A sample analysis system and automated precision management method thereof

Abstract

A sample analysis system (100) and a precision management method thereof can automatically select a quality control sample after the sample analysis system (100) starts a sample test, prepare the quality control sample into a quality control blood smear, then a cell image analysis device (130) photographs and analyzes the quality control blood smear to obtain a detection result based on image photographing and analysis, compares the detection result of the cell image analysis device (130) with a detection result of a blood analyzer (110), and outputs a comparison result, thereby automatically completing precision management of the cell image analysis device (130) or the blood analyzer (110).

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical instruments, in particular to a sample analysis system and an automatic precision management method thereof. BACKGROUND

[0002] In the process of blood analysis, blood analyzers, smear preparation devices (also known as slide pushers), cell image analysis devices, etc. are usually used. In order to ensure the functions and performances of the slide pusher and the cell image analysis device, etc. are normal, quality control must be carried out regularly. In the prior art, the quality control of the slide pusher and the cell image analysis device is completed manually, which is complex and time-consuming, and has low efficiency. SUMMARY

[0003] The present application mainly provides a sample analysis system and an automatic precision management method thereof.

[0004] According to a first aspect, a precision management method of a sample analysis system is provided in an embodiment, comprising the following steps:

[0005] The blood analyzer detects the sample to be tested;

[0006] The controller selects a quality control sample from the samples to be tested which have been detected according to the sample detection results measured by the blood analyzer when the preset quality control trigger condition is met; the result of the quality control sample detected by the blood analyzer is a first detection result;

[0007] The controller controls the scheduling device to transport the quality control sample to the slide pusher;

[0008] The slide pusher prepares the quality control sample into a quality control blood smear;

[0009] The staining machine stains the quality control blood smear;

[0010] The controller controls the scheduling device to transport the quality control blood smear to the cell image analysis device;

[0011] The cell image analysis device photographs and analyzes the quality control blood smear to obtain a second detection result;

[0012] The first detection result and the second detection result of the quality control sample are compared;

[0013] The comparison result is output.

[0014] In the method, the preset quality control trigger condition includes at least one of the first N samples tested after the blood analyzer is started for the first time in each cycle, a preset time, a preset load, and a preset detection result, wherein N is a natural number not less than 1.

[0015] The method further includes:

[0016] The method further includes:

[0017] The method further includes:

[0018] The method further includes:

[0019] The method further includes:

[0020] The method further includes:

[0021] The method further includes:

[0022] The method further includes:

[0023] The method further includes:

[0024] The method further includes:

[0025] The method further includes:

[0026] The method further includes:

[0027] The method further comprises:

[0028] The method further comprises:

[0029] The method further comprises:

[0030] The method further comprises:

[0031] The method further comprises:

[0032] The method further comprises:

[0033] The method further comprises:

[0034] The method further comprises:

[0035] The method further comprises:

[0036] The method further comprises: if the deviation of the corresponding result in the first detection result and the second detection result of the quality control sample exceeds a preset range, reselecting a quality control sample from the detected samples.

[0037] The method further comprises:

[0038] The quality control mark is printed on the quality control sample, the cell image analysis device recognizes the quality control mark, switches to the quality control mode to take and analyze the quality control sample.

[0039] According to a second aspect, an embodiment provides a sample analysis system, comprising:

[0040] The blood analyzer is used for detecting at least one sample;

[0041] The controller is used for obtaining a first detection result of at least one sample based on the analysis of the blood analyzer, and judging in real time whether a preset quality control trigger condition is met, and if the preset quality control trigger condition is met, selecting the sample analyzed by the blood analyzer as a quality control sample; and is further used for controlling the scheduling device to transport the quality control sample to the smear preparation device;

[0042] The smear preparation device prepares the quality control sample into a blood smear;

[0043] The cell image analysis device is used for taking and analyzing the blood smear, and obtaining a second detection result based on image taking and analysis;

[0044] The controller is further used for:

[0045] Comparing the corresponding information in the second detection result and the first detection result; and

[0046] Controlling the display device to output the comparison result.

[0047] In the sample analysis system, the smear preparation device comprises:

[0048] The slide pushing machine is used for pushing the quality control sample according to a preset slide pushing parameter, and the process of pushing comprises distributing the quality control sample to a slide and pushing the sample on the slide to a blood film;

[0049] The staining machine is used for staining the blood film on the slide according to a preset staining parameter;

[0050] The printing device is used for printing sample information on the blood smear of the quality control sample, and the sample information comprises a quality control mark.

[0051] In the sample analysis system, the cell image analysis device comprises an identification device used for identifying the quality control mark on the blood smear of the quality control sample.

[0052] The sample analysis system, the second detection result includes detection information based on cell image shooting and analysis and detection information related to the pushing piece and / or staining quality of the cell image analysis device.

[0053] The sample analysis system, the controller is further configured to judge the pushing piece and / or staining quality of the smearing preparation device according to the detection information related to the pushing piece and / or staining quality of the cell image analysis device in the second detection result.

[0054] The sample analysis system, the blood analyzer is subjected to quality control, and the sample is detected to obtain the first detection result of the sample only after the quality control is qualified.

[0055] The sample analysis system, the controller is further configured to control the display device to output the quality control prompt information of the cell image analysis device if the deviation between the second detection result and the first detection result of the quality control sample exceeds a preset range.

[0056] According to a third aspect, an embodiment provides an automatic precision management method of a sample analysis system, comprising the following steps:

[0057] The blood analyzer detects the sample to obtain the first detection result of the sample;

[0058] The automatic quality control starts, and after the blood analyzer is started for the first time and tests the Nth sample, or after the blood analyzer is started for the first time and a preset time, the controller controls the scheduling device to transport the sample detected by the blood analyzer to the pushing piece machine;

[0059] The pushing piece machine prepares the sample into a quality control blood smear, and the quality control blood smear is provided with a quality control identifier;

[0060] The staining machine stains the quality control blood smear;

[0061] The controller controls the scheduling device to transport the quality control blood smear to the cell image analysis device;

[0062] The cell image analysis device identifies the quality control identifier, switches to a quality control mode, shoots and analyzes the quality control blood smear in the quality control mode, and obtains a second detection result;

[0063] The first detection result and the second detection result of the quality control sample are compared;

[0064] The comparison result is output.

[0065] The method further comprises:

[0066] The automatic quality control option is provided on the display interface for the user to select, and after receiving the instruction of selecting the automatic quality control option, the automatic quality control starting step is executed.

[0067] According to a fourth aspect, a sample analysis system is provided in an embodiment, comprising:

[0068] The smear preparation device comprises a slide pushing machine and a staining machine, which are used to push the quality control sample according to preset slide pushing parameters, so as to push the blood sample of the quality control sample injected onto the slide to form a blood film.

[0069] The staining machine is used to stain the blood film on the slide according to preset staining parameters.

[0070] The cell image analysis device is used to photograph and analyze the blood smear, and obtain a second detection result based on image photographing and analysis, wherein the second detection result comprises detection information related to the slide pushing and staining of the quality control blood smear.

[0071] The controller is further configured to:

[0072] According to the second detection result, the quality of the slide pushing and staining of the quality control blood smear is determined.

[0073] The system further comprises:

[0074] The blood analyzer is used to detect at least one sample.

[0075] The controller is configured to obtain a first detection result of at least one sample based on the analysis of the blood analyzer, and determine in real time whether a preset condition is met, and if the preset condition is met, select the sample analyzed by the blood analyzer as a quality control sample; and further configured to control the scheduling device to transport the quality control sample to the smear preparation device.

[0076] In the system, the smear preparation device comprises a printing device configured to print sample information on the blood smear of the quality control sample, wherein the sample information comprises a quality control identifier.

[0077] In the system, the controller is configured to identify the appearance of the blood film and / or the cell distribution of the quality control blood smear according to the detection information related to the slide pushing in the second detection result, and determine the quality of the slide pushing of the slide pushing machine according to the appearance of the blood film and / or the cell distribution of the quality control blood smear.

[0078] In the system, the controller is configured to identify the appearance of the blood film and / or the cell distribution of the quality control blood smear according to the detection information related to the slide pushing in the second detection result, and determine the quality of the slide pushing of the slide pushing machine according to the appearance of the blood film and / or the cell distribution of the quality control blood smear.

[0079] The system, the controller is further used for: identifying at least one of blood film color and color depth of the quality control blood smear according to the detection information related to dyeing in the second detection result; and judging dyeing quality of the smear preparation device according to at least one of the blood film color and the color depth of the quality control blood smear; wherein the detection information related to dyeing in the second detection result includes at least one of the blood film color and the color depth of the quality control blood smear acquired by the cell image analysis device.

[0080] The system, the controller is further used for: comparing the corresponding result information in the first detection result and the second detection result of the quality control sample; and controlling the display device to output the comparison result.

[0081] According to the fifth aspect, an embodiment provides a sample analysis system, comprising:

[0082] A memory for storing a program;

[0083] A processor for executing the program stored in the memory to implement the method as described above.

