Flowflex COVID-19 Antigen Home Test Instruction Manual

1. Introduction

The Flowflex COVID-19 Antigen Home Test is an over-the-counter (OTC) rapid diagnostic test designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is intended for self-use and provides results in approximately 15 minutes. It is authorized for use on individuals aged 2 years and older.

Figure 1: The Flowflex COVID-19 Antigen Home Test kit box, indicating it is for 1 test and provides quick results.

2. Important Safety Information

• For in vitro diagnostic use only. Do not ingest any components of the kit.
• Read the entire instruction manual carefully before performing the test. Failure to follow instructions may lead to inaccurate results.
• Keep out of reach of children.
• This test is authorized for use on individuals aged 2 years and older. For children under 14 years of age, an adult must perform the sample collection and test procedure.
• Do not use the test kit if the packaging is damaged or the seal is broken.
• Store the test kit at room temperature (36-86°F / 2-30°C) in its original sealed pouch until the expiration date.
• Do not reuse any components of the test kit. Dispose of used test components according to local regulations.

3. Kit Contents

Each Flowflex COVID-19 Antigen Home Test kit contains the following components:

• Test Cassette: A device containing the test strip for result display.
• Disposable Swab: Used for collecting the nasal sample.
• Extraction Buffer Tube: Contains the solution for processing the sample.
• Package Insert: Detailed instructions for use (this document is a summary).

Figure 2: All components included in the Flowflex COVID-19 Antigen Home Test kit: package insert, test cassette, disposable swab, and extraction buffer tube.

4. Preparation and Setup

1. Wash your hands thoroughly with soap and water for at least 20 seconds, then dry them completely.
2. Open the kit box and carefully remove all components.
3. Ensure all components are present and not damaged.
4. Place the extraction buffer tube in a designated holder or stand upright on a flat surface.
5. Open the foil pouch of the test cassette just before use and place it on a clean, flat surface.

5. Testing Procedure (Operating)

Follow these steps to perform the COVID-19 antigen test:

1. Swab Your Nose: Gently insert the entire soft tip of the disposable swab into one nostril about 1/2 to 3/4 inch (1 to 1.5 cm). Firmly rub the swab in a circular motion around the inside wall of the nostril 5 times. Using the same swab, repeat the process in the other nostril.
2. Swirl in the Solution: Immediately insert the swab into the extraction buffer tube. Swirl the swab vigorously in the liquid for 30 seconds, pressing the swab tip against the bottom and side of the tube. Then, roll the swab 5 times while squeezing the tube. Remove the swab while continuing to squeeze the tube. Securely close the cap of the extraction buffer tube.
3. Drop the Sample: Invert the extraction buffer tube and dispense 4 drops of the processed sample into the sample well (S) of the test cassette.
4. Wait for Results: Set a timer for 15 minutes. Do not read the results before 15 minutes or after 30 minutes, as this may lead to inaccurate readings.

Figure 3: Visual guide to the four main steps of the Flowflex COVID-19 Antigen Home Test procedure.

6. Interpreting Results

Read your test results at exactly 15 minutes. Do not interpret results after 30 minutes.

• Positive Result: Two lines appear. A colored line appears at the Control (C) line region and another colored line appears at the Test (T) line region. Even a faint T line indicates a positive result.
• Negative Result: One line appears. A colored line appears at the Control (C) line region only. No colored line appears at the Test (T) line region.
• Invalid Result: No Control (C) line appears. This indicates that the test did not work correctly. Re-test with a new kit.

Figure 4: An example of a test cassette displaying a positive result, with both Control (C) and Test (T) lines visible.

7. Maintenance and Storage

• Store the test kit at room temperature, between 36-86°F (2-30°C).
• Keep the test cassette sealed in its foil pouch until immediately before use.
• Do not freeze the test kit.
• The test kit has a 24-month shelf life from the manufacturing date. Check the expiration date printed on the packaging before use.

8. Troubleshooting

If you encounter issues during testing, consider the following:

• Invalid Result (No Control Line): This usually indicates an error in the testing procedure or a faulty test. Discard the used test and repeat the process with a new test kit, ensuring all steps are followed precisely.
• Difficulty Collecting Sample: Ensure the swab is inserted correctly and rotated firmly against the nasal wall. If discomfort occurs, adjust the angle slightly.
• Unclear Lines: Ensure the test is read within the 15-30 minute window. Reading too early or too late can affect line visibility.
• Missing Components: If any essential component is missing or damaged upon opening, do not use the kit. Contact the manufacturer for assistance.

9. Specifications

10. Manufacturer Information and Support

Manufacturer: ACON Laboratories

For further assistance, questions, or to report issues with the product, please refer to the contact information provided on the product packaging or the official Flowflex website. Specific warranty details are typically outlined in the package insert or on the manufacturer's official product page.