Evaluation of a fluorescent immunochromatography test for fecal calprotectin

Abstract

Background Fecal calprotectin (FC) is widely used to discriminate between patients with inflammatory diseases such as inflammatory bowel disease (IBD) and functional diseases such as irritable bowel syndrome (IBS). ELISA is a time‐consuming method for the measurement of FC, whereas a fluorescent immunochromatography test can obtain results in around 30 minutes and thus enables a rapid response to clinical decision. Methods Two methods, the Proglead® calprotectin (FC Proglead) and the BÜHLMANN fCAL® ELISA (FC BÜHLMANN), were used to quantitatively examine FC in 111 stool samples. The comparison and bias estimation of both assays were assessed using CLSI EP09c protocol. Results The two methods were highly correlated (rho = .96). Deming regression was employed to calculate the regression equation, with a slope of 1.01 and an intercept of −4.98 μg/g. The estimated median bias (FC Proglead − FC BÜHLMANN) was −4.19 μg/g with the 95% limits of agreement (−55.59 to 47.21 μg/g), and the estimated median percent bias was −8.71% with the 95% limits of agreement (−50.31% to 32.90%). There was 4.50% (5/111) of values outside the 95% limits of agreement. Percent biases at the FC cutoff values of 50 and 200 μg/g between both methods evaluated by Deming regression were 8.96% and 1.49%, respectively. The biases were all less than the acceptable standard (10%). And, 99.10% of FC results were in agreement between both methods (kappa = .99, P < .001). Conclusions FC Proglead may be used as a suitable alternative to FC BÜHLMANN for the disease activity assessment for patients with IBD, considering its convenience and shorter turnaround time.

The value of fecal calprotectin measured by fluorescent immunochromatography assay in evaluating clinical and endoscopic activity in ulcerative colitis

“…As the most widely used method currently, ELISA is the standard quantitative test for detecting FC, however, it is expensive and time-consuming 22 . FICA, a valid alternative to ELISA 15 , is easier and faster to perform, and its results have been reported to correlate highly with ELISA results 23 . Through ROC curve analysis, we con rmed that FICA-based FC testing was better at predicting clinical and endoscopic activity in UC than CRP and ESR.…”