CN102116771A

CN102116771A - Enzyme-linked immune analysis method and fully-automatic enzyme-linked immune analyzer

Info

Publication number: CN102116771A
Application number: CN201010042628XA
Authority: CN
Inventors: 何林; 刘清波; 阳辉; 伍坚
Original assignee: Shenzhen Yhlo Biotech Co Ltd
Current assignee: Shenzhen Yhlo Biotech Co Ltd
Priority date: 2010-01-04
Filing date: 2010-01-04
Publication date: 2011-07-06
Anticipated expiration: 2030-01-04
Also published as: CN102116771B

Abstract

The invention relates to an enzyme-linked immune analysis method and a fully-automatic enzyme-linked immune analyzer. The analyzer comprises a rack component, a washing component, a sample adding/reagent adding component, a heating and temperature control component, a fluid path system, an input and output device, an optical measurement component and a control system, wherein the rack component comprises a rack soleplate; a pillar is arranged on the rack soleplate; a lower fixed plate and an upper fixed plate are arranged on the pillar from bottom to top in sequence; a circular reaction plate is arranged between the lower fixed plate and the upper fixed plate; the circular reaction plate is connected with the upper fixed plate and the lower fixed plate through a central shaft; a first motor is fixedly arranged at the lower part of the lower fixed plate; and the first motor is used for driving the circular reaction plate to rotate through a first transmission mechanism. When in use, the enzyme-linked immune analysis method and the fully-automatic enzyme-linked immune analyzer can carry out the detection of corresponding projects without wasting reagent through only one sample; and detection reagents need not to be respectively contained in different reagent bottles, so that the operation is very convenient, and the operation error is not easily caused, thereby ensuring the accuracy of the detection results.

Description

A kind of enzyme-linked immune analytic method and full-automatic enzyme-linked immunoassay instrument

Technical field

The present invention relates to a kind of enzyme-linked immune analytic method and full-automatic enzyme-linked immunoassay instrument.This method and instrument are mainly used in biological sample such as human sample's serum, sputum, urine, ight soil, the antigenic substance in the bile etc. such as the antigen of various pathogenic microorganisms, or the antibody that produces by these pathogenic microorganism antigens infection bodies, and autoimmune disease such as systemic loupus erythematosus, phosphatide syndrome, rheumatoid arthritis, chorionitis, autoimmune liver disease, Sjogren syndrome, systemic vasculitis, polymyositis and dermatomyositis, autoantibody in disease such as autoimmune thyroid disease and the gastrointestinal disease blood samples of patients carries out the fully-automatic analyzer of quantitative measurement or qualitative detection with enzyme-linked immunoassay method.

Background technology

Enzyme linked immunosorbent detection now 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.This method has the specificity and the susceptibility of height, and nearly all soluble antigen one 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 the antigen of pathogen or antibody, protein, non-peptide hormone, medicine, 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 bag by good solid phase carrier, enzyme conjugates, chromogenic substrate, reaction terminating liquid, various dilution and damping fluid, and used titer, correcting fluid, positive control thing or control serum, feminine gender controlled thing or control serum etc. in detecting.Because enzyme-linked immunoassay method needs 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.

At the sample of annotating in the enzyme linked immunosorbent detection, reagent, washing and four troublesome operation of interpretation chromogenic reaction result, prior art---enzyme-linked immuno assay instrument adopts separate type and combined type two class methods to handle respectively.

Separate type enzyme linked immunological instrument mainly contains microplate reader and washes the plate machine, their through application of sample, add reagent, hatch, process such as washing, come result of determination by the absorbance analysis at last.Microplate reader 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 SPECTRACLASSIC, 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 microplate reader and has washed the plate machine, and they are one of important instrument of laboratory indispensability.The outfit of these microplate reader, 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 microplate reader, 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 enzyme-linked immuno assay instrument 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, by instrument by all kinds enzyme linked immunoassay or client in advance the program of design carry out automatically.In full-automatic enzyme-linked immunoassay system, FAME, CAA, the AMP of Australia Si Bang company of BIORAD company, Minilyeser, the TEKTIME of ORGANO company of TECAN company, Personal LAB, the DSX of DYNDRX company of DIVISION STRUMENTI company, the Flex Tek2 of Aksu company, the TRIURUS of BIOASIA company etc. that brand that present laboratory is commonly used and model have HAMILTON company.Steps such as the automatic sample disposal system is mainly used in and finishes complex operation in the enzyme linked immunological experiment, the application of sample of manually makeing mistakes easily, adds reagent, dilution, titration, hatches, washing, after finishing by the microplate reader result of determination, MINITRED, the HYPREPTLUS of HYPERION company, the DLASUltra of DYNEX company etc. that brand that the laboratory is commonly used and model have TECAN company.Pipelining formula enzyme linked immunological combined system is process and the 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, finish course of reaction jointly.The visible assembly line type full-automatic enzyme-linked immunologic workstation patent of invention of the technology prototype publication number CN101303350A 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 enzyme-linked immuno assay instrument 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 now can measure the microplate reader of 384 hole microwell plates by LABSYSTEMS company and the release of BIOTEK company and released by BIORAD company can measure 384 holes, 1536 hole microwell plates, has also developed appearance at the plate machine of washing of 384 holes and 1536 hole microwell plates simultaneously; Can place nearly 10 kinds of wavelength filter and adopt the microplate reader of grating beam splitting principle to 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.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, 12 * 8 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 sample diluting liquid, cleansing solution, enzyme conjugates, enzyme reaction substrate, developer, stop buffer, positive control serum, negative control sera amounts to 8 kinds, quantitative reagent then comprises dilution, cleansing solution, enzyme conjugates, enzyme reaction substrate, developer, stop buffer, the standard items of 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 to change the imbibition nozzle sample of annotating respectively during a kind of reagent of every use, reagent, cleansing solution is to the container of 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 different projects, also need to 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 detectable or kit, and carries out detecting operation respectively.

6, the optical system of instrument only comprises a group and one group of optoelectronic induction device of multi-wavelength's optical filter, lacks two groups or two groups of above optical filters that comprise a plurality of wavelength and corresponding optoelectronic induction device thereof.

7, 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 optical readings more than twice or twice at different time points the color and luster of same reacting hole colored solutions.

8, 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.

9, the detection of single project can not be carried out, or a plurality of projects can not be detected simultaneously.

10, each detection or each bar code that detects no reagent information, or bar code information is not comprehensive, or bar code information only is the information of kit, can only could understand or know the product batch number and the term of validity information of detectable by 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.

11, the instrument application of sample, add body fluid/reagent, the imbibition system is the rectilinearity structure, straight line moves or walks.

12, mechano-electronic structure and control system thereof such as no liquid mixing/mixing.

13, the difference of the visual agents useful for same of detection and difference, and select arbitrarily and use.

14, detection method is traditional E LISA method, by selected reagent decision.

15, can not be immediately per sample situation carry out the individual event order or multinomial purpose detects.

Summary of the invention

The technical matters that the present invention solves is: provide a kind of and can carry out independently, the enzyme-linked immune analytic method of single part detection.

Another object of the present invention provide a kind ofly can carry out independently, the full-automatic enzyme-linked immunoassay instrument of single part detection.

