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Número de publicaciónCN103454410 B
Tipo de publicaciónConcesión
Número de solicitudCN 201210173336
Fecha de publicación15 Abr 2015
Fecha de presentación30 May 2012
Fecha de prioridad30 May 2012
También publicado comoCN103454410A
Número de publicación201210173336.9, CN 103454410 B, CN 103454410B, CN 201210173336, CN-B-103454410, CN103454410 B, CN103454410B, CN201210173336, CN201210173336.9
Inventores周永杨, 唐雪辉, 陈尚斌
Solicitante桂林优利特医疗电子有限公司
Exportar citaBiBTeX, EndNote, RefMan
Enlaces externos:  SIPO, Espacenet
Biologically-safe quality control material for blood tester and preparation method thereof
CN 103454410 B
Resumen  traducido del chino
本发明公开了一种血液测试仪用生物安全质控物及其制备方法。 The present invention discloses a blood tester with biosafety quality control and preparation method. 本发明所述方法是以近似人血红细胞大小的动物血模拟人红细胞,再以红细胞近似人血白细胞大细胞的动物和红细胞近似人血白细胞小细胞的动物血模拟人白细胞、以红细胞近似人血血小板大小的动物血模拟人血小板,分别用2~8%的甲醛对模拟人白细胞和人血小板的动物红细胞进行固化,然后经过清洗并加入牛血清蛋白除去残留的固化剂,再根据需要进行配比以获得单项或全血质控物。 The method of the present invention is based on the approximate size of human red blood cells RBC Sims animal blood, red blood cells and then to approximate human white blood cells and red blood cell large cell of the animal approximate human blood leukocytes small animal blood cells simulate human white blood cells, red blood cells in human blood approximate the size of the animal blood platelet simulate human platelets, respectively, with 2-8% formaldehyde to simulate human white blood cells and red blood cells of human platelet animals cured, then cleaned and bovine serum albumin was added to remove residual curing agent, according to the ratio needed to obtain a single or whole blood quality control material. 本发明所述质控物稳定性好,成本低廉,安全性高,可适用于血细胞分析仪、尿沉渣分析仪及血红蛋白分析仪。 Quality control material of the present invention, good stability, low cost, safe, suitable hematology analyzer, urine sediment analyzer and hemoglobin analyzer.
Reclamaciones(6)  traducido del chino
1. 血液测试仪用生物安全质控物的制备方法,包括(1)红细胞模拟物的制备及(2)白细胞和血小板模拟物的制备,其特征在于: (1) 所述红细胞模拟物的制备方法如下: A) 采集红细胞近似人血红细胞大小的动物的血并采用抗凝剂处理; B) 将上述采集得到的血液离心,去除血浆和白细胞,收集底部红细胞; C) 将收集的红细胞置于细胞保养液保存,即得到红细胞模拟物; (2) 白细胞和血小板模拟物的制备方法如下: D) 分别采集红细胞近似人血白细胞大细胞的动物的血、红细胞近似人血白细胞小细胞的动物的血和红细胞近似人血血小板大小的动物的血,在采集的同时进行抗凝剂处理; E) 将上述采集到的血液分别进行固化,具体的固化操作为:将采集到的血液离心,收集底部的红细胞,加入2〜8% (v/v)的甲醛进行固化12〜72h; F) 将上述三种固化后的血液分别进行去除固化剂的步骤,具体的去除固化剂的操作是将固化后的血液离心,去除上清液,保留细胞以生理盐水清洗,清洗后的细胞加入牛血清蛋白,静置20〜24h,离心,分离出底部细胞; 将上述分离出的近似于人血白细胞大细胞动物的红细胞置于细胞保养液中保存,即得到白细胞大细胞模拟物;将上述分离出的近似于人血白细胞小细胞动物的红细胞置于细胞保养液中保存,即得到白细胞小细胞模拟物;将分离出的近似于人血小板的动物的红细胞置于细胞保养液中保存,即得到血小板模拟物; G) 分别调节红细胞模拟物和血小板模拟物的浓度可作为单项质控物使用,或者是将白细胞大细胞模拟物和白细胞小细胞模拟物混合得到白细胞模拟物作为单项质控物使用;或者是将所述的红细胞模拟物、白细胞大细胞模拟物、白细胞小细胞模拟物和血小板模拟物组合作为全血质控物使用; 上述的制备方法中,提到的细胞保养液的渗透压为300 ± 20m0sm/kg,pH值为7.3±0. 1,其组成为:抗生素0.4〜2g/L、多糖0• 1〜20g/L、牛血清蛋白20〜50g/L、氯化钠0• 1〜10g/L、柠檬酸钠0• 1〜20g/L和柠檬酸0• 001〜5g/L; 其中,步骤D)中, 所述的红细胞近似人血白细胞大细胞的动物为鹅、大雁、龟、鸵鸟或蛇; 所述的红细胞近似人血白细胞小细胞的动物为猫、狗、兔子、猴、牛、鸡或鸭; 所述的红细胞近似人血血小板大小的动物为猫、马、牛、羊或骆驼。 1. Method for preparing a blood tester biosafety quality control material, comprising (1) Preparation of leukocytes and platelets and erythrocytes mimetic mimics the preparation of (2), characterized in that: (1) Preparation of the erythrocytes mimetic as follows: A) collected the blood of animals human red blood cell is approximately the size of red blood cells and the use of anticoagulants treatment; B) The above collection obtained blood was centrifuged to remove plasma and white blood cells, red blood cells collecting at the bottom; C) will be placed in the collection of red blood cells cell maintenance fluid preservation, to obtain red blood cell mimics; preparation method (2) white blood cell and platelet mimetic as follows: D) were collected human white blood cell blood erythrocytes approximation of large animal cells, red blood cells approximate human blood leukocytes small animals blood and animal blood erythrocytes approximate size of human blood platelets, collected