Abstract
IntroductionFaecal 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 methodsFor 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.ResultsThe 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.ConclusionsDue 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.
Highlights
Faecal calprotectin (FC) is a routinely used marker for identifying and monitoring children with inflammatory bowel disease (IBD)
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%
Literature reported elevated calprotectin concentrations in plasma, synovial fluid, urine and faeces in inflammatory state [3]. As it is upregulated in inflammatory gastrointestinal (GI) diseases, FC is used as diagnostic biomarker in the detection and observation of chronic inflammatory bowel diseases (IBD), for more than 10 years [2,3,4,5]
Summary
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. This non-invasive test is very useful for screening children with gastrointestinal symptoms and differentiating organic from functional intestinal disorders, to avoid unnecessary invasive procedures. Calprotectin, a 36 kDa protein, is predominantly located in the cytosol of neutrophil granulocytes [1] It is found in small parts in the cytosol of monocytes and macrophages, supporting the theory of having bactericidal and fungicidal properties [2]. As it is upregulated in inflammatory gastrointestinal (GI) diseases, FC is used as diagnostic biomarker in the detection and observation of chronic inflammatory bowel diseases (IBD), for more than 10 years [2,3,4,5]
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