快速血沉仪.pptx

VASTEC MEDICAL LIMITED 威士达医疗有限公司CEFDAcertified获获CEFDA认证认证先进技术，获欧洲、美国两项专利：先进技术，获欧洲、美国两项专利：EuropeanPatentApplicationNo.96103358.6of05/03/1996U.S.PatentApplicationNo.08/613.233of14/05/98approvedAgcITUD950042新型自动快速微量血沉仪新型自动快速微量血沉仪血沉测试的一项革命性的新产品3 3TubeidentificationTubeidentificationTEST-1WORKFLOWTEST-1WORKFLOWTubeintroductionintotherackTubeintroductionintotherackRackblockingRackblockingRackloadingRackloadingABCD4 4InternalBarCodeReaderInternalBarCodeReaderIDPATIENTIDPATIENTManualBarCodeReaderManualBarCodeReader5 5UseofallthevacutainertubesUseofallthevacutainertubesonthemarket,e.g.:onthemarket,e.g.:-BectonDickinson-BectonDickinson-Terumo-Terumo-Sarstedt-Sarstedt-Grainer-Grainer3differentadaptors3differentadaptorsinterchangeable,guaranteeinginterchangeable,guaranteeingacompletecompatibilitywithallacompletecompatibilitywithallthetubesonthemarketthetubesonthemarketTEST1worksbyloadingTEST1worksbyloadingcellcounterracksdirectlycellcounterracksdirectlyTEST1TEST1ECECRACKRACKPatent pending 传统方法：血球在特定时间內沉降的距离(1/2至 1小時)新方法：在检测区红细胞聚集/沉降所导致的 光学变化(20秒检测1000个变化数据)原理：定量分析毛原理：定量分析毛细细管光管光学检测学检测法法(Quantitative Capillary Photometry)判读判读系統系統 (Reading System)(Reading System)：Lightbeam光源(950nm)Capillarylumen毛细管腔Detector检测器Electronicamplifier电子放大器血样8 8毛细管毛细管毛细管毛细管毛细管毛细管内红细胞的沉降与聚集内红细胞的沉降与聚集内红细胞的沉降与聚集内红细胞的沉降与聚集内红细胞的沉降与聚集内红细胞的沉降与聚集Aggregationstartingt=0Aggregationafter1000scanst=20sec.20秒内读取秒内读取1000个光学变化的数据进行分析个光学变化的数据进行分析LightbeambeforeLightbeamafter 判读判读技术技术(Reading Technique)v连续20秒、1000次扫描去量度血樣本中的血球密集度v测度出血球在检测器(Detector)前消失的速度v建立沉降曲线(Sedimentation Curve)v綜合1000个检测点的数据资料v计算血沉率(Sedimentation Rate)v计算及建立相关(no.of red cells/sec mm/hr Westergren)v （红细胞数量/秒 mm/hr 魏氏法）TEST-1，Micro TEST-1以以最最新新版版NCCLS（1993年年）文文件件标标准准及及ICSH建建议议的最新参考方法为参照：使用的最新参考方法为参照：使用EDTA抗凝血抗凝血*NCCLS（美国临床实验室标准化委员会）ICSH（国际血液学标准化委员会）NCCLSH2-A4文件VOL.20NO.27NCCLS（The National Committee for Clinical Laboratory Standards,美国临床实验室标准化委员会）2000年公布了血沉试验（ESR）的第四版文件H2-A4，这份文件是H2-A3（1993年）的修订版。公布H2-A4文件的目的，是进一步完善血沉试验的标准化。这份文件再次说明血沉试验的参考方法，所使用的血液抗凝剂必须是EDTA。参考方法需要实验条件与操作的严格控制，其中，重要的是必须使用EDTA抗凝血。EDTA是一种附在抗凝管壁的干粉，对血标本基本无稀释，才能称为真正意义的全血；以前所采用的枸橼酸钠抗凝血，由于血液与抗凝剂的比例达到41，血液被稀释，被作为常规试验方法的一种。并且枸橼酸钠抗凝血必须在四小时内完成，有效期短，而EDTA抗凝血的有效期为24个小时。血沉试验参考方法的临床参考值不同于以前使用枸橼酸钠抗凝血做出的值（男：15mm/小时，女：25）或过低（1ml30150ul标本要求枸橼酸钠1：4抗凝EDTA抗凝血标本稳定性2小时24小时标本混匀手工自动专用血沉管需要不需要垂直状态判断有人为误差(手工)无此要求室温干扰部分有无（恒温测定）Hct影响有无与新版NCCLS不符符合（EDTA抗凝血）对ESR的规定消耗品专用采血管+血沉管采血管(可与血常规管共用)与其他血沉仪及手工法对比v可直接从血常规样本管(EDTA抗凝)中吸取血样本进行测试v检测时间20秒，约每30秒報告一个結果v需要血量极少(30500ul)，老人、儿科病人也有足夠的血进行检测v与传統方法(Westergren)魏氏法相关(Correlation)v最快速度：最快约每小时测试180个样本v自动內部质控(Internal Quality Control)v自动打印出結果v可通过RS232连接电脑v可选配条形码识別器(Barcode Reader)去识別标本信息主要主要性能性能特徵特徵Lowinfluenceofhematocrit35HCT应用价值快速检验符合临床检验发展潮流，更好的为病人服务优化工作流程可直接采用EDTA抗凝血，作为血液学分析仪的一个补充、完整，创造一个“EDTA抗凝血标本工作站”，使我们可以任意获得如细胞分类计数和有需要时进行和/或ESR检测低消耗无需专用测定管，并可减少多抽一管血，减低测定成本的同时，减轻病人痛苦创效益用作临床常规普遍开展，增加测试标本量，增加收符合新版NCCLS（1993年）准则：.ESR测定使用EDTA抗凝血 