25-资料8HDL的稳定性研究资料数据

1、高密度脂蛋白胆固醇测定试剂盒(直接测定法)稳定性研究资料全效期稳定性研究试验结果:空白吸光度批号空白吸光度0个月4个月8个月12个月13个月14个月20140117试剂空白吸光 度值A空白 0. 1000.0180.0190.0180.0190.0230.026201401190.0180.0200.0160.0190.0250.025201401200.0190.0180.0180.0180.0240.025分析灵敏度批号分析灵敏度0个月4个月8个月12个月13个月14个月20140117浓度为 2.19 mmol/L时，吸光度 差值 0. 100。0.1210.1180.1230.1230

2、.1220.118201401190.1200.1240.1250.1200.1170.118201401200.1230.1220.1200.1210.1140.117线性范围产品批号：20140117线性范围12345相关系数0个月0.240.470.951.833.910.99944个月0.240.480.961.813.830.99958个月0.260.460.921.783.800.999312个月0.240.460.921.783.850.999213个月0.230.430.891.963.690.999214个月0.250.480.961.983.550.9983线性偏差1234

3、50个月0.030.021.06%-4.86%1.04%4个月0.010.022.31%-4.34%0.87%8个月0.040.01-0.26%-4.91%1.13%12个月0.030.020.08%-5.38%1.20%13个月0-0.03-3.90%5.42%-1.03%14个月-0.05-0.031.01%7.29%-1.73%在(0.01-3.90 )mmol/L 线性范围内，r 0.990。在(0.50-3.90 )mmol/L 范围内偏差不 超过10% 测定结果(0.01-0.50mmolL时绝对偏差不超过0.05 mmol/L 。产品批号：20140119线性范围12345相关系

4、数0个月0.240.450.951.783.840.99924个月0.240.460.921.753.800.99918个月0.250.490.901.823.850.9994线性范围12345相关系数12个月0.240.480.961.813.850.999413个月0.250.430.881.943.650.999314个月0.230.460.941.923.530.9988线性偏差123450个月0.030.013.10%-5.31%1.07%4个月0.030.021.04%-5.88%1.27%8个月0.030.04-3.69%-3.74%0.98%12个月0.010.022.47%-

5、4.76%0.95%13个月0.01-0.03-3.91%4.91%-0.90%14个月-0.04-0.031.01%6.09%-1.44%在(0.01-3.90 ) mmol/L 线性范围内，r 0.990。在(0.50-3.90 ) mmol/L 范围内偏差不 超过10% 测定结果(0.01-0.50mmolL时绝对偏差不超过0.05 mmol/L。产品批号：20140120线性范围12345相关系数0个月0.250.440.961.793.860.99924个月0.240.480.961.793.820.99938个月0.230.470.941.833.930.999412个月0.230

6、.470.911.753.810.999013个月0.240.450.961.943.590.999014个月0.230.470.941.903.500.9989线性偏差123450个月0.04-0.013.29%-5.33%1.09%4个月0.010.022.60%-4.91%0.97%8个月0.020.030.48%-4.64%1.00%12个月0.020.030.55%-5.84%1.26%13个月-0.03-0.041.95%5.40%-1.31%14个月-0.05-0.021.54%5.61%-1.37%在(0.01-3.90 )mmol/L 线性范围内，r 0.990。在(0.50

7、-3.90 )mmol/L 范围内偏差不 超过10% 测定结果(0.01-0.50mmolL时绝对偏差不超过0.05 mmol/L。重复性产品批号：201401170个月4个月8个月12个月13个月14个月水平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211.121.511.181.541.071.471.071.491.031.420.931.4121.101.491.111.571.021.511.021.481.041.401.001.4731.111.531.051.521.061.481.011.480.991.480.991.4041.161.571.171

8、.531.081.551.071.441.031.501.071.4251.141.461.121.511.091.531.031.431.001.470.971.4661.091.521.141.491.051.511.081.451.041.391.041.4571.101.541.071.581.081.501.091.441.081.491.041.4181.111.511.141.581.101.561.101.421.021.411.011.3991.101.571.131.581.101.441.031.520.971.440.971.38101.061.541.141.561.

