CN1834659A

CN1834659A - Sample analyzer and sample analyzing method

Info

Publication number: CN1834659A
Application number: CN 200610071737
Authority: CN
Inventors: 长井孝明; 芝田正治; 吉田敬祥; 朝田祥一郎
Original assignee: Sysmex Corp
Current assignee: Sysmex Corp
Priority date: 2005-03-17
Filing date: 2006-03-16
Publication date: 2006-09-20
Also published as: CN101201349B; CN101201349A

Abstract

The invention relates to a specimen analyzer, which can analyze the mixed specimen with specimen and agent. It comprises: a container, a specimen supplier, the first specimen supplier, the second specimen supplier, the first detecting part, the first mixture specimen supplier, the second detecting part, and the second mixture specimen supplier. Wherein, the container is used to contain the mixture specimen and the specimen; the specimen supplier supplies the specimen to said container; the first specimen supplier supplies the first specimen to the container; the second specimen supplier supplies the second specimen to the container; the first detecting part detects the first mixture specimen of specimen and the first specimen; the first mixture specimen supplier supplies the first mixture specimen from the container to the first detecting pat; the second detecting part detects the second mixture specimen of first specimen and second specimen; the second mixture specimen supplier supplies the second mixture specimen from the container to the second detecting part; the first mixture specimen supplier keeps some first mixture specimen in the container and supplies some to the first detecting part; and the second specimen supplier supplies some second specimen to the container that contains left first mixture specimen to prepare the second mixture specimen.

Description

Assaying device and sample analyzing method and sample analyzing and blood analysis device

Technical field

The present invention relates to assaying device and sample analyzing method and sample analyzing and blood analysis device.

Background technology

In the blood plasma of peripheral blood, be suspended with red blood cell, blood platelet and leucocyte.Owing to can provide many clinical informations according to the blood test of checking these cells, therefore a plurality of samples be checked.

As the elementary item in the blood test, measure RBC number, platelet count, leukocyte count and hemoglobin concentration in the blood, hematocrit etc. is calculated, obtained to these measurement results.This inspection is commonly referred to as CBC, uses haemocytometer more.

Haemocytometer is divided into a plurality of aliquots (aliquot) with blood.For example, the first aliquot diluted is used to measure RBC number and platelet count.Second aliquot is used to measure leukocyte count by adding the hemolytic agent lysed erythrocyte.C grade divides sample by adding the haemoglobin in the hemolytic agent release red blood cell, is used to measure hemoglobin concentration.Haemocytometer calculates with regard to these measurement results, obtains hematocrit etc.

And, in blood test, for the clinical information higher than CBC is provided, beyond the mensuration leukocyte count, also extensively carry out leukocyte differential count inspection with leukocyte differential count lymphoblast, monocyte, neutrocyte, eosinophil, basophilic granulocyte.

As the method that is used for leukocyte differential count, use following method, that is, use the dyeing liquor that particle is dyeed and can keep the hemolytic agent of leukocytic cellular morphology, carry out leukocyte differential count according to optical signalling such as scattered light, fluorescence or electric signal or these combination.

As the haemocytometer that carries out such leukocyte differential count, the XE-2100 that for example has Sysmex company to make.

XE-2100 is divided into blood the blood of measuring RBC number and platelet count, measures the blood of hemoglobin concentration and measure leukocytic blood.XE-2100 further will be used to measure leukocytic blood separated into two parts, in an aliquot, add the reagent of measuring leukocyte count, measure leukocyte count, basophilic granulocyte, in another aliquot, add leukocyte differential count reagent, leucocyte is divided into four classes, carries out the mensuration and the leukocyte differential count of leukocyte count according to two measurement results.

And XE-2100 can move by first pattern and second pattern, and first pattern is carried out the mensuration of leukocyte count but do not carried out leukocyte differential count, and second pattern is carried out the mensuration and the leukocyte differential count of leukocyte count.Such XE-2100 for mensuration and the leukocyte differential count that carries out leukocyte count, needs two aliquots in second pattern.And leukocyte differential count is compared with the mensuration of leukocyte count, and the general inspection frequency is low, therefore, in the existing cell counter that needs special agent in leukocyte differential count, might arrive term of life and form waste with reagent by leukocyte differential count.

And,, put down in writing other cell counter in 656,499 at USP5.This cell counter has a plurality of mixing containers that are used to modulate corresponding to the mixing test portion of a plurality of aliquots.And first aliquot is used for following mensuration,, after carrying out the haemolysis processing, utilizes the multi-angle scattered light of light flow cell (light stream Move セ Le)/sensor from cell that is, measures white blood cell count(WBC) and leukocyte differential count.Second aliquot is used for following mensuration, that is, after carrying out dilution process, the anti-resistiveization when utilizing impedance transducer to check cell by the hole is measured red blood cell count(RBC) and platelet count.C grade divides sample to be used for following mensuration,, after carrying out the haemolysis processing, utilizes the extinction of HGB (haemoglobin) sensor from the haemolysis test portion that is, obtains HGB concentration.

Summary of the invention

The present invention 1 assaying device is used to analyze the mixing test portion that has mixed test portion and reagent, have: accepting container, test portion supply unit, the first reagent supply unit, the second reagent supply unit, first determination part, first mix the test portion supply unit, second determination part and second mixes the test portion supply unit, and described accepting container is used to mix test portion and reagent; Described test portion supply unit is supplied with test portion to above-mentioned accepting container; The described first reagent supply unit is supplied with first reagent to above-mentioned accepting container; The described second reagent supply unit is supplied with second reagent to above-mentioned accepting container; Described first determination part is that object is measured with the first mixing test portion that has mixed above-mentioned test portion and above-mentioned first reagent; Described first mixes the test portion supply unit supplies with from above-mentioned accepting container the above-mentioned first mixing test portion to above-mentioned first determination part; Described second determination part is that object is measured with the second mixing test portion that has mixed above-mentioned test portion and above-mentioned first reagent and above-mentioned second reagent; Described second mixes the test portion supply unit supplies with from above-mentioned accepting container the above-mentioned second mixing test portion to above-mentioned second determination part, above-mentioned first mixes the test portion supply unit, one side is stayed the part that first in the above-mentioned accepting container mixes test portion in the above-mentioned accepting container, and one side is mixed test portion with an other part first and supplied with to above-mentioned first determination part; The above-mentioned second reagent supply unit, a part first is mixed supply second reagent in the above-mentioned accepting container of test portion, modulation second mixes test portion to leaving.

The present invention 2 sample analyzing method and sample analyzing, be used to measure first and mix first determination part of test portion and be used to measure the second assaying device that mixes second determination part of test portion by having, test portion is analyzed, had following operation: mix the test portion and first reagent, make above-mentioned first operation of mixing test portion; After making above-mentioned first being mixed the part of test portion supplies with, measures above-mentioned first operation of mixing test portion at above-mentioned first determination part to above-mentioned first determination part; Above-mentioned first operation of mixing the test portion and second reagent, modulating the above-mentioned second mixing test portion that mixing does not stay to above-mentioned first determination part supply; And mix test portion with above-mentioned second and supply with, measure above-mentioned second operation of mixing test portion at above-mentioned second determination part to above-mentioned second determination part.

The present invention 3 blood analysis device is used for the analyzing blood test portion, have: blood test portion supply unit, the first test portion modulation portion, the second test portion modulation portion, first determination part, second determination part and the 3rd determination part, described blood test portion supply unit are used for supplying with the first blood test portion and the second blood test portion that is partitioned into from the blood test portion; The described first test portion modulation portion is used to modulate first and measures the test portion and the second mensuration test portion, this first mensuration test portion is used for measuring red blood cell and blood platelet from the above-mentioned first blood test portion of being supplied with by above-mentioned blood test portion supply unit, and this second mensuration test portion is used to measure haemoglobin; The described second test portion modulation portion is used to modulate the 3rd and measures test portion, and the 3rd measures test portion is used for measuring leucocyte from the above-mentioned second blood test portion of being supplied with by above-mentioned blood test portion supply unit; Described first determination part is used to measure above-mentioned first and measures test portion; Described second determination part is used to measure above-mentioned second and measures test portion; Described the 3rd determination part is used to measure the above-mentioned the 3rd and measures test portion.

The present invention 4 blood analysis device is used for the analyzing blood test portion, has: test portion cutting part, test portion modulation portion, first determination part, second determination part and the 3rd determination part, described test portion cutting part are used for the blood test portion is divided into two aliquots; Described test portion modulation portion is used to modulate first and measures test portion, the second mensuration test portion and the 3rd mensuration test portion, this first mensuration test portion is used for measuring red blood cell and blood platelet from above-mentioned two aliquots of being cut apart by above-mentioned test portion cutting part, this second mensuration test portion is used to measure haemoglobin, and the 3rd measures test portion is used for leukocyte differential count, counting; Described first determination part is used to measure above-mentioned first and measures test portion; Described second determination part is used to measure above-mentioned second and measures test portion; Described the 3rd determination part is used to measure the above-mentioned the 3rd and measures test portion.

