Reveal What Couldn’t Be Seen Before for Unprecedented Confidence and Insight Into Disease

The Singulex Clarity® system* can help clinicians deliver the right treatment at the right time.

* Singulex Clarity system is in development and is not available for commercial sale in the United States.

The Singulex Clarity System* is a fully automated in vitro diagnostics platform that is designed to deliver groundbreaking advancements in immunoassay technology through ultra-sensitive Single Molecule Counting technology. The system provides precise results across a 6-log reporting range. Full automation, ready-to-use reagents, and on-board resource inventory management provide a streamlined sample-in, result-out workflow to optimize laboratory operations.


* Singulex Clarity system is in development and is not available for commercial sale in the United States.
**Values based on running 1 test per sample up to 5 tests per sample.

Singulex’s Single Molecule Counting technology has been validated in more than 130 peer-reviewed published studies involving over 110,000 patients. These ongoing research applications, and growing clinical adoption add to the scientific integrity of Single Molecule Counting technology.

Singulex’s Single Molecule Counting technology is up to 1000 times more sensitive than contemporary immunoassay platforms, measuring biomarkers at ultra-low levels other tests cannot.

Singulex’s Single Molecule Counting technology can be applied to existing and newly identified biomarkers to aid physician decision making in cardiovascular, oncology, infectious disease, inflammation/immunology, and CNS applications.

How Single Molecule Counting Technology Works

Singulex technology couples proprietary digital Single Molecule Counting technology with robust microparticle-based immunoassays to provide higher sensitivity and broader dynamic range than contemporary immunoassay systems.3 A biological sample (e.g. blood plasma) containing the analyte of interest is combined with paramagnetic microparticles coated with capture antibodies and detection antibodies labeled with fluorescent dye. After a brief incubation, the microparticles are washed to remove any excess detection antibody and then subjected to conditions that disrupt the sandwich complex formed on the microparticles. The resulting eluate, which contains the fluorescently-labeled detection antibodies, is separated from the microparticles and analyzed using Single Molecule Counting technology. Single fluorescently-labeled molecules that pass through a small interrogation space created by a confocal detection system (see below) generate intense flashes of light as they are illuminated by a laser.

The confocal microscopic optics utilized in Single Molecule Counting technology rotate and scan through the bottom of a detection vessel. The intensity of fluorescence encountered in the interrogation space (orange dot) is captured as a function of time. The measured fluorescence is sequestered in 100 micro second time bins as shown below.

A threshold of signal intensity (dotted line) is applied across all time bins and only bins with fluorescence above the threshold are counted as detected digital events. Each of these counted digital events represents a single fluorescently-labeled molecule. The sum of digital events is equivalent to the concentration of analyte in the original biological sample. The Single Molecule Counting technology provides a reading range of more than 6 logs.

Proprietary Intellectual Property

Singulex’s pioneering research has yielded a broad and deep global intellectual property portfolio that includes both Single Molecule Counting technology as well as numerous biomarkers for cardiovascular, oncology, infectious disease, and inflammation/immunology applications.