obtained by recognition can match the pre-stored order information, etc.

[0078] The biological in vitro sample quality control method further includes the step of placing the carriers of multiple biological in vitro samples corresponding to the same order information determined in the test in a transit temporary storage area of ​​the quality inspection workbench. In this embodiment, the quality inspection workbench 10 is provided with a transit temporary storage area 102 for placing the carriers of multiple biological in vitro samples corresponding to the same order information. Figure 2 , Figure 2 In the illustrated embodiment, a transfer temporary storage area 102 is disposed in the quality inspection workbench 10 .

[0079] The quality inspection and control method of the biological in vitro sample also includes the step of determining the quantity information of the biological in vitro sample in the transfer temporary storage area to transfer the biological in vitro sample with incorrect quantity information to the collection area, or transferring the biological in vitro sample with correct quantity information to the next detection station. In some examples, the number of carriers of the biological in vitro sample collected when collecting samples based on the same order is 2 or more. When multiple samples are associated with each other to be recorded in the same order information, the same order information corresponds to the carriers of multiple biological in vitro samples. During the detection process, after the information code loaded on the carrier of the biological in vitro sample is identified to obtain the corresponding order information, it is determined that the order information corresponds to the carriers of multiple biological in vitro samples, and then the carrier of the biological in vitro sample is transferred to the transfer temporary storage area 102. After it is determined that the carriers of the multiple biological in vitro samples corresponding to the order information are all detected and identified (i.e., after they are collected), the carriers of the multiple biological in vitro samples are subsequently circulated.

[0080] The temporary transfer storage area 102 can be used to assist in determining the quantity information. In some embodiments, the method for determining the quantity information of the biological ex vivo sample in the temporary transfer storage area 102 includes:

[0081] Based on the recognition device 12 identifying the order information of the biological in vitro samples and when it is determined that the order information corresponds to a plurality of biological in vitro sample carriers, the biological in vitro samples are placed in the transit temporary storage area 102 and the order information is determined as order information to be inspected, the recognition device 12 continues to recognize the order information of a preset number of biological in vitro samples, and when it is determined that the preset number of biological in vitro samples includes other biological in vitro samples corresponding to the order information to be inspected, the quantity information is determined to be correct. For example, when the order information of a biological sample is identified, if it is found that the number of biological samples corresponding to the order information is multiple, the carrier of the biological sample is transferred to the transit temporary storage area 102, and then a certain number of other samples are processed, for example, other samples in the same carrier or a certain number threshold, such as 20 samples, are processed, and it is determined whether there are biological samples with the same order information. When the remaining samples corresponding to the order information are detected in the preset number of biological samples, it can be determined that the number information of the biological samples is correct. On the contrary, when the remaining samples corresponding to the order information are not detected in the preset number of biological samples (for example, they are lost or recorded incorrectly), it is determined that the number information of the biological samples in the transit temporary storage area 102 is wrong. In the case where the number information of the biological samples is determined to be correct, when the carriers of the multiple biological samples corresponding to the order information are all detected, the multiple biological samples can be removed from the transit temporary storage area 102 for subsequent processing.

[0082] In some embodiments, the temporary transfer storage area 102 is also associated with an alarm device (not shown), and when the temporary transfer storage area 102 is in a state to be unloaded, the alarm device is triggered, and the operator can choose to manually process the biological ex vivo samples in the temporary transfer storage area 102. In an embodiment, the alarm device is, for example, a buzzer or a signal light, and the alarm device can also be used to trigger the device to pause for manual processing or troubleshooting.

[0083] In an embodiment, the unloading state can be customized. For example, the state in which each storage position on the transfer temporary storage area 102 is loaded with carriers of biological ex vivo samples can be defined as a full load state, and the alarm device is triggered when the transfer temporary storage area 102 reaches the full load state. For another example, a trigger rule can be set based on the storage position of the transfer temporary storage area 102. For example, when some storage positions in the transfer temporary storage area 102 are in a loading state, the alarm device can be triggered.

[0084] like Figure 2 In the embodiment shown, the storage positions of the temporary transfer storage area 102 are arranged in 3×8 (3 rows×8 columns), and the temporary transfer storage area 102 can load a total of 24 biological sample carriers at most. When it is determined that the number of biological sample carriers placed in any row of the temporary transfer storage area 102 exceeds 8, or when it is determined that the number of biological sample carriers placed in any column of the temporary transfer storage area 102 exceeds 3, the alarm device can be triggered. Of course, it should be noted that the specifications of the temporary transfer storage area 102 are not limited to this; accordingly, the rules for triggering the alarm device are not limited to this.

[0085] In some embodiments, the quality inspection control device 1 further includes a housing (not shown), which can be configured to cover the quality inspection workbench 10, so as to prevent the external environment from interfering with the operation of the device in the quality inspection workbench 10 and provide a sterile working environment. In some implementations, the housing can also be configured to have one or more transparent windows, through which the operator can instantly view the operating status of the quality inspection workbench 10.

[0086] In some embodiments, a protective pad (not shown) is also arranged inside the quality inspection workbench 10. The protective pad is, for example, a foam material or rubber formed by a material having a cushioning property, or a flexible structure having a cushioning function such as a cloth pad. Figure 2 In the illustrated embodiment, a protective pad is provided inside the quality inspection workbench 10 to avoid or reduce hard contact between the carrier or transfer device 11 and the quality inspection workbench 10 during the transfer of the biological ex vivo sample.

[0087] After the order information of the biological in vitro sample is identified, the carrier of the biological in vitro sample can be transferred to the next work area according to the detection process. Usually, after the order information is identified as qualified, the biological in vitro sample can be quality inspected.

[0088] In step S12, a quality inspection device detects the biological sample in the quality inspection work area to generate quality inspection data, and transmits the quality inspection data to the quality inspection management system, and performs a second diversion process on the carrier containing the biological sample. In the embodiment, please continue to refer to Figure 2 As shown in the figure, a quality inspection device 13 is provided in the quality inspection workbench 10. The quality inspection device 13 detects the biological in vitro sample located in the quality inspection work area to generate quality inspection data, and a quality inspection result can be generated based on the quality inspection data.

[0089] The quality inspection control method for biological in vitro samples also includes a step of comparing the quality inspection data obtained by the quality inspection device for detecting the biological in vitro samples based on the quality inspection qualification standard to obtain the quality inspection result; in an embodiment, the way of generating the quality inspection result from the quality inspection data is: comparing the quality inspection data obtained by the quality inspection device 13 for detecting the biological in vitro samples based on the quality inspection qualification standard to obtain the quality inspection result; wherein, the quality inspection qualification standard is an industry standard, a custom standard, or a standard determined by the quality inspection management system 2.

[0090] The quality inspection qualified standard is, for example, for the quality inspection parameter to be measured, and a qualified numerical range is defined for the parameter value. After the quality inspection device 13 detects and obtains the quality inspection data, it is determined whether the measurement of the quality inspection data is within the qualified numerical range, thereby determining the quality inspection result. The quality inspection qualified standard can be an industry standard, such as a default qualified range preset in the quality inspection control device 1; it can also be a custom standard, such as manually setting a quality inspection parameter or a qualified numerical range; in some examples, the quality inspection qualified standard can also be determined by the quality inspection management system 2. In the implementation scenario, for example, the quality inspection data can be transmitted to the quality inspection management system 2, and the quality inspection management system 2 can compare and determine the quality inspection result.

[0091] In certain embodiments, the quality inspection parameters used to form the quality inspection qualified standard include: one or more of: sample weight, sample volume, and sample weight density. For example, the net weight of the sample is detected and determined, and the relationship between the net weight of the sample and the qualified range of the sample weight in the quality inspection qualified standard is determined, such as being greater than, less than, or within the qualified numerical range. Among them, the net weight of the sample is, for example, determined by calculation, by predetermining the weight of the empty carrier of the biological ex vivo sample, thereby calculating and determining the net weight of the sample based on the actual weighing data (i.e., the total weight of the carrier loaded with the biological ex vivo sample) and the weight of the empty carrier. Of course, in another embodiment, the total weight of the carrier and sample of the biological ex vivo sample can be compared with the qualified range of the total weight of the sample and the carrier in the preset quality inspection qualified standard to determine the quality inspection result.

[0092] In some embodiments, the quality inspection qualified standard includes sample qualified standards corresponding to one or more sample types. For example, different types of samples are respectively set with qualified ranges corresponding to quality inspection parameters. When determining whether the quality inspection result is qualified based on the quality inspection data, for example, the sample type can be determined based on the order information of the biological ex vivo sample, and the quality inspection data can be compared with the sample qualified label corresponding to the sample type to obtain the quality inspection result.

[0093] When the test items or subsequent processing operations corresponding to the biological in vitro samples are different, and the quality requirements corresponding to the samples are different, the specific quality inspection methods performed on the samples before analysis may be different. The quality inspection rules and quality inspection methods determined based on the detection needs are, for example, methods for determining the sample size such as weighing, sample volume identification, etc. The quality inspection device 13 is configured to perform quality inspection on the biological in vitro samples before analysis based on the quality inspection rules. The test items are, for example, conventional pathological detection, qPCR (Quantitative Polymerase chain reaction, quantitative PCR), nucleic acid molecule hybridization such as FISH (Fluorescence in situ hybridization, fluorescence in situ hybridization), Sanger, biochip, NGS (Next generation sequencing, second generation sequencing), mass spectrometry detection, etc., and the subsequent processing operations are, for example, nucleic acid extraction, protein purification, etc.

[0094] In some embodiments, the quality inspection device 13 includes a weighing device for detecting the weight of the biological sample, and comparing the weight of the biological sample obtained by the detection with the quality inspection standard of the quality inspection management system 2 to generate the quality inspection result. Figure 2In the illustrated embodiment, the quality inspection device 13 includes a weighing device, and a corresponding weighing station is provided in the quality inspection work area. The weighing device is used to realize the sample quantity judgment. In some examples, the judgment of the liquid quantity can also be realized by other devices, such as determining the sample volume by visual recognition. The present application provides an embodiment of determining the sample quantity by weighing. The sample quantity can be determined by weighing the sample and its carrier, thus avoiding the process of determining the sample quantity from causing infection to the sample. The weighing device has a certain measurement accuracy. In one example, in order to ensure the accurate detection of the sample quantity, the measurement accuracy of the weighing device is within ±0.01g.

[0095] In some examples, the weighing device has a limiting structure 130 for placing a carrier of the biological sample, for example Figure 2 In the illustrated embodiment, the weighing device is provided with a limiting structure 130 for placing a carrier of a biological sample in vitro, thereby realizing accurate placement of the carrier of the biological sample in vitro on the weighing device to ensure that the carrier is stably placed in a preset position. The limiting structure can be configured to match the geometric shape of the carrier of the biological sample in vitro, for example, when the carrier of the biological sample in vitro is a test tube container, the limiting structure 130 is, for example, a cylindrical structure or a groove structure matching the size of the test tube.

[0096] In some examples, when the device for determining the sample amount is a volume measurement device, a device with a preset volume measurement accuracy may also be selected, for example, a volume measurement accuracy within ±0.05 ml.

[0097] In some scenarios, the samples to be tested in the running state of the quality inspection control device 1 include different types of biological in vitro samples. Corresponding to different liquid types of biological in vitro samples, the starting amount of detection required in the analysis may be different, so the quality inspection qualified standards of the liquid amount are different. In some embodiments, the quality inspection device 13 performs quality inspection on the biological in vitro sample to obtain quality inspection data, and compares the quality inspection data with the quality inspection qualified standards corresponding to the liquid type of the biological in vitro sample to generate a quality inspection result. Among them, the liquid type of the biological in vitro sample can be determined by the quality inspection management system 2, for example, the liquid type of the biological in vitro sample is obtained during the sample collection stage, and the liquid type information is stored in the quality inspection management system 2. Based on different sample liquid types, the quality inspection qualified standards of the samples under the corresponding liquid type are determined. For example, different types of sample liquids have different standard weight (or volume) intervals corresponding to different types of sample liquids. The quality inspection device 13 weighs or detects the biological in vitro sample, and compares the test results with the standard weight or volume corresponding to the liquid type to generate a quality inspection result. In some examples, the standard weight (or volume) corresponding to biological in vitro samples of different liquid types may also be the same.

[0098] After the quality inspection device 13 obtains the quality inspection data through detection, it can generate a quality inspection result based on the quality inspection data, and the quality inspection management system 2 associates the quality inspection result with an identity information. The quality inspection result can be generated by the quality inspection control device 1 or by the quality inspection management system 2; the quality inspection device 13 is used to obtain the quality inspection data of the biological in vitro sample. In one example, when the quality inspection control device 1 receives the quality inspection rule, it can determine whether the quality inspection data meets the quality inspection qualified standard based on the quality inspection rule to generate the quality inspection result; in another example, the quality inspection control device 1 transmits the quality inspection data obtained by the quality inspection device 13 to the quality inspection management system 2, and the quality inspection management system 2 determines whether the detection data meets the quality inspection qualified standard to generate the quality inspection result.

[0099] In some examples, the identity information has a corresponding relationship with the order information of the biological in vitro sample. For example, the identity information can be used as an index for retrieving orders in the order system. In terms of implementation, the quality inspection management system 2 associates the quality inspection result with the identity information, or associates the quality inspection result with the order information of the biological in vitro sample. By means of the corresponding relationship between the order information and the identity information, the association between the quality inspection result and the identity information is achieved. After determining the quality inspection result of the biological in vitro sample, the subsequent transportation location of the biological in vitro sample can be determined. In some examples, after determining that the biological in vitro sample is qualified in quality inspection, the biological in vitro sample can be transported to the qualified product placement area. When it is determined that the biological in vitro sample is unqualified in quality inspection, the biological in vitro sample is transported to the collection area for placing unqualified samples.

