WO2019127958A1 - 一种医用快速生化检测系统及检测方法 - Google Patents

一种医用快速生化检测系统及检测方法 Download PDF

Info

Publication number
WO2019127958A1
WO2019127958A1 PCT/CN2018/081097 CN2018081097W WO2019127958A1 WO 2019127958 A1 WO2019127958 A1 WO 2019127958A1 CN 2018081097 W CN2018081097 W CN 2018081097W WO 2019127958 A1 WO2019127958 A1 WO 2019127958A1
Authority
WO
WIPO (PCT)
Prior art keywords
cup
detection
sample
reagent
card
Prior art date
Application number
PCT/CN2018/081097
Other languages
English (en)
French (fr)
Inventor
徐新
詹小勇
朱建波
周强
宋成桥
缪建
郭敏
Original Assignee
江苏英诺华医疗技术有限公司
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
Priority claimed from CN201711430575.7A external-priority patent/CN107966578B/zh
Priority claimed from CN201721854867.9U external-priority patent/CN208206989U/zh
Application filed by 江苏英诺华医疗技术有限公司 filed Critical 江苏英诺华医疗技术有限公司
Publication of WO2019127958A1 publication Critical patent/WO2019127958A1/zh

Links

Images

Classifications

    • 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
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • 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
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/76—Chemiluminescence; Bioluminescence
    • 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
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • 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
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/82—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a precipitate or turbidity
    • 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
    • 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

