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

Abstract

ObjectivesThis 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 methodsAnalytical 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.ResultsThe 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%).ConclusionsThese results show that Gentian NGAL may be a viable option to other commercial immunoassays for both routine and urgent assessment of serum NGAL.

Enhancing Military Burn- and Trauma-Related Acute Kidney Injury Prediction Through an Automated Machine Learning Platform and Point-of-Care Testing

“…Imprecision of the POC platform was higher for the NGAL assay and may be attributed to the use of both prospectively collected and banked samples. Nonetheless, the performance was comparable to CVs reported in previous literature 20,21 and acceptable for use as a single screening test for AKI when compared to creatinine and UOP.…”

Plasma neutrophil gelatinase-associated lipocalin and kidney graft outcome

“…Samples were stored at room temperature for a maximum of 1 h, centrifuged at 2800 g at 4°C for 10 min and stored at −80°C until analysis. NGAL concentrations were measured in ethylenediamine tetraacetic acid (EDTA)-plasma using a validated particle-enhanced turbidimetric immunoassay (Gentian, Moss, Norway) [ 12 ]. Other clinical chemistry assays including leukocyte count and high-sensitivity C-reactive protein (hs-CRP) and glucose were performed using automated routine spectrophotometric-based methods (Roche Diagnostics, Basel, Switzerland).…”

Plasma neutrophil gelatinase-associated lipocalin and risk of cardiovascular disease: Findings from the PREVEND prospective cohort study

“…The Gentian NGAL assay was calibrated to the commercially available Bioporto NGAL Test, using the value transfer protocol as described by Blirup-Jensen et al [30] In addition, the Gentian NGAL calibrator has been validated according to the Clinical and Laboratory Standards Institute guidelines, with external validation performed by individual laboratories. [31] Fasting plasma glucose (FPG) was measured by dry chemistry (Eastman Kodak, Rochester, New York). Total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, and high sensitivity C-reactive protein (hsCRP) were measured using standard protocols previously described.…”