CN102116771B - Automatic enzyme-linked immune analysis analyzer - Google Patents

Automatic enzyme-linked immune analysis analyzer Download PDF

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Publication number
CN102116771B
CN102116771B CN201010042628XA CN201010042628A CN102116771B CN 102116771 B CN102116771 B CN 102116771B CN 201010042628X A CN201010042628X A CN 201010042628XA CN 201010042628 A CN201010042628 A CN 201010042628A CN 102116771 B CN102116771 B CN 102116771B
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reagent
sample
instrument
application
washing
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CN102116771A (en
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何林
刘清波
阳辉
伍坚
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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 relates to 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 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.The method and instrument are mainly used in biological sample as human sample's serum, sputum, urine, ight soil, antigenic substance in bile etc. is as the antigen of various pathogenic microorganisms, or the antibody produced by these pathogenic microorganism antigens infection bodies, and autoimmune disease is as systemic loupus erythematosus, phosphatide syndrome, rheumatoid arthritis, chorionitis, autoimmune liver disease, Sjogren syndrome, systemic vasculitis, polymyositis and dermatomyositis, autoantibody in the Disease such as autoimmune thyroid disease and gastrointestinal disease blood, carry out the fully-automatic analyzer of quantitative measurement or qualitative detection with enzyme-linked immunoassay method.
Background technology
Enzyme linked immunosorbent detection, as a kind of method in many immuno analytical methods, now has been widely used in the analysis fields such as clinical medicine, animal quarantine, Food Science, plant virus, medicament residue, the prevention and control of plant diseases, pest control.This method has specificity and the susceptibility of height, and nearly all soluble antigen one antibody forming system can be detected with it, and its minimum detection value can reach even pg level of ng.With radiommunoassay, compare, the advantage of enzyme-linked immunoassay is that label is stablized and "dead" harm; With immunofluorescence assay, compare, it is more objective that enzyme-linked immunoassay is judged 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 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 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 be coated with, and in detecting, titer, correcting fluid, positive control thing or control serum, feminine gender used controlled thing or control serum etc.Need to use plurality of reagents due to enzyme-linked immunoassay method, and these reagent are according to test need to adding successively of reaction, also must the micropore of detection reaction plate repeatedly be washed, thereby manual operations is comparatively loaded down with trivial details simultaneously in detection.In order to simplify the operation, especially simplify filling and detect sample and detect in reagent and washing process and repeatedly annotate and inhale the troublesome operation of abandoning cleansing solution, develop at present the multiple instrument for enzyme-linked immunoassay.
For the sample of annotating in enzyme linked immunosorbent detection, reagent, washing and four troublesome operation of interpretation chromogenic reaction result, prior art---enzyme-linked immuno assay instrument adopts respectively separate type and combined type two class methods to be processed.
Separate type enzyme linked immunological instrument mainly contains microplate reader and washes the plate machine, their through application of sample, reagent adding, hatch, the process such as washing, finally by spectrophotometric analysis, carry out result of determination.Microplate reader is a kind of visible ray 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 CF5000 of space flight 283 factories, the Anayech 828 of the safe and sound company in Shanghai, upper Hisoon reach the XD711 of company, and BIORAD company 450,550, Benchmark, Utramark etc.Washing the plate machine 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 brand that laboratory is commonly used and model have respectively the AT-828 type of the safe and sound company in Shanghai, the PW-960 type of Shenzhen Hui Song company, the KWP-100 type of Shenzhen Kate company, the DNX-962 type of Beijing Pu Lang technology company etc.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 enzyme linked immunosorbent detection, whole plate 12 * 8 holes, 8 * 12 holes up to 10 seconds in, and there are wider absorbance measuring scope A=0~6.0, and the 340nm of outfit optical filter is arranged, spectral detection is expanded between ultraviolet region.Also there is incubation function and kinetic measurement function simultaneously, greatly promote and promoted the widespread use of enzyme linked immunosorbent detection technology.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 thering are the basic functions such as the wash number of setting, cleaning microwell plate number, setting soak time, also possessed that bottom is rinsed, imbibition, board-like/bar formula are washed plate, concussion, position adjustments, detergent line automatically at 2, certainly moved liquid, stored the function such as multiple washing procedure, 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 by each step in the enzyme linked immunological experiment, from application of sample, reagent adding, 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 automatically carry out.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 the brand that current laboratory is commonly used and model have HAMILTON company.The steps such as the automatic sample disposal system has been mainly used in complex operation in enzyme linked immunological experiment, the application of sample, reagent adding, dilution, the titration that manually easily make mistakes, hatches, washing, after completing, by the microplate reader result of determination, the brand that laboratory is commonly used and model have MINITRED, the HYPREPTLUS of HYPERION company, the DLASUltra of DYNEX company etc. of TECAN company.Pipelining formula enzyme linked immunological combined system is process and the condition needed according to enzyme linked immunoassay, liquid is added and get system module, constant-temperature incubation module, wash plate system module and interpreting system module as a result, according to the type of enzyme linked immunoassay and step is designed and layout, with track, these system modules are together in series, each system module complete independently task separately under the regulation and control of system computer, can also unify cooperation, jointly complete course of reaction.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.
Special requirement for applicable enzyme linked immunosorbent detection technology, microplate formula enzyme-linked immuno assay instrument has had again some new development recently in all fields, for example from 96 hole patterns to 384 holes, 1536 hole patterns development, the Ultramark that now by LABSYSTEMS company and the release of BIOTEK company, can measure the microplate reader of 384 hole microwell plates and released by BIORAD company can measure 384 holes, 1536 hole microwell plates, has also developed appearance for 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, making that analytical wavelength range is wider, the 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, thereby made enzyme linked immunosorbent detection become a kind of immunoassay technology that range of application is the widest, the use client is maximum, application quantity is maximum, market share is the highest.
