28-資料8ApoB的穩(wěn)定性研究資料數(shù)據(jù)

1、載脂蛋白B測定試劑盒(免疫比濁法)穩(wěn)定性研究資料全效期穩(wěn)定性研究試驗結(jié)果:空白吸光度批號空白吸光度0個月4個月8個月12個月13個月14個月20140120試劑空白吸光 度值A(chǔ)空白 0. 200。0.0330.0340.0350.0360.0380.044201401220.0330.0360.0320.0390.0430.039201401240.0310.0360.0360.0350.0430.047分析靈敏度批號分析靈敏度0個月4個月8個月12個月13個月14個月20140120濃度為1.10 g/L 時，吸光度差值 0. 300。0.3360.3230.3210.3370.3190.3

23240.3240.3330.3260.3170.313201401240.3250.3250.3250.3340.3110.319線性范圍產(chǎn)品批號：20140120線性范圍12345相關(guān)系數(shù)0個月0.210.490.901.922.440.99924個月0.210.470.961.882.380.99938個月0.220.460.911.882.360.999412個月0.220.480.901.852.340.999413個月0.220.460.951.842.320.999214個月0.220.490.891.872.340.9990線性偏差123450個月-0.

3、010.02-3.55%2.81%-1.24%4個月-0.02-0.012.85%2.34%-1.61%8個月-0.01-0.01-1.16%3.22%-1.65%12個月-0.010.01-1.97%2.69%-1.31%13個月-0.02-0.013.48%2.38%-1.70%14個月-0.020.02-2.54%3.36%-1.65%在(0.2-2.50 )g/L線性范圍內(nèi)，r 0.990。在(0.60-2.50 )g/L范圍內(nèi)的相對偏差不 超過15%測定結(jié)果為(0.20-0.60gL時的絕對偏差不超過0.09gL。產(chǎn)品批號：20140122線性范圍12345相關(guān)系數(shù)0個月0.220.

4、490.921.892.380.9993線性范圍12345相關(guān)系數(shù)4個月0.220.460.941.862.370.99958個月0.210.490.931.842.350.999612個月0.220.470.951.892.340.998613個月0.220.460.951.832.280.998814個月0.220.500.931.862.300.9987線性偏差123450個月-0.020.01-0.65%2.89%-1.58%4個月-0.01-0.011.71%2.14%-1.35%8個月-0.030.011.48%1.55%-1.12%12個月-0.02-0.012.08%3.84%

5、-2.35%13個月-0.02-0.024.21%3.01%-2.13%14個月-0.030.010.74%3.62%-2.17%在（0.2-2.50） g/L線性范圍內(nèi)，r 0.990。在（0.60-2.50 ） g/L范圍內(nèi)的相對偏差不超過 15%;測定結(jié)果為（0.20-0.60gL時的絕對偏差不超過0.09gL。產(chǎn)品批號：20140124線性范圍12345相關(guān)系數(shù)0個月0.220.500.891.862.410.99964個月0.210.480.951.782.430.99958個月0.200.490.961.872.370.999212個月0.210.500.941.842.330.9

6、99213個月0.230.470.951.802.280.999314個月0.200.460.931.852.290.9987線性偏差123450個月-0.010.03-3.79%1.16%-0.30%4個月-0.020.012.96%-2.37%0.91%8個月-0.040.012.59%2.27%-1.64%12個月-0.040.021.59%2.18%-1.51%13個月-0.02-0.013.76%2.02%-1.55%14個月-0.03-0.012.42%3.64%-2.31%在（0.2-2.50）g/L線性范圍內(nèi),r0.990。在（0.60-2.50）g/L范圍內(nèi)的相對偏差不超過1

7、5%；測定結(jié)果為（0.20-0.60g/L時的絕對偏差不超過0.09gL。重復(fù)性產(chǎn)品批號：201401200個月4個月8個月12個月13個月14個月水平1水平2水平1水平2水平1水平2水平1水平2水平1水平2水平1水平211.231.561.241.601.151.631.201.531.181.501.231.5021.251.601.201.641.231.501.161.591.231.501.211.5831.251.511.241.611.161.511.191.581.211.491.161.5341.251.551.211.591.201.531.171.481.141.511.

8、211.5951.211.581.241.571.161.541.231.571.181.571.161.4661.191.531.271.611.201.561.171.561.211.561.181.5171.201.611.261.551.181.511.151.521.221.601.171.4081.271.551.211.571.221.551.201.611.171.531.201.5591.271.581.261.611.181.571.151.601.181.611.181.49101.241.641.251.581.161.621.251.501.141.481.211.5

9、5X1.241.571.241.591.191.551.191.551.191.541.191.52S0.0290.0380.0230.0250.0280.0450.0330.0430.0320.0470.0260.057CV2.31%2.45%1.87%1.54%2.39%2.89%2.81%2.77%2.71%3.05%2.18%3.75%產(chǎn)品批號：201401220個月4個月8個月12個月13個月14個月水平1水平2水平1水平2水平1水平2水平1水平2水平1水平2水平1水平211.231.591.271.571.211.531.251.611.231.521.181.5021.221.5