[0100] In step S13, the carrier of the biological in vitro sample that has completed the quality inspection is transported out of the quality inspection workbench or the empty carrier located in the screening area is transported out of the quality inspection workbench for standby. In an embodiment, the quality inspection workbench 10 also has at least one qualified product placement area 104 for placing biological in vitro samples that are identified as qualified for detection. In some embodiments, after completing various detection operations on biological in vitro samples in the quality inspection workbench 10, such as identifying order information and quality inspection, the biological in vitro sample is determined to be a qualified product and then placed in the corresponding qualified product placement area 104. The qualified product placement area 104 set in the quality inspection workbench 10 can be one or more, and can be specifically determined based on the need to place qualified products. For example, a qualified product placement area 104 can be set in the quality inspection workbench 10 to place all biological in vitro samples that are identified as qualified for detection in the qualified product placement area 104; for example, multiple qualified product placement areas 104 can be set in the quality inspection workbench 10 to place different types of qualified products. The number of the qualified product placement areas 104 may be determined based on whether the qualified products of the biological ex vivo samples are placed based on category partitions.

[0101] For example, when the qualified biological in vitro samples are not classified and placed, the corresponding qualified product placement area 104 is one. Therefore, the qualified product placement area 104 described in the present application does not have to be a continuous area, for example, it can be a plurality of partitions; in some embodiments, the classification of qualified products of the biological in vitro samples does not rely on location partitions, for example, the classification of qualified products is based on identifications such as labels, information codes, numbers, etc. In this case, the qualified product placement area 104 can also be recognized as one in number; or, when the qualified products of the biological in vitro samples are all regarded as the same type of qualified products, the qualified product placement area 104 is recognized as one in number.

[0102] In an embodiment, the biological in vitro sample quality control method further comprises a step of transferring the biological in vitro sample in the qualified product placement area out of the quality inspection workbench based on the conveying device. In an embodiment, the at least one qualified product placement area 104 is arranged in the conveying area 101, and the conveying device 14 conveys the biological in vitro sample from the qualified product placement area 104 out of the quality inspection workbench 10.

[0103] The at least one qualified product placement area 104 is set in the conveying area 101. After a series of testing processes for the biological in vitro samples are completed in the quality inspection workbench 10, the carrier of the biological in vitro samples that are determined to be qualified are placed in the qualified product placement area 104, and the conveying device 14 can subsequently transport the carrier of the biological in vitro samples out of the quality inspection workbench 10.

[0104] Of course, in other embodiments, the qualified product placement area 104 may also be placed in an area where materials can be manually unloaded.

[0105] In some embodiments, the quality inspection workbench 10 has a plurality of qualified product placement areas 104, and the plurality of qualified product placement areas 104 are used to place qualified biological in vitro samples of different categories determined according to preset classification rules. In this embodiment, the quality inspection control method of biological in vitro samples also includes a step of determining the qualified type of the biological in vitro samples that have passed the test according to the preset classification rules, so as to place the biological in vitro samples in the corresponding qualified product placement areas according to the qualified types. In an embodiment, the number of the at least one qualified product placement area 104 corresponds to the number of qualified product categories, and the qualified product categories are determined according to preset classification rules, and the preset classification rules can be fixed rules or custom rules.

[0106] In one implementation scenario, the at least one qualified product placement area 104 includes a first-category qualified product placement area, a second-category qualified product placement area, and a third-category qualified product placement area, which are respectively used to place first-category qualified products, second-category qualified products, and third-category qualified products determined according to preset classification rules. Of course, the classification of the qualified products is not limited to three categories, and accordingly, the qualified product placement area 104 is not necessarily three or three categories of qualified product placement areas. For example, it can be divided into six or eight categories, but it is not limited to this. For example, Figure 2 In the illustrated embodiment, a plurality of qualified product placement areas are also provided in the quality inspection workbench 10. In actual application scenarios, in response to different regulatory requirements, the qualified product placement area 104 may be provided with different numbers or types of areas for the classification of qualified products.

[0107] In some scenarios, biological in vitro samples that are deemed qualified for testing are classified and placed, and qualified biological in vitro samples of different categories can be classified and processed. The classification processing is, for example, to discharge different categories of biological in vitro samples to different areas, and subsequently perform different types of testing items on the biological in vitro samples.

[0108] In some embodiments, the classification rule is obtained from the quality inspection management system 2 or defined based on information obtained from the quality inspection management system 2. The classification rule is used to classify qualified biological ex vivo samples into different categories, so as to facilitate different subsequent processing of biological ex vivo samples of different categories.

[0109] The classification method for qualified products of the biological ex vivo samples can be customized by obtaining information from the quality inspection management system 2, for example, the quality inspection management device customizes and determines key information for distinguishing the types of qualified products, and obtains key information from the quality inspection management system 2 to form classification rules; or, the classification rules are determined by the quality inspection management system 2, for example, the classification rules for qualified products are established in the quality inspection management system 2, and the quality inspection management device receives the classification rules determined by the quality inspection management system 2 to place qualified products in different areas. For example, the classification rules can be used to distinguish the biological ex vivo samples according to the corresponding test items, test equipment, or sample types in subsequent tests.

[0110] For example, the classification rules are divided based on the subsequent processing methods required to be performed on the samples. For example, when the biological in vitro sample is a liquid sample to be centrifuged, different samples require different centrifugation methods, so the samples need to be classified and transported to the processing positions of the corresponding centrifugation processes. The conveying area 101 in the quality inspection workbench 10 is arranged in the conveying device 14. In the embodiment shown in the figure, eight types of qualified product placement areas are configured in the conveying area 101, wherein different types of qualified products are distinguished according to the carrier specifications of the biological in vitro sample and the subsequent processing procedures or processing equipment such as centrifugation methods. Different centrifugation methods are determined by different centrifugation procedures, and the carrier specifications are, for example, Streck blood collection tubes of different materials or capacities, Faclon centrifuge tubes, etc. For another example, the classification rules can also be defined by sample characteristics such as sample volume (weight grade), sample type, etc.

[0111] In some embodiments, after the qualified products are classified based on the classification rules, the processing of the biological ex vivo samples, in addition to the above-mentioned partition placement, may also include attaching labels to the carriers of the biological ex vivo samples, assigning numbers, etc.

[0112] In one scenario, the classification rule may also be, for example, a predetermined label or field, for example, the sample type, test item information, etc. of the biological in vitro sample may be represented as a field. In terms of implementation, for example, biological in vitro samples with the same field value may be determined as the same qualified type. For each biological in vitro sample, the field value is determined based on its sample type, test item, and other information. When the biological in vitro sample that has passed the test is placed in the qualified area, the qualified type of the biological in vitro sample is determined by obtaining the field information, and the biological in vitro sample is transferred to the corresponding qualified product placement area 104.

[0113] In some embodiments, the quality inspection workbench 10 is further provided with a screening area 105 for placing a carrier of a biological ex vivo sample to be inspected. By placing the biological ex vivo sample to be inspected in the screening area 105 in the quality inspection workbench 10, the transfer device 11 can obtain the biological ex vivo sample from the screening area 105 for inspection. It should be understood that the type of sample stored in the screening area 105 is not limited to blood.

[0114] In some embodiments, when the quality inspection workbench 10 is provided with a placement area for placing biological in vitro samples that have completed the inspection process or have performed a certain inspection operation, such as the qualified product placement area 104 described in the aforementioned embodiment, by placing the biological in vitro samples to be inspected in the screening area 105, the biological in vitro samples that have been inspected can be distinguished from the biological in vitro samples that have not yet started inspection based on the placement area.

[0115] In the quality inspection process, the conveying device 14 conveys the carrier of the biological in vitro sample to be inspected to the screening area 105 in the quality inspection workbench 10. The step of the conveying device 14 conveying the carrier containing the biological in vitro sample to the quality inspection workbench 10 includes: placing the carrier of the biological in vitro sample to be transported to the quality inspection workbench 10 in the loading area 106 of the conveying device 14, wherein the loading area 106 is located outside the quality inspection workbench 10; then, the conveying device 14 conveys the carrier of the biological in vitro sample to be inspected from the loading area 106 to the screening area 105. In an embodiment, the screening area 105 is provided in the transport area 101, and the conveying device 14 conveys the carrier of the biological in vitro sample to be inspected from the loading area 106 to the screening area 105, or conveys the empty carrier 3 located in the screening area 105 to the loading area 106.

[0116] By arranging the screening area 105 in the transport area 101, the biological in vitro samples to be tested can be automatically loaded. For example, in one case, the conveying device 14 will be transported to the screening area 105, and the transfer device 11 can obtain the biological in vitro samples from the screening area 105 to transport them to various work areas for testing; or, the empty carrier 3 in the screening area 105 can be transported by the conveying device 14 to the loading area 106 or the carrier 3 in the screening area 105 can be transported to the qualified product placement area 104 in the quality inspection workbench 10, thereby realizing the reuse of the carrier 3. In the embodiments of the present application, the term "empty carrier" or "empty carrier" is used to describe a carrier 3 that does not carry a biological in vitro sample.

[0117] Of course, in some scenarios, the conveying device 14 can simultaneously realize the above two functions, that is, to transport the carrier of the biological in vitro sample to be tested from the loading area 106 to the screening area 105, and to transport the empty carrier 3 in the screening area 105 to the loading area 106, so that the carrier 3 can be recycled.

[0118] In another embodiment, the step of marking the identity information of the biological sample obtained from the quality inspection management system on the carrier of the biological sample based on a marking device for secondary diversion processing is also included. Figure 4 , which is a flow chart of another embodiment of the biological in vitro sample quality control method of the present application. As shown in the figure, the quality control method includes steps S10' to S13', wherein step S10' is the same as the relevant description of step 10 above, step S11' is the same as the relevant description of step 11 above, and step S13' is the same as the relevant description of step 13 above, which will not be repeated here.

[0119] In step S12', the communication device is used to receive the identity information of the biological ex vivo sample from the quality inspection management system 2, and the detection process also includes a step of marking the identity information of the biological ex vivo sample obtained from the quality inspection management system on the carrier of the biological ex vivo sample based on an identification device for secondary diversion processing.

[0120] Please refer to Figure 5 , which is a schematic diagram of the device layout of the quality inspection and control device of the present application in another embodiment. As shown in the figure, the quality inspection and control device 1 also includes a marking device 15, which is used to mark the identity information on the carrier of the biological sample. Figure 5 In the embodiment shown, after the biological in vitro sample completes order information identification and quality inspection, the biological in vitro sample is transferred to a subsequent verification device, such as a detection device for analysis, that is, the biological in vitro sample is transferred to another analysis environment. In different analysis environments, in order to identify and determine the detection operation required for each biological in vitro sample or to associate the analysis result with the order information of the biological in vitro sample, the identity information of the biological in vitro sample needs to be verified. Generally speaking, the traceability information in the order information can be used as an identity information, but when the identity information format or rules for the biological in vitro sample are set in the analysis environment, the identity information of the biological in vitro sample needs to be marked on its carrier according to the identity information format in the analysis environment.

[0121] In some examples, the identity information is information that converts the order information of the biological ex vivo sample into a certain format, for example, converting the sample type information in the order information from text to codes and symbols, converting the traceability information of the order information into an information code, etc.

[0122] In a feasible implementation, the identity information identification of the biological in vitro sample can be performed, for example, after the biological in vitro sample is transported to an analysis environment, for example, the order information loaded by the biological in vitro sample is identified in the analysis environment, and the identity information corresponding to the order information is identified on the carrier of the biological in vitro sample.

[0123] Here, the present application provides an embodiment of identifying the identity information of the carrier of the biological ex vivo sample in the quality inspection control equipment 1. By using the order information that has been determined in the detection process, the identification device 15 can directly identify the identity information corresponding to the order information on the carrier of the biological ex vivo sample. This can improve the transportation efficiency of the entire process of sample-based medical verification and avoid repeated verification of information.

[0124] In certain embodiments, the information identified by the identification device 15 on the carrier of the biological ex vivo sample includes numbering information, wherein the numbering information is numbering information obtained from the quality inspection management system 2, or numbering information generated based on information obtained from the quality inspection management system 2.

[0125] In some embodiments, the identity information of the biological in vitro sample obtained from the quality inspection management system 2 includes the numbering information determined by the quality inspection management system 2 based on the numbering rule. Under the numbering rule, the identity information and the numbering information can be set to be unique, so that each numbering information has a unique corresponding order information, and the order information corresponding to the biological in vitro sample and the test results obtained in the previous test process can be determined based on the identity information.

[0126] The numbering rule can be the aforementioned identity information format corresponding to the detection system configured in the analysis environment. In the detection system, the analysis process required to be performed on the sample can be determined by reading the identity information marked on the carrier of the biological ex vivo sample. The numbering rule can be determined by the quality inspection management system 2. In an actual scenario, the quality inspection management system 2 can be, for example, a management system of the detection system configured in the analysis environment, or the quality inspection management system 2 can be communicatively connected to the detection system configured in the analysis environment. When the quality inspection management system 2 determines the identity information format used to identify the sample in the subsequent analysis environment or other sample processing operations, the numbering rule can be formed based on this identity information format. Based on this numbering rule, the corresponding numbering information of the biological ex vivo sample is determined, and the quality inspection control device 1 communicatively connected to the quality inspection management system 2 can mark this numbering information on the carrier of the biological ex vivo sample.

[0127] In some embodiments, the numbering information is numbering information generated based on information obtained from the quality inspection management system 2. For example, the quality inspection system obtains pre-stored information such as sample traceability information from the quality inspection management system 2 to which it is connected for communication. Order number information, etc., and the obtained information is numbered based on certain numbering rules. For another example, the numbering can also be used to characterize information such as sample quantity, sample type, and test items. In this way, when reading the numbering information, for example, in a subsequent analysis environment, the test item information, sample information, etc. corresponding to the sample can be clearly identified by reading the numbering information.

[0128] In some embodiments, the numbering information is formed in any of the following ways:

[0129] In one implementation, the identity information is characterized based on a predetermined format number field in the quality inspection management system 2 based on a preset numbering rule. The preset numbering rule is, for example, a numbering rule configured in the quality inspection management system 2, that is, the numbering rule is, for example, determined by the quality inspection management system 2, and the quality inspection management system 2 can determine the information required for numbering in the pre-stored order information such as sample type, sample quantity, sample collection time, test item information, etc., and form a field of numbering information to be identified based on the numbering rule. The numbering field in the predetermined format is, for example, determined by the quality inspection management system 2, with a numbering length and a representation form, such as a digital number of a certain length; when the numbering rule includes a classification rule, the numbering field in the predetermined format is, for example, a number field that represents the sample type as a digital segment or a letter, etc. In this case, the numbers corresponding to the biological in vitro samples of the same sample type have the same sample type field. In subsequent transportation, the sample type of the biological in vitro sample can be determined by identifying the sample type field in the identification attached to the carrier. That is, in some embodiments, the number field is associated with the diversion information of the biological ex vivo sample, and the diversion information can be used, for example, to determine whether the biological ex vivo sample is qualified and the qualified type or unqualified type. Thus, the diversion information of the biological ex vivo sample can be determined based on the number field, such as the placement location information determined based on the subsequent processing procedure or the target area to be transferred.

