Sirolimus西罗莫司检测试剂盒电化学发光法说明书
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 The last 3 digits -190 have been replaced by -119 for logistic purposes.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。
西罗莫司血药浓度测定方法的建立及在肝移植患者中的应用_百度文.
收稿日期 :2010－08－17作者单位 :1. 大连医科大学附属第二医院药剂科 , 大连 116027; 2. 大连医科大学药学院 , 大连 116044*通讯作者西罗莫司血药浓度测定方法的建立及在肝移植患者中的应用张宁 1, 吕慧怡 1*, 邓卅 2, 范青1[摘要 ]目的建立高效液相色谱法测定西罗莫司血药浓度 , 测定该药在肝移植患者中的药代动力学参数。
方法以沉淀 -萃取法处理全血样品 , 采用Hypersil ODS C 18(250mm ˑ 4. 6mm , 5μm 柱 , 柱温为50ħ , 乙腈 -甲醇 -水 (7. 5ʒ 62. 5ʒ 30 为流动相 , 流速 1. 2mL /min , 以 32-去甲基雷帕霉素为内标 , 在 276nm 波长处 , 检测西罗莫司血药浓度 , 并应用此方法测定 5例肝移植患者的西罗莫司血药浓度。
结果全血中西罗莫司浓度在 2. 0 50. 0ng /mL 范围内线性良好 (r =0. 9997 , 平均相对回收率为 99. 1%(n =5 。
5例肝移植患者的 C max 为 (12. 66ʃ4. 1 ng /mL , t 1/2为 (19. 2ʃ 11. 2 h , t max 为 (1. 8ʃ 0. 3 h 。
结论本方法快速、简便、准确 , 灵敏度高 , 重现性好 , 可用于肝移植患者的西罗莫司临床药物监测。
[关键词 ]西罗莫司 ; 高效液相色谱法 ; 血药浓度 ; 肝移植Determination of sirolimus in human whole blood by HPLC and the exploratory in liver transplantation ZHANG Ning 1, L Hui-yi 1*, DENG Sa 2, FAN Qing 1(1. Department of Pharmacy ,The Second Affiliated Hospital of Dalian Medical University , Dalian 116027, China ; 2. Department of Pharmacology , Dalian Medical University , Dalian 116044, China[Abstract ]Objective To establish an HPLC method to determine the concentration of sirolimus in wholeblood．MethodsThe whole-blood samples were pretreated by precipitation-extraction method , and sirolimus was de-termined by HPLC-UV．Hypersil ODS C 18analysis column (250mm ˑ 4. 6mm ,5μm was used , and the temperature was set at 50ħ ．The mobile phase was a mixture of acetonitrile-methanol-water (7. 5ʒ 62. 5ʒ 30 with a flow rate of 1. 2mL /min．The detection wavelength was set at 276nm．