Automatic quality control method applied to sample analyzer and sample analyzer

Abstract

The embodiment of the invention provides an automatic quality control method applied to a sample analyzer and the sample analyzer, and the sample analyzer determines to start a quality control program according to preset quality control time; driving the extraction mechanism to suck the quality control product; driving the extraction mechanism to suck the reagent so as to mix the reagent with the quality control product to form a mixed solution; detecting the mixed solution to output a detection signal; and outputting a quality control result based on the detection signal. In the embodiment of the invention, the sample analyzer can automatically complete the quality control task according to the preset quality control time, so that the quality control efficiency is improved, manual redissolution is not needed, and the detection stability and accuracy are improved.

Description

Technical Field

[0001] The present application relates to the field of in vitro diagnostic analysis, and in particular to an automatic quality control method applied to a sample analyzer and a sample analyzer. Background Art

[0002] In coagulation testing equipment, quality control calibration tests are often troublesome. For example, the quality control product needs to be manually reconstituted first, and then the reconstituted quality control product is added to the sample tube, and then placed in the loading window of the coagulation testing equipment. The coagulation testing equipment will retrieve it from the loading window to perform the quality control calibration test. However, there are many uncertainties in the manual reconstitution process of quality control products. For example, differences in test results may occur due to differences in operations between different people. It is also easy to produce problems such as uneven reconstitution and the presence of bubbles during the reconstitution process. Moreover, quality control calibration tests need to be done regularly, and manual reconstitution will take up a lot of time, taking up a lot of medical staff's time, and the work efficiency is relatively low. Summary of the invention

[0003] The embodiment of the present application provides an automatic quality control method and a sample analyzer applied to a sample analyzer. The sample analyzer can automatically complete the quality control task according to the preset quality control time, improve the quality control efficiency, do not need manual re-dissolution, and improve the stability and accuracy of the detection.

[0004] The embodiment of the present application provides an automatic quality control method applied to a sample analyzer, wherein the sample analyzer includes an extraction mechanism, a detection mechanism and a controller; wherein the extraction mechanism includes a sample extraction module, a reagent extraction module and a quality control product extraction module which are separately arranged, or includes at least two sample extraction modules, reagent extraction modules and quality control product extraction modules which are integrated; the sample analyzer also includes a sample container storage for storing sample containers, a reagent container storage for storing reagent containers and a quality control product container storage for storing quality control product containers; the sample extraction module is used to absorb the sample in the sample container; the quality control product extraction module is used to absorb the quality control product in the quality control product container; the reagent extraction module is used to absorb the sample in the reagent container The reagent is used to mix with the sample or the quality control product to form a mixed solution; the detection mechanism is used to detect the mixed solution to output a detection signal; the controller is used to drive the extraction mechanism to perform sample extraction, reagent filling and / or quality control product extraction, and output the detection result or quality control result based on the detection signal; wherein the automatic quality control method includes: determining to start the quality control program according to a preset quality control time; driving the extraction mechanism to absorb the quality control product; driving the extraction mechanism to absorb the reagent so that the reagent and the quality control product are mixed to form a mixed solution; detecting the mixed solution to output a detection signal; and outputting the quality control result based on the detection signal.

[0005] In some embodiments, the sample analyzer further comprises a display screen displaying an appointment control, and the method further comprises: setting a quality control time; or, displaying the quality control result on the display screen.

[0006] In some embodiments, the sample analyzer further includes an injection window and a scheduling mechanism, and the method further includes: detecting that the quality control product container is placed in the injection window; and driving the scheduling mechanism to transfer the quality control product container from the injection window to the quality control product container storage location.

[0007] In some embodiments, the sample analyzer also includes an identification mechanism, and an identification code is provided on the quality control product container, and the identification code stores quality control product information of the quality control product contained in the quality control product container; the driving of the scheduling mechanism to transfer the quality control product container from the injection window to the quality control product container storage place includes: driving the scheduling mechanism to transfer the quality control product container from the injection window to the location of the identification mechanism; acquiring the quality control product information; driving the scheduling mechanism to transfer the quality control product container from the location of the identification mechanism to the quality control product container storage place.

[0008] In some embodiments, the sample analyzer also includes a re-dissolution mechanism or is used in conjunction with an external re-dissolution mechanism, the re-dissolution mechanism includes a mixing mechanism and a fixed position, the mixing mechanism is used to perform a mixing action on the quality control product container fixed to the fixed position, so that the quality control product and the re-dissolution solution in the quality control product container are evenly mixed; before driving the extraction mechanism to absorb the quality control product, it includes: driving the quality control product extraction module to mix the re-dissolution solution and the quality control product; driving the scheduling mechanism to move the quality control product container to the fixed position; driving the mixing mechanism to perform the mixing action; driving the scheduling mechanism to transfer the mixed quality control product container to the quality control product container storage place.

[0009] In some embodiments, the control product container contains a mixture of the control product and a reconstitution solution; or, the control product container contains a liquid state of the control product.

[0010] The embodiment of the present application provides a sample analyzer, including an extraction mechanism, a detection mechanism and a controller; wherein the extraction mechanism includes a sample extraction module, a reagent extraction module and a quality control product extraction module which are separately arranged, or includes at least two sample extraction modules, reagent extraction modules and quality control product extraction modules which are integrated; the sample analyzer also includes a sample container storage for storing sample containers, a reagent container storage for storing reagent containers and a quality control product container storage for storing quality control product containers; the sample extraction module is used to absorb the sample in the sample container; the quality control product extraction module is used to absorb the quality control product in the quality control container; the reagent extraction module is used to absorb the reagent in the reagent container to mix it with the sample or the quality control product to form a mixed solution; the detection mechanism The structure is used to detect the mixed solution to output a detection signal; the controller is used to drive the extraction mechanism to perform a sample extraction action and a reagent filling action respectively to form a first mixed solution including the sample and the reagent, and control the detection mechanism to detect the first mixed solution to output a first detection signal, and output a detection result based on the first detection signal; the controller is also used to determine to start a quality control program according to a preset quality control time, and in the quality control program, drive the extraction mechanism to perform a quality control product extraction action and a reagent filling action respectively to form a second mixed solution including the quality control product and the reagent, and control the detection mechanism to detect the second mixed solution to output a second detection signal, and output a quality control result based on the second detection signal.