[0130] In another implementation, a numbering rule for the identity information is customized to determine a numbering field for forming the numbering information. In this example, the information used for numbering and the numbering rule of the information can be customized. For example, the operator can customize the numbering rule based on the information obtained by the quality inspection control device 1, and for each biological in vitro sample, the identity information thereof is represented as a numbering field under the customized numbering rule to obtain its numbering information.

[0131] In some embodiments, the labeling device 15 generates (prints) a label based on the identity information and marks the label on the carrier of the biological ex vivo sample. The label can be used as a carrier of the identity information. For example, when the identity information is number information, the label can be a label with number content, and the identity information can be determined by reading the label; or, the label is associated with the identity information, and the corresponding identity information can be obtained when the label is recognized by an external device.

[0132] In terms of implementation, the identification device 15 can, for example, print a label associated with the identity information generated based on the identity information obtained from the quality inspection management system 2, and attach the printed label to the carrier of the biological ex vivo sample. The process of generating the electronic label to be printed based on the identity information can be performed by the quality inspection management system 2, or by the quality inspection control device 1, and the identification device 15 prints the label based on the electronic label and attaches it to the carrier of the biological ex vivo sample.

[0133] For example, Figure 5 In the illustrated embodiment, the quality inspection workbench 10 is provided with a label printer 150 for generating labels and a labeling station for labeling. In the embodiment, the labeling device 15 is provided with a labeling assembly 150, and the carrier of the biological sample is placed in the labeling position shown in the figure, and the labeling assembly 150 can perform the action of attaching the label to the carrier. Of course, the structure and layout of the equipment used to implement the labeling function can also be changed.

[0134] like Figure 5 As shown, the identification device 15 has a labeling component 150. In a working scenario, the transfer device 11 transfers the carrier of the biological in vitro sample to the labeling position. The labeling position can also be configured with a positioning structure for placing the carrier of the biological in vitro sample. The labeling component 150 can label the carrier of the biological in vitro sample placed in the labeling position.

[0135] In some examples, the identification device 15 can generate a label according to a predetermined standard and mark the label at a predetermined position of the carrier of the biological ex vivo sample. In specific use, the predetermined label, such as the content and format of the printed label, can be adjusted according to demand, wherein the content of the label can be determined by the quality inspection management system 2, and the format of the label can be customized based on printing needs or determined by the quality inspection management system 2; or, the content of the label is determined by the quality inspection control system. When marking the label on the carrier of the biological ex vivo sample, the label can be attached to the predetermined position on the carrier based on the preset labeling requirements. For example, the labeling requirements may include the upper and lower positions of the label on the carrier, such as the distance from the bottom of the carrier, the label attachment direction, such as vertical or horizontal, and the label flatness associated with the label recognition rate (such as whether the pasted label has wrinkles or bubbles, etc., which affect the flatness of subsequent identification). In some examples, when multiple labels need to be attached to the carrier of the same biological ex vivo sample, the labeling requirements may also include requirements for the positional relationship between the attachment of multiple labels, such as multiple labels need to be attached in a non-overlapping state.

[0136] The material of the label can be determined according to the subsequent storage requirements or detection environment requirements of the biological sample. For example, in one example, the label is synthetic paper or coated paper. Figure 6a and Figure 6b ,in, Figure 6a Shown is a schematic diagram of a label style in one embodiment of the present application; Figure 6b Shown is another schematic diagram of a label style in one embodiment of the present application; Figure 6c Shown is a schematic diagram of a test tube with a label attached in one embodiment of the present application; Figure 6a or Figure 6b The label style shown, Figure 6a The label spacing on the middle label paper is 2mm, and the material of the label paper is Avery PET synthetic paper; Figure 6a and Figure 6b The width of the middle label paper is 27mm. Figure 6b The label spacing on the label paper is 3mm, and the material of the label is Avery coated paper; in the embodiment, the size of each label in the label paper is, for example, 24mm×15mm, and the information contained therein is, for example, an order code or management code, test items, patient name and other information (for details, please refer to the identity information described in the aforementioned embodiment). In one example, after the information associated with the label is correctly identified, it can be connected to the aforementioned quality inspection management system 2 to achieve information matching, so as to determine that the order information of the biological ex vivo sample is correct for subsequent testing procedures. In this example, for example, the information carrier pasted on the carrier of the blood collection tube is, for example, a barcode or a QR code, which is presented as follows Figure 6c As shown, Figure 6c It is a schematic diagram showing an information carrier pasted on a carrier of a blood collection tube in one embodiment of the present application.

[0137] exist Figure 3 In the process shown, the quality inspection control method for the biological in vitro sample also includes a step of identifying the label based on a label verification device to determine the label position on the carrier of the biological in vitro sample, or to obtain the identity information corresponding to the label or / and the quality inspection information associated with the identity information. In this embodiment, the quality inspection control device 1 also includes a label verification device (not shown) for identifying the label to determine the label position on the carrier of the biological in vitro sample; or for identifying the label to obtain the identity information corresponding to the label or / and the quality inspection information associated with the identity information.

[0138] In one example, the label verification device is used to determine whether the identification device 15 attaches the label to the carrier of the biological ex vivo sample according to the predetermined labeling requirements. When it is determined that the labeling position of the identification device 15 meets the labeling requirements, the carrier of the biological ex vivo sample with completed identity information labeling can be transferred to the next work area or transportation area 101 determined according to the detection process; or, when the label verification device determines that the labeling position of the identification device 15 does not meet the labeling requirements, it can be determined that the identity information is unqualified. In some examples, the transfer device 11 transfers the biological ex vivo sample with unqualified identity information to the identification error area in the quality inspection workbench 10.

[0139] In one example, the tag verification device can also be used to identify the label to obtain the identity information corresponding to the label or / and the quality inspection information associated with the identity information. The tag verification device can determine whether the identity information after labeling can be identified and whether the content after identification is consistent with the preset identity information content by identifying the identity information corresponding to the label. For example, the tag verification device identifies the label to obtain identity information, and compares the identity information obtained by identification with the identity information identified by the identification device 15. When the contents of the two do not match, it can be determined that the identity information is wrong.

[0140] In some embodiments, the marking verification device can also be used to identify the label to determine the quality inspection information associated with the identity information. For example, the identity information marking operation of the carrier of the biological ex vivo sample is performed after the quality inspection operation, and the marking verification device can be used to verify whether the association between the identity information and the quality inspection information is correct. In this way, it can be verified whether there is a situation where the identity information originally corresponding to the label is identified as another identity information. In some scenarios, the biological ex vivo sample can also be partitioned and placed according to the quality inspection information obtained by identifying the label. Among them, the way of associating the quality inspection information with the identity information is, for example, that the identity information has a corresponding relationship with the order information, and the quality inspection information is associated with the order information, and the quality inspection information is associated with the identity information through the order information.

[0141] In some embodiments, the marking verification device includes a visual recognition device 12. The visual recognition device 12, for example, determines whether the label position meets the labeling requirements or whether the identity information content corresponding to the label can be correctly read by image recognition. The visual recognition device 12, for example, includes an image acquisition device such as a camera and an image analysis device such as a processor and a text recognition module; in some examples, the visual recognition device 12 in the quality inspection control device 1 can be configured to include only an image acquisition device, and the recognition process is realized by transmitting the acquired image to an image analysis device of another terminal and obtaining the analysis result determined by the image analysis device.

[0142] In certain embodiments, the method by which the label verification device identifies the label to determine the label position or to determine whether the label associated information is correct can also be set to a random inspection form, for example, the carriers of the biological ex vivo samples to be sampled can be determined by preset rules such as a certain number interval or time interval. In one implementation scenario, for the carriers of biological ex vivo samples that do not need to be labeled and verified, they can be placed in the corresponding qualified product area or unqualified product area after order information identification, quality inspection and labeling operations; for the carriers of biological ex vivo samples that are sampled and need to be labeled and verified, they are subjected to label verification (i.e., verification of the identity information) after order information identification, quality inspection and labeling operations, and the carriers of biological ex vivo samples are diverted based on the label verification results.

[0143] In some embodiments, after the biological in vitro sample to be inspected is transported to the quality inspection workbench 10, the identification device 12, the quality inspection device 13, and the identification device 15 sequentially identify, inspect, and identify the biological in vitro sample. In some examples, the inspection process in the quality inspection workbench 10 is to first identify the order information of the biological in vitro sample to be inspected, and then perform the quality inspection operation, and then perform the identity information identification operation after the quality inspection operation is completed; or, the inspection process in the quality inspection workbench 10 is to identify the order information of the biological in vitro sample to be inspected, and then perform the identity information identification, and then perform the quality inspection operation.

[0144] In one implementation, the identity information of the biological ex vivo sample can also be identified before the order information is identified. However, in the implementation mode where the order information is identified first, the quality inspection management system 2 can predetermine the association between the identity information and the order information so that the quality inspection control device 1 can identify the identity information corresponding to its order information on the carrier of the biological ex vivo sample.

[0145] In some examples, the inspection process within the quality inspection workbench 10 is to first identify the order information of the biological in vitro samples to be inspected, and then perform a first diversion and placement of the biological in vitro samples based on the identification result of the order information, that is, the biological in vitro samples with qualified order information are transferred to the next inspection work area such as the quality inspection device 13, and the biological in vitro samples with unqualified order information are transferred to the collection area for placing unqualified samples; for the biological in vitro samples with qualified order information, they are quality inspected and their identity information is marked before being diverted and placed for the second time; among them, the biological in vitro samples with unqualified quality inspection results or incorrect identity information can be transferred to the corresponding collection area, and the biological in vitro samples with qualified quality inspection and correct identity information can be transferred to the qualified product placement area.

[0146] The operation procedures in the detection process can be adjusted according to the use needs. In some implementations, when the displacement range of the transfer device 11 includes various working areas, the adjustment or modification of the detection process can be realized according to the instruction control of the transfer device 11 and the identification device 12, the identification device 15 and the quality inspection device 13. By changing the detection process determined by the control management system, or changing the detection process preset in the quality inspection control device 1, the actual processing process of the sample in the quality inspection workbench 10 can be changed.

[0147] In certain embodiments, after the biological in vitro sample to be inspected is transported to the quality inspection workbench 10, the identification device 12, the quality inspection device 13 and the labeling device 15 sequentially identify, inspect, and label the biological in vitro sample, wherein the labeling device 15 marks a label generated based on the identity information of the biological in vitro sample and the quality inspection result on the carrier of the biological in vitro sample.

[0148] In certain embodiments, when the identity information of the carrier of the biological ex vivo sample is marked, the order information of the biological ex vivo sample and the information obtained in the previous order information identification and quality inspection can be marked on the carrier of the biological ex vivo sample to assist in the secondary diversion of the biological ex vivo sample.

[0149] After completing the order information recognition, quality inspection and identity information identification of the biological ex vivo samples in the quality inspection workbench 10, the second diversion of the biological ex vivo samples can be performed. In some examples, the second diversion of the biological ex vivo samples is, for example, transferring the biological ex vivo samples that are determined to be unqualified to the collection area 103 corresponding to the unqualified products, and transferring the qualified products that have completed various quality inspection control processes in the work area 100 to the corresponding placement area. By marking the information obtained from the previous order information recognition and quality inspection on the carrier of the biological ex vivo samples, when identifying the mark attached to the carrier of the biological ex vivo samples, the transfer area of ​​the biological ex vivo samples can be determined, and the second diversion of the biological ex vivo samples can be assisted.

[0150] In some examples, when the placement area of ​​the qualified products is set to include multiple areas for placing biological ex vivo samples of different qualified types, or / and when the collection area 103 corresponding to the unqualified products includes multiple areas for placing biological ex vivo samples of different unqualified types, the label generated by the identification device 15 can also be used to characterize the qualified type and / or unqualified type of the biological ex vivo sample. For example, the qualified type is characterized as a suffix field or other field of the number information in the label, and the next placement area for the biological ex vivo sample can be determined when the label is identified.

[0151] In one scenario, before labeling the biological in vitro samples, the biological in vitro samples with incorrect quantity information are recorded and transferred to the corresponding collection area 103 for samples with incorrect quantity after labeling, and the biological in vitro samples with unqualified quality inspection results are recorded and transferred to the corresponding collection area 103 for samples with incorrect quality inspection after labeling. For the biological in vitro samples with qualified order information and quality inspection results, their markings are verified after labeling, and the biological in vitro samples with correct marking verification results are transferred to the placement area for qualified products, and the biological in vitro samples with incorrect verification results are transferred to the corresponding collection area 103 with incorrect marking (or incorrect identity information).

[0152] In the above-mentioned Figure 4 In the illustrated embodiment, the quality control method further includes a step of performing a third diversion process on the carrier of the biological ex vivo sample based on the identification of the label by the label verification device to determine the label verification result. In some embodiments of the quality inspection control equipment 1 provided in the present application that is configured with a marking verification device, the carrier of the biological in vitro sample can also be set to undergo a total of three diversion judgments, each diversion judgment includes a process for determining the next area to be transferred, for example, based on the verification result of the order information, the carrier of the biological in vitro sample is subjected to a first diversion processing, and the carrier of the biological in vitro sample with qualified order information is transferred to the next station to be inspected; after completing the order information identification, quality inspection and identity information identification of the biological in vitro sample in the quality inspection workbench 10, the second diversion processing of the biological in vitro sample can be performed, and the carrier of the biological in vitro sample with unqualified quality inspection results is transferred to the corresponding placement area, and the carrier of the biological in vitro sample with qualified order information and quality inspection is subjected to marking verification, and a third diversion judgment is performed based on the marking verification result, that is, the carrier of the biological in vitro sample with qualified marking verification results is transferred to the corresponding qualified area, and the carrier of the biological in vitro sample with unqualified marking verification results is transferred to the corresponding unqualified product placement area.

