CN102445557A - Full-automatic immunity analyzer and detection method thereof - Google Patents

Full-automatic immunity analyzer and detection method thereof Download PDF

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CN102445557A
CN102445557A CN2011102938658A CN201110293865A CN102445557A CN 102445557 A CN102445557 A CN 102445557A CN 2011102938658 A CN2011102938658 A CN 2011102938658A CN 201110293865 A CN201110293865 A CN 201110293865A CN 102445557 A CN102445557 A CN 102445557A
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washing
pin
filling
bottle
coaster
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CN102445557B (en
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胡德明
刘清波
何林
阳辉
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Shenzhen Yhlo Biotech Co Ltd
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Shenzhen Yhlo Biotech Co Ltd
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Abstract

The invention discloses a full-automatic immunity analyzer and a detection method thereof for the technical field of immunity analyzers of biological samples, mainly solving the technical problems of poor reliability, unstable and inaccurate obtainment of the consumption of working liquid, and no guarantee of washing quality when a liquid level resistor induction principle of a full-automatic immunity analyzer in the prior art is used for detecting liquid storage content. The full-automatic immunity analyzer is characterized in that: a liquid storage component comprises a cleaning solution bottle, a washing liquid A bottle, and a washing liquid B bottle which are independent of one another, the bottoms of the cleaning solution bottle, the washing liquid A bottle, and the washing liquid B bottle are respectively provided with an on-line weighing sensor for monitoring the weight of the working liquid in each bottle, providing the usage amount and margin signals of the working liquid of each bottle to a control system. According to the invention, the storage amount and usage amount of the working liquids in the liquid storage component can be accurately monitored in real time, the reliability of the control is good, the quality of washing can be guaranteed, and the fault of a fluid path system can be discovered in time.

Description

A kind of automatic lmunoassays analyzer and detection method thereof
Technical field
The present invention relates to a kind of automatic lmunoassays analyzer and detection method thereof.This method and instrument are mainly used in the antigenic substance in biological sample such as human sample's serum, sputum, urine, ight soil, bile etc. such as the antigen of various pathogenic microorganisms; Or the antibody that produces by these pathogenic microorganism antigens infection bodies; And the autoantibody in autoimmune disease such as systemic loupus erythematosus, phosphatide syndrome, rheumatoid arthritis, chorionitis, autoimmune liver disease, Sjogren syndrome, systemic vasculitis, polymyositis and the disease blood samples of patients such as dermatomyositis, AITD and gastrointestinal disease; And other immune indexes such as tumor markers, carry out quantitative measurement or qualitative detection with enzyme-linked immunoassay method.
Background technology
Enzyme linked immunosorbent detection has been widely used in analysis fields such as clinical medicine, animal quarantine, Food Science, plant virus, medicament residue, the prevention and control of plant diseases, pest control as a kind of method in many immuno analytical methods at present.This method has the specificity and the susceptibility of height, and nearly all soluble antigen-antibody forming system can detect with it, and its minimum detection value can reach ng even pg level.Compare with radiommunoassay, the advantage of enzyme-linked immunoassay is the stable and "dead" harm of label; Compare with immunofluorescence assay, it is more objective that enzyme-linked immunoassay is judged the result.
At present; The classification of commercial enzyme-linked immunoassay project or reagent comprise clinical medicine detect in antigen or antibody, protein, non-peptide hormone, the medicine of pathogen; Food microorganisms in the food inspection, microbial toxin, remains of pesticide, food component; Medicament residue, toxin, microorganism, transgenic product during aquatic products detect, and plant virus detects, various pathogen detection, Detecting Pesticide, detection of veterinary drugs in food etc. in the animal quarantine.
In enzyme linked immunosorbent detection; Complete ELISA detection kit should comprise solid phase carrier, enzyme conjugates, chromogenic substrate, reaction terminating liquid, various dilution and the damping fluid that encapsulates, and used titer, correcting fluid, positive quality control thing or control serum, feminine gender controlled Quality Control thing or control serum etc. in detecting.Because enzyme-linked immunoassay method need to use plurality of reagents in detection, and these reagent are that needs according to the test reaction add successively, also must the micropore of detection reaction plate repeatedly be washed simultaneously, thereby manual operations are comparatively loaded down with trivial details.In order to simplify the operation, especially simplify and annotate repeatedly in filling test sample and detectable and the washing process and inhale the troublesome operation of abandoning cleansing solution, develop the multiple instrument that is used for enzyme-linked immunoassay at present.
To the sample of annotating in the enzyme linked immunosorbent detection, reagent, washing and four troublesome operation of interpretation chromogenic reaction result, prior art---ELISA appearance adopts separate type and combined type two class methods to handle respectively.
Separate type enzyme linked immunological instrument mainly contains ELIASA and washes the plate machine, their through application of sample, add reagent, hatch, process such as washing, come result of determination through the absorbance analysis at last.ELIASA is a kind of visible light photolometer that the microwell plate absorbance measurement is used that is exclusively used in essence; Laboratory brand commonly used and model have respectively Elx800, the CLINIBIO company of SPECTR ACLASSIC, the BIOTEK company of MK3, the TECAN company of LABSYSTEMS company 128c, ANTHOS company 2010, the Anayech 828 of the CF5000 of space flight 283 factories, the safe and sound company in Shanghai, go up the XD711 that Hisoon reaches company, and BIORAD company 450,550, Benchmark, Utramark etc.Washing the plate machine then is that machine is abandoned in a kind of filling and suction that is exclusively used in the microwell plate cleansing solution in essence, and the PW-960 type of loose company, the KWP-100 type of Shenzhen Kate company, the DNX-962 type of Beijing Pu Lang technology company etc. converge in AT-828 type, Shenzhen that brand that the laboratory is commonly used and model have the safe and sound company in Shanghai respectively.Every laboratory of carrying out enzyme linked immunosorbent detection mostly has been equipped with ELIASA and has washed the plate machine, and they are one of indispensable important instrument in laboratory.The outfit of these ELIASAs; Not only make absorbance measurement easy and high speed in the enzyme linked immunosorbent detection; Whole plate 12 * 8 holes, 8 * 12 holes up to 10 seconds in, and have absorbance measuring scope A=0~6.0 of broad; And the 340nm of outfit optical filter is arranged, spectral detection is expanded between ultraviolet region.Also have the function of hatching and kinetic measurement function simultaneously, greatly promote and promoted the enzyme linked immunosorbent detection broad application.The same with ELIASA; Washing operation loaded down with trivial details in the enzyme linked immunosorbent detection has not only been simplified in the outfit of washing the plate machine; Except having basic functions such as the wash number of setting, cleaning micropore lath number, setting soak time; Also having possessed bottom flushing, imbibition, board-like/bar formula at 2 washes plate, concussion, position adjustments, detergent line automatically, moves functions such as liquid, the multiple washing procedure of storage certainly; Fully guarantee the effect of test washing, thereby guaranteed the quality of facilitation that experiment detects, rapid and washing.
