AB1692 A NEW, RELIABLE AND PRECISE HIGH-THROUGHPUT SERUM CALPROTECTIN ASSAY TO ASSESS THE INFLAMMATORY STATUS OF PATIENTS

BackgroundSerum calprotectin (sCAL) is a promising biomarker to detect the inflammatory status of patients in rheumatoid arthritis, juvenile idiopathic arthritis and systemic onset juvenile idiopathic arthritis diseases. Serum calprotectin can be a useful tool to monitor disease activity and predict...

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Published inAnnals of the rheumatic diseases Vol. 82; no. Suppl 1; p. 2084
Main Authors Melone, A, Vogt, D, Ohmann, A, Afonso, J, Moniz, C, Guschin, D, Gerhold, C B, Schuster, T
Format Journal Article
LanguageEnglish
Published London BMJ Publishing Group LTD 01.06.2023
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Summary:BackgroundSerum calprotectin (sCAL) is a promising biomarker to detect the inflammatory status of patients in rheumatoid arthritis, juvenile idiopathic arthritis and systemic onset juvenile idiopathic arthritis diseases. Serum calprotectin can be a useful tool to monitor disease activity and predict treatment response in these patients.ObjectivesThe aim of this work was to evaluate the analytical performance of a new sCAL turbidimetric assay, a high throughput test on clinical chemistry analyzers, to determine calprotectin levels in serum.MethodsCLSI guidelines (CLSI C28-A3, EP05-A3, EP07-A3, and EP09-A3) were used to establish sCAL turbidimetric assay characteristics.111 samples were measured with 3 lots over 3 days and compared to another commercially available assay.ResultsThe assay presented an analytical measuring range from 0.23 to 15 µg/mL, extended to 225 µg/mL with an additional dilution in an automated rerun on a clinical chemistry analyzer.Reference limits of 1.77 and 1.10 µg/mL were obtained with 160 self-declared healthy adults (m/w) aged 18 to 83 years when sampled either in native tube or tube with gel separator and processed within 3.4 hours after collection respectively.The method is precise, reliable and suitable for routine use, with a within-laboratory precision up to 5.1% and a reproducibility up to 11.1%. No interference was shown with tested concentrations of oral and injectable pharmaceuticals. Hemolyzed samples are not recommended. A method comparison with another commercial assay presented a good agreement with a bias of 2.45% (Bland-Altman) and a slope of 1.16 (Passing Bablok).ConclusionThe new sCAL turbidimetric assay is a high throughput quantitative method performed on clinical chemistry analyzers to reliably and precisely assess the inflammatory status of patients.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsAnna Melone Employee of: Author is employee of BÜHLMANN Laboratories AG, Dominik Vogt Employee of: Author is employee of BÜHLMANN Laboratories AG, Alexander Ohmann Employee of: Author is employee of BÜHLMANN Laboratories AG, Joana Afonso Employee of: Author is employee of BÜHLMANN Laboratories AG, Clara Moniz Employee of: Author is employee of BÜHLMANN Laboratories AG, Dmitrii Guschin Employee of: Author is employee of BÜHLMANN Laboratories AG, Christian-Benedikt Gerhold Employee of: Author is employee of BÜHLMANN Laboratories AG, Thomas Schuster Employee of: Author is employee of BÜHLMANN Laboratories AG.
ISSN:0003-4967
1468-2060
DOI:10.1136/annrheumdis-2023-eular.2947