Validation of the newly FDA-approved Buhlmann fCal Turbo assay for measurement of fecal calprotectin in a pediatric population

Abstract

ObjectivesInflammatory bowel disease (IBD) is an increasingly prevalent disorder marked by chronic intestinal inflammation. Fecal calprotectin has emerged as a useful biomarker for differential diagnostics and monitoring IBD activity. We validated the newly FDA-approved fCal Turbo fecal calprotectin assay in our pediatric hospital. Design and methodsThe performance of the fCal Turbo assay was assessed on the Vitros 5600 analyzer (Ortho Clinical Diagnostics, USA), including limit of quantitation, linearity, precision, and interference studies. Method comparison was performed with 20 fecal samples with the Buhlmann fCal ELISA, and reference range verification was performed with 33 fecal samples. ResultsThe fCal Turbo assay on the Vitros 5600 was linear between 33.1 and 14,182.5 ​μg/g, with dilution studies extending the range to 33.1–22,000 ​μg/g, Reproducibility of the assay met acceptability criteria, with intra-assay CV of 0.3–3.2% and inter-assay CV of 5.2–8.9%. Interference studies identified acceptable thresholds for protein, bilirubin, and lipids. We verified a reference range of 33.1–60 ​μg/g in our patient population. Deming regression identified acceptable correlation with minor positive bias (2.7%) between the fCal Turbo and fCal ELISA methods. ConclusionsThe fCal Turbo assay performs well on the Vitros 5600 analyzer in our patient population, with the assay being easy to use in our routine chemistry workflow. We anticipate that the fCal Turbo assay will be useful as a rapid screening method for differential diagnostics and disease monitoring of IBD in our patient population.