[0011] In some embodiments, the reagent container and the quality control container have the same base, and the base is used to be fixed at the reagent container storage place and / or the quality control container storage place.

[0012] The embodiment of the present application provides a sample analyzer, including an extraction mechanism, a detection mechanism, a scheduling mechanism, a controller and a temperature control mechanism; wherein the extraction mechanism includes a sample extraction module, a reagent extraction module and a quality control product extraction module that are separately arranged, or includes at least two sample extraction modules, reagent extraction modules and quality control product extraction modules that are integrated; the sample analyzer also includes a storage container; wherein the storage container is provided with a plurality of placement areas, and any one of the placement areas is used to indiscriminately place a reagent container storing a reagent or a quality control product container storing a quality control product and a reconstitution solution; or the storage container is provided with a first placement area and a second placement area, the first placement area is used to place a reagent container storing a reagent, and the second placement area is used to place a quality control product container storing a reconstitution solution. and a quality control product container for reconstitution solution; the scheduling mechanism is used to transfer the reagent container and the quality control product container to the storage container; the temperature control mechanism is arranged on or around the storage container to achieve a low temperature environment of the storage container under the control of the controller; the sample extraction module is used to absorb the sample in the sample container; the quality control product extraction module is used to absorb the quality control product in the quality control container; the reagent extraction module is used to absorb the reagent in the reagent container to mix it with the sample or the quality control product to form a mixed solution; the detection mechanism is used to detect the mixed solution to output a detection signal; the controller is used to drive the extraction mechanism and output a detection result or a quality control result based on the detection signal.

[0013] An embodiment of the present application provides a quality control product storage container, which is used in conjunction with the sample analyzer; the quality control product storage container includes a base, and the base includes at least two chambers, one of which is used to store solid quality control products, and the other chamber is used to store a reconstitution solution.

[0014] In some embodiments, a hook for scheduling is provided on the base, for use in conjunction with a scheduling mechanism of a sample analyzer.

[0015] In some embodiments, the substrate is provided with an information label for displaying the quality control product and / or the reconstitution solution, so as to allow the identification mechanism of the sample analyzer to obtain the information of the quality control product and / or the reconstitution solution.

[0016] In some embodiments, a position sensing device is disposed on the substrate for use in conjunction with a sensor in the sample analyzer so that the sensor acquires a position signal of the quality control product storage container.

[0017] In some embodiments, a handle inclined upward is also provided on the base.

[0018] In some embodiments, each of the at least two chambers is used in conjunction with a container bottle, wherein one of the container bottles is used to store the solid quality control product, and the other container bottle is used to store the reconstitution solution.

[0019] In some embodiments, a scanning window is disposed on the substrate, the position of the scanning window corresponds to the chamber, and the scanning window is used to display an information label disposed on the container bottle.

[0020] In some embodiments, the container bottle and the chamber are detachable.

[0021] In the embodiment of the present application, the sample analyzer determines to start the quality control program according to the preset quality control time; drives the extraction mechanism to absorb the quality control product; drives the extraction mechanism to absorb the reagent to mix the reagent with the quality control product to form a mixed solution; detects the mixed solution to output a detection signal; and outputs the quality control result based on the detection signal. In the embodiment of the present application, the sample analyzer can automatically complete the quality control task according to the preset quality control time, improve the quality control efficiency, do not need manual re-dissolution, and improve the stability and accuracy of the detection. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0023] Figure 1A A structural block diagram of a sample analyzer provided in an embodiment of the present application;

[0024] Figure 1B A structural block diagram of another sample analyzer provided in an embodiment of the present application;

[0025] Figure 2-Figure 5 A schematic diagram of the plan layout of a sample analyzer provided in an embodiment of the present application;

[0026] Figure 6 A schematic diagram of the internal structure of a storage container provided in an embodiment of the present application;

[0027] Figure 7 A schematic diagram of the external structure of a storage container provided in an embodiment of the present application;

[0028] Figure 8 A schematic diagram of the overall appearance of a sample analyzer provided in an embodiment of the present application;

[0029] Fig. 9A partial schematic diagram of the injection window provided in an embodiment of the present application;

[0030] Fig.10 A schematic diagram of the plan layout of the automatic quality control solution provided in the embodiment of the present application;

[0031] Fig.11 A schematic diagram of a temperature control mechanism provided in an embodiment of the present application;

[0032] Fig.12 A schematic diagram of the structure of the reconstitution mechanism provided in an embodiment of the present application;

[0033] Fig.13 A schematic diagram of adding a pop-up window for the quality control products provided for the implementation of this application;

[0034] Fig.14 A schematic diagram of the automatic quality control display interface provided for the implementation of this application;

[0035] Fig.15 A quality control container provided for the implementation of this application;

[0036] Fig.16 Another quality control product container provided in an embodiment of the present application;

[0037] Fig.17 A schematic diagram of the coordination between the dispatching mechanism and the hook provided in the embodiment of the present application;

[0038] Fig.18 A schematic cross-sectional view of a conical container bottle and a quality control product container provided in an embodiment of the present application;

