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Flowflex Rapid test for SARS-CoV-2 antigen (Self-test) Description Lateral flow assay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of symptom onset. The test can be used to analyze samples from asymptomatic subjects. It does not distinguish between SARS-CoV and SARS-CoV-2. The results involve 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 infection. Test results are read visually within the next 15-30 minutes, depending on the presence or absence of colored lines. Positive results indicate the presence of viral antigens, but the patients medical history and other personal diagnostic data are needed to determine the status of the infection. Positive results do not exclude bacterial infections or simultaneous infection with other viruses. The pathogen detected may not be the exact cause of the condition. Negative results obtained in subjects with symptoms lasting more than seven days should be treated as probable negative. If necessary, confirmation by molecular testing is requested. Negative results do not exclude SARS-CoV-2 infection. A colored line, which serves as a procedural control, will always appear in the control line region, indicating that sufficient sample volume has been added and that adsorption to the membrane has occurred. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infection. The usability of self-testing by individuals under the age of 18 has not been established. It is recommended that anyone under the age of 18 be tested by an adult. How to use 1. Preparation : Wash or sanitize your hands. Make sure they are dry before starting the test. Before using the test kit, please read the instructions carefully. Check the expiration date printed on the foil pouch. Open the pouch. Check the results window and the well on the cassette. 2. Sample collection : Anyone 18 years of age or older can perform a self-sample test. Children under 18 must be accompanied by a parent or legal guardian. Follow local guidelines for sample collection for children. 3. Analysis procedure : Unscrew the pipette cap from the extraction solution tube without tightening it. Insert the tube into the hole on the kit box (or place the tube in the tube holder). Open the tampon package at the end. Do not touch the absorbent tip of the tampon with your hands. Insert the entire absorbent tip of the swab into one nostril. Using a gentle twist, push the swab within 2.5 cm of the edge of the nostril. Twist the swab 5 times, gently 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 test tube, rotating it in a circular motion for 30 seconds. Rotate the swab 5 times, simultaneously squeezing the edges of the test tube. Remove the swab while squeezing the test tube. Firmly attach the pipette tip to the extraction buffer tube containing the sample. Mix well by swirling or tapping the bottom of the tube. Unscrew the small cap from the end of the pipette. Gently squeeze the tube and apply 4 drops of solution to 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 that 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 precautions when interacting with others. Current infection is possible even if the test is negative. If you suspect this, repeat the test after 1 or 2 days, as coronavirus cannot be accurately detected at all stages of infection. POSITIVE: Both the control line (C) and the test line (T) appear. This means that SARS-CoV-2 antigen has been detected (Note: Any line, even a very faint one, present in the test line region should be considered positive). A positive test result indicates a very high probability of having COVID-19. Contact your doctor/primary care provider or local health authority immediately. Follow local instructions on self-isolation. A confirmatory PCR test should be performed. INVALID: Control line (C) does not appear. The most likely reasons for an invalid result are insufficient sample volume or incorrect procedure. Re-read the instructions and repeat the test with a new cassette. If your test results continue to be invalid, contact your doctor or a COVID-19 testing center. warnings Before performing the test, read the package insert carefully. Failure to follow the instructions may result in inaccurate test results. Do not use the test after the expiration date written on the sachet. Do not eat, drink, or smoke before and during the test. Do not use the test if the pouch is damaged. All used tests, specimens, and potentially contaminated materials should be disposed of in accordance with local regulations. Humidity and temperature can negatively affect the 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 sample if you have a nosebleed. Wash your hands thoroughly after use. If the extraction swab accidentally comes into contact with skin or eyes, rinse with plenty of water and consult a doctor if necessary. The test is intended for self-testing only: it should only be used for the detection of SARS-CoV-2 nucleocapsid antigen in samples taken from the anterior nasal swab. The intensity of the test line does not necessarily correlate with the SARS-CoV-2 viral load in the sample. A false negative test can occur if the antigen concentration in a sample is below the detection limit of the test or if the sample was collected incorrectly. The results of the analysis must be observed in light of other clinical data available to the physician. Positive results do not exclude the presence of co-infections caused by other pathogens. Positive results do not exclude 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 lasting more than 7 days should be treated as probable negative and, if necessary, verified by molecular testing. Conservation 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 should remain in the sealed pouch until use. Shelf life in intact packaging: 24 months. Format The kit contains: - 1 test cassette - 1 tube with extraction buffer - 1 disposable tampon - 1 garbage bag - the prospectus 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, Pathogenesis of Coronavirus, Advances in Virus Research, Volume 81: 85-164
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Vânzător: Liki24.co.uk
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