[0084] According to the sixth aspect, an embodiment provides a computer readable storage medium, comprising a program, the program can be executed by a processor to implement the method as described above.

[0085] According to the sample analysis system and the precision management method thereof, the quality control sample can be automatically selected after the sample analysis system starts the sample test, the quality control sample is made into a quality control blood smear, then the cell image analysis device photographs and analyzes the quality control blood smear to obtain a detection result based on image photographing and analysis, the detection result of the cell image analysis device is compared with the detection result of the blood analyzer, and the comparison result is output, so that the precision management of the cell image analysis device or the blood analyzer is automatically completed. BRIEF DESCRIPTION OF DRAWINGS

[0086] Figure 1 A structural schematic diagram of the sample analysis system provided by an embodiment of the present application;

[0087] Figure 2 A structural block diagram of the smear preparation device in the sample analysis system provided by an embodiment of the present application;

[0088] Figure 3 A schematic diagram of the blood smear in the sample analysis system provided by an embodiment of the present application;

[0089] Figure 4 A structural block diagram of the cell image analysis device in the sample analysis system provided by an embodiment of the present application;

[0090] Figure 5 A structure diagram of a cell image analysis device in a sample analysis system according to an embodiment of the present application is provided.

[0091] Figure 6 A flowchart of a precision management method in a sample analysis system according to an embodiment of the present application is provided.

[0092] Figure 7 A flowchart of step 1 in the method according to an embodiment of the present application is provided. Figure 6

[0093] A structure diagram of a sample analysis system according to an embodiment of the present application is provided. Figure 8

[0094] A flowchart of a precision management method in a sample analysis system according to an embodiment of the present application is provided. Figure 9

[0095] A flowchart of step S5 in the method according to an embodiment of the present application is provided. Figure 10 Figure 9 A flowchart of step S6 in the method according to an embodiment of the present application is provided.

[0096] Figure 11 Figure 9 A flowchart of step S6 in the method according to an embodiment of the present application is provided.

[0097] Figure 12 A flowchart of a precision management method in a sample analysis system according to an embodiment of the present application is provided.

[0098] Figure 13 A flowchart of a precision management method in a sample analysis system according to an embodiment of the present application is provided.

[0099] Figure 14 A flowchart of a precision management method in a sample analysis system according to an embodiment of the present application is provided. DETAILED DESCRIPTION

[0100] The application will be further described in conjunction with the drawings. Like reference numerals in different embodiments designate like elements. In the following embodiments, many specific details are described in order to provide a thorough understanding of the application. However, it will be apparent to one skilled in the art that the application can be practiced without some or all of these details. In some instances, well-known operations have not been described in detail in order not to obscure the application in unnecessary detail. In other instances, some operations have not been described in detail in order to avoid obscuring the application.

[0101] ​​In addition, features described in the specification, operations or characteristics can be combined in any appropriate manner to form various embodiments. Meanwhile, the steps or actions in the method description can also be sequentially changed or adjusted in a manner that can be apparent to those skilled in the art. Therefore, the various sequences in the specification and the drawings are only for the purpose of clearly describing a certain embodiment, and do not mean that the sequence is necessary, unless otherwise stated that a certain sequence must be followed.

[0102] The serial numbers of the components in the specification, such as "first", "second", etc., are only used to distinguish the described objects, and do not have any sequence or technical meaning. The "connection" and "coupling" in the present application include direct and indirect connections (couplings) unless otherwise specified.

[0103] Figure 1 A structural schematic diagram of a sample analysis system 100 provided by an embodiment of the present application is shown in the figure. The sample analysis system 100 can be a blood analysis pipeline, which includes at least one blood analyzer 110, at least one smear preparation device 120, at least one cell image analysis device 130, and a control device 140.

[0104] The blood analyzer 110 is used for routine blood test of the sample to be tested, the smear preparation device 120 is used for preparing a smear of the sample to be tested, the cell image analysis device 130 is used for image shooting and analysis of cells in the smear, and the control device 140 is in communication connection with the blood analyzer 110, the smear preparation device 120, and the cell image analysis device 130.

[0105] The sample analysis system 100 further includes a first conveying track 150 and a second conveying track 160. The first conveying track 150 is used for conveying a plurality of test tube racks 10 loaded with test tubes 11 containing samples to be tested from the blood analyzer 110 to the smear preparation device 120, and the second conveying track 160 is used for conveying a plurality of glass slide baskets 20 loaded with prepared smears 21 from the smear preparation device 120 to the cell image analysis device 130.

[0106] The control device 140 is in electrical connection with the first conveying track 150 and the second conveying track 160 and controls the actions thereof.

[0107] The sample analysis system 100 further includes feeding mechanisms 170 and 180 respectively arranged corresponding to the blood analyzer 110 and the smear preparation device 120. Each feeding mechanism 170 and 180 includes a loading buffer area 171 and 181, a feeding detection area 172 and 183, and an unloading buffer area 173 and 183.

[0108] When the sample on the test tube rack 20 needs to be transported to the blood analyzer 110 for detection, the test tube rack 20 is first transported from the first conveying track 150 to the loading buffer area 171, then transported from the loading buffer area 171 to the feeding detection area 172 for detection by the blood analyzer 110, after the detection is completed, unloaded from the feeding detection area 172 to the unloading buffer area 173, and finally enters the first conveying track 150 from the unloading buffer area 173.

[0109] Similarly, when the sample on the test tube rack 20 needs to be detected by microscopy, the test tube rack 20 needs to be transported to the smear preparation device 120 for smear preparation. The test tube rack 20 is first transported from the first conveying track 150 to the loading buffer area 181, then transported from the loading buffer area 181 to the feeding detection area 182 for smear preparation by the smear preparation device 120, after the smear preparation is completed, unloaded from the feeding detection area 182 to the unloading buffer area 183, and finally enters the first conveying track 150 from the unloading buffer area 183. The smear preparation device 120 stores the prepared smears in the slide basket 20, and the slide basket 20 containing the to-be-tested smears is transported to the cell image analysis device 130 through the second conveying track 160. The cell image analysis device 130 takes images of the cells in the sample on the to-be-tested smears and analyzes them.

[0110] The sample analysis system 100 further comprises a display device (not shown) for displaying sample detection results and an input device for input. The display device can be a liquid crystal screen, a touch screen, an LED display screen, etc. The control device 140 can output the processed data in the form of image display data to the display device for display, such as analysis data, instrument operating parameters, etc. The input device can be a mouse, a keyboard, various types of keys, a trackball, etc. to facilitate user input operations. The display device can be provided on the blood analyzer 110, the cell image analysis device 130, or the control device 140, or provided separately.

[0111] The smear preparation device 120 can be used for smear preparation of blood, body fluid, etc. As shown in FIG. 2, the smear preparation device 120 comprises a slide pushing machine 121, a dyeing machine 122, and a printing device 123. Figure 2

[0112] The slide pushing machine 121 is used for pushing the sample according to preset pushing parameters. The process of pushing includes dispensing the sample to a slide and spreading the sample on the slide into a blood film. The slide pushing machine 121 comprises a sampling mechanism for sampling, a slide loading mechanism for moving the slide to a working line, a sample loading mechanism for loading the sample to the slide, a slide pushing mechanism for smearing the sample on the slide, and a drying mechanism for drying the blood film on the slide.

[0113] ​The sampling mechanism extracts the sample by mixing the sample first, and then using a sampling device (e.g., a sampling needle) in the sampling mechanism to aspirate the sample. Depending on the sample container, the aspiration can be puncture aspiration (the sample container has a cover, and the sampling device penetrates the cover of the sample container), or open aspiration (the sample container is open, and the sampling device directly aspirates the sample from the opening). If necessary, blood sample information detection can be performed to obtain information and compare the information. In some embodiments, a micro-sample feeding mechanism is also included, which can move the test tube placed by the operator directly towards the sampling device, or the sampling device can move towards the test tube placed by the operator. In other implementations, the micro-sample feeding mechanism can also move the test tube directly towards the sample loading mechanism, or the sample loading mechanism can move towards the test tube placed by the operator, directly aspirating the blood sample through the sample loading mechanism (e.g., a blood dropper) for sample loading. Since blood does not need to be drawn through the sampling mechanism, the demand for blood sample can be reduced, thereby achieving micro-sample and preferential sample loading. After sampling is completed, the blood is prepared to be dropped onto the slide through the sample loading mechanism.

[0114] Correspondingly, the slide loading mechanism extracts the slide and loads the slide to the corresponding position to facilitate the blood dropping operation. In some embodiments, after the operation of extracting the slide is completed, slide left-right detection and slide cleaning operations can also be performed, and then the slide is loaded. The loaded slide can print relevant information, and the slide front-back detection operation can also be performed.

