背景:该研究评估了MindrayN末端B型利钠肽前体(NT-proBNP)在中国健康人群中的表现,专注于为未来的临床应用创建一个参考范围,根据不同的人口统计数据进行调整。
方法:本研究检测了2277名健康个体的NT-proBNP。我们分析了年龄和性别分层数据,执行精度,准确度,线性化,和检测限研究,并评估了Roche和Mindray对724份血清样品的方法比较和一致性。我们用Excel2010,Medcalc,和GraphPad棱镜9。
结果:在男性中,在<45、45至54、55至64、65至74和≥75岁时,第97.5百分位数NT-proBNP浓度为89.4ng/L,126ng/L,206ng/L,386纳克/升和522纳克/升,分别。在女性中,相同年龄的NT-proBNP浓度为132ng/L,229ng/L,262ng/L,297ng/L和807ng/L,分别。NT-proBNP的重复性精密度变异系数(CV%)在分析性能中介于0.86和1.65之间。相比之下,NT-proBNP的重复性精密度(CV%)分别为1.52~3.22.研究发现,低值样品(浓度:148.69)的准确度偏差为3.73%,高值样品(浓度:1939.08)的准确度偏差为7.31%。敏感性,特异性,阳性预测值(PPV),阴性预测值(NPV)为125ng/L,为96.6%,92.3%,84.2%,98.5%,分别。相比之下,300纳克/升的比例为94.0%,98.2%,95.7%和97.5%,分别。
结论:MindrayNT-proBNP测定显示,随着年龄的增长,男性和女性的水平均升高,女性水平较高。它表现良好,符合制造商的规格。我们建议根据人口因素调整临界值。
BACKGROUND: The study evaluated the performance of the Mindray N-terminal pro-B-type natriuretic peptide (NT-proBNP) in a healthy population in China, focusing on creating a reference range for future clinical applications adjusted according to different demographics.
METHODS: The study measured NT-proBNP in 2277 healthy individuals. We analyzed age and sex-stratified data, performed precision, accuracy, linearitcvy, and detection limit studies, and evaluated method comparison and consistency between Roche and Mindray assays on 724 serum samples. We used Excel 2010, Medcalc, and GraphPad Prism 9.
RESULTS: In males, the 97.5th centile NT-proBNP concentration at age < 45, 45 to 54, 55 to 64, 65 to 74 and ≧ 75 were 89.4 ng/L, 126 ng/L, 206 ng/L, 386 ng/L and 522 ng/L, respectively. In females, the concentration of NT-proBNP at the same age was 132 ng/L, 229 ng/L, 262 ng/L, 297 ng/L and 807 ng/L, respectively. The repeatability precision coefficient of variation (CV%) for NT-proBNP was between 0.86 and 1.65 in analytical performance. In contrast, the reproducibility precision (CV%) for NT-proBNP was between 1.52 and 3.22, respectively. The study found a bias of accuracy of 3.73% in low-value samples (concentration: 148.69) and 7.31% in high-value samples (concentration: 1939.08). The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 125 ng/L were 96.6%, 92.3%, 84.2%, and 98.5%, respectively. In contrast, those of 300 ng/L were 94.0%, 98.2%, 95.7% and 97.5%, respectively.
CONCLUSIONS: The Mindray NT-proBNP assay showed increased levels in both males and females with age, with higher levels in women. It performs well and aligns with manufacturer specifications. We recommend adjusting cutoff values based on demographic factors.