Rapid Antigen Test Covid-19 Flowflex Self-diagnostic Qualitative Determination of Sars-Cov-2 Antigens in Nasal Swabs by Immunochromatography Aluminum Tube

Description
Rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. For in vitro diagnostic use only. For self-testing.
The SARS-CoV-2 Antigen Rapid Test is a 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 test specimens from asymptomatic individuals. It does not distinguish between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 antigen. This antigen is usually found in upper respiratory tract specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but anamnesis and other personal diagnostics are needed to determine the infection status. 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 more than seven days before should be treated as probable negative. If necessary, seek confirmation through molecular testing. Negative results do not rule out SARS-CoV-2 infection. The SARS-CoV-2 Rapid Antigen Test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The usability of self-testing by individuals under 18 years of age has not been established. It is recommended that children under 18 years of age be tested by an adult.
The SARS-CoV-2 Antigen Rapid 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 colored procedural control line will always appear in the control line area to indicate that sufficient sample volume has been added and membrane adsorption has occurred.
Clinical performance
Sensitivity: 97.1% (95% CI: 93.1%-98.9%)
Specificity: 99.5% (95% CI: 98.2%-99.9%)
Accuracy: 98.8% (95% CI: 97.6%-99.5%)
LoD: 1.6x10 ² TCID ₅₀ /ml

How to use
Preparation
Wash or disinfect your hands. Make sure they are dry before starting the test. Before using the SARS-CoV-2 Rapid Antigen Test kit, read the instructions. Check the expiration date printed on the foil pouch.
Sample collection
Self-collection: Self-collection of the nasal swab sample can be performed by anyone aged 18 years or older. Children under 18 years of age must be performed by a parent or legal guardian. Follow local guidelines for sampling by children.
Analysis procedure
1. Remove the aluminum foil from the top end of the extraction swab tube.
2. Insert the tube into the hole on the kit box. Or place the tube into the tube holder.
3. Open the swab package at the end of the stick. 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 gentle twist, push the swab within 1 inch of the edge of the nostril.
5. Rotate the swab 5 times while lightly touching the inside of 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 test tube, making a circular motion for 30 seconds.
8. Rotate the swab 5 times, while compressing the side of the tube.
9. Remove the swab while squeezing the tube.
10. Firmly attach the dropper tip to the extraction buffer tube containing the sample. Mix thoroughly by swirling or tapping 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 reaches 15-30 minutes. Do not read if 30 minutes have passed.
Interpretation of results
Positive: Both the control line (C) and the test line (T) appear. This means that the SARS-CoV-2 antigen has been detected. Any line, even a very faint one, in the test line (T) area should be considered positive. A positive result indicates a very high probability that you have COVID-19. Contact your doctor/GP or local health authority immediately. Follow local guidelines regarding self-isolation. A confirmatory PCR test should be performed.
Negative: Only the control line (C) appears and no test line (T). This means that no SARS-CoV-2 antigen was detected. A negative test result means that it is unlikely that you currently have COVID-19. Continue to follow all applicable rules and protective measures when coming into contact with other people. It is possible that you are currently infected even if your 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.
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 the test results continue to be invalid, contact your healthcare provider or a COVID-19 testing center.

Warnings
Before testing, carefully read the package insert for the SARS-CoV-2 Rapid Antigen Test. Failure to follow the instructions may result in 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 testing. Do not use the test if the pouch is damaged. All used tests, specimens and potentially contaminated material should be disposed of according to local regulations. Humidity and temperature may adversely affect results. The test line for a specimen with a high viral load may appear within 15 minutes or sooner when the specimen exceeds the test line area. The test line for a specimen with a low viral load may appear within 30 minutes. Do not collect the nasal swab specimen if you have a nosebleed. Wash your hands thoroughly after use. If the extraction swab accidentally contacts your skin or eyes, rinse with large amounts of water and seek medical attention if necessary. Do not freeze.
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. The intensity of the test line does not necessarily correlate with the SARS-CoV-2 viral load in the specimen. A false negative result may be obtained if the antigen concentration in a specimen is below the detection limit of the test or if the specimen is incorrectly collected. Test results should be viewed in conjunction with other clinical data available to the physician. Positive test results do not exclude the presence of joint infections caused by other pathogens and 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 test result obtained in a subject with symptoms more than seven days previously should be considered as probable negative and, if necessary, verified by molecular testing.

Conservation
Store in a cool, dry place, between 2°C-30°C. Keep away from light.
Validity with intact packaging: 24 months.

Format
Contains:
1 test cassette;
1 extraction swab tube;
1 disposable swab;
1 waste bag;
1 leaflet.

Cod. L031-118M5