罗氏电化学发光免疫分析报告仪定标物保存方法
罗氏电化学发光免疫分析仪测试项目定标物保存方法
罗氏电化学发光免疫分析仪测试项目定标物保存方法无信息定标物和质控物是测试包装内的一部分定标必须被进行：每盒新试剂；每天 (当仪器上使用同一盒试剂)；需要时，如质控不在范围内心肌标志物性激素项目肿瘤标志物贫血诊断指标、骨标志物传染病项目其它唐氏筛查先兆子痫罗氏电化学发光免疫分析仪定标物保存方法（简版）定标物不需要分装冰冻保存的项目：使用时从2-8︒C取出，摇均后吸200μl（此数据为国内实验室试验所得，不代表罗氏官方）到日立杯，马上将剩余定标品放回2-8︒CFT3、FT4、T3、T4、TSH、T-uptake、Anti-TG、HCG+β、HCG STAT、ProgesteroneCEA、CA 125、CA 153、CA 724、Cyfra21-1、NSE、Free PSA、HE4Myoglobin、Myoglobin - STAT 、Digoxin、Digitoxin、Ferritin、IgE、β-CrossLapsAnti-HAV、Anti-HAV IgM、HBsAg、HBsAg II quant、 Anti-HBs、HBeAg、Anti-HBe、Anti-HBc、 Anti-HBc IgM、 HIV combi、HIV Ag 、HIV combi PTToxo IgG、 Toxo IgM、Rubella IgG、Rubella IgM、CMV IgG、CMV IgM定标物需要分装冰冻保存的项目：定标物加水复溶，用子弹头进行分装（分装量为200μl（此数据为国内实验室试验所得，不代表罗氏官方）），然后放在-20︒C保存，使用时取出并平衡到室温TG、Anti-TPO、 Anti-TSHR、CK-MB、CK-MB STAT、ProBNP、Troponin T HS、Troponin T HS STAT free βHCG、PAPP-A、 Insulin、C-peptide、IL-6 、PCT、Anti-CCP.Cortisol、ACTH、Estradiol II、FSH、LH、Prolactin、Testosterone、DHEA-S、SHBG、PIGF、 sFlt-1、hGHAFP、CA 199、TPSA、S100Vitamin B12、Folate III 、N-MID、Total P1NP、PTH、PTH STAT、PTH(1-84)Vitamin D3、Vitamin D totalHSV-1 IgG、 HSV-2 IgG11 / 11'.。
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 The last 3 digits -190 have been replaced by -119 for logistic purposes.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。
罗氏E411全自动电化学发光免疫分析仪常见问题及处理
罗氏E411全自动电化学发光免疫分析仪常见问题及处理发表时间：2015-10-23T14:00:43.717Z 来源：《医药前沿》2015年第24期供稿作者：陆绍科[导读] 贵州省独山县人民医院贵州独山处理方法：打开试剂盒盖子，检查试剂如加得太满，用移液器将试剂吸出后重新执行试剂扫描或手工注册即可。
陆绍科（贵州省独山县人民医院贵州独山 558200）【摘要】罗氏E411全自动电化学发光免疫分析仪它具有操作简便，自动化程度高，精密度高，重复性好样品用量少,节省试剂,检测速度快等优点。
是国际公认的“金标准”，而在使用过程中往往会出现一些小故障,需要自行尽快排除,以至于不影响日常工作。
【中图分类号】R197.3 【文献标识码】A 【文章编号】2095-1752（2015）24-0303-02 仪器在运行过程中，当出现报警信息时，在屏幕上方状态栏的颜色会发生改变，报警颜色呈红色或黄色，当报警颜色为红色时，仪器将发生停止工作，同时报警代码简要的描述以及报警类型及中文提示都会显示出来。
笔者就使用该仪器现场解决处理的一些经验报告如下。
1. 吸样针检测到某项目试剂盒中有气泡1.1 报警此信息多数都是由于用户为了节约试剂,将多个试剂拼装后，拼装的试剂加得太满所致。
处理方法：打开试剂盒盖子，检查试剂如加得太满，用移液器将试剂吸出后重新执行试剂扫描或手工注册即可。
