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WO2013004024A1 - 一种血小板自动化分析仪及其分析方法 - Google Patents

一种血小板自动化分析仪及其分析方法 Download PDF

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Publication number
WO2013004024A1
WO2013004024A1 PCT/CN2011/077120 CN2011077120W WO2013004024A1 WO 2013004024 A1 WO2013004024 A1 WO 2013004024A1 CN 2011077120 W CN2011077120 W CN 2011077120W WO 2013004024 A1 WO2013004024 A1 WO 2013004024A1
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WO
WIPO (PCT)
Prior art keywords
cup
blood sample
analysis
sample
injector
Prior art date
Application number
PCT/CN2011/077120
Other languages
English (en)
French (fr)
Inventor
徐新
董自权
曹宁
李想
余凡
杨维杰
Original Assignee
南京神州英诺华医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 南京神州英诺华医疗科技有限公司 filed Critical 南京神州英诺华医疗科技有限公司
Priority to US13/641,484 priority Critical patent/US20130203175A1/en
Priority to EP11869064.3A priority patent/EP2692290B1/en
Priority to ES11869064.3T priority patent/ES2563245T3/es
Publication of WO2013004024A1 publication Critical patent/WO2013004024A1/zh
Priority to US14/154,666 priority patent/US9291632B2/en
Priority to US15/041,453 priority patent/US9606104B2/en
Priority to US15/041,527 priority patent/US9857352B2/en

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Classifications

    • 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
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; Blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings or valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A61B5/1427—Multiple blood sampling, e.g. at periodic or pre-established intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150229—Pumps for assisting the blood sampling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • 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
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • 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
    • G01N2035/00465—Separating and mixing arrangements
    • G01N2035/00534—Mixing by a special element, e.g. stirrer
    • 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
    • G01N2035/00465—Separating and mixing arrangements
    • G01N2035/00534—Mixing by a special element, e.g. stirrer
    • G01N2035/00544—Mixing by a special element, e.g. stirrer using fluid flow
    • 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
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1004—Cleaning sample transfer devices

Definitions

  • the present invention relates to a medical device and an analysis method, and more particularly to a platelet automated analyzer capable of rapidly and continuously detecting changes in platelet aggregation in blood and an analysis method thereof.
  • Platelets are a kind of cellular granules in the blood and are important factors in blood hemostasis and thrombosis.
  • the rapid and rapid detection of platelet number, volume, aggregation rate and other parameters is of great significance in the diagnosis, prevention and treatment of thrombosis and related diseases.
  • countries have developed instruments that perform single-category, or functional, testing of platelets.
  • Platelet aggregation instrument only for the detection of platelet aggregation related parameters, currently there are mainly analytical instruments using turbidimetry or direct measurement of the electrode resistance method), blood analyzer or blood cell analyzer (this class The detection of platelets by the instrument is limited to counting the number and volume of platelets, and does not have the ability to automatically detect platelets in the same blood sample multiple times, that is, the ability to automatically detect platelet aggregation ability cannot be achieved).
  • the detection principle adopted by the traditional platelet aggregation instrument is: optical turbidimetry or electric resistance method.
  • Optical nephelometry blood plate aggregation detector is more common, but its blood volume is large (usually 2ml whole blood is needed), plasma needs to be separated before testing, and the operation is cumbersome and long.
  • the resistance platelet aggregation analyzer obtains the platelet aggregation rate by detecting changes in platelet aggregation on the electrode, and the blood volume is also 2 ml or more. Both methods are less frequently used because of their poor repeatability.
  • the technical problem to be solved by the present invention is to provide a platelet automated analyzer and an analysis method thereof in view of the deficiencies of the prior art.
  • a platelet automatic analyzer which comprises a sampling cup, a preparation cup, an analysis cup, a sample needle, a blood sample injector, a trapping agent injector, an analysis liquid injector, and a blood sample mixing device;
  • the sampling cup is used for storing blood samples and platelet aggregation reaction; the volume of the sampling cup is generally l ⁇ 5ml, The loading amount of the sample needle and the blood sample syringe is 100 to 1000 ⁇ l.
  • the preparation cup is used for one-time dilution of the blood sample; the volume of the preparation cup is generally 5 to 20 ml, and the amount of the sample by the sample needle and the blood sample syringe is 10 to 50 ⁇ 1, and the dilution is 50 to the volume of the sample volume. 300 times.
  • the analysis cup is used for secondly diluting blood and detecting a blood sample; the volume of the analysis cup is generally 5 to 20 ml, and the amount of each sample to be injected is 10 to 50 ⁇ 1 through the sample needle and the blood sample syringe, and the second dilution is the sample loading. 50 to 300 times the volume.
  • the final concentration of platelets is 1/90000 ⁇ 1/10000 of the original blood sample.
  • the blood sample mixing device is used for mixing a sampling cup, preparing a cup, and analyzing a blood sample in the cup;
  • the trapping agent injector is connected to the trapping agent reservoir for adding a trapping agent to the sampling cup;
  • the analysis liquid injector is connected to the analysis liquid reservoir for adding the analysis liquid to the analysis cup or the preparation cup; the sample insertion needle, the blood sample injector, the trapping agent injector, and the analysis liquid injector are respectively controlled by the motor; the loading The needle is connected to the blood sample injector and the analytical solution syringe through a pipe and a valve;
  • the blood sample is sequentially added to the sampling cup, a part of the blood sample is taken from the sampling cup and added to the preparation cup, and part of the diluted blood is taken from the preparation cup and added to the analysis cup;
  • the sample needle After the sample needle is connected to the analysis liquid injector, it is used to empty the sample needle.
  • the mixing device is an air pump, and the air pump communicates with the sampling cup, the preparation cup and the analysis cup through a pipe and a valve respectively;
  • the inner diameter of the pipe connecting the sampling cups is 0.2mm ⁇ 2mm, and the intake air amount is l ⁇ 20ml/min.
  • the air pump is a rotary pump or a mixing syringe.
  • a cleaning head for cleaning the outer wall of the sample needle is included. After each analysis, the cleaning head automatically cleans the residual blood on the surface of the syringe to prevent the blood sample attached to the needle from causing interference with the analytical data.