Yet, although obtained by comparison many many-sided tremendous developments and progress based on micro-pore plate type enzyme-linked immune analytic method and instrument and enzyme linked immunological prototyping technique, but still have in actual use more deficiency, problem or limitation, these deficiencies, problem and limitation are summed up and mainly contain the following aspects:
1, use 12 * 8 types, 12 * 8 types, complete plate 96 holes or 96 hole multiple Special micro porous plates as the coated articles for use of antigen or antibody and reaction vessel, can only be divided in use 12 batches, 8 batches or whole plate and once use.If use in batches, can not adopt and generally wash that the plate machine is washed plate and can only hole one ground, a hole filling 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 disposable use of whole plate, 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 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 detects reagent all will carry out 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 the reagent used 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, if need to detect 10 projects, the configuration of reagent and use number must be 10 * 96 person-portions, if only have a duplicate samples need to detect 10 different projects, also need to configure the reagent of 10 * 96 person-portions.
4, detect reagent and sample is open mode in testing process, easily causes between various reagent or the cross pollution between each sample and affect testing result or directly affect the operator.
5, a kind of detection reagent can only detect a project, if detect two or three projects, needs three kinds of different detection reagent or kits, and detects respectively operation.
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, optical readings is only carried out one time in the color and luster of each reacting hole colored solutions when selecting single wavelength method, when the double wave regular way, select the optical filter of another kind of wavelength to carry out again optical readings one time, can not carry out the optical readings more than twice or twice at different time points to the color and luster of same reacting hole colored solutions.
8, adopt the mode of washing in batches, a microwell plate once annotated or inhale and abandon 2 holes, 4 holes, 8 holes, 12 ,Huo96 hole, hole cleansing solutions, can not annotate in batches separately or inhale and abandon cleansing solution.
9, can not carry out the detection of single project, or can not detect a plurality of projects simultaneously.
10, each detection or each bar code detected without reagent information, or bar code information is not comprehensive, or bar code information is only the information of kit, can only could understand or know product batch number and the term of validity information that detects reagent by the sign of checking the kit external packing box, and the information of knowing is not controlled in testing process, has very large randomness.
11, the instrument application of sample, add body fluid/reagent, the imbibition system is rectilinearity structure, traveling priority or walking.
12, no liquid such as mixes/mixes at mechano-electronic structure and the control system thereof.
13, the difference of the visual agents useful for same of detection and difference, and choice and operation arbitrarily.
14, detection method is traditional E LISA method, by selected reagent, is determined.
15, can not be immediately per sample situation carry out the detection of individual event order or entry.
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 the detection of single part.
Another object of the present invention be to provide a kind ofly can carry out independently, the full-automatic enzyme-linked immunoassay instrument of the detection of single part.
Technical scheme of the present invention is: a kind of enzyme-linked immune analytic method is provided, the 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, after inserting on reagent device by sample to be detected, be inserted among the full-automatic enzyme-linked immunoassay instrument, operation full-automatic enzyme-linked immunoassay instrument operating system software and data management system software, can treat the project of the needs detection detected in sample and carry out qualitative or quantitative detection; As long as there is in use a duplicate samples can carry out the detection of respective items purpose without the waste of reagent.
The above-mentioned project detected that needs comprises the 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 for placing testing sample, and all the other positions, hole are for placing the micropore of enzyme linked immunological microwell plate.
The mentioned reagent device includes a matrix, be provided with position, two or more holes on matrix, wherein at least one position, hole is for placing testing sample, and at least one position, hole is for placing reagent sample, and all the other positions, hole are for placing the micropore of enzyme linked immunological microwell plate.
Be provided with a handle that detects the bar code of information for hand-held and stickup reagent at described matrix one end.
In above-mentioned matrix for the shape of the position, hole of placing the enzyme linked immunological microwell plate, can be arranged and be made according to the micropore external form or the type that detect selected enzyme linked immunological microwell plate, it can be embedded in the single reacting hole of enzyme linked immunological microwell plate in matrix more expediently.
This reacting hole can be used as the encrusting substance micropore, reaction vessel, colorimetric micropore/cup, the dried detection reagent of splendid attire of enzyme linked immunological etc., and it specifically arranges that inspection is surveyed the difference of project and Method And Principle and different.
Placing the position, hole of the required reagent of enzyme linked immunosorbent detection in above-mentioned matrix, can be both V-type or the U-shaped groove in matrix, can be also the reacting hole of enzyme linked immunological microwell plate.In the open peristoma of this groove or reacting hole, all post sealed membrane.This sealed membrane can stop material outside overflow in groove or in reacting hole and block film as the entering of gas, moisture, grit, bacterium etc. when not using, and can allow very expediently imbibition nozzle or aspirating needle penetrate to draw or filling liquid detecting while using.The reagent of reagent groove or reacting hole institute splendid attire, can be detection antigen used or antibody, enzyme-labelled antigen or antibody, enzyme chromogenic substrate, thinning agent, or be Sample Dilution container used or detect the pilot process reaction vessel, it specifically arranges that inspection is surveyed the difference of project and different.
Paste the bar code that reagent detects information on above-mentioned handle, comprise the sequence number of the test item code that detects reagent, detection reagent product batch 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 not identical.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, comprise housing assembly, wash, application of sample/reagent adding assembly, heating and temperature-controlling module, liquid-way system, input-output unit, optical measurement assembly, control system; Described housing assembly comprises framework soleplate, be provided with pillar on framework soleplate, be provided with successively from the bottom up bottom plate and upper mounted plate on pillar, be provided with circular reaction tray between bottom plate and upper mounted plate, described circular reaction tray is connected with bottom plate with upper mounted plate by central shaft, be fixed with the first motor in the bottom plate bottom, the first motor drives circular reaction tray by the first gear train and rotates; Be provided with wash and application of sample/reagent adding assembly on the upper bottom surface of solid plate described, described application of sample/reagent adding assembly is reciprocating along the slot direction of circular reaction tray by the second motor and the second gear train; Described liquid-way system provides relevant liquid or reagent for wash and application of sample/reagent adding assembly; Described input-output unit is for inputting associative operation information and output detections result.
Described circular reaction tray is provided with several for inserting the slot of reagent device, and circular reaction tray is taken reagent device to wash institute correspondence position, completes washing operation; Take application of sample/reagent adding assembly institute correspondence position to and complete application of sample, reagent adding operation; Take the corresponding position of optical measurement assembly to and complete the optical measurement operation.
