CA1500(MJZ002)血凝分析儀性能驗(yàn)證報(bào)告

1、性能驗(yàn)證報(bào)告單位名稱(chēng)：AAA醫(yī)院科室名稱(chēng)：檢驗(yàn)科實(shí) 驗(yàn) 室：門(mén)急診檢驗(yàn)中心儀器名稱(chēng)：全自動(dòng)凝血分析儀型號(hào)規(guī)格：Sysmex CA1500儀器編號(hào)：MJZ002驗(yàn)證人員： 審 核 人： 批 準(zhǔn) 人：驗(yàn)證日期 ：2012年 8月 1日 2012年 9月 30日AAA醫(yī)院檢驗(yàn)科性能驗(yàn)證報(bào)告驗(yàn)證系統(tǒng)基本信息（試劑、質(zhì)控品名稱(chēng)批號(hào)等）本次性能驗(yàn)證所使用的試劑如下表項(xiàng)目試劑生產(chǎn)商批號(hào)有效期凝血酶原時(shí)間（PT）西門(mén)子5454322013-10-24活化部分凝血酶原時(shí)間（APTT西門(mén)子547127A2013-10-30凝血酶時(shí)間（TT）西門(mén)子417242014-3-22纖維蛋白原（Fib）西門(mén)子5380352

2、014-4-12緩沖液（OVB西門(mén)子5470172014-3-8氯化鈣溶液（Cacl2）西門(mén)子5394752016-11-28反應(yīng)杯西門(mén)子L8377本次精密度驗(yàn)證采用的質(zhì)控品和批號(hào)如下表質(zhì)控品水平生產(chǎn)商批號(hào)有效期水平1（ L）西門(mén)子528111A2014-06-26水平2（ H）西門(mén)子548223A2014-08-07本次準(zhǔn)確定驗(yàn)證的定值質(zhì)控品的批號(hào)和生產(chǎn)商定值質(zhì)控品水平生產(chǎn)商批號(hào)有效期水平1（ N）西門(mén)子528111A2014-06-26水平2（ P）西門(mén)子548223A2014-08-07二、驗(yàn)證過(guò)程1.精密度1.1批內(nèi)精密度根據(jù)NCCLS EP15-Afc件，取二個(gè)水平的質(zhì)控血漿，連續(xù)重

3、復(fù)測(cè)定20次，計(jì)算其變異系數(shù)（CV和標(biāo)準(zhǔn)差（SD。以以下標(biāo)準(zhǔn)（CLIA88規(guī)定的1/4范圍）判斷儀器批內(nèi)精密度是否滿(mǎn)足臨床要求：項(xiàng)目PTAPTTTTFib判定標(biāo)準(zhǔn)CVC2.00%2.00%10.00%4.00%性能驗(yàn)證結(jié)果以及結(jié)論見(jiàn)下表:水平1水平2PT（秒）APTT秒）TT（秒）Fib（g/L）PT（秒）APTT秒）113.229.217.42.34240.642.6213.429.217.32.37241.942.4313.729.616.12.37243.242.7413.130.417.82.40242.743.1513.229.517.72.34242.842.9613.829.21

4、6.72.37242.442.9713.130.216.92.37242.343.4813.329.816.52.40243.142.8913.829.416.72.34242.643.61013.229.717.02.37242.843.21113.829.515.92.37242.742.91213.230.116.72.43242.643.11313.730.316.72.46443.243.11413.229.816.92.40243.143.61513.229.816.42.43243.342.91613.729.917.02.46443.243.31713.429.617.12.4

5、0242.343.21813.629.916.52.43242.743.21913.130.216.42.40242.942.82013.230.516.72.43242.943.6均值13.4029.7916.822.4042.6743.07標(biāo)準(zhǔn)差0.2670.4000.4840.0380.6060.334變異系數(shù)2%1.34%2.88%1.57%1.42%0.78%預(yù)定標(biāo)準(zhǔn)2.0%2.0%10.0%4.0%2.0%2.0%結(jié)論合格合格合格合格合格合格1.2批間精密度根據(jù)NCCLS EP15-Afc件，取二個(gè)水平的質(zhì)控血漿，分別分裝成 20份，凍存于20C冰箱內(nèi)。每 天取出兩個(gè)水平的標(biāo)本各2

