1、,VASTEC MEDICAL LIMITED 威士达医疗有限公司,CE FDA certified 获CE FDA认证先进技术，获欧洲、美国两项专利： European Patent Application No. 96103358.6 of 05/03/1996 U.S. Patent Application No. 08/613.233 of 14/05/98 approved Agc ITUD950042,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,Tube identification,TEST -1 WORKFLOW,Tube introduction into th
2、e rack,Rack blocking,Rack loading,A,B,C,D,4,Internal Bar Code Reader,ID PATIENT,Manual Bar Code Reader,5,Use of all the vacutainer tubes on the market, e.g.:- Becton Dickinson- Terumo- Sarstedt- Grainer,3 different adaptors interchangeable, guaranteeing a complete compatibility with all the tubes on
3、 the market,TEST 1 works by loading cell counter racks directly,TEST 1EC RACK,Patent 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：定量分析毛细管光学检测法 (Quantitative Capillary Photometry)判读系統 (Reading System)：,Light beam光源(950nm),Capillarylumen毛细管腔,Detector检测器,Electron
4、ic amplifier电子放大器,血样,8,毛细管内红细胞的沉降与聚集,Aggregation startingt = 0,Aggregation after 1000 scanst = 20 sec.,20秒内读取1000个光学变化的数据进行分析,Light beambefore,Light beamafter,判读技术 (Reading Technique)连续20秒、1000次扫描去量度血樣本中的血球密集度测度出血球在检测器(Detector) 前消失的速度建立沉降曲线 (Sedimentation Curve)綜合1000个检测点的数据资料计算血沉率 (Sedimentation R
5、ate)计算及建立相关 (no. of red cells/ sec mm/hr Westergren) （红细胞数量/秒 mm/hr 魏氏法）,TEST-1，Micro TEST-1,以最新版NCCLS（1993年）文件标准及ICSH建议的最新参考方法为参照：使用EDTA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）,NCCLS H2-A4文件 VOL.20 NO.27 NCCLS（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（ES
6、R）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
7、出的值（男：15mm/小时，女：25）或过低（ 1ml 30150ul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,可直接从血常规样本管(EDTA抗凝)中吸取血样本进行测试检测时间20秒，约每30秒報告一个結果需要血量极少 (30 500ul)，老人、儿科病人也有足夠的血进行检测与传統方
8、法 (Westergren)魏氏法相关 (Correlation) 最快速度：最快约每小时测试180个样本自动內部质控 (Internal Quality Control)自动打印出結果可通过RS232连接电脑可选配条形码识別器 (Barcode Reader) 去识別标本信息,主要性能特徵,Low influence of hematocrit 35 HCT,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
9、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 It starts from 0 time to 20 sec. following and measuring the evolution of the sed rate curves.2 It measures the optical density related to the concent
10、ration of the erythrocytes/aggregates present at the moment of the analysis.3 Kinetics following the evolution of the curves with a frequency of 50 measures per second.4 The capillary system simulates a in vivo situation and guarantees minimal optical paths in blood subject to sedimentation which en
11、able the detection of small variations.,16,METHODOLOGY CHARACTERISTICS,17,AutodiagnosticsInternal or external bar code readerInterfacing through RS232QUERY HOST Software for PC LAB managementNo dedicated tubesCompatible with cell counter racks (Bayer, Beckman, TOA, etc.)Capacity of 60 samples random
12、 access180 samples/hrAutomatic sample mixingBlood collection according to the ICSH recommendationsFlow control to check of eventual clotsDead volume 1 mlWorking volume 150 L of blood,TECHNICAL CHARACTERISTICS,18,Cell measure volume 1 LThermostatation 37C First result after 80 sec.Low influence of he
13、matocrit 35 HCTNo carryoverAutowashingSafe-control closed cycle systemAutomatic reading and print out of the resultsTotally safe waste volume tankWaste production reducedWaste disposal costs reducedStatistical internal quality controlSafety check cardElectronic calibration for alignement of results,
14、TECHNICAL CHARACTERISTICS,可直接从血常规样本管(EDTA抗凝)中吸取血样本进行测试检测时间20秒，约每30秒報告一个結果需要血量极少 (30 500ul)，老人、儿科病人也有足夠的血进行检测与传統方法 (Westergren)魏氏法相关 (Correlation) 最快速度：每小时测试110-180个样本自动內部质控 (Internal Quality Control)自动打印出結果可通过RS232连接电脑可选配条形码识別器 (Barcode Reader) 去识別标本信息,主要性能特徵,20,VACUTAINER TUBE IN CITRATE,Dilution r
15、atio 1:4,Exceeding level of blood(fresh samples),Correct level of blood,insufficient level of blood(old sample),NO,OK,NO,Errors in the dilution phase,21,VACUTAINER TUBE IN CITRATE,The citrate collected sample is no more suitable to be processed after 4 hours from blood collection,22,VACUTAINER TUBE
16、IN EDTA,THE EDTA COLLECTED SAMPLE REFRIGERATED AT +4C CAN BE TESTED EVEN AFTER 24 HOURS FROM BLOOD COLLECTION,From Clinical Chemistry, Vol. 47, No. 6, Supplement 2001, p. 162 - Internal quality control for erythrocyte sedimentation rate (ESR) measured by TEST 1 analyzer by D. Giavarina, S. Capuzzo,
17、M. Carta, F. Caoduro, G. Soffiati, Clin. Chem. & Hematol Lab - San Bortolo Hospital: Vicenza, Italy,From NCCLS, 3rd ed., Vol. 13, No. 8, August 1993PARAMETERS INFLUENCING THE ESR WITH THE WESTERGREN METHOD,4.4.1 Errors in the diluition step Diameter of the sedimentation tubes 4.4.4 Inclination of th
18、e tubes with respect to the vertical4.4.3 Vibrations4.4.2 Temperature Sample dilution with anticoagulants,23,24,DIFFERENT RESULTS OF THE SAME SAMPLE DILUTEDWITH AUTOLOGOUS PLASMA,Sedimentation as a function of time with different Hct values artificially obtained adding autologous plasma(Blood, Vol.
