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

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

Author information

1
Abbott Laboratories, D-9ML, AP20, 100 Abbott Park Road, Abbott Park, IL 60064, USA. frank.grenier@abbott.com

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.

[Indexed for MEDLINE]

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