Yang Xiaoli, Liu Liping, Hao Qingfang, Zou Deyong, Zhang Xiaoli, Zhang Liping, Li Hongmei, Qiao Yong, Zhao Huansheng, Zhou Lei
Clinical laboratory, General Hospital of Chinese People's Armed Police Forces, Hai Dian District, Beijing, China.
Beijing Hotgen Biotech Co. Ltd., Da Xing Industrial Development Zone, Beijing, China.
PLoS One. 2017 Feb 2;12(2):e0171376. doi: 10.1371/journal.pone.0171376. eCollection 2017.
A newly assay, up-converting phosphor technology-based lateral flow (UPT-LF) assay, was developed for rapid and quantitative detection of N-terminal fragment of B-type natriuretic peptide precursor (NT-proBNP), one of the most important serum molecular maker of heat failure, in plasma samples as a point of care testing (POCT) method for diagnosis of acute heart failure. Human plasma from 197 patients with acute heart failure and 200 healthy controls was assessed using the UPT-LF assay, in a comparison with a Roche Elecsys assay. The limit of detection of the UPT-LF assay, with a coefficient of variation (CV) of less than 15%, was 116 ng/L, which is lower than the clinical diagnosis cutoff (150 ng/mL). The linear range was 50-35,000 ng/L. The CVs were less than 10% for both UPT-LF and Roche Elecsys assays for plasma samples under different storages, demonstrating the good stability and reproducibility. There are certain linear correlations between the results of UPT-LF and Roche Elecsys assay for EDTA-K2 and heparin-anticoagulated plasma, as well as for serum samples. For UPT-LF assay, there is a significant correlation between the values derived from analysis of EDTA-K2 and heparin-anticoagulated plasma samples (R = 0.995). No statistically significant difference was found between serum and plasma samples for UPT-LF assay. Our results demonstrate that NT-proBNP levels in healthy adults are elevated with age and had a relationship with sex, and with the age increase the NT-proBNP levels of females are significantly higher than those of males (p<0.01). The UPT-LF assay has a high reproducibility, stability, sensitivity, specificity, and is consistent with Roche Elecsys assay, and therefore it could be used as a POCT method for the quantitative detection of NT-proBNP in blood for clinical diagnosis and research of acute heart failure.
一种新的检测方法，即基于上转换磷光技术的侧流免疫分析（UPT-LF）法，被开发用于快速定量检测B型利钠肽前体N端片段（NT-proBNP），它是心力衰竭最重要的血清分子标志物之一，该方法用于在血浆样本中进行即时检测（POCT）以诊断急性心力衰竭。使用UPT-LF法对197例急性心力衰竭患者和200例健康对照者的人血浆进行评估，并与罗氏电化学发光免疫分析法进行比较。UPT-LF法的检测限为116 ng/L，变异系数（CV）小于15%，低于临床诊断临界值（150 ng/mL）。线性范围为50 - 35,000 ng/L。对于不同储存条件下的血浆样本，UPT-LF法和罗氏电化学发光免疫分析法的CV均小于10%，表明具有良好的稳定性和重现性。对于乙二胺四乙酸二钾（EDTA-K2）抗凝血浆、肝素抗凝血浆以及血清样本，UPT-LF法和罗氏电化学发光免疫分析法的结果之间存在一定的线性相关性。对于UPT-LF法，EDTA-K2抗凝血浆样本和肝素抗凝血浆样本分析得出的值之间存在显著相关性（R = 0.995）。对于UPT-LF法，血清样本和血浆样本之间未发现统计学上的显著差异。我们的结果表明，健康成年人的NT-proBNP水平随年龄升高，且与性别有关，随着年龄增长，女性的NT-proBNP水平显著高于男性（p<0.01）。UPT-LF法具有高重现性、稳定性、敏感性、特异性，且与罗氏电化学发光免疫分析法一致，因此可作为一种POCT方法用于血液中NT-proBNP的定量检测，以用于急性心力衰竭的临床诊断和研究。
