CorDx TyFast Flu A/B & Covid 19 Multiplex Rapid Test User Manual

1. Product Overview

The CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test is an in-vitro diagnostic test designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2, influenza A, and influenza B in direct anterior nasal swab specimens. This test is intended for use as an aid in the diagnosis of SARS-CoV-2, influenza A, and influenza B infections. Results are available in 10 minutes.

Image: The CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test kit, showing the product box and two individual test cassettes.

Image: This test is clinically accurate and has received FDA and EUA authorization for reliable diagnostic results.

2. What's Included

Each CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test kit contains the following components:

• Multiplex Rapid Tests (2 per kit)
• Instruction Manual (1)
• Sample Processing Solutions (2)
• Nasal Specimen Collection Swabs (2)
• Tube Holder (1)

Image: All components included in the CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test kit.

3. Safety Information

Please read all instructions carefully before performing the test. This test is for in-vitro diagnostic use only. Do not use if the packaging is damaged or open. Keep out of reach of children. Avoid contact of the sample processing solution with skin or eyes. If contact occurs, flush with large amounts of water. If irritation persists, seek medical attention. Dispose of all test components according to local regulations after use.

4. Setup

Before beginning the test, ensure you have all necessary components from the kit. Find a clean, dry, and well-lit surface to perform the test. Wash your hands thoroughly with soap and water for at least 20 seconds before handling any test components. Allow all kit components to reach room temperature (59-86°F / 15-30°C) before use.

5. Operating Instructions

Follow these steps carefully to perform the CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test:

1. Prepare the Sample Processing Solution: Open one sample processing solution tube and place it in the tube holder.
2. Collect Nasal Specimen:
   • Open the nasal swab package from the stick end.
   • Insert the entire soft tip of the swab into one nostril about 1/2 to 3/4 inch (1 to 1.5 cm).
   • Firmly rub the swab in a circular motion against the inside wall of the nostril 5 times.
   • Using the same swab, repeat the process in the other nostril 5 times.
3. Mix Sample and Solution:
   • Immediately insert the swab into the sample processing solution tube.
   • Swirl the swab vigorously 10 times while pressing the swab head against the bottom and side of the tube.
   • Squeeze the tube once firmly around the swab head as you remove it to extract as much liquid as possible. Discard the swab.
4. Add Drops to Test Cassette:
   • Close the cap of the sample processing solution tube.
   • Open the foil pouch containing the test cassette and place it on a clean, flat surface.
   • Invert the tube and add 3 drops of the processed sample into the sample well (S) of the test cassette.
5. Wait for Results: Set a timer for 10 minutes. Do not read results before 10 minutes or after 15 minutes.

Image: Proper technique for collecting a nasal swab and mixing it with the sample processing solution.

Image: A visual guide to the four main steps of the rapid test: swabbing, mixing, dropping, and waiting for results.

6. Reading Results

Interpret your test results at 10 minutes. Do not interpret results after 15 minutes as they may be inaccurate.

Positive Result:

A colored line appears at the Control line (C) region and at least one colored line appears at the Test line (T) region (COV, Flu B, or Flu A). Any faint line in the Test region indicates a positive result. A positive result means that antigens from SARS-CoV-2, influenza A, or influenza B were detected in your specimen.

Negative Result:

A colored line appears at the Control line (C) region, but no colored line appears at the Test line (T) region (COV, Flu B, or Flu A). A negative result means that antigens from SARS-CoV-2, influenza A, and influenza B were not detected in your specimen. A negative result does not rule out infection.

Invalid Result:

No colored line appears at the Control line (C) region. An invalid result indicates that the test did not perform correctly. You should discard the test and repeat with a new test kit.

Image: Visual guide for interpreting test results, including positive, negative, and invalid outcomes.

7. Maintenance and Storage

Store the test kit in its original sealed pouch at room temperature, between 36-86°F (2-30°C). Do not freeze. Ensure the kit is kept in a clean, dry place away from direct sunlight. Do not use the test beyond its expiration date printed on the packaging.

Image: Information regarding the FDA-approved shelf-life extension for specific lot numbers of the CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test.

8. Troubleshooting

If you encounter issues while using the test, consider the following common scenarios:

• No Control Line (Invalid Result): This indicates the test did not run correctly. Ensure you added the correct number of drops to the sample well and that the test cassette was placed on a flat surface. Repeat the test with a new kit.
• Faint Test Line: Even a very faint line in the Test region (COV, Flu B, or Flu A) should be interpreted as a positive result.
• No Lines Appear: If no lines appear at all, the test is invalid. This could be due to insufficient sample volume or an error in the testing procedure. Repeat with a new kit.
• Results After 15 Minutes: Do not interpret results after 15 minutes. The accuracy of the test may decrease, and false results may appear.

9. Specifications