CN103454410B - 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 PDF

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CN103454410B
CN103454410B CN 201210173336 CN201210173336A CN103454410B CN 103454410 B CN103454410 B CN 103454410B CN 201210173336 CN201210173336 CN 201210173336 CN 201210173336 A CN201210173336 A CN 201210173336A CN 103454410 B CN103454410 B CN 103454410B
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tester
safe
quality
method
control
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CN103454410A (en )
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周永杨
唐雪辉
陈尚斌
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桂林优利特医疗电子有限公司
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Abstract

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 and its preparation method biosafety quality control. 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 approximately simulated human animal blood human erythrocytes RBC size, and then to human red blood cells white blood cell large cell approximately animal and human blood leukocytes erythrocytes approximate small animal blood cell analog of human leukocytes, erythrocytes in human blood is approximately the size of the animal blood platelets simulated human platelets, respectively 2 to 8% formaldehyde animal models of human leukocytes and human platelets cured with erythrocytes, and then cleaned to remove the residual bovine serum albumin was added a curing agent, then the ratio required to obtain a single or whole blood control product. 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。 Good quality control according to the present invention, the stability, low cost, high safety, can be applied to blood cell analyzer, and the urine sediment analyzer Hemoglobin Analyzer.

Description

血液测试仪用生物安全质控物及其制备方法 Blood Test substance and preparation method of quality control Biosafety

技术领域 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 technical field, particularly relates to a blood tester biosafety control material and its 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] were used for quality control to check the performance of the analytical instrument or method. 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 for checking the current performance analytical instruments or methods, it must be similar to the analysis of the characteristics of 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, using a variety of clinical blood test instrument is more and more advanced and widespread, not only to provide more clinical laboratory parameters, 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, the results of different instruments and different laboratory tests are comparable, the need for a stable, reliable, multi-parameter control material to confirm the operation of the instrument is working correctly, 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。 At present the greater quality control material used in major hospitals, the use of foreign material quality control, quality control material used mainly foreign human red blood cells, avian nucleated cells, latex, pollen, animal hoof Branch of red blood cells, red blood cells made from human simulation QC RBC matter. 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 which was more expensive, and because red blood cell production is the use of human QC was therefore possible problem of blood contamination may also lead to further spread of 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, blood was also similar quality control materials, as disclosed in patent No. CN101285841 discloses a method for preparing a three-differential complete blood control mimics its blood detection kit prepared, the method of the invention fish with simulated human blood platelets and white blood cells, red blood cells and plasma station livestock waste human erythrocytes simulated human erythrocytes, human blood samples analog actual histogram distribution, the cell pellet suspended in cell suspension was used as a quality control item , or a combination thereof using sake blood control. 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 invention is a quality control QC has a good effect, but not over its shelf life.

发明内容 SUMMARY

[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 present invention is to solve the technical problem of providing a completely animal blood production, to achieve good biological safety and quality control results while preserving long term quality control material tester blood and preparation method thereof.

[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 of [0005] the present invention is prepared by a blood test instrument quality control material comprising (1) Preparation of erythrocyte mimetic (2) leukocytes and platelets mimetic, wherein:

[0006] (1)所述红细胞模拟物的制备方法如下: [0006] (1) The method of preparing the red blood cell 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) red blood cell collection is approximately the size of red blood cells in human and animal use of anticoagulants;

[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 collected blood was centrifuged obtained above, removing plasma and white blood cells, red blood cells collected 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) The collected red blood cell preservative solution was placed preservation, i.e. erythrocytes obtained mimetic;

[0010] (2)白细胞和血小板模拟物的制备方法如下: [0010] (2) Method for preparing leukocytes and platelets mimetics 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 red blood cells white blood cells of blood approximately a large animal cells, erythrocytes of human blood leukocytes approximate blood platelets in human blood is approximately the size of the small blood cells and red blood cells of animals, animals, collected 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) The above collected blood were cured, concrete curing operation as follows: 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; After [0013] F) The blood after the three curing step of removing respectively of the curing agent, the curing agent specific removal operation is cured after blood was centrifuged, the supernatant was removed, the cells retain the saline wash, washing the cells were added bovine serum albumin, allowed to stand 20~24h, was centrifuged to separate the cell bottom;

