CN102621338B - Sample analyzer - Google Patents
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- CN102621338B CN102621338B CN201210095126.2A CN201210095126A CN102621338B CN 102621338 B CN102621338 B CN 102621338B CN 201210095126 A CN201210095126 A CN 201210095126A CN 102621338 B CN102621338 B CN 102621338B
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Abstract
The invention provides a sample analyzer using a first reagent and a second reagent to analyze a sample, comprising: a first reagent container fixer, the first reagent is held in the first reagent container, a first recording element is provided for recording first reagent management information for the first reagent management; a second reagent container fixer, the second reagent is held in the second reagent container, a second recording element is provided; an information reading device; a judging part; a logging-in part; a determining device; and a processor. The invention also provides an analyzing method for analyzing the sample via use of the first reagent and the second reagent in the sample analyzer.
Description
The application is that application number is 200810084891.8, the applying date be March 28 in 2008 day, be called the divisional application of the Chinese invention patent application of being submitted to by same applicant of " sample analyzer ".
technical field:
The present invention relates to a kind of sample analyzer, particularly relate to a kind of sample analyzer of at least using the first reagent and the second reagent analysis institute setting analysis project.
background technology:
All the time, people just know the sample analyzer (such as the open 2005-121492 communique of patent) of useful the first reagent and the second reagent analysis institute setting analysis project.
The sample analyzer of describing on the open 2005-121492 communique of patent, in the time analyzing the analysis project that need to analyze by several agents, uses container that the reagent container that the required several agents of this project of analysis is housed is respectively fixed to one another together.This container is fixed on reagent platform.Always, some analysis projects can use and need to and needn't analyze through the reagent of certain processing through the reagent of certain processing such as stirring.If carried out certain processing for carrying out certain reagent of processing, caused harmful effect to measurement result sometimes.
The sample analyzer of describing on the open 2005-121492 communique of patent, owing to analyzing with the container that the several reagent containers that interfix are housed, is easily managed as the required reagent of same analysis project the several agents comprising in container.On the other hand, also have and be difficult to only to carrying out certain defect of processing through the reagent of certain processing.
Therefore, also can consider to be placed on respectively different placement places by the reagent container that need to carry out the reagent container of certain reagent of processing and the reagent that needn't carry out certain processing is housed is housed.At that rate, just can only carry out certain reagent of processing to needs easily necessarily processes.But, will bring and be difficult to needs to carry out certain reagent of processing and needn't carry out certain reagent of processing as the problem of being managed for the reagent of same analysis project.
summary of the invention:
Scope of the present invention, only by appended claim book defined, is not limit by the statement of this joint summary of the invention in any degree.
The sample analyzer that the invention provides a kind of use the first reagent and the second reagent analysis sample, comprising:
The the first reagent container fixator that can fix several the first reagent containers, wherein this first reagent container holds the first reagent, has first recording element, is recording the first Reagent management information for described the first Reagent management;
The the second reagent container fixator that can fix several the second reagent containers, wherein this second reagent container holds the second reagent, has second recording element, is recording the second Reagent management information for described the second Reagent management;
Read the first information reading device of described the first Reagent management information from described the first recording element;
Read the second information read device of described the second Reagent management information from described the second recording element;
Login part, described the second Reagent management information that described the first Reagent management information reading according to described first information reading device and described the second information read device read is by described the first reagent and described the second agent combination login;
Determinator, with described login, partly corresponding described the first reagent of described combination and described second reagent of login are measured institute's setting analysis project; And
Processor, the measurement result that described determinator is recorded is processed, and obtains the analysis result of sample.
Described sample analyzer also comprises: judgment part, and whether corresponding for judging described the first Reagent management information and described the second Reagent management information.
Described the first Reagent management packets of information is containing the first analysis project information, and described the second Reagent management packets of information is containing the second analysis project information, described judgment part judge the first analysis project information and the second analysis project information whether corresponding.
Described the first Reagent management packets of information is containing the first lot number information; Described the second Reagent management packets of information is containing the second lot number information; Described judgment part judge described the first analysis project information and described the second analysis project information whether corresponding, also judge that whether described the first lot number information and described the second lot number information corresponding simultaneously; When described judgment part judges that described the first analysis project information and described the first lot number information and described the second analysis project information and described the second lot number information are when corresponding, described login part is logined described the first reagent and described the second reagent in groups.
When described judgment part judge described the first Reagent management information and described the second Reagent management Asymmetry information seasonable, described login part forbids logining in groups described the first reagent and described the second reagent.
Described the first Reagent management packets of information is containing the First ray information of described the first reagent container, described the second Reagent management packets of information is containing the second sequence number information of described the second reagent container, described login part, in the time logining in groups described the first reagent and described the second reagent, is also logined the corresponding relation of described First ray information and the second sequence number information.
Described sample analyzer also comprises: customization receiving portion, for the customization of accepting to measure; Have or not reagent set judgment part, for judging the combination that has or not described the first reagent and described the second reagent, so that the customization of carrying out accepting with described customization receiving portion is measured accordingly; And measure and forbid part, in the time that judgement does not have reagent set can carry out measuring accordingly with the customization of described customization receiving portion acceptance, forbid measuring according to described customization.
Described sample analyzer also comprises caveat section, and in the time that the described customization that has or not the judgement of reagent set judgment part not have reagent set can carry out accepting with described customization receiving portion is measured accordingly, warning user forbids measuring according to described customization.
Described sample analyzer also comprises: receiving portion, for accepting the appointment to the described reagent set that will change or take out from user; Wherein, removable described the first reagent container of described the first reagent container fixator; Removable described the second reagent container of described the second reagent container fixator; In the time that the described agent combination that will change or take out has been specified in described receiving portion, corresponding the first reagent of described reagent set the first reagent container is moved to the first extracting position by described the first reagent container fixator, and corresponding the second reagent of described reagent set the second reagent container is moved to the second extracting position by described the second reagent container fixator; Wherein the first extracting position is the position that can take out described the first reagent container that is fixed on described the first reagent container fixator, and the second extracting position is the position that can take out described the second reagent container that is fixed on described the second reagent container fixator.
Described sample analyzer also comprises: the first conveyer, by described the first reagent container from described the first extracting position moves on to described the first reagent container fixator; And second conveyer, by described the second reagent container from described the second extracting position moves on to described the second reagent container fixator; Wherein, in the time that the described reagent set that will change or take out has been specified in described receiving portion, described the first conveyer by the first reagent container that the first reagent in described reagent set is housed from described the first extracting position moves to described the first reagent container fixator, described the second conveyer by the second reagent container that the second reagent in described reagent set is housed from described the second extracting position moves to described the second reagent container fixator.
In the time that the described agent combination that will change or take out has been specified in described receiving portion, described the first conveyer is transported to described the first extracting position by the first reagent container of the first allocation position that is positioned over described the first reagent container fixator outside from described the first allocation position; Described the first reagent container fixator moves to described the first extracting position by the first reagent container that will change the first reagent in reagent set is housed; Described the first conveyer will be equipped with the first reagent container that will change the first reagent in reagent set from described the first extracting position moves to described the first reagent container fixator; Described the second conveyer is transported to described the second extracting position by the second reagent container of the second allocation position that is positioned over described the second reagent container fixator outside from described the second allocation position; Described the second reagent container fixator moves to described the second extracting position by the second reagent container that will change the second reagent in reagent set is housed; Described the second conveyer will be equipped with the second reagent container that will change the second reagent in reagent set from described the second extracting position moves to described the second reagent container fixator.
Rotatable described the first reagent container of described the first reagent container fixator;
Rotatable described the second reagent container of described the second reagent container fixator;
Described the first extracting position is positioned on the path of described the first reagent container rotation;
Described the second extracting position is positioned on the path of described the second reagent container rotation.
Described sample analyzer also comprises: notification section, this notification section is for notifying corresponding the second reagent container of the second reagent in corresponding the first reagent container of described reagent set the first reagent that will change or take out and the described reagent set that will change or take out to change or taken out.
Described sample analyzer also comprises: display; And display controller, on described display, show and be placed on respectively described the first reagent container fixator and the first reagent container of described the second reagent container fixator and the configuration status of the second reagent container.In the time that described the first reagent and the second reagent do not form described reagent set, display can show the first reagent and the second reagent that do not form described reagent set distinctively with the first reagent and the second reagent that form described reagent set described in described display controller control.Also comprise: select part, for selective reagent container on the described display of configuration status that shows described the first reagent container and described the second reagent container; Wherein, when described selection portion component selections while not forming described first reagent of described reagent set or described the second reagent, described display controller control display shows that described reagent container does not form the reason of described agent combination.
The present invention provides the sample analyzer of a kind of use the first reagent and the second reagent analysis institute setting analysis project again, comprising:
The the first reagent container fixator that can fix the first reagent container, wherein this first reagent container holds the first reagent, has first recording element, is recording the first Reagent management information for described the first Reagent management;
The the second reagent container fixator that can fix the second reagent container, wherein this second reagent container holds the second reagent, has second recording element, is recording second dose of management information for described the second Reagent management;
Read the first information reading device of described the first Reagent management information from the first recording element of described the first reagent container;
Read the second information read device of described the second Reagent management information from the second recording element of described the second reagent container;
Judgment part, judges that whether described the second Reagent management information that described the first Reagent management information that described first information reading device reads and described the second information read device read is corresponding;
Determinator, when described judgment part judges that described the first Reagent management information and described the second Reagent management information are at once, by described the first reagent and the second reagent mensuration institute setting analysis project;
Processor, the measurement result that described determinator is recorded is processed, and obtains the analysis result of sample; And
Mensuration is forbidden part, when described judgment part judge described the first Reagent management information and described the second Reagent management Asymmetry information seasonable, forbid that described the first reagent of described determinator and the second reagent measures institute's setting analysis project.
In described sample analyzer: described the first Reagent management packets of information is containing the first lot number information; Described the second Reagent management packets of information is containing the second lot number information; Described judgment part judges that whether the first lot number information is corresponding with the second lot number information.
This sample analyzer also comprises caveat section, this caveat section judge in described judgment part the first lot number information and the second lot number Asymmetry information seasonable, warning user forbids that described determinator measures.
Described sample analyzer is immunity analysis instrument; Described the first reagent and described the second reagent be respectively by conjunction with and catch the reagent of selecting in the seizure antibody of determined antigen or antibody or material group that antigen, magnetic particle, labelled antibody or labelled antigen, dispersion liquid and luminous host form.