Definitions

  • the invention relates to the field of medical testing equipment, in particular to a medical rapid biochemical detection system and a detecting method.
  • Biochemical analysis of blood samples is an important indicator of clinical diagnosis. In clinical work, it is often necessary to quickly complete biochemical tests in emergency situations, and strive for valuable time for patient treatment. Therefore, it is very important to quickly implement biochemical tests in emergency patients.
  • the existing rapid biochemical analyzer system is mainly based on the dry test strip technology, and the detection result has more interference factors and poorer detection results than the liquid biochemical analyzer, and the detection items are also limited by the detection method, resulting in detection. Faster but difficult to diagnose accurately or provide insufficient diagnostic information.
  • the commonly used liquid automatic biochemical analyzer has comprehensive detection items, many detection methods and high accuracy of detection results, but the equipment is bulky, the instrument structure is complex, the reagent consumables are expensive, the operation is cumbersome, and the clinical rapidization and bed cannot be satisfied. Parallel detection and detection under field emergency conditions are required. Moreover, when the large-capacity reagent is opened for a long time and the reagent needle is repeatedly taken, the detection result may be affected by the change of the actual component content and the decrease of the enzyme activity in the later period.
  • the technical problem to be solved by the present invention is to provide a medical rapid biochemical detection system and a detection method for the deficiencies of the prior art.
  • the present invention provides a medical rapid biochemical test card device, comprising a test card mounted on a rotating device, wherein the test card is provided with more than one reagent cup and a sample cup, and the cups are independent of each other. Disagree; each reagent cup is pre-installed with different reagents required for each test item, and each item has a first reagent cup, and each item is completed and detected in the corresponding first reagent cup;
  • the sample cup is used to place the sample, including whole blood, plasma or serum.
  • the detection card is provided with a second reagent cup, and the second reagent is pre-stored. After the sample is added into the first reagent cup, the second reagent in the second reagent cup is sucked into the first reagent cup, and after mixing, Carry out the reaction.
  • some items have only the first reagent, no second reagent is needed, and the first reagent and the sample are mixed and then reacted.
  • the test card is further provided with a water cup which is pre-filled with distilled water or physiological saline for cleaning the sample aspirating needle, diluting the sample or the reaction liquid.
  • the test card is further provided with a cleaning agent cup, and a cleaning agent is pre-installed for cleaning the suction needle.
  • the sample cup on the test card is preloaded with a quantitative hemolytic agent.
  • the sample cup is a double-hole cup, comprising two connected portions of a whole blood cup and a plasma cup, wherein the whole blood cup is located inside the detection card, the plasma cup is located outside the detection card, and the plasma cup and the whole A microporous membrane is arranged between the blood cups, and the blood sample is added to the whole blood cup located inside the detection card in advance, and then the detection card is mounted on the rotating disc of the detecting card, and the centrifugal force generated by the high-speed rotation of the rotating device is used to drive the blood sample.
  • the plasma passes through the microporous membrane into the plasma cup located outside, and the blood cells remain in the whole blood cup.
  • the invention also discloses a medical rapid biochemical detection system, wherein the detector controls the rotation of the detection card, the detector comprises a control and data processing unit, a sample suction needle and a transfer unit, a incubation chamber, a detection disk rotation system, a detection unit and a cleaning unit.
  • the control and data processing unit controls the operation of the aspirating needle and the transfer unit, the detection disk rotation system, the detection unit, and the cleaning unit.
  • the detection card and the detection unit are disposed in the incubation chamber, and the temperature in the incubation chamber is 35-45 °C.
  • the sample aspirating needle and the transfer unit comprise a sample aspirating needle, a diluter and a sample aspirating moving device
  • the sample needle moving device comprises a sample needle moving pipe and a first motor and a second motor disposed on the sample needle moving pipe;
  • the valve, the first motor and the second motor respectively control the up and down movement of the suction needle and the left and right movement.
  • the sample aspirating cleaning unit comprises a cleaning pipe and a pump disposed on the cleaning pipe.
  • the cleaning pipe is respectively cleaned with a needle and a cleaning bottle, the cleaning bottle is provided with a cleaning liquid, and the cleaning needle is provided with a cleaning pool at the lower end.
  • the detecting unit includes a set of optical detecting means including a light source and a photoelectric signal receiver.
  • the invention also discloses a detection method of a medical rapid biochemical detection system, comprising the following steps:
  • Step 1 Take the quantitative whole blood into the whole blood cup of the sample cup, and place the whole blood cup on the test card;
  • Step 2 Place the test card on the rotating device, add the quantitative physiological saline from the saline cup through the aspirating needle to the whole blood cup, turn on the rotating device to make the detection card rotate rapidly, and form a centrifugal force to filter the plasma from the whole blood cup.
  • Step 3 control the sampling needle to enter the plasma cup to absorb the quantitatively diluted plasma, add to each first reagent cup, and then turn on the rotating device to rotate the detection card again to mix the sample and the reagent mixture in each first reagent cup;
  • Step 4 controlling the rotating device to rotate the detecting card at a constant speed, and optically detecting the solution in the first reagent cup through the detecting unit;
  • Step 5 cleaning the inner wall of the sample needle through a diluter, and cleaning the outer wall of the sample needle through the cleaning unit;
  • Step 6 Control the sampling needle to suck the second reagent in each second reagent cup and add it to the first reagent cup, and turn on the rotating device to rotate the detecting card;
  • Step 7 cleaning the inner wall of the sample needle through a diluter, and cleaning the outer wall of the sample needle through the cleaning unit;
  • Step: 8 drive the detection card to rotate at a constant speed, and the detecting unit performs a multi-wavelength detection on the first reagent cup in each rotation cycle, and records the detection result.
  • the rotation device rotates the detection card in the following manner: repeatedly mixing more than once, and the rotation angle is greater than 10 degrees.
  • the instrument automatically re-tests the reactants in the first reagent cup.
  • the system instrument also has the function of performing automatic dilution review on the detection range sample without using another reagent sample. It can be applied to rapid analysis of samples in other fields such as medical, food, and environmental protection.
  • the invention has the advantages that the invention can conveniently and quickly complete the detection and improve the precision of the detection result; and the plurality of biochemical and immunological items can be simultaneously detected on the same detection card, the double reagent detection can be performed, and the sample blank is automatically deducted;
  • the detection card rotates the disc, loads all the required reagents and samples, and reduces the number of cleanings required, and the cleaning is reliable, effectively reducing reagent waste and cross-contamination.
  • the special detection card is placed on the rotating disc of the detecting card during testing, and only one needle completes the suction and distribution of the reagent and the sample; the rotating disc of the instrument detecting card can drive the detecting card to rotate rapidly to generate centrifugal force, and at the same time pass the micropore in the sample cup on the detecting card. Filtration of the membrane automatically separates plasma from whole blood. Therefore, the present invention is more convenient, more accurate, more economical, and more environmentally friendly.
  • Figure 1 is a schematic view of the device as a whole
  • FIG. 2 is a schematic structural view of a test card of the present invention
  • Figure 3 is a schematic view of a sample needle and a transfer unit
  • FIG. 4 is a schematic diagram of a combined detecting device for transmitted light and scattered light
  • Figure 5 is a schematic view showing the structure of the sample cup
  • FIG. 6 is a schematic structural view of a detection card of Embodiment 2
  • FIG. 7 is a schematic structural view of a detection card of Embodiment 3.
  • the test card and the detector controls the rotation of the test card
  • the detector includes a control and data processing unit, a sample suction and transfer unit, a incubation chamber, a detection disk rotation system, a detection unit and a cleaning unit
  • the data processing unit controls the operation of the aspiration needle and the transfer unit, the detection disk rotation system, the detection unit, and the cleaning unit.
  • the aspirating needle and the transfer unit comprise a sample aspirating needle, a diluter and a sample aspirating moving device
