WO2013044454A1 - 一种全自动免疫分析仪及其检测方法 - Google Patents

一种全自动免疫分析仪及其检测方法 Download PDF

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Publication number
WO2013044454A1
WO2013044454A1 PCT/CN2011/080249 CN2011080249W WO2013044454A1 WO 2013044454 A1 WO2013044454 A1 WO 2013044454A1 CN 2011080249 W CN2011080249 W CN 2011080249W WO 2013044454 A1 WO2013044454 A1 WO 2013044454A1
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Prior art keywords
washing
needle
liquid
pulley
filling
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PCT/CN2011/080249
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English (en)
French (fr)
Inventor
胡德明
刘清波
何林
阳辉
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深圳市亚辉龙生物科技有限公司
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Priority to RS20190571A priority Critical patent/RS58684B1/sr
Priority to PCT/CN2011/080249 priority patent/WO2013044454A1/zh
Priority to EP11873277.5A priority patent/EP2762887B1/en
Publication of WO2013044454A1 publication Critical patent/WO2013044454A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/025—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations having a carousel or turntable for reaction cells or cuvettes
    • 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
    • G01N35/1079—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices with means for piercing stoppers or septums
    • 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
    • G01N2035/00346—Heating or cooling arrangements
    • G01N2035/00356—Holding samples at elevated temperature (incubation)
    • G01N2035/00376—Conductive heating, e.g. heated plates
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00613—Quality control
    • G01N35/00663—Quality control of consumables
    • G01N2035/00673—Quality control of consumables of reagents
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0401—Sample carriers, cuvettes or reaction vessels
    • G01N2035/0412—Block or rack elements with a single row of samples
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0401—Sample carriers, cuvettes or reaction vessels
    • G01N2035/0429—Sample carriers adapted for special purposes
    • G01N2035/0436—Sample carriers adapted for special purposes with pre-packaged reagents, i.e. test-packs
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0439—Rotary sample carriers, i.e. carousels
    • G01N2035/0441—Rotary sample carriers, i.e. carousels for samples
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0439—Rotary sample carriers, i.e. carousels
    • G01N2035/0446—Combinations of the above

Definitions

  • the invention relates to a fully automatic immune analyzer and a detection method thereof.
  • the method and the instrument are mainly used for antigens in biological samples such as human sample serum, sputum, urine, feces, bile, etc., such as antigens of various pathogenic microorganisms, or antibodies produced by the pathogenic microorganism antigens infecting the body, And autoimmune diseases such as systemic lupus erythematosus, phospholipid syndrome, rheumatoid arthritis, scleroderma, autoimmune liver disease, Sjogren's syndrome, systemic vasculitis, polymyositis and dermatomyositis, autoimmune Autoimmune antibodies in the blood of patients with diseases such as thyroid diseases and gastrointestinal diseases, as well as other immune indicators such as tumor markers, are quantitatively determined or qualitatively detected by enzyme-linked immunosorbent assay.
  • enzyme-linked immunosorbent assay As one of many immunoassay techniques, enzyme-linked immunosorbent assay has been widely used in the fields of clinical medicine, animal quarantine, food science, plant viruses, drug residues, pest control. This method is highly specific and sensitive, and almost all soluble antigen-antibody systems can be used for detection. Its minimum detection value can reach ng or even pg levels.
  • the advantage of the enzyme-linked immunoassay is that the label is stable and has no radioactive hazard; compared with the immunofluorescence assay, the enzyme-linked immunoassay is more objective.
  • commercial enzyme-linked immunoassay programs or reagents include antigens or antibodies to pathogens in clinical medical tests, proteins, non-peptide hormones, drugs, food microbes, microbial toxins, residual pesticides, food components in food testing.
  • the complete ELISA kit should include a well-coated solid support, enzyme conjugate, chromogenic substrate, reaction stop solution, various diluents and buffers, and the standards used in the assay. Liquid, calibration solution, positive control or control serum, negative control control or control serum, and the like. Since the enzyme-linked immunosorbent assay requires the use of a plurality of reagents in the assay, and these reagents are sequentially added according to the needs of the test reaction, it is also necessary to perform multiple washings on the micropores of the test reaction plate, and thus the manual operation is cumbersome. In order to simplify the operation, in particular to simplify the cumbersome operation of filling the test sample and the test reagent and repeatedly filling and aspirating the wash liquid in the washing process, various instruments for enzyme-linked immunoassay have been developed.
  • the enzyme-linked immunoassay For the enzyme-linked immunoassay, four kinds of cumbersome operations are carried out by adding samples, reagents, washing and color reaction results.
  • the prior art-enzyme-linked immunoassay analyzer adopts two methods of separation and combination.
  • Separate enzyme-linked immunoassay instruments mainly include a microplate reader and a plate washer. They are subjected to the processes of adding, adding reagents, incubating, washing, etc., and finally determining the results by absorbance analysis.
  • the microplate reader is essentially a visible light photoelectric colorimeter dedicated to the measurement of microplate absorbance.
  • the commonly used brands and models in the laboratory are MK3 of LABSYSTEMS and SPECTR of TECAN.
  • the washing machine is a filling and aspirating machine dedicated to the microplate washing liquid.
  • the brands and models commonly used in the laboratory are AT-828 of Shanghai Antai Company and PW-960 of Shenzhen Huisong Company. Type, KWP-100 of Shenzhen Kate Company, DNX-962 of Beijing Prang Technology Company, etc.
  • microplate readers and plate washers which are one of the important instruments necessary for the laboratory.
  • the equipment of the plate washer not only simplifies the cumbersome washing operation in the enzyme-linked immunoassay, but also has the basic functions of setting the number of cleaning times, cleaning the number of microplates, setting the soaking time, etc.
  • Bottom rinsing, two-point aspiration, plate/strip washing, oscillating, position adjustment, automatic cleaning of the pipeline, automatic liquid change, storage of various washing procedures, etc. fully guarantee the effect of the test washing, thus ensuring the experimental detection Convenience, speed and quality of washing.
  • Combined enzyme-linked immunoassay analyzers are divided into three categories: fully automated enzyme-linked immunoassay systems, automated sample processing systems, and pipeline-operated enzyme-linked immunoassay systems.
  • the fully automated enzyme-linked immunoassay system integrates the steps of enzyme-linked immunoassay from sample loading, reagent addition, incubation, washing, shaking, colorimetric to qualitative or quantitative analysis, report storage and printing functions to one instrument.
  • the instrument is automatically performed by various types of enzyme-linked immunoreaction or a program designed by the customer in advance.
  • the brands and models commonly used in laboratories are HAME of HAMILTON, CAA of BIORAD, AMP of Ausbon, Minilyeser of TECAN, TEKTIME of ORGANO, DIVISION STRUMENTI's Personal LAB, DYNDRX's DSX, and Akzo's Flex Tek2, TRIURUS of BIOASIA, etc.
  • the automatic sample processing system is mainly used to complete the cumbersome, artificially error-prone loading, reagent addition, dilution, titration, incubation, washing and other steps in the enzyme-linked immunoassay experiment. After completion, the results are determined by the microplate reader, and the commonly used brands in the laboratory.
  • the pipeline-operated enzyme-linked immunoassay system is based on the processes and conditions required for the enzyme-linked immunoassay, and the liquid addition system module, the constant temperature incubation module, the wash plate system module, and the result interpretation system module, according to the type and steps of the enzyme-linked immunoreactive reaction. Design and layout, use the track to connect these system modules in series, each system module can independently complete the tasks under the control of the system computer, and can also coordinate and complete the reaction process together.
  • microplate-type enzyme-linked immunosorbent analyzer has recently developed some new developments in various aspects, such as the development from 96-well mode to 384-well and 1536-well mode, which has been developed by LABSYSTEMS and BIOTEK has introduced a microplate reader that can measure 384-well microplates and Ultramark, which is available from BIORAD. It can measure 384-well and 1536-well microplates, and a plate washer for 384-well and 1536-well microplates has also been developed.
  • a microplate reader with up to 10 wavelength filters and a grating spectroscopic principle has been developed to provide a wider range of analysis wavelengths, wavelength accuracy and repeatability, measurement accuracy and repeatability, linearity, measurement speed, etc.
  • Technical performance is even better.
  • the introduction of these new methods, new technologies, new forms, new structures, and new devices has greatly promoted the application of enzyme-linked immunoassay, making the enzyme-linked immunoassay the most widely used, the most used, the largest, and the market. An immunoassay with the highest occupancy rate.
  • the reagent for qualitative detection includes at least 8 sample diluents, washing solution, enzyme conjugate, enzyme reaction substrate, color developer, stop solution, positive control serum, and negative control serum
  • the quantitative reagent includes at least a diluent.
  • washing solution, enzyme conjugate, enzyme reaction substrate, color developer, stop solution, at least 5 levels of standards or calibrators, a total of 11 kinds, each test reagent should be filled with reagent bottles, and each use
  • the number of items in the configuration and use of the test kits by the customer is the number of items ⁇ 96 persons. If 10 items need to be tested, the configuration and use of the reagents must be 10 ⁇ 96 persons, if only one copy The sample needs to be tested for 10 different items, and a 10 x 96 person reagent is also required.
  • Detection reagents and samples are open in the detection process, which easily cause cross-contamination between various reagents or between samples, affecting the detection results or directly affecting the operator.
  • test reagent can only detect one item. If two or three items are to be detected, three different test reagents or kits are required, and the test operations are performed separately.
  • the color of the colored solution is only optically read once when the single wavelength method is selected. In the dual wavelength method, another wavelength of the filter is selected for another optical reading, and the same reaction well cannot be colored. The color of the solution was read twice or more at different points in time.
  • Barcodes with no reagent information for each test or test, or bar code information is not comprehensive, or the bar code information is only the information of the kit. Only by checking the logo of the outer box of the kit can you know or know the production of the test reagents. The batch number and expiration date information, and the information that is known is not controlled during the detection process, and has great randomness.
  • Instrument loading, working fluid/reagent, and liquid absorption system are linear structures, moving in a straight line or walking.
  • Test items vary depending on the reagents used, and are arbitrarily selected and used.
  • the detection methods are all traditional ELISA methods, which are determined by the selected reagents.
  • the invention still has some shortcomings, such as: 1.
  • the liquid storage component There is a liquid level sensor, which uses the principle of 4-level liquid level resistance to detect the liquid storage capacity. The reliability is poor. It is impossible to know the usage amount of the working fluid stably and accurately, and the quality of the washing effect is not guaranteed.
  • Optical detection The dynamic detection method adopted by the system requires three sets of optical detection systems, and six optical channel detections change the transmission direction of light in the optical fiber. The lengths of the fibers connecting the three optical detection systems are inconsistent, there are differences in optical channels, and the stability is poor. The influence is large and the cost is high. 3.
  • the liquid system is complicated, the number of solenoid valves and washing pumps required is high, and the cost is high. 4.
  • the syringe driving device of the filling mechanism is to install the stepping motor and the screw on the bottom surface of the lower fixing plate. Into, the stability is poor, the life is short; 5, the filling needle of the filling mechanism bears the puncture and filling work at the same time, the puncture reliability is poor, and the life of the filling needle is short; 6.
  • the washing needle of the washing mechanism adopts the spring structure to adapt to the height of the bottom of the hole. Due to the linear compression of the spring compression force, the force increases with the increase of the compression stroke, the washing needle is easily damaged, and the service life is short; 7.
  • the reaction is performed by using a hot air heater. The disk is partially heated, and there are technical defects such as uneven heating, high noise, and low thermal efficiency.
  • the main object of the present invention is to solve the principle of liquid level resistance sensing in the existing automatic immune analyzer, which is used for detecting the liquid storage amount, has poor reliability, and cannot stably and accurately know the usage amount of the working fluid, and the quality of the washing effect is not good.
