The Reliability of Patient-Performed Fecal Calprotectin Testing in Inflammatory Bowel Disease.

Background: Home use of a buffer-containing extraction device for fecal calprotectin determination can bypass the labor-intensive extraction procedure and potentially prevent degradation at room temperature.

Methods: In this prospective cross-sectional observational study, 2 CALiaGold tubes (extraction device) and one native tube were filled from the same bowel movement by patients with inflammatory bowel disease. Afterwards patients completed a questionnaire including whether they preferred the extraction device or the normal sampling method. All tubes were sent to the laboratory and when they arrived, 2 more CALiaGold tubes were filled at the laboratory from the native sample. The fecal calprotectin concentrations in all tubes were measured by a particle-enhanced turbidimetric immunoassay.

Results: Fifty-three patients were included in the study. Fecal calprotectin levels were significantly higher in samples extracted by the patient compared to the analyst-performed extractions. When patients were divided into 3 groups (i.e., fecal calprotectin levels <50 ug/g, 50 to 200 µg/g, and >200 µg/g) a substantial concordance was found (Cohen kappa 0.654). Patients sampling imprecision was higher (P < 0.018, median CV 16%) compared to the analyst. Most patients preferred this extraction device.

Conclusions: Patient-performed fecal calprotectin extraction seems a realistic alternative sampling method and is preferred by most patients.