[0039] Fig.19 A cross-sectional schematic diagram of a flat-bottom container bottle and a quality control product container provided in an embodiment of the present application;

[0040] Fig. 20 A schematic diagram of a display page for quality control results provided in an embodiment of the present application;

[0041] Fig.21 A schematic diagram of a quality control appointment pop-up window provided in an embodiment of the present application;

[0042] Fig. 22 A schematic diagram of a display page of a quality control chart provided in an embodiment of the present application;

[0043] Fig.23 A flowchart of an automatic quality control method applied to a sample analyzer provided in an embodiment of the present application is provided. DETAILED DESCRIPTION

[0044] In order to enable those skilled in the art to better understand the solution of the present application, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0045] The sample analyzer provided in the present application can complete sample detection tasks and / or quality control product detection tasks simultaneously or separately. When performing sample detection tasks, the sample and reagent are automatically mixed to form a mixed solution of the sample and reagent, and the mixed solution is detected and analyzed; when performing quality control product detection tasks, the quality control product and reagent are automatically mixed to form a mixed solution of the quality control product and reagent, and the mixed solution is detected and analyzed. For the sample analyzer and automatic quality control method provided in this application, please refer to the following content and Figure 1A-Figure 23 :

[0046] See also Figure 1A , Figure 1A A structural block diagram of a sample analyzer provided in an embodiment of the present application, such as Figure 1A As shown, the sample analyzer 1 includes an extraction mechanism 10 , a detection mechanism 20 and at least one storage container 30 .

[0047] Among them, the extraction mechanism 10 includes a sample extraction module 101, a reagent extraction module 102 and a quality control product extraction module 103. The sample extraction module 101 is used to absorb the sample in the sample container; the quality control product extraction module 103 is used to absorb the quality control product in the quality control container; the reagent extraction module 102 is used to absorb the reagent in the reagent container and mix it with the sample or the quality control product to form a mixed solution.

[0048] In some embodiments, the sample extraction module 101, the reagent extraction module 102 and the quality control product extraction module 103 are all separately arranged extraction modules, and each extraction module includes one or more sampling needles 11 and a driving mechanism 12 for the sampling needle 11. The sampling needle 11 is driven by its driving mechanism 12 to absorb the sample, reagent or quality control product in the container to the corresponding loading position.

[0049] In some embodiments, at least two extraction modules among the sample extraction module 101, the reagent extraction module 102, and the quality control product extraction module 103 are integrated, and each extraction module includes more than one sampling needle 11 and a driving mechanism 12 for the sampling needle 11. For example, when the sample extraction module 101 and the reagent extraction module 102 are integrated into one extraction module, if only one sampling needle 11 is included, the sampling needle 11 absorbs the sample under the drive of its driving mechanism 12, performs a needle clearing action, and then absorbs the reagent from the reagent container into the sample; if multiple sampling needles 11 are included, at least one sampling needle 11 is driven to absorb the sample, and at least one sampling needle 11 is driven to absorb the reagent, so that the reagent is mixed with the sample, wherein among the multiple sampling needles 11, a single sampling needle 11 can be fixed to absorb the sample or the reagent, or a single sampling needle 11 can be used to absorb the sample and the reagent.

[0050] The storage container 30 includes a sample container storage place for storing sample containers, a reagent container storage place for storing reagent containers, and a quality control product container storage place for storing quality control product containers.

[0051] In some embodiments, the sample container storage place, the quality control container storage place and the reagent container storage place are three independently set storage containers.

[0052] In some embodiments, the reagent container storage and the quality control container storage are arranged in the same storage container, and the sample container storage is arranged in another storage container. When the reagent container storage and the quality control container storage are arranged in the same storage container, a plurality of placement areas 301 are arranged on the storage container 30. Figure 6 In some embodiments, any one of the placement areas is used to place reagent containers or quality control product containers indiscriminately; in some embodiments, a first placement area and a second placement area are provided on the storage container, wherein the first placement area is used to place reagent containers, and the second placement area is used to place quality control product containers. In this embodiment, the reagent container storage area and the quality control product container storage area are provided in the same storage container, which is conducive to unified preservation.

[0053] The storage container 30 includes a plate cover 31, a small plate cover 32 that can be opened and closed automatically, and a driving device 33 thereof. Figure 7 When the reagent kit is taken or placed, the driving device 33 drives the small plate cover 32 to open. After the taking or placing is completed, the driving device 33 drives the small plate cover 32 to close, thereby ensuring that the storage container 30 is closed for a long time, thereby preventing the problem of excessive condensation water in the storage container 30 due to air convection caused by the temperature difference between the inside and outside of the storage container 30. In some embodiments, the storage container 30 can realize automatic timing rotation to maintain the temperature stability in the storage container 30 and the temperature consistency at different positions.

[0054] According to the above-mentioned embodiment of the extraction mechanism 10 and the storage container 30, please refer to Figure 2-Figure 5 The sample analyzer 1 provided in the embodiment of the present application includes the following examples:

[0055] Example 1: See Figure 2 The sample container storage 302, the quality control product container storage 303, and the reagent container storage 304 are three independently set storage containers. The sample extraction module 101, the reagent extraction module 102, and the quality control product extraction module 103 are all separately set extraction modules, and each extraction module includes more than one sampling needle 11 and a driving mechanism 12 for the sampling needle 11.

[0056] like Figure 2 The sample analyzer shown in the figure, the sample analyzer 1 also includes a loading module 110 and a reaction cup gripper 120, the loading module is used to provide a reaction cup 1101, and the reaction cup gripper includes a gripper 1201 and a driving device 1202 thereof. The process of sample detection includes: the sample extraction module 101 extracts the sample from the sample container storage 302 into the reaction cup, the reaction cup gripper 120 moves the reaction cup to the reagent loading position a, the reagent extraction module 102 extracts the reagent from the reagent container storage 304 into the reaction cup at the reagent loading position a, and the reaction cup gripper 120 moves the reaction cup containing the sample-reagent mixed solution to the detection mechanism 20 for detection.