at the same time carry out an anticoagulant treatment; E) said collected blood were cured concrete curing operation is: the collected blood was centrifuged to collect at the bottom The red blood cells, was added 2~8% (v / v) formaldehyde curing 12~72h; F) after curing the above-described three types of blood removal step of curing agent separately, the specific removal operation of the curing agent is cured after The blood was centrifuged, the supernatant was removed, the cells retain the saline washed cells was added after washing of bovine serum albumin, allowed to stand 20~24h, centrifuged to separate the bottom of the cell; said isolated human white blood cell large cell approximates red blood cells and maintenance of animals placed in fluid preservation, to obtain large white blood cell mimetic; approximates said isolated human white blood cells in animal small red blood cells placed in maintenance saving solution, to obtain small white blood cell mimetic; The isolated human platelets similar to animal cells into erythrocytes maintenance solution to save, obtain platelet mimetic; G), respectively, to adjust the concentration of red blood cells and platelets mimetic mimetic quality control material can be used as single use, or is WBC large cell and small cell mimetic mimetic get mixed leukocyte white blood cell mimics used as a single control material; or a red blood cell mimics the leukocyte cell mimetic large, white blood cells and platelets small cell mimetic analog compositions as the use of whole blood control composition; osmolality above-described production method, referred to as a cell maintenance fluid 300 ± 20m0sm / kg, pH value of 7.3 ± 0 1, consisting of: antibiotic 0.4~2g / L, the polysaccharide. 0 • 1~20g / 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; wherein Step D), the red blood cells in human blood leukocytes large cell approximation of animals geese, geese, turtles, ostrich or snake; the erythrocytes approximate human blood cells, leukocytes small animals, cats, dogs, rabbits, monkeys, cow, chicken or duck; the red blood cells in human blood platelets approximate size of animal cats, horses, cattle, sheep or camels.
2. 根据权利要求1所述的血液测试仪用生物安全质控物的制备方法,其特征在于:步骤A)中,所述的红细胞近似人血红细胞大小的动物为猫、狗、猪、兔子、猴、牛、鸡或鸭。 2. The blood test apparatus according to claim 1, wherein the preparation method of quality control material on Biosafety, which is characterized by: step A), the human red blood cells RBC approximate size of the animal is a cat, dog, pig, rabbit , monkey, cow, chicken or duck.
3. 根据权利要求1所述的血液测试仪用生物安全质控物的制备方法,其特征在于:步骤E)中,甲醛的加入量与收集到的红细胞的体积比为40 :1〜1 :1。 3. The blood test apparatus according to claim 1 for preparing a biological safety quality control material, characterized in that: in step E), the amount of formaldehyde is added to the red blood cells collected with a volume ratio of 40: 1~1: 1.
4. 根据权利要求1所述的血液测试仪用生物安全质控物的制备方法,其特征在于:所述细胞保养液中的抗生素选自青霉素类、氨基糖苷类和酰胺类抗生素的任意一种或两种以上的组合。 4. The blood test apparatus according to claim 1, wherein the preparation method of biological safety quality control material, characterized in that: the cell maintenance liquid antibiotic is selected from any one of the penicillins, aminoglycosides and lactam antibiotics or a combination of two or more.
5. 根据权利要求1所述的血液测试仪用生物安全质控物的制备方法,其特征在于:所述细胞保养液中的多糖选自蔗糖、葡萄糖、果糖、半乳糖、乳糖、麦芽糖、淀粉和糊精中的任一种或两种以上的组合。 Blood test apparatus according to claim 1, wherein the preparation method of biological safety quality control material, characterized in that: said cell maintenance medium polysaccharide selected from sucrose, glucose, fructose, galactose, lactose, maltose, starch and dextrin any one or a combination of two or more.
6.按照权利要求1〜5中任一项所述的制备方法制备得到的质控物。 6. The preparation according to claim production method according to any one of claims 1 ~ 5 obtained quality control material.
Descripción  traducido del chino
血液测试仪用生物安全质控物及其制备方法 Blood tester with biosafety QC and its preparation method

