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

Flowflex rapid test covid SARS-CoV-2 Antigen Rapid Test

Lateral flow assay for the qualitative detection of SARS-CoV-2 capsid core antigen in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first 7 days of onset of symptoms.
The test can be used to analyze samples of people with anxiety.
It does not distinguish between SARS-CoV and SARS-CoV-2.
The results concern 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 the infection.
Positive results indicate the presence of viral antigens, but medical history and other personal diagnostic data are required to determine the status of the infection. Positive results do not exclude the presence of bacterial infections or simultaneous infection with other viruses. The pathogen detected may not be the exact cause of the disease.
Negative results obtained in individuals with symptoms that have appeared for more than seven days should be treated as probable negative. If necessary, seek confirmation through molecular analysis.
Negative results do not rule out SARS-CoV-2 infection.
The test results are read visually over the next 15-30 minutes, based on the presence or absence of the 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.
The test is intended for use as an aid in diagnosing SARS-CoV-2 infection.
The usability of autonomous tests performed by individuals under the age of 18 has not been determined. It is recommended that children under 18 be tested by an adult.

How to use

Preparation
Wash or disinfect your hands. Make sure 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 sample well on the cassette.

Sample collection
The sampling can be done autonomously or by a caregiver.
The autonomous sampling 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.

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 swab.
Warning: 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 slight rotation, push the swab to less than 1 inch from the edge of the nostril. Rotate the swab five times by lightly tapping inside 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, making a circular motion for 30 seconds. Rotate the swab 5 times while squeezing the side of the tube. Withdraw the swab while compressing the tube.
Firmly 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 has reached 15-30 minutes. Do not read if 30 minutes have passed.

Interpretation of results
- 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 1-2 days, as the coronavirus cannot be accurately detected at all stages of the infection.

- POSITIVE: Both the control line (C) and the test line (T) appear. It means that the SARS-CoV-2 antigen has been detected. 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.
Note: Any even very faint line present in the test line area (T) should be considered positive.

- 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 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 if you have a nose bleed.
Wash hands thoroughly after use.
If the extraction pad accidentally comes into contact with the skin or eyes, rinse with large amounts of water and consult a doctor if necessary.
The SARS-CoV-2 Antigen Quick Test is for self-testing only. The test is to be used only for the detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab specimens. Test line intensity is not necessarily correlated with 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 has been incorrectly collected.
Test results should be looked at to sources of other clinical data available to the physician.
The positive results do not exclude the presence of joint infections caused by other pathogens. Positive results do not distinguish 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 in a subject with symptoms that have appeared for more than seven days should be treated as 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.
Validity for intact packaging: 24 months.

Format

The kit contains:
- test cassette;
- extraction buffer tube;
- disposable pad;
- 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: 409-502
2. Susan R. Weiss, Julian L. Leibowitz, Coronavirus Pathogenesis, Advances in Virus Research, Volume 81: 85-164

Cod. L031-11855