  • the sample needle moving device comprises a sample needle moving pipe and a first motor, a second motor and a valve disposed on the sample needle moving pipe, first The motor and the second motor respectively control the up and down movement of the suction needle and the left and right movement.
  • the sample cup 2 is divided into a whole blood cup 4 and a plasma cup 3, the sample cup is located in the inner circle of the test card 1; the test card is provided with a sample cup 2, a saline cup 5, a first reagent cup 10, and a second
  • the reagent cup 9 may include a first cleaning agent cup 6, a second cleaning agent cup 7, and a washing cup 8.
  • the microporous membrane is used to filter the whole blood in the whole blood cup, so that the whole blood cells are retained therein, and the plasma penetrates into the plasma cup through the microporous membrane under the action of centrifugal force;
  • the physiological saline cup is pre-loaded with physiological saline, and is used for Diluting the whole blood;
  • the first reagent cup is pre-loaded with the first reagent required for each test item, and the sample is quantitatively transferred from the sample needle to the first reagent cup for optical detection;
  • the second The reagent cup is pre-installed with the second reagent required for each test item, and the designated second reagent is transferred to the designated first reagent cup by the aspirating needle according to the test item for reaction and detection;
  • the cleaning agent cup is detected; Pre-installed cleaning agent for cleaning the suction needle;
  • the cleaning water cup is pre-installed with deionized water for cleaning the suction needle; when the suction needle needs to be cleaned, it is
  • the system has only one suction needle and is responsible for the absorption of the sample and reagent.
  • the test card is pre-loaded with samples and various reagents required for performing the detection, and each item reaction detection is completed in the first reagent cup of each item, and other reagents required for each detection item except the first reagent, The samples are transferred from the cups of the test card to the first reagent cup by the suction needles.
  • the detector comprises a control and data processing unit, a sample aspirating and transferring unit, a detecting disk rotating system, a detecting unit and a cleaning unit; the detecting disk rotating system is used for driving the detecting card to rotate rapidly, and the micro hole in the sample cup The filtration of the membrane cooperates to separate the plasma from the whole blood by centrifugation; the control and data processing unit is used to control the coordination between the units of the instrument, process the detection data and calculate the detection results;
  • the aspirating needle and the transfer unit are composed of a suction needle, a quantitative diluter, a connecting line, a valve, and a needle moving device for adding plasma to the first reagent cup and taking a quantitative amount in the second reagent cup.
  • the second reagent is added to the corresponding first reagent cup;
  • the detecting unit comprises one or more optical detecting devices, and the device is disposed at the incubator of the detector.
  • the optical detecting device comprises a light source and a photoelectric signal receiver, and the detecting card is sequentially driven to detect the first reagent cups under the rotation of the rotating motor. Position, the instrument repeatedly checks each first reagent cup at a certain time during the whole detection process.
  • the suction needle cleaning unit includes a pump, a connecting line, a valve, and a washing tank.
  • test card can also be free of a saline cup.
  • the test card is disc-shaped, and is mounted on the turntable of the detector when in use, and the first reagent cup is located in the annular incubator 19 of the detector, and the incubator controls the constant temperature of 35-45 ° C; the whole blood cup of the sample cup Set on the off-center side of the test card, the sample cup's plasma cup is located on the side of the deviation detection card away from the center.
  • the micropore filter 25 in the sample cup has a pore size of 10.0 ⁇ m, and the plasma cup 3 of the sample cup is deeper than the whole blood cup 4, and the separated plasma cannot be returned to the whole blood cup.
  • the detection card is provided with a specific identification, and the detector has an identification device that automatically recognizes the identification.
  • the detector can automatically identify the detection card information through the specific identification, including the type of the detection card, the detection item, whether the detection card is in the validity period, and the detection items. Parameter information such as sample loading amount, sample loading procedure, detection conditions, and standard curve.
  • the specific identifier may be a barcode, a two-dimensional code or a chip; when the detection card is placed in the rotating device, the detection barcode is automatically aligned with the detection area of the detector, or the detection barcode is manually aligned with the detection area of the detector. .
  • the detecting card is installed on the special turntable of the instrument and fixed, and the motor 20 can drive the turntable to rotate and drive the detecting card 1 on the rotating; before the detecting, the motor drives the turntable and the detecting card rotates at a high speed, and is filtered through the microporous filter.
  • the blood cells in the whole blood cup are separated from the plasma by centrifugation, so that the blood cells are left in the whole blood cup, and the plasma is filtered into the plasma cup through the microporous membrane; during the detection process, the motor rotates at a constant speed, after each rotation of +1 position
  • the sample is taken up by the aspirating needle and added to the first reagent cup, or the second reagent is aspirated into the corresponding first reagent cup. After the sample and reagent are sucked and dispensed, the motor continues to rotate at a constant speed until the detection process is completed.
  • the instrument drives the turntable and the high-speed rotation of the test card by the motor-emergency stop, and repeatedly makes the liquid in the first reagent cup and the plasma cup change due to the external force, so that the liquid in the cup repeatedly flows and mixes.
  • each cup of the test card When the cups of the test card are supplied to the user, the inside of each cup is filled with reagents as set, and the upper surface has a sealing film 22.
  • the first type of incubation tank 19 is provided with a light source 23 on one side of the side wall and a transmitted light detecting device 24 on the other side;
  • the second side of the second incubation tank 19 is provided with a light source 23 on the side of the side of the incubation tank, the bottom of the incubation tank is provided with a scattered light detecting device 25;
  • a light source 23 is disposed on one side of the side wall of the third incubation tank 19, and a transmitted light detecting device 24 is disposed on the other side.
  • the bottom of the incubator is provided with a scattered light detecting device 25, and the transmitted light detecting device 24 is disposed on the groove wall of each of the cups of the detecting card for detecting the transmitted light of the reagent background and the reagent sample mixture in the first reagent cup; and the scattered light detecting device 25 is disposed on the concave matching cup of the detecting card.
  • the bottom of the tank is used for scattered light detection of the reagent background, reagent and sample mixture in the first reagent cup.
  • This embodiment employs a third incubation tank.
  • the working principle of the sample needle and the transfer unit as shown in Fig. 1, firstly tearing the sealing film 22 on the sample cup 2 of the test card 1 and sucking the quantitative whole blood from the blood collection tube 11 into the whole blood cup 4 of the sample cup; or The separated serum or plasma is directly added to the plasma cup 3 of the test card; then the test card is placed on the test card rotating disc of the detector, and the reagent cup is placed in the annular incubator 19, and the detection button is turned on;
  • the motor 13 and the second motor 14 respectively control the up and down movement of the sample needle to the left and right, to the top of the physiological saline cup 5, the sample needle 12 passes through the sealing film on the physiological saline cup 5, and the quantitative physiological saline is sucked into the whole blood cup for detection.
  • the card rotating disk rotates rapidly, is filtered through the microporous membrane 25, and the plasma in the whole blood is separated into the plasma cup 3, and the detection card is repeatedly rotated rapidly - the acutely stopped mixed plasma is diluted.
  • the instrument aspirating needle draws quantitatively diluted plasma from the plasma cup 3, and the aspirating needle passes through the first reagent cup 10 of each item, respectively, and the diluted plasma is added to the first reagent cup of each item of the detection card, and the detection is performed.
  • the card repeatedly rotates rapidly - emergency stop, so that the liquid in each first test cup is repeatedly mixed, so that the plasma is mixed with the first reagent pre-packed in the first reagent cup, and the detection card is rotated at a constant speed for optical detection;
  • the needle is transferred to the top of the first cleaning agent cup 6, passes through the sealing film on the first cleaning agent cup 6, sucks the quantitative first cleaning agent, and the suction needle moves to the cleaning pool 16 to discharge the cleaning agent sucked in the sampling needle, and cleans
  • the external cleaning needle 17 of the unit is pumped through the pump 18, and the cleaning water in the cleaning bottle 21 is flushed to wash the outer wall of the sampling needle 12;