Described sample analyzer is blood-counter system; Described the first reagent and described the second reagent are respectively the reagent of selecting the colony from being made up of dilution, hemolytic agent, dyeing liquor and sheath fluid.
accompanying drawing explanation:
Fig. 1 is the one-piece construction oblique view of the immunity analysis instrument of an embodiment of the present invention;
Fig. 2 is immunity analysis instrument planimetric map shown in Fig. 1;
The immunity analysis instrument determinator of Fig. 3 an embodiment of the present invention contains controller at interior block diagram;
Fig. 4 is the structured flowchart of the controller of determinator shown in Fig. 3;
Fig. 5 is the block diagram of the immunity analysis instrument control device of an embodiment of the present invention;
Fig. 6 is the one-piece construction oblique view of reagent dispensing unit shown in Fig. 1;
Fig. 7 is the oblique view of the reagent fixed part of reagent dispensing unit shown in Fig. 6;
Fig. 8 is the planimetric map of the reagent fixed part of reagent dispensing unit shown in Fig. 7;
Fig. 9 is the oblique view that the reagent of the immunity analysis instrument use of an embodiment of the present invention holds the support of utensil;
Figure 10 is the oblique view of reagent dispensing unit shown in Fig. 6;
Figure 11 is the oblique view of the lifter of an embodiment;
The reagent that Figure 12 fills R2 reagent holds the oblique view of utensil;
Figure 13 is the oblique view that the reagent of dress R1/R3 reagent holds utensil;
Figure 14 is the demonstration figure of the reagent configuration status picture of Reagent management picture;
Figure 15 is the demonstration figure of the reagent configuration status picture of Reagent management picture;
Figure 16 is the demonstration figure of the project the surveyed picture of Reagent management picture;
Figure 17 is the demonstration figure that reagent is changed picture;
Figure 18 is the demonstration figure that has changed notice picture;
Figure 19 is the oblique view that explanation reagent is changed operation;
Figure 20 is the sectional view of Figure 19 along 100-100 line;
Figure 21 is the oblique view that explanation reagent is changed operation;
Figure 22 is the sectional view of Figure 21 along 200-200 line;
Figure 23 is the process flow diagram of the immunity analysis instrument measurement operation of explanation one embodiment;
Figure 24 is that reagent allocation list shown in explanation Figure 23 generates processing and reagent login list generates the process flow diagram of processing;
Figure 25 is the process flow diagram that shown in explanation Figure 24, the first available reagent judgement is processed;
Figure 26 is the process flow diagram of measuring processing and data processing processing shown in explanation Figure 23;
Figure 27 is the process flow diagram that reagent allocation list shown in explanation Figure 23 upgrades processing and the processing of reagent login list update; And
Figure 28 is the demonstration figure of warning picture.
embodiment:
The specific embodiment of the present invention is described below with reference to the accompanying drawings.
First, describe with regard to the one-piece construction of the immunity analysis instrument 1 of an embodiment of the present invention with reference to Fig. 1～Fig. 6.
The immunity analysis instrument 1 of an embodiment of the present invention is the device that carries out every inspections such as hepatitis B, hepatitis C, tumor marker and thyroid hormone with samples such as blood.When this immunity analysis instrument 1 is measured, first allow the antigen in samples such as catching antibody (R1 reagent) and blood as determination object be combined, then allow magnetic particle (R2 reagent) be combined with above-mentioned seizure antibody.Then use BF(Bound Free) separation vessel 14(sees figures.1.and.2) magnet (without diagram) attract by antigen and in conjunction with (Bound) to the seizure antibody of antigen and the compound of magnetic particle formation, remove the R1 reagent of the seizure antibody that contains unreacted (Free).Allow again antigen and labelled antibody (R3 reagent) combination of magnetic particle combination.The compound forming by the attraction antigen with BF separation vessel 14 with in conjunction with magnetic particle and the labelled antibody of (Bound), removes the R3 reagent containing the labelled antibody of unreacted (Free).The compound of these magnetic particles, antigen, labelled antibody is dispersed in to dispersion liquid (R4 reagent).With labelled antibody course of reaction in add again luminous luminous host (R5 reagent).Then, measure labelled antibody and react the luminous quantity producing with luminous host.Through this process, quantitative measurement is attached to contained antigen or antibody in the sample of labelled antibody.So, five kinds of reagent of immunity analysis instrument 1 use R1～R5 are measured.In these five kinds of reagent, R4 reagent and R5 reagent are general in each mensuration project.And R1 reagent, R2 reagent and R3 reagent are the special agent of each mensuration project.In the present embodiment, R1/ R3 reagent and R2 reagent are kept at respectively different places, are managed for R1/ R3 reagent and the R2 reagent of same project as matched reagent simultaneously.
This immunity analysis instrument 1 as depicted in figs. 1 and 2, by determinator 2, be disposed at sample conveyer (for sample device) 3 above of determinator 2 and be connected with determinator 2 circuit by PC(computer) control device 4 that forms forms.Determinator 2 is made up of sample packing arm 5, reagent dispensing unit 6 and 7, reagent packing arm 8,9 and 10, primary first-order equation unit 11 and secondary reaction unit 12, reaction cup supply 13, BF separation vessel 14 and detecting device 15.Separately as shown in Figure 3, the each device in determinator 2 (various packing arms, reagent dispensing unit 6 and reagent dispensing unit 7 etc.) is controlled by the controller 2a of determinator 2 inside.Particularly, controller 2a receives signal from the various sensors (be included in sensor 60d, 60g and the initial point acquisition sensor 60e covering in 60 assemblies and be included in sensor 70a, 70b and the 70c etc. in lifter 70) that are arranged on reagent dispensing unit 7, and controls the action of the various drive sources (stepper motor 53 and motor 76 etc.) that are arranged on reagent dispensing unit 7.Equally, controller 2a is also controlling cap assemblies 30 and the lifter 40 etc. of reagent dispensing unit 6.The reagent information that is configured in the reagent of reagent dispensing unit 6,7 is read by barcode reader 6a and 7a, is input to controller 2a.Conveyer 3 also controlled device 2a is controlled.After various packing arms, various sensor and various drive source, describe in detail.
CPU2b can carry out and be stored in the computer program of ROM2c and the computer program that RAM2d reads.ROM2c is storing the computer program and the computer program data used that supply CPU2b to carry out.RAM2d is used for reading the computer program that is stored in ROM2c, and provides work space for CPU2b carries out these computer programs.RAM2d stores by being configured in the reagent information of various reagent of reagent dispensing unit 6 and 7 and the reagent allocation list that each reagent forms in the positional information of reagent dispensing unit 6 and 7.The positional information at reagent dispensing unit 6 or 7, mensuration project, reagent type, lot number, the aftermentioned reagent that this reagent allocation list comprises the each reagent that is configured in reagent dispensing unit 6 and 7 hold utensil sequence number, the current number of times surveyed, term of life, have or not the sequence number of another supporting reagent and supporting another reagent.This reagent allocation list generates in the time that instrument starts, and in the time measuring and replacing or take out when reagent and upgrade successively.Process and upgrade to process about the generation of this reagent allocation list and be described in detail later.
Communication interface 2e is connected with control device 4, is mainly optical information (labelled antibody and luminous host react luminous luminous quantity data) from sample to control device 4 that transmit, the signal that receiving control device 4 controller 4a send.The instruction of the each several part of the communication interface 2e driving sample conveyer 3 that also responsible transmission CPU2b assigns and determinator 2.
Control device 4(is with reference to Fig. 1) by formations such as PC (PC), comprise controller 4a, the display 4b and the keyboard 4c that are formed by CPU, ROM and RAM etc.Display 4b is mainly used in digital signal data income analysis result that display analysis detecting device 15 transmits etc.Display 4b also can show each reagent at the configuration status of reagent dispensing unit 6 and 7 and be configured in the reagent of reagent dispensing unit 6 and be configured in mensuration bulleted list that the reagent of reagent dispensing unit 7 can supporting mensuration etc.In the present embodiment, indication is assigned in control device 4 can hold utensil to aftermentioned reagent replacing and taking-up.
Describe with regard to the structure of control device 4 below.As shown in Figure 5, the computing machine 401 being mainly made up of controller 4a, display 4b and keyboard 4c forms control device 4.Controller 4a is mainly made up of CPU401a, ROM401b, RAM401c, hard disk 401d, reading device 401e, input and output interfaces 401f, communication interface 401g and image output interface 401h.CPU401a, ROM401b, RAM401c, hard disk 401d, reading device 401e, input and output interfaces 401f, communication interface 401g and image output interface 401h are connected by bus 401i.
CPU401a can carry out the computer program that is stored in ROM401b and the computer program that downloads to RAM401c.Computing machine 401 is carried out the effect of aftermentioned application program 404a performance control device 4 by CPU401a.
ROM401b is by MASK(mask-type) formation such as ROM, PROM, EPROM, EEPROM, computer program and data used etc. thereof that storage is carried out by CPU401a.
RAM401c is made up of SRAM or DRAM etc., for reading the computer program that is stored in ROM401b and hard disk 401d.Work space can also carry out these computer programs as CPU401a time.
Above-mentioned application program 404a not only can be provided by pocket storage medium 404, also can by this electronic communication circuit of electronic communication line route (no matter wired, wireless) connect, can provide with the external mechanical that computing machine 401 is communicated by letter.Such as, above-mentioned application program 404a is stored in the hard disk of the webserver, and addressable this server of computing machine 401, downloads this application program 404a, is packed into hard disk 401d.
Input and output interfaces 401f is by forming such as the parallel interfaces such as the serial line interfaces such as USB, IEEE1394, RS-232C, SCSI, IDE, IEEE1284 and the analog signal interface that is made up of D/A converter and A/D converter etc.Input and output interfaces 401f meets keyboard 4c, and user can directly input data to computing machine 401 with keyboard 4c.
Be contained in the mensuration sample luminous quantity (digital signal data) that the detecting device 15 of the immunoassay application program 404a determinator 2 in the hard disk 401d of controller 4a transmits and measure antigen or the antibody content with sample.
Sample packing arm 5(sees figures.1.and.2) sample of being transported to by sample conveyer 3 in the test tube 100 of inhaling pan position 1a can be distributed in the reaction cup 150 of the fixed mount 11b that is placed on aftermentioned primary first-order equation unit 11 turntable 11a.This sample packing arm 5 as depicted in figs. 1 and 2, has motor 5a, connects the driving transmitting portions 5b of motor 5a and is arranged on the horn 5d that drives transmitting portions 5b by axle 5c.Drive transmitting portions 5b to allow horn 5d rotate centered by axle 5c by the driving force of motor 5a, and upper and lower (Z direction) is mobile.The top of horn 5d is equipped with and is inhaled the volumetric pipette 5e that moves sample.
Reagent dispensing unit 6(sees figures.1.and.2) hold utensil for placing reagent, this reagent holds utensil and is used for fixing the reagent container of R1 reagent and the reagent container of the R3 reagent that dress contains labelled antibody that are equipped with containing catching antibody.Reagent dispensing unit 6 as shown in Figure 1, contains the reagent fixator 20 placing reagent and hold utensil, is contained in reagent fixator 20 lid 30 and lifter 40 above.The reagent that lifter 40 is changed in reagent fixator 20 by the hole 30a covering on 30 holds utensil.Lifter 40 has plummer 41 for placing reagent when reagent holds utensil etc. and hold utensil changing.Lid 30 is useful on reagent from being fixed on reagent fixator 20 and holds utensil and inhale and move the hole 30b of R1 reagent and inhale the hole 30c that moves R3 reagent.In the present embodiment, reagent dispensing unit 6 is provided with barcode reader 6a, is attached to reagent and holds the bar code on utensil for reading.
Reagent dispensing unit 7(sees figures.1.and.2) hold utensil 300(with reference to Fig. 6 for depositing reagent), this reagent holds utensil 300 and is depositing the reagent container being equipped with containing the R2 reagent of magnetic particle.Structure about reagent dispensing unit 7 is described in detail later.
