甲型肝炎病毒抗体电化学发光检测试剂盒说明书

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 The last 3 digits -190 have been replaced by -119 for logistic purposes.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。

T4甲状腺素化学发光试剂盒使 用 说 明 书济南杏恩生物科技有限公司T4甲状腺素化学发光试剂盒说明书【临床意义】通过化学发光酶免疫法定量分析人血清或血浆中的总T4甲状腺素（Total Thyroxine，tT4）的浓度。

T4增高见于甲抗、T4型甲抗、亚急性甲状腺炎、高TBG血症、甲状腺激素不敏感综合症；减低见于甲减、地方性甲状腺肿、慢性淋巴性甲状腺肿、甲亢治疗期、严重肝病、TBG降低。

【原理】 酶免疫分析测试【试剂存放方式】（所有试剂保存在2-8℃）【试剂盒组成】1． T4 包被板：1板，可拆板，8×12孔。

2． T4 标准品： 6小管，0.3ml/管3． 各个标准品浓度分别为0, 2,5,10,15,25 ug/dl。

4． 浓缩的 T4 标记偶合液（11×）：1小管，0.5ml/管。

5． T4 偶合稀释液：1瓶，5ml/瓶。

6. T4低质控对照品：0.3ml/管7. T4高质控对照品：0.3ml/管8． 发光底物 1：5ml/瓶，含有H2O2的缓冲液。

9． 发光底物 2：5ml/瓶，含有发光触酶的缓冲液。

10. 产品说明书一份。

适用机器: 国内外所有板式化学发光仪 .【样本采集】本测试的样品为血清或血浆。

样品可保存在2-8℃下48小时，如需长期保存需冷冻在-20℃。

样品在解冻后需混合均匀后再进行测试简易操作步骤样品化学发光标记偶合液反应时间 15分钟 （室温25+/-2度）洗板Mediators PHL TM 选定程序 机器自动加底液发光底物1反应时间5分钟（室温25+/-2度发光底物2立即测读（1秒钟之内）计算样品浓度。

文件编号： ABCD-SOP-01-14AB C D 医院 免疫实验室［前言］这种抗体是感染甲肝病毒（HAV ）后病人血中最早出现的一种抗体，属于HAV衣壳抗体。

［原理］Z 本试剂盒采用捕获法检测人血清或血浆中的甲肝IgM 抗体。

具有简便、快速、准确、样本不需稀释等优点，适用于甲型肝炎的早期诊断。

试剂自生产日起避光贮存于2-8℃,有效期内稳定。

［标本的收集与处理］标本为无溶血血清。

［操作步骤］1、加样：将包被板预先编号。

设空白对照1孔，阴、阳性对照各2孔。

力口阴、阳性对照血清各50ul 于相应孔内，其余各孔分别加入50ul 待测样本（不能稀释）, 轻轻振荡后封板。

2、温育：置37℃水浴箱温育30分钟。

3、洗涤：扣去孔内液体，用洗涤液注满各孔，静置2分钟，扣去洗涤液，重复4次，最后一次在吸水纸上拍干。

4、加酶:除空白对照孔外,每孔加入HA.Ag50ul ,酶标记物溶液50ul,轻轻振荡后封板。

5、温育：置37℃水浴箱温育30分钟。

6、洗涤：同步骤3洗涤7、显色：每孔加底物液A 1滴（50ul ）.底物液B1滴（50ul ）,轻拍混匀后,置37℃水浴15分钟，目测结果或加入终止液1滴（50ul ）用酶标仪判读。

［结果判定］1、目测法：在白色背景下观察各孔颜色，无色或极淡兰色判为阴性，呈明显 甲型肝炎病毒IgM （ HAvIgM ） 版序：abed 页码：第1页，共2页［试剂组成］1、包被板条2、阴性对照血清3、阳性对照血清4、醵标记物溶液5, HA. Ag［试剂厂家］深圳月亮湾生物工程有限公司［试剂的稳定性与贮存］ 6、底物液A 7、底物液B 8、终止液 9、浓缩洗涤液 （用蒸储水1： 20稀释后使用）文件编号：ABCD-SOP-01-14 兰色判为阳性。

