Description
Single-use test intended to detect SARS-CoV-2 causing COVID-19 with nasal swab samples collected independently from symptomatic individuals suspected of being infected with COVID-19.
Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory tract samples during the acute phase of infection.
Positive results indicate the presence of viral antigens, but clinical correlation with the patient’s history and other diagnostic information is necessary to determine the infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek further care from their healthcare provider. Positive results do not exclude bacterial infection or co-infection with other viruses.
Negative results do not exclude SARS-CoV-2 infection. Individuals who test negative and continue to exhibit COVID-like symptoms should consult their healthcare provider.

How to use
Wash hands with soap and water for at least 20 seconds before and after testing. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
Remove the cap from the extraction tube with the extraction swab and place the tube in the test tube holder in the box.

Collection of nasal swab sample
Remove the sterile swab from the pouch. Insert the swab into the nostril until you feel slight resistance (about 2 cm up the nose). Slowly rotate the swab, rubbing it along the inside of the nostril for 5-10 times against the nasal wall. This may be uncomfortable.
Do not insert the swab further if you feel strong resistance or pain. When the nasal mucosa is damaged or bleeding, nasal swab collection is not recommended. If collecting swabs from others, please wear a face mask. With children, it may be necessary to insert the swab this deeply into the nostril. For very young children, another person may be needed to hold the child’s head still during the swab collection.
Gently remove the swab. Using the same swab, repeat the procedure in the other nostril.
Withdraw the sterile swab.

Sample preparation
Place the swab in the extraction tube, ensuring it touches the bottom and swirl the swab to mix well. Press the swab head against the tube and rotate the swab for 10-15 seconds. Remove the swab by pressing the swab head against the inside of the extraction tube. Place the swab in the biohazard bag. Close the cap of the extraction tube.

Testing procedure
Remove the test cassette from the sealed aluminum pouch and use it within an hour. The best results are obtained if the test is performed immediately after opening the aluminum pouch.
Place the test cassette on a flat surface.
Open the small cap and invert the extraction tube. Add 3 drops of the extracted sample into the sample well (S) of the test cassette and start the timer.
Do not move the test cassette during the test development.
Read the result after 15 minutes. Do not read the result after 20 minutes.
At the end of the test, place all components in a plastic biohazard bag and dispose of according to local regulations.

Reading results
Please share the test result with your healthcare provider and carefully follow local guidelines/requirements for COVID cases.

POSITIVE: two distinct colored lines appear. One colored line should appear in the control area (C) and another colored line should appear in the test region (T). The intensity of the color in the test line region (T) varies depending on the number of SARS-CoV-2 antigens present in the sample. Therefore, the presence of any shade of color in the test region (T) should be interpreted as a POSITIVE result.
A positive result means it is highly likely that the person has contracted COVID-19. Positive samples must be confirmed. Immediately self-isolate as prescribed by local regulations and contact your healthcare provider or health care district according to local authority instructions. The test will be verified through a confirmatory molecular (PCR) test, and instructions for the next steps will be provided.

NEGATIVE: a single colored line appears in the control area (C) and no colored line appears in the test region (T). It is unlikely that the person has contracted COVID-19. However, it is possible for this test to give a false negative result in some people with COVID-19. This means that one could have contracted COVID-19 even if the test gave a negative result. In case of symptoms such as headache, migraine, fever, loss of taste and smell, contact the nearest healthcare point according to local authority rules. Additionally, it is possible to repeat the test with a new kit.
In case of suspicion, repeat the test after 1-2 days, as the coronavirus cannot be determined in all stages of infection.
Even with a negative result, distancing and hygiene rules must continue to be observed.

INVALID: the line in the control area does not appear. An insufficient sample volume or incorrect procedural techniques are the most likely causes of the absence of the control line. Review the procedure and repeat the test with a new kit or contact your healthcare provider or a COVID-19 diagnostic center.

Warnings
Read all information in the leaflet before performing the test.
For in vitro self-diagnostic use only. Do not use after the expiration date.
Do not eat, drink, or smoke in the area where samples or kits are handled.
Do not drink the buffer solution contained in the kit. Handle with care and avoid contact with skin or eyes. In case of contact, rinse immediately with plenty of running water.
Keep in a dry place, avoiding excessive humidity. Do not use if the aluminum package is damaged or has been opened.
This kit should only be used as a preliminary test, and repeatedly abnormal results should be discussed with a doctor or medical professional.
Strictly follow the indicated timings.
Use the test once only. Do not disassemble and touch the test window of the test cassette.
The kit should not be frozen.
Keep out of reach of children.
The test for children and adolescents should be performed in the presence of an adult. Do not use the test on children under 2 years of age. Young children should have the swab taken with the help of a second adult.
Please ensure that an adequate amount of samples is collected for the test. Too much or too little sample can lead to incorrect results.
The test indicates only the presence of SARS-CoV-2 antigens in the sample.
If the result is negative or non-reactive and clinical symptoms persist, it is because the virus may not be detectable in the early stage of infection. Repeat the test with a new kit or perform a molecular diagnostic test to exclude infection in these individuals.
Negative results do not exclude SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Molecular diagnostic control tests should be considered to exclude infection in these individuals.
Positive results from COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors.
Failure to comply with testing procedures may alter test performance.
False negative results may occur if the sample is collected improperly or if the level of antigens present in the sample is below the test’s minimum detection limit.

Storage
Store at room temperature or refrigerated (2-30 °C). Do not freeze.
The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
Do not use after the expiration date.
Validity in intact packaging: 24 months.

Format
The kit contains:
– 1 test cassette;
– 1 sterile swab;
– 1 extraction swab;
– 1 instruction leaflet;
– 1 biohazard bag.

Code ICOV-802H