2015 AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY

V. Benoit, B. Seignères, M. Lesénéchal, N. Cayet, C. Tourneur, M. Richard, M.C. Bastide, C. Pretis, C. Pease, B. Beyaert, J.M. Dugua, M. Hausmann
bioMérieux S.A., Marcy l’Etoile, France

Background and Objectives

While immunoassays remain the mainstay for the automated, routine dia-gnostics testing of patient samples, early clinical diagnosis often hinges on the ability to reliably measure medically relevant biomarkers at very low-concentrations, beyond the reach of current conventional immunoanalyzer capability. SimoaTM (Single Molecule Array) technology provides the ability to mea-sure protein analytes with unprecedented sensitivity, down to the femto-molar range. Quanterix’s HD-1 system offers full automation of Simoa digi-tal immunoassay technology for life science research applications. This RUO (Research Use Only) system is available with a menu of assays (currently about 30) showing up to 1000x higher sensitivity compared to current best-in-class automated analog immunoassays. In the prospect of developing an IVD-compliant (regulatory approved) ver-sion of the Simoa system, key analytical performance characteristics were evaluated, based on guidelines from the Clinical and Laboratory Stan-dards InstituteTM (CLSI), using two prototype assays for the detection of PSA (prostate-specific antigen) and HIV p24 (human immunodeficiency vi-rus p24 antigen) in human serum or plasma. In the context of these stu-dies, the two prototype assays served as tools for system performance evaluation.