Analytical evaluation of a fully automated immunoassay for faecal calprotectin in a paediatric setting

Abstract

Introduction: Faecal calprotectin (FC) is a routinely used marker for identifying and monitoring children with inflammatory bowel disease (IBD). This non-invasive test is useful for screening children with gastrointestinal symptoms to avoid unnecessary invasive procedures. In this study, we validated for the first time the performance of a fully automated particle-enhanced turbidimetric immunoassay (PETIA) on the VITROS® 5600 analyzer for measurement of FC in symptomatic children and adolescents. Materials and methods: For performance validation of the PETIA (fCAL® turbo, Bühlmann Laboratories, Switzerland) on the VITROS® 5600 analyzer (Ortho Clinical Diagnostics, USA) limit of quantitation (LoQ), linearity, precision data and calibration curve stability were defined. Additionally, 95 faecal samples were measured using the PETIA, an enzyme-linked immunosorbent assay (ELISA; fCAL®, Bühlmann Laboratories, Switzerland) and a semi-quantitative lateral flow assay (Quantum Blue Reader®, Bühlmann Laboratories, Switzerland) for agreement evaluation. Results: The LoQ for calprotectin using PETIA on the VITROS® 5600 analyzer was 21 µg/g. The linearity range was 20 - 2100 µg/g and the precision study showed a total coefficient of variation (CV) between 2.3% and 8.9%. The calibration curve was stable for 4 weeks. Using the clinical samples quantifiable by PETIA, ELISA and the semi-quantitative lateral flow assay, Passing-Bablok regression analysis and Bland-Altman plots showed good agreement. Conclusions: Due to good performance characteristics and agreement with established methods, the fully automated PETIA on the routine chemistry analyzer VITROS® 5600 is a new analytical option for the rapid determination of FC.