Combined type ELISA appearance is divided three classes: full-automatic enzyme-linked immunoassay system, automatic sample disposal system, pipelining formula enzyme linked immunological combined system.Full-automatic enzyme-linked immunoassay system is with each step in the enzyme linked immunological experiment; From application of sample, add reagent, hatch, wash, among concussion, colorimetric all focus on an instrument to qualitative or quantitative test, report storage and printing function, come to carry out automatically by all kinds enzyme linked immunoassay or the prior design of program of client by instrument.In full-automatic enzyme-linked immunoassay system, the FAME that brand that present laboratory is commonly used and model have HAMILTON company, the CAA of BIORAD company, the AMP of Australia Si Bang company, the Minilyeser of TECAN company, the TEKTIME of ORGANO company, the Personal LAB of DIVISION STRUMENTI company, the DSX of DYNDRX company, the Flex Tek2 of Aksu company, the TRIURUS of BIOASIA company etc.Steps such as the automatic sample disposal system is mainly used in the application of sample of accomplishing complex operation, artificial easy error in the enzyme linked immunological experiment, adds reagent, dilution, titration, hatches, washing; After accomplishing by the ELIASA result of determination, the MINITRED that brand that the laboratory is commonly used and model have TECAN company, the HYPREPTLUS of HYPERION company, the DLAS Ultra of DYNEX company etc.Pipelining formula enzyme linked immunological combined system is process and condition according to the enzyme linked immunoassay needs; Liquid added get system module, constant temperature and hatch module, wash plate system module and interpreting system module as a result; According to the type of enzyme linked immunoassay and step designs and layout, with track these system modules are together in series, each system module can independently be finished the work under the regulation and control of system computer separately; Can also unify cooperation, accomplish course of reaction jointly.The visible assembly line type full-automatic enzyme-linked immunologic workstation patent of invention publication number CN101303350A of technological prototype of laboratory brand commonly used and model and full-automatic enzyme-linked immunoassay system patent of invention publication number CN1885037A etc.
In order to be suitable for the special requirement of enzyme linked immunosorbent detection technology; Microplate formula ELISA appearance has had some new development recently again in all fields; For example develop to 384 holes, 1536 hole patterns from 96 hole patterns; The Ultramark that can measure the ELIASA of 384 hole microwell plates by LABSYSTEMS company and the release of BIOTEK company at present and released by BIORAD company can measure 384 holes, 1536 hole microwell plates, has also developed appearance to the plate machine of washing of 384 holes and 1536 hole microwell plates simultaneously; Can place nearly 10 kinds of wavelength filter and come out, make that analytical wavelength range is wideer, technical features such as wavelength accuracy and repeatability, measurement accuracy and repeatability, the linearity, measuring speed are more outstanding with the ELIASA that adopts the grating beam splitting principle.The release of these new methods, new technology, new model, new construction, new equipment; Greatly promoted the application of enzyme linked immunosorbent detection, thus make enzyme linked immunosorbent detection become range of application the widest, use a kind of immunoassay technology that the client is maximum, application quantity is maximum, market share is the highest.
Yet; Although obtained the tremendous development and the progress of numerous aspects by comparison based on micro-pore plate type enzyme-linked immune analytic method and instrument and enzyme linked immunological prototyping technique; But still have more deficiency, problem or limitation in actual use, these deficiencies, problem and limitation are concluded and are mainly contained the following aspects:
1, uses 12 * 8 types, 8 * 12 types, complete plate 96 holes or the special-purpose microwell plates of 96 hole multiples as antigen or antibody sandwich articles for use and reaction vessel, can only be divided into 12 batches, 8 batches or whole plate in use and once use.If use in batches; Then can not adopt and generally wash that the plate machine is washed plate and can only the filling of ground, one hole, a hole and inhale and abandon the washing that cleansing solution carries out reacting hole; Operate very loaded down with trivial detailsly, and one batch of detection/test specimen number is minimum will reach 8 parts or 12 parts, otherwise can cause the waste of reagent.If the whole disposable use of plate, then detection/test specimen number will reach 96 parts or 96 parts of multiple parts, otherwise also can cause the waste of reagent.
2, the reagent of qualitative detection comprises that at least sample diluting liquid, cleansing solution, enzyme conjugates, enzyme reaction substrate, developer, stop buffer, positive control serum, negative control sera amount to 8 kinds; Quantitative reagent comprises at least that then the standard items of dilution, cleansing solution, enzyme conjugates, enzyme reaction substrate, developer, stop buffer, at least 5 levels or calibration object amount to 11 kinds; Each detectable all will be come splendid attire with reagent bottle; And all need change imbibition nozzle sample, reagent, cleansing solution the container that comes to annotate respectively during a kind of reagent of every use to reaction---in the micropore of microwell plate; Not only reagent bottle kind and quantity are a lot; And the operation of filling reagent is also very loaded down with trivial details, even use the full-automatic enzyme non-analysis meter or change the loading amount of each reagent, the species number of employed reagent can not reduce.
3, the client to the configuration of the quantity of test item reagent set and use and be item number * 96 person-portions; Detect 10 projects if desired; Then the configuration of reagent and use number must be 10 * 96 person-portions; If have only a duplicate samples need detect 10 Projects with Different, also need dispose the reagent of 10 * 96 person-portions.
4, detectable and sample are open mode in testing process, cause between all ingredients easily or the cross pollution between each sample and influence testing result or directly influence the operator.
5, a kind of detectable can only detect a project, if detect two or three projects, then needs three kinds of different detection reagent or kit, and carries out detecting operation respectively.
6, the color and luster of each reacting hole colored solutions is only carried out one time optical readings when selecting single wavelength method; When the double wave regular way, then select the optical filter of another kind of wavelength to carry out optical readings again one time, can not carry out the optical readings more than twice or twice at different time points the color and luster of same reacting hole colored solutions.
7, adopt the mode of washing in batches, promptly a microwell plate is once annotated or inhale and abandon 2 holes, 4 holes, 8 holes, 12 holes or 96 hole cleansing solutions, can not annotate in batches separately or inhale and abandon cleansing solution.
8, the detection of single project can only be carried out, or a plurality of projects can not be detected simultaneously.
9, each detection or each bar code that detects no reagent information; Or bar code information is not comprehensive; Or bar code information is merely the information of kit; Can only could understand or know the product batch number and the term of validity information of detectable through the sign of checking the kit external packing box, and the information of being known is not controlled in testing process, has very big randomness.
10, the instrument application of sample, add working fluid/reagent, the imbibition system is the rectilinearity structure, straight line moves or walks.
11, mechano-electronic structure and control system thereof such as no liquid mixing/mixing.
12, the difference of the visual agents useful for same of detection and difference, and select arbitrarily and use.
13, detection method is traditional E LISA method, by selected reagent decision.
14, can not be immediately per sample situation carry out the individual event order or multinomial purpose detects.
Though, the Chinese invention patent that the applicant 2010-01-04 proposes, number of patent application: 201010042628.X; Solved above-mentioned technical matters, but these innovation and creation come with some shortcomings also still, such as: 1, in the liquid storage parts, be provided with liquid level sensor; What adopt is 4 liquid level resistance principle of induction, in order to tracer liquid memory space, poor reliability; Can't stablize the use amount of accurately learning working fluid, the clean result quality can not get ensureing; 2, the detection of dynamic method that optical detection system adopts needs three cover optical detection systems, and 6 optical channels detect, and have changed the transmission direction of light in optical fiber; The fine length that connects three cover optical detection systems is inconsistent, has optical channel difference, poor stability; Affected by environment big, cost is high; 3, liquid-way system is complicated, and the solenoid valve, the washing pump quantity that need are many, and cost is also just high; 4, the injector drive device of filling mechanism is to form at the bottom surface of bottom plate installation stepper motor and screw rod, poor stability, and the life-span is short; 5, the filling pin of filling mechanism is born puncture and filling work simultaneously, the puncture poor reliability, and the filling pin life-span is short; 6, height at the bottom of the washing pin employing spring structure adaptation hole of washing mechanism rises because the length of spring compressed acting force is a straight line, and acting force increases with the increase of compression travel, and the washing pin damages easily, the life-span weak point; Technological deficiencies such as 7, the employing storage heater heats the reaction tray part, exists heating inhomogeneous, and noise is big, and the thermal efficiency is low.
Summary of the invention
Fundamental purpose of the present invention is to solve existing automatic lmunoassays analyzer and exists liquid level resistance principle of induction; In order to the tracer liquid memory space; Poor reliability; Can't stablize the use amount of accurately learning working fluid, the technological deficiency that the clean result quality can not get ensureing, and a kind of automatic lmunoassays analyzer and the detection method thereof that propose.
