EuGeni Rapid Antigen Test for the Qualitative Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Causing COVID19 Disease in Compliance With the World Health Organization (WHO)

Rapid antigen detection (RAD) tests are used to perform rapid diagnosis of SARS-CoV-2 infection based on a qualitative approach. RAD tests detect the viral antigen by the immobilized coated SARS-CoV-2 antibody placed on the device. The results of these tests are available in a short time, reducing the workload in diagnostic hospitals and laboratories and improving the turn-around time. EuGeni SARS-CoV-2 Antigen Rapid Diagnostic Test is an in vitro Diagnostic (IVD) medical device intended to be used for the qualitative detection of SARS-CoV-2 nucleocapsid antigen. The result from this IVD test identifies the presence or absence of the SARS-CoV-2 antigen as an aid for the diagnosis of COVID-19 infection.