ResultsThe calibration curve was linear within the range 2. 050ng /mL (r =0. 9997 . The mean relative recovery was 99. 1%, and the mean absolute recovery was 82. 2%(n =5 ．The intra-day and the inter-day relative standard deviation did not exceed 3. 3%and 6. 3%respectively．In the five transplantationreceptors , C max was (12. 66ʃ 4. 1 ng /mL , t 1/2was (19. 2ʃ 11. 2 h , t max was (1. 8ʃ 0.3 h．Conclusion This method is simple , rapid , sensitive and suitable for therapeutic drug monitoring of sirolimus．Key words :Sirolimus ; HPLC ; Plasma drug concentration ; Liver transplantation西罗莫司 (Sirolimus , SRL , 商品名 Rapamune , 雷帕霉素 , 是一种大环内酯类免疫抑制剂 , 具有抗增殖、抗肿瘤及无肾毒性等特性 , 近年来逐渐应用于肝移植患者 , 使临床获得了防治肝移植术后肾功能不全、慢性排斥反应、肿瘤复发和提高移植物长期存活的新途径 [1]。
化学发光法EMSA检测试剂盒
化学发光法 EMSA 检测试剂盒Chemiluminescent EMSA Detection Kit货号：KGS133 保存温度：-20℃ For Research Use Only说明书修订日期：2015.12.01一、产品简介 本产品是一种通过 Streptavidin-HRP 及 ECL 检测试剂来实现化学发光检测 Biotin 标记的 EMSA 探针的检测试剂盒。
同时本试剂盒也提供 EMSA 检测所需的结合缓冲液和上样缓冲液，及一些关键的相关试剂， 可以实现非同位素的 EMSA 检测。
本试剂盒采用了高质量的 Streptavidin-HRP Conjugate，HRP 和 Streptavidin 共价交联的比例大于 3， 这样比采用 Streptavidin 和 Biotin-HRP conjugate 两种试剂进行检测要更方便，并且灵敏度更高。
本试剂盒采用了非特异性结合比 avidin 更低的 strepatavidin，使检测结果背景更低灵敏度更高。
EMSA/Gel-Shift 结合缓冲液(5X)中含有 poly(dI-dC)等有效成分。
其中 poly(dI-dC)的浓度经过优化， 可以很好的消除蛋白和标记探针间的非特异性结合，同时又不会减弱目的转录因子和标记探针间的结合。
本试剂盒可以用于 20 个蛋白和探针的结合反应，并足够检测至少 2 块有生物素标记 EMSA 探针的膜。
二、组份列表产品组份规格（50T）EMSA/Gel-Shift 结合缓冲液(5X)100µlEMSA/Gel-Shift 上样缓冲液(无色，10X)100µlEMSA/Gel-Shift 上样缓冲液(蓝色，10X)100µlECL Reagent A28mlECL Reagent B28mlStreptavidin-HRP Conjugate50µl封闭液190ml洗涤液(5X)125ml检测平衡液125ml注：如果长期不用，整个试剂盒可-20℃保存，-20℃可以保存更长时间。
西尼罗河病毒检测试剂盒说明书
西尼罗河病毒检测试剂盒【用途】美国FOCUS西尼罗河（West Nile）病毒IGM ELISA，利用了西尼罗重组抗原检测人体血清或血浆中的西尼罗抗体。