[0115] After the blood dropper of the sample loading mechanism drops the sample onto the slide, the slide pushing operation is performed, and the blood is pushed into a blood film shape on the slide through the slide pushing mechanism. Generally, after the slide pushing operation is completed, the blood film on the slide can be dried to stabilize its shape, and the slide is as shown in Figure 2 In some embodiments, before the blood film is dried, the slide can be driven to flip to meet the corresponding requirements. In some embodiments, the dried blood smear can also be subjected to drying detection to determine the drying effect of the blood film. In some embodiments, the dried blood smear can also be subjected to blood film unfolding detection to determine whether the blood film is unfolded and whether the unfolding state meets the requirements.

[0116] The staining machine 122 is used to stain the slide. Specifically, the blood film on the slide is stained according to the preset staining parameters.

[0117] The printing device 123 is used to print the sample information on the blood smear of the sample, as shown in Figure 3 The blood smear is provided with a label area, and the sample information is printed on the label area of the blood smear. The sample information printed on the label area can include sample number, barcode, and quality control identifier, etc.

[0118] The cell image analysis device 130, for example, a cell image analyzer, as shown in Figure 4As shown, it includes at least an imaging device 131, a smear moving device 132, and an image analysis device 133. The imaging device 131 includes a camera 1312 and a lens group 1311 and is used to photograph cells in a sample smeared on a smear. The smear moving device 132 is used to move the smear relative to the imaging device 131 so that the imaging device 131 can capture cell images of a specific area of ​​the smear. The image analysis device 133 is used to analyze the cell images of the smear.

[0119] like Figure 5 As shown, lens group 1311 may include a first objective lens, a second objective lens, and an eyepiece. The first objective lens may be, for example, a 10x objective lens, and the second objective lens may be, for example, a 100x objective lens. Lens group 1311 may also include a third objective lens, which may be, for example, a 40x objective lens.

[0120] The cell image analysis device 130 also includes an identification device 134, a slide gripping device 135, and a smear recycling device 136. The identification device 134 is used to identify the identity information of the smear, the slide gripping device 135 is used to grip the smear from the identification device 134 onto the smear moving device 132 for detection, and the smear recycling device 136 is used to place the detected smear.

[0121] The cell image analysis device 130 also includes a slide basket loading device 137 for loading a slide basket containing a smear to be tested. A slide clamping device 135 is used to clamp the slide to be tested from the slide basket loaded on the slide basket loading device 137 and place it into the identification device 134 for identification information. The slide basket loading device 137 is connected to the first transport track 160 so that the smear prepared by the smear preparation device 120 can be transported to the cell image analysis device 130.

[0122] The blood analysis automated line provided by the present invention includes one, two, or more blood analyzers 110 and one, two, or more cell image analysis devices 130. In one embodiment, as shown... Figure 8 As shown, the example includes two blood analyzers 110 and two cell image analysis devices 130. Figure 8 This is just an example and does not limit the number of each instrument or device. Figure 8 The blood analysis line shown, including the blood analyzer 110, the cell image analysis device 130, and the smear preparation device, has been described above and will not be repeated here.

[0123] The scheduling device is used to schedule samples and blood smears, and includes the first transfer track 150, the second transfer track 160, the feeding mechanism 170 and the feeding mechanism 180 as described above.

[0124] The aforementioned display device includes a monitor, which is mounted on the control device 140. The control device 140 also includes a controller 142 and a memory 143. The memory 143 is used to store various types of data, such as computer programs, test results from the blood analyzer, test results from the cell image analysis device, and data generated by the smear preparation device. The controller 142 includes a processor, which can be used to execute programs for precision management of the blood analysis pipeline. Precision management may include judging the accuracy of instrument results, quality judgment, etc., and can also be referred to as quality control.

[0125] like Figure 6 As shown, in one embodiment, the sample analysis system 100 provides an automated accuracy management method for a blood analysis pipeline, comprising the following steps:

[0126] Step 1: Obtain samples for quality control. There are several ways to obtain samples for quality control, one of which is... Figure 7 As shown, it includes:

[0127] Step 1.1: The user places the sample to be tested, and the blood analyzer 110 tests the sample to obtain the first test result. In this embodiment, the sample is a blood sample, such as fresh blood from a patient.

[0128] Step 1.2: Under the preset quality control trigger conditions, the controller selects quality control samples from the already tested samples based on the sample detection results obtained by the blood analyzer 110. The controller can be the controller 142 of the control device 140, or the controller of other instruments in the sample analysis system, such as the controller of the blood analyzer 110, the controller of the smear preparation device 120, or the controller of the cell image analysis device 130. This embodiment uses the controller 142 of the control device 140 as an example for explanation. The number of selected quality control samples can be one or more, and the number of quality control samples can be determined according to user needs. Different quality control samples can be used to perform quality control on different functions or to perform multiple quality controls on the same function to improve the accuracy of the quality control results. For example, the controller obtains the first detection result of at least one sample based on the analysis of the blood analyzer 110, and determines in real time whether the preset quality control trigger conditions are met. If the preset quality control trigger conditions are met, the sample analyzed by the blood analyzer 110 is selected as the quality control sample. As can be seen, when the blood analyzer 110 is normally testing a sample, this invention can respond in real time to the quality control trigger condition and thus initiate quality control. Quality control (QC) is a necessary operation to determine whether the functions and performance of various systems, instruments, and equipment are normal.

[0129] The preset quality control trigger condition includes at least one of the following: the Nth sample after the blood analyzer is first started in each cycle, a preset time, a preset load, and a preset detection result, where N is a natural number not less than 1. For example, the controller selects a quality control sample after the first sample is tested each day, or the controller selects a quality control sample at 9:00 am each day, or the controller selects a quality control sample when the load of the sample analysis system is lower than a preset value, or the controller determines whether the first detection result of each sample obtained from the blood analyzer 110 is a detection result that meets a preset condition, and if so, the controller selects a quality control sample. The detection result that meets the preset condition can be that all blood routine test result values are within a normal range, or a detection result that includes abnormal information. The former can determine whether the result values of a normal sample detected by the blood analyzer and the cell image analysis device are consistent, and the latter can determine whether the abnormal information of a sample detected by the blood analyzer and the cell image analysis device is consistent. The above trigger conditions can be set by a user, and after the preset quality control trigger condition is met, the quality control process can be automatically performed.

[0130] The controller selects a quality control sample according to the sample detection result measured by the blood analyzer 110. The selected quality control sample can be a sample with a normal result. Specifically, the controller selects a sample with a detection value of a preset type of cell within a preset range in the first detection result as a quality control sample. For example, a sample with a count value of white blood cells (WBC) within a preset first range is selected as a quality control sample, a sample with a count value of red blood cells (RBC) within a preset second range is selected as a quality control sample, and a sample with a mean corpuscular volume (MCV) within a preset third range is selected as a quality control sample. Since the selected quality control sample can be one or more, at least one of the three samples can be selected as a quality control sample, which can be determined according to the quality control requirement. The first range, the second range, and the third range can be set according to the quality control requirement. For example, the first range is 7.0 x 10 9 to 10.0 x 10 9 / L, the second range is 4.0 x 10 12 to 5.5 x 10 12 / L, and the third range is 85-95 fL. Of course, the selected quality control sample can also be a sample with an abnormal result. Specifically, the controller selects a sample including abnormal information in the first detection result as a quality control sample. Preferably, the abnormal information includes at least one of the following: malaria, platelet aggregation, red blood cell aggregation, hematocrit (HCT) higher than a preset threshold, uneven red blood cell size, and abnormal white blood cells. Of course, the selected sample can include both a sample with a normal result and a sample with an abnormal result, so that quality control can be performed from two angles, which can meet various quality control requirements.

[0131] Step 1.3, the controller controls the scheduling device, such as the first track 150, to transport the quality control sample to the slide pusher of the smear preparation device 120.

[0132] Another way to obtain the sample for quality control includes:

[0133] Step 1.1', the blood analyzer 110 detects the sample to obtain the first detection result of the sample, which is the same as step 1.1 of the previous way.

[0134] Step 1.2', the controller controls the scheduling device, such as the first track 150, to transport the sample detected by the blood analyzer 110 to the slide pusher of the smear preparation device 120 when the preset quality control trigger condition is met, and the sample transported to the slide pusher will be the quality control sample. That is, in this way, no sample is selected, and the controller determines in real time whether the preset quality control trigger condition is met, and if the preset quality control trigger condition is met, the sample detected by the blood analyzer 110 is directly transported to the slide pusher of the smear preparation device 120. Similarly, the sample transported to the slide pusher can be one or more, which meets the quality control requirement.

[0135] Another way to obtain the sample for quality control includes:

[0136] Step 1.1", the blood analyzer 110 detects the sample to obtain the first detection result of the sample, which is the same as step 1.1 of the previous way.

[0137] Step 1.2", the blood analyzer 110 transports the sample detected by the blood analyzer 110 to the slide pusher of the smear preparation device 120 after the first sample is tested after the blood analyzer 110 is started for the first time in each cycle or after a preset time. The cycle can be a quality control cycle, for example, a natural day, that is, the blood analyzer 110 transports the sample detected by the blood analyzer 110 to the slide pusher of the smear preparation device 120 after the first sample is tested after the blood analyzer 110 is started for the first time in each day, and then starts the quality control.

