From concept to commercialization: automated high throughput optical modulation biosensing for detection of low concentrations of biomarkers

Rapid, highly sensitive, and high-throughput detection of biomarkers at low concentrations is invaluable for the early diagnosis of various diseases. In many sensitive immunoassays, the protocol is time-consuming and requires a complicated and expensive detection system. Previously, we presented a high-throughput optical modulation biosensing (ht-OMB) system, which enables reading a 96-well plate within 10 minutes. In ht-OMB, to aggregate and immobilize the magnetic beads to one spot, a single cylindrical permanent magnet with a sharp tip is positioned under a 96-well plate. To reduce washing and separation steps, the laser beam is manipulated relative to the fixed magnetic beads. Recently, MagBiosense Inc., which commercializes the ht-OMB technology, provided us with a fully automated OMBi detection system. Here, we show the use of the OMBi system for highly sensitive serological (clinical anti-Zika, anti-DENV, and anti-West Nile IgG) and molecular (SARS-CoV-2) assays. Using the OMBi, to detect 336 RNA extracts from 70 confirmed RT-qPCR SARS-CoV-2-positive patients (Ct≤40) and 236 confirmed RT-qPCR SARS-CoV-2-negative individuals, resulted in 100% specificity and 96% sensitivity.