

Make sure to collect enough specimen material (nasal secretion) with the swab, especially for anterior nasal sampling.ġ0. Correct specimen collection is the most important step in the procedure. Use the swabs included in the test kit to ensure optimal performance of the test.ĩ. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results.Ĩ.

Handle all specimens as potentially infectious.ħ. If the product has been stored in a cool area (less than 15☌), leave it at normal room temperature for 30 minutes before using.Ħ. The product should be used at room temperature (15☌ to 30☌). Store the test device at 4 to 30☌ in the original sealed pouch. Do not use the product if the pouch is damaged or the seal is broken.Ĥ. Do not use the product beyond the expiration date.ģ. IMPORTANT INFORMATION BEFORE THE EXECUTIONĢ. – 97,87% of the different types of results were interpreted correctly – 99,10% of non-professionals carried out the test without requiring assistance Rapid SARS-CoV-2-Antigen Test Card was compared to the confirmed clinical diagnosis. PERFORMANCES (SENSITIVITY AND SPECIFICITY) Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch).Children under 14 years of age should be assisted by an adult. Rapid SARS-CoV-2 Antigen Test Card shall not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test.
