WO2021134664A1 - 一种样本分析***及其自动精度管理方法 - Google Patents

一种样本分析***及其自动精度管理方法 Download PDF

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Publication number
WO2021134664A1
WO2021134664A1 PCT/CN2019/130898 CN2019130898W WO2021134664A1 WO 2021134664 A1 WO2021134664 A1 WO 2021134664A1 CN 2019130898 W CN2019130898 W CN 2019130898W WO 2021134664 A1 WO2021134664 A1 WO 2021134664A1
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WIPO (PCT)
Prior art keywords
quality control
sample
blood
result
smear
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PCT/CN2019/130898
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English (en)
French (fr)
Inventor
姜斌
曾凡顺
李学荣
颜昌银
Original Assignee
深圳迈瑞生物医疗电子股份有限公司
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Application filed by 深圳迈瑞生物医疗电子股份有限公司 filed Critical 深圳迈瑞生物医疗电子股份有限公司
Priority to PCT/CN2019/130898 priority Critical patent/WO2021134664A1/zh
Priority to CN201980103170.3A priority patent/CN114829933A/zh
Priority to EP19958734.6A priority patent/EP4086626A4/en
Publication of WO2021134664A1 publication Critical patent/WO2021134664A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00613—Quality control
    • G01N35/00623—Quality control of instruments
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/2813—Producing thin layers of samples on a substrate, e.g. smearing, spinning-on
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/30—Staining; Impregnating ; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis
    • G01N1/31—Apparatus therefor
    • G01N1/312—Apparatus therefor for samples mounted on planar substrates
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/02—Investigating particle size or size distribution
    • G01N15/0205—Investigating particle size or size distribution by optical means
    • G01N15/0227—Investigating particle size or size distribution by optical means using imaging; using holography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/10—Investigating individual particles
    • G01N15/14—Optical investigation techniques, e.g. flow cytometry
    • G01N15/1429—Signal processing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/10—Investigating individual particles
    • G01N15/14—Optical investigation techniques, e.g. flow cytometry
    • G01N15/1429—Signal processing
    • G01N15/1433—Signal processing using image recognition
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N2015/0092—Monitoring flocculation or agglomeration
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/01—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials specially adapted for biological cells, e.g. blood cells
    • G01N2015/012—Red blood cells
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/01—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials specially adapted for biological cells, e.g. blood cells
    • G01N2015/016—White blood cells
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/01—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials specially adapted for biological cells, e.g. blood cells
    • G01N2015/018—Platelets
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/02—Investigating particle size or size distribution
    • G01N2015/0294—Particle shape
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/10—Investigating individual particles
    • G01N15/14—Optical investigation techniques, e.g. flow cytometry
    • G01N2015/1497—Particle shape
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00039—Transport arrangements specific to flat sample substrates, e.g. pusher blade
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00099—Characterised by type of test elements
    • G01N2035/00138—Slides

Definitions

  • the present invention relates to the field of medical equipment, in particular to a sample analysis system and an automatic precision management method thereof.
  • a blood analyzer In the process of blood analysis, a blood analyzer, a smear preparation device (also known as a pusher staining machine) and a cell image analysis device are usually used.
  • quality control In order to ensure the normal function and performance of instruments such as the slide stainer and cell image analysis device, quality control must be carried out on a regular basis. In the prior art, the quality control of the slide staining machine and the cell image analysis device are all done manually, which is complicated and cumbersome, time-consuming, labor-intensive, and low-efficiency.
  • the present invention mainly provides a sample analysis system and an automatic precision management method thereof.
  • an embodiment provides an accuracy management method of a sample analysis system, which includes the following steps:
  • the blood analyzer detects the sample to be tested
  • the controller selects a quality control sample from the samples to be tested that have been tested according to the sample test result measured by the blood analyzer under the preset quality control trigger condition; the result of the quality control sample tested by the blood analyzer is The first test result;
  • the controller controls the scheduling device to transport the quality control samples to the pusher
  • the slide pusher prepares the quality control sample into a quality control blood smear
  • the controller controls the scheduling device to transport the quality control blood smear to the cell image analysis device
  • the cell image analysis device photographs and analyzes the quality control blood smear to obtain a second detection result
  • the preset quality control trigger conditions include the Nth sample after the first start-up test of the blood analyzer in each cycle, the preset time, the preset load, and the preset test results. At least one of them, where N is a natural number not less than 1.
  • the comparing the first test result and the second test result of the quality control sample includes:
  • the blood analyzer before the blood analyzer performs the test on the sample to be tested, it further includes: quality control of the blood analyzer; if the quality control of the blood analyzer is qualified, the sample is tested to obtain the first test of the sample result.
  • the method further includes: if the deviation of the first detection result value and the second detection result value of the predetermined type of cells of the quality control sample exceeds a predetermined range, outputting the quality control of the cell image analysis device is unqualified Prompt information.
  • the first detection result of the quality control sample includes abnormal information; the first detection result and the second result of the comparison quality control sample include:
  • the abnormal information includes at least one of Plasmodium, platelet aggregation, red blood cell aggregation, hematocrit higher than a preset threshold, uneven red blood cell size, and abnormal white blood cells.
  • the method further includes determining the push and/or staining of the quality control blood smear according to the detection information related to the push and/or staining of the quality control blood smear in the second detection result quality.
  • the detection information related to the push of the slide 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.
  • the detection information related to staining in the second detection result includes at least one of the blood film color and the color depth of the quality control blood smear obtained by a cell image analysis device.
  • comparing the first test result and the second test result of the quality control sample includes:
  • the first test result and the second test result of the quality control sample are compared.
  • the selecting the quality control sample according to the test result of the sample measured by the blood analyzer includes: selecting the sample whose test value of the preset type of cell in the first test result is within a preset range as the quality control sample .
  • the detection value of the preset type of cells in the first detection result is within the preset range, including: the count value of white blood cells is within the preset first range, and the count value of red blood cells is within the preset second range. At least one of the in-range and average red blood cell volume is within the preset third range.
  • the selection of the quality control sample according to the test result of the sample measured by the blood analyzer includes: selecting the sample including the abnormal information in the first test result as the quality control sample; preferably, the abnormal information includes the plasmodium At least one of platelet aggregation, red blood cell aggregation, hematocrit higher than a preset threshold, uneven red blood cell size, and abnormal white blood cells.
  • the method also includes:
  • control the scheduling device to transport the sample to be tested to another blood analyzer for retesting, 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,
  • control the scheduling device to transport the sample to be tested to another cell image analysis device for retesting, To obtain a second retest result based on the cell image analysis device; and compare the first test result with the second retest result; or,
  • the scheduling device is controlled to transport the sample to be tested to the original blood analyzer for retest, and Transported to the original cell image analysis device for retesting, to obtain the first retest result based on the analysis of the blood analyzer and the second retest result based on the cell image analysis device; and compare the first retest result with the second retest result The retest results are compared.
  • the method further includes: if the deviation of the corresponding results in the first test result and the second test result of the quality control sample exceeds a preset range, reselecting the quality control sample from the samples to be tested that have been tested .
  • the method also includes:
  • the quality control mark is printed on the quality control sample, and the cell image analysis device recognizes the quality control mark and switches to the quality control mode to photograph and analyze the quality control sample.
  • an embodiment provides a sample analysis system, including:
  • Hematology analyzer for testing at least one sample
  • the controller is used to obtain at least one sample of the first detection results based on the analysis of the blood analyzer, and determine in real time whether the preset quality control trigger conditions are met, and if the preset quality control trigger conditions are met, select the ones analyzed by the blood analyzer
  • the sample is used as a 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
  • the cell image analysis device is used to take and analyze the blood smear, and obtain a second detection result based on the image taking and analysis;
  • the controller is also used for:
  • the smear preparation device includes:
  • the slide pusher is used to push the quality control samples according to the preset slide parameters.
  • the slide push process includes allocating the quality control samples to the slides and pushing the samples on the slides into a blood film;
  • the staining machine is used to stain the blood film on the glass slide according to the preset staining parameters
  • the printing device is used to print sample information on the blood smear of the quality control sample, and the sample information includes a quality control identifier.
  • the cell image analysis device includes an identification device for identifying the quality control mark on the blood smear of the quality control sample.
  • the second detection result includes detection information based on cell image shooting and analysis and detection information related to the push and/or staining quality of the cell image analysis device.
  • the controller is further configured to push the smear preparation device according to the detection information related to the pushing and/or staining quality of the cell image analysis device in the second detection result. And/or dyeing quality judgment.
  • the blood analyzer undergoes quality control, and the sample is tested only after the quality control is qualified to obtain the first test result of the sample.
  • the controller is further configured to: if the deviation between the second detection result and the first detection result of the quality control sample exceeds a preset range, control the display device to output the cell image analysis device The quality control prompt information.
  • an embodiment provides an automatic accuracy management method for a sample analysis system, which includes the following steps:
  • the blood analyzer detects the sample to obtain the first test result of the sample
  • the automatic quality control start step the Nth sample is tested after the blood analyzer starts the test for the first time in each cycle, or the preset time after the test is started for the first time, the control and scheduling device transports the samples tested by the blood analyzer to the pusher;
  • the slide pushing machine prepares the sample into a quality control blood smear, and the quality control blood smear is provided with a quality control mark;
  • the controller controls the scheduling device to transport the quality control blood smear to the cell image analysis device
  • the cell image analysis device recognizes the quality control mark, switches to a quality control mode, and photographs and analyzes the quality control blood smear in the quality control mode to obtain a second detection result;
  • the method also includes:
  • an embodiment provides a sample analysis system, including:
  • the smear preparation device includes a slide pushing machine and a staining machine, which is used to push the quality control sample according to preset pushing parameters, so as to spread the blood sample of the quality control sample dispensed on the glass slide into a blood film;
  • the staining machine is used to stain the blood film on the glass slide according to the preset staining parameters
  • the cell image analysis device is used to photograph and analyze the blood smear, and obtain a second detection result based on the image shooting and analysis.
  • the second detection result includes the push and analysis of the quality control blood smear. Detection information related to dyeing;
  • the controller is also used for:
  • the said system also includes:
  • Hematology analyzer for testing at least one sample
  • the controller is used to obtain at least one sample of the first detection result based on the analysis of the blood analyzer, and determine whether the preset condition is satisfied in real time, and if the preset condition is satisfied, select the sample analyzed by the blood analyzer as the quality control sample; It is also used to control the scheduling device to transport the quality control sample to the smear preparation device.
  • the smear preparation device includes a printing device for printing sample information on the blood smear of the quality control sample, and the sample information includes a quality control identifier.
  • the controller is used to: identify the blood film appearance and/or cell distribution of the quality control blood smear according to the detection information related to the push in the second detection result; and according to the quality control blood
  • the blood film appearance morphology and/or cell distribution of the smear is used to judge the pushing quality of the pushing machine;
  • the detection information related to the slide push 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.
  • the controller is further configured to: identify at least one of the blood film color and the color shade of the quality control blood smear according to the detection information related to staining in the second detection result; and At least one of the color of the blood film of the quality control blood smear and the shade of the color is used to judge the staining quality of the smear preparation device; wherein the detection information related to the staining in the second detection result includes passing the cell At least one of the blood film color and the color depth of the quality control blood smear obtained by the image analysis device.
  • the controller is further used to: compare the corresponding result information in the first detection result and the second detection result of the quality control sample; and control the display device to output the comparison result.
  • an embodiment provides a sample analysis system, including:
  • Memory used to store programs
  • the processor is configured to execute the program stored in the memory to implement the above-mentioned method.
  • an embodiment provides a computer-readable storage medium, which is characterized by including a program, which can be executed by a processor to implement the method as described above.
  • the quality control samples can be automatically selected, and the quality control samples can be made into quality control blood smears, and then the cell image analysis device can control the quality control samples.
  • the blood smear is taken and analyzed, and the detection result based on the image shooting and analysis is obtained.
  • the cell image analysis device is automatically completed Or the accuracy management of instruments such as blood analyzers.
  • FIG. 1 is a schematic structural diagram of a sample analysis system provided by an embodiment of the present invention
  • FIG. 2 is a structural block diagram of a smear preparation device in a sample analysis system provided by an embodiment of the present invention
  • FIG. 3 is a schematic diagram of a blood smear in the sample analysis system provided by an embodiment of the present invention.
  • FIG. 4 is a structural block diagram of a cell image analysis device in a sample analysis system provided by an embodiment of the present invention.
  • FIG. 5 is a schematic diagram of the structure of a cell image analysis device in a sample analysis system provided by an embodiment of the present invention.
  • FIG. 6 is a flowchart of a method for accuracy management in a sample analysis system provided by an embodiment of the present invention.
  • FIG. 7 is a flowchart of an embodiment of step 1 in FIG. 6;
  • FIG. 8 is a structural block diagram of a sample analysis system provided by an embodiment of the present invention.
  • FIG. 9 is a flowchart of a method for accuracy management in a sample analysis system provided by an embodiment of the present invention.
  • FIG. 10 is a flowchart of step S5 in FIG. 9;
  • FIG. 11 is a flowchart of step S6 in FIG. 9;
  • FIG. 12 is a flowchart of a method for accuracy management in a sample analysis system provided by an embodiment of the present invention.
  • FIG. 13 is a flowchart of a method for accuracy management in a sample analysis system provided by an embodiment of the present invention.
  • FIG. 14 is a flowchart of quality control of a smear preparation device in a sample analysis system provided by an embodiment of the present invention.
  • connection and “connection” mentioned in this application include direct and indirect connection (connection) unless otherwise specified.
  • the sample analysis system 100 may be a blood analysis assembly line, which includes: at least one blood analyzer 110, at least one smear preparation device 120, and at least A cell image analysis device 130 and a control device 140.
  • the blood analyzer 110 is used for routine blood testing of the sample to be tested
  • the smear preparation device 120 is used for preparing smears of the sample to be tested
  • the cell image analysis device 130 is used for image capture and analysis of the cells in the smear
  • 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.
  • the sample analysis system 100 also includes a first transfer track 150 and a second transfer track 160.
  • the first transfer track 150 is used to transport a test tube rack 10 that can hold a plurality of test tubes 11 loaded with samples to be tested from the blood analyzer 110 to the coating.
  • the slide preparation device 120 and the second transport track 150 are used to transport the slide basket 20 that can load a plurality of prepared smears 21 from the smear preparation device 120 to the cell image analysis device 130.
  • the control device 140 is electrically connected to the first transmission track 150 and the second transmission track 160 and controls their actions.
  • the sample analysis system 100 also includes feeding mechanisms 170 and 180 respectively corresponding to the blood analyzer 110 and the smear preparation device 120.
  • Each feeding mechanism 170 and 180 includes loading buffer areas 171 and 181, and feeding detection areas 172 and 183. And unload the cache areas 173 and 183.
  • test tube rack 20 When the sample to be tested on the test tube rack 20 needs to be transported to the blood analyzer 110 for testing, the test tube rack 20 is first transported from the first transfer track 150 to the loading buffer area 171, and then from the loading buffer area 171 to the feeding The detection area 172 is detected by the blood analyzer 110. After the detection is completed, it is unloaded from the feed detection area 172 to the unloading buffer area 173, and finally from the unloading buffer area 173 into the first transport track 150.
  • the test tube rack 20 needs to be transported to the smear preparation device 120 to prepare smears.
