SAA 校準品（質(zhì)控品）穩(wěn)定性檢測數(shù)據(jù)-試生產(chǎn)三批

1、血清淀粉樣蛋白A測定試劑盒(膠乳增強免疫比濁法) ,質(zhì)控品實時穩(wěn)定性檢測結(jié)果匯總,一、試驗儀器,日立全自動生化分析儀,二、試劑批號,181830、181850、181900,三、質(zhì)控品批號,181830、181850、181900,四、確定依據(jù)：,GB/T 26124-2011 3.14、6.9做效期穩(wěn)定性觀察。,五、試驗方法：開封穩(wěn)定性：開封之后檢測合格后置于28條件下保存，作為留樣觀察，每8h檢測一次，檢測到超出相對偏差范圍，其結(jié)果附后。,六、統(tǒng)計學(xué)分析：實時穩(wěn)定性:重復(fù)測試10次，分別計算測量值的平均值和標準差(SD)，（變異系數(shù)，CV）應(yīng)10.0%,測量值相對偏差應(yīng)在15%范圍內(nèi)。,七

2、、數(shù)據(jù)及結(jié)果分析,實時穩(wěn)定性,1.外觀 質(zhì)控品應(yīng)為無色液體。, 儲存時間 批號,2-80天,開封16h,開封32h,開封48h,開封64h181830,符合要求,符合要求,符合要求,符合要求,符合要求181850,符合要求,符合要求,符合要求,符合要求,符合要求181900,符合要求,符合要求,符合要求,符合要求,符合要求,2.裝量 20.5ml,符合要求。,3.均一性,（變異系數(shù)，CV）應(yīng)10.0%。測量值相對偏差應(yīng)在15%范圍內(nèi)。,3.1批號:181830,質(zhì)控品低值,儲存時間,2-80天,開封16h,開封32h,開封48h,開封64h測試次數(shù),測定值,測定值,測定值,測定值,測定值1,1

3、0.6 ,11.0 ,10.8 ,10.9 ,10.5 2,10.8 ,10.7 ,10.6 ,10.7 ,10.8 3,11.1 ,10.9 ,11.3 ,11.0 ,11.1 4,10.5 ,10.6 ,10.7 ,10.7 ,10.6 5,10.5 ,10.7 ,10.9 ,10.9 ,10.6 6,10.7 ,10.6 ,10.3 ,10.6 ,10.4 7,10.9 ,10.4 ,10.9 ,10.6 ,10.8 8,10.7 ,10.6 ,10.8 ,10.8 ,10.9 9,10.9 ,10.9 ,10.4 ,10.7 ,10.6 10,11.1 ,11.0 ,11.1 ,10.

4、6 ,10.9 平均值,10.78 ,10.75 ,10.79 ,10.74 ,10.73 SD,0.23 ,0.19 ,0.30 ,0.15 ,0.21 CV,2.10 ,1.81 ,2.75 ,1.37 ,1.97 標示值,10.80 ,10.80 ,10.80 ,10.80 ,10.80 偏差（%）,-0.17 ,-0.49 ,-0.10 ,-0.57 ,-0.66 結(jié)果判定,符合要求,符合要求,符合要求,符合要求,符合要求, 質(zhì)控品高值,儲存時間,2-80天,開封16h,開封32h,開封48h,開封64h測試次數(shù),測定值,測定值,測定值,測定值,測定值1,37.7 ,37.8 ,38.

5、9 ,37.7 ,38.2 2,37.1 ,38.8 ,39.2 ,37.1 ,38.7 3,37.8 ,38.4 ,37.5 ,38.9 ,38.7 4,38.6 ,37.4 ,38.1 ,38.2 ,38.3 5,39.3 ,39.3 ,39.2 ,39.4 ,38.5 6,37.0 ,39.2 ,38.4 ,37.8 ,38.1 7,38.0 ,37.1 ,37.5 ,38.8 ,38.1 8,38.0 ,38.8 ,37.8 ,38.4 ,38.6 9,37.4 ,39.1 ,39.0 ,37.4 ,38.0 10,37.1 ,38.5 ,37.7 ,37.8 ,37.7 平均值,37

6、.82 ,38.44 ,38.34 ,38.15 ,38.28 SD,0.73 ,0.77 ,0.71 ,0.74 ,0.33 CV,1.94 ,1.99 ,1.86 ,1.93 ,0.87 標示值,38.00 ,38.00 ,38.00 ,38.00 ,38.00 偏差（%）,-0.49 ,1.15 ,0.89 ,0.40 ,0.74 結(jié)果判定,符合要求,符合要求,符合要求,符合要求,符合要求,3.2批號:181850,質(zhì)控品低值,儲存時間,2-80天,開封16h,開封32h,開封48h,開封64h測試次數(shù),測定值,測定值,測定值,測定值,測定值1,10.5 ,10.8 ,10.9 ,10.