6、份進(jìn)行測(cè)定，2次間隔大于2小時(shí)，共測(cè)定10天，（每次測(cè)定都同時(shí)測(cè)定 兩個(gè)水平的質(zhì)控）。連續(xù)重復(fù)測(cè)定20次，計(jì)算CV和SD結(jié)合CLIA 88的要求，本次驗(yàn)證要求批間 精密度的控制范圍見(jiàn)下表：參數(shù)PTAPTTTTFib判定標(biāo)準(zhǔn)CVC5.00%5.00%10.00%10.00%性能驗(yàn)證結(jié)果以及結(jié)論如下表:水平1水平2PT（秒）APTT（秒）TT（秒）Fib（g/L）PT（秒）APTT（秒）第1天114.131.416.32.24838.652.9214.730.916.62.21839.152.1第2天114.231.117.42.21839.953.5214.431.317.22.28039.95

7、3.9第3天114.331.216.92.34538.552.2214.631.316.72.37939.151.5第4天114.531.116.52.31238.252.6214.631.216.72.21838.552.4第5天114.331.116.52.21839.052.6214.431.117.02.21838.653.2第6天113.429.517.32.31237.551.1213.629.217.32.21837.252.2第7天113.529.616.52.28037.050.1213.629.217.22.28036.850.8第8天113.229.517.52.2803

8、7.049.9213.629.317.32.28036.550.8第9天113.129.317.52.28036.350.1213.629.317.42.24836.050.5第10天113.629.716.72.24836.150.0213.629.917.12.24836.050.8均值13.9530.3116.982.2740.1051.66SD0.5110.9020.3870.0461.3001.257CV3.67%2.98%2.28%2.01%3.24%2.43%預(yù)定標(biāo)準(zhǔn)5.00%5.00%10.00%10.00%5.00%5.00%結(jié)論合格合格合格合格合格合格2.正確度由于本臺(tái)儀器

9、沒(méi)有參加衛(wèi)生部臨檢中心的室間質(zhì)評(píng)，因此其正確度的驗(yàn)證通過(guò)儀器間的比對(duì)來(lái)實(shí) 現(xiàn)。用患者樣本進(jìn)行方法對(duì)比實(shí)驗(yàn)及偏差評(píng)估。方法學(xué)比對(duì)用于實(shí)驗(yàn)室同一項(xiàng)目不同檢測(cè)儀器、檢測(cè) 方法間實(shí)驗(yàn)結(jié)果的比對(duì)和校正，以確保同一實(shí)驗(yàn)室同一檢測(cè)項(xiàng)目檢測(cè)結(jié)果的可比性和可溯源性。2.1具體方案：每天收集5份新鮮血漿標(biāo)本，連續(xù)檢測(cè)4天，共20份標(biāo)本，樣本中分析物濃度應(yīng)盡可能寬地分 布在儀器允許的檢測(cè)范圍內(nèi)，特別是要覆蓋醫(yī)學(xué)決定水平，通常情況下，分析物濃度最低值應(yīng)低于該 分析物正常參考范圍的下限值，而最高值應(yīng)在線(xiàn)性范圍內(nèi)盡可能的高。同時(shí)在比對(duì)儀器和基準(zhǔn)儀器（參 加室間質(zhì)評(píng)的儀器）上檢測(cè)，比對(duì)之前先進(jìn)行室內(nèi)質(zhì)控，質(zhì)控合格后開(kāi)始檢測(cè)