Described circular reaction tray is driven in the micro-swinging mode through the first gear train by the first motor, and the reactant of vibration in the test agent device reaches the purpose that mixes married operation.
Be fixed with the position correction device in described bottom plate bottom, the position correction device is accurately located circular reaction tray together with pilot hole corresponding on circular reaction tray.
Be fixed with the lock collar device in described bottom plate bottom, the lock collar device comprises electromagnetic lock, and when circular reaction tray quits work, the lock collar device inserts in circular reaction tray lockhole, pins reaction tray.
Described sample/reagent adding the assembly that adds is included on the upper mounted plate upper bottom surface horizontal guide rail be fixed with along slot direction layout on circular reaction tray, be provided with application of sample/reagent adding frame on horizontal guide rail, be provided with some the first vertical guide rails on application of sample/reagent adding frame, be provided with application of sample/reagent adding needle stand on the first vertical guide rail, be provided with application of sample/reagent adding pin on application of sample/reagent adding needle stand.
At the fixed postlaminar part, also be fixed with for cleaning the cleaning station of application of sample/reagent adding pin; At application of sample/reagent adding frame rear portion, be provided with for driving the 3rd motor of application of sample/reagent adding needle stand motion.
Described application of sample/reagent adding pin is provided with the liquid level sensor for detection of application of sample/reagent adding pin liquid level be connected with control system.
Described application of sample/reagent adding pin is connected to liquid-way system by pipeline, the process of being controlled application of sample, reagent adding and cleaning application of sample/reagent adding pin according to the requirement of predetermined experiment by liquid-way system.
Described wash comprises the some wash stands that are fixedly mounted on the upper mounted plate upper bottom surface, be provided with the second vertical guide rail on wash stand, the second vertical guide rail is provided with the washing needle stand, be fixed with the washing pin on the washing needle stand, be provided with the 4th motor for driving the washing pin by the washing needle stand to the washing of reagent device reacting hole topping up and getting rid of cleansing solution on the washing needle stand; Below the washing pin, the correspondence position of bottom plate, be provided with rinse bath through bottom plate, for washing 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 be arranged on the bottom plate bottom surface, the baffle plate distributed along circular reaction tray cylindrical, be provided with the first thermosistor through bottom plate, be provided with the second thermosistor at the upper mounted plate upper bottom surface, be connected to the Instrument shell on framework soleplate, Instrument shell is provided with radiator fan and air inlet; Wherein bottom plate, baffle plate and circular reaction tray form the constant temperature space of approximate sealing, and storage heater provides thermal source through bottom plate to the constant temperature space; Hot-air is by between circular reaction tray and baffle plate, and the slit of fixed head is blowed upper mounted plate facing up, forms air curtain, between upper mounted plate and bottom plate, forms keeping warmth space, and the gentleness that adds of guarantee reagent device is incubated; The first thermosistor is for detection of the temperature in constant temperature space and control the action of heating of storage heater, the second thermosistor is for detection of the temperature in space in tool housing, when temperature during higher than setting value, open radiator fan, discharge hot-air, suck cool exterior air from air intake opening, temperature in lowering apparatus.
Described optical measurement assembly comprise be arranged on framework soleplate for controlling the light source of brightness and wavelength, be installed with several front end concentration pieces at the upper mounted plate upper bottom surface, be installed with the rear end concentration piece on bottom plate upper bottom surface below the front 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, through the perforate on the upper mounted plate of front end concentration piece below, through groove and the perforate on circular reaction tray, through the rear end concentration piece, project on photoelectric sensor, photoelectric sensor will be changed the electric signal obtained and be sent to control system.
Described liquid-way system is included in the working fluid liquid bottle that framework soleplate arranges, the storage that the needed cleansing solution of washing reagent device is provided and cleans the cleaning fluid of application of sample/reagent adding pin, washing pin; Be provided with the working fluid liquid level sensor in working fluid liquid bottle, in order to the tracer liquid memory space; Be connected to the solenoid valve in working fluid liquid bottle exit for controlling the output of working fluid; Be connected in the conveying for cleansing solution and cleaning fluid of washing pump after solenoid valve; Be connected to solenoid valve after washing pump for controlling cleansing solution and cleaning fluid to the output of washing pin; Be provided with the rinse bath sensor for responding to the cleaning water level on rinse bath; Be connected in the positive displacement pump of washing pin drain side for getting rid of washing and the waste liquid of cleaning reagent device and the waste liquid in rinse bath; Be connected to the waste discharge pond of positive displacement pump outlet for temporary waste liquid; Be provided with the waste discharge sensor for responding to the liquid level of waste liquid in the waste discharge pond; The outlet of waste discharge pond is connected with the waste discharge pump for discharging the waste liquid in the waste discharge pond; Be connected with waste liquid barrel at the waste discharge pump discharge, for collecting waste liquid; Be connected with scavenging pump in working fluid liquid bottle exit for to application of sample/reagent adding pin and cleaning station, providing cleaning fluid; Solenoid valve provides cleaning fluid for controlling to cleaning station; The solenoid valve be connected between working fluid bottle, scavenging pump and application of sample/reagent adding pin provides cleaning fluid for control for application of sample/reagent adding pin; Be connected to syringe on solenoid valve for accurate cleaning fluid is provided 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, the second motor position sensor, position correction device position transducer; The power supply of direct supply, storage heater power supply, printer power supply and the light source of the various voltages that power supply unit provides control circuit to use; Master control board is instrument control center, load master control program, gather each road sensor information, accept operation requests through each input interface, according to software systems and method document output steering order prepared in advance, handle the instrument operation and detect test, the management instrument state, and export corresponding information to outer computer, printer, touch display screen by output unit; Low-voltage-powered buttress provides the driving power to the large capacity execution such as each pump of liquid-way system, solenoid valve, liquid level sensor, dish lock and collecting unit according to the instruction of master control board; 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 be comprised of Single Chip Microcomputer (SCM) program and PLD program; Be installed on and outreach on computing machine the instrument management software of undertaking debugging, 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, mode of operation by screen display membrane keyboard, layer menu and dialog box, realize instrument self checking and calibration, the calibration of reagent project, confirm or input test sample and project information, assigns the experimental implementation instruction, maintenance tool, print and upload the operations such as result data, the display instrument duty, show debugging and error message; External barcode scanner and built-in barcode scanner are 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 identified circular reaction tray has reagent device; Host interface connects external computing machine, transmission experiment information; The expansion service interface is installed, arranges, debugs and safeguard for software systems; Alarming horn sends alarming prompt sound while being used for gross error occurs.