  • the test tube rack 20 is first transported from the first transfer track 150 to the loading buffer area. 181, and then transported from the loading buffer area 181 to the feed detection area 182.
  • the smear preparation device 120 prepares the smear. After the smear preparation is completed, it is unloaded from the feed detection area 182 to the unloading buffer area 183, and finally Enter the first transport track 150 from the unloading buffer area 183.
  • the smear preparation device 120 stores the prepared smears in the slide glass basket 20, and transports the slide glass basket 20 containing the smears to be tested to the cell image analysis device 130 through the second transfer track 160, and the cell image analysis device 130 The cells in the sample on the smear to be tested are imaged and analyzed.
  • the sample analysis system 100 also includes a display device (not shown) for displaying the sample detection result and an input device for input.
  • the display device may be a liquid crystal screen, a touch screen or an LED display screen, and the control device 140 may output the processed data as 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 keys, a trackball, etc., to facilitate the user's input operations.
  • the display device may be provided on the blood analyzer 110, the cell image analysis device 130, or the control device 140, or be provided separately.
  • the smear preparation device 120 can be used to prepare smears for blood, body fluids and other samples. As shown in FIG. 2, the smear preparation device 120 includes a slide pusher 121, a dyeing machine 122 and a printing device 123.
  • the slide pusher 121 is used for pushing the sample according to preset slide pushing parameters.
  • the slide pushing process includes allocating the sample to the slide glass and pushing the sample on the slide glass into a blood film.
  • the slide pusher 121 includes a sampling mechanism for taking samples, a slide loading mechanism for moving the slides to the work line, a sample loading mechanism for loading samples on the slides, and a smoothing of the samples on the slides.
  • the sliding mechanism and the drying mechanism for drying the blood film on the glass slide.
  • the sampling mechanism When the sampling mechanism performs sample extraction, the sample is mixed first, and then the sampling device (such as a sampling needle) in the sampling mechanism is used to aspirate the sample.
  • the aspiration can be puncture aspiration (the sample container has a cover, and the sampling The device passes through the cover of the sample container), or it can be an open sample suction (the sample container is opened, and the sampling device directly sucks the sample from the open portion).
  • blood sample information testing can be performed to obtain information and comparison information.
  • it also includes a micro-injection mechanism, which can directly move the test tube inserted by the operator in the direction of the sampling device, or the sampling device can also move in the direction of the test tube inserted by the operator .
  • the micro-sampling mechanism can also move the test tube directly to the direction of the sample adding mechanism, or the sample adding mechanism can also move to the direction of the test tube inserted by the operator, directly via the sample adding mechanism (such as a blood drip needle). )
  • the sample is loaded after the blood sample is drawn. Since there is no need to draw blood through a sampling mechanism, the demand for blood samples can be reduced, thereby realizing small and preferential sampling. When the sampling is completed, the blood will be dripped onto the glass slide through the sample application mechanism.
  • the slide loading mechanism picks up the slide and loads the slide to the corresponding position to facilitate the blood drip operation.
  • operations such as left and right inspection of the glass slide and cleaning of the glass slide may also be performed, and then the glass slide is loaded.
  • the loaded slide can be printed with relevant information, and at the same time perform operations such as positive and negative detection of the slide.
  • the blood dripping needle of the sample adding mechanism drops the sample onto the glass slide and then performs the slide pushing operation, and the blood is pushed on the slide glass into the shape of a blood film through the slide pushing mechanism.
  • the blood film on the slide can be dried to stabilize its shape, as shown in Figure 2.
  • the glass slide can be driven to turn over to meet corresponding requirements.
  • the dried blood smear can also be tested for drying to determine the effect of blood film drying.
  • the dried blood smear can also be tested for blood film expansion to determine whether the blood film is expanded and whether the expanded state meets the requirements.
  • the staining machine 122 is used for staining the glass slide, specifically, staining the blood film on the glass slide according to preset staining parameters.
  • the printing device 123 is used to print the sample information on the blood smear of the sample. As shown in FIG. 3, a label area is provided on the blood smear. The sample information is printed on the label area of the blood smear, and the sample is printed on the label area.
  • the information may include information such as sample number, barcode, and quality control identification.
  • the cell image analysis device 130 such as a cell image analyzer, as shown in FIG. 4, 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 for coating The cells in the sample smeared on the film are photographed.
  • the smear moving device 132 is used to move the smear relative to the imaging device 131, so that the imaging device 131 captures a cell image of a specific area of the smear, and the image analysis device 133 is used to image the smear. Slice cell images for analysis.
  • the 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 10 times objective lens
  • the second objective lens may be, for example, a 100 times objective lens.
  • the lens group 1311 may further include a third objective lens, and the third objective lens may be, for example, a 40x objective lens.
  • the cell image analysis device 130 further includes an identification device 134, a slide clamping device 135, and a smear recovery device 136.
  • the identification device 134 is used to identify the identity information of the smear
  • the slide clamping device 135 is used to clamp the smear from the identification device 134 to the smear moving device 132 for detection
  • the smear recovery device 136 is used to place the tested Smear.
  • the cell image analysis device 130 also includes a slide basket loading device 137 for loading a slide basket containing the smear to be tested, and the slide gripping device 135 is also used for loading the slide basket loaded on the slide basket loading device 137
  • the glass slide to be tested in is clamped to the identification device 134 for identification information identification.
  • 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.
  • the blood analysis pipeline provided by the present invention includes one, two or more blood analyzers 110, and one, two or more cell image analysis devices 130.
  • it includes Two blood analyzers 110 and two cell image analysis devices 130 are taken as an example for description.
  • Fig. 8 is only used as an example, and does not limit the number of various instruments and devices.
  • the blood analysis pipeline shown in FIG. 8, the blood analyzer 110, the cell image analysis device 130, and the smear preparation device have been described in the above content, and will not be repeated here.
  • the scheduling device is used to schedule samples and blood smears, and includes the first transmission track 150, the second transmission track 160, the feeding mechanism 170, and the feeding mechanism 180 as described above.
  • the above-mentioned display device includes a display, and the display is provided on the control device 140.
  • the control device 140 further includes a controller 142 and a memory 143.
  • the memory 143 is used to store various types of data, such as computer programs, detection results of a blood analyzer, detection results of a cell image analysis device, and data generated by a smear preparation device.
  • the controller 142 includes a processor, which can be used to execute programs to perform accuracy management on the blood analysis pipeline.
  • the accuracy management can include judgments on the accuracy of instrument results, quality judgments, etc., which can also be referred to as quality control.
  • the automatic accuracy management method for the sample analysis system 100 for the blood analysis pipeline includes the following steps:
  • Step 1 Obtain samples for quality control. There are many ways to obtain samples for quality control. One way is shown in Figure 7, including:
  • Step 1.1 The user places a sample to be tested, and the blood analyzer 110 performs a test on the sample to be tested, and obtains the first test result of the sample to be tested.
  • the sample is a blood sample, such as fresh blood from a patient.
  • Step 1.2 The controller selects quality control samples from the samples to be tested that have been tested according to the sample test results measured by the blood analyzer 110 when the preset quality control trigger conditions are met.
  • 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 control of the cell image analysis device 130 Device.
  • the controller 142 of the control device 140 is taken as an example for description.
  • the number of selected quality control samples can be one or more.
  • 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 perform multiple quality control on the same function. , In order to improve the accuracy of quality control results.
  • the controller obtains at least one sample of the first detection result based on the analysis of the blood analyzer 110, and determines in real time whether the preset quality control trigger condition is met, and if the preset quality control trigger condition is met, it is selected and analyzed by the blood analyzer 110
  • the sample is used as a quality control sample.
  • the blood analyzer 110 normally detects samples, and when the quality control trigger condition is reached, the present invention can respond to the quality control trigger condition in real time to start the quality control.
  • Quality control is the abbreviation for quality control, which is necessary to determine whether the functions and performance of various systems, instruments, equipment, etc. are normal.
  • the preset quality control trigger conditions include at least one of the Nth sample, the preset time, the preset load, and the preset test result after the blood analyzer starts the test for the first time in each cycle, where N is A natural number not less than 1.
  • the controller selects quality control samples after the first sample is tested every day, or the controller selects quality control samples at 9 o'clock every morning, or the load of the sample analysis system is lower than the preset value, the controller selects quality control samples, or the controller Determine whether the first test result of each sample obtained from the blood analyzer 110 is a test result that meets a preset condition, and if so, the controller selects a quality control sample, and the test result that meets the preset condition may be the value of each blood routine test result All are in the normal range or include abnormal information.
  • the former can determine whether the normal sample is detected by the blood analyzer and the cell image analysis device.
  • the latter can determine whether the sample is detected by the blood analyzer and the cell image analysis device. Whether the exception information is consistent.
  • the above trigger conditions can be set by the user, and after the preset quality control trigger conditions are met, the quality control process can be automatically executed.
  • the controller selects quality control samples according to the test results of the samples measured by the blood analyzer 110.
  • the selected quality control samples may be samples with normal results.
  • the controller selects the detection value of the preset type of cells in the first test result. Samples within the preset range are used as quality control samples. For example, select the sample with the white blood cell count (WBC) in the preset first range as the quality control sample, select the sample with the red blood cell count (RBC) in the preset second range as the quality control sample, and select the average
  • WBC white blood cell count
  • RBC red blood cell count
  • MCV red blood cell volume
  • the selected quality control sample can be one or more, at least one of the three samples can be selected as the quality control sample , Specific can be determined according to quality control requirements.
  • the first range, the second range and the third range can be set according to quality control requirements.
  • the first range is 7.0 ⁇ 10 9 to 10.0 ⁇ 10 9 /L
  • the second range is 4.0 ⁇ 10 12 to 5.5 ⁇ 10 12 /L
  • the third range is 85-95fL.
  • the selected quality control sample may also be a sample with an abnormal result.
  • the controller selects a sample that includes abnormal information in the first detection result as the quality control sample.
  • the abnormal information includes at least one of Plasmodium, platelet aggregation, red blood cell aggregation, hematocrit (HCT) higher than a preset threshold, uneven red blood cell size, and abnormal white blood cells.
  • the selected samples can include both normal samples and abnormal samples. In this way, quality control can be performed from two perspectives, which can meet various quality control requirements.
  • Step 1.3 The controller controls the scheduling device, such as the first track 150, to transport the quality control sample to the pusher of the smear preparation device 120.
  • Another way to obtain samples for quality control includes:
  • Step 1.1' the blood analyzer 110 detects the sample and obtains the first detection result of the sample. This step is the same as step 1.1 of the previous method.
  • 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 satisfied.
  • the sample from the machine will be used as a quality control sample. That is, in this method, the sample is not 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 smear preparation device 120 pusher. Similarly, there can be one or more samples delivered to the pusher, as long as the quality control requirements are met.
  • Another way to obtain samples for quality control includes:
  • Step 1.1 the blood analyzer 110 detects the sample and obtains the first detection result of the sample. This step is the same as step 1.1 of the previous method.
  • Step 1.2 the Nth sample is tested after the blood analyzer 110 is started for the first time in each cycle, or the preset time after the test is started for the first time, the scheduling device is controlled to transport the sample detected by the blood analyzer 110 to the smear preparation device 120
  • the cycle can be a quality control cycle, such as a natural day, that is, every day the blood analyzer 110 tests the Nth sample after the first start of the test, or the preset time after the first start of the test, the control scheduling device will pass the blood
  • the sample detected by the analyzer 110 is transported to the pusher of the smear preparation device 120, and then the quality control starts.
  • the automatic accuracy management method may further include: the controller provides automatic quality control options on the display interface of the display device for the user to select, and after receiving the selected automatic quality control options After the instruction, execute the automatic quality control start step, that is, step 1.2, step 1.2' or step 1.2".
  • the automatic accuracy management method of the present invention can be turned on or off by the user. If turned off, the user can manually perform quality control operating.
  • the controller controls the pusher of the smear preparation device 120 to prepare the quality control sample into a blood smear, that is, a blood smear.
  • the controller controls the slide pushing machine to push the quality control sample according to preset slide pushing parameters.
  • the slide pushing process includes allocating the quality control sample to the glass slide, and pushing the sample on the glass slide into a blood film.
  • the pushing parameters may include the width, length, tail shape, etc. of the blood film.
  • the pushing machine can push the film according to the preset pushing parameters to prepare a blood smear that meets the preset pushing parameters.
  • the blood smear thus prepared is shown in Figure 2.
  • One or more blood smears can be prepared from the same sample, and the specific number is determined according to the quality control requirements, so as to well meet various quality control requirements.
  • 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 the quality control identification.
  • the printing device prints, sprays, and attaches the quality control identification. , Write or draw on the label area shown in Figure 2, so that the quality control blood smear has a quality control mark for easy identification. Since the quality control label is set, the subsequent dyeing and reading will be different from conventional samples. Corresponding dyeing and reading can be performed according to the quality control requirements, so that quality control can be better.
  • the controller controls the staining machine to stain the quality control blood smear.
  • it controls the staining machine to stain the blood film on the slide according to preset staining parameters or preset staining modes; the preset staining parameters can be
  • the parameter corresponding to the characteristics of the sample blood, body fluid
  • the slide pusher and the staining machine both select preset parameters or modes to push and stain, so as to prepare blood smears that match the preset parameters or preset patterns, and the subsequent cells
  • the detection result can be used to judge the pushing and staining quality of the cell image analysis device 130. It can be seen that the present invention can be based on quality control requirements from sample selection, blood smear preparation to staining. It can quickly complete the quality control.
  • the quality control blood smear is washed and dried, and then the controller controls the scheduling device, such as the second transmission track 160, to transport the quality control blood smear to the cell image analysis device 130.
  • Step 4 The controller controls the cell image analysis device 130 to take and analyze the quality control blood smear to obtain a second detection result. Specifically, the controller controls the cell image analysis device 130 to work, the recognition device of the cell image analysis device 130 recognizes the quality control mark on the blood smear of the quality control sample, and the cell image analysis device 130 knows that the current blood smear is quality. The blood smear of the control sample is then switched to the quality control mode, and the quality control blood smear is photographed and analyzed in the quality control mode to obtain the second test result.
  • the cell image analysis device 130 can use a film reader, and the images taken in the quality control mode are more comprehensive than the images taken in the conventional mode, and the second detection result obtained by the analysis is also more comprehensive than the conventional sample, so as to meet the quality control requirements, that is,
  • the cell image analysis device 130 can perform shooting and analysis according to quality control requirements.
  • the working mode of the cell image analysis device 130 includes white blood cell analysis mode, red blood cell analysis mode, or platelet analysis mode, etc. It can analyze and detect white blood cells, red blood cells, or platelets respectively, and the quality control mode can be these three.
  • the combination mode of this mode can more comprehensively photograph and analyze various types of cells.
  • 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 used as a reference, it can be compared to determine whether the second detection result is accurate, so as to perform quality control on the cell image analysis device 130. If the second detection result is used As a reference, it can be compared to determine whether the first detection result is accurate, so as to perform quality control on the blood analyzer 110. The following will be introduced one by one.
  • step 1 the quality control of the blood analyzer 110 is also performed; if the quality control of the blood analyzer 110 is qualified, the sample is tested to obtain the first test of the sample result. That is, after the quality control of the blood analyzer 110 is qualified, step 1 can be started. In this way, in step 5, the first detection result obtained by the blood analyzer 110 can be used as a reference to perform quality control on the cell image analysis device 130.