[0153] In some examples, such as the aforementioned embodiment, before the biological ex vivo sample is diverted for the second time, the mark on the carrier of the biological ex vivo sample by the identification device 15 can represent its corresponding qualified type. In some embodiments, the qualified product placement area 104 is provided with an information code associated with the qualified category corresponding to the qualified product placement area 104. The information code can be set on the carrier 3 of the qualified product placement area 104 for loading the carrier of the biological ex vivo sample. After the carrier 3 of the qualified product placement area 104 is transferred out of the quality inspection workbench 10, the qualified category of the biological ex vivo sample loaded in the carrier 3 can be determined by identifying the information code on the carrier 3. Among them, the information code is, for example, a barcode or a two-dimensional code.

[0154] In some scenarios, after the carrier 3 in the qualified product placement area 104 is transferred out of the quality inspection workbench 10, the carrier of the biological sample in vitro loaded on the carrier 3 is unloaded, and after unloading, the carrier 3 is transferred to the storage area of ​​the carrier 3 corresponding to its qualified category. In this process, the information code loaded on the empty carrier 3 can be identified again to determine its corresponding qualified category.

[0155] The quality inspection and control method of biological in vitro samples also includes the step of transferring biological in vitro samples that are determined to be unqualified to a collection area in a quality inspection workbench. In an embodiment, the quality inspection workbench 10 also has at least one collection area 103 for placing biological in vitro samples that are determined to be unqualified. As described in the above embodiment, when the quality inspection control device 1 processes biological in vitro samples based on the quality inspection control process, the biological in vitro samples will be diverted for the first time and the second time to divide the unqualified samples and qualified samples determined in the test into different areas. The collection area 103 is used to place unqualified biological in vitro samples, thereby regionally distinguishing between biological in vitro samples that have passed the test and biological in vitro samples that have failed the test, so as to facilitate subsequent corresponding processing based on whether the biological in vitro samples are qualified.

[0156] In some embodiments, the unqualified test includes at least one of the order information, identity information, and quality inspection result being unqualified; the collection area 103 includes at least one of a scan error area for placing biological in vitro samples with incorrect order information or incorrect quantity information, a liquid volume error area for placing biological in vitro samples with incorrect quality inspection results, and an identification error area for placing biological in vitro samples with incorrect identity information.

[0157] The standard for determining whether the biological ex vivo sample is qualified can be customized, for example, the qualified standard is defined by the quality inspection management system 2, or the qualified standard is established by the quality inspection control device 1 after obtaining information from the quality inspection management system 2; the quality inspection control device 1 detects the biological ex vivo sample to obtain detection information to determine whether the detection information meets the qualified standard, so as to obtain a determination result on whether the biological ex vivo sample is qualified. In some embodiments, the unqualified detection includes at least one of the order information, identity information, and quality inspection result being unqualified.

[0158] Among them, the unqualified order information is, for example, that the information code associated with the order information loaded on the biological in vitro sample cannot be recognized or the order information obtained after recognition does not match the pre-stored order information in the quality inspection management system 2, for example, the number of carriers does not match, the identity information in the order information does not match, the position where the information code is attached is wrong, etc.

[0159] The unqualified identity information may be due to, for example, the wrong position or format of the label related to the identity information, or the wrong association between the identity information and other information. For example, the order information and identity information obtained by the quality inspection and control equipment 1 for the same biological in vitro sample do not match the correspondence between the order information and identity information in the quality inspection and control system.

[0160] The unqualified quality inspection result refers to, for example, that the result obtained by quality inspection of the biological in vitro sample does not meet the quality inspection qualification standard.

[0161] The at least one collection area 103 is used to place the above-mentioned biological in vitro samples that are judged to be unqualified for detection. The collection area 103 includes at least one of a scan code error area or a quantity information error area for placing biological in vitro samples with incorrect order information, a liquid volume error area for placing biological in vitro samples with incorrect quality inspection results, and an identification error area for placing biological in vitro samples with incorrect identity information.

[0162] See also Figure 7 , which is a schematic diagram of the collection area of ​​the quality inspection workbench of the quality inspection control device of the present application in one embodiment. As shown in the figure, the collection area 103 is divided according to the type of unqualified. For example, when the order information of the biological sample is detected to be wrong, the biological sample is placed in the code scanning error area 1031 or the quantity information error area 1033 according to the error category; wherein, the sample placed in the code scanning error area 1031 is, for example, the information code loaded on the carrier of the biological sample cannot obtain the corresponding order information after identifying it, or the position of the information code load is wrong, or the order information obtained by the detection matches the information in the pre-stored order information incorrectly; the sample placed in the quantity information error area 1033 is, for example, the number of carriers of the biological sample in the actual detection does not match the number of carriers in the order information pre-stored by the quality inspection management system 2. For example, the number of carriers of the biological sample corresponding to a user in the pre-stored order information is 2, and the number of biological samples corresponding to the order information detected by the quality inspection control device 1 is 1, which is regarded as a mismatch.

[0163] The sample placed in the liquid volume error area 1032 is, for example, a biological in vitro sample whose weight is determined to be inconsistent with the standard weight range after quality inspection by the quality inspection device 13. The weight of the sample can also be expressed in terms of the volume of the sample, both of which are used to illustrate the amount of sample carried in the carrier. Of course, it should be noted that the quality inspection method for biological in vitro samples is not limited to weight judgment. In different detection items, the specific quality inspection required for the sample in the pre-analysis stage is different. Therefore, the liquid volume error area 1032 described in the present application conforms to the needs of the application scenario in some embodiments, and can also be used as other types of placement areas such as hemolyzed sample placement areas, volume error sample placement areas, etc.

[0164] The identification error area for placing biological ex vivo samples with incorrect identity information ( Figure 7 The samples placed corresponding to the information not marked in the figure are samples with unqualified identity information, and the unqualified identity information may be, for example, that the marking method of the information carrier corresponding to the identity information does not meet the preset marking rules, the content of the identity information is wrong, etc.

[0165] It should be noted that the error types corresponding to the at least one collection area 103 are related to the identification type of unqualified detection. In actual applications, when the specific quality inspection rules and identification methods for biological in vitro samples are changed, the corresponding sample qualification standards are different, and the error types of biological in vitro samples placed in the collection area 103 are also changed accordingly, and are not limited to the above-mentioned embodiments. In another embodiment, the carrier of the collection area 103 does not define different error areas. In use, the error types of biological in vitro samples can be customized and the placement area corresponding to each error type of biological in vitro sample can be determined.

[0166] In some embodiments, the collection area 103 also includes a spare area 1034. When a carrier of a certain unqualified type of collection area 103, such as the scanning error area 1031, is unloaded and before the scanning error area 1031 is put back into the carrier 3, the unqualified samples due to scanning errors during the detection can be placed in the spare area 1034. This can ensure the normal operation of the detection process and avoid time-consuming waiting.

[0167] In some embodiments, the plurality of collection areas 103 each have a different identifiable mark, each mark representing a substandard type of collection area 103 .

[0168] It should be understood that when the quality inspection control device 1 has multiple collection areas 103 and they are used to place different types of unqualified products, the multiple unqualified areas should be identifiable so that when unqualified products are detected, they are placed in corresponding areas based on the unqualified types. In some embodiments, the transfer device 11 places the biological ex vivo sample determined to be unqualified in the corresponding collection area 103, and the multiple collection areas 103 correspond to different position areas. At this time, the different marks can be regarded as different coordinates (areas) corresponding to the multiple collection areas 103, and the transfer device 11 realizes the placement of unqualified products based on the coordinates (areas).

[0169] In some embodiments, the plurality of collection areas 103 are marked with different signs so that different areas can be identified manually, thereby facilitating the unloading and subsequent processing of specific types of defective products by operators.

[0170] For example, in some embodiments, the mark is formed by any of the following methods:

[0171] In one embodiment, the mark is formed by the placement positions and corresponding codes assigned to the multiple collection areas 103. In this embodiment, in order to distinguish the areas corresponding to the various collection areas 103, codes are assigned to the multiple collection areas 103 based on the positions to which they are assigned, and the unqualified type corresponding to the collection area 103 can be determined by identifying the codes. The codes are, for example, numbers, symbols, text, coordinates, matrices, etc. In a scenario where the type corresponding to the collection area 103 needs to be manually identifiable, the codes can be marked in the collection area 103, for example, the codes are marked on the carrier 3 of the carrier in the collection area 103.

[0172] In another embodiment, the mark is formed by setting multiple collection areas 103 to different colors so that a color gradient is formed between adjacent areas, so that machine vision can identify or operators can identify different partitions. In this embodiment, by setting each collection area 103 to a different color so that a recognizable color gradient is formed between the collection areas 103, it is possible to use color as a mark of the collection area 103, and by identifying the color of the collection area 103, each collection area 103 can be distinguished from multiple collection areas 103. In the scenario of forming a color gradient between the collection areas 103, for example, the transfer device 11 can be used to place unqualified samples in their corresponding collection areas 103 through visual recognition; in the scenario of unqualified products in the collection area 103, the unloading of the collection area 103 of a specific unqualified type can be realized by identifying different collection areas 103 by color.

[0173] In another embodiment, the mark is formed by providing a recognizable mark at the junction of multiple collection areas 103, and the mark includes at least one of a magnetic stripe and a reflective stripe. In some scenarios of this embodiment, determining each collection area 103 can be achieved by identifying the boundary of the collection area 103, and a recognizable mark is provided at the boundary of multiple collection areas 103, and the mark is, for example, a magnetic stripe, a reflective stripe, etc., so that the multiple collection areas 103 can be distinguished by identifying the boundary of the collection area 103, thereby achieving the correspondence between each collection area 103 and the unqualified type. Among them, the form of the mark is not limited to a magnetic stripe or a reflective strip. For example, a convex or concave structure can also be provided at the boundary of each collection area 103, so that the boundary between different collection areas 103 can be identified.

[0174] In the above examples, the mark of the collection area 103 is used to establish the correspondence between the collection area 103 and the unqualified type. Therefore, this application does not limit the specific presentation form of the mark, as long as the mark can be used to implement or assist in implementing the correspondence of the collection area 103 to the unqualified type.

[0175] The biological sample quality control method further comprises the step of transferring the biological sample carrier in the collection area out of the quality inspection workbench based on a displacement device. Figure 8a , which is a schematic diagram showing that the carrier in the collection area of ​​the present application can be removed in one embodiment. As shown in the figure, the collection area 103 is provided with a shifting device 1030, and the shifting device 1030 is used to set the carrier 3 of the biological in vitro sample carrier, so that the carrier 3 is moved to transfer the unqualified biological in vitro sample carrier out of the quality inspection workbench 10.

[0176] In some examples, in order to facilitate the unloading or subsequent transportation of the biological in vitro samples in the collection area 103, a shifting device 1030 is provided in the collection area 103, and the carrier 3 of the biological in vitro samples is placed on the shifting device 1030, so that the carrier 3 and the biological in vitro samples carried by it can be moved out of the quality inspection workbench 10 based on the degrees of freedom formed by the shifting device 1030.

[0177] The displacement device 1030 may include, for example, a limiting structure and a driving mechanism for determining a displacement path. The carrier 3 is placed on the limiting structure, and the driving mechanism drives the carrier 3 to move along the displacement path determined by the limiting structure, thereby realizing the transfer of the carrier 3 in the collection area 103. Figure 8a In the illustrated embodiment, the carrier 3 moves along the guide rail type displacement mechanism, and can be moved outside the quality inspection workbench 10. In this embodiment, the limiting structure is, for example, a guide rail or a guide groove, and the driving mechanism includes, for example, a driving mechanism of a servo motor. Of course, in some scenarios, the driving mechanism is not a necessary structure, and the carrier 3 can be moved out of the quality inspection workbench 10 by manual operation.

[0178] In some embodiments, when a plurality of collecting areas 103 are provided in the quality inspection workbench 10, each collecting area 103 may be provided with a shifting mechanism, so that when any collecting area 103 is in a fully loaded state or other preset situation requiring unloading, the collecting area 103 may be unloaded separately.

[0179] In some embodiments, the shifting device includes a guide rail mechanism disposed on the quality inspection workbench 10 and extending out of the outside of the quality inspection workbench 10 for disposing the carrier 3 .

[0180] By means of the limiting function of the guide rail mechanism, the carrier 3 arranged on the guide rail mechanism can move along the direction of the guide rail. The guide rail mechanism is arranged to extend outside the quality inspection workbench 10, and the carrier 3 can be moved outside the quality inspection workbench 10 to realize the unloading process.

[0181] In some embodiments, the collection area 103 includes a storage station and at least one standby station, and the carrier 3 disposed on the storage station and the at least one standby station can be moved along the displacement device. The carrier 3 of the biological sample carrier can be placed on each of the storage station and the at least one standby station, and the carrier 3 on any station can be driven to move independently, or the carrier 3 can be loaded or unloaded independently at any station. Figure 8a As shown, each collection area 103 includes a storage station 103a and a standby station 103b. Figure 8a The two workstations shown in .

[0182] In actual operation, when any workstation 103a or 103b in the collection area 103 corresponding to the same unqualified type is in a full-load state, the workstation needs to be transferred out of the quality inspection workbench 10 for unloading, or when any workstation in the collection area 103 is moved out of the quality inspection workbench 10 based on operational requirements, during this process, the quality inspection control equipment 1 can continue to perform sample testing and place the biological in vitro sample that is judged to be unqualified in the test at another workstation in the collection area 103, such as a spare workstation. This can avoid increasing the inspection time for operations such as unloading from the collection area 103 and loading the carrier 3, thereby further improving the efficiency of the quality inspection control equipment 1 in automatically processing samples.

[0183] In some embodiments, the movement mode of the carrier 3 placed in the collection area 103 can be automatic transfer, manual transfer, or can be set to be compatible with both transfer modes; in actual operation, when the carrier 3 in the collection area 103 is in a fully loaded state, that is, all loading positions on the carrier 3 are placed with carriers of biological in vitro samples, the carrier 3 can be automatically transferred out of the quality inspection workbench 10 to achieve unqualified samples Unload and replenish empty carriers 3; in the implementation scenario of manually selecting the transfer of the carrier 3, the operator can determine the transfer time of the carrier 3, for example, when the carrier 3 is not fully loaded, it can also be selected to transfer the carrier 3 out of the quality inspection workbench 10 to perform subsequent unloading operations.

