下载文档原格式
HIGH SENSITIVITY CRP CALIBRATOR SERIES(hsCRP CAL)(HIGH SENSITIVITY CRP CALIBRANT)CAT. NO. CP 2478SIZE: 6 x 2 mlINTENDED USEThis product is intended for in vitro diagnostic use in the calibration of CRP on clinical chemistry systems.SAFETY PRECAUTIONS AND WARNINGSThe calibrator contains human CRP in a stabilised protein matrix. Human source material from which the product has been derivedhas been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibody, HBV DNA, HCV RNA and HIV DNA and found to be NON-REACTIVE. FDA approved methodshave been used to conduct these tests.However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samplesshould be handled as though capable of transmitting infectious diseases and disposed of accordingly.For in vitro diagnostic use only, do not pipette by mouth, exercise the normal precautions required for handling laboratory reagents.This material contains Sodium Azide. Avoid ingestion or contact with skin or mucous membranes. In case of skin contact, flushaffected area with copious amounts of water. In case of contact with eyes or if ingested, seek immediate medical attention.Sodium Azide reacts with lead and copper plumbing, to form potentially explosive azides. When disposing of such reagents flush withlarge volumes of water to prevent azide build up. Exposed metal surfaces should be cleaned with 10% sodium hydroxide.Dispose of this material according to local regulations.STORAGE AND STABILITYThe CRP calibrators are supplied ready for use and are stable up to the expiry date when capped and stored at +2°C to +8°C in the absence of contamination. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial.MATERIALS PROVIDEDCRP CalibratorsLevel 1 (1 x 2 ml) Level 4 (1 x 2 ml)Level 2 (1 x 2 ml) Level 5 (1 x 2 ml)Level 3 (1 x 2 ml) Level 6 (1 x 2 ml)MATERIALS REQUIRED BUT NOT PROVIDEDNoneVALUE ASSIGNMENTCalibration of CRP Calibrators has been preformed at Randox by latex-enhanced immunoturbidimetry with reference to material standardised against an appropriate International Reference Preparation. The assigned values for the batch are listed below.LOT NO. CRP (mg/l) CRP (mg/dl) EXPIRY DATE1986CP 0.00 0.00 2013-031981CP 0.54 0.054 2013-031982CP 1.07 0.107 2013-031983CP 1.61 0.161 2013-031984CP 5.35 0.535 2013-031985CP 10.69 1.069 2013-0314 Sep ’11 neLOT NOS.1981CP -1986CP THIS PAGE IS INTENTIONALLY BLANK。
0843PAGE 1 OF 24LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 1 (LIQ CHEM ASY PREMIUM PLUS 1)Cat. No . LAL 4213 Lot No . 153UL Size : 12 x 5 ml Expiry : 2015-02INTENDED USEThis product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy.DEVICE DESCRIPTIONThe Liquid Assayed Chemistry Control Premium Plus is supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at all three levels.SAFETY PRECAUTIONS AND WARNINGSFor in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents.Human source material from which this product has been derived has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-REACTIVE. FDA approved methods have been used to conduct these tests.However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.Health and Safety Data Sheets are available on request.STORAGE AND STABILITY OPENED: Store refrigerated (+2ºC to + 8ºC). Thawed serum is stable for 7 days at +2ºC to +8ºC, with the followingexceptions: Troponin T is stable for 3 days at +2ºC to +8ºC. