WO2018032718A1 - 血细胞和生化检测仪及其检测方法 - Google Patents

血细胞和生化检测仪及其检测方法 Download PDF

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WO2018032718A1
WO2018032718A1 PCT/CN2017/070574 CN2017070574W WO2018032718A1 WO 2018032718 A1 WO2018032718 A1 WO 2018032718A1 CN 2017070574 W CN2017070574 W CN 2017070574W WO 2018032718 A1 WO2018032718 A1 WO 2018032718A1
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cup
biochemical
sample
detecting
detection
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PCT/CN2017/070574
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English (en)
French (fr)
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徐新
曹宁
董自权
宋成桥
周强
郭敏
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江苏英诺华医疗技术有限公司
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    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N21/49—Scattering, i.e. diffuse reflection within a body or fluid
    • G01N21/51—Scattering, i.e. diffuse reflection within a body or fluid inside a container, e.g. in an ampoule
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/59—Transmissivity
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • 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
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • 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
    • G01N15/10—Investigating individual particles
    • G01N2015/1006—Investigating individual particles for cytology

Definitions

  • the invention belongs to the technical field of medical test and detection, in particular to a blood cell and biochemical detector and a detection method thereof.
  • the existing blood cell detection and biochemical detection are generally performed separately on the blood analyzer and the biochemical analyzer, so two blood samples and two different instruments must be prepared for the detection to perform two types of detection, which is cumbersome and It is often necessary to manually transfer samples, and the sample coding information is prone to errors in manual transmission.
  • This detection mode cannot meet the needs of rapid detection such as outpatient and emergency.
  • the existing instruments for performing routine blood tests and biochemical tests have a single detection project, the structure is complicated, and the process is cumbersome.
  • a technical solution for achieving the object of the present invention is: a blood cell and a biochemical detector, the detector comprising a transfer module, a hemolytic agent addition module, a diluent addition module, a cleaning agent addition module, a first detection cup, a second detection cup, and a cleaning Module, mixing module and control module;
  • the transfer module is configured to transfer a biochemical reagent and a sample, including a biochemical reagent bit, a sample bit, a sample aspirating needle, a first liquid extracting device, and a moving device; the mobile device is used to drive the aspirating needle in the sample position, biochemical Moving between the reagent position, the first detection cup and the second detection cup;
  • the hemolytic agent addition module includes a hemolytic agent site and a second liquid extraction device for adding a hemolytic agent to the first test cup;
  • the diluent addition module includes a dilution liquid level and a third liquid extraction device for adding a diluent to the first detection cup and the second detection cup;
  • the cleaning agent adding module includes a cleaning agent position and a fourth liquid extracting device for adding a cleaning agent to the first detecting cup;
  • the first detecting cup is used for first dilution of the blood sample, and the first detecting cup wall is provided with a first particle counting detecting device and a transmitted light detecting device, and the first particle counting detecting device is used for the first Check
  • the white blood cell particles in the measuring cup are used for detecting the hemoglobin in the first detecting cup and the biochemical test on the blood sample after adding the biochemical reagent.
  • the second detecting cup is configured to receive the diluted blood sample transferred from the first detecting cup and perform a second dilution, and the second detecting cup wall is provided with a second particle counting detecting device for the second dilution Red blood cells and platelets in the sample in the back cup are tested;
  • the cleaning module comprises a sample aspirating washer, a waste liquid discharge pipe and a waste liquid pump, wherein the sample suction needle cleaner is used for cleaning the outer wall of the sample suction needle, and the waste liquid discharge pipe is for discharging the waste liquid in the test cup, and sucking The waste liquid generated after the sample needle cleaner is cleaned, and the waste liquid pump provides power for discharging the waste liquid;
  • the mixing module agitates and mixes the liquid in the detecting cup by blowing the bottom of the first and second detecting cups;
  • the control module is configured to control the operation of the transfer module, the diluent addition module, the hemolytic agent addition module, the cleaning agent addition module, the cleaning module, the mixing module, the first detection cup and the second detection cup, and perform detection data Analyze processing, display, print, and output test results.
  • a method for detecting a blood cell and a biochemical detector includes the following steps:
  • Step 1 Quantitatively draw the whole blood sample from the sample cup through the aspirating needle, transfer it to the first detection cup, and add the quantitative dilution solution to the first detection cup through the diluent addition module, and pass the mixing module to the first detection.
  • the liquid in the cup is mixed; the outer wall of the suction needle is cleaned by a suction needle cleaner;
  • Step 2 Aspirating the quantitatively diluted and mixed blood sample from the first test cup by the aspirating needle to the second test cup, and the diluent addition module adds a quantitative dilution solution to the second test cup, and the sample is aspirated
  • the blood sample transferred by the needle is diluted, the liquid in the second test cup is mixed by the mixing module, and the second particle counting detecting device performs the red blood cell and platelet detection on the blood sample mixed in the second detecting cup; through the suction needle cleaner Cleaning the outer wall of the sample needle;
  • Step 3 adding a quantitative hemolytic agent to the first detection cup through the hemolytic agent adding module, and mixing the liquid in the first detection cup through the mixing module, and the first particle counting detecting device and the transmitted light detecting device respectively perform the first detecting
  • the blood sample after mixing in the cup is subjected to white blood cell detection and hemoglobin detection;
  • Step 4 Move the aspirating needle to the biochemical reagent position, absorb the quantitative biochemical reagent and transfer it to the first detection cup, mix the liquid in the first detection cup again, and use the transmitted light detecting device to mix and dilute after adding the biochemical reagent. The sample is tested and the test results of the corresponding biochemical items are obtained.
  • the significant effects of the present invention are: (1) the present invention uses a whole blood sample The product quickly completes the routine and biochemical tests of blood on one instrument, and combines the original independent detection processes once, avoiding the repetition of some processes, reducing the sample, saving the detection time and simplifying the operation process; (2) the invention Two different types of blood routine and biochemical tests are performed in one system, and the obtained test results can be very efficiently and accurately unified with the original coded information of the sample; (3) The present invention can be modified by a new design.
  • Fig. 1 ⁇ 1 is a schematic diagram showing the mutual positional relationship between the sample position Cs, the first biochemical reagent position R1, the first detection cup C1 and the second detection cup C2, and a schematic diagram of the movement path of the suction needle.
  • Fig. 1 ⁇ 2 is a schematic diagram showing the mutual positional relationship between the sample position Cs, the first biochemical reagent position R1, the second biochemical reagent position R1', the first detection cup C1 and the second detection cup C2, and a schematic diagram of the movement path of the suction needle.
  • Fig. 1 ⁇ 3 is a schematic diagram showing the mutual positional relationship between the sample position Cs, the first detection cup C1, the second detection cup C2 and the first biochemical reagent position R1, and a schematic diagram of the movement path of the suction needle.
