CA7000(LJ004)血凝儀性能驗證報告

1、性能驗證報告單位名稱：AAAM院科室名稱：檢驗科實 驗室：臨床血液與體液學(xué)實驗室儀器名稱：全自動血凝分析儀型號規(guī)格：CA-7000儀器編號：LJ-004驗證人員：審 核 人：批 準(zhǔn) 人：驗證日期： 2012年 7月 20 日-2012 年 9月 20 日一、檢測系統(tǒng)信息：項目：凝血檢驗(PT,APTT,TT,Fib)試劑及廠商：西門子公司原裝配套試劑名稱批號后效期ThromborelS5454322013-10-24Dade Actin ActivatedCephaloplastin Reagent547127A2013-10-30Cacl2 Solution5394752016-11-28T

2、est Thrombin Reagent417242014-3-22OV Buffer5470172014-3-8Dade Thrombin Reagent5380352014-4-12Reaction Tube SU-40L8377二、驗證過程.精密度批內(nèi)不精密度實驗方案：取兩個水平的質(zhì)控血漿，連續(xù)重復(fù)測定 20次，計算CM SD1.1.2 要求：CV或SD要求在下表儀器標(biāo)定的范圍內(nèi)。參數(shù)PTAPIITTFib判定標(biāo)準(zhǔn)CVC3.75%3.75%5.00%4.00%標(biāo)準(zhǔn)依據(jù)1/4CLIA881/4CLIA88廠家標(biāo)準(zhǔn)1/4CLIA881.1.3 結(jié)果1.1.3.1 水平 1日期：2012-8-

3、3 樣本號：201-220樣本來源：Control N Lot: 528111A EXP : 2014-06-26參數(shù)PTAPTTTTFib單位秒秒秒g/L111.626.818.32.421211.827.018.42.408311.726.918.32.415411.626.718.32.421511.626.918.02.430611.626.718.22.422711.526.618.42.425811.726.618.32.423911.626.918.52.4221011.926.518.02.4211111.626.518.52.4261211.726.918.52.422131

4、1.626.718.22.4231411.627.018.62.4251511.726.918.32.4231611.626.818.62.4251711.526.618.22.4211811.726.818.22.4251911.826.318.52.4232011.826.918.42.425MEAN11.6626.7518.342.42SD0.1050.1880.1730.004CV0.90%0.70%0.94%0.18%判定標(biāo)準(zhǔn)CV3.75%3.75%5.00%5.00%結(jié)論合格合格合格合格1.1.3.2 水平 2日期：2012-8-3樣本號：301-320樣本來源：Control P

5、 Lot: 548223A EXP : 2014-08-07參數(shù)PTAPIITTFib單位秒秒秒g/L141.244.816.52.366241.244.916.22.364341.544.716.32.367441.244.916.52.363541.544.516.32.362641.544.916.62.367741.544.616.32.366841.244.916.32.364941.344.916.52.3651041.544.816.52.3651141.644.916.42.3641241.344.916.42.3661341.244.916.52.3661441.144.51

6、6.12.3651541.244.916.32.3651641.344.716.52.3641741.244.916.62.3661841.344.916.42.3641941.544.816.42.3652041.244.916.32.365MEAN41.3344.8116.402.36SD0.1520.1370.1320.001CV0.37%0.31%0.80%0.05%判定標(biāo)準(zhǔn)CV3.75%3.75%5.00%5.00%結(jié)論合格合格合格合格1.2、批間不精密度1.2.1實驗方案：1.2.2 要求：CV或SD要求在下表儀器標(biāo)定的范圍內(nèi)參數(shù)PTAPTTTTFib判定標(biāo)準(zhǔn)CVC5.00%5.0

7、0%10.00%6.70%標(biāo)準(zhǔn)依據(jù)CLIA88CLIA88廠家標(biāo)準(zhǔn)CLIA881.2.3 結(jié)果1.2.3.1 水平 1日期：2012-7-20 2012-8-8樣本號：1001樣本來源： Control N Lot: 528111A EXP : 2014-06-26參數(shù)PTAPIITTFib單位秒秒秒g/L112.427.918.12.456212.226.916.72.456311.927.516.72.425412.328.316.62.395512.028.316.52.365612.228.315.72.450712.228.316.92.480811.629.717.22.31291

8、2.228.616.72.3381012.430.017.52.1651112.229.716.82.1881212.428.816.42.4501312.829.617.72.2611412.829.617.22.0771512.230.917.32.4211611.626.818.32.4501711.426.318.12.4501812.128.417.82.5461911.928.517.92.5122011.627.817.72.421MEAN12.1228.5117.192.38SD0.3751.1630.6890.123CV3.09%4.08%4.01%5.17%判定標(biāo)準(zhǔn)CV5.