[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-described isolated human white blood cell large cell similar animal red blood cell preservative solution was placed in storage, i.e., to obtain white blood cell large mimetic; similar to the above-described isolated human white blood cell erythrocytes opposed small cells of the animal stored in the cell maintenance fluid, i.e., to obtain small white blood cell mimetic; the isolated human platelets similar to animal cell erythrocyte preservative solution is placed in storage, i.e., to obtain platelet mimetics;

[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) adjusting the concentration of each red blood cell and platelet mimetic mimics quality control material as a single use, or a large white blood cells and white blood cell-small cell mimetic mimetic mimetic mixed leukocyte obtained as a single quality control substance use; or mimic the erythrocytes, leukocytes mimetic large cell, small white blood cell and platelet analog mimetic compositions was used as whole blood control;

[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 preparation method, mentioned osmotic cell maintenance fluid 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, NaCl 0 • 1~10g / L, sodium citrate 0 • 1~20g / L citric acid and 0 • 001~5g / L.

[0017] 上述技术方案中: [0017] The technical solution:

[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 animal erythrocytes approximate size of human erythrocytes may be a cat, dog, pig, rabbit, monkey, cow, chicken or duck.

[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 white blood cell erythrocytes approximate human animal cells may be large geese, geese, turtles, ostrich, snake, alligator or shark.

[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 white blood cell erythrocytes approximate human animal cells may be small cats, dogs, pigs, rabbits, Fen vector, cow, chicken or duck.

[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 may be a cat, horse, cow, 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), the amount of formaldehyde added to the volume of red blood cells collected 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 antibiotic is selected from penicillin cell maintenance fluid, and any one aminoglycoside antibiotic or a combination of amides 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。 With the above may be specifically penicillin, benzathine penicillin, gentamicin, chloramphenicol, streptomycin, and one or a combination of two. 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 selecting an antibiotic a combination of two or more 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, glucose, fructose, galactose, lactose, maltose, starch, and any one or two or more dextrins in the cell maintenance fluid composition 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 the polysaccharide is selected combination of at least two kinds 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。 Anticoagulant according [0025] to a 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 further comprises a preparation obtained by the above production process quality control substance.

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

[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 needs to simulate human white blood cells and platelets human animal erythrocytes curing, 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, the use of high concentrations of formaldehyde to animal models of human platelets and human leukocytes erythrocytes curing, fast curing high concentrations of formaldehyde cells, more thorough cure, the stability observations show high concentrations of curing, can be cured to ensure that the cells the longer stability; after curing by washing and addition of bovine serum albumin to remove the residual curing agent, the curing residue overcome the quality control of the finished product results in a difference in cell volume, quality control to ensure the stability thereof;

[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 the cell maintenance fluid, to ensure that 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, was produced in all animal blood, lower cost, higher safety;

[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, the use of animal blood quality control material production, can prevent harm to human blood products for use in infectious diseases, 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 convenient, controllable big, greatly increasing product availability, quality control material to increase the diversity of domestic products and 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, long shelf life is quality control, wide application range, can be applied to blood cell analyzer, and the urine sediment analyzer 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] In the following embodiments of the invention will be further explained at the end, 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 QC was prepared hemoglobin analyzer: 1 case [0035] Embodiment

[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) collecting blood and anticoagulated goat, anticoagulants EDTA-K2, in an amount of 1. 5~2 2MG / ml blood anticoagulation 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 blood collected was centrifuged to obtain the above-goat, and plasma depleted white blood cells, red blood cells collected 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) The collected red blood cell preservative solution is placed in accordance with the quality control material to be prepared hemoglobin content, adjusting the concentration of red blood cells in the maintenance of fluid, i.e., the corresponding concentration of hemoglobin control material; Cell Maintenance liquid composition is: penicillin square 15g / L, gentamycin 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 acid, 0. 01g / L; osmolality of the cell maintenance fluid 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 Preparation of Three categories of blood cell analyzer of the whole blood control composition: [0039] Example 2

