Albers Stefanie, Mir Thomas S, Haddad Munif, Läer Stephanie
Clinical Pharmacy and Pharmacotherapy, Heinrich-Heine University, Düsseldorf, Germany.
Clin Chem Lab Med. 2006;44(1):80-5. doi: 10.1515/CCLM.2006.016.
The aim of the present study was the investigation of N-terminal pro-brain natriuretic peptide (NT-proBNP) in the pediatric population. This is essential for adequate monitoring and classification of pediatric patients with heart disease, but no consistent data are available yet. In addition, the comparability of two commercially available NT-proBNP assays and the inter-laboratory variability for the most suitable one were assessed. For this purpose, 408 subjects (1-29 years) were included. NT-proBNP was determined with a non-competitive electrochemiluminescent immunoassay (Roche NT-proBNP; n = 402) and a competitive enzyme-immunoassay (Biomedica NT-proBNP; n = 402). Inter-laboratory variability was evaluated for the Roche assay by stepwise inclusion of four and 11 centers throughout Germany, respectively. Roche NT-proBNP ranged from 5.0 to 391.5 ng/L, with higher values for younger children. The 97.5th (75th) percentile curve ranged from 319.9 ng/L (231.2 ng/L, 1-3 years) to 114.9 ng/L (53.3 ng/L, 18 years). In contrast, Biomedica NT-proBNP ranged from 253.7 to 7602.8 ng/L, with no significant age dependency. The mean difference between the assays was 1649.7 ng/L (95% confidence interval 1546.3-1753.1 ng/L). Inter-laboratory variability ranged from 6.5% to 3.8%, covering a range from 51.3 to 6618.1 ng/L. The assay seems to influence the interpretation of resulting NT-proBNP values and therefore has to be chosen carefully. For the monitoring and classification of pediatric patients with congenital heart disease, age-based NT-proBNP values should be used.
本研究的目的是调查儿科人群中的N末端前脑钠肽（NT-proBNP）。这对于对患有心脏病的儿科患者进行充分监测和分类至关重要，但目前尚无一致的数据。此外，评估了两种市售NT-proBNP检测方法的可比性以及最合适方法的实验室间变异性。为此，纳入了408名受试者（1至29岁）。使用非竞争性电化学发光免疫分析法（罗氏NT-proBNP；n = 402）和竞争性酶免疫分析法（Biomedica NT-proBNP；n = 402）测定NT-proBNP。通过分别逐步纳入德国各地的4个和11个中心，对罗氏检测法的实验室间变异性进行了评估。罗氏NT-proBNP的范围为5.0至391.5 ng/L，年幼儿童的值较高。第97.5百分位数（第75百分位数）曲线范围从319.9 ng/L（231.2 ng/L，1至3岁）到114.9 ng/L（53.3 ng/L，18岁）。相比之下，Biomedica NT-proBNP的范围为253.7至7602.8 ng/L，无明显年龄依赖性。两种检测方法之间的平均差异为1649.7 ng/L（95%置信区间1546.3 - 1753.1 ng/L）。实验室间变异性范围为6.5%至3.8%，覆盖范围从51.3至6618.1 ng/L。该检测方法似乎会影响所得NT-proBNP值的解释，因此必须谨慎选择。对于先天性心脏病儿科患者的监测和分类，应使用基于年龄的NT-proBNP值。