For solving technical matters proposed by the invention; The technical scheme that adopts is: a kind of automatic lmunoassays analyzer includes: mainframe parts, reaction tray parts, filling mechanism, washing mechanism, liquid storage parts, liquid-way system, attemperating unit, optical detection system and control system; Described mainframe parts comprise framework soleplate, on framework soleplate, are provided with pillar, on pillar, are provided with bottom plate and upper mounted plate from the bottom up successively; Described reaction tray parts are located between upper mounted plate and the bottom plate; Circular array is shown the bearing groove that card is put the reagent ship that is made up of sample well, reagent wells, light path permeability and flat reacting hole and dilution holes that is used to more than four on the reaction tray parts, below bottom plate, is fixed with the reaction tray driver part that is used to drive the rotation of reaction tray parts with it; The described mechanism that annotates is located at the top of upper mounted plate, is used for absorption and filling to sample or reagent between the reagent ship hole that is placed on reaction tray parts bearing groove; Said filling mechanism includes injection device, filling pin, filling pin mobile device and filling pin rinse bath; Described washing mechanism is located at the top of upper mounted plate, is used for the reacting hole of the reagent ship of the bearing groove that is placed on the reaction tray parts is washed; Described washing mechanism includes liquid feeding washing pin, discharge opeing washing pin, washing pin mobile device and washing pin rinse bath; Described liquid storage parts are located on the framework soleplate, include the cleaning fluid bottle that is used for the splendid attire cleaning fluid, be used for the Washing liquid bottle of splendid attire A cleansing solution and be used for the Washing liquid bottle of splendid attire B cleansing solution; Described liquid-way system connects liquid storage parts, washing mechanism and filling mechanism, is used for each working fluid of liquid storage parts is transported to washing mechanism and filling mechanism; Described attemperating unit is located at the below of reaction tray parts, is used for the reagent ship that reaction tray parts card is put is heated; Described optical detection system includes optical transmitting set body and optical receiving set body; Said optical transmitting set body is located at the top of upper mounted plate; Said optical receiving set body is located at reaction tray parts belows and the corresponding position of optical transmitting set body, is used for the material that card is placed in the reagent ship reacting hole of reaction tray bearing groove is carried out optical detection; Described control system includes instrument control circuit and is written in the embedded software in the instrument control circuit; The washing pin mobile device of the filling pin mobile device of the reaction tray driver part of described reaction tray parts, filling mechanism, washing mechanism, each washing pump and solenoid valve, attemperating unit, optical detection system and the instrument control circuit of liquid-way system are controlled running according to the programmed instruction of embedded software; The cleaning fluid bottle of described liquid storage parts, A Washing liquid bottle and B Washing liquid bottle are three independently bottles; Bottle bottom at cleaning fluid bottle, A Washing liquid bottle and B Washing liquid bottle respectively is provided with a weight that is used to monitor working fluid in each bottle, and the online weighing induction installation of each bottle working fluid use amount and residual signal is provided to control system.
Described optical transmitting set body includes two groups of electroluminescent lamps that are arranged side by side; What the light source of two groups of electroluminescent lamps all adopted is led light source; Front end at led light source is provided with optical fiber; Front end at optical fiber is provided with optical filter, and the front end of optical filter also is provided with light-collecting lens, and wherein two electroluminescent lamps have the optical filter of different wave length; Described optical receiving set body includes and two corresponding light-collecting lens of electroluminescent lamp and two optical receivers being located at the rear of light-collecting lens.
Said filling mechanism also includes: first puncture needle and second puncture needle; Described filling pin includes the first filling pin and the second filling pin; Described filling pin mobile device includes coaster, is provided with and the hard-wired coaster guide rail of upper mounted plate at arse, is provided with at the side of coaster guide rail and drives the coaster shifting part that coaster moves horizontally along the coaster guide rail; Wherein, described coaster includes a coaster support, vertically is provided with the first needle guide rail, the second needle guide rail, the 3rd needle guide rail and the 4th needle guide rail in the front of coaster support; The described first filling pin, the second filling pin, first puncture needle and second puncture needle are respectively through the first filling pin slide block, the second filling pin slide block, the first puncture needle slide block and the second puncture needle slide block and the first needle guide rail, the second needle guide rail, the 3rd needle guide rail and the 4th needle guide rail activity clamping; Be provided with at the back side of coaster support and be used for filling pin that alternatively up and down moves the first filling pin and the second filling pin and promote drive unit and be used for the puncture needle that alternatively up and down moves first puncture needle and second puncture needle and promote drive unit; Described filling pin promotes drive unit and includes to be installed on and move the pin motor on the coaster support; The axle that moves the pin motor is provided with and moves the pin driving pulley; On the coaster support, be provided with and move the passive belt wheel of pin; Moving the pin driving pulley and moving to be provided with between the passive belt wheel of pin and move pin and be with synchronously, moving pin and be fixedly connected with strap clamp respectively and between the first filling pin slide block and the second filling pin slide block in the both sides of band synchronously; It is identical with filling pin lifting driving device structure that described puncture needle promotes drive unit, and the pin that moves that puncture needle promotes drive unit is fixedly connected with strap clamp respectively and between the first puncture needle slide block and the second puncture needle slide block in the both sides of band synchronously; Wherein, Described coaster shifting part includes and the hard-wired coaster motor of upper mounted plate; And be located at the passive belt wheel of coaster on the upper mounted plate; The axle of coaster motor is provided with the coaster driving pulley, is provided with coaster between the passive belt wheel of coaster driving pulley and coaster and is with synchronously, and coaster band synchronously is fixedly connected with the bottom of coaster support through strap clamp.
Described washing mechanism, include the first identical washing mechanism of structure and the second washing mechanism; Two groups are washed mechanism, have included: liquid feeding washing pin, discharge opeing washing pin, washing pin mobile device and washing pin rinse bath; Described washing pin mobile device includes a wash stand that is fixedly mounted on the upper mounted plate; On wash stand, be provided with washing motor; On the washing motor axle, be provided with driving pulley, on wash stand, also be provided with driven pulley, between driving pulley and driven pulley, be provided with synchronous band; Vertically be provided with guide rod at wash stand, movable sleeve is useful on the washing needle stand that pin is washed in fixing liquid feeding washing pin and discharge opeing on guide rod; Be provided with the guide rail parallel with guide rod at wash stand, on guide rail, be provided with slide block, slide block is provided with one and is fixedly connected with synchronous band; Running with synchronous band drives the strap clamp that slide block slides up and down, and slide block is provided with the fixture block that raises up, and the washing needle stand is provided with fixture block and matches; When slide block rises; Rise with slide block and liquid feeding to be washed pin and discharge opeing washing pin lift, when slide block descends, with the draw-in groove that washs the free-falling of needle stand self gravitation.
Described liquid-way system includes the cleansing solution in the cleaning fluid in the cleaning fluid bottle, the A Washing liquid bottle is drawn to pipeline, solenoid valve, the washing pump of discharging in the fluid injection washing pin of first washing components; Be used for being connected pipeline, the positive displacement pump of discharge opeing to main waste liquid tank with the discharge opeing washing pin of first washing components; Waste liquid in first washing components washing pin rinse bath is drained into the pipeline in the main waste liquid tank; Cleansing solution in cleaning fluid in the cleaning fluid bottle, the B Washing liquid bottle is drawn to pipeline, solenoid valve, the washing pump of discharging in the fluid injection washing pin of second washing components; Be used for being connected pipeline, the positive displacement pump of discharge opeing to main waste liquid tank with the discharge opeing washing pin of second washing components; Waste liquid in second washing components washing pin rinse bath is drained into the pipeline in the main waste liquid tank, be used for the cleaning fluid of cleaning fluid bottle extract out be used for cleaning filling mechanism injection device and filling pin, pipeline, washing pump, solenoid valve and be used for the filling pin sink waste liquid that cleans filling mechanism is drained into the pipeline in the main waste liquid tank.
Described attemperating unit is one and the corresponding plate-like electric hot plate of reaction tray parts.