Reagent packing arm 8(sees figures.1.and.2) be responsible for inhaling the reagent that moves reagent dispensing unit 6 and hold the R1 reagent in utensil, and the R1 reagent that suction is moved divides and installs to primary first-order equation unit 11 and divided in the reaction cup 150 that sample is housed.This reagent packing arm 8 has motor 8a, connects the driving transmitting portions 8b of motor 8a and is arranged on the horn 8d that drives transmitting portions 8b by axle 8c.Drive transmitting portions 8b to allow horn 8d carry out back rotation centered by axle 8c by the driving force of motor 8a, and move up and down.The top of horn 8d is equipped with to inhale and is moved volumetric pipette 8e(that reagent holds the R1 reagent in utensil with reference to Fig. 1).That is, volumetric pipette 8e inhales and moves the reagent that is placed on reagent dispensing unit 6 and hold after the R1 reagent in utensil, and the R1 reagent that suction is moved divides and installs to primary first-order equation unit 11 and divided in the reaction cup 150 that sample is housed.
Reagent packing arm 9(sees figures.1.and.2) be distributed in the reaction cup 150 of having injected sample and R1 reagent in primary first-order equation unit 11 for the R2 reagent reagent of reagent dispensing unit 7 being held in utensil 300.This reagent packing arm 9 has motor 9a, connects the driving transmitting portions 9b of motor 9a and is arranged on the horn 9d that drives transmitting portions 9b by axle 9c.Drive transmitting portions 9b to allow horn 9d carry out back rotation centered by axle 9c by the driving force of motor 9a, and move up and down.The top of horn 9d is equipped with to inhale and is moved volumetric pipette 9e(that reagent holds the R2 reagent in utensil 300 with reference to Fig. 1).Therefore, volumetric pipette 9e inhales and moves the reagent that is placed on reagent dispensing unit 7 and hold after the R2 reagent in utensil 300, and the R2 reagent that suction is moved divides and installs to primary first-order equation unit 11 and divided in the reaction cup 150 that sample and R1 reagent are housed.
Reagent packing arm 10(sees figures.1.and.2) reagent that moves reagent dispensing unit 6 for inhaling holds the R3 reagent in utensil, and the R3 reagent that suction is moved injects secondary reaction unit 12 and injected in the reaction cup 150 of sample, R1 reagent and R2 reagent.This reagent packing arm 10 has motor 10a, connects the driving transmitting portions 10b of motor 10a and is arranged on the horn 10d that drives transmitting portions 10b by axle 10c.Drive transmitting portions 10b allow centered by horn 10d axle 10c and to carry out back rotation by the driving force of motor 10a, and move up and down.The top of horn 10d is equipped with to inhale and is moved volumetric pipette 10e(that reagent holds the R3 reagent in utensil with reference to Fig. 1).That is, volumetric pipette 10e inhales and moves the reagent that is placed on reagent dispensing unit 6 and hold after the R3 reagent in utensil, and the R3 reagent that suction is moved divides and installs to secondary reaction unit 12 and divided in the reaction cup 150 that sample, R1 reagent and R2 reagent are housed.
As depicted in figs. 1 and 2, at regular intervals, (present embodiment is 18 seconds) turns an angle the reaction cup 150 being fixed on turntable 11a fixed mount 11b in primary first-order equation unit 11, simultaneously sample, R1 reagent and the R2 reagent in stirring reaction cup 150.The effect that, primary first-order equation unit 11 is set is to allow the antigen in R2 reagent and the sample that contains magnetic particle react in reaction cup 150.This primary first-order equation unit 11 is by seeing figures.1.and.2 for rotating sample, R1 reagent and the R2 reagent in turntable 11a and the stirring reaction cup 150 that transports the reaction cup 150 that sample, R1 reagent and R2 reagent are housed and the reaction cup 150 that sample, R1 reagent and R2 reagent after stirring are housed being transported to aftermentioned BF separation vessel 14() container handling device 11c form.
Secondary reaction unit 12(sees figures.1.and.2) there is a structure the same with primary first-order equation unit 11, be used for (present embodiment is 18 seconds) at regular intervals the reaction cup 150 being fixed on turntable 12a fixed mount 12b is turned an angle, simultaneously sample, R1 reagent, R2 reagent, R3 reagent and the R5 reagent in stirring reaction cup 150.The object that secondary reaction unit 12 is set is to allow the antigen in R3 reagent and the sample that contains sample antibody react in reaction cup 150, allows the R5 reagent of luminous host and the labelled antibody of R3 reagent react simultaneously.R5 reagent is installed in the reaction cup 150 that sample, R1 reagent, R2 reagent and R3 reagent are housed of secondary reaction unit 12 by the R5 reagent packing arm (without diagram) point that is arranged on 12 sides, secondary reaction unit.This secondary reaction unit 12 is transported sample, R1 reagent, R2 reagent, R3 reagent and R5 reagent in turntable 12a and the stirring reaction cup 150 of the reaction cup 150 that sample, R1 reagent, R2 reagent, R3 reagent and R5 reagent are housed and the container handling device 12c that the reaction cup 150 that the materials such as the sample after stirring are housed is transported to aftermentioned BF separation vessel 14 is formed by rotation.The reaction cup 150 that container handling device 12c is responsible for that BF separation vessel 14 is processed moves back to the fixed mount 12b of turntable 12a again.About the detailed construction of secondary reaction unit 12, because of the same with primary first-order equation unit 11, description will be omitted.
Reaction cup supply 13(sees figures.1.and.2) can provide several reaction cup 150 to the turntable 11a fixed mount 11b of primary first-order equation unit 11 successively.
The effect of BF separation vessel 14 is that the sample in the reaction cup 150 of transporting from the container handling device 11c of primary first-order equation unit 11 separates unreacted R1 reagent (not composition) and magnetic particle, and the reaction cup 150(transporting from the container handling device 12c of secondary reaction unit 12 is with reference to Fig. 1) in sample separate unreacted R3 reagent (not composition) and magnetic particle.
Detecting device 15(sees figures.1.and.2) obtain the light sending with the labelled antibody of being combined through certain sample antigen of processing and luminous host in course of reaction by photomultiplier (Photo Multiplier Tube), measure the antigenic content in this sample.
Fig. 7～Figure 11 is the accompanying drawing that describes reagent dispensing unit shown in Fig. 6 in detail.Figure 12 and Figure 13 are respectively reagent that the reagent that holds R2 reagent holds utensil and hold R1/R3 reagent and hold the oblique view of utensil.Below, the structure that the reagent that holds utensil 300 with reference to Fig. 1, Fig. 2 and Fig. 6～Figure 13 with regard to the reagent dispensing unit 7 of the immunity analysis instrument 1 of an embodiment of the present invention and the reagent that is positioned over reagent dispensing unit 7 and be positioned over reagent dispensing unit 6 holds utensil 200 describes.
Rotating shaft 52 is installed with the support 600 of placing several reagent and hold utensil 300 for ring-type above.Reagent is held to utensil 300 and be placed on support 600, rotating shaft 52, makes to be placed with the support 600 that reagent holds utensil 300 and rotates, thereby holds utensil 300 and move on to hole 60b on aftermentioned lid 60 and the below of access hole 60c the reagent that will inhale the reagent moving is housed.This support 600 as shown in Figure 9, have insertion rotating shaft 52 use of being located at support 600 centers insertion position 601, be looped around and insert position 601 and around place reagent and hold several fixed bits 602 of utensil 300 and give prominence at the initial point inserting above position 601 and find out sheet 603.Fixed bit 602 is made up of dividing plate 602a and holder 602b.Dividing plate 602a at a certain angle with interval arrange several, to insert position 601 as radius origin radiated entends.Holder 602b is inwardly arranged at the dividing plate 602a bottom of part and the bottom of insertion position 601 relatively highlightedly.When each reagent holds utensil 300 and configures, bottom 323(is with reference to Figure 12) a surrounding 602b that is fixed is fixed in a pair of dividing plate 602a institute clip space.As shown in Figure 8, because the outside of the top of fixed bit 602, bottom and radius is open, therefore, the plummer 71 of lifter 70 holds utensil 300 with the fixed bit 602 ground lifting reagent that horn 72 can not contact support 600.
Lid 60 as shown in Figure 6, is arranged on reagent fixator 50 by hinge 60a, can switch.This lid 60 can intercept the air of outside, and keeping the temperature in reagent dispensing unit 7 is low temperature (15 ℃), meanwhile, can also inhale from outside the reagent that move in reagent dispensing unit 7, and loads and unloads reagent at reagent dispensing unit 7 and hold utensil 300.Particularly, lid 60 has the reagent container 310(that holds utensil 300 from reagent with reference to Figure 12) inhale the hole 60b of the volumetric pipette 9e that inserts reagent packing arm 9 while moving reagent and load and unload reagent and hold the access hole 60c of utensil 300 with lifter 70 from reagent dispensing unit 7.Lid 60 is provided with to survey and on the fixed bit 602 of support 600, whether is placed with reflection sensor 60d, the transmission-type initial point acquisition sensor 60e that surveys support 600 origin positions that reagent holds utensil 300 and detection and is placed on transmission type sensors 60g(that the reagent on aftermentioned lifter 70 plummers 71 holds utensil 300 with reference to Figure 10).Initial point acquisition sensor 60e is configured in and covers 60 medial surfaces, and sensor 60f is configured in and covers 60 surfaces.Sensor 60g steps out hand-hole 60c and is configured in and covers 60 surfaces.The initial point that transmission-type initial point acquisition sensor 60e is located at support 600 by detection is found out sheet 603, learns the origin position of the support 600 of rotation.
At this, in the present embodiment, lifter 70 is for holding utensil 300 to the interior handling reagent of reagent dispensing unit 7.Lifter 70 as shown in figure 11, have place the jib 73 of the plummer 71 of reagent holder 300, the horn 72 of support bearing platform 71, fixing horn 72, by being fixed with straight action-oriented frame, the motor 76 that the slide block 74 of jib 73 and guide rail 75 that bootable slide block 74 slides up and down form, belt 77 and the support 78 that transmits motor 76 driving forces.Three transmission type sensors 70a, 70b and 70c are housed on this support 78.
As shown in figure 11, being arranged on jib 73 two stator 73a bark pocket bands 77 is above fixed on belt 77.With this, the driving force of motor 76 can be delivered to jib 73 by belt 77.On jib 73, be also provided with and find out sheet 73b and highlight.This finds out sheet 73b and can be detected by sensor 70a, 70b and 70c, thereby finds out the upper-lower position of plummer 71.Particularly, when finding out sheet 73b while being detected by sensor 70a, plummer 71 is positioned at the loading position (upper limit) that can load and unload reagent and hold utensil 300.When finding out sheet 73b while being detected by sensor 70b, plummer 71 is positioned at fixed bit 602 belows (lower limit) of support 600.When plummer 71 is positioned at lower limit, the reagent in support 600 hold utensil 300 below, support 600 can rotate like this.Between support 600 and lower limit, be provided with certain space, now sensor 70c may detect and finds out sheet 73b.Accordingly, controller 2a can know the locus of plummer 71 between support 600 fixed bits 602 and lower limit.Like this, in the time that plummer 71 is positioned at locus, can avoid runing rest 600 and plummer 71 is contacted with support 600.Belt 77 can rotarily actuate by the pulley 77a by the pulley (without diagram) on the rotating shaft of motor 76 (without diagram) and this axle and above being located at.