AB C D医院免疫实验室版序：abed甲型肝炎病毒IgM( HAvIgM ) 页码：第2页，共2页2、酶标仪检测法(选择波长450nm)：用空白孔校零，测定各孔吸光度0D值。

化学发光hcv试剂说明书化学发光HCV试剂说明书第一部分：产品介绍1.1 产品名称：化学发光HCV试剂1.2 产品编号：HCV1-20211.3 适用范围：本试剂适用于检测人类乙型肝炎病毒（HCV）感染的血清或血浆样本。

1.4 检测原理：本试剂采用化学发光技术，利用一种特定的发光底物和酶标抗体反应，产生发光信号，用于HCV抗体的检测。

1.5 环境要求：试剂应在2-8°C冷藏保存，避免暴露在光线直射下，避免反复冻融。

1.6 有效期：本试剂有效期为生产日期后12个月。

第二部分：试剂组成2.1 试剂盒配置本试剂盒包含以下试剂：- 试剂A：包含特定的抗原液，用于与待测样本中的HCV抗体结合。

- 试剂B：包含辣根过氧化物酶（HRP）偶联的检测抗体，用于与HCV抗体结合的复合物与底物发生反应产生发光。

- 洗涤缓冲液：用于洗涤微孔板中的非特定结合物。

- 底物液：一种特定的发光底物，在HRP反应催化下发光。

- 停止液：可用于停止发光反应。

2.2 试剂储存- 试剂A、试剂B、洗涤缓冲液：储存在2-8°C冷藏条件下。

- 底物液、停止液：室温储存。

第三部分：试剂使用步骤3.1 实验准备- 取出所需试剂并根据试剂使用说明预先配制。

- 预热微孔板洗涤器至37°C。

- 将未开封的试剂储存在2-8°C冷藏条件下。

3.2 样本处理- 取出待测样本，将样本离心10分钟以去除悬浮的颗粒物。

- 将样本稀释至适当浓度，根据试剂说明书中的建议稀释比例进行稀释。

3.3 试剂处理- 取出所需试剂和微孔板，按照试剂使用说明书中的建议加入试剂至微孔板孔中。

- 使用洗涤缓冲液进行洗涤，移除非特异结合物。

- 加入底物液进行发光反应，停止液可选用。

3.4 发光检测- 将微孔板放入合适的发光仪中，根据仪器说明书检测发光强度。

- 检测结果可根据试剂盒提供的标准曲线进行计算。

第四部分：结果解读4.1 阳性结果- 当待测样本中存在HCV抗体时，样本中的HCV抗体会与试剂中的抗原结合，形成抗原-抗体复合物。

人甲肝病毒IgG抗体（HAV-IgG）ELISA试剂盒使用说明书本试剂仅供研究使用目的：本试剂盒用于检测人血清，血浆及相关液体样本中人甲肝病毒IgG抗体（HAV-IgG）水平。

实验原理：本试剂盒采用双抗原夹心酶联免疫法（ELISA）测定标本中人甲肝病毒IgG抗体（HA V-IgG）。

用纯化的抗原包被微孔板，制成固相抗原，可与样品中甲肝病毒IgG抗体（HA V-IgG）相结合，经洗涤除去未结合的抗体和其他成分后再与HRP标记的抗原结合，形成抗原-抗体-酶标抗原复合物，经过彻底洗涤后加底物TMB显色。