Described injection device of annotating mechanism is to adopt the stepper motor of encapsulating structure and the piston driver that screw rod constitutes.
Described upper mounted plate is provided with to be discerned the project bar code on the handle of reagent ship, and identification signal is flowed to the built-in screen bar code recognizer of control system.
On the bottom of main shaft, being provided with one, to be used to respond to the main axis rotation angle be that control system provides reaction tray parts mobile message, and by the scrambler of control system control step motor rotation state the reaction tray parts are accurately located.
The instrument control circuit of described control system includes the USB interface of setting up communication with main control system, can be through 1 ~ 10 said automatic lmunoassays analyzer operation of 1 main control system control.
A kind of method of using above-mentioned automatic lmunoassays analyzer realization immune detection, this method includes following steps:
1, testing sample is put into the sample well of reagent ship, posted on the handle of reagent ship and the corresponding project information bar code of sample;
2, reagent ship card is placed in the bearing groove of reaction tray parts;
3, start-up control system, the running of reaction tray parts rotates to the corresponding position of filling mechanism with the reagent ship; Mechanism is filled into the sample in the sample well in the dilution holes by filling; Dilution in one of them reagent wells joined be re-introduced in the reacting hole after diluting in the dilution holes, react and wash according to control system is pre-conditioned, in the washing process; Control system is according to before the washing and after the washing; The detection signal of three online weighing induction installations at the bottle end of cleaning fluid bottle, A Washing liquid bottle and B Washing liquid bottle calculates three kinds of working fluid consumptions, judges whether operate as normal of washing process, if not normal control system is warned prompting; After adding last a kind of reagent, can adopt dynamic method to read absorbance immediately or after reaction is accomplished, in reacting hole, inject the stop buffer cessation reaction, adopt end-point method to read absorbance then;
When 4, reading absorbance; The reaction tray parts move on to the pairing position of optical detection system with the rotation of reagent ship; By the optical detection system material in the reacting hole is carried out optical detection, and testing result is offered control system, handle, store and export by control system.
Described reagent is to detect used antigen or antibody, enzyme-labelled antigen or antibody, enzyme chromogenic substrate, dilution, adsorption liquid, stop buffer; Concrete reagent type is looked the requirement of test item and is provided with, and these reagent are concentrated and are contained in the specific disposable separate single person-portion reagent device.
Beneficial effect of the present invention is: novel immunologic detection method and instrument that the present invention adopts; Use independently, single part, special-purpose, disposable, reagent device reagent ship that planform is very unique; And the special-purpose automatic lmunoassays analyzer that matches with it; Compare with other immune analysis methods, reagent device and analytical instrument, have following advantage:
First; It is a kind of independently, single part detectable and analytical equipment; Need not as general ELISA method, use 12 * 8 types, 8 * 12 types or complete plate 96 hole special enzyme-linked immune microwell plates as antigen or antibody sandwich articles for use and reaction vessel, not have the waste of reagent as long as there is a duplicate samples can carry out the detection of respective items purpose in use.If the quantity of sample surpasses a, press the actual sample number and use this reagent and analytical equipment to get final product.
Second; No matter be qualitative detection or detection by quantitative; It detects necessary reagent with each and is contained in the reagent wells position of a reagent device, and need not detectable is come splendid attire with different reagent bottles respectively, and not only operation is very easy; And be not easy to cause bust, thereby guarantee the correctness of testing result.
The 3rd; It all has a special-purpose bar code to each reagent device; The numerical value of bar code comprises every and detects pairing test item code, detectable product batch number, the reagent term of validity, qualitative detection correction coefficient, quantitative measurement typical curve parameter, concrete enzyme linked immunoassay type, the information such as sequence number of reagent device; Can not arbitrarily be changed, during use strictness controlled, especially when use surpassing term of validity detectable; To be identified and stop and send examining report, thereby can guarantee the accuracy that detects.
The 4th, it is effectively separated each detectable and seals, and can not cause the cross pollution between all ingredients and influences testing result.
The 5th, it is a kind of reagent device that is exclusively used in the particular analysis instrument, in testing process with full automatic accurate charger annotate detectable or sample, operation automation, dosage is accurate, the accuracy of testing result and precision are high.
The 6th, in the configuration of the quantity of test item reagent set and use, all need be equipped with by reality uses and get final product, especially multinomial visual inspection are being surveyed, and are equipped with more in right amount, can not occur surpassing and dispose operating position.
The 7th; On a reagent device, can place the detectable of 2~4 projects, can carry out the detection of 2~4 projects of a sample simultaneously; 2~4 duplicate detection of the perhaps detection of 1~3 of a sample same project dilutability multiple, an or sample same project.
Eight, on detecting operation, adopt the instrument analytical method of full-automatic discrete enzyme linked immunological, thereby realized the full-automatic detection of independent individual event or the group of enzyme linked immunological project, guaranteed to detect with the property used;
Nine, reach in nature in test sample, both can carry out qualitative/detection by quantitative of single part, also can carry out the qualitative/detection by quantitative of sample in batches, guaranteed the dirigibility that detects;
Ten, detecting on interpretation and the data processing, adopt the terminal point method, adding stop buffer, after stopping to react, single main optical system for testing has been guaranteed the accuracy that detects, and stability is affected by environment little;
The 11, in the processing of detectable, the required reagent concentrated loads of various enzyme linked immunoassay in the reagent device of a uniqueness, have not only been guaranteed the independence that each item detects, more guaranteed the convenience that each detectable is used;
The 12, on detection speed, adopt rotary microseismic activity mode to quicken the hybrid reaction liquid phase, promote the combination between the reaction molecular; Make the reaction time shorten dramatically; Detection speed is improved, and has shortened the time hand-manipulated, has guaranteed the rapidity and the instantaneity that detect;
The 13, apparatus preparation accurate, complete temperature control system and reagent and fluid level detection system; Be quick on the draw, control accuracy is high, guarantees that enzyme linked immune assay reacts under steady temperature and liquid-phase condition; Not only guarantee the repeatability of testing result, more guarantee the accuracy that detects.
In addition, the technical scheme of the Chinese invention patent of the present invention and number of patent application: 201010042628.X creation is compared and is had following beneficial effect:
The first, respectively be provided with a weight that is used to monitor each bottle working fluid at the bottle end of cleaning fluid bottle, A Washing liquid bottle and B Washing liquid bottle; The online weighing induction installation of each bottle working fluid use amount and residual signal is provided to control system; Realize accurately monitoring in real time working fluid storage capacity and the use amount in the liquid storage parts; The good reliability of control is protected the quality of washing, when liquid-way system breaks down, can in time find.
The second, optical detection system is a cover; Can add last a kind of reaction reagent to reacting hole after, adopt dynamic method to read absorbance; Also can stop to read absorbance after the reaction, and lack than triple optical readings before and the needed optical detection system quantity of several data fitting analyzing method (needing three covers) to reacting hole adding stop buffer.
Three, liquid-way system is simplified, and the solenoid valve, the washing pump quantity that need are few, have lowered production cost.
Four, the injector drive device stability of the filling mechanism of employing sleeve structure is good, and volume is little, and cost is low, long service life.
Five, adopt electric hot plate that the reaction tray parts are heated, homogeneous heating, noiselessness, the thermal efficiency is high.
Six, filling mechanism has increased the puncture needle that the puncture of film is sealed in the aperture that is exclusively used in the reagent ship under the situation that power part does not increase, and makes the filling pin be specifically designed to the filling of reagent or sample, in the life-span of improving the filling pin, has improved the puncture reliability simultaneously.
Seven, washing mechanism adopts gravity structure to adapt to height at the bottom of the hole, after discharge opeing washing pin touches the end, does not receive moving down of slide block and increases the downward acting force of discharge opeing washing pin, has avoided the damage of washing pin, and the life-span is longer, and is more reliable.