  • a waste liquid pump is connected, and the waste liquid pump communicates with the sampling cup, the preparation cup, the analysis cup and the cleaning head respectively, and when the corresponding analysis is completed, the waste liquid pump assists in cleaning the cups and cups. The residue is emptied.
  • the invention also discloses a method for analyzing platelets, comprising the following steps:
  • Step 1 connect the blood sample syringe and the sample needle, suck the blood sample to be tested, add it to the sampling cup, and mix the blood sample;
  • Step 2 quantitatively absorb the blood sample in the sampling cup through the blood sample syringe and the sample needle, and add the preparation cup;
  • Step 3 The sample solution is added to the preparation cup by the analysis liquid syringe for quantitative dilution, and the blood sample is mixed;
  • Step 4 the blood sample injector and the sample needle are connected, and the blood sample in the preparation cup is quantitatively taken, and added to the analysis cup;
  • Step 5 adding the analytical solution to the analysis cup through the analytical liquid injector for secondary quantitative dilution, and mixing the blood sample;
  • Step 6 detecting the original platelet quantity of the blood sample in the analysis cup;
  • Step 7 adding a trapping agent to the sampling cup through the attracting agent syringe, and mixing the blood sample; the volume ratio of the blood sample to the attracting agent is 1: 1 to 20: 1.
  • the attracting agent is typically an aqueous solution of adenosine diphosphate, or arachidonic acid, or epinephrine.
  • Step 8 Repeat steps 2 to 5 at intervals of time to detect the number of platelets of the blood sample in the analysis cup at each time point after the addition of the trapping agent; the general interval is 30 to 300 s.
  • Step 9 The platelet aggregation rate was obtained by comparing the number of platelets at each time point after the addition of the attracting agent with the amount of the original platelets.
  • the blood sample is mixed by a gassing method.
  • Traditional platelet analysis equipment can only statically analyze the number of platelets in the blood, and it is impossible to analyze the ability of platelet aggregation continuously for a certain period of time, because the blood plate will appear uneven after a certain period of time. The study found that the results of the analysis using the aeration method are the most accurate.
  • the analysis solution is required to not affect the aggregation reaction of platelets in the blood sample, nor react with any component in the blood sample, and does not contain particulate impurities, generally in deionized physiological saline or in a commercially available blood cell analyzer.
  • the analysis liquid an analysis liquid having an osmotic pressure close to the blood osmotic pressure is preferred.
  • the platelet detection information obtained after the first detection of the present invention is original state information. Subsequent detection differences will reflect the change in the number and volume of individual platelets in the blood sample due to platelet aggregation in the blood sample after the addition of the bleeding sample. Thereby, the amount and volume of the original platelets in the blood and the changes in platelet aggregation in the blood after the addition of the attracting agent are obtained.
  • the outstanding advantage of the present invention is that the test sample directly uses whole blood, and the platelet aggregation rate can be detected without separating the plasma; and the required blood volume is small (less than 500 ul); the trapping agent is added by direct detection. Changes in the number of platelets before and after, continuous detection of the number of platelets in the blood, can obtain the detection results at various time points in a period of time. Moreover, the instrument detection process is completely automated, so the detection is convenient and fast, artificially The influencing factors are small.
  • Figure 1 is a schematic view showing the structure of the apparatus of the present invention.
  • Figure 2 is a correlation analysis between the instrument and the turbidimetric instrument for determining the maximum aggregation rate of platelets in the present invention.
  • the present invention discloses a platelet automated analyzer comprising a sampling cup 1, a preparation cup 2, an analysis cup 3, a sampling needle 4, a blood sample injector 5, a trapping agent injector 6, an analyte liquid injector 7, and Blood sample mixing device.
  • the sampling cup is for storing a blood sample;
  • the preparation cup is used for one time to dilute a blood sample;
  • the analysis cup is for secondly diluting blood and detecting a blood sample;
  • the blood sample mixing device is for mixing a sampling cup, preparing a cup, and analyzing a blood sample in the cup;
  • the trapping agent injector is connected to the trapping agent reservoir 10 for applying an attracting agent to the sampling cup.
  • the analytical fluid injector is connected to the analytical fluid reservoir 11 for adding analytical fluid to the analysis cup or preparation cup.
  • the sample needle, the blood sample injector, the trapping agent injector, and the analysis liquid injector are respectively controlled by the motor; the needle is connected to the blood sample injector and the analysis liquid syringe through the pipeline and the valve respectively; the sample needle is connected with the blood sample injector Afterwards, the blood sample is sequentially added to the sampling cup, a part of the blood sample is taken from the sampling cup and added to the preparation cup, and part of the diluted blood is taken from the preparation cup and added to the analysis cup; the sample needle is connected with the analysis liquid injector, and is used for emptying and adding Sample needle.
  • the mixing device is an air pump, and the air pump communicates with the sampling cup, the preparation cup and the analysis cup through a pipe and a valve respectively; wherein the inner diameter of the pipe connecting the sample cup is 0.2 mm to 2 mm, and the intake air amount is l ⁇ 20 ml/min.
  • the air pump is a rotary pump 8 or a mixing syringe 9, which can be used alternatively or simultaneously.
  • the invention includes a cleaning head 12 for cleaning the outer wall of the syringe.
  • the present invention includes a waste liquid pump 13, which is connected to a sampling cup, a preparation cup, and an analysis cup and a cleaning head, respectively.
  • the invention also discloses a method for analyzing platelets, comprising the following steps:
  • Step 1 connect the blood sample syringe and the sample needle, suck the blood sample to be tested, add it to the sampling cup, and mix the blood sample;
  • Step 2 quantitatively absorb the blood sample in the sampling cup through the blood sample syringe and the sample needle, and add the preparation cup;
  • Step 3 The sample solution is added to the preparation cup by the analysis liquid syringe for quantitative dilution, and the blood sample is mixed;
  • Step 4 the blood sample injector and the sample needle are connected, and the blood sample in the preparation cup is quantitatively taken, and added to the analysis cup;
  • Step 5 adding the analytical solution to the analysis cup through the analytical liquid injector for secondary quantitative dilution, and mixing the blood sample;
  • Step 6 detecting the original platelet quantity of the blood sample in the analysis cup;
  • Step 7 adding a trapping agent to the sampling cup through the trap of the attractant, and mixing the blood sample;
  • Step 8 Repeat steps 2 to 5 at intervals of time to detect the number of platelets of the blood sample in the analysis cup at each time point after the addition of the trapping agent;
  • Step 9 The platelet aggregation rate was obtained by comparing the number of platelets at each time point after the addition of the attracting agent with the amount of the original platelets.