技术领域 TECHNICAL FIELD

[0001] 本发明涉及血液检测技术领域,具体涉及血液测试仪用生物安全质控物及其制备方法。 [0001] The present invention relates to a blood test the technical field, particularly involving blood tester with biosafety quality control and preparation method.

背景技术 Background technique

[0002] 质控物用于检查分析仪器或方法的性能。 [0002] The quality control material used to check the performance of the instruments or methods. 当物质用于检查分析仪器或方法当前性能的常规测试时,它的分析特性必须与患者样本的相似。 When the conventional test substance or method of analytical instruments used to check the current performance of its analytical characteristics must be similar patient samples.

[0003] 随着医学诊断技术的飞速发展,各种血液临床测试仪器的使用越来越先进及普遍,不但为临床提供了更多的实验指标,也大大提高了临床测试工作效率与准确性。 [0003] With the rapid development of medical diagnostic technology, a variety of clinical blood test instruments using increasingly sophisticated and widespread, not only to provide a more experimental clinical indicators, but also greatly improve the efficiency and accuracy of clinical testing. 然而要得到准确可靠的结果,使不同仪器和不同实验室检测的结果有可比性,需要有一种稳定、可靠、多参数的质控物来确认仪器的操作功能运作正常,各项测定参数是否偏倚。 However, to obtain accurate and reliable results, so the results of different instruments and different laboratory tests are comparable, the need for a stable, reliable, multi-parameter quality control material to verify instrument operation functions work properly, the determination of whether the parameter bias . 目前国内各大医院使用的质控物大者采用国外质控物,国外质控物主要采用人血红细胞、鸟类有核细胞、胶乳、花粉、蹄科动物红细胞,制成人血红细胞模拟质控物的红细胞。 Currently QC was greater major hospitals using quality control material abroad, foreign control material used mainly human red blood cells, avian nucleated cells, latex, pollen, animal hoof Branch erythrocytes, red blood cells made from human simulation QC RBC thereof. 国外质控物其价格较为昂贵,而且由于是采用人血红细胞制作质控物,因而有可能存在血污染的问题,也可能导致肝炎、艾滋病、性病等其它通过血液传染的疾病的传播。 Foreign QC was its price is more expensive, but also because it is the use of human red blood cell production quality control material, and therefore there could be blood contamination problems may lead to the spread of other blood-borne diseases, hepatitis, AIDS, and other sexually transmitted diseases. 目前,国内也有人血类似质控品,如公开号为CN101285841的发明专利公开了一种三分类全血质控物模拟物的制备方法及其制得的血型检测试剂盒,该发明所述方法用鱼类血液模拟人白细胞和血小板,家畜红细胞和浆站废弃人血红细胞模拟人血红细胞,模拟人血样本实际的直方图分布,将细胞颗粒混悬于细胞悬液中作单项质控物使用,或组合成全血质控物使用。 At present, the domestic blood was also similar control materials, such as Publication No. CN101285841 the invention discloses a method for preparing three categories of whole blood quality control mimetics and prepared blood test kit, the method of the invention with fish blood simulate human white blood cells and platelets, red blood cells and plasma stations livestock waste human blood cells simulate human blood cells to simulate human blood samples of actual histogram distribution of particles suspended in the cell as a single cell suspension using quality control material , or a combination of blood quality control material use sake. 该本发明所述质控物具有较好的质控效果,但其保存期限不够理想。 The present composition of the invention has better quality control quality control results, but its shelf life is not ideal.

发明内容 SUMMARY OF THE INVENTION

[0004] 本发明要解决的技术问题是提供一种完全采用动物血制作,达到生物安全且质控效果好同时保存期限长的血液测试仪用质控物及其制备方法。 [0004] The technical problem to be solved by the present invention is to provide a full use of animal blood production, achieve better quality control of bio-safety and effectiveness while preserving the long-term blood tester with quality control and preparation method.

