Rapid qualitative serological tests make it possible to find out if the subject has come into contact with the virus and his immune system has therefore produced responding antibodies.
The antibodies involved are IgM immunoglobulins (the first to be produced in case of infection) and IgG (they follow IgM when the level of the former drops).
If IgG are detected in the blood sample, it means that the infection has occurred in the past.
The serological test therefore highlights the presence of antibodies against the virus and indicates any exposure to SARS-CoV-2; the positivity is belated and therefore is not a suitable test to detect an infection in progress.
Therefore it cannot replace the molecular test (the swab) to verify or not the positivity of a subject.
This type of test can be useful in the epidemiological field to estimate the spread of the infection within a community.
In the case of swabs and rapid serological for professional use – i.e. intended to be administered by medical / health personnel – they can be EC marked directly by the manufacturer or importer.
Product intended for professional use only, therefore it must be used exclusively by health professionals in medical centers and clinical laboratories. It is not intended for self-analysis.