10、，在標(biāo)本老化之前（ 2h 之內(nèi)）檢測(cè)完畢，每份標(biāo)本在每臺(tái)儀器上檢測(cè) 2遍，取均值，然后將此平均值與靶值（參加室間質(zhì)評(píng)的儀器檢測(cè)值）相比較計(jì)算偏倚：偏倚 =丨測(cè)定值-靶值/靶值*100%2.2判定標(biāo)準(zhǔn)：80沖上的數(shù)據(jù)符合1/2 CLIA 88允許總誤差或生物學(xué)變異即為通過(guò)，如下表:參數(shù)PTAPTTFibT T偏倚7.50%7.50%10.00%10.00%2.3 比對(duì)時(shí)間及編號(hào)：2012-8-28至2012-8-312.4比對(duì)結(jié)果與數(shù)據(jù)PT基準(zhǔn)儀器 CA-7000 (LJ004)CA-1500 (MJZ002偏倚測(cè)試1測(cè)試2平均測(cè)試1測(cè)試2平均112.712.512.6012.712.612.6

11、55.42212.011.911.9512.312.512.45.08311.411.2P 11.3011.71211.85P 6.76411.611.411.5012.912.412.6512.95511.210.911.0511.511.111.33.67636.636.6P 36.6033.432.833.16.23 1711.611.711.6511.711.111.44.59811.411.211.3011.811.411.65.45911.311.4P 11.3511.411.811.67.411012.712.412.5512.712.112.43.331112.112.012.

12、051111.811.41.791213.213.7P 13.4512.312.612.455.511313.613.713.6512.612.812.72.421412.011.9P 11.9512.9r 13.113r 15.041512.712.6r 12.6512.512.912.75.831612.412.612.5012.112.412.252.941712.512.6P 12.5512.8r 12.112.45r 5.511811.210.911.0511.111.311.25.661911.611.411.5011.811.411.62.652012.412.212.3011.

13、9r 12.112r 2.56比對(duì)要求w（CV%7.5符合率90% （20份樣本有18份符合要求）結(jié)論合格1APTT基準(zhǔn)儀器 CA-7000 ( LJ004)CA-1500 (MJZ002偏倚測(cè)試1測(cè)試2平均測(cè)試1測(cè)試2平均129.329.029.1529.12929.050.85226.126.0P 26.0529.6P 28.829.2r 11.88324.724.424.5525.125.425.252.23430.230.030.1031.431.831.64.64527.727.8P 27.7529.2P 29.629.46.14660.860.660.7061.262.161.65

14、1.40729.128.929.0030.531.130.85.84825.425.3P 25.3527.226.927.056.50923.523.323.402525.325.157.0210 :38.238.0:38.1039.1:38.738.9:1.831129.228.9P 29.0531.131.331.26.851228.028.028.0029.129.529.34.6413:36.035.7P 35.8537.1P 36.9372.781428.128.0P 28.0529.629.129.354.451533.032.932.9534.73534.855.6116 :30

15、.030.0P 30.0031.5P 31.131.3:4.331732.332.132.2032.833.132.952.011836.236.036.1037.436.837.12.491923.523.4P 23.4524.9P 24.724.8P 5.532029.829.929.8530.531.230.853.52比對(duì)要求w （CV%7.5符合率95% （20份樣本有19份符合要求）結(jié)論合格TT基準(zhǔn)儀器 CA-7000（ LJ004）CA-1500( MJZ002偏倚測(cè)試1測(cè)試2平均測(cè)試1測(cè)試2平均118.618.5P 18.5517.817.317.555.65 1217.617

16、.217.4016.216.716.456.533117.016.8P 16.9016.2r 1616.15.29 |416.916.4P 16.6515.815.315.557.99 1516.216.016.1015.415.115.255.866 :26.226.0r 26.1025.3r 25.125.2:3.82 1716.616.4r 16.5016.116.416.252.11 1816.816.616.7015.916.1164.769:18.318.0r 18.1518.1r 18.218.15:0.82 11018.018.1r 18.0517.817.917.850.83