19、70, No 5, Nov. 1987: pp 1572-1576).,SEDIMENTATION (mm),TIME (minutes),0,20,40,60,80,100,120,140,0,20,40,60,80,100,120,140,160,180,200,LOW INFLUENCE OF HEMATOCRIT ON TEST 1,From Thomas L.Fabry, Mechanism of Erythrocyte Aggregation and Sedimentation, Blood, Vol. 70, No. 5 (Nov.), 1987: pp 1572-1576.,F
20、ormula to adjust the value of ESR,Example of adjustment for a sample with hematocrit 30.3,- Correct value = 69.2- WG non corrected value = 114- TEST 1 = 67,Example of adjustment for a sample with hematocrit 26.3,- Correct value = 66.3- WG non corrected value = 127- TEST 1 = 67,25,TEST 1受红细胞压积的影响小,Fr
21、om Thomas L.Fabry, Mechanism of Erythrocyte Aggregation and Sedimentation, Blood, Vol. 70, No. 5 (Nov.), 1987: pp 1572-1576.,Formula to adjust the value of ESR,例如红细胞压积30.3的调整,-正确值 = 69.2- 魏氏法没修正的值 = 114- TEST 1 = 67,- 正确值 = 66.3-魏氏法没修正的值 = 127- TEST 1 = 67,26,例如红细胞压积26.3的调整,27,TEST1ECESRTELEMETRY,28
22、,CAPACITY OF SEDIMENTATION AND AGGREGATION,Aggregation startingt = 0,Aggregation after 1000 scanst = 20 sec.,TEST 1EC studies the sedimentation and aggregation capacity of the blood red cells via optical densityEvery sample is read 1000 times in 20 seconds verifying the aggregation and sedimentation
23、 capacity of the blood red cells,Light beambefore,Light beamafter,N. de Jonge, I. Sewkaransing, J. Slinger, J.J.M. Rijsdijk (dept. Clinical Chemistry, Leyenburg Hospital, The Netherlands), “Erythrocyte Sedimentation Rate by TEST 1 Alifax Analyzer”.,CORRELATION TEST 1 WESTERGREN,29,From Clinical Chem
24、istry, June 2000, 46:881-882,“ the correlation coefficient was 0.97; ”,The mathematical algorithm converts the results from optical density toERYTHROCYTE SEDIMENTATION RATEof the microvolume analyzed,fromsample optical density,tomm/hr Westergren,30,CALCULATION METHODOLOGY OF RESULTS,31,TEST 1EC EDTA
25、 Collected SAMPLE STABILITY after 24 H,32,CORRELATION TEST1/Westergren,33,TEST 1EC REPRODUCIBILITY OF TWO INSTRUMENTS,原理：定量分析毛细管光学检测法 (Quantitative Capillary Photometry)判读系統 (Reading System)：,Light beam光源(950nm),Capillarylumen毛细管腔,Detector检测器,Electronic amplifier电子放大器,血样,判读技术 (Reading Technique)连续20
26、秒、1000次扫描去量度血樣本中的血球密集度测度出血球在检测器(Detector) 前消失的速度建立沉降曲线 (Sedimentation Curve)綜合1000个曲线的资料计算血沉率 (Sedimentation Rate)计算及建立相关 (no. of red cells/ sec mm/hr Westergren) （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),Light Beam,1,2,3,Point of measure washedNO CONTAMINATION,Blood
27、 flow,SAMPLE 2,SAMPLE 1,SAMPLE 3,point of measure,38,measure cell 1 L,air bubble,air bubble,150 L,150 L,150 L,沒有携带污染的問題 (No Contamination Carryover)样本与样本间被空气泡所间隔开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,Sample 2样本2,Air bubble气泡,Sample 1样本1,Samp
28、le 3,Air bubble,Sample 2,Blood Flow,Measure cell,废液处理 (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,测试磁卡(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,唯一的使用成本,质控(Quality Control)不需要另外购买QC材料Microtest 1仪器质控：把当天的标本储存在4oC，第二天在室温预 溫后，再进行测試兩天結果的稳定性作为Internal Control,操作要点：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）.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 .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）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,
