26-资料8LDL的稳定性研究资料数据

1、低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20140118试剂空白吸光 度值A空白 0. 1000.0100.0120.0120.0140.0160.014201401200.0110.0120.0130.0140.0160.016201401220.0120.0100.0120.0140.0140.014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20140118浓度为3.36mmolL 时，吸 光 度 差 值 0. 100。0.1240.1250.1220.122

2、0.1110.106201401200.1200.1230.1220.1240.1150.112201401220.1250.1240.1210.1190.1170.114线性范围产品批号：20140118线性范围12345相关系数0个月0.541.202.174.699.000.99964个月0.581.192.134.659.020.99968个月0.541.132.124.628.780.999412个月0.551.162.074.628.690.999213个月0.531.132.164.588.540.999214个月0.521.082.154.738.610.9983线性偏差123

3、450个月-0.040.05-4.74%3.35%-0.58%4个月0.010.04-5.92%2.57%-0.34%8个月-0.030.01-4.62%4.31%-0.78%12个月-0.030.03-6.46%4.93%-0.85%13个月-0.07-0.01-2.16%5.18%-1.10%14个月-0.07-0.05-3.38%7.51%-1.55%在(0.01-10.00 )mmol/L 线性范围内，r 0.990。在(1.50-10.00)mmol/L 范围内偏差不超过10% 测疋结果(0.01-1.50mmolL时绝对偏差不超过 0.15mmolL 。产品批号：20140120线

4、性范围12345相关系数0个月0.581.152.154.749.120.99954个月0.551.142.124.698.940.9994线性范围12345相关系数8个月0.541.152.114.628.840.999512个月0.551.132.124.648.640.999113个月0.551.122.114.658.670.999014个月0.541.112.114.668.450.9984线性偏差123450个月0.020.01-5.79%3.42%-0.52%4个月-0.010.01-5.49%4.07%-0.68%8个月-0.030.03-5.19%3.71%-0.63%12个

5、月-0.05-0.01-4.36%5.55%-1.08%13个月-0.04-0.01-4.96%5.70%-1.08%14个月-0.06-0.03-4.33%7.47%-1.51%在(0.01-10.00 ) mmol/L 线性范围内，r 0.990。在(1.50-10.00) mmol/L 范围内偏差不超过10% 测疋结果(0.01-1.50mmolL时绝对偏差不超过 0.15mmolL。产品批号：20140122线性范围12345相关系数0个月0.551.142.184.729.080.99964个月0.531.162.154.679.010.99968个月0.541.172.124.66

6、8.810.999312个月0.531.112.184.668.570.998813个月0.521.192.144.668.540.998614个月0.541.162.134.708.480.9982线性偏差123450个月-0.010.01-4.21%3.33%-0.57%4个月-0.020.03-4.75%3.14%-0.52%8个月-0.040.03-5.10%4.51%-0.82%12个月-0.08-0.04-1.89%6.31%-1.36%13个月-0.100.03-4.03%6.55%-1.36%14个月-0.09-0.01-4.65%7.81%-1.60%在(0.01-10.00

7、 ) mmol/L 线性范围内，r 0.990。在(1.50-10.00) mmol/L 范围内偏差不超过10% 测疋结果(0.01-1.50mmolL时绝对偏差不超过 0.15mmolL 。重复性产品批号：201401180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213.394.903.414.703.474.663.454.683.154.193.314.2023.444.663.534.703.484.463.154.663.054.613.044.0633.424.593.404.543.404.793.234.77

8、3.274.303.374.1843.594.893.584.833.404.473.304.353.394.583.024.4053.504.873.544.823.294.493.314.603.344.433.384.4363.484.563.404.693.274.883.404.603.044.333.234.3773.604.593.594.873.574.853.224.563.334.393.154.1383.464.893.524.683.474.513.274.363.274.463.014.1193.614.703.414.533.274.563.324.333.414.