[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 ostriches blood, were treated with an anticoagulant in the collection process; selected anticoagulant EDTA-K2, an 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) a portion of the collection to take the idea was centrifuged to remove the upper middle leukocytes and plasma, red blood cells collected 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) mixing with RBC preservative solution collected by the blood cell analyzer, the adjustment to the maintenance of RBC count was 8. 0X1012 / L ± 1.OXlO1VL, 1 volume ratio of about: 1,5 ° C Condition under storage, i.e., red blood cells of mimetic;

[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 remaining Gouxue centrifugation, red blood cells collected in the bottom, was added 3% (v / v) formaldehyde curing 56h at 30 ° C incubator; the amount of formaldehyde was added to the collected red blood cells 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 was centrifuged to take the above collection, to collect red blood cells at the bottom, was added 3% (v / v) formaldehyde curing 56h at 30 ° C incubator; the amount of formaldehyde was 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] The above centrifugation Ostrich blood collection, the collection of red blood cells at the bottom, was added 3% (v / v) formaldehyde curing 56h at 30 ° C incubator; the amount of formaldehyde was 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 the curing operation after removal of the curing agent, in particular the idea that after curing centrifuged, the supernatant was removed, the cells retain the saline washed and then centrifuged, washing operation was repeated 3 times, centrifugal cells were added to give a concentration of 38% bovine serum albumin (wherein the volume ratio of cells with bovine serum albumin to 1: 1), left for 24h after centrifugation, the separated cells that is similar to the bottom-small cell human leukocyte dog erythrocytes (concentration 98%), which was maintained with the cells 1: 2 volume ratio of mixing, i.e., to obtain 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] Bovine blood removal after the curing operation of the curing agent, with the idea that the specific operation, the bottom cell is the isolated human platelets similar to bovine erythrocytes (concentration 99%), which was maintained with the cells 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] Emu blood removal after the curing operation of the curing agent, with the idea that the specific operation, the bottom cell is the isolated human white blood cell large cell approximates ostrich erythrocytes (concentration 98.5%), the maintenance of the cell which was 1: 5 volume ratio mixture, i.e., to obtain a large leukocyte 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) The step C) prepared in erythrocytes mimetic, step E) obtained in leukocytes small cell mimetics, platelet mimetics and leukocytes large cell mimetic of 3: 1: 1: 1 volume ratio , packaging, i.e., to obtain three categories of blood cell analyzer whole blood control composition;

[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] The composition of the cell preservative solution methods mentioned are: penicillin 0. 2g / L, gentamycin 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, citric acid, 0. 01g / L; osmolality which 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 above Example 2 was obtained in quality control, blood cell analyzer uniformity of quality control material of the bottle, the bottle uniformity and accuracy of observation, the following results:

[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] The quality control material of any bottle taken, taking three samples, sample No. 1, samples 2 and 3, respectively, to blood cell analyzer URIT-3000 (Li Tai Po New District Guilin Medical Electronics Co., Ltd.) for testing, test was repeated 11 times, removing the first test results, taking the remaining 10 test results, as shown in table 1 below. 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 was calculated value QC uniformity coefficient of variation vial according to formula (1), the equation (2), Equation (3), the results shown in Table 2, in line with industry standards.

Figure CN103454410BD00071

[0058] 式中: [0058] wherein:

[0059] J- 一平均值; [0059] J- a mean 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-- designated parameter of the i-th measured value.

[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); Test results, according to the formula (the I), equation (2) calculates an average value (¾) 10 each parameter results and standard deviation (SD1 of);

[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 bottle with the bottle 10 above the continuous quality control test was 11 times, removing the first test results, calculated according to formula (1), the equation (2) the remaining 10 test result the average individual parameters (foot ) and standard deviation (SD2 are);

[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] The parameter values ​​of the respective quality control substance according to formula (4), equation (5) calculating the uniformity as shown in Table 3 uniformity coefficient of variation between the results obtained between the vial bottle, industry standard.

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] by taking 2 obtained by the method of Example quality control, testing was observed for three months, the measurement data as shown in the following Table, the long-term quality control material to test the accuracy of the results as shown in Table 54.

