Point of care testing of fecal calprotectin as a substitute for routine laboratory analysis

Objectives: Fecal calprotectin (FC) is widely used to monitor the activity of inflammatory bowel disease (IBD) and to tailor medical treatment to disease activity. Laboratory testing of fecal samples may have a turnaround time of 1-2 weeks, whereas FC home testing allows results within hours and thus enables a rapid response to clinical deterioration. Design and methods: Fifty-five stool samples were analyzed by the IBDoc (R) Calprotectin Home Testing kit and the BUHLMANN fCAL (R) turbo assay on a Roche Cobas 6000 c501. The correlation between the assays was assessed using Spearman's Rho correlation coefficient and the intermediate imprecision of both assays was calculated. Results: We found a strong correlation coefficient of 0.887 between FC measured on IBDoc (R) and the laboratory assay BUHLMANN fCAL (R) turbo. The coefficients of variation (CVs) at three different FC levels were in the range 2.3-5.5% (BUHLMANN fCAL (R) turbo) and in the range of 4.8-26.6% (IBDoc (R)). Conclusions: This study suggests that IBDoc (R) is a suitable alternative for the assessment of disease activity in IBD patients.