9、111.511.011.450.991.400.981.38X1.111.521.121.551.081.511.051.461.021.441.001.42S0.0280.0340.0390.0310.0250.0350.0350.0320.0330.0410.0400.033CV2.52%2.25%3.50%2.00%2.30%2.34%3.30%2.17%3.20%2.84%3.95%2.32%产品批号：201401190个月4个月8个月12个月13个月14个月水平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211.121.521.061.541.071.551.0

10、31.381.051.401.021.4121.101.461.101.531.081.481.091.490.981.401.081.4831.071.551.121.581.011.521.091.521.021.431.051.3941.141.561.101.541.111.560.981.511.041.501.051.3951.121.531.071.501.071.491.091.501.091.431.051.4761.141.571.121.571.091.531.091.461.041.420.991.4871.141.571.101.531.021.461.001.431

11、.051.430.971.3581.121.531.101.541.041.481.011.510.991.381.081.4591.081.571.111.491.061.491.021.490.981.441.011.36101.141.551.101.501.091.480.981.470.991.401.071.40X1.121.541.101.531.061.501.041.481.021.421.041.42S0.0270.0340.0210.0290.0300.0330.0480.0440.0380.0330.0380.047CV2.39%2.19%1.91%1.87%2.86%

12、2.22%4.57%3.01%3.71%2.31%3.63%3.34%产品批号：201401200个月4个月8个月12个月13个月14个月水平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211.091.451.111.511.091.611.091.411.071.431.011.4321.081.551.091.551.081.521.091.420.981.481.031.3831.091.521.111.491.041.481.021.431.071.401.031.4341.101.531.121.531.051.521.051.431.041.490.991.4

13、051.141.441.041.571.101.520.991.500.991.441.051.3561.081.491.021.501.041.530.991.481.061.391.021.4571.101.541.101.561.111.461.061.510.981.440.981.4181.061.541.051.511.091.471.081.501.021.391.091.4891.151.551.031.591.071.491.031.451.031.431.001.36101.111.541.121.541.101.541.091.411.061.421.081.39X1.1

14、01.521.081.531.081.521.051.451.031.431.031.41S0.0280.0410.0400.0330.0250.0430.0400.0390.0380.0360.0360.040CV2.52%2.73%3.70%2.14%2.36%2.82%3.84%2.68%3.68%2.52%3.53%2.84%准确度批号项目质控品靶值0个月4个月8个月12个月13个月14个月20140117校准血清1.07(0.91-1.23)mmol/L1.101.111.081.091.051.03相对偏差2.80%3.74%0.93%1.87%-1.87%-3.74%是否在控在控

15、在控在控在控在控在控20140119校准血清1.111.111.051.031.031.02相对偏差3.74%3.74%-1.87%-3.44%-3.74%-4.67%是否在控在控在控在控在控在控在控20140120校准血清1.081.061.081.041.021.03相对偏差0.93%-0.93%0.93%-2.80%-4.67%-3.74%是否在控在控在控在控在控在控在控批号项目质控品靶值0个月4个月8个月12个月13个月14个月20140117校准血清1.51(1.28-1.74)mmol/L1.531.551.521.441.431.42相对偏差1.32%2.65%0.80%-4.6

16、4%-5.30%-6.24%是否在控在控在控在控在控在控在控20140119校准血清1.561.551.491.471.411.43相对偏差3.18%2.65%-1.32%-2.65%-6.52%-5.30%是否在控在控在控在控在控在控在控20140120校准血清1.531.521.491.501.411.45相对偏差1.32%0.66%-1.32%-0.66%-6.62%-3.97%是否在控在控在控在控在控在控在控开瓶稳定性结果空白吸光度批号空白吸光度0天5天10天15天16天17天20140117试剂空白吸光0.0200.0200.0170.0210.0250.02720140119度值A

17、空白0.0190.0190.0180.0210.0250.02520140120 0. 1000.0190.0180.0200.0190.0260.024分析灵敏度批号分析灵敏度0天5天10天15天16天17天20140117浓度为 2.19 mmol/L 时，吸 光度差值 0. 100。0.1260.1240.1190.1220.1140.113201401190.1240.1180.1230.1200.1140.114201401200.1170.1260.1240.1200.1160.112线性范围产品批号：20140117线性范围12345相关系数0天0.240.440.961.833

18、.870.99955天0.250.460.941.793.860.999110天0.250.480.961.773.720.999415天0.230.460.951.793.820.999416天0.220.430.871.933.610.999117天0.230.440.941.953.600.9989线性偏差123450天0.03-0.012.94%-4.11%0.82%5天0.040.011.35%-5.53%1.20%10天0.010.013.67%-4.52%0.85%15天0.010.013.10%-4.58%0.89%16天-0.01-0.02-3.61%5.67%-1.10%1

