Display options
Cite
Salvagno GL, Ferrari A, Gelati M, et al. Analytical validation of Gentian NGAL particle-enhanced enhanced turbidimetric immunoassay (PETIA). Pract Lab Med. 2017;8:60-64doi: 10.1016/j.plabm.2017.04.006.
Salvagno, G. L., Ferrari, A., Gelati, M., Brocco, G., & Lippi, G. (2017). Analytical validation of Gentian NGAL particle-enhanced enhanced turbidimetric immunoassay (PETIA). Practical laboratory medicine, 860-64. https://doi.org/10.1016/j.plabm.2017.04.006
Salvagno, Gian Luca, et al. "Analytical validation of Gentian NGAL particle-enhanced enhanced turbidimetric immunoassay (PETIA)." Practical laboratory medicine vol. 8 (2017): 60-64. doi: https://doi.org/10.1016/j.plabm.2017.04.006
Salvagno GL, Ferrari A, Gelati M, Brocco G, Lippi G. Analytical validation of Gentian NGAL particle-enhanced enhanced turbidimetric immunoassay (PETIA). Pract Lab Med. 2017 Apr 27;8:60-64. doi: 10.1016/j.plabm.2017.04.006. eCollection 2017 Aug. PMID: 28856229; PMCID: PMC5575407.
Copy Download .nbib Format: NLM
Share it on

Pract Lab Med. 2017 Apr 27;8:60-64. doi: 10.1016/j.plabm.2017.04.006. eCollection 2017 Aug.

Analytical validation of Gentian NGAL particle-enhanced enhanced turbidimetric immunoassay (PETIA).

Practical laboratory medicine

Gian Luca Salvagno, Anna Ferrari, Matteo Gelati, Giorgio Brocco, Giuseppe Lippi

Affiliations

  1. Section of Clinical Biochemistry, University of Verona, Verona, Italy.
  2. Laboratory of Clinical Chemistry and Hematology, University Hospital of Verona, Verona, Italy.

PMID: 28856229 PMCID: PMC5575407 DOI: 10.1016/j.plabm.2017.04.006

Abstract

OBJECTIVES: This study was designed to validate the analytical performance of the new Gentian particle-enhanced enhanced turbidimetric immunoassay (PETIA) for measuring neutrophil gelatinase-associated lipocalin (NGAL) in serum samples.

DESIGN AND METHODS: Analytical validation of the Gentian NGAL assay was carried out on a Roche Cobas c501 and was based on assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity and concordance with the BioPorto NGAL test.

RESULTS: The LOB and LOD of Gentian NGAL were found to be 3.8 ng/mL and 6.3 ng/mL, respectively. An analytical coefficient of variation (CV) of 20% corresponded to a NGAL value of 10 ng/mL. The intra-assay and inter-assay imprecision (CV) was between 0.4 and 5.2% and 0.6 and 7.1% and the total imprecision (CV) was 3.7%. The linearity was optimal at NGAL concentrations between 37 and 1420 ng/mL (r=1.00; p<0.001). An excellent correlation was observed between values measured with Gentian NGAL and BioPorto NGAL in 74 routine serum samples (r=0.993). The mean percentage bias of the Gentian assay versus the Bioporto assay was +3.1% (95% CI, +1.6% to +4.5%).

CONCLUSIONS: These results show that Gentian NGAL may be a viable option to other commercial immunoassays for both routine and urgent assessment of serum NGAL.

Keywords: Acute kidney injury; Analytical validation; NGAL; Neutrophil gelatinase-associated lipocalin

References

  1. Clin Chem Lab Med. 2008;46(10):1470-9 - PubMed
  2. Clin Chim Acta. 2012 Jul 11;413(13-14):1160-1 - PubMed
  3. Adv Clin Chem. 2014;64:179-219 - PubMed
  4. Scand J Clin Lab Invest. 2014 Jan;74(1):20-6 - PubMed
  5. Acta Biomed. 2014 Dec 17;85(3):289-94 - PubMed
  6. Clin Biochem Rev. 2008 Aug;29 Suppl 1:S49-52 - PubMed
  7. Clin Biochem. 2010 Apr;43(6):615-20 - PubMed
  8. Postepy Hig Med Dosw (Online). 2016 Apr 18;70:329-36 - PubMed
  9. PLoS One. 2016 Dec 1;11(12 ):e0167334 - PubMed
  10. Crit Care. 2016 Sep 27;20(1):299 - PubMed
  11. Eur J Cardiothorac Surg. 2016 Mar;49(3):746-55 - PubMed
  12. Clin Chem. 1984 Feb;30(2):290-2 - PubMed
  13. Clin Lab. 2014;60(3):377-81 - PubMed
  14. Oncotarget. 2016 Dec 27;7(52):86064-86074 - PubMed
  15. Am J Kidney Dis. 2009 Dec;54(6):1012-24 - PubMed
  16. J Am Soc Nephrol. 2003 Oct;14 (10 ):2534-43 - PubMed
  17. Clin Chim Acta. 2013 Mar 15;418:59-62 - PubMed
  18. Clin Chem Lab Med. 2011 Dec 21;50(9):1581-4 - PubMed
  19. Cancer Biomark. 2016 Mar 11;16(4):537-43 - PubMed
  20. Clin Chem Lab Med. 2012;50(9):1483-7 - PubMed

Publication Types