Eight, main control software is installed on the external main control system; Can realize 1 ~ 10 automatic lmunoassays analyzer operation of 1 main control system control through USB interface; The user can be according to sample size flexible configuration analyser, thereby satisfies the detection demand of large, medium and small type medical institutions comprehensively.
Description of drawings
Fig. 1 is an one-piece construction synoptic diagram of the present invention;
Fig. 2 is the plan structure synoptic diagram of reaction tray parts of the present invention;
Fig. 3 is the A-A sectional structure synoptic diagram of Fig. 2;
Fig. 4 is the cross section structure synoptic diagram of reagent ship of the present invention;
Fig. 5 is the structural representation before reagent ship of the present invention is in the bearing groove that is placed into the reaction tray parts;
Fig. 6 is reagent ship of the present invention structural representation after the bearing groove operation that is placed into the reaction tray parts is accomplished;
Fig. 7 is the positive perspective view of the mechanism that annotates of the present invention;
Fig. 8 is the back side perspective view of the mechanism that annotates of the present invention;
Fig. 9 is the wherein perspective view of one group of washing mechanism of the present invention;
Figure 10 is the structural representation of optical detection of the present invention system;
Figure 11 is an electric hot plate mounting structure synoptic diagram of the present invention;
Figure 12 is the structure principle chart of liquid-way system of the present invention;
Figure 13 is a control system block scheme of the present invention.
Embodiment
Below in conjunction with accompanying drawing and preferred specific embodiment, structure of the present invention is done explanation further:
Shown in Fig. 1 and Fig. 5, include: mainframe parts 1, reaction tray parts 2, reagent ship 3, filling mechanism 4, washing mechanism 5, liquid storage parts 6, liquid-way system 7, attemperating unit 8, optical detection system 9, built-in screen bar code recognizer 10 and control system.
Described mainframe parts 1 comprise framework soleplate 11, on framework soleplate 11, are provided with pillar 12, on pillar 12, are provided with bottom plate 13 and upper mounted plate 14 from the bottom up successively.
Shown in ginseng Fig. 1, Fig. 2, Fig. 3, Fig. 5 and Fig. 6; Described reaction tray parts 2 are located between upper mounted plate 14 and the bottom plate 13; Said reaction tray parts 2 are a circular discoid structure; Circular array is shown more than four the bearing groove 21 that card is put reagent ship 3 that is used to of (in the accompanying drawing be example explanation with 30) above that, and described reagent ship 3 is connected in the bearing groove 21 of reaction tray parts 2.In order to make 3 clampings of reagent ship stable, the front end cell wall of bearing groove 21 is provided with the slide block 23 that clamps the reagent ship, and slide block 23 is applied the spring 24 of elastic force, and the lock pin 25 that comes off of anti-limited slip block.Below bottom plate 13, be fixed with a reaction tray driver part 22 that is used to drive 2 rotations of reaction tray parts.Said reaction tray driver part 22 includes a main shaft 221 that is connected with reaction tray parts 2 center fixation; Main shaft 221 is connected with bottom plate 13 with spindle drum 223 through bearing 222; On main shaft 221, be provided with a driven pulley 224; Side at spindle drum 223 is provided with one and bottom plate 13 hard-wired electric machine support seats 225, in electric machine support seat 225, is provided with a stepper motor 226, and the motor shaft 2261 of stepper motor 226 is provided with a driving pulley 227; Be provided with synchronous cog belt 228 at driving pulley 227 and 224 of driven pulleys, on electric machine support seat 225, be provided with belt wheel stretcher 2261.On the bottom of main shaft 221, also being provided with one, to be used to respond to main shaft 221 anglecs of rotation be that control system provides the reaction tray parts 2 mobile messages, and by the scrambler 229 of control system control step motor 226 operating conditions.
Shown in Fig. 4, described reagent ship 3 includes the handle 32 of a matrix 31 and matrix one end.Described matrix 31 is provided with a sample well 311, five reagent wells 312, a reacting hole 313 and a dilution holes 314, is the flat of light path permeability at the bottom of the hole of reacting hole 313; That is to say at the bottom of the hole splendid attire colourless/during blank reagent solution, the absorbance of visible/ultraviolet/fluorescence is leveled off to zero.Post the project bar code on the handle 32, the information of project bar code comprises: the test item code of detectable, detectable product batch number, the reagent term of validity, qualitative detection correction coefficient, quantitative measurement typical curve parameter, concrete enzyme linked immunoassay type, the sequence number of reagent device etc.
Shown in Fig. 1, Fig. 7 and Fig. 8, the described mechanism 4 that annotates is located at the top of upper mounted plate 14, is used for absorption and filling to sample or reagent between reagent ship 3 holes that are placed on reaction tray parts bearing groove 21; Said filling mechanism 4 includes injection device 41, filling pin 42,43, filling pin mobile device 46 and filling pin rinse bath 47; Compare also with existing filling mechanism and to include: first puncture needle 44 and second puncture needle 45.
Wherein, described injection device 41 is that existing syringe, stepper motor, screw mandrel and position transducer are constituted with assembling mode, has changed into plunger, screw mandrel and motor shaft are integrated encapsulation; Precision is high, and error is little, and index of aging becomes ten to tens of times improvement; Can use reagent more accurately; Practice thrift cost, volume reduces to 1/5th of original volume, service free and maintenance.
Described filling pin includes the first filling pin 42 and the second filling pin 43; Described filling pin mobile device 46 is used for the first filling pin 42, second filling pin 43, first puncture needle 44 and second puncture needle, 45 executive levels or moves up and down operation, realizes the filling to the puncture of sealing film, sample or the reagent of reagent ship 3.
Filling pin mobile device 46 includes coaster 461; Be provided with and upper mounted plate 14 hard-wired coaster guide rails 462 in coaster 461 bottoms; Side at coaster guide rail 462 is provided with driving coaster 461 along the coaster shifting part 463 that coaster guide rail 462 moves horizontally, and that is to say that the combination of coaster guide rail 462 and coaster shifting part 463 realizes coaster 461 is realized moving horizontally.Described coaster 461 includes a coaster support 4611, vertically is provided with the first needle guide rail 4612, the second needle guide rail 4613, the 3rd needle guide rail 4614 and the 4th needle guide rail 4615 in the front of coaster support 4611; The described first filling pin 42, the second filling pin 43, first puncture needle 44 and second puncture needle 45 are respectively through the first filling pin slide block 4616, the second filling pin slide block 4617, the first puncture needle slide block 4618 and the second puncture needle slide block 4619 and the first needle guide rail 4612, the second needle guide rail 4613, the 3rd needle guide rail 4614 and the 4615 activity clampings of the 4th needle guide rail; Be provided with at the back side of coaster support 4611 and be used for the filling pin that alternatively up and down moves the first filling pin 42 and the second filling pin 43 and promote drive unit 4620 and be used for the puncture needle lifting drive unit 4621 that alternatively up and down moves first puncture needle 44 and second puncture needle 45.Described filling pin promotes drive unit 4620 and includes to be installed on and move pin motor 46201 on the coaster support 4611; The axle that moves pin motor 46201 is provided with and moves the pin driving pulley, on coaster support 4611, is provided with and moves the passive belt wheel 46203 of pin, is moving the pin driving pulley and is moving to be provided with between the passive belt wheel 46203 of pin and move pin and be with 46204 synchronously; The said pin that moves is a kind of belts that have latch with 46204 synchronously; Move pin synchronously with 46204 both sides respectively and the first filling pin slide block 4616 and second 4617 of the filling pin slide blocks be fixedly connected with strap clamp, move pin motor 46201 through one and control the first filling pin 42 and the second filling pin 43 simultaneously, when moving pin motor 46201 and working; The first filling pin 42 is opposite with the second filling pin, 43 moving directions; For example: when the first filling pin 42 was lifted to the extreme higher position, the second filling pin 43 drops to extreme lower position, and was opposite; When the first filling pin 42 dropped to extreme lower position, the second filling pin 43 rose to the extreme higher position.It is identical with filling pin lifting drive unit 4620 structures that described puncture needle promotes drive unit 4621; Puncture needle promote drive unit 4621 move pin synchronously with 46214 both sides respectively and the first puncture needle slide block 4618 and 4619 of the second puncture needle slide blocks be fixedly connected with strap clamp, pin motor 46211 is alternately controlled first puncture needle 44 and second puncture needle 45 moves up and down by moving.