  • Fig. 1 ⁇ 4 is a schematic diagram showing the mutual positional relationship between the sample position Cs, the first detection cup C1, the second detection cup C2, the first biochemical reagent position R1 and the second biochemical reagent position R1', and a schematic diagram of the movement path of the suction needle.
  • Fig. 1 ⁇ 5 is a schematic diagram showing the mutual positional relationship between the sample position Cs, the first detection cup C1, the second detection cup C2, the first biochemical reagent position R1 and the second biochemical reagent position R1′, and the arc motion path of the suction needle schematic diagram.
  • Figure 2 ⁇ 1 is a schematic view of two test cups of the present invention, in which the first test cup is provided with two light sources and two optical detecting devices.
  • Figures 2 ⁇ 2 to 2 ⁇ 5 show top view of the first test cup when the filters F1, F2 and F3 of three different wavelengths are arranged at different positions.
  • Figure 3 ⁇ 1 is a schematic view of two test cups of the present invention, wherein the first test cup is provided with only two light sources and one optical detecting device; and Figures 3 ⁇ 2 and 3 ⁇ 3 respectively set three filters in the first A top view of the test cup at different positions.
  • Figure 4 is a schematic view showing the structure of the biochemical detector of the present invention.
  • Figure 5 is a schematic view of the syringe cleaner of the present invention.
  • Fig. 6 is a graph showing the correlation analysis between the existing biochemical analyzer and the analyzer of the present invention for detecting CRP results.
  • Fig. 7 is a graph showing the correlation analysis between the existing biochemical analyzer and the analyzer of the present invention for detecting HbA1c results.
  • a blood cell and biochemical detector and detection method thereof comprising a transfer module, a hemolytic agent addition module, a diluent addition module, a cleaning agent addition module, a first detection cup, a second detection cup, a cleaning module, a mixing module And control modules.
  • the transfer module is configured to transfer a reagent and a sample, including a biochemical reagent bit, a sample bit, a sample aspirating needle, a first liquid extracting device, a connecting line, and a moving device; the moving device is configured to drive the aspirating sample in the sample Position, biochemical reagent position, movement between the first detection cup and the second detection cup;
  • the hemolytic agent addition module includes a hemolytic agent site and a second liquid extraction device for adding a hemolytic agent to the first test cup;
  • the diluent addition module includes a dilution liquid level and a third liquid extraction device for Adding a diluent to the first detection cup and the second detection cup;
  • the cleaning agent adding module includes a cleaning agent position and a fourth liquid extraction device for adding a cleaning agent to the first detection cup;
  • the first detecting cup is used for first dilution of the blood sample, and the first detecting cup wall is provided with a first particle counting detecting device and a transmitted light detecting device, and the first particle counting detecting device is used for the white blood cell particles in the cup Performing detection, the transmitted light detecting device is used for detecting hemoglobin and performing biochemical test on the blood sample after adding the biochemical reagent;
  • the second detecting cup is configured to receive the diluted blood sample transferred from the first detecting cup, and perform a second dilution on the blood sample, and the second detecting cup wall is provided with a second particle counting detecting device for the second Red blood cells and platelets in the cup after the second dilution;
  • the mixing module realizes mixing the liquid in the detecting cup by agitating the bottom of the first and second detecting cups to agitate the liquid in the detecting cup;
  • the cleaning module comprises a suction needle cleaner, a waste liquid discharge tube and a waste liquid pump, and the sample suction needle cleaner is used for cleaning the outer wall of the suction needle to reduce cross-contamination, and the waste liquid is discharged as shown in FIG. 5 .
  • the tube is used for removing the waste liquid in the test cup and the waste liquid generated after the sample needle cleaner is cleaned, and the waste liquid pump provides power for discharging the waste liquid;
  • the control module is configured to control a transfer module, a diluent addition module, a hemolytic agent addition module, and a cleaning
  • the detection device of the agent addition module, the cleaning module, the mixing module, the first detection cup and the second detection cup work, and performs detection data analysis processing, display, printing, and output detection results.
  • the first detection cup wall is further provided with a scattered light detecting device for performing biochemical detection on the blood sample after adding the biochemical reagent.
  • the scattered light detecting device and the transmitted light detecting device are single wavelength detecting devices or multi-wavelength detecting devices.
  • the scattered light detecting means and the transmitted light detecting means switch the wavelength according to the detection, and the switching of the detected wavelength is realized by switching the light source, switching the voltage, or installing a monochromator device capable of changing the wavelength before the detector.
  • the transfer module includes more than one biochemical reagent position.
  • the biochemical detector is further provided with a washer for cleaning the outer wall of the sample needle.
  • a shielding cover is disposed around the first detecting cup and the second detecting cup, and an opening is arranged above the shielding cover, and a cover that can be automatically opened and closed is provided at the opening, and the cover is closed when detecting, and the cover is added when the sample is loaded. Open.
  • the first test cup also has a constant temperature and heating device to ensure accurate biochemical test results.
  • the invention also provides a method for detecting a blood cell and a biochemical detector, comprising the following steps:
  • Step 1 Quantitatively draw the whole blood sample from the sample cup through the aspirating needle, transfer it to the first detection cup, and add the quantitative dilution solution to the first detection cup through the diluent addition module, and pass the mixing module to the first detection.
  • the liquid in the cup is mixed; the outer wall of the suction needle is cleaned by a suction needle cleaner;
  • Step 2 Aspirating the quantitatively diluted and mixed blood sample from the first test cup by the aspirating needle to the second test cup, and the diluent addition module adds a quantitative dilution solution to the second test cup, and the sample is aspirated
  • the blood sample transferred by the needle is diluted, the liquid in the second test cup is mixed by the mixing module, and the second particle counting detecting device performs the red blood cell and platelet detection on the blood sample mixed in the second detecting cup; through the suction needle cleaner Cleaning the outer wall of the sample needle;
  • Step 3 adding a quantitative hemolytic agent to the first detection cup through the hemolytic agent adding module, and mixing the liquid in the first detection cup through the mixing module, and the first particle counting detecting device and the transmitted light detecting device respectively perform the first detecting
  • the blood sample after mixing in the cup is subjected to white blood cell detection and hemoglobin detection;
  • Step 4 Move the aspirating needle to the biochemical reagent position, absorb the quantitative biochemical reagent and transfer it to the first detection cup, mix the liquid in the first detection cup again, and mix the biochemical reagent by using the transmitted light detecting device. The diluted sample is tested and the test results of the corresponding biochemical items are obtained.
  • step 4 the scattered light detecting device is used to replace the transmitted light detecting device to detect the biochemical component in the sample, and the corresponding biochemical item detecting result is obtained.