本实验仅用于辅助诊断人感染了西尼罗病毒，不用于筛查血液或血液成分。
仅供专业人员体外诊断使用。
【代理商】广州健仑生物科技有限公司【概述】感染了西尼罗病毒会导致包括脑炎等一系列症状的疾病，西尼罗病毒在世界广泛传播，已在50多个国家检测出该病毒。
本试验经CDC提供的试剂检验与验证。
本试验使用了一种称为WNRA的重组抗原，它可以作为西尼罗病毒感染的快速血清学指标，WNRA蛋白是一种重组抗原，它是由含有西尼罗病毒两个抗原的序列多肽构成。
【实验原理】检测西尼罗病毒IgG/IgM ELISA 是基于两步夹心法原理制造的。
【提供材料】1.微孔板（96孔 12x8）：即用每孔均包被结合西尼罗重组抗原的单抗。
2－8℃下保存至保质期。
注意：WNRA和NCA已包被于微孔板。
2.IGM样品稀释液：1支 25ml 即用 2-8℃下保存至使用。
3.IGM阴性质控：1支 30ul 2-8℃下保存至使用。
要长时间储存，将其分装于小瓶里，在-70℃下储存。
4.IGM阳性质控：1支 30ul 2-8℃下保存至使用。
要长时间储存，将其分装于小瓶里，在-70℃下储存。
5.洗涤液（10X）：1瓶 120ml 2－8℃下保存至使用。
6.EnWash：1瓶 20ml 2－8℃下保存至使用。
7.酶联物：一瓶6ml 即用 2－8℃下保存至使用。
8.TMB底物液：1支9ml 即用 2－8℃下保存至使用。
9.终止液；1支6ml 即用2－8℃下保存至使用。
试剂应避免反复冻融。
【操作步骤】在使用前将所有试剂和样品平衡至室温，并轻轻倒转使其充分混匀。
实验准备：将10X的浓缩洗涤液稀释,将120ml的浓缩洗涤液加上1080ml的蒸馏水，摇匀，至无任何沉淀，稀释好的洗涤液最多可在室温下放置两个星期。
准备实验所需的板条，剩余的板条应尽快放入袋子里重新密封，在2－8℃下储存至保质期。
化学发光法 说明书
化学发光法说明书化学发光法说明书一、引言化学发光法是一种常用的分析技术，它通过特定的化学反应产生发光现象，并利用测量发光强度来确定待测物质的浓度。
本说明书将介绍化学发光法的原理、实验步骤、仪器设备及应用领域。
二、原理化学发光法的原理基于化学反应产生发光的特性。
当特定的化学物质与待测物质发生反应时，会产生激发态的化学物种。
随后，激发态的化学物种会通过辐射或非辐射的方式回到基态，释放出能量并产生光。
通过测量发光强度，可以间接推测出待测物质的浓度。
三、实验步骤1. 准备样品：将待测物质制备成合适的浓度，并与特定的试剂混合。
2. 反应：在适当的条件下，使待测物质与试剂发生化学反应，产生发光。
3. 测量：利用发光仪器测量发光强度，并记录下来。
4. 构建标准曲线：根据已知浓度的标准样品的发光强度，绘制标准曲线。
5. 计算待测物质浓度：通过待测样品的发光强度，在标准曲线上找到对应的浓度值，并计算待测物质的浓度。
四、仪器设备化学发光法的实验需要使用特定的仪器设备，主要包括：1. 发光仪：用于测量样品的发光强度。
2. 标准样品：已知浓度的样品，用于构建标准曲线。
3. 试剂：与待测物质发生反应，产生发光的化学试剂。
4. 试管或微孔板：用于混合样品和试剂，进行反应。
五、应用领域化学发光法广泛应用于许多领域，包括：1. 生物医学研究：用于检测生物标志物、药物浓度等。
2. 环境监测：用于测定水中重金属、有机物等的浓度。
3. 食品安全：用于检测食品中的农药残留、添加剂等。
4. 公共安全：用于检测爆炸物、毒品等危险物质。
六、实验注意事项1. 实验操作要规范，遵守实验室安全规定。
2. 样品和试剂要保持干净和干燥，避免受到外界污染。
3. 仪器设备要正确校准，确保测量结果准确可靠。
4. 实验过程中要注意控制反应条件，如温度、pH值等。
5. 标准曲线的制备要精确可靠，避免误差产生。
七、总结化学发光法作为一种敏感、快速和准确的分析方法，在科学研究和实际应用中具有重要的地位。
西罗莫司片(雷帕鸣)中文说明书
