朗道--质控管理解决方案
朗道多项生化定值质控

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___________________________________________________________________________________________________。
室内质控实用操作

检验中心室内质控基本操作文件支持:1、《全国临床检验操作规程》(第三版、第四版)2、《临床检验定量测定室内质量控制》(国标WS/T641-2018)3、《深圳市非公立医院临床检验质量评估标准》(2018)一、质控品的选择:(1)国家卫健部门临检中心推荐的市售商品,如朗道和伯乐(生化、免疫),康彻思坦(酶免),四川新成(血球),上海伊华(尿液),西门子(血凝)等;(2)仪器或试剂厂家提供的专用质控品,必须有批准文号;(3)没有现成质控品的项目,实验室可制作质控品,但操作要求较高,不推荐。
我们一般使用前两种质控品。
二、质控频率:(1)实验室所有测试项目必须有室内质控(可采用不同方式,但必须有质控行为),要求100%;(2)质控随当日标本测试进行,无标本测试可不做质控;(3)所有结果必须在质控正常情况下发出。
三、质控方式:(1)常用方法是检测质控品并绘图分析;(2)金标快检项目,以质控带的显示为质控正常,并记录;(3)镜检项目,以2人以上对同一标本的观察结果比较为质控方式,并记录;(4)新开项目无正式质控品的,可采用不同仪器不同实验室间定期结果对比方式,并记录。
等等。
质控方式可不同,但一定要达到质控目的,就是做到对结果准确性心中有底,有可溯源性。
四、质控品位置:(1)质控测试在样本测试前做,其结果只能说明仪器开机后的状态;(2)在样本测试中做质控,能有效检出随机误差和监测结果漂移;(3)非连续测试,在样本测试结束前质控能检出结果偏倚。
检验中心标本是集中连续测试,且时间持续短(<24h),可在标本检测前质控,但最好是随标本测试进行,但无论任何情况下,都要在结果报告前分析评价质控。
五、质控次数:检验中心标本集中测试,批次时间较短(<24h),每天只做1次质控即可。
六、质控方法:我们采用“多规则质控法”(westgard)。
七、质控浓度水平选择:按规范要求三级医院要选用2个以上浓度水平,其他医疗机构选1个(以上)即可,检验中心生化仪一台主机可选用2个浓度水平质控,其余仪器均采用1个浓度(北京总部批准)。
朗道血凝质控说明书

PAGE 1OF 7COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)Cat No. CG5022 Lot No. 138CG Size: 12 x 1ml Expiry: 2014-07INTENDED USEThis product is intended for in vitro diagnostic use and in the quality control of coagulation systems. The Coagulation Controls are for the control of accuracy and precision.DEVICE DESCRIPTIONThe Coagulation Controls are supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the analytes listed in the values section.SAFETY PRECAUTIONS AND WARNINGSThe controls are intended for in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents and controls.Human source material which has been added 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 was 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 STABILITYOPENED: Store refrigerated (+2°C to +8°C). APTT, TT, PT, Fibrinogen and Antithrombin III in reconstituted serum are stable for 24 hours at +2°C to +8°C if kept capped in original container and free from contamination. Protein C, Protein S, Plasminogen, and Factors II, V, VII, VIII, IX, X, XI, XII are stable for 8 hours at +2°C to +8°C. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial.UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.PREPARATION FOR USEThe Coagulation Controls are supplied lyophilised.1. Carefully reconstitute each vial of lyophilised control with exactly 1ml of distilled water at +15°C to +25°C. Closethe bottle and allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid the formation of foam. Do not shake the vial.2. Refer to the Control section of the individual analyser application.3. Refrigerate any unused material. Prior to reuse, mix the contents of the vial thoroughly.MATERIALS PROVIDEDCoagulation Control - Level 2 12 x 1mlMATERIALS REQUIRED BUT NOT PROVIDED Volumetric pipette Distilled waterASSIGNED VALUESEach batch of Coagulation Control 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. The expected range of the mean is provided to aid laboratory until it has established its own mean and SD for its test methods.11 May ’12 ne。
朗道质控HN1530717UN