[0138] Regardless of the way of step 1, before step 1, the automatic precision management method can further include: the controller provides an automatic quality control option on the display interface of the display device for the user to select, and after receiving the instruction of selecting the automatic quality control option, the automatic quality control start step, that is, step 1.2, step 1.2' or step 1.2", is executed. In this way, the automatic precision management method of the present application can be selected to be started or stopped by the user, and if it is stopped, the user can manually perform the quality control operation.

[0139] Step 2, the controller controls the slide preparation device 120 to prepare the quality control sample into a blood smear, that is, a blood smear. Specifically, the controller controls the slide preparation device 120 to prepare the quality control sample into a blood smear according to the preset slide preparation parameters. The slide preparation parameters can include the width, length, tail shape, etc. of the blood film. The slide preparation device 120 can prepare a blood smear according to the preset slide preparation parameters. The blood smear prepared in this way is shown in FIG. 13A. One or more blood smears can be prepared from the same sample, and the number of blood smears is determined according to the quality control requirements, so as to meet various quality control requirements. Figure 2

[0140] During the preparation of the blood smear, the controller also controls the printing device to set the sample information on the blood smear of the quality control sample. The sample information includes a quality control identifier. For example, the printing device prints, sprays, attaches, writes or draws the quality control identifier on the label area shown in FIG. 13B, so that the quality control blood smear has a quality control identifier, which is convenient for identification. Because the quality control identifier is set, the subsequent staining and reading will be different from the conventional sample, and the corresponding staining and reading can be performed according to the quality control requirements, so that the quality control can be better performed. Figure 2

[0141] Step 3, the controller controls the staining machine to stain the quality control blood smear. For example, the controller controls the staining machine to stain the blood film on the slide according to the preset staining parameters or the preset staining mode. The preset staining parameters can be parameters corresponding to the characteristics (blood, body fluid) of the sample, or can be parameters corresponding to one staining mode of the cell image analysis device 130. In an embodiment, the slide preparation device 120 and the staining machine select the preset parameters or mode to prepare the blood smear and to stain the blood smear, so that the blood smear prepared according to the preset parameters or mode can be analyzed by the cell image analysis device 130, and the detection result can be used to judge the quality of the slide preparation and the staining of the cell image analysis device 130. It can be seen that the sample selection, blood smear preparation and staining can be performed according to the quality control requirements, and the quality control can be quickly completed.

[0142] After the staining machine stains the quality control blood smear, the quality control blood smear is cleaned and dried. Then, the controller controls the scheduling device, for example, the second conveying track 160, to convey the quality control blood smear to the cell image analysis device 130.

[0143] ​​Step 4, the controller controls the cell image analysis device 130 to take and analyze the quality control blood smear, and obtains a second detection result. Specifically, the controller controls the cell image analysis device 130 to work, the identification device of the cell image analysis device 130 identifies the quality control mark on the blood smear of the quality control sample, and the cell image analysis device 130 learns that the current blood smear is the blood smear of the quality control sample, and then switches to the quality control mode, and takes and analyzes the quality control blood smear in the quality control mode to obtain the second detection result. The cell image analysis device 130 can adopt a film reading machine, and the image taken in the quality control mode is more comprehensive than the image taken in the conventional mode, and the second detection result obtained by analysis is also more comprehensive than the conventional sample, so as to meet the quality control requirement, that is, the cell image analysis device 130 can take and analyze according to the quality control requirement. For example, the working mode of the cell image analysis device 130 includes a white blood cell analysis mode, a red blood cell analysis mode, or a platelet analysis mode, which can be used to analyze and detect white blood cells, red blood cells, or platelets respectively, and the quality control mode can be a combination mode of the three modes, which can more comprehensively take and analyze various types of cells.

[0144] Step 5, the controller obtains the second detection result of the quality control blood smear from the cell image analysis device 130, compares the first detection result and the second detection result of the quality control sample, and controls the display device to output the comparison result. The first detection result and the second detection result are compared, if the first detection result is taken as the reference, it can be compared and judged whether the second detection result is accurate, so as to control the cell image analysis device 130, if the second detection result is taken as the reference, it can be compared and judged whether the first detection result is accurate, so as to control the blood analyzer 110. The following will be introduced one by one.

[0145] Figure 6 The method shown, before the blood analyzer 110 detects the sample to be detected, also controls the blood analyzer 110; if the blood analyzer 110 is qualified, the sample is detected to obtain the first detection result of the sample. That is, after the blood analyzer 110 is qualified, step 1 can be started, so that in step 5, the first detection result obtained by the blood analyzer 110 can be taken as the reference to control the cell image analysis device 130. The quality control of the blood analyzer 110 can include using standard quality control products to control the blood analyzer, or comparing the results of multiple blood analyzers to control the blood analyzer, if the detection result of the blood analyzer 110 on the standard quality control product is within the preset range, or the detection result of the blood analyzer 110 on the same sample is consistent with the detection result of other analyzers, the blood analyzer 110 is qualified.

[0146] The comparison of the first detection result and the second detection result of the quality control sample can specifically include: comparing the first detection result value of the preset type of cells of the quality control sample in the first detection result and the second detection result value in the second detection result, for example, comparing the result values of lymphocytes and neutrophils in the first detection result and the second detection result; if the deviation of the first detection result value and the second detection result value of the preset type of cells of the quality control sample exceeds the preset range, a prompt information is output. For example, if the proportion of lymphocytes of the quality control sample in the first detection result is 20%, and the proportion of lymphocytes of the quality control sample in the second detection result is 30%, and the preset deviation range of lymphocytes is -5%-5%, the deviation of both in the first detection result and the second detection result exceeds the preset range, and the display interface can show the deviation of 10% of both, and can also prompt that the deviation of both exceeds the preset range, that is, it indicates that at least one of the blood analyzer and the cell image analysis device is inaccurate, and the quality control of at least one of the blood analyzer and the cell image analysis device is unqualified.

[0147] In an embodiment, if the selected quality control sample is a normal sample, for example, the count value of WBC (white blood cell) of the sample is within 7.0x10 9 to 10.0x10 9 / L, the count value of RBC (red blood cell) is within 4.0x10 12 to 5.5x10 12 / L, and the MCV (mean corpuscular volume value) is within 85-95 fL, the controller compares the count value of white blood cells of the quality control sample in the first detection result and the count value in the second detection result, and the deviation of both does not exceed the preset range, indicating that the detection of the white blood cell count value by the cell image analysis device 130 meets the accuracy requirement. The controller compares the count value of red blood cells of the quality control sample in the first detection result and the count value in the second detection result, and the deviation of both does not exceed the preset range, indicating that the detection of the red blood cell count value by the cell image analysis device 130 meets the accuracy requirement. The controller compares the mean corpuscular volume of red blood cells of the quality control sample in the first detection result and the mean corpuscular volume in the second detection result, and the deviation of both does not exceed the preset range, indicating that the detection of the mean corpuscular volume by the cell image analysis device 130 meets the accuracy requirement.

[0148] If the blood analyzer has been qualified before the sample test, and the qualification is qualified, the embodiment can compare the deviation of the preset parameters in the first detection result and the second detection result to determine whether the detection of the cell image analysis device 130 meets the requirements. If the deviation exceeds the preset range, the controller outputs the prompt information that the cell image analysis device 130 is not qualified. Of course, the deviation rate of the results of the preset parameters in the first detection result and the second detection result can also be compared to determine whether the detection of the cell image analysis device 130 meets the requirements. Specifically, the controller compares the deviation rate between the second detection result and the first detection result of the quality control sample, that is, the deviation percentage. For example, the deviation rate can be obtained by dividing the first detection result value by 100%. If the deviation rate between the second detection result and the first detection result of the quality control sample exceeds the corresponding preset range, the controller outputs the prompt information that the cell image analysis device 130 is not qualified through the display device. Of course, the prompt information can be more specific, for example, the detection result of the cell image analysis device 130 on a certain type of cell does not meet the accuracy requirements.

[0149] The deviation rate of the first detection result and the second detection result of the quality control sample exceeding the preset range can include: comparing the result values of a plurality of preset parameters. The result values of the preset parameters can be the detection values of a plurality of cells such as neutrophil granulocytes, lymphocytes, and eosinophils. If the result values of any of the cells in the first detection result and the second detection result deviate beyond the range, the deviation rate of the first detection result and the second detection result of the quality control sample exceeds the preset range. If all the preset parameters do not exceed the preset range in the first detection result and the second detection result, the deviation rate of the first detection result and the second detection result of the quality control sample does not exceed the preset range.

[0150] Of course, in an optional embodiment, if the deviation of the corresponding results in the first detection result and the second detection result of the quality control sample exceeds the preset range, the controller controls the scheduling device to transport the sample (the quality control sample) to another blood analyzer for retesting to obtain the first retesting result based on the blood analyzer analysis. The controller compares the first retesting result with the second detection result to determine whether the deviation of the first retesting result value and the second detection result value exceeds the preset range, whether the deviation rate of the first retesting result and the second detection result exceeds the preset range, and the like. The specific process is the same as the comparison process of the first detection result and the second detection result described above, which is not repeated here. Re-testing after replacing the blood analyzer can exclude the interference of the blood analyzer itself on the qualification of the cell image analysis device 130.

