CN107966578B - Medical rapid biochemical detection system and detection method - Google Patents

Medical rapid biochemical detection system and detection method Download PDF

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Publication number
CN107966578B
CN107966578B CN201711430575.7A CN201711430575A CN107966578B CN 107966578 B CN107966578 B CN 107966578B CN 201711430575 A CN201711430575 A CN 201711430575A CN 107966578 B CN107966578 B CN 107966578B
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cup
detection
sample
reagent
cleaning
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CN107966578A (en
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徐新
詹小勇
朱建波
周强
宋成桥
缪健
郭敏
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Jiangsu Kelundi Instrument And Equipment Manufacturing Co ltd
Sinnowa Medical Science & Technology Co ltd
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Clindiag Systems Co ltd
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Priority to CN201711430575.7A priority Critical patent/CN107966578B/en
Priority to PCT/CN2018/081097 priority patent/WO2019127958A1/en
Publication of CN107966578A publication Critical patent/CN107966578A/en
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • 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
    • G01N21/763—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
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • 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
    • 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
    • G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
    • G01N35/1011—Control of the position or alignment of the transfer device
    • 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
    • G01N35/1065—Multiple transfer devices
    • 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
    • G01N2021/7769—Measurement method of reaction-produced change in sensor
    • G01N2021/7783—Transmission, loss
    • 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
    • G01N2035/00475—Filters
    • G01N2035/00485—Filters combined with sample carriers
    • 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
    • G01N2035/00495—Centrifuges
    • 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
    • G01N2035/1027—General features of the devices
    • G01N2035/1032—Dilution or aliquotting

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  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • 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)

Abstract

The invention provides a medical rapid biochemical detection system and a detection method, wherein the system comprises a special detector and a detection card matched with the special detector and used for being arranged on a rotating device, and the detection card is provided with a reagent cup, a sample cup, a physiological saline cup, a cleaning agent cup and a cleaning water cup; the reagent cup is used for placing a reagent; the sample cup is used for placing a sample; the physiological saline cup is used for placing physiological saline; the cleaning agent cup is used for placing cleaning agent; the washing cup is used for placing washing water. The system can rapidly complete detection of a plurality of items of one sample by using one detection card at a time, can detect double reagents, centrifugally separates cells and plasma by means of the detection card by an instrument, and has simple and convenient operation and more accurate detection result. The system instrument also has the function of automatically judging and executing dilution rechecking on samples beyond the detection range without adopting other reagents and samples. The cups of the detection cards are different from each other, and during detection, samples and reagents are quantitatively and orderly transferred by the sample sucking needle of the instrument.

Description

Medical rapid biochemical detection system and detection method
Technical Field
The invention relates to the field of medical detection equipment, in particular to a medical rapid biochemical detection system and a medical rapid biochemical detection method.
Background
The biochemical analysis and detection of blood samples is an important index for clinical diagnosis, and the biochemical detection needs to be completed quickly in case of emergency in clinical work, so that precious time is reserved for patient treatment. Therefore, the method is very important for rapid implementation of biochemical detection for emergency patients. However, the existing rapid biochemical analyzer system is mainly based on a dry test strip technology, and compared with a liquid biochemical analyzer, the detection result has more interference factors and poor accuracy, and the detection item is limited by the detection method, so that the detection speed is high, but accurate diagnosis is difficult, or enough diagnosis information cannot be provided. The conventional liquid type automatic biochemical analyzer has the advantages of comprehensive detection items, more detection methods and high accuracy of detection results, but huge equipment volume, complex instrument structure, large consumption of reagent consumables and complex operation, and can not meet the detection requirements of clinical rapid detection, bedside detection and field emergency treatment conditions. And the reagent is opened for a long time and the reagent is repeatedly taken by the detection reagent needle, so that the detection result can be influenced by the change of the actual component content, the decrease of the enzyme activity and the like of the reagent in the later period of use.
Disclosure of Invention
The invention aims to: the invention aims to solve the technical problem of providing a medical rapid biochemical detection system and a medical rapid biochemical detection method aiming at the defects of the prior art.