分析用人基质质控血清水平II货号:HN1530 批号:717UN 包装:20×5ml 效期:01/2015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,然后将结果用相同的统计分析赋值。
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20-25℃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。
5. 将小瓶倒置,确保所有的冻干物完全溶解。
6. 勿摇晃小瓶。
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4℃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25℃下可以稳定24小时,在4℃下可以稳定7天,在-20℃至少可以稳定1个月(见受限情况)。
受限情况1、对于总酸性磷酸酶和前列腺酸性磷酸酶及醛缩酶来说,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和酸性磷酸酶在25℃下至少可以稳定2小时,在4℃下至少可以稳定2天,在-20℃下至少可以稳定1个月(只能冻融1次)。
朗道质控

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。
RANDX-朗道质控

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。
英国朗道食品诊断有限公司——提供可靠的食品安全筛查方案

英国朗道食品诊断有限公司——提供可靠的食品安全筛查方案□ Nicola Kane 吴长红 英国朗道实验诊断有限公司ANAlySIS & TEST分析与检测英国朗道食品诊断有限公司是英国朗道实验诊断有限公司的全资子公司,在诊断市场有30年丰富经验和一个专业研发小组。
朗道食品诊断有限公司是一个专门负责在全世界范围内分销朗道药物残留检验试剂盒、葡萄酒检验试剂盒和分析仪的公司。
英国朗道采用内部研发的抗体和抗原,拥有一系列食品安全检测产品,为食品中抗生素、生长促进激素和滥用药物的检测提供一整套卓越的筛查方案,且所有的检测平台提供极低的检测限和简单的样本制备方法。
英国朗道食品诊断公司产品组合包括27种ELISA试剂盒和7个多分析物筛查组合。
所有产品都产自英国最先进的经ISO 13485认证的制造厂商。
生物芯片概念生物芯片(9mm×9mm)是一个可化学性激活的固相基质,在生物芯片上生物分子精确地分配、固定和稳定于产生试验点微阵列的预定义位置。
这个生物芯片平台可用于完成免疫学反应。
载体上生物芯片开封即用,每个载体有3×3个生物芯片,相当于9个反应器。
生物芯片阵列技术为了实行有效的食品检验方法,满足法律要求,工业部门和研究实验室需要能快速和准确检测药物残留的筛查方法。
朗道食品诊断有限公司利用生物芯片阵列技术提供世界上唯一的多分析物半定量药物残留分析仪,即EvidenceInvestigator。
生物芯片阵列技术是在单一生物芯片上整合一组相关测试项目和单套试剂,提供了一个能从单一完整样本中同时测定多个分析物的平台。
它使用微型化试验程序,对减少样本、试剂消耗和实验成本具有很大意义。
该技术以夹心和竞争性免疫测定法的酶联免疫学原理为基础。
多特异性配体(抗体或抗原)连接在生物芯片表面的预定义离散测试区。
样本中的分析物引起HRP(辣根过氧化物酶)标记的轭合物结合,信号试剂的添加导致光信号产生。
运用生物芯片阵列技术的条件试剂盒提供的检验特定试剂和制备好的样本加入到生物芯片表面。
生化类体外诊断试剂开瓶稳定性研究

