自建胱抑素C检测系统分析性能的评价

Performance evaluation of a self-built cystatin C detection system

目的通过应用CLSI EP系列方案分别对一种国产颗粒增强免疫比浊法胱抑素C试剂结合日立7600-020全自动生化分析仪建立的检测系统的分析性能进行评价,了解该检测系统分析性能能否满足临床需要。方法采用EP-5A2、EP-6A对自建检测系统精密度、最低检测限、线性、试剂稳定性等技术指标进行测定。采用EP-9A2与进口检测系统进行方法比对试验。结果自建检测系统批内、批间、天间及总不精密度均低于8%;最低检测限为0.11mg/L;4℃试剂稳定性大于或等于30d;标本胱抑素C水平为0.5~8.0mg/L时,线性良好,偏倚较小;方法比对试验结果Y=0.829 1 X＋0.007 5,r2=0.993 8。结论国产胱抑素C试剂结合日立7600-020生化分析仪检测性能可以满足临床实验室的需要,与进口检测系统比对结果差异无统计学意义（P〉0.05）。

Objective To evaluate the performance of a detection system established by a domestic particle re- inforced immune turbidimetry cystatin C reagent combined with the Hitachi 7600-020 fully automatic biochemical an- alyzer through using CLSI EP scheme to understand whether the performance of this detection system can meet the clinical needs. Methods EP-5A2 and EP-6A were adopted to measure the precision,minimal detection limit,lineari- ty,reagent stability and other technical indicators of the self-built detection system. EP-9A2 was adopted to conduct the methodological comparative test. Results The intra-batch,inter-batch,inter-day and total imprecision of the self- built detection system all were 〈 8%;the minimal detection limit was 0.11mg/L;4 ℃ reagent stability was≥30 d, when the cystatin C content of the sample was in the range of 0.5-8.0 mg/L,the linearity was good with small bi- as;the methodological comparison results was Y=0. 829 1X＋0. 007 5,r2 =0. 993 8. Conclusion The domestic Cys- tain C reagent combined with the detection performance of the Hitachi 7600-020 biochemical analyzer can meet the needs of clinical laboratory, the results difference of its comparison with the import detection system has no statistical significance（P〉0.05）.