TMB在HRP酶的催化下转化成蓝色，并在酸的作用下转化成最终的黄色。

用酶标仪在450nm波长下测定吸光度（OD值），与CUTOFF值相比较，从而判定标本中人甲肝病毒IgG抗体（HA V-IgG）的存在与否。

试剂盒组成：样本处理及要求：1. 血清：室温血液自然凝固10-20分钟，离心20分钟左右（2000-3000转/分）。

仔细收集上清，保存过程中如出现沉淀，应再次离心。

2. 血浆：应根据标本的要求选择EDTA或柠檬酸钠作为抗凝剂，混合10-20分钟后，离心20分钟左右（2000-3000转/分）。

仔细收集上清，保存过程中如有沉淀形成，应该再次离心。

3. 尿液：用无菌管收集，离心20分钟左右（2000-3000转/分）。

仔细收集上清，保存过程中如有沉淀形成，应再次离心。

胸腹水、脑脊液参照实行。

4. 细胞培养上清：检测分泌性的成份时，用无菌管收集。

离心20分钟左右（2000-3000转/分）。

仔细收集上清。

检测细胞内的成份时，用PBS（PH7.2-7.4）稀释细胞悬液，细胞浓度达到100万/ml左右。

通过反复冻融，以使细胞破坏并放出细胞内成份。

离心20分钟左右（2000-3000转/分）。

仔细收集上清。

保存过程中如有沉淀形成，应再次离心。

5. 组织标本：切割标本后，称取重量。

加入一定量的PBS，PH7.4。

人抗甲型肝炎病毒IgG抗体（anti-HAV）酶联免疫分析试剂盒使用说明书本试剂盒仅供体外研究使用!预期应用ELISA法定量测定人血清、血浆或其它相关生物液体中anti-HAV IgG含量。

实验原理用纯化的抗体包被微孔板，制成固相载体，往包被抗anti-HAV IgG抗体的微孔中依次加入标本或标准品、生物素化的抗anti-HAV IgG抗体、HRP标记的亲和素，经过彻底洗涤后用底物TMB显色。

TMB在过氧化物酶的催化下转化成蓝色，并在酸的作用下转化成最终的黄色。

颜色的深浅和样品中的anti-HAV IgG呈正相关。

用酶标仪在450nm波长下测定吸光度（OD值），计算样品浓度。

试剂盒组成及试剂配制1.酶联板：一块（96孔）2.标准品（冻干品）：2瓶，每瓶临用前以样品稀释液稀释至1ml，盖好后静置10分钟以上，然后反复颠倒/搓动以助溶解，其浓度为10ng/ml，做系列倍比稀释（注：不要直接在板中进行倍比稀释）后，分别稀释成10ng/ml，5ng/ml，2.5ng/ml，1.25ng/ml，0.625ng/ml，0.312ng/ml，0.156ng/ml，样品稀释液直接作为标准浓度0ng/ml，临用前15分钟内配制。

如配制5ng/ml标准品：取0.5ml（不要少于0.5ml）10ng/ml 的上述标准品加入含有0.5ml样品稀释液的Eppendorf管中，混匀即可，其余浓度以此类推。

3.样品稀释液：1×20ml。

4.检测稀释液A：1×10ml。

5.检测稀释液B：1×10ml。

6.检测溶液A：1×120μl（1:100）临用前以检测稀释液A1:100稀释，稀释前根据预先计算好的每次实验所需的总量配制（100μl/孔），实际配制时应多配制0.1-0.2ml。