Second mode determination that the present invention 5 the changeable one-tenth of assaying device is used to measure first mode determination of test portion and is used to measure test portion, have: test portion supply unit, common reagent supply unit, special agent supply unit, mode selection part and determination part, described test portion supply unit is used to supply with test portion; Described common reagent supply unit is used for supplying with the common reagent that uses at above-mentioned first mode determination and above-mentioned second mode determination; Described special agent supply unit is used for supplying with the special agent that uses at above-mentioned second mode determination; Described mode selection part is used to select one of above-mentioned first mode determination and above-mentioned second mode determination; Described determination part is used to measure above-mentioned test portion, in above-mentioned first mode determination, above-mentioned test portion supply unit and above-mentioned common reagent supply unit move, to make the first pattern test portion that constitutes by above-mentioned test portion and above-mentioned common reagent, said determination portion moves, to measure the above-mentioned first pattern test portion; In above-mentioned second mode determination, above-mentioned test portion supply unit and above-mentioned common reagent supply unit move, to make the second pattern test portion that is made of above-mentioned test portion, above-mentioned common reagent and above-mentioned special agent, said determination portion moves, to measure the above-mentioned second pattern test portion.

Second mode determination that the present invention 6 the changeable one-tenth of assaying device is used to measure first mode determination of test portion and is used to measure test portion, have: accepting container, common reagent supply unit, special agent supply unit and control part, described accepting container be used for making first mode determination uses first mix use in the test portion and second mode determination second mix test portion; Described common reagent supply unit is used to supply with the common reagent that uses in order to make the above-mentioned first mixing test portion and above-mentioned second mix test portion in above-mentioned accepting container; Described special agent supply unit is used to supply with the special agent that uses in order to make the above-mentioned second mixing test portion in above-mentioned accepting container; Described control part is used to control the action of above-mentioned common reagent supply unit and above-mentioned special agent supply unit, in above-mentioned second mode determination, above-mentioned control part is controlled above-mentioned common reagent supply unit and above-mentioned special agent supply unit, they are moved successively, so that (a) supply with above-mentioned special agent, (b) supply with above-mentioned common reagent to above-mentioned accepting container to above-mentioned accepting container.

The present invention 7 sample analyzing method and sample analyzing is used for analyzing the test portion of the assaying device of changeable one-tenth first mode determination and second mode determination, has following operation: (a) select in first mode determination and second mode determination; (b) make the first pattern test portion, the above-mentioned first pattern test portion of mensuration that constitutes by test portion and common reagent; And (c) make the second pattern test portion that constitutes by test portion, above-mentioned common reagent and special agent, measure the above-mentioned second pattern test portion; Operation (b) is imported into above-mentioned first mode determination, and operation (c) is imported into above-mentioned second mode determination.

Second mode determination that the present invention 8 the changeable one-tenth of assaying device is used to measure first mode determination of blood test portion and is used to measure the blood test portion has: the test portion cutting part, and this test portion cutting part is used to cut apart the blood test portion; The first reagent supply unit, this first reagent supply unit is used to supply with red blood cell reagent; The second reagent supply unit, this second reagent supply unit is used to supply with the first leucocyte reagent; The 3rd reagent supply unit, the 3rd reagent supply unit is used to supply with the second leucocyte reagent; The 4th reagent supply unit, the 4th reagent supply unit is used to supply with haemoglobin reagent; First determination part, this first determination part is used to measure the red blood cell test portion, this red blood cell test portion is made of the first blood test portion and above-mentioned red blood cell reagent in order to measure red blood cell, the described first blood test portion splits from above-mentioned blood test portion by above-mentioned test portion cutting part, and described red blood cell reagent is supplied with from the above-mentioned first reagent supply unit; Second determination part, this second determination part is used for measuring any one of the first leucocyte test portion and the second leucocyte test portion, the described first leucocyte test portion is by the second blood test portion that is split from above-mentioned blood test portion by above-mentioned test portion cutting part for the counting that carries out leukocyte count, constitute with the above-mentioned first leucocyte reagent supplied with from the above-mentioned second reagent supply unit, the described second leucocyte test portion is for leukocyte count being classified and counting and by the above-mentioned second blood test portion that is split from above-mentioned blood test portion by above-mentioned test portion cutting part, constitute with the above-mentioned second leucocyte reagent supplied with from above-mentioned the 3rd reagent supply unit; The 3rd determination part, the 3rd determination part is used to measure the haemoglobin test portion, this haemoglobin test portion is made of the 3rd blood test portion and above-mentioned haemoglobin reagent in order to measure haemoglobin, described the 3rd blood test portion is split from above-mentioned blood test portion by above-mentioned test portion cutting part, and above-mentioned haemoglobin reagent is supplied with from above-mentioned the 4th reagent supply unit; And mode selection part, this mode selection part is used for selecting above-mentioned first mode determination and above-mentioned second mode determination one; In above-mentioned first mode determination, above-mentioned first determination part is measured above-mentioned red blood cell test portion, and above-mentioned second determination part is measured the above-mentioned first leucocyte test portion, and above-mentioned the 3rd determination part is measured above-mentioned haemoglobin test portion; In above-mentioned second mode determination, above-mentioned first determination part is measured above-mentioned red blood cell test portion, and above-mentioned second determination part is measured the above-mentioned second leucocyte test portion, and above-mentioned the 3rd determination part is measured above-mentioned haemoglobin test portion.

Description of drawings

Fig. 1 is the overall perspective view of the assaying device of expression an embodiment of the invention.

Fig. 2 is the stereographic map of the state after the shell of assaying device shown in Figure 1 is removed in expression.

Fig. 3 is the front elevation of the state after the shell of assaying device shown in Figure 1 is removed in expression.

Fig. 4 is the control flow chart of expression assaying device.

Fig. 5 is the first half of the fluid circuit diagram of expression assaying device shown in Figure 1.

Fig. 6 is the latter half of the fluid circuit diagram of expression assaying device shown in Figure 1.

Fig. 7 is the fluid circuit diagram around the discharge opeing chamber.

Fig. 8 is the fluid circuit diagram around the membrane pump.

Fig. 9 is the process flow diagram of selecting about mode determination.

Figure 10 is the process flow diagram of first mode determination.

Figure 11 is the process flow diagram of second mode determination.

Figure 12 is the summary construction diagram of optical detection portion.

Figure 13 is the leukocytic scatter diagrams of expression five classes.

Figure 14 is the histogram that the expression leucocyte number of degrees distribute.

Figure 15 is the process flow diagram that the mensuration order that RBC/PLT measures and HGB measures is carried out in expression.

Figure 16 is the production process skeleton diagram that mixes test portion.

Embodiment

Below, with reference to the accompanying drawings, be elaborated with regard to embodiments of the present invention.

[one-piece construction]

Fig. 1 is the overall perspective view of assaying device S of expression an embodiment of the invention, and Fig. 2 is the stereographic map that the state behind the shell 1 of this assaying device S is removed in expression, the front key diagram of the state of Fig. 3 after to be that expression is same remove shell.

This assaying device S can be connected communicatedly with the treating apparatus PC with display, input media, CPU, reservoir etc. (being typically the microcomputer that necessary computer program is installed), constitutes the assaying system by assaying device S and treating apparatus PC.

Treating apparatus PC is equipped with the operation that is used to carry out assaying device S, about the various settings analyzed, display analysis result's etc. assaying device software, by with assaying device S between communicate by letter, can send instruction to assaying device S, S accepts determination data from the assaying device.

Assaying device S is a device (blood analysis device) of analyzing (measure, analyze) as the blood (test portion) in the heparin tube 3 of airtight container (the initial stage accepting container of test portion) to being housed in, mainly is made of device body 2 and the shell 1 of accommodating this device body 2.