西罗莫司片（雷帕鸣）中文说明书警示语：具有免疫抑制作用，不推荐用于肝或肺移植患者•由于免疫抑制作用，本品可增加感染机会也可能引发淋巴瘤及其他恶性肿瘤。
由于免疫抑制作用，本品可增加感染机会也可能引发淋巴瘤。
有免疫治疗和管理肾移植经验的医师方可使用本品。
使用本品的病人，应在具有一定资质条件的医疗机构内接受管理。
负责维持治疗的医师，应该不断完善病人的随访信息。
（见【注意事项】）•西罗莫司作为免疫抑制剂用于肝移植或肺移植患者的安全性和疗效尚未明确，因此，不推荐在此类患者中使用。
（见【注意事项】）•肝移植一死亡率增加、移植物失去功能及肝动脉血栓形成（HAT）在一项对新接受肝移植的患者进行的试验中，发现西罗莫司与他克莫司联合使用与死亡率和移植物失去功能增加相关。
这些患者中许多在死亡时或临近死亡时有感染的迹象。
在该试验及另一项对新接受肝移植患者进行的试验中，西罗莫司与环抱素或他克莫司联合使用与HAT发生率升高相关，大部份HAT发生于移植后30天内，并且大多导致了移植物失去功能或死亡。
（见【注意事项】）・肺移植一气管吻合处开裂新肺移植患者接受包括西罗莫司在内的免疫抑制治疗，有气管吻合处开裂的病例报道，大部分为致命性。
（见【注意事项】）【通用名称】西罗莫司片【商品名称】雷帕鸣【英文名称】Siro1.imusTab1.ets【汉语拼音】Xi1.uomosiPian【成份】本品的主要成份为西罗莫司。
化学名称：（3S,6R,7E,9R z10R,12R,14S z15E,17E z19E,21S,23S,26R,27R,34aS）-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a・十六氢∙9,27∙二羟基∙3-［（1.R）∙2-［（1.S,3R,4R）-4.羟基3甲氧环己基卜1•甲基乙基卜10,21・二甲氧・6,8,12,14,20,26・六甲基・23,27•环氧・3H・口比咤并［2,IyH4］氧杂氮杂三H^一环烯・1,5,11,28,29（4H,6H,31H）∙戊酮化学结构式：分子式：C SI H79NO I3分子量：914.2本品辅料为：乳糖一水合物，聚乙二醇8000粉末，硬脂酸镁，滑石粉，聚乙二醇20000,单油酸甘油酯（60%）,药用釉料（虫胶），无水硫酸钙，微晶纤维素，蔗糖，二氧化钛，泊洛沙姆188,聚维酮（K29/32）,维生素E（&・八生育酚），巴西棕檎蜡和其他成份。
罗氏电化学发光项目介绍
E2
Testo
Prog
LH
FSH
Prolactin
SHBG
CEA
fPSA
PSA
ßXlaps
Osteocalcin
PTH
bio-int. PTH
Vit D3
Vit D2/D3
P1NP
CA19-9
CA125
CA15-3
CA72-4
CYFRA
NSE
S100
GF-AP
anti-CCP
PCT
IL-6
IgE
Ferritin
B12
Folate
RBC Fol
Hepcidin
hCG+ß
AFP
fßhCG
PAPP-A
uE3
Inhibin A
hCG STAT
PlGF
sFLT1
TSH
FT4
FT3
T4
T3
T-uptake
TnT
hsTnT
TnI
Myoglobin
CK-MB
Cyclosp. A
Tacrolimus
Sirolimus
创始人
1926年进入中国
南京路上的办事处
江泽民参观罗氏总部
罗氏集团的两大事业部门
药品事业部 诊断事业部
罗氏集团架构
诊断
健康医护部
应用科学部
制药
制药
中外
基因泰克
专业诊断部
分子诊断部
组织诊断部
罗氏诊断覆盖领域
ER/ICU: Emergency Room, Intensive Care Unit
病人
04
Part
其他项目简介
一种西罗莫司纳米片剂及其制备方法[发明专利]
![一种西罗莫司纳米片剂及其制备方法[发明专利]](https://img.taocdn.com/s3/m/6eb2dc5aa55177232f60ddccda38376baf1fe09c.png)