  • the platelet analyzer of the present embodiment includes a sampling cup 1, the sampling cup 1 is connected to the trapping agent reservoir 10 through the trapping agent addition pipe I and the valve V16, and the valve V16 is The trapping agent injector 6 is connected.
  • the bottom valve V4 of the sampling cup 1 communicates with the mixing syringe 9 and the valve V8, respectively.
  • a valve V10 is disposed between the valve V4 and the mixing syringe 9, and the valve V10 is also in communication with the outside air.
  • the analysis cup 3 is a combination of equipment, and the KX-21 model blood analyzer manufactured by Japan sysmex company can be used. Of course, the specific structure described below can also be adopted, and the principles of the two are the same.
  • the analysis cup mainly includes a cup body 31, a doser 32, and a vacuum cup 33.
  • the analysis liquid addition pipe ⁇ on the cup body 31 is connected to the valve V15.
  • the bottom of the cup body 31 communicates with the rotary pump 8 and the valve V8 through a valve VI, and a valve V6 is provided between the valve VI and the rotary pump 8.
  • the lower portion of the side wall of the cup body 31 is provided with an analysis hole 311 through which the analyzer hole 311 and the cleaning liquid reservoir 14 are respectively connected.
  • a valve V5 and a bypass valve V9 that communicates with air are provided between the analysis hole 311 and the doser 32.
  • the doser 32 communicates with the rotary pump 8 and the vacuum cup 33 via a valve V3, respectively, and the vacuum cup 33 is connected to the valve V8 through a pipe.
  • a valve V17 is provided between the analysis hole 311 and the cleaning liquid reservoir 14, and the cleaning liquid in the cleaning liquid reservoir 14 is used to clean the doser 32 and the vacuum cup 33.
  • valve V8 is connected to the waste liquid pump 13 and the valve VI I at the same time, the valve VI I is connected to the cleaning head 12, and the cleaning head 12 is connected to the analytical liquid reservoir 11 through the valve V12 and the valve V13.
  • the valve V13 is connected to the analysis liquid reservoir 11 through a pipe.
  • the syringe 4 is connected to the valve V14 and the valve V12, respectively.
  • the blood sample injector 5 is connected to a valve V14.
  • Step 1 the control valve V14 is connected to the sample needle 4 and the blood sample injector 5, and 200 ⁇ 500 uL of whole blood is taken as a blood sample from a test tube (not shown) containing sodium sulphate anticoagulant sample, and the sample is moved.
  • the control valve V14 the blood sample is injected into the sampling cup, and through the control valve V10 and the valve V4, the mixing syringe 9 injects air into the bottom of the sampling cup, and the gas is mixed from the bottom to the top.
  • the sample needle 4 is moved to the cleaning head 12, and through the control valve V12 and the valve V13, the cleaning head cleans the outer wall of the sample needle with the analysis liquid, and controls the blood sample injector 5 to clean the inner wall of the sample needle with the analysis liquid, thereby cleaning and removing the glue. Residual blood attached to the inner and outer surfaces of the needle.
  • Step 2 the control valve V14 is connected to the sample needle 4 and the blood sample injector 5, and 10 to 30 uL of the mixed blood sample is taken from the sample cup and added to the preparation cup 2.
  • Step 3 through the control valve V13, valve V12, valve V14, valve V15, from the analytical solution syringe and the sample needle, and the analysis solution addition pipe ⁇ add 3.25ml of the analysis solution to the preparation cup for one dilution of the blood sample.
  • the analysis solution can be added either by the analysis solution syringe and the sample needle, or by adding the pipe to the analysis solution. This embodiment is selected to be added at the same time.
  • Rotary pump 8 Inject air into the bottom of the preparation cup through valve V7 and valve V2 and mix the diluted blood sample.
  • the needle is moved to the cleaning head, and through the control valve V12 and the valve V13, the cleaning head uses the analysis liquid to clean the outer wall of the sample needle, and the blood sample injector 5 is controlled to clean the inner wall of the sample needle with the analysis liquid, thereby cleaning and removing the adhesion. Residual blood on the inner and outer surfaces of the needle.
  • Step 4 the control valve V14 is connected to the sample needle 4 and the blood sample injector 5, and 10 ⁇ 30 uL of the diluted and mixed blood sample is taken from the preparation cup and added to the analysis cup 3.
  • Step 5 through the control valve V13, valve V12, valve V14, valve V15, through the analysis liquid injector and the needle, and the analysis liquid addition pipe, add 3.25ml of the analysis solution to the analysis for the second dilution of the blood sample.
  • the analysis solution can be added either by the analysis solution syringe and the sample needle, or by adding the pipe to the analysis solution. This embodiment selects to add at the same time.
  • the rotary pump 8 passes through the valve V6, and the valve VI injects air into the bottom of the preparation cup to mix the second diluted blood sample.
  • the waste liquid pump 13 vacuums the vacuum cup 33 through the valve V8 to form a negative pressure, and the vacuum cup draws the second diluted blood sample of the analysis cup through the valve V3 and the valve V5 from the analysis hole 311, and the metering device 32 measures the amount of each extraction. The liquid is consistent.
  • the control valve V9 is opened and then closed, so that the negative pressure formed in the pipeline during the detection is released, and the pipeline is restored to the air pressure consistent with the external environment. Step 6. Detect the amount of original platelets in the blood sample in the analysis cup.
  • the analytical solution injector 7 adds 4 ml of the analysis solution to the preparation cup 2 and the analysis cup 1 through the control valve V13, the valve V12, the valve V14, and the valve V15, and soaks and waits for the next test.
