罗氏电化学发光法
罗氏电化学发光法
罗氏电化学发光法是一种基于电化学原理的分析方法，通过测量电化学发光信号来分析样品中的分析物含量。
它结合了电化学和发光技术的优势，能够实现对微量分析物的高灵敏度检测。
在罗氏电化学发光法中，通常采用电化学发光细胞作为检测器。
该细胞由一个阳极和一个阴极组成，它们之间通过一个电解质溶液相连。
当外加电压施加在阳极和阴极之间时，电解质溶液中的分析物会被氧化或还原，产生电化学反应。
这些反应会产生电流，并激发发光物质发出光信号。
罗氏电化学发光法的原理是基于电化学发光物质的特性。
这些发光物质通常是有机化合物，具有发光的性质。
当发光物质被激发时，它们会从一个激发态返回到基态，释放出能量并发出光信号。
这个过程是可逆的，可以重复使用。
在进行罗氏电化学发光分析时，首先需要选择合适的电化学发光物质。
这个物质应该具有良好的发光性质，能够在特定条件下发出稳定的光信号。
然后，需要确定适当的电化学条件，包括电压、电流和电解质浓度等。
这些条件应该能够使发光物质发出最大的光信号，并且与样品中的分析物发生特异性反应。
在实际应用中，罗氏电化学发光法被广泛用于药物分析、环境监测和生物分析等领域。
它具有高灵敏度、高选择性和高稳定性的优点。
相比于传统的光谱分析方法，罗氏电化学发光法能够实现对微量分析物的快速和准确检测。
然而，罗氏电化学发光法也存在一些限制。
首先，需要选择合适的发光物质和电化学条件，这对于初学者来说可能具有一定的挑战性。
其次，该方法对样品的前处理要求较高，需要去除干扰物质并提高分析物的浓度。
最后，罗氏电化学发光法在样品矩阵复杂或含有多种分析物的情况下可能会受到干扰。
总的来说，罗氏电化学发光法是一种有效的分析方法，能够实现对微量分析物的高灵敏度检测。
它的发展为化学分析提供了新的思路和方法，为科学研究和实际应用带来了许多便利。
随着技术的进一步发展，相信罗氏电化学发光法将在更多领域得到应用和推广。
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 The last 3 digits -190 have been replaced by -119 for logistic purposes.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。
电化学发光法检测孕中期孕妇产前筛查的结果
电化学发光法检测孕中期孕妇产前筛查的结果摘要：目的：应用电化学发光法检测在孕中期孕妇产前筛查中的效果及价值，并分析筛查结果。
方法：随机抽取2020年3月～2021年3月于我院门诊接受常规检查的孕妇786例，以电化学发光法，对所有孕妇实施二联检查，主要检查项目为甲胎蛋白和游离HCG。
结果：786例孕妇中，共计有23例孕妇筛查出有21-三体综合征高风险，阳性率为1.93%。
有15例孕妇遵循医生建议，进一步做羊水穿刺检测。
经过染色体核型分析，确诊10例。
有2例孕妇筛查出有18-三体综合征高风险，阳性率为0.25%。
有8例孕妇筛查出有神经管缺陷高风险，阳性率为1.02%。
有1例低风险孕妇，因B超检查结果显示畸形，做染色体后确诊唐氏综合征。
结论：孕中期孕妇产前二联筛查中，应用电化学发光法检测的安全性较高，且能够从相对全面的角度上了解筛查结果，及时发现唐氏综合征风险，在降低缺陷儿方面的作用比较明显，可将其广泛应用于临床中。
关键词：电化学发光法；孕中期；产前筛查近年来，唐氏儿的发生率有所上升[1]。
与此同时，越来越多的孕妇在孕中期开始加强对唐氏综合征筛查的重视。
在孕中期产前诊断中，唐氏综合征筛查是关键环节，也是孕妇是否行羊水穿刺的依据。
产前筛查，是非创伤性的简便检查方式[2]。
目前，产前筛查中比较常用的方法是电化学发光法。
通过电化学发光法，能够筛查出唐筛高风险，为孕妇是否做羊水穿刺检查提供依据。
本次研究为明确电化学发光法检测对孕周期孕妇产前筛查的结果，展开如下探讨。
1 资料与方法1.1一般资料随机抽取2020年3月～2021年3月于我院门诊接受常规检查的孕妇786例，将其纳入到试验中展开探究。
在上述入选孕妇中，最低年龄孕妇是22岁，最高年龄孕妇是38岁，年龄平均值（30.26±2.54）岁；最低孕周是15周，最高孕周是20周，孕周平均值（17.59±2.65）周。
纳入标准：（1）入选对象均为一胎孕妇；（2）入选对象均处于妊娠中期（15周-20周）；（3）入选对象接受并且认可本次研究；（4）研究经过院内伦理委员会批准。
罗氏免疫新项目及特有项目介绍
Pro-GRP
anti-CCP
PCT
anti-TSHR anti-TPO anti-TG
TG Calcitonin
IgE AFP
IGF-1 hCG+β Ferritin
IL-6 hGH
CEA
