Description
Lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab specimens directly from individuals suspected of having COVID-19 within the first seven days of symptom onset.
The test can be used to analyze samples from asymptomatic subjects.
It does not distinguish between SARS-CoV and SARS-CoV-2.
The results involve the identification of the SARS-CoV-2 antigen. This antigen is generally found in samples taken from the upper respiratory tract during the acute phase of infection.
Test results are read visually within the next 15-30 minutes, based on the presence or absence of colored lines.
Positive results indicate the presence of viral antigens, but a patient's medical history and other personal diagnostic data are required to determine the infection status. Positive results do not rule out bacterial infections or simultaneous infection with other viruses. The detected pathogen may not be the exact cause of the condition.
Negative results obtained in subjects with symptoms lasting more than seven days should be treated as probable negative. If necessary, seek confirmation through molecular testing. Negative results do not rule out SARS-CoV-2 infection.
A colored line, serving as a procedural control, will always appear in the control line area, indicating that sufficient sample volume has been added and membrane adsorption has occurred.
The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infection.
The usability of self-testing by individuals under 18 has not been established. It is recommended that anyone under 18 be tested by an adult.

How to use
1. Preparation :
Wash or disinfect your hands. Make sure they are dry before starting the test.
Before using the test kit, please read the instructions carefully.
Check the expiration date printed on the foil pouch. Open the pouch. Check the result window and sample well on the cassette.

2. Sample collection :
Anyone 18 years of age or older can perform a self-swab test. Children under 18 must be accompanied by a parent or legal guardian. Follow local guidelines for sample collection for children.

3. Analysis 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 end of the stick. Do not touch the absorbent tip of the swab with your hands.
Insert the entire absorbent tip of the swab into one nostril. Using a gentle rotation, push the swab within 1 inch of the nostril's edge. Rotate the swab 5 times, gently touching the inside of the nostril. Remove the swab, insert it into the other nostril, and repeat the procedure.
Remove the swab and insert it into the test tube, rotating it in a circular motion for 30 seconds. Rotate the swab 5 times, simultaneously squeezing the sides of the test tube. Remove the swab while squeezing the test tube.
Firmly attach the dropper tip to the extraction buffer tube containing the sample. Mix thoroughly by swirling or tapping 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 well.
Read the result when the timer reaches 15-30 minutes. Do not read if 30 minutes have passed.

4. Interpretation of results :
NEGATIVE: Only the control line (C) appears and no test line (T). This means that no SARS-CoV-2 antigen has been detected.
A negative test result indicates that you are unlikely to have COVID-19 at this time.
Continue to follow all applicable rules and precautions when interacting with others. A current infection is possible even if the test is negative. If you suspect this, repeat the test after 1 or 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 that the SARS-CoV-2 antigen has been detected (Note: Any line, even a very faint one, present in the test line area should be considered positive).
A positive test result indicates a very high probability that you have COVID-19. Contact your doctor/primary care provider or local health authority immediately. Follow local guidelines regarding self-isolation. A confirmatory PCR test must be performed.

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

Warnings
Before performing the test, read the package insert carefully. Failure to follow the instructions may result in inaccurate test results.
Do not use the test after the expiration date shown 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, specimens, and potentially contaminated material must be disposed of in accordance with local regulations.
Humidity and temperature can negatively affect results.
The test line for a sample with a high viral load may appear within 15 minutes or even sooner, when the sample exceeds 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 you have a nosebleed.
Wash hands thoroughly after use.
If the extraction swab accidentally comes into contact with skin or eyes, rinse with large amounts of water and consult a doctor if necessary.
The test is for self-testing only: it should only be used for the detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab specimens.
The intensity of the test line does not necessarily correlate with the SARS-CoV-2 viral load in the sample.
A false negative test may occur if the antigen concentration in a sample is below the test's detection limit or if the sample was collected incorrectly.
The results of the analysis must be observed in the light of other clinical data available to the physician.
Positive results do not rule out the presence of co-infections caused by other pathogens. Positive results do not rule out SARS-CoV and SARS-CoV-2.
Negative test results do not rule out the presence of other viral or bacterial infections. A negative result obtained in a subject with symptoms lasting more than 7 days should be treated as probable negative and, if necessary, verified by molecular testing.

Conservation
Store at 2°C to 30°C. Do not freeze.
The test is stable until the expiration date printed on the sealed pouch. Do not use after the expiration date.
The test must remain in the sealed pouch until ready for use.
Shelf life in intact packaging: 24 months.

Format
The kit contains:
- 1 test cassette
- 1 extraction swab tube
- 1 disposable swab
- 1 waste bag
- package 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. 6:490-502
2. Susan R. Weiss, Julian L. Leibowitz, Coronavirus Pathogenesis, Advances in Virus Research, Volume 81: 85-164