  • the waste pump 13 empties the preparation cup 2 through the control valve V8 and the valve V2, and the waste pump 13 empties the analysis cup 3 through the control valve V8 and the valve VI.
  • Step 7 through the control valve V16 connected to the trapping agent injector 6, the trapping agent reservoir 10 and the trapping agent adding pipe I, adding 10 to 50 ul of the trapping agent to the sampling cup 1, and controlling the valve V4 and the valve V10 to be mixed
  • the syringe 9 and the sampling cup 1 are filled with air into the bottom of the sampling cup 1.
  • the inner diameter of the tube is 1 mm, and the intake air amount is 1 to 20 ml/min, thereby mixing the blood sample after the addition of the trapping agent.
  • Step 8 Repeat steps 2 to 5 at intervals of 60 s. Add the blood sample after the addition of the trapping agent to the preparation cup and the analysis cup, perform second dilution and mixing, and analyze the time points after the addition of the trapping agent. Analyze the number of platelets in the blood sample in the cup.
  • Step 9 The platelet aggregation rate was obtained by comparing the number of platelets at each time point after the addition of the attracting agent with the amount of the original platelets.
  • the analytical solution injector 7 adds 4 ml of the analysis solution to the preparation cup 2 and the analysis cup 1 through the valve V13, the valve V12, the valve V14, and the valve V15, and soaks and waits for the next test.
  • the analysis liquid injector 7 injects 2 ml of the analysis liquid into the sampling cup through the valve V13, the valve V12, the valve V14 and the sample needle line, and then the waste liquid pump 13 evacuates the sampling cup through the control valve V8 and the valve V4, and repeats this step 3 times to realize The sample cup is cleaned and used to wait for the analysis of another blood sample.
  • the analysis liquid in this embodiment should be kept at a constant temperature (a certain temperature in 18 to 39 ° C, the reagent constant temperature error is less than ⁇ 1.5 ° C), and the constant temperature method may be pre-heating of the reagent bottle, or analysis of the liquid injection preparation cup.
  • the heating pipe is arranged on the pipeline before the analysis cup; or the reagent bottle heating is combined with the heating of the pipeline, and the sampling needle, the sampling cup, the preparation cup and the analysis cup thermostat are arranged to ensure the temperature of the blood sample in all the detection processes. Not less than 18 ° C; and the temperature difference of each link shall not exceed ⁇ 1.5. C. This can be accomplished by applying a thermostat to each of the associated components or by designing an overall thermostat within the instrument.
  • a platelet analyzer detects the repeatability of test results of platelet aggregation rate and the correlation with the results of turbidimetric detection of platelet aggregation rate.
  • 1) The apparatus of the present invention and a certain turbidimetric method see: Born GVR. Aggregation of blood platelets by adenosine diphosphate and its reversal. Nature (Lond.). 1 962; 194: 927) Comparison.
  • the apparatus in this embodiment is the same as the apparatus in the first embodiment, and the steps are the same as those in the first embodiment.
  • the analysis solution used is physiological saline
  • the trapping agent is an aqueous solution of adenosine diphosphate.
  • the first dilution factor is 240
  • the second dilution factor is 240.
  • Table 1 The apparatus of the present invention measures the platelet aggregation rate within 1 to 5 minutes (instrument model: PL-11)
  • SD standard deviation
  • CV coefficient of variation
  • the repeatability (in CV) of the partial detection of platelet aggregation rate was determined to be greater than 0%.
  • the optical nephelometry method for detecting platelet aggregation instrument repeatability is inferior to the instrument of the present invention.
  • the instrument was used to measure 40 samples simultaneously with the conventional turbidimetric aggregometer.
  • the maximum aggregation rate of 40 samples was as follows: Table 3: Comparison of the maximum aggregation rate (%) between the instrument and the turbidimetric instrument for determining the maximum aggregation rate of platelets
  • the measurement result of the instrument of the present invention is the X-axis
  • the measurement result of the turbidimetric aggregometer is the y-axis
  • a scattergram is drawn.
  • the results of this instrument were higher than those measured by the turbidimetry instrument, and there was a significant difference between the two (P ⁇ 0.05).
  • the invention can automatically complete the detection of a plurality of parameters such as the number of platelets, the average volume of platelets, the platelet volume distribution, the platelet aggregation rate (including the platelet aggregation rate at different times after the addition of the inducer, the maximum aggregation rate, the maximum aggregation time) after a blood sample is taken. And reports. Its testing programs are more and more comprehensive.
  • the instrument can automatically add an inducer to calculate the platelet aggregation function by directly counting the changes in the number of platelets before and after the addition of the attractant in the blood sample.
  • the invention provides an idea of a platelet automatic analyzer and an analysis method thereof.
  • the method and the method for implementing the technical solution are numerous, and the above is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can also do without departing from the principle of the present invention. A number of improvements and retouchings are also considered to be within the scope of the invention.
  • the components not specifically defined in this embodiment can be realized by the prior art.