  • the quality control of the blood analyzer 110 may include the use of standard quality control products to perform quality control on the blood analyzer, or the comparison of the results of multiple blood analyzers for quality control, if the blood analyzer 110 checks the test results of the standard quality control products Within the preset range, or the detection result of the blood analyzer 110 on the same sample is consistent with the detection results of other analyzers, the quality control of the blood analyzer 110 is qualified.
  • Comparing the first test result and the second test result of the quality control sample may specifically include: comparing the first test result value in the first test result of the predetermined type of cells of the quality control sample and the second test result in the second test result.
  • Test result value for example, compare the lymphocytes and neutrophils in the first test result and the second test result; if the first test result value and the second test result value of the preset type of cells in the quality control sample If the deviation exceeds the preset range, a prompt message will be output.
  • the display interface can display 10% of the deviation between the two, and it can also indicate that the deviation between the two exceeds the preset range.
  • the controller compares the white blood cell count value of the quality control sample in the first test result and the second test result. The difference between the count values in the detection result does not exceed the preset range, which indicates that the detection of the white blood cell count value by the cell image analysis device 130 meets the accuracy requirements.
  • the controller compares the red blood cell count value of the quality control sample in the first test result and the count value in the second test result. The difference between the two does not exceed the preset range, indicating that the cell image analysis device 130 detects the red blood cell count value in accordance with the accuracy Claim.
  • the controller compares the average red blood cell volume in the first test result and the average red blood cell volume in the second test result of the red blood cells of the quality control sample, and the difference between the two does not exceed the preset range, indicating that the cell image analysis device 130 detects the average red blood cell volume Meet the accuracy requirements.
  • this embodiment can judge the cell image analysis device 130 by comparing the result deviation of the preset parameters in the first test result and the second test result. If the detection meets the requirements, and the deviation exceeds the preset range, a prompt message indicating that the quality control of the cell image analysis device 130 is unqualified is output. Of course, it is also possible to judge whether the detection of the cell image analysis device 130 meets the requirements by comparing the deviation rate of the results of the preset parameters in the first detection result and the second detection result.
  • the controller compares the deviation rate between the second test result of the quality control sample and the first test result, that is, the deviation percentage, for example, the deviation is divided by the first test result value and multiplied by 100% to obtain the deviation rate . If the deviation rate between the second test result of the quality control sample and the first test result exceeds the corresponding preset range, the controller outputs a prompt message indicating that the quality control of the cell image analysis device 130 is unqualified through the display device, of course, the prompt message It can be more specific. For example, the detection result of a certain type of cell by the output cell image analysis device 130 does not meet the accuracy requirement.
  • whether the deviation rate of the first test result and the second test result of the quality control sample exceeds the preset range may include: one is to compare the result value of multiple preset parameters, and the result value of the preset parameter may be a neutral score. If the detection value of leaf nuclear granulocytes, lymphocytes, eosinophils and other cells, if any of the cells in the first test result and the second test result have a deviation beyond the range, the quality control sample The deviation rate of the first test result and the second test result exceeds the preset range; if all the preset parameters do not exceed the preset range in the first test result and the second test result, the first test result and the second test result of the quality control sample The deviation rate of the test results did not exceed the preset range.
  • the controller controls the scheduling device to send the sample to be tested (quality control sample ) Transport to another blood analyzer for retesting to obtain the first retest result based on the analysis of the blood analyzer; the controller compares the first retest result with the second test result to determine the value of the first retest result Whether the deviation from the second test result value exceeds the preset range, whether the deviation rate between the first retest result and the second test result exceeds the preset range, etc., the specific process is the same as the above-mentioned comparison process of the first test result and the second test result , I won’t repeat it here. Re-testing after replacing the blood analyzer can eliminate the interference of the blood analyzer itself on the quality control of the cell image analysis device 130.
  • the controller may also control the scheduling device to send the sample to be tested (quality control sample) Transport to another cell image analysis device for retesting to obtain a second retest result based on the cell image analysis device; then compare the second retest result with the first test result to determine the first test result Whether the deviation between the value and the second retest result value exceeds the preset range, whether the deviation rate between the first test result and the second retest result exceeds the preset range, etc., the specific process is the same as the above-mentioned first test result and second test result The comparison process will not be repeated here. Re-testing after replacing the cell image analysis device 130 can eliminate the interference of the cell image analysis device 130 on the quality control of the cell analyzer.
  • the controller can also control the scheduling device to send the sample to be tested (quality control).
  • the sample is transported to the original blood analyzer for retesting, and transported to the original cell image analysis device for retesting to obtain the first retest result based on the original blood analyzer analysis and the second retest based on the original cell image analysis device.
  • Re-test result and then compare the first re-test result with the second re-test result.
  • the specific process of the comparison is the same as the above-mentioned comparison process of the first test result and the second test result, which will not be repeated here.
  • the re-testing of quality control samples includes retesting with a blood analyzer, retesting with a cell image analysis device, or retesting with the original blood analyzer or cell image analysis device.
  • the quality control sample is re-tested again, and the quality control judgment can be made again to obtain more accurate quality control results.
  • the controller can reselect the quality control sample weight from the samples to be tested that have been tested. Test, and perform quality control judgment again to improve accuracy.
  • the cell image analysis device 130 and the blood analyzer 110 have their own advantages in sample detection.
  • the cell image analysis device 130 is more accurate than the blood analyzer 110 in detecting the morphology of cells, so the detection results of the cell image analysis device 130 can be used.
  • the quality control judgment of the blood analyzer 110 is performed.
  • the first detection result of the quality control sample includes abnormal information that meets the preset quality control trigger condition. For example, in step 1, the sample including the abnormal information is selected as the quality control sample, and then the quality control sample is used to perform the blood test.
  • the analyzer 110 performs quality control.
  • the controller compares whether the abnormal information in the first test result of the quality control sample is consistent with the abnormal information in the second test result; 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 ,
  • the corresponding prompt information is output through the display device, for example, the prompt information that the blood analyzer 110 fails to pass the abnormal information detection, of course, if the abnormal information of the two detection results is consistent, the blood analyzer 110 is output through the display device Prompt information that the detection of abnormal information is qualified. For example, for malaria parasites, PLT aggregation, red blood cell aggregation, abnormal cell alarms and other abnormal information, the cell image analysis device 130 can usually obtain the corresponding detection results more accurately.
  • the blood can be analyzed based on the detection results of the cell image analysis device 130.
  • the meter 110 performs accuracy management.
  • the embodiment of the present invention not only realizes the automatic quality control of the cell image analysis device 130, but also realizes the automatic quality control of the blood analyzer 110.
  • the embodiment of the present invention can also judge the pushing and staining quality of the quality control blood smear according to the second detection result measured by the cell image analysis device 130, that is, it can also perform quality control judgments on the pushing machine and the staining machine.
  • the second detection result includes detection information based on cell image shooting and analysis, and detection information related to the pushing and staining quality of the cell image analysis device.
  • the cell image analysis device 130 When the cell image analysis device 130 shoots the quality control blood smear in the quality control mode, it can shoot the image of the quality control blood smear, and the blood film shape and blood film color can be recognized according to the image recognition algorithm; cell image analysis device 130 can also scan the blood smear through its objective lens to identify the cell distribution, blood film boundary, blood film shape, blood film color and other information of the quality control blood smear; after obtaining these information related to the push and staining , It can be judged whether the quality of pushing and dyeing meets expectations.
  • the blood film size, shape, cell distribution, and color of the quality control blood smear should be the same as the preset
  • the slide parameters are consistent with the preset staining parameters or staining modes. If the blood film size, shape, cell distribution, and color of the quality control blood smear are found by the cell image analysis device 130, they are consistent with the preset slide parameters and presets. If the dyeing parameters or dyeing patterns do not match, the quality control of the smear preparation device can be judged as unqualified.
  • the controller may identify at least one of the appearance of the blood film and the cell distribution of the quality control blood smear according to the detection information related to the push in the second detection result; and according to the quality control blood smear At least one of the blood film appearance and cell distribution is used to judge the quality of the film pusher.
  • the detection information related to the slide 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.
  • the image analysis device 130 may The blood film appearance morphology image and cell distribution image of the quality control blood smear obtained.
  • the controller can recognize the appearance of the blood film in the image according to the appearance of the blood film of the quality control blood smear.
  • the controller recognizes the cell distribution according to the cell distribution image of the quality control blood smear, for example, judges whether the position distribution of the specified cells on the blood film meets the requirements, and if it does not meet the requirements, it indicates that the quality of the push film is unqualified.
  • the controller can also identify at least one of the blood film color and color depth of the quality control blood smear according to the detection information related to staining in the second detection result; according to the quality control blood smear At least one of the color of the blood film and the shade of the color is used to judge the staining quality of the smear preparation device.
  • the detection information related to staining in the second detection result includes at least one of the blood film color and the color depth of the quality control blood smear obtained by the cell image analysis device 130.
  • the controller recognizes the color of the blood film (such as chromaticity value) and the depth of the color (such as gray value) according to the blood film image in the second detection result.
  • the quality control blood coating can also be obtained directly through the cell image analysis device 130.
  • the blood film color and color depth of the film determine whether the blood film color is the preset color, if not, it means the dyeing quality of the dyeing machine is unqualified, judge whether the blood film color meets the preset depth, and if it does not, it means the dyeing quality is not good qualified.
  • step 6 After the second detection result is obtained in step 4, the controller executes the judgment of the push film quality and dyeing quality. After the push film quality and dyeing quality are judged to meet the requirements, step 5 is executed. That is, after judging and confirming that the pusher and the staining machine are stained normally, the quality control of the cell image analysis device 130 is performed, which eliminates the interference of the quality of the pusher and the dyeing quality on the quality control of the cell image analysis device 130. The accuracy is good.
  • the present invention is based on the entire blood analysis pipeline system to realize the quality control of the slide pusher, the dyeing machine, and the slide reader. Not only is it processed automatically by the entire blood analysis pipeline, without manual or only a small amount of participation, but the test results can also reflect the consistency and relevance of the entire 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 a part of the system. However, the process of selecting samples, pushing films, dyeing, and reading films according to the present invention is in accordance with quality control. When the demand is in progress, the system's various functional characteristics can be covered, the quality control judgment is comprehensive, and the accuracy is high.
  • an automatic accuracy management method for 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 step.
  • Step S1 After the pipeline is ready, the user places the sample to be tested.
  • the pipeline readiness means that the software and hardware of the pipeline are ready to be tested after the pipeline is turned on or exited from sleep. After the sample to be tested is put in, the system can start the process of automatic sample transportation and testing.
  • the batch sample refers to the samples placed on one or more sample racks placed by the user.
  • the blood analyzer can test these samples in sequence.
  • the sample rack is used to carry at least one sample, and usually can carry multiple samples.
  • Step S2 The blood analyzer detects the current sample at its detection position to obtain the first detection result of the sample.
  • This embodiment is the blood routine detection result.
  • Step S3 The controller automatically screens samples for preparing quality control blood smears based on the results of routine blood tests; the samples must meet specific parameter requirements: for example, the count value of WBC is between 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 85-95fL and so on. If the blood routine test 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 samples can also be multiple samples. For example, part of the quality control samples are samples with all test items within the normal range, or part of the quality control samples are samples with some parameters exceeding the limit, such as high HCT in the results of routine blood tests , Samples with uneven RBC size and abnormal white blood cells.
  • Step S4 The controller automatically transports the quality control samples to the pusher through the scheduling device.
  • Step S5. The controller prepares the quality control blood smear through the smear preparation device, and collects the blood sample and drops it on the glass slide to form a blood film.
  • the preparation method of the quality control blood smear includes the following steps:
  • Step S51 The printing device prints sample information on the label area on the glass slide.
  • the sample information includes sample number, barcode, quality control identification, etc.
  • Step S52 The slide pusher collects the quality control sample and drops it onto the glass slide.
  • Step S53 The slide pusher pushes the blood on the slide into a blood film.
  • the controller controls the slide pusher to push the blood on the slide into a blood film according to preset slide push parameters.
  • the pushing parameters may include the width, length, tail shape, etc. of the blood film.
  • the pushing machine can push the film according to the preset pushing parameters to prepare a blood smear that meets the preset pushing parameters.
  • the blood smear thus prepared is shown in Figure 2.
  • each quality control sample can prepare one or more quality control blood smears according to the quality control requirements, or prepare multiple blood smears of different quality control samples.
  • Step S54 detection of the appearance of the blood film, for example, a film pusher detects the appearance of the blood film, so as to facilitate the judgment in the next step.
  • Step S55 Determine whether the blood film appearance and blood cell distribution meet the requirements. For example, the film pusher judges whether the detected blood film appearance (the width, length, tail shape, etc.) of the blood film meets the preset push film parameters, and then judges the designation Whether the position distribution of the cells on the blood membrane meets the requirements.
  • the film pusher judges whether the detected blood film appearance (the width, length, tail shape, etc.) of the blood film meets the preset push film parameters, and then judges the designation Whether the position distribution of the cells on the blood membrane meets the requirements.
  • Step S56 If the blood film appearance and blood cell distribution of the quality control blood smear meet the requirements, the quality control blood smear is transported to the staining machine or the staining module through the scheduling device. If at least one of the blood film appearance and blood cell distribution of the quality control blood smear does not meet the requirements, return to step S51 to prepare a blood smear of the quality control sample again.
  • Step S6 The staining machine or the staining module stains the quality control blood smear.
  • dyeing can specifically include the following steps:
  • Step S61 the dyeing machine or dyeing module automatically sets the dyeing mode and dyeing parameters; there are usually many dyeing modes and dyeing parameters of the dyeing machine or dyeing module, and different dyeing modes or dyeing parameters correspond to different dyeing effects. For quality control samples, You can select the dyeing mode and/or dyeing parameters corresponding to the quality control mode.
  • Step S62 the staining machine or the staining module stains the next quality control blood smear.
  • Step S63 the staining machine or the staining module determines whether there is an unstained quality control blood smear; if not, proceed to the next step S64; if there is an unstained quality control blood smear, then return to step S61 to continue to the next The sample is stained.
  • step S64 the working mode of the staining machine or the staining module is switched to the normal staining mode to prepare for staining the blood smears of ordinary patients other than the quality control samples.
  • Step S65 the dyeing machine or the dyeing module cleans and drys the dyed quality control slides.
  • Step S7 The controller delivers the quality control blood smear to the cell image analysis device through the scheduling device.
  • Step S8 After the stained and dried slides are 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 shooting in the quality control mode. Analyze and get the second test result.
  • the controller relies on the imaging and analysis of the blood smear by the cell image analysis device to determine whether the pusher and stainer are working properly.
  • Step S9 The controller compares the morphological analysis result of the cell image analysis device with the detection result of the previous one or more blood analyzers to confirm whether the quality control of the cell image analysis device is normal.
  • the foregoing embodiment provides a specific process for the controller to compare the morphological analysis results of the cell image analysis device with the detection results of the previous blood analyzer.
  • multiple blood analyzers can also be used to test the quality control samples in advance.
  • the controller relies on the morphological analysis result of the cell image analysis device to compare with the detection results of multiple blood analyzers, so as to further ensure the accuracy of the first detection result, so as to make quality control judgments on the cell image analysis device.
