罗氏 cobas 6000 生化免疫分析仪简易操作手册
罗氏 cobas e 801 电化学发光免疫分析仪使用说明书 - 检测抗 HBs 抗体的试剂盒
Elecsys Anti-HBs IIREFSYSTEM********************** 300cobas e 801EnglishSystem information Short name ACN (application code number) AHBS 2 10138 Immunoassay for the in vitro quantitative determination of human antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma.Anti-HBs assays are used within the scope of hepatitis B vaccination to check the necessity and success of vaccination. In addition, anti-HBs assays are used to monitor the course of disease following acute hepatitis B infection. This test is not intended for diagnosis.The e lectro c hemi l uminescence i mmuno a ssay “ECLIA” is intended for use on the cobas e 801 immunoassay analyzer.Note: Please note that the catalogue number appearing on the package insert retains only the first 8 digits of the licensed 11-digit Catalogue Number: 07026854190 for the Elecsys Anti-HBs II assay. The last 3 digits -190 have been replaced by -119 for logistic purposes. SummaryAnti-HBs is a specific (generally IgG) antibody that is directed against the hepatitis B surface antigen (HBsAg).1,2 Anti ‑HBs can be detected several weeks after the disappearance of hepatitis B surface antigen.3,4 Anti ‑HBs can be formed following a hepatitis B infection or after hepatitis Bvaccination.3,4 Antibodies are formed against the HBsAg determinant a, which is common to all subtypes, and against subtype-specific determinants.1,5,6Anti ‑HBs assays are used within the scope of hepatitis B vaccination to check the necessity and success of vaccination.2,4,7 In addition, anti ‑HBs assays are used to monitor the course of disease following acute hepatitis B infection.3The Elecsys Anti ‑HBs II assay uses a mixture of purified antigens fromhuman serum (HBsAg subtype ad), and recombinant HBsAg subtype ay from CHO (Chinese Hamster Ovary) cells. Test principleSandwich principle. Total duration of assay: 18 minutes.▪ 1st incubation: Anti ‑HBs in the sample (24 μL), biotinylated HBsAg(ad/ay), and HBsAg (ad/ay) labeled with a ruthenium complex a) react to form a sandwich complex.▪ 2nd incubation: After addition of streptavidin-coated microparticles, thecomplex becomes bound to the solid phase via interaction of biotin and streptavidin.▪ The reaction mixture is aspirated into the measuring cell where themicroparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.▪ Results are determined via a calibration curve which is instrument-specifically generated by 2‑point calibration and a master curve provided via the cobas link.a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)32+)Reagents – working solutionsThe cobas e pack (M, R1, R2) is labeled as AHBS 2. M Streptavidin-coated microparticles, 1 bottle, 13.2 mL:Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 HBsAg~biotin, 1 bottle, 16.7 mL:Biotinylated HBsAg (ad/ay) human/recombinant, > 0.5 mg/L; MES b) buffer 85 mmol/L, pH 6.5; preservative. R2 HBsAg~Ru(bpy)32+, 1 bottle, 15.8 mL:HBsAg (ad/ay) human/recombinant, labeled with ruthenium complex > 0.3 mg/L; MES buffer 85 mmol/L, pH 6.5; preservative.b) MES = 2-morpholino-ethane sulfonic acidAHBS 2 Cal1 Calibrator 1, 1 bottle of 1.3 mL:Anti ‑HBs (human) in human serum; preservative.AHBS 2 Cal2 Calibrator 2, 1 bottle of 1.3 mL:Anti ‑HBs (human) in human serum; preservative.Precautions and warnings For in vitro diagnostic use.Exercise the normal precautions required for handling all laboratory reagents. Disposal of all waste material should be in accordance with local guidelines. Safety data sheet