KEY INFORMATION

• The CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in anterior nasal swab specimens. It is intended for home users.
• • Specimen Type: Nasal Swab

COUNTRY/PLACE OF ORIGIN

PREPARATION

• 1. Remove the swab from the pouch.
• Note: Be careful not to touch the swab tip (soft end) with your hand.
• 2. Insert the entire soft end of the swab into the nostril no more than 3/4 of an inch (1.5 cm). Firmly and slowly rotate the swab 5 times, brushing against the inside walls of the nostril to ensure both mucus and cells are collected.
• - Do not push the swab further if you meet resistance.
• - For young children do not insert more than 1/2 inch.
• Using the same swab, repeat this process for the other nostril to ensure an adequate sample is collected from both nostrils.
• 3. insert the swab into the tube until it touches the bottom. Rotate the swab at least 10 times while pressing the swab head against the bottom and side of the tube.
• 4. Remove the swab while squeezing the sides of the tube. Attach the dropper tip firmly onto the tube.
• 5. Slowly squeeze the tube and dispense 3 drops of solution into the sample well.
• Note: Invalid results can occur if less than 3 drops are added to the Sample Well.
• 6. Wait 10 minutes. Read the result after 10 minutes but before 30 minutes.
• Do not read the result after 30 minutes.
• Note: False results can occur if the test is read before 10 minutes or after 30 minutes.

STORAGE INFORMATION

• • Directions:
• 1. Store the test kit between 2~30°C (36~86°F) in a place out of direct sunlight. Reagents and materials must be used at room temperature (15~30°C/59~86°F).
• 2. The unsealed cassette is valid for 1 hour. It is recommended to use the test kit immediately after opening.
• 3. The expiration date is labelled on the package.

ADDITIONAL INFORMATION

• • Warnings:
• 1. Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.
• 2. Serial testing should be performed in symptomatic individuals with SARS-CoV-2 negative results at least twice over three days (with 48 hours between tests) . You may need to purchase additional tests to perform this serial (repeat) testing.
• 3. Consistent with serial testing recommendations for SARS-CoV-2, for multi-analyte tests, symptomatic individuals who test positive for influenza A or B on the initial test but test negative for SARS-CoV-2 should be tested again in 48 hours to evaluate for co-infection with SARS-CoV-2 infection.
• 4. An anterior nasal swab sample can be self-collected by an individual aged 14 years and older. Children aged 2 to 13 years should be tested by an adult.
• 5. Do not use on anyone under 2 years of age.
• 6. Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
• 7. Do not use if any of the test kit contents or packaging is damaged or open.
• 8. Test components are single-use. Do not re-use.
• 9. Do not use the test kit after its expiration date.
• 10. Do not touch swab tip when handling the swab.
• 11. Exposure to hand sanitizer may cause false positive results with this test.
• 12. When collecting a sample, only use the swab provided in the kit.
• 13. Once opened, the test cassette should be used within 60 minutes. If the pouch is open for more than an hour, invalid test results may occur.
• 14. Testing should be performed in an area with good lighting.
• 15. Do not read test results before 10 minutes or after 30 minutes. Results read before 10 minutes or after 30 minutes may lead to a false positive, false negative, or invalid result.
• 16. Faint lines may appear on the test strip prior to running the test when tests are stored opened at hot and humid conditions. Do not read or interpret test results until after the sample has been added to the test cassette and the test has been allowed to run for 10 minutes.
• 17. Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. The reagent solution contains harmful chemicals. If the solution contacts your skin, eyes, nose, or mouth, flush with large amounts of water.