Comparing a New Flow Immune-Chromatography Fast Assay with a Random Access Semi-Automatic Chemiluminescent Immunoassay to Measure Fecal Calprotectin

Objective. The biomarker fecal calprotectin is an efficacious tool for evaluating the level of disease activity in Crohn's and Ulcerative colitis, as well as for discriminating between inflammatory bowel disease and irritable bowel syndrome. The aim of this investigation was to appraise the analytical proficiency of a novel flow immune-chromatography assay through comparison with the established gold standard system in our laboratory. Methods. A cohort comprising of 125 stool samples, submitted for the purpose of routine calprotectin levels analysis, underwent assessment using two distinct approaches: the Liaison XL system and the SmarTest assay, while adhering to identical cut-off criteria. The present study assessed the performance of the SmarTest assay by calculating its sensitivity, specificity, and accuracy measures. Results. The sensitivity, specificity, and accuracy of the SmarTest assay were found to be 97.75%, 80.56%, and 92.80%, respectively, upon comparison with the gold standard. Moreover, the Pearson correlation coefficient analysis ascertained that the linear correlation pertaining to the calprotectin levels, as identified between both assays, was statistically significant (R=0.8158, P values <0.0001). Conclusions. Upon comparison with the Liaison XL system, it was found that the SmarTest assay demonstrated satisfactory results in both qualitative and quantitative aspects. This novel and expedient diagnostic assay is commended for evaluating fecal calprotectin in situations where access to laboratory services may be insufficient or nonexistent, rendering it an ideal option for point-of-care or at-home testing purposes.