罗氏电化学发光免疫分析(精)

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'.。

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 The last 3 digits -190 have been replaced by -119 for logistic purposes.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E 601 电化学发光免疫分析仪用户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 e601免疫分析模块..................................................... .. . .. (5)第二章软件系统简介1、系统状态概览......................................................................... .. (12)2、日常工作菜单......................................................................... .. (13)第三章常规操作1、开机......................................................................... ................ .. (15)2、仪器准备......................................................................... . (16)3、增加新项目......................................................................... . (18)4、增加校准品........................................... ........ ...... .... ... ..... ..... (23)5、增加质控品 ........................................... ........ ...... .... ... ..... ..... (25)6、校准和质控检测 (30)7、样本检测 ........................................... ........ ...... .... ... ..... ..... ... .... .. 388、关机 ........................................... ........ ...... .... ... ..... ..... ... .... .. .... .. 44第四章维护保养1、每日保养......................................................................... . (46)2、每周保养......................................................................... .. (46)3、每两周保养......................................................................... . (48)4、每季保养......................................................................... . (49)5、按需保养......................................................................... . (49)第六章仪器报警信息......................................................................... .. 51第一章系统概述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。

罗氏电化学发光免疫剖析技术是罗氏企业开发的,但全自动机械制造却由日本的日立企业肩负,所以仪器上还有Hitachi的标记。

这个仪器让大家惊讶的一大原由就在于向来在实验室研究的电致化学发光竟然已经真实地家产化了,此中我们向来没法解决的诸多问题(特别是重现性均已获得解答,看来罗氏确实花了许多心血开发这款仪器。

罗氏电化学发光免疫剖析技术的性能特色——创新的技术,独出心裁一、最初进的检测原理电化学发光免疫测定,是当前最初进的标记免疫测定技术,是继放射免疫、酶免疫、荧光免疫、化学发光免疫测定此后的新一代标记免疫测定技术,拥有敏感、快速和稳固的特色,在固相标记免疫测定中技术上居当先地位。

电化学发光(ECL是一种在电极表面由电化学引起的特异性化学发光反响,实质上是电化学和化学发光两个过程的完满联合。

电化学发光与一般化学发光的主要差别在于前者是电启动发光反响,循环及多次发光,后者是经过化合物混淆启动发光反响,是单次瞬时发光。

所以ECL反响易精准控制,重复性极好。

电化学发光免疫测定是电化学发光(ECL和免疫测定相联合的产物,直接以[Ru(bpy3]2+标记抗体,反响时标记物直接发光。

且[Ru(bpy3]2+在电极表面的反响过程能够循环往复进行,产生很多光子,使光信号得以加强。

二、专利的包被技术链霉亲和素(streptoavidin,SA和生物素(biotin,B是拥有很强的非共价互相作用的一对化合物,特异性强且联合密切。

一分子SA可与四分子B相联合,增大了抗体联合量,达到放大成效。

在ECL的试剂中,SA经过特别的蛋白联合物平均坚固地包被在磁性微粒上,形成通用的能与B联合的固相载体,另一试剂为活化的B衍生物化合的抗原或抗体。

两种试剂混淆时,抗原或抗体即包被在磁性微粒上。

三、独到的载体ECL中采纳的固相载体是带有磁性的直径约2.8m的聚苯乙烯微粒。

其特色是反响面踊跃大,比板式扩大20-30倍,使反响在近乎液相中进行,反响速度大大加速,利用氧化铁的磁性,使用电磁场分别联合态和游离态,方便快速,实现了精准的全自动化。

