体外诊断试剂研发记录模板 测试数据附件.docx

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1、XXX产品0月稳定性测试数据附件1、试剂空白:批号201405012014050220140503测试10.0470.0470.046测试20.0460.0460.047测试30.0460.0470.047平均值0.0470.0470.0472、分析灵敏度：批号201405012014050220140503灵敏度0.1200.1180.1173、线性：批号201405012014050220140503测试11.0010.9791.090测试21.0250.8350.852测试30.8951.0770.996平均值0.97350.96370.9793估计值1.041.180.92绝对偏差-0

2、.07-0.220.06测试11.8212.2072.116测试21.7032.0392.092测试32.1831.9311.845平均值1.90212.05902.0176估计值2.042.111.91绝对偏差-0.14-0.050.11测试14.1424.3573.327测试24.4224.3573.824测试34.4174.1974.278平均值4.32714.30383.8095估计值4.043.963.88相对偏差7.00%8.67%-1.79%测试18.047.147.51测试27.627.568.64测试38.338.246.73平均值8.0017.6487.627估计值8.04

3、7.667.82相对偏 差-0.53%-0.20%-2.47%测试117.614.515.9测试216.217.114.9测试314.213.416.6平均值16.0215.0115.80估计值16.0415.0715.70相对偏 差-0.17%-0.39%0.62%批号201405012014050220140503理论值规格0.969平均值1#0.97350.96370.97931.938平均值2#1.90212.05902.01763.875平均值3#4.32714.30383.80957.75平均值4#8.0017.6487.62715.50平均值5#16.0215.0115.80回归

4、系数0.99990.99980.9999估计值11.041.180.92估计值22.042.111.91估计值34.043.963.88估计值48.047.667.82估计值516.0415.0715.70绝对/相对偏0月（日立7060）差批号2014050120140502201405031#-0.07-0.220.062#-0.14-0.050.113#7.00%8.67%-1.79%4#-0.53%-0.20%-2.47%5#-0.17%-0.39%0.62%4.1、重复性:肝素钠批号20140501201405022014050311.565.621.545.301.485.3421.

5、575.441.595.441.525.5431.555.521.615.401.545.4541.585.541.625.501.545.5151.505.641.595.371.525.4261.535.641.585.331.535.6671.555.501.605.511.485.3381.555.631.635.471.495.5491.565.541.615.541.495.39101.515.491.625.491.555.55平均值1.555.561.605.441.515.47S0.020.070.030.080.030.10CV1.59%1.28%1.63%1.51%1.7

6、3%1.91%4.2、批间差：批号201405012014050220140503XIX2X3测试值11.521.571.54测试值21.531.611.58测试值31.581.491.581.001.542.001.563.001.571.55R1.53%5、准确度：批号201405012014050220140503测试值11.525.691.635.501.545.45测试值21.625.241.595.561.635.19测试值31.555.341.515.471.545.50平均值1.565.421.585.511.575.38相对偏差0.78%-0.47%1.70%1.14%1.1

7、9%-1.24%6、抗干扰：批号201405012014050220140503测试值11.331.341.33测试值21.321.341.32测试值31.331.331.35平均值1.331.341.33相对偏差-14.30%-13.76%-13.98%血红蛋白批号201405012014050220140503测试值11.341.341.34测试值21.341.351.33测试值31.341.341.34平均值1.341.341.34相对偏差-13.45%-13.26%-13.72%胆红素批号201405012014050220140503测试值11.321.331.32测试值21.331.341.32测试值31.341.321.34平均值1.331.331.33相对偏差-14.28%-14.06%-14.40%甘油三酯批号201405012014050220140503测试值11.351.351.34测试值21.341.341.33测试值31.331.341.33平均值1.341.341.33相对偏差-13.68%-13.51%-13.95%