[0005] 本发明所述的血液测试仪用质控物的制备方法,包括(1)红细胞模拟物的制备及(2)白细胞和血小板模拟物的制备,其中: Preparation method of quality control substance and preparation [0005] The blood test apparatus according to this invention, comprising (1) red blood cell mimics (2) Preparation of white blood cells and platelets mimics, in which:

[0006] (1)所述红细胞模拟物的制备方法如下: [0006] (1) Preparation of the erythrocytes mimetic follows:

[0007] A)采集红细胞近似人血红细胞大小的动物的血并采用抗凝剂处理; [0007] A) collected the blood of animals RBC approximate size of human red blood cells and the use of anticoagulant treatment;

[0008] B)将上述采集得到的血液离心,去除血浆和白细胞,收集底部红细胞; [0008] B) The above collection obtained blood was centrifuged to remove plasma and white blood cells, red blood cells collecting at the bottom;

[0009]C)将收集的红细胞置于细胞保养液保存,即得到红细胞模拟物; [0009] C) to collect red blood cells placed in fluid preservation and maintenance, to obtain red blood cell mimics;

[0010] (2)白细胞和血小板模拟物的制备方法如下: [0010] (2) Preparation of leukocytes and platelets mimics follows:

[0011] D)分别采集红细胞近似人血白细胞大细胞的动物的血、红细胞近似人血白细胞小细胞的动物的血和红细胞近似人血血小板大小的动物的血,在采集的同时进行抗凝剂处理; [0011] D) were collected human white blood cell blood erythrocytes approximation of large animal cells, red blood cells in human blood leukocytes approximate the blood of animals small animal blood cells and red blood cells in human blood platelets approximate size of the collection at the same time be an anticoagulant deal with;

[0012] E)将上述采集到的血液分别进行固化,具体的固化操作为:将采集到的血液离心,收集底部的红细胞,加入2〜8%(v/v)的甲醛进行固化12〜72h; [0012] E) said collected blood were cured, concrete curing operation is: The collected blood was centrifuged to collect red blood cells at the bottom, was added 2~8% (v / v) formaldehyde curing 12~72h ;

[0013] F)将上述三种固化后的血液分别进行去除固化剂的步骤,具体的去除固化剂的操作是将固化后的血液离心,去除上清液,保留细胞以生理盐水清洗,清洗后的细胞加入牛血清蛋白,静置20〜24h,离心,分离出底部细胞; [0013] F) The blood after curing were the three step removal of the curing agent, the specific removal operation of the curing agent is cured after the blood was centrifuged, the supernatant was removed, the cells retain the saline wash, after washing The cells were added to bovine serum albumin, allowed to stand 20~24h, centrifuged to separate the bottom of the cell;

[0014] 将上述分离出的近似于人血白细胞大细胞动物的红细胞置于细胞保养液中保存, 即得到白细胞大细胞模拟物;将上述分离出的近似于人血白细胞小细胞动物的红细胞置于细胞保养液中保存,即得到白细胞小细胞模拟物;将分离出的近似于人血小板的动物的红细胞置于细胞保养液中保存,即得到血小板模拟物; [0014] The above isolated large cells similar to human blood leukocytes erythrocytes animal care and placed in cell preservation solution, namely to give large white blood cell mimetic; approximates said isolated human white blood cells in animal erythrocytes small set in cell maintenance solution to save, obtain leukocyte small cell mimetic; the isolated human platelets similar to animal cells into erythrocytes maintenance solution to save, obtain platelet mimetic;

[0015] G)分别调节红细胞模拟物和血小板模拟物的浓度可作为单项质控物使用,或者是将白细胞大细胞模拟物和白细胞小细胞模拟物混合得到白细胞模拟物作为单项质控物使用;或者是将所述的红细胞模拟物、白细胞大细胞模拟物、白细胞小细胞模拟物和血小板模拟物组合作为全血质控物使用; [0015] G), respectively, to adjust the concentration of red blood cells and platelets mimetic mimetic quality control material can be used as single use, or are large white blood cells and white blood cell mimics small cell mimetic get mixed leukocyte mimetic quality control material used as a single; or the red blood cell mimics, large cell mimetic leukocyte, white blood cells and platelets small cell mimetic analog compositions as whole blood quality control material use;

[0016] 上述的制备方法中,提到的细胞保养液的渗透压为300±20m0sm/kg,pH值为7. 3±0. 1,其组成为:抗生素0.4〜2g/L、多糖5〜20g/L、牛血清蛋白20〜50g/L、氯化钠0• 1〜10g/L、柠檬酸钠0• 1〜20g/L和柠檬酸0• 001〜5g/L。 [0016] The production method described above, maintenance of osmotic pressure mentioned cell liquid was 300 ± 20m0sm / kg, pH value of 7. 3 ± 0 1, consisting of: antibiotic 0.4~2g / L, polysaccharides -5 to 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.