  • the cleaning method includes the following methods: 1. Direct internal and external water cleaning; 2. Suction cleaning agent 1-washing; suction cleaning agent 2-washing; 3. Water absorption cleaning; 4. Different cleaning methods can be used for different types of reagents to be absorbed. .
  • the aspirating needles are respectively transferred to the second reagent of each item, respectively pass through each sealing membrane, and the second reagent 9 of each item is sucked into the corresponding first reagent cup and mixed, and the aspirating needle is added to the first reagent every time.
  • the first cleaning agent is sucked up to the first cleaning agent cup 5, and is moved to the cleaning tank 16 disposed on one side of the detecting card, and the external cleaning needle 17 of the cleaning unit is sucked into the cleaning bottle 21 through the pump 18.
  • the washing water washes the outer wall of the sucking needle 12 for cleaning; then, the second cleaning agent cup 6 draws the quantitative second cleaning agent, moves to the cleaning pool 16 to be drained, and simultaneously cleans the needle surface; when the detecting, the motor 20 drives the detecting card Rotate at a constant speed and pause for a short time at the position where the sample and reagents need to be aspirated and dispensed.
  • the detection device performs a multi-wavelength detection on each reagent cup in each rotation cycle to record the detection result. After the sample and reagent suction distribution is completed, the test card continues to rotate at a constant speed until the end of the test, and the instrument rotates the disk to stop rotating.
  • the present application also discloses another medical rapid biochemical detection system and detection method, including the following steps:
  • Step 1 Place the test card on the rotating disc of the test card of the tester, extend the blood collection tube under the suction needle, press the instrument detection button, and the sample suction needle automatically draws the quantitative whole blood from the blood collection tube and adds it to the sample cup.
  • the sample needle moves to the cleaning pool, and the washing unit washes the outer wall of the sample needle
  • 2 The sample needle is moved into the whole blood cup of the sample cup, and the whole blood is added into the whole blood cup. Then, the sample needle is taken from the physiological saline cup and the quantitative physiological saline is added into the whole blood cup, and the detection card rotates rapidly.
  • the plasma in the whole blood is separated into the plasma cup, and the rotating disk drives the detection card to repeatedly rotate rapidly - the emergency stop mixes the diluted plasma;
  • Step 3 The instrument aspirating the sample draws the quantitatively diluted plasma from the plasma cup; after that, the aspirating needle adds the diluted plasma to the first reagent cup of each item of the detection card, and after the first reagent is added, the detection card is repeatedly rotated rapidly.
  • the liquid in the first reagent cup is continuously flowing, so that the mixture is repeatedly mixed, and the plasma is mixed with the first reagent pre-packed in the first reagent cup, and the detection card is uniform.
  • Step 4 Aspirating the needle to suck each item
  • the second reagent is added to each item corresponding to the first reagent cup, and after sucking the second reagent into the first reagent cup, the sample needle is sucked into the first cleaning cup.
  • Quantitative cleaning agent moved to the cleaning tank to drain;
  • Step 5 The instrument detection card repeatedly mixes the liquid in the first reagent cup according to the rapid rotation-emergency stop mode
  • Step 6 During the detection, the motor drives the detection card to rotate at a constant speed, and pauses at a position where the sample and the reagent need to be sucked and dispensed. In each rotation cycle, the detecting device performs a multi-wavelength detection on each reagent cup, and records the detection result. After the sample and reagent are dispensed and dispensed, the test card continues to rotate at a constant speed until the end of the test, and the instrument rotating disk stops rotating.
  • the test card of the device is further provided with a whole blood test cup, wherein a quantitative hemolytic agent is pre-installed, and a blood sample is quantitatively added to the whole blood test cup by a manual or aspiration needle during the test, and the blood sample is mixed with the hemolysis reagent diluted hemolysis. After homogenization, the hemoglobin content in the cup is measured, and the ratio and content of red blood cells and plasma in the blood sample are automatically determined according to the hemoglobin content. Due to the different plasma content in the whole blood of different individuals, the amount of plasma obtained by separation is different. After obtaining the red blood cell and plasma content of the blood sample and the total amount of whole blood taken, and based on the total amount of the diluted solution, the full calculation can be more accurately calculated.
  • plasma to volume ratio of whole blood 100% - (measured hemoglobin concentration ⁇ factor K)%, wherein the unit of hemoglobin concentration is g / l, the factor K ⁇ 30, other units can be calculated according to the corresponding proportion K factor.
  • the concentration of each component in plasma was calculated based on the amount of plasma added.
  • the plasma volume can be determined by measuring the turbidity of blood sample cells during system detection of the device.
  • the specific method comprises pre-setting a blood sample cell turbidity detecting cup on the test card, and pre-loading the quantitative physiological saline in the cup. Quantitative whole blood is added to the cup and mixed according to the requirements of the test card before the test.
  • the detector When the test card is placed on the detector, the detector first detects the turbidity of the blood cells after adding the blood cells, and then calculates the blood sample of the cells.
  • the content in the whole blood, the volume after deducting the cell content in the whole blood is the plasma (serum) content, and all the test results are based on the actual plasma (serum) content to calculate the detection concentration results of various components in the plasma (serum).
  • the formula for calculating plasma concentration is:
  • the sample cup is divided into a whole blood cup and a plasma cup, and the sample cup is located on the outer circumference of the test card.
  • the sample cup is a single-hole cup, in which no reagent or diluent is added in advance, and serum, plasma or whole blood is directly isolated without being separated.
  • the sample cup of the test card is a single hole, in which a certain amount of reagent having a hemolysis function and a dilution function is pre-preloaded.
  • a certain amount of whole blood sample is directly added into the sample cup, and after the sample is added, a hemolysis sample is formed and mixed. Used for testing.
  • test card is set in the incubation bin, that is, the entire test card and the detector are located in a constant temperature incubation bin.
  • the instrument when the instrument detects that the absorbance OD value of the reaction liquid is greater than or equal to a predetermined value, the sample aspirate automatically absorbs the physiological saline in the physiological saline cup, and dilutes the reaction solution in the corresponding reagent cup and re-detects the dilution factor. It is 0.5-20 times. The instrument is again calculated based on the diluted absorbance to obtain a more accurate test result without re-absorbing new samples and reagents for dilution and retest.
  • the detection results are calculated differently:
  • concentration of reaction solution before dilution absorbance of diluted reaction solution ⁇ dilution factor ⁇ coefficient K1, where K1 is the relationship between absorbance and concentration of the reaction solution before dilution, K1 For any value between 0.1 and 500, the K1 value varies according to the project;
  • the concentration of the reaction solution before dilution absorbance of the diluted reaction solution ⁇ dilution factor ⁇ K2, where K2 is the relationship between the concentration of the reaction solution before dilution and the absorbance/time value, K2 is 0.1 ⁇
  • K2 is the relationship between the concentration of the reaction solution before dilution and the absorbance/time value
  • K2 is 0.1 ⁇
  • the sample and reagents are quantitatively measured according to the detection, and are transferred between different cups on the detection card in an orderly manner (the existing flow or diffusion method cannot be accurately quantified), and the detection card can be completed. Multiple items of a sample are detected.
  • the second reagent cup is disposed on the test card, and the second reagent required for the detection item is pre-installed, and the designated second reagent is transferred to the designated first reagent cup according to the required quantity and sequence of the test item by the suction needle. After the mixing reaction, optical detection was performed again.
  • the present invention provides a medical rapid biochemical detection system and a detection method.
  • the above description is only a preferred embodiment of the present invention, and it should be noted that those skilled in the art will It is to be understood that a number of modifications and refinements may be made without departing from the principles of the invention, and such modifications and refinements are also considered to be within the scope of the invention.
  • the components that are not clear in this embodiment can be implemented by the prior art.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Plasma & Fusion (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