Described coaster shifting part 463 includes and upper mounted plate 14 hard-wired coaster motors 4631; And be located at the passive belt wheel 4633 of coaster on the upper mounted plate 14; The axle of coaster motor 4631 is provided with coaster driving pulley 4632; Be provided with coaster between the passive belt wheel 4633 of coaster driving pulley 4632 and coaster and be with 4634 synchronously, coaster is fixedly connected with the bottom of coaster support 4611 through strap clamp with 4634 synchronously, by coaster motor 4631 control movable blocks.
Shown in Fig. 1 and Fig. 9, the described mechanism 5,5 ' of washing includes the first identical washing mechanism 5 of structure and the second washing mechanism 5 '.With the first washing mechanism is that example is elaborated: the first washing mechanism 5 includes: liquid feeding washing pin 51, discharge opeing washing pin 52, washing pin mobile device 53 and washing pin rinse bath 54.
Described washing pin mobile device 53 includes a wash stand 531 that is fixedly mounted on the upper mounted plate 14; On wash stand 531, be provided with washing motor 532; On 532 of washing motors, be provided with driving pulley 533; On wash stand 531, also be provided with driven pulley 534, between driving pulley 533 and driven pulley 534, be provided with and be with 535 synchronously; Vertically be provided with guide rod 536 at wash stand 531, movable sleeve is useful on the washing needle stand 537 of fixing liquid feeding washing pin 51 and discharge opeing washing pin 52 on guide rod 536; Be provided with the guide rail 538 parallel side by side at wash stand 531, on guide rail 538, be provided with slide block 539 with guide rod 536, slide block 539 be provided with one be with 535 to be fixedly connected synchronously; With driving the strap clamp 5391 that slide block 539 slides up and down with 535 running synchronously, slide block 539 is provided with the fixture block 5392 that raises up, and washing needle stand 537 is provided with fixture block 5392 and matches; When slide block 539 rises, rise with slide block 539, thereby being washed pin 51, upwards lifts liquid feeding with discharge opeing washing pin 52; When slide block 539 descends; With the draw-in groove 5371 of washing needle stand 537 self gravitation free-fallings, that is to say that liquid feeding washing pin 51 and discharge opeing washing pin 52 are the tops that freely are suspended on slide block 539 through washing needle stand 537, break away from slide block 539 suppressing action power; Because the aspect ratio liquid feeding washing pin 51 of discharge opeing washing pin 52 is low; Be to rely on discharge opeing washing pin 52 to touch the end to discharge cleansing solution when washing, thereby this structure prolong the life-span of discharge opeing washing pin 52 effectively.
Shown in Fig. 1, described liquid storage parts 6 are located on the framework soleplate 11, include cleaning fluid bottle 61, A Washing liquid bottle 62 and B Washing liquid bottle 63; Cleaning fluid bottle 61, A Washing liquid bottle 62 and B Washing liquid bottle 63 are three and are separated from each other independently bottle; The bottle end at cleaning fluid bottle 61, A Washing liquid bottle 62 and B Washing liquid bottle 63 is equipped with a weight that is used to monitor working fluid in each bottle 61,62,63; To control system the online weighing induction installation 631 (only demonstrating an online weighing induction installation among the figure) of each bottle working fluid use amount and residual signal is provided; Realize accurately monitoring in real time working fluid storage capacity and the use amount in liquid storage parts 6; Good reliability is protected the quality of washing, when liquid-way system breaks down, can in time find.
Shown in Fig. 1 and Figure 12, described liquid-way system 7 connects liquid storage parts 6, washing mechanism 5 and filling mechanism 4, is used for the working fluid of liquid storage parts 6 is transported to washing mechanism 5 and filling mechanism 4.
This liquid-way system 7 includes the cleansing solution in the cleaning fluid in the cleaning fluid bottle 61, the A Washing liquid bottle 62 is drawn to pipeline, solenoid valve 71, the washing pump 72 of discharging in the fluid injection washing pin 51 of first washing components; Be used for being connected pipeline, the positive displacement pump 74 of discharge opeing to main waste liquid tank 73 with the discharge opeing washing pin 52 of first washing components; Waste liquid in first washing components washing pin rinse bath 54 is drained into the pipeline in the main waste liquid tank 73; Cleansing solution in cleaning fluid in the cleaning fluid bottle 61, the B Washing liquid bottle 63 is drawn to pipeline, solenoid valve (75), the washing pump (76) of discharging in the fluid injection washing pin 51 ' of second washing components; Be used for being connected pipeline, the positive displacement pump (77) of discharge opeing to main waste liquid tank (73) with the discharge opeing washing pin 52 ' of second washing components; Waste liquid in second washing components washing pin rinse bath 54 ' is drained into the pipeline in the main waste liquid tank (73); Be used for extracting the cleaning fluid of cleaning fluid bottle 61 out be used for cleaning filling mechanism injection device 41 and filling pin 42,43 pipeline, washing pump 78, solenoid valve 711,79,710, and be used for filling pin sink 47 waste liquids that clean filling mechanism are drained into the pipeline in the main waste liquid tank 73.Main waste liquid tank 73 also is connected with waste liquid barrel 712, is provided with positive displacement pump 713 and pipeline between main waste liquid tank 73 and the waste liquid barrel 712.
Shown in Fig. 3 and Figure 11, described attemperating unit 8 is located at the below of reaction tray parts 2, is used for reaction tray parts 2 are heated, and that is to say reagent ship 3 reacting holes are heated, the temperature environment that the sampling reaction is required.What attemperating unit 8 of the present invention adopted is a block-shaped and corresponding plate-like electric hot plate of the bearing grooves reaction tray parts.
Shown in Fig. 1 and Figure 10; Described optical detection system 9 includes optical transmitting set body 91 and optical receiving set body 92; Said optical transmitting set body also is located at the top of upper mounted plate, and the optical receiving set body is located at the below of reaction tray parts accordingly, is used for the reacting hole J of reagent ship is carried out optical detection; Each optical transmitting set body 91 includes two groups of electroluminescent lamps that are arranged side by side; Two groups of electroluminescent lamps all include led light source 911; Front end at led light source 911 is provided with optical fiber 912; Front end at optical fiber 912 is provided with optical filter 913, and the front end of optical filter 913 also is provided with light-collecting lens 914, and wherein two electroluminescent lamps have the optical filter of different wave length; Described optical receiving set body 92 includes and two corresponding light-collecting lens 921 of electroluminescent lamp and two optical receivers 922 being located at the rear of light-collecting lens.In the use, move optical transmitting set body 91 as required and make corresponding electroluminescent lamp corresponding with reacting hole 313, use the material in the reacting hole 313 of reagent ship is carried out optical detection with optical receiving set with optical receiving set body 92.This optical detection system 9 compares with existing optical detection system, changes existing Halogen lamp LED into led light source, and is luminous stable, is difficult for decay, and the calibration cycle is long; Calibrate simple and easyly, elapsed time is short; Not fragile, the life-span is long; Thermal value reduces significantly, and is energy-conservation.In addition, because the change and the increase of reagent components used in the present invention make the testing that needs three optical detection systems 9 to accomplish originally only need a cover optical detection system can accomplish 9, provide cost savings; Also have,, need 6 optical channels altogether owing to be originally that the light that a light source is sent through optical fiber is transferred to the optical detection system of three diverse locations simultaneously; Every fiber lengths is inconsistent, and passage is long, has channel difference; Complex structure; Poor stability, affected by environment big, and the present invention has solved the problems referred to above up hill and dale.
