CN101672853B - Blood cell analyzer calibrator and preparation process thereof - Google Patents
Blood cell analyzer calibrator and preparation process thereof Download PDFInfo
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- CN101672853B CN101672853B CN200910186118.7A CN200910186118A CN101672853B CN 101672853 B CN101672853 B CN 101672853B CN 200910186118 A CN200910186118 A CN 200910186118A CN 101672853 B CN101672853 B CN 101672853B
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- 230000000694 effects Effects 0.000 claims abstract description 8
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- 210000004369 blood Anatomy 0.000 claims description 29
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- PXIPVTKHYLBLMZ-UHFFFAOYSA-N Sodium azide Chemical compound [Na+].[N-]=[N+]=[N-] PXIPVTKHYLBLMZ-UHFFFAOYSA-N 0.000 claims description 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 9
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- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims description 6
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 6
- 210000002381 plasma Anatomy 0.000 claims description 6
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims description 3
- 229930024421 Adenine Natural products 0.000 claims description 3
- GFFGJBXGBJISGV-UHFFFAOYSA-N Adenine Chemical compound NC1=NC=NC2=C1N=CN2 GFFGJBXGBJISGV-UHFFFAOYSA-N 0.000 claims description 3
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- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 claims description 3
- 229930040373 Paraformaldehyde Natural products 0.000 claims description 3
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims description 3
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- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims description 3
- 239000000022 bacteriostatic agent Substances 0.000 claims description 3
- 235000009508 confectionery Nutrition 0.000 claims description 3
- 239000008103 glucose Substances 0.000 claims description 3
- 235000011187 glycerol Nutrition 0.000 claims description 3
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 3
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- 238000007789 sealing Methods 0.000 claims description 3
- 239000011780 sodium chloride Substances 0.000 claims description 3
- 239000001509 sodium citrate Substances 0.000 claims description 3
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 3
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 3
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- 235000016709 nutrition Nutrition 0.000 abstract description 2
- 102000004169 proteins and genes Human genes 0.000 abstract description 2
- 108090000623 proteins and genes Proteins 0.000 abstract description 2
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- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 2
- CWHJIJJSDGEHNS-MYLFLSLOSA-N Senegenin Chemical compound C1[C@H](O)[C@H](O)[C@@](C)(C(O)=O)[C@@H]2CC[C@@]3(C)C(CC[C@]4(CCC(C[C@H]44)(C)C)C(O)=O)=C4[C@@H](CCl)C[C@@H]3[C@]21C CWHJIJJSDGEHNS-MYLFLSLOSA-N 0.000 description 2
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- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
The invention uses synergetic combination effect of multiple cytoactive protection solution and a stabilizer, and a protective agent provides nutrition components and living environment required by maintaining normal physiological activity for blood cells for anaerobic glycolysis; the stabilizer containing cytolemma and cytoplasm fixed substances with lower concentration can slowly permeate the cytolemma to act on the cytoplasm and firmly combine with biomolecule of cell components such as protein, enzyme, lipid and the like effectively, thus enabling white blood cells, red blood cells and blood platelets to be fixed in different degrees and get effective protection and enabling blood cells to keep apparent morphological characteristics thereof. The blood cells in protection and good stabilized treatment is subjected to assignment according to traceability link delivery procedures and reference methods thereof, and can be used as blood cell analyzer calibrators for clinic usage. The invention uses stem complete blood cell (CBC) from human beings or animals, thus having good stability; the invention can be used in microscope manual counting and cell staining analysis, and has longer expirydate compared with the current full blood cell calibrators.
Description
Technical field
The present invention relates to the preparation of the bioactivity-protected liquid of haemocyte and stabilizing agent and calibration object (thing) fabricating technology for cellanalyzer.