Reagent holds utensil 300 as shown in figure 12, is made up of containing the reagent container 310 of the R2 reagent of magnetic particle and the box 320 of storage reagent container 310 dress.Box 320 321 slip lids 322 that are provided with for sealed reagent container 310 above.Slip lid 322 is by being arranged on valve device (without the diagram) switch that covers 60.Box 320 bottoms 323 are provided with the cruciform rib 323a with the groove 71a interlock of lifter 70 plummers 71.Reagent holds utensil 300 sides and posts bar code 300a.This bar code 300a contains about the reagent information that is contained in reagent and holds the R2 reagent in the reagent container 310 of utensil 300.Particularly, reagent information comprises: mensuration project, reagent type, lot number, reagent hold the sequence number of utensil 300, the term of life that reagent just begins to survey number of times and reagent.
Reagent holds utensil 200 as shown in figure 13, has the container 230 that holds the reagent container 210 of R1 reagent, the reagent container 220 that holds R3 reagent, storage reagent container 210 and reagent container 220 to form.Container 230 231 is provided with slip lid 232 and 233 above, for difference sealed reagent container 210 and 220.Container 230 bottoms 234 are provided with the groove 41a(of the plummer 41 of lifter 40 and see figures.1.and.2) the cruciform rib 234a of interlock.Reagent holds utensil 200 sides and reagent, and to hold utensil 300 the same, posts bar code 200a, and this bar code 200a contains about the reagent information that is contained in reagent and holds the reagent (R1/R3 reagent) in utensil 200.
In the present embodiment, magnetic particle weight, free settling, therefore, at the reagent dispensing unit 7 of placing R2 reagent, the support 600 that holds utensil 300 by carrying out back rotation fixating reagent stirs reagent and holds the R2 reagent in utensil 300.At reagent dispensing unit 6, without stirring R1 reagent and R3 reagent, therefore different from reagent dispensing unit 7, swinging mounting does not stir reagent back and forth.A mensuration project is measured with the R2 reagent that is arranged on several R1 reagent of reagent dispensing unit 6 and R3 reagent and is arranged on reagent dispensing unit 7.The immunity analysis instrument 1 of present embodiment can confirm to be equipped with according to the reagent information of bar code 200a and 300a that to measure that the R1 reagent of project and the reagent of R3 reagent holds utensil 200 and be equipped with for holding utensil 300 with the reagent of the R2 reagent of this mensuration project same measured project be a combination for measuring one.Particularly, when the mensuration project and the lot number that are contained in reagent and hold the reagent of utensil 200 hold the mensuration project of reagent of utensil 300 and lot number when consistent with being contained in reagent, immunity analysis instrument 1 just thinks that these reagent are one group.This immunity analysis instrument 1 can the Reagent management such as change with a composite unit by R1 reagent, R2 reagent and R3 reagent.Be described in detail later about Reagent management.
Figure 14～Figure 18 is the picture being presented on control device display.Be presented at the picture structure on control device display below with reference to Figure 14～Figure 18 explanation.
In the present embodiment, as shown in figure 14, control device 4 can be presented at display 4b by the Reagent management picture 410 for Reagent management.At this Reagent management picture 410, select label (reagent configuration status) 410a, just can visualizingre agent configuration status picture 420.The reagent that is presented at reagent dispensing unit 6 on reagent configuration status picture 420 holds utensil 200(R1 reagent and R3 reagent) configuration status and hold utensil 300(R2 reagent at the reagent of reagent dispensing unit 7) configuration status.
Reagent configuration status picture 420 comprises corresponding to the reagent configuration viewing area 421 of reagent dispensing unit 6 and configures viewing area 422 corresponding to the reagent of reagent dispensing unit 7.Reagent configuration viewing area 421 holds the configuration status of utensil 200 at the reagent of reagent dispensing unit 6 for actual disposition, circular demonstration representative is fixed on each locational reagent and holds the mark 421a of utensil 200.Corresponding to each mark 421a, be assigned be illustrated in the positional information in reagent dispensing unit 6 1～N(in the present embodiment, N=13) numeral.In mark 421a, show the mensuration project that reagent holds the reagent (R1 reagent and R3 reagent) that utensil 200 fills.It is same that reagent configuration viewing area 422 and reagent configure viewing area 421, and corresponding to reagent dispensing unit 7, circular demonstration comprises reagent and hold the mark 422a of the mensuration project of 300 installed reagents of utensil (R2 reagent).
At this reagent configuration status picture 420, think and hold 200 installed reagents of utensil and reagent by reagent to hold 300 installed reagents of utensil be matched reagent when instrument, judge when it can be used for measuring when no problem (measure), those reagent hold the corresponding mark 421a of utensil and 422a shows take certain color (in the present embodiment as white).Such as, at Figure 14, at the mark 422a(of the positional information " 1 " (mensuration project " HBsAg ") of reagent configuration viewing area 422 hereinafter referred to as reagent " 1 ") be shown as white, represent and hold the supporting reagent of utensil 300 corresponding to the reagent of this reagent " 1 " and hold utensil 200 and be configured in reagent dispensing unit 6.Equally, about reagent " 2 "～reagent " 4 ", reagent " 7 ", reagent " 10 " and the reagent " 11 " of reagent configuration viewing area 422, also demonstration formation combination the other side's reagent holds utensil 200 and is configured in reagent dispensing unit 6.
At this reagent configuration status picture 420, when reagent itself no problem, but (do not have to draw while drawing the required calibration curve of final analysis result and when surplus (can survey number of times) is less than 10 times) while being necessary to give a warning, holding with those reagent mark 421a and the 422a that utensil is corresponding shows take certain color (present embodiment, as yellow, is shown as the oblique line of wide interval in figure).Such as, the yellow demonstration for reagent " 3 " (mensuration project " HIV ") of the reagent " 6 " (mensuration project " HIV ") of reagent configuration viewing area 422 and reagent configuration viewing area 421, representing does not have calibration curve or surplus (can survey number of times) to be less than 10 times.
At this reagent configuration status picture 420, in the time that reagent itself has problem (when reagent surplus (can survey number of times) is 0 time, operating period out-of-date), holding with those reagent mark 421a and the 422a that utensil is corresponding shows take certain color (present embodiment, as red, is shown as the oblique line at narrow interval in figure).Such as, the red display for reagent " 11 " (mensuration project " HBsAg ") of the reagent " 12 " (mensuration project " HBsAg ") of reagent configuration viewing area 422 and reagent configuration viewing area 421, represents that surplus (can survey number of times) is 0 time or operating period mistake.
In addition, at this reagent configuration status picture 420, in the time that bar code (bar code 200a and 300a) reads unsuccessfully, hold with those reagent mark 421a that utensil is corresponding and for 422a edge certain color (present embodiment is for red, in figure with the edge of thick line show tags) show, be not mensuration project but " ERR " with showing in tense marker.Such as, reagent " 9 " the edge red display of the reagent " 9 " of reagent configuration viewing area 422 and reagent configuration viewing area 421, with showing " ERR " in tense marker, represent to be attached to the bar code that reagent holds utensil and read failure, reagent information is not identified by instrument.
At this reagent configuration status picture 420, the reagent that the reagent configuring when side's reagent dispensing unit holds utensil is not in the time that another reagent dispensing unit has supporting with it reagent, and the reagent of this another reagent dispensing unit holds the corresponding mark 421a of utensil and certain color (present embodiment is for red) demonstration for 422a edge.Such as, reagent " 7 " (mensuration project " HCV ") the edge red display of the reagent " 5 " (mensuration project " HCV ") of reagent configuration viewing area 422 and reagent configuration viewing area 421, represents that the matched reagent (reagent that mensuration project is consistent with lot number) that forms those reagent does not exist.So, the mark (only edge redness) while there is not matched reagent can be when having matched reagent mark (showing " ERR " in white, yellow, redness or edge redness and mark) difference show.
As shown in figure 15, can be by show the state of the corresponding reagent of selected mark with the selected marker 421a such as indicator P or 422a.Such as, the reagent " 9 " of selective reagent configuration viewing area 422, demonstrates " bar code reads failure ".The reagent " 12 " of selective reagent configuration viewing area 422, demonstrates " can survey number of times 0 ".
In the present embodiment, as shown in figure 16, control device 4 can show the project the surveyed picture 430 for representing the mensuration project that can survey on display 4b.Can survey project picture 430 can select by label (can test agent) 410b.
This can survey reagent (R1 reagent and R3 reagent) that visualizingre agent on project picture 430 holds utensil 200 and reagent and hold mensuration project and the consistent measurable mensuration project that becomes matched reagent of lot number of the reagent (R2 reagent) of utensil 300.Can survey project picture 430 with reference to this, user can confirm current measurable mensuration project.Can survey project picture 430 in the time there is no calibration curve and when surplus (can survey number of times) is less than 10 times, also use certain color (in the present embodiment for yellow, but being oblique line in figure) to show the corresponding part of those mensuration projects.Such as, mensuration project is that " HCV ", the lot number mensuration project that is " QQ0006 " is because not drawing calibration curve, therefore project, lot number and calibration curve part represent by yellow.Mensuration project is that the project that " HIV ", lot number are " QQ0010 " is 9 times (being less than 10 times) because surveying number of times, therefore project, lot number and calibration curve part represent by yellow.
Reagent is changed indivedual reagent that picture 440 comprises that the matched reagent of once changing matched reagent is changed picture 450, the indivedual reagent of only changing the reagent of reagent dispensing unit 6 are changed pictures (without diagram) and only change the reagent of reagent dispensing unit 7 and is changed pictures (without illustrating).Matched reagent is changed picture 450 by selection label (R1/R3, R2(Set)) 440a shows.Indivedual reagent that the indivedual reagent of only changing the reagent of reagent dispensing unit 6 are changed pictures (without diagram) and only changed the reagent of reagent dispensing unit 7 are changed pictures (without diagram) respectively by selection label (R1/R3(Indivisual)) 440b and label (R2(Indivisual)) 440c shows.Reagent is changed picture 440 button 441 of replacing, take out button 442 and X button 443.
Matched reagent is changed picture 450 and is shown reagent set replaceable in matched reagent or that take out.It is also the same with reagent configuration status picture 420 that matched reagent is changed picture 450, the state of color separation visualizingre agent group.Such as, mensuration project is that the reagent set surplus (can survey number of times) that " HBsAg ", lot number are " ZA9999 " is 0, therefore uses redness (being narrow interval oblique line in figure) to show.To be " HIV ", the lot number reagent set surplus (can survey number of times) that is " QQ0009 " be less than 10 times for 9(mensuration project), therefore use yellow (being wide interval oblique line in figure) demonstration.
Change indivedual reagent of picture and R2 reagent about indivedual reagent of R1/R3 reagent and change picture, except the reagent list this point that demonstration does not match, the same with matched reagent replacing picture 450, therefore detailed.Change picture at indivedual reagent and can change or take out indivedual reagent.