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Abstract

本发明公开了一种血小板自动化分析仪，包括采样杯、准备杯、分析杯、加样针、血样注射器、诱聚剂注射器、分析液注射器以及血样混匀装置。本发明还公开了一种血小板分析方法，包括以下步骤：步骤1，吸取待检测血样，加入采样杯中；步骤2，吸取采样杯中的血样，加入准备杯；步骤3，向准备杯中加入分析液进行一次定量稀释；步骤4，定量吸取准备杯中的血样，加入分析杯；步骤5，向分析杯中加入分析液进行二次定量稀释；步骤6，检测分析杯中血样的原始血小板数量；步骤7，向采样杯中加入诱聚剂；步骤8，每间隔一定时间重复步骤2~步骤5，检测加入诱聚剂后的各个时间点的分析杯中血样的血小板数量；步骤9，获得血小板聚集率。

Description

一种血小板自动化分析仪及其分析方法
技术领域
本发明涉及一种医疗器材以及分析方法， 特别是一种用于能够快速连续检测血液 中血小板聚集变化的血小板自动化分析仪及其分析方法。
背景技术
血小板是血液中的一种细胞类颗粒成份， 是血液止血与血栓形成的重要因素。 对 血小板数量、 体积、 聚集率等参数进行方便快速检测， 在血栓及相关疾病的诊断、 预 防和治疗指导上有着十分重要的意义。 随着技术进步和对血小板研究的深入， 各国已 经开发出一些对血小板进行单项类别， 或功能检测的仪器。 如现已有的： 血小板聚集 仪 (只单纯检测血小板聚集相关参数， 目前主要有以比浊法或直接测量探测电极电阻法 为检测原理的分析仪器)、 血液分析仪或血细胞分析仪 （该类仪器对血小板的检测仅限 于计数血小板数量、 体积等， 不具备自动连续多次对同一血样检测血小板的能力， 即 无法实现自动对血小板聚集能力检测的功能） 。 因此， 迄今为止尚未见采用自动化的、 连续计数经诱聚剂处理的血样中血小板数量变化为原理检测血小板聚集率的仪器； 也 未见一台能同时自动完成对血小板数量、 体积检测并还同时完成对血小板聚集率功能 等多项参数检测的仪器。
传统的血小板聚集仪所采用的检测原理为： 光学比浊法或电阻法。 光学比浊法血 小板聚集检测仪更为常见， 但其用血量较大 （一般需要采 2ml全血） ， 检测前还需要 分离血浆， 操作繁琐检测时间长。 而电阻法血小板聚集仪是通过检测血小板聚集在电 极上的变化获得血小板聚集率结果的， 用血量也要 2ml以上。 且二种方法均由于其检 测结果重复性较差， 临床较少使用。
发明内容
发明目的： 本发明所要解决的技术问题是针对现有技术的不足， 提供一种血小板 自动化分析仪及其分析方法。
为了解决上述技术问题， 本发明公开了一种血小板自动化分析仪， 包括采样杯、 准备杯、 分析杯、 加样针、 血样注射器、 诱聚剂注射器、 分析液注射器以及血样混匀 装置；
所述采样杯用于储存血样以及血小板聚集反应； 采样杯容积一般为 l〜5ml， 通过 加样针和血样注射器的每次加样量为 100〜1000μ1。
所述准备杯用于一次稀释血样； 所述准备杯容积一般为 5〜20ml， 通过加样针和血 样注射器的每次加样量为 10〜50μ1， 一次稀释为该加样量体积的 50〜300倍。
所述分析杯用于二次稀释血液和检测血样； 所述分析杯容积一般为 5〜20ml， 通过 加样针和血样注射器的每次加样量为 10〜50μ1，二次稀释为该加样量体积的 50〜300倍。
经过二次稀释， 使得血小板的终浓度为原始血样的 1/90000〜1/10000。
所述血样混匀装置用于混匀采样杯、 准备杯以及分析杯内的血样；
所述诱聚剂注射器连通诱聚剂储藏器， 用于向采样杯内加诱聚剂；
所述分析液注射器连通分析液储藏器， 用于向分析杯或准备杯加分析液； 所述加样针、 血样注射器、 诱聚剂注射器、 分析液注射器分别由电机控制运动； 所述加样针通过管道和阀分别连通血样注射器和分析液注射器；
所述加样针与血样注射器连通后， 依次将血样加入采样杯， 从采样杯中吸取部分 血样加入准备杯， 从准备杯中吸取部分稀释血液加入分析杯；
所述加样针与所述分析液注射器连通后， 用于清空加样针。
本发明中， 所述混匀装置为空气泵， 空气泵通过管道和阀分别连通采样杯、 准备 杯以及分析杯；
其中连通采样杯的管道内径为 0.2mm〜2mm， 进气量为 l〜20ml/min。
本发明中， 优选地， 所述空气泵为旋转泵或混匀注射器。
本发明中， 优选地， 包括一个用于清洗加样针外壁的清洗头。 每次分析后， 清洗 头自动清洗加样针外表残留血液， 防止附着在加样针上的血样造成分析数据干扰。
本发明中， 优选地， 包括一个废液泵， 所述废液泵分别连通采样杯、 准备杯以及 分析杯以及清洗头， 当相应的分析完成后废液泵协助将各杯进行清洗并将杯中残余物 排空。
本发明还公开一种了血小板分析方法， 包括以下步骤：
步骤 1，连通血样注射器与加样针， 吸取待检测血样，加入采样杯中， 并混匀血样； 步骤 2， 通过血样注射器和加样针定量吸取采样杯中的血样， 加入准备杯； 步骤 3，通过分析液注射器向准备杯中加入分析液进行一次定量稀释，并混匀血样； 步骤 4， 连通血样注射器与加样针， 定量吸取准备杯中的血样， 加入分析杯； 步骤 5，通过分析液注射器向分析杯中加入分析液进行二次定量稀释，并混匀血样； 步骤 6， 检测分析杯中血样的原始血小板数量；
步骤 7， 通过诱聚剂注射器向采样杯中加入诱聚剂， 并混匀血样； 所述血样和所述 诱聚剂的体积比为 1 : 1〜20: 1。 诱聚剂一般为二磷酸腺苷、 或花生四烯酸、 或肾上腺素 的水溶液。
步骤 8，每间隔一定时间重复步骤 2〜步骤 5，检测加入诱聚剂后的各个时间点的分 析杯中血样的血小板数量； 一般间隔时间为 30〜300s。
步骤 9，将加入诱聚剂后的各个时间点的血小板数量与原始血小板数量相比， 获得 血小板聚集率。