如10μl检测溶液A加990μl检测稀释液A的比例配制，轻轻混匀，在使用前一小时内配制。

7.检测溶液B：1×120μl/瓶（1:100）临用前以检测稀释液B1:100稀释。

医疗器械产品技术要求编号：甲型肝炎病毒IgM抗体检测试剂盒(酶联免疫法)1. 产品型号/规格及其划分说明1.1产品规格：48人份/盒、96人份/盒。

2. 性能指标用企业参考品进行检定。

2.1外观检查试剂盒标签、瓶签上的名称、批号、保存方法和有效期应准确清晰。

试剂各组分品种和数量齐全，说明书无缺，液体组分应澄清，外盒清洁平整，包被抗人IgM的微孔板封存良好。

2.2 阴性参考品符合率对15份阴性参考品进行检测，假阳性不得多于1份。

2.3阳性参考品符合率对15份阳性参考品进行检测，假阴性不得多于1份。

2.4 最低检出量对系列稀释参考品进行检测，应不低于1:8稀释度。

2.5精密性用精密性参考品测试，平行测定10孔，CV(%)≤15%。

2.6 稳定性试剂37℃放置6天，检测结果应符合2.2、2.3、2.4、2.5要求。

3. 检验方法3.1外观检查目力观察试剂盒外包装及内容物，检测应符合2.1要求。

3.2 阴性参考品的检测按试剂盒操作说明书及参考品使用说明要求，对15份阴性参考品进行检测，检测结果符合2.2要求。

3.3 阳性参考品的检测按试剂盒操作说明书及参考品使用说明要求，对15份阳性参考品进行检测，检测结果符合2.3要求。

3.4 最低检出量按试剂盒操作说明书及参考品使用说明要求，对系列稀释参考品进行检测，结果符合2.4要求。

3.5 精密性检测按试剂盒操作说明书及参考品使用说明要求，用精密性参考品进行测试，平行测定10孔，精密性(CV)计算公式：CV(%)=SD/m×100% (SD为各个测定值的标准差，m为各个测定值的算术平均值)，检测结果符合2.5要求。

3.6 稳定性试验将试剂各组分37 C放置6天，取出平衡至室温后，按试剂盒操作说明书及参考品使用说明要求进行实验，检定结果符合2.6要求。

化学发光hcv试剂说明书一、产品概述化学发光HCV试剂是一种用于检测丙型肝炎病毒(HCV)的试剂。

本试剂采用化学发光免疫分析技术，能够快速、精准地定性和定量检测人体血液中的HCV抗体。

二、产品组成化学发光HCV试剂包括以下成分：1. HCV抗原液：用于与血液中的HCV抗体发生特异性反应。

2. 特异性标记物：用于标记与HCV抗体结合的复合物。

3. 化学发光底物：用于产生化学发光信号。

三、试剂使用方法1. 取出化学发光HCV试剂盒，并根据包装上的说明书，将所需试剂恢复至室温。

2. 将待测试样(血清或血浆)与HCV抗原液共孵育，使其中的HCV 抗体与HCV抗原发生特异性结合反应。

3. 加入特异性标记物，产生HCV抗原-抗体-标记物的复合物。

4. 加入化学发光底物，启动化学反应，产生化学发光信号。

5. 通过化学发光免疫分析仪，测定样品中化学发光信号的强度，根据标准曲线，判断样品中是否存在HCV抗体。

四、试剂存储与保存1. 试剂盒应在2-8摄氏度的冰箱中保存，避免阳光直射。

2. 未使用的试剂保质期为1年。

3. 试剂开封后，建议尽快使用，避免反复冻融。

五、注意事项1. 本试剂仅用于临床实验室研究，不能用于诊断用途。

2. 使用本试剂前，确保操作人员具备相关技术培训，并遵循操作规程，以确保结果的准确性。

3. 使用过程中请注意个人防护，避免接触试剂直接进入眼睛、口腔或鼻腔。

4. 试剂过期、变质或包装破损的，禁止使用。

5. 请按照法律法规和伦理要求正确处置已使用的试剂及试剂盒。

六、结果解读1. 阳性结果：化学发光免疫分析仪测定结果显示化学发光信号强度大于检测阈值，表明样品中存在HCV抗体。

2. 阴性结果：化学发光免疫分析仪测定结果显示化学发光信号强度小于检测阈值，表明样品中不存在HCV抗体。

七、质量控制1. 每次试验中应包括阴性对照品和阳性对照品，用于验证实验操作和试剂组分的稳定性。

2. 阳性对照品应显示出阳性结果，阴性对照品应显示出阴性结果，以确保结果的准确性。

人甲肝病毒IgG抗体（HA V-IgG）ELISA试剂盒使用说明书本试剂仅供研究使用目的：本试剂盒用于检测人血清，血浆及相关液体样本中人甲肝病毒IgG抗体（HA V-IgG）水平。