  • the specific quality control of the cell image analysis device has been described in the above embodiments, and will not be repeated here.
  • the controller also relies on the morphological analysis result of the cell image analysis device (the instrument classification result of the cell image analysis device or the accurate result obtained under artificial adjustment) to confirm whether some test results of the blood analyzer meet the expectations; for example, the blood analyzer
  • the conventional quality control of blood analyzers usually fails to obtain accurate quality control results.
  • the image analysis device is more intuitive and accurate for the detection of malaria parasites, PLT aggregation, red blood cell aggregation, abnormal cell alarms and other items.
  • the detection results of the blood analyzer can be quality controlled through the detection results of the cell image analysis device. .
  • Step S81 The cell image analysis device reads the quality control mark of the quality control blood smear.
  • Step S82 The cell image analysis device automatically switches to the quality control mode under the trigger of the quality control flag.
  • 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 a corresponding image and output it to the controller.
  • Step S84 The controller judges whether the appearance of the blood film is normal. If it is abnormal, it means that the quality of the film pushing machine does not meet the requirements, and it can output a corresponding prompt through the display. The specific process has been described in the foregoing embodiment, and will not be repeated here.
  • Step S85 the cell image analysis device scans the overall color of the blood film, evaluates the color color and the color depth, and outputs it to the controller.
  • Step S86 The controller judges whether the blood film color is abnormal, and if it is abnormal, it means that the dyeing quality of the dyeing machine does not meet the requirements. The specific process has been described in the foregoing embodiment, and will not be repeated here.
  • Step S87 The cell image analysis device scans the distribution characteristics of the blood film under the microscope, and recognizes the cell distribution shape. For example, the normal blood film becomes thinner in sequence from the head to the tail.
  • Step S88 Scan the distribution characteristics of the blood film under the microscope through the cell image analysis device, and the controller recognizes whether the blood film distribution or cell distribution meets the requirements. If the cell distribution does not meet the requirements, it means that the pusher quality does not meet the requirements. Corresponding prompt information can be output. The specific process has been described in the foregoing embodiment, and will not be repeated here.
  • Step S91 The cell image analysis device locates and photographs the cells of the blood smear.
  • the controller obtains the photos taken by the cell image analysis device.
  • Step S92 The controller judges whether the positioning and shooting function of the cell image analysis device meets the requirements; usually the cell image analysis device locates the cells on the blood smear through a low-power lens, such as a 10x lens, and locates the target number of cells For example, after locating 100 white blood cells, switch to a high-power lens. For example, a 100-fold lens takes pictures of the localized cells. If the cell image analysis device cannot locate the target number of cells, or after the target number of cells, the high-power lens If the target number of cells cannot be photographed, it means that the positioning or photographing function of the cell image analysis device does not meet the requirements.
  • a low-power lens such as a 10x lens
  • Step S93 The cell image analysis device performs cell shooting and pre-classification on the quality control blood smear.
  • the cell image analysis device has multiple types of cells, and can output different types of cell images and pre-classify these cells.
  • the pre-classification is It means that the cell image analysis device automatically classifies and counts the captured cells.
  • the pre-classification results usually need to be manually confirmed and adjusted before the detection result of the cell image analysis device can be output.
  • Step S94 The controller judges 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 the cell image
  • the accuracy of the classification result of the analysis device does not meet the requirements. For example, if the deviation between the five classification results of white blood cells measured by blood cell analysis and the pre-classification result of the cell image analysis device exceeds the allowable range, it means that the accuracy of the classification result of the cell image analysis device does not meet the requirements.
  • the accuracy of the classification result of the cell image analysis device meets the requirements. If the five classification results of white blood cells measured by the blood cell analysis are consistent with the pre-classification result of the cell image analysis device or the deviation is within the allowable range, it means that the accuracy of the classification result of the cell image analysis device meets the requirements.
  • an automatic accuracy management method applied to a sample analysis system may be a blood analysis pipeline including a blood analyzer, a smear preparation device, and a cell image analysis device ,
  • the method includes the following steps.
  • Step S2' The blood analyzer analyzes the sample to obtain a first test result of the sample, such as a blood routine test result.
  • Step S3' It is judged whether the quality control conditions are met, and if not, the normal sample counting process is performed on the currently tested sample.
  • the quality control conditions include that the first test result meets the preset conditions. For example, if the white blood cell count in the first test result of the sample is greater than 7.0 (10 ⁇ 9 /L), it can be selected as a quality control sample; the quality control conditions can be further Including the preset time, for example, between 8:00-8:30 every day, select the sample whose first test result meets the preset conditions; or, the quality control condition can also include the Nth sample that has been tested in each quality control cycle For example, once a day for quality control, the quality control cycle is one day.
  • the blood analyzer After the line is started every day, the blood analyzer will automatically start the quality control process after the first sample is measured, or after the line is started every day, the blood analyzer will test multiple samples (e.g. 3 samples) and then select the sample whose first test result meets the preset conditions from these multiple samples to start the quality control process; in this way, the quality control process can be automatically completed immediately after the test is started every day on the assembly line to ensure that the day Accuracy of sample analysis; quality control conditions can also include preset loads, such as selecting a time when the load is small for quality control, which can increase the speed of quality control and avoid affecting the normal testing of patient samples.
  • preset loads such as selecting a time when the load is small for quality control, which can increase the speed of quality control and avoid affecting the normal testing of patient samples.
  • Step S4' If the quality control conditions are met, the sample is transported to the smear preparation device.
  • Step S5' The smear preparation device prepares the sample and prints the quality control mark on the blood smear of the sample.
  • Step S7' The blood smear of the sample is transported to the cell image analysis device.