[0017] 上述技术方案中: [0017] The above-mentioned modes:

[0018] 步骤A)中,所述的红细胞近似人血红细胞大小的动物可以是猫、狗、猪、兔子、猴、 牛、鸡或鸭。 [0018] Step A), the human red blood cells RBC approximate size of the animal can be cats, dogs, pigs, rabbits, monkeys, cattle, chickens or ducks.

[0019] 步骤D)中,所述的红细胞近似人血白细胞大细胞的动物可以是鹅、大雁、龟、鸵鸟、蛇、鲨鱼或鳄鱼。 [0019] Step D), the red blood cells in human blood leukocytes approximate large animal cells can be geese, geese, turtles, ostrich, snake, shark or crocodile.

[0020] 步骤D)中,所述的红细胞近似人血白细胞小细胞的动物可以是猫、狗、猪、兔子、 汾矢、牛、鸡或鸭。 [0020] Step D), the red blood cells in human blood leukocytes approximate small-cell animals can be cats, dogs, pigs, rabbits, Fen vector, cattle, chickens or ducks.

[0021] 步骤D)中,所述的红细胞近似人血血小板大小的动物可以是猫、马、牛、羊或骆驼。 [0021] Step D), the red blood cells in human blood platelets approximate size of the animal can be cats, horses, cattle, sheep or camels.

[0022] 步骤E)中,甲醛的加入量与收集到的红细胞的体积比优选为40 :1〜I: 1。 [0022] Step E) in an amount of formaldehyde and the collected volume of red blood cells is preferably from 40: 1~I: 1.

[0023] 所述细胞保养液中的抗生素选自青霉素类、氨基糖苷类和酰胺类抗生素的任意一种或两种以上的组合。 [0023] The cell maintenance medium is selected from penicillin antibiotics, any kind of aminoglycosides and lactam antibiotics or a combination of two or more. 具体可以是采用青霉素、苄星青霉素、庆大霉素、链霉素和氯霉素中的一种或两种以上的组合。 Specifically is the use of one or both penicillin, benzathine penicillin, gentamicin, chloramphenicol, streptomycin, and combinations of the above. 当抗生素的选择为上述两种以上的组合时,它们之间的配比可以为任意配比。 When the antibiotic is selected for two or more combinations of the above, the ratio between them can be any ratio.

[0024] 所述细胞保养液中的多糖选自蔗糖、葡萄糖、果糖、半乳糖、乳糖、麦芽糖、淀粉和糊精中的任一种或两种以上的组合。 [0024] selected from sucrose, a combination of glucose, fructose, galactose, lactose, maltose, starch and dextrin any one or two or more of the cell maintenance medium polysaccharide. 当多糖的选择为上述两种以上的组合时,它们之间的配比可以为任意配比。 When selecting polysaccharide two or more combinations of the above, the ratio between them can be any ratio.

[0025] 所述的抗凝剂为常规采血中采用的常规抗凝剂。 Anticoagulants [0025], wherein conventional anticoagulants used in conventional blood sampling.

[0026] 本发明还包括由上述制备方法制备得到的质控物。 [0026] The present invention also includes a method for preparing the above preparation obtained by the quality control material.

[0027] 与现有技术相比,本发明的优点在于: [0027] Compared with the prior art, the advantages of the present invention is:

[0028] 1、仅需要对模拟人白细胞和人血小板的动物红细胞进行固化,简化了工艺; [0028] 1, only to simulate human white blood cells and red blood cells of human platelet animals cured, simplifying the process;

[0029] 2、采用高浓度的甲醛对模拟人白细胞和人血小板的动物红细胞进行固化,高浓度甲醛能快速固化细胞,固化更彻底,从稳定性观察中显示,固化浓度高,能够保证固化细胞稳定性越长;在固化后通过清洗并加入牛血清蛋白除去残留的固化剂,克服因固化残留导致成品质控物中细胞体积产生变化,保证了质控物的稳定性; [0029] 2, using high concentrations of formaldehyde to simulate human white blood cells and red blood cells of human platelet animals cured, high concentrations of formaldehyde can be quickly cured cells, cured more thoroughly, from the stability of observation have shown that high concentrations of curing, to ensure that the curing cells Stability longer; after curing by washing and bovine serum albumin was added to remove residual curing agents, curing residual lead to overcome the finished quality control material produced in cell volume change, to ensure the stability of quality control material;

[0030] 3、采用特殊配比的细胞保养液,保证红细胞的活性与稳定性; [0030] 3, using a special ratio of cell maintenance solution to ensure the activity and stability of red blood cells;