Shell 1 is made by synthetic resin or the steel plate that passed through antirust processing, utilizes the stationary installation of bolt etc. to be fixed on the device body 2.On the lower right-most portion of the one side of housing 1 (being the side in left side), form peristome 5 in Fig. 1, heparin tube 3 can be inserted in the body apparatus 2 by peristome 5.That is, slide block 7 can from above-mentioned peristome 5 be arranged on with freely coming in and going out the bottom one of device body 2 distolateral on, slide block 7 is provided with and is used for above-mentioned heparin tube 3 is loaded near its end loading stage 6.And the lid 8 of closing above-mentioned peristome 5 is arranged on the top of above-mentioned slide block 7 free to rotately, this lid 8 by not shown spring-loaded, tilt the laterally angle (with reference to Fig. 1) of regulation only.Device is under non-operating condition (this state can by closing lamp in the button 15 on the one side that is arranged on above-mentioned shell 1, externally showing), in case push this button 15, then above-mentioned slide block 7 moves to the foreign side of device body 2.At this moment, install under the non-operating condition, above-mentioned peristome 5 tegmentums 8 are closed, but move by the foreign side of slide block 7 to device body 2, and the teat 8a of this lid 8 is disengaged with the engaging of recess 9 of the periphery that is formed on above-mentioned peristome 5, and lid 8 is opened.And, by removing engaging of above-mentioned teat 8a and recess 9, the angle of above-mentioned lid 8 regulation because the reinforcing of spring is only tilted laterally.

On loading stage 6, be formed with the recess (not having diagram) that the bottom of heparin tube 3 can be inserted, this recess is inserted in the bottom of heparin tube 3, in case push above-mentioned button 15, then above-mentioned slide block 7 retreats in device body 2, and above-mentioned heparin tube 3 is arranged on assigned position.Then, resist spring acting force, above-mentioned lid 8 is erected, close peristome 5 with covering 8.At this moment, because above-mentioned teat 8a engages with recess 9, therefore can prevent that covering 8 opens.And, carry out following setting, that is, detect peristome 5 certain tegmentums 8 by the pick-up unit that utilizes microswitch etc. and close, can carry out test portion inhalation process afterwards etc.

In addition, the one side of the side of shell 1 (being the side on right side in Fig. 1) is by use bolt 10 to be fixed on the device body 2, can carry out the interior inspection and maintenance maintenance of device body 2 etc. easily.And in Fig. 1,16 mainly is the exhausr port that the heat utilization fan (omitting diagram) that is used for will be in device body 2 producing is discharged to the outside.

Device body 2 has: be used for the test portion that above-mentioned heparin tube 3 is arranged on the assigned position in the device is provided with portion 4; Be used for the blood in the heparin tube 3 quantitatively, dilution etc., the test portion modulation portion of the mixing test portion that Modulation analysis is used; And determination part D1, the D2, the D3 that measure the blood after diluting etc.

[test portion is provided with portion]

Test portion is provided with portion 4 and is used for heparin tube 3 is arranged on position on the assigned position in the device body 2, described heparin tube 3 is housed in inside with sealing state with test portion (blood), and this test portion is provided with portion 4 and is made of above-mentioned loading stage 6, slide block 7 and the drive source (not having diagram) that drives the stepping motor etc. of this slide block 7.

[test portion modulation portion]

Above-mentioned test portion modulation portion is by the blood of suction ormal weight in heparin tube 3, at first mixing chamber (first accepting container; The HGB/RBC chamber) MC1 or second mixing chamber (second accepting container; Second mixing chamber) the interior and reagent mix of MC2, modulate the position of the mixing test portion of various analysis usefulness with this, its have puncture seal heparin tube 3 inside key 3a, suck the tail pipe 13 of the test portion in this heparin tube 3, with the horizontal drive portion that this tail pipe 13 is moved horizontally, and make vertical drive portion of above-mentioned tail pipe 13 vertical moving etc.In addition, horizontal drive portion has stepping motor 28 as drive source, and vertical drive portion has stepping motor 68 (with reference to Fig. 4) as drive source.

Above-mentioned tail pipe 13 then is not particularly limited in the present invention as long as have to the stream of longitudinal extension in inside and be formed with the suction inlet that sucks test portion or air near front end.

[reagent container]

Shown in the fluid circuit diagram of Fig. 5 and Fig. 6, device body 2 is provided with the reagent container that is used to accommodate reagent.Specifically be, has diluent container (first reagent container) EPK-V that is used to accommodate as dilution (cleaning fluid) EPK of first reagent as reagent container, be used to accommodate haemoglobin hemolytic agent container (second reagent container) SLS-V as the haemoglobin hemolytic agent SLS of second reagent, be used to accommodate the leukocyte differential count leukocyte differential count of hemolytic agent FFD hemolytic agent container F FD-V, and be used to accommodate the leukocyte differential count leukocyte differential count of dyeing liquor FFS dyeing liquor container F FS-V.

[test portion supply unit]

As from the test portion supply unit of heparin tube 3, be provided with above-mentioned tail pipe 13 and whole blood and suck syringe pump SP1 to the first mixing chamber MC1 and/or second mixing chamber MC2 supply test portion.Tail pipe 13 sucks syringe pump SP1 sucks ormal weight from heparin tube 3 whole blood test portion by whole blood, move position to the first mixing chamber MC1 and the second mixing chamber MC2, sucks syringe pump SP1 by whole blood and distribute the whole blood test portion of supplying with ormal weight to chamber MC1, MC2 respectively.

[reagent supply unit]

Diluent container EPK-V and hemolytic agent container SLS-V can supply with reagent ground with the first mixing chamber MC1 as accepting container of the present invention and be connected.That is, supply with (EPK uses) membrane pump DP1 by dilution, can supply with dilution to the first mixing chamber MC1 from diluent container EPK-V, this EPK has constituted the reagent supply unit of using as the dilution of first reagent (the first reagent supply unit) with membrane pump DP1.

And, supply with (SLS uses) membrane pump DP3 by hemolytic agent, can supply with hemolytic agent to the first mixing chamber MC1 from hemolytic agent container SLS-V, this SLS has constituted the test portion supply unit of using as the hemolytic agent of second reagent (the second reagent supply unit) with membrane pump DP3.

Hemolytic agent container F FD-V and dyeing liquor container F FS-V can supply with reagent ground with the second mixing chamber MC2 and be connected.That is, can supply with hemolytic agent to the second mixing chamber MC2 by hemolytic agent from hemolytic agent container F FD-V with (FFD uses) membrane pump DP4, this FFD has constituted the reagent supply unit that hemolytic agent is used with membrane pump DP4.

And, can supply with dyeing liquor to the second mixing chamber MC2 by dyeing liquor from dyeing liquor container F FS-V with (FFS uses) membrane pump DP5, this FFS constitutes the reagent supply unit that dyeing liquor is used with membrane pump DP5.

[reagent supply road]

The road supplied with by reagent from diluent container EPK-V to the first mixing chamber MC1 and the reagent from hemolytic agent container SLS-V to the first mixing chamber MC1 is supplied with junction of two streams CR1 interflow halfway, road, and two kinds of general reagent of reagent are supplied with road T1 and are connected (with reference to Fig. 5) with the first mixing chamber MC1.Therefore,, have only a test portion supply port to get final product, can make to simplify the structure to the first mixing chamber MC1 though two kinds of reagent are supplied with to the first mixing chamber MC1.

And, reagent from hemolytic agent container F FD-V to the second mixing chamber MC2 supply with road and reagent from dyeing liquor container F FS-V to the second mixing chamber MC2 supply with the road also halfway junction of two streams CR2 collaborate, two kinds of general reagent of reagent are supplied with road T2 and are connected (with reference to Fig. 6) with the second mixing chamber MC2.Therefore,, have only a test portion supply port to get final product, can make to simplify the structure to the second mixing chamber MC2 though two kinds of reagent are supplied with to the second mixing chamber MC2.

In addition, also can reagent supply road T1, T2 all be set each reagent.That is, also two reagent supply ports can be set respectively on each chamber MC1, MC2.

[determination part]

As the D1 of said determination portion, D2, D3, have the first determination part D1 that carries out relevant red blood cell and blood platelet mensuration, the 3rd determination part D3 that carries out the second determination part D2 of relevant hemoglobinometry and carry out relevant leucocyte mensuration.

The above-mentioned first mixing chamber MC1 is the position that modulation mixes test portion, this mixing test portion is used to carry out relevant red blood cell, haemoglobin and hematoblastic analysis, and the mixing test portion of modulating in mixing chamber MC1 is used for the mensuration of carrying out at the first determination part D1 and the second determination part D2.

The above-mentioned second mixing chamber MC2 is the position that modulation is used to carry out the mixing test portion of relevant leukocytic analysis, and the mixing test portion of modulating in the second mixing chamber MC2 is used for the mensuration of carrying out at the 3rd determination part D3.

[first determination part: RBC/PLT test section]

Above-mentioned first determination part D1 conduct carrying out RBC measures the RBC/PLT test section of (mensuration of RBC number) and PLT mensuration (platelet count mensuration) and constitutes.This RBC/PLT test section D1 can flow the mensuration that the DC detection method is carried out RBC and PLT by sheath.

[second determination part: HGB test section]

The above-mentioned second determination part D2 constitutes as carrying out HGB to measure the HGB test section of (measuring the hemochrome amount in the blood).This HGB test section D2 can measure HGB by SLS-haemoglobin method.

