GENSPEED Biotech

Within 20 minutes the GENSPEED FSME IgG xPOC antibody test provides results on vaccine induced protection against TBE (tick-borne encephalitis) in lab quality. Results from the clinical evaluation study substantiated this giving a sensitivity of 99,3% and a specificity of 100%.

From the manufacturer's own website. Source

GENSPEED Biotech manufactures point-of-care (POC) diagnostic cartridges and analyzers for rapid testing, including the xPOC Cartridge for general use, the Perio POC Pro Cartridge for periodontal health assessments, and specific antibody tests like the FSME IgG xPOC for tick-borne encephalitis immunity. Additional tests cover Vitamin D levels and other clinical markers, delivered via the GENSPEED R2 Analyzer platform.

The company’s devices fall under EU regulatory categories, including Class A and Class B medical devices as well as In Vitro Diagnostic (IVD) General devices, all registered in the EU’s eudamed database. The portfolio is developed and listed in compliance with EU medical device and IVD regulations, with the company headquartered in Austria.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.