Description

The 2SAN COVID COMBO RAT COVID-19 & FLU A/B is an innovative rapid antigen test kit designed for the simultaneous detection of COVID-19, Influenza A, and Influenza B. Manufactured by Assure Tech in China and distributed by 2San Pty Ltd in Australia, this test kit offers a convenient solution for self-testing at home.

Key Features

• Intended Use: Suitable for individuals experiencing symptoms, this test is designed for use with nasal swab specimens. It is appropriate for adults and children over the age of two, with adult assistance recommended for those aged 2 to 18.

• Detection Method: Utilizes an immunochromatographic double antibody sandwich method, providing clear visual results through colored lines on the test strip.

• Ease of Use: The kit includes all necessary components such as sterilized nasal swabs, test cassettes, and a bio-safety waste bag, ensuring a straightforward testing process.

Test Procedure

1. Sample Collection: Use the provided swab to collect a sample from both nostrils.
2. Sample Processing: Mix the swab in the extraction buffer and apply three drops to the test cassette.
3. Result Timing: Results are available within 15 to 20 minutes. Interpretation should not occur before 15 minutes, and results are valid up to 20 minutes.
4. Disposal: Safely dispose of used materials using the provided waste bag.

Result Interpretation

• Positive Results: Indicated by the appearance of specific lines for SARS-CoV-2, Influenza A, or Influenza B alongside a control line.
• Negative Result: Only the control line appears.
• Invalid Result: Absence of the control line or unclear test lines.

Performance Metrics

• Sensitivity:
• COVID-19: Up to 99.0%
• Influenza A: Ranges from 55.6% to 98.12%

• Influenza B: 98.33%

• Specificity:

• COVID-19 and Influenza A: 99.8%

• Variant Detection: Effective against SARS-CoV-2 variants including Delta and Omicron.

Packaging and Storage

• Packaging Options: Available in boxes containing 1, 2, 5, or 20 tests.
• Storage Conditions: Store between 2°C and 30°C, avoiding freezing and direct sunlight. Each test is single-use and should be conducted shortly after opening.

Additional Information

The kit is TGA-listed and CE-marked, ensuring compliance with regulatory standards. It requires no special training or equipment, making it accessible for home use. Comprehensive instructions are provided, covering sample collection, processing, and result interpretation.

For any performance or usability concerns, users are advised to contact the sponsor or appropriate medical device authorities. The product version is dated 13/10/2022, with ARTG approval valid until 25 September 2024.