10、91.211.471.251.631.201.521.211.541.221.6131.221.511.221.561.181.591.151.611.211.531.131.6041.181.551.121.571.211.501.161.581.201.571.211.4551.271.571.231.561.191.521.261.511.181.541.171.4261.241.541.241.551.241.521.231.501.181.591.171.4771.271.621.201.621.181.611.161.561.191.461.181.5181.211.601.211

11、.651.261.521.161.521.171.581.191.6191.241.611.221.601.251.561.231.571.231.561.131.52101.201.581.271.631.191.501.251.551.231.531.131.58X1.231.581.221.581.221.551.211.551.201.541.171.53S0.0290.0340.0410.0510.0310.0470.0430.0390.0230.0380.0320.069CV2.36%2.16%3.39%3.21%2.55%3.04%3.56%2.54%1.94%2.45%2.69

12、%4.53%產(chǎn)品批號：201401240個月4個月8個月12個月13個月14個月水平1水平2水平1水平2水平1水平2水平1水平2水平1水平2水平1水平211.241.641.211.621.251.561.221.501.181.461.151.4821.221.631.251.591.231.611.171.621.161.471.231.4631.251.571.241.621.241.611.161.551.181.511.181.4841.241.611.231.651.251.641.191.561.141.501.141.5251.171.641.201.551.181.561.2

13、31.541.131.581.241.4261.251.651.211.611.261.511.211.601.141.481.191.5171.221.571.261.551.241.541.241.561.161.481.201.4681.231.641.281.631.221.531.161.611.191.461.201.5291.231.581.241.551.211.511.171.571.161.591.211.55101.261.641.251.551.211.511.201.501.211.581.131.56X1.231.611.241.591.231.561.201.56

14、1.171.511.191.50S'0.0260.0320.0260.0410.0250.0470.0300.0410.0240.0550.0360.044CV2.09%1.98%2.10%2.58%2.05%3.05%2.47%2.62%2.10%3.62%3.06%2.93%準(zhǔn)確度批號項目質(zhì)控品靶值0個月4個月8個月12個月13個月14個月20140120校準(zhǔn)血清1.24(1.02-1.90)g/L1.201.261.181.181.211.17相對偏差-3.23%1.61%-4.84%-4.84%-2.42%-5.65%是否在控在控在控在控在控在控在控20140122校準(zhǔn)血清1.

15、261.221.201.211.181.17相對偏差1.61%-1.61%-3.23%-2.42%-4.84%-5.65%是否在控在控在控在控在控在控在控20140124校準(zhǔn)血清1.211.221.231.231.141.21相對偏差-2.42%-1.61%-0.81%-0.81%-8.06%-2.42%是否在控在控在控在控在控在控在控批號項目質(zhì)控品靶值0個月4個月8個月12個月13個月14個月20140120校準(zhǔn)血清1.60(1.31-1.89)g/L1.571.581.541.551.581.46相對偏差-1.88%-1.25%-3.75%-3.12%-1.25%-8.75%是否在控在控在

16、控在控在控在控在控20140122校準(zhǔn)血清1.581.581.551.521.531.46相對偏差-1.25%-1.25%-3.12%-5.00%-4.38%-8.75%是否在控在控在控在控在控在控在控20140124校準(zhǔn)血清1.621.571.541.571.511.46相對偏差1.25%-1.88%-3.75%-1.88%-5.63%-8.75%是否在控在控在控在控在控在控在控開瓶穩(wěn)定性結(jié)果空白吸光度批號空白吸光度0天5天10天15天16天17天20140120試劑空白吸光0.0350.0370.0310.0340.0420.04320140122度值A(chǔ)空白0.0360.0350.0350

17、.0330.0390.04220140124 0. 2000.0350.0380.0350.0350.0440.048分析靈敏度批號分析靈敏度0天5天10天15天16天17天20140120濃度為1.10 g/L 時，吸光度差值 0. 300。0.3250.3360.3390.3190.3220.319201401220.3210.3390.3240.3150.3170.317201401240.3390.3320.3230.3360.3180.316線性范圍產(chǎn)品批號：20140120線性范圍12345相關(guān)系數(shù)0天0.220.500.951.882.400.99955天0.210.500.96

18、1.882.370.999310天0.220.470.951.882.380.999415天0.210.490.911.862.350.999416天0.220.470.951.812.280.998917天0.210.470.891.902.340.9985線性偏差123450天-0.030.011.21%1.98%-1.31%5天-0.040.012.40%2.18%-1.57%10天-0.02-0.012.48%2.34%-1.56%15天-0.020.02-0.95%2.61%-1.41%16天-0.03-0.014.78%2.37%-1.87%17天-0.010.01-2.99%4.

