Evaluation of the ARCHITECT urine NGAL assay: Assay performance, specimen handling requirements and biological variability

Objectives: 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. Methods: 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. Results: 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. Conclusions: The ARCHITECT NGAL assay proved to be a precise and reproducible assay for the determination of urine NGAL (C) 2009 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.