available for professional user on request.This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:n ‑Octyl ‑N,N ‑dimethyl ‑3‑ammonio ‑1‑propanesulfonateEUH 208 May produce an allergic reaction.Product safety labeling primarily follows EU GHS guidance. All human material should be considered potentially infectious.The calibrators (AHBS 2 Cal1 and AHBS 2 Cal2) have been preparedexclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA ‑approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.The HBsAg starting material used was inactivated prior to labeling with biotin or ruthenium by heating to 60 °C for 15 hours. In addition, any virus particles remaining were removed by ultracentrifugation.However, as no inactivation or testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.8,9 Avoid foam formation in all reagents and sample types (specimens, calibrators and controls). Reagent handlingThe reagents (M, R1, R2) in the kit are ready-for-use and are supplied in cobas e packs. CalibratorsThe calibrators are supplied ready ‑for ‑use in bottles compatible with the system.Unless the entire volume is necessary for calibration on the analyzer, transfer aliquots of the ready ‑for ‑use calibrators into empty snap ‑cap bottles (CalSet Vials). Attach the supplied labels to these additional bottles. Store the aliquots at 2‑8 °C for later use.Perform only one calibration procedure per aliquot.All information required for correct operation is available via the cobas link. Storage and stability Store at 2‑8 °C. Do not freeze.Store the cobas e pack upright in order to ensure complete availability of the microparticles during automatic mixing prior to use. Stability of the cobas e pack: unopened at 2‑8 °Cup to the stated expiration date on the cobas e 801 analyzer 16 weeksStability of the calibrators: unopened at 2‑8 °C up to the stated expiration date after opening at 2‑8 °C 16 weeks on the cobas e 801 analyzer at 20‑25 °Cuse only onceadhering to the snap ‑cap.Specimen collection and preparationOnly the specimens listed below were tested and found acceptable.Serum collected using standard sampling tubes or tubes containing separating gel.K2‑EDTA and K3‑EDTA plasma.Criterion: Slope 1.00 ± 0.15 + intercept 0 ± 2 IU/L + bias at 10 IU/L: ≤ 30 %. Stable for 3 days at 20‑25 °C, 6 days at 2‑8 °C, 3 months at ‑20 °C(± 5 °C). The samples may be frozen 5 times.For plasma treated with lithium heparin, lithium heparin with gel or sodium heparin, the values found were on average up to 20 % lower than those obtained in serum. For plasma treated with sodium citrate, the values found were on average up to 30 % lower than those obtained with serum.The sample types listed were tested with a selection of sample collection tubes or systems that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.Centrifuge samples containing precipitates and thawed samples before performing the assay.Do not use heat‑inactivated samples.Do not use samples and controls stabilized with azide.Ensure the samples and calibrators are at 20‑25 °C prior to measurement. Due to possible evaporation effects, samples and calibrators on the analyzers should be analyzed/measured within 2 hours.The performance of the Elecsys Anti‑HBs II assay has not been established with cadaveric samples or body fluids other than serum and plasma. Materials providedSee “Reagents –working solutions” section for reagents.