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, presented three posters, including one in collaboration with Stanford University, related to its investigational Singulex Clarity C. diff toxins A/B assay at the 2018 European Congress of Clinical Microbiology and Infectious Diseases.

Findings demonstrate the ultrasensitive Singulex Clarity C. diff toxins A/B assay, for use on the Singulex Clarity system (how does it work), 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 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.

“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.”

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.

The three posters were on view at ECCMID 2018.

Abstract Poster #P2281 Title: Clinical evaluation of the Singulex Clarity C. diff toxins A/B assay, currently in development, for ultrasensitive detection of Clostridium difficile toxins A and B Summary: In a study together with Dr. Niaz Banaei at Stanford University Medical Center, it was shown that the Singulex Clarity C. diff toxins A/B assay yielded 98% sensitivity and 100% specificity compared to multistep PCR-and-toxin testing. It was concluded that the assay is ultrasensitive and highly specific and may offer a standalone solution for the rapid detection and quantitation of free toxins in stool.

Abstract Poster #P2282 Title: Evaluation of the Singulex Clarity C. diff toxins A/B assay, currently in development, for ultrasensitive detection of Clostridium difficile toxins Summary: In a study evaluating the analytical performance of the Singulex Clarity C. diff toxins A/B assay, it was shown that the assay can detect C. difficile toxins at concentrations lower than commercially available toxin assays and that it had high sensitivity and specificity compared to CCNA. The Singulex Clarity C. diff toxins A/B assay demonstrated reactivity to common C. difficile strains, did not show cross-reactivity to common gastrointestinal pathogens, was robust against common interferents at relevant concentrations, allowed for detection of toxins in both fresh and frozen stool samples and up to three freeze-thaw cycles, and provided results with high reproducibility.

Abstract Poster #P2283 Title: Preliminary performance evaluation of an automated Singulex Clarity C. diff toxins A/B assay and comparison to PCR and multi-step algorithms Summary: The clinical performance of the Singulex Clarity C. diff toxins A/B assay compared to CCNA and relative to current C. difficile testing options was determined in a study together with TriCore Reference Laboratories in Albuquerque, New Mexico, USA. When assessing sensitivity and specificity compared to CCNA, the Singulex Clarity C. diff toxins A/B assay outperformed PCR, EIA, and two multistep algorithms.

The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 140,000 subjects, resulting in over 180 peer-reviewed publications. The Singulex Clarity system and Singulex Clarity cTnI assay have the CE mark and are commercially available in Europe. The company anticipates registration of the C. difficile toxins A/B assay for use with the Singulex Clarity system to the US Food and Drug Administration before the end of 2018.

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