Background technology
At cellanalyzer quality control procedure, calibration or the correction of instrument are absolutely necessary, and new instrument is installed or after maintenance, all should be carried out the calibration of instrument at every turn.Cellanalyzer calibration object is the standard substance of authoritative department accreditation.The calibration object of a certain model, can only be used for calibrating the instrument of same model, can not be used for the calibration of other brand instruments.The testing result of whole blood cell analysis only has and traces to the source directly or indirectly to reference method, the comparability of the accuracy of guarantee result and different experiments chamber testing result.Complete blood cell calibration object is the metered dose of haemocyte (liquid) analyser traceability indispensability; As the metrology traceability of cellanalyzer measurement result, evaluate and guarantee the unique foundation of clinical trial result accuracy.At present, cellanalyzer calibration adopts two kinds of methods conventionally: 1. new blood, as calibration object, is 2. stablized blood or substitute.Domestic and international whole blood calibration object great majority employing animal (as bird) haemocyte or macromolecular material (as plastic pellet or nano-substance) as an alternative product are widely used in clinical examination.The complete blood cell calibration object using just clinically, put 2～8 DEG C preserve the terms of validity be 1～3 month not etc., uncork rear stability is 1～3 day.
Summary of the invention
The present invention utilizes the combined effect of various kinds of cell active protection liquid and stabilizing agent; Comprise Rb liquid, Wb
10and Wb
22liquid; Rb liquid is complete blood cell active protection liquid (agent), Wb
10and Wb
22liquid is combined as complete blood cell stabilizing agent in appropriate ratio.
1. formula composition
(1) complete blood cell active protection liquid (Rb liquid) is made by following component and concentration range: chemical reagent is pure for analyzing; sodium chloride 4.0～6.0g/L, citric acid 0.15～0.3g/L, sodium citrate 1.0～2.0g/L, sodium dihydrogen phosphate 0.5～1.5g/L, adenine 0.1～0.6g/L, glucose 4.0～10.0g/L, sweet mellow wine 4.2～15.0g/L, trehalose 5.0～10g/L, D-MANNOSE 0.5～1.0g/L, glycerine 5.0～10g/L, 1.2-propylene glycol 0.2～1.0g/L, EDTA0.1～0.5g/L, biological bacteriostatic agent appropriate (being less than 0.5%).
(2) complete blood cell stabilizing agent I (Wb
10liquid) to make by following component and concentration range: chemical reagent is pure for analyzing, and its concentration range is respectively: Rb liquid 100.0mL, dimethyl sulfoxide 0.1～1.0mL, formaldehyde 1.0～3.0mL, glutaraldehyde 0.01～0.08mL, sodium azide 0.1～0.25g.
(3) complete blood cell stabilizing agent II (Wb
22liquid) to make by following component and concentration range: chemical reagent is pure for analyzing, and its concentration range is respectively: Rb liquid 100.0mL, formaldehyde 1.0～3.0mL, paraformaldehyde 0.05～0.60g, acetaldehyde 0.5～5.0mL, sodium azide 0.1～0.25g.
(4) A liquid, Wb
10and Wb
22after liquid preparation, (φ 0.2 μ) processes after filtration, puts 2～8 DEG C of Refrigerator stores and uses.
2. blood cell analyzer calibrator preparation technology
(1) blood source: the blood donation of Blood Center Healthy People or larger animal source property anticoagulated whole blood.Specification is 200mL/ bag or 400mL/ bag blood constituent.
(2) quality requirements: RBC, MCV, HGB, PLT and WBC and classification value thereof approach reference range; Biological borne causal agent is as all negative in infectiousness indexs such as hepatitis type B virus (HBsAg), anti-HCV, anti-HIV.
(3) complete blood cell separates: get the fresh anticoagulated whole blood of the mankind (or animal derived) (" O " or " A ", " B ", AB blood group) 225mL/ bag, putting horizontal centrifuge 3000 leaves the heart 25～30min and makes blood cell composition and separating plasma, slowly draw blood plasma, count its volume X mL, residual blood volume is that (225mL-X) is stand-by.
(4) complete blood cell protection: first slowly add Wb in about 200mL whole blood
10liquid 18～20mL, shakes up gently and puts 2～8 DEG C of 24h and preserve stand-by.