  • a fully automatic immunoassay analyzer and its detection method are proposed to the technical defects of the guarantee.
  • a fully automatic immune analyzer comprising: a main frame component, a reaction disk component, a filling mechanism, a washing mechanism, a liquid storage component, a liquid path system, a temperature control device, an optical detection system and a control system;
  • the main frame component comprises a bottom plate of the rack, and a pillar is arranged on the bottom plate of the rack, and a lower fixing plate and an upper fixing plate are sequentially arranged on the pillar from bottom to top;
  • the reaction disk member is disposed between the upper fixing plate and the lower fixing plate, and the annular array on the reaction disk member has four or more reaction holes for diluting the sample hole, the reagent hole, the light path permeability and the flat bottom, and the dilution.
  • the filling mechanism is disposed above the upper fixed plate for placing the reaction Extracting and filling the sample or reagent between the reagent ship holes in the tray component carrying groove;
  • the filling mechanism comprises an injector device, a filling needle, a filling needle moving device and a filling needle cleaning tank;
  • the washing mechanism is disposed above the upper fixing plate for washing the reaction hole of the reagent vessel placed in the bearing groove of the reaction disk component;
  • the washing mechanism comprises a liquid adding washing needle, a liquid discharging needle, and washing a needle moving device and a washing needle cleaning tank;
  • the liquid storage member is disposed on the bottom plate of the rack, and includes a cleaning liquid bottle for containing the cleaning liquid, a washing liquid bottle for containing the A washing liquid, and a washing liquid bottle for holding the B washing liquid a washing liquid bottle;
  • the liquid path system is connected to the liquid storage
  • the light emitter body comprises two sets of light-emitting lamps arranged side by side, the light source of the two sets of light-emitting lamps adopts an LED light source, an optical fiber is arranged at the front end of the LED light source, and a filter is arranged at the front end of the optical fiber, and the filter is arranged.
  • the front end of the light sheet is further provided with a collecting lens, wherein the two light emitting lamps have filters of different wavelengths; the light receiving body body comprises a collecting lens corresponding to the two light emitting lamps and a rear side of the collecting lens. Two light receivers.
  • the filling mechanism further includes: a first puncture needle and a second puncture needle; the refilling needle includes a first refilling needle and a second refilling needle; the refilling needle moving device includes a trolley a trolley rail fixedly mounted on the bottom of the trolley is fixedly mounted on the side of the trolley rail, and a trolley shifting component for driving the carriage horizontally along the trolley rail is disposed on a side of the trolley rail; wherein the trolley comprises a trolley bracket, The front side of the trolley bracket is vertically provided with a first needle guide rail, a second needle guide rail, a third needle guide rail and a fourth needle guide rail; the first filling needle, the second filling needle, the first puncture needle and the second The puncture needle passes through the first filling needle slider, the second filling needle slider, the first puncture needle slider and the second puncture needle slider, and the first needle guide, the second needle guide, the third needle guide and the first The four-needle guide is movablely engaged; the back of the trolley bracket is provided with a filling needle lifting
  • the washing mechanism comprises a first washing mechanism and a second washing mechanism having the same structure; the two washing mechanisms comprise: a liquid washing needle, a liquid washing needle, a washing needle moving device and a washing needle washing tank;
  • the washing needle moving device comprises a washing rack fixedly mounted on the upper fixing plate, a washing motor is arranged on the washing rack, a driving pulley is arranged on the washing motor shaft, and a driven belt is further arranged on the washing rack.
  • a timing belt is arranged between the driving pulley and the driven pulley;
  • a guiding rod is vertically arranged on the washing rack, and a washing needle for fixing the adding washing needle and the discharging washing needle is arranged on the guiding rod
  • a washing rail is provided with a guide rail parallel to the guide rod, and a slider is arranged on the guide rail, and the slider is provided with a belt clip fixedly connected with the timing belt, and the slider is driven to slide up and down with the operation of the timing belt, the slider
  • the upper protruding block is arranged, and the washing needle seat is matched with the clamping block.
  • the liquid path system includes a pipeline, a solenoid valve, and a washing pump for discharging the washing liquid in the washing liquid bottle and the washing liquid in the A washing liquid bottle to the liquid washing needle of the first washing unit, and is used for Connecting the draining washing needle of the first washing component to the pipeline and the draining pump in the main waste liquid tank, and discharging the waste liquid in the washing tank cleaning tank of the first washing component to the pipeline in the main waste liquid tank And discharging the washing liquid in the washing liquid bottle and the washing liquid in the B washing liquid bottle to the pipe, the electromagnetic valve, the washing pump discharged from the liquid washing washing needle of the second washing part, and the row for the second washing part
  • the liquid washing needle is connected to the pipeline and the drain pump in the main waste liquid tank, and the waste liquid in the washing tank cleaning tank of the second washing component is discharged to the pipeline in the main waste liquid tank for the cleaning liquid bottle
  • the cleaning liquid is pumped out to clean the filling mechanism injector device and the filling needle, the pipeline, the washing pump, the sole
  • the temperature control device is a disk-shaped electric heating plate corresponding to the reaction disk member.
  • the injector device of the filling mechanism is a piston driving device comprising a stepping motor and a screw of a package structure.
  • the upper fixing plate is provided with an item barcode identifying the handle of the reagent vessel, and the identification signal is sent to the built-in barcode identifier of the control system.
  • an encoder for sensing the rotation angle of the main shaft for the control system to provide movement information of the reaction disc member, and the encoder for controlling the operation state of the stepping motor is accurately positioned to accurately position the reaction disc member.
  • the instrument control circuit of the control system comprises a USB interface for establishing communication with the control host, and one to 10 sets of the automatic immune analyzer can be controlled by one control host.
  • a method for implementing immunoassay using the above-described fully automatic immunoassay analyzer comprising the following steps:
  • the sample to be tested is placed in the sample hole of the reagent ship, and the item information bar code corresponding to the sample is attached to the handle of the reagent ship;
  • the detection signals of the three online weighing sensing devices at the bottom of the liquid bottle calculate the consumption of the three working fluids, determine whether the washing process is working normally, and if the abnormal control system gives a warning reminder; after adding the last reagent, the dynamic method can be used. Immediately reading the absorbance value or after the reaction is completed, injecting a stop solution into the reaction well to terminate the reaction, and then reading the absorbance value by the end point method;
  • the reaction disk component rotates the reagent ship to the position corresponding to the optical detection system, and the optical detection system optically detects the substance in the reaction hole, and provides the detection result to the control system, and is controlled by The system processes, stores, and outputs.
  • the reagent is an antigen or antibody, an enzyme labeled antigen or an antibody, an enzyme chromogenic substrate, a diluent, an adsorption solution, and a stop solution, and the specific reagent type is set according to the requirements of the detection item, and the reagents are concentrated in a specific one.
  • One-time independent single-agent device is an antigen or antibody, an enzyme labeled antigen or an antibody, an enzyme chromogenic substrate, a diluent, an adsorption solution, and a stop solution, and the specific reagent type is set according to the requirements of the detection item, and the reagents are concentrated in a specific one.
  • One-time independent single-agent device is an antigen or antibody, an enzyme labeled antigen or an antibody, an enzyme chromogenic substrate, a diluent, an adsorption solution, and a stop solution, and the specific reagent type is set according to the requirements of the detection item, and the reagent
  • the invention has the beneficial effects that the novel immunoassay method and apparatus adopted by the invention use an independent, single-person, special-purpose, disposable reagent device with a unique structural shape and a matching reagent ship.
  • the dedicated automatic immunoassay analyzer has the following advantages compared with other immunoassay methods, reagent devices and analytical instruments:
  • the reagent and analytical device is an independent, single-agent detection reagent and analysis device. It is not necessary to use a 12 ⁇ 8 type, 8 ⁇ 12 type or full-plate type 96-well special enzyme-linked immunoplate as a general-purpose ELISA method.
  • the antigen-inhibiting or antibody-coated product and the reaction container can be tested for the corresponding item as long as there is one sample at the time of use without waste of the reagent. If the number of samples exceeds one, use the reagent and analytical device according to the actual number of samples.
  • the value of the barcode includes the test item code corresponding to each test, the test reagent production batch number, the reagent validity period, the qualitative detection correction coefficient, the quantitative measurement standard curve parameter, and the specific Information such as the type of enzyme-linked immunoreactor and the serial number of the reagent device cannot be changed at will, and it is strictly controlled during use. Especially when using the detection reagent over the expiration date, it will be identified and prevented from being sent out, thus ensuring accurate detection. Sex.
  • the detection process uses a fully automatic precision liquid applicator to fill the test reagent or sample.
  • the operation is automated, the amount is accurate, and the accuracy and precision of the test result. high.
  • two to four items of detection reagents can be placed, and one or two samples of one sample can be simultaneously tested, or one sample of one or three dilutions of the same item can be detected, or One sample is repeatedly tested 2 to 4 times in the same item.
  • the instrumental analysis method of fully automatic discrete enzyme-linked immunoassay is adopted in the detection operation, thereby realizing the automatic detection of the independent single item or group item of the enzyme-linked immunological project, and ensuring the usability of the detection;
  • the end point method is adopted. After the termination liquid is added and the reaction is stopped, the single main test optical path ensures the accuracy and stability of the detection and is less affected by the environment;
  • the rotary micro-vibration method is used to accelerate the mixed reaction liquid phase, promote the combination of the reaction molecules, so that the reaction time is greatly shortened, the detection speed is improved, the manual operation time is shortened, and the detection is ensured. Quickness and immediacy;
  • the instrument is equipped with a precise and complete temperature control system and reagent and liquid level detection system. It is sensitive and has high control precision. It ensures the enzyme-linked immunoassay to react under constant temperature and liquid phase conditions, which not only guarantees the test results. Repeatability ensures the accuracy of the test.
  • the present invention has the following beneficial effects as compared with the technical solution created by the Chinese invention patent of the patent application number: 201010042628.X:
  • a weight for monitoring the working fluid of each bottle body is provided, and the working fluid usage amount and the residual amount signal of each bottle body are provided to the control system.
  • the online weighing and sensing device realizes real-time and accurate monitoring of the storage volume and usage of the working fluid in the liquid storage component, and the reliability of the control is good, so that the quality of the washing is ensured, and can be found in time when the liquid system is faulty.
  • the optical detection system is a set, and the absorbance value can be read by dynamic method after adding the last reaction reagent to the reaction well, or the absorbance value can be read after adding the stop solution to the reaction well to stop the reaction, and before The number of optical detection systems required for triple optical readings and multiple data fitting analysis methods (requires three sets) is small.
  • the syringe driving device with the feeding mechanism of the set structure has good stability, small volume, low cost and long service life.
  • the heating plate is heated by the electric heating plate, the heating is uniform, no noise, and the thermal efficiency is high.
  • the filling mechanism increases the puncture needle dedicated to the puncture sealing film of the reagent ship without increasing the power component, so that the filling needle is specially used for the filling of the reagent or the sample, and the filling needle is improved. The life expectancy while improving the reliability of the puncture.
  • the washing mechanism adopts the gravity structure to adapt to the height of the bottom of the hole, and after the liquid discharging needle is bottomed, the downward force of the liquid discharging needle is increased without being moved downward of the slider, thereby avoiding damage of the washing needle and having a longer life. ,more reliable.
  • the main control software is installed on the external control host, and one control host can control 1 ⁇ 10 automatic immune analyzers through the USB interface. Users can flexibly configure the analyzer according to the sample size, thus fully satisfying the large and medium. The testing needs of small medical institutions.
  • Figure 1 is a schematic view of the overall structure of the present invention
  • Figure 2 is a schematic plan view showing the structure of the reaction disk member of the present invention.