罗氏电化学发光原理罗氏电化学发光原理是指在电化学发光（Electrochemiluminescence，ECL）过程中，通过电化学手段激发物质发光的原理。

这一原理在生物医学领域中有着广泛的应用，特别是在免疫分析和生物传感器领域。

本文将对罗氏电化学发光原理进行详细介绍，以便更好地理解其在实际应用中的作用。

首先，罗氏电化学发光原理的基本过程是通过电化学反应来产生激发态物质，从而激发发光。

这一过程通常涉及到两种基本的反应，氧化还原反应和化学发光反应。

在氧化还原反应中，通过施加电压或电流，使得电极上的物质发生氧化还原反应，产生激发态物质。

而在化学发光反应中，激发态物质通过与另一种物质发生化学反应，释放出光子，产生发光现象。

这两种反应的结合，构成了罗氏电化学发光的基本原理。

其次，罗氏电化学发光原理的应用主要集中在生物医学领域。

在免疫分析中，罗氏电化学发光被广泛应用于检测生物分子，如蛋白质、核酸和细胞等。

通过将待测物与特定的标记物结合，利用罗氏电化学发光技术来检测标记物的信号强度，从而实现对待测物的定量分析。

在生物传感器领域，罗氏电化学发光也被用于构建高灵敏度、高选择性的生物传感器，用于检测生物分子的存在和浓度。

此外，罗氏电化学发光原理还具有许多优势。

首先，它具有高灵敏度和高选择性，能够在复杂的生物样品中进行精准的分析。

其次，罗氏电化学发光技术还具有快速、简便的特点，适用于高通量的实验操作。

此外，由于其不需要外部光源的激发，可以减少背景信号的干扰，提高检测的准确性。

总的来说，罗氏电化学发光原理是一种重要的生物分析技术，具有广泛的应用前景。

通过对其原理和应用的深入理解，可以更好地推动生物医学领域的研究和应用，为人类健康事业做出更大的贡献。

在实际应用中，我们需要不断改进和优化罗氏电化学发光技术，提高其灵敏度、稳定性和成本效益，以满足不断增长的生物医学研究和临床检测需求。

相信随着技术的不断进步和创新，罗氏电化学发光原理将会发挥更加重要的作用，为人类健康事业带来更多的突破和进步。

罗氏电化学发光项目介绍
罗氏电化学发光（Roche Electrochemiluminescence，ECL）是一种
高灵敏度、高选择性的电化学发光技术，适用于生物分析领域。

该
技术利用电化学激发发光反应，通过电化学电位的调节，使标记在
生物分析物上的激发粒子释放出能量并产生发光。

罗氏电化学发光技术的主要步骤包括样本处理、标记物的添加、电
池的组装以及丰富分析物等。

在样本处理过程中，可以使用多种方法，如离心、洗涤和预处理，以提取和纯化样品中的目标分子。

接
下来，将标记物添加到样品中，通常通过特异性结合或酶反应进行
标记。

在电池组装过程中，需要组装特定的电极系统以产生电化学发光反应。

通常，电极系统由工作电极、反应电极和参考电极组成。

工作
电极是发生反应并生成电流的电极，反应电极用于触发电化学反应，而参考电极则用于测量电流。

1
丰富分析物是指通过改变电化学条件或添加特定的试剂来提高分析
物的测量灵敏度和特异性。

例如，通过改变电极电位或添加酶反应
底物来增强发光信号。

罗氏电化学发光技术在生物分析中具有许多优点。

首先，它具有高
灵敏度和高特异性，可以检测到极低浓度的目标分子。

其次，该技
术的操作简单，结果可靠，且具有广泛的应用范围，包括分子诊断、药物筛选、基因表达分析等。

总之，罗氏电化学发光技术是一种高灵敏度、高选择性的电化学发
光技术，适用于生物分析领域，可用于检测低浓度的目标分子，并
在医学诊断、药物筛选等领域有广泛应用。

2。

罗氏E170电化学发光自动免疫分析仪使用体会论文电化学发光免疫分析仪具有灵敏度高、精细度好、检测速度快、检测工程多、试剂无核素污染等特点，是各临床实验室优先选择的免疫分析仪。

罗氏公司电化学发光自动免疫分析仪包括三个型号：1010、xx及E170，其中E170试剂位最多（25个）、检测速度最快（可达170个测试/小时），适合样本量大、开展工程多的大型医疗机构使用。

我们使用该仪器已有两年多，现把使用体会报道如下，供同行分享和探讨。

临床医生对检测工程要求有较高的准确性和稳定性，以利于疾病诊断和疗效观察。

该仪器所用试剂为全封闭试剂，试剂及耗材全部依赖进口，路途遥远，运输和保存条件均会影响试剂的质量，操作者除定期进展工程校准和仪器维护外，还应坚持室内质控制度，以观察检测工程的稳定性，同时也可监测仪器的工作状态。

室内质控品可选择仪器配套质控品，或进口的免疫室内质控品，也可用自制质控品。

该仪器共有两个流动测量池，虽为同一检测系统，但检测结果也有差异。

我们刚开始使用该仪器时，为了追求最快检测速度，设置每个流动测量池均可检测所有工程，结果发现同一工程室内质控累积靶值有较大差异，后来根据本实验室各检测工程的使用频度分配检测工程在固定的流动测量池，进展室内质控时，靶值就容易确定，同时校准时减少了校准品及试剂的消耗、室内质控时质控品和试剂的消耗，保证了检测结果的稳定性，实验室进展认可时也不必进展结果的比对。

罗氏xx进展试剂扫描后，试剂是否校准通过，是否可用一目了然，但对于E170，装载试剂后，在试剂（Reagent）界面无法知道试剂的校准情况，必须到校准（Calibration）界面才可知道检测工程的校准状态（工程为红色为未校准或校准未通过），这一点要引起重视，因为E170当您进展检测时，仪器不管该工程是否可用，均消耗试剂，造成试剂不必要的浪费；罗氏xx在样品盘装载标准品后，仪器优先校准该工程未校准批号，但E170必须要选择所需校准工程的位置号，详细方法为：CalibrationStatus→全选所有工程→Full→Save→按住Ctrl选择所需工程→Full→Save，所需工程后的FULL变为兰色即可进展校准；E170为样本架进样，按顺序好样本后，一定要注意起始号正确后才能开始进展检测，否那么导致样本张冠李戴。