本发明中， 考虑到分析精度和分析设备的体积问题， 采用了两次稀释的方式， 通 过准备杯和分析杯两个杯子， 完成稀释， 相比较传统的一杯稀释的方式， 检测精度更 好。
本发明所述方法中， 优选地， 采用鼓气法进行血样混匀。 传统的血小板分析设备 只能静态分析血液中的血小板的数量， 无法实现在一定时间， 连续的对血小板聚集能 力进行分析， 因为血液在一定时间后会出现血小板不均匀的情况， 申请人通过大量对 比研究发现， 采用鼓气法的分析结果最为精确。 当然， 也可以采用机械搅拌法或者是 利用加样针或者另外的吸管进行抽吸的方法实现待分析血样的混匀。
本发明中， 所述的分析液要求不影响血样中血小板的聚集反应， 也不与血样中的 任何成分发生反应， 不含有颗粒杂质， 一般去离子生理盐水或者市场上出售的血细胞 分析仪中的分析液就可以， 优选渗透压与血液渗透压接近的分析液。
本发明首次检测后获得的血小板检测信息为原始状态信息。 其后检测的差异将反 映出血样加入诱聚剂后， 由于血样中血小板聚集， 因此血样中单个血小板数量、 体积 改变的信息。 从而得到血液中原始血小板数量、 体积以及经过加入诱聚剂后， 血液中 血小板聚集变化。
有益效果： 本发明突出的优点是其检测样本直接使用全血， 无需分离血浆即可完 成血小板聚集率的检测； 而且所需用血量较小 （可小于 500ul); 通过直接检测加入诱 聚剂前后血小板数量的变化， 连续进行检测血液中血小板数量， 能够获取一段时间内 各个时间点检测结果。 而且该仪器检测过程完全自动化， 因此检测方便、 快速， 人为 影响因素小。
附图说明
下面结合附图和具体实施方式对本发明做更进一步的具体说明， 本发明的上述和 / 或其他方面的优点将会变得更加清楚。
图 1为本发明的装置结构示意图。
图 2为本发明仪器与比浊法仪器测定血小板最大聚集率的相关性分析
具体实施方式
如图 1所示， 本发明公开了一种血小板自动化分析仪， 包括采样杯 1、 准备杯 2、 分析杯 3、 加样针 4、 血样注射器 5、 诱聚剂注射器 6、 分析液注射器 7以及血样混匀 装置。 所述采样杯用于储存血样； 所述准备杯用于一次稀释血样； 所述分析杯用于二 次稀释血液和检测血样； 所述血样混匀装置用于混匀采样杯、 准备杯以及分析杯内的 血样； 所述诱聚剂注射器连通诱聚剂储藏器 10， 用于向采样杯内加诱聚剂。 所述分析 液注射器连通分析液储藏器 11， 用于向分析杯或准备杯加分析液。 所述加样针、 血样 注射器、 诱聚剂注射器、 分析液注射器分别由电机控制运动； 所述加样针通过管道和 阀分别连通血样注射器和分析液注射器； 所述加样针与血样注射器连通后， 依次将血 样加入采样杯， 从采样杯中吸取部分血样加入准备杯， 从准备杯中吸取部分稀释血液 加入分析杯； 所述加样针与所述分析液注射器连通后， 用于清空加样针。 所述混匀装 置为空气泵， 空气泵通过管道和阀分别连通采样杯、 准备杯以及分析杯； 其中连通采 样杯的管道内径为 0.2mm〜2mm， 进气量为 l〜20ml/min。 所述空气泵为旋转泵 8或混 匀注射器 9， 可以择一使用或者同时配合使用。
本发明包括一个用于清洗加样针外壁的清洗头 12。
本发明包括一个废液泵 13， 所述废液泵分别连通采样杯、 准备杯以及分析杯以及 清洗头。
本发明还公开了一种血小板分析方法， 包括以下步骤：
步骤 1，连通血样注射器与加样针， 吸取待检测血样，加入采样杯中， 并混匀血样； 步骤 2， 通过血样注射器和加样针定量吸取采样杯中的血样， 加入准备杯； 步骤 3，通过分析液注射器向准备杯中加入分析液进行一次定量稀释，并混匀血样； 步骤 4， 连通血样注射器与加样针， 定量吸取准备杯中的血样， 加入分析杯； 步骤 5，通过分析液注射器向分析杯中加入分析液进行二次定量稀释，并混匀血样； 步骤 6， 检测分析杯中血样的原始血小板数量；
步骤 7， 通过诱聚剂注射器向采样杯中加入诱聚剂， 并混匀血样；
步骤 8，每间隔一定时间重复步骤 2〜步骤 5，检测加入诱聚剂后的各个时间点的分 析杯中血样的血小板数量；
步骤 9，将加入诱聚剂后的各个时间点的血小板数量与原始血小板数量相比， 获得 血小板聚集率。
本发明中， 优选地， 采用鼓气法进行血样混匀。
实施例 1
更具体地说， 如图 1所示， 本实施例所述的血小板分析仪包括采样杯 1， 采样杯 1 通过诱聚剂添加管道 I以及阀 V16连通诱聚剂储藏器 10， 同时阀 V16与诱聚剂注射器 6连通， 采样杯 1的底部过阀 V4分别连通混匀注射器 9以及阀 V8， 阀 V4与混匀注射 器 9之间设有阀 V10， 阀 V10还与外部空气连通。
准备杯 2通过分析液添加管道 II连接阀 V15， 阀 V15依次通过管道连接阀 V14、 阀 V12、 阀 V13， 最终连通分析液储藏器 11。 准备杯 2底部通过阀 V2分别连通旋转 泵 8以及阀 V8， 阀 V2与旋转泵 8之间设有阀 V7。
分析杯 3是一套器材的组合， 可以采用日本 sysmex 公司生产的 KX-21型号的血 液分析仪， 当然也可以采用以下描述的具体结构， 两者的原理是相同的。 就本实施例 而言， 所述的分析杯主要包括杯体 31、 定量器 32以及真空杯 33， 杯体 31上的分析液 添加管道 ΠΙ与阀 V15连接。 杯体 31底部通过阀 VI连通旋转泵 8以及阀 V8， 阀 VI 与旋转泵 8之间设有阀 V6。杯体 31侧壁的下部设有分析孔 311， 分析孔 311分别通过 管道连通定量器 32和清洗液储藏器 14。 分析孔 311与定量器 32之间设有阀 V5以及 连通空气的旁路阀 V9。 定量器 32通过阀 V3分别连通旋转泵 8和真空杯 33， 真空杯 33通过管道连接阀 V8。 分析孔 311和清洗液储藏器 14之间设有阀 V17， 清洗液储藏 器 14内的清洗液用于清洗定量器 32以及真空杯 33。