[0151] In an optional embodiment, if the deviation of the corresponding results in the first detection result and the second detection result of the quality control sample exceeds the preset range, the controller can also control the scheduling device to transport the to-be-detected sample (the quality control sample) to another cell image analysis device for re-detection to obtain a second re-detection result based on the cell image analysis device; and then compare the second re-detection result with the first detection result to determine whether the deviation of the first detection result value and the second re-detection result value exceeds the preset range, whether the deviation rate of the first detection result and the second re-detection result exceeds the preset range, and the like. The specific process is the same as the comparison process of the first detection result and the second detection result described above, and will not be repeated here. The re-detection after replacing the cell image analysis device 130 can exclude the interference of the cell image analysis device 130 itself on the quality control of the cell analyzer.

[0152] In an optional embodiment, if the deviation of the corresponding results in the first detection result and the second detection result of the quality control sample exceeds the preset range, the controller can also control the scheduling device to transport the to-be-detected sample (the quality control sample) to another cell image analysis device for re-detection to obtain a second re-detection result based on the cell image analysis device; and then compare the second re-detection result with the first detection result to determine whether the deviation of the first detection result value and the second re-detection result value exceeds the preset range, whether the deviation rate of the first detection result and the second re-detection result exceeds the preset range, and the like. The specific process is the same as the comparison process of the first detection result and the second detection result described above, and will not be repeated here. The re-detection after replacing the cell image analysis device 130 can exclude the interference of the cell image analysis device 130 itself on the quality control of the cell analyzer.

[0153] As described above, the re-detection of the quality control sample includes re-detection by replacing the blood analyzer, re-detection by replacing the cell image analysis device, or re-detection by the original blood analyzer or cell image analysis device. In the case of unqualified initial quality control, the quality control sample is re-detected again, the quality control is judged again, and a more accurate quality control result is obtained.

[0154] In an optional embodiment, if the deviation of the corresponding results in the first detection result and the second detection result of the quality control sample exceeds the preset range, the controller can also control the scheduling device to transport the to-be-detected sample (the quality control sample) to another cell image analysis device for re-detection to obtain a second re-detection result based on the cell image analysis device; and then compare the second re-detection result with the first detection result to determine whether the deviation of the first detection result value and the second re-detection result value exceeds the preset range, whether the deviation rate of the first detection result and the second re-detection result exceeds the preset range, and the like. The specific process is the same as the comparison process of the first detection result and the second detection result described above, and will not be repeated here. The re-detection after replacing the cell image analysis device 130 can exclude the interference of the cell image analysis device 130 itself on the quality control of the cell analyzer.

[0155] As can be seen, through the above process, automatic quality control of the cell image analysis device 130 is realized, which facilitates the user to control the precision of the cell image analysis device 130, and ensures the accuracy of the detection result after the quality control is qualified.

[0156] The cell image analysis device 130 and the blood analyzer 110 have respective advantages in sample detection. The cell image analysis device 130 is more accurate than the blood analyzer 110 in morphological detection of cells, and thus the detection result of the cell image analysis device 130 can be used to perform quality control judgment on the blood analyzer 110. Specifically, the first detection result of the quality control sample includes abnormal information that meets a preset quality control trigger condition, for example, samples including abnormal information are selected as quality control samples at step 1, and then the blood analyzer 110 is controlled using these quality control samples. The controller compares whether the abnormal information in the first detection result of the quality control sample is consistent with the abnormal information in the second detection result; if the abnormal information in the first detection result of the quality control sample is not consistent with the abnormal information in the second detection result, corresponding prompt information is output through the display device, for example, prompt information that the detection of abnormal information by the blood analyzer 110 is unqualified is output. Of course, if the abnormal information of the two detection results is consistent, prompt information that the detection of abnormal information by the blood analyzer 110 is qualified is output through the display device. For example, for abnormal information such as malaria, PLT aggregation, red blood cell aggregation, and abnormal cell alarm, the cell image analysis device 130 can usually more accurately obtain the corresponding detection result, and at this time, the detection result of the cell image analysis device 130 can be used to perform precision management on the blood analyzer 110. The embodiment of the present application not only realizes automatic quality control of the cell image analysis device 130, but also realizes automatic quality control of the blood analyzer 110.

[0157] Further, the embodiment of the present application can also judge the quality of the pusher and the staining machine according to the second detection result measured by the cell image analysis device 130, that is, the quality of the pusher and the staining machine can also be judged. The second detection result includes detection information based on cell image shooting and analysis and detection information related to the quality of the pusher and the staining machine of the cell image analysis device. When the cell image analysis device 130 shoots the quality control blood smear in the quality control mode, the image of the quality control blood smear can be shot, and the blood film shape and blood film color can be recognized according to the image recognition algorithm; the cell image analysis device 130 can also scan the blood smear through the objective lens, so as to recognize the cell distribution, the blood film boundary, the blood film shape, the blood film color and other information of the quality control blood smear; after obtaining these information related to the pusher and the staining, it can be judged whether the quality of the pusher and the staining meets the expectation. Since the quality control blood smear is prepared according to the preset pusher parameters and the preset staining parameters or staining mode, the blood film size, shape, cell distribution, and color of the quality control blood smear should be consistent with the preset pusher parameters and the preset staining parameters or staining mode, and if the cell image analysis device 130 finds that the blood film size, shape, cell distribution, and color of the quality control blood smear are inconsistent with the preset pusher parameters and the preset staining parameters or staining mode, it can be judged that the quality control of the smear preparation device is unqualified.

[0158] Specifically, the controller can identify the appearance of the blood film and at least one of the cell distribution of the quality control blood smear according to the detection information related to the pushing slice in the second detection result, and make a judgment on the pushing slice quality of the pushing slice machine according to the appearance of the blood film and at least one of the cell distribution of the quality control blood smear. Wherein, the detection information related to the pushing slice in the second detection result includes at least one of the appearance of the blood film and the cell distribution of the quality control blood smear obtained by the cell image analysis device 130, for example, the image analysis device 130 can obtain the appearance image of the blood film and the cell distribution image of the quality control blood smear. The controller can identify the appearance of the blood film in the image according to the appearance image of the blood film of the quality control blood smear. The controller can identify the cell distribution according to the cell distribution image of the quality control blood smear, for example, judge whether the position distribution of the specified cells on the blood film meets the requirements, if not, it means that the pushing slice quality is unqualified.

[0159] Similarly, the controller can also identify at least one of the color and the color depth of the blood film of the quality control blood smear according to the detection information related to the staining in the second detection result, and make a judgment on the staining quality of the smear preparation device according to at least one of the color and the color depth of the blood film of the quality control blood smear. Wherein, the detection information related to the staining in the second detection result includes at least one of the color and the color depth of the blood film of the quality control blood smear obtained by the cell image analysis device 130. For example, the controller can identify the color (such as the color value) and the color depth (such as the gray value) of the blood film according to the blood film image in the second detection result, of course, the color and the color depth of the blood film of the quality control blood smear can also be obtained directly by the cell image analysis device 130; judge whether the color of the blood film is the preset color, if not, it means that the staining quality of the staining machine is unqualified, and judge whether the color depth of the blood film meets the preset depth, if not, it means that the staining quality is unqualified.

[0160] Therefore, through the above process, automatic quality control of the sample analysis system can be realized, and the automation degree is high.

[0161] In Figure 6 In the process shown in the figure, after obtaining the second detection result in step 4, the controller performs the above-mentioned pushing slice quality and staining quality judgment, and after the pushing slice quality and the staining quality are judged to meet the requirements, step 5 is performed again, that is, after judging and confirming that the pushing of the pushing slice machine and the staining of the staining machine are normal, the cell image analysis device 130 is controlled, so that the interference of the pushing slice quality and the staining quality on the quality control of the cell image analysis device 130 is excluded, and the quality control accuracy is good.

[0162] In summary, the present application realizes quality control of the slide pushing machine, the staining machine and the slide reading machine based on the whole blood analysis pipeline system. The whole blood analysis pipeline is automatically processed without human intervention or with only a small amount of intervention, and the detection results can reflect the consistency and correlation of the whole pipeline, which is conducive to the comprehensive judgment of the pipeline. Since the detection of conventional samples only needs to obtain the results according to the detection items, the detection process is simple, and the results can only reflect the functional characteristics of part of the system. In the present application, the sample selection, slide pushing, staining and slide reading are all carried out according to the quality control requirements, and the functional characteristics of the system are covered, so that the quality control is comprehensive and the accuracy is high.

[0163] As shown in Figure 9 , in an embodiment, an automatic precision management method of a sample analysis system is applied to a blood analysis pipeline including a blood analyzer, a smear preparation device, and a cell image analysis device. The method includes the following steps.

