Correlation of rapid point-of-care vs send-out fecal calprotectin monitoring in pediatric inflammatory bowel disease.

Abstract

Aim: To assess the correlation between the send-out enzyme-linked immuno sorbent assay (ELISA) and the point-of-care (POC) calprotectin test in pediatric inflammatory bowel disease (IBD) patients.

Methods: We prospectively collected stool samples in pediatric IBD patients for concomitant send-out ELISA analysis and POC calprotectin testing using the Quantum Blue^® (QB) Extended immunoassay. Continuous results between 17 to 1000 μg/g were considered for comparison. Agreement between the two tests was measured by a Bland-Altman plot and statistical significance was determined using Pitman's test.

Results: Forty-nine stool samples were collected from 31 pediatric IBD patients. The overall means for the rapid and ELISA tests were 580.5 and 522.87 μg/g respectively. Among the 49 samples, 18 (37.5%) had POC calprotectin levels of ≤ 250 μg/g and 31 (62.5%) had levels > 250 μg/g. Calprotectin levels ≤ 250 μg/g show good correlation between the two assays. Less correlation was observed at quantitatively higher calprotectin levels.

Conclusion: In pediatric IBD patients, there is better correlation of between ELISA and POC calprotectin measurements at clinically meaningful, low-range levels. Future adoption of POC calprotectin testing in the United States may have utility for guiding clinical decision making in real time.