▪ 2 x 6 bottle labelsMaterials required (but not provided)▪REF 11876317122, PreciControl Anti‑HBs, 16 x 1.3 mL▪REF 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles▪REF***********,DiluentUniversal,45.2mLsamplediluent▪▪cobas e 801 analyzerAccessories for the cobas e 801 analyzer:▪REF***********,ProCellIIM,2x2Lsystemsolution▪REF 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning solution ▪REF***********,ReservoirCups,8cupstosupplyProCellIIMand CleanCell M▪REF***********,PreCleanIIM,2x2Lwashsolution▪REF***********,AssayTip/AssayCuptray,6magazinesx6magazine stacks x 105 assay tips and 105 assay cups, 3 wasteliners▪REF***********,LiquidFlowCleaningCup,2adaptorcupstosupply ISE Cleaning Solution/Elecsys SysClean for Liquid Flow CleaningDetection Unit▪REF***********,PreWashLiquidFlowCleaningCup,1adaptorcupto supply ISE Cleaning Solution/Elecsys SysClean for Liquid Flow Cleaning PreWash Unit▪REF 11298500316, ISE Cleaning Solution/Elecsys SysClean,5 x 100 mL system cleaning solutionAssayFor optimum performance of the assay follow the directions given in this document for the analyzer concerned. Refer to the appropriate operator’s manual for analyzer‑specific assay instructions.Resuspension of the microparticles takes place automatically prior to use. Place the cooled (stored at 2‑8 °C) cobas e pack on the reagent manager. Avoid foam formation. The system automatically regulates the temperature of the reagents and the opening/closing of the cobas e pack. Calibrators:Place the calibrators in the sample zone.Read in all the information necessary for calibrating the assay.CalibrationTraceability: This method has been standardized against the 1st WHO Reference Standard 1977.The predefined master curve is adapted to the analyzer using AHBS 2 Cal1 and AHBS 2 Cal2.Calibration frequency: Calibration must be performed once per reagent lot using AHBS 2 Cal1, AHBS 2 Cal2 and fresh reagent (i.e. not more than24 hours since the reagent kit was registered on the analyzer).Renewed calibration is recommended as follows:▪after 12 weeks when using the same reagent lot▪after 28 days when using the same cobas e pack on the analyzer▪as required: e.g. quality control findings with PreciControl Anti‑HBs outside the defined limitsQuality controlFor quality control, use PreciControl Anti‑HBs.Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration.The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.If necessary, repeat the measurement of the samples concerned.Follow the applicable government regulations and local guidelines for quality control.CalculationThe analyzer automatically calculates the analyte concentration of each sample in IU/L.Interpretation of the resultsNumeric result Result message Interpretation< 10 IU/L Non-reactive Negative for anti-HBs≥ 10 IU/L Reactive Positive for anti-HBsvary depending on the testing procedure used. Results obtained from a single sample using tests from different manufacturers can therefore differ by up to a factor of 4 (or even a factor of 10 in rare cases). If there is a change in the assay procedure used during the monitoring of vaccination protection, then the anti‑HBs values obtained upon changing over to the new method must be confirmed by parallel measurements by both methods. Vaccination strategies in certain risk groups are based on the measured anti‑HBs concentration. Respective recommendations are given by national or regional guidelines. Limitations - interferenceThe effect of the following endogenous substances and pharmaceutical compounds on assay performance was tested. Interferences were tested up to the listed concentrations and no impact on results was observed. Endogenous substancesCompound Concentration testedBilirubin ≤ 513 μmol/L or ≤ 30 mg/dL Hemoglobin ≤ 0.621 mmol/L or ≤ 1000 mg/dL Intralipid ≤ 1500 mg/dLBiotin ≤ 41 nmol/L or ≤ 10 ng/mL Rheumatoid factors ≤ 1200 IU/mLAlbumin ≤ 7.0 g/dLIgG ≤ 7.0 g/dLIgA ≤ 1.6 g/dLIgM ≤ 1.0 g/dL2 / 42017-09, V 1.0 Can EnglishCriterion: Recovery for samples from Limit of Detection to 10 IU/L:≤ ± 2 IU/L, and samples > 10 IU/L: ≤ ± 20 % of initial value.Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration.Pharmaceutical substancesIn vitro tests were performed on 16 commonly used pharmaceuticals. No interference with the assay was found.In addition, the following special drugs used in hepatitis B therapy were tested. No interference with the assay was found.Special drugsDrug Concentration testedmg/LPeginterferon alfa‑2a ≤ 0.18Peginterferon alfa‑2b ≤ 1.6Lamivudine ≤ 300Adefovir ≤ 10Entecavir ≤ 10Tenofovir ≤ 600Telbivudine ≤ 245Due to high-dose hook effect c), results from anti‑HBs concentrations of> 200000 IU/L may be found below the upper limit of the measuring range of 1000 IU/L. In rare cases, a high-dose hook effect from anti HBs concentrations of < 20000 IU/L cannot be excluded. Therefore in case of any unexpected low result the sample should be diluted 1:100 (refer to chapter “Dilution”) and tested again.In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur. The test contains additives which minimize these effects.c) High-dose hook effect: A sample with a true concentration clearly above the measuring range, but found within the measuring range.Limits and rangesMeasuring range2‑1000 IU/L (defined by the Limit of Detection and the maximum of the master curve). Values below the Limit of Detection are reported as< 2 IU/L.Values above the measuring range are reported as > 1000 IU/L (or up to 100000 IU/L for 100‑fold diluted samples).DilutionSamples with anti‑HBs concentrations above the measuring range can be diluted with Diluent Universal. The recommended dilution is 1:100 (either automatically by the analyzer or manually). The concentration of the diluted sample must be > 10 IU/L.After manual dilution, multiply the result by the dilution factor.After dilution by the analyzer, the software automatically takes the dilution into account when calculating the sample concentration.Manual dilution can also be made with negative human serum.Note: Antibodies to HBsAg are heterogeneous. In some isolated cases, this may lead to non-linear dilution behavior.Specific performance dataRepresentative performance data on the analyzer is given below. Results obtained in individual laboratories may differ.PrecisionPrecision was determined using Elecsys reagents, samples and controls in a protocol (EP05‑A3) of the CLSI (Clinical and Laboratory Standards Institute): 2 runs per day in duplicate each for 21 days (n = 84). The following results were obtained:cobas e 801 analyzerRepeatability d)Intermediateprecision e)Sample MeanIU/LSDIU/LCV%SDIU/LCV% Human serum 1 4.33 0.224 5.2 0.272 6.3 Human serum 2 12.0 0.237 2.0 0.277 2.3 Human serum 3 475 6.81 1.4 7.55 1.6 PC f) Anti-HBs 1 < 2.00 - - - -PC Anti-HBs 2 83.8 1.08 1.3 1.28 1.5d) Repeatability = within-run precisione) Intermediate precision = between-run precisionf) PC = PreciControlAnalytical specificityNo cross-reactions with HAV, HCV, HEV, CMV, EBV, HIV, Rubella, Toxoplasma gondii, Treponema pallidum, rheumatoid arthritis, autoimmune response or alcoholic liver disease were observed.Measurements were performed on each of the pathogens listed above using ≥ 8 serum or plasma samples which were positive for antibodies to the above-mentioned pathogens.Relative sensitivityPerformance of the Elecsys Anti‑HBs II assay has been assessed by testing a total of 669 samples at two different study sites. 