In order to solve the technical problems, the invention provides a medical rapid biochemical detection card device, which comprises a detection card arranged on a rotating device, wherein more than one reagent cup and sample cup are arranged on the detection card, and the cups are independent and are not communicated with each other; each reagent cup is preloaded with different reagents required by each detection item, each item is provided with a first reagent cup, and each item is reacted and detected in the corresponding first reagent cup;
the sample cup is used for placing a sample, including whole blood, plasma or serum.
In the invention, a second reagent cup is arranged on the detection card, a second reagent is prestored, after a sample is added into the first reagent cup, the second reagent in the second reagent cup is sucked and added into the first reagent cup, and the reaction is carried out after uniform mixing. However, some items have only a first reagent and do not require a second reagent, and the reaction can be performed after the first reagent and the sample are mixed uniformly.
In the invention, the detection card is also provided with a water cup, and the water cup is preloaded with distilled water or normal saline and is used for cleaning a sample suction needle, diluting a sample or a reaction liquid.
In the invention, the detection card is also provided with a cleaning agent cup, and is preloaded with a cleaning agent for cleaning the sample suction needle.
In the invention, a sample cup on the detection card is preloaded with a quantitative hemolytic agent.
The invention discloses a double-hole blood sample cup, which comprises a whole blood cup and a blood plasma cup, wherein the whole blood cup is positioned at the inner side of a detection card, the blood plasma cup is positioned at the outer side of the detection card, a microporous filter membrane is arranged between the blood plasma cup and the whole blood cup, when in use, a blood sample is added into the whole blood cup positioned at the inner side of the detection card in advance, then the detection card is arranged on a rotating disc of the detection card, and the centrifugal force formed by high-speed rotation of a rotating device is utilized to drive blood plasma in the blood sample to enter the blood plasma cup positioned at the outer side through the microporous filter membrane, so that blood cells are reserved in the whole blood cup.
The invention also discloses a medical rapid biochemical detection system, the detector controls the rotation of the detection card, and the detector comprises a control and data processing unit, a sample sucking needle and transferring unit, wen Yocang, a detection disc rotating system, a detection unit and a cleaning unit, wherein the control and data processing unit controls the operation of the sample sucking needle and transferring unit, the detection disc rotating system, the detection unit and the cleaning unit.
In the invention, the detection card and the detection unit are arranged in the incubation bin, and the temperature in Wen Yocang is 35-45 ℃.
In the invention, the sample sucking needle and the transferring unit comprise a sample sucking needle, a diluter and a sample sucking needle moving device, wherein the sample needle moving device comprises a sample needle moving pipeline, a first motor, a second motor and a valve, wherein the first motor, the second motor and the valve are arranged on the sample needle moving pipeline, and the first motor and the second motor respectively control the sample sucking needle to move up and down and left and right.
In the invention, the sample suction needle cleaning unit comprises a cleaning pipeline and a pump arranged on the cleaning pipeline, wherein the two ends of the cleaning pipeline are respectively provided with a cleaning needle and a cleaning bottle, cleaning liquid is placed in the cleaning bottle, and the lower end of the cleaning needle is provided with a cleaning pool.
In the present invention, the detection unit comprises a set of optical detection devices including a light source and an optoelectronic signal receiver.
The invention also discloses a detection method of the medical rapid biochemical detection system, which comprises the following steps:
step 1: taking a certain amount of whole blood, adding the whole blood into a whole blood cup of the sample cup, and placing the whole blood cup on a detection card;
step 2: placing the detection card on a rotating device, sucking quantitative physiological saline from a physiological saline cup through a sample sucking needle, adding the quantitative physiological saline into a whole blood cup, starting the rotating device to enable the detection card to rotate rapidly, and forming centrifugal force to enable plasma to be filtered from the whole blood cup to a plasma cup;
step 3: controlling a sample sucking needle to enter a plasma cup to suck quantitative diluted plasma, adding the quantitative diluted plasma into each first reagent cup, and starting a rotating device to reciprocally rotate a detection card again to uniformly mix samples and reagent mixed liquid in each first reagent cup;
step 4: controlling the rotating device to enable the detection card to rotate at a constant speed, and optically detecting the solution in the first reagent cup through the detection unit;
step 5: the inner wall of the sample suction needle is cleaned through the diluter, and the outer wall of the sample suction needle is cleaned through the cleaning unit;
step 6: controlling a sampling needle to absorb the second reagent in each second reagent cup, adding the second reagent into the first reagent cup, and starting a rotating device to rotate a detection card;
step 7: the inner wall of the sample suction needle is cleaned through the diluter, and the outer wall of the sample suction needle is cleaned through the cleaning unit;
the method comprises the following steps: the detection card is driven to rotate at a constant speed, the detection unit performs multi-wavelength detection on the first reagent cup once in each rotation period, and the detection result is recorded.
