Lau Chin-Shern, Liang Ya Li, Phua Soon Kieng, Murtagh Gillian, Hoefer Imo E, Stokwielder Ron H, Kosevich Milica, Yen Jennifer, Sickan Jaganathan, Varounis Christos, Aw Tar-Choon
Department of Laboratory Medicine, Changi General Hospital, 2 SIMEI STREET 3, Singapore 529889, Singapore.
Abbott Laboratories, Abbott Park, IL 60064, USA.
Diagnostics (Basel). 2022 May 8;12(5):1172. doi: 10.3390/diagnostics12051172.
Background: We evaluated the performance of the Abbott N-terminal pro-brain natriuretic peptide (NT-proBNP) assay against the Roche NT-proBNP immunoassay across two sites. Methods: Precision, linearity, and sensitivity studies were performed. A combined method of comparison and regression analysis was performed between the Roche and Abbott assays using samples from both sites (n = 494). To verify biotin interference, lyophilised biotin powder was reconstituted and spiked into serum samples at two medical decision levels (final concentration 500/4250 ng/mL) and compared to controls. NT-proBNP was also measured in anonymised leftover sera (n = 388) in a cardio-renal healthy population and stratified into three age bands—<50 (n = 145), 50−75 (n = 183) and >75 (n = 60). Results: Between-run precision (CV%) for NT-proBNP was 4.17/4.50 (139.5/142.0 pg/mL), 3.83/2.17 (521.6/506.3), and 4.60/2.51 (5053/4973), respectively. The assay was linear from 0.7−41,501 pg/mL. The limit of blank/quantitation was 1.2/7.9 pg/mL. The assay showed no interference from biotin up to 4250 ng/mL. Passing−Bablok regression analysis showed excellent agreement between the two assays (r = 0.999, 95% CI 0.999 to 0.999, p < 0.0001). The Roche assay had a slightly persistent, negative bias across different levels of NT-proBNP. ESC age cut-offs for diagnosing acute heart failure are applicable for the Abbott assay, with the median NT-proBNP of subjects < 50 years old at 43.0 pg/mL (range 4.9−456 pg/mL), 50−75 years old at 95.1 pg/mL (range 10.5−1079 pg/mL), and >75 years old at 173.1 pg/mL (range 23.2−1948 pg/mL). Conclusions: The Abbott Architect NT-proBNP assay has good performance that agrees with the manufacturer’s specifications. ESC/AHA recommended NT-proBNP age groups for acute heart failure diagnosis are applicable to this assay.
我们在两个地点评估了雅培N末端脑钠肽前体（NT-proBNP）检测法相对于罗氏NT-proBNP免疫检测法的性能。方法：进行了精密度、线性和灵敏度研究。使用来自两个地点的样本（n = 494）对罗氏和雅培检测法进行了比较和回归分析相结合的方法。为验证生物素干扰，将冻干的生物素粉末复溶并在两个医学决定水平（终浓度500/4250 ng/mL）加入血清样本中，并与对照进行比较。还对心血管肾脏健康人群的匿名剩余血清（n = 388）进行了NT-proBNP检测，并分为三个年龄组——<50岁（n = 145）、50 - 75岁（n = 183）和>75岁（n = 60）。结果：NT-proBNP的批间精密度（CV%）分别为4.17/4.50（139.5/142.0 pg/mL）、3.83/2.17（521.6/506.3）和4.60/2.51（5053/4973）。该检测法在0.7 - 41,501 pg/mL范围内呈线性。空白/定量限为1.2/7.9 pg/mL。该检测法在高达4250 ng/mL时未显示生物素干扰。Passing - Bablok回归分析表明两种检测法之间具有良好的一致性（r = 其在不同水平的NT-proBNP上存在轻微的持续负偏差。欧洲心脏病学会（ESC）诊断急性心力衰竭的年龄临界值适用于雅培检测法，<50岁受试者的NT-proBNP中位数为43.0 pg/mL（范围4.9 - 456 pg/mL），50 - 75岁为95.1 pg/mL（范围10.5 - 1079 pg/mL），>75岁为173.1 pg/mL（范围23.2 - 1948 pg/mL）。结论：雅培Architect NT-proBNP检测法性能良好，与制造商的规格相符。ESC/AHA推荐的用于急性心力衰竭诊断的NT-proBNP年龄组适用于该检测法。
