摘要
目的对Roche Cobas E601电化学发光分析仪检测人附睾蛋白4（HE4）的分析性能进行方法学评价。方法根据美国临床实验室标准化委员会（NCLLS）的EP文件要求，制定定量检测方法的方法学评价方案，通过RocheCobasE601电化学发光分析仪测定低、高值混合血清和HE4定值校准品的HE4含量，对仪器检测HE4的精密度、准确度、分析测量范围和携带污染率进行评价。结果低、高值混合血清批内精密度的变异系数（CV）分别为1．75％和2．40％，批间精密度的cV为2．19％和2．85％；测定定值校准品的检测结果与靶值的偏倚为0．21％，准确度满足判断标准；分析测量范围线性为19．81～1213．5pmol／L（d值在0．95～1．05，产≥O．98）；携带污染率为0．074％（2．0％）。结论Roche Cobas E601电化学发光分析仪检测HE4的精密度好、准确度高、线性范围宽、携带污染率低，检测性能可满足临床要求。
Objective To evaluate the performance methodology for determining human epididymis secretory protein 4 （HE4） by using Roche Cobas E601 electrochemiluminescence analyzer. Methods According to the EP documents by U. S. Committee for Clinical Laboratory Standards （NCLLS） recommended, we developed the evaluation Program of quantitative detection methods through the Roche Cobas E601 electrochemiluminescence analyzer. The precision,accuracy,analytical measurement range （AMR） and carry-over rate of HE4 were determined. Results The coefficient of variation （CV） of within-run precision of low and high value pooled serum were respectively 1.75% and 2.40%. The CVof between run precision were respectively 2.19% and 2.85%; The bias of calibrator between the measured value and the target value was 0.21%,and the accuracy meeted the criteria; The analytical measurement range （AMR） was from 19.81 pmol/L, to 1213.5 pmol/L. The carry over rate was 0. 074% （2.0%）. Conclusion The precision,accuracy,analytical measurement range and carry-over rate of Roche Cobas E601 electrochemiluminescence analyzer for determining HE4 meet the clinical requirements.
出处
《检验医学与临床》
CAS
2013年第A02期20-22,共3页
Laboratory Medicine and Clinic