[the 3rd determination part: optical detection portion]

Above-mentioned the 3rd determination part D3 conduct can carrying out WBC measures the optical detection portion of (white blood cell count(WBC)) and DIFF mensuration (leukocyte differential count) and constitutes.The D3 of optical detection portion can carry out WBC mensuration and DIFF mensuration by the fluid observation of having used semiconductor laser.

[control part]

As shown in Figure 4, device body 2 has the control part 100 of control above-mentioned test portion modulation portion and determination part D1, D2, D3.And, device body 2 also has driving circuit portion 110, be used for driving solenoid valve SV1～SV33, SV40, SV41 or various pump, motor 28,68, SP1, SP2, P, V, DP1, DP2, DP3, DP4, the DP5 of the fluid circuit that constitutes test portion modulation portion etc. etc., control part 100 drives solenoid valves etc. by driving circuit portion 110.

Control part 100 can communicate with treating apparatus PC by not shown communication interface, can and treating apparatus PC between carry out the exchange of various signals or data etc.

[kind of mode determination]

Assaying device S has two kinds of mode determinations at the 3rd determination part D3 to the mensuration of carrying out as the leucocyte in the blood of test portion.First mode determination is the CBC mode determination, is the mode determination of elementary item of measuring quantity, hemoglobin concentration and the hematocrit etc. of leucocyte (WBC), red blood cell (RBC) and blood platelet (PLT).Second mode determination is the CBC+DIFF mode determination, is the mode determination that is divided into five kinds of neutrocytes, lymphocyte, monocyte, eosinophil, basophilic granulocyte beyond above-mentioned elementary item, with leucocyte.

[model selection]

The user of assaying system can utilize treating apparatus PC to select any pattern in CBC mode determination (first mode determination) and the CBC+DIFF mode determination to measure.Treating apparatus PC is as the function that is used to carry out this selection, having the user is used on picture selecting any menu display function of CBC and CBC+DIFF and selects any CBC and the CBC+DIFF and the function of the input carried out, these functions formation mode selection parts from acceptance such as mouse, keyboards.

Specifically be, as shown in Figure 9, utilize mode determination to select (step S11), in a single day the user selects CBC, and then treating apparatus PC will carry out the instruction of CBC pattern mensuration to assaying device S conveying (step S12).Like this, assaying device S moves, measures with the CBC mode determination, and this determination data is carried to treating apparatus PC.Treating apparatus PC carries out data processing (step S14) to this CBC determination data after receiving CBC determination data (step S13) from assaying device S, and the display mode of result with regulation is presented on the picture or is saved in the file.

In addition, utilize mode determination to select (step S11), in a single day the user selects CBC+DIFF, and then treating apparatus PC will carry (step S15) to the instruction of carrying out CBC pattern mensuration to assaying device S.Like this, the assaying device S that has received CBC mode instruction signal moves, measures with the CBC+DIFF mode determination, and this determination data is carried to treating apparatus PC.Treating apparatus PC carries out data processing (step S17) to this CBC+DIFF determination data after receiving CBC+DIFF determination data (step S16) from assaying device S, and the display format of result with regulation is presented on the picture or is saved in the file.

[CBC mode determination; First mode determination]

Assaying device S is in the CBC mode determination, mix whole blood test portion (11 μ L) and hemolytic agent (1mL) and make CBC mode determination test portion (the first pattern test portion), in the D3 of optical detection portion, utilize the fluid observation to measure with test portion this CBC mode determination, measure quantity of leucocyte as the 3rd determination part.

Figure 10 represents the action step of the assaying device S in the CBC mode determination.Following one side is with reference to the fluid circuit diagram of Fig. 5～Fig. 8, and one side describes with regard to this action step.At first, from supplying with hemolytic agent FFD (0.5mL) (step S21) to the second mixing chamber MC2 as common reagent as accepting container as the hemolytic agent container F FD-V of common reagent container.In addition, the hemolytic agent that uses leukocyte differential count to use as common reagent, general with the hemolytic agent that uses in the CBC+DIFF mode determination as second mode determination.And common reagent also can contain dilution.Perhaps also can only use dilution as common reagent according to measuring content.

Step S21 specifically is, by opening valve SV19, shut-off valve SV20, simultaneously, opens valve SV22, shut-off valve SV21, drives FFD membrane pump D4 with this with negative pressure, with hemolytic agent FFD from hemolytic agent container F FD-V to FFD with the additional 0.5mL of membrane pump D4.

And, by shut-off valve SV19 and open valve SV20, simultaneously, open valve SV21, shut-off valve SV22, drive FFD membrane pump D4 with this with malleation, by the hemolytic agent FFD of membrane pump D4 to second mixing chamber MC2 supply 0.5mL.

And, by opening valve SV19 and shut-off valve SV20, simultaneously, shut-off valve SV21, open valve SV22, drive FFD membrane pump D4 with this with negative pressure, and once more from hemolytic agent container F FD-V to FFD with the additional 0.5mL hemolytic agent FFD of membrane pump D4.

Then, quantitatively suck the whole blood test portion (step S22) of heparin tube 3 with tail pipe (piercer) 13.Step S22 inserts tail pipe 13 in the heparin tube 3, and by the driving of whole blood suction syringe pump SP1, quantitatively (20 μ L) sucks the whole blood test portion.

Then, tail pipe 13 is extracted from heparin tube 3, tail pipe 13 drops to the second mixing chamber MC2 (step S23).Under this state, suck syringe pump SP1 by driving whole blood, the whole blood test portion of 11 μ L (being the part of the test portion that sucks in step S22) is discharged (step S24) from the inlet hole of tail pipe 13 to the second mixing chamber MC2.

After discharging end, with membrane pump D4 hemolytic agent FFD is supplied with (step S25) to the second mixing chamber MC2 once more by FFD, by the whole blood test portion being flowed into stirring, modulation, make the CBC mode determination of erythrocytolysis in second mixing chamber MC2 test portion (the first pattern test portion) (step S26).

Then, be object with the CBC mode determination with test portion (the first pattern test portion), in WBC test section (optical detection portion; The 3rd determination part) carries out the mensuration (step S27) of CBC mode determination (first mode determination) on the D3.Step S27 specifically is, by opening valve SV4, valve SV29, valve SV22 and shut-off valve SV21, drives charging membrane pump DP2 with this, with the CBC mode determination with test portion charging 1.0mL exactly.Shut-off valve SV4, valve SV29, valve SV22 finish the charging to WBC test section D3 then.

Then, by opening valve SV9 and valve SV31, supply with sheath fluid (dilution) EPK to WBC test section D3 from EPK accepting container EPK-C.Then, under valve SV1 closing state, open valve SV3, simultaneously, drive test portion and supply with syringe pump SP2, in WBC test section D3, detect.

In addition, charging has constituted the supply unit that is used for using with test portion (the first pattern test portion) and/or CBC+DIFF mode determination to WBC test section D3 supply CBC mode determination test portion (the second pattern test portion) with membrane pump DP2 and test portion supply syringe pump SP2.

[CBC+DIFF mode determination; Second mode determination]

Assaying device S is in the CBC+DIFF mode determination, mix whole blood test portion (11 μ L) and leukocyte differential count hemolytic agent (1mL) and leukocyte differential count dyeing liquor (20 μ L), make the CBC+DIFF mode determination with test portion (the second pattern test portion), measure this CBC+DIFF mode determination test portion with the flow cytometry method at the D3 of optical detection portion.The mensuration here is to carry out the mensuration of leukocyte count and the mensuration of leucocyte five classification, and the mensuration of leukocyte count and first mode determination repeat.

Figure 11 is illustrated in the action step of the assaying device S in the CBC+DIFF mode determination.At first, supply with hemolytic agent FFD (0.5mL) (step S31) from hemolytic agent container F FD-V to the second mixing chamber MC2 as general test portion.

Step S31 specifically is, by opening valve SV19, shut-off valve SV20, simultaneously, opens valve SV22, shut-off valve SV21, drives FFD membrane pump D4 with this with negative pressure, from hemolytic agent container F FD-V to the hemolytic agent FFD of FFD with the additional 0.5mL of membrane pump D4.

And, by opening valve SV19, shut-off valve SV20, simultaneously, shut-off valve SV21, open valve SV22, drive FFD membrane pump D4 with this with negative pressure, once more from hemolytic agent container F FD-V to the hemolytic agent FFD of FFD with the additional 0.5mL of membrane pump D4.

Then, quantitatively suck the whole blood test portion (step S32) of heparin tube 3 by tail pipe (piercer) 13.Step S32 specifically is, tail pipe 13 is inserted in the heparin tube 3, sucks the driving of syringe pump SP1 by whole blood, and the whole blood test portion is sucked by quantitatively (20 μ L).

