CN103454410A - Biologically-safe quality control material for blood tester and preparation method thereof - Google Patents
Biologically-safe quality control material for blood tester and preparation method thereof Download PDFInfo
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- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention discloses a biologically-safe quality control material for a blood tester and a preparation method thereof. The preparation method comprises that animal red blood cells having the sizes similar to sizes of human red blood cells are used for simulation of human red blood cells; animal red blood cells having the sizes similar to sizes of large cells in human white blood cells and animal red blood cells have the sizes similar to sizes of small cells in human white blood cells are used for simulation of human white blood cells; animal red blood cells have the sizes similar to sizes of human blood platelets are used for simulation of human blood platelets; the animal red blood cells for simulation of human white blood cells and human blood platelets are cured by formaldehyde having the content of 2-8%; the cured animal red blood cells are cleaned and then are added with bovine serum albumin so that the cure agent is removed; and according to requirements, through blending, the single-component or whole blood quality control material is obtained. The biologically-safe quality control material has good stability, a low cost and high safety, and is suitable for a blood cell analyzer, a urinary sediment analyzer and a hemoglobin analyzer.
Description
Technical field
The present invention relates to the blood testing technical field, be specifically related to bio-safety Quality Control thing and preparation method thereof for the blood testing instrument.
Background technology
The Quality Control thing is for checking the performance of analytical instrument or method.When material, when checking the conventionally test of analytical instrument or method current performance, what its analytical characteristics must be to clinical samples is similar.
Along with the develop rapidly of medical diagnostic techniqu, the use of various blood clinical trial instruments is more and more advanced and general, not only for clinical, provides more experimental index, has also greatly improved clinical trial work efficiency and accuracy.Yet obtain result accurately and reliably, the result that different instruments and different experiments chamber are detected has comparability, the operating function running that need to have a kind of Quality Control thing stable, reliable, multiparameter to confirm instrument is normal, and whether every location parameter bias.The large person of Quality Control thing that current domestic various big hospital is used adopts external Quality Control thing, and external Quality Control owner will adopt human red cell, birds karyocyte, latex, pollen, hoof section animal erythrocyte, makes the red blood cell of human red cell simulation Quality Control thing.External its price of Quality Control thing is comparatively expensive, and owing to being to adopt human red cell to make the Quality Control thing, thereby the problem that likely exists blood stains to dye, also may cause hepatitis, acquired immune deficiency syndrome (AIDS), venereal disease etc. other by the transmission of disease of blood-borne.At present; domestic also have a similar quality-control product of human blood; the patent of invention that is CN101285841 as publication number discloses a kind of preparation method of three classifications whole blood quality control substance simulant and the blood type detection kit made thereof; this invents Fish Blood simulation human leukocyte and blood platelet for described method; the discarded human red cell simulation of domestic animal red blood cell and slurry station human red cell; the histogram distribution of simulation human blood sample reality; cell granulations is suspended in cell suspension and does the use of individual event Quality Control thing, or be combined into the whole blood quality control materials use.This Quality Control thing of the present invention has Quality Control effect preferably, but its pot-life is not ideal enough.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of animal blood that adopts fully and makes, and reaches Quality Control thing and preparation method thereof for the blood testing instrument of storage life limit for length of effective while of bio-safety and Quality Control.