[0164] Step S1. After the pipeline is ready, the user places the sample to be tested. The pipeline is ready, which means that after the pipeline is turned on or exits from hibernation, the software and hardware of the pipeline are ready, and the pipeline enters a state where the sample can be tested. After the sample to be tested is placed, the system can start the process of automatic sample transportation and testing.

[0165] Start batch sample testing. The batch sample refers to the sample on one or more sample racks placed by the user, and the blood analyzer can detect these samples in sequence. The sample rack is used to carry at least one sample, and can usually carry multiple samples.

[0166] Step S2. The blood analyzer detects the current sample in its detection position to obtain the first detection result of the sample, which is the blood routine detection result in this embodiment.

[0167] Step S3. The controller automatically selects a sample for preparing a quality control blood smear based on the blood routine detection result; the sample needs to meet specific parameter requirements: for example, the count value of WBC is within 7.0×10 9 to 10.0×10 9 / L, the count value of RBC is within 4.0×10 12 to 5.5×10 12 / L, and the MCV value is within 85-95 fL, etc. If the blood routine detection result of a sample meets this requirement, it can be automatically selected as a quality control sample, and the number of quality control samples can be one sample. The quality control sample can also be multiple samples, for example, some quality control samples are samples with all detection items within the normal range, or some quality control samples are samples with some parameters exceeding the limit, such as samples with high HCT, uneven RBC size, and abnormal white blood cells.

[0168] Step S4. The controller automatically transports the quality control sample to the slide pusher by the scheduling device.

[0169] Step S5. The controller prepares the quality control blood smear by the smear preparation device, and collects the blood sample drop on the slide to push the blood film. As shown in Figure 10 , the preparation method of the quality control blood smear includes the following steps:

[0170] Step S51, the printing device prints sample information on the label area of the slide, and the sample information includes sample number, barcode, and quality control identification, etc.

[0171] Step S52, the slide pusher collects the quality control sample and drops it on the slide.

[0172] Step S53, the slide pusher pushes the blood on the slide to the blood film. Specifically, the controller controls the slide pusher to push the blood on the slide to the blood film according to the preset slide pushing parameters. The slide pushing parameters can include the width, length, and tail shape of the blood film, and the slide pusher can push the slide according to the preset slide pushing parameters to prepare the blood smear that meets the preset slide pushing parameters. As shown in Figure 2 , in the embodiment of the application, one or more quality control blood smears can be prepared for each quality control sample according to the quality control requirements, or blood smears of multiple different quality control samples can be prepared.

[0173] Step S54, detection of the appearance of the blood film, for example, the slide pusher detects the appearance of the blood film to facilitate the judgment of the next step.

[0174] Step S55, judging whether the appearance of the blood film and the distribution of blood cells meet the requirements, for example, the slide pusher judges whether the detected appearance of the blood film (the width, length, and tail shape of the blood film) meets the preset slide pushing parameters, and whether the position distribution of the specified cells on the blood film meets the requirements.

[0175] Step S56, if the appearance of the blood film and the distribution of blood cells of the quality control blood smear meet the requirements, the quality control blood smear is transported to the staining machine or the staining module by the scheduling device. If at least one of the appearance of the blood film and the distribution of blood cells of the quality control blood smear does not meet the requirements, return to step S51 to re-prepare the blood smear of the quality control sample.

[0176] Step S6. The staining machine or the staining module stains the quality control blood smear. As shown in Figure 11 , the staining specifically can include the following steps:

[0177] Step S61, the dyeing machine or dyeing module automatically sets the dyeing mode and dyeing parameters; the dyeing mode and dyeing parameters of the dyeing machine or dyeing module are usually many, different dyeing modes or dyeing parameters correspond to different dyeing effects, for the quality control sample, the dyeing mode and / or dyeing parameters corresponding to the quality control mode can be selected.

[0178] Step S62, the dyeing machine or dyeing module dyes the next quality control blood smear.

[0179] Step S63, the dyeing machine or dyeing module judges whether there is still an undyed quality control blood smear; if not, it goes to the next step S64; if there is still an undyed quality control blood smear, it returns to step S61 to continue dyeing the next sample.

[0180] Step S64, the working mode of the dyeing machine or dyeing module is switched to the normal dyeing mode to prepare for dyeing the blood smears of ordinary patients other than the quality control samples.

[0181] Step S65, the dyeing machine or dyeing module washes and dries the dyed quality control slide.

[0182] Step S7. The controller transports the quality control blood smear to the cell image analysis device through the scheduling device.

[0183] Step S8. After the above dyed and dried slide is transported to the cell image analysis device, the cell image analysis device automatically switches to the quality control mode according to the quality control mark on the blood smear, and performs cell image shooting and analysis in the quality control mode to obtain a second detection result.

[0184] The controller determines whether the pusher and the dyeing machine are working normally by the shooting and analysis of the blood smear by the cell image analysis device.

[0185] Step S9. The controller compares the morphological analysis result of the cell image analysis device with the detection result of the previous blood analyzer or blood analyzers to confirm whether the quality control of the cell image analysis device is normal. The foregoing embodiment gives a specific process of comparing the morphological analysis result of the cell image analysis device with the detection result of the previous blood analyzer, of course, a plurality of blood analyzers can also be used to detect the quality control sample in advance, and then the controller compares the morphological analysis result of the cell image analysis device with the detection results of the plurality of blood analyzers, so as to further ensure the accuracy of the first detection result, so as to control the quality of the cell image analysis device. The quality control of the cell image analysis device has been described in the foregoing embodiment, and will not be repeated here.

[0186] The controller also relies on the morphological analysis results of the cell image analysis device (instrument classification results of the cell image analysis device or accurate results obtained under human adjustment) to confirm whether certain detection results of the blood analyzer meet expectations; for example, certain items that cannot be detected by the conventional quality control of the blood analyzer, such as the accuracy of malaria detection, PLT aggregation, red blood cell aggregation, abnormal cell alarm, etc. The conventional quality control of the blood analyzer cannot usually obtain accurate quality control results, while the cell image analysis device is more intuitive and accurate in detecting items such as malaria detection, PLT aggregation, red blood cell aggregation, and abnormal cell alarm. At this time, the detection results of the blood analyzer for these items can be quality controlled by the detection results of the cell image analysis device.

[0187] Thus, a method for automatically managing the precision of various instruments on the production line using quality control blood smears can be extended, as shown in Figure 12 The method specifically includes the following steps:

[0188] Step S81, the cell image analysis device reads the quality control identifier of the quality control blood smear.

[0189] Step S82, the cell image analysis device automatically switches to the quality control mode under the trigger of the quality control identifier.

[0190] Step S83, the cell image analysis device scans the appearance of the blood film, for example, scans the appearance of the blood film to obtain corresponding image output to the controller.

[0191] Step S84, the controller determines whether the appearance of the blood film is normal. If not, it indicates that the quality of the slide pusher does not meet the requirements, and the corresponding prompt can be output through the display. The specific process has been described in the above embodiment and will not be repeated here.

[0192] Step S85, the cell image analysis device scans the overall color of the blood film, evaluates the color and color depth, and outputs to the controller.

[0193] Step S86, the controller determines whether the color of the blood film is abnormal. If it is abnormal, it indicates that the dyeing quality of the dyeing machine does not meet the requirements. The specific process has been described in the above embodiment and will not be repeated here.

[0194] Step S87, the cell image analysis device scans the microscopic distribution characteristics of the blood film, identifies the cell distribution pattern, for example, the normal blood film is gradually thinned from the head to the tail.

[0195] Step S88, by scanning the microscopic distribution characteristics of the blood film through the cell image analysis device, the controller identifies whether the blood film distribution or cell distribution meets the requirements. If the cell distribution does not meet the requirements, it indicates that the quality of the slide pusher does not meet the requirements, and the corresponding prompt information can be output. The specific process has been described in the above embodiment and will not be repeated here.

[0196] Step S91, the cell image analysis device locates and photographs the cells of the blood smear. The controller acquires the photograph taken by the cell image analysis device.

[0197] Step S92, the controller determines whether the locating and photographing functions of the cell image analysis device meet the requirements; generally, the cell image analysis device locates the cells on the blood smear through a low-power objective lens, such as a 10x objective lens, locates a target number of cells, for example, 100 white blood cells, and then switches to a high-power objective lens, such as a 100x objective lens, to photograph the located cells. If the cell image analysis device fails to locate a target number of cells or fails to photograph a target number of cells after locating a target number of cells, it indicates that the locating or photographing function of the cell image analysis device does not meet the requirements.

[0198] Step S93, the cell image analysis device photographs and pre-classifies the cells of the quality control blood smear. The cell image analysis device can output cell images of different types and pre-classify the cells. The pre-classification result usually needs to be confirmed and adjusted manually before the detection result of the cell image analysis device can be output.

[0199] Step S94, the controller determines whether the pre-classification result of the quality control blood smear is consistent with the result of the blood analyzer or the deviation is within the allowable range. If the results of the two are inconsistent or the deviation is greater than the allowable range, it indicates that the accuracy of the classification result of the cell image analysis device does not meet the requirements. For example, if the five-classification result of white blood cells measured by the blood cell analysis and the pre-classification result of the cell image analysis device deviate more than the allowable range, it indicates that the accuracy of the classification result of the cell image analysis device does not meet the requirements. The specific process has been described in the above embodiment and will not be repeated here.

