B-028 Clinical Performance of a Fully-Automated Fecal Calprotectin Chemiluminescence Immunoassay (CLIA)

Abstract

Abstract Background Fecal calprotectin is a noninvasive marker for inflammatory bowel disease (IBD). Traditionally, calprotectin is measured by the well-established enzyme linked immunosorbent assay (ELISA) method. More recently, advances in fully automated platforms allow for comparable performance and diagnostic accuracy whilst improving laboratory efficiency. In this study, we assessed the diagnostic performance of the fully automated ALPCO calprotectin chemiluminescence immunoassay (CLIA), and compared it to the predicate, ALPCO’s 510(k) cleared manual calprotectin chemiluminescence ELISA. Methods Fecal calprotectin levels were measured with the ALPCO Calprotectin Chemiluminescence ELISA and the recently developed ALPCO Calprotectin CLIA, utilizing glow and flash chemiluminescence, respectively. An IRB approved study included over 400 individuals with clinical suspicion of IBD. The estimates of clinical sensitivity, and clinical specificity of the ALPCO Calprotectin Chemiluminescence ELISA and the ALPCO Calprotectin CLIA were determined by comparing analytical test results of the prospectively collected stool specimens against the clinical diagnosis made by the clinical investigator/gastroenterologist with ileocolonoscopic and histopathological sampling (reference standard). Results When distinguishing IBD from irritable bowel syndrome (IBS) and healthy persons, the sensitivity (70/76) and specificity (322/348), at a fecal calprotectin cut-off level of 50 µg/g, were 92.1% and 92.5%, respectively for the ALPCO Calprotectin Chemiluminescence ELISA. Sensitivity (73/78) and specificity (319/342), at a fecal calprotectin cut-off level of 50 µg/g, were 93.6% and 93.3%, respectively for the ALPCO Calprotectin CLIA. Conclusion The ALPCO Calprotectin CLIA showed comparable clinical performance for detection of IBD compared to the predicate 510(k) cleared ALPCO Calprotectin Chemiluminescence ELISA. The automation of the ALPCO calprotectin immunoassay allows for increased laboratory efficiency without sacrificing diagnostic accuracy.