The preparation method of Quality Control thing for blood testing instrument of the present invention, comprise the preparation of (1) red blood cell analogies and the preparation of (2) leucocyte and platelet analogue, wherein:
(1) preparation method of described red blood cell analogies is as follows:
A) gather the approximate human red cell size of red blood cell animal blood and adopt anti-coagulants to process;
B) by the above-mentioned centrifugal blood collected, remove blood plasma and leucocyte, collect the bottom red blood cell;
C) red blood cell of collection is placed in to the cell Precerving liquid and preserves, obtain the red blood cell analogies;
(2) preparation method of leucocyte and platelet analogue is as follows:
D) gather respectively the blood of the animal of the blood of animal of blood, the approximate human blood leukocyte's cellule of red blood cell of the approximate Magnocellular animal of human blood leukocyte of red blood cell and the approximate human blood Platelet Size of red blood cell, when gathering, carry out the anti-coagulants processing;
E) the above-mentioned blood collected is cured respectively, concrete curing operation is: by the centrifugal blood collected, collect the red blood cell of bottom, add the formaldehyde of 2～8% (v/v) to be cured 12～72h;
F) blood after above-mentioned three kinds are solidified is removed respectively the step of hardening agent, the operation of concrete removal hardening agent is by the centrifugal blood after solidifying, remove supernatant, retaining cell cleans with physiological saline, cell after cleaning adds bovine serum albumin, standing 20～24h, centrifugal, isolate the bottom cell;
The red blood cell of the above-mentioned isolated human blood leukocyte's of being similar to maxicell animal is placed in to the cell Precerving liquid and preserves, obtain leucocyte maxicell analogies; The red blood cell of the above-mentioned isolated human blood leukocyte's of being similar to cellule animal is placed in to the cell Precerving liquid and preserves, obtain leucocyte cellule analogies; The isolated red blood cell that is similar to the animal of human blood platelets is placed in to the cell Precerving liquid and preserves, obtain platelet analogue;
The concentration of G) regulating respectively red blood cell analogies and platelet analogue can be used as individual event Quality Control thing and uses, or leucocyte maxicell analogies and leucocyte cellule analogies are mixed to get to the leucocyte analogies use as individual event Quality Control thing; Or described red blood cell analogies, leucocyte maxicell analogies, leucocyte cellule analogies and platelet analogue combination are used as whole blood quality control materials;
In above-mentioned preparation method, the osmotic pressure of the cell Precerving liquid of mentioning is 300 ± 20mOsm/kg, the pH value is 7.3 ± 0.1, and it consists of: microbiotic 0.4～2g/L, polysaccharide 5～20g/L, bovine serum albumin 20～50g/L, sodium chloride 0.1～10g/L, sodium citrate 0.1～20g/L and citric acid 0.001～5g/L.
In technique scheme:
Steps A), in, the animal of the approximate human red cell size of described red blood cell can be cat, dog, pig, rabbit, monkey, ox, chicken or duck.
Step D), in, the approximate Magnocellular animal of human blood leukocyte of described red blood cell can be goose, wild goose, tortoise, ostrich, snake, shark or crocodile.
Step D), in, the animal of the approximate human blood leukocyte's cellule of described red blood cell can be cat, dog, pig, rabbit, monkey, ox, chicken or duck.
Step D), in, the animal of the approximate human blood Platelet Size of described red blood cell can be cat, horse, ox, sheep or camel.
Step e), in, the addition of formaldehyde is preferably 40:1～1:1 with the erythrocytic volume ratio of collecting.
Microbiotic in described cell Precerving liquid is selected from penicillins, aminoglycoside and amide-type antibiotic any one or two or more combinations.It can be specifically one or more the combination adopted in penicillin, tardocillin, gentamicin, streptomysin and chloromycetin.When antibiotic, while being chosen as above-mentioned two or more combination, the proportioning between them can be any proportioning.
Polysaccharide in described cell Precerving liquid is selected from any one or more combination in sucrose, glucose, fructose, galactose, lactose, maltose, starch and dextrin.When the above-mentioned two or more combination of being chosen as of polysaccharide, the proportioning between them can be any proportioning.
Described anti-coagulants is the conventional anti-coagulants adopted in conventional blood sampling.
The present invention also comprises the Quality Control thing prepared by above-mentioned preparation method.
Compared with prior art, the invention has the advantages that:
1, only need the animal erythrocyte of simulation human leukocyte and human blood platelets is cured, simplified technique;
2, adopt the formaldehyde of high concentration to be cured the animal erythrocyte of simulating human leukocyte and human blood platelets, high-concentration formaldehyde energy rapid curing cell, curing more thorough, from stability observing, show, curing concentration is high, can guarantee to solidify cell stability longer; By cleaning and adding bovine serum albumin to remove residual hardening agent, overcome because of curing residual and cause cell volume in finished product Quality Control thing to change after solidifying, guaranteed the stability of Quality Control thing;
3, adopt the cell Precerving liquid of special proportioning, guarantee erythrocytic activity and stability;
4, all adopt animal blood to be made, cost is lower, and security is higher;
5, the Quality Control thing adopts animal blood to make, and can stop the harm that people's blood borne diseases is used at product, allows the user can under better environment, carry out work; And raw material sources are extensive, avoid the contention of people's blood resource, it is convenient to gather, and controllability is large, greatly increases the product practicality, increases the diversity of domestic Quality Control produce product, promotes the benign competition of market like product;
6, Quality Control thing storage life limit for length of the present invention, applied widely, applicable to cellanalyzer, urine sediments analyzer and hemoglobin analyser.