一种医用快速生化检测系统及检测方法，该系统包括专用检测仪及配套的用于安装在转动装置上的检测卡(1)，检测卡上设有试剂杯(9,10)、样品杯(2)、生理盐水杯(5)、清洗剂杯(6,7)以及清洗水杯(8)；试剂杯(9,10)用于放置试剂；样品杯(2)用于放置样品；生理盐水杯(5)用于放置生理盐水；清洗剂杯(6,7)用于放置清洗剂；清洗水杯(8)用于放置清洗水。该系统一次使用一个检测卡即可快速完成对一个样本多个项目检测，且可以进行双试剂检测，并借助仪器对检测卡离心分离细胞和血浆，操作简便，检测结果更准确。该系统仪器还具备对超出检测范围样本无需另采用试剂、样品即可自动判断执行稀释复查的功能。检测卡各杯间互不相通，检测时样品及试剂由仪器吸样针定量有序转移。

Description

一种医用快速生化检测系统及检测方法 技术领域
本发明涉及医学检测器材领域，特别是一种医用快速生化检测系统及检测方法。
背景技术
对血样进行生化分析检测是临床诊断的重要指标，在临床工作中常常遇到紧急情况下需要快速完成生化检测，为患者救治争得宝贵的时间。因此对于急诊患者快速实施生化检测十分重要。但现有的快速生化分析仪系统主要基于干式试纸条技术，其检测结果与液体式生化分析仪相比存在干扰因素多、检测结果准确性差，检测项目也受到检测方法限制，导致虽然检测速度较快但难以准确诊断，或无法提供足够的诊断信息。而目前常用的液体式自动生化分析仪具有检测项目全面、检测方法多、检测结果准确性高，但设备体积庞大，仪器结构复杂，试剂耗材消耗大，操作较繁琐，无法满足临床快速化、床旁化检测以及野外急救条件下的检测需要。且大瓶试剂长时间敞开及检测试剂针反复取试剂，可导致试剂使用到后期实际成分含量改变、酶活性下降等影响检测结果。
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，提供一种医用快速生化检测系统及检测方法。
为了解决上述技术问题，本发明提供了一种医用快速生化检测卡装置，包括安装在转动装置上的检测卡，所述检测卡上设有一个以上的试剂杯和样品杯，各杯间相互独立不相通；所述各试剂杯分别预装各检测项目所需不同试剂，每个项目都具有一个第一试剂杯，每个项目在对应第一试剂杯中完成反应并检测；
样品杯用于放置样品，包括全血、血浆或血清。
本发明中，所述检测卡上设有第二试剂杯，预存第二试剂，在第一试剂杯中加入样品后，吸取第二试剂杯中第二试剂加入第一试剂杯中，混匀后进行反应。但有些项目只有第一试剂，无需第二试剂，第一试剂和样品混匀后即可进行反应。
本发明中，所述检测卡还设有水杯，水杯预装蒸馏水或生理盐水，用于清洗吸样针、稀释样品或反应液。
本发明中，所述检测卡还设有清洗剂杯，预装清洗剂，用于清洗吸样针。
本发明中，检测卡上的样品杯预装定量溶血剂。
本发明中，所述样品杯为双孔杯，包括全血杯和血浆杯两个相连的部分，其中全血杯位于检测卡的内侧，血浆杯位于检测卡的外侧，所述血浆杯与全血杯之间设有微孔滤膜,使用时预先将血样加入位于检测卡内侧的全血杯,而后将检测卡安装在检测卡旋转盘上,利用转动装置高速旋转形成的离心力，驱动血样中的血浆通过微孔滤膜进入位于外侧的血浆杯,血细胞保留在全血杯中。
本发明还公开了一种医用快速生化检测系统，检测仪控制检测卡旋转，所述检测仪包括控制及数据处理单元、吸样针及转移单元、温育仓、检测盘旋转系统、检测单元和清洗单元，控制及数据处理单元控制吸样针及转移单元、检测盘旋转系统、检测单元和清洗单元的运转工作。
本发明中，所述检测卡及检测单元设置在温育仓内，温育仓内的温度为35-45℃。
本发明中，吸样针及转移单元包括吸样针、稀释器以及吸样针移动装置，样品针移动装置包括样品针移动管道和设置在样品针移动管道上的第一电机、第二电机以及阀门，第一电机和第二电机分别控制吸样针上下运动以及左右运动。
本发明中，吸样针清洗单元包括清洗管道以及设置在清洗管道上的泵，清洗管道两端分别清洗针和清洗瓶，清洗瓶中放有清洗液，清洗针下端设有清洗池。
本发明中，检测单元包括一组光学检测装置，光学检测装置包括光源和光电信号接收器。
本发明还公开了一种医用快速生化检测系统的检测方法，包括如下步骤：
步骤1：取定量全血加入到样品杯的全血杯中，并将全血杯放置在检测卡上；
步骤2：将检测卡放置在转动装置上，通过吸样针自生理盐水杯中吸取定量生理盐水加入全血杯中，开启转动装置使检测卡快速旋转，形成离心力使血浆从全血杯过滤到血浆杯；
步骤3：控制吸样针进入血浆杯中吸取定量稀释的血浆，加入到各第一试剂杯中，再次开启旋转装置往返旋转检测卡使得各第一试剂杯中的样品、试剂混合液混匀；
步骤4：控制旋转装置使得检测卡匀速转动，通过检测单元对第一试剂杯内溶液进行光学检测；
步骤5：通过稀释器对吸样针内壁进行清洗，通过清洗单元对吸样针外壁进行清洗；
步骤6：控制取样针吸取各第二试剂杯中第二试剂加入到第一试剂杯中，开启旋转装置 旋转检测卡；
步骤7：通过稀释器对吸样针内壁进行清洗，通过清洗单元对吸样针外壁进行清洗；
步骤:8：驱动检测卡匀速旋转，检测单元在每一旋转周期中都对第一试剂杯进行一次多波长检测，记录检测结果。
本发明中，步骤2、步骤3和步骤6中旋转装置旋转检测卡的方式如下：反复混匀一次以上，旋转角度大于10度。
本发明中，检测过程中，当第一试剂杯检测吸光度OD值大于1.6时，仪器自动对第一试剂杯中的反应物稀释重测。、
该系统仪器还具备对检测范围样本无需另采用试剂样品即可执行自动稀释复查的功能。可适用于医疗、食品、环保等其它领域的样品快速分析。
有益效果：本发明可以方便快速完成检测，同时提高检测结果的精度；而且同一检测卡上可同时完成多个生化及免疫项目检测，可以执行双试剂检测，并自动扣除样本空白；仪器仅有一个检测卡转动盘，装载了全部需要的试剂和样品，且所需要清洗次数减少，而且清洗确实可靠，有效减少试剂浪费和交叉污染。检测时专用检测卡放置于检测卡转动盘上，且只有一个针完成试剂和样品的吸取及分配；仪器检测卡转动盘可带动检测卡快速旋转产生离心力，同时通过检测卡上样品杯中微孔滤膜的过滤，自动分离全血中的血浆。因此本发明更方便、更准确、更经济、更环保。
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，本发明的上述或其他方面的优点将会变得更加清楚。
图1为装置整体示意图；
图2为本发明检测卡结构示意图；
图3为样品针及转移单元示意图；
图4为透射光和散射光复合检测装置示意图；
图5为样品杯结构示意图；
图6为实施例2检测卡结构示意图
图7为实施例3检测卡结构示意图
具体实施方式
下面将结合附图对本发明作详细说明。
如图1，检测卡和检测仪，检测仪控制检测卡旋转，所述检测仪包括控制及数据处理单元、吸样针及转移单元、温育仓、检测盘旋转系统、检测单元和清洗单元，控制及数据处理单元控制吸样针及转移单元、检测盘旋转系统、检测单元和清洗单元的运转工作。吸样针及转移单元包括吸样针、稀释器以及吸样针移动装置，样品针移动装置包括样品针移动管道和设置在样品针移动管道上的第一电机、第二电机以及阀门，第一电机和第二电机分别控制吸样针上下运动以及左右运动。
如图2中，样品杯2分为全血杯4和血浆杯3，样品杯位于检测卡1内圈；检测卡上设有样品杯2、生理盐水杯5、第一试剂杯10、第二试剂杯9、并可含有第一清洗剂杯6、第二清洗剂杯7和清洗水杯8。微孔滤膜用于过滤全血杯内全血，使全血的细胞保留在其中，而血浆在离心力作用下透过微孔滤膜渗透进入血浆杯；生理盐水杯预装生理盐水，用于对全血进行稀释；第一试剂杯分别预装各检测项目所需的第一试剂，检测时由吸样针将血浆定量转移至第一试剂杯中，用于进行光学检测；所述第二试剂杯分别预装各检测项目所需的第二试剂，检测时由吸样针将指定的第二试剂按照检测项目要求转移至指定的第一试剂杯中进行反应并检测；所述清洗剂杯预装清洗剂，用于清洗吸样针；所述清洗水杯预装去离子水，用于清洗吸样针；吸样针当需要清洗时按照所检测项目的程序到指定的清洗剂杯中吸取清洗剂，而后到清洗池排除，随后再到清洗水杯吸取清洗水，而后到清洗池排除，实现对吸样针内外清洗。
该系统的吸样针仅一个,且承担样品及试剂的吸取分配。在该检测卡上预先装有执行检测所需要的样本、各种试剂，且各项目反应检测都在各项目的第一试剂杯中完成，除第一试剂外各检测项目所需要的其它试剂、样本都由吸样针由检测卡的各杯吸取转移至第一试剂杯。
所述检测仪包括控制及数据处理单元、吸样针及转移单元、检测盘旋转系统、检测单元和清洗单元；所述检测盘旋转系统用于带动检测卡快速旋转，并在样品杯中微孔滤膜的过滤协同下，离心分离出全血中的血浆；控制及数据处理单元用于控制仪器各单元间的协调工作、处理检测数据并计算检测结果等；
吸样针及转移单元由一个吸样针、一个定量稀释器、连接管路、阀门以及吸样针移动装置组成，用于向第一试剂杯中添加血浆，并吸取第二试剂杯中定量的第二试剂加入 到对应的第一试剂杯中；
检测单元包括一个以上光学检测装置，该装置设置在检测仪的温育槽处，光学检测装置包括光源、光电信号接收器，检测卡在旋转电机带动下将各第一试剂杯按照顺序依次经过检测位置，仪器在整个检测过程中对各第一试剂杯逐一定时反复检测。
吸样针清洗单元包括泵、连接管路、阀门和清洗池。
检测卡也可以没有生理盐水杯。
检测卡为圆盘状，使用时安装于检测仪的转盘上，且第一试剂杯都位于检测仪的环形温育槽19内，温育槽控制恒温35-45℃；样品杯的全血杯设置在检测卡的偏中心一侧，样品杯的血浆杯位于偏检测卡远离中心一侧。