In the invention, the manner of rotating the detection card by the rotating device in the step 2, the step 3 and the step 6 is as follows: repeatedly and uniformly mixing for more than one time, wherein the rotation angle is more than 10 degrees.
In the detection process, when the OD value of the absorbance detected by the first reagent cup is larger than 1.6, the instrument automatically re-measures the dilution of the reactant in the first reagent cup. A step of
The system instrument also has the function of executing automatic dilution and review on the detection range sample without adopting a reagent sample. Can be suitable for rapid analysis of samples in other fields such as medical treatment, food, environmental protection and the like.
The beneficial effects are that: the invention can conveniently and rapidly finish detection and improve the precision of detection results; multiple biochemical and immunological project detection can be completed on the same detection card, double-reagent detection can be performed, and a sample blank is automatically deducted; the instrument only has one detection card rotating disc, all required reagents and samples are loaded, the required cleaning times are reduced, the cleaning is reliable, and the reagent waste and the cross contamination are effectively reduced. The special detection card is placed on the detection card rotating disc during detection, and only one needle is used for completing the sucking and distributing of the reagent and the sample; the instrument detection card rotating disc can drive the detection card to rotate rapidly to generate centrifugal force, and meanwhile, the plasma in the whole blood is automatically separated through the filtration of the microporous filter membrane in the sample cup on the detection card. Therefore, the invention is more convenient, more accurate, more economical and more environment-friendly.
Drawings
The foregoing and other advantages of the invention will become more apparent from the following detailed description of the invention when taken in conjunction with the accompanying drawings and detailed description.
FIG. 1 is a schematic diagram of the overall apparatus;
FIG. 2 is a schematic diagram of a test card according to the present invention;
FIG. 3 is a schematic diagram of a sample needle and transfer unit;
FIG. 4 is a schematic diagram of a device for detecting the recombination of transmitted light and scattered light;
FIG. 5 is a schematic view of a sample cup structure;
FIG. 6 is a schematic diagram of a test card according to embodiment 2
FIG. 7 is a schematic diagram of a test card according to embodiment 3
Detailed Description
The present invention will be described in detail with reference to the accompanying drawings.
Referring to fig. 1, the detector controls the rotation of the detection card, and comprises a control and data processing unit, a sample sucking needle and transferring unit, wen Yocang, a detection disc rotating system, a detection unit and a cleaning unit, wherein the control and data processing unit controls the operation of the sample sucking needle and transferring unit, the detection disc rotating system, the detection unit and the cleaning unit. The sample sucking needle and the transferring unit comprise a sample sucking needle, a diluter and a sample sucking needle moving device, the sample needle moving device comprises a sample needle moving pipeline, a first motor, a second motor and a valve, the first motor, the second motor and the valve are arranged on the sample needle moving pipeline, and the first motor and the second motor respectively control the sample sucking needle to move up and down and left and right.
As shown in fig. 2, the sample cup 2 is divided into a whole blood cup 4 and a plasma cup 3, and the sample cup is positioned at the inner ring of the detection card 1; the test card is provided with a sample cup 2, a physiological saline cup 5, a first reagent cup 10, a second reagent cup 9, and a first cleaning agent cup 6, a second cleaning agent cup 7 and a cleaning water cup 8. The microporous filter membrane is used for filtering the whole blood in the whole blood cup, so that the cells of the whole blood are reserved in the whole blood cup, and the blood plasma permeates through the microporous filter membrane to enter the blood plasma cup under the action of centrifugal force; the physiological saline cup is preloaded with physiological saline and is used for diluting whole blood; the first reagent cups are respectively preloaded with first reagents required by all detection items, and plasma is quantitatively transferred into the first reagent cups by a sample suction needle during detection for optical detection; the second reagent cups are respectively preloaded with second reagents required by each detection item, and the appointed second reagents are transferred into the appointed first reagent cups by the sample sucking needle for reaction and detection according to the detection item requirements during detection; the cleaning agent cup is preloaded with a cleaning agent and is used for cleaning the sample suction needle; the cleaning water cup is preloaded with deionized water and is used for cleaning the sample suction needle; when the sample sucking needle needs to be cleaned, the cleaning agent is sucked into a designated cleaning agent cup according to the program of the detected item, then discharged into a cleaning pool, then sucked into a cleaning water cup, and then discharged into the cleaning pool, so that the inside and outside cleaning of the sample sucking needle is realized.