The present invention also is provided with casing assembly; Described casing assembly comprises the bearing structure of each assembly consisted of sheet metal and machined part; Be provided with the shell and the door closure that are formed by plastics on described bearing structure; Be provided with the castor of mobile instrument under described bearing structure, be provided with the adjustable support foot cup that possesses the rubber shock-absorbing structure on described castor.
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 dedicated full-automatic enzyme-linked immuno assay instrument matched with it, compare with other enzyme-linked immune analytic methods, reagent device and analytical instrument, there is following advantage:
First, it be a kind of independently, single part detection reagent 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 the coated articles for use of antigen or antibody and reaction vessel, as long as there is in use a duplicate samples can carry out the detection of respective items purpose without the waste of reagent.If the quantity of sample surpasses a, by the actual sample number, use this reagent and analytical equipment to get final product.
Second, no matter be qualitative detection or quantitatively detection, it detects each in the reagent wells position that necessary reagent is contained in a reagent and analytical equipment, and carry out splendid attire with different reagent bottles respectively without detecting reagent, not only operation is very easy, and be not easy to cause bust, thereby guarantee the correctness of testing result.
The 3rd, it has a Special bar code to each reagent and analytical equipment, the numerical value of bar code comprise every detect corresponding 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, strictly controlled during use, especially when using over term of validity detection reagent, to be identified and stop and send examining report, thereby can guarantee the accuracy detected.
The 4th, it detects reagent by each and effectively separates and seal, and can not cause the cross pollution between various reagent and affects testing result.
The 5th, it is a kind of reagent and analytical equipment that is exclusively used in the particular analysis analytical instrument, annotate and detect reagent or sample with full automatic accurate charger in testing process, and operation automation, dosage is accurate, and accuracy and the precision of testing result are high.
The 6th, in the configuration of the quantity of test item reagent set and use, all are equipped with and get final product with needs by reality, especially on to the entry detection, are equipped with more in right amount, not there will be to surpass to configure service condition.
The 7th, on a reagent and analytical equipment, can place the detection reagent 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, detecting the instrument analytical method that adopts full-automatic discrete enzyme linked immunological in operation, thereby realizing the full-automatic detection of the independent individual event of enzyme linked immunological project or group, guaranteed to detect with the property used;
Nine, at the detection sample, reach in nature, the qualitative/quantitative that can carry out single part detects, and the qualitative/quantitative that also can carry out batch sample detects, and has guaranteed the dirigibility of detection;
Ten, detecting in interpretation and data processing, adopt triple optical readings and several data fitting analyzing method, guaranteed the accuracy detected;
The 11, in the processing that detects reagent, by the required reagent concentrated loads of various enzyme linked immunoassay, in the reagent and reaction unit of a uniqueness, instrument has not guaranteed the independence of every detection, has more guaranteed that each detects the convenience that reagent is used;
The 12, on detection speed, adopt rotary microseismic activity mode to accelerate the hybrid reaction liquid phase, promote the combination between reaction molecular, make the reaction time shorten dramatically, detection speed is improved, within the shortest 30 minutes, can obtain testing result, 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, control accuracy is high, guarantees that enzyme linked immune assay is reacted with liquid-phase condition at the invariance degree temperature, not only guarantee the repeatability of testing result, more guarantee the accuracy detected.
The accompanying drawing explanation
Fig. 1 is the structural representation of a kind of embodiment of reagent device in the present invention.
Fig. 2 is the plan structure schematic diagram of Fig. 1.
Fig. 3 is the structural representation of the reagent device the second embodiment in the present invention.
Fig. 4 is the plan structure schematic diagram of Fig. 3.
Fig. 5 is the structural representation of the third embodiment of reagent device in the present invention.
Fig. 6 is the plan structure schematic diagram of Fig. 5.
The structural representation of the 4th kind of embodiment of reagent device in Fig. 7 the present invention.
Fig. 8 is the plan structure schematic diagram of Fig. 7.
Fig. 9 is the structural representation of the 5th kind of embodiment of reagent device in the present invention.
Figure 10 is the plan structure schematic diagram of Fig. 9.
The structural representation of the 6th kind of embodiment of reagent device in Figure 11 the present invention.
Figure 12 is the plan structure schematic diagram of Figure 11.
Figure 13 is full-automatic enzyme-linked immunoassay instrument agent structure schematic diagram in the present invention.
Figure 14 is full-automatic enzyme-linked immunoassay instrument housing assembly structural representation.
Figure 15 is the perspective view of the circular reaction tray in Figure 14.
Figure 16 is full-automatic enzyme-linked immunoassay instrument housing assembly structural representation.
Figure 17 is full-automatic enzyme-linked immunoassay instrument application of sample reagent adding modular construction schematic diagram.
Figure 18 is full-automatic enzyme-linked immunoassay instrument wash structural representation.
Figure 19 is the heating of full-automatic enzyme-linked immunoassay instrument and temperature-controlling module structural representation.
Figure 20 is full-automatic enzyme-linked immunoassay instrument optical measurement assembly layout schematic diagram.
Figure 21 is full-automatic enzyme-linked immunoassay instrument liquid-way system principle schematic.
Figure 22 is full-automatic enzyme-linked immunoassay instrument circuit system architecture schematic diagram.
Figure 23 is full-automatic enzyme-linked immunoassay instrument software system framework schematic 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, the 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, after inserting on reagent device by sample to be detected, be inserted 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 the antigen that detects in sample or antibody of can treating are carried out qualitative or quantitative detection; As long as there is in use a duplicate samples can carry out the detection of respective items purpose without the waste of reagent.
Above-mentioned circular reaction tray is a disk, and take the center of circle of disk is radiant, at the even circumferential of disk, is distributed with several slots, and reagent device is inserted in 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 also the reagent quantitatively detected, 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.