Then, tail pipe 13 is extracted from heparin tube 3, tail pipe 13 drops to the second mixing chamber MC2 (step S33).Under this state, suck syringe pump by driving whole blood, discharge the whole blood test portion (being the part of the test portion that among step S32, sucks) (step S34) of 11 μ L to the second mixing chamber MC2 from the inlet hole of tail pipe 13.

After discharging end, FFS supplies with (step S35) to the second mixing chamber MC2 with dyeing liquor (special agent).Step S35 specifically is, replenish with valve SV40, close dyeing liquor and supply with under the state of usefulness valve SV41 opening dyeing liquor, by shut-off valve SV21 when opening valve SV22, drive dyeing liquor with this negative pressure and supply with, replenish the dyeing liquor FFS of 20 μ L to FFS with membrane pump DP5 with membrane pump (FFS membrane pump) DP5.

And, by at shut-off valve SV40, open valve SV41 in, open valve SV21, shut-off valve SV22, malleation drives FFS membrane pump DP5, supplies with the dyeing liquor FFS of 20 μ L to the second mixing chamber MC2 with this.In addition, as special agent, also can contain other reagent, for example dilution or damping fluid can also only use dilution, damping fluid as special agent.

Then, hemolytic agent (common reagent) FFD is supplied with (step S36) to the second mixing chamber MC2.Promptly, shut-off valve SV22, valve SV19, open valve SV21, valve SV20, and utilize FFD to supply with the hemolytic agent FFD of 0.5mL to the second mixing chamber MC2 with membrane pump DP4, stir by flowing into, modulate the whole blood test portion, in the second mixing chamber MC2, make the CBC+DIFF mode determination test portion (the second pattern test portion) (step S26) that red blood cell is dissolved, leucocyte is colored.

Will be after the second mixing chamber MC2 supplies with as the dyeing liquor of the reagent that in the CBC mode determination, does not have to use, by supplying with to the second mixing chamber MC2, clean common reagent with this by hemolytic agent and supply with road T as the hemolytic agent of reagent general in two kinds of patterns.Therefore, even behind the CBC+DIFF mode determination, carry out the CBC mode determination, can prevent that also unwanted dyeing liquor from sneaking into the CBC mode determination with in the test portion.

Then, be object, on WBC test section (optical detection portion) D3, carry out the mensuration (step S38) of CBC+DIFF mode determination (second mode determination) with test portion (the second pattern test portion) with the CBC+DIFF mode determination.Step S38 specifically is, by opening valve SV4, valve SV29, valve SV22, shut-off valve SV21 drives charging membrane pump DP2 with this, with the CBC+DIFF mode determination with test portion charging 1.0mL exactly.Then, shut-off valve SV4, valve SV29, valve SV22 finish the charging to WBC test section D3.

Then, by opening valve SV9 and valve SV31, supply with sheath fluid (dilution) EPK to the WBC test section from EPK accepting container EPK-C.Then, under valve SV1 closing state, open valve SV3, simultaneously, drive test portion and supply with syringe pump SP2, in WBC test section D3, measure.

[optical detection portion (WBC test section)]

Figure 12 is the summary structure of expression as the D3 of optical detection portion (WBC test section) of the 3rd determination part.The D3 of this optical detection portion sends into test portion (first pattern with the test portion or the second pattern test portion) in the flow cell 101, produces liquid stream in flow cell 101, and the cell irradiation that semiconductor laser is contained in flowing by the liquid flow cell 101 in, measures.Have sheath streaming system 100, light beam spot formation system 110, forward scattering light receiving system 120, side scattered light receiving system 130, side fluorescence receiving system 140.

Sheath streaming system 100 makes test portion flow in flow cell 101 with the state that state, the cell that is encased by sheath fluid is arranged in row, can improve Cytometric accuracy and repeatability.

Light beam spot system 110 constitutes from the light of semiconductor laser 111 irradiations shines to flow cell 101 by collimation lens 112 and condenser 113.And light beam spot system 110 also has light beam interceptor 114.

Forward scattering light receiving system 120 constitutes the scattered light optically focused of inciting somebody to action forwards by the place ahead collector lens 121, will be subjected to light by photodiode (forward scattering light light accepting part) 123 by the light of unthreaded hole 122.

Side scattered light receiving system 130 constitutes by side collector lens 131 will simultaneously, with dichronic mirror 132 antireflection part light, be subjected to light by photodiode (side scattered light light accepting part) 133 to the scattered light optically focused of side.

Light scattering is owing to the particle as cell is present on the working direction of light as barrier, light changes the phenomenon that its working direction produces.By detecting this scattered light, can obtain about the size of particle or the information of material.Especially can obtain the information of the size of particle (cell) from the place ahead scattered light.And, can obtain the information of particle inside from the side scattered light.Under the situation of laser radiation to the cell particle, the side scattered light intensity depends on the complicacy (amount of the shape of nuclear, size, density or particle) of cell interior.Therefore, by utilizing this characteristic of side scattered light intensity, can carry out leukocytic classification and determination and other mensuration.

Side fluorescence receiving system 140 constitutes the light that makes through dichroscope 132 and further passes through spectro-film 141, is subjected to light with photomultiplier (fluorescence light accepting part) 142.

In case rayed on the fluorescent material as cell that is colored, then will be sent the long light of light wavelength of wavelength ratio irradiation.Intensity of fluorescence dyes stronger and stronger, by measuring this fluorescence intensity, can obtain the information of the dye levels of cells involved.Therefore, can be according to (side) fluorescence intensity poor, carry out leukocytic classification and determination and other mensuration.

In case be subjected to light by each light accepting part 123,133,142, then each light accepting part 123,133,142 sends electric impulse signal.Make determination data from this electric impulse signal.Determination data is carried (step S13, step S16) from assaying device S to treating apparatus PC, and handles, analyzes in treating apparatus PC.

Treating apparatus PC by being subjected to light according to the scattered light on the scattered light light accepting part, carries out leukocytic sreen analysis in the CBC mode determination, calculate the CBC mode determination with the leukocyte count that contains in the test portion with this.More particularly calculate leukocyte count according to the photometry that is subjected on the scattered light light accepting part 123 forwardly.

Figure 14 is illustrated in the leukocytic histogram that shows among the treating apparatus PC.This histogram is that X-axis, population are Y-axis with the place ahead scattered light intensity.The line L that shows in this histogram is erythrocytic ghost image (go one スト) and the leukocytic line that is used to separate after containing dissolving, detects histogrammic low ebb automatically by treating apparatus PC and sets.In this histogram, the side that forward scattering light strength ratio line L is littler is a ghost image, and the side that forward scattering light strength ratio line L is big is a leucocyte.Therefore, the summation of the population by obtaining the bigger side of forward scattering light strength ratio line L can be calculated leukocyte count.

And, treating apparatus PC is in the CBC+DIFF mode determination, be subjected to the fluorescence on light and the fluorescence light accepting part to be subjected to light (side fluorescence is subjected to light) according to the scattered light on the scattered light light accepting part, carry out of calculating and the leukocytic classification (five classification of lymphocyte, neutrocyte, eosinophil, basophilic granulocyte and monocyte) of CBC+DIFF mode determination with the leukocyte count that contains in the test portion.Figure 13 is the scatter diagram that is illustrated in the leukocyte differential count that shows among the treating apparatus PC.This scatter diagram is to be that X-axis, fluorescence intensity are Y-axis with the side scattered light intensity.Leucocyte is divided into lymphocyte, neutrocyte, eosinophil, basophilic granulocyte and five set of monocyte.From this scatter diagram, as can be seen, in treating apparatus PC, leucocyte can be divided into these five cell masses and detect.Treating apparatus PC further carries out various processing, calculates the cell quantity that contains in each classification, the quantity ratios between the classification etc.

Quantity of leucocyte in the CBC+DIFF mode determination can be the summation of the cell quantity that contains in five cell masses of this scatter diagram, also can calculate by histogram shown in Figure 14.

In addition, in the whole blood test portion that tail pipe 13 sucks, be not used in leukocytic analysis and test portion that remaining whole blood test portion is used as red blood cell and hemoglobinometry in the first mixing chamber MC1 uses, this test portion is measured in the first determination part D1 and the second determination part D2.

Having under the situation of general reagent composition (being hemolytic agent in the above-described embodiment) as the reagent of first mode determination and second mode determination, if prepare out the reagent (mixed liquor of hemolytic agent and dyeing liquor) that the reagent (hemolytic agent) that first mode determination uses and second mode determination are used respectively, then under the high situation of the frequency of a side mode determination, the common segment of the reagent of the opposing party's mode determination (hemolytic agent) will be wasted, but as above-mentioned embodiment, in second mode determination, owing to be blended in first mode determination common reagent as universaling component (hemolytic agent) that also uses and necessary special agent (dyeing liquor) in second mode determination, make the second pattern test portion, therefore can suppress the waste of the universaling component (hemolytic agent) of reagent.