The system has only one sample sucking needle and bears the sucking and distributing of the sample and the reagent. The sample and various reagents required by the execution of detection are pre-arranged on the detection card, the reaction detection of each item is completed in the first reagent cup of each item, and other reagents and samples required by each detection item except the first reagent are sucked and transferred to the first reagent cup by each cup of the detection card through the sample sucking needle.
The detector comprises a control and data processing unit, a sample sucking needle and transferring unit, a detecting disc rotating system, a detecting unit and a cleaning unit; the detection disc rotating system is used for driving the detection card to rotate rapidly, and centrifugally separating plasma in the whole blood under the cooperation of filtration of the microporous filter membrane in the sample cup; the control and data processing unit is used for controlling coordination work among the units of the instrument, processing detection data, calculating detection results and the like;
the sample sucking needle and the transferring unit consist of a sample sucking needle, a quantitative diluter, a connecting pipeline, a valve and a sample sucking needle moving device, and are used for adding plasma into the first reagent cup, sucking a quantitative second reagent in the second reagent cup and adding the quantitative second reagent into the corresponding first reagent cup;
the detection unit comprises more than one optical detection device, the device is arranged at the incubation groove of the detector, the optical detection device comprises a light source and a photoelectric signal receiver, the detection card sequentially passes through the detection positions of the first reagent cups under the drive of the rotating motor, and the detector repeatedly detects the first reagent cups one by one in a timing manner in the whole detection process.
The sample suction needle cleaning unit comprises a pump, a connecting pipeline, a valve and a cleaning pool.
The test card may also be devoid of a physiological saline cup.
The detection card is disc-shaped, is installed on a turntable of the detector when in use, and the first reagent cups are all positioned in the annular Wen Yocao 19 of the detector, and the incubation groove is controlled to be constant at 35-45 ℃; the whole blood cup of sample cup sets up in the off-centre one side of detection card, and the plasma cup of sample cup is located off-centre one side of detection card far away from the center.
The aperture of the microporous filter membrane 25 in the sample cup is less than or equal to 10.0 mu m, the plasma cup 3 of the sample cup is deeper than the whole blood cup 4, and the separated plasma can not flow back into the whole blood cup.
The detection card is attached with a specific mark, the detector is provided with a recognition device for automatically recognizing the mark, and the detector can automatically recognize the information of the detection card through the specific mark, including the type of the detection card, detection items, whether the detection card is in the validity period, the sample adding amount of each detection item, the sample adding flow, the detection conditions, the standard curve and other parameter information. Specifically, the specific identifier may be a bar code, a two-dimensional code or a chip; when the detection card is placed in the rotating device, the bar code of the detection card is automatically aligned with the reading area of the detector, or the bar code of the detection card is manually aligned with the reading area of the detector.
The detection card is arranged on a turntable specially arranged on the instrument and fixed when in use, and the motor 20 can drive the turntable to rotate and drive the detection card 1 on the turntable to rotate; the motor drives the turntable and the detection card to rotate at a high speed before detection, the blood cells in the whole blood cup and the blood plasma are centrifugally separated through the microporous filter membrane, so that the blood cells are left in the whole blood cup, and the blood plasma is filtered into the blood plasma cup through the microporous filter membrane; in the detection process, the motor rotates at a constant speed, and after every rotation of +1 position, the sample is sucked by the sample sucking needle and added into the first reagent cup, or the second reagent is sucked and added into the corresponding first reagent cup. After the sample and the reagent are sucked and distributed, the motor continuously rotates at a constant speed, and the motor is not stopped until the detection process is completed.
The instrument drives the turntable and the detection card to rotate at a high speed through the motor, and the turntable and the detection card are stopped suddenly and repeatedly for a plurality of times, so that the liquid in the first reagent cup and the plasma cup is mixed evenly due to the repeated turning and flowing of the liquid in the cup caused by the change of external force.