296 samples from vaccinated persons and 373 samples from patients recovered from a hepatitis B infection have been measured with the Elecsys Anti‑HBs II assay and another commercially available fully automated anti‑HBs assay. Discrepant samples were tested with additional anti‑HBs assays to achieve a consensus.Characterization ofsamplesN ElecsysAnti‑HBs IIreactiveAnti‑HBscomparisontest reactiveSensitivity%Anti-HBs positive:vaccinees 296 296 296 100Anti-HBs positive:recovered from ahepatitis B infection373 373 373 100 Total 669 669 669 100 Relative specificityPerformance of the Elecsys Anti‑HBs II assay has been assessed by testing 2673 samples from blood donors negative for anti‑HBs at two different study sites and 1623 anti‑HBs negative samples from laboratory routine at three different study sites. Discrepant samples were tested with additional anti‑HBs assays to achieve a consensus.Characterization of samples N ElecsysAnti‑HBs IIfalsepositiveSpecificity%Anti-HBs negative: blood donors 2673 6 99.78 Anti-HBs negative: routinesamples1623 9 99.45 References1Seeger C, Zoulim F, Mason WS. Hepadnaviruses. In: Field’s Virology, Knipe DM, Howley RM (eds), 2007 5th edition, Lippincott Williams andWilkins, Philadelphia, USA. Chapter 76, pp2977-3029.2WHO. Hepatitis B vaccines. Wkly Epidemiol Rec 2009;84:405-420.3Liaw YF, Chu CM. Hepatitis B virus infection. Lancet2009;373:582-592.4Caspari G, Gerlich WH. The serologic markers of hepatitis B virus infection – proper selection and standardized interpretation. Clin Lab2007;53:335-343.5Kramvis A, Kew M, François G. Hepatitis B virus genotypes. Vaccine 2005;23:2409-2423.6Michel ML, Tiollais P. Hepatitis B vaccines: protective efficacy and therapeutic potential. Pathol Biol 2010;58:288-295.7Elgouhari HM, Abu-Rajab Tamimi TI, Carey WD. Hepatitis B virus infection: understanding its epidemiology, course, and diagnosis. Cleve Clin J Med 2008;75:881-889.8Occupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.9Directive 2000/54/EC of the European Parliament and Council of18 September 2000 on the protection of workers from risks related toexposure to biological agents at workFor further information, please refer to the appropriate operator’s manual for the analyzer concerned, the respective application sheets, the product information and the Method Sheets of all necessary components (if available in your country).A point (period/stop) is always used in this Method Sheet as the decimal separator to mark the border between the integral and the fractional parts of a decimal numeral. Separators for thousands are not used.SymbolsRoche Diagnostics uses the following symbols and signs in addition to those listed in the ISO 15223‑1 standard:CONTENT Contents of kitSYSTEM Analyzers/Instruments on which reagents can be used REAGENT ReagentCALIBRATOR CalibratorVolume after reconstitution or mixingGTIN Global Trade Item NumberCOBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of Fresenius Kabi AB.All other product names and trademarks are the property of their respective owners. Additions, deletions or changes are indicated by a change bar in the margin.© 2016, Roche DiagnosticsRoche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim。
COBAS生化仪操作指南
输入最后样本编号
Start 将样本放到定义 好的急诊位
Start
4 关机
1C8000 需做关机前保养;请按以下程序执行;在Wash Rack绿架子上加入