[0057] Among them, the automatic quality control process includes: the quality control product extraction module 103 extracts the quality control product from the quality control product container storage 303 to the reaction cup at the reagent loading position a, the reagent extraction module 102 extracts the reagent from the reagent container storage 304 to the reaction cup at the reagent loading position a, and obtains the quality control product-reagent mixed solution, and the reaction cup gripper 120 moves the reaction cup to the detection mechanism 20 for detection.

[0058] Among them, the sample analyzer also includes a sample cleaning pool b, a reagent cleaning pool c, and a quality control product cleaning pool d, which are used to clean the corresponding sampling needles; it also includes a cup throwing position e, which is used for the reaction cup gripper 120 to move the reaction cup to the cup throwing position e after the detection is completed to send the reaction cup out of the sample analyzer 1.

[0059] Example 2: See Figure 3 The sample container storage 302, the quality control product container storage 303, and the reagent container storage 304 are three independently set storage containers, the sample extraction module 101 is an independently set extraction module, and the reagent extraction module 102 and the quality control product extraction module 103 are integrated on the first extraction module 104.

[0060] Example 3: See Figure 4The sample container storage 302 is an independently set storage container, and the quality control product container storage 303 and the reagent container storage 304 are set in the first storage container 305. A plurality of placement areas are set on the first storage container 305, wherein any placement area is used to place the reagent container or the quality control product container indiscriminately. The sample extraction module 101 is an independently set extraction module, and the reagent extraction module 102 and the quality control product extraction module 103 are integrated on the first extraction module 104.

[0061] Example 4: See Figure 5 The sample container storage 302 is an independently set storage container, and the quality control product container storage 303 and the reagent container storage 304 are set in the first storage container 305. The first storage container 305 is provided with a first placement area 3051 and a second placement area 3052, wherein the first placement area 3051 is used to place the reagent container, and the second placement area 3052 is used to store the quality control product container. The sample extraction module 101 is an independently set extraction module, and the reagent extraction module 102 and the quality control product extraction module 103 are integrated on the first extraction module 104.

[0062] Of course, the sample analyzer 1 provided in the present application may also include other structures besides the above four examples, and the sample container storage 302, the quality control container storage 303, the reagent container storage 304 and the sample extraction module 101, the reagent extraction module 102, and the quality control product extraction module 103 may be arranged and combined according to actual needs.

[0063] The detection mechanism 20 is used to detect the sample-reagent mixed solution and / or the quality control product-reagent mixed solution to output a detection signal. For example, for blood coagulation detection, an optical method can be used for detection, such as the detection mechanism 20 can be a chemiluminescent device, or a resistance detection method can be used for detection, such as the detection mechanism 20 can be a thromboelastography instrument.

[0064] See also Figure 1B In some embodiments, the sample analyzer 1 further includes a sample injection window 40 , a scheduling mechanism 50 and a temperature control mechanism 60 .

[0065] Injection window 40, see Figure 8-Figure 9, used to place sample containers, reagent containers and quality control product containers. In some embodiments, it also includes a first container detection sensor 401, which is used to detect the storage conditions of sample containers, reagent containers and quality control product containers. In some embodiments, the injection window 40 is provided with a plurality of placement positions 402, and the plurality of placement positions 402 can be used to place sample containers, reagent containers and quality control product containers indiscriminately. In some embodiments, the injection window 40 is provided with a plurality of placement positions 402, and each placement position is fixedly used to place a maximum of two containers among sample containers, reagent containers and quality control product containers. Specifically, the plurality of placement positions 402 are divided into sample placement positions, reagent placement positions, and quality control product placement positions, and each placement position can only place the corresponding container; or, the plurality of placement positions 402 are divided into sample placement positions, reagent / quality control product placement positions, and the sample placement position is used to place the sample container, and the reagent / quality control product placement position can place both the reagent container and the quality control product container.

[0066] Each placement position 402 is provided with a corresponding indicator light 403 , and the corresponding indicator light 403 will change after the first container detection sensor 401 detects the presence of a container.

[0067] The dispatch mechanism 50 is a multi-drive mechanism that can move horizontally, rotate or vertically, and is used to transfer the sample container, reagent container and quality control container to the corresponding container storage after the injection window 40 detects that the sample container, reagent container and quality control container are placed in the injection window 40. Fig.10 , Fig.10 This is a schematic diagram of the planar layout of the automatic quality control solution provided in an embodiment of the present application. When the first container detection sensor 401 detects that the quality control product container is placed in the injection window 40, the indicator light 403 is always on, and the scheduling mechanism 50 transfers the quality control product container to the quality control product container storage area 303.

[0068] Temperature control mechanism 60, see Fig.11 It includes a refrigeration source 601 and a refrigeration connecting pipe 602 , which are arranged on or around the storage container 30 to achieve a low temperature environment of the storage container 30 under the control of the controller 100 .

[0069] Among them, for quality control products, quality control products include solid quality control products or liquid quality control products. When liquid quality control products are stored in the quality control product container, the liquid quality control products can be directly extracted and mixed with reagents when performing quality control tasks, and then tested; wherein, liquid quality control products can refer to the quality control products themselves in liquid form, or they can refer to liquid quality control products formed after the solid quality control products are redissolved outside the sample analyzer 1. When solid quality control products are stored in the quality control product container, a redissolution solution is stored in the quality control product storage container 30. Before performing the quality control task, the solid quality control products need to be mixed with the redissolution solution to obtain a liquid quality control product. In some embodiments, the redissolution solution and the solid quality control products are placed in the same quality control product container; in some embodiments, the redissolution solution and the solid quality control products are placed in different quality control product containers.

