论文部分内容阅读
目的初步评价血管紧张素转移酶检测试剂盒性能。方法依据临床和实验室标准协会颁布的《定量临床检验方法的初步评价,批准指南第2版(EP10-A2)》提供的方法,按特定的顺序连续测定低、中、高浓度的质控品5d,对该试剂盒检测方法的性能进行初步评价。结果血管紧张素转移酶低、中、高浓度的质控血清的靶值分别为49、89.5、130U/L时,按特定的顺序连续测定5d,没有离群值。线性回归方程为y=0.879x+8.45,相关系数为0.9964;绝对偏差分别是0.64、1.26、-9.6U/L;总不精密度(CV%)分别为4.39%、2.26%、1.39%。结论血管紧张素转移酶检测试剂盒检测方法的线性、总变异和抗交叉污染能力均达到EP10-A2文件的标准,符合临床应用要求。高值的偏差提示超出可接受范围,需要进一步进行评估。
Objective To evaluate the performance of the angiotensin-converting enzyme assay kit. Methods Based on the methods provided in the Preliminary Evaluation of Quantitative Clinical Laboratory Tests and the Second Edition of the Approval Guide (EP10-A2) promulgated by Clinical and Laboratory Standards Institute, the quality control products of low, medium and high concentrations were continuously measured in a specific order 5d, a preliminary evaluation of the performance of the kit test method. Results The target values of the low, middle and high quality control sera of angiotensin-converting enzyme were 49, 89.5 and 130U / L, respectively, and were continuously measured in a specific order for 5 days with no outliers. The linear regression equation was y = 0.879x + 8.45 with a correlation coefficient of 0.9964. The absolute deviations were 0.64, 1.26, -9.6U / L, respectively. The total inaccuracy (CV%) was 4.39%, 2.26% and 1.39%, respectively. Conclusion The linearity, total variation and cross-contamination resistance of the detection kit of angiotensin-converting enzyme test kit both meet the standards of EP10-A2 and meet the requirements of clinical application. High-value discrepancies indicate that they are beyond acceptable limits and require further evaluation.