Description
Lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens from individuals suspected of COVID-19 within the first seven days of symptom onset.
The test can be used to test asymptomatic individuals.
It does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. This antigen is generally detectable in upper respiratory specimens during the acute phase of infection.
The test results are visually read between 15 and 30 minutes, based on the presence or absence of colored lines.
Positive results indicate the presence of viral antigens, but clinical history and other diagnostic information are necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The detected pathogen may not be the exact cause of the disease.
Negative results from symptomatic individuals whose symptoms began more than seven days ago should be treated as presumptive negatives. If necessary, seek confirmation through molecular analysis. Negative results do not rule out SARS-CoV-2 infection.
A colored line, functioning as a procedural control, will always appear in the control line region, indicating that a sufficient volume of specimen has been added and membrane wicking 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 recommended that minors under 18 years of age be tested by an adult.

Instructions for use
1. Preparation:
Wash or sanitize hands. Make sure they are dry before starting the test.
Read the instructions carefully before using the test kit.
Check the expiration date printed on the foil pouch. Open the pouch. Check the result window and the sample well on the cassette.

2. Sample collection:
Self-collection of nasal swabs can be performed by individuals aged 18 years or older. Children under 18 years of age should be assisted by a parent or legal guardian. Follow local guidelines for sample collection from children.

3. Test 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. 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 (1 inch) from the edge of the nostril. Rotate the swab 5 times, lightly 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 tube, swirling it in a circular motion for 30 seconds. Rotate the swab 5 times, pressing against the sides of the tube. Remove the swab while squeezing the tube.
Securely attach the dropper tip to 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 well.
Read the result when the timer reaches 15-30 minutes. Do not read after 30 minutes.

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

POSITIVE: Both the control line (C) and the test line (T) appear. This means SARS-CoV-2 antigen was 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 a COVID-19 infection is ongoing. Contact your doctor/general practitioner or local health authority immediately. Follow local guidelines for self-isolation. A confirmatory PCR test should be performed.

INVALID: The control line (C) does not appear. The most likely reasons for an invalid result are insufficient sample volume or 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
Read the package insert carefully before performing the test. Failure to follow the instructions may lead to inaccurate test results.
Do not use the test after the expiration date printed 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 results.
The test line for a sample with a high viral load may appear within 15 minutes or even earlier, as 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 a nasal swab sample if you have 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 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 is not necessarily related to 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 rule out co-infections caused by other pathogens. Positive results do not differentiate between 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 from a symptomatic individual whose symptoms began more than 7 days ago should be treated as a presumptive negative and, if necessary, verified by molecular analysis.

Storage
Store at a temperature between 2°C and 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 use.
Shelf life when unopened: 24 months.

Format
The kit contains:
- 1 test cassette
- 1 extraction buffer tube
- 1 disposable swab
- 1 waste bag
- package insert

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