As shown in figure 18, change or take out after reagent, control device 4 shows and has changed notice picture 460 at display 4b.User can complete notice picture 460 by this replacing and understand reagent and change.
Figure 19～Figure 22 is the accompanying drawing that explanation reagent is changed operation.Illustrate that below with reference to Fig. 8, Figure 10 and Figure 19～Figure 22 immunity analysis instrument 1 in present embodiment changes and take out reagent supporting in reagent dispensing unit 7 and hold the operation steps of utensil 200 and 300.This explanation describes with regard to the situation of changing or taking out matched reagent.
As shown in figure 10, plummer 71 is configured in loading position (sensor 70a is ON state) under holding state.Equally, plummer 41 is also configured in loading position.Change reagent and hold utensil 200 and at 300 o'clock, first as shown in Figure 19 and Figure 20, user puts respectively the reagent that will append at each plummer 41 and plummer 71 and holds utensil 200 and 300.
In this state, user assigns reagent by control device 4 and changes indication.Particularly, change picture 450 at matched reagent, after the reagent set that selection will be changed, press and change button 441.Start to change supporting reagent with this and hold utensil 200 and 300.
Now, at reagent dispensing unit 7, at stepper motor 53(with reference to Fig. 8) driving under, support 600 rotates, the fixed bit 602 that fixating reagent does not hold utensil 300 moves to the access hole 60c below of covering 60.Then as shown in figure 20,, under the driving of motor 76, plummer 71 starts to move down.As shown in Figure 21 and Figure 22, when holder 602b by fixed bit 602 of plummer 71, the marginal portion that reagent holds utensil 300 bottoms 323 602b that is fixed holds, and reagent holds utensil 300 and is fixed to fixed bit 602.
Find out sheet 73b while being detected by sensor 70b, motor 76 stops driving.In this state, stepper motor 53 driving arms 600 rotate, and place the position of readiness that fixed bit 602 that the reagent of changing picture 450 selected reagent at reagent holds utensil 300 is housed moves to below access hole 60c (above the plummer 71 of lower limit).Placement is equipped with fixed bit that the reagent of changing picture 450 selected reagent at reagent holds utensil 200 and is also moved to the position of readiness below access hole 30a.At reagent dispensing unit 7, plummer 71 starts to move up under the driving of motor 76.On the plummer 71 that moves hold up reagent on the holder 602b that is fixed on fixed bit 602 and hold utensil 300 and move on continuing.Till moving on to sensor 70b on plummer 71 and detecting and find out sheet 73b, be configured to loading position.With this, the reagent that change holds utensil 300 and is taken out from reagent dispensing unit 7.Also the reagent that will change by same operation at reagent dispensing unit 6 holds utensil 200 and takes out from reagent dispensing unit 6.In the present embodiment, so change supporting reagent set (reagent holds utensil 200 and reagent holds utensil 300).After supporting replacing reagent finishes, notice picture 460 has been changed in display 4b demonstration.
Take out when reagent set, do not place reagent hold utensil at the plummer 41 of loading position and plummer 71, user assigns the indication of taking out reagent by control device 4.Change picture 450 at matched reagent, under the state of having selected the reagent set that will take out, press and take out button 442.Take out with this that supporting reagent holds utensil 200 and reagent holds utensil 300.Take out operation the same with replacing, therefore detailed.
Figure 23 is the process flow diagram of the measurement operation step of explanation determinator controller and control device controller.First the measurement operation step of the immunity analysis instrument 1 of an embodiment of the present invention is described with reference to Figure 14, Figure 16, Figure 17 and Figure 23.
First, the controller 2a of determinator 2 connects the power supply (without diagram) of determinator 2, at step S1, carries out the initialization (program initialization) of controller 2a, checks determinator 2 each several part ruuning situations simultaneously.Then the power supply (without diagram) of connecting control device 4, carries out the initialization (initialization of program) of controller 4a at step S101 at control device 4 controller 4a.
Then,, at step S2, carry out reagent allocation list by the controller 2a of determinator 2 and generate processing.Generate to process about this reagent allocation list and be described in detail later.Control device 4 controller 4a generate reagent login list at step S102.Generation about this reagent login list is described in detail later.
After this, the reagent configuration status picture 420(of user on display 4b is with reference to Figure 14) and can survey project picture 430(with reference to Figure 16) etc. Selective determination start button 412, to control device 4 assign start measure indication.The controller 4a of control device 4 is at step S103, and judgement has or not reception mensuration to start indication.If judgement starts indication without measuring, processing is jumped to step S106.Start indication if judgement has to measure, the controller 4a of control device 4 transmits and measures commencing signal to the controller 2a of determinator 2 at step S104.Then, the controller 4a of control device 4 carries out data analysis processing at step S105.Be described in detail later about this analyzing and processing.
On the other hand, the controller 2a of determinator 2 judges whether to receive mensuration commencing signal from control device 4 at step S3.If measured signal is not received in judgement, process and jump to step S6.If mensuration commencing signal is received in judgement, the controller 2a of determinator 2 measures processing at step S4.Measure to process about this and be described in detail later.
User changes picture 440(with reference to Figure 17 at reagent) or indivedual reagent replacing pictures (without diagram), selecting after reagent set to be replaced or that take out or indivedual reagent, changing button 441 by selection and assign the indication of changing selected reagent set or indivedual reagent to control device 4.
The controller 4a of control device 4 judges whether to receive reagent replacing indication at step S106.If judge without reagent and change indication, process and jump to step S109.If judgement has reagent to change indication, the controller 4a of control device 4 transmits and indicates the signal of changing reagent to determinator 2 controller 2a at step S107.
The controller 4a of control device 4 step S108 along with changing reagent novel agent login column table more.Renewal processing about this reagent login list is described in detail later.
At step S5, judged whether to receive reagent replacing indicator signal from control device 4 by the controller 2a of determinator 2.If judgement is not received reagent and is changed indicator signal, carries out the processing of step S7.If judgement is received reagent and changed indicator signal, carry out reagent allocation list at step S6 and upgrade processing.Upgrade to process about this reagent allocation list and be described in detail later.
User assigns shutdown indication at the display 4b of control device 4.Now, the controller 4a of control device 4 judges whether to receive shutdown indication at step S109.If shutdown indication is not received in judgement, return to the processing of step S103.If shutdown indication is received in judgement, the controller 4a of control device 4 is sent to shutdown indicator signal at step S110 the controller 2a of determinator 2.So far, the measurement operation of the controller 4a of control device 4 completes.
The controller 2a of determinator 2 judges whether to receive off signal from control device 4 at step S7.If not receiving, judgement returns to step S3 by off signal.If off signal is received in judgement, implement shutdown at step S8.So far, the measurement operation of the controller 2a of determinator 2 completes.
Figure 24 is the process flow diagram that the controller of determinator shown in explanation Figure 23 generates the controller generation reagent login column list processing (LISP) of control device shown in the processing of reagent allocation list and Figure 23.Below, with reference to Figure 24 describe in detail reagent allocation list in the step S2 of Figure 23 generate process and the step S102 of Figure 23 in reagent login column table generate the process of processing.
Generate and process as the reagent allocation list of determinator 2, first at step S11, runing rest 600, makes first reagent container (" 1 " (holding utensil 300 with the reagent of mensuration project " HBsAg " relevant position) of Figure 14 moves on to reagent strip shape code and read position 7b(with reference to Fig. 8) of reagent dispensing unit 7.
The controller 2a of determinator 2 reads the bar code 300a that is attached to reagent and holds utensil 300 sides by barcode reader 7a at step S12.The information (bar code information) that is recorded in this bar code 300a comprises mensuration project, lot number, reagent container sequence number and the number of times etc. that just begins to survey.Then the bar code information that, the controller 2a of determinator 2 reads barcode reader 7a at step S13 and the allocation position information of reagent are sent to the controller 4a of control device 4 accordingly.
The controller 2a of determinator 2 judges that at step S14 whether the reading and transmit of bar code information of above-mentioned steps S12 and step S13 holds utensil 300 and implement being configured in whole reagent of reagent dispensing unit 7 again.If above-mentioned processing not yet holds utensil 300 to all reagent and implements, the controller 2a of determinator 2 holds utensil 300 by runing rest 600 by the reagent of next (second) position at step S15 and moves on to reagent strip shape code and read position 7b, the reagent of second position is held to utensil 300 simultaneously and carries out the processing of above-mentioned steps S12 and step S13.Equally, hold utensil 300 for a 3rd～N reagent and also carry out the processing of above-mentioned steps S12 and step S13.
First the controller 4a of control device 4 judges whether to receive allocation position information and bar code information from the controller 2a of determinator 2 at step S111.If do not received, this judgement repeatedly.If received, the controller 4a of control device 4 judges at step S112 whether reagent lane database has and the corresponding reagent information of bar code information.Whether the bar code information again reading after the data (reagent information) while judging measuring of storing in control device 4 above start with device is consistent.If reagent database has the corresponding reagent information of bar code information, carry out the processing of step S115.If there is no the corresponding reagent information of bar code information in reagent database, illustrate when having the reagent of this bar code information to hold utensil is former mensuration unexistent, the controller 4a of control device 4 by analyzing bar code information, generates this reagent and holds the reagent information of utensil institute installed reagents at step S113.The controller 4a of control device 4 reagent information generating at above-mentioned steps S113 to reagent Input of Data at step S114.
Then, the controller 4a of control device 4, at step S115, reads in from reagent database the corresponding reagent information of bar code information that above-mentioned steps S111 receives, and in this reagent information, appends allocation position information at step S116.
The controller 4a of control device 4, at step S117, judges whether that all reagent (reagent holds utensil) to being configured in reagent dispensing unit 6 and 7 have completed the processing of above-mentioned steps S111～step S116.If not yet all reagent is carried out to above-mentioned processing, return to step S111.If all reagent has completed processing, the controller 4a of control device 4 judges the first available reagent judgement processing of matched reagent at step S118.This first available reagent judgement is processed and is described in detail later.
After this, the controller 4a of control device 4 at step S119 to the sequence number each other that appends and upgrade matched reagent and hold utensil (reagent that mensuration project can be surveyed) in the reagent information of reagent database.The controller 4a of control device 4 transmits the reagent information after upgrading at step S120 to the controller 2a of determinator 2 again.
When judging that at step S14 when all reagent is held utensil 300 and completed above-mentioned processing, the controller 2a of determinator 2 judges whether to receive reagent information from control device 4 at step S16.This reagent information is except bar code information, and the reagent that also have the current number of times surveyed information, have or not another supporting reagent, holds another reagent while having matched reagent holds the sequence number of utensil 300 and uses priority.If do not receive reagent information, this judgement repeatedly.If receive reagent information, the controller 2a of determinator 2 generates reagent allocation list at step S17 according to the reagent information of receiving at above-mentioned steps S16.
Next, the controller 2a of determinator 2 sends the more new demand signal of the controller 4a refresh display 4b picture that requires control device 4 to the controller 4a of control device 4 at step S18.Like this, reagent allocation list is just made.In the above description, be only illustrated with regard to the reagent that is configured in reagent dispensing unit 7, carry out too reagent allocation list about the reagent that is configured in reagent dispensing unit 6 and generate processing.