[0184] The biological in vitro sample quality control method further includes a step of detecting the carrier based on a sensing device when the carrier moves along the displacement device so as to move the carrier to a preset position. In an embodiment, the collection area 103 is further provided with a sensing device (not shown) for detecting the carrier 3 so as to move the carrier 3 to a preset position. For example, the sensing device is a photoelectric sensor, and when the carrier 3 moves along the displacement mechanism, the photoelectric sensor can sense and determine whether the carrier 3 has moved to the preset position, thereby achieving accurate positioning of the carrier 3.

[0185] In some embodiments, the sensor may also be a ranging sensor. Here, for example, the distance detection direction of the ranging sensor may be set to the moving direction of the vehicle 3. Examples of the ranging sensor may be an infrared ranging sensor, a laser distance sensor, an ultrasonic sensor, a radar sensor, and the like.

[0186] In some embodiments, when it is determined that the carrier 3 moves to the preset position, the carrier 3 may be fixed so that the carrier 3 remains at the preset position. For example, when the carrier 3 includes a ferromagnetic material, the carrier 3 may be locked and fixed at the preset position by a magnet.

[0187] In certain embodiments, the detection process according to which the transfer device 11 transfers the carrier of the biological ex vivo sample is a detection process determined by the quality inspection management system 2 or a detection process preset in the quality inspection control device 1 .

[0188] In another embodiment, the carrier 3 of the collection area 103 may also be arranged in an upper and lower double-layer manner, for example, an ascending or descending driving mechanism is used to place or remove the carrier.

[0189] In another embodiment, the storage stations 103a and 103b of the carriers in the collection area 103 may also be arranged in an upper and lower double-layer manner, for example, an ascending or descending driving mechanism is used to place or remove the carriers, as shown in FIG. Figure 8b The embodiment shown, Figure 8b It is a schematic diagram showing that the carrier in the collection area of ​​the present application can be moved out in another embodiment.

[0190] It should be understood that in the pre-analysis stage of the sample, the sample needs to be processed in multiple ways, so there is a corresponding detection process. Generally, the detection process can be determined based on the needs before the analysis of the sample. For example, for biological samples corresponding to different detection equipment or detection items, the pre-treatment process of the biological samples may be different; for example, when the biological samples are processed in different scenarios during the analysis, such as analysis within the hospital or analysis in a testing laboratory, the specific detection process that needs to be performed on the biological samples before analysis may be different.

[0191] In the implementation, the detection process can be determined by the quality inspection management system 2, and the transfer device 11 moves the biological ex vivo sample according to the detection process; it should be understood that the quality inspection control device 1 is in communication with the quality inspection management system 2, and the detection process is determined by the quality inspection management system 2, and the quality inspection control device 1 can generate control instructions for the transfer device 11 based on the detection process. Alternatively, the detection process is a detection process preset in the quality inspection control device 1. In some scenarios, the detection process preset in the quality inspection control device 1 can be modified. Usually, the quality inspection control device 1 also includes a control device, which can be connected to various detection devices such as the identification device 12, the quality inspection device 13, the conveying device 14 and the transfer device 11. The control device can control the transfer device 11 based on the preset detection process to realize the automatic transfer of samples according to the detection process and control the operations performed by each detection device.

[0192] For example, in one scenario, the detection process is to identify the order information of the biological ex vivo sample, and then transfer the biological ex vivo sample to the quality inspection work area for quality inspection, and after the quality inspection, transfer the biological ex vivo sample to the transportation area 101 for unloading. It should be noted that the detection process that can be used to implement the pre-analysis processing of the sample is not unique. For example, in some embodiments, the quality inspection can be performed first and then the order information of the sample can be identified. However, by first detecting and determining the order information corresponding to the biological ex vivo sample, the obtained test results can be associated with the order information of the biological ex vivo sample in various subsequent tests, thereby further improving the processing efficiency by designing the detection process.

[0193] See also Fig. 9 , which is a schematic diagram of a transfer device of the present application in one embodiment, as shown in the figure, the transfer device 11 includes a multi-axis manipulator assembly 110. The end effector 111 of the multi-axis manipulator assembly 110 can be used to grasp the sample A. The degree of freedom formed by the multi-axis can realize the transfer of the sample A between the transport area 101 and / or the working area 100 when the end effector 111 grasps the sample A. In this embodiment, the sample A is the above-mentioned biological in vitro sample or a carrier of the biological in vitro sample.

[0194] like Fig. 9As shown, the multi-axis manipulator assembly 110 is a four-axis manipulator assembly. By determining the range of motion of the four-axis manipulator assembly, the area to which the biological sample A is automatically transferred can be determined. In one scenario, the four-axis manipulator assembly can obtain the biological sample A to be tested in the screening area 105 in the quality inspection workbench 10, and transport the captured biological sample A to the identification device 12 and the quality inspection device 13 according to the detection process, and transfer the biological sample A after the quality inspection to the qualified product placement area 104 in the quality inspection workbench 10, or transfer the biological sample A judged as unqualified in the detection to the collection area 103 in the quality inspection workbench 10, and then obtain another biological sample A to be tested in the screening area 105 to repeat the above process.

[0195] In certain embodiments, the end effector 111 of the multi-axis manipulator assembly 110 is further provided with a supporting structure for a carrier of the biological ex vivo sample A to protect the carrier and reduce damage to the carrier during the transfer process.

[0196] The end effector 111 is provided with a supporting structure (not shown). During the transfer process, the supporting structure can be supported on the bottom of the carrier of the biological sample A, thereby protecting the carrier; at the same time, the supporting structure can also be configured to move relative to the carrier clamped by the end effector 111, so that the supporting structure can rotate along the axis to make the carrier out of the supported state. In some scenarios, for example, when weighing and quality testing the biological sample A, the transfer device 11 transfers the carrier of the biological sample A to the quality testing device 13, and rotates the supporting structure to release the carrier of the biological sample A, so that the weighing component can detect the weight of the sample A.

[0197] In some embodiments, the supporting structure may also be configured as a buffer layer structure having a flexible material to protect the carrier grasped by the end effector 111 .

[0198] In some embodiments, the transfer device 11 is provided with a brake device to protect the carrier of the biological sample A. In an embodiment, the brake device is, for example, a brake, which limits the excessive displacement of the end effector 111 to prevent the carrier from being damaged during the process of the transfer device 11 grabbing and transferring the carrier of the biological sample A.

[0199] In some scenarios, the braking device can also serve as a protective device in the event of equipment abnormality or failure. For example, by configuring a braking device on the multi-axis instrument hand assembly in the direction of the vertical line to limit its displacement range, it can be prevented from falling and damaging sample A or causing impact damage to the internal devices of the equipment in abnormal situations such as power failure of the equipment.

[0200] In some embodiments, the braking device includes a power-off protection device, which is used to control the end effector 111 of the transfer device 11 so that the end effector 111 maintains a clamping state on the carrier of the biological ex vivo sample A in a power-off state.

[0201] The transfer device 11 is provided with a power-off protection device to control the force state of the end effector 111 in the power-off state, so as to control the clamping force on the carrier, thereby preventing the sample A from being damaged due to a fault or unpredictable environmental factors and disturbing the environment of the quality inspection workbench 10. For example, in one implementation, the power-off protection device has a spring that can control the end effector 111 to determine the stiffness or strength of the end effector 111 at a certain clamping size, such as the opening and closing size of the jaws of the end effector 111, so as to determine that when the carrier of the biological ex vivo sample A is clamped in the power-off state, the clamping stiffness and strength can be controlled and the carrier remains in the clamped state.

[0202] In some embodiments, the transfer device 11 has a rotatable end effector 111 to drive the carrier of the biological ex vivo sample A to rotate along the central axis of the carrier when grabbing the carrier.

[0203] When the carrier contains the biological sample A, the carrier should be placed in a manner that prevents the biological sample A from overflowing from the container opening of the carrier. Therefore, the central axis of the carrier is usually required to be in a vertical state. The end effector 111 can drive the carrier of the biological ex vivo sample A to rotate along the central axis of the carrier when grabbing the carrier, that is, to rotate the carrier along the axis in the direction of the vertical line. In some scenarios, for example, when the end effector 111 of the transfer device 11 grabs the carrier of the biological ex vivo sample A for the identification device 12 to identify the order information loaded on the carrier, when the order information is associated with the information code or chip on the carrier, the end effector 111 drives the carrier to rotate along its central axis, and the identification device 12 can achieve full-angle, i.e. 360° identification; or, in some scenarios, when the end effector 111 grabs the carrier of the biological ex vivo sample A for the device for attaching a mark to the carrier, such as the identification device 15, to label the carrier, the end effector 111 drives the carrier to rotate along its central axis, and the identification device 15 can determine the labelable position at all angles of the carrier.

[0204] In certain embodiments, the transfer device 11 is configured to keep the carrier of the biological isolated sample A in a vertical state when transferring the carrier of the biological isolated sample A. In order to prevent the biological isolated sample A from spilling and leaking from the container mouth of the carrier while the carrier of the biological isolated sample A is being transferred, the present application also provides an embodiment in which the transfer device 11 is configured to keep the carrier in a vertical state when transferring the carrier of the biological isolated sample A. For example, in one embodiment, the multi-axis manipulator assembly 110 of the transfer device 11 drives the end effector 111 to move by rotation in a plane or lifting and lowering in a vertical direction, so that the carrier of the biological isolated sample A can be prevented from tilting or flipping.

[0205] In some examples, the quality inspection control device 1 is equipped with a visual recognition device (not shown). After the transfer device 11 transfers the biological ex vivo sample between various working areas according to the detection process to complete the detection, the transfer device 11 also places the biological ex vivo sample in the qualified product placement area 104 or the collection area 103 for placing unqualified products in the quality inspection workbench 10 based on the detection results. The visual recognition device can determine the position of each area or the qualified type and unqualified type corresponding to each area, so that the transfer device 11 can realize the partition placement of the biological ex vivo sample according to the detection results. The visual recognition device is, for example, an image acquisition device such as a camera device configured on the transfer device 11.

[0206] In some implementation scenarios, the visual recognition device is configured to determine at least one of the working area 100, the conveying area 101, and the placement area within the quality inspection workbench 10 through image analysis. For example, by determining the detection positions corresponding to the recognition device and the quality inspection device 13 in the working area 100, respectively, the transfer device 11 is enabled to transfer the carrier of the biological ex vivo sample according to the detection position; or, the visual recognition device identifies the carrier 3 of the biological ex vivo sample in the quality inspection workbench 10, obtains the carrier of the biological ex vivo sample by determining the loading position and loading status of the carrier 3, or places the carrier of the biological ex vivo sample at a predetermined loading position.

[0207] In some implementation scenarios, the visual recognition device is configured to determine the position of the carrier of the biological sample in vitro by image analysis, and when the transfer device 11 grabs the carrier of the biological sample in vitro, the carrier of the biological sample in vitro can be clamped according to a predetermined grabbing position. For example, the position where the end effector 111 grabs the sample is below the container cover of the carrier. The visual recognition device can acquire images by imaging with a camera or a video camera, and the shooting device for acquiring images includes but is not limited to: a camera, a video camera, a camera module integrated with a lens and a CCD, or a camera module integrated with a lens and a CMOS, etc.

[0208] exist Figure 2 or Figure 5 In the example, the transfer device 11 can determine the transfer path of the carrier of the biological ex vivo sample based on the positions of the working area 100, the qualified product placement area 104, and the collection area 103 in the quality inspection workbench 10. For example, a control instruction for the transfer device 11 can be generated based on the coordinates of each working area, the placement area, and the collection area 103, so that the transfer device 11 can realize the transfer of the carrier of the biological ex vivo sample according to the transfer path determined by the control instruction; wherein the transfer path can be updated in real time, for example, the transfer device 11 first transports the carrier of the biological ex vivo sample to be inspected in the quality inspection workbench 10 to the working area corresponding to the identification device 12, and determines the subsequent transfer path of the carrier of the biological ex vivo sample based on the verification result of the order information by the identification device 12, for example, the qualified biological ex vivo sample is transferred to the quality inspection working area corresponding to the quality inspection device 13, and the unqualified biological ex vivo sample is transferred to the corresponding collection area 103.

[0209] The quality inspection control method of the biological sample in vitro also includes a step of configuring a register of the carrier of the carrier based on a control system to determine the loading state of the carrier. In an embodiment, the transfer device 11 realizes the precise clamping, transfer and placement of the carrier of the biological sample in vitro between each working area, and the transfer path of the transfer device 11 is controlled by a PLC (Programmable Logic Controller) control system, and registers are configured for the carriers 3 of each placement area and transfer area. Based on the loading state displayed by the register, the PLC control system can determine that the transfer device 11 can determine the full load position in the carrier 3 where the carrier can be clamped or the empty load position where the carrier can be placed. The transfer device 11 realizes precise positioning and clamps or places the carrier of the biological sample in the predetermined position according to the instructions of the PLC control system. Of course, the control system for configuring registers for the carrier 3 and controlling the running path of the transfer device 11 is not limited to a PLC control system, for example, it can also be a DSC control system (Distributed Control System), FCS (Fieldbus Control System), etc.

[0210] Present as Figure 6c As shown, the carrier is a test tube type container, please refer to Fig.10, which is a schematic diagram of the structure of the carrier of the present application in one embodiment. As shown in the figure, the carrier 3 is configured as a well plate structure, and each loading position (i.e., well position) 30 of the carrier 3 is configured with a register. When the well position carries a carrier of a biological sample in vitro, the corresponding register is displayed as fully loaded. On the contrary, when the well position is empty, the corresponding register is displayed as unloaded. At the same time, in some examples, the state of the register can also be used to determine the conveying control of the conveying area 101 by the conveying device 14. For example, when each register on the carrier 3 in the screening area 105 is displayed as unloaded, it can be determined that the carrier 3 is in an unloaded state as a whole, and the empty carrier 3 can be transferred out of the quality inspection workbench 10 accordingly.