[0070] In order to realize automatic quality control of solid quality control products, the sample analyzer 1 also includes a re-dissolution mechanism 70. In some embodiments, the re-dissolution mechanism 70 is disposed in the sample analyzer 1; in some embodiments, the re-dissolution mechanism 70 is an external re-dissolution mechanism 70 independently disposed outside the sample analyzer 1.

[0071] The dispatching mechanism 50 is also used to transfer the quality control product container to the reconstitution mechanism 70, and to transfer the quality control product container from the reconstitution mechanism 70 to the quality control product storage container 30. Fig.10 and Fig.12 The reconstitution mechanism 70 includes a mixing mechanism 701 and a fixing position 702. For example, the fixing position 702 is a groove similar to the shape and structure of the quality control product container, which is used to load and position the quality control product container. In some embodiments, a second container detection sensor 703 is provided on the fixing position 702 to determine whether there is a quality control product container on the reconstitution mechanism 70. If there is, the mixing mechanism 701 starts to work to reconstitute the quality control product. The mixing mechanism 701 is used to mix the quality control product and the reconstitution solution in the quality control product container by eccentric oscillation.

[0072] When the reconstitution is completed, the small plate cover 32 is opened, and the dispatching mechanism 50 transfers the quality control product container back to the quality control product container storage 303 .

[0073] The sample analyzer 1 further includes a display screen 80. Figure 8 , the display screen 80 is used to set the quality control time; or, the quality control result is displayed on the display screen 80. In some embodiments, the display screen 80 is a touch screen. In some embodiments, the display screen 80 is a non-touch screen, and the sample analyzer 1 further includes an input device, such as a keyboard, or is transmitted to the controller 100 of the sample analyzer 1 through other terminal devices.

[0074] In some embodiments, the sample analyzer 1 further includes an identification mechanism 90. Fig.10The identification mechanism 90 is used to scan and identify the information label set on the quality control product container, and the information label stores the information of the quality control product and / or the reconstitution solvent contained in the quality control product container.

[0075] Among them, the process of transferring the quality control product container from the injection window 40 to the quality control product container storage place 303 includes: driving the scheduling mechanism 50 to transfer the quality control product container from the injection window 40 to the position of the identification mechanism 90; obtaining the quality control product information through the identification mechanism 90; driving the scheduling mechanism 50 to transfer the quality control product container from the position of the identification mechanism 90 to the quality control product container storage place 303.

[0076] After the identification mechanism 90 obtains the information of the quality control product and / or the reconstitution solvent, the information of the quality control product and / or the reconstitution solvent is displayed on the display screen 80. Fig.14 , an automatic quality control display interface 14 is displayed on the display screen 80, and the automatic quality control display interface 14 includes a menu bar 141. The menu bar 141 includes menu controls and commonly used function controls, such as quality control detection controls and sample detection controls; click the quality control detection control to display the task bar 142 and its corresponding display content, the task bar 142 includes several controls such as quality control charts, quality control results, quality control settings, and on-machine quality control. Click the quality control chart and quality control result controls to view the detection results of the quality control products that have been quality controlled; click the quality control setting control to set the quality control process; click the on-machine quality control control to display the quality control product status in the content display area 143, and the quality control product status includes the quality control product level, quality control batch number, effective days, validity period, loading date, storage location or remaining amount or status of the loaded quality control products.

[0077] In some embodiments, the loaded quality control product information can also be obtained by manual addition. Fig.14 , the automatic quality control display interface 14 also displays a quality control product adding control. After the quality control product adding control is triggered, a quality control product adding pop-up window is displayed. Fig.13 The quality control product addition pop-up window 13 is used to set the added quality control product information, such as the quality control product name, quality control product level, quality control product batch number, barcode, production validity period, storage location, and determine the project applicable to the quality control product and the corresponding target value, target value upper and lower limits, standard deviation, unit, etc. After all the information is set, click the confirmation control to create the information of the quality control product loaded into the quality control product container storage 303.

[0078] In some embodiments, the quality control product information may also be sent to the sample analyzer 1 through other terminal devices. After receiving the quality control product information, the sample analyzer 1 displays the quality control product information on the automatic quality control display interface 14 .

[0079] See also Figure 15-19The quality control product container 16 is used in conjunction with the sample analyzer 1 .

[0080] Among them, the quality control product container 16 includes a base 161, and the base 161 includes at least two chambers 162. For liquid quality control products, the quality control product container 16 is used to store the quality control product solution; for solid quality control products, one chamber is used to store the solid quality control product, and the other chamber is used to store the reconstitution solution.

[0081] In some embodiments, the quality control product and / or the reconstitution solution are directly stored in the chamber 162 of the quality control product container 16. Fig.15 In some embodiments, each of the at least two chambers 162 is used in conjunction with a container bottle 163, and the quality control product and / or the reconstitution solution are stored in the container bottle 163 and then stored in the chamber 162 of the quality control product container 16. Figure 18-19 , wherein the container bottle 163 and the chamber 162 are detachable. Therefore, in some scenarios, after the quality control product and / or the reconstitution solution in the container bottle is consumed, only a new container bottle containing the quality control product and / or the reconstitution solution can be replaced to replenish the quality control product and / or the reconstitution solution, which is conducive to reducing the cost of consumables.

[0082] The base 161 is provided with a hook 164 for dispatching, which is used in conjunction with the dispatching mechanism 50 of the sample analyzer 1. The process of the hooking is shown in FIG. Fig.17 shown.

