Performance of a FRET-Based Point-of-Care Immunoassay for the Quantitation of Fecal Calprotectin

A fast (~5 min), time-resolved fluorescence resonance energy transfer based immunoassay (Procise FCP™) was developed for the point-of-care quantitative detection of fecal calprotectin (FCP) using 15 mg of fecal specimen eluted in collection fluid from the Procise Stool Collection Device™. Studies were performed to characterize analytical performance of the Procise FCP assay on the ProciseDx™ analyzer. The Procise FCP assay showed good analytical performance with respect to sensitivity, specificity, linearity, and precision suitable for routine clinical use in a point-of-care setting as well as excellent analytical agreement with a current commercial FCP measurement method. Results indicate that the Procise FCP assay is sensitive, specific, and precise yielding results in less than 5 minutes. This indicates the Procise FCP assay is useful for obtaining fast and accurate FCP quantitation, thus avoiding delays inherent to current methods and enabling immediate clinical assessment to be made during a single patient visit.