C-Peptide Insulin Cortisol ACTH
fPSA
PSA
hs TG
fβhCG hCG STAT
Digitoxin
激素类
ACTH
Cortisol C-peptide DHEA-S
Estradiol
Free β-HCG FSH
HCG+B Insulin
LH PAPP-A Progesterone Prolactin SHBG Testosterone
hGH
甲状腺疾病 骨标志物 贫血/其它
T3
Total-PINP Ferritin
罗氏电化学发光检测新项目及特有项目
项目名称
临床应用
杭州收费标准
产 PAPP-A妊娠相关血浆蛋 唐氏综合征的早期产前 收费申请中
前 白A
筛查，提前到孕早期10
筛
～14周即能监测,检出
查 f-βHCG 游离绒毛膜促 率82~87%明显高于中期 40元
性腺激素
(67~69%)
先 sFlt-1 可溶性fms样酪 罗氏是目前唯一的全自 收费申请中
2014.Q2 2014.Q1
预计2015.Q2上市
IM Assay Update
2012年开始陆续上市产品
Panel 骨标志物 生长激素
Product Name
Content
Estimated Launch date of China
罗氏电化学发光检测项目参考范围一览表V201301 - 副本
名称
单位
参考范围
单位
参考范围
AFP
甲胎蛋白
CEA
癌胚抗原
CA125 CA15-3 CA19-9 CA72-4
糖基抗原CA125 糖基抗原CA153 糖基抗原CA199 糖基抗原CA724
Total-PSA 总前列腺特异性抗原
%fPSA
游离前列腺特异性抗 原%
Cyfra21-1 细胞角蛋白19片段
IU/ml
妊娠14周:<23.2 妊娠15周:<25.6
妊娠16周:<36.1
妊娠16周:<30.0
妊娠17周:<40.4
妊娠17周:<33.5
妊娠18周:<48.3
妊娠18周:<40.1
妊娠19周:<54.8
妊娠19周:<45.5
20-69岁：<4.7
≥40岁：<5.2
ng/ml 非吸烟者20-69岁：<3.8 非吸烟者≥40岁：<5.0
NSE
神经元特4
人附睾蛋白4
成人<=7.0
成人<=5.8
儿童<30天：50-100000
儿童<30天：41.5-83000
儿童1－3月：40-1000
儿童1－3月：33.2-830
儿童4月到18岁：<12
儿童4月到18岁：<9.96
ng/ml
妊娠14周:<27.9 妊娠15周:<30.9
吸烟者20-69岁：<5.5
吸烟者≥40岁：<6.5
U/ml <35.0
U/ml <25.0
U/ml <27.0
罗氏 E 601 电化学发光免疫分析仪用户操作手册(中文)
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COBAS6000全自动电化学发光免疫分析仪性能验证
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罗 氏 Ｃ Ａ ６０ ＯＢ Ｓ０ ０全 自动 电化 学发 光 免 疫 分 析仪 性 能 验 证
罗氏2010化学发光SOP
罗氏诊断Elecsys 2010SOP文件运行条件ROCHE（罗氏）Elecsys 2010全自动电化学发光免疫分析仪1、环境条件为了确保系统操作的正常运转，应该保证以下的条件：∙无灰尘的、良好通风的环境∙无直接日照∙地面水平(角度：<1/200 º)∙地面足够坚硬能够承受仪器的重量∙温度：18~32摄氏度∙当系统启动时，温度的改变应该小于2度/小时∙屋内湿度：20%~85%∙电源电压没有明显的波动∙在附近没有会产生电磁波的仪器∙有接地的三相电源∙噪音应该小于65分贝2，水质要求∙无菌 (< 10 cfu/ml)，去离子水∙ 1.5 MΩ电阻值 (最大1.0 Ms/cm)∙15-25 磅/英寸2 (0.5~3.5 kg/cm2或 49~343 kpa)安全注意事项尤其要注意以下安全注意事项。
如果忽视了这些安全注意事项，则操作人员可能遭受重伤或致命伤害。
每个注意事项都很重要。
操作人员资格操作应在技术人员的监督之下进行，该技术人员曾于销售代理指定的实验室培训过。
认真遵守操作手册中规定的程序进行系统操作和维护。
本操作手册中没有说明的维护应由经过培训的罗氏技术支持人员进行。
安装要求安装由罗氏诊断代表进行。
客户负责提供必要的设施。
接通仪器在停机后1秒内不要接通电源。
电气安全注意事项对于任何电子设备，可能出现触电的危险。
不要企图接近标有该标签的仪器部件。
不要企图在任何电子室中工作。
只有经过授权的和具备资格的人员才能进行安装、维护和修理。
固体和液体废物与废液接触会导致感染。
在进行维护时，要确保佩带防护设备。