  • the glycated hemoglobin reagent is added to the first detecting cup and mixed, and the scattered light detecting device performs the glycated hemoglobin detection on the mixed liquid.
  • the ratio of glycated hemoglobin to hemoglobin was calculated based on the hemoglobin test result and the glycated hemoglobin test result.
  • the instrument automatically performs the biochemical test results of this part of the project. Amend to ensure that the results of biochemical tests detected by this instrument are consistent with the results of serum and plasma tests.
  • the specific correction method is:
  • the volume of white blood cells can also be calculated according to the following formula:
  • White blood cell volume average white blood cell volume ⁇ large white blood cell number ⁇ correction factor c + small white blood cell volume ⁇ small white blood cell number ⁇ correction factor d, the correction factors c and d range from 0.3 to 4.0, respectively;
  • volume of white blood cells can also be calculated according to the following formula:
  • Leukocyte volume average lymphocyte volume ⁇ number of lymphocytes ⁇ correction factor e + neutrophil volume ⁇ number of neutrophils ⁇ correction factor f + intermediate cell volume ⁇ number of intermediate cells ⁇ correction factor g, correction factors e, f and g
  • the range is 0.3 ⁇ 4.0.
  • test result is required to be a certain biochemical component in whole blood, rather than a certain biochemical component in serum or plasma, the above correction is not required.
  • the sample position, the first test cup, the second test cup, the first biochemical reagent position and the second biochemical reagent position of the detector are designed in the movement track of the suction needle.
  • the specific layout is as follows: :
  • sample position Cs ⁇ first biochemical reagent position R1 ⁇ first detection cup C1 ⁇ second detection Cup C2;
  • sample position Cs ⁇ first biochemical reagent position R1 ⁇ second biochemical reagent position R1 ' ⁇ first detection cup C1 ⁇ second detection cup C2;
  • sample position Cs ⁇ first test cup C1 ⁇ second test cup C2 ⁇ first biochemical reagent position R1 ⁇ second biochemical reagent position R1';
  • the detector comprises a transfer module, a hemolytic agent addition module, a diluent addition module, a cleaning agent addition module, a first detection cup, a second detection cup, a cleaning module, a mixing module and a control module;
  • the suction needle N1 moves into the sample cup, the second valve V2 is closed, the first valve V1 is opened, the first liquid extraction device S1 is pulled back, the quantitative sample is sucked into the suction needle N1, and the mobile device drives the suction needle.
  • the N1 moves to the first detecting cup C1, the first valve V1 is closed, the second valve V2 is opened, and the first liquid extracting device S1 pushes the blood sample of the sucking needle N1 into the first detecting cup C1; the diluent adding module
  • the sixth valve V6 is opened, the second valve V2, the thirteenth valve V13 and the fifth valve V5 are closed, and the third liquid extracting device S3 is pulled back to draw the diluent R3 into the third liquid extracting device S3, and the sixth valve V6 is closed.
  • the thirteenth valve V13 is opened, and the third liquid extracting device S3 is pushed by the piston, and the diluent in the original third liquid extracting device S3 enters the first detecting cup C1 along N3; the tenth valve V10 and the tenth in the mixing module
  • the second valve V12 is closed, the ninth valve V9 and the eleventh valve V11 are opened, the air pump P1 is blown, and the driving gas enters the bottom of the first detecting cup C1 along the pipeline to mix the liquid in the cup.
  • the aspirating needle N1 sucks a partially diluted diluted sample from the first detecting cup C1, and transfers to the second detecting cup C2, and the sixth valve V6 in the diluent adding module is opened, the fifth valve V5, the second valve V2 and the first The thirteenth valve V13 is closed, the third liquid extracting device S3 pulls back the suction to draw the quantitative dilution liquid R3, the sixth valve V6 and the thirteenth valve V13 are closed, and the fifth valve V5, the first valve V1 and the second valve V2 are opened, The third liquid extracting device S3 pushes the quantitative diluent in the third liquid extracting device S3 into the second detecting cup C2 through the second diluent needle N3', and enters the sucking needle N1 through the pipe, and the inside of the sucking needle N1 Wash it.
  • the ninth valve V9 and the twelfth valve V12 in the mixing module are closed, and the tenth valve V10 and the eleventh valve V11 are opened, the air pump P1 is blown, and the driving gas enters the bottom of the second detecting cup C2 along the pipeline to mix the liquid in the cup.
  • the second particle count detecting means D5 detects the number and volume of sample platelets and red blood cells in the second detecting cup C2.
  • the external needle cleaner cleans the outside of the suction needle N1.
  • the fourth valve V4 is opened, the third valve V3 is closed, the second liquid extracting device S2 is pulled back, the hemolytic agent R2 is sucked into the second liquid extracting device S2, the fourth valve V4 is closed, the third valve V3 is opened, and the second liquid is drawn.
  • the device S2 is advanced by the piston to cause the quantitative hemolytic agent to enter the first test cup C1.
  • the eleventh valve V11 and the ninth valve V9 are opened, the tenth valve V10 and the twelfth valve V12 are closed, the air pump P1 is blown, and the driving gas enters the bottom of the first detecting cup C1 along the pipeline, and the mixing cup is mixed.
  • Medium liquid Medium liquid.
  • the first particle counting device D4 in the first detecting cup C1 detects the number and volume of white blood cells in the cup, and the first transmitted light source L1 or the second transmitted light source L1' is turned on, the first transmitted light detecting device D1 or the second transmitted light detecting device D1' detects hemoglobin content.
  • the aspirating needle N1 moves to the biochemical reagent position R1, and the aspirating needle N1 penetrates into the biochemical reagent position R1, and is sucked by the biochemical reagent position R1 under the cooperation of the first liquid extracting device S1, the first valve V1 and the second valve V2.
  • Quantitative biochemical reagent then the sample needle N1 moves to the first test cup C1, the biochemical reagent is added to the first test cup C1, the tenth valve V10 and the twelfth valve V12 of the mixing module are closed, the ninth valve V9 and the The eleventh valve V11 is opened, the air pump P1 is blown, and the driving gas enters the bottom of the first detecting cup C1, and the liquid in the cup is mixed.
  • the first transmitted light source L1 is turned on, and the first transmitted light detecting device D1 detects the transmitted light signal to obtain a single reagent biochemical item detection result.
  • the ninth valve V9, the tenth valve V10, the twelfth valve V12, the waste liquid pump P2 are pumped, and the detection waste liquid in each test cup, the needle outer cleaner and the pipeline is discharged into the waste liquid collector.