[0211] In the aforementioned steps, the identification device 12, the quality inspection device 13 and the marking device 15 realize continuous processing of the sample. Inevitably, the transfer device 11 transfers the carrier of the biological in vitro sample between the various working areas, and the detection device configured in each working area can execute the corresponding detection procedure; at the same time, when the biological in vitro sample is continuously transferred between the various placement areas in the quality inspection workbench 10, it is necessary to realize the transportation of the carrier 3 in and outside the quality inspection workbench 10 to ensure that the quality inspection control process is continuous. For example, the biological in vitro sample to be inspected is transported to the quality inspection workbench 10, and the carrier 3 loaded with the biological in vitro sample to complete the inspection in the quality inspection workbench 10 is transported out of the quality inspection workbench 10.

[0212] The conveying device 14 can be used to transport the carrier 3 loaded with the biological in vitro sample to be tested to the quality inspection workbench 10, or to transport the carrier of the biological in vitro sample that has completed the test in the quality inspection workbench 10 out of the quality inspection workbench 10 through the carrier 3, thereby realizing the automated operation of sample processing.

[0213] Specifically, the conveying device 14 is, for example, a conveying line that overlaps with or passes through the quality inspection workbench 10 , and the conveying line can be driven to move the carrier 3 of the biological ex vivo sample placed on the conveying line to a preset fixed point position.

[0214] The conveyor line can be set to match the carrier 3 of the carrier, so that the carrier 3 can remain relatively still with the conveyor line after being loaded on the conveyor line, thereby determining the conveying path of the carrier 3 by controlling the displacement of the conveyor line. The conveyor line is equipped with a driving device, and when the quality inspection control device 1 is in working state, the movement state of the conveyor line can be controlled based on the transportation demand for biological isolated samples in the quality inspection workbench 10. Among them, the carrier 3 can be a carrier loaded with biological isolated samples, for example, when the screening area 105 in the quality inspection workbench 10 needs to be supplemented with biological isolated samples to be inspected, the conveyor line is controlled to transport the carrier 3 loaded with biological isolated samples to the screening area 105; in some examples, the carrier 3 can also be an empty carrier 3, for example, when the quality inspection workbench 10 needs to be supplemented with an empty carrier 3 in the qualified product placement area 104 where the samples that have been tested are placed, the conveying device 14 transports the empty carrier 3 to the qualified product placement area 104.

[0215] In some embodiments, the conveying device 14 includes a loading area 106 located outside the quality inspection workbench 10, which is used to place the carrier of the biological in vitro sample to be transported to the quality inspection workbench 10. During the process of testing the biological in vitro sample in the quality inspection workbench 10, the biological in vitro sample to be tested needs to be continuously or at certain intervals transported to the quality inspection workbench 10 to ensure the normal operation of the testing process in the quality inspection workbench 10. The loading area 106 is used to place the carrier of the biological in vitro sample to be transported to the quality inspection workbench 10, and the conveying device 14 can transfer the carrier of the biological in vitro sample in the loading area 106 to the quality inspection workbench 10 during operation.

[0216] The quality inspection and control method of biological in vitro samples also includes the step of transporting the empty carriers in the screening area to the empty carrier buffer area outside the quality inspection workbench. In an embodiment, the loading area 106 is also provided with an empty carrier buffer area for placing the carrier 3 to be loaded with biological in vitro samples. The empty carrier buffer area can pre-store a certain number of empty carriers 3, so that when the quality inspection workbench 10 of the quality inspection control equipment 1 is performing loading and unloading operations (or detection operations), the loading and unloading (or detection) speeds can be allowed to be not completely consistent. During the operation of the equipment, for example, when the unloading (or detection) speed is greater than the loading speed, the empty carrier can be stored in the empty carrier buffer area, and the quality inspection control equipment 1 can maintain normal operation. The empty carrier buffer area can be set as a loading buffer area for sample loading and unloading, or for temporarily storing empty carriers 3 to be transported to the quality inspection workbench 10.

[0217] The biological sample quality control method further includes the step of disinfecting the empty carrier. Figure 2 or Figure 5In the embodiment shown, the loading area 106 is also provided with a disinfection device 16, and the disinfection device 16 is used to disinfect the empty carrier of the carrier carrying the biological ex vivo sample. During the operation of the quality inspection control device 1, the carrier 3 can be reused by determining the transfer path of the carrier 3 used to load the biological ex vivo sample. In order to prevent the carrier 3 from being infected or gradually accumulated with pathogenic viruses, bacteria, etc. during the operation of repeated use, the present application also provides an embodiment of setting the disinfection device 16 in the loading area 106. The loading area 106 is provided with an ultraviolet sterilization lamp, so that the carrier 3 includes the disinfection area corresponding to the disinfection device 16 in the operation path, and the disinfection device 16 can achieve disinfection of the carrier 3.

[0218] In one implementation scenario, the conveying device 14 conveys the empty carrier 3 in the screening area 105 in the quality inspection workbench 10 out of the quality inspection workbench 10, and transports the empty carrier 3 to the disinfection area corresponding to the disinfection device 16 for disinfection. The empty carrier 3 can be reused after disinfection, for example, by being transported to the qualified product placement area 104 in the quality inspection workbench 10.

[0219] In some implementations, the specific type of the disinfection device 16 can be determined based on disinfection requirements and at least one of the material of the carrier 3, disinfection time requirements, and structural layout requirements of the conveying device 14. In some embodiments, the disinfection device 16 includes an ultraviolet disinfection device 16.

[0220] In practical applications, the area connected to the loading area 106 can be determined according to the application environment of the quality inspection control equipment 1; for example, the loading area 106 is usually required to load the carrier of the biological ex vivo sample into the carrier 3, and accordingly, the loading area 106 can be set to be connected to the storage room or the receiving room of the biological ex vivo sample.

[0221] In some embodiments, the conveying device 14 further includes a material unloading area 107 located outside the quality inspection workbench 10 , which is used to transport the biological ex vivo samples judged to be qualified for the test from the quality inspection workbench 10 to the material unloading area 107 .

[0222] In one implementation, the conveying line of the conveying device 14 can be configured to include a conveying section located outside the quality inspection workbench 10, and a placement area 104 for placing qualified products that have completed the inspection in the quality inspection workbench 10 is set in the conveying area 101, and the conveying line is driven to operate so that the carrier 3 loaded with the biological in vitro sample in the qualified product placement area 104 is transferred to the conveying section, thereby realizing the transportation of the biological in vitro sample that is judged to be qualified from the quality inspection workbench 10 to the unloading area 107.

[0223] In some embodiments, when the quality inspection workbench 10 is provided with a plurality of qualified product placement areas 104, the unloading area 107 may also be configured to have a plurality of unloading partitions corresponding to the plurality of qualified product placement areas 104. The conveying device 14 conveys the carrier 3 of the biological ex vivo sample placed in the qualified product placement area 104 that has completed the inspection in the quality inspection workbench 10 to the corresponding unloading partition, so that a specific type of biological ex vivo sample can be obtained at different unloading partitions, which is conducive to the subsequent execution of different operations or detections on the biological ex vivo sample based on the sample type. For example, the transport area 101 on the quality inspection workbench is provided with a first-category qualified product placement area, a second-category qualified product placement area, and a third-category qualified product placement area, and correspondingly, the unloading area 107 of the conveying device 14 is provided with unloading partitions for placing the first-category qualified product, the second-category qualified product, and the third-category qualified product.

[0224] In some embodiments, the unloading area 107 is connected to a designated circulation area, and the designated circulation area is determined based on the transportation requirements of the biological ex vivo samples that have completed the test.

[0225] In certain embodiments, when the conveying device 14 is in working condition, it is used to convey the carrier of the biological in vitro sample placed in the loading area 106 to the screening area 105 in the quality inspection workbench 10, to convey the carrier of the biological in vitro sample that has completed quality inspection from the quality inspection workbench 10 to the unloading area 107, and to transport the empty carrier 3 in the screening area 105 to the disinfection device 16 for disinfection and then transport it to the loading area 106 for standby use, or to transport the empty carrier 3 after disinfection to the qualified product placement area 104 in the quality inspection workbench 10.

[0226] The conveying device 14 can be configured to convey the carrier of the biological in vitro sample in the loading area 106 outside the quality inspection workbench 10 to the screening area 105 in the quality inspection workbench 10 based on the loading and unloading requirements in the quality inspection workbench 10 during operation, so that the transfer device 11 can obtain the biological in vitro sample from the screening area 105 for testing; at the same time, during the testing process in the quality inspection workbench 10, the biological in vitro sample that has completed the test is gradually loaded into the carrier 3 of the qualified product placement area 104. When the carrier 3 of the qualified product placement area 104 is in a full-load state, the carrier 3 of the qualified product placement area 104 is fully loaded. The conveying device 14 conveys the carrier of the biological in vitro sample that has been tested according to the testing process from the quality inspection workbench 10 to the unloading area 107; at the same time, in order to realize the reuse of the carrier 3, when the biological in vitro samples loaded on the carrier 3 in the screening area 105 are transferred to other areas, the empty carrier 3 in the screening area 105 is transported to the disinfection device 16 for disinfection. The empty carrier 3 after disinfection can be transported to the qualified product placement area 104 to place the carrier of the biological in vitro sample that has completed the test, or it can be transported to the loading area 106 for standby.

[0227] In some embodiments, the conveying device 14 is a fixed-point conveying line robot. Fig.11 , which is a schematic diagram of the structure of the conveying device of the quality inspection control device of the present application in one embodiment. In one example, the conveying device 14 of the fixed-point conveying line manipulator includes: a conveying line 140, a conveying manipulator 141, and a guide rail mechanism 142.

[0228] The conveyor line 140 is used to carry the carrier 3 of the biological in vitro sample carrier; wherein the conveyor line 140 is provided with a loading area 106 outside the quality inspection workbench 10, a transportation area 101 located inside the quality inspection workbench 10, and an unloading area 107 outside the quality inspection workbench 10. The conveying manipulator 141 is arranged on the guide rail mechanism 142, and is used to move the carrier 3 between different positions / different partitions on the conveyor line 140 in a linear motion on the guide rail mechanism 142.

[0229] In one implementation, the loading area 106 is equipped with a conveyor belt, and the carriers 3 in the loading area 106 are transferred to one end of the loading area 106 close to the quality inspection workbench 10 by the conveyor belt, which can effectively reduce the transfer path length of the conveyor robot 141. The length of the conveyor belt in the loading area 106 can be used to determine the number of carriers 3 cached in the loading area 106. In an embodiment, the conveyor belt in the loading area 106 can also be set to be relatively independent from the conveyor robot 141. When the number of caches in the conveyor belt of the loading area 106 reaches a preset threshold, the loading operation in the loading area 106 can be suspended alone, and other parts of the conveyor line 140, such as the transport area 101, will not be affected.

[0230] The conveyor line 140 can be used to load the carrier 3 of the biological in vitro sample carrier. By dividing the conveyor line 140 into different locations, the conveying robot 141 can transport the carrier 3 between different locations, so as to collaboratively realize the conveying function of the conveying device 14. The functional location on the conveyor line 140 can be set according to the requirements of the quality inspection control device 1. For example, referring to the above embodiment, the screening area 105 and the qualified product placement area 104 in the quality inspection workbench 10 can be set in the transportation area 101 on the conveyor line 140. Thus, the conveying robot 141 can transport the biological in vitro sample carrier in the loading area 106 outside the quality inspection workbench 10 to the screening area 105 in the quality inspection workbench 10; at the same time, the conveying robot 141 can transport the carrier 3 in the qualified product placement area 104 in the quality inspection workbench 10 to the unloading area 107, or / and transport the empty carrier 3 in the screening area 105 to the carrier buffer area 108.

[0231] In some examples, the carrier cache area 108 can also be set to a double-layer or multi-layer structure. For example, two carriers 3 can be set in a single layer of the orifice plate cache area, and the carrier 3 cache area 108 is configured as a total of 5 layers, thereby providing the carrier cache area 108 with a carrier storage capacity and effectively utilizing the equipment space.

[0232] In some embodiments, the moving direction of the conveying robot 141 determined by the guide rail mechanism 142 of the fixed-point conveying line 140 is the direction of the conveying line 140. Here, the direction of the conveying line 140 is the arrangement direction of different locations on the conveying line 140, and can also be regarded as the direction of the shortest distance between different locations. The present application provides an embodiment in which the guide rail mechanism 142 is arranged along the direction of the conveying line 140, thereby effectively shortening the transfer path when the conveying robot 141 moves along the guide rail mechanism 142, thereby improving the conveying efficiency. In one implementation, in order to realize that the conveying robot 141 transfers the carrier 3 between different locations, the guide rail mechanism 142 is arranged across the two ends of the quality inspection workbench 10 to ensure that the moving distance of the conveying robot 141 can cover each location on the conveying line 140.

[0233] In some embodiments, the guide rail mechanism 142 is set above the conveyor line 140, and the conveying robot 141 also includes a lifting component to control the position of the end effector in the lifting direction. In the implementation scenario, the lifting component determines the position of the end effector in the lifting direction to achieve the grabbing, conveying and placing of the carrier 3 on the conveyor line 140. For example, the end effector is lowered to a preset position to ensure that the carrier 3 can be grabbed, and then the end effector, that is, the grabbed carrier 3, is controlled to rise to a certain height for transportation, thereby avoiding collision and interference between different components during the transportation process. When the conveying robot 141 transports the carrier 3 to the top of the target location, the end effector is controlled to drive the carrier 3 to descend to a predetermined position and then release the carrier 3 to ensure that the carrier 3 is safely placed.

[0234] exist Fig.11 In the embodiment shown, the transport area 101 is provided with a plurality of qualified product placement areas 104, and the unloading area 107 is used to place or transport the carrier 3 of the biological in vitro sample transported from the plurality of qualified product placement areas 104 out of the quality inspection workbench 10, and the carrier 3 is also a qualified product carrier. Fig.11 As shown, the unloading area 107 is arranged on a conveyor belt, and a certain number of carriers 3 can be placed on the conveyor belt. When the transmission belt of the unloading area 107 is stationary, the unloading area 107 can be used as a temporary storage area for the qualified product carriers; at the same time, the conveyor belt can be driven to move, and the conveying robot 141 transfers the qualified product carriers in the qualified product placement area 104 to the unloading area 107. The transmission belt of the unloading area 107 can drive the carriers 3 it carries to move, so as to make full use of the carrying position of the conveyor belt.