The controller 4a of control device 4 judges whether to receive at step S121 the more new demand signal that requires to upgrade picture.If do not receive the more new demand signal of picture, this judgement repeatedly.If receive the more new demand signal of picture, the controller 4a of control device 4 is at more novel agent configuration status picture 420 and can test agent picture 430 of step S122.So carry out the generation processing of reagent login list.
Figure 25 is that the controller 4a of control device 4 shown in explanation Figure 24 carries out the process flow diagram that the first available reagent judgement is processed.Describe the process that in the step S118 of Figure 24, the first available reagent judgement is processed in detail below with reference to Figure 25.
In the first available reagent judgement is processed, first, at step S131, represent that it is the integer below 1 above N at the numbering i(i of the allocation position of reagent dispensing unit 7 that reagent holds utensil 300) be set to i=1.In the present embodiment, N=13.
The controller 4a of control device 4 judges at step S132 whether the reagent (hereinafter referred to as reagent " i=1 ") filling in the allocation position of reagent dispensing unit 7 holds utensil 300 for the reagent of " 1 " is R1/R3 reagent.If reagent " i=1 " is not R1/R3 reagent, enter step S152.If reagent " i=1 " is R1/R3 reagent, the controller 4a of control device 4, at step S133, judges whether the reagent information of reagent " i=1 " has the sequence number of another supporting reagent.If contain the sequence number of another reagent in reagent information, judge at step S134 whether the specific R2 reagent of this sequence number (reagent holds utensil 300) is disposed at reagent dispensing unit 7.If configuration will have or not supporting the other side to be made as " having ", and enter step S152 in the reagent information of reagent " i=1 " at step S135.If not configuration, or in reagent information during not containing the other side's sequence number, will in the reagent information of reagent " i=1 ", have or not supporting the other side to be made as " nothing " at step S136, and enter step S152.
At step S133, if do not contain the other side's sequence number in reagent information, the controller 4a of control device 4 is the integer below 1 above N at step S137 by the numbering j(j of the reagent holder allocation position that is illustrated in reagent dispensing unit 6) be made as j=1.
The controller 4a of control device 4, at step S138, judges whether the reagent (hereinafter referred to as reagent " j=1 ") filling in the allocation position of reagent dispensing unit 6 holds utensil 200 for the reagent of " 1 " is R2 reagent.If reagent " j=1 " is not R2 reagent, enter step S143.If reagent " j=1 " is R2 reagent, the controller 4a of control device 4, at step S139, judges whether the reagent information of reagent " j=1 " has the sequence number of another supporting reagent.If do not contain the other side's sequence number in reagent information, enter step S145.
At step S139, if contain the sequence number of another reagent in reagent information, the controller 4a of control device 4 judges at step S140 whether the specific R1/R3 reagent of this sequence number (reagent holds utensil 200) is disposed at reagent dispensing unit 6.If the R1/R3 reagent as another reagent is configured in reagent dispensing unit 6, will in the reagent information of reagent " j=1 ", has or not the other side to be made as " having " at step S142, and enter step S143.If, will have or not supporting the other side to be made as " nothing " in the reagent information of reagent " j=1 " at step S141, and enter step S143 for not having the specific reagent of configuration sequence number institute to hold utensil 200 at step S140.
At step S143, judge whether to meet j=N.If do not meet j=N, at step S144, j value increment.Be made as j=2.After this, step S138～step S144 carries out repeatedly, until meet j=N.At step S143, in the time meeting j=N, enter step S152.
At step S145, judge that whether reagent " i " is consistent with the analysis project of reagent " j ".If judge that the analysis project of reagent " i " and reagent " j " is inconsistent, at step S147 by having or not matched reagent to be made as after " nothing " in the reagent information of reagent " i " and reagent " j ", enter step S143.If reagent " i " is consistent with the analysis project of reagent " j ", judge that at step S146 whether reagent " i " is consistent with the lot number of reagent " j ".If the lot number of reagent " i " and reagent " j " is inconsistent, at step S147, by having or not matched reagent to be made as after " nothing " in the reagent information of reagent " i " and reagent " j ", enter step S143.If reagent " i " is consistent with the lot number of reagent " j ", judges that reagent " i " and reagent " j " are matched reagent, and enter step S148.
At step S148, as the sequence number of matched reagent, the sequence number of additive reagent in the reagent information of reagent " i " " j ".At step S149, will in the reagent information of reagent " i ", have or not matched reagent to be made as " having ".Then at step S150, as the sequence number of sequence number additive reagent " i " in the reagent information of reagent " j " of matched reagent.And at step S151, will in the reagent information of reagent " j ", have or not matched reagent to be made as " having ".
At step S152, judge whether i=N.If not i=N, at step S153, the value increment of i, and enter step S132.The processing of step S132～step S153 is carried out repeatedly until i=N.At step S152, if meet i=N, finish the first available reagent judgement and process.
In the first available reagent judgement is processed, as mentioned above, whether consistent with lot number with the whole various combination discriminatory analysis projects of several reagent that are configured in reagent dispensing unit 7 to the several reagent that is configured in reagent dispensing unit 6, distinguish supporting reagent " i " and reagent " j " with this.Then additional sequence number each other in the reagent information of the supporting reagent " i " of distinguishing and reagent " j ".About being judged as analysis project inconsistent or the inconsistent reagent of lot number " i " and reagent " j ", in reagent login list, will have or not respectively matched reagent to be made as " nothing " with regard to each reagent " i " and reagent " j ".Forbid that with this mentioned reagent " i " and mentioned reagent " j " are used as reagent set login.
Figure 26 is that the controller of determinator shown in explanation Figure 23 is measured the process flow diagram that the controller of control device shown in processing and Figure 23 carries out data analysis processing.Below, be elaborated with regard to the data analysis processing in the step S105 of the mensuration processing in the step S4 of Figure 23 and Figure 23 with reference to Fig. 1, Fig. 2 and Figure 26.
As the controller 2a aspect of determinator 2, at step S21, the pipe support 101 that sample is housed is transported to aspirating specimen position 1a(and sees figures.1.and.2).At step S22, in the process being transported at pipe support 101, read the bar code pasting on the test tube 100 that sample is housed without illustrated barcode reader.The controller 2a of determinator 2 is delivered at step S23 the mark this shop recording on this bar code the controller 4a of control device 4.
The controller 4a of control device 4 judges whether to receive mark this shop from the controller 2a of determinator 2 at step S161.If confiscate mark this shop, repeat this judgement.If receive mark this shop, obtain the customized information of analyzing specimen at step S162.So-called customized information is the information that comprises the analysis project corresponding with the information of specific sample.According to this customization, determinator 2 is known which mensuration project of which sample of this mensuration.Customization is manually input to control device 4 and stores by signing in to the principal computer that is connected with control device 4 (without diagram) or user.Obtain after sample bar code information, control device 4 is retrieved corresponding information from be stored in inner customization, or inquiry principal computer obtains customized information take sample ID as key word.Then,, at step S163, the controller 4a of control device 4 sends customized information to the controller 2a of determinator 2.
The controller 2a of determinator 2 judges whether to receive customization at step S24.If do not receive customization, repeat this judgement.
And if receive customization, at step S25, judged whether that according to being stored in reagent allocation list in controller 2a reagent is applicable to measuring the corresponding analysis project of this customization.If judgement has applicable reagent set, enter step S27, measure., according to customization, with antigenic content in R1/R3 reagent and R2 agent combination, R4 reagent and R5 reagent mensuration sample.
On the other hand, if do not have reagent set to be applicable to measuring the corresponding analysis project of this customization in step S25 judgement, do not enter step 27, to forbid that the reagent that does not form reagent set is for measuring.Replace, enter step S26, send warning indication to the controller 4a of control device 4, with reminding user.Then enter aftermentioned step S31.
The controller 4a of control device 4 judges whether to receive warning indication from the controller 2a of determinator 2 at step S164.If confiscate warning indication, enter aftermentioned step S166.If receive warning indication, show warning picture at step S165 at display 4b, warning does not have reagent set to be applicable to measuring and the corresponding analysis project of customization.Figure 28 is this illustration.Warning picture 480 comprises and shows the warning content viewing area 481 of warning content and show the related description of warning and the explanation district 482 of the method for disposal to warning.In this example, the displaying contents of warning content viewing area 481 is: nothing and the corresponding available reagent group of customization.The displaying contents that district 482 is described is about the HBsAg in analysis project, without available reagent group.Even while showing other pictures such as Reagent management picture 410, reagent configuration status picture 420 on display 4b, warning picture 480 also preferentially shows before these pictures.
At step S28, the surplus of agents useful for same (can survey number of times) depreciation.At step S29, the balance information of agents useful for same after step S28 depreciation and allocation position information are sent to the controller 4a of control device 4 accordingly.
The controller 4a of control device 4 judges whether to receive balance information and allocation position information at step S166.If do not receive balance information and allocation position information, repeat this judgement.If receive balance information and allocation position information, the reagent information of this this reagent of information updating of receiving in step S167 basis.
The controller 4a of control device 4 judges whether to upgrade picture at step S168.When the carrying out along with measuring, when reagent surplus reduces, judge whether in reagent configuration status picture 420 grades, to show warning (mark becomes yellow or redness).Particularly, it is that 10 times above or 1 time above below 9 times that judgement can be surveyed number of times, or is 0 time.If without upgrading picture, enter step S170.If need to upgrade picture, at step S169, more novel agent configuration status picture and can test agent picture.,, in the time can surveying number of times and reduce to 9 times from 10 times and while reducing to 0 time from 1 time, respectively marker color is updated to yellow by white, and is updated to redness from yellow.
After this, the controller 2a of determinator 2, at step S30, transmits determination data to the controller 4a of control device 4.At step S31, according to customization, judge whether all samples to measure.If judgement is not yet measured all samples, be moved further at step S32 the pipe support 101 that sample is housed, enter step S22.After this, repeatedly carry out step S22～step S32, until all samples have been measured.At step S31, if judge all samples are measured, the controller 2a of determinator 2 finishes to measure and processes.
The controller 4a of control device 4, at step S170, judges whether to receive measurement result from the controller 2a of determinator 2.If do not receive measurement result, repeat this judgement.If receive measurement result, at step S171, carry out analyzing and processing according to measurement result.Then, the controller 4a of control device 4, at step S172, is presented at display 4b by analysis result (analysis result).At step S173, judge whether all samples to analyze.If whole samples are not analyzed, enter step S161, and repeatedly carry out step S161～step S173, until all sample completes analysis.At step S173, if judge that whole samples analyze, the controller 4a of control device 4 finishes analyzing and processing.
Figure 27 be the controller of determinator shown in explanation Figure 23 carry out reagent allocation list upgrade process and Figure 23 shown in the controller of control device carry out reagent and login the process flow diagram of list update processing.Below, be elaborated with regard to the reagent login list update processing in the reagent allocation list renewal processing of the step S6 in Figure 23 and the step S108 of Figure 23 with reference to Figure 27.This explanation only describes with regard to the situation of changing reagent.
Upgrade and process as reagent allocation list, first change as mentioned above reagent at step S41.