7、9 ,11.0 2,10.6 ,10.8 ,10.8 ,10.6 ,10.9 3,11.2 ,11.1 ,10.9 ,10.9 ,11.1 4,10.8 ,10.6 ,11.0 ,10.9 ,10.5 5,11.1 ,10.9 ,10.8 ,10.5 ,11.0 6,10.7 ,10.4 ,10.5 ,10.4 ,10.4 7,10.5 ,10.7 ,10.9 ,11.0 ,11.0 8,10.5 ,11.0 ,10.8 ,10.5 ,10.9 9,10.7 ,10.4 ,10.8 ,10.7 ,10.9 10,10.9 ,10.7 ,10.9 ,11.0 ,10.8 平均值,10.75 ,1

8、0.75 ,10.81 ,10.75 ,10.84 SD,0.24 ,0.24 ,0.13 ,0.21 ,0.24 CV,2.26 ,2.23 ,1.24 ,1.92 ,2.20 標示值,10.80 ,10.80 ,10.80 ,10.80 ,10.80 偏差（%）,-0.47 ,-0.49 ,0.12 ,-0.43 ,0.41 結(jié)果判定,符合要求,符合要求,符合要求,符合要求,符合要求, 質(zhì)控品高值,儲存時間,2-80天,開封16h,開封32h,開封48h,開封64h測試次數(shù),測定值,測定值,測定值,測定值,測定值1,37.4 ,39.3 ,39.1 ,38.4 ,38.6 2,38.9 ,

9、37.4 ,38.2 ,39.1 ,37.1 3,37.1 ,39.2 ,39.3 ,37.4 ,38.5 4,38.2 ,38.9 ,38.5 ,38.4 ,38.2 5,38.3 ,38.9 ,38.3 ,38.8 ,38.6 6,37.7 ,38.6 ,38.4 ,38.3 ,38.5 7,37.6 ,37.2 ,39.1 ,38.2 ,38.2 8,39.0 ,37.0 ,37.6 ,38.9 ,37.8 9,38.1 ,38.1 ,37.9 ,37.6 ,38.6 10,37.2 ,38.0 ,38.6 ,38.1 ,38.3 平均值,37.96 ,38.26 ,38.49 ,38.

10、32 ,38.24 SD,0.67 ,0.84 ,0.55 ,0.55 ,0.47 CV,1.77 ,2.21 ,1.43 ,1.44 ,1.22 標示值,38.00 ,38.00 ,38.00 ,38.00 ,38.00 偏差（%）,-0.09 ,0.70 ,1.30 ,0.84 ,0.63 結(jié)果判定,符合要求,符合要求,符合要求,符合要求,符合要求,3.3批號:181900,質(zhì)控品低值,儲存時間,2-80天,開封16h,開封32h,開封48h,開封64h測試次數(shù),測定值,測定值,測定值,測定值,測定值1,10.9 ,10.9 ,10.8 ,10.7 ,10.6 2,10.7 ,11.2 ,

11、10.9 ,10.7 ,11.2 3,11.1 ,11.2 ,10.9 ,10.7 ,11.1 4,10.8 ,10.8 ,10.9 ,10.9 ,10.8 5,10.5 ,10.5 ,10.7 ,11.0 ,10.5 6,10.5 ,10.5 ,10.4 ,10.6 ,10.5 7,10.6 ,10.5 ,10.5 ,10.9 ,10.6 8,10.8 ,10.9 ,11.0 ,10.8 ,10.6 9,10.5 ,10.4 ,10.4 ,10.8 ,10.4 10,11.2 ,11.0 ,11.0 ,11.1 ,10.9 平均值,10.76 ,10.79 ,10.75 ,10.82 ,10

12、.71 SD,0.25 ,0.30 ,0.24 ,0.16 ,0.28 CV,2.29 ,2.80 ,2.19 ,1.49 ,2.64 標示值,10.80 ,10.80 ,10.80 ,10.80 ,10.80 偏差（%）,-0.36 ,-0.11 ,-0.48 ,0.18 ,-0.79 結(jié)果判定,符合要求,符合要求,符合要求,符合要求,符合要求, 質(zhì)控品高值,儲存時間,2-80天,開封16h,開封32h,開封48h,開封64h測試次數(shù),測定值,測定值,測定值,測定值,測定值1,37.9 ,39.1 ,39.1 ,37.1 ,39.3 2,37.3 ,38.1 ,37.7 ,37.3 ,38.6 3,38.4 ,38.1 ,39.3 ,37.1 ,38.3 4,37.7 ,39.0 ,38.9 ,37.6 ,37.1 5,37.5 ,37.3 ,39.3 ,37.6 ,39.0 6,37.4 ,38.2 ,37.2 ,37.7 ,38.4 7,38.2 ,38.9 ,37.3 ,38.4 ,38.7 8,38.9 ,37.9 ,37.2 ,38.4 ,37.8 9,37.8 ,38.9 ,38.1 ,37.7 ,37.7 10,37.0 ,37.3 ,38.7 ,37.2 ,37.4 平均值,37.80 ,38.28 ,38.27 ,37.61 ,38.23 SD,0.5