iHealth COVID-19, Flu A&B 3-in-1 Antigen Rapid Test User Manual

1. Product Overview

The iHealth COVID-19, Flu A&B 3-in-1 Antigen Rapid Test is an FDA-authorized over-the-counter diagnostic test designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2, influenza A virus, and influenza B virus. This test is intended for home use and provides rapid results within 15 minutes, utilizing a non-invasive nasal swab sample.

Intended Use

This test is authorized for individuals aged 2 years and older. For individuals aged 2-13 years, sample collection must be performed by an adult. Individuals aged 14 years and older may self-collect their samples. The test aids in the rapid identification of COVID-19, Influenza A, and Influenza B infections, allowing for timely action to protect public health.

2. What's in the Box

Each iHealth COVID-19, Flu A&B 3-in-1 Antigen Rapid Test kit contains the following components:

• Nasal Swab
• Extraction Tube with Buffer Solution
• Test Card

Image: The iHealth COVID-19, Flu A&B 3-in-1 Antigen Rapid Test kit box, showing the product name and key features.

3. Setup and Preparation

Before performing the test, ensure you have read all instructions thoroughly. Gather all necessary materials and prepare your testing area.

• Read Instructions: Carefully read the entire instruction manual before starting the test.
• Wash Hands: Wash your hands thoroughly with soap and water for at least 20 seconds before handling the test components.
• Check Expiry Date: Verify the expiry date printed on the kit packaging. Do not use expired tests.
• Room Temperature: Ensure all test components are at room temperature (59-86°F / 15-30°C) before use.
• Open Kit: Open the foil pouch containing the test card just before use.

4. Operating Instructions: Performing the Test

Follow these four simple steps to perform the iHealth COVID-19, Flu A&B 3-in-1 Antigen Rapid Test:

Step 1: Swab Collection

Carefully insert the entire soft tip of the swab into one nostril about 1/2 to 3/4 inch (1 to 1.5 cm) until resistance is met. Rotate the swab 5 times against the inside of the nostril. Using the same swab, repeat the process in the other nostril. Ensure adequate sample collection from both nostrils.

Image: A diagram illustrating the correct depth and rotation for nasal swab collection.

Step 2: Sample Mixing

Immediately insert the swab into the extraction tube containing the buffer solution. Swirl the swab vigorously 10 times, pressing the swab head against the bottom and sides of the tube to ensure the sample is thoroughly mixed with the solution. Remove the swab while squeezing the sides of the tube to extract as much liquid as possible from the swab.

Image: A diagram demonstrating how to mix the nasal swab in the extraction tube.

Step 3: Applying Sample to Test Card

Place the dropper cap firmly onto the extraction tube. Hold the tube vertically above the sample well (marked 'S') on the test card. Gently squeeze the tube to dispense exactly 5 drops of the mixed solution into the sample well. Avoid touching the test card with the dropper tip.

Image: A diagram illustrating the process of dripping 5 drops of the sample onto the test card's sample well.

Step 4: Waiting for Results

Set a timer for 15 minutes. Read the results at exactly 15 minutes. Do not read the results before 15 minutes or after 30 minutes, as this may lead to inaccurate readings.

Image: A diagram depicting a timer indicating a 15-minute waiting period for test results.

5. Interpreting Results

The test card has three result lines: C (Control), A (Flu A), B (Flu B), and T (COVID-19 Test). The presence or absence of these lines determines the test result.

Image: Visual examples of test results, showing positive lines for Flu A, Flu B, and COVID-19.

6. Maintenance

Storage and Handling

Store the test kit at room temperature (59-86°F / 15-30°C) in its original sealed pouch until the expiry date. Do not freeze the kit. Keep away from direct sunlight and moisture. Ensure the kit is not damaged before use.

Disposal

After use, all test components, including the used swab, extraction tube, and test card, should be placed in a sealed plastic bag and disposed of according to local regulations for biohazardous waste. Do not dispose of used test components in regular household trash without proper containment.

7. Troubleshooting

If you encounter issues during testing or with your results, refer to the following common troubleshooting tips:

• No Control Line (C line): If the control line (C) does not appear, the test is invalid. This may be due to insufficient sample volume, incorrect procedure, or a defective test kit. Repeat the test with a new kit, ensuring all steps are followed precisely.
• Faint Lines: Faint test lines (A, B, or T) should still be considered positive. However, if the lines are extremely faint or unclear, it is recommended to retest with a new kit or consult a healthcare professional.
• Reading Results Outside Window: Reading results before 15 minutes or after 30 minutes can lead to inaccurate results. Always adhere strictly to the 15-minute reading window. If you missed the window, perform a new test.
• Symptoms Persist After Negative Result: A negative result does not rule out infection. If symptoms persist or worsen, consider retesting in 24-48 hours or consult a healthcare professional.

8. Specifications

9. Warranty and Support

Warranty Information

The iHealth COVID-19, Flu A&B 3-in-1 Antigen Rapid Test comes with a 1-Year Limited Warranty from the date of purchase. Please retain your proof of purchase for warranty claims.

Customer Support

For technical assistance, questions about test results, or warranty inquiries, please contact iHealth's US-Based Customer Support. Visit the official iHealth website for contact details and additional resources.