三种快速定量检测NT-proBNP仪器分析性能验证比较

Analysis Performance Verification of Three Kinds of Rapid Quantitative Detection Instrument for NT pro BNP

目的对三种快速定量检测NT-pro BNP(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-pro BNP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-pro BNP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-pro BNP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 Roche Cobas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。

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 W ith the reference of national clinical test procedures, the precision, accuracy, linearity range, reference range of three kinds of PO CTinstrumentations for detection of NT-pro B NP were verified. Results The total imprecisions of three kinds of PO CTinstrumentations were less than 15% of the statement CV value. The linear correlation analysis showed that the correlation coefficient r^2 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-pro B NP 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, ② regression analysis has the highest correlation coefficient r^2, which has comparability with the corresponding evaluation method R oche Cobas, clinically acceptable. R eference range validation shows that the three kinds have similar instrument test results in different age.