[0031] 4、全部采用动物血进行制作,成本更低,安全性更高; [0031] 4, all with animal blood for production, lower cost, higher security;

[0032] 5、质控物采用动物血制作,可杜绝人血传染病在产品使用的危害,让使用者能处于更好的环境下进行工作;而且原料来源广泛,避免人血资源的争夺,采集方便,可控性大, 大大增加产品实用性,增加国内质控物产品的多样性,促进市场同类产品的良性竞争; [0032] 5, controls the use of animal blood was making, can harm human blood to prevent infectious diseases in the product, allowing users to work in a better environment under; and a wide range of sources of raw materials to avoid competition for resources, human blood, collection and convenient, controllable big, greatly increasing product availability, increase domestic control material product diversity, promote healthy competition in the market of similar products;

[0033] 6、本发明所述的质控物保存期限长、适用范围广,可适用于血细胞分析仪、尿沉渣分析仪及血红蛋白分析仪。 [0033] 6, quality control was a long shelf life, wide application, suitable for hematology analyzer, urine sediment analyzer and hemoglobin analyzer of the present invention.

具体实施方式 DETAILED DESCRIPTION

[0034] 下面以实施例对末发明进行进一步说明,但本发明并不局限于这些实施例。 [0034] The following examples further illustrate the invention will be late, but the present invention is not limited to these embodiments.

[0035] 实施例1 :血红蛋白分析仪的质控物的制备 Preparation of hemoglobin analyzer quality control substance: 1. Example [0035] Example

[0036] A)采集山羊血并进行抗凝处理,抗凝剂为EDTA-K2,用量为1. 5〜2. 2MG/ml血液进行抗凝处理; [0036] A) collected the blood of goats and anticoagulant treatment anticoagulant is EDTA-K2, the amount of 1. 5~2 2MG / ml blood anticoagulant treatment.;

[0037] B)将上述采集得到的山羊血离心,去除血浆和白细胞,收集底部红细胞,得到浓度高于95%的红细胞; [0037] B) The goat blood collection obtained above was centrifuged to remove plasma and white blood cells, red blood cells collecting at the bottom, to give a concentration of greater than 95% of the red blood cells;

[0038] C)将收集的红细胞置于细胞保养液中,根据要制备的质控物中血红蛋白的含量, 调节红细胞在细胞保养液中的浓度,即得到相应浓度的血红蛋白质控物;细胞保养液的组成为:青霉素〇. 15g/L、庆大霉素0. 15g/L、氯霉素0.lg/L、葡萄糖2g/L、牛血清蛋白20g/L、 氯化钠6. 3g/L、柠檬酸钠7. 8g/L,柠檬酸0. 01g/L;所述细胞保养液的渗透压为305m0sm/ kg,pH值为7. 32。 [0038] C) to collect red blood cells placed in care solution, based on quality control was to be prepared in the content of hemoglobin, red blood cell concentration in regulating cell maintenance solution, namely to give the corresponding concentration of hemoglobin quality control material; cell maintenance The liquid composition is: Penicillin square 15g / L, gentamicin 0. 15g / L, chloramphenicol 0.lg / L, glucose 2g / L, bovine serum albumin 20g / L, sodium chloride 6. 3g / L, sodium citrate 7. 8g / L, citric 0. 01g / L; osmotic pressure of the cell maintenance fluid was 305m0sm / kg, pH value of 7.32.

[0039] 实施例2 :三分类血细胞分析仪的全血质控物的制备 2 [0039] Example 2: Preparation of three categories of blood cell analyzer of whole blood control material

[0040]A)分别采集狗、牛和鸵鸟的血,在采集的过程中分别用抗凝剂处理;抗凝剂选用EDTA-K2,用量为2.OMG/ml血液; [0040] A) were collected from dogs, cattle and ostrich blood, collected in the course of treatment with an anticoagulant, respectively; anticoagulant choice EDTA-K2, the amount of 2.OMG / ml of blood;

[0041] B)取采集的狗血的一部分进行离心,去除上层血浆和中层白细胞,收集底部红细胞,得到浓度为98. 5%的红细胞; [0041] B acquired idea that taking part) were centrifuged to remove the upper middle leukocytes and plasma, red blood cells collecting at the bottom, to give a concentration of 98.5% of the red blood cells;

[0042] C)将收集的红细胞与保养液混合,用血细胞分析仪测试,用保养液调节至RBC计数为8. 0X1012/L±1.OXlO1VL,体积比约为1:1,5°C条件下保存,即得到红细胞模拟物; [0042] C) The collected erythrocytes were mixed and maintenance, with the blood cell analyzer with maintenance RBC count was adjusted to 8. 0X1012 / L ± 1.OXlO1VL, the volume ratio of about 1: 1,5 ° C condition Under Save, to obtain red blood cell mimics;

