CA7000LJ005血凝仪性能验证报告

性能验证报告单位名称：AAAM院科室名称：检验科实验室：临床血液与体液学实验室仪器名称：全自动血凝分析仪型号规格：CA-7000仪器编号：LJ-005验证人员：审核人：批准人：验证日期：2012年7月20日--2012年9月20日

一、检测系统信息：项目：凝血检验(PT,APTT,TT,Fib)试剂及厂商：西门子公司原装配套试剂名称批号后效期Thromborel'S5454322013-10-24DadeActinActivatedCephaloplastinReagent547127A2013-10-30Cacl2Solution5394752016-11-28TestThrombinReagent417242014-3-22OVBuffer5470172014-3-8DadeThrombinReagent5380352014-4-12ReactionTubeSU-40L8377二、验证过程1.精密度1.1、批内不精密度1.1.1实验方案：取两个水平的质控血浆，连续重复测定20次，计算CMSD1.1.2要求：CV或SD要求在下表仪器标定的范围内。参数PTAPIITTFib判定标准CV<3.75%3.75%5.00%4.00%标准依据1/4CLIA'881/4CLIA'88厂家标准1/4CLIA'881.1.3结果1.1.3.1水平1日期：2012-9-18样本号：201-220样本来源：ControlNLot:528111AEXP:2014-06-26参数PTAPTTTTFib单位秒秒秒g/L112.627.417.32.431

212.827.617.42.418312.727.517.32.425412.627.317.32.431512.627.5172.44612.627.317.22.432712.527.217.42.435812.727.217.32.433912.627.517.52.4321012.927.1172.4311112.627.117.52.4361212.727.517.52.4321312.627.317.22.4331412.627.617.62.4351512.727.517.32.4331612.627.417.62.4351712.527.217.22.4311812.727.417.22.4351912.826.917.52.4332012.827.517.42.435MEAN12.6627.3517.342.43SD0.1050.1880.1730.004CV0.83%0.69%1.00%0.18%判定标准CV3.75%3.75%5.00%5.00%结论合格合格合格合格1.1.3.2水平2日期：2012-9-18样本号：301-320样本来源：ControlPLot:548223AEXP:2014-08-07参数PTAPIITTFib单位秒秒秒g/L140.645.416.72.346240.645.516.42.344340.945.316.52.347440.645.516.72.343540.945.116.52.342

640.945.516.82.347740.945.216.52.346840.645.516.52.344940.745.516.72.3451040.945.416.72.345114145.516.62.3441240.745.516.62.3461340.645.516.72.3461440.545.116.32.3451540.645.516.52.3451640.745.316.72.3441740.645.516.82.3461840.745.516.62.3441940.945.416.62.3452040.645.516.52.345MEAN40.7345.4116.602.34SD0.1520.1370.1320.001CV0.37%0.30%0.79%0.05%判定标准CV3.75%3.75%5.00%5.00%结论合格合格合格合格1.2、批间不精密度1.2.1实验方案：收集连续20天的两个水平的质控数据，计算CMSD1.2.2要求：CV或SD要求在下表仪器标定的范围内参数PTAPTTTTFib判定标准CVC5.00%5.00%10.00%6.70%标准依据1/3CLIA'881/3CLIA'88厂家标准1/3CLIA'881.2.3结果1.2.3.1水平1

日期：2012-8-28〜2012-9-19样本号：1001参数PTAPIITTFib单位秒秒秒g/L112.627.018.12.622212.427.518.12.549312.026.719.52.699411.727.317.92.549512.627.519.72.394612.727.619.12.549711.827.217.92.622811.926.717.82.480912.126.617.52.3941012.225.917.02.5141112.126.216.82.6221211.727.016.72.4511312.528.116.32.2641411.726.017.12.4511512.427.317.72.3671612.125.217.12.5491712.127.317.32.5141811.727.117.42.4801911.226.017.72.5142012.628.017.52.422MEAN12.1126.9117.712.50SD0.4010.7490.8860.103CV3.31%2.78%5.00%4.12%判定标准CV5.00%5.00%10.00%6.70%样本来源:ControlNLot:528111AEXP:2014-06-26结论合格合格合格合格1.2.3.2水平2日期：2012-8-28〜2012-9-19样本号：1002样本来源：ControlPLot:548223AEXP:2014-08-07参数PTAPIITTFib单位秒秒秒g/L139.645.517.42.264238.945.816.02.315338.144.717.52.422440.145.417.12.367541.546.317.52.216641.246.716.12.264741.446.317.32.289842.445.317.52.105944.445.016.32.4801045.644.815.52.3151140.745.115.72.2641240.145.216.42.2641342.045.915.92.2641443.445.415.72.2891541.944.116.42.3411641.645.716.52.3151742.144.315.92.3151843.245.015.92.3411941.942.516.42.3942044.145.016.12.367MEAN41.7145.2016.462.310SD1.8630.9120.6790.079

