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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Editorial Board Member: Gillery, Philippe / Kazmierczak, Steven / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Whitfield, John B.

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Evaluation of NGAL Test™, a fully-automated neutrophil gelatinase-associated lipocalin (NGAL) immunoassay on Beckman Coulter AU 5822

1 / Rosalia Aloe1 / Antonietta Storelli2 / Gianfranco Cervellin2 / Tommaso Trenti3

1U.O. Diagnostica Ematochimica, Dipartimento di Patologia e Medicina di Laboratorio, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy

2U.O. Pronto Soccorso e Medicina d’Urgenza, Dipartimento di Emergenza-Urgenza, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy

3Dipartimento di Patologia Clinica, AUSL di Modena, Modena, Italy

Corresponding author: Prof. Giuseppe Lippi, U.O. Diagnostica Ematochimica, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci 14, 43126 Parma, Italy Phone: +39 0521 703050/703791

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 50, Issue 9, Pages 1581–1584, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/cclm.2011.839, December 2011

Publication History

Received:
2011-11-04
Accepted:
2011-12-05
Published Online:
2011-12-21

Abstract

Background: The neutrophil gelatinase associated lipocalin (NGAL) has been identified as the most promising biomarker of acute kidney injury (AKI). This study was aimed to evaluate a NGAL immunoassay on Beckman Coulter AU 5822.

Methods: NGAL Test™ (BioPorto Diagnostics A/S) is a particle-enhanced turbidimetric immunoassay. The within-and between-run imprecision were assessed on three urine samples. The linearity was assessed by serially diluting two urine samples with low and high NGAL concentration. The comparison study was performed with Abbott ARCHITECT NGAL, on 70 urine samples.

Results: The within-run imprecision was comprised between 1.0% and 2.3%, whereas the between-run imprecision was between 1.2% and 2.0%. The linearity was excellent in the range between 18 ng/mL and 790 ng/mL (r=1.000; p<0.001). A highly significant agreement was observed between NGAL Test™ on Beckman Coulter AU5822 and Abbott ARCHITECT NGAL (r=0.925; p<0.001), although the method exhibited a bias of +65%. Excellent sensitivity and specificity against the ARCHITECT values were found at 200 ng/mL.

Conclusions: This analytical evaluation attests that the NGAL Test™ has several technical and analytical advantages, including no manual pretreatment, low volume of sample (i.e., 3 μL), fast turnaround time (approx. 10 min), low imprecision, wide dynamic range, optimal linearity.

Keywords: acute kidney failure; creatinine; evaluation; neutrophil gelatinase-associated lipocalin (NGAL)

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