[0043] D)将剩余的狗血离心,收集底部的红细胞,加入3%(v/v)的甲醛于30°C的恒温箱中固化56h;所述甲醛的加入量与收集到的红细胞的体积比为20 :1 ; [0043] D) The idea that the remaining was centrifuged to collect red blood cells at the bottom, was added 3% (v / v) formaldehyde at 30 ° C in an incubator curing 56h; the amount of formaldehyde is added to the red blood cells and the collection volume ratio of 20: 1;

[0044] 取上述采集的牛血离心,收集底部的红细胞,加入3%(v/v)的甲醛于30°C的恒温箱中固化56h;所述甲醛的加入量与收集到的红细胞的体积比为20 :1 ; [0044] Bovine blood collected above centrifugation, red blood cells collected at the bottom, was added 3% (v / v) formaldehyde at 30 ° C in an incubator curing 56h; the amount of formaldehyde is added to the collected volume of red blood cells ratio of 20: 1;

[0045] 取上述采集的鸵鸟血离心,收集底部的红细胞,加入3%(v/v)的甲醛于30°C的恒温箱中固化56h;所述甲醛的加入量与收集到的红细胞的体积比为20 :1 ; [0045] Ostrich collected blood was centrifuged to take the above, the collection of red blood cells at the bottom, was added 3% (v / v) formaldehyde at 30 ° C in an incubator curing 56h; the amount of formaldehyde is added to the collected volume of red blood cells ratio of 20: 1;

[0046] E)将上述固化后的狗血进行去除固化剂的操作,具体是将固化后的狗血离心,去除上清液,保留细胞以生理盐水清洗然后离心,重复3次清洗操作,离心得到的细胞加入浓度为38%牛血清蛋白(其中细胞与牛血清蛋白的体积比为1:1),静置24h后离心,分离出的底部细胞即为近似于人血白细胞小细胞的狗红细胞(浓度为98%),将其与细胞保养液按1:2的体积比混合,即得到小白细胞模拟物; [0046] E) The idea that after the removal of the curing hardener operation, in particular the idea that after curing centrifugation, the supernatant was removed, the cells retain the saline wash followed by centrifugation, washing operation was repeated 3 times, centrifugal The resulting cells were added to a concentration of 38% bovine serum albumin (wherein the volume ratio of cells with bovine serum albumin 1: 1), standing 24h After centrifugation, the separated bottom cell is similar to human blood cells, leukocytes small dog erythrocyte (concentration 98%), which with cell maintenance solution 1: 2 volume ratio of mixing, that is to give small leukocyte mimetic;

[0047] 将上述固化后的牛血进行去除固化剂的操作,具体操作同狗血,分离出的底部细胞即为近似于人血小板的牛红细胞(浓度为99%),将其与细胞保养液按1:3的体积比混合, 即得到血小板细胞模拟物; [0047] The bovine blood after removal of the curing operation of the curing agent, the specific operation is the same idea that isolated at the bottom of the cell is similar to human platelets bovine red blood cells (99% concentration), which with cell maintenance solution 1: 3 volume ratio, i.e., to obtain platelet cell mimetic;

[0048] 将上述固化后的鸵鸟血进行去除固化剂的操作,具体操作同狗血,分离出的底部细胞即为近似于人血白细胞大细胞的鸵鸟红细胞(浓度为98. 5%),将其与细胞保养液按1:5的体积比混合,即得到大白细胞模拟物; [0048] The ostrich blood after removal of the curing operation of the curing agent, the specific operation is the same idea that isolated at the bottom of the cell is similar to human cells, white blood cell large ostrich red blood cells (concentration of 98.5%), the with cell maintenance solution 1: 5 volume ratio of mixing, that is to obtain a large white blood cell mimetic;

[0049] F)将步骤C)中制得的红细胞模拟物、步骤E)制得的白细胞小细胞模拟物、血小板模拟物和白细胞大细胞模拟物按3 :1 :1 :1的体积比混合,分装,即得到三分类血细胞分析仪的全血质控物; [0049] F) will step C) in red blood cell mimics obtained in step E) obtained in small cell mimetic WBC, platelet and white blood cell large cell mimetic mimetic of 3: 1: 1: 1 volume ratio , packaging, namely to give three categories hematology analyzer whole blood quality control material;

[0050] 上述方法中提到的细胞保养液的组成为:青霉素0. 2g/L、庆大霉素0. 25g/L、氯霉素0•lg/L、葡萄糖2. 5g/L、果糖I. 5g/L、半乳糖2g/Lg/L、牛血清蛋白25g/L、氯化钠6g/L、 柠檬酸钠8.Og/L、柠檬酸0. 01g/L;其渗透压为300m0sm/kg,pH值为7. 35。 [0050] composition mentioned in the above-described method for cell maintenance fluid: penicillin 0. 2g / L, gentamicin 0. 25g / L, chloramphenicol 0 • lg / L, glucose 2. 5g / L, fructose I. 5g / L, galactose 2g / Lg / L, bovine serum albumin 25g / L, sodium chloride 6g / L, sodium citrate 8.Og / L, citrate 0. 01g / L; its osmolality 300m0sm / kg, pH value of 7.35.

