The artus C. difficile QS-RGQ kit, designed, developed, and manufactured for Qiagen by IMDx, Waltham, Mass, received CE marking in December, 2013, for use with the QIAsymphony SP/AS and Rotor-Gene Q instruments from Qiagen. Shortly after, in April 2014, the kit received FDA clearance for sale in the United States. C. difficile is the most common cause of hospital-associated diarrhea and can lead to complications such as pseudomembranous colitis and toxic megacolon when not treated properly. The artus C. difficile QS-RGQ kit detects the presence of toxigenic C. difficile in human liquid or soft stool from patients suspected of having C. difficile-associated disease. The test is intended for direct use on patient samples to assist in diagnosis of infection. The artus C. difficile QS-RGQ kit is distributed by Qiagen.