  • the seventh valve V7 is closed, the fourth liquid extraction device S4 is pulled back, the cleaning agent R4 is sucked into the fourth liquid extraction device S4, and then the eighth valve V8 is closed, and the seventh
  • the valve V7 is opened, the fourth liquid extracting device S4 is advanced, and the cleaning agent R4 is injected into the first detecting cup C1, and then the ninth valve V9 and the twelfth valve V12 are opened, the waste liquid pump P2 is evacuated, and the cleaning waste liquid is discharged into the waste. Liquid collector.
  • the sixth valve V6 in the diluent addition module is opened, the fifth valve V5, the second valve V2 and the thirteenth valve V13 are closed, the third liquid extraction device S3 piston pulls back to draw the quantitative dilution liquid R3, and then the sixth valve V6 Closing, the fifth valve V5, the thirteenth valve V13, the first valve V1 and the second valve V2 are opened, and the third liquid extracting device S3 pushes the piston to pass the quantitative diluent in the third liquid extracting device S3 through the first diluent needle N3 and the second diluent needle N3' are injected into the first detecting cup C1 and the second detecting cup C2, At the same time, the suction needle N1 is entered through the pipeline, and the inside of each test cup and the suction needle N1 is cleaned.
  • the suction needle N1 also performs external cleaning of the needle at this time. After the cleaning is completed, the ninth valve V9, the tenth valve V10, the twelfth valve V12, the waste liquid pump P2 are pumped, and the cleaning waste liquid is discharged into the waste liquid collector.
  • the suction needle N1, the first liquid extraction device S1, the first valve V1 and the second valve V2 constitute a transfer module;
  • the hemolytic agent needle N2, the second liquid extraction device S2, the third valve V3 and the fourth valve V4 constitute Hemolysis agent addition module;
  • diluent needles N3' and N3, third liquid extraction device S3, fifth valve V5, sixth valve V6, thirteenth valve V13 constitute a diluent addition module;
  • the device S4, the seventh valve V7 and the eighth valve V8 constitute a cleaning agent adding module;
  • the air pump P1, the ninth valve V9, the tenth valve V10, the eleventh valve V11 and the twelfth valve V12 constitute a mixing module.
  • the biochemical detector of the present embodiment is different from the embodiment 1 in that the blood routine and the two-reagent biochemical project are detected in the embodiment, that is, the embodiment includes two biochemicals. Reagent position.
  • the suction needle N1 moves to the first biochemical reagent position R1, and the suction needle N1 penetrates into the first biochemical reagent position R1, and is matched by the first liquid extraction device S1, the first valve V1 and the second valve V2, by the first
  • the first biochemical reagent is taken up in the biochemical reagent position R1, and then the aspirating needle N1 is moved to the first detecting cup C1, the first biochemical reagent is added to the first detecting cup C1, and the tenth valve V10 and the tenth in the mixing module are