在不能确认是哪瓶试剂所致的报警时，可执行试剂扫描，当试剂针探测到某个试剂有问题时就会马上报警，此致即可确认是某个试剂的问题即可将其取出。
1.2 报此信息的另一个问题是：试剂在运输过程中受到振动可能的产生气泡。
处理方法：此时应将试剂静置30分钟后再用。
日常工作在取出试剂使用时应当避免人为晃动或颠倒试剂。
2.由于电导率升高导致某项目试剂的液面误检/运动过程中，样本/试剂针液面感应错误2.1 报警此信息多数是样本/试剂针表面有静电或有污物附着，处理方法：在关机状态下，手工移动样本/试剂针到方便擦拭的位置，用纱布沾上70％酒精，轻轻擦拭针的表面和针尖；再用蒸馏水清洁1次即可。
罗氏电化学发光免疫分析仪定标物保存方法
罗氏电化学发光免疫分析仪定标物保存方法罗氏电化学发光免疫分析仪是一种常见的实验仪器，用于检测和定量分析生物样本中的特定生物分子，如蛋白质、抗体、激素等。
定标是使用已知浓度的标准物质来建立分析仪器的检测曲线和定量范围。
定标物的保存方法对于保证分析仪器的准确性和稳定性非常重要。
本文将从两个方面介绍罗氏电化学发光免疫分析仪定标物的保存方法，包括标准物质的选择和保存条件。
选择标准物质：在进行定标前，首先需要选择与待测分析物相同或相似的标准物质进行定标。
标准物质应具有以下特点：1.纯度高：标准物质的纯度应尽可能接近100%，以减少不纯物质对分析结果的影响。
2.稳定性好：标准物质应具有良好的化学稳定性和物理稳定性，以确保在保存期间不发生分解、降解或溶解。
3.可溶性好：标准物质应易于溶解于使用的溶剂中，以便在定标过程中进行稀释。
4.经济适用：标准物质的价格应相对较低，以降低实验成本。
保存条件：标准物质的保存条件直接影响着其稳定性和可靠性，因此需要注意以下几个方面：1.存储温度：一般来说，标准物质的保存温度应根据其化学性质和稳定性来确定。
一些易降解的标准物质需在低温下保存，如-20℃或更低。
而一些稳定性较好的标准物质可以在常温下保存，但应避免暴露在光照、高温或高湿环境中。
2.容器选择：标准物质应存放在密封、不透光的容器中，以防止光和空气的影响。
常见的存储容器有玻璃瓶、塑料管或聚丙烯封口袋等。
3.避免冷冻解冻：对于需要在冷冻状态下保存的标准物质，应避免频繁的冷冻解冻过程，以免影响其稳定性。
可以根据实验需要，将标准物质分装成适量的小份，每次只取一小部分使用，并立即将剩余的封存起来。
4.防潮防湿：标准物质应避免接触水分和湿气，以免发生水解、分解或结晶现象。
可以在存放容器中加入干燥剂，如无水硫酸钠、碳酸钠或干燥的硅胶等，以吸湿保持干燥环境。
5.定期检测：定期对保存的标准物质进行检测，以确保其浓度和稳定性。
可以使用同一批次的标准物质进行再次定标，以验证保存的标准物质是否保持稳定。
罗氏电化学发光免疫分析仪定标物保存方法
罗氏电化学发光免疫分析仪测试项目定标物保存方法Cal 1/Cal未开包装稳定时间（2-8C）打开后稳定时间（2-8 C）2/40 pmol/l 1.3/26-- pg/ml1 ml 15 l10/45pmol/l0.78/3.5 ng/dl1 ml 15 l1.25/8.5nmol/l0.8/5.5 ng/ml1 ml 30 l50/230nmol/l3.9/17.9 µg/dl1 ml 15 l0/1.5 µIU/ml 1.3 ml 50 l0.5/1.3 TBI1 ml 15 l4/800 ng/ml1 次(-20 C / 3月)1 ml20 lAnti-TG 0636860340/3250IU/ml有效期限 6 周是不可1.5 ml10 µlAnti-TPO 0647293135/350IU/ml有效期限8小时是1 次(-20 C / 8周)1.5 ml20 µlAnti-TSHR 1/25 IU/l有效期限是1 次(-20 C / 3月)2 ml50 µl无信息定标物和质控物是测试包装内的一部分定标必须被进行：每盒新试剂；每天 (当仪器上使用同一盒试剂)；需要时，如质控不在范围内心肌标志物定标液及其货号定标频率靶值Cal 1/Cal2未开包装稳定时间（2-8C）打开后稳定时间（2-8C）定标物状态可否冰冻保存每瓶容量/每次吸样量冻干，需溶解液体，打开即用CK-MB11821601(18 min)1．当需要时，如质控不在范围内2．每月，使用同一批号试剂3．