9、383.344.03103.474.843.544.873.554.663.224.603.324.663.164.53X3.504.753.494.723.424.633.294.553.264.433.204.24S0.0800.1410.0780.1240.1110.1600.0900.1540.1330.1480.1450.175CV2.28%2.98%2.24%2.63%3.25%3.46%2.73%3.38%4.09%3.34%4.53%4.12%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

10、平213.594.563.514.733.514.853.344.763.084.653.364.5123.374.613.604.663.254.613.404.643.374.683.314.2933.524.813.564.543.524.813.374.473.224.613.334.5543.414.873.434.763.474.663.364.433.094.523.304.4753.394.863.434.703.484.863.474.623.294.313.154.2463.354.793.334.853.524.633.374.353.284.503.264.2273.4

11、84.913.454.743.434.713.254.783.124.583.184.3483.444.853.324.893.344.873.494.803.224.493.034.5193.494.653.454.873.494.493.484.553.374.643.034.44103.474.773.444.633.334.633.514.683.324.313.414.06X3.454.773.454.743.434.713.404.613.234.533.244.36S0.0740.1220.0880.1120.0930.1300.0830.1560.1080.1330.1330.

12、159CV2.13%2.55%2.55%2.36%2.71%2.75%2.45%3.38%3.35%2.94%4.10%3.64%产品批号：201401220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213.464.653.414.623.424.553.364.483.044.233.314.6023.554.853.494.893.614.773.234.573.324.483.084.3233.444.613.404.653.364.533.474.633.074.543.244.5843.474.613.604.743

13、.464.533.414.523.344.543.264.2253.384.643.604.793.594.823.254.413.254.563.324.3963.374.593.544.633.474.823.494.803.134.613.214.4673.574.593.504.733.424.703.294.503.124.533.374.3983.514.833.364.673.344.733.484.773.154.663.004.1293.604.603.444.853.454.533.284.513.294.413.164.09103.354.763.384.843.604.

14、483.454.493.024.473.104.14X3.474.673.474.743.474.653.374.573.174.503.214.33S0.0880.1000.0890.0970.0970.1340.101).127 0.118 0.119 0.1170.188CV2.52%2.15%2.55%2.05%2.79%2.89%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20140118校准血清3.34(2.84-3.84)mmol/L3.523.513.323.343.263.21相对偏差5.39%

15、5.09%-0. 60%0.00%-2.40%-3.89%是否在控在控在控在控在控在控在控20140120校准血清3.383.403.493.403.223.24相对偏差1.20%1.80%4.49%1.80%-3.59%-2.99%是否在控在控在控在控在控在控在控20140122校准血清3.403.583.503.383.243.26相对偏差1.80%7.19%4.79%1.20%-2.99%-2.40%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20140118校准血清4.53(3.85-5.21)mmol/L4.774.784.614.52

16、4.454.40相对偏差5.30%5.52%1.77%-0.22%-1.77%-2.87%是否在控在控在控在控在控在控在控20140120校准血清4.844.774.724.474.444.31相对偏差6.84%5.30%4.19%-1.32%-1.99%-4.86%是否在控在控在控在控在控在控在控20140122校准血清4.744.724.724.574.574.36相对偏差4.64%4.19%4.19%0.88%0.88%-3.75%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20140118试剂空白吸光 度值A空白 0. 1000

17、.0110.0110.0130.0130.0140.016201401200.0100.0110.0120.0130.0150.015201401220.0120.0120.0140.0130.0150.015分析灵敏度批号分析灵敏度0天5天10天15天16天17天20140118浓度为3.36mmol/L 时，0.1260.1250.1200.1260.1120.109201401200.1220.1230.1190.1250.1140.11420140122吸光度差值 0. 100。0.1250.1260.1210.1210.1090.113线性范围产品批号：20140118线性范围123

18、45相关系数0天0.561.152.224.758.940.99945天0.531.142.224.708.920.999510天0.521.112.164.668.870.999515天0.521.202.114.598.680.999316天0.551.112.144.598.530.999117天0.531.112.184.648.410.9984线性偏差123450天-0.05-0.02-2.89%4.75%-0.96%5天-0.05-0.01-2.16%4.03%-0.83%10天-0.04-0.01-3.23%4.19%-0.81%15天-0.070.07-5.19%4.26%-0

19、.79%16天-0.05-0.02-2.90%5.49%-1.12%17天-0.10-0.05-1.36%7.25%-1.61%在(0.01-10.00 )mmol/L 线性范围内，r 0.990。在(1.50-10.00)mmol/L 范围内偏差不超过10% 测疋结果(0.01-1.50mmolL时绝对偏差不超过 0.15mmolL。产品批号：20140120线性范围12345相关系数0天0.561.122.184.729.040.99965天0.531.132.084.649.010.999610天0.521.162.204.708.900.999415天0.541.132.134.648

