Clin Lab. 2024 Jul 1;70(7). doi: 10.7754/Clin.Lab.2024.240102.
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.
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.
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).
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.
BNP 是一种用于早期心力衰竭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 血浆样本。本研究旨在评估使用全血样本与血浆样本相比的 BNP 测试的临床性能,并评估抗凝剂类型对 BNP 测试结果的影响。
共有 106 名来自大华医院的不同 BNP 水平的患者自愿参加了这项研究。收集了临床同质样本,包括 EDTA 抗凝剂血浆、EDTA 全血和肝素抗凝剂血浆,并使用 i-Reader S 自动免疫分析仪及其配套试剂进行分析。采用 Pearson 相关和加权最小二乘线性回归分析、Bland-Altman 绘图和 Kappa 检验进行统计学分析。
相关性分析表明,从 EDTA 抗凝血浆样本中测量的 BNP 浓度与全血样本中的 BNP 具有良好的线性回归关系,斜率为 0.9477,r = 0.9978,p < 0.05。从 EDTA 抗凝血浆样本和肝素抗凝血浆样本中观察到类似的相关性,斜率为 0.8413,r = 0.9793,p < 0.05。从肝素血浆样本中测量的 BNP 浓度低于 EDTA 血浆样本。用于评估 BNP 浓度一致性的 Bland-Altman 分析表明,在检测系统范围内,EDTA 全血与 EDTA 血浆之间没有离群率,EDTA 抗凝剂与肝素抗凝剂之间也没有离群率。同源 EDTA 抗凝剂和肝素抗凝剂之间的 BNP 浓度的 Kappa 系数为 0.8553(p < 0.001),EDTA 抗凝剂和同源全血之间的 Kappa 系数为 0.8941(p < 0.001)。
对于 BNP 测试,EDTA 抗凝全血样本的诊断性能与 EDTA 抗凝血浆样本没有显著差异。本研究表明,在 2 小时内,EDTA 抗凝剂和肝素抗凝剂血浆测量之间没有显著差异。如果 BNP 样本在体外放置时间较长,则在进行 BNP 测试时应仔细选择抗凝剂类型。