[RBC/PLT measures and HGB measures]

Below, just RBC/PLT mensuration and the HGB mensuration of implementing with two kinds of patterns of CBC pattern and CBC+DIFF mode determination describes.Carry out these mensuration simultaneously with above-mentioned CBC mensuration or CBC+DIFF mensuration.

Carrying out under the situation that RBC/PLT measures and HGB measures, needing RBC/PLT to measure the mixing test portion of usefulness and the mixing test portion that HGB measures usefulness.Measure the reagent of mixing test portion of usefulness to measure the reagent of mixing test portion of usefulness different with being used to make HGB owing to be used to make RBC/PLT, therefore, need modulation respectively,, need two mixing chambers usually in order to make these mixing test portions.

And in the present embodiment, with a mixing chamber (first mixing chamber; The HGB/RBC chamber) two kinds of mix reagents of MC1 modulation.Below, according to Figure 15 and Figure 16, be elaborated with regard to the determination step that comprises this modulation step.

[RBC/PLT measures modulation, the mensuration with mix reagent]

At first, in step S22 or S32 (with reference to Figure 10 and 11), quantitatively suck the whole blood test portion of (20 μ L) heparin tube 3 with tail pipe (piercer) 13.Specifically be that tail pipe 13 is inserted in the heparin tube 3, the driving by whole blood suction syringe pump SP1 quantitatively sucks the whole blood test portion.

Then, will supply with (step S41) to the first mixing chamber MC1 as the dilution EPK of first reagent.Step S41 specifically is, in order to discharge the liquid of the first mixing chamber MC1 inside, and opens the about 1.0sec of valve SV23.Then, open valve SV21 and valve SV24, utilize the dilution replenished dilution EPK in advance with (EPK with) membrane pump DP1, the dilution EPK of 1.0mL is supplied with to the first mixing chamber MC1.Afterwards, shut-off valve SV21 and valve SV24 open valve SV22 and valve SV32, replenish dilution EPK to EPK with membrane pump DP1.

Then, tail pipe 13 descends (step S42) to the first mixing chamber MC1, discharges the whole blood test portion (step S43) of 4 μ L to the first mixing chamber MC1 from the inlet hole of tail pipe 13.In addition, step S42 and 43 is implementing the enforcement at once of step S24 or S34 (with reference to Figure 10 and 11) back.

After discharging end, once more to the dilution EPK (step S44) of first mixing chamber MC1 supply as first reagent.Step S44 specifically is, discharge finish after, utilize EPK to supply with the dilution EPK of 1.0mL once more to the first mixing chamber MC1, so shut-off valve SV22 and valve SV32 with membrane pump DP1, open valve SV21 and valve SV24.Like this, in the first mixing chamber MC1, stir whole blood test portion (4 μ L) and dilution EPK (2mL), the modulation first mixing test portion (RBC/PLT measures with mixing test portion) (step S45).

In addition, after the first mixing test portion modulation, in order to replenish dilution EPK to EPK with membrane pump, shut-off valve SV21 and valve SV24 open valve SV22 and valve SV32.

Then, first part of mixing test portion (RBC/PLT measures with mixing test portion) is supplied with (step S46) to RBC/PLT test section D1.Step S46 opens valve SV2 and valve SV25, by charging membrane pump DP2, mix test portion charging 1.0mL (part of the mixing of first the first mixing chamber MC1 in test portion) on the stream between the first mixing chamber MC1 and RBC/PLT test section D1 exactly with first.Shut-off valve SV2, valve SV25, valve SV22 and valve SV32 finish charging afterwards.And, open valve SV8, valve SV9, supply with the sheath fluid that is used to measure to RBC/PLT test section D1.

And, first after the charging mixed test portion supply with to RBC/PLT test section D1, carry out RBC/PLT and measure (step S47).Step S47 specifically is, opens valve SV1, drives test portion and supply with syringe pump SP2, with first mixing test portion and supply with to RBC/PLT test section D1 after charging on the stream, carries out the counting of RBC number, PLT number.Then, shut-off valve SV8, valve SV9 and valve SV1 finish counting.

In addition, above-mentioned charging is supplied with syringe pump SP2 with membrane pump DP2 and test portion, has constituted from the first mixing chamber MC1 to measure with the first mixing test portion supply unit that mixes test portion as first RBC/PLT that mixes test portion to RBC/PLT test section D1 supply.

[HGB measures with modulation, the mensuration of mixing test portion]

RBC/PLT measures even be through with, and also has first of 1mL as residual test portion and mix test portion in the first mixing chamber MC1.To measure with mixing test portion in order modulating, in the first mixing chamber MC1, further to supply with hemolytic agent SLS (step S48) with residual test portion as second HGB that mixes test portion.Step S48 specifically is, opens valve SV21 and valve SV18, and the haemoglobin hemolytic agent by having replenished hemolytic agent SLS is in advance supplied with hemolytic agent SLS with (SLS with) membrane pump DP3 to the first mixing chamber MC1.Like this, stir hemolytic agent SLS and first and mix test portion, modulation mixes the HGB that mixes hemolytic agent SLS (0.5mL) in the test portion (1.0mL) and make to first and measures with mixing test portion (second mixes test portion).

Then, wait for that HGB measures with the reaction (step S49) that mixes test portion.Random time between the wait reaction period is opened valve SV21 and valve SV27, is carried out the discharge of charging with membrane pump DP2, prepares following charging.

Then, open valve SV22 and valve SV28, beginning is carried out HGB to HGB test section D2 and is measured the charging of using the mixing test portion, by shut-off valve SV22 and valve SV28, finishes charging (step S50).Then, carry out HGB and measure (step S51).

In addition, charging has constituted the second mixing test portion supply unit of using the mixing test portion from the first mixing chamber MC1 to HGB test section D2 supply as the second HGB mensuration of mixing test portion with membrane pump DP2.

The present invention is not limited to above-mentioned embodiment.For example, first mode determination and second mode determination are not limited to the described pattern of above-mentioned embodiment, also can be that first mode determination adopts the pattern of measuring red blood cell (RBC), second mode determination adopts the pattern of measuring red blood cell (RBC) and granulophilocyte.In this case, as the common reagent that becomes common reagent, the swelling agent that red blood cell is expanded, the special agent as only using in second mode determination can use granulophilocyte to represent the dyeing liquor of staining reaction.Promptly, in first mode determination, utilize first pattern of mixing above-mentioned swelling agent and blood sample to measure, in second mode determination, can utilize second pattern of mixing above-mentioned swelling agent, above-mentioned dyeing liquor and blood sample to measure with test portion with test portion.

And in the above-described embodiment, first mode determination mixes in general accepting container (the second mixing chamber MC2) with test portion with the test portion and second mode determination, also can use accepting container to mix respectively.

And, in the above-described embodiment, carrying out the mensuration of first mode determination and the mensuration of second mode determination at general determination part D3, also can in determination part separately, measure.

And in the above-described embodiment, the assaying system is made of assaying device S and other treating apparatus PC, but also assaying device S and treating apparatus PC both sides' function can be loaded in jointly on the device.

And when implementing, not necessarily two of the mode determinations that assaying system or assaying device S are had also can have the mode determination more than three or three.In this case, as reagent, second special agent of for example preparing common reagent general in first mode determination, second mode determination and the 3rd mode determination, first special agent that in second mode determination, uses and in the 3rd mode determination, using.

And, the first pattern test portion that first mode determination is used, test portion and common reagent can be mixed and made into, the second pattern test portion that second mode determination is used, test portion, common reagent and first special agent can be mixed and made into, the three-mode test portion that the 3rd mode determination is used can be mixed and made into test portion, common reagent and second special agent.

Perhaps, the three-mode used of the 3rd mode determination also can be mixed and made into test portion, common reagent, first special agent and second special agent with test portion.In this case, use between the test portion with test portion and three-mode in second pattern, first special agent is as common reagent.

And, in the above-described embodiment, first pattern contains hemolytic agent with test portion, second pattern contains hemolytic agent and dyeing liquor with test portion, but also can constitute the assaying device as described below, that is, first pattern contains hemolytic agent with test portion, and second pattern contains other special agents to replace hemolytic agent with test portion.