  • the second valve V12 is closed, the ninth valve V9 and the eleventh valve V11 are opened, the air pump P1 is blown, and the driving gas enters the bottom of the first detecting cup C1 to mix the liquid in the cup.
  • the sample needle N1 is moved to the second biochemical reagent position R1', and the second biochemical reagent is aspirated in the same manner and transferred to the first test cup C1 to turn on the first transmitted light source L1, and the first transmitted light detecting device D1 detects The light signal is transmitted to obtain the detection result of the two-reagent biochemical project.
  • the biochemical detector of the present embodiment is different from the embodiment 1 in that the first detecting cup of the present embodiment is provided with a first transmitted light source L1 and a scattered light source L2, and the first transmitted light source L1 and the scattering are combined with FIG.
  • the light source L2 shares a detection device D3.
  • the first transmitted light source L1 is disposed opposite the detecting device D3, and the scattered light source L2 and the detecting device D3 are at an angle of 30-120.
  • the first transmitted light source L1 is turned on, the scattered light source L2 is turned off, and the detecting device D3 detects the transmitted light signal to obtain a biochemical item detection result.
  • the difference between this embodiment and the third embodiment is that the scattered light source L2 is turned on, the first transmitted light source L1 is turned off, and the detecting device D3 detects the scattered light signal to obtain the biochemical item detection result.
  • the biochemical detector of the present embodiment is different from Embodiments 1 and 2 in that the present embodiment obtains the biochemical item detection result by the second transmission light source L1' and the second transmitted light detecting device D1'.
  • the present embodiment detects by using the first filter F1, the second filter F2, and the third filter F3 of different wavelengths. Select a specific wavelength based on the detection needs.
  • the first filter F1 is rotated to the light-emitting portion of the light source and before the receiving portion of the detecting device, the dominant wavelength is set to 510 nm, the absorbance of the detected sample is A1; and the second filter F2 is rotated to the light source.
  • FIG. 6 is the CRP detection result

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Abstract

一种血细胞和生化检测仪及其检测方法，该检测仪包括转移模块、稀释液添加模块、溶血剂添加模块、清洗剂添加模块、第一检测杯（C1）、第二检测杯（C2）、清洗模块、混匀模块和控制模块；第一检测杯（C1）用于对血样的第一次稀释，并能同时检测同一血样的白细胞、血红蛋白等指标，并可同时执行对该血样的另一种生化成份检测，第二检测杯（C2）用于执行对血样的第二次稀释并执行对稀释血样的红细胞及血小板检测。实现了在同一台生化检测仪上快速完成血液常规检测及另一种生化成份检测，功能更加完善，可以快速同时完成临床急需血常规及生化项目检测，具有样品消耗少、操作流程简便及产生废弃物少等优点。

Description

血细胞和生化检测仪及其检测方法 技术领域
本发明属于医学检验检测技术领域，特别是一种血细胞和生化检测仪及其检测方法。
背景技术
在医学临床诊断中常需要实验室同时获得患者血液血细胞检测信息和生化检测信息，实验室提供的综合检查信息可以给临床疾病诊断和治疗提供更加完善的指导信息。
现有血液细胞检测和生化检测一般是分别在血液分析仪和生化分析仪上分别进行，因此检测时必须准备两份血样和两部不同仪器方可以完成两种类型检测，操作较为繁琐，且由于常常需要人工传递样本，样品编码信息在人工传递中易发生错误，这种检测模式无法满足门诊、急诊等快速检测的需要。且现有的可执行血液常规及生化检测的仪器检测项目单一，结构较复杂，流程较繁琐。
发明内容
本发明的目的在于提供一种血细胞和生化检测仪及其检测方法。
实现本发明目的的技术方案为：一种血细胞和生化检测仪，该检测仪包括转移模块、溶血剂添加模块、稀释液添加模块、清洗剂添加模块、第一检测杯、第二检测杯、清洗模块、混匀模块和控制模块；
所述转移模块用于转移生化试剂和样品，包括生化试剂位、样品位、一个吸样针、第一液体抽取装置和一个移动装置；所述移动装置用于驱动吸样针在样品位、生化试剂位、第一检测杯、第二检测杯之间移动；
所述溶血剂添加模块包括一个溶血剂位和第二液体抽取装置，用于向第一检测杯中添加溶血剂；