Pos W1: Multiclean Pos W2: ISE Cleaning Solution SysClean Pos W3: ISE Activator
Start
单个标本
Save
项目相同
Repeat
输入起始号;回车
急诊样本
Stat
选择样本类型 输入样
本位置样本号
手工重测
如果仪器处在Standby或S stop 模式
选择需要重测的样本;编辑需重测的项目;检查样本位置
输入起始号;回车位
Start
选择项目
2 结果浏览
SaveΒιβλιοθήκη WorkplaceData Review
Calibration
Calibrator
Rack Assign
选定标液及空 位置
Add
OK
3 应用设置 Utility
3 质控设置
1 质控品装载
Application
Others
在1 2 3… 中填入定标液的编 码;下面填入样本量
Save
2 安排质控品架号
QC
Chemistry
Install
原装 手工
DailyMaintenance设置状态自动运行 C 查看Reagent preparing状态;是否添加试剂
或其他液体一般前一天关机前加好;以备第二 天顺利使用 D 查看Calibration情况;准备定标液和定标架
COBAS8000生化仪操作指南
3 COBAS8000生化仪Standby状态操作 A 进行Sample Data Clear清除以往数据 B 进行Calib and QC Select操作;按设置规定
罗氏血气分析仪系列课件罗氏血气培训流程操作快速指南
罗氏血气分析仪系列课件罗氏血气培训流程操作快速指南罗氏血气cobas b 123 POC system安装与培训流程一、检查仪器、试剂、环境准备情况，如果达到要求则连接电源并安装仪器。
二、介绍仪器整体情况。
三、开机，按照屏幕提示执行9步操作并详细介绍。
四、测定程序介绍、示范。
五、更换试剂耗材步骤介绍、示范。
六、介绍各个页面功能：[综述][工作区][仪器][效用]七、让学习人员自己动手操作样本检测、耗材更换，培训工程师当场进行监督、指导。
非常重要！正确的操作会大大减少不必要的故障。
八、强调注意事项：1、血液抗凝必须处理好，检测前充分混合（不能过于剧烈，防止溶血）。
2、建议采血使用动脉血气针；如果使用肝素化的注射器，建议使用2mL容量的型号，采血量要达到1.5mL；如果是5mL容量的注射器，采血量要达到3mL。
3、操作者务必仔细察看屏幕，严格按照屏幕上的指示进行操作，操作者确实完成屏幕指示的动作后，再按下按钮确认。
尤其是更换Sensor Cartridge，请务必仔细观察屏幕指示，做到正确安装。
4、更换Sensor Cartridge后，选择[效用]菜单，用新鲜的血浆（当天的标本）做8次Sensor Cartridge 常规浸润，再做1次Sensor Cartridge 内部常规湿化，接着系统会自动定标，如果有飘红的重复以上步骤浸润和湿化步骤，直至全部项目通过定标。
然后再做两个新鲜全血样本（当天的标本）的测定，进一步活化Sensor Cartridge，整个过程大概需要20多分钟。
请务必在刚刚更换Sensor Cartridge后做好上述活化步骤，过了一段时间再做效果会大大降低。
5、提示使用科室：请保留所有的Sensor Cartridge银色包装袋以及因故障更换下来的Fluid Pack，这些是工程师与罗氏厂家交流维修资料的依据。
九、交流和答疑。
十、留下使用说明和操作快速指南，在仪器合适位置放置工程师名片。
罗氏Cobas6000全自动电化学发光分析仪检测CA153的性能评价
罗氏Cobas6000全自动电化学发光分析仪检测CA153的性能评价发表时间：2018-09-03T14:22:15.413Z 来源：《医药前沿》2018年8月第24期作者：赵有利张尚弟陈丽刘玉梅（通讯作者）[导读] 罗氏Cobas6000型全自动电化学发光分析仪检测CA153的主要分析性能均符合厂商声明的性能和有关的质量要求。
（兰州大学第二医院检验医学中心甘肃兰州 730030）【摘要】目的：对在罗氏公司Cobas6000型全自动电化学发光分析仪上检测的糖类抗原153(CA153)的分析性能进行评价。
方法：参考美国临床和实验室标准化协会性能评价方法和相关报道，并根据临床需求和实际要求，对在罗氏Cobas6000型分析仪测定CA153的精密度、线性范围、生物参考区间和最大稀释倍数4项分析性能进行验证和评价。
结果：批内精密度变异系数(CV)高低值分别为2.67%和3.94%，＜1/4美国临床实验室改进修正法案（CLIA'88）允许总误差(TEa)(6.25%)；批间精密度CV高低值分别为3.68%和2.52%，＜1/3 CLIA'88 TEa(8.33%)；测量线性范围与厂家提供的范围相近；CAl53的测量数值100%在提供的参考区间内。
高浓度的标本可经稀释后再行测定，测定结果显示测定指标的相对偏差在允许误差范围内，具有较高的临床参考价值。
结论：罗氏Cobas6000型全自动电化学发光分析仪检测CA153的主要分析性能均符合厂商声明的性能和有关的质量要求，检测结果准确性较高、可靠性较好，临床参考价值较高，故可满足临床需求。
【关键词】全自动电化学发光分析仪；CA153；性能验证；精密度【中图分类号】R446 【文献标识码】A 【文章编号】2095-1752（2018）24-0057-02 罗氏Cobas6000型全自动电化学发光分析仪可用于多种肿瘤标志物、心肌损害标志物、贫血标志物等80多种生化指标的检测，其采用了国际先进的电化学发光免疫技术，具有操作简单、结果准确、自动化程度高等优点[1-2]。
Cobas c 501分析仪用户操作手册解读
第一章系统概述罗氏Cobas 6000是全自动免疫测定与光度测定分析系统，可定性或定量测定检测项目，Cobas 6000包括两部分：cobas c 501生化分析模块：进行分光光度测定和离子选择电极测定cobas e 601免疫分析模块：进行电化学发光测定下面从控制单元、核心单元、cobas c 501生化分析模块等三部分介绍该系统（cobas e 601免疫分析模块不作介绍）。
1、控制单元A 显示器（连接cobas ） D 触摸式显示器（主机）B 键盘/鼠标（连接cobas） E 键盘/鼠标（主机）C 计算机（连接cobas） F 计算机（主机）G 人体学PC支架2、核心单元1）核心单元轨道A 核心单元 E 模块轨道B 急诊标本位 F 常规标本上机位C 条形码阅读器G 标本退出位D 标本架转盘急诊标本位A 标本架托盘B 标本架C 标本杯、微量杯2）标本架及标本容器标本架不同类型、颜色和相应编号如下：标本容器有三种类型：标本试管、标本杯、定标及质控小瓶标本试管直径为13mm或16mm，长度为75mm或100mm；标本杯可插入16 mm标本试管中用。
A 标本架上的标本杯 D 16mm×100mm试管B 16mm×75mm试管 E 16mm×100mm试管上的标本杯C 16mm×75mm试管上标本杯3、cobas c 501生化分析模块A、B 标本吸样区 E、F 试剂吸样区C 反应盘区 G 试剂盒装载区D ISE模块A、B 标本吸样区A 、B 标本针 D 标本针抽干区C 屏蔽管（防静电） E 标品针冲洗站C 反应盘区A SMS （位置2）、 Multiclean （位置1）B 水位感受器C 超声混合单元D 光度计单元 F 反应盘 G 杯冲洗装置 HHitergent从左往右依次为：Internal standard solution Internal standard solution Diluent solution Diluent solutionReference electrode solution更换以上系统试剂后，进入reagent—status,选择reagent volumn reset 后按ok,仪器即自动更新系统试剂可用量。
cobas 8000日常操作卡
过期试剂报警
OK
罗氏诊断产品（上海）有限公司
邮政编码：200031
技术服务热线：800 820 8864 / 400 820 8864 电话： +86 21 33971000 传真： +86 21 33971888
4
上海市淮海中路1045号淮海国际广场12楼
cobas® 8000 日常操作卡
2、 定标设置
批量标本 （项目相同）
检查标本测试项目，将标 本放在定义的常规标本位