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial.UNOPENED: Store frozen at -20ºC to -70ºC. Stable to expiration date printed on individual vials (see Limitations).LIMITATIONSFor Total Acid Phosphatase, the material should be stabilised by adding 1 drop (25 µl – 30 µl) of 0.7M Acetic acid solution to 1ml of the serum after thawing. After stabilisation, Total Acid Phosphatase is stable for 7 days at +2ºC to +8ºC. Bilirubin in the serum is light sensitive and it is recommended that the serum is stored in the dark.ALT, Total Acid Phosphatase, Alkaline Phosphatase, Total and Direct Bilirubin values may gradually decrease during the products shelf life.Bacterial contamination of the thawed serum will cause reductions in the stability of many components. The control should not be used as a calibration material.PREPARATION1. Allow the frozen control to thaw at room temperature (+15ºC to +25ºC) until completely thawed. Swirl the contents to ensurehomogeneity.2. Refer to the Control section of the individual analyser application.3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.MATERIALS PROVIDEDLiquid Assayed Chemistry Control Premium Plus - Level 1 12 x 5 mlMATERIALS REQUIRED BUT NOT PROVIDED NoneASSIGNED VALUESEach lot of serum is submitted to a number of external laboratories. Values are assigned from a consensus of results obtained by these laboratories and internal testing conducted at Randox Laboratories Ltd. With each batch, a control range is provided for individual parameters and each parameter method.If an instrument specific value is not available, refer to the Mean of all Instruments section. If necessary, contact Randox Laboratories – Customer Technical Services, Northern Ireland, Tel: +44 (0) 28 9445 1070 or email Technical.Services@29 Nov 13 rwPage 2 of 2429/11/2013___________________________________________________________________________________________________RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912Email: applications@ Website: Page 3 of 24 29/11/2013___________________________________________________________________________________________________RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912Email: applications@ Website: Page 4 of 24 29/11/2013___________________________________________________________________________________________________RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912Email: applications@ Website: Page 5 of 2429/11/2013___________________________________________________________________________________________________RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912Email: applications@ Website: Page 6 of 2429/11/2013___________________________________________________________________________________________________RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912Email: applications@ Website: Page 7 of 2429/11/2013___________________________________________________________________________________________________RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912Email: applications@ Website: Page 8 of 