所述稀释液添加模块包括一个稀释液位和第三液体抽取装置，用于向第一检测杯和第二检测杯中添加稀释液；
所述清洗剂添加模块包括一个清洗剂位和第四液体抽取装置，用于向第一检测杯中添加清洗剂；
所述第一检测杯用于对血样进行第一次稀释，第一检测杯杯壁上设置有第一颗粒计数检测装置和透射光检测装置，所述第一颗粒计数检测装置用于对第一检 测杯中白细胞颗粒进行检测，所述透射光检测装置用于对第一检测杯中血红蛋白进行检测以及对加入生化试剂后的血样进行生化项目检测。
所述第二检测杯用于接受由第一检测杯转移来的稀释血样，并进行第二次稀释，第二检测杯杯壁上设置有第二颗粒计数检测装置，用于对第二次稀释后杯中样本中的红细胞和血小板进行检测；
所述清洗模块包括吸样针清洗器、废液排出管以及废液泵，所述吸样针清洗器用于清洗吸样针外壁，所述废液排出管用于排出检测杯中废液，及吸样针清洗器清洗后产生的废液，所述废液泵为废液排出提供动力；
所述混匀模块通过向第一、第二检测杯底部鼓气，对检测杯中的液体进行搅动混匀；
所述控制模块用以控制转移模块、稀释液添加模块、溶血剂添加模块、清洗剂添加模块、清洗模块、混匀模块、第一检测杯和第二检测杯中检测装置工作，并进行检测数据分析处理、显示、打印以及输出检测结果。
一种血细胞和生化检测仪的检测方法，包括以下步骤：
步骤1、通过吸样针自样品杯中定量吸取全血样品，转移到第一检测杯中，稀释液添加模块向第一检测杯中加入定量的稀释液，并通过混匀模块对第一检测杯中液体混匀；通过吸样针清洗器对吸样针外壁进行清洗；
步骤2、通过吸样针自第一检测杯中吸取定量的稀释、混匀后的血样转移至第二检测杯，稀释液添加模块向第二检测杯中加入定量的稀释液，并与吸样针转移来的血样进行稀释，由混匀模块对第二检测杯中液体混匀，第二颗粒计数检测装置对第二检测杯中混匀后血样进行红细胞及血小板检测；通过吸样针清洗器对吸样针外壁进行清洗；
步骤3、通过溶血剂添加模块向第一检测杯中加入定量的溶血剂并经混匀模块对第一检测杯内液体混匀，第一颗粒计数检测装置和透射光检测装置分别对第一检测杯中混匀后的血样进行白细胞检测和血红蛋白检测；
步骤4、将吸样针移动至生化试剂位，吸取定量的生化试剂并转移至第一检测杯，再次混匀第一检测杯中液体，采用透射光检测装置对加入生化试剂后混匀的稀释样品进行检测，获得相应生化项目的检测结果。
与现有技术和产品相比，本发明的显著效果为：(1)本发明采用一份全血样 品在一台仪器上快速完成血液常规与生化检测，将原来各自独立的检测过程合并一次完成，避免了部分流程的重复，可减少样品，并节省检测时间和简化操作流程；(2)本发明将血液常规和生化检测两种不同类型的检测在一个***内完成，所获得的检测结果可以非常高效和准确的与样品的原始编码信息统一；(3)本发明通过新设计的修正公式，可以更好、更准确满足由于不同生化成份在血浆及细胞中不同分布可能导致采用全血样本与血浆/血清样本的检测结果差异，检测结果的准确性可以满足临床检验需要；(4)本发明采用仅仅在一台三分类血球仪基础上仅仅增加一个生化试剂位和一个透射光/散射光检测装置，就可以一次完成血细胞和生化项目测试，总体结构简单，检测所产生的废液更少，有利于环保。
附图说明
图1‐1为样品位Cs、第一生化试剂位R1、第一检测杯C1和第二检测杯C2之间的相互位置关系示意图及吸样针运动轨迹示意图。
图1‐2为样品位Cs、第一生化试剂位R1、第二生化试剂位R1’、第一检测杯C1和第二检测杯C2之间的相互位置关系示意图及吸样针运动轨迹示意图。
图1‐3为样品位Cs、第一检测杯C1、第二检测杯C2及第一生化试剂位R1之间的相互位置关系示意图及吸样针运动轨迹示意图。
图1‐4为样品位Cs、第一检测杯C1、第二检测杯C2、第一生化试剂位R1和第二生化试剂位R1’之间的相互位置关系示意图及吸样针运动轨迹示意图。
图1‐5为样品位Cs、第一检测杯C1、第二检测杯C2、第一生化试剂位R1和第二生化试剂位R1’之间的相互位置关系示意图及吸样针弧线运动轨迹示意图。
图2‐1为本发明的两个检测杯示意图，图中第一检测杯设有两个光源和两个光学检测装置。
图2‐2～2‐5分别为三个不同波长的滤光片F1、F2和F3设置在不同位置时的第一检测杯俯视图。
图3‐1为本发明的两个检测杯示意图，其中第一检测杯仅设有两个光源和一个光学检测装置；图3‐2和图3‐3分别为三个滤光片设置在第一检测杯不同位置时的俯视图。
图4为本发明生化检测仪结构示意图。
图5为本发明的吸样针清洗器示意图。
图6为现有生化仪与本发明分析仪检测CRP结果相关性分析图。
图7为现有生化仪与本发明分析仪检测HbA1c结果相关性分析图。
具体实施方式
本发明的一种血细胞和生化检测仪及其检测方法，包括转移模块、溶血剂添加模块、稀释液添加模块、清洗剂添加模块、第一检测杯、第二检测杯、清洗模块、混匀模块和控制模块。
所述转移模块用于转移试剂和样品，包括生化试剂位、样品位、一个吸样针、第一液体抽取装置、连接管路和一个移动装置；所述移动装置用于驱动吸样针在样品位、生化试剂位、第一检测杯、第二检测杯之间移动；
所述溶血剂添加模块包括一个溶血剂位和第二液体抽取装置，用于向第一检测杯中添加溶血剂；所述稀释液添加模块包括一个稀释液位和第三液体抽取装置，用于向第一检测杯和第二检测杯中添加稀释液；所述清洗剂添加模块包括一个清洗剂位和第四液体抽取装置，用于向第一检测杯中添加清洗剂；
所述第一检测杯用于对血样进行第一次稀释，第一检测杯杯壁上设置有第一颗粒计数检测装置和透射光检测装置，第一颗粒计数检测装置用于对杯中白细胞颗粒进行检测，透射光检测装置用于对血红蛋白进行检测以及对加入生化试剂后的血样进行生化项目检测；
所述第二检测杯用于接受由第一检测杯转移来的稀释血样，并对血样进行第二次稀释，第二检测杯杯壁上设置有第二颗粒计数检测装置，用于对第二次稀释后杯中红细胞和血小板进行检测；
所述混匀模块通过向第一、第二检测杯底部鼓气，对检测杯中的液体搅动实现对检测杯中液体混匀；
所述清洗模块包括吸样针清洗器、废液排出管以及废液泵，所述吸样针清洗器如图5所示，用于清洗吸样针外壁，减少交叉污染，所述废液排出管用于排除检测杯中废液，及吸样针清洗器清洗后产生的废液，所述废液泵为废液排出提供动力；
所述控制模块用以控制转移模块、稀释液添加模块、溶血剂添加模块、清洗 剂添加模块、清洗模块、混匀模块、第一检测杯和第二检测杯中检测装置工作，并进行检测数据分析处理、显示、打印以及输出检测结果。
进一步的，所述第一检测杯杯壁上还设置有散射光检测装置，用于对加入生化试剂后的血样进行生化项目检测。
进一步的，所述散射光检测装置和透射光检测装置为单波长检测装置或多波长检测装置。散射光检测装置和透射光检测装置根据检测需要切换波长，检测波长的切换通过切换光源、切换电压或检测器前安装可改变波长的单色器装置实现。
进一步的，所述转移模块包括一个以上的生化试剂位。
进一步的，生化检测仪还设置有一个可清洗吸样针外壁的清洗器。
进一步的，所述第一检测杯和第二检测杯四周均设有屏蔽罩，所述屏蔽罩上方设置有开口，开口处设置有可自动开闭的盖子，检测时盖子关闭，加样时盖子开启。
进一步的，第一检测杯还具有恒温及加热装置，确保获得准确的生化检测结果。
本发明还提供一种血细胞和生化检测仪的检测方法，包括以下步骤：
步骤1、通过吸样针自样品杯中定量吸取全血样品，转移到第一检测杯中，稀释液添加模块向第一检测杯中加入定量的稀释液，并通过混匀模块对第一检测杯中液体混匀；通过吸样针清洗器对吸样针外壁进行清洗；
步骤2、通过吸样针自第一检测杯中吸取定量的稀释、混匀后的血样转移至第二检测杯，稀释液添加模块向第二检测杯中加入定量的稀释液，并与吸样针转移来的血样进行稀释，由混匀模块对第二检测杯中液体混匀，第二颗粒计数检测装置对第二检测杯中混匀后血样进行红细胞及血小板检测；通过吸样针清洗器对吸样针外壁进行清洗；
