Description
Lateral flow immunoassay method for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in the nasal swab of subjects with symptoms or other epidemiological reasons leading to suspicion of COVID-19 infection.
The test is intended for use by non-professionals 15 years of age and older and, as the case may be, adults to test another person under the age of 15. Individuals over 65 should request assistance in performing the test.
The test provides only a preliminary screening result for the SARS-CoV-2 virus. Positive results must be confirmed by a laboratory PCR test.
People with a negative test result who continue to experience COVID-19-like symptoms should seek medical attention.

How to use
Test preparation
Ensure that all test components are at room temperature (15-30°C).
Keep a clock, timer, or stopwatch handy.
Check that the package is intact. Do not use the test if the package is visibly damaged.
Open the test cassette package only at the time of use. Use the test cassette within one hour of opening the package.
Wash your hands with soap and water and dry them thoroughly.

Test run
Open the tube containing the extraction reagent by carefully removing the film. Insert the test tube into the test tube holder (hole present on the package).
Remove the swab from the pouch: open the pouch at the stick end. Do not touch the swab head. Withdraw the swab and gently insert the entire swab head into the nostril, to a depth of approximately 2.5cm. Rotate the swab against the nostril wall at least 5 times. Remove the swab, insert it into the other nostril and repeat the same operation. Perform this operation carefully: false negative results may occur if the nasal swab is not performed correctly.
Insert the swab into the tube containing the extraction reagent. Rotate the swab 5 times into the reagent, pressing the swab head against the bottom and side of the tube. leave the swab in the reagent for 1 minute. Remove the swab by squeezing the sides of the tube to force liquid out of the swab. Close the tube tightly with the cap.
Open the sealed pouch containing the test cassette and remove it. Place the test cassette on a flat surface.
Hold the tube vertically above the sample well and add 3 drops to the well by gently squeezing the sides of the tube. A false negative result may occur if less than 3 drops of sample are added to the well. The result will not be affected if you add 1-2 more drops of sample, provided you can read the control line (C).
Start the clock/stopwatch or timer. Read the test result after 15-20 minutes, do not read the result after more than 20 minutes. Erroneous results can occur if test results are read before 15 minutes or after 20 minutes.
After testing, collect the used kit parts and swab samples in a waste bag and dispose of them with household waste. Wash hands thoroughly after handling.

Interpretation of results
- POSITIVE: two lines appear, the control line (C) and the test line (T). The color intensity of the test line (T) can be very weak, the result must however be interpreted as positive. A positive test result indicates that you probably are