  • Figure 3 is a schematic cross-sectional view of the A-A of Figure 2;
  • Figure 4 is a schematic cross-sectional structural view of a reagent ship of the present invention.
  • Figure 5 is a schematic view showing the structure of the reagent ship of the present invention before being placed in the carrying groove of the reaction disk member;
  • Figure 6 is a schematic view showing the structure of the reagent ship of the present invention after the operation of the carrying tank placed on the reaction disk member is completed;
  • Figure 7 is a front perspective view showing the filling mechanism of the present invention.
  • Figure 8 is a perspective view showing the back side of the filling mechanism of the present invention.
  • Figure 9 is a perspective view showing the structure of one of the washing mechanisms of the present invention.
  • Figure 10 is a schematic structural view of an optical detecting system of the present invention.
  • Figure 11 is a schematic view showing the installation structure of the electric heating plate of the present invention.
  • Figure 12 is a schematic structural view of a liquid path system of the present invention.
  • Figure 13 is a block diagram of a control system of the present invention.
  • the main frame member 1, the reaction disk member 2, the reagent ship 3, the filling mechanism 4, the washing mechanism 5, the liquid storage member 6, the liquid path system 7, and the temperature control device 8 are included.
  • the main frame member 1 includes a rack bottom plate 11 on which a pillar 12 is disposed, and a lower fixing plate 13 and an upper fixing plate 14 are sequentially disposed on the pillar 12 from bottom to top.
  • the reaction disk member 2 is disposed on the upper fixing plate 14 Between the lower fixing plate 13 and the lower fixing plate 13, the reaction disk member 2 is a circular disk-shaped structure, and four or more annular arrays (illustrated by 30 in the drawing) are used for the carding reagent boat 3
  • the carrying tank 21 is fastened to the loading tank 21 of the reaction disk unit 2.
  • the front end groove wall of the carrying groove 21 is provided with a slider 23 for clamping the reagent ship, a spring 24 for applying an elastic force to the slider 23, and a lock pin 25 for preventing the slider from coming off.
  • a reaction disk drive member 22 for driving the rotation of the reaction disk member 2 is fixedly disposed below the lower fixing plate 13.
  • the reaction disk drive unit 22 includes a main shaft 221 fixedly coupled to the center of the reaction disk unit 2, and the main shaft 221 is coupled to the lower fixed plate 13 via a bearing 222 and a spindle holder 223, and a driven pulley 224 is disposed on the main shaft 221.
  • a motor bracket 225 fixedly mounted to the lower fixing plate 13 is disposed on a side of the main shaft base 223.
  • a stepping motor 226 is disposed in the motor bracket 225, and a motor shaft 2261 of the stepping motor 226 is provided with a stepping motor 226
  • the driving pulley 227 is provided with a synchronous toothed belt 228 between the driving pulley 227 and the driven pulley 224, and a pulley tensioner 2261 is provided on the motor bracket 225.
  • Also provided on the bottom end of the main shaft 221 is an encoder 229 for sensing the rotation angle of the main shaft 221 for the control system to provide movement information of the reaction disk unit 2, and for controlling the operation state of the stepping motor 226 by the control system.
  • the reagent vessel 3 includes a base 31 and a handle 32 at one end of the base.
  • the substrate 31 is provided with a sample hole 311, five reagent holes 312, a reaction hole 313 and a dilution hole 314.
  • the bottom of the reaction hole 313 is a flat bottom of the optical path permeability; that is, the bottom of the hole is not contained.
  • the absorbance value for visible light/ultraviolet light/fluorescence approaches zero.
  • the item barcode is attached to the handle 32, and the item barcode information includes: detection item code of the detection reagent, detection reagent production batch number, reagent validity period, qualitative detection correction coefficient, quantitative measurement standard curve parameter, specific enzyme-linked immunoreaction type, reagent device Serial number, etc.
  • the filling mechanism 4 is disposed above the upper fixing plate 14 for the sample or reagent between the reagent vessels 3 placed in the reaction tray member carrying groove 21.
  • the filling mechanism 4 includes an injector device 41, a filling needle 42 and 43, a filling needle moving device 46, and a filling needle cleaning tank 47; and the existing filling mechanism further includes The first puncture needle 44 and the second puncture needle 45.
  • the syringe device 41 is configured by assembling a conventional syringe syringe, a stepping motor, a screw rod and a position sensor, and is integrated into a plunger, a screw rod and a motor shaft, and has high precision and small error. Lifetime indicators are improved by ten to tens of times, allowing more accurate use of reagents, saving costs, and reducing the volume to one-fifth of the original volume without maintenance and repair.
  • the filling needle includes a first filling needle 42 and a second filling needle 43; the filling needle moving device 46 is used for the first filling needle 42, the second filling needle 43, and the first The puncture needle 44 and the second puncture needle 45 perform a horizontal or vertical movement operation to achieve puncture of the sealing film of the reagent ship 3, and filling of the sample or the reagent.
  • the filling needle moving device 46 includes a trolley 461, and a trolley rail 462 fixedly mounted to the upper fixing plate 14 is disposed at the bottom of the trolley 461, and a sliding block of the driving pulley 461 horizontally moving along the trolley rail 462 is disposed at a side of the trolley rail 462.
  • the combination of the position member 463, i.e., the trolley guide 462 and the pulley shifting member 463, enables horizontal movement of the trolley 461.
  • the trolley 461 includes a trolley bracket 4611, and a first needle rail 4612, a second needle rail 4613, a third needle rail 4614 and a fourth needle rail 4615 are vertically disposed on the front surface of the pulley bracket 4611;
  • a filling needle 42, a second filling needle 43, a first puncture needle 44 and a second puncture needle 45 respectively pass the first filling needle slider 4616, the second filling needle slider 4617, and the first puncture needle slider.
  • 4618 and the second puncture needle slider 4619 are movably engaged with the first needle guide 4612, the second needle guide 4613, the third needle guide 4614, and the fourth needle guide 4615; and are arranged on the back of the pulley bracket 4611 for alternately moving up and down.
  • the needle lifting drive device 4620 includes a needle moving motor 46201 mounted on the pulley bracket 4611.
  • the needle moving motor 46201 is provided with a needle moving active pulley on the shaft, and a needle moving belt is disposed on the pulley bracket 4611.
  • the wheel 46203 is provided with a needle shifting belt 46204 between the needle moving pulley and the needle moving pulley 46203.
  • the needle timing belt 46204 is a belt with a toothed belt, and the needle timing belt 46204 A belt clip is fixedly connected between the two sides of the first filling needle slider 4616 and the second filling needle slider 4617, and the first filling needle 42 and the second filling needle 43 are simultaneously controlled by a needle moving motor 46201.
  • the needle moving motor 46201 When the needle moving motor 46201 is in operation, the first filling needle 42 and the second filling needle 43 move in opposite directions, for example, when the first filling needle 42 is lifted to the highest position, the second filling needle 43 is lowered to the lowest position, Conversely, when the first filling needle 42 is lowered to the lowest position, the second filling needle 43 is raised to the highest position.
  • the puncture needle lifting driving device 4621 has the same structure as the filling needle lifting driving device 4620.
  • the two sides of the needle moving timing belt 46214 of the puncture needle lifting driving device 4621 are respectively slid with the first puncture needle slider 4618 and the second puncture needle.
  • a band clamp is fixedly connected between the blocks 4619, and the first puncture needle 44 and the second puncture needle 45 are alternately controlled to move up and down by the needle moving motor 46211.
  • the pulley shifting member 463 includes a pulley motor 4631 fixedly mounted to the upper fixing plate 14, and a pulley passive pulley 4633 disposed on the upper fixing plate 14.
  • the pulley driving motor belt 4631 is provided with a pulley driving pulley 4632.
  • a pulley timing belt 4634 is disposed between the pulley driving pulley 4632 and the pulley passive pulley 4633.
  • the pulley timing belt 4634 is fixedly connected to the bottom of the pulley bracket 4611 by the belt clamp, and the moving pulley is controlled by the pulley motor 4631.
  • the washing mechanism 5, 5' includes a first washing mechanism 5 and a second washing mechanism 5' having the same structure.
  • the first washing mechanism 5 will be described in detail as an example.
  • the first washing mechanism 5 includes a liquid adding washing needle 51, a liquid discharging washing needle 52, a washing needle moving device 53, and a washing needle washing tank 54.
  • the washing needle moving device 53 includes a washing frame 531 fixedly mounted on the upper fixing plate 14, a washing motor 532 is disposed on the washing frame 531, and a driving pulley 533 is disposed on the washing motor 532 shaft.
  • the carrier 531 is further provided with a driven pulley 534.
  • a timing belt 535 is disposed between the driving pulley 533 and the driven pulley 534.
  • a guiding rod 536 is vertically disposed on the washing frame 531, and a movable sleeve is arranged on the guiding rod 536.
  • washing needle holder 537 for fixing the liquid adding washing needle 51 and the liquid discharging washing needle 52;
  • the washing frame 531 is provided with a guide rail 538 parallel to the guiding rod 536, and the sliding rail 539 is provided on the guide rail 538, and the slider 539 is provided thereon.
  • a belt clip 5391 which is fixedly connected with the timing belt 535 and drives the slider 539 to slide up and down with the operation of the timing belt 535.
  • the slider 539 is provided with an upwardly convex block 5392, and the cleaning needle holder 537 is provided with a card.
  • the block 5392 cooperates, and as the slider 539 rises, it rises with the slider 539, thereby lifting the liquid addition washing needle 51 and the liquid discharge washing needle 52 upward, and when the slider 539 is lowered, the gravity of the washing needle holder 537 itself
  • the free-falling card slot 5371 that is, the dosing washing needle 51 and the draining washing needle 52, is passed through the needle holder 537.
  • the pressing force of the slider 539 is released, and since the height of the liquid discharging needle 52 is lower than that of the liquid adding needle 51, the washing liquid is discharged to the bottom by the liquid discharging needle 52 during washing.
  • the structure effectively extends the life of the drainage washing needle 52.
  • the liquid storage component 6 is disposed on the bottom plate 11 of the rack, and includes a cleaning liquid bottle 61, an A washing liquid bottle 62, and a B washing liquid bottle 63; a cleaning liquid bottle 61 and an A washing liquid bottle.
  • the 62 and B washing liquid bottles 63 are three separate and independent bottles.
  • One of the bottles of the cleaning liquid bottle 61, the A washing liquid bottle 62 and the B washing liquid bottle 63 is provided for monitoring each of the bottles 61 and 62.
  • the weight of the working fluid in 63, the online weighing sensing device 631 (only an online weighing sensing device is shown in the figure) that provides the working fluid usage and residual signal of each bottle to the control system, realizing accurate monitoring in real time.
  • the storage amount and usage amount of the working fluid in the liquid storage member 6 are good in reliability, so that the quality of the washing is ensured, and can be found in time when the liquid system is malfunctioning.
  • the liquid path system 7 is connected to a liquid storage member 6, a washing mechanism 5 and a filling mechanism 4 for conveying the working fluid in the liquid storage member 6 to the washing mechanism 5 and Note mechanism 4.
  • the liquid path system 7 includes a line for discharging the cleaning liquid in the cleaning liquid bottle 61 and the washing liquid in the A cleaning liquid bottle 62 to the liquid filling washing needle 51 of the first washing member, the solenoid valve 71, and the washing pump. 72.
  • the pipeline for draining the liquid to the main waste liquid tank 73 and the drain pump 74 are connected to the liquid discharge washing needle 52 of the first washing unit, and discharging the waste liquid in the first washing unit washing needle cleaning tank 54 to
  • the piping in the main waste liquid tank 73 extracts the washing liquid in the cleaning liquid bottle 61 and the washing liquid in the B washing liquid bottle 63 to the piping and solenoid valve discharged from the liquid filling washing needle 51' of the second washing unit.