(5) complete blood cell is stable: through the complete blood cell of conservation treatment, more slowly add Wb
22liquid 1.0～2.5mL, limit edged shakes up gently, fully mixes rear sealing and puts 2～8 DEG C of preservations, and interval 4～8h puts upside down 2～4 times gently fully mixes it, after reserved sample observing result is feasible, uses by required ormal weight (0.5mL～5.0mL/ props up) packing.
(6) points for attention: the essential clean and autoclave sterilization sterilizing of experimental apparatus using; Whole blood calibration object is prepared overall process must sterile working or carry out in 100,000 grades of environment purifications.
3. quality monitoring:
(1) No. 1 pipe of contrast: get before blood separates and fully mix gently complete blood cell 2.0mL × 1;
(2) 2～No. 3 pipes of experiment: draw complete blood cell stable process mix blood 2.0mL × 2 as reserved sample observing;
(3) 1～No. 3 blood samples are upper at the cellanalyzer of having calibrated (as serial instruments such as Sysmex, Cell-Dyn, Coulter, MEK, COBAS/ABX, TEK, BC, AC, CA) respectively, by 1,3,5,7,8～10 results of interval date METHOD FOR CONTINUOUS DETERMINATION of 9....Analyze and observation of cell change procedure, after complete blood cell form stable, adopt vacuum test tube to carry out piercing quantitative separating, make the heparin tube after packing still keep vacuum state.Whole blood calibration object is put 2～8 DEG C, and to preserve time limit be 6 months, and uncork is used 2～8 DEG C of preservations can stablize one week.This product is through biological traceability chain program, the reference method assignment that ICSH or NCCLS provide; Complete blood cell calibration object can be used for cellanalyzer calibration before the deadline.
The present invention adopts to be had histocyte protection and slowly fixing chemical substance of protein, enzyme and lipid, and after making fresh anticoagulated whole blood cell in vitro, haemocyte still keeps certain metabolism and physiologically active in a long time.Centrifugal blood separates and obtains blood cell composition, under the Cell protective solutions of proper proportion (as 4: 1 to 5: 1) and the synergy of cytotostatic agent, on the one hand, protection liquid provides and has maintained the needed nutritional labeling of orthocytosis physiologically active and living environment and be beneficial to and carry out anerobic glycolysis for activity coordination, complementation and superposition between biological reagent and effect; On the other hand, in stabilizing agent, contain cell membrane and the tenuigenin fixed substance of low concentration, utilize the combined effect of various kinds of cell active protection liquid and stabilizing agent, permeation cell membrane interaction is in tenuigenin lentamente, thereby effectively leucocyte, red blood cell, blood platelet is fixed to some extent and effectively protection with the biomolecule strong bonded such as cell component-protein, enzyme, lipid; Make haemocyte keep its mode of appearance feature.Therefore, the haemocyte of handling well, through biological traceability chain program and reference method assignment thereof; Whole blood quality control materials or calibration object before the deadline, can be used as the calibration object of cellanalyzer, in the time adding the supporting hemolytic agent of instrument and dilution, red blood cell in calibration object can dissolve rapidly, and leucocyte apparent volume and inner structure generation significant change under the effect that is subject to surfactant in hemolytic agent meet cellanalyzer counting and reach the effect of classification.
The complete blood cell calibration object viscosity of the present invention's development is low, easily mixes, and does not have matrix effect; 2～8 DEG C of vacuum seal postposition are preserved time limit and are at least 6 months, and uncork is used 2～8 DEG C of preservations can stablize one week, and it is 36h that room temperature (15 DEG C～25 DEG C) can be preserved the term of validity.
The present invention adopts the mankind or animal derived complete blood cell; utilize the synergistic combination effect of various kinds of cell active protection liquid and stabilizing agent; the complete blood cell calibration object of handling well through cytoprotection and stabilization technique has good stability; not only can cell dyeing and microscopic counting, and the more clinical existing whole blood calibration object of the term of validity (thing) or Quality Control thing (product) long.