生化类体外诊断试剂开瓶稳定性研究摘要】分析生化类体外诊断试剂的开瓶稳定性。
方法:以朗道质控品为检测样本,利用全自动生化分析仪对总蛋白试剂盒、丙氨酸氨基转移酶检验试剂盒和肌酐检测试剂盒进行检测,分析开瓶时间对检测结果的影响。
结果:在开瓶时间不断增加的情况下,总蛋白(TP)、肌酐(Cre)与谷丙转氨酶(ALT)的误差指标的相对偏差均呈现出上升趋势。
结论:不同类型的生化类体外诊断试剂的开瓶稳定性存在差异。
生化类体外诊断试剂开瓶以后需要尽快使用,在每次检测实施前都需要重新校准。
【关键词】生化类体外诊断试剂;总蛋白;肌酐;谷丙转氨酶随着临床检验技术的不断发展,生化试剂在临床检验领域的作用日渐突出。
医疗设备产业的发展进步,让生化试剂的产品类型呈现出了多样化的特点[1]。
受生产规模、技术水平及产品质量等因素的影响,来自不同厂家的生化类体外试剂的产品质量存在一定的差异[2]。
在临床检验领域,生化试剂中的部分组分在受热、受潮及受光以后出现的分解、失活现象也会给临床诊断结果的准确性带来不利的影响。
受业务量的影响,一些医院在试剂开瓶以后,往往需要利用很长的时间消耗试剂,试剂开瓶后放置时间对临床诊断结果的影响是一些研究者所关注的内容。
本次研究旨在分析生化类体外诊断试剂的开瓶稳定性。
1.资料及方法1.1一般资料本次研究以朗道质控品为检测样本,利用全自动生化分析仪开展开瓶稳定性实验,对总蛋白试剂盒、丙氨酸氨基转移酶检验试剂盒和肌酐检测试剂盒进行检测。
应用于本次研究的朗道质控品中包含有TP、Cre与ALT等物质,参考值分别为45.0g/L、138U/L与366μmol/L。
总蛋白试剂盒的组成成分以硫酸铜、铝氧化钠、酒石酸钾钠与碘化钾为主。
丙氨酸氨基转移酶检测试剂盒中包含有Tris-HCl、L-丙氨酸、α-酮戊二酸、NADH、乙二醇和L-乳酸脱氢酶。
肌酐检测试剂盒的组成成分以苦味酸及氢氧化钠为主。
应用于本次研究的实验设备为DS-800全自动生化分析仪。
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$%&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。
247提供一个快速有效的途径让管理者可以确保结果的准确。
Why is it important to use the right serum controls?-使用正确的质控血清的重要性Importance of right control material Some manufacturer’s controls are advertised as “human serum based”-很多质控品上标注是人血清基质的–These are quite different to fully human-人基质和全人基质是有很大区别的Use of ‘human based’serum withantibody/antigen methodologies can lead to target values shifting between reagent lots–Extra work needed to re-set targets–Extra time and costs-免疫方法学项目的质控使用人基质血清会导致不同批号的试剂间靶值浮动,需要花时间去定值,导致时间和成本的浪费Importance of right control material When used in peer group reporting and EQAthis becomes even more important-在同群组报告和EQA中这一点更加重要Chances are that participants that is comparing to each other are using different reagent batches-很可能参加数据比对者使用的试剂都是不同的,其中的抗体也不一样–Different antibodies in each batchDifferences between participants will be greater-不同参加者差异更大CVs will be higher within Instrument and/or Method groups-同仪器/方法群组中CVs更高Importance of right control material Therefore all RANDOX controls using immunological / immunoassay methods are 100%fully human-RANDOX质控中涉及到免疫学方法的质控物都是100%全人基质的For Example:•Immunoassay-免疫•Specific Protein-特定蛋白•Lipid-血脂•Cardiac-心肌Importance of right control material Our aim is to have much more over our control range working with 247 in the future –我们的目标是拥有更广范围的247配套质控物Chemistry Controls-生化Specific Protein Controls-特定蛋白Immunoassay Controls-免疫TDM Controls-治疗药物Lipid Controls-血脂Cardiac Control-心肌Urine Controls-尿液C.S.F. Controls-脑脊液Cytokine Controls-细胞因子 Single analyte Controls-单个分析物Blood gas Controls-血气Coagulation Controls-血凝Maternal Screening Controls-孕妇筛查Tumour Marker Controls-肿瘤标志物Liquid Cardiac (NT-proBNP & BNP) Controls-液态心肌质控Urinalysis Controls-尿常规Urine Toxicology Controls-尿毒理学质控Range of RANDOX QCNew Developments-新发展New Features in Software-软件的新特点24/7 software is getting a complete new look Including many new features and functions Upgrades to the 24/7 software will come in 3 PhasesPhase 1 almost complete全新的界面,包含很多新的特点和功能,软件升级将分三阶段进行,第一阶段已基本完成Phase 1 New designand coloursPhase 1It will work differently than before Let’s show you some examples: 几个新界面的例子First the Instruments are shownWhen opening it up, the lots used on that instrument is shownAfter that the analytes used in the lot numbers are showedMenus have been replaced with ‘Tabs’ for quicker navigationReports are