Technical scheme of the present invention is: a kind of enzyme-linked immune analytic method is provided, this method comprises reagent device and full-automatic enzyme-linked immunoassay instrument, this reagent device be independently, the single part required necessary reagent of enzyme linked immunosorbent detection that is packaged with, be inserted into after inserting sample to be detected on the reagent device among the full-automatic enzyme-linked immunoassay instrument, operation full-automatic enzyme-linked immunoassay instrument operating system software and data management system software promptly can be treated the project of the needs detection in the test sample and carry out qualitative or detection by quantitative; There is not the waste of reagent as long as there is a duplicate samples can carry out the detection of respective items purpose in use.

The above-mentioned project that needs to detect comprises projects such as antibody or antigen.

The mentioned reagent device includes a matrix, is provided with position, two or more holes on matrix, and wherein at least one position, hole is used to place testing sample, and all the other positions, hole are used to place the micropore of enzyme linked immunological microwell plate.

The mentioned reagent device includes a matrix, on matrix, be provided with position, two or more holes, wherein at least one position, hole is used to place testing sample, and at least one position, hole is used to place reagent sample, and all the other positions, hole are used to place the micropore of enzyme linked immunological microwell plate.

Be provided with a handle that is used for the bar code of hand-held and stickup reagent detection information at described matrix one end.

Be used to place the shape of the position, hole of enzyme linked immunological microwell plate in the above-mentioned matrix, can be provided with and make according to the micropore external form or the type that detect selected enzyme linked immunological microwell plate, it can be more expediently be embedded in the single reacting hole of enzyme linked immunological microwell plate in the matrix.

This reacting hole can be used as the encrusting substance micropore, reaction vessel, colorimetric micropore/cup, the dried detectable of splendid attire of enzyme linked immunological etc., and it is provided with specifically that inspection is surveyed the difference of project and method principle and different.

Placing the position, hole of the required reagent of enzyme linked immunosorbent detection in the above-mentioned matrix, both can be V-type or the U type groove in the matrix, also can be the reacting hole of enzyme linked immunological microwell plate.In the open peristoma of this groove or reacting hole, all post and seal film.This seal film when not using, can stop liquid in the groove or in the reacting hole overflow with block film outside the entering of material such as gas, moisture, grit, bacterium etc., can allow imbibition nozzle or aspirating needle penetrate when using very expediently detecting to draw or filling liquid.The reagent of reagent groove or reacting hole institute splendid attire, can be the used antigen of detection or antibody, enzyme-labelled antigen or antibody, enzyme chromogenic substrate, thinning agent, or be the used container of diluted sample or detect the pilot process reaction vessel that it is provided with specifically that inspection is surveyed the difference of project and different.

On above-mentioned handle, paste the bar code that reagent detects information, comprise the test item code, detectable product batch number, the reagent term of validity, qualitative detection correction coefficient, quantitative measurement typical curve parameter of detectable, the sequence number of concrete enzyme linked immunoassay type, reagent and analytical equipment etc.Information/numerical value that all bar codes comprise is all inequality.The set specifying information of each bar code/numerical value inspection is surveyed the difference of sequence number of project, trial production lot number, the reagent term of validity, qualitative detection correction coefficient, quantitative measurement typical curve parameter, concrete enzyme linked immunoassay type, reagent and different.

A kind of full-automatic enzyme-linked immunoassay instrument provided by the invention comprises housing assembly, wash, application of sample/add reagent assembly, heating and temperature-controlling module, liquid-way system, input-output unit, optical measurement assembly, control system; Described housing assembly comprises framework soleplate, on framework soleplate, be provided with pillar, on pillar, be provided with bottom plate and upper mounted plate from the bottom up successively, between bottom plate and upper mounted plate, be provided with circular reaction tray, described circular reaction tray is connected with bottom plate with upper mounted plate by central shaft, be fixed with first motor in the bottom plate bottom, first motor drives circular reaction tray by first gear train and rotates; Be provided with wash and application of sample/add reagent assembly described on the upper bottom surface of solid plate, described application of sample/add the reagent assembly is reciprocating along the slot direction of circular reaction tray by second motor and second gear train; Described liquid-way system is wash and application of sample/add the reagent assembly relevant liquid or reagent is provided; Described input-output unit is used to import associative operation information and output testing result.

Described circular reaction tray is provided with the slot that several are used to insert reagent device, and circular reaction tray is taken reagent device to wash institute correspondence position, finishes washing operation; Taking application of sample/add reagent assembly institute correspondence position to finishes application of sample, adds the reagent operation; Take the pairing position of optical measurement assembly to and finish the optical measurement operation.

Described circular reaction tray is driven in swing mode a little through first gear train by first motor, and the reactant of vibration in the test agent device reaches the purpose of mixing married operation.

Be fixed with the position correction device in described bottom plate bottom, pilot hole corresponding on position correction device and the circular reaction tray is accurately located circular reaction tray together.

Be fixed with the lock collar device in described bottom plate bottom, the lock collar device comprises electromagnetic lock, and when circular reaction tray quit work, the lock collar device inserted in the circular reaction tray lockhole, pins reaction tray.

Described sample/the add reagent assembly that adds is included in and is fixed with the horizontal guide rail of arranging along slot direction on the circular reaction tray on the upper mounted plate upper bottom surface, on horizontal guide rail, be provided with application of sample/add reagent rack, be provided with some first vertical guide rails on the reagent rack at application of sample/add, on first vertical guide rail, be provided with application of sample/add reagent needle stand, be provided with application of sample/add reagent needles on the reagent needle stand at application of sample/add.

Also be fixed with at described upper mounted plate rear portion and be used to clean application of sample/the add cleaning station of reagent needles; Be provided with at application of sample/add reagent rack rear portion and be used to drive application of sample/add the 3rd motor of reagent needle stand motion.

Described application of sample/add reagent needles is provided with being used to of being connected with control system and detects application of sample/the add liquid level sensor of reagent needles liquid level.

Described application of sample/add reagent needles to be connected to liquid-way system by pipeline, by liquid-way system according to predetermined experimental requirements control application of sample, add reagent and clean application of sample/the add process of reagent needles.

Described wash comprises the plurality of washing frame that is fixedly mounted on the upper mounted plate upper bottom surface, wash stand is provided with second vertical guide rail, second vertical guide rail is provided with the washing needle stand, washing is fixed with the washing pin on the needle stand, is provided with the 4th motor and is used for driving the washing pin to the washing of reagent device reacting hole topping up and get rid of cleansing solution by the washing needle stand on the washing needle stand; Below the washing pin, the correspondence position of bottom plate passes bottom plate and is provided with rinse bath, is used to wash the cleaning of pin; The washing pin is connected to liquid-way system by the road, and liquid-way system provides cleansing solution or cleaning fluid according to the order of predetermined requirement of experiment, gets rid of the waste liquid after cleaning.