Embodiment
Below with embodiment, the end invention is further described, but the present invention is not limited to these embodiment.
Embodiment 1: the preparation of the Quality Control thing of hemoglobin analyser
A) gather blood of goats and carry out the anti-freezing processing, anti-coagulants is EDTA-K2, and consumption is that 1.5～2.2MG/ml blood carries out the anti-freezing processing;
B) the above-mentioned blood of goats collected is centrifugal, remove blood plasma and leucocyte, collect the bottom red blood cell, obtain concentration higher than 95% red blood cell;
C) red blood cell of collection is placed in to the cell Precerving liquid, according to the content of haemoglobin in the Quality Control thing that will prepare, regulates the concentration of red blood cell in the cell Precerving liquid, obtain the haemoglobin Quality Control thing of respective concentration; Consisting of of cell Precerving liquid: penicillin 0.15g/L, gentamicin 0.15g/L, chloromycetin 0.1g/L, glucose 2g/L, bovine serum albumin 20g/L, sodium chloride 6.3g/L, sodium citrate 7.8g/L, citric acid 0.01g/L; The osmotic pressure of described cell Precerving liquid is 305mOsm/kg, and the pH value is 7.32.
The preparation of the whole blood quality control materials of 2: three classification cellanalyzers of embodiment
A) gather respectively the blood of dog, ox and ostrich, process with anti-coagulants respectively in the process gathered; Anti-coagulants is selected EDTA-K
2, consumption is 2.0MG/ml blood;
A part of B) getting the dog blood of collection is carried out centrifugal, removes upper plasma and middle level leucocyte, collects the bottom red blood cell, obtains the red blood cell that concentration is 98.5%;
C) red blood cell of collecting is mixed with Precerving liquid, with the cellanalyzer test, be adjusted to RBC with Precerving liquid and be counted as 8.0X10
12/ L ± 1.0X10
12/ L, volume ratio is about 1:1, under 5 ℃ of conditions, preserves, and obtains the red blood cell analogies;
D) remaining dog blood is centrifugal, collect the red blood cell of bottom, add the formaldehyde of 3% (v/v) to solidify 56h in the constant temperature oven of 30 ℃; The addition of described formaldehyde is 20:1 with the erythrocytic volume ratio of collecting;
The ox blood of getting above-mentioned collection is centrifugal, collects the red blood cell of bottom, adds the formaldehyde of 3% (v/v) to solidify 56h in the constant temperature oven of 30 ℃; The addition of described formaldehyde is 20:1 with the erythrocytic volume ratio of collecting;
The ostrich blood of getting above-mentioned collection is centrifugal, collects the red blood cell of bottom, adds the formaldehyde of 3% (v/v) to solidify 56h in the constant temperature oven of 30 ℃; The addition of described formaldehyde is 20:1 with the erythrocytic volume ratio of collecting;
The operation of E) the dog blood after above-mentioned solidifying being removed to hardening agent, specifically that the dog blood after solidifying is centrifugal, remove supernatant, retaining cell cleans then centrifugal with physiological saline, repeat 3 times cleaning operation, it is 38% bovine serum albumin (wherein the volume ratio of cell and bovine serum albumin is 1:1) that the centrifugal cell obtained adds concentration, centrifugal after standing 24h, isolated bottom cell is the dog red blood cell (concentration is 98%) that is similar to human blood leukocyte's cellule, it is mixed by the volume ratio of 1:2 with the cell Precerving liquid, obtain the SL analogies;
The operation that ox blood after above-mentioned solidifying is removed to hardening agent, concrete operations are with dog blood, isolated bottom cell is the ORBC (concentration is 99%) that is similar to human blood platelets, and it is mixed by the volume ratio of 1:3 with the cell Precerving liquid, obtains the platelet cell analogies;
The operation that ostrich blood after above-mentioned solidifying is removed to hardening agent, concrete operations are with dog blood, isolated bottom cell is and is similar to the Magnocellular ostrich red blood cell of human blood leukocyte (concentration is 98.5%), it is mixed by the volume ratio of 1:5 with the cell Precerving liquid, obtain large leucocyte analogies;
F) by step C) in the red blood cell analogies, the step e that make) the leucocyte cellule analogies, platelet analogue and the leucocyte maxicell analogies that make mix by the volume ratio of 3:1:1:1, packing, obtain the whole blood quality control materials of three classification cellanalyzers;
Consisting of of the cell Precerving liquid of mentioning in said method: penicillin 0.2g/L, gentamicin 0.25g/L, chloromycetin 0.1g/L, glucose 2.5g/L, fructose 1.5g/L, galactose 2g/Lg/L, bovine serum albumin 25g/L, sodium chloride 6g/L, sodium citrate 8.0g/L, citric acid 0.01g/L; Its osmotic pressure is 300mOsm/kg, and the pH value is 7.35.