[0235] In one implementation scenario, when the carrier 3 in the qualified product placement area 104 is in a fully loaded state, the conveying robot 141 transfers the carrier 3 to a predetermined placement area on the conveyor belt. After the carrier 3 is securely placed on the conveyor belt, the conveyor belt drives the carrier 3 to move a certain distance toward the unloading end, so that the predetermined placement area determined by the moving range of the conveying robot 141 is in a non-fully loaded state, that is, storage space for the next carrier is reserved; for example, each time a carrier is placed on the conveyor belt in the unloading area 107, the conveyor belt is driven to move the position of one carrier toward the unloading end. When the carrier placed on the conveyor belt contacts the unloading end, a corresponding alarm device can be triggered. When the alarm device is triggered, the conveying robot 141 can be ordered to suspend the transfer of the carrier from the qualified product placement area 104 to the unloading area 107, and perform unloading on the carrier on the conveyor belt in the unloading area 107, such as manually transferring the carrier carrying qualified products.

[0236] See also Fig.12 , which is a schematic diagram of the structure of the conveying manipulator of the conveying device in the present application in one embodiment. As shown in the figure, the end effector of the conveying manipulator 141 is a clamping jaw adapted to the carrier 3 of the biological sample carrier, and the clamping jaw includes a first clamping jaw 1411 and a second clamping jaw 1412 arranged opposite to each other. By driving at least one of the first clamping jaw 1411 and the second clamping jaw 1412 to adjust the clamping jaw spacing, the clamping jaw can grasp and release the carrier 3.

[0237] The biological sample quality control method further includes a step of determining the moving position of the conveying robot to the carrier based on a positioning detection device. Fig.11 As shown, the quality inspection control device 1 is also equipped with a positioning detection device 144 for detecting the moving position of the carrier 3 by the conveying robot 141 to determine that the carrier 3 is moved to a predetermined position. In an embodiment, the positioning detection device 144 is a shooting device, which includes but is not limited to: a camera, a video camera, a camera module integrated with a lens and a CCD, or a camera module integrated with a lens and a CMOS, etc.

[0238] In order to achieve accurate positioning of the carrier 3, the positioning detection device can detect or monitor the transfer process of the carrier 3 by the conveying robot 141. In one example, the positioning detection device can detect the position of the carrier at a certain time interval, or detect the position of the carrier when the end effector of the conveying robot 141 moves to the top of the target area to perform the descending action, or detect the position of the carrier when the end effector of the conveying robot 141 releases the carrier; in another example, the positioning detection device can continuously monitor the conveying process to determine that the conveying robot 141 moves along a predetermined path.

[0239] In certain embodiments, the conveying device may also be a double-layer fixed-point conveying device (not shown). It should be understood that the screening area and the qualified product placement area in the quality inspection workbench are both fixed positions. In order to realize that the carrier of the biological ex vivo sample is driven to a preset fixed position based on the conveying device, the present application also provides an embodiment of setting the conveying device as a double-layer fixed-point conveying device. In this example, the conveying device has a higher degree of freedom for the conveying path of the carrier it carries, that is, it can perform conveying operations based on the loading and unloading requirements in the quality inspection workbench; at the same time, the double-layer fixed-point conveying device can reduce the equipment space occupied by the quality inspection control equipment. The conveying device is a double-layer fixed-point conveying device having an upper conveying line and a lower conveying line.

[0240] In certain embodiments, the upper conveyor line of the double-layer fixed-point conveying device is used to perform at least one of the fixing of the carrier of the biological ex vivo sample, sample loading, and sample unloading, and the lower conveyor line is used to transport the carrier of the biological ex vivo sample to different locations. For example, in the loading area, an empty carrier can be fixed to the upper conveyor line at the upper conveyor line, and the sample loading operation can also be performed on the empty carrier at the upper conveyor line in the loading area; the sample unloading operation is performed on the carrier at the upper conveyor line in the unloading area; the screening area and the qualified product placement area in the quality inspection workbench can be the upper conveyor line provided in the conveying device, and during the inspection operation in the quality inspection workbench, the carrier in the screening area is in the process of sample unloading, and the carrier in the qualified product placement area is in the process of sample loading.

[0241] In some embodiments, in order to achieve accurate positioning and fixation of the carrier, the conveying device is further configured with a locking mechanism for fixing the carrier, and the locking mechanism is, for example, a cylinder, for fixing the carrier at a preset loading position. In one embodiment, the carrier is loaded on the conveying device, and the conveying device is configured with a cylinder for fixing the carrier.

[0242] The lower conveyor line is used to transport carriers of biological ex vivo samples to different locations. When the upper conveyor line performs operations such as loading and unloading of samples, the lower conveyor line can transport carriers that have completed sample loading or empty carriers that have unloaded samples. In this way, the conveying device can simultaneously perform different flow processing on biological ex vivo samples.

[0243] A lifting mechanism is provided between the upper conveyor line and the lower conveyor line, which is used to transfer the carrier located on the upper conveyor line to the lower conveyor line to realize the transportation of the carrier, or to transfer the carrier located on the lower conveyor line to the upper conveyor line to realize the sample loading or unloading operation of the carrier. In some implementations, each position of the upper conveyor line is set to a fixed functional position, and the preset processing of the sample or carrier is performed at each functional position; the switching of the carrier between the upper conveyor line and the lower conveyor line is realized by the lifting mechanism, so that the functional position of the upper conveyor line can maintain the replacement and update of the carrier. In some implementation scenarios, multiple lifting mechanisms can be provided in the conveying device to realize the switching of the carrier 3 between the upper conveyor line and the lower conveyor line at multiple positions.

[0244] For further explanation, the working process of the quality control device in the quality control method of the biological sample in vitro of the present application is shown in FIG. Figures 13 to 19 When in working state, the conveying device 14 is used to convey the carrier of the biological in vitro sample placed in the loading area 106 to the screening area 105 in the quality inspection workbench 10, to convey the carrier of the biological in vitro sample that has completed quality inspection from the quality inspection workbench 10 to the unloading area 107, and to convey the empty carrier 3 in the screening area 105 to the carrier buffer area 108, or to convey the empty carrier 3 to the qualified product placement area 104 in the quality inspection workbench 10, or if the carrier buffer area 108 is full, it will be conveyed to the unloading area 107 for use as an empty carrier.

[0245] See also Fig.13 , which is a schematic diagram of the quality inspection control device of the present application taking samples from the screening area in one embodiment. As shown in the figure, the conveying device 14 performs sample transfer and conveys the sample from the loading area to the screening area 105. The transfer device 11 in the quality inspection workbench 10 obtains the carrier of the biological in vitro sample to be inspected from the screening area 105 according to the inspection process, transfers the carrier of the biological in vitro sample between the work area 100 provided with the transfer temporary storage area 102, the collection area 103, or / and the qualified product placement area 104 and the conveying area 101 to complete the inspection, and places the qualified sample that has completed the inspection in the qualified product placement area 104 in the quality inspection workbench 10. Among them, the inspection process includes:

[0246] The transfer device 11 in the quality inspection workbench 10 transports the captured biological sample carrier to the identification work area according to the detection process so that the identification device 12 can identify it. Fig.14, showing a schematic diagram of sample identification in one embodiment of the quality inspection control device of the present application. As shown in the figure, in the identification work area corresponding to the identification device 12, the order information of the carrier of the biological ex vivo sample is identified to obtain the verification result of the order information; wherein, the identification process is, for example, performed by the transfer device 11 grabbing the carrier of the biological ex vivo sample, but the carrier is attached with an information carrier associated with the order information, such as an information code, and the corresponding identification device 12 can be configured as a scanning device. During the scanning process, the carrier of the biological ex vivo sample can be driven to rotate by the transfer device 11 to achieve 360° scanning of the carrier.

[0247] After the order information is identified, the order information can be transmitted to the quality inspection management system 2 via the communication device. The order information obtained by identification is compared with the order information pre-stored in the quality inspection management system 2 to determine whether the order information loaded on the carrier of the biological ex vivo sample is correct. The communication device can receive the verification feedback of the order information from the quality inspection management system 2, and based on the feedback result, control the transfer device 11 to transfer the carrier of the biological ex vivo sample with qualified order information verification result to the quality inspection device 13 in the quality inspection work area for quality inspection, as shown in the following figure. Fig.15 As shown, Fig.15 The schematic diagram of the quality inspection control device of the present application placing the sample in the quality inspection work area in one embodiment is shown. In one embodiment, the order information is, for example, one or more of the following information: sample type, test item, test content, diversion information, sample quantity, and sample ID; in another embodiment, the order information is, for example, traceability information such as user identification information, communication information, etc.; in yet another embodiment, the order information may also include characteristic information of the sample such as sample type, sample quantity, sample collection time, etc., or information on the test items to be performed on the sample.

[0248] The transfer device 11 transfers the biological in vitro samples that have passed the order information verification to the quality inspection work area, and the quality inspection device 13 performs quality inspection on the biological in vitro samples to generate quality inspection data, and compares the quality inspection data with the quality inspection qualified standards to determine the quality inspection results of the biological in vitro samples. Among them, the structure and quality inspection method of the quality inspection device 13 can be determined according to the quality inspection requirements of the samples. In some examples, the quality inspection device 13 is a weighing device, which determines whether the sample volume of the biological in vitro sample meets the quality inspection qualified standards by weighing. The quality inspection qualified standards can also be determined by the quality inspection management system 2. In some scenarios, the quality inspection qualified standards can also be determined according to the sample type, and the type information of the sample can be obtained from the quality inspection management system 2, for example.

[0249] When the order information verification result is unqualified, the carrier of the biological sample is transferred by the transfer device 11 to the collection area 103 for placing unqualified samples, as shown in Fig.16 As shown, Fig.16 Alternatively, when the quality inspection result of the quality inspection device 13 is not satisfactory to the quality inspection qualified standard, the carrier of the biological sample will also be transferred by the transfer device 11 to the collection area 103 for placing unqualified samples.

[0250] In one embodiment, after the quality inspection is completed, the transfer device 11 can transfer the carrier of the biological ex vivo sample to the identification device 15, and the identification device 15 will identify the identity information of the biological ex vivo sample obtained from the quality inspection management system 2 on the carrier of the biological ex vivo sample. For example, the identification device 15 generates a label associated with the content of the identity information based on the identity information obtained from the quality inspection management system 2, and attaches the label to the carrier of the biological ex vivo sample. Fig.17 As shown, Fig.17 It is a schematic diagram showing the quality inspection control device of the present application in one embodiment where a sample is placed on a marking device.

[0251] Present as Fig.18 As shown, Fig.18 The schematic diagram of the quality inspection control device of the present application placing the sample in the qualified product placement area in one embodiment is shown. The transfer device 11 then transfers the carrier of the biological ex vivo sample with qualified information identification to the qualified product placement area 104, or transfers the carrier of the biological ex vivo sample with unqualified information identification or unqualified quality inspection result to the corresponding collection area 103; wherein, the determination of whether the information identification is qualified is, for example, to determine whether the identity information obtained by identification is consistent with the identity information preset and associated with the label when the label is generated by identifying the label. When it is determined that the quality inspection result and information identification of the biological ex vivo sample are both qualified, the carrier of the biological ex vivo sample can be transferred to the qualified product placement area 104 for placing qualified samples that have completed the test; when either the quality inspection result or the information identification is unqualified, the carrier of the biological ex vivo sample is transferred to the corresponding collection area 103.

[0252] In this way, the biological in vitro samples are tested according to the testing process in the quality inspection workbench 10, and the carrier of the biological in vitro samples obtained from the screening area 105 is placed in the qualified product placement area 104 or the collection area 103 for placing unqualified products based on the test results; at the same time, the conveying device 14 conveys the biological in vitro samples to be tested to the screening area 105, and transfers the biological in vitro samples in the qualified product placement area 104 out of the quality inspection workbench 10, so as to be transported from the quality inspection workbench 10 to the unloading area 107, so as to realize automatic processing of samples and determine the continuity of equipment operation.

[0253] In some examples, when collecting samples based on the same order, the number of carriers of biological in vitro samples collected is 2 or more. When multiple samples are associated with each other to be recorded in the same order information, the same order information corresponds to multiple carriers of biological in vitro samples. During the detection process, after identifying the information code carried on the carrier of the biological in vitro sample to obtain the corresponding order information, it is determined that the order information corresponds to multiple carriers of biological in vitro samples, and then the carrier of the biological in vitro sample is transferred to the transit temporary storage area 102. After it is determined that the carriers of the multiple biological in vitro samples corresponding to the order information are all detected and identified (i.e., after they are collected), the carriers of the multiple biological in vitro samples are subsequently circulated. Fig.19 As shown, Fig.19 Shown is a schematic diagram of placing samples in a transit temporary storage area in one embodiment of the quality inspection control device of the present application.

[0254] The quality inspection and control equipment provided in the second aspect of the present application can effectively reduce the error rate of sample pre-analysis processing and significantly improve sample processing efficiency.

[0255] In summary, the quality inspection and control method of biological in vitro samples of the present application can be implemented based on the information provided by the quality inspection management system, the determined detection rules, or the determined detection process; by associating the sample processing process with the quality inspection management system, it can be determined based on the quality inspection management system how to adjust the processing process, such as increasing or decreasing the processing steps or adjusting the sequence, and the information provided by the quality inspection management system can assist in determining the detection method, detection results or transportation method of the samples in each processing step. While realizing automated processing of samples to improve sample processing efficiency and reduce sample detection error rate, the quality inspection control equipment associated with the quality inspection management system can further improve the detection accuracy of automated processing of samples; furthermore, the present application provides the structural composition, functions and positional relationships between the structures of the quality inspection control equipment to realize automated processing of samples under a preset sample processing process, thereby improving processing efficiency by forming a standardized processing process for samples.

[0256] The quality inspection control method provided in the present application realizes automated processing of samples through a transfer device, an identification device, a quality inspection device and a conveying device, and realizes continuous operation of sample pre-analysis processing operations based on the coordinated operation between multiple devices; by allowing the identification device, the quality inspection device and the quality inspection management system to interact with each other, it can assist in controlling the detection process in the quality inspection workbench or assist in generating detection results. The quality inspection control method of biological in vitro samples has higher adaptability. For example, the order information of biological in vitro samples can be verified through the identification device, which can effectively reduce the pre-analysis errors of samples caused by sample circulation in the actual application environment; for example, the specific quality inspection method of the sample and the quality inspection qualification judgment method of the sample can be adjusted based on the information provided by the quality inspection management system, which can be applied to the pre-analysis processing of samples for various detection items.