Each cup of the test card contains a reagent according to a set condition in each cup when supplied to a user, and has a sealing film 22 on its upper surface.
In the present embodiment, as shown in FIG. 4a, a light source 23 is provided on one side of the side wall of the first incubation groove 19, and a transmitted light detecting means 24 is provided on the other side;
as shown in fig. 4b, a light source 23 is arranged on one side of the side wall of the second incubation groove 19, and a scattered light detecting device 25 is arranged at the bottom of the incubation groove;
as shown in fig. 4c, a light source 23 is disposed on one side of the sidewall of the third incubation groove 19, a transmitted light detection device 24 is disposed on the other side of the sidewall, a scattered light detection device 25 is disposed at the bottom of the incubation groove, and the transmitted light detection device 24 is disposed on the wall of the recess of each cup of the detection card, which is matched with each other, and is used for performing transmitted light detection on the reagent background and the reagent sample mixed solution in the first reagent cup; the scattered light detection device 25 is arranged at the bottom of the groove matched with each cup of the detection card and is used for detecting scattered light of the reagent background, the reagent and the sample mixed solution in the first reagent cup.
The third incubation tank was used in this example.
Sample needle and transfer unit theory of operation: as shown in fig. 1, the sealing film 22 on the sample cup 2 of the test card 1 is manually torn first, and a fixed amount of whole blood is sucked from the blood collecting tube 11 and added into the whole blood cup 4 of the sample cup; or the separated serum or plasma is directly added into the plasma cup 3 of the detection card; then placing the detection card on a detection card rotating disc of a detector, placing the reagent cup in the ring Wen Yocao 19, and starting a detection key; the first motor 13 and the second motor 14 respectively control the sample sucking needle to move up and down and left and right to the upper part of the physiological saline cup 5, the sample sucking needle 12 penetrates through a sealing film on the physiological saline cup 5, quantitative physiological saline is sucked and added into the whole blood cup, a rotating disc of a detection card rotates rapidly, the blood plasma in the whole blood is filtered by a microporous filter membrane 25 and separated into a plasma cup 3, and the detection card repeatedly rotates rapidly and rapidly to mix evenly and dilute the blood plasma in an emergency stop mode.
As shown in fig. 1, an instrument sample sucking needle sucks quantitative diluted plasma from a plasma cup 3, the sample sucking needle penetrates through each item of first reagent cup 10 respectively, the diluted plasma is added into each item of first reagent cup of a detection card respectively, the detection card repeatedly rotates rapidly and suddenly stops, liquid in each first detection cup is uniformly mixed repeatedly, and after the plasma is mixed with a first reagent preloaded in the first reagent cup, the detection card rotates at a uniform speed for optical detection; then the sample sucking needle is transferred to the upper part of the first cleaning agent cup 6, passes through a sealing film on the first cleaning agent cup 6, sucks a fixed amount of first cleaning agent, moves to the cleaning pool 16 to discharge the cleaning agent sucked in the sample sucking needle, and the external cleaning needle 17 of the cleaning unit sucks cleaning water in the cleaning bottle 21 to flush the outer wall of the sample sucking needle 12 through the pump 18;
the cleaning modes comprise the following modes: 1. directly cleaning the inside and outside water; 2. sucking cleaning agent 1-flushing; sucking cleaning agent for 2-flushing; 3. absorbing water and cleaning; 4. different cleaning modes can be adopted according to different types of sucked reagents.
The sample sucking needle is respectively transferred to the upper parts of the second reagents of all items and respectively passes through all sealing films, the second reagents 9 of all items are sucked and added into corresponding first reagent cups and are uniformly mixed, after the second reagents are added into the first reagent cups each time the sample sucking needle is sucked, a certain amount of first cleaning agent is sucked into a first cleaning agent cup 5, the sample sucking needle is moved to a cleaning pool 16 arranged at one side of a detection card to be discharged, and the external cleaning needle 17 of the cleaning unit sucks cleaning water in a cleaning bottle 21 to clean the outer wall of the sample sucking needle 12 by flushing water through a pump 18; then the second cleaning agent cup 6 is used for sucking a fixed amount of second cleaning agent, and the second cleaning agent cup is moved to the cleaning pool 16 to be discharged, and the outer surface of the needle is cleaned; during detection, the motor 20 drives the detection card to rotate at a constant speed, and stops briefly at the position where the sample and the reagent are required to be sucked and distributed, and the detection device performs multi-wavelength detection on each reagent cup once in each rotation period, and records the detection result. After the sample and reagent are sucked and distributed, the detection card continuously rotates at a constant speed until the detection is finished, and the instrument rotating disc stops rotating.