标本直接上机，大大减轻医务人员工作量和被感染的机会与传统魏氏法相关性好 美国FDA、欧洲CE国际标准认可产品1 1 It starts from 0 time to 20 sec.It starts from 0 time to 20 sec.following and measuring the following and measuring the evolutionevolution of the sed rate curves.of the sed rate curves.2 2 It measures the optical density related to the concentration of the It measures the optical density related to the concentration of the erythrocytes/aggregates erythrocytes/aggregates present at the moment of the analysis.present at the moment of the analysis.3 3 Kinetics Kinetics following the evolution of the curves with a frequency of following the evolution of the curves with a frequency of 5050 measures per second.measures per second.4 4 The capillary system simulates a in vivo situation and guaranteesThe capillary system simulates a in vivo situation and guarantees minimal optical paths in blood subject to sedimentation which minimal optical paths in blood subject to sedimentation which enableenable the detection of small variations.the detection of small variations.1616METHODOLOGYCHARACTERISTICS1717AutodiagnosticsInternalorexternalbarcodereaderInterfacingthroughRS232QUERYHOSTSoftwareforPCLABmanagementNodedicatedtubesCompatiblewithcellcounterracks(Bayer,Beckman,TOA,etc.)Capacityof60samplesrandomaccess180samples/hrAutomaticsamplemixingBloodcollectionaccordingtotheICSHrecommendationsFlowcontroltocheckofeventualclotsDeadvolume 1mlWorkingvolume150LofbloodTECHNICALCHARACTERISTICSTECHNICALCHARACTERISTICS1818Cellmeasurevolume1LThermostatation37CFirstresultafter80sec.Lowinfluenceofhematocrit35HCTNocarryoverAutowashingSafe-controlclosedcyclesystemAutomaticreadingandprintoutoftheresultsTotallysafewastevolumetankWasteproductionreducedWastedisposalcostsreducedStatisticalinternalqualitycontrolSafetycheckcardElectroniccalibrationforalignementofresultsTECHNICALCHARACTERISTICSTECHNICALCHARACTERISTICSv可直接从血常规样本管(EDTA抗凝)中吸取血样本进行测试v检测时间20秒，约每30秒報告一个結果v需要血量极少(30500ul)，老人、儿科病人也有足夠的血进行检测v与传統方法(Westergren)魏氏法相关(Correlation)v最快速度：每小时测试110-180个样本v自动內部质控(Internal Quality Control)v自动打印出結果v可通过RS232连接电脑v可选配条形码识別器(Barcode Reader)去识別标本信息主要主要性能性能特徵特徵2020VACUTAINERTUBEINCITRATEVACUTAINERTUBEINCITRATEDilutionratio1:4Dilutionratio1:4Exceeding level of Exceeding level of bloodblood(fresh samples)(fresh samples)CorrectlevelofbloodCorrectlevelofbloodinsufficient level of insufficient level of bloodblood(old sample)(old sample)NONOOKOKNONOErrors in the dilution phaseErrors in the dilution phaseErrors in the dilution phase2121VACUTAINERTUBEINCITRATEVACUTAINERTUBEINCITRATEThecitratecollectedsampleisnomoresuitabletobeprocessedafter4hoursfrombloodcollection2222VACUTAINERTUBEINEDTAVACUTAINERTUBEINEDTATHEEDTACOLLECTEDSAMPLEREFRIGERATEDAT+4CCANBETESTEDEVENAFTER24HOURSFROMBLOODCOLLECTIONFromClinical Chemistry,Vol.47,No.6,Supplement2001,p.162-Internalqualitycontrolforerythrocytesedimentationrate(ESR)measuredbyTEST1analyzerbyD.Giavarina,S.Capuzzo,M.Carta,F.Caoduro,G.Soffiati,Clin.Chem.