Refer to 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 in the present invention, meet position, two or more hole, 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, lower same), wherein first position, hole 1 is for placing testing sample, and all the other positions, hole are for placing the micropore of enzyme linked immunological microwell plate; Also can as required a part wherein be used for placing reagent.
Refer to Fig. 3 and Fig. 4, the mentioned reagent device includes a matrix 10, be provided with position, 7 holes (number in the figure is 1-7) on matrix 10, wherein first position, hole 1 is for placing testing sample, position, second hole 2 is the holes 9 for placing reagent, and all the other positions, hole are for placing the micropore of enzyme linked immunological microwell plate.
Refer to Fig. 5 and Fig. 6, Fig. 5 compares with the embodiment shown in Fig. 4 with Fig. 3 with the reagent device shown in Fig. 6, and its basic structure is identical, and difference is that position, second hole 2 and the 3rd position, hole (3) in figure is all the holes 9 for placing reagent.
Refer to Fig. 7 and Fig. 8, Fig. 7 compares with the embodiment shown in Fig. 6 with Fig. 5 with the reagent device shown in Fig. 8, and its basic structure is identical, and difference is that the hole 9 of position, three holes for placing reagent arranged in figure.
Fig. 9 and Figure 10 have the hole 9 of position, four holes for placing reagent.
Figure 11 and Figure 12 have the hole 9 of position, five holes for placing reagent.
In above-mentioned matrix 10 for the shape of the position, hole of placing the enzyme linked immunological microwell plate, can be arranged and be made according to detecting selected enzyme linked immunological microwell plate external form or type, it can be embedded in the single reacting hole of enzyme linked immunological microwell plate in matrix more expediently.
This reacting hole can be used as the encrusting substance micropore, reaction vessel, colorimetric micropore/cup, the dried detection reagent of splendid attire of enzyme linked immunological etc., and it specifically arranges that inspection is surveyed the difference of project and Method And Principle and different.
Placing the position, hole of the required reagent of enzyme linked immunosorbent detection in above-mentioned matrix 10, can be both V-type or the U-shaped groove in matrix, can be also the reacting hole of enzyme linked immunological microwell plate.In the open peristoma of this groove or reacting hole, all post sealed membrane.This sealed membrane can stop material outside overflow in groove or in reacting hole and block film as the entering of gas, moisture, grit, bacterium etc. when not using, and can allow very expediently imbibition nozzle or aspirating needle penetrate to draw or filling liquid detecting while using.The reagent of reagent groove or reacting hole institute splendid attire, can be detection antigen used or antibody, enzyme-labelled antigen or antibody, enzyme chromogenic substrate, thinning agent, or be Sample Dilution container used or detect the pilot process reaction vessel, it specifically arranges that inspection is surveyed the difference of project and different.
In the present invention, at described matrix 10 1 ends, be provided with a handle 8 that detects the bar code of information for hand-held and stickup reagent.
Paste the bar code that reagent detects information on above-mentioned handle 8, comprise the test item code that detects reagent, detect the sequence number of producing 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 as a trial etc.Information/numerical value that all bar codes comprise is all not identical.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.
Refer to Figure 13 to Figure 16, a kind of full-automatic enzyme-linked immunoassay instrument provided by the invention, comprise housing assembly 11, wash 12, application of sample/reagent adding 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, be provided with pillar 112 on framework soleplate 111, be provided with successively from the bottom up bottom plate 113 and upper mounted plate 115 on pillar 112, be provided with circular reaction tray 114 between bottom plate 113 and upper mounted plate 115, described circular reaction tray 114 is connected with bottom plate 113 with upper mounted plate 115 by central shaft 116, be fixed with the first motor 118, the first motors 118 in bottom plate 113 bottoms and drive circular reaction tray 114 rotations by the first gear train 117; Be provided with wash 12 and application of sample/reagent adding assembly 13 on the upper bottom surface of solid plate 115 described, described application of sample/reagent adding assembly 13 is slot 1110 directions reciprocating (seeing Figure 17) along circular reaction tray 114 by the second motor 136 and the second gear train 139; Described liquid-way system 15 provides relevant liquid or reagent for wash 12 and application of sample/reagent adding assembly 13; Described input-output unit 16 is for inputting associative operation information and output detections result.Described circular reaction tray 114 is provided with several slots 1110 for inserting reagent device 10, and circular reaction tray 114 is taken reagent device 10 to wash 12 correspondence positions, completes washing operation; Take application of sample/13 of reagent adding assemblies correspondence position to and complete application of sample, reagent adding operation; Take the corresponding position of optical measurement assembly 17 to and complete the optical measurement operation.Described circular reaction tray 114 is driven in the micro-swinging mode through the first gear train 117 by the first motor 118, and the reactant of vibration in test agent device 10 reaches the purpose (realizing by the programmed control in control system 18) that mixes married operation.Be fixed with position correction device 1113 in described bottom plate 113 bottoms, position correction device 1113 is accurately located (seeing Figure 16) to circular reaction tray 114 together with pilot hole 1114 corresponding on circular reaction tray 114.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 quits work, lock collar device 1112 inserts 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 in Figure 15 is at a disk, take the center of circle of disk is radiant, even circumferential at disk is distributed with several slots 1110, three reagent devices 10 have been drawn respectively in figure, one of them reagent device 10 is in not inserting state, 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.
Refer to Figure 17, described sample/reagent adding the assembly 13 that adds comprises horizontal guide rail 138, described horizontal guide rail 138 is arranged on fixed head 115 upper bottom surfaces, and arrange along 1110 directions of slot on circular reaction tray 114, be provided with two application of samples/reagent adding frame 134 on horizontal guide rail 138, be provided with first vertical guide rail 133 on each application of sample/reagent adding frame 134, be provided with application of sample/reagent adding needle stand 132 on each first vertical guide rail 133, be provided with application of sample/reagent adding pin 131 on each application of sample/reagent adding needle stand 132.At fixed plate 115 rear portions, also be fixed with for cleaning the cleaning station 137 of application of sample/reagent adding pin 131; At application of sample/reagent adding frame 134 rear portions, be provided with for driving the 3rd motor 135 of application of sample/reagent adding needle stand 132 vertical movements.Described application of sample/reagent adding pin 131 be provided with control system 18, be connected for detection of application of sample/reagent adding pin 131 liquid level level detection mechanisms.Described application of sample/reagent adding pin 131 is connected to liquid-way system 15 by pipeline, the process of being controlled application of sample, reagent adding and cleaning application of sample/reagent adding pin 131 according to the requirement of predetermined experiment by liquid-way system 15.
