Description
Single-use test kit intended to detect SARS-CoV-2 causing COVID-19 in self-collected nasal swab samples.
The test is intended for use in symptomatic individuals who meet the case definition for COVID-19, as well as in asymptomatic individuals, limited to contacts of confirmed or probable COVID-19 cases and at-risk healthcare workers.
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 patient history and other diagnostic information is necessary to determine 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 a healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not rule out SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should consult a healthcare provider.

Instructions for use
Procedure
Wash hands with soap and water for at least 20 seconds before and after the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.

Remove the cap from the tube containing the buffer extraction solution and place the tube in the tube holder on the box.

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

Sample preparation
Place the swab in the extraction tube, ensuring it touches the bottom, and agitate the swab to mix thoroughly. 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.

Test procedure
Remove the test cassette from the sealed foil pouch and use it within one hour. Best results are obtained if the test is performed immediately after opening the foil pouch.
Place the test cassette on a flat surface.
Open the small cap and invert the sample extraction tube, then add 3 drops of the extracted sample to the well (S) of the test cassette and start the timer. Do not move the test cassette during testing.
Read the result at 15 minutes. Do not read the result after 20 minutes.

After the test, place all components in the plastic biohazard bag and dispose of according to local regulations.

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

POSITIVE: Two colored lines appear. One colored line should appear in the control zone (C) and another colored line should appear in the test region (T). The intensity of the color in the test line region (T) will vary depending on the number of SARS-CoV-2 antigens present in the sample. Therefore, any shade of color in the test region (T) should be interpreted as a positive result.
A positive result means it is very likely that the person is infected with COVID-19.
Positive samples must be confirmed. Immediately self-isolate as prescribed by local regulations and contact your doctor or healthcare district as instructed by local authorities. The test result will be verified by a confirmatory molecular test (PCR) and instructions on the next steps will be provided.

NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test line region (T). It is unlikely that you have been infected with COVID, however, it is possible that this test may give an incorrect result (a false negative) in some people with COVID-19. This means you could have COVID-19 even if the test gave a negative result.
You can repeat the test with a new kit. If in doubt, repeat the test after 1-2 days, as the coronavirus cannot be detected at all stages of infection. Even with a negative result, social distancing and hygiene rules must continue to be observed.

INVALID: The control line does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely causes of the missing control line.
Review the procedure and repeat the test with a new kit or contact your doctor or a COVID-19 diagnostic center.

Warnings
Please 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 extraction solution contained in the kit.
Handle the swab carefully and avoid contact with skin or eyes; rinse immediately with plenty of running water in case of contact.
Please do not use if the foil packaging is damaged or has been opened.
This test kit should only be used as a preliminary test, and repeatedly abnormal results should be discussed with a doctor or healthcare professional.
Strictly follow the indicated timings.
Use the test only once.
Do not disassemble and touch the test window of the test cassette.
The kit must not be frozen or used after the expiration date printed on the packaging.
Keep out of reach of children.
Testing for children and adolescents should be performed in the presence of an adult. Young children should have the swab performed with the help of a second adult.
Wash hands thoroughly before and after handling.
Please ensure that an adequate amount of sample is used for testing. Too much or too little sample can lead to inaccurate results.
Performance has only been evaluated with nasal swab samples, using the procedures described in the leaflet.
The test will only indicate the presence of SARS-CoV-2 antigens in the sample.
If the test result is negative or non-reactive and clinical symptoms persist, it is because the infection virus is very early and may not be detected. It is recommended to re-test with a new kit or with a molecular diagnostic device to rule out infection in these individuals.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Control tests with molecular diagnostics should be considered to rule out infection in these individuals.
Positive COVID-19 results may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors.
Failure to follow testing procedures can alter test performance.
False negative results may occur if a sample is collected or handled improperly or if insufficient levels of virus are present in the sample.

Storage
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30 °C). Do not freeze.
The test is stable until the expiration date printed on the sealed pouch. Do not use beyond the expiration date.
The test must remain in the sealed pouch until use.
Shelf life when unopened: 24 months.

Format
The kit contains:
- 1 test cassette;
- 1 sterile swab;
- 1 buffer extraction solution;
- 1 biohazard bag;
- 1 leaflet.

Code INCP-502HALL