CV4.47%2.02%4.13%3.43%判定标准CV5.00%5.00%10.00%6.70%结论合格合格合格合格2、正确度验证由于本台仪器没有参加卫生部临检中心的室间质评，因此其正确度的验证通过仪器间的比对来实现。用患者样本进行方法对比实验及偏差评估。方法学比对用于实验室同一项目不同检测仪器、检测方法问实验结果的比对和校正，以确保同一实验室同一检测项目检测结果的可比性和可溯源性。具体方案：每天收集5份新鲜血浆标本，连续检测4天，共20份标本，样本中分析物浓度应尽可能宽地分布在仪器允许的检测范围内，特别是要覆盖医学决定水平，通常情况下，分析物浓度最低值应低于该分析物正常参考范围的下限值，而最高值应在线性范围内尽可能的高。同时在比对仪器和基准仪器（参加室间质评的仪器）上检测，比对之前先进行室内质控，质控合格后开始检测，在标本老化之前（2h之内）检测完毕，每份标本在每台仪器上检测2遍，取均值，然后将此平均值与靶值（参加室间质评的仪器检测值）相比较计算偏倚：偏倚=I测定值-靶值/靶值*100%判定标准：80犯上的数据符合1/2CLIA'88允许总误差或生物学变异即为通过，如下表：参数PTAPTTFibTT偏倚％c7.50%7.50%10.00%10.00%2.3比对时间及编号：2012-8-28至2012-8-31比对结果与数据PT基准仪器CA-7000(LJ004)CA-7000(LJ005)偏倚测试1测试2平均测试1测试2平均112.712.512.6011.911.711.806.35212.011.911.9511.911.711.801.26311.411.2P11.3011.111.211.15r1.331411.611.411.5011.211.111.153.04511.210.911.0510.910.510.703.17636.636.6:36.6035.3P34.935.10r4.101711.611.711.6510.911.111.005.58811.411.211.3011.011.211.101.77911.311.4P11.3510.8r10.510.65r6.1711012.712.412.5512.011.911.954.78

1112.112.012.0511.211.311.256.641213.213.7P13.4511.8P11.911.85P11.90]1313.613.713.6512.412.312.359.5214112.011.9P11.9511.3P11.211.25P5.86]1512.712.612.6512.011.911.955.531612.412.612.5011.911.711.805.601712.512.6P12.5511.8P11.911.85P5.58]1811.210.911.0510.610.510.554.5219:11.611.4P11.5011.3P11.211.25P2.17|2012.412.212.3011.711.911.804.07比对要求&（CV%7.5符合率[90%（20份样本有18份符合要求）结论合格APTT基准仪器CA-7000(LJ004)CA-7000(LJ005)偏倚测试1测试2平均测试1测试2平均129.329.029.1528.228.028.103.60226.126.026.0524.224.024.107.49324.724.4:24.5523.4「23.223.305.09430.230.030.1029.529.329.402.33527.727.827.7526.126.026.056.136160.860.6:60.7060.8:60.760.750.08729.128.929.0027.927.727.804.14825.425.325.3524.224.024.104.939123.523.3P23.4023.2P22.823.001.711038.238.0P38.1036.836.636.703.671129.228.929.0529.028.728.850.6912128.028.0P28.0028.6[28.528.55r1.961336.035.7P35.8537.4P37.137.25p3.91]1428.128.028.0528.128.028.050.0015]33.032.9[32.9531.9r31.531.70r3.791630.030.0r30.0028.0P27.827.90r7.0011732.332.132.2031.831.531.651.711836.236.036.1035.735.235.451.801923.523.4P23.4522.5P22.222.35P4.6912029.829.929.8529.729.529.600.84比对要求&（CV%7.5符合率100%（20份样本都符合要求）结论合格TT基准仪器CA-7000(LJ004)CA-7000(LJ005)偏倚测试1测试2平均测试1测试2平均118.618.518.5517.317.017.157.55