  • Step S8' The cell image analysis device recognizes the quality control mark of the sample, switches to the quality control mode, and shoots and analyzes the blood smear of the sample to obtain a second detection result based on the image shooting and analysis.
  • 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.
  • the specific process of each step has been described in the above embodiment, and will not be repeated here.
  • 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.
  • the quality control of the smear preparation device is performed separately, that is, the quality of pushing and dyeing is judged.
  • the specific process is shown in Figure 14, including steps S1, S2, S4-S8, S9' , Where steps S1, S2, S4-S8 may be the same as the embodiment shown in FIG. 9, and will not be repeated here.
  • step S9' the controller judges the pushing and staining quality of the quality control blood smear according to the second detection result.
  • the specific process has been described in detail in the foregoing embodiment, and will not be repeated here.
  • the program may be stored in a computer-readable storage medium.
  • the storage medium may include: read-only memory, random access memory, magnetic disk, optical disk, hard disk, etc.
  • the computer executes the program to realize the above-mentioned functions.
  • the program is stored in the memory of the device, and when the program in the memory is executed by the processor, all or part of the above functions can be realized.
  • the program can also be stored in a storage medium such as a server, another computer, a magnetic disk, an optical disk, a flash disk, or a mobile hard disk, and saved by downloading or copying.
  • a storage medium such as a server, another computer, a magnetic disk, an optical disk, a flash disk, or a mobile hard disk, and saved by downloading or copying.
  • the principles herein can be reflected in a computer program product on a computer-readable storage medium, which is pre-installed with computer-readable program code.
  • a computer-readable storage medium Any tangible, non-transitory computer-readable storage medium can be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROM, DVD, Blu Ray disks, etc.), flash memory and/or the like .
  • These computer program instructions can be loaded on a general-purpose computer, a special-purpose computer, or other programmable data processing equipment to form a machine, so that these instructions executed on the computer or other programmable data processing device can generate a device that realizes the specified function.
  • Computer program instructions can also be stored in a computer-readable memory, which can instruct a computer or other programmable data processing equipment to operate in a specific manner, so that the instructions stored in the computer-readable memory can form a piece of Manufactured products, including realizing devices that realize designated functions.
  • Computer program instructions can also be loaded on a computer or other programmable data processing equipment, so as to execute a series of operation steps on the computer or other programmable equipment to produce a computer-implemented process, so that the execution on the computer or other programmable equipment Instructions can provide steps for implementing specified functions.
  • Coupled refers to physical connection, electrical connection, magnetic connection, optical connection, communication connection, functional connection and/or any other connection.

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Abstract

一种样本分析***（100）及其精度管理方法，可在样本分析***（100）启动样本测试后，自动挑选质控样本，将质控样本制作成质控血涂片，之后细胞图像分析装置（130）对质控血涂片进行拍摄及分析，得到基于图像拍摄及分析的检测结果，通过将细胞图像分析装置（130）的检测结果与血液分析仪（110）的检测结果进行比较，并输出比较结果，从而自动完成对细胞图像分析装置（130）或血液分析仪（110）等仪器的精度管理。

Description

一种样本分析***及其自动精度管理方法 技术领域
本发明涉及医疗器械领域，具体涉及一种样本分析***及其自动精度管理方法。
背景技术
血液分析的过程中，通常会用到血液分析仪、涂片制备装置(又称推片染色机)及细胞图像分析装置等。为了确保推片染色机和细胞图像分析装置等仪器的功能和性能正常，必须定期进行质控。现有技术中，对于推片染色机和细胞图像分析装置的质控都是人工完成的，操作复杂繁琐，耗时费力，效率低。
发明内容
本发明主要提供一种样本分析***及其自动精度管理方法。
根据第一方面，一种实施例中提供一种样本分析***的精度管理方法，包括如下步骤：
血液分析仪对待测样本进行检测；
控制器在满足预设的质控触发条件下，根据血液分析仪测得的样本检测结果从已经检测完成的待测样本中挑选质控样本；所述质控样本经血液分析仪检测的结果为第一检测结果；
控制器控制调度装置将质控样本运送至推片机；
推片机将所述质控样本制备成质控血涂片；
染色机对所述质控血涂片进行染色；
控制器控制调度装置将质控血涂片运送至细胞图像分析装置；
细胞图像分析装置对所述质控血涂片进行拍摄及分析，得到第二检测结果；
将所述质控样本的第一检测结果及第二检测结果进行比较；
输出所述比较结果。
所述的方法中，所述预设的质控触发条件包括每个周期血液分析仪首次启动测试后测试完第N个样本、预设的时间、预设的负载和预设的 检测结果中的至少其中之一，其中N为不小于1的自然数。
所述的方法中，所述将所述质控样本的第一检测结果及第二检测结果进行比较包括：
比较所述质控样本的预设类型的细胞在第一检测结果中的第一检测结果值及在第二检测结果中的第二检测结果值；
如果所述质控样本的预设类型的细胞的第一检测结果值及第二检测结果值的偏差超过预设范围，则输出提示信息。
所述的方法中，在血液分析仪对待测样本进行检测之前，还包括：对所述血液分析仪进行质控；如果血液分析仪质控合格，则对样本进行检测以得到样本的第一检测结果。
所述的方法中，还包括：如果所述质控样本的预设类型的细胞的第一检测结果值及第二检测结果值的偏差超过预设范围，则输出细胞图像分析装置质控不合格的提示信息。
所述的方法中，所述质控样本的第一检测结果包括异常信息；所述比较质控样本的第一检测结果及第二结果包括：
比较所述质控样本的第一检测结果中的异常信息与所述第二检测结果中的异常信息是否一致；
如果所述质控样本的第一检测结果中的异常信息与所述第二检测结果中的异常信息不一致，则输出提示信息。
所述的方法中，所述异常信息包括疟原虫、血小板聚集、红细胞聚集、红细胞压积高于预设阈值、红细胞大小不均、及异常白细胞中的至少其中之一。
所述的方法中，还包括根据所述第二检测结果中与所述质控血涂片的推片和/或染色相关的检测信息判断所述质控血涂片的推片和/或染色质量。
所述的方法中，第二检测结果中与推片相关的检测信息包括通过细胞图像分析装置获取的所述质控血涂片的血膜外观形态及细胞分布中的至少其中之一。
所述的方法中，所述第二检测结果中与染色相关的检测信息包括通过细胞图像分析装置获取的所述质控血涂片的血膜颜色、颜色深浅中的至少其中之一。
所述的方法中，将所述质控样本的第一检测结果及第二检测结果进 行比较包括：
推片质量及染色质量经过判断符合要求之后，将所述质控样本的第一检测结果及第二检测结果进行比较。
所述的方法中，所述根据血液分析仪测得的样本检测结果挑选质控样本包括：挑选第一检测结果中预设类型的细胞的检测值在预设的范围内的样本作为质控样本。
所述的方法中，第一检测结果中预设类型的细胞的检测值在预设的范围内包括：白细胞的计数值在预设的第一范围内、红细胞的计数值在预设的第二范围内及平均红细胞体积在预设的第三范围内中的至少其中之一。
所述的方法中，所述根据血液分析仪测得的样本检测结果挑选质控样本包括：挑选第一检测结果中包括异常信息的样本作为质控样本；优选地，所述异常信息包括疟原虫、血小板聚集、红细胞聚集、红细胞压积高于预设阈值、红细胞大小不均、及异常白细胞中的至少其中之一。
所述的方法中，还包括：
如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，则控制所述调度装置将所述待测样本运送至另一台血液分析仪进行重测，以获取基于血液分析仪分析的第一重测结果；及将所述第一重测结果与第二检测结果进行比较；或者，
如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，则控制所述调度装置将所述待测样本运送至另一细胞图像分析装置进行重测，以获取基于细胞图像分析装置的第二重测结果；及将所述第一检测结果与第二重测结果进行比较；或者，
如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，则控制所述调度装置将所述待测样本运送至原来的血液分析仪进行重测，还运送至原来的细胞图像分析装置进行重测，以获取基于血液分析仪分析的第一重测结果以及基于细胞图像分析装置的第二重测结果；及将所述第一重测结果与第二重测结果进行比较。
所述的方法中，还包括：如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，则重新从已经检测完成的待测样本中挑选质控样本。
所述的方法中，还包括：
打印质控标识于质控样本上，细胞图像分析装置识别到所述质控标识，切换为质控模式以对质控样本进行拍摄及分析。
根据第二方面，一种实施例中提供一种样本分析***，包括：
血液分析仪,用于对至少一样本进行检测；
控制器，用于获取至少一样本基于血液分析仪分析的第一检测结果，并实时判断是否满足预设的质控触发条件，如果满足预设的质控触发条件则挑选经血液分析仪分析的样本作为质控样本；还用于控制调度装置将该质控样本运送至涂片制备装置；
涂片制备装置将所述质控样本制备成血涂片；
细胞图像分析装置，用于对所述血涂片进行拍摄及分析，并得到基于图像拍摄及分析的第二检测结果；
所述控制器还用于：
将所述第二检测结果及第一检测结果中的相应信息进行比较；及
控制显示装置输出比较结果。
所述的样本分析***中，所述涂片制备装置包括：
推片机，用于根据预设的推片参数对质控样本进行推片，推片的过程包括将质控样本分配至玻片，并将玻片上的样本推展成血膜；
染色机，用于根据预设的染色参数对玻片上的血膜进行染色；
打印装置，用于将样本信息打印于所述质控样本的血涂片上，所述样本信息包括质控标识。
所述的样本分析***中，所述细胞图像分析装置包括识别装置，用于识别所述质控样本的血涂片上的质控标识。
所述的样本分析***中，所述第二检测结果包括基于细胞图像拍摄及分析的检测信息及与细胞图像分析装置的推片和/或染色质量相关的检测信息。
所述的样本分析***中，所述控制器还用于根据所述第二检测结果中与细胞图像分析装置的推片和/或染色质量相关的检测信息对所述涂片制备装置进行推片和/或染色质量判断。
所述的样本分析***中，所述血液分析仪经过了质控，且在质控合格后才对样本进行检测以得到样本的第一检测结果。
所述的样本分析***中，所述控制器还用于：如果所述质控样本的第二检测结果及第一检测结果之间的偏差超过预设范围，则控制显示装 置输出细胞图像分析装置的质控提示信息。
根据第三方面，一种实施例中提供一种样本分析***的自动精度管理方法，包括如下步骤：
血液分析仪对样本进行检测，以获取样本的第一检测结果；
自动质控开始步骤、每个周期血液分析仪首次启动测试后测试完第N个样本，或首次启动测试后预设时间，控制调度装置将经血液分析仪检测的样本运送至推片机；
推片机将所述样本制备成质控血涂片，所述质控血涂片设有质控标识；
染色机对所述质控血涂片进行染色；
控制器控制调度装置将质控血涂片运送至细胞图像分析装置；
细胞图像分析装置识别所述质控标识，切换成质控模式，在质控模式下对所述质控血涂片进行拍摄及分析，得到第二检测结果；
将所述质控样本的第一检测结果及第二检测结果进行比较；
输出所述比较结果。
所述的方法中，还包括：
在显示界面上提供自动质控选项供用户选定，在接收到选定自动质控选项的指令后，执行自动质控开始步骤。
根据第四方面，一种实施例中提供一种样本分析***，包括：
涂片制备装置，包括推片机及染色机，用于根据预设的推片参数对质控样本进行推片，以将分注至玻片上的所述质控样本的血样推展成血膜；
染色机，用于根据预设的染色参数对玻片上的血膜进行染色；
细胞图像分析装置，用于对所述血涂片进行拍摄及分析，并得到基于图像拍摄及分析的第二检测结果，所述第二检测结果包括与所述质控血涂片的推片及染色相关的检测信息；
所述控制器还用于：
根据所述第二检测结果判断所述质控血涂片的推片及染色质量。
所述的***中，还包括：
血液分析仪,用于对至少一样本进行检测；
控制器，用于获取至少一样本基于血液分析仪分析的第一检测结果，并实时判断是否满足预设的条件，如果满足预设的条件则挑选经血液分 析仪分析的样本作为质控样本；还用于控制调度装置将该质控样本运送至涂片制备装置。
所述的***中，所述涂片制备装置包括：打印装置，用于将样本信息打印于所述质控样本的血涂片上，所述样本信息包括质控标识。
所述的***中，所述控制器用于：根据第二检测结果中与推片相关的检测信息识别该质控血涂片的血膜外观形态和/或细胞分布；并根据所述质控血涂片的血膜外观形态和/或细胞分布对所述推片机进行推片质量判断；
其中，第二检测结果中与推片相关的检测信息包括通过细胞图像分析装置获取的所述质控血涂片的血膜外观形态及细胞分布中的至少其中之一。
