CA1500(MJZ002)血凝分析儀性能驗證報告

1、性能驗證報告單位名稱：AAA醫(yī)院科室名稱：檢驗科實 驗 室：門急診檢驗中心儀器名稱：全自動凝血分析儀型號規(guī)格：Sysmex CA1500儀器編號：MJZ002驗證人員： 審 核 人： 批 準 人：驗證日期 ：2012年 8月 1日 2012年 9月 30日AAA醫(yī)院檢驗科性能驗證報告驗證系統(tǒng)基本信息（試劑、質控品名稱批號等）本次性能驗證所使用的試劑如下表項目試劑生產商批號有效期凝血酶原時間（PT）西門子5454322013-10-24活化部分凝血酶原時間（APTT西門子547127A2013-10-30凝血酶時間（TT）西門子417242014-3-22纖維蛋白原（Fib）西門子5380352

2、014-4-12緩沖液（OVB西門子5470172014-3-8氯化鈣溶液（Cacl2）西門子5394752016-11-28反應杯西門子L8377本次精密度驗證采用的質控品和批號如下表質控品水平生產商批號有效期水平1（ L）西門子528111A2014-06-26水平2（ H）西門子548223A2014-08-07本次準確定驗證的定值質控品的批號和生產商定值質控品水平生產商批號有效期水平1（ N）西門子528111A2014-06-26水平2（ P）西門子548223A2014-08-07二、驗證過程1.精密度1.1批內精密度根據(jù)NCCLS EP15-Afc件，取二個水平的質控血漿，連續(xù)重

3、復測定20次，計算其變異系數(shù)（CV和標準差（SD。以以下標準（CLIA88規(guī)定的1/4范圍）判斷儀器批內精密度是否滿足臨床要求：項目PTAPTTTTFib判定標準CVC2.00%2.00%10.00%4.00%性能驗證結果以及結論見下表: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標準差0.2670.4000.4840.0380.6060.334變異系數(shù)2%1.34%2.88%1.57%1.42%0.78%預定標準2.0%2.0%10.0%4.0%2.0%2.0%結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，取二個水平的質控血漿，分別分裝成 20份，凍存于20C冰箱內。每 天取出兩個水平的標本各2

6、份進行測定，2次間隔大于2小時，共測定10天，（每次測定都同時測定 兩個水平的質控）。連續(xù)重復測定20次，計算CV和SD結合CLIA 88的要求，本次驗證要求批間 精密度的控制范圍見下表：參數(shù)PTAPTTTTFib判定標準CVC5.00%5.00%10.00%10.00%性能驗證結果以及結論如下表: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%預定標準5.00%5.00%10.00%10.00%5.00%5.00%結論合格合格合格合格合格合格2.正確度由于本臺儀器

9、沒有參加衛(wèi)生部臨檢中心的室間質評，因此其正確度的驗證通過儀器間的比對來實 現(xiàn)。用患者樣本進行方法對比實驗及偏差評估。方法學比對用于實驗室同一項目不同檢測儀器、檢測 方法間實驗結果的比對和校正，以確保同一實驗室同一檢測項目檢測結果的可比性和可溯源性。2.1具體方案：每天收集5份新鮮血漿標本，連續(xù)檢測4天，共20份標本，樣本中分析物濃度應盡可能寬地分 布在儀器允許的檢測范圍內，特別是要覆蓋醫(yī)學決定水平，通常情況下，分析物濃度最低值應低于該 分析物正常參考范圍的下限值，而最高值應在線性范圍內盡可能的高。同時在比對儀器和基準儀器（參 加室間質評的儀器）上檢測，比對之前先進行室內質控，質控合格后開始檢測

10、，在標本老化之前（ 2h 之內）檢測完畢，每份標本在每臺儀器上檢測 2遍，取均值，然后將此平均值與靶值（參加室間質評的儀器檢測值）相比較計算偏倚：偏倚 =丨測定值-靶值/靶值*100%2.2判定標準：80沖上的數(shù)據(jù)符合1/2 CLIA 88允許總誤差或生物學變異即為通過，如下表:參數(shù)PTAPTTFibT T偏倚7.50%7.50%10.00%10.00%2.3 比對時間及編號：2012-8-28至2012-8-312.4比對結果與數(shù)據(jù)PT基準儀器 CA-7000 (LJ004)CA-1500 (MJZ002偏倚測試1測試2平均測試1測試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比對要求w（CV%7.5符合率90% （20份樣本有18份符合要求）結論合格1APTT基準儀器 CA-7000 ( LJ004)CA-1500 (MJZ002偏倚測試1測試2平均測試1測試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比對要求w （CV%7.5符合率95% （20份樣本有19份符合要求）結論合格TT基準儀器 CA-7000（ LJ004）CA-1500( MJZ002偏倚測試1測試2平均測試1測試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比對要求w （CV%10.0符合率 100% （20份樣本都符合要求）結論合格Fib基準儀器 CA-7000 (LJ004)CA-1500 (MJZ002偏倚測試1測試2平均測試1測試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比對要求w （CV%10.0符合率95% （20份樣本有19份符合要求）結論合格3.線性驗證選取一份Fib接近預期上限的高值全血樣本（H）,分別按100% 75% 50% 25% 12.5%的比例 進行稀釋，每個稀釋度重復測定 2次，計算均值。將實測值與理論值作比較（偏離應小于 10%，計 算y=ax+b，驗證線性范圍。要求a值在1 0.05范圍內，相關系數(shù)r 0.975。驗證結果以及結論如下：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的檢測在0.88-7.12的范圍內具有線性。4檢測靈敏度連續(xù)測定0水平標準品或接近0水平血漿10次，記錄結果。CV%0.95 ;同時根據(jù)實驗數(shù)據(jù)建立實驗室自己的參考范圍。6.2判斷方式及標準：R=測定結果在參考區(qū)間范圍內的例數(shù)/總測定例數(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測定結果序號日期樣本號性別年齡（歲）PT(S)APTT(S)TT(S)Fib(g/L)12012-9-1053男3711.426.316.73.61322012-9-1141女3311.826