217.617.217.4016.516.416.455.46317.016.8P16.9015.8P15.615.70P7.10]416.916.416.6516.116.016.053.60516.216.016.1016.116.016.050.31626.226.0P26.1026.3P26.026.15P0.19]716.616.416.5016.416.316.350.91816.816.616.7016.016.016.004.19918.318.0P18.1517.9r17.617.75r2.2011018.018.118.0517.217.017.105.261117.117.017.0517.317.117.200.8812116.115.8P15.9516.1P16.016.05P0.63]1315.315.2P15.2515.1P15.215.15P0.6611417.417.117.2516.016.016.007.2515119.719.8P19.7519.0r19.119.05P3.541617.417.2P17.3017.717.617.652.021716.816.616.7017.016.816.901.2018「16.016.0P16.0016.6P16.116.35r2.191915.715.5r15.6015.415.615.500.642015.515.315.4015.515.215.350.32比对要求&（CV%10.0符合率100%（20份样本都符合要求）结论合格Fib基准仪器CA-7000(LJ004)CA-7000(LJ005)偏倚测试1测试2平均测试1测试2平均12.9342.91812.9262.9112.8982.9050.73522.6152.6252.6202.6602.6502.6551.33634.0724.068P4.0704.032P4.0234.028r1.044143.5833.5753.5793.7203.7003.7103.66055.0925.0945.0935.3205.3105.3154.35960.6550.668P0.6620.613r0.6070.610P7.785174.2014.2114.2064.1464.1104.1281.8548「3.8323.830P3.8314.0324.0214.027r5.10392.3932.388P2.3912.315:2.2862.3013.765102.6512.6442.6482.6222.6182.6201.03911:4.0724.081P4.0774.265[4.1854.225P3.643123.7203.7253.7233.6483.6243.6362.3241135.9585.9435.9516.1106.0906.1002.512142.7262.721:2.7242.739P2.7282.734P0.367]1511.8041.7891.7971.79811.7581.7781.030162.6882.6682.6782.6992.6592.6790.037173.3963.385P3.3913.326:3.3203.323r1.991i184.2014.1974.1994.1464.1264.1361.500

194.3374.3354.3364.2654.2254.2452.099203.8323.830P3.8313.923P3.8983.911P2.0751比对要求&(CV%10.0符合率「100%(20份样本都符合要求)结论合格3、携带污染率3.1实验方案：取高浓度样本，混合均匀后连续测定三次，测定值分别为H1、H2H3;再取低浓度样本，连续测定3次，测定值分别为L1、L2、L3o按下列公式计算携带污染率。计算：携带污染率(CV%=(L1-L3)/(H3-L3)*100%3.1.2要求：CV要求在下表仪器标定的范围内。参数PTAPTTFibTT要求10.0%10.0%10.0%10.0%3.1.3日期：2012-9-7LIS中样本编号：201-2243.1.4结果试验材料新鲜血标本参数PTAPTTFibTT单位SSg/LSH155.258.44.99847.5H255.658.64.89747.8H355.458.94.9848.9L111.522.51.67916.8L211.622.61.68816.5L311.322.41.66816.6携带污染率0.45%0.36%0.33%0.62%要求10.0%10.0%10.0%10.0%结论合格合格合格合格4、线性实验方案:

选取一份接近预期上限的高值血浆样本（H）,分别按100%80%60%40%20%勺比例进行稀释，每个稀释度重复测定3次，计算均值。计算y=ax+b,验证线性范围。由于PKAPTTTT仪器直接检测凝固时间，因此不适用线性验证。本实验只验证Fib的线性范围。要求：a值在1±0.05范围内，相关系数r>0,9754.3,所用标本项目日期样本来源条码号Fib2012-9-1912091870545LIS编号201-2154.4结果：稀释度第一次第二次第三次均值理论值1004.8064.8664.8394.8374.837803.8703.9803.9503.9333.870602.8892.8282.7292.8152.902401.9571.9571.9451.9531.935200.9190.9040.9120.9120.967a1.0162r0.99944.5结论参数单位ar线性范围FIBg/L1.01620.99940.912〜4.8375、可报告范围（最大稀释度）实验方案选取一份接近预期上限的高浓度血浆（沙，用仪器自带的缓冲液（L）按照如下比例进行稀释：1:0（0倍）、1:1（2倍）、1:3（4倍）、1:7（8倍）、1:15（16倍）、1:31（32倍）……每个浓度测定三次，将均值与理论值进行比较得出R,R在0.8到1.2之间的最大稀释度为可报告范围。实验时间：2012-9-20标本来源：条码号：12091970888;LIS中样本编号：201-216实验数据稀释倍数02481632Fib理论值5.0142.5071.2540.6270.3130.157测试值14.9602.3941.1560.6340.3290.198测试值25.1222.4221.1500.6420.3340.201测试值34.9602.4361.2050.6220.3200.211均值5.0142.4171.1700.6330.3280.203R1.000.960.931.021.051.30判断标准80%<R<120%合格合格合格合格合格不合格5.5结论FIB最大稀释度为：原始样本的16倍；PKAPTTTT均为比浊法直接检测标本凝固时间，不存在线性曲线，沿用厂家报告范围PT:（7-100）s;APTT（15-150）s;TT:（7-150）s。根据实验室所检测的标本并结合临床，以上报告范围可以满足临床需求；若有大于或小于上述范围时，以大于或小于线性值报告。6.生物参考区间实验方案选取20例正常人标本验证厂家提供的生物参考区问，考虑性别和年龄比例（本次验证选取男女各10例，年龄28-56岁），分别检测各参数，计算均值、SD,及结果落在正常参考范围的例数与总标本数的比例，即R值，要求R>0.95;同时根据实验数据建立实验室自己的参考范围.判断方式及标准：R=M定结果在参考区间范围内的例