Reference values for urinary neutrophil gelatinase-associated lipocalin (NGAL) in pediatric age measured with a fully automated chemiluminescent platform
Cangemi, Giuliana ; Storti, Simona ; Cantinotti, Massimiliano ; Fortunato, Antonio ; Emdin, Michele ; Bruschettini, Matteo LU
; Bugnone, Daniela
; Melioli, Giovanni
and Clerico, Aldo
(2013)
In Clinical Chemistry and Laboratory Medicine
51(5).
p.1101-1105
- Abstract
- Background: Neutrophil gelatinase-associated lipocalin (NGAL) has been suggested as the most promising biomarker of acute kidney injury. However, there are no reliable data on analytical sensitivity and reference limits of urinary NGAL (uNGAL) assay in pediatric age. The aim of the present study is to evaluate the analytical sensitivity and the reference range of uNGAL measured in urine specimens of pediatric age with the fully automated platform ARCHITECT (R) i1000. Methods: A total of 333 urine samples were collected from 25 healthy newborns (16 males and 9 females; age 1-4 days) and 308 children (150 males and 147 females; mean age 80.7 months, range 0.63-248 months) and assayed for uNGAL by two different Italian centers (Department of... (More)
- Background: Neutrophil gelatinase-associated lipocalin (NGAL) has been suggested as the most promising biomarker of acute kidney injury. However, there are no reliable data on analytical sensitivity and reference limits of urinary NGAL (uNGAL) assay in pediatric age. The aim of the present study is to evaluate the analytical sensitivity and the reference range of uNGAL measured in urine specimens of pediatric age with the fully automated platform ARCHITECT (R) i1000. Methods: A total of 333 urine samples were collected from 25 healthy newborns (16 males and 9 females; age 1-4 days) and 308 children (150 males and 147 females; mean age 80.7 months, range 0.63-248 months) and assayed for uNGAL by two different Italian centers (Department of Laboratory Medicine of the Fondazione Toscana G. Monasterio of Pisa and Massa and the Clinical Pathology Laboratory Unit of Istituto Giannina Gaslini of Genova). Results: The calculated limits of blank (LOB) and detection (LOD) values were 0.5 ng/mL and 0.95 ng/mL, respectively. The distribution of uNGAL values approximated a log-normal distribution (median 5.2 ng/mL, interquartile range 2.5-12.8 ng/mL, 99th percentile 117.6 ng/mL). uNGAL values of the 25 neonates were significantly higher than those of 308 children (neonates: mean 44.2 ng/mL, median 30.3 ng/mL, range 5.2-137.4 ng/mL; children: mean 10.2 ng/mL, median 4.6 ng/mL, range 0.2-146.7 ng/mL; p<0.0001). Conclusions: uNGAL assay shows a good analytical sensitivity and imprecision, which allows the measurement of uNGAL values around the cut-off value (i.e., 117.6 ng/mL) with an imprecision <5 CV%. The distribution of uNGAL values in pediatric age approximates a log-normal distribution, with values which are higher in neonates compared to children. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/7855475
- author
- Cangemi, Giuliana
; Storti, Simona
; Cantinotti, Massimiliano
; Fortunato, Antonio
; Emdin, Michele
; Bruschettini, Matteo
LU
; Bugnone, Daniela
; Melioli, Giovanni
and Clerico, Aldo
- publishing date
- 2013
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- reference values urine, pediatric age, NGAL, creatinine
- in
- Clinical Chemistry and Laboratory Medicine
- volume
- 51
- issue
- 5
- pages
- 1101 - 1105
- publisher
- De Gruyter
- external identifiers
-
- wos:000318495900033
- scopus:84882263723
- pmid:23183760
- ISSN
- 1434-6621
- DOI
- 10.1515/cclm-2012-0540
- language
- English
- LU publication?
- no
- id
- 8d77ed5f-885a-4e61-afec-4dc466ff8147 (old id 7855475)
- date added to LUP
- 2016-04-01 11:06:40
- date last changed
- 2022-02-10 08:53:34
@article{8d77ed5f-885a-4e61-afec-4dc466ff8147,
abstract = {{Background: Neutrophil gelatinase-associated lipocalin (NGAL) has been suggested as the most promising biomarker of acute kidney injury. However, there are no reliable data on analytical sensitivity and reference limits of urinary NGAL (uNGAL) assay in pediatric age. The aim of the present study is to evaluate the analytical sensitivity and the reference range of uNGAL measured in urine specimens of pediatric age with the fully automated platform ARCHITECT (R) i1000. Methods: A total of 333 urine samples were collected from 25 healthy newborns (16 males and 9 females; age 1-4 days) and 308 children (150 males and 147 females; mean age 80.7 months, range 0.63-248 months) and assayed for uNGAL by two different Italian centers (Department of Laboratory Medicine of the Fondazione Toscana G. Monasterio of Pisa and Massa and the Clinical Pathology Laboratory Unit of Istituto Giannina Gaslini of Genova). Results: The calculated limits of blank (LOB) and detection (LOD) values were 0.5 ng/mL and 0.95 ng/mL, respectively. The distribution of uNGAL values approximated a log-normal distribution (median 5.2 ng/mL, interquartile range 2.5-12.8 ng/mL, 99th percentile 117.6 ng/mL). uNGAL values of the 25 neonates were significantly higher than those of 308 children (neonates: mean 44.2 ng/mL, median 30.3 ng/mL, range 5.2-137.4 ng/mL; children: mean 10.2 ng/mL, median 4.6 ng/mL, range 0.2-146.7 ng/mL; p<0.0001). Conclusions: uNGAL assay shows a good analytical sensitivity and imprecision, which allows the measurement of uNGAL values around the cut-off value (i.e., 117.6 ng/mL) with an imprecision <5 CV%. The distribution of uNGAL values in pediatric age approximates a log-normal distribution, with values which are higher in neonates compared to children.}},
author = {{Cangemi, Giuliana and Storti, Simona and Cantinotti, Massimiliano and Fortunato, Antonio and Emdin, Michele and Bruschettini, Matteo and Bugnone, Daniela and Melioli, Giovanni and Clerico, Aldo}},
issn = {{1434-6621}},
keywords = {{reference values urine; pediatric age; NGAL; creatinine}},
language = {{eng}},
number = {{5}},
pages = {{1101--1105}},
publisher = {{De Gruyter}},
series = {{Clinical Chemistry and Laboratory Medicine}},
title = {{Reference values for urinary neutrophil gelatinase-associated lipocalin (NGAL) in pediatric age measured with a fully automated chemiluminescent platform}},
url = {{http://dx.doi.org/10.1515/cclm-2012-0540}},
doi = {{10.1515/cclm-2012-0540}},
volume = {{51}},
year = {{2013}},
}