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Single Molecule Counting (SMC™) Technology

Originally developed by Singulex®, Inc., Single Molecule Counting (SMC™) technology, utilizing the SMCxPRO™ and Erenna® instruments, enables researchers to measure femtogram levels of biomarkers and better understand the clinical relevance from healthy to disease. Providing maximum immunoassay performance while following a workflow similar to traditional ELISA technology, SMC™ technology combines a unique assay elution step and robust digital counting to achieve improved signal-to-noise ratios over traditional immunoassay technologies. The SMC™ technology thus provides enhanced quantification at both low and high levels of expression on one complete system. Learn more about our SMC™ technology, immunoassay kits, and how you can design your own custom assay to meet your critical research needs.

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Digital Counting Improves Sensitivity and Dynamic Range

The SMCxPRO™ and Erenna® instruments capture the sum of all digital events counted above the background threshold. The digital event algorithm of the SMCxPRO™ instrument computes digital events across a spectrum of time series for a single standard. On the Erenna® instrument, at lower concentrations, photons are digitally counted as single molecules. At higher concentrations, molecules are counted in analog and a proprietary algorithm computes the total sum of all photons recorded. The digital counting of molecules thus improves the assay sensitivity and extending the assay dynamic range beyond what can be achieved with traditional methods.

Verification Criteria for SMC™ Immunoassays

A comprehensive set of criteria evaluating ultimate quantitative performance are used to qualify verified immunoassays, including:

  • Lower limit of quantitation: Lowest point on standard curve with CV <20% and accuracy within 20% of expected values
  • Inter- and intra-assay precision: Samples run on multiple plates over multiple days. Spiked and un-spiked samples within 20% across experiments
  • Spike recovery: Minimum of 10 samples spiked with acceptable recovery between 80–120%
  • Dilutional linearity and parallelism (where feasible): Assays within 20% of expected value endogenous range, minimum of 10 samples from individual healthy donors assessed for biomarker levels for each verified assay and lot-to-lot

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Contract Research Organizations Using SMC™ Technology

  • Aptuit Verona Srl
  • Beijing Evergreen Biotech Ltd
  • Covance Laboratories, Inc.
  • Charles River Laboratories
  • Eurofins BioAnalytics USA
  • Evotec AG
  • Firalis SAS
  • GX Sciences
  • IRBM
  • KCAS Bioanalytical Service
  • LGC Limited
  • LSI Medicine
  • Nuvisan GmbH
  • Pacific Biomarkers
  • PBL Assay Science
  • PDXen
  • PRA Health Sciences
  • Radix Biosolutions
  • SBH Diagnostics
  • Smithers Avanza
  • SNBL Japan
  • Swiss Bioquant
  • The Scientists Lab
  • Unimed
  • United-Power Pharma Tech co., Ltd
  • VINTAR Research Laboratories
  • WuxiApp Tech