Embodiment
Cytoactive protection liquid of the present invention and stabilizing agent comprise protection liquid (agent), Wb
10and Wb
22liquid.
Formula composition
(1) complete blood cell active protection liquid (Rb liquid): sodium chloride 5.0g/L, citric acid 0.2g/L, sodium citrate 2.0g/L, sodium dihydrogen phosphate 0.75g/L, adenine 0.3g/L, glucose 7.5g/L, sweet mellow wine 10.0g/L, trehalose 7.8g/L, D-MANNOSE 0.6g/L, glycerine 8.0g/L, 1.2-propylene glycol 0.4g/L, EDTA0.25g/L, biological bacteriostatic agent is appropriate.2～8 DEG C of Refrigerator stores are for subsequent use.
(2) complete blood cell stabilizing agent I (Wb
10liquid): Rb liquid 100.0mL, dimethyl sulfoxide 0.5mL, formaldehyde 3.0mL, glutaraldehyde 0.05mL, sodium azide 0.15g.2～8 DEG C of Refrigerator stores are for subsequent use.
(3) complete blood cell stabilizing agent II (Wb
22liquid): Rb liquid 100.0mL, formaldehyde 1.0mL, paraformaldehyde 0.25g, acetaldehyde 4.5mL, sodium azide 0.2g.2～8 DEG C of Refrigerator stores are for subsequent use.
Cellanalyzer of the present invention is as follows by calibration object production technology:
(1) complete blood cell separates: get the fresh anticoagulated whole blood of the mankind (or animal derived) (" O " or " A ", " B ", AB blood group) 225mL/ bag, putting horizontal centrifuge 3000 leaves the heart 25～30min and makes blood cell composition and separating plasma, slowly draw blood plasma, count its volume X mL (X is for being 20-28mL), residual blood volume is that (225mL-X) is stand-by.Mixing rear sampling 2.0mL is No. 1 control tube.
(2) complete blood cell protection: first slowly add Wb in above-mentioned 225mL-X whole blood
10liquid 18～20mL, shakes up gently and puts 2～8 DEG C of 24h and preserve stand-by.Mixing rear sampling 2.0mL is No. 2 pipes.
(3) complete blood cell is stable: through the complete blood cell of conservation treatment, more slowly add Wb
22liquid 1.0～2.5mL, limit edged shakes up gently, fully mixes rear sealing and puts 2～8 DEG C of preservations, and interval 4～8h puts upside down 2～4 times gently fully mixes it, after reserved sample observing result is feasible, uses by required ormal weight packing.Mixing rear sampling 2.0mL is No. 3 pipes.
(4) 1～No. 3 pipe of quality monitoring is on the Sysmex kx-21 cellanalyzer of having calibrated, by 1,3,5,7,8～10 results of interval date METHOD FOR CONTINUOUS DETERMINATION of 9....5 index results of blood analysis such as histogram and WBC, RBC, MCV/HCT, HGB, PLT and histogram quality inspection are qualified or conform with the regulations and require can vacuum be distributed into product.
(5) vacuum packing: make according to actual needs a set of piercing quantitative separating frock, after whole blood calibration object fully mixes, adopt vacuum test tube (2.0～5.0mL specification) to carry out piercing quantitative separating, make the heparin tube after packing still keep vacuum state.
(6) traceability assignment: by a continual relatively chain with regulation uncertainty, the characteristic that the value of measurement result or measurement standard can be connected with the normative reference of regulation or method.Normally set up a set of reference measure program, the reference method providing according to ICSH or NCCLS carries out assignment to whole blood calibration object.
(7) preserve and clinical use: 2～8 DEG C of preservations of whole blood calibration object vacuum seal postposition, for clinical cellanalyzer calibration, limited period is at least 6 months, and uncork is used 2～8 DEG C of preservations can stablize one week, and it is 36h that room temperature (15 DEG C～25 DEG C) can be preserved the term of validity.