所述的***中，所述控制器还用于：根据第二检测结果中的与染色相关的检测信息识别该质控血涂片的血膜色彩、颜色深浅中的至少其中之一；并根据所述质控血涂片的血膜色彩，颜色深浅中的至少其中之一对所述涂片制备装置进行染色质量判断；其中，所述第二检测结果中与染色相关的检测信息包括通过细胞图像分析装置获取的所述质控血涂片的血膜颜色、颜色深浅中的至少其中之一。
所述的***中，所述控制器还用于：将所述质控样本的第一检测结果及第二检测结果中相应的结果信息进行比较；并控制显示装置输出所述比较结果。
根据第五方面，一种实施例中提供一种样本分析***，包括：
存储器，用于存储程序；
处理器，用于执行所述存储器存储的程序以实现如上所述的方法。
根据第六方面，一种实施例中提供一种计算机可读存储介质，其特征在于，包括程序，所述程序能够被处理器执行以实现如上所述的方法。
依据上述实施例的样本分析***及其精度管理方法，可在样本分析***启动样本测试后，自动挑选质控样本，将质控样本制作成质控血涂片，之后细胞图像分析装置对质控血涂片进行拍摄及分析，得到基于图像拍摄及分析的检测结果，通过将细胞图像分析装置的检测结果与血液分析仪的检测结果进行比较，并输出比较结果，从而自动完成对细胞图像分析装置或血液分析仪等仪器的精度管理。
附图说明
图1为本发明一实施例提供的样本分析***的结构示意图；
图2为本发明一实施例提供的样本分析***中，涂片制备装置的结构框图；
图3为本发明一实施例提供的样本分析***中，血涂片的示意图；
图4为本发明一实施例提供的样本分析***中，细胞图像分析装置的结构框图；
图5为本发明一实施例提供的样本分析***中，细胞图像分析装置的结构示意图；
图6为本发明一实施例提供的样本分析***中，其精度管理方法的流程图；
图7为图6中步骤1一实施例的流程图；
图8为本发明一实施例提供的样本分析***的结构框图；
图9为本发明一实施例提供的样本分析***中，其精度管理方法的流程图；
图10为图9中步骤S5的流程图；
图11为图9中步骤S6的流程图；
图12为本发明一实施例提供的样本分析***中，其精度管理方法的流程图；
图13为本发明一实施例提供的样本分析***中，其精度管理方法的流程图；
图14为本发明一实施例提供的样本分析***中，对涂片制备装置进行质控的流程图。
具体实施方式
下面通过具体实施方式结合附图对本发明作进一步详细说明。其中不同实施方式中类似元件采用了相关联的类似的元件标号。在以下的实施方式中，很多细节描述是为了使得本申请能被更好的理解。然而，本领域技术人员可以毫不费力的认识到，其中部分特征在不同情况下是可以省略的，或者可以由其他元件、材料、方法所替代。在某些情况下，本申请相关的一些操作并没有在说明书中显示或者描述，这是为了避免本申请的核心部分被过多的描述所淹没，而对于本领域技术人员而言， 详细描述这些相关操作并不是必要的，他们根据说明书中的描述以及本领域的一般技术知识即可完整了解相关操作。
另外，说明书中所描述的特点、操作或者特征可以以任意适当的方式结合形成各种实施方式。同时，方法描述中的各步骤或者动作也可以按照本领域技术人员所能显而易见的方式进行顺序调换或调整。因此，说明书和附图中的各种顺序只是为了清楚描述某一个实施例，并不意味着是必须的顺序，除非另有说明其中某个顺序是必须遵循的。
本文中为部件所编序号本身，例如“第一”、“第二”等，仅用于区分所描述的对象，不具有任何顺序或技术含义。而本申请所说“连接”、“联接”，如无特别说明，均包括直接和间接连接(联接)。
图1为本申请实施例提供的一种样本分析***100的结构示意图，样本分析***100可以是血液分析流水线，其包括：至少一台血液分析仪110、至少一台涂片制备装置120、至少一台细胞图像分析装置130和控制装置140。
血液分析仪110用于对待测样本进行血常规检测，涂片制备装置120用于制备待测样本的涂片，细胞图像分析装置130用于对涂片中的细胞进行图像拍摄和分析，控制装置140与血液分析仪110、涂片制备装置120和细胞图像分析装置130通信连接。
样本分析***100还包括第一传输轨道150和第二传输轨道160，第一传输轨道150用于将可放置多个装载有待测样本的试管11的试管架10从血液分析仪110运送至涂片制备装置120，第二传输轨道150用于将可装载多个制备好的涂片21的玻片篮20从涂片制备装置120运送至细胞图像分析装置130。
控制装置140与第一传输轨道150和第二传输轨道160电连接并控制其动作。
样本分析***100还包括分别对应于血液分析仪110和涂片制备装置120设置的进给机构170和180，各进给机构170和180包括装载缓存区171和181、进给检测区172和183以及卸载缓存区173和183。
当试管架20上的待测样本需要被运送至血液分析仪110进行检测 时，试管架20首先从第一传输轨道150被运送到装载缓存区171，然后从装载缓存区171被运送到进给检测区172由血液分析仪110进行检测，在检测结束之后，再从进给检测区172被卸载到卸载缓存区173，最后再从卸载缓存区173进入第一传输轨道150。
同理，当试管架20上的待测样本需要进行镜检时，需要将试管架20运送至涂片制备装置120制备涂片，试管架20首先从第一传输轨道150被运送到装载缓存区181，然后从装载缓存区181被运送到进给检测区182由涂片制备装置120制备涂片，在涂片制备结束之后，再从进给检测区182被卸载到卸载缓存区183，最后再从卸载缓存区183进入第一传输轨道150。涂片制备装置120将制备好的涂片收纳在玻片篮20中，通过第二传输轨道160将收纳有待测涂片的玻片篮20运送至细胞图像分析装置130，细胞图像分析装置130对待测涂片上的样本中的细胞进行图像拍摄并进行分析。
样本分析***100还包括用于显示样本检测结果的显示装置(未示出)以及用于输入的输入装置。显示装置可以是液晶屏、触摸屏或LED显示屏等，控制装置140可以将处理的数据以图像显示数据输出到显示装置上进行显示，例如：分析数据、仪器运行参数等。输入装置可以是鼠标、键盘、各类按键、轨迹球等，以便于用户进行输入操作。显示装置可设置在血液分析仪110、细胞图像分析装置130或控制装置140上，或者另外设置。
涂片制备装置120可用于血液、体液等样本的涂片制备。如图2所示，该涂片制备装置120包括推片机121、染色机122和打印装置123。
推片机121用于根据预设的推片参数对样本进行推片，推片的过程包括将样本分配至玻片，并将玻片上的样本推展成血膜。推片机121包括用于抽取样本的取样机构、用于将玻片移至工作线的玻片装载机构、用于将样本加载到玻片的加样机构、用于将玻片上的样本抹平的推片机构以及用于对玻片上血膜进行干燥的干燥机构。
取样机构进行样本提取时，先进行样本混匀，然后利用取样机构中的采样装置(例如采样针)吸样，根据样本容器的不同，吸样可以是穿 刺吸样(样本容器具有盖体，采样装置穿过样本容器的盖体)，也可以是开放吸样(样本容器敞开，采样装置直接从敞口部吸样)。必要时，可进行血样信息检测，以获取信息和比对信息。某些实施例中，还包括微量进样机构，该微量进样机构可以将操作人员放入的试管直接向采样装置的方向移动，或者，采样装置也可以向操作人员放入的试管的方向移动。其他实现方式中，微量进样机构还可以将试管直接向加样机构的方向移动，或者，加样机构也可以向操作人员放入的试管的方向移动，直接经由加样机构(例如滴血针)吸取血样后进行样本加载，由于无需通过取样机构抽取血液，可以减少血样的需求，从而实现微量及优先进样。当取样完成后，经由加样机构准备将血液滴落到玻片上。
相应地，玻片装载机构提取玻片，并将玻片装载到相应位置，以便于进行滴血操作。一些实施例中，在完成提取玻片操作后，还可以进行玻片左右检测和玻片清洁等操作，之后再装载玻片。装载后的玻片可以打印相关信息，同时进行玻片正反检测等操作。
加样机构的滴血针将样本滴落到玻片上后进行推片操作，通过推片机构将血液在玻片上推成血膜形状。通常，在完成推片动作后，可对玻片上的血膜进行干燥，稳定其形态，玻片如图2所示。在一些实施例中，可在对进行血膜干燥前，驱动玻片翻转，以满足相应需求。一些实施例中，干燥后的血涂片还可进行干燥检测，用来判定血膜干燥效果。一些实施例中，干燥后的血涂片还可以进行血膜展开检测，用以判断血膜是否展开以及展开状态是否符合要求。
染色机122用于对玻片进行染色，具体的，根据预设的染色参数对玻片上的血膜进行染色。
打印装置123用于将样本信息打印于样本的血涂片上，如图3所示，血涂片上设置有标签区域，样本信息打印于该血涂片的标签区域，打印于标签区域的样本信息可包括样本编号、条码、及质控标识等信息。
细胞图像分析装置130，例如细胞图像分析仪，如图4所示，至少包括成像装置131、涂片移动装置132和图像分析装置133，成像装置 131包括相机1312和透镜组1311并且用于对涂片上涂抹的样本中的细胞进行拍摄，涂片移动装置132用于使涂片相对于成像装置131运动，以便成像装置131拍摄涂片的特定区域的细胞图像，图像分析装置133用于对涂片的细胞图像进行分析。
如图5所示，透镜组1311可以包括第一物镜、第二物镜和目镜。第一物镜例如可以为10倍物镜，第二物镜例如可以为100倍物镜。透镜组1311还可以包括第三物镜，第三物镜例如可以为40倍物镜。
细胞图像分析装置130还包括识别装置134、玻片夹取装置135和涂片回收装置136。识别装置134用于识别涂片的身份信息，玻片夹取装置135用于将涂片从识别装置134夹取到涂片移动装置132上进行检测，涂片回收装置136用于放置经检测的涂片。
细胞图像分析装置130还包括玻片篮装载装置137，用于装载装有待测涂片的玻片篮，玻片夹取装置135还用于将玻片篮装载装置137上装载的玻片篮中的待测玻片夹取到识别装置134进行身份信息识别。玻片篮装载装置137与第一传输轨道160连接，以便由涂片制备装置120制备的涂片能够运送至细胞图像分析装置130。
本发明提供的血液分析流水线，其包括一台、两台或者多台血液分析仪110，一台、两台或者多台细胞图像分析装置130，一实施例中，如图8所示，以包括两台血液分析仪110和两台细胞图像分析装置130为例进行说明。图8只是用于举例，并不限定各个仪器、装置的数量。图8所示的血液分析流水线，血液分析仪110、细胞图像分析装置130和涂片制备装置在上述内容中已叙述，在此不做赘述。
调度装置用于调度样本以及血涂片，包括如上所述的第一传输轨道150、第二传输轨道160、进给机构170和进给机构180。
上述的显示装置包括显示器，显示器设置在控制装置140上。控制装置140还包括控制器142和存储器143。存储器143用于存储各类数据，例如计算机程序、血液分析仪的检测结果、细胞图像分析装置的检测结果以及涂片制备装置产生的数据等。控制器142包括处理器，可用于执行程序以对血液分析流水线进行精度管理，精度管理可以包括对仪器结果准确性的判断，质量判断等，也可以称之为质控。
如图6所示，在一实施例中，样本分析***100为血液分析流水线的自动精度管理方法包括如下步骤：
步骤1、获取用于质控的样本。有多种方式获取用于质控的样本，一种方式如图7所示，包括：
步骤1.1、用户放置待测样本，血液分析仪110对待测样本进行检测，得到待测样本的第一检测结果。本实施例中，样本为血液样本，例如患者的新鲜血液。
步骤1.2、控制器在满足预设的质控触发条件下，根据血液分析仪110测得的样本检测结果从已经检测完成的待测样本中挑选质控样本。控制器可以是控制装置140的控制器142，也可以是样本分析***中其他仪器的控制器，例如血液分析仪110的控制器、涂片制备装置120的控制器或细胞图像分析装置130的控制器。本实施例以控制装置140的控制器142为例进行说明。挑选的质控样本数量可以是一个也可以是多个，质控样本的数量可以根据用户需求而定，不同的质控样本可用于对不同的功能进行质控或者对同一功能进行多次质控，以提高质控结果的准确性。例如，控制器获取至少一样本基于血液分析仪110分析的第一检测结果，并实时判断是否满足预设的质控触发条件，如果满足预设的质控触发条件则挑选经血液分析仪110分析的样本作为质控样本。可见，平时血液分析仪110正常检测样本，在达到质控触发条件时，本发明可实时响应质控触发条件进而启动质控。质控(QC)是质量控制的简称，是为了判断各类***、仪器、设备等的功能和性能是否正常，而进行的必要操作。
预设的质控触发条件包括每个周期血液分析仪首次启动测试后测试完第N个样本、预设的时间、预设的负载和预设的检测结果中的至少其中之一，其中N为不小于1的自然数。例如每天第一个样本测试完毕后控制器挑选质控样本，或者每天上午九点控制器挑选质控样本，或者样本分析***的负载低于预设值则控制器挑选质控样本，或者控制器判断从血液分析仪110获取的各个样本的第一检测结果是否为满足预设条件的检测结果，若是则控制器挑选质控样本，满足预设条件的检测结果可以是各项血常规检测结果值均在正常范围，或者是包括异常信息的检测结果，前者可以判断正常样本通过血液分析仪及细胞图像分析装置检测的结果值是否一致，后者可以判断样本通过血液分析仪及细胞图像分析 装置检测的异常信息是否一致。上述触发条件可以通过用户设置，在满足预设的质控触发条件后，则可自动执行质控流程。
控制器根据血液分析仪110测得的样本检测结果挑选质控样本，挑选的质控样本可以是结果正常的样本，具体的，控制器挑选第一检测结果中预设类型的细胞的检测值在预设的范围内的样本作为质控样本。例如，挑选白细胞的计数值(WBC)在预设的第一范围内的样本作为质控样本，挑选红细胞的计数值(RBC)在预设的第二范围内的样本作为质控样本，挑选平均红细胞体积(MCV)在预设的第三范围内的样本作为质控样本，由于挑选的质控样本可以是一个或多个，故可挑选这三种样本中的至少其中之一作为质控样本，具体可根据质控需求而定。其中，第一范围、第二范围和第三范围可根据质控需求进行设置，例如，第一范围为7.0×10 9至10.0×10 9/L，第二范围为4.0×10 12至5.5×10 12/L，第三范围为85-95fL。当然，挑选的质控样本也可以是结果异常的样本，具体的，控制器挑选第一检测结果中包括异常信息的样本作为质控样本。优选地，异常信息包括疟原虫、血小板聚集、红细胞聚集、红细胞压积(HCT)高于预设阈值、红细胞大小不均、及异常白细胞中的至少其中之一。当然，挑选的样本可以既包含结果正常的样本，又包含异常的样本，如此可以从两个角度出发进行质控，能满足各种质控需求。
步骤1.3、控制器控制调度装置例如第一轨道150将质控样本运送至涂片制备装置120的推片机。
获取用于质控的样本的另一种方式则包括：
步骤1.1’、血液分析仪110对样本进行检测，得到样本的第一检测结果，本步骤同上一方式的步骤1.1。
步骤1.2’、控制器在满足预设的质控触发条件下，控制调度装置例如第一轨道150将经血液分析仪110检测的样本运送至涂片制备装置120的推片机，运送至推片机的样本将作为质控样本。也就是本方式中，不挑选样本，控制器实时判断是否满足预设的质控触发条件，如果满足预设的质控触发条件则将经血液分析仪110检测的样本直接运送至涂片制备装置120的推片机。同样的，运送至推片机的样本可以是一个或多个，满足质控需求即可。
获取用于质控的样本的还一种方式则包括：
步骤1.1”、血液分析仪110对样本进行检测，得到样本的第一检测结果，本步骤同上一方式的步骤1.1。
步骤1.2”、每个周期血液分析仪110首次启动测试后测试完第N个样本，或首次启动测试后预设时间，控制调度装置将经血液分析仪110检测的样本运送至涂片制备装置120的推片机。周期可以是质控周期，例如一个自然日，也就是每天血液分析仪110首次启动测试后测试完第N个样本，或首次启动测试后预设时间，控制调度装置将经血液分析仪110检测的样本运送至涂片制备装置120的推片机，进而开始质控。
不论步骤1采用何种方式，在步骤1之前，自动精度管理方法还可以包括：控制器在显示装置的显示界面上提供自动质控选项供用户选定，在接收到选定自动质控选项的指令后，执行自动质控开始步骤，也就是步骤1.2、步骤1.2’或步骤1.2”。如此，本发明的自动精度管理方法可以由用户选择开启或关闭，若关闭，则用户可手动进行质控操作。
步骤2、控制器控制涂片制备装置120的推片机将质控样本制备成血涂片，也即是血液涂片。具体的，控制器控制推片机根据预设的推片参数对质控样本进行推片，推片的过程包括将质控样本分配至玻片，并将玻片上的样本推展成血膜。推片参数可以包括血膜的宽度、长度、尾部形态等，推片机可以按照预设的推片参数进行推片，以制备出符合预设推片参数的血涂片。由此制备的血涂片如图2所示。同一样本可制备一张或多张血涂片，具体数量根据质控需求而定，从而很好的满足各种质控需求。
血涂片的制备过程中，控制器还控制打印装置将样本信息设置在质控样本的血涂片上，样本信息包括质控标识，例如，打印装置将质控标识打印、喷码、贴附、书写或描绘在图2所示的标签区域，使质控血涂片具有质控标识，便于识别。由于设置了质控标识，后续染色、阅片时，将有别于常规样本，可根据质控需求进行对应的染色、阅片，能更好的进行质控。
步骤3、控制器控制染色机对质控血涂片进行染色，例如，控制染色机根据预设的染色参数或预设的染色模式对玻片上的血膜进行染色；预设的染色参数可以是与样本的特征(血液、体液)对应的参数，也可以是与细胞图像分析装置130的一种染色模式对应的参数。在一实施方 式中，针对质控样本，推片机及染色机均选择预设的参数或模式进行推片及染色，从而制备出与预设参数或预设模式相符的血涂片，后续细胞图像分析装置130对该血涂片进行分析后，检测结果可用来判断细胞图像分析装置130的推片及染色质量，可见本发明从挑选样本、制备血涂片到染色，均可根据质控需求来进行，能快速的完成质控。
染色机对质控血涂片进行染色后，对质控血涂片进行清洗烘干，之后，控制器控制调度装置例如第二传输轨道160将质控血涂片运送至细胞图像分析装置130。
步骤4、控制器控制细胞图像分析装置130对质控血涂片进行拍摄及分析，得到第二检测结果。具体的，控制器控制细胞图像分析装置130工作，细胞图像分析装置130的识别装置识别质控样本的血涂片上的质控标识，细胞图像分析装置130从而得知当前的血涂片为质控样本的血涂片，进而切换成质控模式，在质控模式下对质控血涂片进行拍摄及分析，得到第二检测结果。细胞图像分析装置130可以采用阅片机，其质控模式拍摄的图像比常规模式拍摄的图像要全面，分析得到的第二检测结果也比常规样本要全面，以便于满足质控需求，也就是细胞图像分析装置130能根据质控需求进行拍摄及分析。例如，细胞图像分析装置130的工作模式包括白细胞分析模式，红细胞分析模式、或血小板分析模式等，可以分别有针对性的对白细胞、红细胞、或血小板进行分析及检测，质控模式可以是这三种模式的组合模式，能够更全面的拍摄及分析各种类型的细胞。