步骤3、通过溶血剂添加模块向第一检测杯中加入定量的溶血剂并经混匀模块对第一检测杯内液体混匀，第一颗粒计数检测装置和透射光检测装置分别对第一检测杯中混匀后的血样进行白细胞检测和血红蛋白检测；
步骤4、将吸样针移动至生化试剂位，吸取定量的生化试剂并转移至第一检测杯，再次混匀第一检测杯中液体，采用透射光检测装置对加入生化试剂后混匀 的稀释样品进行检测，获得相应生化项目的检测结果。
进一步的，步骤4中使用散射光检测装置替换透射光检测装置对样本中的生化成份进行检测，并获得相应的生化项目检测结果。
进一步的，第一颗粒计数检测装置和透射光检测装置分别进行白细胞和血红蛋白检测后，向第一检测杯中加入糖化血红蛋白试剂并混匀，散射光检测装置对混匀后液体进行糖化血红蛋白检测，根据血红蛋白检测结果和糖化血红蛋白检测结果计算糖化血红蛋白占血红蛋白的比例。
对于主要分布在血清、血浆中生化成份检测结果，由于采用全血检测时得到的结果与使用血清或血浆样本的检测结果有显著的差异，因此，仪器自动对这部分项目的生化项目检测结果进行修正，确保本仪器检测的生化项目结果与采用血清及血浆检测结果一致。具体修正方式为：
Figure PCTCN2017070574-appb-000001
检测结果为单位体积血浆/血清中某种生化成分的浓度，其中血清/血浆体积＝全血体积－血细胞体积，其中“/”的含义为或；细胞体积＝全血中血小板数量×血小板平均体积+全血中红细胞数量×红细胞平均体积+全血中白细胞数量×全部白细胞平均体积×修正因子b，修正因子a和b的范围分别为0.3‐4.0。
其中白细胞的体积也可以按照如下公式计算：
白细胞体积＝大白细胞平均体积×大白细胞数量×修正因子c+小白细胞体积×小白细胞数量×修正因子d，修正因子c和d的范围为分别为0.3‐4.0；
或其中白细胞的体积也可以按照如下公式计算：
白细胞体积＝淋巴细胞平均体积×淋巴细胞数量×修正因子e+中性粒细胞体积×中性粒细胞数量×修正因子f+中间细胞体积×中间细胞数量×修正因子g，修正因子e、f和g的范围为分别为0.3‐‐4.0。
但如果要求获得的检测结果为全血中某种生化成份含量，而不是血清或血浆中的某种生化成份的含量时，则不需要对结果进行上述修正。
结合图1‐1～1‐5，检测仪的样品位、第一检测杯、第二检测杯、第一生化试剂位、第二生化试剂位均设计在吸样针移动轨迹中，具体布局如下：
如图1‐1所示：样品位Cs→第一生化试剂位R1→第一检测杯C1→第二检测 杯C2；
如图1‐2所示：样品位Cs→第一生化试剂位R1→第二生化试剂位R1’→第一检测杯C1→第二检测杯C2；
如图1‐3所示：样品位Cs→第一检测杯C1→第二检测杯C2→第一生化试剂位R1；
如图1‐4和1‐5所示：样品位Cs→第一检测杯C1→第二检测杯C2→第一生化试剂位R1→第二生化试剂位R1’；
下面结合附图和实施例对本发明作进一步说明。
实施例1
结合图1‐1、图2‐1以及图4，本实施例中检测血常规和单试剂生化项目。
该检测仪包括转移模块、溶血剂添加模块、稀释液添加模块、清洗剂添加模块、第一检测杯、第二检测杯、清洗模块、混匀模块和控制模块；
检测时，吸样针N1移动到样品杯中，第二阀门V2关闭、第一阀门V1打开，第一液体抽取装置S1活塞回拉，定量样品吸入吸样针N1中，移动装置带动吸样针N1移动至第一检测杯C1，第一阀门V1关闭，第二阀门V2打开，第一液体抽取装置S1活塞推进将吸样针N1中血样加入到第一检测杯C1中；稀释液添加模块中第六阀门V6开启，第二阀门V2、第十三阀门V13和第五阀门V5关闭，第三液体抽取装置S3活塞回拉将稀释液R3吸入第三液体抽取装置S3中，第六阀门V6关闭、第十三阀门V13开启，第三液体抽取装置S3活塞推进，则原吸入第三液体抽取装置S3中的稀释液沿N3进入第一检测杯C1；混匀模块中第十阀门V10和第十二阀门V12关闭，第九阀门V9和第十一阀门V11开启，空气泵P1鼓气，驱动气体沿管路进入第一检测杯C1底部，混匀杯中液体。
吸样针N1自第一检测杯C1中吸取部分混匀后的稀释样本，转移至第二检测杯C2，稀释液添加模块中第六阀门V6开启，第五阀门V5、第二阀门V2和第十三阀门V13关闭，第三液体抽取装置S3活塞回拉吸取定量的稀释液R3，第六阀门V6和第十三阀门V13关闭，第五阀门V5、第一阀门V1和第二阀门V2开启，第三液体抽取装置S3活塞推进将第三液体抽取装置S3中的定量稀释液通过第二稀释液针N3’注入第二检测杯C2，同时通过管道进入吸样针N1，对吸样针N1内部进行清洗。混匀模块中第九阀门V9和第十二阀门V12关闭，第十阀门 V10和第十一阀门V11开启，空气泵P1鼓气，驱动气体沿管路进入第二检测杯C2底部，混匀杯中液体。第二颗粒计数检测装置D5对第二检测杯C2中样品血小板和红细胞的数量和体积进行检测。
针外清洗器对吸样针N1外部进行清洗。之后第四阀门V4开启，第三阀门V3关闭，第二液体抽取装置S2回拉，溶血剂R2吸入第二液体抽取装置S2中，第四阀门V4关闭，第三阀门V3开启，第二液体抽取装置S2活塞推进，使定量溶血剂进入第一检测杯C1。混匀模块中第十一阀门V11和第九阀门V9开启，第十阀门V10和第十二阀门V12关闭，空气泵P1鼓气，驱动气体沿管路进入第一检测杯C1底部，混匀杯中液体。第一检测杯C1中第一颗粒计数装置D4对杯中白细胞数量和体积进行检测，第一透射光源L1或第二透射光源L1’开启，第一透射光检测装置D1或第二透射光检测装置D1’对血红蛋白含量进行检测。
吸样针N1移动至生化试剂位R1处，吸样针N1深入生化试剂位R1内，在第一液体抽取装置S1、第一阀门V1和第二阀门V2配合下，由生化试剂位R1中吸取定量生化试剂，之后吸样针N1移动至第一检测杯C1处，将生化试剂加入第一检测杯C1，混匀模块中第十阀门V10和第十二阀门V12关闭，第九阀门V9和第十一阀门V11开启，空气泵P1鼓气，驱动气体进入第一检测杯C1底部，混匀杯中液体。如图2‐2、2‐3、2‐4和2‐5，通过第一透射光源L1开启，第一透射光检测装置D1检测透射光信号，获得单试剂生化项目检测结果。
检测结束后，打开第九阀门V9、第十阀门V10，第十二阀门V12，废液泵P2抽气，将各检测杯、针外清洗器及管路中检测废液排入废液收集器中；之后清洗剂添加模块中的第八阀门V8开启，第七阀门V7关闭，第四液体抽取装置S4回拉，清洗剂R4吸入第四液体抽取装置S4，之后第八阀门V8关闭，第七阀门V7开启，第四液体抽取装置S4推进，向第一检测杯C1中注入清洗剂R4，之后打开第九阀门V9、第十二阀门V12，废液泵P2抽气，清洗废液排入废液收集器。稀释液添加模块中的第六阀门V6开启，第五阀门V5、第二阀门V2和第十三阀门V13关闭，第三液体抽取装置S3活塞回拉吸取定量的稀释液R3，之后第六阀门V6关闭，第五阀门V5、第十三阀门V13、第一阀门V1和第二阀门V2开启，第三液体抽取装置S3活塞推进将第三液体抽取装置S3中的定量稀释液通过第一稀释液针N3和第二稀释液针N3’注入第一检测杯C1和第二检测杯C2中， 同时通过管路进入吸样针N1，对各检测杯及吸样针N1内部进行清洗。吸样针N1此时也执行针外部清洗，清洗结束后打开第九阀门V9、第十阀门V10，第十二阀门V12，废液泵P2抽气，清洗废液排入废液收集器。
图4中吸样针N1、第一液体抽取装置S1、第一阀门V1和第二阀门V2构成转移模块；溶血剂针N2、第二液体抽取装置S2、第三阀门V3和第四阀门V4构成溶血剂添加模块；稀释液针N3’和N3、第三液体抽取装置S3、第五阀门V5、第六阀门V6、第十三阀门V13构成稀释液添加模块；清洗剂针N4、第四液体抽取装置S4、第七阀门V7和第八阀门V8构成清洗剂添加模块；空气泵P1、第九阀门V9、第十阀门V10、第十一阀门V11和第十二阀门V12构成混匀模块。