also easily accessed from the main Data Entry ScreenLevey-Jennings can be viewed with date plotted based on both SD or % DeviationPeer Groups can be changed on the same page as the chart allowing for troubleshootingPop up calendar to change datesPhase 1 When Transferring Data there is now a window to show that the software is exchanging data with host server – This was a comment that came from users in Guangxi This window will change again in the future to show more detail how far along the transfer is – At the moment only showing that transfer is on going传输数据时有一个窗口显示正在进行与主服务器交换数据,这也是一位 来自广西的用户的建议,将来升级到更新的阶段,会显示更详细的传 输进度的信息,现在仅显示正在传输Phase 1 Making the system open so that the user can add parameters, methods, instruments, reagents and units– These added items will not used as part of peer group 系统更加开放,用户可以添加参数,方法学,仪器,试剂和单位等信 息;这些新增数据不会在同群组数据中使用Phase 1Inclusion and display of performance limits –Standard Deviation, % Deviation, BiologicalVariation, CLIA etc...Improve communication to LIS and instruments–On board LIMS integration software包含并显示各评价指标提高LIS系统和仪器的通讯功能-在线的实验室信息系统管理整合软件Phase 2Data Logging–Records when data is entered or removed and by whomData Review option–Ability to review all/suspect data and mark asreviewed数据录入;记录数据何时输入,何时更改,以及是谁更改的,数据查看;查看所有或可疑数据,并做标记Phase 2Information appearing on individual data points when mouse is placed on them–Date, result etc.Multiple levels of controls on one chart overlappingMultiple instruments on one chart to see differences鼠标点在某个数据上,会显示这个数据的相关信息,例如日期,结果 多个水平的质控显示在同一个图表上,多台仪器显示在同一图表以进行对比Phase 2Levey Jennings chart–Ability to scroll through charts back in time-图表可按时间滚动查看,Improve panel setup to make it easierImprove communication to peer group host –To make transferring date quickerData entry to log time of entry改进了组合设置,使其更简易改进了与同组群主机的通讯,使数据传输更快捷根据登陆时间查询数据录入Phase 2Import facility of fixed means for Randox controls-RANDOX质控品固定均值输入更加便捷–Eliminating manual input-取消了手工输入Improve group co-ordinator report-改进同群组报告功能–To display individual lab‘s charts-显示独立实验室图表 Report for poor results only for quick review of performance-不好的结果也可以报告,仅用于快速浏览回顾 Improve searching abilities through statistics 提高统计搜索功能Phase 2Simplify system for setup-简化了系统设置–Selection of Multirules to apply for all assays–Not having to set rules for each one-质控规则的选择应用于所有项目,不需每个项目单独设置Improve network setup installation–To allow for several user computers in the same lab for the same programme-提高网络工作安装功能,允许同实验室的几台电脑都可以操作这个程序Improve data entry screen with colour coding system–Red, Yellow or Green showing performance使色彩编码改进数据输入界面–红, 黄或绿色显示Phase 3Provide ability to archive expired lots and associated QC test results/stats-可存档过期批号的质控结果和统计数据–Easy access to relevant and up-to-date data-更易于查询相关和更新的数据Ability to free type in comments section –Instead of numbers-自由添加备注的功能,取代数字编号的备注Ability to add comments on manually un-rejected results-可对手工接受的结果进行备注Additional PhasesWeb based software?-基于WEB的软件–No installation required-无需安装247软件Continuing to improve the functions of the software and benefits to our customers-将根据用户的需求不断改进以帮助用户解决更多问题SummaryRANDOX always listen to our customers-倾听用户的声音 This is very clear in these changes we have made and the changes we have planned–They are all comments from our customers-这在我们已经做的和正在计划进行的改进中都可以清楚的看到。