三种快速定量检测NT-proBNP仪器分析性能验证比较

摘要

Objective To verify the analysis performance of three kinds of rapid quantitative detection instrument for NT-proBNP (POCT), and to verify the comparability with chemiluminescence detection system. Methods With the reference of national clinical test procedures, the precision, accuracy, linearity range, reference range of three kinds of POCT instrumentations for detection of NT-proBNP were verified. Results The total imprecisions of three kinds of POCT instrumentations were less than 15%of the statement CV value. The linear correlation analysis showed that the correlation coefficient r2 values of concentration and its corresponding evaluation method for the determination of instrument measurements were 0.990, 0.990, 0920. In addition to a value beyond the reference range of vendors, the reference interval validation showed that the NT-proBNP concentrations were in the reference range. Conclusions From the aspects of precision validation, total precisions of three instruments are all less than 15%manufacturer statement CV value. From the aspects of linear validation,②regression analysis has the highest correlation coefficient r2, which has comparability with the corresponding evaluation method RocheCobas, clinically acceptable. Reference range validation shows that the three kinds have similar instrument test results in different age.%目的：对三种快速定量检测NT-proBNP （POCT）仪器进行分析性能的验证，同时与化学发光法进行检测系统之间的可比性验证。方法参考全国临床检验操作规程，对三台检测NT-proBNP的POCT仪器进行精密度、正确度和线性范围、参考区间验证，确定其是否适用于本实验室。结果三种检测NT-proBNP的仪器总不精密度小于厂家声明的CV 值的15%；三台仪器测定的浓度与其对应的评价方法测定值，经线性相关分析得到相关系数r2值为0.990、0.992、0920；三种仪器参考区间验证中NT-proBNP浓度除了一个检测值超出厂商提供的参考区间外，其余均在参考区间内。结论从精密度验证方面，三种仪器总精密度均小于厂家声明的CV 值15%。从线性验证方面，②号机的回归分析相关系数r2最高，与对应评价方法RocheCobas间具有可比性，临床上可接受。从参考区间验证表明，三种仪器在不同年龄检测结果相似。