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

摘要

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; p0.001). 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.