单人份全自动化学发光免疫分析法测定降钙素原的性能评价

Performance Valuation of Individually Full-automatic Chemiluminescent Immunoassay in Determining Procalcitomin

该研究评价了单人份全自动化学发光免疫分析法测定降钙素原(PCT)的性能,采用双位点夹心化学发光免疫分析法对PCT测定试剂盒的线性、检测限、准确度、重复性进行评价,显示单人份全自动化学发光免疫分析法测定降钙素原试剂盒在0~100 ng/ml范围内的线性关系良好且相关系数r为0.99999,检测限均低于空白限0.02 ng/ml的检测结果的数量为0个,准确度最大偏差的绝对值为6.88%,重复性变异系数CV小于4%,说明单人份全自动化学发光免疫分析系统及其配套的PCT测定试剂盒线性、检测限、准确度、重复性结果良好。

Double-site sandwich individual chemiluminescent immunoassay was established to evaluate the performance of procalcitonin(PCT) kit in linearity, limit of detection(LoD), accuracy and repeatability. It revealed that the linear correlation coefficient was 0.99999 from 0 to 100 ng/ml. The limit of detection(LoD) results were all higher than the limit of blank(LoB) which is 0.02 ng/ml. The absolute value of maximum relative deviation was 6.88%.The repeatability coefficient of variation(CV) was less than 4%. In conclusion, this developed PCT kit using individually full-automatic chemiluminescent immunoassay system showed a good linearity, LoD, accuracy, and repeatability in determining procalcitomin.