每周，使用同一盒试剂 1.5/25ng/ml有效期限 2 周是1次(-20 C / 3月)1 ml15 lCK-MB STAT11731572 (9 min) 1.5/25ng/ml有效期限 2 周是1次(-20 C / 3月)1 ml15 lMyoglobin 12178222 (18 min) 35/1200ng/ml有效期限12周是-1 ml15 µlMyoglobin STAT 11820893(9min) 35/1200ng/ml有效期限12周是-1 ml15 µlTroponin Ths 05092736 (9 min)0.1/10ng/ml有效期限2周是1次(-20 C / 3月)1 ml15 l0.1/10 ng/ml1次(-20 C / 3月)1 ml15 l140/2700pg/ml 16.6/320 pmol/l1次(-20 C / 3月)0.61/3.61ng/ml,0.78/4.62nmol/l5.00/60ng/ml,6.55/79nmol/l性激素项目Cal 1/Cal 未开包装稳定时间（2-8C）打开后稳定时间（2-8C）HCG+03302652 1.5/2000mIU/ml10/5000mIU/ml12.5/1000 nmol/l0.45/36 µg/dl1次(-20 C / 3月)15/120 pg/ml1 次(-20 C / 1月)1 ml50 l0.14/20µmol/l5/750 µg/dl1次(-20 C / 3月)73/11000 pmol/l20/3000 pg/ml1次(-20 C / 3月)1/55 mIU/ml1次(-20 C / 3月)1/45 mIU/ml1次(-20 C / 3月)0.6/169 nmol/l0.2/53 ng/ml2/2000 µIU/ml 0.09/94 ng/ml1次(-20 C / 3月)0/40 nmol/l1次(-20 C / 2月)< 1.2/ 40 nmol/l< 0.4/ 11.5 ng/ml1次(-20 C / 3月)0/10 ng/ml0/10000 pg/ml1次(-20 C / 28天)未开包装稳定时间（2-8C）打开后稳定时间（2-8C）5/50 IU/ml, 6/60 ng/ml1次(-20 C / 6周)1 ml10 l5/50 ng/ml1 ml 10 l35/500 U/ml 15/100 U/ml20/250 U/ml1次(-20 C / 2月)1/70 U/ml 0/50 ng/ml。
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。
罗氏电化学发光仪Cobas e411使用体会
罗氏电化学发光仪Cobas e411使用体会芮桥安【摘要】@@ 电化学发光仪Cobas e411是罗氏公司2008年推出的Elecsys 2010的升级版,是全自动、随机的异相免疫分析系统.该系统采用最先进的电化学发光免疫分析技术,具有快速、准确、特异、灵敏度高的特点[1].本科室于2010年3月将Elecsys 2010更换成了罗氏电化学发光仪Cobas e411.该仪器对实验室条件、对定标、对耗材的要求更高,对试剂的封闭把关更加严格,因而具有更好的测试稳定性.作者就如何使用好Cobas e411谈几点体会.【期刊名称】《检验医学与临床》【年(卷),期】2012(009)006【总页数】1页(P768)【关键词】质量控制;检验;电化学发光仪【作者】芮桥安【作者单位】云南省丽江市人民医院检验科,674100【正文语种】中文电化学发光仪Cobas e411是罗氏公司2008年推出的Elecsys 2010的升级版，是全自动、随机的异相免疫分析系统。
该系统采用最先进的电化学发光免疫分析技术，具有快速、准确、特异、灵敏度高的特点［1］。
本科室于2010年3月将Elecsys 2010更换成了罗氏电化学发光仪Cobas e411。
该仪器对实验室条件、对定标、对耗材的要求更高，对试剂的封闭把关更加严格，因而具有更好的测试稳定性。
作者就如何使用好Cobas e411谈几点体会。
1 实验室条件该仪器最适宜操作温度18～32℃，湿度20%～80%，需要安装空调。
尽管丽江是四季如春的城市，但冬季、春季气温仍然偏低，不安装空调对测试结果有一定影响。
2 定标新批号试剂需定标。
最好直接向试剂供应商购买复溶分装好的定标液。
自己购买成套装的定标液来复溶分装，很容易使用不完而过期，造成浪费。
