A Point of Care IVD Platform for In-Theater and En Route Warfighter Care

J. deSa, M. Neidrauer
Instadiagnostics, Pennsylvania, United States

Keywords: point of care tests, in vitro diagnostics, multiplexed

Instadiagnostics is developing a multi-technology platform diagnostic device for rapidly detecting multiple proteins, antibodies, enzymes, small-molecule metabolites, and ions/electrolytes from a single sample at the point of care (POC). The system consists of disposable multiplexed cartridges and a single portable reader. Our system accepts unprocessed whole blood samples (nasal swab, saliva, urine in the future), and automatically detects up to twelve biomarkers per cartridge in under 20 minutes without any user intervention. We envision a menu of cartridges that can run most of the immuno- and electrochemical assays currently run in CLIA laboratories. Further, Instadiagnostics’ system is uniquely suited for rapid development of new tests in response to emerging biological threats. The same biochips that are used in our POC system are used in our laboratory-based development system to monitor antigen / antibody binding kinetics in real-time. This translates directly to assay performance in the POC system. We have generated significant preliminary data from human samples containing Hepatitis B (HBsAg, anti-HBs, anti-HBc), Hepatitis C (anti-HCV), and host-response biomarkers (both immuno- and electrochemical, PCT, CRP, D-dimer, lactate, creatinine, bilirubin, BUN). Pilot HBV and HCV clinical studies are scheduled within the next 12 months.