Start
输入起始号，回车
Start
将样本放到 定义好的急 诊位
急诊样本
Stat
选择样本类型、 输入样本位置 (样本号)
选择项目
Save
手工重测
如果仪器处在Standby或S stop 模式 选择需要重测的样本,编辑需重测的项目,检查样本位置 输入起始号，回车位
Start
Start
2）、结果浏览
Workplace Data Review
4、关机
1）C8000 需做关机前保养，请按以下程序执行,在Wash Rack绿架子上加入 Pos. W1: Multiclean Pos. W2: ISE Cleaning Solution SysClean Pos. W3: ISE Activator Start Start
Reagent Reagent
setting
Reagent Registration
Execute
开放通道（C701模块）： setting Manual Registration Test Name OK
将试剂瓶放入试剂仓在同一空试剂位
注:试剂HIT-D只能在B盘,而NAOH-D和SMS在A和B盘各放一套 罗氏诊断产品（上海）有限公司
罗氏Cobas6000全自动电化学发光免疫分析仪条码双工的设置与应用
罗氏Cobas6000全自动电化学发光分析系统是一种用于免疫测定的全自动检测系统。
其作为一种功能强大的实验室诊断工具，具有模块化、灵敏度高、精密度好、检测快、检测项目多、试剂无放射性污染、操作简便、维护方便等特点，广泛应用于各临床实验室[1]。
我院的Cobas6000全自动电化学发光分析系统由2个E601免疫分析模块组成，一直使用非条码双工模式，即先将样本编号，然后在瑞美实验室信息管理系统（LIS）中按顺序扫码录入，再双工到全自动分析仪上完成检测。
2017年6月，我们将该设备设置为条码双工模式，提高了工作效率，减轻了劳动强度，向自动化实验室迈出了关键意义的一步。
现总结近两年的应用经验，将条码双工模式设置方法和应用情况报道如下。
1 条码双工模式通信参数设置（1）关闭通信端口：在Stand By状态下，点击“Start”按钮，将“Host Communication On”设为“Off”。
（2）设置条码双工模式的通信参数：在Stand By状态下，选择页面“Utility”，选择子页面“System”，将“Routine/Stat”设为“Yes”，其他2项设为“No”；在“System”中点击“Host Comm.”按钮，将“Communication Setting”中“RS232C Setting”区域的“Speed”设为“9600”，“parity”设为“8Bit+NONE+2StopBit”，“System”设为“Cobas6000”，“Host”设为“host”，“System ID”为“1”，Host ID为“2”，Communication Trace打勾；在“Text Setting”中进行设置，左侧按照由上而下的顺序依次设置Result Only不打勾（必须）， TS Timeout 打勾，后面为18 Seconds，Auto Rerun TS 不打勾，Manual Rerun TS 不打勾，Stat TS 打勾， TS inquire Always 打勾，TS Ask in Barcode Read Error 打勾，TS Priority Mode不打勾；右侧按照由上而下的顺序依次设置Sample ID 22 Digits 打勾，Change Rack No. 打勾， New Mode 打勾，Send 1st/Rerun Information打勾， Send Concent 打勾，Send Time stamp of pipetting Sample打勾，余下的参数均不打勾；将“Result Upload Setting”中的2个下拉列表中均设置为“by Sample”，余下项目默认，点击“OK”保存设置；在“System”画面上点击“page ?/4”直至到“Page 3/4”，点击“Check Digit Setting”，将Code 39 打勾，NW 7打勾，下拉列表选中“Modulus 16”。
Cobase411电化学发光免疫分析仪用户操作手册分析
cobas e411（Disk）操作手册罗氏诊断产品（上海）有限公司广州分公司第一章一．二．三．四．五．第二章一．二．1．2．3．三．1．2．3．四．第三章一．二．三．四．五．第四章第一章系统概述一．e411主要部件A：操作开关 B：样本（30个位置）／试剂区（18个位置，具自动开关盖装置） C：测试区 D：消耗品区 E：显示及控制单元位于仪器右侧面位于仪器左侧面A：主电源开关 B：电源线 A：USB接口 C：HOST接口二． 控制单元三． 样品／试剂区A ：取样区B ：样品盘保护盖 A ：磁珠搅拌针 B ：冲洗站C ：样本/试剂针BA ：触摸屏B ：虚拟键盘（触摸屏幕 上需输入内容区域 时，自动在屏幕下方 跳出）C ：数字键盘 A ：定标/质控条形码阅读口B ：带开关盖装置的试剂仓 （18个位置） CA B四． 测试区A ：孵育池（共32个孵育位）B ：吸样位A ：系统试剂保护门B ：Sipple 针C ：CleanCell （黑盖）D ：ProCell （白盖）五． 消耗品区BDCA ：吸头位1-2B ：反应杯位3-5C ：吸头丢弃位D ：反应杯丢弃位废吸头/反应杯盒 A：蒸馏水桶 B：废液桶BABA：抓手B：抓手移动时的横纵轴C：吸头/反应杯区1（120个吸头，60个反应杯）D：吸头/反应杯区2（120个吸头，60个反应杯）E：吸头/反应杯区3（120个吸头，60个反应杯）第二章基本操作一．开机a．检查蒸馏水桶，将SysWash浓缩液配置为1:100的系统用水b．清空废液桶c．打开ProCell和CleanCell盖子，关好系统试剂保护门。
注意：运行过程中不能打开系统试剂保护门，否则仪器将停止运行。
d．打开仪器右面主电源开关，再打开仪器前面操作开关，等界面出现后，录入用户名和密码，仪器自动初始化后进入待机状态注意：仪器分不同级别及权限使用，可根据实际情况设定；添加用户名后，第一次输入的密码即为以后的密码。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
罗氏cobas 6000生化免疫分析仪简易操作手册罗氏诊断产品（上海）有限公司目录第一章系统概述1、控制单元......................................................................... .. (3)2、核心单元......................................................................... (4)3、cobas c 501生化分析模块..................................................... .. . .. (7)4、cobas e 601免疫分析模块..................................................... .. . .. (10)第二章软件系统简介1、系统状态概览......................................................................... .. (15)2、日常工作菜单......................................................................... .. (16)第三章基本操作1、开机......................................................................... ................ .. (17)2、开机后确认......................................................................... . (18)3、申请新项目......................................................................... . (18)4、申请新校准品......................................................................... (25)5、申请新质控物.............................................. .... ........... .... ........ . . (27)6、校准................ ......................................................... ....... ......... .. (28)7、质控................... ............................................................ (30)8、标本检测............. ............................................................ (32)9、基本操作注意事项............................................................ . (34)第四章维护保养1、每日保养......................................................................... . (35)2、每周保养......................................................................... .. (36)3、每两周保养......................................................................... . (37)4、每月保养.................................................................... . (38)5、每两月保养........................................................................ .. (38)6、每季保养....................................................................... . (39)7、每半年保养................................................................. ......... . (39)7、按需保养......................................................................... . (40)8、保养项目设置...................................................................... . (40)第五章仪器报警信息 (37)第一章系统概述罗氏cobas 6000是全自动免疫测定与光度测定分析系统，可定性或定量测定检测项目，cobas 6000包括两部分：cobas c 501生化分析模块：进行分光光度测定和离子选择电极测定cobas e 601免疫分析模块：进行电化学发光测定下面从控制单元、核心单元、cobas c 501生化分析模块、cobas e 601免疫分析模块等四部分介绍该系统。
1、控制单元A显示器（连接cobas link） D 触摸式显示器（主机）B键盘/鼠标（连接cobas link） E键盘/鼠标（主机）C计算机（连接cobas link） F计算机（主机）G人体学PC支架2、核心单元1）核心单元轨道A核心单元 E 模块轨道B急诊标本位 F 常规标本上机位 C条形码阅读器G 标本退出位D标本架转盘急诊标本位A 标本架托盘B 标本架C 标本杯、微量杯2）标本架及标本容器标本架不同类型、颜色和相应编号如下：标本容器有三种类型：标本试管、标本杯、校准及质控小瓶标本试管直径为13mm或16mm，长度为75mm或100mm；标本杯可插入16 mm标本试管中用。
A标本架上的标本杯D16mm×100mm试管B16mm×75mm试管E16mm×100mm试管上的标本杯C16mm×75mm试管上标本杯3、cobas c 501生化分析模块A、B 标本吸样区 E、F 试剂吸样区C 反应盘区 G 试剂盒装载区D ISE模块A、B 标本吸样区A、B 标本针 D 标本针吹干区C 屏蔽管（防静电） E 标品针冲洗站C 反应盘区A SMS （位置2）、 Multiclean （位置1）B 水位感受器C 超声混合单元D 光度计单元 F 反应盘 G 杯冲洗装置 H Hitergent更换以上系统试剂后，进入reagent —status,选择reagent volume reset 后按ok,仪器即自动更新系统试剂可用量。
D ISE 模块从左往右依次为：Internal standard solution Internal standard solution Diluent solution Diluent solutionReference electrode solutionK 、Na 、Cl 、参比电极仓E、F 试剂吸样区A 试剂针 D R2试剂吸样口B 试剂放入口 E 试剂盘开盖处（关闭状态）C R1试剂吸样口 F试剂盘开盖处（打开状态）G 试剂盒装载区A 试剂盒抓手 B试剂盒装载口 C 试剂盒装载区平台 D 废试剂盒出口4、cobas e 601免疫分析模块e 601模块主要部件如下：A 前清洗区 C 测量区 E 系统试剂区（在前门后面）B 试剂区 D 耗品区A 试剂盘 D 磁珠搅拌棒 F 试剂针B 条件码阅读器 E 磁珠搅拌棒冲洗站 G 试剂针冲洗站C 试剂盖开盖器 H 探针清洗站I 试剂注射器A 标本针 E 标本注射器B 孵育盘 F sipper注射器C sipper针D sipper冲洗站D 耗品区A 抓手 E TIP/CUP 盒升降器B 涡流混合站 F TIP/CUP 丢弃袋C TIP/CUP G TIP/CUP 盒丢弃区D 指示灯指示器灯“亮”时抽屉可安全打开指示器灯“灭”时抽屉严禁打开E 系统试剂区第二章软件系统简介1、系统状态概览日常保养数据清除试剂准备校准质控下载参数下载标本运行状态2、日常工作菜单系统状态概览仪器状态操作者日期时间第三章基本操作1、开机a 、检查供水、排水系统是否正常，打开供水系统电源b 、接通仪器左侧操作电源开关c 、打开计算机（主机）开关A 标本架上机/退出区 C 操作电源开关B 急诊标本位 D 主开关电路断路器c 、登录：输入用户名及密码，仪器初始化后进入Stand by 状态注意：仪器分不同级别及权限使用，可根据实际情况设定；添加用户名后，第一次输入的密码即为以后的密码。
2、开机后确认a、进入System Overview，点击Daily Maintenance按键，检查保养工作是否完成（仪器自动完成，但如果保养液不够量，自动保养会中断）；如保养未完成，确认保养液够量后，进入Utility—Maintenance，用光标选中需做的保养项目，点Select，再点Execute，手工要求仪器完成保养工作。
b、清除标本数据库：进入系统OVERVIEW，点Sample Data Clear，选择CLEAR后点OK，即可清除以往所有的病人结果数据。
c、检查试剂盘内试剂是否足够：进入REAGENT界面，点击SETTING按键,从该画面下检查试剂量,按需要更换试剂。
3、申请新项目 (确认已打开E-LIBRARY 电脑）a、下载新项目参数进入Utility—Application—Download ，进行如上界面，在Application name一栏选定所要申请的项目（如果开放项目,则在Application Code栏选定开放通道代码311-320），按 Search行参数查找，找到后按Download则出现以下界面如果罗氏原装试剂，直接按OK；如果是开放项目，则输入开放项目的名称及单位，然后按OK。
b、项目参数修改(罗氏原装生化、免疫试剂)进入Utility—Application—Range，填入项目报告名称及单位，并设定是否启用自动重测功能，如启用，输入重测的范围。