9、00%5.00%10.00%6.70%結(jié)論合格合格合格合格1.2.3.2 水平 2日期：2012-7-20 2012-8-8樣本號：1002樣本來源：Control PLot: 548223A EXP : 2014-08-07參數(shù)PTAPIITTFib單位秒秒秒g/L139.345.115.92.425238.345.715.72.154339.048.215.62.309440.746.016.32.255540.145.915.92.395639.845.914.42.338737.446.317.22.338837.845.916.12.393941.247.716.42.2121041

10、.646.016.42.2611140.845.816.12.2611241.648.216.52.3931343.545.316.22.2611441.045.816.32.2361542.848.116.82.3651641.344.816.42.3121740.445.516.12.3651840.547.216.82.4501938.845.716.92.3652039.745.116.52.312MEAN40.2846.2116.232.320SD1.5711.0690.5880.077CV3.90%2.31%3.63%3.31%判定標(biāo)準(zhǔn)CV5.00%5.00%10.00%6.70%

11、結(jié)論合格合格合格合格2、正確度驗證根據(jù)衛(wèi)生部臨檢中心的室間質(zhì)評成績（PK FIB、APTT,成績在80犯上判定為通過，本次列舉 最近三次的室間質(zhì)評成績，其結(jié)果如下：， 1 vunet衛(wèi)生部臨床檢驗中心2012年全國凝血試驗室間質(zhì)評成績匯總科室1實齡診斷科日期12012/7/5實驗室名枸;工濟南軍區(qū)危醫(yī)院“哈童編碼106025溯定|卬：2012/6/8PT551005510055100滿意. - J1NR551005510055100酒久成功551005510055100，也：h0.9754.3.所用標(biāo)本項目日期樣本來源條碼號Fib2012-9-4120721603654.4 結(jié)果:稀釋度第一次

12、第二次第三次均值理論值1004.9604.9584.9614.9604.960803.8803.9803.9503.9373.968602.7892.6282.7292.7152.976401.9771.9571.9651.9661.984200.8920.9040.9120.9030.992a1.0166r0.99794.5結(jié)論參數(shù)單位ar線性范圍Fibg/L1.01660.99790.903 4.9605、可報告范圍（最大稀釋度）實驗方案選取一份接近預(yù)期上限的高濃度血漿 （沙，用儀器自帶的緩沖液（L）按照如下比例進行稀釋：1: 0 （0 倍）、1: 1 （2 倍）、1: 3 （4 倍）、1

13、: 7 （8 倍）、1: 15 （16倍）、1: 31 （32 倍）每個濃度 測定三次，將均值與理論值進行比較得出 R, R在0.8到1.2之間的最大稀釋度為可報告范圍。實驗時間：2012-9-18標(biāo)本來源：條碼號：12091770485; LIS中樣本編號：301-318實驗數(shù)據(jù)稀釋倍數(shù)02481632Fib理論值4.9992.4991.2500.6250.3120.156測試值15.0252.3861.1490.6120.3590.187測試值25.0112.3921.1380.6320.3540.208測試值34.9602.4161.2050.6420.3490.191均值4.9992.

14、3981.1640.6290.3540.195R1.000.960.931.011.131.25判斷標(biāo)準(zhǔn)80%R0.95;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(biāo)準(zhǔn)：R=M定結(jié)果在參考區(qū)間范圍內(nèi)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(jié)果在舁 廳P日期樣本號性別年齡 (歲)PT(S)APII(S)TT(S)Fib(g/L)12012-8-2859男5211.426.819.12.65122012-8-2827女5811.724.419.32.806

15、32012-8-2834男4610.823.518.42.16542012-8-2846女5111.025.116.93.33852012-8-2829男7110.222.916.73.83262012-8-2818女4310.627.418.02.54672012-8-2875女3112.026.117.62.61582012-8-2823男9012.526.317.63.94992012-8-2877女2911.630.216.93.583102012-8-2881女2911.425.416.83.832112012-8-2819男2510.930.418.02.077122012-8-2817男3011.227.817.53.174132012-8-2885女2511.824.117.62.688142012-8-2882男4112.127.518.73.456152012-8-2883男110.226.419.62.365162012-8-2889女3012.026.618.13.72172012-8-2863男4611.328.418.1