Flowflex ™ SARS-CoV-2 Rapid Antigen Test (Self Test) 1 Piece

Flowflex ™ Rapid Antigen Test for SARS-CoV-2 (Self Test)

A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. For the self-test.
The SARS-CoV-2 Rapid Antigen Test is a test for the detection of SARS-CoV-2 nucleocapsid antigen in human anterior nasal swab specimens. The test results are read visually over the next 15-30 minutes, based on the presence or absence of colored lines. A procedural control colored line will always appear in the control line area to indicate that sufficient sample volume has been inserted and membrane absorption has occurred. Autonomous sampling with nasal swab can be performed by anyone over 18 years of age. Children under 18 must be performed by a parent or legal guardian. Follow local guidelines for child sampling.

How to use

- Preparation:
1. Wash or disinfect your hands. Make sure they are dry before starting the test.
2. Read the instructions before using the SARS-CoV-2 Rapid Antigen Test Kit.
3. Check the expiration date printed on the foil pouch.
4. Open the envelope. Check the result window and sample well on the cassette.
- Analysis procedure:
1. Remove the aluminum foil from the top end of the Extraction Buffer tube.
2. Insert the tube into the hole on the kit box. (Or place the tube in the tube holder).
3. Open the swab package at the end of the swab. Warning: do not touch the absorbent tip of the swab with your hands.
4. Insert the entire absorbent tip of the swab into one nostril. Using a slight rotation, push the swab to less than 1 inch from the edge of the nostril.
5. Rotate the swab 5 times by lightly tapping inside the nostril. Remove the swab and insert it into the other nostril. Repeat step 4.
6. Remove the swab from the nostril.
7. Insert the swab into the tube, making a circular motion for 30 seconds.
8. Rotate the swab 5 times while compressing the side of the tube.
9. Withdraw the swab while compressing the tube.
10. Firmly attach the dropper tip to the Extraction Buffer tube containing the sample. Mix thoroughly by swirling or flicking the bottom of the tube.
11. Gently squeeze the tube and dispense 4 drops of solution into the sample well.
12. Read the result when the timer has reached 15-30 minutes. Do not read if 30 minutes have passed.
- Interpretation of the results:
POSITIVE: Both the control line (C) and the test line (T) appear. It means the SARS-CoV-2 antigen has been detected. NOTE: Any line, even very faint, present in the test line area (T) must be considered positive. A positive test result indicates a very high probability that COVID-19 infection is present. Contact your doctor / primary care physician or local health authority immediately. Follow local guidelines regarding self-isolation. A confirmatory PCR test should be performed.
NEGATIVE: Only the control line (C) and no test line (T) appears. It means that no SARS-CoV-2 antigen was detected. A negative result of the analysis indicates that it is unlikely that you are suffering from COVID-19 at this time. Continue to comply with all applicable rules and protective measures when dealing with other people. It is possible that there is an infection in progress even if the test is negative. If suspected, repeat the test after 1 or 2 days, as the coronavirus cannot be accurately detected at all stages of the infection.
INVALID: the control line (C) does not appear. The most likely reasons for the invalid result are insufficient sample volume or incorrect procedure. Read the instructions again and repeat the test with a new cassette. If the test results continue to show invalid, contact your doctor or a testing center for COVID-19.

Warnings

- Before performing the test, carefully read the package insert in the SARS-CoV-2 Rapid Antigen Test package. Failure to follow directions can 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 should be disposed of according to local regulations.
- Humidity and temperature can adversely affect results.
- The test line for a high viral load sample may appear within 15 minutes or sooner when the sample passes the test line area.
- The test line for a low viral load sample may appear within 30 minutes.
- Do not collect the nasal swab sample in case of nosebleeds.
- Wash hands thoroughly after use.
- If the extraction pad accidentally comes into contact with the skin or eyes, rinse with large quantities of water and consult a doctor if necessary.

storage

The kit can be stored at a temperature between 2 ° C and 30 ° C. 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. Do not freeze.

Format

Contains:
- Test cassette
- Extraction buffer tube
- Disposable pad
- Waste bag
- Test tube support
- 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: 85-1 64.

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