And, in the above-described embodiment, modulation RBC/PLT measures with mixing test portion and HGB and measures with mixing test portion in the first mixing chamber MC1, modulation CBC measures the mixing test portion (the first pattern test portion) and the CBC+DIFF mensuration mixing test portion (the second pattern test portion) of usefulness in the second mixing chamber MC2, but be not limited thereto, it for example also can be following structure, promptly, have three chambers, modulation RBC/PLT measures with mixing test portion in first Room, should mix test portion after determination part is supplied with, the RBC/PLT mensuration that remains in first Room is supplied with to second Room with mixing test portion, simultaneously, supplied with haemoglobin hemolytic agent SLS to this second Room, at the mixing test portion of the second indoor modulation HGB mensuration usefulness, use mixing test portion and CBC+DIFF to measure in the 3rd indoor modulation CBC mensuration and use the mixing test portion.And, also can in other chamber, modulate CBC and measure with mixing test portion and CBC+DIFF mensuration with mixing test portion.

Claims

1. assaying device, be used to analyze the mixing test portion that has mixed test portion and reagent, have: accepting container, test portion supply unit, the first reagent supply unit, the second reagent supply unit, first determination part, first mix the test portion supply unit, second determination part and second mixes the test portion supply unit, and described accepting container is used to mix test portion and reagent; Described test portion supply unit is supplied with test portion to above-mentioned accepting container; The described first reagent supply unit is supplied with first reagent to above-mentioned accepting container; The described second reagent supply unit is supplied with second reagent to above-mentioned accepting container; Described first determination part is that object is measured with the first mixing test portion that has mixed above-mentioned test portion and above-mentioned first reagent; Described first mixes the test portion supply unit supplies with from above-mentioned accepting container the above-mentioned first mixing test portion to above-mentioned first determination part; Described second determination part is that object is measured with the second mixing test portion that has mixed above-mentioned test portion and above-mentioned first reagent and above-mentioned second reagent; Described second mixes the test portion supply unit supplies with from above-mentioned accepting container the above-mentioned second mixing test portion to above-mentioned second determination part,

Above-mentioned first mixes the test portion supply unit, and one side is stayed the part of the mixing of first in above-mentioned accepting container test portion in the above-mentioned accepting container, and an one side part first mixing test portion is in addition supplied with to above-mentioned first determination part;

The above-mentioned second reagent supply unit, a part first is mixed supply second reagent in the above-mentioned accepting container of test portion, modulation second mixes test portion to leaving.

2. assaying device as claimed in claim 1 is characterized in that, above-mentioned first reagent is dilution, and above-mentioned second reagent is hemolytic agent.

3. assaying device as claimed in claim 1 is characterized in that, above-mentioned first determination part is the RBC number determination part, and above-mentioned second determination part is a hemoglobinometry portion.

4. assaying device as claimed in claim 1 is characterized in that, above-mentioned first determination part is the platelet count determination part, and above-mentioned second determination part is a hemoglobinometry portion.

5. assaying device as claimed in claim 1 is characterized in that, the above-mentioned first test portion supply unit is supplied with above-mentioned first reagent in that above-mentioned test portion is passed through above-mentioned test portion supply unit to the front and back that above-mentioned accepting container is supplied with to above-mentioned accepting container.

6. assaying device as claimed in claim 1 has: second accepting container that is used to mix above-mentioned test portion, the 3rd reagent and the 4th reagent; Supply with the 3rd reagent supply unit of the 3rd reagent to above-mentioned second accepting container; Supply with the 4th reagent supply unit of the 4th reagent to above-mentioned second accepting container; To mix test portion be the 3rd determination part that object is measured to have mixed the 3rd of above-mentioned test portion, above-mentioned the 3rd reagent and above-mentioned the 4th reagent; And supply with the 3rd of above-mentioned the 3rd mixing test portion from above-mentioned second accepting container to above-mentioned the 3rd determination part and mix the test portion supply unit, above-mentioned test portion supply unit is supplied with above-mentioned test portion to above-mentioned accepting container and above-mentioned second accepting container respectively.

7. assaying device as claimed in claim 6 is characterized in that, above-mentioned the 3rd determination part is the leucocyte determination part.

8. sample analyzing method and sample analyzing, be used to measure first and mix first determination part of test portion and be used to measure the second assaying device that mixes second determination part of test portion by having, test portion is analyzed, had following operation: the operation of mixing the test portion and first reagent, the above-mentioned first mixing test portion of modulation; After the modulation above-mentioned first being mixed the part of test portion supplies with, measures above-mentioned first operation of mixing test portion at above-mentioned first determination part to above-mentioned first determination part; Above-mentioned first operation of mixing the test portion and second reagent, modulating the above-mentioned second mixing test portion that mixing does not stay to above-mentioned first determination part supply; And mix test portion with above-mentioned second and supply with, measure above-mentioned second operation of mixing test portion at above-mentioned second determination part to above-mentioned second determination part.

9. sample analyzing method and sample analyzing as claimed in claim 8 is characterized in that, the above-mentioned first mixing test portion and above-mentioned second mixes test portion and modulates in identical accepting container.

10. blood analysis device, be used for the analyzing blood test portion, have: blood test portion supply unit, the first test portion modulation portion, the second test portion modulation portion, first determination part, second determination part and the 3rd determination part, described blood test portion supply unit are used for supplying with the first blood test portion and the second blood test portion that is partitioned into from the blood test portion; The described first test portion modulation portion is used to modulate first and measures the test portion and the second mensuration test portion, this first mensuration test portion is used for measuring red blood cell and blood platelet from the above-mentioned first blood test portion of being supplied with by above-mentioned blood test portion supply unit, and this second mensuration test portion is used to measure haemoglobin; The described second test portion modulation portion is used to modulate the 3rd and measures test portion, and the 3rd measures test portion is used for measuring leucocyte from the above-mentioned second blood test portion of being supplied with by above-mentioned blood test portion supply unit; Described first determination part is used to measure above-mentioned first and measures test portion; Described second determination part is used to measure above-mentioned second and measures test portion; Described the 3rd determination part is used to measure the above-mentioned the 3rd and measures test portion.

11. a blood analysis device is used for the analyzing blood test portion, has: test portion cutting part, test portion modulation portion, first determination part, second determination part and the 3rd determination part, described test portion cutting part are used for the blood test portion is divided into two aliquots; Described test portion modulation portion is used to modulate first and measures test portion, the second mensuration test portion and the 3rd mensuration test portion, this first mensuration test portion is used for measuring red blood cell and blood platelet from above-mentioned two aliquots of being cut apart by above-mentioned test portion cutting part, this second mensuration test portion is used to measure haemoglobin, and the 3rd measures test portion is used for leukocyte differential count, counting; Described first determination part is used to measure above-mentioned first and measures test portion; Described second determination part is used to measure above-mentioned second and measures test portion; Described the 3rd determination part is used to measure the above-mentioned the 3rd and measures test portion.

12. assaying device, second mode determination that changeable one-tenth is used to measure first mode determination of test portion and is used to measure test portion, have: test portion supply unit, common reagent supply unit, special agent supply unit, mode selection part and determination part, described test portion supply unit is used to supply with test portion; Described common reagent supply unit is used for supplying with the common reagent that uses at above-mentioned first mode determination and above-mentioned second mode determination; Described special agent supply unit is used for supplying with the special agent that uses at above-mentioned second mode determination; Described mode selection part is used to select one of above-mentioned first mode determination and above-mentioned second mode determination; Described determination part is used to measure above-mentioned test portion,

In above-mentioned first mode determination, above-mentioned test portion supply unit and above-mentioned common reagent supply unit move, and to make the first pattern test portion that is made of above-mentioned test portion and above-mentioned common reagent, said determination portion moves, to measure the above-mentioned first pattern test portion;

In above-mentioned second mode determination, above-mentioned test portion supply unit and above-mentioned common reagent supply unit move, to make the second pattern test portion that is made of above-mentioned test portion, above-mentioned common reagent and above-mentioned special agent, said determination portion moves, to measure the above-mentioned second pattern test portion.

13. assaying device as claimed in claim 12 is characterized in that, the mensuration project in first mode determination and some repetition of mensuration project in second mode determination.

14. assaying device as claimed in claim 13, it is characterized in that, first mode determination is the pattern that is used for measuring the population that test portion contains, and second mode determination is to be used for measuring the population that test portion contains, the pattern that detects the specified particle group in the above-mentioned test portion.

15. assaying device as claimed in claim 12 is characterized in that, above-mentioned common reagent is haemolysis reagent and/or dilution, and above-mentioned special agent is a dyeing liquor.

16. assaying device as claimed in claim 12, it is characterized in that, also has the accepting container that is used to make the first pattern test portion and the second pattern test portion, above-mentioned common reagent supply unit is supplied with above-mentioned common reagent to above-mentioned accepting container, and above-mentioned special agent supply unit is supplied with above-mentioned special agent to above-mentioned accepting container.