Shown in Fig. 1, described built-in screen bar code recognizer 10 is located on the upper mounted plate 14, is used for the bar code of pasting on the reagent ship handle is discerned, and identification signal is flowed to control system, realizes the automatic corresponding output of testing result and sample message.
With reference to shown in Figure 13, described control system includes instrument control circuit and is written in the embedded software in the instrument control circuit, and described instrument control circuit includes USB interface, is connected with the main control system communication through USB interface; The washing pin mobile device 53 of the filling pin mobile device 46 of the reaction tray driver part 22 of described reaction tray parts 2, filling mechanism 4, washing mechanism, each washing pump of liquid-way system are connected with main control system through instrument control circuit with solenoid valve, attemperating unit 8, optical detection system 9, built-in screen bar code recognizer 10; Programmed instruction according to embedded software is controlled running; Embedded software is accepted the heat transfer agent input of all parts simultaneously and is received the detection information of optical detection system 9, built-in screen bar code recognizer 10, and carries out data processing according to the program of embedded software; Through associative operations such as USB interface executable operations input in main control system, demonstration output and printings.
Use above-mentioned automatic lmunoassays analyzer and realize the method for immune detection, this method includes following steps:
1, testing sample is put into the sample well of reagent ship, posted on the handle of reagent ship and the corresponding project information bar code of sample;
2, reagent ship card is placed in the bearing groove of reaction tray parts;
3, start-up control system, the running of reaction tray parts rotates to the corresponding position of filling mechanism with the reagent ship; Mechanism is filled into the sample in the sample well in the dilution holes by filling; Dilution in one of them reagent wells joined be re-introduced in the reacting hole after diluting in the dilution holes, react and wash according to control system is pre-conditioned, in the washing process; Control system is according to before the washing and after the washing; The detection signal of three online weighing induction installations at the bottle end of cleaning fluid bottle, A Washing liquid bottle and B Washing liquid bottle calculates three kinds of working fluid consumptions, judges whether operate as normal of washing process, if not normal control system is warned prompting.After adding last a kind of reagent, can adopt dynamic method to read absorbance immediately or after reaction is accomplished, in reacting hole, inject the stop buffer cessation reaction, adopt end-point method to read absorbance then;
When 4, reading absorbance; The reaction tray parts move on to the pairing position of optical detection system with the rotation of reagent ship; By the optical detection system material in the reacting hole is carried out optical detection, and testing result is offered control system, handle, store and export by control system.
Described reagent is to detect used antigen or antibody, enzyme-labelled antigen or antibody, enzyme chromogenic substrate, dilution, adsorption liquid, stop buffer; Concrete reagent type is looked the requirement of test item and is provided with, and these reagent are concentrated and are contained in the specific disposable separate single person-portion reagent device.

Claims (12)

1. an automatic lmunoassays analyzer includes: mainframe parts (1), reaction tray parts (2), filling mechanism (4), washing mechanism's (5,5 '), liquid storage parts (6), liquid-way system (7), attemperating unit (8), optical detection system (9) and control system; Described mainframe parts (1) comprise framework soleplate (11), on framework soleplate (11), are provided with pillar (12), on pillar (12), are provided with bottom plate (13) and upper mounted plate (14) from the bottom up successively; Described reaction tray parts (2) are located between upper mounted plate (14) and the bottom plate (13); Reaction tray parts (2) are gone up circular array and are shown the bearing groove (21) that card is put the reagent ship (3) that is made up of sample well, reagent wells, light path permeability and flat reacting hole and dilution holes that is used to more than four, are fixed with it in the below of bottom plate (13) to be used to drive the reaction tray driver part (22) that reaction tray parts (2) rotate; Described filling mechanism (4) is located at the top of upper mounted plate (14), is used for absorption and filling to sample or reagent between reagent ship (3) hole that is placed on reaction tray parts bearing groove (21); Said filling mechanism (4) includes injection device (41), filling pin (42,43), filling pin mobile device (46) and filling pin rinse bath (47); Described washing mechanism (5) is located at the top of upper mounted plate (14), is used for the reacting hole (313) of the reagent ship (3) of the bearing groove (21) that is placed on the reaction tray parts is washed; Described washing mechanism (5) includes liquid feeding washing pin (51,51 '), discharge opeing washing pin (52,52 '), washing pin mobile device (53) and washing pin rinse bath (54,54 '); Described liquid storage parts (6) are located on the framework soleplate (11), the Washing liquid bottle (63) that includes the cleaning fluid bottle (61) that is used for the splendid attire cleaning fluid, the Washing liquid bottle (62) that is used for splendid attire A cleansing solution and be used for splendid attire B cleansing solution; Described liquid-way system (7) connects liquid storage parts (6), washing mechanism's (5,5 ') and filling mechanism (4), is used for each working fluid of liquid storage parts (6) is transported to washing mechanism's (5,5 ') and filling mechanism (4); Described attemperating unit (8) is located at the below of reaction tray parts (2), is used for the reagent ship (3) that reaction tray parts (2) card is put is heated; Described optical detection system (9) includes optical transmitting set body (91) and optical receiving set body (92); Said optical transmitting set body (91) is located at the top of upper mounted plate (14); Said optical receiving set body (92) is located at reaction tray parts (2) belows and the corresponding position of optical transmitting set body (91), is used for the material that card is placed in the reagent ship reacting hole (313) of reaction tray bearing groove (21) is carried out optical detection; Described control system includes instrument control circuit and is written in the embedded software in the instrument control circuit; The washing pin mobile device (53) of the filling pin mobile device (46) of the reaction tray driver part (22) of described reaction tray parts (2), filling mechanism (4), washing mechanism, each washing pump and solenoid valve, attemperating unit (8), optical detection system (9) and the instrument control circuit of liquid-way system are controlled running according to the programmed instruction of embedded software;
It is characterized in that: the cleaning fluid bottle (61) of described liquid storage parts (6), A Washing liquid bottle (62) and B Washing liquid bottle (63) are three independently bottles; Bottle bottom at cleaning fluid bottle (61), A Washing liquid bottle (62) and B Washing liquid bottle (63) respectively is provided with a weight that is used to monitor working fluid in each bottle (61,62,63), and the online weighing induction installation (631) of each bottle working fluid use amount and residual signal is provided to control system.
2. a kind of automatic lmunoassays analyzer according to claim 1; It is characterized in that: described optical transmitting set body (91) includes two groups of electroluminescent lamps that are arranged side by side; What the light source of two groups of electroluminescent lamps all adopted is led light source (911); Front end at led light source (911) is provided with optical fiber (912); Front end at optical fiber (912) is provided with optical filter (913), and the front end of optical filter (913) also is provided with light-collecting lens (914), and wherein two electroluminescent lamps have the optical filter (913) of different wave length; Described optical receiving set body (92) includes with two corresponding light-collecting lens of electroluminescent lamp (921) and is located at two optical receivers (922) at the rear of light-collecting lens.