2429/11/2013___________________________________________________________________________________________________RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912Email: applications@ Website: Page 9 of 2429/11/2013___________________________________________________________________________________________________RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912Email: applications@ Website: Page 10 of 2429/11/2013___________________________________________________________________________________________________RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QYTel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912Email: applications@ Website: Page 11 of 2429/11/2013___________________________________________________________________________________________________Page 12 of 2429/11/2013___________________________________________________________________________________________________Page 13 of 2429/11/2013___________________________________________________________________________________________________Page 14 of 2429/11/2013___________________________________________________________________________________________________Page 15 of 2429/11/2013___________________________________________________________________________________________________Page 16 of 2429/11/2013___________________________________________________________________________________________________Page 17 of 2429/11/2013___________________________________________________________________________________________________Page 18 of 2429/11/2013___________________________________________________________________________________________________Page 19 of 2429/11/2013___________________________________________________________________________________________________Page 20 of 2429/11/2013___________________________________________________________________________________________________Page 21 of 2429/11/2013___________________________________________________________________________________________________Page 22 of 2429/11/2013___________________________________________________________________________________________________Page 23 of 2429/11/2013___________________________________________________________________________________________________Page 24 of 2429/11/2013___________________________________________________________________________________________________。
氨/乙醇质控水平1 : 包装规格 6 x 2 ml : 分类。
编号 EA1366氨/乙醇质控水平2 : 包装规格 6 x 2 ml : 分类。
编号 EA1367氨/乙醇质控水平3 : 包装规格 6 x 2 ml : 分类。
编号 EA1368水平分析物 1 2 3 单位氨 6.9 187 372 μmol/l乙醇0.55 1.55 2.73 g/l高值胆红素质控特征•l 总胆红素靶值接近290 μmol/l•用于监测儿科医学的胆红素水平•冻干品，稳定性强。
•牛基质•根据不同方法提供靶值和范围稳定性•未复溶+2 - 8°C 可稳定至有效期末•复溶后+2 - 8°C可稳定5天特征产品说明高值胆红素质控品 : 包装规格 10 x 3 ml : 分类。
货号BE454甘油质控品特征•冻干品，稳定性强•人基质产品稳定性•未复溶+2 - 8°C可稳定至有效期末•复溶后25°C时可稳定8小时，+2 - 8°C 可稳定7天，-20°C可稳定1个月产品说明甘油质控水平1 : 包装规格 3 x 5 ml : 分类。
货号 .GY1369葡萄糖-6-磷酸脱氢酶质控品特征•冻干品，稳定性强•人基质全血稳定性•+2 - 8°C 可稳定至有效期末•复溶后+2 - 8°C 可稳定5天产品说明葡萄糖-6-磷酸脱氢酶低含量质控品 : 包装规格 6 x 0.5 ml : 分类。
货号 .PD2617 葡萄糖-6-磷酸脱氢酶正常值质控品 : 包装规格 6 x 0.5 ml : 分类。
货号 .PD2618 脑脊液质控特征•包含10个分析物•冻干品，稳定性强•100%全人基质无动物添加成分•适用于大多数的临床分析仪•为常用仪器和方法提供靶值和参考范围稳定性•+2 - 8°C 稳定至有效期末•复溶后在+2 - 8°C可稳定5天，-20°C可稳定1个月。
R A N D X尿液生化多项检测用质控品货号: AU2352 包装: 12 x 10 ml批号: 792UC 效期: 2019-03产品用途该质控品用于临床生化体外诊断中尿液检测分析的质量控制。