  • the waste liquid in the washing member washing needle cleaning tank 54' is discharged to the piping in the main waste liquid tank (73) for extracting the cleaning liquid in the cleaning liquid bottle 61 for cleaning the filling mechanism injector device 41 and filling
  • the main waste liquid tank 73 is also connected with a waste liquid tank 712, and a drain pump 713 and a pipeline are disposed between the main waste liquid tank 73 and the waste liquid tank 712.
  • the temperature control device 8 is disposed below the reaction disk member 2 for heating the reaction disk member 2, that is, heating the reaction vessel 3 reaction well to provide a sample.
  • the temperature environment required for the reaction employs a disk-shaped electric heating plate having a shape corresponding to the bearing groove of the reaction disk member.
  • the optical detecting system 9 includes a light emitter body 91 and a light receiver body 92.
  • the light emitter body is also disposed above the upper fixing plate, and the light receiver body corresponds to It is disposed under the reaction plate member for optical detection of the reaction hole J of the reagent ship;
  • each of the light emitter bodies 91 includes two sets of illuminating lamps arranged side by side, and the two sets of illuminating lamps each include an LED light source 911.
  • An optical fiber 912 is disposed at a front end of the LED light source 911, and a filter 913 is disposed at a front end of the optical fiber 912.
  • the front end of the optical filter 913 is further provided with a collecting lens 914, wherein the two luminous lamps have filters of different wavelengths;
  • the light receiver body 92 includes a condensing lens 921 corresponding to two illuminating lamps and two light receivers 922 disposed at the rear of the condensing lens. During use, the light emitter body 91 and the light receiver body 92 are moved as needed to cause the corresponding light-emitting lamp and light receiver to correspond to the reaction holes 313, and the substances in the reaction holes 313 of the reagent ship are optically detected.
  • the optical detection system 9 converts the existing halogen lamp into an LED light source, and has stable illumination, is not easy to be attenuated, and has a long calibration period.
  • the calibration is simple, the consumption time is short, the damage is not easy, and the life is long.
  • the heat generation is greatly reduced and energy saving.
  • the detection work which originally required three optical detection systems 9 can be completed by only one optical detection system, 9 is saved, and the cost is saved; It is originally an optical detection system that transmits light from one light source to three different positions through optical fiber. A total of six optical channels are required, each fiber length is inconsistent, the channel length is long, there are channel differences, the structure is complex, the stability is poor, and the environment is affected. The influence is large, and the present invention completely solves the above problems.
  • the built-in barcode identifier 10 is disposed on the upper fixing plate 14 for identifying the barcode attached to the handle of the reagent vessel, and transmitting the identification signal to the control system to realize the detection result and The sample information is automatically output.
  • the control system includes an instrument control circuit and embedded software written in the instrument control circuit, and the instrument control circuit includes a USB interface and communicates with the control host through the USB interface;
  • the optical detection system 9 and the built-in barcode identifier 10 are connected to the control host through the instrument control circuit, and perform control operations according to the program instructions of the embedded software.
  • the embedded software simultaneously accepts the sensing information input and receiving optical detection system of all components.
  • the bar code identifier 10 detects the information and performs data processing according to the program of the embedded software; performs operation operations such as operation input, display output, and printing in the control host through the USB interface.
  • the method for realizing immunodetection by using the above automatic immunoassay analyzer comprises the following steps:
  • the sample to be tested is placed in the sample hole of the reagent ship, and the item information bar code corresponding to the sample is attached to the handle of the reagent ship;
  • the detection signals of the three online weighing sensing devices at the bottom of the liquid bottle calculate the consumption of the three working fluids to determine whether the washing process is working normally, and if the abnormal control system performs a warning reminder.
  • the absorbance value can be read immediately by dynamic method or after the reaction is completed, the reaction solution is injected into the reaction well to terminate the reaction, and then the absorbance value is read by the end point method;
  • the reaction disk component rotates the reagent ship to the position corresponding to the optical detection system, and the optical detection system optically detects the substance in the reaction hole, and provides the detection result to the control system, and is controlled by The system processes, stores, and outputs.
