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Analytical evaluation of a fully automated immunoassay for faecal calprotectin in a paediatric setting
Britta Noebauer1, Lejla Ramic1, Andrea Konstantin1
1Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.
Insights
A new automated assay for fecal calprotectin (FC) measurement in children shows good performance. This particle-enhanced turbidimetric immunoassay (PETIA) on the VITROS® 5600 analyzer offers a reliable option for diagnosing inflammatory bowel disease (IBD).
Area of Science:
- Clinical chemistry
- Immunodiagnostics
- Pediatric gastroenterology
Background:
- Faecal calprotectin (FC) is a key biomarker for pediatric inflammatory bowel disease (IBD).
- Non-invasive FC testing aids in screening children with gastrointestinal symptoms, reducing the need for invasive procedures.
- Evaluating new automated assays is crucial for efficient laboratory diagnostics.
Purpose of the Study:
- To validate the performance of a fully automated particle-enhanced turbidimetric immunoassay (PETIA) for measuring fecal calprotectin (FC).
- To assess the suitability of the VITROS® 5600 analyzer for routine FC determination in symptomatic children and adolescents.
Main Methods:
- Performance characteristics including limit of quantitation (LoQ), linearity, and precision were determined for the PETIA assay.
- Calibration curve stability was assessed over a 4-week period.
- Agreement was evaluated by comparing PETIA results with ELISA and a semi-quantitative lateral flow assay using 95 fecal samples.
Main Results:
- The PETIA assay demonstrated an LoQ of 21 µg/g and a linearity range of 20-2100 µg/g.
- Precision studies showed a total coefficient of variation (CV) between 2.3% and 8.9%.
- Good agreement was observed between the PETIA assay and established methods (ELISA, lateral flow assay) via regression analysis and Bland-Altman plots.
Conclusions:
- The fully automated PETIA on the VITROS® 5600 analyzer exhibits robust performance characteristics.
- This assay demonstrates good agreement with existing methods for FC measurement.
- It represents a valuable new analytical option for rapid FC determination in pediatric IBD screening.
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.