Described heating and temperature-controlling module comprise the storage heater that is arranged on the bottom plate bottom surface, baffle plate along circular reaction tray cylindrical distribution, pass bottom plate and be provided with first thermosistor, be provided with second thermosistor at the upper mounted plate upper bottom surface, be connected the Instrument shell on the framework soleplate, Instrument shell is provided with radiator fan and air inlet; Wherein bottom plate, baffle plate and circular reaction tray constitute the constant temperature space of approximate sealing, and storage heater passes bottom plate and provides thermal source to the constant temperature space; Hot-air is blowed upper mounted plate by between circular reaction tray and baffle plate towards the slit of upper mounted plate, forms air curtain, forms keeping warmth space between upper mounted plate and bottom plate, and the gentleness that adds of guarantee reagent device is incubated; First thermosistor is used to detect the temperature in constant temperature space and controls the action of heating of storage heater, second thermosistor is used for the temperature in space in the detecting instrument shell, when temperature is higher than setting value, open radiator fan, discharge hot-air, suck cool exterior air from air intake opening, temperature in the lowering apparatus.

Described optical measurement assembly comprises that being arranged on being used on the framework soleplate controls the light source of brightness and wavelength, be installed with several front end concentration pieces at the upper mounted plate upper bottom surface, on the bottom plate upper bottom surface below the front end concentration piece, be installed with the rear end concentration piece, be provided with photoelectric sensor below the concentration piece of rear end, being provided with optical fiber between light source and front end concentration piece is connected, measuring light is sent by light source, pass to the front end concentration piece through optical fiber, pass the perforate on the upper mounted plate of front end concentration piece below, pass groove and perforate on the circular reaction tray, project on the photoelectric sensor through the rear end concentration piece, photoelectric sensor will be changed the electric signal that obtains and be sent to control system.

Described liquid-way system is included in the working fluid liquid bottle that framework soleplate is provided with, and the needed cleansing solution of washing reagent device is provided and cleans application of sample/the add storage of the cleaning fluid of reagent needles, washing pin; In working fluid liquid bottle, be provided with the working fluid liquid level sensor, in order to the tracer liquid memory space; The solenoid valve that is connected working fluid liquid bottle exit is used for the output of Control work liquid; Be connected in washing pump behind the solenoid valve and be used for the conveying of cleansing solution and cleaning fluid; Be connected solenoid valve behind the washing pump and be used to control cleansing solution and cleaning fluid to the output of washing pin; On rinse bath, be provided with the rinse bath sensor and be used for induction cleaning water level; The positive displacement pump that is connected in washing pin drain side is used to get rid of the waste liquid of washing and cleaning reagent device and the waste liquid in the rinse bath; The waste discharge pond that is connected the positive displacement pump outlet is used for temporary waste liquid; In the waste discharge pond, be provided with the liquid level that the waste discharge sensor is used to respond to waste liquid; Waste discharge pond outlet is connected with the waste discharge pump and is used to discharge waste liquid in the waste discharge pond; Be connected with waste liquid barrel at the waste discharge pump discharge, be used to collect waste liquid; Being connected with scavenging pump in working fluid liquid bottle exit is used for to application of sample/add reagent needles and cleaning station provides cleaning fluid; Solenoid valve is used for control provides cleaning fluid to cleaning station; Be connected in working fluid bottle, scavenging pump and application of sample/the add solenoid valve between the reagent needles and be used to be controlled to be application of sample/add reagent needles cleaning fluid is provided; The syringe that is connected on the solenoid valve is used for providing accurate cleaning fluid to reagent device.

Described control system comprises power interface, master control board, low-voltage-powered plate, interface board, power supply unit, power panel, actuating doors sensor, the 4th motor position sensor, syringe position transducer, second motor position sensor, position correction device position transducer; Power supply unit provides the power supply of direct supply, storage heater power supply, printer power supply and the light source of the various voltages that control circuit uses; Master control board is an instrument control center, load master control program, gather each road sensor information, accept operation requests through each input interface, the output steering order of working out in advance according to software systems and method document, handle the instrument operation and detect test, manage instrument state, and export corresponding information to outer computer, printer, touch display screen by output unit; Low-voltage-powered buttress provides according to the instruction of master control board high capacity such as each pump of liquid-way system, solenoid valve, liquid level sensor, dish lock is carried out and the driving power of collecting unit; Interface board interface is provided and outreach computing machine, external barcode scanner is connected, the input and output information.

Described software systems comprise the main control software of being made up of Single Chip Microcomputer (SCM) program and PLD program; Be installed on and outreach the instrument management software of undertaking debugging on the computing machine, safeguarding main control software; Receive instrument test experience data, and the data analysis system software that manages and analyze.

Described input-output unit comprises touch display screen, external barcode scanner, built-in barcode scanner, thermal printer, reagent device sensor, host interface, expansion service interface, alarming horn; Touch display screen display instrument operation interface and duty, by shielding the mode of operation of apparent membrane keyboard, layer menu and dialog box, realize instrument self checking and calibration, the calibration of reagent project is confirmed or input test sample and project information, assigns the experimental implementation instruction, maintenance tool, print and upload operations such as result data, the display instrument duty shows debugging and error message; External barcode scanner and built-in barcode scanner are used for identification agent device bar code information; Thermal printer is printed experimental result, instrument state, test result, debugging and error message in the automatic or manual mode; Whether each slot that the reagent device sensor is discerned circular reaction tray has reagent device; Host interface connects external computing machine, transmission experiment information; The expansion service interface is used for software systems and installs, is provided with, debugs and safeguard; When being used to gross error takes place, sends alarming horn alarm sound.

The present invention also is provided with casing assembly; Described casing assembly comprises the bearing structure of each assembly that is made of metal panel beating and machined part; On described bearing structure, be provided with the shell and the door closure that constitute by plastics; Under described bearing structure, be provided with the castor of mobile instrument, on described castor, be provided with the adjustable support foot cup that possesses the rubber shock-absorbing structure.

Novel enzyme linked immune analytic method and instrument that the present invention adopts, use independently, single part, special-purpose, disposable, the enzyme immune reaction reagent device that planform is very unique and the special-purpose full-automatic enzyme-linked immunoassay instrument that matches with it, compare with other enzyme-linked immune analytic methods, reagent device and analytical instrument, have following advantage:

First, it be a kind of independently, single part detectable and analytical equipment, need not as general ELISA method, use 12 * 8 types, 12 * 8 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, use this reagent and analytical equipment to get final product by the actual sample number.

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 reagent and analytical equipment, and need not detectable is come splendid attire with different reagent bottles respectively, 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 and analytical equipment, the numerical value of bar code comprise every detect pairing test item code, detect the trial production lot number, the information such as sequence number of the reagent term of validity, qualitative detection correction coefficient, quantitative measurement typical curve parameter, concrete enzyme linked immunoassay type, reagent and analytical equipment, can not arbitrarily be changed, strictness is controlled during use, especially when using above 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 and analytical equipment that is exclusively used in the particular analysis analytical 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 height.

The 6th, in the configuration of the quantity of test item reagent set and use, all use to be equipped with by reality 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 reagent and analytical equipment, 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 the independent individual event of enzyme linked immunological project or group, guaranteed to detect with the property used;

Nine, reach in nature in test sample, promptly 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 triple optical readings and several data fitting analyzing method, guaranteed the accuracy that detects;

The 11, in the processing of detectable, in the reagent and reaction unit of a uniqueness, instrument has not guaranteed the independence of every detection with the required reagent concentrated loads of various enzyme linked immunoassay, has 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, can obtain testing result in the shortest 30 minutes, 30 samples can send examining report at 30～90 minutes, had 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, the control accuracy height guarantees that enzyme linked immune assay reacts with liquid-phase condition under the invariance degree temperature, not only guarantee the repeatability of testing result, more guarantee the accuracy that detects.

