Analytical and clinical evaluation of DiaSorin Liaison® Calprotectin fecal assay adapted for serum samples

Abstract

Background Calprotectin is a calcium-binding protein that can be measured in serum, plasma, and feces. Increased serum and plasma calprotectin concentrations have been found in chronic inflammatory rheumatic disorders. An analytical and clinical evaluation of the DiaSorin Liaison (R) fecal Calprotectin assay using LIAISON (R) XL was performed. Methods The protocol included an analytical and clinical evaluation in which imprecision, the linearity of dilution, differences between serum and plasma samples and method comparison with CalproLab (TM) ELISA kit were assessed. Serum calprotectin concentrations in active (n = 26) and remission (n = 23) rheumatoid arthritis (RA) patients were compared. Results The intra-day and inter-day analytical imprecision CVs ranged from 2.9% to 4.0% and 2.7% to 10.4%, respectively. Correlation between measured and expected values was high (R > 0.99), indicating good linearity. The Wilcoxon signed-rank test showed that serum and plasma matched samples presented statistically significant differences (p < 0.001) being the highest concentrations of calprotectin observed in serum samples. Deming regression equation was as follows: Diasorin calprotectin (mu g/ml) = -0.32 (95% CI: -0.65 - -0.05) +1.58 (95% CI: 1.42-1.79).* Calprolab calprotectin (mu g/ml). Significantly higher serum calprotectin levels were found in RA patients with active disease when compared to patients with low disease activity or in clinical remission (mean +/- SD) [(3.35 mu g/ml +/- 1.55) vs. (1.63 mu g/ml +/- 0.52), p < 0.001] and these levels correlated well with all disease activity indices. Conclusions The DiaSorin Liaison (R) fecal Calprotectin assay adapted for serum samples showed adequate technical performances and the clinical performances were similar to other assays.