The application also discloses another medical rapid biochemical detection system and detection method, comprising the following steps:
step 1: placing the detection card on a detection card rotating disc of a detector, extending the blood collection tube to the position below the sample suction needle, pressing down an instrument detection key, automatically sucking quantitative whole blood from the blood collection tube by the sample suction needle, and adding the quantitative whole blood into a whole blood cup of a sample cup; or sucking the separated serum or plasma from the blood collecting tube, and adding the separated serum or plasma into a plasma cup of the detection card; then the sample sucking needle moves to a cleaning pool, and the outer wall of the sample sucking needle is cleaned by the flushing of the cleaning unit; step 2: the sample sucking needle moves to a whole blood cup of the sample cup, whole blood is added to the whole blood cup, then the sample sucking needle sucks quantitative normal saline from the normal saline cup and adds the quantitative normal saline to the whole blood cup, the rotating disc of the detection card rapidly rotates to separate plasma in the whole blood to the plasma cup, and the rotating disc drives the detection card to repeatedly rapidly rotate and rapidly stop uniformly mixing to dilute the plasma;
step 3: the instrument sample sucking needle sucks quantitative diluted plasma from the plasma cup; then the sample sucking needle adds diluted blood plasma into the first reagent cups of all items of the detection card, after all the first reagents are added, the detection card repeatedly and rapidly rotates and suddenly stops, the liquid in the first reagent cup continuously changes direction and flows due to unbalanced liquid state in the cup, and the mixture is repeatedly and uniformly mixed, so that the blood plasma is mixed with the first reagents preloaded in the first reagent cup, and then the detection card uniformly rotates for optical detection; transferring the sample sucking needle to a first cleaning agent cup position, sucking a fixed amount of first cleaning agent, transferring the sample sucking needle to a cleaning pool, discharging the cleaning agent sucked in the sample sucking needle, and cleaning the inner wall and the outer wall of the sample sucking needle by using a cleaning unit;
step 4: the sample sucking needle sucks the second reagent of each item and respectively adds the second reagent of each item into the corresponding first reagent cup, and after the second reagent is added into the first reagent cup every time the sample sucking needle sucks the quantitative cleaning agent into the first cleaning agent cup, the sample sucking needle moves to the cleaning pool to be discharged;
step 5: the instrument detection card repeatedly mixes the liquid in the first reagent cup according to a rapid rotation-emergency stop mode;
step 6: during detection, the motor drives the detection card to rotate at a constant speed, and the detection card is stopped briefly at the position where the sample and the reagent are required to be sucked and distributed, and the detection device performs multi-wavelength detection on each reagent cup once in each rotation period, and records the detection result. After the sucking and dispensing of the sample and the reagent are completed, the detection card continuously rotates at a constant speed until the detection is completed, and the rotation of the instrument rotating disc is stopped.
The device is characterized in that a whole blood detection cup is further arranged on the detection card, quantitative hemolysis agent is preloaded in the whole blood detection cup, a quantitative whole blood sample is added into the whole blood detection cup by a manual or sample sucking needle during detection, the blood sample and the hemolysis agent are diluted and hemolyzed uniformly, the hemoglobin content in the whole blood detection cup is measured, and the proportion and the content of red blood cells and plasma in the blood sample are automatically judged according to the hemoglobin content. Because the blood plasma content in the whole blood of different individuals is different, the actual content of each component in the blood plasma in the whole blood sample can be more accurately calculated according to the total added dilution after the red blood cells and the blood plasma content of the blood sample and the total taken whole blood are obtained. The calculation formula is as follows: the volume ratio of the plasma to the whole blood=100% -where the measured hemoglobin concentration is expressed in g/l by a factor K > 30, and the K factor can be calculated in other units according to the corresponding ratio.