The Quality Control thing that above-described embodiment 2 is made, observe homogeneity and accuracy in homogeneity, bottle in the bottle of Quality Control thing with cellanalyzer, and result is as following:
1, test result
1.1 homogeneity in bottle
Get arbitrarily 1 bottle of Quality Control thing, get 3 samples, be numbered sample 1, sample 2 and sample 3, with cellanalyzer URIT-3000 (Guilin High-Tech Zone Baolitai Medical Electronic Co., Ltd.), tested respectively, repeated test 11 times, remove test result the 1st time, get 10 test results of residue, as described in Table 1.Intermediate value Quality Control thing parameters is pressed a homogeneity coefficient of variation in formula (1), formula (2), formula (3) calculating bottle, and result is as shown in table 2, meets industry standard.
In formula:
The SD--standard deviation;
The CV--coefficient of variation;
N--measures number of times;
X
i--the i time measured value of designated parameter.
Table 1:
Table 2:
1.2 homogeneity between bottle
Get 10 bottles of Quality Control things of the same lot number prepared by embodiment 2 methods, every bottle of Quality Control thing is tested 2 times, removes test result the 1st time, presses the mean value of formula (1), 10 results of formula (2) calculating parameters
and standard deviation (SD
1);
Another with 1 bottle of follow-on test in above-mentioned 10 bottles of Quality Control things 11 times, remove test result the 1st time, press the mean value that formula (1), formula (2) calculating remain 10 test result parameters
and standard deviation (SD
2);
Intermediate value Quality Control thing parameters is pressed formula (4), formula (5) calculates homogeneity between bottle, and between the gained bottle, homogeneity coefficient of variation result is as shown in table 3, meets industry standard.
Work as SD
1<SD
2the time, make CV
between bottle=0
In formula:
SD---standard deviation.
Table 3:
2, accuracy
Producer's assignment
| Parameter | WBC×10 9/L | RBC×10 12/L | HGB g/L | MCV fL | PLT×10 9/L |
| With reference to assignment | 9.6±0.6 | 4.43±0.2 | 86±5 | 61.3±5 | 237±30 |
Get the Quality Control thing made by embodiment 2 methods, scheduled to last trimestral observation test, as described in Table 4, the long-term test accuracy result of Quality Control thing is as shown in table 5 for determination data.
Table 4:
Table 5:
Can find out the requirement of homogeneity and the accuracy of Quality Control thing between the interior homogeneity of the satisfied bottle of the Quality Control thing of being made by the method for the invention, bottle from above-mentioned every observation test.