[0083] The base 161 is provided with an information label 165 for displaying the quality control product and / or the reconstitution solution, so as to allow the identification mechanism 90 of the sample analyzer 1 to obtain the information of the quality control product and / or the reconstitution solution.

[0084] In some embodiments, the information label 165 is disposed on the base 161 of the quality control product container 16. Fig.15 In some embodiments, a scanning window 166 is disposed on the base 161, and the position of the scanning window 166 corresponds to the chamber 162. The information label 165 is disposed on the container bottle 163, and the scanning window 166 is used to display the information label 165 disposed on the container bottle 163. Fig.16 .

[0085] The base 161 is provided with an in-place sensing device 167 for use with a sensor in the sample analyzer 1 so that the sensor obtains an in-place signal of the quality control product container 16. In some embodiments, the sensor is an optical coupling sensor, and the in-place sensing device 167 is an in-place baffle.

[0086] Among them, a handle 168 tilted upward is also provided on the base 161 to facilitate manual grasping; in some embodiments, the handle 168 has an anti-slip groove to increase the friction between the quality control product container 16 and the operator's thumb and reduce the risk of the quality control product container 16 falling.

[0087] In some embodiments, Fig.16 The quality control container 16 shown in the figure also has an adapter disposed in the chamber 162. Figure 18-19 The adapter includes a buckle 1691 disposed on the inner wall of the chamber 162 , and the buckle 1691 is used to fix the container bottle 163 inserted into the chamber 162 .

[0088] In some embodiments, see Fig.19 The adapter also includes a slope 1692, which is disposed on the inner wall of the chamber 162 opposite to the buckle 1691. The slope 1692 cooperates with the buckle 1691 to allow the container bottle 163 to be placed in the chamber 162 at an angle. Fig.19 The container bottle 163 shown has a flat bottom, and it is not easy for the sampling needle 11 to absorb the substance in the container bottle 163, resulting in residue. By adjusting the adapter, the container bottle 163 is placed in an inclined position in the chamber 162, which facilitates the sampling needle 11 to absorb the substance in the container bottle 163 and reduces the residue in the bottle. The inclined surface 1692 is provided with a rotation-stopping protrusion 1693, and the bottom of the chamber 162 is provided with a rotation-stopping groove 1694. The rotation-stopping protrusion 1693 and the rotation-stopping groove 1694 cooperate to fix the inclined surface 1692.

[0089] In some embodiments, both ends of the base 161 where the handle 168 and the hook 164 are located are triangular structures to fit the storage container 30 in the sample analyzer 1 which is circular and used to store the quality control product container 16. Figure 6 .

[0090] In some embodiments, the angle of the front end A of the two ends of the base 161 where the handle 168 and the hook 164 are located is smaller than the angle of the rear end B, and the front end A is the end of the storage container 30 that is close to the center of the circle. The angle of the front end A ranges from 25° to 35°, preferably 30°.

[0091] In some embodiments, front end A is the end where the handle 168 is located.

[0092] In some embodiments, the base of the quality control container is the same as the base of the reagent container, and thus can be installed in the reagent container storage area and / or the quality control container storage area without distinction, which is particularly suitable for the case where the quality control container storage area and the reagent container storage area are integrated together. The same here can be understood as at least the same in the installation matching structure.

[0093] The controller 100 is used to control the various components of the sample analyzer 1 to perform sample detection tasks and / or automatic quality control tasks simultaneously or separately.

[0094] The specific process of the controller 100 performing the sample detection task includes:

[0095] S11, after receiving the first signal from the container detection sensor, the calling mechanism is driven to transfer the sample container or the reagent container to the corresponding sample storage container 30 and the reagent storage container 30;

[0096] S12, driving the sample extraction module 101 to extract a sample, and driving the reagent extraction module 102 to extract a reagent into the sample to form a sample-reagent mixed solution;

[0097] S13, controlling the detection mechanism 20 to detect the sample-reagent mixed solution;

[0098] S14, receiving the sample test result from the testing mechanism 20, and displaying the sample test result on the display screen 80.

[0099] The specific process of the controller 100 performing the automatic quality control task includes:

[0100] Before executing the automatic quality control task, the quality control product needs to be stored in the quality control product and reagent storage container 30. For the specific process, please refer to the specific method involved in the embodiment of the above-mentioned identification mechanism 90, which will not be repeated here. The user can view the remaining amount of the quality control product through the display, for example, Fig.14 , on the automatic quality control display interface 14, including the quality control product status display area, used to display the quality control product level, quality control batch number, effective days, validity period, loading date, storage location, remaining quantity, status and other information of the quality control product. When the quality control product remaining quantity is 0, such as the quality control product PCT control (M), it is necessary to prompt the user to replenish it. When the quality control product remaining quantity is not 0, the automatic quality control task can be executed.

[0101] The setting process of automatic quality control task is as follows:

[0102] See Fig.14 The automatic quality control display interface 14 also includes an appointment control. After receiving a trigger operation on the appointment control, a quality control appointment pop-up window 21 is displayed. Fig.21The quality control appointment pop-up window 21 includes a quality control product applicable project selection area 211 and a quality control information setting area 212. The quality control product applicable project selection area 211 displays a variety of project types, such as PT, APTT, TT, etc., which is used to set which project tests the current quality control product can be used for; the quality control information setting area 212 is used to set the automatic quality control appointment cycle and the number of repetitions and other information, wherein the automatic quality control appointment cycle includes the set quality control time, interval hours, interval sample number, after calibration, after the use of a new bottle and other information. The quality control appointment pop-up window 21 is also used to display information such as the quality control product level and batch number.

[0103] After the settings are completed, click the confirmation control to generate the corresponding quality control task and display it in Fig.14 The quality control task display area 144 is shown.