  • the reagent is an antigen or antibody, an enzyme labeled antigen or an antibody, an enzyme chromogenic substrate, a diluent, an adsorption solution, and a stop solution, and the specific reagent type is set according to the requirements of the detection item, and the reagents are concentrated in a specific one.
  • One-time independent single-agent device is an antigen or antibody, an enzyme labeled antigen or an antibody, an enzyme chromogenic substrate, a diluent, an adsorption solution, and a stop solution, and the specific reagent type is set according to the requirements of the detection item, and the reagents are concentrated in a specific one.
  • One-time independent single-agent device is an antigen or antibody, an enzyme labeled antigen or an antibody, an enzyme chromogenic substrate, a diluent, an adsorption solution, and a stop solution, and the specific reagent type is set according to the requirements of the detection item, and the reagent

Abstract

一种用于对生物样品分析的全自动免疫分析仪及其检测方法。该分析仪所包括的储液部件（6）的清洗液瓶（61）、A洗涤液瓶（62）及B洗涤液瓶（63）为三个独立的瓶体，在清洗液瓶（61）、A洗涤液瓶（62）及B洗涤液瓶（63）的瓶底部各设有一个用于监控各瓶体内工作液的重量，向控制系统提供各瓶体工作液使用量及余量信号的在线称重感应装置（631）。解决了现有全自动免疫分析仪所存在的应用液位电阻感应原理来检测液体存储量，可靠性差的技术缺陷。实现了实时精确地监测在储液部件内的工作液储存量及使用量，控制的可靠性好，使洗涤的质量得到保障，在液路系统出现故障时能及时发现。

Description

一种全自动免疫分析仪及其检测方法
技术领域
本发明涉及一种全自动免疫分析仪及其检测方法。该方法和仪器主要用于对生物样品如人体样品血清、痰液、尿液、粪便、胆汁等中的抗原物质如各种病原微生物的抗原，或由这些病原微生物抗原感染机体而产生的抗体，以及自身免疫性疾病如系统性红斑狼疮、磷脂综合征、类风湿关节炎、硬皮病、自身免疫性肝病、干燥综合征、系统性血管炎、多发性肌炎和皮肌炎、自身免疫性甲状腺疾病和胃肠病等疾病患者血液中的自身抗体，以及肿瘤标志物等其他免疫指标，以酶联免疫方法进行定量测定或定性检测。
背景技术
酶联免疫检测作为诸多免疫分析技术中的一种方法，现已广泛用于临床医学、动物检疫、食品科学、植物病毒、药物残留、病虫害防治等分析领域。这种方法具有高度的特异性和敏感性，几乎所有的可溶性抗原—抗体系统都可以用其来进行检测，它的最小检测值可达到ng甚至pg水平。与放射免疫测定比较，酶联免疫测定的优点是标记物稳定且无放射性危害；与免疫荧光测定比较，酶联免疫测定对结果判定更客观。
目前，商品化的酶联免疫测定项目或试剂的类别包括临床医学检测中病原体的抗原或抗体、蛋白质、非肽类激素、药物，食品检测中的食品微生物、微生物毒素、残留农药、食物组份，水产品检测中的药物残留、毒素、微生物、转基因产品，以及植物病毒检测、动物检疫中各种病原体检测、农药残留检测、兽药残留检测等。
在酶联免疫检测中，完整的ELISA检测试剂盒应包括包被好的固相载体、酶结合物、显色底物、反应终止液、各种稀释液和缓冲液，以及检测中所用的标准液、校正液、阳性质控物或对照血清、阴性控质控物或对照血清等。由于酶联免疫方法在检测中需要使用多种试剂，并且这些试剂是根据试验反应的需要依次加入的，同时还须对检测反应板的微孔进行多次洗涤，因而手工操作较为繁琐。为了简化操作，尤其是简化加注检测样品和检测试剂以及洗涤过程中反复加注和吸弃洗涤液的繁琐操作，目前研制出多种用于酶联免疫测定的仪器。
针对酶联免疫检测中加注样品、试剂、洗涤和判读显色反应结果四项繁琐操作，现有技术——酶联免疫分析仪分别采用分离式和组合式两类方法来进行处理。
分离式酶联免疫仪器主要有酶标仪和洗板机，它们经过加样、加试剂、孵育、洗涤等过程，最后通过吸光度分析来判定结果。酶标仪本质上是一种专用于微孔板吸光度测定用的可见光光电比色计，实验室常用品牌及型号分别有LABSYSTEMS公司的MK3、TECAN公司的SPECTR ACLASSIC、BIOTEK公司的Elx800、CLINIBIO公司的128c、ANTHOS公司的2010、航天283厂的CF5000、上海安泰公司的Anayech 828、上海迅达公司的XD711，以及BIORAD公司的450、550、Benchmark、Utramark等。洗板机本质上则是一种专用于微孔板洗涤液的加注与吸弃机，实验室常用的品牌及型号分别有上海安泰公司的AT-828型、深圳汇松公司的PW-960型、深圳凯特公司的KWP-100型、北京普朗技术公司的DNX-962型等。凡是开展酶联免疫检测的实验室大都配备了酶标仪及洗板机，它们是实验室必备的重要仪器之一。这些酶标仪的配备，不仅使酶联免疫检测中的吸光度测定简便化和高速化，整板12×8孔，8×12孔高达10秒以内，而且具有较宽的吸光度测量范围A=0～6.0，并有配备340nm滤光片，将光谱检测扩展到紫外光区间。同时还具有孵育功能和动力学检测功能，极大地推动和促进了酶联免疫检测技术的广泛应用。与酶标仪一样，洗板机的配备不仅简化了酶联免疫检测中繁琐的洗涤操作，除了具有设置清洗次数、清洗微孔板条数、设定浸泡时间等基本功能之外，还具备了底部冲洗、两点吸液、板式/条式洗板、震荡、位置调节、自动清洗管路、自动换液、存储多种洗涤程序等功能，充分保证了试验洗涤的效果，从而保证了实验检测的便捷化、快速化及洗涤的质量。
组合式酶联免疫分析仪分为三类：全自动酶联免疫分析系统、自动样品处理系统、流水线作业式酶联免疫组合系统。全自动酶联免疫分析系统是将酶联免疫实验中的各个步骤，从加样、加试剂、孵育、洗涤、震荡、比色到定性或定量分析、报告存储与打印功能全部集中到一台仪器之中，由仪器按各种类型酶联免疫反应或客户事先设计的程序来自动进行。在全自动酶联免疫分析系统中，目前实验室常用的品牌及型号有HAMILTON公司的FAME、BIORAD公司的CAA、澳斯邦公司的AMP、TECAN公司的Minilyeser、ORGANO公司的TEKTIME、DIVISION STRUMENTI公司的Personal LAB、DYNDRX公司的DSX、阿克苏公司的Flex Tek2、BIOASIA公司的TRIURUS等。自动样品处理系统主要用于完成酶联免疫实验中操作繁琐、人工容易出错的加样、加试剂、稀释、滴定、孵育、洗涤等步骤，完成之后由酶标仪判定结果，实验室常用的品牌及型号有TECAN公司的MINITRED、HYPERION公司的HYPREPTLUS、DYNEX公司的DLAS Ultra等。流水线作业式酶联免疫组合系统是根据酶联免疫反应需要的过程和条件，将液体加取系统模块、恒温孵育模块、洗板系统模块和结果判读系统模块，按照酶联免疫反应的类型与步骤进行设计与布局，用轨道将这些系统模块串联起来，各系统模块在系统计算机的调控下既能各自独立完成任务，还可以统一协作，共同完成反应过程。实验室常用品牌及型号的技术原型可见流水线式全自动酶联免疫工作站发明专利公开号CN101303350A和全自动酶联免疫分析系统发明专利公开号CN1885037A等。
为了适用酶联免疫检测技术的特殊需要，微板式酶联免疫分析仪新近又在各个方面有了一些新的发展，例如从96孔模式向384孔、1536孔模式发展，现已由LABSYSTEMS公司和BIOTEK公司推出可测量384孔微孔板的酶标仪和由BIORAD公司推出的Ultramark可以测量384孔、1536孔微孔板，同时针对384孔和1536孔微孔板的洗板机也已研制问世；可放置多达10种波长滤光片和采用光栅分光原理的酶标仪已经问世，使得分析波长范围更宽、波长准确性和重复性、测量准确性和重复性、线性度、测量速度等技术性能更为优秀。这些新方法、新技术、新形式、新结构、新装置的推出，极大地促进了酶联免疫检测的应用，从而使酶联免疫检测成为应用范围最广、使用客户最多、应用量最大、市场占有率最高的一种免疫检测技术。
然而，尽管基于微孔板式酶联免疫分析方法及仪器与酶联免疫原型技术比较起来取得了众多方面的长足发展与进步，但在实际使用中仍然存在较多不足、问题或局限，这些不足、问题和局限归纳起来主要有以下几个方面：
1、使用12×8型、8×12型、整板型96孔或96孔倍数专用微孔板作为抗原或抗体包被用品和反应容器，在使用时只能分成12批次、8批次或整板一次使用。如果分批次使用，则不能采用通用洗板机来洗板而只能一孔一孔地加注和吸弃洗涤液来进行反应孔的洗涤，操作极为繁琐，而且一批次检测/试验样品数最少要达到8份或12份，否则会造成试剂的浪费。如果整板一次性使用，则检测/试验样品数要达到96份或96份倍数份，否则也会造成试剂的浪费。
2、定性检测的试剂至少包括样品稀释液、洗涤液、酶结合物、酶反应底物、显色剂、终止液、阳性对照血清、阴性对照血清共计8种，定量的试剂则至少包括稀释液、洗涤液、酶结合物、酶反应底物、显色剂、终止液、至少5个水平的标准品或校准品共计11种，每一种检测试剂都要用试剂瓶来盛装，并且每使用一种试剂时都需要更换吸液嘴来分别加注样品、试剂、洗涤液到反应的容器——微孔板的微孔中，不但试剂瓶种类和数量很多，而且加注试剂的操作也极为繁琐，即使使用全自动酶免分析仪或改变每一种试剂的装量，所使用的试剂的种类数也不能减少。
3、在客户对检测项目成套试剂的数量配置及使用上均为项目数×96人份，如果需要检测10个项目，则试剂的配置及使用数须为10×96人份，如果只有一份样品需要检测10个不同的项目，也需要配置10×96人份的试剂。
4、检测试剂和样品在检测过程中为开放方式，容易引起各种试剂之间或各样品之间的交叉污染而影响检测结果或直接影响操作者。
5、一种检测试剂只能检测一个项目，如果要检测二个或三个项目，则需要三种不同的检测试剂或试剂盒，并分别进行检测操作。
6、对每一反应孔有色溶液之色泽在选择单波长法时仅进行一次光学读数，在双波长法时则选择另一种波长的滤光片再进行一次光学读数，不能对同一反应孔有色溶液之色泽在不同时点进行两次或两次以上的光学读数。
7、采用批量洗涤的方式，即对一块微孔板一次加注或吸弃2孔、4孔、8孔、12孔、或96孔洗涤液，不能单独分批次加注或吸弃洗涤液。
8、只能进行单个项目的检测，或同时不能检测多个项目。
9、每一检测或每次检测无试剂信息的条形码，或条码信息不全面，或条码信息仅为试剂盒的信息，只能通过查看试剂盒外包装盒的标识才能了解或知悉检测试剂的生产批号及有效期信息，而且所知悉的信息在检测过程中不受控，具有很大的随意性。
10、仪器加样、加工作液/试剂、吸液系统为直线性结构，直线移动或行走。
11、无液体混合/混匀等机械电子结构及其控制系统。
12、检测项目视所用试剂的不同而不同，且任意选择和使用。
13、检测方法均为传统ELISA法，由所选择的试剂决定。
14、不能即时根据样品情况进行单项目或多项目的检测。