Description of drawings

Fig. 1 is the structural representation of a kind of embodiment of reagent device among the present invention.

Fig. 2 is the plan structure synoptic diagram of Fig. 1.

Fig. 3 is the structural representation of the second kind of embodiment of reagent device among the present invention.

Fig. 4 is the plan structure synoptic diagram of Fig. 3.

Fig. 5 is the structural representation of the third embodiment of reagent device among the present invention.

Fig. 6 is the plan structure synoptic diagram of Fig. 5.

The structural representation of the 4th kind of embodiment of reagent device among Fig. 7 the present invention.

Fig. 8 is the plan structure synoptic diagram of Fig. 7.

Fig. 9 is the structural representation of the 5th kind of embodiment of reagent device among the present invention.

Figure 10 is the plan structure synoptic diagram of Fig. 9.

The structural representation of the 6th kind of embodiment of reagent device among Figure 11 the present invention.

Figure 12 is the plan structure synoptic diagram of Figure 11.

Figure 13 is a full-automatic enzyme-linked immunoassay instrument agent structure synoptic diagram among the present invention.

Figure 14 is a full-automatic enzyme-linked immunoassay instrument housing assembly structural representation.

Figure 15 is the perspective view of the circular reaction tray among Figure 14.

Figure 16 is a full-automatic enzyme-linked immunoassay instrument housing assembly structural representation.

Figure 17 is that full-automatic enzyme-linked immunoassay instrument application of sample adds reagent modular construction synoptic diagram.

Figure 18 is a full-automatic enzyme-linked immunoassay instrument wash structural representation.

Figure 19 is heating of full-automatic enzyme-linked immunoassay instrument and temperature-controlling module structural representation.

Figure 20 is a full-automatic enzyme-linked immunoassay instrument optical measurement assembly layout synoptic diagram.

Figure 21 is a full-automatic enzyme-linked immunoassay instrument liquid-way system principle schematic.

Figure 22 is a full-automatic enzyme-linked immunoassay instrument circuit system architecture synoptic diagram.

Figure 23 is a full-automatic enzyme-linked immunoassay instrument software system framework synoptic diagram.

Embodiment

Below in conjunction with accompanying drawing, the present invention is explained in more detail.

Please in conjunction with Fig. 1 to Figure 12, a kind of enzyme-linked immune analytic method of the present invention, this method comprises reagent device and full-automatic enzyme-linked immunoassay instrument, this reagent device be independently, the single part required necessary reagent of enzyme linked immunosorbent detection that is packaged with, be inserted into after inserting sample to be detected on the reagent device among the slot of the circular reaction tray of full-automatic enzyme-linked immunoassay instrument, operation full-automatic enzyme-linked immunoassay instrument operating system software and data management system software, the projects such as antigen in the test sample or antibody of promptly can treating are carried out qualitative or detection by quantitative; There is not the waste of reagent as long as there is a duplicate samples can carry out the detection of respective items purpose in use.

Above-mentioned circular reaction tray is a disk, is radiant with the center of circle of disk, is evenly distributed with several slots at the circumference of disk, and reagent device is inserted in the described slot.

Above-mentioned necessary reagent can be the reagent of qualitative detection, comprise that sample diluting liquid, cleansing solution, enzyme conjugates, enzyme reaction substrate, developer, stop buffer, positive control serum, negative control sera amount to 8 kinds, can be the reagent of detection by quantitative also, comprise that 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.

See also Fig. 1 and Fig. 2, the mentioned reagent device includes a matrix 10, (number in the figure is 1-7 to be provided with position, 7 holes on matrix 10, as long as in fact satisfy position, two or more hole among the present invention, that is to say that the position, hole can establish 2,3,4 ..., the position, hole is minimum will establish 2, but should not be greater than 10, down together), wherein first position, hole 1 is used to place testing sample, and all the other positions, hole are used to place the micropore of enzyme linked immunological microwell plate; Also can be as required wherein a part be used to place reagent.

See also Fig. 3 and Fig. 4, the mentioned reagent device includes a matrix 10, on matrix 10, be provided with position, 7 holes (number in the figure is 1-7), wherein first position, hole 1 is used to place testing sample, position, second hole 2 is the holes 9 that are used to place reagent, and all the other positions, hole are used to place the micropore of enzyme linked immunological microwell plate.

See also Fig. 5 and Fig. 6, Fig. 5 and reagent device shown in Figure 6 and Fig. 3 compare with embodiment shown in Figure 4, and its basic structure is identical, and different is among the figure position, second hole 2 and the 3rd position, hole (3) all are the holes 9 that are used to place reagent.

See also Fig. 7 and Fig. 8, Fig. 7 and reagent device shown in Figure 8 and Fig. 5 compare with embodiment shown in Figure 6, and its basic structure is identical, and different is to have position, three holes to be used to place the hole 9 of reagent among the figure.

Fig. 9 and Figure 10 have position, four holes to be used to place the hole 9 of reagent.

Figure 11 and Figure 12 have position, five holes to be used to place the hole 9 of reagent.

Be used to place the shape of the position, hole of enzyme linked immunological microwell plate in the above-mentioned matrix 10, can be provided with and make according to detecting selected enzyme linked immunological microwell plate external form or type, it can be more expediently be embedded in the single reacting hole of enzyme linked immunological microwell plate in the matrix.

Placing the position, hole of the required reagent of enzyme linked immunosorbent detection in the above-mentioned matrix 10, both can be V-type or the U type groove in the matrix, also can be the reacting hole of enzyme linked immunological microwell plate.In the open peristoma of this groove or reacting hole, all post and seal film.This seal film when not using, can stop liquid in the groove or in the reacting hole overflow with block film outside the entering of material such as gas, moisture, grit, bacterium etc., can allow imbibition nozzle or aspirating needle penetrate when using very expediently detecting to draw or filling liquid.The reagent of reagent groove or reacting hole institute splendid attire, can be the used antigen of detection or antibody, enzyme-labelled antigen or antibody, enzyme chromogenic substrate, thinning agent, or be the used container of diluted sample or detect the pilot process reaction vessel that it is provided with specifically that inspection is surveyed the difference of project and different.

Among the present invention, be provided with a handle 8 that is used for the bar code of hand-held and stickup reagent detection information at described matrix 10 1 ends.

On above-mentioned handle 8, paste the bar code that reagent detects information, comprise detectable the test item code, detect the sequence number of trial production lot number, the reagent term of validity, qualitative detection correction coefficient, quantitative measurement typical curve parameter, concrete enzyme linked immunoassay type, reagent and analytical equipment etc.Information/numerical value that all bar codes comprise is all inequality.The set specifying information of each bar code/numerical value inspection is surveyed the difference of sequence number of project, trial production lot number, the reagent term of validity, qualitative detection correction coefficient, quantitative measurement typical curve parameter, concrete enzyme linked immunoassay type, reagent and different.