样品杯内微孔滤膜25孔径≦10.0μm，且样品杯的血浆杯3比全血杯4更深，分离后的血浆不可回流到全血杯中。
检测卡附有特定标识，检测仪具有自动识别该标识的识读装置，检测仪可以通过该特定标识自动识别检测卡信息，包括检测卡类型、检测项目、检测卡是否在有效期、各检测项目的加样量、加样流程、检测条件、标准曲线等参数信息。具体的是，特定标识可以是条码、二维码或芯片；将检测卡置于旋转装置时，检测卡条码自动对准检测仪识读区，或人工将检测卡条码对准检测仪识读区。
所述检测卡使用时安装在仪器专设的转盘上并固定，电机20可驱动转盘旋转并带动其上的检测卡1旋转；检测前电机带动转盘及检测卡高速旋转，经微孔滤膜过滤，将全血杯中血细胞与血浆离心分离，使得血细胞留在全血杯中，血浆经微孔滤膜过滤到血浆杯中；在检测过程中，电机匀速转动，每旋转一圈+1位后停止，由吸样针吸取样本加入第一试剂杯，或吸取第二试剂加入到相应的第一试剂杯中。样品、试剂吸取及分配完成后，电机持续匀速不停顿转动，直至检测过程完成。
仪器通过电机带动转盘及检测卡高速旋转-急停，反复多次的方式，使得第一试剂杯、血浆杯中的液体由于外力的改变，导致杯内液体反复变向流动而混匀。
检测卡各杯在提供给用户时各杯内部按照设定装有试剂，且上表面有密封膜22。
如图4a，本实施例中，第一种温育槽19的侧壁上一侧设有光源23，另一侧设有透射光检测装置24；
如图4b，第二种温育槽19的侧壁上一侧设有光源23，温育槽的底部设有散射光检 测装置25；
如图4c，第三种温育槽19的侧壁上一侧设有光源23，另一侧设有透射光检测装置24，温育槽的底部设有散射光检测装置25，透射光检测装置24设置于检测卡各杯位相匹配的凹槽壁,用于对第一试剂杯中试剂本底、试剂样本混合液进行透射光检测；散射光检测装置25设置于检测卡各杯位相匹配的凹槽底部，用于对第一试剂杯中试剂本底、试剂和样本混合液进行散射光检测。
本实施例采用第三种温育槽。
样品针及转移单元工作原理：如图1，首先人工撕开检测卡1样品杯2上的密封膜22，从采血管11中吸取定量全血加入到样品杯的全血杯4中；或将分离的血清或血浆，直接加入到检测卡的血浆杯3中；随后将检测卡放在检测仪的检测卡转动盘上，则试剂杯置于环形温育槽19内，开启检测键；第一电机13和第二电机14分别控制吸样针上下、左右移动，至生理盐水杯5上方，吸样针12穿过生理盐水杯5上的密封膜，吸取定量生理盐水加入全血杯中，检测卡转动盘快速旋转，经微孔滤膜25过滤，全血中血浆分离至血浆杯3，检测卡反复快速旋转—急停混匀稀释血浆。
如图1，仪器吸样针自血浆杯3中吸取定量稀释血浆，吸样针分别穿过各项目第一试剂杯10，分别将稀释血浆加入到检测卡的各项目第一试剂杯中，检测卡反复快速旋转-急停，如此反复实现各第一检测杯内液体混匀，使血浆与预装在第一试剂杯中的第一试剂混合后，检测卡匀速旋转进行光学检测；之后吸样针转移至第一清洗剂杯6上方，穿过第一清洗剂杯6上的密封膜，吸取定量第一清洗剂，吸样针移动至清洗池16排出吸样针内吸入的清洗剂，清洗单元的外部清洗针17通过泵18，吸取清洗瓶21中清洗水对吸样针12外壁冲水进行清洗；
清洗方式包括如下几种方式：1、直接内外水清洗；2、吸清洗剂1-冲洗；吸清洗剂2-冲洗；3、吸水清洗；4、可以针对所吸试剂类型不同采用不同的清洗方式。
吸样针分别转移至各项目第二试剂上方，分别穿过各密封膜，吸取各项目第二试剂9加入对应第一试剂杯并混匀，吸样针在每吸取一次第二试剂加入第一试剂杯中后，至第一清洗剂杯5吸取定量第一清洗剂，移动至设置在检测卡一侧的清洗池16排掉，清洗单元的外部清洗针17通过泵18，吸取清洗瓶21中清洗水对吸样针12外壁冲水进行清洗；再到第二清洗剂杯6吸取定量第二清洗剂，移动到清洗池16排掉，同时对针外 表进行清洗；检测时电机20驱动检测卡匀速旋转，并在需要吸取、分配样品及试剂的位置短暂停顿，每一旋转周期中检测装置都对各试剂杯进行一次多波长检测，记录检测结果。在样品和试剂吸取分配完成后，检测卡持续恒速旋转直至检测结束，仪器转动盘停止旋转。
本申请还公开了另一种医用快速生化检测系统及检测方法，包括下列步骤：
步骤1：将检测卡放在检测仪的检测卡转动盘上，将采血管伸到吸样针下，按下仪器检测键，吸样针自动从采血管中吸取定量全血，加入到样品杯的全血杯中；或从采血管中吸取已分离的血清或血浆，加入到检测卡的血浆杯中；随后吸样针移动至清洗池，清洗单元的冲洗针对吸样针外壁进行清洗；步骤2：吸样针移动至样品杯的全血杯中，将全血加入全血杯中，之后吸样针自生理盐水杯中吸取定量生理盐水加入全血杯中，检测卡转动盘快速旋转将全血中血浆分离至血浆杯，转动盘再带动检测卡反复快速旋转-急停混匀稀释血浆；
步骤3：仪器吸样针从血浆杯中吸取定量稀释的血浆；之后吸样针将稀释血浆加入到检测卡的各项目第一试剂杯中，各第一试剂加完后，检测卡反复快速旋转-急停，由于杯中液体状态不平衡导致第一试剂杯中的液体不断变向流动，如此反复混匀，使血浆与预装在第一试剂杯中的第一试剂混合后，检测卡匀速旋转进行光学检测；之后吸样针转移至第一清洗剂杯位，吸取定量第一清洗剂，而后吸样针移动至清洗池排出吸样针内吸入的清洗剂，且清洗单元对吸样针内外壁冲水进行清洗；
步骤4：吸样针吸取各项目第二试剂分别加入各项目对应第一试剂杯，吸样针在每吸取一次第二试剂加入第一试剂杯中后，吸样针至第一清洗剂杯吸取定量清洗剂，移动至清洗池排掉；
步骤5：仪器检测卡按照快速旋转-急停方式，反复混匀第一试剂杯中液体；
步骤6：检测时电机驱动检测卡匀速旋转，并在需要吸取、分配样品及试剂的位置短暂停顿，每一旋转周期中检测装置都对各试剂杯进行一次多波长检测，记录检测结果。在样品、试剂吸取分配完成后，检测卡持续恒速旋转直至检测结束，仪器旋转盘停止旋转。
本装置的检测卡上还另设置有一个全血检测杯，其中预装定量溶血剂，检测时人工或吸样针将定量全血血样加入该全血检测杯中，血样与溶血试剂稀释溶血混匀后，测定该杯中血色素含量，根据血色素含量自动判断该血样中红细胞及血浆的比例及含量。由 于不同个体全血中血浆含量不同，分离获得血浆量不同，在获得该血样的红细胞及血浆含量及总取用的全血量后，并根据总加入稀释液量，就可以更准确计算出全血样品中的血浆中各成分实际含量。计算公式：血浆占全血的体积比＝100％﹣(测得的血色素浓度×因子K)％，其中血色素浓度单位为g/l时，因子K≧30，其它单位时可按照相应比例计算K因子。
Figure PCTCN2018081097-appb-000001
结果都根据加入的血浆量计算各种成份在血浆中的浓度。
本装置的系统检测时可通过测定血样细胞浊度判断血浆体积。具体方法为检测卡上预先设置血样细胞浊度检测杯，杯中预装定量生理盐水。在检测前按照检测卡要求向该杯中加入定量全血并混匀，当检测卡放置在检测仪上时，检测仪先检测该杯中加入血液细胞后的浊度，随后计算出细胞在血样中的含量，全血中扣除细胞含量后的体积即为血浆(血清)的含量，所有检测结果都根据实际血浆(血清)含量计算出血浆(血清)中各种成份的检测浓度结果。血浆浓度的计算公式为：
Figure PCTCN2018081097-appb-000002
实施例2：
如图6，样品杯分为全血杯和血浆杯，样品杯位于检测卡外圈。
实施例3：
如图7，样品杯为单孔杯，其中不预先加入任何试剂或稀释液，接受血清、血浆或全血不分离直接进行检测。
实施例4：
检测卡的样品杯为单孔，其中预先预装一定量的具有溶血功能和稀释功能的试剂，使用时在样品杯内直接加入一定量的全血样本，样本加入后形成溶血样本，经混匀后用于检测。
实施例5：
检测卡设置在温育仓内,即整个检测卡以及检测仪都设在一个恒温温育仓内。
实施例6：
本发明中，当仪器检测反应液吸光度OD值大于1.6以上的预先设定值时，吸样针自动吸取生理盐水杯中的生理盐水,对相应试剂杯中反应液进行稀释后重新检测，稀释 倍数为0.5-20倍。仪器根据稀释后的吸光度再次计算获得更准确的检测结果，无需重新吸取新的样本和试剂进行稀释重新检测。
根据不同检测方法，检测结果计算方式有所不同：
A.对于生化终点法、酶标检测法及化学发光检测法，稀释前反应液浓度＝稀释后反应液吸光度×稀释倍数×系数K1，其中K1为稀释前反应液吸光度与浓度的关系系数，K1为0.1～500间任意数值，K1值根据项目不同有差异；
B.对于生化速率法和两点法检测，稀释前反应液浓度＝稀释后反应液吸光度×稀释倍数×K2，其中K2为稀释前反应液浓度与吸光度/时间值的关系系数，K2为0.1～3000间任意数值，K2值根据项目不同有差异。在速率法检测时，由于时间控制不精确，计算获得的结果不一定非常精确，实验证明该方法获得的检测结果远远优于其他方法所获得的检测结果。
实施例7：
检测仪上仅有一个吸样针，将样品及试剂按照检测所需定量，有序地在该检测卡上不同杯间转移(现有流动或扩散的方式不能准确定量)，检测卡可以完成对一个样本的多个项目检测。
实施例8：
检测卡上设有第二试剂杯，预装检测项目所需的第二试剂，检测时由吸样针将指定的第二试剂按照检测项目要求量及顺序转移至指定的第一试剂杯中，经混匀反应后再次进行光学检测。
本发明提供了一种医用快速生化检测系统及检测方法，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 (10)