步骤5、控制器从细胞图像分析装置130中获取质控血涂片的第二检测结果，将质控样本的第一检测结果及第二检测结果进行比较，并控制显示装置输出比较结果。对第一检测结果及第二检测结果进行比较，若以第一检测结果为基准，则能比较判断第二检测结果是否准确，从而对细胞图像分析装置130进行质控，若以第二检测结果为基准，则能比较判断第一检测结果是否准确，从而对血液分析仪110进行质控。下面将一一进行介绍。
图6所示的方法，在血液分析仪110对待测样本进行检测之前，还对血液分析仪110进行质控；如果血液分析仪110质控合格，则对样本进行检测以得到样本的第一检测结果。也就是可以在血液分析仪110质控合格之后，开始步骤1，如此，在步骤5中即可将血液分析仪110得 到的第一检测结果作为基准，对细胞图像分析装置130进行质控。血液分析仪110的质控可以包括利用标准质控品对血液分析仪进行质控，或者将多台血液分析仪的结果进行比较进行质控，如果血液分析仪110对标准质控品的检测结果在预设的范围内，或者血液分析仪110对同一样本的检测结果与其它分析仪的检测结果一致，则该血液分析仪110的质控合格。
比较质控样本的第一检测结果及第二检测结果具体可包括：比较质控样本的预设类型的细胞在第一检测结果中的第一检测结果值及在第二检测结果中的第二检测结果值，例如比较第一检测结果及第二检测结果中的淋巴细胞、中性粒细胞的结果值；如果质控样本的预设类型的细胞的第一检测结果值及第二检测结果值的偏差超过预设范围，则输出提示信息。例如，如果第一检测结果中该质控样本的淋巴细胞比例为20％，而在第二检测结果中该质控样本的淋巴细胞比例为30％，如淋巴细胞的预设偏差范围为-5％ˉ5％，则第一检测结果及第二检测结果中两者的偏差超过预设范围，显示界面可展示二者的偏差10％，还可以提示两者的偏差超过预设范围，也即表明血液分析仪和细胞图像分析装置至少其中之一结果不准确，血液分析仪和细胞图像分析装置至少其中之一的质控不合格。
在一实施例中，如果挑选的质控样本为正常样本，例如该样本的WBC(白细胞)的计数值在7.0×10 9至10.0×10 9/L之内、RBC(红细胞)的计数值在4.0×10 12至5.5×10 12/L之内、及MCV(平均红细胞体积值)在85-95fL之内，控制器比较质控样本的白细胞在第一检测结果中的计数值及在第二检测结果中的计数值，两者偏差不超过预设范围说明细胞图像分析装置130对白细胞计数值的检测符合精度要求。控制器比较质控样本的红细胞在第一检测结果中的计数值及在第二检测结果中的计数值，两者偏差不超过预设范围说明细胞图像分析装置130对红细胞计数值的检测符合精度要求。控制器比较质控样本的红细胞在第一检测结果中的平均红细胞体积及在第二检测结果中的平均红细胞体积，两者偏差不超过预设范围说明细胞图像分析装置130对平均红细胞体积的检测符合精度要求。
如果血液分析仪在进行样本测试之前已经进行过质控，且质控合格，则本实施例可以通过比较第一检测结果及第二检测结果中预设参数的 结果偏差来判断细胞图像分析装置130的检测是否符合要求，偏差超过预设范围，则输出细胞图像分析装置130质控不合格的提示信息。当然，还可以通过比较第一检测结果及第二检测结果中预设参数的结果的偏差率来判断细胞图像分析装置130的检测是否符合要求。具体的，控制器比较质控样本的第二检测结果及第一检测结果之间的偏差率，也就是偏差百分比，例如，偏差除以第一检测结果值再乘以100％即可得到偏差率。如果质控样本的第二检测结果及第一检测结果之间的偏差率超过对应的预设范围，则控制器通过显示装置输出细胞图像分析装置130质控不合格的提示信息，当然，提示信息可以更为具体，例如，输出细胞图像分析装置130对某一类细胞的检测结果不符合精度要求。
其中，质控样本的第一检测结果及第二检测结果的偏差率是否超出预设范围可以包括：一种是比较多种预设参数的结果值，预设参数的结果值可以是中性分叶核粒细胞、淋巴细胞、嗜酸性粒细胞等多种细胞的检测值，如果其中任一种细胞在第一检测结果及第二检测结果中的结果值偏差超范围，则质控样本的第一检测结果及第二检测结果的偏差率超出预设范围；如果所有预设参数在第一检测结果及第二检测结果中没有超出预设范围，则质控样本的第一检测结果及第二检测结果的偏差率没有超过预设范围。
当然，在可选的实施例中，如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，则控制器控制调度装置将待测样本(质控样本)运送至另一台血液分析仪进行重测，以获取基于血液分析仪分析的第一重测结果；控制器将第一重测结果与第二检测结果进行比较，判断第一重测结果值与第二检测结果值的偏差是否超过预设范围，第一重测结果与第二检测结果的偏差率是否超过预设范围等，具体过程同上述第一检测结果与第二检测结果的比较过程，在此不做赘述。更换血液分析仪后进行重测，可排除血液分析仪自身原因对细胞图像分析装置130质控的干扰。
在可选的实施例中，如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，控制器也可控制调度装置将待测样本(质控样本)运送至另一细胞图像分析装置进行重测，以获取基于细胞图像分析装置的第二重测结果；进而将所述第二重测结果与所述第一检测结果进行比较，判断第一检测结果值与第二重测结果值的偏差是 否超过预设范围，第一检测结果与第二重测结果的偏差率是否超过预设范围等，具体过程同上述第一检测结果与第二检测结果的比较过程，在此不做赘述。更换细胞图像分析装置130后进行重测，可排除细胞图像分析装置130自身原因对细胞分析仪质控的干扰。
在可选的实施例中，如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，控制器也可控制器控制调度装置将待测样本(质控样本)运送至原来的血液分析仪进行重测，并运送至原来的细胞图像分析装置进行重测，以获取基于原血液分析仪分析的第一重测结果以及基于原细胞图像分析装置的第二重测结果；进而将所述第一重测结果与第二重测结果进行比较，两者比较的具体过程同上述第一检测结果与第二检测结果的比较过程，在此不做赘述。
如上所述，对质控样本的重测包括换一台血液分析仪重测，换一台细胞图像分析装置重测，或者通过原来的血液分析仪或细胞图像分析装置重测,在初次质控不合格的情况下，再次对质控样本进行重测，可以再次进行质控判断，得出更准确的质控结果。
在可选的实施例中，如果质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，控制器可以重新从已经检测完成的待测样本中挑选质控样本重测，并再次进行质控判断，以提高准确性。
可见，通过上述流程，实现了对细胞图像分析装置130的自动质控，便于用户掌控细胞图像分析装置130的精度，质控合格后方可保证其检测结果的准确性。
细胞图像分析装置130和血液分析仪110在样本检测上有各自的优势，细胞图像分析装置130在对细胞的形态检测上较血液分析仪110更为准确，故可用细胞图像分析装置130的检测结果对血液分析仪110进行质控判断。具体的，质控样本的第一检测结果包括符合预设的质控触发条件的异常信息，例如，在步骤1时就挑选包括异常信息的样本作为质控样本，进而利用这些质控样本对血液分析仪110进行质控。控制器比较质控样本的第一检测结果中的异常信息与第二检测结果中的异常信息是否一致；如果质控样本的第一检测结果中的异常信息与第二检测结果中的异常信息不一致，则通过显示装置输出对应的提示信息，例如，输出血液分析仪110对异常信息的检测不合格的提示信息，当然，若两个检测结果的异常信息一致，则通过显示装置输出血液分析仪110对异 常信息的检测合格的提示信息。例如，对于疟原虫，PLT聚集，红细胞聚集，异常细胞报警等异常信息，细胞图像分析装置130通常能更准确的得出相应检测结果，此时可以根据细胞图像分析装置130的检测结果对血液分析仪110进行精度管理。本发明实施例不仅实现了对细胞图像分析装置130的自动质控，还实现了对血液分析仪110的自动质控。
进一步的，本发明实施例还能根据细胞图像分析装置130测得的第二检测结果判断质控血涂片的推片及染色质量，即，还能对推片机和染色机进行质控判断。第二检测结果包括基于细胞图像拍摄及分析的检测信息及与细胞图像分析装置的推片及染色质量相关的检测信息。细胞图像分析装置130在质控模式下对质控血涂片进行拍摄时，可拍摄质控血涂片的图像，根据图像识别算法可以识别的血膜形状及血膜颜色等；细胞图像分析装置130还可通过其物镜对血涂片进行扫描，从而识别质控血涂片的细胞分布情况、血膜边界、血膜形状、血膜颜色等信息；获取这些与推片及染色相关的信息后，可以判断推片及染色质量是否符合预期。由于质控血涂片是根据预设的推片参数及预设的染色参数或染色模式而制备的，质控血涂片的血膜大小、形状、细胞分布、及颜色等应该与预设的推片参数及预设的染色参数或染色模式相符，如果通过细胞图像分析装置130发现质控血涂片的血膜大小、形状、细胞分布、及颜色等与预设的推片参数及预设的染色参数或染色模式不相符，则可判断涂片制备装置的质控不合格。
具体的，控制器可根据第二检测结果中与推片相关的检测信息识别该质控血涂片的血膜外观形态，细胞分布中的至少其中之一；并根据所述质控血涂片的血膜外观形态，细胞分布中的至少其中之一对推片机进行推片质量判断。其中，第二检测结果中与推片相关的检测信息包括通过细胞图像分析装置130获取的质控血涂片的血膜外观形态及细胞分布中的至少其中之一，例如，图像分析装置130可以获取的质控血涂片的血膜外观形态图像及细胞分布图像。控制器可以根据质控血涂片的血膜外观形态图像识别出图像中的血膜外观形态。控制器根据质控血涂片的细胞分布图像识别出细胞分布，例如判断指定的细胞在血膜上的位置分布是否符合要求，不符合则说明推片质量不合格。
类似的，控制器还可以根据第二检测结果中的与染色相关的检测信息识别该质控血涂片的血膜色彩、颜色深浅中的至少其中之一；根据所 述质控血涂片的血膜色彩，颜色深浅中的至少其中之一对所述涂片制备装置进行染色质量判断。其中，第二检测结果中与染色相关的检测信息包括通过细胞图像分析装置130获取的质控血涂片的血膜颜色、颜色深浅中的至少其中之一。例如，控制器根据第二检测结果中的血膜图像识别出血膜色彩(例如色度值)以及颜色深浅(例如灰度值)，当然，也可以直接通过细胞图像分析装置130获取质控血涂片的血膜色彩以及颜色深浅；判断血膜色彩是否为预设的颜色，若不是则说明染色机染色质量不合格，判断血膜颜色深浅是否符合预设的深浅，不符合则说明染色质量不合格。
由此，通过上述过程，可实现样本分析***的自动质控，自动化程度高。
在图6所示的流程中，在步骤4中得到第二检测结果之后，控制器执行上述推片质量及染色质量判断，在推片质量及染色质量经过判断符合要求之后，再执行步骤5，也就是在判断确认推片机推片和染色机染色正常之后，再对细胞图像分析装置130进行质控，如此排除了推片质量和染色质量对细胞图像分析装置130质控的干扰，质控准确性好。
综上所述，本发明基于整个血液分析流水线***来实现对推片机，染色机，阅片机的质量控制。不仅由整个血液分析流水线全自动处理，无需人工参与或仅需少量参与，而且检测结果也能反映出整个流水线的一致性和相关性，有利于对流水线的综合判断。由于常规样本的检测只需根据检测项目得到结果即可，因此检测过程简单，其结果仅能反映***一部分的功能特点，而本发明挑选样本、推片、染色、阅片等过程均按照质控需求进行，***各项功能特点都能覆盖到，质控判断全面，准确度高。
如图9所示，在一实施例中，一种样本分析***的自动精度管理方法，其应用于包括血液分析仪、涂片制备装置、及细胞图像分析装置的血液分析流水线，该方法包括以下步骤。
步骤S1.流水线准备就绪后，用户放置待测样本。流水线准备就绪是指流水线开启或退出休眠后，流水线的软件及硬件都准备就绪，进入可以测试样本的状态，待测样本放入后，***即可启动样本自动运输及测试的流程。
启动批量样本测试，批量样本是指用户放入的一个或多个样本架上 的样本，血液分析仪能对这些样本进行依次检测。样本架用于承载至少一个样本，通常能承载多个样本。
步骤S2.血液分析仪对处于其检测位置的当前样本进行检测，以得出该样本的第一检测结果，本实施例为血常规检测结果。
步骤S3.控制器通过血常规检测结果自动筛选用于制备质控血涂片的样本；该样本要满足具体的参数要求：例如WBC的计数值在7.0×10 9至10.0×10 9/L之内、RBC的计数值在4.0×10 12至5.5×10 12/L之内、及MCV值在85-95fL之内等等。如果某一样本的血常规检测结果满足这个要求，就可以自动将其挑选为质控样本，质控样本的数量可以是一支样本。质控样本也可以是多支样本，例如，部分质控样本是所有检测项均在正常范围内的样本，或部分质控样本是某些参数超限的样本，如血常规检测结果存在高HCT，RBC大小不均，存在异常白细胞等情况的样本。
步骤S4.控制器通过调度装置将质控样本自动输送到推片机。
步骤S5.控制器通过涂片制备装置制备质控血涂片，采集血样滴在载玻片上推展成血膜。如图10所示，质控血涂片的制备方法包括如下步骤：
步骤S51、打印装置在玻片上标签区域打印样本信息，样本信息包括样本编号、条码及质控标识等。
步骤S52、推片机采集质控样本并将其滴到玻片上。
步骤S53、推片机将玻片上的血液推展成血膜。具体的，控制器控制推片机根据预设的推片参数将玻片上的血液推展成血膜。推片参数可以包括血膜的宽度、长度、尾部形态等，推片机可以按照预设的推片参数进行推片，以制备出符合预设推片参数的血涂片。由此制备的血涂片如图2所示。在本发明实施例中，每个质控样本可以根据质控要求制备一张或多张质控血涂片，或者制备多个不同质控样本的血涂片。
步骤S54、血膜外观形态的检测，例如推片机对血膜外观形态进行检测，以便于下一步骤的判断。
步骤S55、判断血膜外观形态、血细胞分布是否符合要求，例如推片机判断检测到的血膜外观形态(血膜的宽度、长度、尾部形态等)是否符合预设的推片参数，判断指定的细胞在血膜上的位置分布是否符合要求。
步骤S56、如果质控血涂片的血膜外观形态、血细胞分布符合要求， 则通过调度装置将质控血涂片运送至染色机或染色模块。如果质控血涂片的血膜外观形态、血细胞分布中至少有一个不符合要求，则返回步骤S51，重新制备该质控样本的血涂片。
步骤S6.染色机或染色模块对质控血涂片进行染色。如图11，染色具体可包括以下步骤：
步骤S61、染色机或染色模块自动设置染色模式及染色参数；染色机或染色模块的染色模式及染色参数通常有很多中，不同的染色模式或染色参数对应的染色效果不同，对于质控样本，可以选择质控模式对应的染色模式和/或染色参数。
步骤S62、染色机或染色模块对下一个质控血涂片进行染色。
步骤S63、染色机或染色模块判断是否还有未染色的质控血涂片；如果没有，则进入下一步S64；如果还有未染色的质控血涂片，则返回步骤S61继续对下一个样本进行染色。
步骤S64、染色机或染色模块的工作模式切换至正常染色模式，以准备对质控样本以外的普通病人的血涂片进行染色。
步骤S65、染色机或染色模块将染色后的质控玻片清洗烘干。
步骤S7.控制器通过调度装置将质控血涂片运送至细胞图像分析装置。
步骤S8.上述经过染色并干燥的玻片输送至细胞图像分析装置后，细胞图像分析装置根据血涂片上的质控标识，自动切换成质控模式，并在质控模式进行细胞图像拍摄及分析，得到第二检测结果。
控制器依靠细胞图像分析装置对血涂片的拍摄及分析，判断推片机和染色机的工作是否正常。
步骤S9.控制器依靠细胞图像分析装置的形态学分析结果与前一台或多台血液分析仪的检测结果进行比较，确认细胞图像分析装置的质控是否正常。前述实施例给出了控制器依靠细胞图像分析装置的形态学分析结果与前一台血液分析仪检测结果进行比较的具体过程，当然，也可以预先让多台血液分析仪对质控样品进行检测，进而控制器依靠细胞图像分析装置的形态学分析结果与多台血液分析仪的检测结果进行比较，如此进一步确保第一检测结果的准确性，以便于对细胞图像分析装置进行质控判断。具体对细胞图像分析装置的质控在上述实施例中已阐述，在此不做赘述。
控制器还依靠细胞图像分析装置的形态学分析结果(细胞图像分析装置的仪器分类结果或在人为调整下获得的准确结果)，确认血液分析仪的某些检测结果是否符合预期；例如血液分析仪的常规质控不能检测的某些项目，例如，对于疟原虫，PLT聚集，红细胞聚集，异常细胞报警的准确性等，血液分析仪的常规质控通常不能得出准确的质控结果，而细胞图像分析装置对于疟原虫，PLT聚集，红细胞聚集，异常细胞报警等项目的检测更为直观和准确，此时，可以通过细胞图像分析装置的检测结果对血液分析仪这些项目的检测结果进行质控。
由此，可延伸出利用质控血涂片对流水线上的各种仪器进行自动精度管理的方法，该方法如图12所示，具体包括如下步骤：
步骤S81、细胞图像分析装置读取质控血涂片的质控标识。
步骤S82、细胞图像分析装置在质控标识的触发下自动切换为质控模式。
步骤S83、细胞图像分析装置扫描血膜外观，例如扫描血膜外观得到对应的图像输出给控制器。
步骤S84、控制器判断血膜外观是否正常，如果不正常，则表示推片机的推片质量不符合要求，可以通过显示器输出相应提示。具体过程在上述实施例中已阐述，在此不做赘述。
步骤S85、细胞图像分析装置扫描血膜的整体颜色，评估颜色色彩及颜色深浅并输出给控制器。
步骤S86、控制器判断血膜颜色是否异常，如果异常则表示染色机的染色质量不符合要求。具体过程在上述实施例中已阐述，在此不做赘述。
步骤S87、细胞图像分析装置扫描血膜的镜下分布特征，识别细胞分布形态，例如正常的血膜是从头部到尾部血膜厚度依次变薄。
步骤S88、通过细胞图像分析装置扫描血膜的镜下分布特征，控制器识别血膜分布或细胞分布是否符合要求，如果细胞分布不符合要求，则表示推片机的推片质量不符合要求，可输出相应的提示信息。具体过程在上述实施例中已阐述，在此不做赘述。
步骤S91、细胞图像分析装置对血涂片的细胞进行定位和拍摄。控制器获取细胞图像分析装置拍摄的照片。
步骤S92、控制器判断细胞图像分析装置的定位及拍摄功能是否符 合要求；通常细胞图像分析装置通过低倍镜，如10倍镜对血涂片上的细胞进行定位，定位到目标数量的细胞后，例如定位到100个白细胞后，再切换为高倍镜，例如100倍镜对定位的细胞进行拍摄，如果细胞图像分析装置无法定位到目标数量的细胞，或者定位到目标数量的细胞后，高倍镜下拍摄不到目标数量的细胞，则表示细胞图像分析装置的定位或拍摄功能不符合要求。
