Singulex, Alameda, Calif, recently announced the commercial introduction of its Clarity C. difftoxin A/B assay, a rapid, high-sensitivity, high-precision, one-step solution to C. difficile toxin testing. The assay matches the sensitivity and specificity of cell cytotoxicity neutralization assays, the current gold standard, giving it the potential to reduce the false positives of polymerase chain reaction-based tests and the false negatives of current, less-sensitive toxin immunoassays.

“The Clarity toxin A/B assay offers a new approach to testing for C. diff and represents a significant and much-needed advance in infection control,” says Stephen Young, PhD, emeritus professor of pathology at the University of New Mexico, and director of research and clinical trials at TriCore Reference Laboratories. “Despite sophisticated technologies and prevention measures, hospitals continue to struggle with increasing rates of C. diff due to numerous factors, one of which is the varying level of certainty with existing testing methods, which too often result in either undertreating or overtreating patients.”


Guido Baechler, Singulex.

Powered by single molecule counting technology, the ultrasensitive Clarity C. diff toxin A/B assay detects C. difficile toxins at a concentration of just one hundredth that of current immunoassays, delivering accurate, clinically actionable results in less than 35 minutes.

The Centers for Disease Control and Prevention (CDC) has classified C. difficile, which can cause life-threatening diarrhea and colitis, as an urgent threat. C. difficile infection (CDI) is regarded as one of the most serious, expensive, and potentially avoidable consequences of hospitalization.

“Currently available methods for the diagnosis of true C. difficile infection are complicated, only detect the organism, and/or lack in sensitivity or specificity, making it very difficult for hospitals to gain control of this very serious infection” says Guido Baechler, president and CEO at Singulex. “We are pleased to offer laboratories, clinicians, and hospital administrators a better choice to detect true CDI. Our Singulex Clarity C. diff toxin A/B assay delivers simple, rapid, accurate, and automated detection of true CDI so they can have confidence in diagnosis, improve antibiotic stewardship, and decrease costs.”

For additional information, visit Singulex.