  1. 一种医用快速生化检测卡装置，其特征在于，包括安装在转动装置上的检测卡，所述检测卡上设有一个以上的试剂杯和样品杯，各杯之间相互独立不相通；所述各试剂杯分别预装各检测项目所需试剂，每个检测项目都至少具有一个第一试剂杯，每个检测项目在对应第一试剂杯中完成反应并检测；
    样品杯用于放置样品，样品为全血、血浆或血清。
  2. 根据权利要求1所述的一种医用快速生化检测卡装置，其特征在于，所述检测卡上设有第二试剂杯，预装检测项目所需的第二试剂，检测时由吸样针将指定的第二试剂按照检测项目要求量及顺序转移至指定的第一试剂杯中，经混匀反应后再次进行光学检测。
  3. 根据权利要求1所述的一种医用快速生化检测卡装置，其特征在于，所述检测卡还设有水杯，水杯预装蒸馏水或生理盐水，用于清洗吸样针、稀释样品或反应液。
  4. 根据权利要求1所述的一种医用快速生化检测卡装置，其特征在于，所述检测卡还设有清洗剂杯，清洗剂杯预装清洗剂，用于清洗吸样针。
  5. 根据权利要求1所述的一种医用快速生化检测卡装置，其特征在于，检测卡上的样品杯预装定量溶血剂。
  6. 根据权利要求1所述的一种医用快速生化检测卡装置，其特征在于，所述样品杯为双孔杯，包括全血杯和血浆杯两个相连的部分，其中全血杯位于检测卡的内侧，血浆杯位于检测卡的外侧，所述血浆杯与全血杯之间设有微孔滤膜,使用时预先将血样加入位于检测卡内侧的全血杯,而后将检测卡安装在检测卡旋转盘上,利用转动装置高速旋转形成的离心力，驱动血样中的血浆通过微孔滤膜进入位于外侧的血浆杯,血细胞保留在全血杯中。
  7. 一种医用快速生化检测系统，其特征在于，该系统包括检测卡和检测仪，检测仪控制检测卡旋转，所述检测仪包括控制及数据处理单元、吸样针及转移单元、温育仓、检测盘旋转系统、检测单元和清洗单元，控制及数据处理单元控制吸样针及转移单元、检测盘旋转系统、检测单元和清洗单元的运转工作。
  8. 根据权利要求7所述的一种医用快速生化检测系统，其特征在于，吸样针清洗单元包括清洗管道以及设置在清洗管道上的泵，清洗管道两端分别清洗针和清洗水瓶，清洗水瓶中放有清洗水，清洗针下端设有清洗池。
  9. 一种医用快速生化检测系统的检测方法，其特征在于，检测卡上设有生理盐水杯，检测的样本为定量的血清或血浆，检测过程中吸样针先吸取定量的生理盐水直接加入样品杯，对样品稀释混匀，而后吸取样品定量分配至各第一试剂杯，进行检测。
  10. 一种医用快速生化检测系统的检测方法，其特征在于，包括如下步骤：
    步骤1：取定量全血加入到样品杯的全血杯中，并将全血杯放置在检测卡上；
    步骤2：将检测卡放置在转动装置上，通过吸样针自生理盐水杯中吸取定量生理盐水加入全血杯中，开启转动装置使检测卡快速旋转，形成离心力使血浆从全血杯过滤到血浆杯；
    步骤3：控制吸样针进入血浆杯中吸取定量稀释的血浆，加入到各第一试剂杯中，再次开启旋转装置往返旋转检测卡使得各第一试剂杯中的样品、试剂混合液混匀；
    步骤4：控制旋转装置使得检测卡匀速转动，通过检测单元对第一试剂杯内溶液进行光学检测；
    步骤5：通过稀释器对吸样针内壁进行清洗，通过清洗单元对吸样针外壁进行清洗；
    步骤6：控制取样针吸取各第二试剂杯中第二试剂加入到第一试剂杯中，开启旋转装置旋转检测卡；
    步骤7：通过稀释器对吸样针内壁进行清洗，通过清洗单元对吸样针外壁进行清洗；
    步骤:8：驱动检测卡匀速旋转，检测单元在每一旋转周期中都对第一试剂杯进行一次多波长检测，记录检测结果。
PCT/CN2018/081097 2017-12-26 2018-03-29 一种医用快速生化检测系统及检测方法 WO2019127958A1 (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201711430575.7A CN107966578B (zh) 2017-12-26 2017-12-26 一种医用快速生化检测系统及检测方法
CN201721854867.9 2017-12-26
CN201711430575.7 2017-12-26
CN201721854867.9U CN208206989U (zh) 2017-12-26 2017-12-26 一种医用快速生化检测卡装置及系统