Claims (9)
1. the preparation method of bio-safety Quality Control thing for the blood testing instrument, comprise the preparation of (1) red blood cell analogies and the preparation of (2) leucocyte and platelet analogue, it is characterized in that:
(1) preparation method of described red blood cell analogies is as follows:
A) gather the approximate human red cell size of red blood cell animal blood and adopt anti-coagulants to process;
B) by the above-mentioned centrifugal blood collected, remove blood plasma and leucocyte, collect the bottom red blood cell;
C) red blood cell of collection is placed in to the cell Precerving liquid and preserves, obtain the red blood cell analogies;
(2) preparation method of leucocyte and platelet analogue is as follows:
D) gather respectively the blood of the animal of the blood of animal of blood, the approximate human blood leukocyte's cellule of red blood cell of the approximate Magnocellular animal of human blood leukocyte of red blood cell and the approximate human blood Platelet Size of red blood cell, when gathering, carry out the anti-coagulants processing;
E) the above-mentioned blood collected is cured respectively, concrete curing operation is: by the centrifugal blood collected, collect the red blood cell of bottom, add the formaldehyde of 2～8% (v/v) to be cured 12～72h;
F) blood after above-mentioned three kinds are solidified is removed respectively the step of hardening agent, the operation of concrete removal hardening agent is by the centrifugal blood after solidifying, remove supernatant, retaining cell cleans with physiological saline, cell after cleaning adds bovine serum albumin, standing 20～24h, centrifugal, isolate the bottom cell;
The red blood cell of the above-mentioned isolated human blood leukocyte's of being similar to maxicell animal is placed in to the cell Precerving liquid and preserves, obtain leucocyte maxicell analogies; The red blood cell of the above-mentioned isolated human blood leukocyte's of being similar to cellule animal is placed in to the cell Precerving liquid and preserves, obtain leucocyte cellule analogies; The isolated red blood cell that is similar to the animal of human blood platelets is placed in to the cell Precerving liquid and preserves, obtain platelet analogue;
The concentration of G) regulating respectively red blood cell analogies and platelet analogue can be used as individual event Quality Control thing and uses, or leucocyte maxicell analogies and leucocyte cellule analogies are mixed to get to the leucocyte analogies use as individual event Quality Control thing; Or described red blood cell analogies, leucocyte maxicell analogies, leucocyte cellule analogies and platelet analogue combination are used as whole blood quality control materials;
In above-mentioned preparation method, the osmotic pressure of the cell Precerving liquid of mentioning is 300 ± 20mOsm/kg, the pH value is 7.3 ± 0.1, and it consists of: microbiotic 0.4～2g/L, polysaccharide 0.1～20g/L, bovine serum albumin 20～50g/L, sodium chloride 0.1～10g/L and sodium citrate 0.1～20g/L and citric acid 0.001～5g/L.
2. the preparation method of bio-safety Quality Control thing for blood testing instrument according to claim 1, it is characterized in that: steps A), the animal of the approximate human red cell size of described red blood cell is cat, dog, pig, rabbit, monkey, ox, chicken or duck.
3. the preparation method of bio-safety Quality Control thing for blood testing instrument according to claim 1, it is characterized in that: step D), the approximate Magnocellular animal of human blood leukocyte of described red blood cell is goose, wild goose, tortoise, ostrich, snake, shark or crocodile.
4. the preparation method of bio-safety Quality Control thing for blood testing instrument according to claim 1, it is characterized in that: step D), the animal of the approximate human blood leukocyte's cellule of described red blood cell is cat, dog, pig, rabbit, monkey, ox, chicken or duck.
5. the preparation method of bio-safety Quality Control thing for blood testing instrument according to claim 1, it is characterized in that: step D), the animal of the approximate human blood Platelet Size of described red blood cell is cat, horse, ox, sheep or camel.
6. the preparation method of bio-safety Quality Control thing for blood testing instrument according to claim 1, it is characterized in that: step e), the addition of formaldehyde is 40:1～1:1 with the erythrocytic volume ratio of collecting.
7. the preparation method of bio-safety Quality Control thing for blood testing instrument according to claim 1 is characterized in that: the microbiotic in described cell Precerving liquid is selected from penicillins, aminoglycoside and amide-type antibiotic any one or two or more combinations.
8. the preparation method of bio-safety Quality Control thing for blood testing instrument according to claim 1, it is characterized in that: the polysaccharide in described cell Precerving liquid is selected from any one or more combination in sucrose, glucose, fructose, galactose, lactose, maltose, starch and dextrin.
9. the Quality Control thing prepared according to the described preparation method of any one in claim 1～8.
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