This SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) is intended for use by laypeople in the home environment. The application is carried out using saliva as a sample. - Patient-friendly - Saliva as a sample - User-friendly - simple and time-saving thanks to pre-filled sample tubes - Reliable - meets the valid requirements of the RKI and the BfArM and was evaluated by the Paul Ehrlich Institute PEI - Result within 15 minutes - All necessary materials in the pack contain specifications: - Colloidal gold immunoassay - Sensitivity: 95.51% (7 days after onset of symptoms) - Specificity: 99.45% - Sample material: saliva - Pack size: 1 test - Storage: 2 - 30 C - Shelf life: 18 months - Special approval for laypeople by the BfArM (BfArM GZ: 5640-S-032/21) - Specifications positively evaluated by the PEI (Paul-Ehrlich-Institut) Permitted users: Self-test for laypeople Scope of delivery per pack: 5x test cassette packed in foil pouch 5x sample tubes with extraction buffer 5x sterile disposable swabs 1x instructions for use 1x brief instruction