17. assaying device as claimed in claim 16 is characterized in that, above-mentioned common reagent is supplied with the above-mentioned accepting container of road direction with above-mentioned special agent from the reagent that is connected with above-mentioned accepting container and is supplied with.

18. assaying device as claimed in claim 12, it is characterized in that, said determination portion has light source and light accepting part, and this light source is used for the liquid stream irradiates light to above-mentioned first pattern test portion or the above-mentioned second pattern test portion, and this light accepting part is used to receive the light that is radiated on the above-mentioned liquid stream.

19. assaying device as claimed in claim 18 is characterized in that, above-mentioned light accepting part has scattered light test section and fluoroscopic examination portion, and described scattered light test section is used to detect the scattered light that the light of above-mentioned light source is produced to the irradiation of above-mentioned liquid stream; Described fluoroscopic examination portion is used to detect the fluorescence that the light of above-mentioned light source is produced to the irradiation of above-mentioned liquid stream.

20. assaying device as claimed in claim 19, it is characterized in that, in above-mentioned first mode determination, said determination portion utilizes above-mentioned scattered light light accepting part to measure the above-mentioned first pattern test portion, to calculate the leukocyte count that contains in the above-mentioned first mode determination test portion; In above-mentioned second mode determination, said determination portion utilizes above-mentioned scattered light light accepting part and above-mentioned fluorescence light accepting part to measure the above-mentioned second pattern test portion, calculating the leukocyte count that contains in the above-mentioned second mode determination test portion, and be specific classification item with the leukocyte differential count that contains in the above-mentioned second pattern test portion.

21. assaying device as claimed in claim 19, it is characterized in that, above-mentioned scattered light test section has forward scattering optical detection part and side scattered light test section, described forward scattering optical detection part is used to detect the forward scattering light of scattering on the optical axis direction that links above-mentioned light source and above-mentioned liquid stream, and described side scattered light test section is used to detect the side scattered light of scattering on the direction of intersecting with above-mentioned optical axis.

In above-mentioned first mode determination, said determination portion utilizes above-mentioned forward scattering optical detection part to measure the above-mentioned first pattern test portion, measure the leukocyte count that contains in the test portion to calculate above-mentioned first, in above-mentioned second mode determination, said determination portion utilizes above-mentioned side scattered light light accepting part and above-mentioned fluorescence light accepting part to measure the above-mentioned second pattern test portion, to calculate the leukocyte count that contains in the above-mentioned second pattern test portion, and the leukocyte differential count that contains in the above-mentioned second pattern test portion to be become specific classification item.

22. assaying device, second mode determination that changeable one-tenth is used to measure first mode determination of test portion and is used to measure test portion, have: accepting container, common reagent supply unit, special agent supply unit and control part, described accepting container be used for making first mode determination uses first mix use in the test portion and second mode determination second mix test portion; Described common reagent supply unit is used to supply with the common reagent that uses in order to make the above-mentioned first mixing test portion and above-mentioned second mix test portion in above-mentioned accepting container; Described special agent supply unit is used to supply with the special agent that uses in order to make the above-mentioned second mixing test portion in above-mentioned accepting container; Described control part is used to control the action of above-mentioned common reagent supply unit and above-mentioned special agent supply unit,

In above-mentioned second mode determination, above-mentioned control part is controlled above-mentioned common reagent supply unit and above-mentioned special agent supply unit, they are moved successively,, (b) supply with above-mentioned common reagent to above-mentioned accepting container so that (a) supply with above-mentioned special agent to above-mentioned accepting container.

23. assaying device as claimed in claim 22, it is characterized in that, in second mode determination, above-mentioned control part is controlled above-mentioned common reagent supply unit and above-mentioned special agent supply unit, it is moved successively, so that (c) supply with special agent to above-mentioned accepting container, (a) supply with above-mentioned special agent to above-mentioned accepting container, (b) supply with common reagent to above-mentioned accepting container.

24. assaying device as claimed in claim 23, it is characterized in that, also has the test portion supply unit that is used for supplying with test portion to above-mentioned accepting container, in second mode determination, above-mentioned control part is further controlled, so that (d) supply with above-mentioned test portion to above-mentioned accepting container, operation (d) is imported between operation (c) and the operation (b).

25. assaying device as claimed in claim 24 is characterized in that, operation (d) is imported between operation (c) and the operation (a).

26. assaying device as claimed in claim 22 is characterized in that, above-mentioned common reagent is supplied with the above-mentioned accepting container of road direction with above-mentioned special agent by the reagent that is connected with above-mentioned accepting container and is supplied with.

27. assaying device as claimed in claim 22 is characterized in that above-mentioned special agent is a dyeing liquor.

28. a sample analyzing method and sample analyzing is used for analyzing the test portion of the assaying device of changeable one-tenth first mode determination and second mode determination, has following operation: (a) select in first mode determination and second mode determination; (b) make the first pattern test portion, the above-mentioned first pattern test portion of mensuration that constitutes by test portion and common reagent; And (c) make the second pattern test portion that constitutes by test portion, above-mentioned common reagent and special agent, measure the above-mentioned second pattern test portion; Operation (b) is imported into above-mentioned first mode determination, and operation (c) is imported into above-mentioned second mode determination.

29. sample analyzing method and sample analyzing as claimed in claim 28, it is characterized in that the above-mentioned production process of above-mentioned operation (c) constitutes to the operation (e) that above-mentioned accepting container is supplied with above-mentioned common reagent afterwards by operation (d) from above-mentioned special agent to accepting container that supply with in above-mentioned operation (d).

30. sample analyzing method and sample analyzing as claimed in claim 29 is characterized in that, the above-mentioned production process of above-mentioned operation (c) also has the operation (f) of supplying with above-mentioned common reagent in above-mentioned operation (d) before to above-mentioned accepting container.

31. sample analyzing method and sample analyzing as claimed in claim 30 is characterized in that, the above-mentioned production process of above-mentioned operation (c) also has in above-mentioned operation (f) and supplies with (g) of above-mentioned test portion (e) to above-mentioned accepting container.

32. second mode determination that a blood analysis device, changeable one-tenth are used to measure first mode determination of blood test portion and are used to measure the blood test portion has:

The test portion cutting part, this test portion cutting part is used to cut apart the blood test portion;

The first reagent supply unit, this first reagent supply unit is used to supply with red blood cell reagent;

The second reagent supply unit, this second reagent supply unit is used to supply with the first leucocyte reagent;

The 3rd reagent supply unit, the 3rd reagent supply unit is used to supply with the second leucocyte reagent;

The 4th reagent supply unit, the 4th reagent supply unit is used to supply with haemoglobin reagent;

First determination part, this first determination part is used to measure the red blood cell test portion, this red blood cell test portion is made of the first blood test portion and above-mentioned red blood cell reagent in order to measure red blood cell, the described first blood test portion splits from above-mentioned blood test portion by above-mentioned test portion cutting part, and described red blood cell reagent is supplied with from the above-mentioned first reagent supply unit;

Second determination part, this second determination part is used for measuring any one of the first leucocyte test portion and the second leucocyte test portion, the described first leucocyte test portion is by the second blood test portion that is split from above-mentioned blood test portion by above-mentioned test portion cutting part for the counting that carries out leukocyte count, constitute with the above-mentioned first leucocyte reagent supplied with from the above-mentioned second reagent supply unit, the described second leucocyte test portion is for leukocyte count being classified and counting and by the above-mentioned second blood test portion that is split from above-mentioned blood test portion by above-mentioned test portion cutting part, constitute with the above-mentioned second leucocyte reagent supplied with from above-mentioned the 3rd reagent supply unit;

The 3rd determination part, the 3rd determination part is used to measure the haemoglobin test portion, this haemoglobin test portion is made of the 3rd blood test portion and above-mentioned haemoglobin reagent in order to measure haemoglobin, described the 3rd blood test portion is split from above-mentioned blood test portion by above-mentioned test portion cutting part, and above-mentioned haemoglobin reagent is supplied with from above-mentioned the 4th reagent supply unit;

And mode selection part, this mode selection part is used for selecting above-mentioned first mode determination and above-mentioned second mode determination one;

In above-mentioned first mode determination, above-mentioned first determination part is measured above-mentioned red blood cell test portion, and above-mentioned second determination part is measured the above-mentioned first leucocyte test portion, and above-mentioned the 3rd determination part is measured above-mentioned haemoglobin test portion;

In above-mentioned second mode determination, above-mentioned first determination part is measured above-mentioned red blood cell test portion, and above-mentioned second determination part is measured the above-mentioned second leucocyte test portion, and above-mentioned the 3rd determination part is measured above-mentioned haemoglobin test portion.

33. blood analysis device as claimed in claim 32 is characterized in that, the above-mentioned second leucocyte test portion also has the above-mentioned first leucocyte reagent.