(19)中华人民共和国国家知识产权局(12)发明专利申请(10)申请公布号 (43)申请公布日 (21)申请号 201711090619.6(22)申请日 2017.11.08(71)申请人 北京化工大学地址 100029 北京市朝阳区北三环东路15号(72)发明人 乐园 沈煜栋 陈鹏 林谡轩 (74)专利代理机构 北京志霖律师事务所 11575代理人 张文祎(51)Int.Cl.A61K 9/20(2006.01)A61K 47/26(2006.01)A61K 47/38(2006.01)A61K 47/32(2006.01)A61K 47/36(2006.01)A61K 47/20(2006.01)A61K 31/436(2006.01)A61P 37/06(2006.01)(54)发明名称一种西罗莫司纳米片剂及其制备方法(57)摘要本发明公开了一种西罗莫司纳米片剂包括如下重量份数的原料：西罗莫司纳米药物组合物2-15份，赋形剂80-160份，填充剂80-120份，崩解剂30-50份，粘合剂30-60份，润滑剂5-15份；本发明还公开了西罗莫司纳米片剂的制备方法。
本发明制备得到的西罗莫司纳米片剂，溶出度较进口片剂提高约15-30％，生物利用度更高，稳定性更好；便于包装、储存、运输及携带；便于吞服，服用方便，吸收性好，减少服用过程中药物损失。
本发明制备工艺过程简单，对设备无特殊要求，容易实现，能耗少，效率高，成本低，且非常容易放大，达到工业化生产的发明目标。
权利要求书1页 说明书8页 附图3页CN 107811979 A 2018.03.20C N 107811979A1.一种西罗莫司纳米片剂，其特征在于，包括如下重量份数的原料：西罗莫司纳米药物组合物 2-15份，赋形剂 80-160份，填充剂 80-120份，崩解剂30-50份，粘合剂30-60份，润滑剂5-15份。
2.根据权利要求1所述西罗莫司纳米片剂，其特征在于：所述西罗莫司纳米药物组合物中，西罗莫司纳米颗粒的平均粒径小于400nm，西罗莫司药物有效成分占15％-20％。
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监测药物浓度的一个关键原因是剂量并不 能很好地预测药物暴露量。对于肝功能受 损患者，当西罗莫司的清除接近肝脏血流 时，应检测西罗莫司血药浓度，据此调整 剂量。西罗莫司经细胞色素P450-3A4同工 酶代谢，该酶也参与很多其他药 物的代谢，因此应密切检测药物浓度，以 了解药物-药物相互作用。关于可能导致西 罗莫司血药浓度升高或降低的药物相互作 用已有大量数据，例如西罗莫司与环孢素 和他克莫司的相互作用。7
概要 西罗莫司（雷帕霉素）是吸水链霉素产生 的一种大环抗生素。该药最早是在复活节 岛（拉帕努伊岛）的泥土样本中发现。西 罗莫司最早被用作抗真菌药。在1988年发 现其具有免疫抑制作用。1999年，FDA批 准西罗莫司用于预防肾移植术后排斥反 应。西罗莫司和依维莫司等mTOR抑制剂是 降低移植患者的钙调神经蛋白抑制剂用 量，因此可减少非肾移植患者的肾毒性， 同时也能延长肾移植患者的长期异基因移 植生存时间。1,2
西罗莫司给药后约2小时达到浓度峰值 （Cmax）。经过吸收，大量西罗莫司（约 92%）结合血浆蛋白。西罗莫司是CYP3A4 和P-糖蛋白的底物，主要经肝脏和肠壁代 谢，从小肠上皮细胞转移到肠腔内。西罗 莫司经O-脱甲基化和（或）羟基化代谢， 全血中可测出的代谢物主要有7种。超过 90%的免疫抑制活性由母体化合物提供。情 况稳定的肾移植患者经过多次西罗莫司给 药后，西罗莫司的消除半衰期约为60小 时。4
【检验原理】 手工沉淀 在使用 Elecsys 西罗莫司检测试剂检测之 前，必须根据 Elecsys ISD 样本预处理方法 对患者样本、定标液和质控品进行预处 理。
06327974190
2018-04，V1.0
Sirolimus
西罗莫司检测试剂盒（电化学发光法）说明书
