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

Clin Biochem. 2010 Apr;43(6):615-20. doi: 10.1016/j.clinbiochem.2009.12.008. Epub 2009 Dec 21.

Abstract

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.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Acute Kidney Injury / diagnosis*
  • Acute Kidney Injury / urine
  • Acute-Phase Proteins / analysis
  • Acute-Phase Proteins / urine*
  • Adult
  • Biomarkers / analysis
  • Biomarkers / urine
  • Child
  • Drug Incompatibility
  • Efficiency
  • Enzyme-Linked Immunosorbent Assay / instrumentation
  • Enzyme-Linked Immunosorbent Assay / methods
  • Humans
  • Lipocalin-2
  • Lipocalins / analysis
  • Lipocalins / urine*
  • Observer Variation
  • 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

Substances

  • Acute-Phase Proteins
  • Biomarkers
  • LCN2 protein, human
  • Lipocalin-2
  • Lipocalins
  • Proto-Oncogene Proteins