[0104] The quality control task display area 144 is used to display multiple quality control tasks that are set, wherein a single quality control task will not be automatically deleted after execution, unless the delete control 1441 of the automatic quality control task is clicked to delete it.

[0105] In some embodiments, after the quality control task is set, the quality control task can be automatically started according to the set quality control time. In some embodiments, after the quality control task is set, the quality control task also includes an on / off control 1442. When the on / off control 1442 is in the on state, the quality control task automatically starts the quality control task according to the set quality control time; when the on / off control 1442 is in the off state, the quality control task will not automatically start the quality control task according to the set quality control time.

[0106] See also Fig.23 , Fig.23 A flow chart of an automatic quality control method for a sample analyzer provided in an embodiment of the present application is shown as follows: Fig.23 As shown, the automatic quality control method includes:

[0107] S21, determining to start the quality control procedure according to the preset quality control time.

[0108] S22, driving the extraction mechanism to absorb the quality control product.

[0109] If it is a liquid quality control product, directly execute the step shown in S22; if it is a solid quality control product, it is necessary to first dissolve the solid quality control product and then execute the step shown in S22.

[0110] The reconstitution process is as follows:

[0111] The controller 100 drives the quality control product extraction module 103 to mix the reconstituted solution and the solid quality control product; in some embodiments, the quality control product extraction module 103 extracts the reconstituted solution into the chamber 162 where the solid quality control product is located;

[0112] The controller 100 drives the dispatching mechanism 50 to move the control product container to the fixed position 702 of the reconstitution mechanism 70;

[0113] The controller 100 drives the mixing mechanism 701 to perform a mixing action to mix the reconstituted solution and the solid quality control product;

[0114] The controller 100 drives the dispatching mechanism 50 to transfer the mixed quality control product container to the quality control product container storage place; this is conducive to the proper preservation of the reconstituted quality control product to facilitate the use of multiple quality control procedures.

[0115] S23, driving the extraction mechanism to absorb the reagent so that the reagent and the quality control product are mixed to form a mixed solution.

[0116] S24, detecting the mixed solution to output a detection signal.

[0117] S25, outputting quality control results based on the detection signal.

[0118] In some embodiments, the quality control results are output via display screen 80. Fig. 20 and Fig. 22 , click the quality control result control of the automatic quality control display interface 14, and the quality control result will be displayed in the content display area 143. Among them, you can set the filter conditions in the condition filter bar 1431, and display the corresponding quality control items through the search control. The filter conditions include but are not limited to the completion date, project, quality control level, quality control batch, etc., and you can also reselect the filter conditions through the reset control. Click the quality control chart control of the automatic quality control display interface 14, and the quality control test result curve chart 1432 will be displayed in the content display area 143, such as Fig. 22 As shown, multiple quality control batches can be selected in the conditional filter bar 1431 for comparative display. Clicking any point in the result curve graph can display the detection details of the detection point, including but not limited to the quality control name, quality control batch, test results, target value and other contents. The content display area 143 also includes a quality control result summary area 1433, which is used to summarize the test results of each quality control product. The content display area 143 also includes controls such as a re-marking control, a delete control, and a display deleted data control. The re-marking control is used to mark abnormal detection points in the result curve graph 1432, including alarm, failure and other states. The delete control is used to delete abnormal data. The display deleted data control is used to mark deleted data so that the deleted data can still be displayed in the result curve graph 1432.

[0119] Mentioning "embodiment" and "implementation method" in this application means that the specific features, structures or characteristics described in conjunction with the embodiment may be included in at least one embodiment of the present application. The appearance of the phrases in various places in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described in this application can be combined with other embodiments. In addition, it should also be understood that the features, structures or characteristics described in the various embodiments of the present application can be arbitrarily combined to form another embodiment that does not deviate from the spirit and scope of the technical solution of the present application, provided that there is no contradiction between them.

[0120] Finally, it should be noted that the above implementation modes are only used to illustrate the technical solution of the present application and are not intended to limit it. Although the present application has been described in detail with reference to the above preferred implementation modes, a person of ordinary skill in the art should understand that the technical solution of the present application may be modified or replaced by equivalents without departing from the spirit and scope of the technical solution of the present application.

Claims

1. An automatic quality control method applied to a sample analyzer, characterized in that: The sample analyzer includes an extraction mechanism, a detection mechanism and a controller; wherein the extraction mechanism includes a sample extraction module, a reagent extraction module and a quality control product extraction module that are separately arranged, or includes at least two sample extraction modules, reagent extraction modules and quality control product extraction modules that are integrated; the sample analyzer also includes a sample container storage place for storing sample containers, a reagent container storage place for storing reagent containers and a quality control product container storage place for storing quality control product containers; The sample extraction module is used to absorb the sample in the sample container; The quality control product extraction module is used to absorb the quality control product in the quality control product container; The reagent extraction module is used to absorb the reagent in the reagent container and mix it with the sample or the quality control product to form a mixed solution; The detection mechanism is used to detect the mixed solution to output a detection signal; The controller is used to drive the extraction mechanism to perform a sample extraction action, a reagent injection action and / or a quality control product extraction action, and also output a test result or a quality control result based on the test signal; Wherein, the automatic quality control method comprises: Determine to start the quality control procedure according to the preset quality control time; Driving the extraction mechanism to absorb the quality control product; Driving the extraction mechanism to absorb the reagent so that the reagent is mixed with the quality control product to form a mixed solution; Detecting the mixed solution to output a detection signal; Based on the detection signal, the quality control result is output.

2. The method according to claim 1, characterized in that The sample analyzer further includes a display screen displaying a reservation control, and the method further includes: Set the quality control time; or, The quality control result is displayed on the display screen.

