ULTRASENSITIVE IMMUNOASSAY DEVELOPMENT WHITE PAPER

Abstract

Ultrasensitive Immunoassay Development with Single-Molecule Array (Simoa™)Technology

Drawing on our knowledge and experience of Luminex xMAP® technology, Rules-Based Medicine, a Q² Solutions Company (formerly Myriad RBM) began developing Simoa™ ultrasensitive immunoassays in 2014. These assays are capable of detecting analytes in the femtomolar range in biological samples. This extreme sensitivity detects clinically important biomarkers at concentrations that extend below the detection limits of currently used immunoassay technologies. RBM’s expertise in assay development methodology, quality manufacturing, and clinical laboratory experience has enabled us to take the Simoa-based technology to a high level of reproducibility and ruggedness.

RBM assays meet performance criteria important to clinical trial customers

• Validated according to CLSI Guidelines
• Proprietary blockers to eliminate interference
• High quality, consistent reagents sourced from qualified vendors
• Key validation parameters include LLOQ, LDD, specificity, cross reactivity, linearity, and precision