19、42%-2.13%在(0.2-2.50 ) g/L線性范圍內(nèi)，r 0.990。在(0.60-2.50 ) g/L范圍內(nèi)的相對偏差不 超過15%測定結(jié)果為(0.20-0.60gL時的絕對偏差不超過0.09gL 。產(chǎn)品批號：20140122線性范圍12345相關(guān)系數(shù)0天0.230.480.881.872.400.99955天0.210.500.891.862.390.999410天0.230.500.941.872.360.999415天0.220.460.901.882.350.999216天0.230.470.931.852.310.999217天0.210.480.931.852.310.9

20、990線性偏差123450天0.010.02-4.72%2.05%-0.63%5天-0.010.03-3.71%1.91%-0.76%10天-0.020.010.23%2.44%-1.45%15天-0.01-0.01-1.56%3.40%-1.70%16天-0.02-0.011.67%2.96%-1.84%17天-0.030.011.24%3.20%-1.97%在(0.2-2.50)g/L線性范圍內(nèi)，r 0.990。在(0.60-2.50)g/L范圍內(nèi)的相對偏差不超過 15%;測定結(jié)果為(0.20-0.60g/L時的絕對偏差不超過0.09gL。產(chǎn)品批號：20140124線性范圍12345相關(guān)系

21、數(shù)0天0.230.480.881.862.380.99955天0.220.470.901.772.440.9993線性范圍12345相關(guān)系數(shù)10天0.220.470.941.852.350.999615天0.220.460.931.862.350.999416天0.230.490.931.852.310.999017天0.220.470.961.882.310.9982線性偏差123450天0.010.01-3.81%2.23%-0.84%5天0.010.02-0.80%-2.95%1.67%10天-0.010.001.81%2.02%-1.32%15天-0.01-0.011.06%2.65%

22、-1.56%16天-0.020.011.27%3.21%-1.96%17天-0.03-0.023.65%4.09%-2.67%在（0.2-2.50） g/L線性范圍內(nèi)，r 0.990。在（0.60-2.50 ） g/L范圍內(nèi)的相對偏差不超過 15%;測定結(jié)果為（0.20-0.60gL時的絕對偏差不超過0.09gL。重復(fù)性產(chǎn)品批號：201401200天5天10天15天16天17天水平1水平2水平1水平2水平1水平2水平1水平2水平1水平2水平1水平211.211.581.221.551.261.571.141.581.231.531.201.5721.251.581.221.621.201.61

23、1.231.511.151.511.221.4831.281.631.241.591.181.581.251.501.201.471.161.5241.191.651.251.621.171.581.261.491.221.471.191.5251.231.651.211.601.191.631.211.541.211.581.181.4661.211.621.191.651.231.531.151.611.191.541.221.5671.251.581.261.621.221.531.231.591.191.571.221.5881.211.601.261.631.151.571.251.

24、491.141.481.151.6191.211.561.231.541.221.531.241.501.171.601.221.57101.221.631.211.491.171.531.251.531.151.521.161.47X1.231.611.231.591.201.571.221.531.191.531.191.53S0.0270.0320.0240.0490.0310.0350.0410.0440.0310.0470.0300.053CV2.18%1.99%1.96%3.08%2.61%2.22%3.39%2.89%2.59%3.07%2.48%3.43%產(chǎn)品批號：201401

25、220天5天10天15天16天17天水平1水平2水平1水平2水平1水平2水平1水平2水平1水平2水平1水平211.261.641.191.621.241.581.191.481.171.571.191.5321.261.611.211.561.211.611.201.591.151.481.161.4531.221.561.261.641.221.611.171.571.211.501.181.6141.241.541.211.641.201.561.161.521.171.511.161.5351.211.561.211.591.211.561.171.611.141.571.211.546

26、1.181.591.221.611.141.611.191.541.241.481.141.5371.281.551.241.561.161.641.191.501.131.541.141.4581.251.581.231.641.231.551.211.611.161.511.131.5391.191.641.231.551.211.541.201.511.131.541.171.51101.251.631.221.541.221.591.181.491.221.561.241.53X1.241.591.221.591.211.581.191.541.171.531.171.52S0.032

27、0.0370.0200.0390.0330.0320.0160.0500.0370.0330.0330.045CV2.58%2.33%1.61%2.44%2.70%2.01%1.35%3.21%3.16%2.18%2.82%2.97%產(chǎn)品批號：201401240天5天10天15天16天17天水平1水平2水平1水平2水平1水平2水平1水平2水平1水平2水平1水平211.221.571.231.621.171.581.191.571.191.461.141.5621.281.601.201.581.181.611.191.601.231.571.191.5331.261.601.241.471.171.591.181.501.151.541.181.5641.271.581.241.591.181.561.161.591.221.601.161.4551.211.611.211.501.201.521.201.551.161.551.221.4861.201.651.231.591.181.611.261.571.171.601.191.4871.251.621.191.591.141.561.231.611.161.541.151.5381.251.501.161.571.231.601.151