收到定标液后切忌反复冻融，须尽快定标。
如果当天来不及定标，可暂时放2～8℃冰箱保存。
定标时必须用该定标液的定标卡，不同批号定标液的定标卡不可混用。
罗氏E2010电化学发光分析仪常见报警及其处理
4101软盘读写故障
及时更换新的格式化过的软盘，并要做好备份工作
14
4401结果传输故障
检查硬件连接，检查软件启动情况，然后手工打开端口
15
500204样本不能被处理，系统没有定义
检查相关配套的稀释液、预处理液等
16
定标没有通过
检查定标液操作、保存有无异常，报告定标光子量给工程师
17
单独项目结果突然大批量的异常
检查结果的单位是否相互匹配
18
经定标过的试剂扫描后要重新定标
检查是否已经打开了“Daily Calib request”标选项
尽量不修改时间（有时用户为了适应过期试剂），否则会出现正常日期的项目丢失等现象。
LLD报警
1、清洁S/R针，2、检查水桶滤网有无异物，水质情况怎么样，3、检染病，样本不准用，特别是定标。专做管路清洁用的
4
S/R针、搅拌浆下降遇到故障
检查下降位置下面的试剂包的盖子是否会自己倒下。
或者试剂是否有结冰的现象。
5
扫描器不能扫描条码
用干布清洁扫描窗口
6
抓手故障
换备份软盘启动机器
7
19-01固体废弃物机械故障
拿出废物盒，伸手掏出溢出的头和杯
8
罗氏E2010电化学发光分析仪
常见故障报警及其处理
1
350107
370105吸样报警
1、检查S/R针电压，有无异常。2，检查蒸馏水情况。
3、反复擦洗SR针，以及用配比洗液冲洗SR针，
2
S/R冲洗站漏水
用户经过反复冲洗S/R冲洗站管路，依然水流不畅通，然后检查SIP针站下水情况，也不畅通。原因：SIP针站的不畅会导致S/R站下水也不畅通的。
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罗氏电化学发光免疫分析仪测试项目定标物保存方法
无信息定标物和质控物是测试包装的一部分
定标必须被进行：每盒新试剂；每天 (当仪器上使用同一盒试剂)；需要时，如质控不在围
心肌标志物
性激素项目
肿瘤标志物
贫血诊断指标、骨标志物
传染病项目
其它
唐氏筛查
罗氏电化学发光免疫分析仪定标物保存方法（简版）
定标物不需要分装冰冻保存的项目：
使用时从2-8︒C取出，摇均后吸200μl（此数据为国实验室试验所得，不代表罗氏官方）到日立杯，马上将剩余定标品放回2-8︒C
FT3、FT4、T3、T4、TSH、T-uptake、Anti-TG、
HCG+β、HCG STAT、Progesterone
CEA、CA 125、CA 153、CA 724、Cyfra21-1、NSE、Free PSA、HE4
Myoglobin、Myoglobin - STAT 、Digoxin、Digitoxin、Ferritin、IgE、β-CrossLaps
Anti-HAV、Anti-HAV IgM、HBsAg、HBsAg II quant、 Anti-HBs、HBeAg、Anti-HBe、Anti-HBc、 Anti-HBc IgM、 HIV combi、
HIV Ag 、HIV combi PT
Toxo IgG、 Toxo IgM、Rubella IgG、Rubella IgM、CMV IgG、
CMV IgM
定标物需要分装冰冻保存的项目：
定标物加水复溶，用子弹头进行分装（分装量为200μl（此数据为国实验室试验所得，不代表罗氏官方）），然后放在-20︒C保存，使用时取出并平衡到室温
TG、Anti-TPO、 Anti-TSHR、CK-MB、CK-MB STAT、ProBNP、Troponin T HS、Troponin T HS STAT free βHCG、PAPP-A、 Insulin、C-peptide、IL-6 、PCT、Anti-CCP
Cortisol、ACTH、Estradiol II、FSH、LH、Prolactin、Testosterone、DHEA-S、SHBG、PIGF、 sFlt-1、hGH
文档
AFP、CA 、TPSA、S100
Vitamin B12、Folate III 、N-MID、Total P1NP、PTH、PTH STAT、PTH(1-84) Vitamin D3、Vitamin D total
HSV-1 IgG、 HSV-2 IgG。