Abbott Laboratories, D-9ML, AP20, 100 Abbott Park Road, Abbott Park, IL 60064, USA.
Clin Biochem. 2010 Apr;43(6):615-20. doi: 10.1016/j.clinbiochem.2009.12.008. Epub 2009 Dec 21.
NGAL (Neutrophil Gelatinase-Associated Lipocalin) has emerged as a new biomarker for the identification of acute kidney injury. Reliable clinical evaluations require a simple, robust test method for NGAL, and knowledge of specimen handling and specimen stability characteristics. We evaluated the performance of a new urine NGAL assay on the ARCHITECT analyzer.
Assay performance characteristics were evaluated using standard protocols. Urine specimen storage requirements were determined and biological variability was assessed in a self-declared apparently healthy population.
Assay performance data showed good precision, sensitivity and lot-to-lot reproducibility. There was good short term 2-8 degrees C sample stability, however, long term storage samples must be kept at -70 degrees C or colder. The largest variance component in a biological variance study was within-day.
The ARCHITECT NGAL assay proved to be a precise and reproducible assay for the determination of urine NGAL.
中性粒细胞明胶酶相关脂质运载蛋白（NGAL）已成为鉴定急性肾损伤的一种新的生物标志物。可靠的临床评估需要一种简单、强大的 NGAL 检测方法，并了解标本处理和标本稳定性特征。我们评估了新的尿液 NGAL 分析在 ARCHITECT 分析仪上的性能。
使用标准方案评估分析性能特征。确定尿液标本的储存要求，并在自称健康的人群中评估生物学变异性。
分析性能数据显示出良好的精密度、灵敏度和批间重现性。短期 2-8°C 样本稳定性良好，但长期储存样本必须保持在-70°C 或更低。生物学变异性研究中最大的方差分量是日内。
ARCHITECT NGAL 分析证实是一种精确且可重复的尿液 NGAL 测定方法。