3. The method according to claim 1, characterized in that The sample analyzer further includes a sample injection window and a scheduling mechanism, and the method further includes: Detecting that the quality control product container is placed in the injection window; The scheduling mechanism is driven to transfer the quality control product container from the injection window to the quality control product container storage place.

4. The method according to claim 3, characterized in that The sample analyzer further comprises an identification mechanism, the quality control product container is provided with an identification code, and the identification code stores quality control product information of the quality control product contained in the quality control product container; The step of driving the scheduling mechanism to transfer the quality control product container from the injection window to the quality control product container storage location includes: Driving the scheduling mechanism to transfer the quality control product container from the injection window to the location of the identification mechanism; Obtaining the quality control product information; The dispatching mechanism is driven to transfer the quality control product container from the location of the identification mechanism to the quality control product container storage location.

5. The method according to claim 3, characterized in that: The sample analyzer further includes a re-dissolving mechanism or is used in conjunction with an external re-dissolving mechanism, wherein the re-dissolving mechanism includes a mixing mechanism and a fixing position, and the mixing mechanism is used to perform a mixing action on the quality control product container fixed at the fixing position, so that the quality control product and the re-dissolving solution in the quality control product container are evenly mixed; Before driving the extraction mechanism to absorb the quality control product, the method includes: Driving the quality control product extraction module to mix the reconstituted solution and the quality control product; Driving the dispatching mechanism to move the quality control product container to the fixed position; Driving the mixing mechanism to perform the mixing action; The dispatching mechanism is driven to transfer the mixed quality control product container to the quality control product container storage place.

6. A sample analyzer, characterized in that: The sample analyzer comprises an extraction mechanism, a detection mechanism and a controller; wherein the extraction mechanism comprises a sample extraction module, a reagent extraction module and a quality control product extraction module which are separately arranged, or comprises at least two sample extraction modules, reagent extraction modules and quality control product extraction modules which are integrated; the sample analyzer further comprises a sample container storage place for storing sample containers, a reagent container storage place for storing reagent containers and a quality control product container storage place for storing quality control product containers; The sample extraction module is used to absorb the sample in the sample container; The quality control product extraction module is used to absorb the quality control product in the quality control container; The reagent extraction module is used to absorb the reagent in the reagent container and mix it with the sample or the quality control product to form a mixed solution; The detection mechanism is used to detect the mixed solution to output a detection signal; The controller is used to drive the extraction mechanism to perform a sample extraction action and a reagent injection action respectively to form a first mixed solution including the sample and the reagent, and control the detection mechanism to detect the first mixed solution to output a first detection signal, and output a detection result based on the first detection signal; The controller is also used to determine to start a quality control program according to a preset quality control time, and in the quality control program, drive the extraction mechanism to respectively perform the quality control product extraction action and the reagent filling action to form a second mixed solution including the quality control product and the reagent, and control the detection mechanism to detect the second mixed solution to output a second detection signal, and output a quality control result based on the second detection signal.

7. The sample analyzer according to claim 6, characterized in that: The reagent container and the quality control product container have the same base, and the base is used to be fixed at the reagent container storage place and / or the quality control product container storage place.

8. A sample analyzer, characterized in that: It includes an extraction mechanism, a detection mechanism, a scheduling mechanism, a controller and a temperature control mechanism; wherein the extraction mechanism includes a sample extraction module, a reagent extraction module and a quality control product extraction module that are separately arranged, or includes at least two sample extraction modules, reagent extraction modules and quality control product extraction modules that are integrated; The sample analyzer also includes a storage container; The storage container is provided with a plurality of placement areas, any one of which is used to indiscriminately place a reagent container containing a reagent or a quality control product container containing a quality control product and a reconstitution solution; or the storage container is provided with a first placement area and a second placement area, the first placement area is used to place a reagent container containing a reagent, and the second placement area is used to place a quality control product container containing a quality control product and a reconstitution solution; The dispatching mechanism is used to transfer the reagent container and the quality control product container to the storage container; The temperature control mechanism is arranged on or around the storage container to realize a low temperature environment of the storage container under the control of the controller; The sample extraction module is used to absorb the sample in the sample container; The quality control product extraction module is used to absorb the quality control product in the quality control container; The reagent extraction module is used to absorb the reagent in the reagent container and mix it with the sample or the quality control product to form a mixed solution; The detection mechanism is used to detect the mixed solution to output a detection signal; The controller is used to drive the extraction mechanism and output a detection result or a quality control result based on the detection signal.

9. A quality control product storage container, characterized in that: The quality control product storage container is used in conjunction with the sample analyzer; the quality control product storage container includes a base body, and the base body includes at least two chambers, one of which is used to store solid quality control products, and the other is used to store reconstitution solution.

10. The quality control product storage container according to claim 9, characterized in that: Each of the at least two chambers is used in conjunction with a container bottle, wherein one of the container bottles is used to store the solid quality control product, and the other container bottle is used to store the reconstitution solution.

11. The quality control product storage container according to claim 10, characterized in that: The container bottle and the chamber are detachable.

12. The quality control product storage container according to claim 10, characterized in that: The base is provided with a hook for scheduling, which is used in conjunction with a scheduling mechanism of a sample analyzer; or The substrate is provided with an information label for displaying the quality control product and / or the reconstituted solution, so as to allow the identification mechanism of the sample analyzer to obtain the information of the quality control product and / or the reconstituted solution; or The base is provided with an in-place sensing device for use in conjunction with a sensor in the sample analyzer so that the sensor obtains an in-place signal of the quality control product storage container; or The base is also provided with a handle inclined upward; or The base is provided with a scanning window, the position of the scanning window corresponds to the chamber, and the scanning window is used to display the information label provided on the container bottle.

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