肌钙蛋白I检测系统评价及临床应用

Clinical utilization and evaluation of assay for cardiac troponin I

目的对强生电化学发光系统检测肌钙蛋白I(cTnI)的方法进行评估和初步应用。方法连续测定10次cTnI0水平标准,计算分析灵敏度;用不同浓度低值血浆连续检测10d,检测功能灵敏度;用美国临床实验室标准化委员会EP15-A提供的方案对该方法的线性、不精密度进行研究;最后对标本的稳定性和临床应用进行研究。结果该方法的分析灵敏度为0.036μg/L;功能灵敏度为0.12μg/L;线性范围为0～95.4μg/L,r=0.9996;批内不精密度为1.0%～3.9%,总不精密度为2.0%～4.3%;循证检验医学研究发现血清cTnI假阳性为10.0%(3/30),4℃保存72h不发生变化;临床诊断符合率为97.2%。结论强生电化学发光系统检测cTnI各项性能指标良好,符合要求,系统推荐用肝素锂抗凝血浆进行检测。

Objective To evaluate the determination method of cardiac troponin I with Ortho Clinical Diagnostics Vitros ECiQ system and its preliminary application.Methods The zero level of cardiac troponin I was tested 10 times for analytical sensitivity;a series of low lever serum was analyzed 10 d for the functional sensitivity;linearity,imprecision were studied according to National Committee for Clinical Laboratory Standards（NCCLS）EP15-A protoco1.At last,to study the sample stability of cardiac troponin I and clinical application.Results The analytical sensitivity of this method was 0.036 μg/L,the functional sensitivity of this method was 0.12 μg/L,the linearity range was 0-95.4 μg/L,within-run and total imprecision were 1.0%-3.9% and 2.0%-4.3% respectively.the serum cardiac troponin I false positive rate was 10%（3/30） in terms of evidence-based laboratory medicine,the cardiac troponin I kept stability for 3 d under 4 ℃,the clinical diagnostic accurate rate was 97.2%.Conclusion The ECIQ method used to detect the cardiac troponin I level has good performance and corresponds to clinical needs,heparin plasma is recommended for detection.