[0200] If the results of the two are consistent or the deviation is within the allowable range, it indicates that the accuracy of the classification result of the cell image analysis device meets the requirements. If the five-classification result of white blood cells measured by the blood cell analysis and the pre-classification result of the cell image analysis device are consistent or the deviation is within the allowable range, it indicates that the accuracy of the classification result of the cell image analysis device meets the requirements.

[0201] Please refer to Figure 13 In another embodiment, an automatic precision management method applied to a sample analysis system, which can be a blood analysis pipeline including a blood analyzer, a smear preparation device, and a cell image analysis device, includes the following steps.

[0202] Step S2'. The blood analyzer analyzes the sample to obtain a first detection result of the sample, such as a blood routine detection result.

[0203] Step S3'. It is judged whether the quality control condition is met. If not, the ordinary sample counting process is performed on the currently tested sample. The quality control condition includes that the first detection result meets the preset condition, for example, the white blood cell count in the first detection result of the sample is greater than 7.0 (10^ 9 / L), which can be selected as a quality control sample; the quality control condition can further include a preset time, for example, between 8:00-8:30 every day, and the sample whose first detection result meets the preset condition is selected; or the quality control condition can also include that the Nth sample is tested in each quality control period, for example, once a day, and the quality control period is one day. After the blood analyzer starts the pipeline every day, the quality control process is automatically started after the first sample is tested, or after a plurality of samples (for example, 3 samples) are tested, the sample whose first detection result meets the preset condition is selected from the plurality of samples, and the quality control process is started. In this way, the quality control process can be automatically completed immediately after the pipeline starts testing every day, ensuring the accuracy of sample analysis on the same day. The quality control condition can also include a preset load, for example, selecting a low load time for quality control, which can improve the quality control speed and avoid affecting the normal testing of patient samples.

[0204] Step S4'. If the quality control condition is met, the sample is transported to the smear preparation device.

[0205] Step S5'. The smear preparation device prepares the sample, and also prints a quality control mark on the blood smear of the sample.

[0206] Step S7'. The blood smear of the sample is transported to the cell image analysis device.

[0207] Step S8'. The cell image analysis device identifies the quality control mark of the sample, switches to the quality control mode, and photographs and analyzes the blood smear of the sample to obtain a second detection result based on image photographing and analysis.

[0208] Step S9'. The second detection result of the sample is compared with the first detection result, and quality control reference information is output according to the comparison result.

[0209] Figure 13 In the embodiments shown, the specific processes of each step have been described in the above embodiments, and will not be repeated here. Of course, each of the above embodiments can also be combined with each other, especially the quality control of the blood analyzer, the quality control of the smear preparation device, and the quality control of the cell image analysis device can be combined with each other. For example, based on the above sample analysis system, the smear preparation device is individually quality controlled, that is, the quality of the push piece and the staining is judged, and the specific process is as follows:Figure 14 As shown in the embodiment, the steps S1, S2, S4-S8, S9’ are included, wherein the steps S1, S2, S4-S8 can be the same as those of the embodiment shown in the above, and will not be repeated here. Figure 9 As shown in the embodiment, the steps S1, S2, S4-S8, S9’ are included, wherein the steps S1, S2, S4-S8 can be the same as those of the embodiment shown in the above, and will not be repeated here.

[0210] For step S9’: the controller judges the quality of the pushing and staining of the quality control blood smear according to the second detection result, and the specific process has been described in detail in the above embodiment, and will not be repeated here.

[0211] Those skilled in the art can understand that all or part of the functions of the various methods in the above embodiments can be realized by hardware or by a computer program. When all or part of the functions in the above embodiments are realized by a computer program, the program can be stored in a computer readable storage medium, which can include read-only memory, random access memory, magnetic disk, optical disk, hard disk, etc. The above functions are realized by executing the program by a computer. For example, the program is stored in the memory of the device, and when the program in the memory is executed by the processor, the above all or part of the functions are realized. In addition, when all or part of the functions in the above embodiments are realized by a computer program, the program can also be stored in a server, another computer, a storage medium such as a disk, an optical disk, a flash disk or a mobile hard disk, and is downloaded or copied into the memory of the local device, or the system of the local device is updated, and when the program in the memory is executed by the processor, all or part of the functions in the above embodiments are realized.

[0212] The various exemplary embodiments are described herein. However, those skilled in the art will recognize that changes and modifications can be made to the exemplary embodiments without departing from the scope hereof. For example, various operational steps and components for carrying out the operational steps can be implemented in different sequences and / or omitted, combined, or combined as desired in particular applications to implement the described functionality of the system in different ways.

[0213] Additionally, as will be appreciated by those skilled in the art, the principles described herein can be reflected in a computer program product having a computer-readable medium pre-loaded with computer-readable program code. Any tangible, non-transitory computer-readable storage medium can be used, including magnetic storage devices (hard disk; floppy disk, etc.), optical storage devices (CD-ROM; DVD; Blu Ray disc, etc.), flash memory, and / or the like. These computer program instructions can be loaded onto a general purpose computer, a special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions that execute on the computer or other programmable data processing apparatus create means for implementing the functions specified. These computer program instructions can also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including an implementation to

[0214] While the principles described herein have been illustrated in various embodiments, many modifications, adaptations, and variations can be made to the structures, arrangements, proportions, elements, materials, and components described and illustrated without departing from the principles of the present disclosure. Such modifications and variations are considered to be within the scope of the disclosure.

[0215] The foregoing detailed description has been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made thereto without departing from the scope of the present disclosure. Accordingly, the description is to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present disclosure. Likewise, that individual elements or features of the disclosure can be readily separated from one or more disclosed implementation without departing from the scope of the disclosure. Additionally, none of the individual elements or features of the disclosure are intended to be essential, essential, or critical to the disclosure unless explicitly designated as such. As used herein, the terms "comprises," "comprising," "includes," "including," and the like can mean "including but not limited to." As used herein, the term "coupled" and variations thereof means physical, electrical, magnetic, optical, communicative, functional, and / or any other connection.

[0216] Those skilled in the art will recognize that many modifications can be made to the details of the above-described embodiments without departing from the underlying principles of the present application. The scope of the present application should, therefore, be determined only by the following claims.

Claims

1. An automatic accuracy management method for a sample analysis system, characterized in that, Includes the following steps: The blood analyzer tests the sample to be tested; the sample to be tested is a fresh blood sample; Under preset quality control trigger conditions, the controller selects quality control samples from the already tested samples based on the sample test results obtained by the blood analyzer; the result of the blood analyzer test on the quality control samples is the first test result; The controller directs the scheduling device to transport the quality control samples to the pusher. The slide pusher prepares the quality control samples into quality control blood smears; The staining machine stains the quality control blood smears; The controller directs the scheduling device to transport the quality control blood smear to the cell image analysis device; The cell image analysis device captures and analyzes the quality control blood smear to obtain a second detection result; The first and second test results of the quality control samples are compared. Output the comparison results; Based on the comparison results, the controller automatically performs quality control on the blood analyzer or the cell image analysis device.

2. The method as described in claim 1, characterized in that, The preset quality control triggering conditions include at least one of the following: after the blood analyzer is first started and the Nth sample is tested in each cycle, a preset time, a preset load, and a preset test result, where N is a natural number not less than 1.

3. The method as described in claim 1, characterized in that, The comparison of the first and second test results of the quality control sample includes: Compare the first detection result value of the preset type of cells in the quality control sample in the first detection result and the second detection result value in the second detection result; Based on the comparison results, the controller automatically performs quality control on the blood analyzer or the cell image analysis device, including: If the deviation between the first and second detection result values ​​of the cells of the preset type in the quality control sample exceeds a preset range, a prompt message will be output.

4. The method as described in claim 1, characterized in that, Before the blood analyzer tests the sample, the process also includes: quality control of the blood analyzer; if the blood analyzer passes the quality control, the sample is tested to obtain the first test result.

5. The method as described in claim 4, characterized in that, Based on the comparison results, the controller automatically performs quality control on the blood analyzer or the cell image analysis device, including: If the deviation between the first and second detection result values ​​of the cells of the preset type in the quality control sample exceeds a preset range, a prompt message indicating that the cell image analysis device has failed quality control will be output.

6. The method as described in claim 1, characterized in that, The first test result of the quality control sample includes anomaly information; The first and second test results of the comparative quality control samples include: Compare the abnormal information in the first test result of the quality control sample with the abnormal information in the second test result to see if they are consistent; Based on the comparison results, the controller automatically performs quality control on the blood analyzer or the cell image analysis device, including: If the abnormal information in the first test result of the quality control sample is inconsistent with the abnormal information in the second test result, a prompt message will be output.

7. The method as described in claim 6, characterized in that, The abnormal information includes at least one of the following: malaria parasites, platelet aggregation, red blood cell aggregation, hematocrit exceeding a preset threshold, uneven red blood cell size, and abnormal white blood cells.