&Hematol Lab-San Bortolo Hospital:Vicenza,ItalyFromNCCLS,FromNCCLS,FromNCCLS,3rded.,Vol.13,No.8,August3rded.,Vol.13,No.8,August3rded.,Vol.13,No.8,August199319931993PARAMETERSINFLUENCINGTHEESRPARAMETERSINFLUENCINGTHEESRWITHTHEWESTERGRENMETHODWITHTHEWESTERGRENMETHOD 4.4.14.4.1 Errors in the diluition step Errors in the diluition step Diameter of the sedimentation tubes Diameter of the sedimentation tubes 4.4.44.4.4 Inclination of the tubes with respect to the Inclination of the tubes with respect to the verticalvertical4.4.34.4.3 Vibrations Vibrations4.4.24.4.2 Temperature Temperature Sample dilution with anticoagulants Sample dilution with anticoagulants23232424DIFFERENTRESULTSOFTHESAMESAMPLEDIFFERENTRESULTSOFTHESAMESAMPLEDILUTEDDILUTEDWITHAUTOLOGOUSPLASMAWITHAUTOLOGOUSPLASMASedimentationasafunctionoftimewithdifferentHctvaluesartificiallyobtainedaddingautologousplasma(Blood,Vol.70,No5,Nov.1987:pp1572-1576).Hctof26Hctof26Hctof28Hctof28Hctof34Hctof34Hctof45Hctof45SEDIMENTATIONSEDIMENTATION(mm)(mm)TIME(minutes)TIME(minutes)0 020204040606080801001001201201401400 02020 4040 6060 8080 100100120120140140160160180180200200LOWINFLUENCEOFHEMATOCRITONTESTLOWINFLUENCEOFHEMATOCRITONTEST1 1FromFromThomasL.Fabry,ThomasL.Fabry,Mechanism of Erythrocyte Aggregation and Mechanism of Erythrocyte Aggregation and Sedimentation,BloodSedimentation,Blood,Vol.70,No.5(Nov.),1987:pp1572-1576.,Vol.70,No.5(Nov.),1987:pp1572-1576.FormulatoadjustthevalueofESRFormulatoadjustthevalueofESRExampleofadjustmentforasamplewithhematocritExampleofadjustmentforasamplewithhematocrit30.330.3-Correctvalue=69.2-WGnoncorrectedvalue=114-TEST1=6767 ExampleofadjustmentforasamplewithhematocritExampleofadjustmentforasamplewithhematocrit26.326.3-Correctvalue=66.3-WGnoncorrectedvalue=127-TEST1=6767 2525TEST1TEST1受红细胞压积的影响小受红细胞压积的影响小受红细胞压积的影响小受红细胞压积的影响小FromFromThomasL.Fabry,ThomasL.Fabry,Mechanism of Erythrocyte Aggregation and Mechanism of Erythrocyte Aggregation and Sedimentation,BloodSedimentation,Blood,Vol.70,No.5(Nov.),1987:pp1572-1576.,Vol.70,No.5(Nov.),1987:pp1572-1576.FormulatoadjustthevalueofESRFormulatoadjustthevalueofESR例如红细胞压积例如红细胞压积例如红细胞压积例如红细胞压积30.330.3的调整的调整的调整的调整-正确值=69.2-魏氏法没修正的值=114-TEST1=6767-正确值=66.3-魏氏法没修正的值=127-TEST1=6767 2626例如红细胞压积例如红细胞压积例如红细胞压积例如红细胞压积26.326.3的调整的调整的调整的调整 2727TEST1TEST1ECECESRESRTELEMETRYTELEMETRY2828CAPACITYOFSEDIMENTATIONANDCAPACITYOFSEDIMENTATIONANDCAPACITYOFSEDIMENTATIONANDAGGREGATIONAGGREGATIONAGGREGATIONAggregationstartingt=0Aggregationafter1000scanst=20sec.TEST1ECstudiesthesedimentationandaggregationcapacityofthebloodredcellsviaopticaldensityEverysampleisread1000timesin20secondsverifyingtheaggregationandsedimentationcapacityofthebloodredcellsLightbeambeforeLightbeamafterN.N.dede Jonge,Jonge,I.I.Sewkaransing,Sewkaransing,J.J.Slinger,Slinger,J.J.M.J.J.M.RijsdijkRijsdijk(dept.