Pre Diagnostics uses a digital immunoassay (Simoa, Quanterix). Paramagnetic particles coupled with PreDx proprietary antibodies, designed to bind to the specific biomarker, are added to the sample. Subsequently, detection antibodies – capable of generating fluorescent product – are added. The objective is to form an immunocomplex consisting of the bead, bound protein, and detection antibody. At low concentrations, each bead will contain one bound protein, or none.
The sample is loaded into arrays, in the Simoa disc, consisting of more than 200,000 microwells – each large enough to hold one bead. The signal intensity on each bead is read and sample concentration determined from a calibration curve. To support future high-volume demand, the unique set of antibodies and reagents used in the digital immunoassay will be further optimized to ensure compatibility with the high-volume immunoassay instruments available in routine IVD laboratories.