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

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.

journal_name

Clin Biochem

journal_title

Clinical biochemistry

authors

Grenier FC,Ali S,Syed H,Workman R,Martens F,Liao M,Wang Y,Wong PY

doi

10.1016/j.clinbiochem.2009.12.008

subject

Has Abstract

pub_date

2010-04-01 00:00:00

pages

615-20

issue

6

eissn

0009-9120

issn

1873-2933

pii

S0009-9120(09)00556-6

journal_volume

43

pub_type

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