Primacovid - Model 200063-1 - COVID-19 Antigen Self-Test

SARS-CoV-2 VIRUS
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been recognized as the virus responsible for the COVID-19 pandemic.

As with other respiratory diseases, SARS-CoV-2 can cause an asymptomatic infection, causing mild symptoms such as cold, sore throat, cough and fever, loss of taste and/or sense of smell, or more severe symptoms such as pneumonia and respiratory distress with a fatal outcome. The incubation period of SARS-CoV-2 varies from 1 to 14 days.

WHO IS THIS TEST FOR?
COVID-19 ANTIGEN SELF-TEST is dedicated for anyone who wants to verify a possible SARS-CoV-2 ongoing infection.

Antigenic tests for COVID-19 allow to carry out a qualitative detection of SARS-CoV-2 in nasal samples and are intended as rapid diagnostic devices to be carried out for home use. It is recommended to use COVID-19 ANTIGEN SELF-TEST during the time frame relating to possible exposure to the virus.

• Negative: SARS-CoV-2 antigens levels are not present in the sample or they are present in very low concentrations, which are not detectable by the device.
• Positive: SARS-CoV-2 antigens have been detected by the diagnostic system. It is suggested to contact a specialist or the local health department for further information.

COVID-19 ANTIGEN SELF-TEST is an immunochromatographic assay for the qualitative detection of Nucleocapsid antigens in nasal specimens.

• Specificity symptomatic subjects: 99.5%
• Specificity asymptomatic subjects: 99%
• Sensitivity symptomatic subjects: 97.2%
• Sensitivity asymptomatic subjects: 97.8%
• Accuracy symptomatic subjects: 98.6%
• Accuracy asymptomatic subjects: 98.4%

• 1 test cassette
• 1 vial with dropper containing the extraction buffer
• 1 nasal swab
• instructions for use

1. Place the vial in the hole on the back of the package and open it, unscrewing the blue cap;
2. Collect the nasal sample by inserting the swab inside the first nostril up about 1.5 cm. Rotate the swab, extract it and repeat the procedure in the second nostril;
3. Insert the swab inside the extraction liquid, rotate it and remove it by squeezing the sides of the tube, in order to extract as much liquid as possible;
4. Add 3 drops of the extracted sample and wait 15 minutes before reading the result.