Evaluation of a fluorescent immunochromatography test for fecal calprotectin

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(R) calprotectin (FC Proglead) and the BuHLMANN fCAL(R) ELISA (FC BuHLMANN), 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 mu g/g. The estimated median bias (FC Proglead - FC BuHLMANN) was -4.19 mu g/g with the 95% limits of agreement (-55.59 to 47.21 mu g/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 mu g/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 BuHLMANN for the disease activity assessment for patients with IBD, considering its convenience and shorter turnaround time.