21性能分析数据Word格式文档下载.docx

1、47.2 99.1 189.4 估计值13.0 24.9 48.5 95.9 190.6 标准值12.0 24.0 48.0 96.0 192.0 绝对偏差-1.10.5 相对偏差-2.68%3.32%-0.66%相关系数0.999625.6 50.1 99.9 188.3 10.9 23.0 52.4 101.8 191.6 25.8 49.9 96.6 190.8 24.8 50.8 99.5 190.2 13.6 49.2 96.8 191.8 -2.1 -0.7 3.17%2.80%-0.80%11.5 25.7 47.9 99.6 189.7 11.8 23.6 102.1 12.2

2、 25.9 49.6 101.7 189.2 25.1 49.1 101.1 189.9 49.3 191.9 12244896192-1.8 -0.4 -0.31%4.47%-1.02%0.9994表5 批内精密度测定结果40.3 77.7 39.9 81.3 40.8 79.1 80.3 38.3 80.6 78.4 39.3 78.2 40.6 78.6 40.0 77.9 483.1 39.5 80.0 41.2 78.9 538.8 82.4 40.9 81.9 79.2 641.0 82.3 77.8 39.4 740.4 39.6 38.4 83.0 878.8 38.5 81.

3、7 980.2 40.7 82.5 1082.6 77.6 39.2 78.0 39.7 80.5 39.8 79.8 40.1 79.9 S0.918 2.028 0.861 1.613 0.875 1.881 CV2.32%2.52%2.17%2.02%2.18%2.35%重复性：变异系数（CV）应5%，均符合要求。表6 批间差测定结果X1X2X338.840.440.639.9R4.46%批间差：相对偏差（R）8%，均符合要求。表7 准确度测定结果靶值范围40.9 U/L（34.8-47）81.8 U/L（69.6-94）38.339.541.283.180.078.940.982.48

4、1.979.241.039.482.377.880.340.082.679.979.5-3.67%-2.20%-1.22%0.98%-2.32%-2.81%是否在控在控标准要求用参考物质作为样本进行检测，其测量结果的相对偏差不超过15%。质控测试：用质控品测试，测定值在质控品靶值范围内。表8 抗干扰测定结果抗坏血酸白蛋白测试值135.6 36.1 36.2 36.4 36.7 35.8 测试值236.0 36.8 34.8 35.1 35.9 测试值335.2 35.4 35.56 36.15 36.31 35.55 35.88 35.92 -13.06%-11.61%-11.22%-13.0

5、8%-12.28%-12.19%胆红素尿素36.6 35.0 35.3 36.3 35.26 36.16 35.32 35.98 36.21 -13.80%-11.60%-13.64%-12.03%-11.46%-11.62% 分析性能评估资料-日立76000.0400.0500.0440.0540.0460.0580.0380.0470.0410.0250.01825.2 48.2 97.4 184.1 45.2 97.2 180.2 193.0 47.5 98.2 185.8 13.5 94.6 187.3 -1.7 0.4 -1.44%3.76%-0.83%0.999547.8 102.

6、4 190.0 12.5 22.5 49.5 101.6 193.8 98.6 188.5 12.1 24.6 48.8 100.9 13.3 96.9 192.5 -1.2 4.04%-0.89%192.1 48.4 100.0 12.3 47.7 101.9 192.7 101.4 191.4 97.3 193.2 12.024.048.096.0192.0-1.4 0.1 4.31%-0.90%79.3 82.7 38.1 80.4 38.2 81.0 80.7 79.0 82.8 81.6 39.1 81.8 38.0 81.2 38.9 82.9 40.2 78.3 78.7 81.

7、1 81.5 38.7 0.809 1.711 1.004 1.626 1.147 1.821 2.05%2.12%2.54%2.03%2.89%2.27%41.1 41.9 40.5 40.540.31.40%40.9U/L（34.8-47）81.8U/L（69.6-94）81.082.881.681.878.481.282.980.280.4-3.91%-4.16%-2.69%-1.96%-1.71%0.12%35.7 35.77 35.75 35.40 35.90 36.25 36.57 -12.53%-12.60%-13.44%-12.23%-11.37%-10.58%36.5 35.

8、22 36.09 35.70 35.46 35.58 36.13 -13.88%-11.76%-12.70%-13.29%-13.00%-11.67%N-乙酰-D-氨基葡萄糖苷酶测定试剂盒（比色法）分析性能评估资料-西门子16500.0490.0360.0350.0590.0370.0430.051A/min0.022 0.019 24.1 187.9 24.3 24.5 100.3 188.0 188.9 49.0 96.3 191.0 -1.0 -0.30%4.75%-1.07%0.999323.4 98.8 23.9 98.5 182.3 97.9 186.9 23.3 49.4 187.0 13.1 95.0 188.7 -1.3 -1.5 2.38%3.53%188.6 179.2 24.2 186.5 13.7 48.7 95.3 1.42%4.53%-1.10%81.4 78.5 37.8 37.9 82.2 80.9 77.4 77.1 77.0 79.5 82.0 1.094 1.648 0.960 2.321 1.200 1.421 2.78%2.43%3.05%1.76%39.840.839.66.76%40.739.337.979.080.581.538.738.280.782.240.182.580.881.780.9-6.36%-1.24%-0.12%