[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 test was observed, produced by the method of the present invention was to satisfy the uniformity of quality control bottle, bottle between uniformity and accuracy requirements of quality control material.

Claims (6)

  1. 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 1. Method for preparing a blood tester biosafety quality control material comprising (1) Preparation of leukocytes and platelets mimetics mimetics erythrocyte preparation and (2), characterized in that: Preparation of (1) mimetic RBC method follows: a) collecting blood erythrocyte human erythrocytes is approximately the size of the animal and the use of anticoagulants; B) the above-collected blood was centrifuged obtained, remove plasma and white blood cells, red blood cells collected at the bottom; C) placed in the collected red blood cells cell maintenance fluid preservation, i.e., red blood cells of mimetics; production method (2) leukocytes and platelets mimetics as follows: D) were collected erythrocytes approximate human white blood cells of blood magnocellars animal erythrocytes approximation animal human blood leukocytes minicell erythrocytes and blood platelets in human blood is approximately the size of the blood of the animal, in the simultaneously acquired anticoagulants; E) above the collected blood were cured, concrete curing operation is: blood will be collected by centrifugation, collected at the bottom erythrocytes, was added 2~8% (v / v) formaldehyde curing 12~72h; F) above, respectively, after three curing blood 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 OK curing agent removal step, the removal of the specific operation of the blood was centrifuged curing agent is cured, removing the supernatant, the cells retain the saline washed cells were washed added bovine serum albumin, allowed to stand 20~24h, centrifugation isolated cell bottom; the above-described isolated human white blood cell large cell similar animal red blood cell preservative solution was placed in storage, i.e., to obtain white blood cell large mimetic; similar to the above-described isolated human blood leukocytes small animal cell red blood cell preservative solution was placed in storage, i.e., to obtain small white blood cell mimetic; the animal isolated human platelets similar to the cell maintenance was placed erythrocytes stored, i.e., to obtain platelet mimetics; G) are analog adjustment RBC and platelet concentration mimetics can be used as single quality control material used, or the mixed leukocyte white blood cell large cell and small cell mimetic mimetic mimetic leukocyte obtained as a single control material used; or the erythrocyte mimetic , white blood cell large mimetic, small white blood cell and platelet mimetics mimetic 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。 Cooperation purified using whole blood control; the osmotic cell preservative solution preparation method, mentioned are 300 ± 20m0sm / kg, pH value 7.3 ± 0 1, consisting of: antibiotic 0.4~2g / L. , polysaccharides 0 • 1~20g / L, bovine serum albumin 20~50g / L, NaCl 0 • 1~10g / L, sodium citrate 0 • 1~20g / L citric acid and 0 • 001~5g / L ; wherein step D), the white blood cell erythrocytes approximate human animal cells are large geese, geese, turtles, ostrich or snake; approximate the human blood leukocytes erythrocytes small animal cells are cats, dogs, rabbits, monkey, cow, chicken or duck; the erythrocytes of human blood platelets approximate size animal is a cat, horse, cow, sheep or camels.
  2. 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 prepared by the method of biosafety control material, wherein: step A), the red blood cell is approximately the size of the animal is human erythrocytes cats, dogs, pigs, rabbits , monkey, cow, chicken or duck.
  3. 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。 The blood test apparatus according to claim 1 prepared by the method of biosafety control material, wherein: step E), the amount of formaldehyde was added to the collected red blood cell volume ratio of 40: 1~1: 1.
  4. 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。 The blood test apparatus according to claim 1 prepared by the method of biosafety control material, wherein: the cell maintenance fluid is selected from any one antibiotic penicillins, aminoglycosides and lactams or a combination of two or more.
  5. 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。 The blood test apparatus according to claim 1 prepared by the method of biosafety control material, wherein: the cell maintenance fluid polysaccharide selected from sucrose, glucose, fructose, galactose, lactose, maltose, starch and a combination of any of a dextrin or two or more.
  6. 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. Preparation process according to any of the quality control 1 ~ 5 was obtained according to the claims.
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