Original scientific paper

https://doi.org/10.11613/BM.2017.030710

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

Britta Noebauer ; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria
Lejla Ramic ; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria
Andrea Konstantin ; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria
Christina Zachbauer ; Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria
Elisa Einwallner ; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria

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.

Keywords

calprotectin; faeces; particle-enhanced turbidimetric immunoassay (PETIA); inflammatory bowel disease

Hrčak ID:

187593

URI

https://hrcak.srce.hr/187593

Publication date:

15.10.2017.

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