Comparative Evaluation of Two NGAL Automated Immunoassays in Urine and Plasma. (5th January 2022)

• Record Type: Journal Article
• Authors: Whitehead, Simon J; Chadwick, Katie; Ford, Clare; Giri, Ramesh; Luckraz, Heyman; Gama, Rousseau
• Is Part Of: Journal of applied laboratory medicine. Volume 7:Number 3(2022)
• Page Start: 747
• Page End: 761
• Publication Date: 2022-01-05
• Subjects: NGAL -- immunoassay -- AKI -- verification -- urine -- EDTA plasma; Clinical chemistry -- Periodicals; Diagnosis, Laboratory -- Periodicals; 616.0756
• DOI: 10.1093/jalm/jfab167
• Languages: English
• ISSNs: 2576-9456

Abstract

Abstract: Background: Acute kidney injury (AKI), a frequent and serious complication of hospitalized patients, is associated with increased mortality and morbidity. Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker for the early identification of AKI. We report a comparative laboratory verification of the Abbott Diagnostics (ARCHITECT ® urine NGAL) and BioPorto Diagnostics (NGAL Test TM ) assays including an assessment of the Abbott assay's performance in EDTA plasma. Methods: Intra-/interbatch imprecision, linearity, recovery, and limit of quantitation (LoQ) were assessed and an interassay comparison performed ( n = 51). Between-laboratory agreement was assessed against other laboratories using the Abbott ( n = 48) and BioPorto ( n = 94) assays. Plasma NGAL (pNGAL) levels were measured in non-AKI patients with a range of estimated glomerular filtration rates ( n = 80). Results: Coefficients of variation (CVs) for intra- and interbatch imprecision were 0.7%–12.4% and 1.9%–27.5% for the BioPorto assay, respectively, and 1.4%–6.3%/3.4%–6.8%, respectively, for the Abbott assay. The BioPorto assay exhibited a higher LoQ (27.5 ng/mL vs 1.2 ng/mL). Both assays were linear over the range 5–6000 ng/mL. Recovery of recombinant NGAL was 113.1 ± 7.1% and 96.5 ± 7.8% for the Abbott and BioPorto assays, respectively. On average, the Abbott assay gave results 9.2% lower than the BioPorto assay. Mean differences of 0.2% (Abbott) and 20.2% (BioPorto) were observed in the between-laboratory comparison. In patients without AKI, pNGAL levels were inversely proportional to eGFR. Conclusions: Performance of the Abbott and BioPorto assays was similar although the latter performed less well at lower NGAL concentrations. The Abbott assay tended to yield lower results, exhibited a lower LoQ and over-recovered NGAL. Although only Conformité Européenne-marked and marketed for use in urine, the Abbott assay demonstrated equivalent performance to the BioPorto assay with EDTA plasma.