Refer to 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 the second vertical guide rail 123 on each wash stand 124, the second vertical guide rail 123 is provided with washing needle stand 122, be fixed with washing pin 121 on washing needle stand 122, be provided with the 4th motor 125 for driving washing pin 121 by washing needle stand 122 to reagent device 10 reacting hole topping up washings and getting rid of cleansing solution on washing needle stand 122; Below the washing pin, the correspondence position of bottom plate 113, be provided with rinse bath 126 through bottom plate 113, for washing 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.
Refer to Figure 19, described heating and temperature-controlling module 14 comprise the storage heater 142 be arranged on bottom plate 113 bottom surfaces, the baffle plate 143 distributed along circular reaction tray 114 cylindricals, be provided with the first thermosistor 141 through bottom plate 113, be provided with the second thermosistor 144 at the upper mounted plate upper bottom surface, be connected to the Instrument shell 19 on framework soleplate 111, Instrument shell 19 is provided with radiator fan 145 and air inlet 148; Wherein bottom plate 113, baffle plate 143 and circular reaction tray 114 form the constant temperature space 147 of approximate sealing, and storage heater 142 provides thermal source through bottom plate 113 to constant temperature space 147; Hot-air is by 143, circular reaction tray 114 and baffle plate, and the slit 146 of fixed head 115 blows to upper mounted plate 115 facing up, forms air curtain, between upper mounted plate 115 and bottom plate 113, forms keeping warmth space, guarantee reagent device 10 add gentle insulation; The first thermosistor 141 is for detection of the temperature in constant temperature space 147 and control the action of heating of storage heater 142, the second thermosistor 144 is for detection of the temperature in tool housing 19 interior spaces, when temperature during higher than setting value, open radiator fan 145, discharge hot-air, suck cool exterior air from air intake opening 148, temperature in lowering apparatus.
Refer to Figure 20, described optical measurement assembly 17 comprises: be arranged on brightness on framework soleplate 111 and the light source 181 of controlled wavelength, be installed with several front end concentration pieces 182 at the upper mounted plate upper bottom surface, be installed with rear end concentration piece 184 on bottom plate 113 upper bottom surfaces below the front end concentration piece, be provided with photoelectric sensor 183 below 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, through the perforate on front end concentration piece 182 below upper mounted plates 115, through groove and the perforate on circular reaction tray 114, through rear end concentration piece 184, project on photoelectric sensor 183, photoelectric sensor 183 converts light signal to electric signal and is sent to control system 18.
Refer to Figure 21, described liquid-way system 15 is included in three working fluid liquid bottles 1501,1503,1505 that framework soleplate 111 arranges, the storage that the needed cleansing solution of washing reagent device 10 is provided and cleans the cleaning fluid of application of sample/reagent adding pin 131, washing pin 121; Be provided with working fluid liquid level sensor 1502,1504,1506 in working fluid liquid bottle 1501,1503,1505, in order to the tracer liquid memory space; Be connected to the solenoid valve 1507,1508,1509,1510 in working fluid liquid bottle 1501,1503,1505 exits for controlling the output of working fluid; Be connected in washing pump 1511,1512 conveyings for cleansing solution and cleaning fluid after solenoid valve 1510; Be connected to solenoid valve 1513,1514 after washing pump 1511,1512 for controlling cleansing solution and cleaning fluid to 121 outputs of washing pin; Be provided with rinse bath sensor 1517,1521 for responding to the cleaning water level on rinse bath 126; Be connected in waste liquid and the rinse bath 126 interior waste liquid of positive displacement pump 1515,1516,1518,1519,1520,1522,1523 for getting rid of washing and cleaning reagent device 10 of washing pin 121 drain sides; Be connected to the waste discharge pond 1524 of positive displacement pump 1515,1516,1518,1519,1520,1522,1523 outlets for temporary waste liquid; Be provided with waste discharge sensor 1525,1526 for responding to the liquid level of waste liquid in waste discharge pond 1524; 1524 outlets of waste discharge pond are connected with waste discharge pump 1527 for discharging the waste liquid in waste discharge pond 1524; Be connected with waste liquid barrel 1528 in 1527 outlets of waste discharge pump, for collecting waste liquid; Be connected with scavenging pump 1529 for to application of sample/reagent adding pin 131 and cleaning station 137, providing cleaning fluid in working fluid liquid bottle 1501 exits; Solenoid valve 1530,1531 provides cleaning fluid for controlling to cleaning station 137; The solenoid valve 1532,1533,1534,1335 be connected between working fluid bottle 1501, scavenging pump 1529 and application of sample/reagent adding pin provides cleaning fluid for control for application of sample/reagent adding pin 131; Be connected to syringe 1536 on solenoid valve 1534,1535 for to reagent device 10, providing accurate cleaning fluid.
Refer to 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, the second motor position sensor 1710, position correction device position transducer 1711; Direct supply, storage heater 142 power supplys, printer 1606 power supplys and light source 181 power supplys of the various voltages that power supply unit 1702 provides control circuit to use; Master control board 1705 is instrument control center, load master control program, gather each road sensor information, accept operation requests through each input interface, according to software systems and method document rule output prepared in advance steering order, handle the instrument operation and detect test, the management instrument state, and export corresponding information to outer computer, printer 1606, touch display screen 1607 by output unit; Low-voltage-powered plate 1706 provides the driving power to the large capacity execution such as liquid-way system 15 each pumps, solenoid valve, liquid level sensor, dish lock and collecting unit according to the instruction of master control board 1705; 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, mode of operation by screen display membrane keyboard, layer menu and dialog box, realize instrument self checking and calibration, the calibration of reagent project, confirm or input test sample and project information, assigns the experimental implementation instruction, maintenance tool, print and upload the operations such as result data, the display instrument duty, show debugging and error message; External barcode scanner 1603 and built-in barcode scanner 1608 are 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 identification has reagent device 10; Host interface 1601 connects external computing machine, transmission experiment information; Expansion service interface 1602 is installed, arranges, debugs and safeguard for software systems; Alarming horn 1604 sends alarming prompt sound when gross error occurs.