[0257] The present application also discloses a computer-readable storage medium, including a stored computer program, wherein when the computer program is executed by a processor of a computer, the computer is controlled to execute and implement the above-mentioned Figures 1 to 19 The quality inspection and control method for biological in vitro samples described in any of the embodiments. If the functions of the quality inspection and control method for biological in vitro samples provided by the present application are implemented in the form of software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present application, or the part that contributes to the prior art, or the part of the technical solution, can be embodied in the form of a software product, which is stored in a storage medium and includes a number of instructions for a computer device (which can be a personal computer, a server, or a network device, etc.) to perform all or part of the steps of the method described in each embodiment of the present application.

[0258] In the embodiments provided in the present application, the computer readable and writable storage medium may include a read-only memory, a random access memory, an EEPROM, a CD-ROM or other optical disk storage device, a disk storage device or other magnetic storage device, a flash memory, a USB flash drive, a mobile hard disk, or any other medium that can be used to store a desired program code in the form of an instruction or data structure and can be accessed by a computer. In addition, any connection can be appropriately referred to as a computer-readable medium. For example, if the instruction is sent from a website, a server or other remote source using a coaxial cable, an optical fiber cable, a twisted pair, a digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwaves, the coaxial cable, optical fiber cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwaves are included in the definition of the medium. However, it should be understood that computer readable and writable storage media and data storage media do not include connections, carriers, signals, or other temporary media, but are intended to be non-temporary, tangible storage media. Disk and disc, as used in this application, includes compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk and Blu-ray disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers.

[0259] In one or more exemplary aspects, the functions described by the computer program of the method described in the present application can be implemented in hardware, software, firmware, or any combination thereof. When implemented in software, these functions can be stored or transmitted as one or more instructions or codes on a computer-readable medium. The steps of the method or algorithm disclosed in the present application can be embodied in a processor-executable software module, wherein the processor-executable software module can be located on a tangible, non-temporary computer-readable and writable storage medium. A tangible, non-temporary computer-readable and writable storage medium can be any available medium that a computer can access.

[0260] The flow chart and block diagram in the above-mentioned accompanying drawings of the present application illustrate the possible architecture, function and operation of the system, method and computer program product according to various embodiments of the present application. Based on this, each box in the flow chart or block diagram can represent a module, a program segment or a part of a code, and the module, the program segment or a part of the code contains one or more executable instructions for realizing the specified logical function. It should also be noted that in some implementations as replacements, the functions marked in the box can also occur in a different order from the order marked in the accompanying drawings. For example, two boxes represented in succession can actually be executed substantially in parallel, and they can sometimes be executed in the opposite order, depending on the functions involved. It should also be noted that each box in the block diagram and / or flow chart, and the combination of the boxes in the block diagram and / or flow chart can be realized by a dedicated hardware-based system that performs a specified function or operation, or can be realized by a combination of dedicated hardware and computer instructions.

[0261] The above embodiments are merely illustrative of the principles and effects of the present application and are not intended to limit the present application. Anyone familiar with the technology may modify or change the above embodiments without violating the spirit and scope of the present application. Therefore, all equivalent modifications or changes made by a person of ordinary skill in the art without departing from the spirit and technical ideas disclosed in the present application shall still be covered by the claims of the present application.

Claims

1. A method for quality control of biological in vitro samples, characterized in that: The following steps are involved: A transporting step, transporting the carrier containing the biological sample in vitro to a quality inspection workbench; A transfer step, transferring the carrier containing the biological in vitro sample between the transport area and multiple work areas of the quality inspection workbench according to the detection process; wherein the detection process includes: identifying the order information of the transferred biological in vitro sample to transmit it to a quality inspection management system, and performing a first diversion process on the carrier containing the biological in vitro sample according to the feedback of the quality inspection management system, and transferring the carrier of the biological in vitro sample with qualified order information to the next inspection station; the quality inspection management system is communicatively connected to a quality inspection control device, and the quality inspection control device includes a quality inspection workbench, a transfer device, an identification device, a quality inspection device and a conveying device to collaboratively realize the automated detection and conveying of the sample; A quality inspection step, detecting the biological in vitro sample located in the quality inspection work area to generate quality inspection data, transmitting the quality inspection data to the quality inspection management system, and subjecting the carrier containing the biological in vitro sample to a second diversion process; an identification step, obtaining the identity information of the biological ex vivo sample from the quality inspection management system, and marking the label generated based on the identity information on the carrier of the biological ex vivo sample for secondary diversion processing; the second diversion processing of the biological ex vivo sample includes: marking the carrier of the biological ex vivo sample whose order information or quality inspection result does not match, and transferring the carrier of the biological ex vivo sample to the collection area, marking the biological ex vivo sample whose order information and quality inspection result are qualified, so as to determine that the biological ex vivo sample is transferred to the corresponding qualified product placement area or collection area; The label verification step is used to identify the label to determine the label position on the carrier of the biological ex vivo sample, or to obtain the identity information corresponding to the label or / and the quality inspection information associated with the identity information; identify the label to determine the label verification result, so as to perform a third diversion process on the carrier of the biological ex vivo sample, and transport the carrier of the biological ex vivo sample with qualified label verification results to the corresponding qualified area, and transport the carrier of the biological ex vivo sample with unqualified label verification results to the corresponding unqualified product placement area; The carrier of the biological in vitro sample that has completed quality inspection is transported out of the quality inspection workbench, or the empty carrier located in the screening area is transported out of the quality inspection workbench for standby use.

2. The biological in vitro sample quality control method according to claim 1, characterized in that: In the identification step, the information identified on the carrier of the biological ex vivo sample includes numbering information, wherein the numbering information is numbering information obtained from the quality inspection management system, or numbering information generated based on identity information obtained from the quality inspection management system.

3. The biological sample quality control method according to claim 2, characterized in that: The serial number information corresponding to the same biological in vitro sample is associated with the order information.

4. The biological sample quality control method according to claim 2, characterized in that: The numbering information is formed in any of the following ways: Based on the quality inspection management system, the identity information is represented based on a number field of a predetermined format based on a preset numbering rule; A numbering rule for the identity information is customized to determine a numbering field for forming the numbering information.

5. The biological in vitro sample quality control method according to claim 1, characterized in that: The method also includes the step of placing the biological in vitro samples that are deemed to be qualified in the qualified product placement area in the quality inspection workbench.

6. The biological in vitro sample quality control method according to claim 1 or 5, characterized in that: The method also includes a step of determining the qualified type of the qualified biological ex vivo sample according to a preset classification rule, so as to place the biological ex vivo sample in a corresponding qualified product placement area according to the qualified type.

7. The biological in vitro sample quality control method according to claim 6, characterized in that: The biological ex vivo sample is placed in the corresponding qualified product placement area according to the qualified type by identifying the information code corresponding to the qualified type set on the qualified product placement area.

8. The biological sample quality control method according to claim 7, characterized in that: The classification rule may be determined in any of the following ways: Obtaining sample information from the quality inspection management system to define classification rules; The classification rules are obtained from the quality inspection management system.

9. The biological in vitro sample quality control method according to claim 1, characterized in that: The conveying step also includes the step of transferring the biological ex vivo sample in the qualified product placement area out of the quality inspection workbench.

10. The biological in vitro sample quality control method according to claim 1, characterized in that: The method also includes the step of transferring the biological in vitro samples that are determined to be unqualified for testing to a collection area in a quality inspection workbench.

11. The biological in vitro sample quality control method according to claim 10, characterized in that: The unqualified test includes at least one of the order information, identity information, and quality inspection result being unqualified; the collection area includes at least one of a scan error area for placing biological in vitro samples with incorrect order information or incorrect quantity information, a liquid quantity error area for placing biological in vitro samples with incorrect quality inspection results, and an identification error area for placing biological in vitro samples with incorrect identity information.

12. The biological in vitro sample quality control method according to claim 11, characterized in that: The multiple collection areas in the quality inspection workbench are equipped with identifiable marks, which are used to characterize the unqualified types corresponding to the collection areas. The biological ex vivo samples are placed in the collection areas corresponding to their unqualified types by identifying the marks.

13. The biological in vitro sample quality control method according to claim 12, characterized in that: The mark is formed by any of the following methods: The placement positions and corresponding codes assigned to the plurality of collection areas; The plurality of collection areas are set to different colors so as to form a color gradient between adjacent areas; An identifiable mark is provided at the junction of the plurality of collection areas, and the mark comprises at least one of a magnetic strip and a reflective strip.

14. The biological sample quality control method according to claim 10, characterized in that: The method also includes a displacement step, which is a step of transferring the carrier of the biological ex vivo sample in the collection area out of the quality inspection workbench.

15. The biological in vitro sample quality control method according to claim 14, characterized in that: The shifting step is completed by a shifting device, and when the carrier moves along the shifting device, a sensing device detects the carrier so as to move the carrier to a preset position.

16. The biological in vitro sample quality control method according to claim 1, characterized in that: The method also includes placing carriers of multiple biological in vitro samples corresponding to the same order information determined in the test in a transfer temporary storage area of ​​the quality inspection workbench.

17. The biological in vitro sample quality control method according to claim 16, characterized in that: The method also includes the step of determining the quantity information of the biological ex vivo samples in the transfer temporary storage area to transfer the biological ex vivo samples with incorrect quantity information to the collection area, or to transfer the biological ex vivo samples with correct quantity information to the next detection station.

18. The biological sample quality control method according to claim 16, characterized in that: Methods for determining the quantity information of the biological ex vivo samples in the temporary transfer storage area include: Based on the identified order information of the biological ex vivo sample and when it is determined that the order information corresponds to a plurality of biological ex vivo sample carriers, the biological ex vivo sample is placed in a transit temporary storage area and the order information is determined as order information to be inspected; Continue to identify the order information of the preset number of biological ex vivo samples, and determine that the quantity information is correct when it is determined that the preset number of biological ex vivo samples includes other biological ex vivo samples corresponding to the order information to be inspected.

19. The biological in vitro sample quality control method according to claim 1, characterized in that: In the transfer step, the detection process according to which the carrier of the biological ex vivo sample is transferred is the detection process determined by the quality inspection management system or the detection process preset in the quality inspection control device.

20. The biological in vitro sample quality control method according to claim 1, characterized in that: The method of identifying the order information of the biological ex vivo sample includes at least one of the following: The order information is obtained by scanning and identifying the information code on the carrier of the biological ex vivo sample, and the order information is used to compare with the information pre-stored in the quality inspection management system to obtain the verification result; The information code on the carrier of the biological ex vivo sample is identified by scanning the code to determine whether the order information associated with the information code can be read, and the verification result of the order information is determined based on the reading status of the information code.

21. The biological sample quality control method according to claim 1, characterized in that: The order information includes traceability information of the biological ex vivo sample, and the traceability information includes at least one of user identification information, communication information, biometric information, and order number information.

22. The biological in vitro sample quality control method according to claim 21, characterized in that: The traceability information is also associated with the detection item information and sample information of the biological ex vivo sample; wherein the sample information includes at least one of the collection time of the biological ex vivo sample, the collection sample volume, the sample type, and the number of sample carriers.

23. The biological sample quality control method according to claim 1, characterized in that: The method further includes comparing the quality inspection data obtained by testing the biological in vitro sample based on the quality inspection qualified standard to obtain the quality inspection result, wherein the quality inspection qualified standard is an industry standard, a custom standard, or a standard determined by a quality inspection management system.

24. The biological sample quality control method according to claim 23, characterized in that: The quality inspection step includes a weighing step for detecting the mass of the biological ex vivo sample, and comparing the mass of the biological ex vivo sample obtained by the detection with the quality inspection qualified standard to generate the quality inspection result.

25. The biological sample quality control method according to claim 23, characterized in that: The quality inspection parameters used to form the quality inspection acceptance standard include: one or more of sample weight, sample volume, and sample weight density.

26. The biological sample quality control method according to claim 1, characterized in that: The transporting step includes transporting the carrier of the biological ex vivo sample to be tested to the screening area in the quality inspection workbench.

27. The biological in vitro sample quality control method according to claim 26, characterized in that: The step of transporting the carrier containing the biological sample in vitro to the quality inspection workbench in the transport step includes: Placing the carrier of the biological in vitro sample to be transported to the quality inspection workbench in a loading area, wherein the loading area is located outside the quality inspection workbench; The carrier of the biological sample to be tested is transported from the loading area to the screening area.

28. The biological sample quality control method according to claim 26, characterized in that: The method also includes the step of transporting the empty carriers in the screening area to an empty carrier buffer area outside the quality inspection workbench.

29. The biological in vitro sample quality control method according to claim 28, characterized in that: The step of conveying the carrier of the biological in vitro sample that has completed the quality inspection out of the quality inspection workbench includes: transporting the biological in vitro sample that is determined to be qualified for the inspection from the quality inspection workbench to the unloading area.

30. The biological sample quality control method according to claim 29, characterized in that: The conveying step is completed by a conveying device. When the conveying device is in working state, it conveys the carrier of the biological in vitro sample placed in the loading area to the screening area in the quality inspection workbench, conveys the carrier of the biological in vitro sample that has completed quality inspection from the quality inspection workbench to the unloading area, and conveys the empty carrier in the screening area to a disinfection device for disinfection and then conveys it to the qualified product placement area in the quality inspection workbench.

31. The biological sample quality control method according to claim 1, characterized in that: The method also includes configuring a carrier register of the carrier based on a control system to determine a loading status of the carrier.

32. The biological sample quality control method according to claim 1, characterized in that: The biological in vitro sample is a liquid sample.

33. The biological sample quality control method according to claim 32, characterized in that: The biological samples were used for molecular diagnosis.

34. A computer-readable storage medium, characterized in that: It comprises a stored computer program, wherein when the computer program is executed by a processor of a computer, the computer is controlled to execute and implement the quality inspection and control method for biological in vitro samples as described in any one of claims 1 to 33.

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