title: Evaluation of the ARCHITECT urine NGAL assay: assay performance, specimen handling requirements and biological variability.
abstract: OBJECTIVE
  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.
authors.affiliation: Abbott Laboratories, D-9ML, AP20, 100 Abbott Park Road, Abbott Park, IL 60064, USA. frank.grenier@abbott.com
authors.forename: Frank C
authors.initials: FC
authors.lastname: Grenier
authors.forename: Salman
authors.initials: S
authors.lastname: Ali
authors.forename: Hina
authors.initials: H
authors.lastname: Syed
authors.forename: Ryan
authors.initials: R
authors.lastname: Workman
authors.forename: Frans
authors.initials: F
authors.lastname: Martens
authors.forename: Ming
authors.initials: M
authors.lastname: Liao
authors.forename: Y
authors.initials: Y
authors.lastname: Wang
authors.forename: Pui-Yuen
authors.initials: PY
authors.lastname: Wong
mesh_terms: D058186:Acute Kidney Injury / Q000175:diagnosis* / Q000652:urine; D000209:Acute-Phase Proteins / Q000032:analysis / Q000652:urine*; D000328:Adult; D015415:Biomarkers / Q000032:analysis / Q000652:urine; D002648:Child; D004344:Drug Incompatibility; D004526:Efficiency; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation / Q000379:methods; D006801:Humans; D000071068:Lipocalin-2; D054834:Lipocalins / Q000032:analysis / Q000652:urine*; D015588:Observer Variation; D011379:Prognosis; D011518:Proto-Oncogene Proteins / Q000032:analysis / Q000652:urine*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods* / Q000592:standards; D016482:Urinalysis / Q000295:instrumentation* / Q000379:methods* / Q000592:standards
chemical_list: D000209:Acute-Phase Proteins; D015415:Biomarkers; C489506:LCN2 protein, human; D000071068:Lipocalin-2; D054834:Lipocalins; D011518:Proto-Oncogene Proteins