3. a kind of automatic lmunoassays analyzer according to claim 1 is characterized in that: said filling mechanism (4) also includes: first puncture needle (44) and second puncture needle (45); Described filling pin includes the first filling pin (42) and the second filling pin (43); Described filling pin mobile device (46) includes coaster (461); Be provided with and the hard-wired coaster guide rail of upper mounted plate (14) (462) in coaster (461) bottom, be provided with at the side of coaster guide rail (462) and drive the coaster shifting part (463) that coaster (461) moves horizontally along coaster guide rail (462); Wherein, Described coaster (461) includes a coaster support (4611), vertically is provided with the first needle guide rail (4612), the second needle guide rail (4613), the 3rd needle guide rail (4614) and the 4th needle guide rail (4615) in the front of coaster support (4611); The described first filling pin (42), the second filling pin (43), first puncture needle (44) and second puncture needle (45) are respectively through the first filling pin slide block (4616), the second filling pin slide block (4617), the first puncture needle slide block (4618) and the second puncture needle slide block (4619) and the first needle guide rail (4612), the second needle guide rail (4613), the 3rd needle guide rail (4614) and the 4th needle guide rail (4615) activity clamping; Be provided with at the back side of coaster support (4611) and be used for the filling pin that alternatively up and down moves the first filling pin (42) and the second filling pin (43) and promote drive unit (4620) and be used for the puncture needle lifting drive unit (4621) that alternatively up and down moves first puncture needle (44) and second puncture needle (45); Described filling pin promotes drive unit (4620) and includes to be installed on and move pin motor (46201) on the coaster support (4611); The axle that moves pin motor (46201) is provided with and moves the pin driving pulley; On coaster support (4611), be provided with and move the passive belt wheel of pin (46203); Moving the pin driving pulley and moving to be provided with between the passive belt wheel of pin (46203) and move pin and be with (46204) synchronously, move pin synchronously with the both sides of (46204) respectively and the first filling pin slide block (4616) and second annotate and be fixedly connected with strap clamp between pin slide block (4617); It is identical with filling pin lifting drive unit (4620) structure that described puncture needle promotes drive unit (4621), and the pin that moves that puncture needle promotes drive unit (4621) is fixedly connected with strap clamp respectively and between the first puncture needle slide block (4618) and the second puncture needle slide block (4619) with the both sides of (46214) synchronously; Wherein, Described coaster shifting part (463) includes and the hard-wired coaster motor of upper mounted plate (14) (4631); And be located at the passive belt wheel of coaster (4633) on the upper mounted plate (14); The axle of coaster motor (4631) is provided with coaster driving pulley (4632); Be provided with coaster between coaster driving pulley (4632) and the passive belt wheel of coaster (4633) and be with (4634) synchronously, coaster is fixedly connected with the bottom of coaster support (4611) through strap clamp with (4634) synchronously.
4. a kind of automatic lmunoassays analyzer according to claim 1 is characterized in that: described washing mechanism (5,5 ') includes the first identical washing mechanism (5) of structure and second washing mechanism's (5 '); Two groups of washing mechanisms (5,5 ') have included: liquid feeding washing pin (51,51 '), discharge opeing washing pin (52,52 '), washing pin mobile device (53) and washing pin rinse bath (54,54 '); Described washing pin mobile device (53) includes a wash stand (531) that is fixedly mounted on the upper mounted plate (14); On wash stand (531), be provided with washing motor (532); On washing motor (532) axle, be provided with driving pulley (533); On wash stand (531), also be provided with driven pulley (534), between driving pulley (533) and driven pulley (534), be provided with synchronous band (535); On wash stand (531), vertically be provided with guide rod (536), go up movable sleeve at guide rod (536) and be useful on the washing needle stand (537) that fixedly liquid feeding washing pin (51) and discharge opeing wash pin (52); Be provided with the guide rail (538) parallel at wash stand (531) with guide rod (536); On guide rail (538), be provided with slide block (539); Slide block (539) is provided with one and is fixedly connected with synchronous band (535); Running with synchronous band (535) drives the strap clamp (5391) that slide block (539) slides up and down, and slide block (539) is provided with the fixture block (5392) that raises up, and washing needle stand (537) is provided with fixture block (5392) and matches; When slide block (539) rises; Rise with slide block (539) and liquid feeding to be washed pin (51) and discharge opeing washing pin (52) lift, when slide block (539) descends, with the draw-in groove (5371) that washs needle stand (537) self gravitation free-falling.
5. a kind of automatic lmunoassays analyzer according to claim 4; It is characterized in that: described liquid-way system includes the cleansing solution in the cleaning fluid in the cleaning fluid bottle (61), the A Washing liquid bottle (62) is drawn to pipeline, solenoid valve (71), the washing pump (72) of discharging in the fluid injection washing pin (51) of first washing components; Be used for being connected pipeline, the positive displacement pump (74) of discharge opeing to main waste liquid tank (73) with the discharge opeing washing pin (52) of first washing components; Waste liquid in first washing components washing pin rinse bath (54) is drained into the pipeline in the main waste liquid tank (73); Cleansing solution in cleaning fluid in the cleaning fluid bottle (61), the B Washing liquid bottle (63) is drawn to pipeline, solenoid valve (75), the washing pump (76) of discharging in the fluid injection washing pin (51 ') of second washing components; Be used for being connected pipeline, the positive displacement pump (77) of discharge opeing to main waste liquid tank (73) with the discharge opeing washing pin (52 ') of second washing components; Waste liquid in second washing components washing pin rinse bath (54 ') is drained into the pipeline in the main waste liquid tank (73); Be used for extracting the cleaning fluid of cleaning fluid bottle (61) out be used for cleaning filling mechanism's injection device (41) and filling pin (42,43) pipeline, washing pump (78), solenoid valve (711,79,710), and be used for filling pin sink (47) waste liquid that cleans filling mechanism is drained into the pipeline in the main waste liquid tank (73).
6. a kind of automatic lmunoassays analyzer according to claim 1 is characterized in that: described attemperating unit (8) is one and the corresponding plate-like electric hot plate of reaction tray parts (2).
7. a kind of automatic lmunoassays analyzer according to claim 1 is characterized in that: the injection device (41) of described filling mechanism (4) is to adopt the stepper motor of encapsulating structure and the piston driver that screw rod constitutes.
8. a kind of automatic lmunoassays analyzer according to claim 1; It is characterized in that: described upper mounted plate (14) is provided with to be discerned the project bar code on the handle of reagent ship (3), and identification signal is flowed to the built-in screen bar code recognizer (10) of control system.
9. a kind of automatic lmunoassays analyzer according to claim 1; It is characterized in that: on the bottom of main shaft (221), being provided with one, to be used to respond to main shaft (221) anglec of rotation be that control system provides reaction tray parts (2) mobile message, and by the scrambler (229) of control system control step motor (226) operating condition the reaction tray parts are accurately located.
10. a kind of automatic lmunoassays analyzer according to claim 1; It is characterized in that: the instrument control circuit of described control system includes the USB interface that is used for setting up with main control system communication, can be through 1 ~ 10 said automatic lmunoassays analyzer operation of 1 main control system control.
11. an application rights requires 1 method to each said automatic lmunoassays analyzer realization immunoassay detection of claim 10, this method includes following steps:
1), testing sample is put into the sample well of reagent ship, posts on the handle of reagent ship and the corresponding project information bar code of sample;
2), reagent ship card is placed in the bearing groove of reaction tray parts;
3), the start-up control system, reaction tray parts runnings rotates to the corresponding position of filling mechanism with the reagent ship; Mechanism is filled into the sample in the sample well in the dilution holes by filling; Dilution in one of them reagent wells joined be re-introduced in the reacting hole after diluting in the dilution holes, react and wash according to control system is pre-conditioned, in the washing process; Control system is according to before the washing and after the washing; The detection signal of three online weighing induction installations at the bottle end of cleaning fluid bottle, A Washing liquid bottle and B Washing liquid bottle calculates three kinds of working fluid consumptions, judges whether operate as normal of washing process, if not normal control system is warned prompting; After adding last a kind of reagent, can adopt dynamic method to read absorbance immediately or after reaction is accomplished, in reacting hole, inject the stop buffer cessation reaction, adopt end-point method to read absorbance then;
When 4), reading absorbance; The reaction tray parts move on to the pairing position of optical detection system with the rotation of reagent ship; By the optical detection system material in the reacting hole is carried out optical detection, and testing result is offered control system, handle, store and export by control system.
12. according to the said immunologic detection method of claim 11; It is characterized in that: described reagent is to detect used antigen or antibody, enzyme-labelled antigen or antibody, enzyme chromogenic substrate, dilution, adsorption liquid, stop buffer; Concrete reagent type is looked the requirement of test item and is provided with, and these reagent are concentrated and are contained in the specific disposable separate single person-portion reagent device.
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