试剂会裂解细胞、提取西罗莫司并致多数 血浆蛋白沉淀。离心预处理后的样本，使 用 Elecsys 西罗莫司检测试剂对含西罗莫司 的上清液进行检测。 竞争法。总检测时间：18 分钟。 ▪ 第 1 次孵育：使用西罗莫司特异性生物 素化抗体孵育 35 μL 预处理样本，西罗莫 司与抗体形成免疫复合物，免疫复合物的 数量取决于样本中的分析物浓度。 ▪ 第 2 次孵育：加入链霉亲合素包被微球 和钌复合物 a)标记的西罗莫司衍生物之 后，生物素化抗体的空位点被占据，形成 抗体-半抗原复合体。整个复合物通过生物 素和链霉亲和素的相互作用与固相结合。 ▪ 未与磁珠微粒结合的物质通过 ProCell/ProCell M 除去。给电极加以一定的 电压，使复合物化学发光，并通过光电倍 增器测量发光强度。 ▪ 通过检测仪的定标曲线得到最后的检测 结果，定标曲线是通过 2 点定标和试剂条 形码上获得的主曲线生成的。 a) Tris（2,2'-双吡啶）钌(II)-复合体 (Ru(bpy)32+)
Sirolimus 西罗莫司检测试剂盒（电化学发光法）说明书
【产品名称】 通用名称：西罗莫司检测试剂盒（电化学 发光法） 英文名称：Sirolimus
【包装规格】 100 测试/盒
【预期用途】 主要用途 用于人全血中西罗莫司的体外定量测定的 免疫分析，用于辅助管理接受西罗莫司治 疗的肾脏移植患者。 Elecsys和cobas e免疫分析仪的工作原理是 电化学发光免疫分析“ECLIA”。
西罗莫司的常见副作用包括高血压、高脂 血症、贫血、血小板减少症、电解质紊乱 （低钾和低磷）、周围性水肿、腹痛、关 节痛、皮肤疾病、发热、头痛、恶心、腹 泻或便秘，淋巴管瘤的发生率升高。5
需要对西罗莫司谷浓度（C0）进行治疗药 物监测（TDM），主要是因为该药的药代 动力学存在较大的个体内与个体间差异。2,6 给药前样本（也称为谷浓度样本或C0样 本）的血药浓度-时间曲线下面积（AUC） 反映了总暴露量。研究显示西罗莫司C0浓 度与AUC之间存在良好的相关性。西罗莫 司与环孢素或他克莫司联用时，该相关性 依然存在。7,8
Байду номын сангаас
• REF 05889073190，ISD 样本预处理试 剂，1 x 30 mL • REF 06327982190，西罗莫司 CalSet，6 x
1.0 mL • REF 05889081190，PreciControl ISD，3 x
3.0 mL • REF 11732277122，Diluent Universal，规 格 2 x 16 mL 样本稀释液，或 REF03183971122，Diluent Universal，规格 2 x 36 mL 样本稀释液，或 REF 05192943190，Diluent Universal 2，2 x 36 mL 样本稀释液 • REF 11776576322，CalSet Vials，2 x 56 只压盖式小空瓶
• 通用实验室设备
• 微量移液器（对 ISD 样本预处理试剂操 作，仅可使用正排量移液器）
• 微量离心管（2.0 mL） • 微型离心机（至少 10000 g） • 涡旋搅拌机
• 滚轴混合器或搅拌器
• MODULAR ANALYTICS E170 或 cobas e 分析仪
【主要组成成分】 试剂—工作溶液 该试剂rackpack标记为SRL。 M 包被链霉亲合素的磁珠微粒（透明 瓶盖），1瓶，6.5 mL： 包被链霉亲合素的微粒：0.72 mg/mL；防 腐剂。 R1 生物素标记的抗西罗莫司抗体（灰 色瓶盖），1瓶，9 mL： 生物素标记的抗西罗莫司单克隆抗体 （兔）35 μg/L；磷酸盐缓冲液100 mmol/L, pH 7.8；防腐剂。 R2 Ru(bpy)32+标记的西罗莫司衍生物 （黑色瓶盖）,1瓶，9 mL： 钌复合物标记的西罗莫司衍生物18 μg/L； 柠檬酸盐缓冲液10 mmol/L，pH 6.0；防腐 剂。