[0051] 将上述实施例2制得的质控物,用血细胞分析仪对质控物的瓶内均匀性、瓶内均匀性和准确度观察,结果如以下: [0051] The second embodiment of quality control was obtained by the blood cell analyzer for quality control material of the bottle homogeneity, uniformity and accuracy bottle observation results are the following:

[0052] 1、测试结果 [0052] 1, the test results

[0053] I. 1瓶内均匀性 [0053] I. 1 vial uniformity

[0054] 任意取质控物1瓶,取3个样品,编号为样品1、样品2和样品3,分别以血细胞分析仪URIT-3000 (桂林高新区宝利泰医疗电子有限公司)进行测试,重复测试11次,除去第1次测试结果,取剩余10个测试结果,如下述表1所示。 [0054] 1 bottle of quality control material taken any, take three samples, sample No. 1, Samples 2 and 3, respectively, blood cell analyzer URIT-3000 (Guilin High-tech Zone Li Tai Po Medical Electronics Co., Ltd.) for testing, Repeat the test 11 times, removing the first test results, taking the remaining 10 test results, as shown in the following Table 1. 中值质控物各个参数按公式(1)、 公式(2)、公式(3)计算瓶内均匀性变异系数,结果如表2所示,符合行业标准。 Each parameter value of quality control substance according to formula (1), the equation (2), the equation (3) Calculate the coefficient of variation of the uniformity of the bottle, the results shown in Table 2, in line with industry standards.

Figure CN103454410BD00071

[0058] 式中: [0058] where:

[0059] J- 一平均值; [0059] J- an average value;

[0060] SD--标准差; [0060] SD-- standard deviation;

[0061] CV--变异系数; [0061] CV-- coefficient of variation;

[0062] n--测量次数; [0062] n-- number of measurements;

[0063] Xi--指定参数第i次测量值。 [0063] Xi-- specified parameters i-th measurement.

[0064]表1 : [0064] Table 1:

[0065] [0065]

Figure CN103454410BD00081

次测试结果,按公式(I)、公式(2)计算各个参数10个结果的平均值(¾)和标准差(SD1); The test results, according to the formula (I), formula (2) calculation of the various parameters of the average of 10 (¾) and standard deviation (SD1);

[0071] 另用上述10瓶质控物中的1瓶连续测试11次,除去第1次测试结果,按公式(1)、 公式(2)计算剩余10个测试结果各个参数的平均值(足)和标准差(SD2); [0071] Another continuous test 11 times with 10 bottles of quality control material above the bottle, remove the first test results, according to the formula (1), the equation (2) calculation of the remaining 10 test results mean for each parameter (foot ) and standard deviation (SD2);

[0072] 中值质控物各个参数按公式(4)、公式(5)计算瓶间均匀性,所得瓶间均匀性变异系数结果如表3所示,符合行业标准。 [0072] values of various parameters in quality control substance according to formula (4), the equation (5) calculated between bottle homogeneity between bottles of uniformity coefficient of variation obtained results are shown in Table 3, in line with industry standards.

Figure CN103454410BD00091

[0084] 取按实施例2方法制得的质控物,进行为期三个月的观察测试,测定数据如下述表4所示,质控物长期测试准确度结果如表5所示。 [0084] to take the method of Example 2 was obtained in quality control, to observe a three-month test, measurement data as shown in the following table, the long-term quality control material test accuracy of the results as shown in Table 5.

[0085]表4 : [0085] Table 4:

[0086] [0086]

Figure CN103454410BD00092

[0087] 表5 : [0087] Table 5:

[0088] [0088]

Figure CN103454410BD00101

[0089] 从上述各项观察测试可以看出,由本发明所述方法制作的质控物满足瓶内均匀性、瓶间均匀性和质控物准确度的要求。 [0089] As can be seen from the above observation test, by the method of the present invention produced uniformity of quality control material to meet the bottle, the bottle between uniformity and quality control material accuracy requirements.

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Clasificación internacionalG01N33/48
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