Publications (1)

Publication Number Publication Date
WO2019127958A1 true WO2019127958A1 (zh) 2019-07-04

Family

ID=67065013

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2018/081097 WO2019127958A1 (zh) 2017-12-26 2018-03-29 一种医用快速生化检测系统及检测方法

Country Status (1)

Country Link
WO (1) WO2019127958A1 (zh)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1603820A (zh) * 2003-09-29 2005-04-06 株式会社立佳 一种分离生物样品的仪器及其分离方法
EP1830175A2 (en) * 2006-03-01 2007-09-05 Gemoscan International Inc. A system, method and apparatus for use in blood testing through luminescence
CN202204820U (zh) * 2011-08-12 2012-04-25 石家庄禾柏生物技术股份有限公司 一体化组合试剂盒
CN106124751A (zh) * 2016-08-17 2016-11-16 江苏英诺华医疗技术有限公司 血液细胞及生化成分分析仪及方法
CN106980026A (zh) * 2017-03-29 2017-07-25 盐城拜明生物技术有限公司 全自动化学发光免疫分析检测执行装置
CN107271703A (zh) * 2016-04-08 2017-10-20 爱-森新株式会社 可离心分离的圆形卡盒及利用它的模块式自动分析仪

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1603820A (zh) * 2003-09-29 2005-04-06 株式会社立佳 一种分离生物样品的仪器及其分离方法
EP1830175A2 (en) * 2006-03-01 2007-09-05 Gemoscan International Inc. A system, method and apparatus for use in blood testing through luminescence
CN202204820U (zh) * 2011-08-12 2012-04-25 石家庄禾柏生物技术股份有限公司 一体化组合试剂盒
CN107271703A (zh) * 2016-04-08 2017-10-20 爱-森新株式会社 可离心分离的圆形卡盒及利用它的模块式自动分析仪
CN106124751A (zh) * 2016-08-17 2016-11-16 江苏英诺华医疗技术有限公司 血液细胞及生化成分分析仪及方法
CN106980026A (zh) * 2017-03-29 2017-07-25 盐城拜明生物技术有限公司 全自动化学发光免疫分析检测执行装置

Similar Documents

Publication Publication Date Title
CN109884289B (zh) 低样本容量的凝血检测
CN107966578B (zh) 一种医用快速生化检测系统及检测方法
CN104833813B (zh) 一种同时具有血液常规和生化检测功能的分析仪
JPS58154662A (ja) 前処理機能を備えた自動分析装置
CN105628947B (zh) 全血自动发光免疫分析即时检测仪
CN205656141U (zh) 一种可同时测量crp和血常规的分析设备
JPS5916667B2 (ja) 自動血液分析装置
CN105699380A (zh) 一种可同时测量crp和血常规的分析设备和方法
WO2018032718A1 (zh) 血细胞和生化检测仪及其检测方法
US20140134051A1 (en) Automated platelet function analyzer and its analytical methods
JP2008542753A (ja) 自動化臨床分析機において少量の液体試料中の妨害因子を確認するための方法
CN108663303A (zh) 一种血液分析仪
CN111712703A (zh) 样本分析仪及样本分析方法
US20190298317A1 (en) Instrumented receptacle apparatus for health analysis of body fluids
CN107966579A (zh) 一种具有生化、酶免及化学发光快速检测系统及方法
CN109959549A (zh) 样本检测方法及样本分析仪
CN113466443A (zh) 一种用于存放检测试纸的试纸盒和样本检测装置
CN107515194A (zh) 一种尿液检测仪及其检测方法
WO2019127958A1 (zh) 一种医用快速生化检测系统及检测方法
JP6570522B2 (ja) 体外自動診断方法
CN208420635U (zh) 一种血液分析仪
CN215641281U (zh) 生物样本检测分析仪的液路系统及生物样本检测分析仪
CN208206989U (zh) 一种医用快速生化检测卡装置及系统
WO2019127959A1 (zh) 一种具有生化、酶免及化学发光快速检测系统及方法
CN207798857U (zh) 一种具有生化、酶免及化学发光快速检测系统

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18894929

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18894929

Country of ref document: EP

Kind code of ref document: A1