所述阀 V8同时连通废液泵 13和阀 VI I， 阀 VI I连接清洗头 12， 清洗头 12通过 阀 V12和阀 V13连通分析液储藏器 11。 其中阀 V13通过管道连接分析液储藏器 11。
所述加样针 4分别连接阀 V14和阀 V12。 所述血样注射器 5连接阀 V14。
本实施例中未特别说明的部件之间的连通方式， 均采用管道直接连通。
本实施例的使用流程为：
步骤 1，控制阀 V14连通加样针 4与血样注射器 5， 从装有拘橼酸钠抗凝血样的试 管 （图中未示出） 中吸取 200〜500uL的全血作为血样， 加样针移到采样杯 1 内， 控制 阀 V14， 将血样注入到采样杯中， 通过控制阀 V10和阀 V4， 由混匀注射器 9向采样杯 底部注入空气， 气体由下向上混匀血样。 在此期间将加样针 4移动至清洗头 12， 通过 控制阀 V12和阀 V13， 清洗头使用分析液清洗加样针外壁， 控制血样注射器 5使用分 析液清洗加样针内壁， 从而清洗去除粘附在针内外表面的残余血液。
步骤 2， 控制阀 V14连通加样针 4与血样注射器 5从采样杯中吸取 10〜30uL的混 匀血样， 并加入准备杯 2中。
步骤 3， 通过控制阀 V13， 阀 V12， 阀 V14， 阀 V15， 由分析液注射器和加样针， 以及分析液添加管道 Π加入 3.25ml的分析液到准备杯中进行血样的一次稀释。分析液 既可以通过分析液注射器和加样针添加， 也可以通过分析液添加管道 ΠΙ添加， 本实施 例选择同时添加。 旋转泵 8通过阀 V7和阀 V2向准备杯底部注入空气混匀一次稀释的 血样。 在此期间将加样针移动至清洗头， 通过控制阀 V12和阀 V13， 清洗头使用分析 液清洗加样针外壁， 控制血样注射器 5使用分析液清洗加样针内壁， 从而清洗去除粘 附在针内外表面的残余血液。
步骤 4， 控制阀 V14连通加样针 4与血样注射器 5从准备杯中吸取 10〜30uL的一 次稀释并混匀后的血样， 并加入分析杯 3中。
步骤 5， 通过控制阀 V13， 阀 V12， 阀 V14， 阀 V15， 经过分析液注射器和加样针， 以及分析液添加管道 ΠΙ加入 3.25ml的分析液到分析中进行血样的二次稀释。分析液既 可以通过分析液注射器和加样针添加， 也可以通过分析液添加管道 ΠΙ添加， 本实施例 选择同时添加。 旋转泵 8通过阀 V6， 阀 VI向准备杯底部注入空气混匀二次稀释的血 样。 废液泵 13通过阀 V8把真空杯 33抽真空形成负压， 真空杯通过阀 V3、 阀 V5把 分析杯的二次稀释的血样从分析孔 311抽出， 通过定量器 32计量保证每次抽出的液体 一致。每次检测完成后， 控制阀 V9起开后再关闭， 使管路中在检测时形成的负压释放 掉， 管路内恢复成与外环境一致的气压。 步骤 6， 检测分析杯中血样的原始血小板数量。
本次检测结束后， 分析液注射器 7通过控制阀 V13、 阀 V12、 阀 V14、 阀 V15分 别向准备杯 2和分析杯 1加入 4ml分析液， 浸泡等待下次测试。 在下次测试前， 废液 泵 13通过控制阀 V8和阀 V2排空准备杯 2，废液泵 13通过控制阀 V8和阀 VI排空分 析杯 3。
步骤 7， 通过控制阀 V16连通诱聚剂注射器 6、 诱聚剂储藏器 10以及诱聚剂添加 管道 I， 向采样杯 1中添加 10〜50ul诱聚剂， 并控制阀 V4和阀 V10连通混匀注射器 9 和采样杯 1， 向采样杯 1的底部注入空气， 该管道内径为 lmm， 进气量为 l〜20ml/min， 由此混匀加入诱聚剂后的血样。
步骤 8， 每间隔 60s， 重复步骤 2〜步骤 5， 将加入诱聚剂后的血样依次加入准备杯 和分析杯， 进行二次稀释和混匀， 并分析加入诱聚剂后的各个时间点的分析杯中血样 的血小板数量。
步骤 9，将加入诱聚剂后的各个时间点的血小板数量与原始血小板数量相比， 获得 血小板聚集率。
本血样分析完成之后， 分析液注射器 7通过阀 V13、 阀 V12、 阀 V14、 阀 V15分 别向准备杯 2和分析杯 1加入 4ml分析液， 浸泡等待下次测试。
分析液注射器 7通过阀 V13、 阀 V12、 阀 V14和加样针管路向采样杯注入 2ml分 析液， 然后废液泵 13通过控制阀 V8、 阀 V4排空采样杯， 重复本步骤 3次， 以实现采 样杯的清洗干净， 用于等待另一份血样的检测分析。
本实施例中的分析液要保持恒温（18〜39°C中某特定温度， 试剂恒温要求误差小于 ±1.5°C), 其恒温的方式可以是试剂瓶预先加温， 或分析液体注入准备杯、 分析杯前的 管路上设加温装置实现； 或设置试剂瓶加温结合管路加温、 以及设置加样针、 采样杯、 准备杯、 分析杯恒温设施确保血样在全部检测过程中的温度不得低于 18°C ; 且各环节 温差不得大于 ±1.5。C。其实现方式可以是在各个相关部件上加恒温装置或在仪器内部设 计总体恒温机构。
实施例 2
一种血小板分析仪检测血小板聚集率测试结果重复性， 及与比浊法检测血小板聚 集率结果相关性比较。 1 )本发明仪器与某比浊法（该比浊法参见： Born GVR. Aggregation of blood platelets by adenosine diphosphate and its reversal. Nature (Lond.). 1 962; 194: 927) 仪器测 定结果的重复性比较。
以 1份枸橼酸钠抗凝全血为标本，分别用本发明的仪器及比浊法仪器检测其 0-5分 钟内的血小板聚集率， 各重复检测 10次。 结果见下表。
