Improving IBD diagnosis and monitoring by understanding preanalytical, analytical and biological fecal calprotectin variability
| Autor: | Daniela Basso, Dania Bozzato, Renata D'Incà, Andrea Padoan, Carlo-Federico Zambon, Claudia Mescoli, R. Caccaro, Stefania Moz, Mario Plebani, Massimo Rugge, Maria Luisa Scapellato, Greta Lorenzon, Rudi De Bastiani |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Clinical effectiveness Clinical Biochemistry Pre-Analytical Phase Enzyme-Linked Immunosorbent Assay calprotectin Gastroenterology Clinical biochemistry Sensitivity and Specificity inflammatory bowel diseases biological variability 03 medical and health sciences Feces Young Adult Crohn's disease ulcerative colitis 0302 clinical medicine Nephelometry and Turbidimetry Reference Values Internal medicine medicine Humans Aged business.industry Biochemistry (medical) Inflammatory Bowel Diseases Reproducibility of Results General Medicine Middle Aged ROC Curve 030220 oncology & carcinogenesis Area Under Curve Case-Control Studies 030211 gastroenterology & hepatology Female Calprotectin business Leukocyte L1 Antigen Complex Biological variability |
| Popis: | Background: The appropriate clinical use of fecal calprotectin (fCal) might be compromised by incomplete harmonization between assays and within- and between-subjects variability. Our aim was to investigate the analytical and biological variability of fCal in order to provide tools for interpreting fCal in the clinical setting. Methods: Experiments were conducted to investigate the effects of temperature and storage time on fCal. Thirty-nine controls were enrolled to verify biological variability, and a case-control study was conducted on 134 controls and 110 IBD patients to compare the clinical effectiveness of three different fCal assays: ELISA, CLIA and turbidimetry. Results: A 12% decline in fCal levels was observed within 24 h following stool collection irrespective of storage temperature. Samples were unstable following a longer storage time interval at room temperature. Within- and between-subjects fCal biological variability, at 31% and 72% respectively, resulted in a reference change value (RCV) in the region of 100%. fCal sensitivity in distinguishing between controls and IBD patients is satisfactory (68%), and the specificity high (93%) among young ( Conclusions: We recommend a standardized preanalytical protocol for fCal, avoiding storage at room temperature for more than 24 h. Different cutoffs are recommended for different fCal assays. In monitoring, the difference between two consecutive measurements appears clinically significant when higher than 100%, the fCal biological variability-derived RCV. |
| Databáze: | OpenAIRE |
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