产品描述朗道供应两种浓度水平的尿液生化多项检测用质控品（水平2：AU2352；水平3：AU2353）。
为以下分析项目提供了两个水平的靶值和范围：淀粉酶、钙、氯、铜、皮质醇（氢化可的松）、肌酐、多巴胺、肾上腺素、血糖、5-羟吲哚乙酸（5-HIAA）、镁、变肾上腺素、微量白蛋白、去甲肾上腺素、去甲变肾上腺素、同渗重摩、草酸盐、无机磷、钾、总蛋白、钠、尿素、尿酸和香草扁桃酸（VMA）。
安全预防措施和警告本产品仅用于体外诊断。
禁止用口吸，按照实验室常规预防措施对试剂进行处理。
该质控品采用人源性成分，对所有人源性成分均进行了HIV（HIV1、HIV2）抗体、肝炎B表面抗原（HbsAg）和肝炎C病毒（HCV）抗体的测试，发现均呈阴性。
所采用的方法均经FDA认证。
但既然没有一种方法能够完全保证其没有传染物质，因此该质控品和所有的病人样品均应当按照能够传播疾病的样品小心处理。
保存和稳定性开瓶后，2～8℃保存。
复溶后若原瓶，并且无污染，可在15～25℃稳定8小时，可在2～8℃稳定5天，可在-20℃稳定14天。
每次使用只吸取所需用量，剩余的样品不可返回原瓶。
儿茶酚胺、VMA、草酸盐的样品制备及稳定性：这些分析物在尿液样本中不稳定，完全复溶后15分钟，取一定量，按每1 mL加入8 μL HCl (6 M)，2～8℃可稳定5天。
对草酸盐的测试，建议每10 mL尿液中加入5 mg EDTA，以此阻止形成草酸钙沉淀。
5-羟基吲哚乙酸（5-HIAA）的样品制备及稳定性：该分析物在尿液样本中不稳定，完全复溶后15分钟，取一定量，按每1 mL加入10 μL冰醋酸（17.4 M），2～8℃可稳定7天。
如使用亚硝基萘酚法，需往每毫升复溶尿液中加入12 μL HCl (6 M)，2～8℃可稳定7天。
$%&quality management solutions 质控管理解决方案Why is it important for laboratories to use 247?--为什么要使用247?Importance for laboratories to use 247使用247的重要性1. Improper Quality Control leads to increased costs in the laboratory-质量控制做的不好会导致实验室成本增加–Due to possible repeated tests-可能导致重复检测–Improper patient treatment because of incorrect test results –因检验结果不准确导致的治疗不当Could be detected using 247 –可通过247发现问题Importance for laboratories to use 247使用247的重要性2. Result Validation-结果的确认–Data being entered can be validated using multi rule QC procedures-可通过多规则质控程序保证结果可靠–The advantages of Multirule QC procedures are that false rejections can be kept low while at the same time maintaining high error detection-使用多规则质控程序的好处在于可降低误拒绝率同时提高错误检出率Importance for laboratories to use 247使用247的重要性3.Turnaround time for reporting test result to clinicians can be reduced–Through minimising false rejections that requires repeat analysis of controls and re-runs of patient samples–误拒绝的结果需进行质控和样本的重新检测，通过最小化这种错误拒绝，可减少向临床报告检验结果的时间Importance for laboratories to use 247 4.Can be used as a trouble-shooting tool–If there are concerns that the controlmaterial is not performing well-如果担心质控物有问题–247 enables the lab to separate the effects of the method from suspected effects ofthe control by looking at the effect of thesame controls in other labs-可通过247观察其他实验室的数据迅速区分是质控物的问题还是分析系统的问题–Leading to more rapid and effectiveproblem solving –更加快速有效的解决问题Importance for laboratories to use 247 5. 247 provides means and SD’s for the material that are relevant because they reflect current testing conditions among labs 247软件可以提供相关质控物的均值和SD范围，反映实验室间的检测情况Importance for laboratories to use 247 6. Many managers ‘sign off’on the results without really investigating if those results are in fact accurate–247 provides an easy and fast way for laboratory managers to be confident that the results theysign for are correct.–实验室管理者在检验报告单上签字时往往并没有去考察结果是否可靠。
丙氨酸氨基转移酶测定试剂（ALT）（酶法）1. 检测原理本试剂采用国际临床化学联合会（IFCC）推荐方法：丙氨酸+α-酮戊二酸−−→−ALT丙酮酸+L-谷氨酸丙酮酸+NADH+H+−−→−LDH L-乳酸+NAD++H2ONADH氧化成NAD+引起340nm处吸光度的下降，下降速率与样品中ALT活性成正比。
2．标本采集与处理2.1 受检者的准备：病人空腹12h，不饮酒24h后采集血样。
体检对象抽血前应有两周的的正常状况记录。
注意有无应用影响测试项目的药物。
此外，对于体检者，采血的季节都应做相关记录，因为样本中各项目的含量有季节性变动，为了前后比较应在每年同一季节检验。
应嘱体检对象在抽血前24小时内不做剧烈运动。
2.2 静脉采血：除非是卧床的病人，一般在采血时取坐位。
体位影响水分在血管内外的分布，会影响测试项目的浓度。
在采血前至少应静坐5分钟，一般从肘静脉取血，使用止血带的时间不超过1分钟，穿刺成功后立即松开止血带。
2.3 抗凝剂：血浆使用肝素或EDTA（1mg/mL）作为抗凝剂2.4 标本的处理和储存：1血标本室温放置30min～45min后离心分离血清，置洁净试管加盖低温保存。
2标本在2-8℃可稳定3天，避免溶血。
