Journal Information
Journal ID (publisher-id): BM
Journal ID (nlm-ta): Biochem Med (Zagreb)
Title: Biochemia Medica
Abbreviated Title: Biochem. Med. (Zagreb)
ISSN (print): 1330-0962
ISSN (electronic): 1846-7482
Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
Article Information
Copyright statement: Croatian Society of Medical Biochemistry and Laboratory Medicine.
Copyright: 2017, Croatian Society of Medical Biochemistry
License (open-access):
This is an Open Access article distributed under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Date received: 06 May 2017
Date accepted: 10 September 2017
Publication date (print and electronic): 15 October 2017
Volume: 27
Issue: 3
Electronic Location Identifier: 030710
Publisher ID: bm-27-3-030710
DOI: 10.11613/BM.2017.030710
Analytical evaluation of a fully automated immunoassay for faecal calprotectin in a paediatric setting
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.
Keywords: calprotectin; faeces; particle-enhanced turbidimetric immunoassay (PETIA); inflammatory bowel disease