All the results of the tests were calculated from the amount of plasma added to calculate the concentration of each component in the plasma.
The system of the device can determine the plasma volume by measuring the cell turbidity of the blood sample during detection. The specific method is that a blood sample cell turbidity detection cup is preset on the detection card, and quantitative physiological saline is preloaded in the cup. Before detection, quantitative whole blood is added into the cup according to the requirements of the detection card and uniformly mixed, when the detection card is placed on the detector, the turbidity of the blood cells added into the cup is detected by the detector, then the content of the cells in the blood sample is calculated, the volume of the whole blood after the cell content is subtracted is the content of plasma (serum), and all detection results calculate the detection concentration results of various components in plasma (serum) according to the actual content of the plasma (serum). The calculation formula of the plasma concentration is:
the coefficient N is ∈ 0.1.
Example 2:
as shown in fig. 6, the sample cup is divided into a whole blood cup and a plasma cup, and the sample cup is positioned on the outer ring of the detection card.
Example 3:
as shown in fig. 7, the sample cup is a single well cup in which no reagent or diluent is added in advance, and the sample cup is directly tested without separation of serum, plasma or whole blood.
Example 4:
the sample cup of the detection card is a single hole, a certain amount of reagent with a hemolysis function and a dilution function is preloaded in advance, a certain amount of whole blood sample is directly added into the sample cup when the detection card is used, the sample is added to form a hemolysis sample, and the hemolysis sample is used for detection after being uniformly mixed.
Example 5:
the detection card is arranged in the incubation bin, i.e. the whole detection card and the detector are arranged in one constant temperature Wen Yocang.
Example 6:
in the invention, when the absorbance OD value of the reaction liquid detected by the instrument is larger than a preset value above 1.6, the sample sucking needle automatically sucks the physiological saline in the physiological saline cup, and the reaction liquid in the corresponding reagent cup is re-detected after being diluted, wherein the dilution multiple is 0.5-20 times. The instrument calculates again according to the absorbance after dilution to obtain a more accurate detection result, and does not need to absorb new samples and reagents again for dilution and re-detection.
According to different detection methods, the detection result calculation modes are different:
A. for a biochemical end point method, an enzyme-labeled detection method and a chemiluminescent detection method, the concentration of the reaction liquid before dilution=the absorbance of the reaction liquid after dilution×the dilution multiple×the coefficient K1, wherein K1 is a relation coefficient between the absorbance and the concentration of the reaction liquid before dilution, K1 is any value between 0.1 and 500, and the K1 value is different according to different projects;
B. for biochemical rate method and two-point method detection, the concentration of the reaction solution before dilution=the absorbance of the reaction solution after dilution×the dilution multiple×k2, wherein K2 is a relation coefficient of the concentration of the reaction solution before dilution and the absorbance/time value, K2 is any value between 0.1 and 3000, and the K2 values are different according to different projects. In the detection of the rate method, the time control is inaccurate, the result obtained by calculation is not necessarily very accurate, and experiments prove that the detection result obtained by the method is far better than the detection results obtained by other methods.
Example 7:
the detector is provided with only one sample suction needle, samples and reagents are quantitatively determined according to detection requirements, the samples and the reagents are sequentially transferred between different cups on the detection card (the existing flowing or diffusing mode can not accurately quantify), and the detection card can finish detection of a plurality of items of one sample.
Example 8:
the detection card is provided with a second reagent cup, second reagents required by detection items are preloaded, the appointed second reagents are transferred into the appointed first reagent cup by the sample suction needle according to the required quantity and sequence of the detection items during detection, and optical detection is performed again after uniform mixing reaction.
The invention provides a medical rapid biochemical detection system and a detection method, and the method and the way for realizing the technical scheme are numerous, the above is only the preferred embodiment of the invention, and it should be pointed out that a plurality of improvements and modifications can be made to the person skilled in the art without departing from the principle of the invention, and the improvements and modifications are also considered as the protection scope of the invention. The components not explicitly described in this embodiment can be implemented by using the prior art.