如果废液与皮肤接触，立即用水冲洗并加以消毒剂。
向内科医生咨询。
运动部件在仪器操作期间，不要将手放入仪器中。
接触标本机构、试剂移液机构、搅拌机构或其它机构可造成伤害。
在开始操作或维护/检查之前，要保证关闭并锁紧顶盖。
不要在操作期间，打开顶盖。
在打开顶盖进行维护和检查时，要保证遵循本手册中提供的程序。
罗氏Cobase601电化学发光免疫分析仪的故障分析与维修
图1 试剂针及传动组件实物图
用于测定试剂针垂直方向是否停留在准确位置的传）试剂针传动组件出现故障。
传动组件由电机
图2 卡簧断裂的轴承
图3 完好的轴承
故障案例二
4.1 故障现象
仪器在使用过程中，操作软件出现一级报警
Tip/Cup Gripper Movement”，报警代码为
此报警内容为：抓手出现异常动作
对这项报警有更详细的描述“Tip Cup Gripper finger did 表示抓手未关闭。
故障分析
抓手开合动作的位置是否准确由传感器来检测
传感器表面被灰尘污染会导致抓手报警。
（
图4 抓手整体构造图
故障处理
对于第一种故障原因，应用洗耳球清洁传感器再从操作软件的“综合功能”的“维护”界面中执行抓手重复动作的命令。
（2）对于第二种故障原因，若发现抓手片表面附着血清，则应用棉签清除血清。
（3）在
面中执行抓手动作的命令，若抓手能启动，则基本可以排除。
笔者在本次的维修中，观察到抓手片表面附着大量固体
而且很难彻底清除，这就是出现本次故障的直接原因经过本次维修，笔者将清洁抓手片的项目添加到这台机器的，以定期维护，大大降低抓手的故障率
Cobas e601电化学发光免疫分析仪有强大的故障
，仪器通过自身的传感器，在其运转过程中实时或在固定时间段进行测量，获取压力、位置等信息
件中对故障有详细的描述，同时会对故障进行初步判断并给，维修人员可以将软件中故障解决方案和维修经验相结合的方式对仪器进行故障分析与维修。
罗氏Cobas E411及Cobas E601电化学发光免疫分析仪的故障分析与维修
维修工程ZHONGGUO YIXUEZHUANGBEI159插入16 mm标本试管中用。
3 罗氏Cobas E601报警故障3.1 故障案例一(1)故障现象。
搅拌棒运动异常，报警代码为161和162。
(2)故障分析。
①搅拌棒未在复位期间离开回转的初始位置；②搅拌棒未在复位期间回转的初始位置停止；③搅拌棒未在回转的初始位置停止；④搅拌棒未在回转的混合位置停止；⑤搅拌棒未在初始位置(向上的)的垂直位置停止。
(3)故障处理。
先清理搅拌棒移动路径上的障碍，再运行“机械检查”(10个循环)，在“综合功能”工作的“维护”界面上，观察操作，若故障依旧，需联系厂商维修工程师进行处理。
杜 涛① 魏晓峰① 袁聪玲①*[文章编号] 1672-8270(2017)11-0159-02 [中图分类号] R197.39 [文献标识码] B罗氏Cobas E411及Cobas E601电化学发光免疫分析仪的故障分析与维修DOI: 10.3969/J.ISSN.1672-8270.2017.11.048[关键词] 电化学发光；免疫分析仪；报警故障；故障维修①荆州市第一人民医院核医学科 湖北 荆州 434000*通讯作者：108483796@作者简介杜涛,男,(1978- ),本科学历，主管技师。
荆州市第一人民医院核医学科，从事核医学科实验室检验工作。
中国医学装备2017年11月第14卷第11期 China Medical Equipment 2017 November V ol.14 No.11化学发光免疫分析法(chemiluminescence immu-noassay，CLIA)具有的高特异性灵敏度的特点，在电生化分析、法医鉴定以及食品安全等方面起到至关重要的作用，广泛适用于各学科不同领域的应用需求。
荆州市第一人民医院先后引进罗氏Cobas E411及Cobas E601电化学发光免疫分析仪，由于设备使用频率高，发生故障时会报警提示，医学工程人员按照操作手册及使用经验，以最短时间对故障进行妥善处理。
罗氏E601电化学发光免疫分析仪用户操作手册(中文)
第六章 仪器报警信息......................................................................... .. 51
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第一章 系统概述
1、 控制单元
A 显示器（连接cobas link） B 键盘/鼠标（连接cobas link） C 计算机（连接cobas link） G 人体学PC支架
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