MADRID, (April 24, 2018) – New data presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) reveal that the ultrasensitive diagnostic test for C. difficile – the Singulex Clarity C. diff toxins A/B assay – offers rapid results and a high level of sensitivity and specificity for the detection of Clostridium difficile toxins A and B in stool compared with currently available testing options. The company presented this data in three posters at the meeting, including one in collaboration with Stanford University.
“Commercially available tests used to diagnose C. difficile infection lack either in sensitivity or specificity,” said Niaz Banaei, Associate Professor of Pathology and Medicine (Infectious Diseases) at the Stanford University Medical Center and primary investigator of one study (poster #2881). “Data show that this new, rapid, standalone immunoassay addresses these shortcomings by detecting nearly all cell cytotoxicity neutralization assay (CCNA)-positive samples. The Singulex assay offers clinicians a new tool for accurate diagnosis of C. difficile infection.”
Over the last two decades Clostridium difficile has been reported as the greatest cause of healthcare associated infections in North America and Europe. Since 2000, a considerable increase in the number of Clostridium difficile infections (CDIs) leading to substantial morbidity, mortality and attributable costs has been observed, at least in North America and Europe.
Singulex, an immunodiagnostics company at the forefront of Single Molecule Counting technology, a novel immunoassay technology recognized for unprecedented ultrasensitivity in the precision measurement of biomarkers. The Singulex Clarity system is a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. With up to 1000 times higher sensitivity than existing technologies, Single Molecule Counting reveals the presence or absence of disease more clearly and definitively than possible before. The Singulex Clarity C. diff toxins A/B assay, powered by Single Molecule Counting, aims to be the first ultrasensitive test to offer physicians and laboratorians the specificity intrinsic to toxin tests but at a sensitivity level that rivals molecular methods.