Refer to Figure 23, described software systems comprise the main control software 1770 be comprised of Single Chip Microcomputer (SCM) program 1771 and PLD program 1772; Be installed on and outreach on computing machine the instrument management software 1780 of undertaking debugging, 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 consisted of sheet metal and machined part; Be provided with the shell and the door closure that are formed by plastics on described bearing structure; Be provided with the castor of mobile instrument under described bearing structure, be provided with the adjustable support foot cup (signal of not drawing) that possesses the rubber shock-absorbing structure on described castor.

Claims (18)

1. a full-automatic enzyme-linked immunoassay instrument, comprise housing assembly (11), wash (12), application of sample/reagent adding 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), be provided with pillar (112) on framework soleplate (111), be provided with successively from the bottom up bottom plate (113) and upper mounted plate (115) on pillar (112), be provided with circular reaction tray (114) between bottom plate (113) and upper mounted plate (115), described circular reaction tray (114) is connected with bottom plate (113) with upper mounted plate (115) by central shaft (116), be fixed with the first motor (118) in bottom plate (113) bottom, the first motor (118) drives circular reaction tray (114) by the first gear train (117) and rotates, be provided with wash (12) and application of sample/reagent adding assembly (13) on the upper bottom surface of solid plate (115) described, described application of sample/reagent adding assembly (13) pass through the second motor (136) and the second gear train (139) reciprocating along slot (1110) direction of circular reaction tray (114), described liquid-way system (15) provides relevant liquid or reagent for wash (12) and application of sample/reagent adding assembly (13), described input-output unit (16) is for inputting associative operation information and output detections result.
2. full-automatic enzyme-linked immunoassay instrument as claimed in claim 1, it is characterized in that, described circular reaction tray (114) is provided with several slots (1110) for inserting reagent device (10), circular reaction tray (114) is taken reagent device (10) to wash (12) institute correspondence position, completes washing operation; Take application of sample/reagent adding assembly (13) institute correspondence position to and complete application of sample, reagent adding operation; Take the corresponding position of optical measurement assembly (17) to and complete the optical measurement operation.
3. full-automatic enzyme-linked immunoassay instrument as claimed in claim 1, it is characterized in that, described circular reaction tray (114) is driven in the micro-swinging mode through the first gear train (117) by the first motor (118), and the reactant of vibration in test agent device (10) reaches the purpose that mixes married operation.
4. full-automatic enzyme-linked immunoassay instrument as claimed in 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 accurately located circular reaction tray (114) together with the upper corresponding pilot hole (1114) of circular reaction tray (114).
5. full-automatic enzyme-linked immunoassay instrument as claimed in 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) while quitting work, lock collar device (1112) inserts circular reaction tray (114)) in lockhole (1115), pin reaction tray (21).
6. full-automatic enzyme-linked immunoassay instrument as claimed in claim 1, it is characterized in that, described sample/reagent adding the assembly (13) that adds is included on upper mounted plate (115) upper bottom surface the horizontal guide rail (138) be fixed with along upper slot (1110) the direction layout of circular reaction tray (114), be provided with application of sample/reagent adding frame (134) on horizontal guide rail (138), be provided with some the first vertical guide rails (133) on application of sample/reagent adding frame (134), be provided with application of sample/reagent adding needle stand (132) on the first vertical guide rail (133), be provided with application of sample/reagent adding pin (131) on application of sample/reagent adding needle stand (132).
7. full-automatic enzyme-linked immunoassay instrument as claimed in claim 1, is characterized in that, at fixed plate (115) rear portion, also is fixed with for cleaning the cleaning station (137) of application of sample/reagent adding pin (131); At application of sample/reagent adding frame (134) rear portion, be provided with for driving the 3rd motor (135) of application of sample/reagent adding needle stand (132) motion.
8. full-automatic enzyme-linked immunoassay instrument as claimed in claim 1, is characterized in that, described application of sample/reagent adding pin (131) be provided with control system (18), be connected for detection of application of sample/reagent adding pin (131) liquid level level detection mechanism.
9. full-automatic enzyme-linked immunoassay instrument as claimed in claim 1, it is characterized in that, described application of sample/reagent adding pin (131) is connected to liquid-way system (15) by pipeline, the process of being controlled application of sample, reagent adding and cleaning application of sample/reagent adding pin (131) according to the requirement of predetermined experiment by liquid-way system (15).
10. full-automatic enzyme-linked immunoassay instrument as claimed in claim 1, it is characterized in that, described wash (12) comprising: be fixedly mounted on the some wash stands (124) on upper mounted plate (115) upper bottom surface, be provided with the second vertical guide rail (123) on wash stand (124), the second vertical guide rail (123) is provided with washing needle stand (122), be fixed with washing pin (121) on washing needle stand (122), be provided with the 4th motor (125) for driving washing pin (121) by washing needle stand (122) to the washing of reagent device (10) reacting hole topping up and getting rid of cleansing solution on washing needle stand (122), below the washing pin, the correspondence position of bottom plate (113), be provided with rinse bath (126) through bottom plate (113), for washing 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 as claimed in claim 1, it is characterized in that, described heating and temperature-controlling module (14) comprise the storage heater (142) be arranged on bottom plate (113) bottom surface, the baffle plate (143) distributed along circular reaction tray (114) cylindrical, be provided with the first thermosistor (141) through bottom plate (113), be provided with the second thermosistor (144) at the upper mounted plate upper bottom surface, be connected to the Instrument shell (19) on 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) form the constant temperature space (147) of approximate sealing, and storage heater (142) provides thermal source through bottom plate (113) to constant temperature space (147); Hot-air is by between circular reaction tray (114) and baffle plate (143), the slit (146) of fixed head (115) is blowed upper mounted plate (115) facing up, 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; The first thermosistor (141) is for detection of the temperature of constant temperature space (147) and control the action of heating of storage heater (142), the second thermosistor (144) is for detection of the temperature in the interior space of tool housing (19), when temperature during higher than setting value, open radiator fan (145), discharge hot-air, suck cool exterior air from air intake opening (148), temperature in lowering apparatus.