(dept.ClinicalClinicalChemistry,Chemistry,LeyenburgLeyenburgHospital,Hospital,TheTheNetherlands),Netherlands),“Erythrocyte“ErythrocyteSedimentationRatebyTEST1AlifaxAnalyzer”SedimentationRatebyTEST1AlifaxAnalyzer”.CORRELATIONTEST1WESTERGRENCORRELATIONTEST1WESTERGREN2929FromClinicalChemistry,June2000,46:881-882FromClinicalChemistry,June2000,46:881-882FromClinicalChemistry,June2000,46:881-882“the correlation coefficientwas 0.97;”The mathematical algorithm converts the results from optical density toERYTHROCYTE SEDIMENTATION RATEof the microvolume analyzedfromfromsampleopticaldensitysampleopticaldensitytotomm/hrWestergrenmm/hrWestergren3030CALCULATIONMETHODOLOGYOFRESULTS3131TEST1TEST1ECECEDTACollectedSAMPLESTABILITYafterEDTACollectedSAMPLESTABILITYafter24H24HDayafterDayafter1stday1stday3232CORRELATIONTEST1/WestergrenCORRELATIONTEST1/Westergren3333TEST1TEST1ECECREPRODUCIBILITYOFTWOREPRODUCIBILITYOFTWOINSTRUMENTSINSTRUMENTS原理：定量分析毛原理：定量分析毛细细管光管光学检测学检测法法(Quantitative Capillary Photometry)判读判读系統系統 (Reading System)(Reading System)：Lightbeam光源(950nm)Capillarylumen毛细管腔Detector检测器Electronicamplifier电子放大器血样 判读判读技术技术(Reading Technique)v连续20秒、1000次扫描去量度血樣本中的血球密集度v测度出血球在检测器(Detector)前消失的速度v建立沉降曲线(Sedimentation Curve)v綜合1000个曲线的资料v计算血沉率(Sedimentation Rate)v计算及建立相关(no.of red cells/sec mm/hr Westergren)v （红细胞数量/秒 mm/hr 魏氏法）传统方法：血球在特定时间內沉降的距离(1/2至 1小時)新方法：血球在检测器前消失的速度(20秒)LightBeam123PointofmeasurewashedNOCONTAMINATIONBloodflowBloodflowSAMPLE2SAMPLE2SAMPLE1SAMPLE1SAMPLE3SAMPLE3pointofmeasurepointofmeasure3838measurecell1Lmeasurecell1Lairbubbleairbubbleairbubbleairbubble150L150L150L150L150L150L沒有携带污染的問題(No Contamination Carryover)v样本与样本间被空气泡所间隔开v毛细内管壁是疏水性的(Hydrophobic)（Teflon特富龙涂层），減 少血在管壁的黏付v后一样本可把付附在管壁上先前殘留的样本冲走，检测读数范围集中在毛细管的中部，即量度样本的最后部分Sample2样本2Airbubble气泡Sample1样本1Sample3AirbubbleSample2BloodFlowMeasurecell废液处理废液处理 (Waste Disposal)(Waste Disposal)测试完的血样会被排到密封的瓶中，可加进漂白水(Sodium Hypochlorite)去中和测试测试磁磁卡卡(Magnetic Card)(Magnetic Card)分为4000、10000及20000次测试/卡 几种。使用完指定测定次数，则要更换新卡只需把新卡插进仪器一次，便会提供指定的测试次数 质控质控(Quality Control)(Quality Control)v不需要另外购买QC材料vMicrotest 1仪器质控：把当天的标本储存在4oC，第二天在室温预 溫后，再进行测試v兩天結果的稳定性作为Internal Control 操作要点操作要点：v检查废液瓶，必要时倒清废液（废液瓶约可容纳500个测试的废）.v开机后约10分钟才可进行测试，让仪器预热到37oC.采用EDTA抗凝血.v样本置于室温（25oC），则可稳定数小时；若置于冰箱保存，则在测试前先于室温放置约30分钟v吸样前，标本必须充分混匀（TEST-1：仪器自动混匀器或Micro-Test-1：人工颠倒混匀）v测试完成，使用“WASHING”冲洗操作程序冲洗针及管道，一般，停顿超过10分钟没吸样，再次吸样前，也先采用“WASHING”冲洗程序