See also Figure 13 to Figure 16, a kind of full-automatic enzyme-linked immunoassay instrument provided by the invention comprises housing assembly 11, wash 12, application of sample/add reagent assembly 13, heating and temperature-controlling module 14, liquid-way system 15, input-output unit 16, optical measurement assembly 17, control system 18; Described housing assembly 11 comprises framework soleplate 111, on framework soleplate 111, be provided with pillar 112, on pillar 112, be provided with bottom plate 113 and upper mounted plate 115 from the bottom up successively, between bottom plate 113 and upper mounted plate 115, be provided with circular reaction tray 114, described circular reaction tray 114 is connected with bottom plate 113 with upper mounted plate 115 by central shaft 116, be fixed with first motor, 118, the first motors 118 in bottom plate 113 bottoms and drive circular reaction tray 114 rotations by first gear train 117; Be provided with wash 12 and application of sample/add reagent assembly 13 described on the upper bottom surface of solid plate 115, described application of sample/add reagent assembly 13 is by second motor 136 and second gear train 139 slot 1110 directions reciprocating (seeing Figure 17) along circular reaction tray 114; Described liquid-way system 15 is wash 12 and application of sample/add reagent assembly 13 relevant liquid or reagent is provided; Described input-output unit 16 is used to import associative operation information and output testing result.Described circular reaction tray 114 is provided with several slots 1110 that is used to insert reagent device 10, and circular reaction tray 114 is taken reagent device 10 to wash 12 correspondence positions, finishes washing operation; Taking application of sample/add 13 correspondence positions of reagent assembly to finishes application of sample, adds the reagent operation; Take optical measurement assembly 17 pairing positions to and finish the optical measurement operation.Described circular reaction tray 114 is driven in swing mode a little through first gear train 117 by first motor 118, and the reactant of vibration in test agent device 10 reaches the purpose (realizing by the programmed control in the control system 18) of mixing married operation.Be fixed with position correction device 1113 in described bottom plate 113 bottoms, pilot hole 1114 corresponding on position correction device 1113 and the circular reaction tray 114 is accurately located (seeing Figure 16) to circular reaction tray 114 together.Be fixed with lock collar device 1112 in described bottom plate 113 bottoms, lock collar device 1112 comprises electromagnetic lock, and when circular reaction tray 114 quit work, lock collar device 1112 inserted in circular reaction tray 114 lockholes 1115, pins circular reaction tray 114.In the present embodiment, described pillar 112 is four, lays respectively at four jiaos of framework soleplate 111, and described bottom plate 113 and upper mounted plate 115 are positioned at the top of four pillars, is provided with circular reaction tray 114 between bottom plate 113 and upper mounted plate 115.Circular reaction tray 114 among Figure 15 is at a disk, the center of circle with disk is a radiant, circumference at disk is evenly distributed with several slots 1110, three reagent devices 10 have drawn respectively among the figure, one of them reagent device 10 is in the state of insertion, and another reagent device 10 is in half insertion state, and the 3rd reagent device 10 is in full insertion state, after described reagent device 10 inserts fully, can be located by jump ring 1141.

See also Figure 17, the described sample/add reagent assembly 13 of adding comprises horizontal guide rail 138, described horizontal guide rail 138 is arranged on fixed head 115 upper bottom surfaces, and along slot 1110 directions layout on the circular reaction tray 114, on horizontal guide rail 138, be provided with two application of samples/add reagent rack 134, be provided with one first vertical guide rail 133 on the reagent rack 134 at each application of sample/add, on each first vertical guide rail 133, be provided with application of sample/add reagent needle stand 132, be provided with application of sample/add reagent needles 131 on the reagent needle stand 132 at each application of sample/add.Also be fixed with at described upper mounted plate 115 rear portions and be used to clean application of sample/the add cleaning station 137 of reagent needles 131; Be provided with at application of sample/add reagent rack 134 rear portions and be used to drive application of sample/add the 3rd motor 135 of reagent needle stand 132 vertical movements.Described application of sample/add reagent needles 131 is provided with being used to of being connected with control system 18 and detects application of sample/add reagent needles 131 liquid level level detection mechanisms.Described application of sample/add reagent needles 131 to be connected to liquid-way system 15 by pipeline, by liquid-way system 15 according to predetermined experimental requirements control application of sample, add reagent and clean application of sample/the add process of reagent needles 131.

See also Figure 18, described wash 12 comprises: be fixedly mounted on the one or more wash stand 124 on upper mounted plate 115 upper bottom surfaces, be respectively arranged with second vertical guide rail 123 on each wash stand 124, second vertical guide rail 123 is provided with washing needle stand 122, washing is fixed with washing pin 121 on the needle stand 122, is provided with the 4th motor 125 and is used for driving washing pins 121 to the washing of reagent device 10 reacting hole topping ups and get rid of cleansing solution by washing needle stand 122 on washing needle stand 122; The correspondence position of bottom plate 113 passes bottom plate 113 and is provided with rinse bath 126 below the washing pin, is used to wash the cleaning of pin 121; Washing pin 121 is connected to liquid-way system 15 by the road, and liquid-way system 15 provides cleansing solution or cleaning fluid according to the order of predetermined requirement of experiment, gets rid of the waste liquid after cleaning.

See also Figure 19, described heating and temperature-controlling module 14 comprise the storage heater 142 that is arranged on bottom plate 113 bottom surfaces, baffle plate 143 along circular reaction tray 114 cylindricals distribution, pass bottom plate 113 and be provided with first thermosistor 141, be provided with second thermosistor 144 at the upper mounted plate upper bottom surface, be connected the Instrument shell 19 on the framework soleplate 111, Instrument shell 19 is provided with radiator fan 145 and air inlet 148; Wherein bottom plate 113, baffle plate 113 and circular reaction tray 114 constitute the constant temperature space 147 of approximate sealing, and storage heater 142 passes bottom plate 113 and provides thermal source to constant temperature space 147; Hot-air is by 143 on circular reaction tray 114 and baffle plate, blows to upper mounted plate 115 towards the slit 146 of upper mounted plate 115, forms air curtain, forms keeping warmth space between upper mounted plate 115 and bottom plate 113, guarantee reagent device 10 add gentle insulation; First thermosistor 141 is used to detect the temperature in constant temperature space 147 and controls the action of heating of storage heater 142, second thermosistor 144 is used for the temperature in space in the detecting instrument shell 19, when temperature is higher than setting value, open radiator fan 145, discharge hot-air, suck cool exterior air from air intake opening 148, temperature in the lowering apparatus.

See also Figure 20, described optical measurement assembly 17 comprises: be arranged on the brightness on the framework soleplate 111 and the light source 181 of controlled wavelength, be installed with several front end concentration pieces 185 at the upper mounted plate upper bottom surface, on 113 upper bottom surfaces of the bottom plate below the front end concentration piece, be installed with rear end concentration piece 184, be provided with photoelectric sensor 183 below the rear end concentration piece 184, being provided with optical fiber 185 between light source 181 and front end concentration piece is connected, measuring light is sent by light source 181, pass to front end concentration piece 182 through optical fiber 185, pass the perforate on the front end concentration piece 182 below upper mounted plates 115, pass groove and perforate on the circular reaction tray 114, project on the photoelectric sensor 183 through rear end concentration piece 184, photoelectric sensor 183 converts light signal to electric signal and is sent to control system 18.