12. full-automatic enzyme-linked immunoassay instrument as claimed in claim 1, it is characterized in that, described optical measurement assembly (17) comprising: be arranged on the light source (181) for controlling brightness and wavelength on framework soleplate (111), be installed with several front end concentration pieces (185) at the upper mounted plate upper bottom surface, be installed with rear end concentration piece (184) on bottom plate below the front end concentration piece (113) upper bottom surface, be provided with photoelectric sensor (183) below 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), through the perforate on front end concentration piece (182) below upper mounted plate (115), through groove and the perforate on circular reaction tray (114), through rear end concentration piece (184), project on photoelectric sensor (183), photoelectric sensor (183) will be changed the electric signal obtained and be sent to control system.
13. full-automatic enzyme-linked immunoassay instrument as claimed in 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) arranges, the storage that the needed cleansing solution of washing reagent device (10) is provided and cleans the cleaning fluid of application of sample/reagent adding pin (131), washing pin (121); Be provided with working fluid liquid level sensor (1502,1504,1506) in working fluid liquid bottle (1501,1503,1505), in order to the tracer liquid memory space; Be connected to the solenoid valve (1507,1508,1509,1510) in working fluid liquid bottle (1501,1503,1505) exit for controlling the output of working fluid; Be connected in the conveying for cleansing solution and cleaning fluid of washing pump (1511,1512) after solenoid valve (1510); Be connected to solenoid valve (1513,1514) after washing pump (1511,1512) for controlling cleansing solution and cleaning fluid to washing pin (121) output; Be provided with rinse bath sensor (1517,1521) for responding to the cleaning water level on rinse bath (126); Be connected in waste liquid and rinse bath (126) the interior waste liquid of positive displacement pump (1515,1516,1518,1519,1520,1522,1523) for getting rid of washing and cleaning reagent device (10) of washing pin (121) drain side; Be connected to the waste discharge pond (1524) of positive displacement pump (1515,1516,1518,1519,1520,1522,1523) outlet for temporary waste liquid; Be provided with waste discharge sensor (1525,1526) for responding to the liquid level of waste liquid in waste discharge pond (1524); Waste discharge pond (1524) outlet is connected with waste discharge pump (1527) for discharging the waste liquid in waste discharge pond (1524); Be connected with waste liquid barrel (1528) in waste discharge pump (1527) outlet, for collecting waste liquid; Be connected with scavenging pump (1529) in working fluid liquid bottle (1501) exit for to application of sample/reagent adding pin (131) and cleaning station (137), providing cleaning fluid; Solenoid valve (1530,1531) provides cleaning fluid for controlling to cleaning station (137); The solenoid valve (1532,1533,1534,1335) be connected between working fluid bottle (1501), scavenging pump (1529) and application of sample/reagent adding pin provides cleaning fluid for controlling for application of sample/reagent adding pin (131); Be connected to syringe (1536) on solenoid valve (1534,1535) for to reagent device (10), providing accurate cleaning fluid.
14. full-automatic enzyme-linked immunoassay instrument as claimed in 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), the second motor position sensor (1710), position correction device position transducer (1711); Direct supply, storage heater (142) power supply, printer (1606) power supply and light source (181) power supply of the various voltages that power supply unit (1702) provides control circuit to use; Master control board (1705) is instrument control center, load master control program, gather each road sensor information, accept operation requests through each input interface, according to software systems and method document output steering order prepared in advance, handle the instrument operation and detect test, the management instrument state, and export corresponding information to outer computer, printer (1606), touch display screen (11607) by output unit; Low-voltage-powered plate (1706) provides the driving power to the large capacity execution such as each pump of liquid-way system (15), solenoid valve, liquid level sensor, dish lock and collecting unit according to the instruction of master control board (1705); Interface board (1704) interface is provided and outreach computing machine, external barcode scanner (1603) is connected, the input and output information.
15. the full-automatic enzyme-linked immunoassay instrument, is characterized in that as claimed in claim 14, described software systems comprise the main control software (1770) be comprised of Single Chip Microcomputer (SCM) program (1771) and PLD program (1772); Be installed on and outreach on computing machine the instrument management software (1780) of undertaking debugging, 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 as claimed in claim 1, it is characterized in that, described input-output unit (16) comprises touch display screen (1607), external barcode scanner (1603), built-in barcode scanner (1608) thermal printer (1606), reagent device sensor (1605), host interface (1601), expansion service interface (1602), alarming horn (1604); Touch display screen (1607) display instrument operation interface and duty, mode of operation by screen display membrane keyboard, layer menu and dialog box, realize instrument self checking and calibration, the calibration of reagent project, confirm or input test sample and project information, assigns the experimental implementation instruction, maintenance tool, print and upload the operations such as result data, the display instrument duty, show debugging and error message; External barcode scanner (1603) and built-in barcode scanner (1608) are 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 identified circular reaction tray (114) has reagent device (10); Host interface (1601) connects external computing machine, transmission experiment information; Expansion service interface (1602) is installed, arranges, debugs and safeguard for software systems; Alarming horn (1604) sends alarming prompt sound when gross error occurs.
17. the full-automatic enzyme-linked immunoassay instrument, is characterized in that as claimed in claim 1, the present invention also is provided with casing assembly (19).
18. the full-automatic enzyme-linked immunoassay instrument, is characterized in that as claimed in claim 17, described casing assembly (19) comprises the bearing structure of each assembly consisted of sheet metal and machined part; Be provided with the shell and the door closure that are formed by plastics on described bearing structure; Be provided with the castor of mobile instrument under described bearing structure, be provided with the adjustable support foot cup that possesses the rubber shock-absorbing structure on described castor.
CN201010042628XA 2010-01-04 2010-01-04 Automatic enzyme-linked immune analysis analyzer Active CN102116771B (en)

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