步骤S93、细胞图像分析装置对质控血涂片进行细胞拍摄及预分类，细胞图像分析装置拍摄的细胞类型有多种，能输出不同类型的细胞图像并对这些细胞进行预分类，预分类是指细胞图像分析装置对拍摄的细胞进行自动分类及计数，预分类结果通常还需要人工确认及调整，方可输出细胞图像分析装置的检测结果。
步骤S94、控制器判断所述质控血涂片的预分类结果与血液分析仪的结果是否一致或偏差在允许的范围内，如果两者的结果不一致或者偏差大于允许的范围，则表示细胞图像分析装置的分类结果的准确性不符合要求。例如，如果血液细胞分析测量的白细胞的五分类结果与细胞图像分析装置的预分类结果偏差超过允许范围，则表示细胞图像分析装置的分类结果的准确性不符合要求。具体过程在上述实施例中已阐述，在此不做赘述。
如果两者的结果一致或者偏差在允许的范围内，则表示细胞图像分析装置的分类结果的准确性符合要求。如果血液细胞分析测量的白细胞的五分类结果与细胞图像分析装置的预分类结果一致或偏差在允许的范围内，则表示细胞图像分析装置的分类结果的准确性符合要求。
请参阅图13，在又一实施例中，一种应用于样本分析***的自动精度管理方法，该样本分析***可以是包括血液分析仪、涂片制备装置、及细胞图像分析装置的血液分析流水线，该方法包括以下步骤。
步骤S2’.血液分析仪对样本进行分析，以得到该样本的第一检测结果，如血常规检测结果。
步骤S3’.判断是否符合质控条件，如果不符合，则对当前测试的样本进行普通样本计数流程。质控条件包括第一检测结果符合预设条件，例如该样本的第一检测结果中白细胞计数大于7.0(10^ 9/L)，则可将其选为质控样本；质控条件还可以进一步包括预设的时间，例如每天8:00-8:30之间，选择第一检测结果符合预设条件的样本；或者，质控条 件还可以包括每个质控周期内测试完第N个样本，例如每天一次质控，质控周期是一天，每天流水线启动后，血液分析仪测完第一个样本就自动启动质控流程，或者每天流水线启动后，血液分析仪测完多个样本(例如3个样本)后在这多个样本中挑选第一检测结果符合预设条件的样本，开始质控流程；如此，可以在流水线每日刚开始启动测试后，即时自动完成质控流程，确保当日样本分析的准确性；质控条件还可以包括预设的负载，例如选择负载小的时间做质控，可以提高质控速度，也可以避免影响病人样本的正常测试。
步骤S4’.如果符合质控条件，则将该样本运送至涂片制备装置。
步骤S5’.涂片制备装置对该样本进行制片，还将质控标识打印于该样本血涂片上。
步骤S7’.将该样本的血涂片运送至细胞图像分析装置。
步骤S8’.细胞图像分析装置识别出该样本的质控标识，切换至质控模式，对该样本血涂片进行拍摄及分析，以得到基于图像拍摄及分析的第二检测结果。
步骤S9’.将该样本的第二检测结果与第一检测结果进行比较，根据比较结果输出质控参考信息。
图13所示的实施例中，各个步骤的具体过程在上述实施例中已阐述，在此不做赘述。当然，以上各个实施例也可以相互结合，尤其是对血液分析仪的质控、涂片制备装置的质控以及细胞图像分析装置的质控等可以相互结合。例如，基于上述的样本分析***，单独对涂片制备装置进行质控，也就是对推片和染色质量进行判断,具体过程如图14所示，包括步骤S1、S2、S4-S8、S9’，其中步骤S1、S2、S4-S8可以与图9所示的实施例相同，在此不做赘述。
对于步骤S9’：控制器根据第二检测结果判断质控血涂片的推片及染色质量，具体过程在上述实施例中已详细叙述，在此不做赘述。
本领域技术人员可以理解，上述实施方式中各种方法的全部或部分功能可以通过硬件的方式实现，也可以通过计算机程序的方式实现。当上述实施方式中全部或部分功能通过计算机程序的方式实现时，该程序可以存储于一计算机可读存储介质中，存储介质可以包括：只读存储器、随机存储器、磁盘、光盘、硬盘等，通过计算机执行该程序以实现上述功能。例如，将程序存储在设备的存储器中，当通过处理器执行存储器 中程序，即可实现上述全部或部分功能。另外，当上述实施方式中全部或部分功能通过计算机程序的方式实现时，该程序也可以存储在服务器、另一计算机、磁盘、光盘、闪存盘或移动硬盘等存储介质中，通过下载或复制保存到本地设备的存储器中，或对本地设备的***进行版本更新，当通过处理器执行存储器中的程序时，即可实现上述实施方式中全部或部分功能。
本文参照了各种示范实施例进行说明。然而，本领域的技术人员将认识到，在不脱离本文范围的情况下，可以对示范性实施例做出改变和修正。例如，各种操作步骤以及用于执行操作步骤的组件，可以根据特定的应用或考虑与***的操作相关联的任何数量的成本函数以不同的方式实现(例如一个或多个步骤可以被删除、修改或结合到其他步骤中)。
另外，如本领域技术人员所理解的，本文的原理可以反映在计算机可读存储介质上的计算机程序产品中，该可读存储介质预装有计算机可读程序代码。任何有形的、非暂时性的计算机可读存储介质皆可被使用，包括磁存储设备(硬盘、软盘等)、光学存储设备(CD-ROM、DVD、Blu Ray盘等)、闪存和/或诸如此类。这些计算机程序指令可被加载到通用计算机、专用计算机或其他可编程数据处理设备上以形成机器，使得这些在计算机上或其他可编程数据处理装置上执行的指令可以生成实现指定的功能的装置。这些计算机程序指令也可以存储在计算机可读存储器中，该计算机可读存储器可以指示计算机或其他可编程数据处理设备以特定的方式运行，这样存储在计算机可读存储器中的指令就可以形成一件制造品，包括实现指定功能的实现装置。计算机程序指令也可以加载到计算机或其他可编程数据处理设备上，从而在计算机或其他可编程设备上执行一系列操作步骤以产生一个计算机实现的进程，使得在计算机或其他可编程设备上执行的指令可以提供用于实现指定功能的步骤。
虽然在各种实施例中已经示出了本文的原理，但是许多特别适用于特定环境和操作要求的结构、布置、比例、元件、材料和部件的修改可以在不脱离本披露的原则和范围内使用。以上修改和其他改变或修正将被包含在本文的范围之内。
前述具体说明已参照各种实施例进行了描述。然而，本领域技术人员将认识到，可以在不脱离本披露的范围的情况下进行各种修正和改变。因此，对于本披露的考虑将是说明性的而非限制性的意义上的，并且所 有这些修改都将被包含在其范围内。同样，有关于各种实施例的优点、其他优点和问题的解决方案已如上所述。然而，益处、优点、问题的解决方案以及任何能产生这些的要素，或使其变得更明确的解决方案都不应被解释为关键的、必需的或必要的。本文中所用的术语“包括”和其任何其他变体，皆属于非排他性包含，这样包括要素列表的过程、方法、文章或设备不仅包括这些要素，还包括未明确列出的或不属于该过程、方法、***、文章或设备的其他要素。此外，本文中所使用的术语“耦合”和其任何其他变体都是指物理连接、电连接、磁连接、光连接、通信连接、功能连接和/或任何其他连接。
具有本领域技术的人将认识到，在不脱离本发明的基本原理的情况下，可以对上述实施例的细节进行许多改变。因此，本发明的范围应根据以下权利要求确定。

Claims (34)

  1. 一种样本分析***的自动精度管理方法,其特征在于，包括如下步骤：
    血液分析仪对待测样本进行检测；
    控制器在满足预设的质控触发条件下，根据血液分析仪测得的样本检测结果从已经检测完成的待测样本中挑选质控样本；所述质控样本经血液分析仪检测的结果为第一检测结果；
    控制器控制调度装置将质控样本运送至推片机；
    推片机将所述质控样本制备成质控血涂片；
    染色机对所述质控血涂片进行染色；
    控制器控制调度装置将质控血涂片运送至细胞图像分析装置；
    细胞图像分析装置对所述质控血涂片进行拍摄及分析，得到第二检测结果；
    将所述质控样本的第一检测结果及第二检测结果进行比较；
    输出所述比较结果。
  2. 如权利要求1所述的方法,其特征在于，所述预设的质控触发条件包括每个周期血液分析仪首次启动测试后测试完第N个样本、预设的时间、预设的负载和预设的检测结果中的至少其中之一，其中N为不小于1的自然数。
  3. 如权利要求1所述的方法,其特征在于，所述将所述质控样本的第一检测结果及第二检测结果进行比较包括：
    比较所述质控样本的预设类型的细胞在第一检测结果中的第一检测结果值及在第二检测结果中的第二检测结果值；
    如果所述质控样本的预设类型的细胞的第一检测结果值及第二检测结果值的偏差超过预设范围，则输出提示信息。
  4. 如权利要求1-3任意一项所述的方法,其特征在于，在血液分析仪对待测样本进行检测之前，还包括：对所述血液分析仪进行质控；如果血液分析仪质控合格，则对样本进行检测以得到样本的第一检测结果。
  5. 如权利要求4所述的方法,其特征在于，还包括：如果所述质控样本的预设类型的细胞的第一检测结果值及第二检测结果值的偏差超过预设范围，则输出细胞图像分析装置质控不合格的提示信息。
  6. 如权利要求1所述的方法,其特征在于，所述质控样本的第一检测结果包括异常信息；所述比较质控样本的第一检测结果及第二结果包括：
    比较所述质控样本的第一检测结果中的异常信息与所述第二检测结果中的异常信息是否一致；
    如果所述质控样本的第一检测结果中的异常信息与所述第二检测结果中的异常信息不一致，则输出提示信息。
  7. 如权利要求6所述的方法,其特征在于，所述异常信息包括疟原虫、血小板聚集、红细胞聚集、红细胞压积高于预设阈值、红细胞大小不均、及异常白细胞中的至少其中之一。
  8. 如权利要求1所述的方法,其特征在于，还包括根据所述第二检测结果中与所述质控血涂片的推片和/或染色相关的检测信息判断所述质控血涂片的推片和/或染色质量。
  9. 如权利要求8所述的方法,其特征在于，第二检测结果中与推片相关的检测信息包括通过细胞图像分析装置获取的所述质控血涂片的血膜外观形态及细胞分布中的至少其中之一。
  10. 如权利要求8所述的方法,其特征在于，所述第二检测结果中与染色相关的检测信息包括通过细胞图像分析装置获取的所述质控血涂片的血膜颜色、颜色深浅中的至少其中之一。
  11. 如权利要求8所述的方法,其特征在于，将所述质控样本的第一检测结果及第二检测结果进行比较包括：
    推片质量及染色质量经过判断符合要求之后，将所述质控样本的第一检测结果及第二检测结果进行比较。
  12. 如权利要求1所述的方法,其特征在于，所述根据血液分析仪测得的样本检测结果挑选质控样本包括：挑选第一检测结果中预设类型的细胞的检测值在预设的范围内的样本作为质控样本。
  13. 如权利要求12所述的方法,其特征在于，第一检测结果中预设类型的细胞的检测值在预设的范围内包括：白细胞的计数值在预设的第一范围内、红细胞的计数值在预设的第二范围内及平均红细胞体积在预设的第三范围内中的至少其中之一。
  14. 如权利要求1所述的方法,其特征在于，所述根据血液分析仪测得的样本检测结果挑选质控样本包括：挑选第一检测结果中包括异常信 息的样本作为质控样本；优选地，所述异常信息包括疟原虫、血小板聚集、红细胞聚集、红细胞压积高于预设阈值、红细胞大小不均、及异常白细胞中的至少其中之一。
  15. 如权利要求1-14任意一项所述的方法,其特征在于，还包括：
    如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，则控制所述调度装置将所述待测样本运送至另一台血液分析仪进行重测，以获取基于血液分析仪分析的第一重测结果；及将所述第一重测结果与第二检测结果进行比较；或者，
    如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，则控制所述调度装置将所述待测样本运送至另一细胞图像分析装置进行重测，以获取基于细胞图像分析装置的第二重测结果；及将所述第一检测结果与第二重测结果进行比较；或者，
    如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，则控制所述调度装置将所述待测样本运送至原来的血液分析仪进行重测，还运送至原来的细胞图像分析装置进行重测，以获取基于血液分析仪分析的第一重测结果以及基于细胞图像分析装置的第二重测结果；及将所述第一重测结果与第二重测结果进行比较。
  16. 如权利要求1-14任意一项所述的方法,其特征在于，还包括：如果所述质控样本的第一检测结果及第二检测结果中相应结果的偏差超过预设范围，则重新从已经检测完成的待测样本中挑选质控样本。
  17. 如权利要求1所述的方法,其特征在于，还包括：
    打印质控标识于质控样本上，细胞图像分析装置识别到所述质控标识，切换为质控模式以对质控样本进行拍摄及分析。
  18. 一种样本分析***,其特征在于，包括：
    血液分析仪,用于对至少一样本进行检测；
    控制器，用于获取至少一样本基于血液分析仪分析的第一检测结果，并实时判断是否满足预设的质控触发条件，如果满足预设的质控触发条件则挑选经血液分析仪分析的样本作为质控样本；还用于控制调度装置将该质控样本运送至涂片制备装置；
    涂片制备装置将所述质控样本制备成血涂片；
    细胞图像分析装置，用于对所述血涂片进行拍摄及分析，并得到基于图像拍摄及分析的第二检测结果；
    所述控制器还用于：
    将所述第二检测结果及第一检测结果中的相应信息进行比较；及
    控制显示装置输出比较结果。
  19. 如权利要求18所述的样本分析***,其特征在于，所述涂片制备装置包括：
    推片机，用于根据预设的推片参数对质控样本进行推片，推片的过程包括将质控样本分配至玻片，并将玻片上的样本推展成血膜；
    染色机，用于根据预设的染色参数对玻片上的血膜进行染色；
    打印装置，用于将样本信息打印于所述质控样本的血涂片上，所述样本信息包括质控标识。
  20. 如权利要求19所述的样本分析***,其特征在于，所述细胞图像分析装置包括识别装置，用于识别所述质控样本的血涂片上的质控标识。
  21. 如权利要求18-20中任意一项所述的样本分析***,其特征在于，所述第二检测结果包括基于细胞图像拍摄及分析的检测信息及与细胞图像分析装置的推片和/或染色质量相关的检测信息。
  22. 如权利要求21所述的样本分析***,其特征在于，所述控制器还用于根据所述第二检测结果中与细胞图像分析装置的推片和/或染色质量相关的检测信息对所述涂片制备装置进行推片和/或染色质量判断。
  23. 如权利要求18-22所述的样本分析***,其特征在于，所述血液分析仪经过了质控，且在质控合格后才对样本进行检测以得到样本的第一检测结果。
  24. 如权利要求18所述的样本分析***,其特征在于，所述控制器还用于：如果所述质控样本的第二检测结果及第一检测结果之间的偏差超过预设范围，则控制显示装置输出细胞图像分析装置的质控提示信息。
  25. 一种样本分析***的自动精度管理方法,其特征在于，包括如下步骤：
    血液分析仪对样本进行检测，以获取样本的第一检测结果；
    自动质控开始步骤、每个周期血液分析仪首次启动测试后测试完第N个样本，或首次启动测试后预设时间，控制调度装置将经血液分析仪检测的样本运送至推片机；
    推片机将所述样本制备成质控血涂片，所述质控血涂片设有质控标 识；
    染色机对所述质控血涂片进行染色；
    控制器控制调度装置将质控血涂片运送至细胞图像分析装置；
    细胞图像分析装置识别所述质控标识，切换成质控模式，在质控模式下对所述质控血涂片进行拍摄及分析，得到第二检测结果；
    将所述质控样本的第一检测结果及第二检测结果进行比较；
    输出所述比较结果。
  26. 如权利要求25所述的方法,其特征在于，还包括：
    在显示界面上提供自动质控选项供用户选定，在接收到选定自动质控选项的指令后，执行自动质控开始步骤。
  27. 一种样本分析***,其特征在于，包括：
    涂片制备装置，包括推片机及染色机，用于根据预设的推片参数对质控样本进行推片，以将分注至玻片上的所述质控样本的血样推展成血膜；
    染色机，用于根据预设的染色参数对玻片上的血膜进行染色；
    细胞图像分析装置，用于对所述血涂片进行拍摄及分析，并得到基于图像拍摄及分析的第二检测结果，所述第二检测结果包括与所述质控血涂片的推片及染色相关的检测信息；
    所述控制器还用于：
    根据所述第二检测结果判断所述质控血涂片的推片及染色质量。
  28. 如权利要求27所述的***,其特征在于，还包括：
    血液分析仪,用于对至少一样本进行检测；
    控制器，用于获取至少一样本基于血液分析仪分析的第一检测结果，并实时判断是否满足预设的条件，如果满足预设的条件则挑选经血液分析仪分析的样本作为质控样本；还用于控制调度装置将该质控样本运送至涂片制备装置。
  29. 如权利要求28所述的样本分析***,其特征在于，所述涂片制备装置包括：打印装置，用于将样本信息打印于所述质控样本的血涂片上，所述样本信息包括质控标识。
  30. 如权利要求28或29所述的样本分析***,其特征在于，所述控制器用于：根据第二检测结果中与推片相关的检测信息识别该质控血涂片的血膜外观形态和/或细胞分布；并根据所述质控血涂片的血膜外观 形态和/或细胞分布对所述推片机进行推片质量判断；
    其中，第二检测结果中与推片相关的检测信息包括通过细胞图像分析装置获取的所述质控血涂片的血膜外观形态及细胞分布中的至少其中之一。
  31. 如权利要求28-30中任意一项所述的样本分析***,其特征在于，所述控制器还用于：根据第二检测结果中的与染色相关的检测信息识别该质控血涂片的血膜色彩、颜色深浅中的至少其中之一；并根据所述质控血涂片的血膜色彩，颜色深浅中的至少其中之一对所述涂片制备装置进行染色质量判断；其中，所述第二检测结果中与染色相关的检测信息包括通过细胞图像分析装置获取的所述质控血涂片的血膜颜色、颜色深浅中的至少其中之一。
  32. 如权利要求28-31中任意一项所述的样本分析***,其特征在于，所述控制器还用于：将所述质控样本的第一检测结果及第二检测结果中相应的结果信息进行比较；并控制显示装置输出所述比较结果。
  33. 一种样本分析***,其特征在于，包括：
    存储器，用于存储程序；
    处理器，用于执行所述存储器存储的程序以实现如权利要求1-17、25和26中任一项所述的方法。
  34. 一种计算机可读存储介质，其特征在于，包括程序，所述程序能够被处理器执行以实现如权利要求1-17、25和26中任一项所述的方法。
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