实施例2
结合图1‐2、图2‐1和图4，本实施例的生化检测仪与实施例1的区别在于，本实施例中检测血常规和双试剂生化项目，即本实施例包括两个生化试剂位。
吸样针N1移动至第一生化试剂位R1处，吸样针N1深入第一生化试剂位R1内，在第一液体抽取装置S1、第一阀门V1和第二阀门V2配合下，由第一生化试剂位R1中吸取定量第一生化试剂，之后吸样针N1移动至第一检测杯C1处，将第一生化试剂加入第一检测杯C1，混匀模块中的第十阀门V10和第十二阀门V12关闭，第九阀门V9和第十一阀门V11开启，空气泵P1鼓气，驱动气体进入第一检测杯C1底部，混匀杯中液体。之后吸样针N1移动至第二生化试剂位R1’处，按照同样方式吸取定量第二生化试剂并转移至第一检测杯C1，开启第一透射光光源L1，第一透射光检测装置D1检测透射光信号，获得双试剂生化项目的检测结果。
实施例3
结合图3‐1，本实施例的生化检测仪与实施例1的区别在于，本实施例的第一检测杯上设置有第一透射光源L1和散射光源L2，且第一透射光源L1和散射光源L2共用一个检测装置D3。第一透射光源L1设置在检测装置D3对面，散射光源L2与检测装置D3呈30‐120°夹角。
第一透射光源L1开启，散射光源L2关闭，检测装置D3检测透射光信号，获得生化项目检测结果。
实施例4
本实施例与实施例3的区别在于，散射光源L2开启，第一透射光源L1关闭，检测装置D3检测散射光信号，获得生化项目检测结果。
实施例5
本实施例的生化检测仪与实施例1和2的区别在于，本实施例通过第二透射光源L1’和第二透射光检测装置D1’获得生化项目检测结果。
实施例6
结合图2‐2～2‐5和图3‐2～3‐3，本实施例通过使用不同波长的第一滤光片F1、第二滤光片F2和第三滤光片F3，在检测时根据检测需要选择特定波长。
以双波长法测定糖化血红蛋白为例，第一滤光片F1旋转至光源发光处和在检测装置接收处之前，设定主波长510nm，检测样品吸光度为A1；第二滤光片F2旋转至光源和检测装置中间，设定副波长600nm，检测样品吸光度为A2；样品真实吸光度A样品＝A1‐A2，通过采用双波法检测，可以有效消除样品中干扰物质对检测结果的影响。
实施例7
本实施例采用现有的生化仪与本发明分析仪检测20个不同样品，并进行结果相关性比较，统计数据如表1。
表1不同样品分别用现有生化仪与本发明分析仪检测两种生化成份结果比较
Figure PCTCN2017070574-appb-000002
Figure PCTCN2017070574-appb-000003
分别采用现有生化仪与本发明分析仪对20个不同样品进行检测，并进行相关性分析，如图6和图7所示，图6为CRP检测结果，图7为HbA1c检测结果，两种不同方法检测结果相关性：RCRP＝0.9974≥0.95，RHbA1c＝0.9783≥0.95，说明现有生化仪和本发明分析仪的检测结果相关性良好。

Claims (10)

  1. 一种血细胞和生化检测仪，其特征在于，该检测仪包括转移模块、溶血剂添加模块、稀释液添加模块、清洗剂添加模块、第一检测杯、第二检测杯、清洗模块、混匀模块和控制模块；
    所述转移模块用于转移生化试剂和样品，包括生化试剂位、样品位、一个吸样针、第一液体抽取装置和一个移动装置；所述移动装置用于驱动吸样针在样品位、生化试剂位、第一检测杯、第二检测杯之间移动；
    所述溶血剂添加模块包括一个溶血剂位和第二液体抽取装置，用于向第一检测杯中添加溶血剂；
    所述稀释液添加模块包括一个稀释液位和第三液体抽取装置，用于向第一检测杯和第二检测杯中添加稀释液；
    所述清洗剂添加模块包括一个清洗剂位和第四液体抽取装置，用于向第一检测杯中添加清洗剂；
    所述第一检测杯用于对血样进行第一次稀释，第一检测杯杯壁上设置有第一颗粒计数检测装置和透射光检测装置，所述第一颗粒计数检测装置用于对第一检测杯中白细胞颗粒进行检测，所述透射光检测装置用于对第一检测杯中血红蛋白进行检测以及对加入生化试剂后的血样进行生化项目检测。
    所述第二检测杯用于接受由第一检测杯转移来的稀释血样，并进行第二次稀释，第二检测杯杯壁上设置有第二颗粒计数检测装置，用于对第二次稀释后杯中样本中的红细胞和血小板进行检测；
    所述清洗模块包括吸样针清洗器、废液排出管以及废液泵，所述吸样针清洗器用于清洗吸样针外壁，所述废液排出管用于排出检测杯中废液以及吸样针清洗器清洗后产生的废液，所述废液泵为废液排出提供动力；
    所述混匀模块通过向第一、第二检测杯底部鼓气，对检测杯中的液体进行搅动混匀；
    所述控制模块用以控制转移模块、稀释液添加模块、溶血剂添加模块、清洗剂添加模块、清洗模块、混匀模块、第一检测杯和第二检测杯中检测装置工作，并进行检测数据分析处理、显示、打印以及输出检测结果。
  2. 根据权利要求1所述的血细胞和生化检测仪，其特征在于，第一检测杯杯壁上还设置有散射光检测装置，用于对加入生化试剂后的血样进行生化项目检 测。
  3. 根据权利要求2所述的血细胞和生化检测仪，其特征在于，所述散射光检测装置和透射光检测装置为多波长检测装置。
  4. 根据权利要求1所述的血细胞和生化检测仪，其特征在于，生化检测仪还包括一个用于清洗吸样针外壁的清洗器。
  5. 根据权利要求1所述的血细胞和生化检测仪，其特征在于，所述转移模块包括一个以上的生化试剂位。
  6. 根据权利要求1所述的血细胞和生化检测仪，其特征在于，所述第一检测杯外周设置有恒温及加热装置。
  7. 一种基于权利要求1所述的血细胞和生化检测仪的检测方法，其特征在于，该方法包括以下步骤：
    步骤1、通过吸样针自样品杯中定量吸取全血样品，转移到第一检测杯中，稀释液添加模块向第一检测杯中加入定量的稀释液，并通过混匀模块对第一检测杯中液体混匀；通过吸样针清洗器对吸样针外壁进行清洗；
    步骤2、通过吸样针自第一检测杯中吸取定量的稀释、混匀后的血样转移至第二检测杯，稀释液添加模块向第二检测杯中加入定量的稀释液，并与吸样针转移来的血样进行稀释，由混匀模块对第二检测杯中液体混匀，第二颗粒计数检测装置对第二检测杯中混匀后血样进行红细胞及血小板检测；通过吸样针清洗器对吸样针外壁进行清洗；
    步骤3、通过溶血剂添加模块向第一检测杯中加入定量的溶血剂并经混匀模块对第一检测杯内液体混匀，第一颗粒计数检测装置和透射光检测装置分别对第一检测杯中混匀后的血样进行白细胞检测和血红蛋白检测；
    步骤4、将吸样针移动至生化试剂位，吸取定量的生化试剂并转移至第一检测杯，再次混匀第一检测杯中液体，采用透射光检测装置对加入生化试剂后混匀的稀释样品进行检测，获得相应生化项目的检测结果。
  8. 根据权利要求7所述的血细胞和生化检测仪的检测方法，其特征在于，步骤4中使用散射光检测装置替换透射光检测装置对样本中的生化成份进行检测，并获得相应的生化项目检测结果。
  9. 根据权利要求7所述的血细胞和生化检测仪的检测方法，其特征在于， 仪器检测时自动对生化项目检测结果进行修正，检测结果修正计算公式如下：
    Figure PCTCN2017070574-appb-100001
    其中修正因子a用于修正其它影响因素导致的误差其范围为0.3‐4.0。
  10. 根据权利要求7所述的血细胞和生化检测仪的检测方法，其特征在于，第一颗粒计数检测装置和透射光检测装置分别进行白细胞和血红蛋白检测后，向第一检测杯中加入糖化血红蛋白试剂并混匀，散射光检测装置对混匀后液体进行糖化血红蛋白检测，根据血红蛋白检测结果和糖化血红蛋白检测结果计算糖化血红蛋白占血红蛋白的比例。
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