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

• Published in: Clinical biochemistry Vol. 43; no. 6; pp. 615 - 620
• Main Authors: Grenier, Frank C., Ali, Salman, Syed, Hina, Workman, Ryan, Martens, Frans, Liao, Ming, Wang, Y., Wong, Pui-Yuen
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier Inc 01.04.2010; Elsevier
• Subjects: Acute Kidney Injury; Acute Kidney Injury - diagnosis; Acute Kidney Injury - urine; Acute-Phase Proteins - analysis; Acute-Phase Proteins - urine; Adult; Architect; Biological and medical sciences; Biomarkers - analysis; Biomarkers - urine; Child; Drug Incompatibility; Efficiency; Enzyme-Linked Immunosorbent Assay - instrumentation; Enzyme-Linked Immunosorbent Assay - methods; Humans; Immunoassay; Investigative techniques, diagnostic techniques (general aspects); Kidneys; Lipocalin-2; Lipocalins - analysis; Lipocalins - urine; Medical sciences; Nephrology. Urinary tract diseases; NGAL; Observer Variation; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; Prognosis; Proto-Oncogene Proteins - analysis; Proto-Oncogene Proteins - urine; Reproducibility of Results; Sensitivity and Specificity; Specimen Handling - methods; Specimen Handling - standards; Urinalysis - instrumentation; Urinalysis - methods; Urinalysis - standards; Urinary system; Urinary system involvement in other diseases. Miscellaneous; NGAL; Immunoassay; Architect; Acute Kidney Injury; Kidney disease; Performance evaluation; Human; Urine; Urinary system disease; Healthy subject; Acute kidney injury; Biological marker; Biology; Immunological method; Sensitivity; Reproducibility; Neutrophil gelatinase associated lipocalin
• ISSN: 0009-9120; 1873-2933; 1873-2933
• DOI: 10.1016/j.clinbiochem.2009.12.008

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 °C sample stability, however, long term storage samples must be kept at − 70 °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.