虽然，本申请人2010-01-04提出的中国发明专利，专利申请号：201010042628.X，解决了上述技术问题，但是该发明创造仍然还存在一些不足，比如：1、在储液部件内设有液位传感器，采用的是4位液位电阻感应原理，用以检测液体存储量，可靠性差，无法稳定精确地得知工作液的使用量，洗涤效果质量得不到保障；2、光学检测系统采用的动态检测法需要有三套光学检测系统，6条光通道检测，改变了光在光纤中的传输方向，连接三套光学检测系统的纤长度不一致，存在光通道差异，稳定性差，受环境影响大，成本高；3、液路系统复杂，需要的电磁阀、洗涤泵数量多，成本也就高；4、加注机构的注射器驱动装置是在下固定板的底面安装步进电机和螺杆而成，稳定性差，寿命短；5、加注机构的加注针同时承担穿刺和加注工作，穿刺可靠性差，加注针寿命短；6、洗涤机构的洗涤针采用弹簧结构适应孔底高度，由于弹簧压缩作用力为直线上升，作用力随压缩行程的增加而增加，洗涤针容易损坏，寿命短；7、采用热风加热器对反应盘局部进行加热，存在加热不均匀，噪音大，热效率低等技术缺陷。
发明内容
本发明的主要目的在于解决现有全自动免疫分析仪存在着液位电阻感应原理，用以检测液体存储量，可靠性差，无法进行稳定精确地得知工作液的使用量，洗涤效果质量得不到保障的技术缺陷，而提出的一种全自动免疫分析仪及其检测方法。
为解决本发明所提出的技术问题，采用的技术方案为：一种全自动免疫分析仪，包括有：主机架部件、反应盘部件、加注机构、洗涤机构、储液部件、液路系统、温控装置、光学检测系统及控制系统；所述的主机架部件包括机架底板，在机架底板上设有支柱，在支柱上从下往上依次设有下固定板和上固定板；所述的反应盘部件设于上固定板和下固定板之间，反应盘部件上环形阵列有四个以上的用于卡放由样品孔、试剂孔、光路通透性且平底的反应孔及稀释孔构成的试剂船的承载槽，在下固定板的下方与其固定设有用于驱动反应盘部件旋转的反应盘驱动部件；所述的加注机构设于上固定板的上方，用于对放置在反应盘部件承载槽中的试剂船孔间样本或试剂的吸取及加注；所述加注机构包括有注射器装置、加注针、加注针移动装置及加注针清洗槽；所述的洗涤机构设于上固定板的上方，用于对放置在反应盘部件的承载槽中的试剂船的反应孔进行洗涤；所述的洗涤机构包括有加液洗涤针、排液洗涤针、洗涤针移动装置及洗涤针清洗槽；所述的储液部件设于机架底板上，包括有用于盛装清洗液的清洗液瓶、用于盛装A洗涤液的洗涤液瓶和用于盛装B洗涤液的洗涤液瓶；所述的液路系统连接储液部件、洗涤机构和加注机构，用于将储液部件中的各工作液输送到洗涤机构和加注机构；所述的温控装置设于反应盘部件的下方，用于对反应盘部件卡放的试剂船进行加热；所述的光学检测系统包括有光发射器体和光接受器体，所述光发射器体设于上固定板的上方，所述光接受器体设于反应盘部件下方与光发射器体相对应的位置，用于对卡放在反应盘承载槽中的试剂船反应孔中的物质进行光学检测；所述的控制系统包括有仪器控制电路以及写入在仪器控制电路内的嵌入式软件，所述的反应盘部件的反应盘驱动部件、加注机构的加注针移动装置、洗涤机构的洗涤针移动装置、液路系统的各洗涤泵和电磁阀、温控装置、光学检测系统与仪器控制电路，根据嵌入式软件的程序指令进行控制运作；所述的储液部件的清洗液瓶、A洗涤液瓶及B洗涤液瓶为三个独立的瓶体，在清洗液瓶、A洗涤液瓶及B洗涤液瓶的瓶底部各设有一个用于监控各瓶体内工作液的重量，向控制系统提供各瓶体工作液使用量及余量信号的在线称重感应装置。
所述的光发射器体包括有并排设置的两组发光灯，两组发光灯的光源均采用的是LED光源，在LED光源的前端设有光纤，在光纤的前端设有滤光片，滤光片的前端还设有聚光镜片，其中两个发光灯具有不同波长的滤光片；所述的光接受器体包含有与两个发光灯相对应的聚光镜片和设于聚光镜片的后方的两个光接收器。
所述加注机构还包括有：第一穿刺针和第二穿刺针；所述的加注针包括有第一加注针和第二加注针；所述的加注针移动装置包括有滑车，在滑车底部设有与上固定板固定安装的滑车导轨，在滑车导轨的侧边设有驱动滑车沿滑车导轨水平移动的滑车移位部件；其中，所述的滑车包括有一个滑车支架，在滑车支架的正面竖直设有第一针导轨、第二针导轨、第三针导轨及第四针导轨；所述的第一加注针、第二加注针、第一穿刺针和第二穿刺针分别通过第一加注针滑块、第二加注针滑块、第一穿刺针滑块和第二穿刺针滑块与第一针导轨、第二针导轨、第三针导轨及第四针导轨活动卡接；在滑车支架的背面设有用于上下交替移动第一加注针和第二加注针的加注针提升驱动装置和用于上下交替移动第一穿刺针和第二穿刺针的穿刺针提升驱动装置；所述的加注针提升驱动装置包括有安装于滑车支架上的移针电机，移针电机的轴上设有移针主动带轮，在滑车支架上设有移针被动带轮，在移针主动带轮与移针被动带轮之间设有移针同步带，移针同步带的两侧分别与第一加注针滑块和第二加注针滑块间固定连接有带夹；所述的穿刺针提升驱动装置与加注针提升驱动装置结构相同，穿刺针提升驱动装置的移针同步带的两侧分别与第一穿刺针滑块和第二穿刺针滑块间固定连接有带夹；其中，所述的滑车移位部件包括有与上固定板固定安装的滑车电机，以及设于上固定板上的滑车被动带轮，滑车电机的轴上设有滑车主动带轮，滑车主动带轮与滑车被动带轮之间设有滑车同步带，滑车同步带通过带夹与滑车支架的底部固定连接。
所述的洗涤机构、包括有结构相同的第一洗涤机构和第二洗涤机构；两组洗涤机构、均包括有：加液洗涤针、排液洗涤针、洗涤针移动装置及洗涤针清洗槽；所述的洗涤针移动装置包括有一个固定安装在上固定板上的洗涤架，在洗涤架上设有洗涤电机，在洗涤电机轴上设有主动带轮，在洗涤架上还设有从动带轮，在主动带轮与从动带轮之间设有同步带；在洗涤架竖直设有导杆，在导杆上活动套有用于固定加液洗涤针和排液洗涤针的洗涤针座；在洗涤架设有与导杆平行的导轨，在导轨上设有滑块，滑块上设有一个与同步带固定连接，随同步带的运转而带动滑块上下滑动的带夹，滑块设有向上凸起的卡块，洗涤针座上设有与卡块相配合，在滑块上升时，随滑块而上升将加液洗涤针和排液洗涤针抬起，在滑块下降时，随洗涤针座自身重力自由下落的卡槽。
所述的液路系统包括有将清洗液瓶中的清洗液、A洗涤液瓶中的洗涤液抽出至第一洗涤部件的注液洗涤针中排出的管路、电磁阀、洗涤泵，用于与第一洗涤部件的排液洗涤针连接排液至主废液槽中的管路、排液泵，将第一洗涤部件洗涤针清洗槽中的废液排至主废液槽中的管路，将清洗液瓶中的清洗液、B洗涤液瓶中的洗涤液抽出至第二洗涤部件的注液洗涤针中排出的管路、电磁阀、洗涤泵，用于与第二洗涤部件的排液洗涤针连接排液至主废液槽中的管路、排液泵，将第二洗涤部件洗涤针清洗槽中的废液排至主废液槽中的管路，用于将清洗液瓶中的清洗液抽出用来清洗加注机构注射器装置和加注针、的管路、洗涤泵、电磁阀以及用于将清洗加注机构的加注针洗涤槽中废液排至主废液槽中的管路。
所述的温控装置为一块与反应盘部件相对应的盘状电热板。
所述的加注机构的注射器装置是采用封装结构的步进电机和螺杆构成的活塞驱动装置。
所述的上固定板上设有对试剂船的手柄上的项目条码进行识别，并将识别信号输送给控制系统的内置条码识别器。
在主轴的底端上设有一个用于感应主轴旋转角度为控制系统提供反应盘部件移动信息，并由控制系统控制步进电机运转状态的编码器对反应盘部件进行精确定位。
所述的控制系统的仪器控制电路包含有与控制主机建立通讯的USB接口，可通过1台控制主机控制1~10台所述全自动免疫分析仪运行。
一种应用上述全自动免疫分析仪实现免疫检测的方法，该方法包括有如下步骤：
1、将待测样品放入试剂船的样品孔中，试剂船的手柄上贴有与样品相对应的项目信息条码；
2、将试剂船卡放在反应盘部件的承载槽中；
3、启动控制系统，反应盘部件运转，将试剂船旋转至加注机构对应的位置，由加注机构将样品孔中的样品加注到稀释孔中，将其中的一个试剂孔中的稀释液加入到稀释孔中进行稀释后再注入到反应孔中，按照控制系统预设条件进行反应及洗涤，洗涤过程中，控制系统根据洗涤之前和洗涤之后，清洗液瓶、A洗涤液瓶及B洗涤液瓶的瓶底的三个在线称重感应装置的检测信号计算三种工作液消耗量，判定洗涤过程是否正常工作，若非正常控制系统进行警告提醒；加入最后一种试剂后，可采用动态法立即读取吸光度值或在反应完成后，在反应孔中注入终止液终止反应，然后采用终点法读取吸光度值；
4、读取吸光度值时，反应盘部件将试剂船旋转移到光学检测系统所对应的位置，由光学检测系统对反应孔中的物质进行光学检测，并将检测结果提供给控制系统，由控制系统进行处理、储存和输出。
所述的试剂是检测所用的抗原或抗体、酶标记抗原或抗体、酶显色底物、稀释液、吸附液、终止液，具体试剂种类视检测项目的要求而设置，这些试剂集中盛装在特定的一次性独立单人份试剂装置中。
本发明的有益效果为：本发明采用的新型免疫检测方法及仪器，使用独立的、单人份的、专用的、一次性的、结构形状极为独特的试剂装置试剂船，及与之相配套的专用全自动免疫分析仪，与其他免疫分析方法、试剂装置及分析仪器比较，具有如下优点：
第一，它是一种独立的、单人份的检测试剂及分析装置，无须像通用ELISA法那样使用12×8型、8×12型或整板型96孔专用酶联免疫微孔板作为抗原抑或抗体包被用品和反应容器，在使用时只要有一份样品即可进行对应项目的检测而无试剂的浪费。如果样品的数量超过一份，按实际样品数使用该试剂及分析装置即可。
第二，无论是定性检测还是定量检测，它将每一检测必须的试剂盛装在一个试剂装置的试剂孔位内，而无需将检测试剂分别用不同的试剂瓶来盛装，不但操作极为简便，而且不容易造成操作差错，从而保证检测结果的正确性。
第三，它对每一个试剂装置都有一个专用条形码，条形码的数值包含每项检测所对应的检测项目代码、检测试剂生产批号、试剂有效期、定性检测校正系数、定量测定标准曲线参数、具体的酶联免疫反应类型、试剂装置的序列号等信息，不能随意被改变，使用时严格受控，尤其是在使用超过有效期检测试剂时，将被识别并阻止发出检测报告，从而可以确保检测的准确性。
第四，它将每一检测试剂进行有效分隔和密封，不会引起各种试剂之间的交叉污染而影响检测结果。
第五，它是一种专用于特定分析仪器的试剂装置，在检测过程用全自动的精密加液器来加注检测试剂或样品，操作自动化，加量精确，检测结果的准确度和精密度高。
第六，在检测项目成套试剂的数量配置及使用上，一切按实际使用需要来进行配备即可，尤其是在对多项目检测上，配备更为适量，不会出现超配置使用情况。
第七，在一个试剂装置上，可以放置2～4个项目的检测试剂，可以同时进行一个样品2～4个项目的检测，或者一个样品同一项目的1～3个稀释度倍数的检测，或一个样品同一项目的2～4次重复检测。
第八、在检测操作上采用全自动分立式酶联免疫的仪器分析方法，从而实现了酶联免疫项目的独立单项或组项的全自动检测，确保了检测的随用性；
第九、在检测样品及性质上，既可以进行单人份的定性/定量检测，也可以进行批量样品的定性/定量检测，确保了检测的灵活性；
第十、在检测判读及数据处理上，采用终点方法，在加入终止液，停止反应后，单一主测试光路，确保了检测的精确性，稳定性，受环境影响小；
第十一、在检测试剂的处理上，将各种酶联免疫反应所需试剂集中装载在一个独特的试剂装置中，不仅保证了各项检测的独立性，更确保了每一检测试剂使用的便利性；
第十二、在检测速度上，采用旋转式微震动方式来加速混合反应液相，促进反应分子之间的结合，使得反应时间大为缩短，检测速度得以提高，缩短了手工操作时间，保证了检测的快速性和即时性；
第十三、仪器配备了精密、齐备的温控系统和试剂及液面检测系统，反应灵敏，调控精度高，确保酶联免疫试验在恒定温度和液相条件下进行反应，不但保证检测结果的重复性，更保证检测的准确性。
另外，本发明与专利申请号：201010042628.X的中国发明专利创造的技术方案相比存在如下有益效果：
第一、在清洗液瓶、A洗涤液瓶及B洗涤液瓶的瓶底各设有一个用于监控各瓶体工作液的重量，向控制系统提供各瓶体工作液使用量及余量信号的在线称重感应装置，实现实时精确地监测在储液部件内的工作液储存量及使用量，控制的可靠性好，使洗涤的质量得到保障，在液路系统出现故障时能及时发现。
第二、光学检测系统为一套，可在向反应孔加入最后一种反应试剂后采用动态法读取吸光度值，也可在向反应孔加入终止液停止反应后读取吸光度值，且比之前的三重光学读数和多种数据拟合分析方法所需要的光学检测系统数量（需要三套）少。
第三、液路系统进行简化，需要的电磁阀、洗涤泵数量少，减低了生产成本。
第四、采用套装结构的加注机构的注射器驱动装置稳定性好，体积小，成本低，使用寿命长。
第五、采用电热板对反应盘部件进行加热，加热均匀，无噪音，热效率高。
第六、加注机构在动力部件不增加的情况下，增加了专用于试剂船的孔口封口膜的穿刺的穿刺针，使加注针专门用于试剂或样品的加注，提高加注针的寿命，同时提高了穿刺可靠性。
第七、洗涤机构采用重力结构适应孔底高度，在排液洗涤针触底之后，不受滑块的下移而增加排液洗涤针向下作用力，避免了洗涤针的损坏，寿命更长，更可靠。
第八、主控软件安装在外接控制主机上，可通过USB接口实现1台控制主机控制1~10台全自动免疫分析仪运行，用户可根据样本量灵活配置分析仪，从而全面满足大、中、小型医疗机构的检测需求。
附图说明
图1为本发明的整体结构示意图；
图2为本发明的反应盘部件的俯视结构示意图；