本实施例中的设备与实施例 1中的设备相同， 步骤与实施例 1的步骤相同， 其中， 使用的分析液为生理盐水， 诱聚剂为二磷酸腺苷水溶液， 第一次稀释倍数为 240， 第二 次稀释倍数为 240。
表 1 : 本发明仪器测定 1〜5分钟内血小板聚集率 （仪器型号： PL-11 )
Figure imgf000010_0001
根据 10次测定结果分别求得每分钟对应的标准差 （SD ) 和平均值。 再根据 SD和 平均值按下列公式计算变异系数 （CV)。
〔¥=80/平均值 100%
1-5分钟内， 10次测定血小板聚集率检测的重复性 （以 CV表示） 都不大于 5%， 说明本仪器用于聚集率测定时， 重复性良好。 表 2: 血小板聚集率检测结果 （某比浊法血小板聚集仪)
Figure imgf000011_0001
1〜5分钟内， 10次测定血小板聚集率检测部分结果的重复性 （以 CV表示） 大于 0%。 说明光学比浊法检测血小板聚集仪器重复性比本发明仪器重复性差。
) 本发明仪器与某比浊法仪器测定结果的相关性
用本仪器与传统比浊法聚集仪同时测定 40份样本， 40份样本的最大聚集率如下： 表 3 : 本发明仪器与比浊法仪器测定血小板最大聚集率的结果对比 最大聚集率 （％)
样本
本发明仪器 某比浊法聚集仪
1 75.5 61.7
2 56.1 50.2
3 54.3 48.1
4 66.8 59.3
5 45.2 36.5
Figure imgf000012_0001
(Η
OZULO/llOZSiD/lDd wo簡 ειοζ Ο 34 53.0 39.8
35 62.8 44.6
36 51.2 37.8
37 65.9 48.9
38 59.3 53.7
39 58.2 52.8
40 46.8 42.6 平均聚集率 57.1±11.9 47.4±10.5 以本发明仪器测定结果为 X轴， 比浊法聚集仪测定结果为 y轴， 绘制散点图。 同 时进行线性回归分析， 可得图 2。 由图 2结果可知， 本发明方法与比浊法仪器测定结果 的相关系数 R2=0.8965， R=0.9468， 相关性良好。 但本仪器测定的结果高于比比浊法仪 器测定的结果， 两者有显著性差异 （P<0.05 )。
本发明在一次吸取血样后能够自动同时完成血小板数量、 血小板平均体积、 血小 板体积分布、 血小板聚集率 （含加入诱导剂后不同时间血小板聚集率、 最大聚集率、 最大聚集时间） 等多项参数检测和报告。 其检测项目更多、 更全面。 仪器可自动加入 诱聚剂， 以直接计数血样中加入诱聚剂前后血小板数量的变化计算获得血小板聚集功 能结果。
本发明提供了一种血小板自动化分析仪及其分析方法的思路。 具体实现该技术方 案的方法和途径很多， 以上所述仅是本发明的优选实施方式， 应当指出， 对于本技术 领域的普通技术人员来说， 在不脱离本发明原理的前提下， 还可以做出若干改进和润 饰， 这些改进和润饰也应视为本发明的保护范围。 本实施例中未明确的各组成部分均 可用现有技术加以实现。

Claims

1、 一种血小板自动化分析仪， 其特征在于： 包括采样杯、 准备杯、 分析杯、 加样 针、 血样注射器、 诱聚剂注射器、 分析液注射器以及血样混匀装置；
所述采样杯用于储存血样；
所述准备杯用于一次稀释血样；
所述分析杯用于二次稀释血液和检测血样；
所述血样混匀装置用于混匀采样杯、 准备杯以及分析杯内的血样；
所述诱聚剂注射器连通诱聚剂储藏器， 用于向采样杯内加诱聚剂；
所述分析液注射器连通分析液储藏器， 用于向分析杯或准备杯加分析液； 所述加样针、 血样注射器、 诱聚剂注射器、 分析液注射器分别由电机控制运动； 所述加样针通过管道和阀分别连通血样注射器和分析液注射器；
所述加样针与血样注射器连通后， 依次将血样加入采样杯， 从采样杯中吸取部分 血样加入准备杯， 从准备杯中吸取部分稀释血液加入分析杯；
所述加样针与所述分析液注射器连通后， 用于清空加样针。
2、 根据权利要求 1所述的一种血小板自动化分析仪， 其特征在于， 所述混匀装置 为空气泵， 空气泵通过管道和阀分别连通采样杯、 准备杯以及分析杯；
其中连通采样杯的管道内径为 0.2mm~2mm， 进气量为 l~20ml/min。
3、 根据权利要求 2所述的一种血小板自动化分析仪， 其特征在于， 所述空气泵为 旋转泵或混匀注射器。
4、 根据权利要求 1或 2所述的一种血小板自动化分析仪， 其特征在于， 包括一个 用于清洗加样针外壁的清洗头。
5、 根据权利要求 4所述的一种血小板自动化分析仪， 其特征在于， 包括一个废液 泵， 所述废液泵分别连通采样杯、 准备杯以及分析杯以及清洗头。
6、一种使用权利要求 1所述血小板自动化分析仪的血小板分析方法，其特征在于， 包括以下步骤：
步骤 1，连通血样注射器与加样针， 吸取待检测血样，加入采样杯中， 并混匀血样； 步骤 2， 通过血样注射器和加样针定量吸取采样杯中的血样， 加入准备杯； 步骤 3，通过分析液注射器向准备杯中加入分析液进行一次定量稀释，并混匀血样； 步骤 4， 连通血样注射器与加样针， 定量吸取准备杯中的血样， 加入分析杯； 步骤 5，通过分析液注射器向分析杯中加入分析液进行二次定量稀释，并混匀血样； 步骤 6， 检测分析杯中血样的原始血小板数量；
步骤 7， 通过诱聚剂注射器向采样杯中加入诱聚剂， 并混匀血样；
步骤 8，每间隔一定时间重复步骤 2~步骤 5，检测加入诱聚剂后的各个时间点的分 析杯中血样的血小板数量；
步骤 9，将加入诱聚剂后的各个时间点的血小板数量与原始血小板数量相比， 获得 血小板聚集率。
7、 根据权利要求 6所述的一种血小板分析方法， 其特征在于， 采用鼓气法进行血 样混匀。
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