Then, reagent dispensing unit 7 holds utensil 300 at step S42 by the reagent that newly configures (appending) and moves to bar code and read position 7b.The same with step S13 with above-mentioned steps S12 with step S44 at step S43 again, reading reagent holds the bar code 300a of utensil 300, and the positional information that bar code information and reagent hold utensil 300 is sent to accordingly to the controller 4a of control device 4.
At step S45, have severally if the reagent appending holds utensil 300, all reagent of appending of judgement hold utensil 300 and whether have all transmitted bar code information and positional information.If all bar code informations and the positional information of not yet appending all transmit, drive reagent dispensing unit 7 at step S46, make the reagent of new configuration (appending) hold utensil 300 and move to bar code and read position 7b.After this repeating step S43～step S46, has transmitted bar code information and positional information until all reagent that append hold utensil 300.
The controller 4a of control device 4 judges whether to receive from the controller 2a of control device 2 allocation position information and the bar code information of changing reagent at step S181.If do not received, judgement repeatedly.If received, the controller 4a of control device 4 is the same with the step S112 of Figure 24 at step S182, judges whether the corresponding reagent information of bar code information has deposited reagent database in.If the corresponding reagent information of bar code information has deposited reagent database in, enter step S185.If the corresponding reagent information of bar code information does not deposit reagent database in, carry out the processing same with the step S113 of Figure 24 and step S114 at step S183 and step S184.
Next, the controller 4a of control device 4 carries out the processing same with the step S115 of Figure 24 and step S116 at step S185 and step S186.
The controller 4a of control device 4 judges at step S187 whether above-mentioned steps S181～step S186 has completed the processing of having changed reagent (reagent holds utensil) to all.If not yet complete the processing of whole reagent.Return to step S181.If all reagent completes, the controller 4a of control device 4 carries out processing with the first available reagent judgement shown in Figure 25 the second available reagent judgement processing of same step at step S188.Then, the controller 4a of control device 4 is the same with step S120 with the step S119 of above-mentioned Figure 24 with step S190 at step S189, upgrades reagent information, and this reagent information is sent to the controller 2a of determinator 2.
The controller 2a of determinator 2 judges whether to receive from the controller 4a of control device 4 reagent information of changing reagent at step S47.If confiscated, repeat this judgement.If received, the more novel agent allocation list of reagent information of receiving in step S48 basis.The same with the step S18 of Figure 24 at step S49, transmit frame updating to the controller 4a of control device 4 and require signal.The controller 2a of determinator 2 is just performed such reagent allocation list renewal processing.In the above description, the situation of reagent dispensing unit 7 has only been described, reagent dispensing unit 6 also carries out same processing.
The controller 4a of control device 4 is same with step S121 and the step S122 of Figure 24 at step S191 and step S192, judges whether to receive frame updating requirement, and more novel agent configuration status picture 420 and can survey project picture 430 of the reagent of just changing.It is exactly like this that the renewal of reagent login list is processed.
In the present embodiment, as mentioned above, the reagent information reading according to barcode reader 6a and 7a is logined in groups several reagent and is held the reagent of specifying reagent to hold in utensil 200 to hold in utensil 200 and several reagent and hold the combination of specifying reagent to hold the reagent holding in utensil 300 in utensil 300, therefore the combination that is fixed on the reagent of reagent dispensing unit 6 and is fixed on the reagent of reagent dispensing unit 7 automatically can be managed as matched reagent.Like this, can very like a cork the several reagent that are separately fixed at two fixed-sites be managed as the required reagent of same analysis project.
In the present embodiment, as mentioned above, the reagent that analysis project and lot number correspond to each other is logined as reagent set, and not only discriminatory analysis project also judges the corresponding relation of lot number, so analyzes with the identical reagent of lot number, can draw correct measurement result., reagent manufacturer, in the time producing the analysis project of measuring by several agents and use reagent, will have combining of same lot number to carry out reagent performance validation tests, dispatch from the factory to several agents.Therefore,, while using reagent after dispatching from the factory to carry out sample analysis, to the analysis project of measuring by several agents, the agent combination that has identical lot number is got up to use the reliability that more can improve measurement result on sample analyzer.
In the present embodiment, as mentioned above, while logining the combination of reagent as reagent set, also the corresponding relation of login sequence information, therefore, reagent set can be managed by the sequence number without duplicate numbers, is prevented from measuring with the combination beyond logined reagent set.
In the present embodiment, as mentioned above, visualizingre agent configuration status picture 420 on display 4b, show that the several reagent that are individually fixed in reagent dispensing unit 6 and 7 hold the configuration status of utensil 200 and 300, user can be by checking display 4b, and understanding reagent holds the configuration status of utensil.
In the present embodiment, as mentioned above, can show distinctively non-matched reagent with the reagent that forms reagent set, user can, by checking display 4b, understand the situation of non-matched reagent.With this, can change or the processing such as taking-up the non-matched reagent of learning from display 4b, facilitate the management of reagent.
This time disclosed embodiment should think to be to illustrate in all respects, there is no restriction.Scope of the present invention is not limit by the explanation of the above-described embodiment and examples, is as the criterion, and comprises with claim scope having all changes in the equal meaning and scope thereof with the scope of claim.
Such as above-mentioned embodiment illustrates, be provided with 7 two reagent dispensing units of reagent dispensing unit 6 and reagent dispensing unit, but the invention is not restricted to this, reagent dispensing unit also can arrange more than three.Or a reagent dispensing unit configuration several agents.
Above-mentioned embodiment illustrates, independently be provided with respectively the first reagent dispensing unit (reagent dispensing unit 6) for placing R1/R3 reagent and for placing the second reagent dispensing unit (reagent dispensing unit 7) of R2 reagent, but the invention is not restricted to this, also can establish the function of double the first reagent dispensing unit of a bench teat agent inking device and the second reagent dispensing unit.
Above-mentioned embodiment illustrates, be provided with respectively the first barcode reader (barcode reader 6a) that reads R1/R3 reagent strip shape code and the second barcode reader (barcode reader 7a) that reads R2 reagent strip shape code, but the invention is not restricted to this, also can one the barcode reader function of the first barcode reader and the second barcode reader of holding concurrently.
In the above-described embodiment, in the time that the controller 2a of determinator 2 judgement does not have reagent set to be suitable for measuring with the corresponding analysis project of customization, forbid measuring with the reagent not matching.Whether whether this also can comprise having R1/R3 reagent and have the R2 reagent corresponding with this analysis project to judge, when lack R1/R3 reagent or R2 reagent one of them time all forbid measuring above-mentioned analysis project.Also can comprise and all existing when R1/R3 reagent or R2 reagent, judge that whether the lot number of these reagent is consistent, when the lot number of R1/R3 reagent and the lot number of R2 reagent are forbidden these agent combination to be got up for measuring above-mentioned analysis project when inconsistent.
Above-mentioned embodiment illustrates, and the replacing that display notification reagent is changed or taking-up processing finishes on display 4b completes notice picture 460, notifies user to have changed notice picture 460.But the invention is not restricted to this, also can an indicator be set at determinator, when reagent, to change or take out processing luminous while finishing, or by notices such as sound.
Above-mentioned embodiment illustrates, and in the time that judgement does not have reagent to be suitable for carrying out measuring with customization is corresponding, warns user to forbid measuring this mensuration project by warning picture 480.The invention is not restricted to this, also can an indicator be set at determinator, luminous in the time of reagent set without applicable, or with warnings such as sound.
Above-mentioned embodiment illustrates, in the time that indication is changed agent combination in groups, plummer 41 and plummer 71 move down into respectively the position of readiness of reagent fixator separately, hold utensil 200 and 300 and be transported to respectively two reagent fixators being placed on new reagent on plummer 41 and plummer 71, rotate again reagent fixator, make reagent to be replaced hold utensil 200 and 300 to move to the position of readiness of reagent fixator separately, again, move plummer 41 and plummer 71, making reagent to be replaced hold utensil 200 and 300 is automatically transported to reagent fixator from the position of readiness of reagent fixator separately.The invention is not restricted to this, the plummer from utensil to reagent fixator handling reagent and its device of lifting that hold also can be set, user manually holds utensil to reagent fixator handling reagent.Under this structure, in the time that reagent set to be replaced is changed in indication, respectively two reagent are held to utensil and move to the appointment loading position of reagent fixator separately by rotating reagent fixator, user takes out and holds utensil at the reagent of loading position, novel agent is held to utensil and be put into loading position, change reagent with this.In the time that reagent set is taken out in indication, user's taking-up moves to the reagent of the loading position of reagent fixator separately by rotation reagent fixator and holds utensil.
In the above-described embodiment, in the time that immunity analysis instrument 1 is measured institute's setting analysis project, monitor that (R1 is for catching antibody reagent for R1/R3 reagent, R3 is labelled antibody reagent) lot number whether consistent with the lot number of R2 reagent (R2 is magnetic particle reagent), if unanimously, these reagent are logined as reagent set.But, can monitor that reagent type and combination that whether lot number is consistent are not limited to this.Such as, use in conjunction with and catch the various reagent such as seizure antibody (R1), magnetic particle (R2), labelled antibody (R3), dispersion liquid (R4) and luminous host (R5) of determined antigen at immunity analysis instrument 1.Get up and measure when precision for measuring to be expected to improve when the agent combination of same lot number in these reagent, also can carry out the whether consistent supervision of lot number to any number of agent combination wherein.
In the above-described embodiment, determination object is antigen, and the seizure reagent (R1) that therefore catches it is antibody reagent.The invention is not restricted to this, such as in the time that determination object is antibody, also can change antigen reagent into by catching reagent.Equally, labelled antibody (R3) can be also labelled antigen.
In the above-described embodiment, enumerate the present invention and be applicable to the example of immunoassay 1, the invention is not restricted to this, also gone for other analytical equipments such as Biochemical Analyzer and blood coagulation analyzer of one or more reagent dispensing units.The present invention also goes for blood-counter system.Such as the reagent of using as blood-counter system, the known dilution, leucocyte hemolytic agent and the coloring agent of the specific haemocyte that dyes etc. that for red blood cell, hemolytic agent, damaged particular types leucocyte cell membrane are used of lyse red blood cell that has dilution blood sample.Using in the blood-counter system of Flow Cytometry, also use sheath fluid, to flow be coated on sample stream in flow cell around.Get up and measure when precision for measuring to be expected to improve when the agent combination of same lot number in these reagent, also can carry out the whether consistent supervision of lot number to any number of agent combination wherein.
In the above-described embodiment, in the time that different types of reagent lot number is each other consistent, use combines these reagent as reagent set.Also can be not limited to lot number, and the identifying information that uses the reagent producer to distribute to each reagent arbitrarily.The reagent producer sets in advance the identifying information of the reagent that can form reagent set, also can use the corresponding reagent of this combination to measure.
Claims (23)
1. with a sample analyzer for the first reagent and the second reagent analysis sample, comprising:
The the first reagent container fixator that can fix several the first reagent containers, wherein this first reagent container holds the first reagent, has first recording element, is recording the first Reagent management information for described the first Reagent management;
The the second reagent container fixator that can fix several the second reagent containers, wherein this second reagent container holds the second reagent, has second recording element, is recording the second Reagent management information for described the second Reagent management;
Read described the first Reagent management information and read a station information reading device of described the second Reagent management information from described the second recording element from described the first recording element;
For described the second whether corresponding judgment part of Reagent management information that judges that described the first Reagent management information that a described station information reading device reads and a described station information reading device read;
Login part, when described judgment part judges that described the second Reagent management information that described the first Reagent management information that a described station information reading device reads and a described station information reading device read is at once, by described the first reagent and described the second agent combination login;
Determinator, with described login, partly corresponding described the first reagent of described combination and described second reagent of login are measured institute's setting analysis project; And
Processor, the measurement result that described determinator is recorded is processed, and obtains the analysis result of sample.