图3为图2的A-A剖视结构示意图；
图4为本发明的试剂船的截面结构示意图；
图5为本发明的试剂船在放置到反应盘部件的承载槽中之前的结构示意图；
图6为本发明的试剂船在放置到反应盘部件的承载槽操作完成之后结构示意图；
图7为本发明的加注机构的正面立体结构示意图；
图8为本发明的加注机构的背面立体结构示意图；
图9为本发明的其中一组洗涤机构的立体结构示意图；
图10为本发明的光学检测系统的结构示意图；
图11为本发明的电热板安装结构示意图；
图12为本发明的液路系统的结构原理图；
图13为本发明的控制系统方框图。
具体实施方式
以下结合附图和优选的具体实施例，对本发明的结构作进一步地说明：
参照图1和图5中所示，包括有：主机架部件1、反应盘部件2、试剂船3、加注机构4、洗涤机构5、储液部件6、液路系统7、温控装置8、光学检测系统9、内置条码识别器10及控制系统。
所述的主机架部件1包括机架底板11，在机架底板11上设有支柱12，在支柱12上从下往上依次设有下固定板13和上固定板14。
照参图1、图2、图3、图5及图6中所示，所述的反应盘部件2设于上固定板14 和下固定板13之间，所述反应盘部件2为一圆形盘状结构，在其上环形阵列有四个以上（附图中以30个为例说明）的用于卡放试剂船3的承载槽21，所述的试剂船3卡接在反应盘部件2的承载槽21中。为了使试剂船3卡接稳定，承载槽21的前端槽壁上设有夹紧试剂船的滑块23，对滑块23施加弹力的弹簧24，以及防止滑块脱落的锁销25。在下固定板13的下方固定设有一个用于驱动反应盘部件2旋转的反应盘驱动部件22。所述反应盘驱动部件22包括有一根与反应盘部件2中心固定连接的主轴221，主轴221通过轴承222和主轴座223与下固定板13连接，在主轴221上设有一个从动带轮224，在主轴座223的侧边设有一个与下固定板13固定安装的电机支架座225，在电机支架座225中设有一个步进电机226，步进电机226的电机轴2261上设有一个主动带轮227，在主动带轮227与从动带轮224间设有同步齿形带228，在电机支架座225上设有带轮张紧器2261。在主轴221的底端上还设有一个用于感应主轴221旋转角度为控制系统提供反应盘部件2移动信息，并由控制系统控制步进电机226运转状态的编码器229。
参照图4中所示，所述的试剂船3包括有一个基体31和基体一端的手柄32。所述的基体31上设有一个样品孔311、五个试剂孔312、一个反应孔313及一个稀释孔314，反应孔313的孔底为光路通透性的平底；也即是孔底盛装无色／空白试剂溶液时，对可见光／紫外光／荧光的吸光度值趋近于零。手柄32上贴有项目条码，项目条码的信息包括：检测试剂的检测项目代码、检测试剂生产批号、试剂有效期、定性检测校正系数、定量测定标准曲线参数、具体的酶联免疫反应类型、试剂装置的序列号等。
参照图1、图7和图8中所示，所述的加注机构4设于上固定板14的上方，用于对放置在反应盘部件承载槽21中的试剂船3孔间样本或试剂的吸取及加注；所述加注机构4包括有注射器装置41、加注针42、43、加注针移动装置46及加注针清洗槽47；与现有加注机构相比还包括有：第一穿刺针44和第二穿刺针45。
其中，所述的注射器装置41是将现有的针管注射器、步进电机、丝杆及位置传感器以组装方式构成，改为了将柱塞、丝杆及电机轴整合封装，精度高，误差小，寿命指标成十至数十倍改善，可以更精确地使用试剂，节约成本，体积减少到原有体积的五分之一，无需保养及维修。
所述的加注针包括有第一加注针42和第二加注针43；所述的加注针移动装置46用于对第一加注针42、第二加注针43、第一穿刺针44和第二穿刺针45执行水平或上下移动操作，实现对试剂船3的封口膜的穿刺、样本或试剂的加注。
加注针移动装置46包括有滑车461，在滑车461底部设有与上固定板14固定安装的滑车导轨462，在滑车导轨462的侧边设有驱动滑车461沿滑车导轨462水平移动的滑车移位部件463，也即是滑车导轨462和滑车移位部件463的结合实现对滑车461实现水平移动。所述的滑车461包括有一个滑车支架4611，在滑车支架4611的正面竖直设有第一针导轨4612、第二针导轨4613、第三针导轨4614及第四针导轨4615；所述的第一加注针42、第二加注针43、第一穿刺针44和第二穿刺针45分别通过第一加注针滑块4616、第二加注针滑块4617、第一穿刺针滑块4618和第二穿刺针滑块4619与第一针导轨4612、第二针导轨4613、第三针导轨4614及第四针导轨4615活动卡接；在滑车支架4611的背面设有用于上下交替移动第一加注针42和第二加注针43的加注针提升驱动装置4620和用于上下交替移动第一穿刺针44和第二穿刺针45的穿刺针提升驱动装置4621。所述的加注针提升驱动装置4620包括有安装于滑车支架4611上的移针电机46201，移针电机46201的轴上设有移针主动带轮，在滑车支架4611上设有移针被动带轮46203，在移针主动带轮与移针被动带轮46203之间设有移针同步带46204，所述移针同步带46204是一种带有卡齿的皮带，在移针同步带46204的两侧分别与第一加注针滑块4616和第二加注针滑块4617间固定连接有带夹，通过一个移针电机46201同时控制第一加注针42和第二加注针43，移针电机46201工作时，第一加注针42和第二加注针43移动方向相反，例如：当第一加注针42提起到最高位置时，第二加注针43下降到最低位置，相反，第一加注针42下降到最低位置时，第二加注针43上升到最高位置。所述的穿刺针提升驱动装置4621与加注针提升驱动装置4620结构相同，穿刺针提升驱动装置4621的移针同步带46214的两侧分别与第一穿刺针滑块4618和第二穿刺针滑块4619间固定连接有带夹，由移针电机46211交替控制第一穿刺针44和第二穿刺针45上下移动。
所述的滑车移位部件463包括有与上固定板14固定安装的滑车电机4631，以及设于上固定板14上的滑车被动带轮4633，滑车电机4631的轴上设有滑车主动带轮4632，滑车主动带轮4632与滑车被动带轮4633之间设有滑车同步带4634，滑车同步带4634通过带夹与滑车支架4611的底部固定连接，由滑车电机4631控制移动滑车。
参照图1和图9中所示，所述的洗涤机构5、5’包括有结构相同的第一洗涤机构5和第二洗涤机构5’。以第一洗涤机构为例进行详细说明：第一洗涤机构5包括有：加液洗涤针51、排液洗涤针52、洗涤针移动装置53及洗涤针清洗槽54。
所述的洗涤针移动装置53包括有一个固定安装在上固定板14上的洗涤架531，在洗涤架531上设有洗涤电机532，在洗涤电机532轴上设有主动带轮533，在洗涤架531上还设有从动带轮534，在主动带轮533与从动带轮534之间设有同步带535；在洗涤架531竖直设有导杆536，在导杆536上活动套有用于固定加液洗涤针51和排液洗涤针52的洗涤针座537；在洗涤架531设有与导杆536并排平行的导轨538，在导轨538上设有滑块539，滑块539上设有一个与同步带535固定连接，随同步带535的运转而带动滑块539上下滑动的带夹5391，滑块539设有向上凸起的卡块5392，洗涤针座537上设有与卡块5392相配合，在滑块539上升时，随滑块539而上升，从而将加液洗涤针51和排液洗涤针52向上抬起，在滑块539下降时，随洗涤针座537自身重力自由下落的卡槽5371，也即是加液洗涤针51和排液洗涤针52是通过涤针座537自由悬挂在滑块539的上方，摆脱滑块539下压作用力，由于排液洗涤针52的高度比加液洗涤针51低，在洗涤时是依靠排液洗涤针52触底排出洗涤液的，因而，该结构有效地延长排液洗涤针52的寿命。
参照图1中所示，所述的储液部件6设于机架底板11上，包括有清洗液瓶61、A洗涤液瓶62及B洗涤液瓶63；清洗液瓶61、A洗涤液瓶62及B洗涤液瓶63为三个相互分离独立的瓶体，在清洗液瓶61、A洗涤液瓶62及B洗涤液瓶63的瓶底均设有一个用于监控各瓶体61、62、63内工作液的重量，向控制系统提供各瓶体工作液使用量及余量信号的在线称重感应装置631（图中仅显示出一个在线称重感应装置），实现实时精确地监测在储液部件6内的工作液储存量及使用量，可靠性好，使洗涤的质量得到保障，在液路系统出现故障时能及时发现。
参照图1和图12中所示，所述的液路系统7连接储液部件6、洗涤机构5和加注机构4，用于将储液部件6中的工作液输送到洗涤机构5和加注机构4。
该液路系统7包括有将清洗液瓶61中的清洗液、A洗涤液瓶62中的洗涤液抽出至第一洗涤部件的注液洗涤针51中排出的管路、电磁阀71、洗涤泵72，用于与第一洗涤部件的排液洗涤针52连接排液至主废液槽73中的管路、排液泵74，将第一洗涤部件洗涤针清洗槽54中的废液排至主废液槽73中的管路，将清洗液瓶61中的清洗液、B洗涤液瓶63中的洗涤液抽出至第二洗涤部件的注液洗涤针51’中排出的管路、电磁阀(75)、洗涤泵(76)，用于与第二洗涤部件的排液洗涤针52’连接排液至主废液槽(73)中的管路、排液泵(77)，将第二洗涤部件洗涤针清洗槽54’中的废液排至主废液槽(73)中的管路，用于将清洗液瓶61中的清洗液抽出用来清洗加注机构注射器装置41和加注针42、43的管路、洗涤泵78、电磁阀711、79、710，以及用于将清洗加注机构的加注针洗涤槽47中废液排至主废液槽73中的管路。主废液槽73还连接有废液桶712，主废液槽73与废液桶712之间设有排液泵713和管路。
参照图3和图11中所示，所述的温控装置8设于反应盘部件2的下方，用于对反应盘部件2进行加热，也即是对试剂船3反应孔进行加热，提供样品反应所需的温度环境。本发明的温控装置8采用的是一块形状与反应盘部件的承载槽相对应的盘状电热板。
参照图1和图10中所示，所述的光学检测系统9包括有光发射器体91和光接受器体92，所述光发射器体也设于上固定板的上方，光接受器体对应地设于反应盘部件的下方，用于对试剂船的反应孔J进行光学检测；每一个光发射器体91包括有并排设置的两组发光灯，两组发光灯均包含有LED光源911，在LED光源911的前端设有光纤912，在光纤912的前端设有滤光片913，滤光片913的前端还设有聚光镜片914，其中两个发光灯具有不同波长的滤光片；所述的光接受器体92包含有与两个发光灯相对应的聚光镜片921和设于聚光镜片的后方的两个光接收器922。使用过程中，根据需要移动光发射器体91和光接受器体92使相应的发光灯和光接受器与反应孔313相对应，用对试剂船的反应孔313中的物质进行光学检测。该光学检测系统9与现有的光学检测系统相比，将现有的卤素灯改为LED光源，发光稳定，不易衰减，定标周期长；定标简易，消耗时间短；不易损坏，寿命长；发热量大幅度减小，节能。另外，由于本发明所使用的试剂组份的改变和增加，使得原来需要三个光学检测系统9才能完成的检测工作只需一套光学检测系统即可完成9，节省了成本；还有，由于原来是通过光纤将一个光源发出的光同时传输到三个不同位置的光学检测系统，总共需要6条光通道，每条光纤长度不一致，通道长，存在通道差异，结构复杂，稳定性差，受环境影响大，而本发明彻底地解决了上述问题。
参照图1中所示，所述的内置条码识别器10设在上固定板14上，用于对试剂船手柄上贴的条码进行识别，并将识别信号输送给控制系统的，实现检测结果与样品信息自动对应输出。
参照图13所示，所述的控制系统包括有仪器控制电路以及写入在仪器控制电路内的嵌入式软件，所述的仪器控制电路包含有USB接口，通过USB接口与控制主机通讯连接；所述的反应盘部件2的反应盘驱动部件22、加注机构4的加注针移动装置46、洗涤机构的洗涤针移动装置53、液路系统的各洗涤泵和电磁阀、温控装置8、光学检测系统9、内置条码识别器10通过仪器控制电路与控制主机连接，根据嵌入式软件的程序指令进行控制运作，嵌入式软件同时接受所有部件的传感信息输入和接收光学检测系统9、内置条码识别器10的检测信息，并根据嵌入式软件的程序进行数据处理；通过USB接口在控制主机中执行操作输入、显示输出以及打印等相关操作。
应用上述全自动免疫分析仪实现免疫检测的方法，该方法包括有如下步骤：
1、将待测样品放入试剂船的样品孔中，试剂船的手柄上贴有与样品相对应的项目信息条码；
2、将试剂船卡放在反应盘部件的承载槽中；
3、启动控制系统，反应盘部件运转，将试剂船旋转至加注机构对应的位置，由加注机构将样品孔中的样品加注到稀释孔中，将其中的一个试剂孔中的稀释液加入到稀释孔中进行稀释后再注入到反应孔中，按照控制系统预设条件进行反应及洗涤，洗涤过程中，控制系统根据洗涤之前和洗涤之后，清洗液瓶、A洗涤液瓶及B洗涤液瓶的瓶底的三个在线称重感应装置的检测信号计算三种工作液消耗量，判定洗涤过程是否正常工作，若非正常控制系统进行警告提醒。加入最后一种试剂后，可采用动态法立即读取吸光度值或在反应完成后，在反应孔中注入终止液终止反应，然后采用终点法读取吸光度值；