See also Figure 21, described liquid-way system 15 is included in three working fluid liquid bottles 1501,1503,1505 that framework soleplate 111 is provided with, and washing reagent device 10 needed cleansing solutions is provided and cleans application of sample/the add storage of the cleaning fluid of reagent needles 131, washing pin 121; In working fluid liquid bottle 1501,1503,1505, be provided with working fluid liquid level sensor 1502,1504,1506, in order to the tracer liquid memory space; The solenoid valve 1507,1508,1509,1510 that is connected working fluid liquid bottle 1501,1503,1505 exits is used for the output of Control work liquid; Be connected in washing pump 1511,1512 behind the solenoid valve 1510 and be used for the conveying of cleansing solution and cleaning fluid; Be connected solenoid valve 1513,1514 behind the washing pump 1511,1512 and be used to control cleansing solution and cleaning fluid to 121 outputs of washing pin; On rinse bath 126, be provided with rinse bath sensor 1517,1521 and be used for induction cleaning water level; The positive displacement pump 1515,1516,1518,1519,1520,1522,1523 that is connected in washing pin 121 drain sides is used to get rid of the waste liquid of washing and cleaning reagent device 10 and the waste liquid in the rinse bath 126; The waste discharge pond 1524 that is connected positive displacement pump 1515,1516,1518,1519,1520,1522,1523 outlets is used for temporary waste liquid; In waste discharge pond 1524, be provided with the liquid level that waste discharge sensor 1525,1526 is used to respond to waste liquid; Waste discharge pond 1524 outlet is connected with waste discharge pump 1527 and is used to discharge waste liquid in the waste discharge pond 1524; Be connected with waste liquid barrel 1528 in 1527 outlets of waste discharge pump, be used to collect waste liquid; Being connected with scavenging pump 1529 in working fluid liquid bottle 1501 exits is used for to application of sample/add reagent needles 131 and cleaning station 137 provides cleaning fluid; Solenoid valve 1530,1531 is used for control provides cleaning fluid to cleaning station 137; Be connected in working fluid bottle 1501, scavenging pump 1529 and application of sample/the add solenoid valve 1532,1533,1534,1335 between the reagent needles and be used to be controlled to be application of sample/add reagent needles 131 cleaning fluid is provided; The syringe 1536 that is connected on the solenoid valve 1534,1535 is used for providing accurate cleaning fluid to reagent device 10.

See also Figure 22, described control system 18 comprises power interface 1701, master control board 1705, low-voltage-powered plate 1706, interface board 1704, power supply unit 1702, power panel 1703, actuating doors sensor 1707, the 4th motor position sensor 1708, syringe position transducer 1709, second motor position sensor 1710, position correction device position transducer 1711; Power supply unit 1702 provides direct supply, storage heater 142 power supplys, printer 1606 power supplys and light source 181 power supplys of the various voltages of control circuit use; Master control board 1705 is an instrument control center, load master control program, gather each road sensor information, accept operation requests through each input interface, work out rule output steering order in advance according to software systems and method document, handle the instrument operation and detect test, manage instrument state, and export corresponding information to outer computer, printer 1606, touch display screen 1607 by output unit; Low-voltage-powered plate 1706 provides according to the instruction of master control board 1705 high capacity such as liquid-way system 15 each pump, solenoid valve, liquid level sensor, dish lock is carried out and the driving power of collecting unit; Interface board 1704 interface is provided and outreach computing machine, external barcode scanner 1603 is connected, the input and output information.

Described input-output unit 16 comprises touch display screen 1607, external barcode scanner 1603, built-in barcode scanner 1608 thermal printers 1606, reagent device sensor 1605, host interface 1601, expansion service interface 1602, alarming horn 1604; Touch display screen 1607 display instrument operation interface and duties, by shielding the mode of operation of apparent membrane keyboard, layer menu and dialog box, realize instrument self checking and calibration, the calibration of reagent project is confirmed or input test sample and project information, assigns the experimental implementation instruction, maintenance tool, print and upload operations such as result data, the display instrument duty shows debugging and error message; External barcode scanner 1603 and built-in barcode scanner 1608 are used for identification agent device 10 bar code information; Thermal printer 1606 is printed experimental result, instrument state, test result, debugging and error message in the automatic or manual mode; Whether each slot 1110 of the circular reaction tray 114 of reagent device sensor 1605 identifications has reagent device 10; Host interface 1601 connects external computing machine, transmission experiment information; Expansion service interface 1602 is used for software systems and installs, is provided with, debugs and safeguard; Alarming horn 1604 sends alarm sound when being used to gross error takes place.

See also Figure 23, described software systems comprise the main control software of being made up of Single Chip Microcomputer (SCM) program 1771 and PLD program 1,772 1770; Be installed on and outreach the instrument management software 1780 of undertaking debugging on the computing machine, safeguarding main control software; Acquisition instrument test experience data, and manage the data analysis system software 1790 of analysis.

The present invention also is provided with casing assembly 19; Described casing assembly 19 comprises the bearing structure of each assembly that is made of metal panel beating and machined part; On described bearing structure, be provided with the shell and the door closure that constitute by plastics; Under described bearing structure, be provided with the castor of mobile instrument, on described castor, be provided with the adjustable support foot cup (signal of not drawing) that possesses the rubber shock-absorbing structure.

Claims

1. full-automatic enzyme-linked immunoassay instrument is characterized in that: comprise housing assembly (11), wash (12), application of sample/add reagent assembly (13), heating and temperature-controlling module (14), liquid-way system (15), input-output unit (16), optical measurement assembly (17), control system (18); It is characterized in that: described housing assembly (11) comprises framework soleplate (111), on framework soleplate (111), be provided with pillar (112), on pillar (112), be provided with bottom plate (113) and upper mounted plate (115) from the bottom up successively, between bottom plate (113) and upper mounted plate (115), be provided with circular reaction tray (114), described circular reaction tray (114) is connected with bottom plate (113) with upper mounted plate (115) by central shaft (116), be fixed with first motor (118) in bottom plate (113) bottom, first motor (118) drives circular reaction tray (114) by first gear train (117) and rotates; Be provided with wash (12) and application of sample/add reagent assembly (13) described on the upper bottom surface of solid plate (115), reagent assembly (13) passes through second motor (136) and second gear train (139) is reciprocating along slot (1110) direction of circular reaction tray (114) for described application of sample/add; Described liquid-way system (15) is wash (12) and application of sample/add reagent assembly (13) relevant liquid or reagent is provided; Described input-output unit (16) is used to import associative operation information and output testing result.

2. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, described circular reaction tray (114) is provided with several slots that is used to insert reagent device (10) (1110), circular reaction tray (114) is taken reagent device (10) to wash (12) institute correspondence position, finishes washing operation; Taking application of sample/add reagent assembly (13) institute correspondence position to finishes application of sample, adds the reagent operation; Take the pairing position of optical measurement assembly (17) to and finish the optical measurement operation.

3. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, described circular reaction tray (114) is driven in swing mode a little through first gear train (117) by first motor (118), and the reactant of vibration in test agent device (10) reaches the purpose of mixing married operation.

4. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, be fixed with position correction device (1113) in described bottom plate (113) bottom, position correction device (1113) is gone up corresponding pilot hole (1114) with circular reaction tray (114) and together circular reaction tray (114) is accurately located.

5. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, be fixed with lock collar device (1112) in described bottom plate (113) bottom, lock collar device (1112) comprises electromagnetic lock, when circular reaction tray (114) when quitting work, lock collar device (1112) inserts circular reaction tray (114)) in the lockhole (1115), pin reaction tray (21).

6. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, described sample/the add reagent assembly (13) that adds is included in to be fixed with on upper mounted plate (115) upper bottom surface along circular reaction tray (114) and goes up the horizontal guide rail (138) that slot (1110) direction is arranged, on horizontal guide rail (138), be provided with application of sample/add reagent rack (134), be provided with some first vertical guide rails (133) on the reagent rack (134) at application of sample/add, on first vertical guide rail (133), be provided with application of sample/add reagent needle stand (132), be provided with application of sample/add reagent needles (131) on the reagent needle stand (132) at application of sample/add.

7. full-automatic enzyme-linked immunoassay instrument according to claim 1 is characterized in that, also is fixed with at described upper mounted plate (115) rear portion to be used to clean application of sample/the add cleaning station (137) of reagent needles (131); Be provided with at application of sample/add reagent rack (134) rear portion and be used to drive application of sample/add the 3rd motor (135) of reagent needle stand (132) motion.

8. full-automatic enzyme-linked immunoassay instrument according to claim 1 is characterized in that, described application of sample/add reagent needles (131) is provided with being used to of being connected with control system (18) and detects application of sample/add reagent needles (131) liquid level level detection mechanism.

9. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, described application of sample/add reagent needles (131) to be connected to liquid-way system (15) by pipeline, by liquid-way system (15) according to predetermined experimental requirements control application of sample, add reagent and clean application of sample/the add process of reagent needles (131).

10. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, described wash (12) comprising: be fixedly mounted on the plurality of washing frame (124) on upper mounted plate (115) upper bottom surface, wash stand (124) is provided with second vertical guide rail (123), second vertical guide rail (123) is provided with washing needle stand (122), be fixed with washing pin (121) in washing needle stand (122), on washing needle stand (122), be provided with the 4th motor (125) and be used for driving washing pin (121) to the washing of reagent device (10) reacting hole topping up and get rid of cleansing solution by washing needle stand (122); The correspondence position of bottom plate (113) passes bottom plate (113) and is provided with rinse bath (126) below the washing pin, is used to wash the cleaning of pin (121); Washing pin (121) is connected to liquid-way system (15) by the road, and liquid-way system (15) provides cleansing solution or cleaning fluid according to the order of predetermined requirement of experiment, gets rid of the waste liquid after cleaning.

11. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, described heating and temperature-controlling module (14) comprise the storage heater (142) that is arranged on bottom plate (113) bottom surface, baffle plate (143) along the distribution of circular reaction tray (114) cylindrical, pass bottom plate (113) and be provided with first thermosistor (141), be provided with second thermosistor (144) at the upper mounted plate upper bottom surface, be connected the Instrument shell (19) on the framework soleplate (111), Instrument shell (19) is provided with radiator fan (145) and air inlet (147); Wherein bottom plate (113), baffle plate (143) and circular reaction tray (114) constitute the constant temperature space (147) of approximate sealing, and storage heater (142) passes bottom plate (113) and provides thermal source to constant temperature space (147); Hot-air is by between circular reaction tray (114) and baffle plate (143), slit (146) towards upper mounted plate (115) is blowed upper mounted plate (115), form air curtain, form keeping warmth space between upper mounted plate (115) and bottom plate (113), the gentleness that adds of guarantee reagent device (10) is incubated; First thermosistor (141) is used to the action of heating that detects the temperature in constant temperature space (147) and control storage heater (142), second thermosistor (144) is used for the temperature in the interior space of detecting instrument shell (19), when temperature is higher than setting value, open radiator fan (145), discharge hot-air, suck cool exterior air from air intake opening (148), temperature in the lowering apparatus.

12. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, described optical measurement assembly (17) comprising: be arranged on the light source that is used to control brightness and wavelength (181) on the framework soleplate (111), be installed with several front end concentration pieces (185) at the upper mounted plate upper bottom surface, on the bottom plate below the front end concentration piece (113) upper bottom surface, be installed with rear end concentration piece (184), be provided with photoelectric sensor (183) below the rear end concentration piece (184), being provided with optical fiber (185) between light source (181) and front end concentration piece is connected, measuring light is sent by light source (181), pass to front end concentration piece (182) through optical fiber (185), pass the perforate on front end concentration piece (182) the below upper mounted plate (115), pass groove and perforate on the circular reaction tray (114), project on the photoelectric sensor (183) through rear end concentration piece (184), photoelectric sensor (183) will be changed the electric signal that obtains and be sent to control system.

13. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that, described liquid-way system (15) is included in the working fluid liquid bottle (1501,1503,1505) that framework soleplate (111) is provided with, and the needed cleansing solution of washing reagent device (10) is provided and cleans application of sample/the add storage of the cleaning fluid of reagent needles (131), washing pin (121); In working fluid liquid bottle (1501,1503,1505), be provided with working fluid liquid level sensor (1502,1504,1506), in order to the tracer liquid memory space; The solenoid valve (1507,1508,1509,1510) that is connected working fluid liquid bottle (1501,1503,1505) exit is used for the output of Control work liquid; Be connected in washing pump (1511,1512) behind the solenoid valve (1510) and be used for the conveying of cleansing solution and cleaning fluid; Be connected solenoid valve (1513,1514) behind the washing pump (1511,1512) and be used to control cleansing solution and cleaning fluid to washing pin (121) output; On rinse bath (126), be provided with rinse bath sensor (1517,1521) and be used for induction cleaning water level; The positive displacement pump (1515,1516,1518,1519,1520,1522,1523) that is connected in washing pin (121) drain side is used for getting rid of the waste liquid of washing and cleaning reagent device (10) and the waste liquid in the rinse bath (126); The waste discharge pond (1524) that is connected positive displacement pump (1515,1516,1518,1519,1520,1522,1523) outlet is used for temporary waste liquid; In waste discharge pond (1524), be provided with the liquid level that waste discharge sensor (1525,1526) is used to respond to waste liquid; Waste discharge pond (1524) outlet is connected with waste discharge pump (1527) and is used to discharge the interior waste liquid in waste discharge pond (1524); Be connected with waste liquid barrel (1528) in waste discharge pump (1527) outlet, be used to collect waste liquid; Being connected with scavenging pump (1529) in working fluid liquid bottle (1501) exit is used for to application of sample/add reagent needles (131) and cleaning station (137) provides cleaning fluid; Solenoid valve (1530,1531) is used for control provides cleaning fluid to cleaning station (137); Be connected in working fluid bottle (1501), scavenging pump (1529) and application of sample/the add solenoid valve (1532,1533,1534,1335) between the reagent needles and be used to be controlled to be application of sample/add reagent needles (131) cleaning fluid is provided; The syringe (1536) that is connected on the solenoid valve (1534,1535) is used for providing accurate cleaning fluid to reagent device (10).

14. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that described control system (18) comprises that power supply connects (1701), master control board (1705), low-voltage-powered plate (1706), interface board (1704), power supply unit (1702), power panel (1703), actuating doors sensor (1707), the 4th motor position sensor (1708), syringe position transducer (1709), second motor position sensor (1710), position correction device position transducer (1711); Power supply unit (1702) provides direct supply, storage heater (142) power supply, printer (1606) power supply and light source (181) power supply of the various voltages of control circuit use; Master control board (1705) is an instrument control center, load master control program, gather each road sensor information, accept operation requests through each input interface, the output steering order of working out in advance according to software systems and method document, handle the instrument operation and detect test, manage instrument state, and export corresponding information to outer computer, printer (1606), touch display screen (11607) by output unit; Low-voltage-powered plate (1706) provides according to the instruction of master control board (1705) high capacity such as each pump of liquid-way system (15), solenoid valve, liquid level sensor, dish lock is carried out and the driving power of collecting unit; Interface board (1704) interface is provided and outreach computing machine, external barcode scanner (1603) is connected, the input and output information.

15., it is characterized in that described software systems comprise the main control software of being made up of Single Chip Microcomputer (SCM) program (1771) and PLD program (1772) (1770) as full-automatic enzyme-linked immunoassay instrument as described in the claim 14; Be installed on and outreach the instrument management software (1780) of undertaking debugging on the computing machine, safeguarding main control software; Acquisition instrument test experience data, and manage the data analysis system software (1790) of analysis.

16. full-automatic enzyme-linked immunoassay instrument according to claim 1, it is characterized in that described input-output unit (16) comprises that touch display screen (1607), external barcode scanner (1603), built-in barcode scanner (1608) thermal printer (1606), reagent device sensor (1605), main frame connect (1601), expansion service interface (1602), alarming horn (1604); Touch display screen (1607) display instrument operation interface and duty, by shielding the mode of operation of apparent membrane keyboard, layer menu and dialog box, realize instrument self checking and calibration, the calibration of reagent project is confirmed or input test sample and project information, assigns the experimental implementation instruction, maintenance tool, print and upload operations such as result data, the display instrument duty shows debugging and error message; External barcode scanner (1603) and built-in barcode scanner (1608) are used for identification agent device (10) bar code information; Thermal printer (1606) is printed experimental result, instrument state, test result, debugging and error message in the automatic or manual mode; Whether each slot (1110) that reagent device sensor (1605) is discerned circular reaction tray (114) has reagent device (10); Host interface (1601) connects external computing machine, transmission experiment information; Expansion service interface (1602) is used for software systems and installs, is provided with, debugs and safeguard; Alarming horn (1604) sends alarm sound when being used to gross error takes place.

17. the full-automatic enzyme-linked immunoassay instrument is characterized in that according to claim 1, the present invention also is provided with casing assembly (19).

18., it is characterized in that described casing assembly (19) comprises the bearing structure of each assembly that is made of metal panel beating and machined part as full-automatic enzyme-linked immunoassay instrument as described in the claim 17; On described bearing structure, be provided with the shell and the door closure that constitute by plastics; Under described bearing structure, be provided with the castor of mobile instrument, on described castor, be provided with the adjustable support foot cup that possesses the rubber shock-absorbing structure.

19. enzyme-linked immune analytic method, this method comprises reagent device and full-automatic enzyme-linked immunoassay instrument, this reagent device be independently, the single part required necessary reagent of enzyme linked immunosorbent detection that is packaged with, be inserted into after inserting sample to be detected on the reagent device among the full-automatic enzyme-linked immunoassay instrument, operation full-automatic enzyme-linked immunoassay instrument operating system software and data management system software promptly can be treated the project of the needs detection in the test sample and carry out qualitative or detection by quantitative; There is not the waste of reagent as long as there is a duplicate samples can carry out the detection of respective items purpose in use.

20. as enzyme-linked immune analytic method as described in the claim 19, it is characterized in that, the mentioned reagent device includes a matrix, on matrix, be provided with position, two or more holes, wherein at least one position, hole is used to place testing sample, and all the other positions, hole are used to place the micropore of enzyme linked immunological microwell plate.

21. as enzyme-linked immune analytic method as described in the claim 19, it is characterized in that, the mentioned reagent device includes a matrix, on matrix, be provided with position, two or more holes, wherein at least one position, hole is used to place testing sample, at least one position, hole is used to place reagent, and all the other positions, hole are used to place the micropore of enzyme linked immunological microwell plate.

22., it is characterized in that the open peristoma in position, described hole is all posted and sealed film as enzyme-linked immune analytic method as described in claim 20 or 21; This seal film when not using, can stop liquid in the groove or in the reacting hole overflow with block film outside the entering of material such as gas, moisture, grit, bacterium etc., can allow imbibition nozzle or aspirating needle penetrate when using very expediently detecting to draw or filling liquid.

23. as enzyme-linked immune analytic method as described in claim 20 or 21, it is characterized in that, be provided with one at described matrix one end and be used for hand-held and paste the handle that reagent detects the bar code of information.

24. as enzyme-linked immune analytic method as described in the claim 19, it is characterized in that, be used to place the shape of the position, hole of enzyme linked immunological microwell plate in the above-mentioned matrix, be to be provided with and to make, it is embedded in the single reacting hole of enzyme linked immunological microwell plate in the matrix more expediently according to detecting selected enzyme linked immunological microwell plate external form or type.

25. as enzyme-linked immune analytic method as described in the claim 24, it is characterized in that, this reacting hole setting is encrusting substance micropore, reaction vessel, colorimetric micropore/cup, the dried detectable of splendid attire as enzyme linked immunological, and it specifically is provided with that inspection is surveyed project and method principle and adopts corresponding setting.

26. enzyme-linked immune analytic method according to claim 1, it is characterized in that, described necessary reagent is to detect used antigen or antibody, enzyme-labelled antigen or antibody, enzyme chromogenic substrate, thinning agent, or the used container of diluted sample or detect the pilot process reaction vessel, the inspection that specifically is provided with of necessary reagent is surveyed the requirement of project and is provided with.

27. as enzyme-linked immune analytic method as described in the claim 25, it is characterized in that, on above-mentioned handle, paste the bar code that reagent detects information, comprise detectable the test item code, detect the sequence number of trial production lot number, the reagent term of validity, qualitative detection correction coefficient, quantitative measurement typical curve parameter, concrete enzyme linked immunoassay type, reagent and analytical equipment.

28., it is characterized in that information/numerical value that all bar codes comprise is all inequality as enzyme-linked immune analytic method as described in the claim 27; The set specifying information of each bar code/numerical value inspection survey project, trial production lot number, the reagent term of validity, qualitative detection correction coefficient, quantitative measurement typical curve parameter, concrete enzyme linked immunoassay type, reagent sequence number and corresponding information/numerical value is set.