背景:BNP是一种用于心力衰竭早期诊断的敏感且广泛使用的生物标志物。目前,大多数商业BNP检测产品使用EDTA血浆样品。这项研究的目的是通过使用全血样品与血浆样品比较来评估BNP测试的临床性能,并评价抗凝剂类型对BNP检测结果的影响。
方法:总共,来自大华医院的106名不同BNP水平的患者自愿参加了这项研究。临床上均匀的样本,包括EDTA抗凝血浆,EDTA全血,和肝素抗凝血浆,通过i-ReaderS自动免疫分析仪及其配套试剂盒进行采集和分析。皮尔逊相关和加权最小二乘线性回归分析,Bland-Altman密谋,采用Kappa检验进行统计学分析。
结果:相关分析表明,BNP浓度,从EDTA抗凝血浆样品中测量,与全血样本中的BNP具有良好的线性回归关系,斜率为0.9477,r=0.9978,p<0.05。在EDTA抗凝血浆样品和肝素抗凝血浆之间观察到类似的相关性,斜率为0.8413,r=0.9793,p<0.05。从肝素血浆样品测量的BNP浓度低于EDTA血浆样品。评估BNP浓度一致性的Bland-Altman分析显示,在检测系统的范围内,EDTA全血和EDTA血浆之间没有异常比值,以及EDTA抗凝血浆和肝素抗凝血浆之间没有异常值。同系EDTA抗凝血浆和肝素抗凝血血浆BNP浓度Kappa系数为0.8553(p<0.001),EDTA抗凝血浆和同源全血分别为0.8941(p<0.001)。
结论:EDTA抗凝全血样品的诊断性能与EDTA抗凝血浆样品的BNP测试没有显着差异。这项研究表明,在2小时内,EDTA抗凝血浆和肝素抗凝血浆的测量值之间没有很大的显着差异。如果BNP样品长时间在体外进行BNP测试,则应仔细选择抗凝剂的类型。
BACKGROUND: BNP is a sensitive and widely used biomarker for an early diagnosis of heart failure. Currently, most commercial BNP detection products use EDTA plasma samples. The aim of this study was to evaluate the clinical performance of the BNP test by using whole blood samples compared to plasma samples, and to evaluate the effect of the anticoagulant type on the BNP test result.
METHODS: In total, 106 patients with different BNP levels from the Dahua Hospital volunteered for this study. Clinically homogenous samples, including EDTA anticoagulant plasma, EDTA whole blood, and
heparin anticoagulant plasma, were collected and analyzed by using i-Reader S automatic immuno-analyzer and its supporting reagent kits. Pearson\'s correlation and weighted least squares linear regression analysis, Bland-Altman plotting, and Kappa test were used for statistical analysis.
RESULTS: Correlation analysis showed that BNP concentrations, measured from EDTA anticoagulated plasma samples, had a good linear regression relationship with BNP from whole blood samples, with a slope of 0.9477, r = 0.9978, p < 0.05. A similar correlation was observed between EDTA anticoagulated plasma samples and
heparin anticoagulant plasma, with a slope of 0.8413, r = 0.9793, p < 0.05. The BNP concentration measured from the
heparin plasma samples were lower than of the EDTA plasma samples. Bland-Altman analysis for assessing BNP concentration agreement showed there was no outlier ratio between EDTA whole blood and EDTA plasma within the range of the detection system, as well as no outlier between EDTA anticoagulated and heparin anticoagulant plasma. Kappa coefficient of BNP concentration between homologous EDTA anticoagulated and
heparin anticoagulant plasma was 0.8553 (p < 0.001), and for EDTA anticoagulated plasma and homologous whole blood it was 0.8941 (p < 0.001).
CONCLUSIONS: The diagnostic performance of EDTA anticoagulated whole blood samples did not differ significantly from EDTA anticoagulated plasma samples for the BNP test. This study showed no big significant difference between EDTA anticoagulated and
heparin anticoagulated plasma measurements within 2 hours. The type of anticoagulant should be carefully chosen when performing the BNP test if BNP samples were in vitro for a long time.