Rapid antigenic tests look for the surface proteins of the virus (antigens) and not the viral genome (as is the case with molecular testing).
The sample is collected through a nasopharyngeal swab and the response time is very short (about 15-30 minutes, whereas the molecular test takes about 24-48 hours).
These products are classified as in vitro diagnostic (IVD) medical devices and certified according to Directive 98/79/EC.
In the case of swabs and rapid serological tests for professional use – i.e. intended to be administered by medical/health care personnel – they can be CE marked directly by the manufacturer or importer.
This product is intended for professional use only, i.e. to be used only by healthcare professionals in medical centres and clinical laboratories. It is not intended for self-testing.