2. sample analyzer as claimed in claim 1, it is characterized in that: described the first Reagent management packets of information is containing the first analysis project information, described the second Reagent management packets of information is containing the second analysis project information, described judgment part judge described the first analysis project information and described the second analysis project information whether corresponding.
3. sample analyzer as claimed in claim 2, is characterized in that:
Described the first Reagent management packets of information is containing the first lot number information;
Described the second Reagent management packets of information is containing the second lot number information;
Described judgment part judge described the first analysis project information and described the second analysis project information whether corresponding, also judge that whether described the first lot number information and described the second lot number information corresponding simultaneously;
When described judgment part judges that described the first analysis project information and described the first lot number information and described the second analysis project information and described the second lot number information are when corresponding, described login part is logined described the first reagent and described the second reagent in groups.
4. sample analyzer as claimed in claim 1, it is characterized in that: when described judgment part judge described the first Reagent management information and described the second Reagent management Asymmetry information seasonable, described login part forbids logining in groups described the first reagent and described the second reagent.
5. sample analyzer as claimed in claim 1, it is characterized in that: described the first Reagent management packets of information is containing the First ray information of described the first reagent container, described the second Reagent management packets of information is containing the second sequence number information of described the second reagent container, described login part, in the time logining in groups described the first reagent and described the second reagent, is also logined the corresponding relation of described First ray information and the second sequence number information.
6. sample analyzer as claimed in claim 1, also comprises:
Customization receiving portion, for the customization of accepting to measure;
Have or not agent combination judgment part, for judging the combination that has or not described the first reagent and described the second reagent, so that the customization of carrying out accepting with described customization receiving portion is measured accordingly; And
Mensuration is forbidden part, in the time that the disconnected customization that does not have agent combination can carry out accepting with described customization receiving portion is measured accordingly, forbids measuring according to described customization.
7. sample analyzer as claimed in claim 6, it is characterized in that: also comprise caveat section, in the time that the described customization that has or not the judgement of agent combination judgment part not have agent combination can carry out accepting with described customization receiving portion is measured accordingly, warning user forbids measuring according to described customization.
8. sample analyzer as claimed in claim 1, characterized by further comprising:
Receiving portion, for accepting the appointment to the described agent combination that will change or take out from user;
Wherein, removable described the first reagent container of described the first reagent container fixator;
Removable described the second reagent container of described the second reagent container fixator;
In the time that the described agent combination that will change or take out has been specified in described receiving portion, corresponding the first reagent of described agent combination the first reagent container is moved to the first extracting position by described the first reagent container fixator, and corresponding the second reagent of described agent combination the second reagent container is moved to the second extracting position by described the second reagent container fixator;
Wherein the first extracting position is the position that can take out described the first reagent container that is fixed on described the first reagent container fixator, and the second extracting position is the position that can take out described the second reagent container that is fixed on described the second reagent container fixator.
9. sample analyzer as claimed in claim 8, characterized by further comprising:
The first conveyer, by described the first reagent container from described the first extracting position moves on to described the first reagent container fixator; And
The second conveyer, by described the second reagent container from described the second extracting position moves on to described the second reagent container fixator;
Wherein, in the time that the described agent combination that will change or take out has been specified in described receiving portion, described the first conveyer by the first reagent container that the first reagent in described agent combination is housed from described the first extracting position moves to described the first reagent container fixator, described the second conveyer by the second reagent container that the second reagent in described agent combination is housed from described the second extracting position moves to described the second reagent container fixator.
10. sample analyzer as claimed in claim 9, it is characterized in that: in the time that the described agent combination that will change or take out has been specified in described receiving portion, described the first conveyer is transported to described the first extracting position by the first reagent container of the first allocation position that is positioned over described the first reagent container fixator outside from described the first allocation position;
Described the first reagent container fixator moves to described the first extracting position by the first reagent container that will change the first reagent in agent combination is housed;
Described the first conveyer will be equipped with the first reagent container that will change the first reagent in agent combination from described the first extracting position moves to described the first reagent container fixator;
Described the second conveyer is transported to described the second extracting position by the second reagent container of the second allocation position that is positioned over described the second reagent container fixator outside from described the second allocation position;
Described the second reagent container fixator moves to described the second extracting position by the second reagent container that will change the second reagent in agent combination is housed;
Described the second conveyer will be equipped with the second reagent container that will change the second reagent in agent combination from described the second extracting position moves to described the second reagent container fixator.
11. sample analyzers as claimed in claim 8, is characterized in that:
Rotatable described the first reagent container of described the first reagent container fixator;
Rotatable described the second reagent container of described the second reagent container fixator;
Described the first extracting position is positioned on the path of described the first reagent container rotation;
Described the second extracting position is positioned on the path of described the second reagent container rotation.
12. sample analyzers as claimed in claim 8, characterized by further comprising: notification section, this notification section is for notifying corresponding the second reagent container of the second reagent in corresponding the first reagent container of described agent combination the first reagent that will change or take out and the described agent combination that will change or take out to change or taken out.
13. sample analyzers as claimed in claim 1, characterized by further comprising: display; And display controller, on described display, show and be placed on respectively described the first reagent container fixator and the first reagent container of described the second reagent container fixator and the configuration status of the second reagent container.
14. sample analyzers as claimed in claim 13, it is characterized in that: in the time that described the first reagent and the second reagent do not form described agent combination, display can show the first reagent and the second reagent that do not form described agent combination distinctively with the first reagent and the second reagent that form described agent combination described in described display controller control.
15. sample analyzers as claimed in claim 14, characterized by further comprising: select part, for selective reagent container on the described display of configuration status that shows described the first reagent container and described the second reagent container;
Wherein, when described selection portion component selections while not forming described first reagent of described agent combination or described the second reagent, described display controller control display shows that described reagent container does not form the reason of described agent combination.
16. 1 kinds of sample analyzers by the first reagent and the second reagent analysis institute setting analysis project, comprising:
The the first reagent container fixator that can fix the first reagent container, wherein this first reagent container holds the first reagent, has first recording element, is recording the first Reagent management information for described the first Reagent management;
The the second reagent container fixator that can fix the second reagent container, wherein this second reagent container holds the second reagent, has second recording element, is recording second dose of management information for described the second Reagent management;
Read described the first Reagent management information and read a station information reading device of described the second Reagent management information from the second recording element of described the second reagent container from the first recording element of described the first reagent container;
Judgment part, judges that whether described the second Reagent management information that described the first Reagent management information that a described station information reading device reads and a described station information reading device read is corresponding;
Determinator, when described judgment part judges that described the first Reagent management information and described the second Reagent management information are at once, by described the first reagent and the second reagent mensuration institute setting analysis project;
Processor, the measurement result that described determinator is recorded is processed, and obtains the analysis result of sample; And
Mensuration is forbidden part, when described judgment part judge described the first Reagent management information and described the second Reagent management Asymmetry information seasonable, forbid that described the first reagent of described determinator and the second reagent measures institute's setting analysis project.
17. as the sample analyzer as described in arbitrary in claim 1～2,4～16, it is characterized in that:
Described the first Reagent management packets of information is containing the first lot number information;
Described the second Reagent management packets of information is containing the second lot number information;
Described judgment part judges that whether the first lot number information is corresponding with the second lot number information.
18. sample analyzers as claimed in claim 17, is characterized in that: also comprise caveat section, this caveat section judge in described judgment part the first lot number information and the second lot number Asymmetry information seasonable, warning user forbids that described determinator measures.
19. as the sample analyzer as described in arbitrary in claim 1～16, it is characterized in that:
Described sample analyzer is immunity analysis instrument;
Described the first reagent and described the second reagent be respectively by conjunction with and catch the reagent of selecting in the seizure antibody of determined antigen or antibody or material group that antigen, magnetic particle, labelled antibody or labelled antigen, dispersion liquid and luminous host form.
20. as the sample analyzer as described in arbitrary in claim 1～16, it is characterized in that:
Described sample analyzer is blood-counter system;
Described the first reagent and described the second reagent are respectively the reagent of selecting the colony from being made up of dilution, hemolytic agent, dyeing liquor and sheath fluid.
21. as the sample analyzer as described in arbitrary in claim 1～10,13～16, it is characterized in that:
Rotatable described the first reagent container of described the first reagent container fixator;
Rotatable described the second reagent container of described the second reagent container fixator.
22. as the sample analyzer as described in arbitrary in claim 1～16, it is characterized in that:
Described the second reagent container fixator stirs described the second reagent in described the second reagent container.
23. analytical approachs of with the first reagent and the second reagent, sample being analyzed in sample analyzer, comprising:
The first reagent fixing step, is fixed to the first reagent container in described sample analyzer, and wherein said the first reagent container holds described the first reagent, has first recording element, is recording the first Reagent management information for described the first Reagent management;
The second reagent fixing step, is fixed to the second reagent container in described sample analyzer, and wherein said the second reagent container holds described the second reagent, has second recording element, is recording the second Reagent management information for described the second Reagent management;
Information read step, reads described the first Reagent management information by a station information reading device from described the first recording element, reads described the second Reagent management information by a described station information reading device from described the second recording element;
Determining step, judges that whether described the second Reagent management information reading in described the first Reagent management information of reading in described information read step and described information read step is corresponding;
Login step, when judging in described determining step that described the second Reagent management information that described the first Reagent management information that information read device reads and described information read device read is at once, by described the first reagent and described the second agent combination login;
Determination step, measures institute's setting analysis project with corresponding described the first reagent of the described combination of logining in described login step and described the second reagent; And
Analytical procedure, processes the measurement result recording in described determination step, obtains the analysis result of sample.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2007-093070 | 2007-03-30 | ||
| JP2007093070 | 2007-03-30 | ||
| JP2008-015538 | 2008-01-25 | ||
| JP2008015538A JP5179890B2 (en) | 2007-03-30 | 2008-01-25 | Sample analyzer |
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| JP5366747B2 (en) * | 2009-09-30 | 2013-12-11 | シスメックス株式会社 | Analysis equipment |
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| JP5430452B2 (en) * | 2010-03-11 | 2014-02-26 | シスメックス株式会社 | Sample analyzer and reagent management method |
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| CN103616381A (en) * | 2013-07-03 | 2014-03-05 | 青岛大学 | System and method for production and usage of reagent |
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| JP7043572B2 (en) * | 2020-11-30 | 2022-03-29 | シスメックス株式会社 | Display method, sample analyzer and control program |
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Also Published As
| Publication number | Publication date |
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| CN101275961A (en) | 2008-10-01 |
| JP5179890B2 (en) | 2013-04-10 |
| JP2008275585A (en) | 2008-11-13 |
| CN102621338A (en) | 2012-08-01 |
| CN101275961B (en) | 2012-06-06 |
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