19、7天-0.03-0.040.98%5.89%-1.37%在(0.01-3.90 ) mmol/L 线性范围内，r 0.990。在(0.50-3.90 ) mmol/L 范围内偏差不 超过10% 测定结果(0.01-0.50mmolL时绝对偏差不超过0.05 mmol/L。产品批号：20140119线性范围12345相关系数0天0.240.460.931.833.910.99945天0.240.470.921.933.630.999410天0.250.480.881.823.830.999515天0.240.460.951.773.790.999316天0.230.440.921.923.560

20、.997917天0.240.500.891.953.610.9975线性偏差123450天0.030.02-0.34%-4.39%1.00%5天-0.02-0.01-2.03%4.61%-0.96%10天0.030.03-4.30%-3.14%0.87%15天0.020.013.43%-5.16%1.02%16天-0.02-0.030.17%5.47%-1.23%17天-0.030.01-5.03%5.77%-1.12%在(0.01-3.90 )mmol/L 线性范围内，r 0.990。在(0.50-3.90 )mmol/L 范围内偏差不超 过10% 测定结果(0.01-0.50mmolL时绝

21、对偏差不超过 0.05 mmol/L。产品批号：20140120线性范围12345相关系数0天0.250.470.951.773.800.99925天0.240.440.941.973.730.999510天0.240.470.941.793.810.9994线性范围12345相关系数15天0.250.460.941.753.750.999216天0.230.490.871.913.570.999017天0.230.430.931.953.560.9985线性偏差123450天0.020.012.44%-5.30%1.09%5天-0.01-0.03-0.32%4.28%-0.93%10天0.0

22、20.011.96%-4.58%0.95%15天0.020.013.09%-5.23%1.05%16天-0.030.02-5.42%5.28%-1.00%17天-0.03-0.050.36%6.92%-1.56%在(0.01-3.90 ) mmol/L 线性范围内，r 0.990。在(0.50-3.90) mmol/L 范围内偏差不超过10% 测定结果(0.01-0.50mmolL时绝对偏差不超过 0.05 mmol/L。重复性产品批号：201401170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211.081.601.141.581.

23、071.561.011.441.051.380.981.4821.121.471.111.571.041.531.071.481.021.441.051.4031.061.561.061.531.081.611.051.511.051.500.961.4041.101.571.141.541.041.511.001.451.011.480.991.4351.081.511.101.531.081.471.021.441.051.500.981.4261.071.541.111.491.061.511.021.481.001.480.931.3771.151.551.101.551.041.42

24、1.041.520.981.441.061.4281.091.521.101.411.071.491.051.480.991.440.951.4491.081.531.151.511.031.541.031.461.081.480.981.46101.141.531.121.431.041.530.981.541.031.461.001.45X1.101.541.111.511.061.521.031.481.031.460.991.43S0.0300.0370.0260.0550.0200.0510.0270.0340.0320.0370.0420.032CV2.71%2.38%2.29%3

25、.66%1.87%3.33%2.62%2.31%3.14%2.50%4.22%2.26%产品批号：201401190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211.101.551.151.501.091.481.081.471.061.501.031.4821.111.451.101.521.121.551.091.440.981.501.061.3831.051.531.121.581.061.541.001.491.061.391.071.3741.081.571.141.621.041.471.001.451.041.501.0

26、01.3851.061.511.081.571.051.550.991.521.011.401.011.3961.141.451.121.561.081.511.021.531.011.451.101.3971.101.541.061.571.101.481.011.521.031.420.991.4681.121.561.141.551.111.551.061.531.041.480.981.3691.111.551.091.571.041.541.081.521.041.410.991.44101.061.561.111.531.071.511.061.441.021.441.051.42

27、X1.091.531.111.561.081.521.041.491.031.451.031.41S0.0300.0430.0300.0340.0290.0320.0390.0380.0250.0450.0390.041CV2.72%2.83%2.72%2.21%2.71%2.09%3.77%2.52%2.45%3.08%3.82%2.94%产品批号：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211.141.491.101.641.051.501.011.430.971.411.001.4721.141.411.091

28、.531.071.451.021.431.041.421.091.4831.081.511.101.491.041.530.991.451.081.490.991.3641.101.511.111.561.081.541.041.521.041.431.091.4651.081.531.081.531.071.471.021.441.041.421.061.4561.081.571.131.521.101.521.071.500.981.401.011.4171.081.561.141.521.111.501.021.460.971.400.991.3681.141.551.071.511.0