17、 11117.117.017.0516.216.516.354.39 1216.115.815.9515.915.715.81.86 11315.315.2P 15.2514.814.514.654.25 11417.417.117.2517.317.217.250.86 1519.719.819.7519.119.319.22.54 i1617.417.2r 17.3016.817.116.952.59 11716.816.616.7016.216.116.153.871816.016.016.0015.915.715.81.25 i1915.715.5r 15.6015.115.415.2

18、52.87 12015.515.315.4015.415.115.251.61比對(duì)要求w （CV%10.0符合率 100% （20份樣本都符合要求）結(jié)論合格Fib基準(zhǔn)儀器 CA-7000 (LJ004)CA-1500 (MJZ002偏倚測(cè)試1測(cè)試2平均測(cè)試1測(cè)試2平均12.9342.9182.9262.8312.8292.833.545 122.6152.6252.6202.5092.5032.5064.16834.0724.068 :4.070 :4.0684.062:4.0650.172 :43.5833.5753.5793.5213.5293.5251.619 155.0925.0945

19、.0935.0015.0045.00251.75860.6550.668 :0.662 :0.6430.647:0.6451.527 174.2014.2114.2064.1884.1924.190.262 183.8323.8303.8313.8223.8233.82250.24892.3932.3882.391 :2.2612.278:2.26955.161；102.6512.6442.6482.2342.2312.232515.786 1114.0724.0814.0774.0344.0384.0360.884123.7203.7253.7233.633.65:3.642.151；135

20、.9585.9435.9515.8325.8415.83652.039 1142.7262.7212.7242.7012.7092.7050.770151.8041.7891.7971.7611.769:1.7652.162 1162.6882.6682.6782.6382.6422.641.786 1173.3963.3853.3913.3813.3763.37850.515184.2014.1974.1994.1084.105:4.10652.249 :194.3374.3354.3364.3124.316P 4.3140.530 1203.8323.8303.8313.7173.7233

21、.722.923比對(duì)要求w （CV%10.0符合率95% （20份樣本有19份符合要求）結(jié)論合格3.線(xiàn)性驗(yàn)證選取一份Fib接近預(yù)期上限的高值全血樣本（H）,分別按100% 75% 50% 25% 12.5%的比例 進(jìn)行稀釋?zhuān)總€(gè)稀釋度重復(fù)測(cè)定 2次，計(jì)算均值。將實(shí)測(cè)值與理論值作比較（偏離應(yīng)小于 10%，計(jì) 算y=ax+b，驗(yàn)證線(xiàn)性范圍。要求a值在1 0.05范圍內(nèi)，相關(guān)系數(shù)r 0.975。驗(yàn)證結(jié)果以及結(jié)論如下：稀釋度第一次第二次均值理論值偏移1007.1957.057.12257.56-5.787755.1255.2045.16455.67-8.915503.8343.8343.8343.78

22、1.4286251.9731.9731.9731.8904.391512.50.8890.8840.88650.945-6.19a0.9758r0.9978因此，F(xiàn)ib的檢測(cè)在0.88-7.12的范圍內(nèi)具有線(xiàn)性。4檢測(cè)靈敏度連續(xù)測(cè)定0水平標(biāo)準(zhǔn)品或接近0水平血漿10次，記錄結(jié)果。CV%0.95 ;同時(shí)根據(jù)實(shí)驗(yàn)數(shù)據(jù)建立實(shí)驗(yàn)室自己的參考范圍。6.2判斷方式及標(biāo)準(zhǔn)：R=測(cè)定結(jié)果在參考區(qū)間范圍內(nèi)的例數(shù)/總測(cè)定例數(shù)95%即合格。參數(shù)PTAPTTTTFib單位SSSg/L參考區(qū)間10.0-14.022.0-35.014.0-21.02.000-4.0006.3測(cè)定結(jié)果序號(hào)日期樣本號(hào)性別年齡（歲）PT(S)APTT(S)TT(S)Fib(g/L)12012-9-1053男3711.426.316.73.61322012-9-1141女3311.826