3．试剂3.1 试剂及配套品：3.1.1试剂：本科使用重庆中元生物技术有限公司ALT试剂盒，为液体双试剂，各组分如下：试剂R1：Tris缓冲液NADH 100mmol/L 0.3mmol/L试剂R2：Tris缓冲液100mmol/Lα-酮戊二酸85mmol/LL-丙氨酸 800mmol/LLDH ≥8.5kU/L不同批号试剂盒中各组份不能互换。
3.1.2配套品：无配套品。
3.2 试剂的稳定性：1.原包装试剂储存在2-8℃至标签所示失效日期。
试剂的有效期为12个月。
2.试剂开瓶后，在仪器中至少可保存30天4：校准4.1校准血清：朗道复合校准品4.2校准方式：使用去离子水与校准血清两点定标。
CALIBRATION SERUM LEVEL 2 (CAL 2)20 x 5mlCAT. NO. CAL 2350 SIZE:2014-01LOT NO. 746UN EXP:INTENDED USEFor use as a Calibrator in clinical chemistry assays. RANDOX Calibration Sera are based on lyophilised human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays on a wide range of automatic analysers. Constituent concentrations are available at 2 levels.SAFETY PRECAUTIONS AND WARNINGSHuman source material from which this product has been derived has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-REACTIVE. FDA approved methods have been used to conduct these tests. However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.For IN VITRO diagnostic use only.STORAGE AND STABILITYUnreconstituted serum is stable up to the expiry date shown on the side of each individual bottle. Once reconstituted, the components of the Calibration Sera are stable for 8 hours at +25°C, 7 days at +2°C to +8°C and 1 month at -20°C when frozen once (see limitations).PREPARATION FOR USESerum must only be reconstituted using the following procedure:1. Open the vial carefully, avoiding any loss of material.2. Reconstitute by pipetting exactly 5ml of distilled water at +20°C to +25°C, into the vial.3. Replace the rubber stopper and leave to stand for 30 minutes out of bright light before use.4. Swirl gently several times during the reconstitution period to ensure that the contents are completely dissolved.5. Prior to use, mix the contents by inverting the vial. Do not shake the vial as the formation of foam should be avoided. Ensure that no lyophilised material remains unreconstituted.6. The serum is then ready for use with either a manual test or with an automated instrument.MATERIALS PROVIDEDCalibration Serum - Level 2Cat No. CAL2350 20 x 5mlMATERIALS REQUIRED BUT NOT PROVIDEDCalibrated Pipette, double deionised water.LIMITATIONSAfter reconstitution, Bicarbonate is stable for 8 hours in the closed bottle and 1 hour in the open bottle.For Total and Prostatic Acid Phosphatase, the material should be stabilised by adding 1 drop (25H l - 30H l) of 0.7M Acetic acid solution to 1ml of the serum exactly 30 minutes after reconstitution. After stabilisation, Total & Prostatic Acid Phosphatase are stable for 2 hours at +25°C, 2 days at +2°C to +8°C and 1 month when frozen once at -20°C. Alkaline Phosphatase levels in the reconstituted serum will rise over the stability period. It is recommended that the reconstituted serum be allowed to stand for 1 hour at +25°C before measurement.Bilirubin in the serum is light sensitive and it is recommended that the serum be stored in the dark. Stored in the dark it is stable for 1 day at +2°C to +8°C. Do not store at +15°C to +25°C. Do not freeze.Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. Different lot numbers of this calibrator should not be interchanged as the values assigned to the calibrators vary from lot to lot.LOT NO. 746UNVALUE ASSIGNMENTEach batch of serum is distributed to approximately 3000 laboratories worldwide and values are assigned by a consensusof results obtained by these laboratories. The Calibration values for each instrument have been determined in at least 10 independent laboratories. Values are verified against a master lot of calibrator which is traceable to reference methods or reference materials. In some cases values may be assigned at Randox Laboratories in comparison to a master lot ofcalibrator which is traceable to reference methods or reference materials.If an instrument specific value is not available, refer to the Mean of all Instruments section. If necessary contact Randox Laboratories - Technical Support, Northern Ireland, tel: (028) 9442 2413 or email Technical.Support@NOTES ® All trademarks recognised.(1) Values established by reference laboratories officially recognised by the Federal Chamber of Physicians inGermany.(2) DGKC : German Society for Clinical Chemistry(3) IFCC : International Federation of Clinical Chemistry(4) SCE : Scandinavian Committee on Enzymes14 Nov ’11 nePage 1 of 3Page 2 of 3Page 3 of 3Page 1 of 2Page 2 of 2Page 1 of 1Page 1 of 3Page 2 of 3Page 3 of 3Page 1 of 3Page 2 of 3Page 3 of 3Page 1 of 1Page 1 of 1Page 1 of 3Page 2 of 3Page 3 of 3Page 1 of 4Page 2 of 4Page 3 of 4Page 4 of 4Page 1 of 2Page 2 of 2Page 1 of 2Page 2 of 2Page 1 of 7Page 2 of 7Page 3 of 7Page 4 of 7Page 5 of 7Page 6 of 7Page 7 of 7Page 1 of 1Page 1 of 1Page 1 of 3Page 2 of 3Page 3 of 3Page 1 of 2Page 2 of 2Page 1 of 3Page 2 of 3Page 3 of 3Page 1 of 1Page 1 of 1Page 1 of 2Page 2 of 2Page 1 of 2Page 2 of 2。
氨/乙醇质控水平1 : 包装规格 6 x 2 ml : 分类。
编号 EA1366氨/乙醇质控水平2 : 包装规格 6 x 2 ml : 分类。
编号 EA1367氨/乙醇质控水平3 : 包装规格 6 x 2 ml : 分类。
编号 EA1368水平分析物 1 2 3 单位氨 6.9 187 372 μmol/l乙醇0.55 1.55 2.73 g/l高值胆红素质控特征•l 总胆红素靶值接近290 μmol/l•用于监测儿科医学的胆红素水平•冻干品，稳定性强。
•牛基质•根据不同方法提供靶值和范围稳定性•未复溶+2 - 8°C 可稳定至有效期末•复溶后+2 - 8°C可稳定5天特征产品说明高值胆红素质控品 : 包装规格 10 x 3 ml : 分类。
货号BE454甘油质控品特征•冻干品，稳定性强•人基质产品稳定性•未复溶+2 - 8°C可稳定至有效期末•复溶后25°C时可稳定8小时，+2 - 8°C 可稳定7天，-20°C可稳定1个月产品说明甘油质控水平1 : 包装规格 3 x 5 ml : 分类。
货号 .GY1369葡萄糖-6-磷酸脱氢酶质控品特征•冻干品，稳定性强•人基质全血稳定性•+2 - 8°C 可稳定至有效期末•复溶后+2 - 8°C 可稳定5天产品说明葡萄糖-6-磷酸脱氢酶低含量质控品 : 包装规格 6 x 0.5 ml : 分类。
货号 .PD2617 葡萄糖-6-磷酸脱氢酶正常值质控品 : 包装规格 6 x 0.5 ml : 分类。
货号 .PD2618 脑脊液质控特征•包含10个分析物•冻干品，稳定性强•100%全人基质无动物添加成分•适用于大多数的临床分析仪•为常用仪器和方法提供靶值和参考范围稳定性•+2 - 8°C 稳定至有效期末•复溶后在+2 - 8°C可稳定5天，-20°C可稳定1个月。
分析用人基质质控血清水平II货号：HN1530 批号：944UN 包装：20×5ml 效期：06/2018准确量取5ml蒸馏水，小心复溶一瓶冻干质控血清。
注释：：注册商标(1). 只适用于德国。
根据德国内科医生联邦议院的方针制订范围(中文说明已略，如需请另行参见英文说明)。
(2). 德国内科医生联邦议院官方认可的参考实验室测定的浓度值。
(3). DGKC：德国临床化学协会(4). IFCC：国际临床化学联盟(5). SCE：斯堪的纳维亚酶委员会使用说明朗道的人基质质控血清为冻干品，用于临床准确性或者重复性质量控制。
朗道供应2种水平的质控血清。
赋值每一批质控血清都要送到参考实验室，根据国际参考标准进行赋值。
若没有国际参考标准，就使用参考方法。
朗道也将质控血清送到全世界3000多家实验室，然后将结果用独特的统计分析赋值。
各个批号的每个分析物，每个方法学都会提供一个质控范围，质控范围值是平均值±2S.D.。
该结果非常准确可靠，实验室尽可放心使用。
准备1. 小心打开瓶盖，避免内容物的任何损失。
2. 在15-25℃的室温下，准确量取5ml蒸馏水复溶1瓶质控血清。
3. 盖上橡皮塞，拧紧瓶盖，使用前避光放置30分钟。
4. 轻轻旋转，确保内容物完全溶解。
勿摇晃，避免形成泡沫。
5. 将小瓶倒置，确保所有的冻干物完全溶解。
复溶后的血清既可以用于手工测试，也可以用于全自动生化分析仪。
该血清只能按照上述步骤复溶。
稳定性该血清自生产之日起，在2-8℃下保存可以稳定4年。
效期标在试剂盒的侧面。
该血清一旦复溶，在15-25℃下可以稳定8小时，在2-8℃下可以稳定7天，在-20℃下稳定28天（只能冻融一次）（见受限情况）。
受限情况1、为保证总酸性磷酸酶和前列腺酸性磷酸酶的稳定性，复溶30分钟后，该血清每1ml应当加入1滴（25-30μl）0.7M的醋酸溶液。
其稳定作用可以使总酸性磷酸酶和前列腺酸性磷酸酶在15-25℃下稳定2小时，在2℃-8℃下稳定2天，在-20℃下稳定28天（只能冻融1次）。