Claims (5)

1. The medical rapid biochemical detection system is characterized by comprising a detection card and a detector, wherein the detector controls the rotation of the detection card, and comprises a control and data processing unit, a sample sucking needle and transferring unit, wen Yocang, a detection disc rotating system, a detection unit and a cleaning unit, wherein the control and data processing unit controls the operation of the sample sucking needle and transferring unit, the detection disc rotating system, the detection unit and the cleaning unit;
the detection card is provided with more than one reagent cup and more than one sample cup, and the cups are independent and are not communicated with each other; each reagent cup is preloaded with reagents required by each detection item, each detection item is provided with at least one first reagent cup, and each detection item is reacted and detected in the corresponding first reagent cup;
the sample cup is used for placing a sample, and the sample is whole blood, blood plasma or blood serum;
the detection card and the detection unit are arranged in the incubation bin, and the temperature in Wen Yocang is 35-45 ℃;
the sample cup is a double-hole cup and comprises two connected parts of a whole blood cup and a plasma cup, wherein the whole blood cup is positioned at the inner side of the detection card, the plasma cup is positioned at the outer side of the detection card, a microporous filter membrane is arranged between the plasma cup and the whole blood cup, when the sample cup is used, a blood sample is added into the whole blood cup positioned at the inner side of the detection card in advance, then the detection card is arranged on a rotating disc of the detection card, and the centrifugal force formed by high-speed rotation of a rotating device is utilized to drive blood plasma in the blood sample to enter the plasma cup positioned at the outer side through the microporous filter membrane, so that blood cells are kept in the whole blood cup;
the detection card is provided with a physiological saline cup, a detected sample is quantitative serum or plasma, a sample sucking needle firstly sucks quantitative physiological saline in the detection process and directly adds the quantitative physiological saline into the sample cup, the sample is diluted and mixed uniformly, and then the sucked sample is quantitatively distributed to each first reagent cup for detection;
the detection method of the medical rapid biochemical detection system comprises the following steps:
step 1: taking a certain amount of whole blood, adding the whole blood into a whole blood cup of the sample cup, and placing the whole blood cup on a detection card;
step 2: placing the detection card on a rotating device, sucking quantitative physiological saline from a physiological saline cup through a sample sucking needle, adding the quantitative physiological saline into a whole blood cup, starting the rotating device to enable the detection card to rotate rapidly, and forming centrifugal force to enable plasma to be filtered from the whole blood cup to a plasma cup;
step 3: controlling a sample sucking needle to enter a plasma cup to suck quantitative diluted plasma, adding the quantitative diluted plasma into each first reagent cup, and starting a rotating device to reciprocally rotate a detection card again to uniformly mix samples and reagent mixed liquid in each first reagent cup;
step 4: controlling the rotating device to enable the detection card to rotate at a constant speed, and optically detecting the solution in the first reagent cup through the detection unit;
step 5: the inner wall of the sample suction needle is cleaned through the diluter, and the outer wall of the sample suction needle is cleaned through the cleaning unit;
step 6: controlling a sample sucking needle to suck the second reagent in each second reagent cup, adding the second reagent into the first reagent cup, and starting a rotating device to rotate the detection card;
step 7: the inner wall of the sample suction needle is cleaned through the diluter, and the outer wall of the sample suction needle is cleaned through the cleaning unit; the method comprises the following steps: the detection card is driven to rotate at a constant speed, the detection unit performs multi-wavelength detection on the first reagent cup once in each rotation period, and the detection result is recorded.
2. The medical rapid biochemical detection system according to claim 1, wherein the second reagent cup is arranged on the detection card, the second reagent required by the detection project is preloaded, the appointed second reagent is transferred into the appointed first reagent cup by the sample sucking needle according to the required quantity and sequence of the detection project during detection, and the optical detection is carried out again after uniform mixing reaction.
3. The medical rapid biochemical detection system according to claim 1, wherein the detection card is further provided with a cleaning agent cup, and the cleaning agent cup is preloaded with a cleaning agent for cleaning the sample suction needle.
4. The rapid biochemical detection system according to claim 1, wherein the sample cup on the detection card is preloaded with a quantitative hemolysis agent.
5. The rapid biochemical detection system according to claim 1, wherein the sample suction needle cleaning unit comprises a cleaning pipeline and a pump arranged on the cleaning pipeline, two ends of the cleaning pipeline are respectively connected with a cleaning needle and a cleaning water bottle, cleaning water is placed in the cleaning water bottle, and a cleaning pool is arranged at the lower end of the cleaning needle.
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