【摘要】 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。更多还原

【Abstract】 Objective To evaluate the angiotensin converting enzyme(ACE) test kit.Methods According to the CLSI document EP10-A2,Preliminary Evaluation of Quantitative Clinical Laboratory Methods;Approved Guideline-Second Edition,the low,middle and high control materials were tested with the specific sequence for five days.The dates were analyzed and the preliminary decision was made for the acceptability of the ACE test kit.Results The ACE values of the low,middle,and high control materials were 49,89.5 and 130 U/L,respectively.There were not outliers and the multiple regression equation of ACE was y=0.879x+8.45,r2 =0.9964.The absolute bias was 0.64,1.26 and-9.6 U/L,respectively,and imprecision(CV%)were 4.39%,2.26% and 1.39%,respectively.Conclusion Nonlinearity,imprecision and sample carry-over of the ACE test kit were accepted by EP10-A2.The high level bias should be studied in the future.更多还原