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.

Inclusion Criteria:Specimens from subjects over 12 years old agreeing to participate in the study and with a legal representative able to provide informed consent, OR;Specimens from subjects over 18 years old able to provide informed consent.Specimens collected with nasopharyngeal swabs, OR;Combined nasal mid-turbinate and throat specimen collection.Exclusion Criteria:Specimens and testing methods that are not deemed to be in line with gold-standard RT-PCR standards.Specimens stored for over 2 hours at 2-8 ºC temperature between collection and testing with EuGeni SARS-CoV-2 Ag RDT.Specimens stored for over 5 days at -20ºC between collection and testing with RT-PCR.Specimens stored for over 24h at 4ºC between collection and testing with RT-PCR.Contamination and/or deterioration of the specimen which, in the opinion of the investigator, may affect its handling and/or analysis.The subject is deemed unsuitable to participate in the study by the investigator.