A-096 <i>Novel Gastrointestinal Testing:</i> Comparative Performance of the ALPCO Five-Plex Gastrointestinal Marker Assay compared to Conventional ELISA/CLIA testing for Human Stool Samples

Abstract Background All modern gastrointestinal (GI) testing laboratories face a similar challenge: How to test panel of analytes from the same stool or plasma/serum sample and deliver clinically accurate results in timely fashion. GI are tested primarily on ELISAs that while accurate, manual ELISA is time-consuming work intensive. In this study, we utilize automated ALPCO five-plex assay (AutoPlex™) measure five key biomarkers: Calprotectin (CP), Pancreatic Elastase (PE), Lactoferrin (LF), Eosinophil derived neurotoxin (EDN), Hemoglobin (Hgb). These biomarkers widely recognized indicators gut inflammation disease, including inflammatory bowel pancreatic insufficiency, colorectal cancer. The employs simple efficient preparation protocol utilizes multiplexed bead-based technology quantify each biomarker at dilution time point an determine how new performs against gold standard ELISA/CLIAs analytes. Methods Capture detector antibodies were optimized for perform beads, buffers allow all be measured simultaneously. A extraction device was utilized extract 386 human samples both healthy controls populations with suspected impairment. Samples analyzed using 5-Plex (AutoPlex) run Multiplier® - fully-automated chemiluminescence analyzer (DYNEX® Technologies, Chantilly, VA), conventional Chemiluminescence ELISA/CLIA methods. Results Comparative analysis respective analyte, showed strong clinical correlation between two platforms. With cut-off 50 ug/g calprotectin had 91% Similarly, 200 µg/g PE 91%, LF 7.24 83%, EDN 4.6 97%, Hgb 20 98% Conclusions generated by demonstrated average &amp;gt;90% matching 5 when compared their counterparts. Since allows simultaneous measurement common occur single one concurrent workflow, saves as it eliminates need multiple tests reduces processing samples.