8. The method as described in claim 1, characterized in that, It also includes judging the quality of the spreading and / or staining of the quality control blood smear based on the detection information related to the spreading and / or staining of the quality control blood smear in the second detection results.

9. The method as described in claim 8, characterized in that, The detection information related to the slide in the second detection result includes at least one of the blood membrane morphology and cell distribution of the quality control blood smear obtained by the cell image analysis device.

10. The method as described in claim 8, characterized in that, The staining-related detection information in the second detection result includes at least one of the blood film color and color intensity of the quality control blood smear obtained by the cell image analysis device.

11. The method as described in claim 8, characterized in that, Comparing the first and second test results of the quality control samples includes: After the slide quality and staining quality are judged to meet the requirements, the first test result and the second test result of the quality control sample are compared.

12. The method as described in claim 1, characterized in that, The selection of quality control samples based on the sample test results obtained by the blood analyzer includes: selecting samples whose cell test values ​​of a preset type in the first test results are within a preset range as quality control samples.

13. The method as described in claim 12, characterized in that, The detection values ​​of the preset cell types in the first detection result are within the preset range, including at least one of the following: white blood cell count within the preset first range, red blood cell count within the preset second range, and mean corpuscular volume within the preset third range.

14. The method as described in claim 1, characterized in that, The selection of quality control samples based on the sample test results obtained by the blood analyzer includes: selecting samples with abnormal information in the first test results as quality control samples; the abnormal information includes at least one of the following: malaria parasites, platelet aggregation, red blood cell aggregation, hematocrit higher than a preset threshold, uneven red blood cell size, and abnormal white blood cells.

15. The method according to any one of claims 1-14, characterized in that, Also includes: If the deviation between the corresponding results in the first and second test results of the quality control sample exceeds a preset range, the scheduling device is controlled to transport the sample to be tested to another blood analyzer for retesting in order to obtain the first retest result based on the analysis of the blood analyzer. And compare the first retest result with the second test result; or, If the deviation between the corresponding results in the first and second detection results of the quality control sample exceeds a preset range, the scheduling device is controlled to transport the sample to be tested to another cell image analysis device for retesting, so as to obtain a second retest result based on the cell image analysis device. And compare the first detection result with the second retest result; or, If the deviation of the corresponding results in the first and second test results of the quality control sample exceeds a preset range, the scheduling device is controlled to transport the sample to be tested to the original blood analyzer for retesting, and also to the original cell image analysis device for retesting, so as to obtain the first retest result based on the blood analyzer analysis and the second retest result based on the cell image analysis device. And compare the first retest result with the second retest result.

16. The method according to any one of claims 1-14, characterized in that, Also includes: If the deviation between the corresponding results of the first and second test results of the quality control sample exceeds a preset range, a new quality control sample will be selected from the already tested samples.

17. The method as described in claim 1, characterized in that, Also includes: A quality control label is printed on the quality control sample. The cell image analysis device recognizes the quality control label and switches to quality control mode to photograph and analyze the quality control sample.

18. A sample analysis system, characterized in that, include: A blood analyzer for testing at least one sample; the sample is a fresh blood sample. The controller is used to acquire the first test result of at least one sample based on the blood analyzer analysis, and to determine in real time whether the preset quality control trigger conditions are met. If the preset quality control trigger conditions are met, the sample analyzed by the blood analyzer is selected as the quality control sample. It is also used to control the dispatching device to transport the quality control sample to the smear preparation device; The smear preparation device prepares the quality control sample into a blood smear; A cell image analysis device is used to capture and analyze the blood smear and obtain a second detection result based on the image capture and analysis. The controller is also used for: Compare the second detection result with the corresponding information in the first detection result; The control display device outputs the comparison result; Based on the comparison results, the blood analyzer or the cell image analysis device is automatically subjected to quality control.

19. The sample analysis system as described in claim 18, characterized in that, The smear preparation apparatus includes: A slide pusher is used to push quality control samples according to preset slide pushing parameters. The slide pushing process includes distributing the quality control samples onto a glass slide and spreading the samples on the glass slide into a blood film. A staining machine is used to stain blood films on glass slides according to preset staining parameters; A printing device for printing sample information onto a blood smear of the quality control sample, the sample information including a quality control identifier.

20. The sample analysis system as described in claim 19, characterized in that, The cell image analysis device includes an identification device for identifying quality control markings on the blood smear of the quality control sample.

21. The sample analysis system according to any one of claims 18-20, characterized in that, The second detection result includes detection information based on cell image capture and analysis, as well as detection information related to the slide preparation and / or staining quality of the cell image analysis device.

22. The sample analysis system as described in claim 21, characterized in that, The controller is also used to judge the slide preparation device's slide preparation quality based on the detection information related to the slide pushing and / or staining quality of the cell image analysis device in the second detection result.

23. The sample analysis system as described in claim 18, characterized in that, The blood analyzer has undergone quality control, and samples are only tested after the quality control is passed to obtain the first test result.

24. The sample analysis system as described in claim 18 or 23, characterized in that, Based on the comparison results, the controller automatically performs quality control on the blood analyzer or the cell image analysis device, including: If the deviation between the second test result and the first test result of the quality control sample exceeds a preset range, the control display device will output quality control prompt information from the cell image analysis device.

25. An automatic accuracy management method for a sample analysis system, characterized in that, Includes the following steps: The blood analyzer tests the sample to obtain the first test result; the sample is a fresh blood sample. The automatic quality control starts after the blood analyzer is first started and the Nth sample is tested, or after a preset time after the first test, the control and scheduling device will transport the sample tested by the blood analyzer to the slide pusher. The slide pusher prepares the sample into a quality control blood smear, and the quality control blood smear is marked with a quality control label; The staining machine stains the quality control blood smears; The controller directs the scheduling device to transport the quality control blood smear to the cell image analysis device; The cell image analysis device identifies the quality control identifier, switches to quality control mode, and then captures and analyzes the quality control blood smear in quality control mode to obtain a second detection result. The first test result of the sample prepared into the quality control blood smear and the second test result of the quality control blood smear are compared; Output the comparison results; Based on the comparison results, the controller automatically performs quality control on the blood analyzer or the cell image analysis device.

26. The method as described in claim 25, characterized in that, Also includes: The display interface provides an automatic quality control option for the user to select. After receiving the instruction to select the automatic quality control option, the automatic quality control start step is executed.

27. A sample analysis system, characterized in that, include: A blood analyzer for testing at least one sample; the sample is a fresh blood sample. The controller is used to acquire the first test result of at least one sample based on the blood analyzer analysis and to determine in real time whether the preset conditions are met. If the preset conditions are met, the sample analyzed by the blood analyzer is selected as the quality control sample. It is also used to control the dispatching device to transport the quality control sample to the smear preparation device; A smear preparation apparatus, including a slide pusher and a staining machine; The slide pusher is used to push the quality control sample into a blood film according to preset slide pushing parameters. The staining machine is used to stain the blood film of the quality control sample on the glass slide according to preset staining parameters; A cell image analysis device is used to capture and analyze blood smears of the quality control samples and obtain a second detection result based on the image capture and analysis. The second detection result includes detection information related to the spreading and staining of the blood smears of the quality control samples. The controller is also used for: The quality of the blood smear and staining of the quality control sample is determined based on the second test result.

28. The sample analysis system as described in claim 27, characterized in that, The smear preparation apparatus includes a printing device for printing sample information onto the blood smear of the quality control sample, wherein the sample information includes a quality control identifier.

29. The sample analysis system as described in claim 27, characterized in that, The controller determines the quality of the quality control blood smear based on the second detection result, including: The blood film morphology and / or cell distribution of the quality control blood smear are identified based on the detection information related to the smear in the second detection result; and the smear quality of the smear is judged based on the blood film morphology and / or cell distribution of the quality control blood smear. The detection information related to the slide in the second detection result includes at least one of the blood membrane morphology and cell distribution of the quality control blood smear obtained by the cell image analysis device.

30. The sample analysis system according to any one of claims 27-29, characterized in that, The controller determines the staining quality of the quality control blood smear based on the second detection result, including: Based on the staining-related detection information in the second detection result, identify at least one of the blood film color and color depth of the quality control blood smear; and judge the staining quality of the smear preparation device based on at least one of the blood film color and color depth of the quality control blood smear. The staining-related detection information in the second detection result includes at least one of the blood film color and color depth of the quality control blood smear obtained by the cell image analysis device.

31. The sample analysis system according to any one of claims 27-29, characterized in that, The controller is also used to: compare the corresponding result information in the first test result and the second test result of the quality control sample; and control the display device to output the comparison result.

32. A sample analysis system, characterized in that, include: Memory, used to store programs; A processor for executing a program stored in the memory to implement the method as described in any one of claims 1-17, 25 and 26.

33. A computer-readable storage medium, characterized in that, Includes a program that can be executed by a processor to implement the method as described in any one of claims 1-17, 25 and 26.

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