Description
Lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab samples directly from individuals suspected of COVID-19 within the first 7 days of symptom onset.
The test can be used to analyze samples from asymptomatic subjects.
Does not distinguish between SARS-CoV and SARS-CoV-2.
Results relate to the identification of SARS-CoV-2 antigen. This antigen is generally found in samples taken from the upper respiratory tract during the acute phase of infection.
Positive results indicate the presence of viral antigens, but a personal medical history and other diagnostic data are needed to determine the infection status. Positive results do not exclude the presence of bacterial infections or co-infection with other viruses. The detected pathogen may not be the exact cause of the illness.
Negative results obtained from subjects with symptoms appearing more than seven days ago should be treated as probable negatives. If necessary, seek confirmation through molecular analysis.
Negative results do not exclude SARS-CoV-2 infection.
Test results are read visually within the subsequent 15-30 minutes, based on the presence or absence of colored lines.
A colored line serving as a procedural control will always appear in the control line area, indicating that a sufficient sample volume has been applied and membrane absorption has occurred.
The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infection.
The usability of self-tests performed by individuals under 18 years of age has not been determined. It is advisable for minors under 18 to be tested by an adult.

Instructions for use
Preparation
Wash or disinfect hands. Ensure they are dry before starting the test. Read the instructions carefully before performing the test.
Check the expiration date printed on the foil pouch. Open the pouch and check the result window and the sample well on the cassette.

Sample collection
Sample collection can be done by oneself or by a caregiver.
Self-collection of the sample can be performed by individuals aged 18 or older.
Children under 18 must be tested by a parent or legal guardian. Follow local guidelines for collecting samples from children.

Procedure
Unscrew the dropper cap from the extraction solution tube without squeezing it. Insert the tube into the hole on the kit box (or place the tube in the tube holder). Open the swab package at the stick end.
Caution: Do not touch the absorbent tip of the swab with your hands.
Insert the entire absorbent tip of the swab into one nostril. Using gentle rotation, push the swab less than 2.5 cm from the edge of the nostril. Rotate the swab five times, gently touching the inside of the nostril. Remove the swab and insert it into the other nostril, repeating the step. Remove the swab from the nostril and insert it into the tube, swirling it in a circular motion for 30 seconds. Rotate the swab 5 times, while compressing the side of the tube. Remove the swab while compressing the tube.
Securely fasten the dropper tip onto the extraction buffer tube containing the sample. Mix thoroughly by swirling or flicking the bottom of the tube. Unscrew the small cap from the end of the dropper. Gently squeeze the tube and dispense 4 drops of solution into the sample wells.
Read the result when the timer reaches 15-30 minutes. Do not read if 30 minutes have passed.

Interpretation of results
- NEGATIVE: Only the control line (C) appears and no test line (T). This means no SARS-CoV-2 antigen has been detected. A negative test result indicates that it is unlikely you have COVID-19 at this time. Continue to follow all current rules and protective measures when in contact with other people. It is possible that an infection is present even if the test is negative. If suspected, repeat the test after 1-2 days, as the coronavirus cannot be accurately detected at all stages of infection.

- POSITIVE: Both the control line (C) and the test line (T) appear. This means SARS-CoV-2 antigen has been detected. A positive test result indicates a very high probability of active COVID-19 infection. Immediately contact your doctor/GP or local health authority. Follow local guidelines regarding self-isolation. A confirmatory PCR test must be performed.
Note: any line, even a very faint one, present in the test line area (T) must be considered positive.

- INVALID: The control line (C) does not appear. The most likely reasons for an invalid result are insufficient sample volume or an incorrect procedure. Reread the instructions and repeat the test with a new cassette. If test results continue to be invalid, contact your doctor or a COVID-19 testing center.

Warnings
Before performing the test, carefully read the leaflet in the test package. Failure to follow the instructions may lead to inaccurate test results.
Do not use the test after the expiration date stated on the pouch.
Do not eat, drink, or smoke before and during the test.
Do not use the test if the pouch is damaged.
All used tests, samples, and potentially contaminated material must be disposed of according to local regulations.
Humidity and temperature can negatively affect the results.
The test line for a sample with a high viral load may appear within 15 minutes or even earlier, when the sample passes the test line area.
The test line for a sample with a low viral load may appear within 30 minutes.
Do not collect the nasal swab sample if there is a nosebleed.
Wash hands thoroughly after use.
If the extraction buffer accidentally comes into contact with skin or eyes, rinse with large amounts of water and consult a doctor if necessary.
The SARS-CoV-2 Antigen Rapid Test is for self-testing only. The test should only be used for the detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab samples. The intensity of the test line is not necessarily correlated with the SARS-CoV-2 viral load in the sample.
A false negative test may be obtained if the antigen concentration in a sample is below the detection limit of the test or if the sample was collected incorrectly.
Test results should be considered in conjunction with other clinical data available to the physician.
Positive results do not exclude the presence of co-infections caused by other pathogens. Positive results do not distinguish between SARS-CoV and SARS-CoV-2.
Negative test results do not exclude the presence of other viral or bacterial infections.
A negative result obtained from a subject with symptoms appearing more than seven days ago should be treated as a probable negative and, if necessary, verified by molecular analysis.

Storage
Store the kit at a temperature between 2°C and 30°C. Do not freeze.
The test must remain in the sealed pouch until use.
The test is stable until the expiration date printed on the sealed pouch. Do not use after the expiration date.
Shelf life unopened: 24 months.

Format
The kit contains:
- test cassette;
- extraction buffer tube;
- disposable swab;
- waste bag;
- instruction leaflet.

Bibliography
1. Shuo Su, Gary Wong, Weifeng Shi, et al. Epidemiology, Genetic recombination and pathogenesis of coronaviruses. Trends in Microbiology, June 2016, vol. 24, No. 6: 409-502
2. Susan R.Weiss, Julian L. Leibowitz, Coronavirus Pathogenesis, Advances in Virus Research, Volume 81: 85-164

Code L031-11855