Claims (2)
1. a blood cell analyzer calibrator, is characterized in that: utilize the synergistic combination effect of various kinds of cell active protection liquid and stabilizing agent, comprise Rb liquid, Wb
10and Wb
22liquid; Rb liquid is complete blood cell active protection liquid, Wb
10and Wb
22liquid is combined as complete blood cell active stabilizer in proportion;
(1), Rb liquid makes by following component and concentration range: sodium chloride 4.0～6.0g/L, citric acid 0.15～0.3g/L, sodium citrate 1.0～2.0g/L, sodium dihydrogen phosphate 0.5～1.5g/L, adenine 0.1～0.6g/L, glucose 4.0～10.0g/L, sweet mellow wine 4.2～15.0g/L, trehalose 5.0～10g/L, D-MANNOSE 0.5～1.0g/L, glycerine 5.0～10g/L, 1.2-propylene glycol 0.2～1.0g/L, EDTA0.1～0.5g/L, biological bacteriostatic agent is appropriate;
(2), complete blood cell stabilizing agent is made by following component and concentration range:
Wb
10liquid: Rb liquid 100.0mL, dimethyl sulfoxide 0.1～1.0mL, formaldehyde 1.0～3.0mL, glutaraldehyde 0.01～0.08mL, sodium azide 0.1～0.25g;
Wb
22liquid: Rb liquid 100.0mL, formaldehyde 1.0～3.0mL, paraformaldehyde 0.05～0.60g, acetaldehyde 0.5～5.0mL, sodium azide 0.1～0.25g.
2. a preparation technology for blood cell analyzer calibrator as claimed in claim 1, is characterized in that, is made up of following production technology:
(1), complete blood cell separates: get the mankind or animal derived fresh anticoagulated whole blood, " O " or " A ", " B ", AB blood group, 225mL/ bag, putting horizontal centrifuge 3000 leaves the heart 25～30min and makes after blood cell composition and separating plasma, slowly draw blood plasma, count its volume X mL, residual blood volume is that 225mL-X complete blood cell is stand-by;
(2), complete blood cell protection: first slowly add Wb in above-mentioned 225mL-X complete blood cell
10liquid 18～20mL, shakes up gently and puts 2～8 DEG C of 24h and preserve stand-by;
(3), complete blood cell is stable: through the complete blood cell of conservation treatment, more slowly add Wb
22liquid 1.0～2.5mL, limit edged shakes up gently, fully mixes rear sealing and puts 2～8 DEG C of preservations, and interval 4～8h puts upside down gently and 2～4 times it is fully mixed, and final vacuum packing is used;
(4), blood cell analyzer calibrator term of validity stability: the complete blood cell calibration object after vacuum seal is put 2～8 DEG C and preserved time limit and be at least 6 months, uncork is used rearmounted 2～8 DEG C of preservations can stablize one week, and 15 DEG C～25 DEG C preservation terms of validity of room temperature are 24h.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910186118.7A CN101672853B (en) | 2009-09-28 | 2009-09-28 | Blood cell analyzer calibrator and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910186118.7A CN101672853B (en) | 2009-09-28 | 2009-09-28 | Blood cell analyzer calibrator and preparation process thereof |
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| Publication Number | Publication Date |
|---|---|
| CN101672853A CN101672853A (en) | 2010-03-17 |
| CN101672853B true CN101672853B (en) | 2014-11-05 |
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|---|---|---|---|
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102221490B (en) * | 2010-04-16 | 2012-11-21 | 北京航天总医院 | Processing method for activity stability of enzyme in human serum |
| CN102435724A (en) * | 2011-01-04 | 2012-05-02 | 中山市滔略生物科技有限公司 | Quality control material and calibration material for calibrating blood cell analyzer and preparation method thereof |
| GB2503949A (en) * | 2012-07-14 | 2014-01-15 | Nobel Biocare Services Ag | An agent for promoting osseointegration of implants |
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