4、读取吸光度值时，反应盘部件将试剂船旋转移到光学检测系统所对应的位置，由光学检测系统对反应孔中的物质进行光学检测，并将检测结果提供给控制系统，由控制系统进行处理、储存和输出。
所述的试剂是检测所用的抗原或抗体、酶标记抗原或抗体、酶显色底物、稀释液、吸附液、终止液，具体试剂种类视检测项目的要求而设置，这些试剂集中盛装在特定的一次性独立单人份试剂装置中。

Claims (12)

  1. 一种全自动免疫分析仪，包括有：主机架部件（1）、反应盘部件（2）、加注机构（4）、洗涤机构（5、5’）、储液部件（6）、液路系统（7）、温控装置（8）、光学检测系统（9）及控制系统； 所述的主机架部件（1）包括机架底板（11），在机架底板（11）上设有支柱（12），在支柱（12）上从下往上依次设有下固定板（13）和上固定板（14）； 所述的反应盘部件（2）设于上固定板（14）和下固定板（13）之间，反应盘部件（2）上环形阵列有四个以上的用于卡放由样品孔、试剂孔、光路通透性且平底的反应孔及稀释孔构成的试剂船（3）的承载槽（21），在下固定板（13）的下方与其固定设有用于驱动反应盘部件（2）旋转的反应盘驱动部件（22）； 所述的加注机构（4）设于上固定板（14）的上方，用于对放置在反应盘部件承载槽（21）中的试剂船（3）孔间样本或试剂的吸取及加注；所述加注机构（4）包括有注射器装置（41）、加注针（42、43）、加注针移动装置（46）及加注针清洗槽（47）；
    所述的洗涤机构（5）设于上固定板（14）的上方，用于对放置在反应盘部件的承载槽（21）中的试剂船（3）的反应孔（313）进行洗涤；所述的洗涤机构（5）包括有加液洗涤针（51、51’）、排液洗涤针（52、52’）、洗涤针移动装置（53）及洗涤针清洗槽（54、54’）； 所述的储液部件（6）设于机架底板（11）上，包括有用于盛装清洗液的清洗液瓶（61）、用于盛装A洗涤液的洗涤液瓶（62）和用于盛装B洗涤液的洗涤液瓶（63）； 所述的液路系统（7）连接储液部件（6）、洗涤机构（5、5’）和加注机构（4），用于将储液部件（6）中的各工作液输送到洗涤机构（5、5’）和加注机构（4）； 所述的温控装置（8）设于反应盘部件（2）的下方，用于对反应盘部件（2）卡放的试剂船（3）进行加热； 所述的光学检测系统（9）包括有光发射器体（91）和光接受器体（92），所述光发射器体（91）设于上固定板（14）的上方，所述光接受器体（92）设于反应盘部件（2）下方与光发射器体（91）相对应的位置，用于对卡放在反应盘承载槽（21）中的试剂船反应孔（313）中的物质进行光学检测； 所述的控制系统包括有仪器控制电路以及写入在仪器控制电路内的嵌入式软件，所述的反应盘部件（2）的反应盘驱动部件（22）、加注机构（4）的加注针移动装置（46）、洗涤机构的洗涤针移动装置（53）、液路系统的各洗涤泵和电磁阀、温控装置（8）、光学检测系统（9）与仪器控制电路，根据嵌入式软件的程序指令进行控制运作； 其特征在于：所述的储液部件（6）的清洗液瓶（61）、A洗涤液瓶（62）及B洗涤液瓶（63）为三个独立的瓶体，在清洗液瓶（61）、A洗涤液瓶（62）及B洗涤液瓶（63）的瓶底部各设有一个用于监控各瓶体（61、62、63）内工作液的重量，向控制系统提供各瓶体工作液使用量及余量信号的在线称重感应装置（631）。
  2. 据权利要求1所述的一种全自动免疫分析仪，其特征在于：所述的光发射器体（91）包括有并排设置的两组发光灯，两组发光灯的光源均采用的是LED光源（911），在LED光源（911）的前端设有光纤（912），在光纤（912）的前端设有滤光片（913），滤光片（913）的前端还设有聚光镜片（914），其中两个发光灯具有不同波长的滤光片（913）；所述的光接受器体（92）包含有与两个发光灯相对应的聚光镜片（921）和设于聚光镜片的后方的两个光接收器（922）。
  3. 根据权利要求1所述的一种全自动免疫分析仪，其特征在于：所述加注机构（4）还包括有：第一穿刺针（44）和第二穿刺针（45）；所述的加注针包括有第一加注针（42）和第二加注针（43）；所述的加注针移动装置（46）包括有滑车（461），在滑车（461）底部设有与上固定板（14）固定安装的滑车导轨（462），在滑车导轨（462）的侧边设有驱动滑车（461）沿滑车导轨（462）水平移动的滑车移位部件（463）；其中，所述的滑车（461）包括有一个滑车支架（4611），在滑车支架（4611）的正面竖直设有第一针导轨（4612）、第二针导轨（4613）、第三针导轨（4614）及第四针导轨（4615）；所述的第一加注针（42）、第二加注针（43）、第一穿刺针（44）和第二穿刺针（45）分别通过第一加注针滑块（4616）、第二加注针滑块（4617）、第一穿刺针滑块（4618）和第二穿刺针滑块（4619）与第一针导轨（4612）、第二针导轨（4613）、第三针导轨（4614）及第四针导轨（4615）活动卡接；在滑车支架（4611）的背面设有用于上下交替移动第一加注针（42）和第二加注针（43）的加注针提升驱动装置（4620）和用于上下交替移动第一穿刺针（44）和第二穿刺针（45）的穿刺针提升驱动装置（4621）；所述的加注针提升驱动装置（4620）包括有安装于滑车支架（4611）上的移针电机（46201），移针电机（46201）的轴上设有移针主动带轮，在滑车支架（4611）上设有移针被动带轮（46203），在移针主动带轮与移针被动带轮（46203）之间设有移针同步带（46204），移针同步带（46204）的两侧分别与第一加注针滑块（4616）和第二加注针滑块（4617）间固定连接有带夹；所述的穿刺针提升驱动装置（4621）与加注针提升驱动装置（4620）结构相同，穿刺针提升驱动装置（4621）的移针同步带（46214）的两侧分别与第一穿刺针滑块（4618）和第二穿刺针滑块（4619）间固定连接有带夹；其中，所述的滑车移位部件（463）包括有与上固定板（14）固定安装的滑车电机（4631），以及设于上固定板（14）上的滑车被动带轮（4633），滑车电机（4631）的轴上设有滑车主动带轮（4632），滑车主动带轮（4632）与滑车被动带轮（4633）之间设有滑车同步带（4634），滑车同步带（4634）通过带夹与滑车支架（4611）的底部固定连接。
  4. 根据权利要求1所述的一种全自动免疫分析仪，其特征在于：所述的洗涤机构（5、5’）包括有结构相同的第一洗涤机构（5）和第二洗涤机构（5’）；两组洗涤机构（5、5’）均包括有：加液洗涤针（51、51’）、排液洗涤针（52、52’）、洗涤针移动装置（53）及洗涤针清洗槽（54、54’）；所述的洗涤针移动装置（53）包括有一个固定安装在上固定板（14）上的洗涤架（531），在洗涤架（531）上设有洗涤电机（532），在洗涤电机（532）轴上设有主动带轮（533），在洗涤架（531）上还设有从动带轮（534），在主动带轮（533）与从动带轮（534）之间设有同步带（535）；在洗涤架（531）上竖直设有导杆（536），在导杆（536）上活动套有用于固定加液洗涤针（51）和排液洗涤针（52）的洗涤针座（537）；在洗涤架（531）设有与导杆（536）平行的导轨（538），在导轨（538）上设有滑块（539），滑块（539）上设有一个与同步带（535）固定连接，随同步带（535）的运转而带动滑块（539）上下滑动的带夹（5391），滑块（539）设有向上凸起的卡块（5392），洗涤针座（537）上设有与卡块（5392）相配合，在滑块（539）上升时，随滑块（539）而上升将加液洗涤针（51）和排液洗涤针（52）抬起，在滑块（539）下降时，随洗涤针座（537）自身重力自由下落的卡槽（5371）。
  5. 根据权利要求4所述的一种全自动免疫分析仪，其特征在于：所述的液路系统包括有将清洗液瓶（61）中的清洗液、A洗涤液瓶（62）中的洗涤液抽出至第一洗涤部件的注液洗涤针（51）中排出的管路、电磁阀（71）、洗涤泵（72），用于与第一洗涤部件的排液洗涤针（52）连接排液至主废液槽（73）中的管路、排液泵（74），将第一洗涤部件洗涤针清洗槽（54）中的废液排至主废液槽（73）中的管路，将清洗液瓶（61）中的清洗液、B洗涤液瓶（63）中的洗涤液抽出至第二洗涤部件的注液洗涤针（51’）中排出的管路、电磁阀(75)、洗涤泵(76)，用于与第二洗涤部件的排液洗涤针（52’）连接排液至主废液槽(73)中的管路、排液泵(77)，将第二洗涤部件洗涤针清洗槽（54’）中的废液排至主废液槽(73)中的管路，用于将清洗液瓶（61）中的清洗液抽出用来清洗加注机构注射器装置（41）和加注针（42、43）的管路、洗涤泵（78）、电磁阀（711、79、710），以及用于将清洗加注机构的加注针洗涤槽（47）中废液排至主废液槽（73）中的管路。
  6. 根据权利要求1所述的一种全自动免疫分析仪，其特征在于：所述的温控装置（8）为一块与反应盘部件（2）相对应的盘状电热板。
  7. 根据权利要求1所述的一种全自动免疫分析仪，其特征在于：所述的加注机构（4）的注射器装置（41）是采用封装结构的步进电机和螺杆构成的活塞驱动装置。
  8. 根据权利要求1所述的一种全自动免疫分析仪，其特征在于：所述的上固定板（14）上设有对试剂船（3）的手柄上的项目条码进行识别，并将识别信号输送给控制系统的内置条码识别器（10）。
  9. 根据权利要求1所述的一种全自动免疫分析仪，其特征在于：在主轴（221）的底端上设有一个用于感应主轴（221）旋转角度为控制系统提供反应盘部件（2）移动信息，并由控制系统控制步进电机（226）运转状态的编码器（229）对反应盘部件进行精确定位。
  10. 根据权利要求1所述的一种全自动免疫分析仪，其特征在于：所述的控制系统的仪器控制电路包含有用于与控制主机建立通讯的USB接口，可通过1台控制主机控制1~10台所述全自动免疫分析仪运行。
  11. 一种应用权利要求1至权利要求10任一项所述全自动免疫分析仪实现免疫分析检测的方法，该方法包括有如下步骤：
    1）、将待测样品放入试剂船的样品孔中，试剂船的手柄上贴有与样品相对应的项目信息条码；
    2）、将试剂船卡放在反应盘部件的承载槽中；
    3）、启动控制系统，反应盘部件运转，将试剂船旋转至加注机构对应的位置，由加注机构将样品孔中的样品加注到稀释孔中，将其中的一个试剂孔中的稀释液加入到稀释孔中进行稀释后再注入到反应孔中，按照控制系统预设条件进行反应及洗涤，洗涤过程中，控制系统根据洗涤之前和洗涤之后，清洗液瓶、A洗涤液瓶及B洗涤液瓶的瓶底的三个在线称重感应装置的检测信号计算三种工作液消耗量，判定洗涤过程是否正常工作，若非正常控制系统进行警告提醒；加入最后一种试剂后，可采用动态法立即读取吸光度值或在反应完成后，在反应孔中注入终止液终止反应，然后采用终点法读取吸光度值；
    4）、读取吸光度值时，反应盘部件将试剂船旋转移到光学检测系统所对应的位置，由光学检测系统对反应孔中的物质进行光学检测，并将检测结果提供给控制系统，由控制系统进行处理、储存和输出。
  12. 根据权利要求11所述免疫检测方法，其特征在于：所述的试剂是检测所用的抗原或抗体、酶标记抗原或抗体、酶显色底物、稀释液、吸附液、终止液，具体试剂种类视检测项目的要求而设置，这些试剂集中盛装在特定的一次性独立单人份试剂装置中。
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CN116448698B (zh) * 2023-06-14 2023-09-05 北京市计量检测科学研究院 一种高通量一体化固体样品检测装置
CN116448698A (zh) * 2023-06-14 2023-07-18 北京市计量检测科学研究院 一种高通量一体化固体样品检测装置
CN116519963B (zh) * 2023-07-05 2023-09-22 深圳市瑞图生物技术有限公司 样本检测系统、样本检测方法及存储介质
CN116519963A (zh) * 2023-07-05 2023-08-01 深圳市瑞图生物技术有限公司 样本检测系统、样本检测方法及存储介质
CN117706087A (zh) * 2024-02-01 2024-03-15 山东益生种畜禽股份有限公司 一种用于滑液囊支原体ms-one的便携式检测装置
CN117706087B (zh) * 2024-02-01 2024-04-16 山东益生种畜禽股份有限公司 一种用于滑液囊支原体ms-one的便携式检测装置

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