实验原理：本试剂盒采用双抗原夹心酶联免疫法（ELISA）测定标本中人甲肝病毒IgG抗体（HA V-IgG）。

用纯化的抗原包被微孔板，制成固相抗原，可与样品中甲肝病毒IgG抗体（HA V-IgG）相结合，经洗涤除去未结合的抗体和其他成分后再与HRP标记的抗原结合，形成抗原-抗体-酶标抗原复合物，经过彻底洗涤后加底物TMB显色。

TMB在HRP酶的催化下转化成蓝色，并在酸的作用下转化成最终的黄色。

用酶标仪在450nm波长下测定吸光度（OD值），与CUTOFF值相比较，从而判定标本中人甲肝病毒IgG抗体（HA V-IgG）的存在与否。

样本处理及要求：1. 血清：室温血液自然凝固10-20分钟，离心20分钟左右（2000-3000转/分）。

仔细收集上清，保存过程中如出现沉淀，应再次离心。

2. 血浆：应根据标本的要求选择EDTA或柠檬酸钠作为抗凝剂，混合10-20分钟后，离心20分钟左右（2000-3000转/分）。

仔细收集上清，保存过程中如有沉淀形成，应该再次离心。

3. 尿液：用无菌管收集，离心20分钟左右（2000-3000转/分）。

仔细收集上清，保存过程中如有沉淀形成，应再次离心。

胸腹水、脑脊液参照实行。

4. 细胞培养上清：检测分泌性的成份时，用无菌管收集。

离心20分钟左右（2000-3000转/分）。

仔细收集上清。

检测细胞内的成份时，用PBS（PH7.2-7.4）稀释细胞悬液，细胞浓度达到100万/ml左右。

通过反复冻融，以使细胞破坏并放出细胞内成份。

离心20分钟左右（2000-3000转/分）。

仔细收集上清。

保存过程中如有沉淀形成，应再次离心。

5. 组织标本：切割标本后，称取重量。

加入一定量的PBS，PH7.4。

用液氮迅速冷冻保存备用。

甲型肝炎病毒抗体电化学发光检测试剂盒说明书Elecsys Anti-HAVElecsys 2010/MODULAR ANALYTICS E17011820605 100人份【名称】通用名：甲型肝炎病毒抗体电化学发光检测试剂盒英文名：Elecsys Anti-HAV汉语拼音：Jia xing gan yan bing du kang ti dian hua xue fa guang jian ce shi ji he【使用目的】用免疫学方法定量测定人血清或血浆中的甲型肝炎病毒总抗体。

甲型肝炎病毒抗体检测有助于检测过去或现在的甲肝病毒感染，观察甲肝疫苗注射后的免疫反应。

电化学发光免疫测定试剂，适用于罗氏Elecsys2010和MODULAR ANALYTICS E170免疫测定分析仪。

【概述】甲肝病毒是一种没有胞膜的RNA病毒。

它属于细小的核糖核酸病毒家族。

至今，仅1种人血清型和7种基因型被记述。

病毒衣壳由三种蛋白 (VP1-VP3) 组成，在病毒颗粒表面形成一个免疫决定簇结构，它被高度表达在所有基因型。

在注射疫苗后或正常感染后这个结构诱发免疫反应1。

甲型肝炎是最普通的急性病毒性肝炎，通过消化道传播。

这种肝炎不会发展成慢性肝炎，病毒也不会持续存在组织中2。

甲型肝炎病毒是引起病毒性肝炎爆发流行的最常见原因(10-20%)3。

甲型肝炎感染发作时总的甲型肝炎抗体呈阳性。

在自然感染后，抗HAV-IgG抗体能够终生存在，如果组织再次感染会对机体起到保护作用4。

现在已经有甲肝病毒疫苗和甲肝和乙肝混合疫苗5。

在注射甲肝疫苗后, 抗HAV-IgG抗体两周后就可以检测到。

在完全免疫过程中，这种保护作用可以持续很多年6。

免疫保护作用对于抗体值没有限定，但是抗HAV浓度在10-20IU/L以上对机体有保护作用。

抗HAV抗体检测用于检查甲型肝炎病毒存在或过去感染过。

同时也用于观察甲肝疫苗注射后的免疫反应。

【原理】竞争法：总检测时间18分钟。