20、.630.999116天0.531.162.124.628.630.999217天0.521.072.114.638.570.9989线性偏差123450天-0.01-0.01-3.87%3.75%-0.67%5天0.010.03-6.49%3.02%-0.41%10天-0.080.01-2.31%4.36%-0.91%15天-0.05-0.01-4.03%5.54%-1.09%16天-0.060.02-4.43%5.21%-1.02%17天-0.04-0.04-3.61%6.30%-1.26%在(0.01-10.00 ) mmol/L 线性范围内，r 0.990。在(1.50-10.00)

21、mmol/L 范围内偏差不超过10% 测疋结果(0.01-1.50mmolL时绝对偏差不超过 0.15mmolL。产品批号：20140122线性范围12345相关系数0天0.551.092.144.688.880.99945天0.531.152.174.688.910.999510天0.531.152.164.688.920.999515天0.531.162.184.608.670.999416天0.551.152.214.608.550.999217天0.531.122.154.708.520.9983线性偏差123450天-0.01-0.03-4.38%4.45%-0.80%5天-0.04

22、0.01-3.68%3.97%-0.75%10天-0.060.02-3.58%4.10%-0.80%15天-0.070.01-2.44%4.31%-0.90%16天-0.08-0.02-1.22%5.08%-1.12%17天-0.08-0.04-3.33%7.57%-1.59%在(0.01-10.00 ) mmol/L 线性范围内，r 0.990。在(1.50-10.00) mmol/L 范围内偏差不超过10% 测疋结果(0.01-1.50mmolL时绝对偏差不超过 0.15mmolL。重复性0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

23、213.504.643.484.823.244.783.444.683.254.533.104.5723.364.823.454.903.584.773.274.753.374.493.324.0933.494.763.404.733.454.513.174.413.384.533.174.1843.504.733.364.903.374.693.264.803.384.533.344.4753.404.793.374.843.374.843.424.503.214.313.234.5263.544.683.534.713.444.713.384.343.214.613.054.2173.51

24、4.593.524.573.574.453.274.623.194.513.304.5183.364.583.364.813.404.833.244.393.364.453.094.1893.404.683.554.913.394.853.254.503.114.343.124.19103.574.853.514.533.484.713.184.713.214.713.054.17X3.464.713.454.773.434.713.294.573.274.503.184.31S0.0750.0940.0740.1360.1000.1370.0930.1610.0990.1160.1130.1

25、83CV2.16%2.00%2.14%2.84%2.92%2.90%2.85%3.52%3.02%2.57%3.57%4.24%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213.614.853.384.693.464.803.144.803.074.173.054.3023.424.673.564.743.254.833.414.663.324.483.014.1533.374.713.544.853.384.443.204.623.214.673.164.0743.574.813.454.673.474.5

26、63.154.413.264.703.374.4153.484.553.524.903.254.573.334.543.464.343.064.2063.454.753.414.883.514.633.414.353.004.563.164.4473.474.613.534.873.564.733.334.733.054.463.184.6083.544.683.494.573.504.883.464.603.374.673.364.2093.474.633.424.913.384.613.214.503.324.173.004.18103.444.613.454.843.374.503.45

27、4.663.114.603.274.15X3.484.693.484.793.414.653.314.593.224.483.164.27S0.0730.0960.0630.1150.1070.1490.1250.1400.1530.1990.1370.166CV2.10%2.05%1.81%2.39%3.14%3.20%3.78%3.06%4.76%4.43%4.34%3.88%产品批号：201401220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213.344.633.614.653.494.673.474.493.124.513.

28、274.3623.454.813.444.833.284.773.424.433.394.463.114.4933.474.633.394.713.514.453.464.793.044.403.304.4743.344.753.534.613.564.433.244.723.204.583.074.3753.414.803.424.543.504.903.454.523.324.313.264.5063.414.823.554.683.494.713.394.563.164.343.224.1373.574.663.354.553.384.683.224.673.224.583.154.3983.574.843.4