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Flowflex Rapid antigen test for SARS-CoV-2 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 analyze samples from asymptomatic individuals. It does not distinguish between SARS-CoV and SARS-CoV-2. Results identify SARS-CoV-2 antigen. This antigen is generally found in samples taken from the upper respiratory tract during the acute phase of infection. Positive results indicate the presence of viral antigens, but a history and other personal diagnostic tests are required to determine the infection status. Positive results do not exclude the presence of bacterial infections or simultaneous infection with other viruses. The detected pathogen may not be the exact cause of the disease. Negative results obtained in individuals with symptoms that have been present for 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. 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 anyone under 18 be tested by an adult. 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. Test results are read visually within 15 to 30 minutes, based on the presence or absence of colored lines. A colored procedural control line will always appear in the control line region, indicating that sufficient specimen volume has been added and membrane adsorption has occurred. Clinical performances 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: Anyone 18 years of age or older can collect their own nasal swab specimen. Children under 18 must be collected by a parent or legal guardian. Follow local guidelines for collecting specimens from 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 in 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 nostrils edge. 5. Rotate the swab 5 times, gently touching the inside of your 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 simultaneously 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 the 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) region should be considered positive. A positive 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 should be performed. 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 it is unlikely that you currently have COVID-19. Continue to follow all applicable rules and precautions when coming into contact with others. You may still have an active infection 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 specimen volume or incorrect testing 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 these 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 materials must be disposed of according to local regulations. Humidity and temperature may adversely 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 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 consult a doctor if necessary. Do not freeze. For self-testing only. The test should only be used to detect 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 occur if the antigen concentration in a specimen is below the tests detection limit or if the specimen was collected incorrectly. Test results should be considered in conjunction with other clinical data available to the physician. Positive results do not exclude the presence of co-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 result obtained in a subject with symptoms more than seven days previously should be considered probable negative and, if necessary, verified by molecular analysis. Conservation Store in a cool, dry place between 2°C and 30°C. Keep away from light. Shelf life in intact packaging: 24 months. Format Contains: 1 test cassette; 1 extraction swab tube; 1 disposable swab; 1 waste bag; 1 leaflet. Cod. L031-118M5
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