Description

The Medomics SARS-CoV-2 Influenza A/B Antigen Rapid Self-test Kit offers a convenient and efficient solution for detecting respiratory infections at home or in the workplace. This in vitro diagnostic tool is designed for the qualitative detection of antigens related to SARS-CoV-2, Influenza A, and Influenza B using anterior nasal swab specimens. Results are available within 15 to 20 minutes, making it an ideal choice for timely testing within the first week of symptom onset.

Intended Use

• Target Users: Suitable for self-testing by laypersons, either independently or under adult supervision.
• Diagnostic Purpose: Provides preliminary results that should be confirmed with PCR testing for accurate diagnosis.

Test Principle

The kit employs a lateral flow immunoassay (LFIA) technique, utilizing a double antibody sandwich method to detect specific antigens. It is compatible with various SARS-CoV-2 strains, including major mutations such as Delta and Omicron.

Kit Contents

Each kit includes:

• Individually packed test cassette
• Lysis buffer and dropper
• Anterior nasal swab
• Instructions for use
• Bio-safety bag

Packaging Options

Available in boxes containing 1, 2, 5, or 20 tests, catering to different testing needs.

Test Procedure

1. Sample Collection: Use the provided swab to collect a nasal sample.
2. Sample Processing: Mix with lysis buffer and apply to the test cassette.
3. Result Reading: After 15–20 minutes, interpret results based on visible lines for control and each virus type.

Performance and Limitations

• Detection Limits: May not detect low virus concentrations; retesting is advised if necessary.
• Usage Conditions: Avoid using after the expiration date or if the test cassette pouch is open for over an hour.

Storage Instructions

Store the kit at temperatures between 2°C and 30°C, away from direct sunlight. The shelf life is prioritized at 24 months, allowing for room temperature storage and transport.

Safety and Disposal

• Single Use: Dispose of all components using the provided bio-safety bag.
• Proper Sampling: Essential for accurate results, with adult supervision recommended.

Regulatory Information

The kit is listed under ARTG (408222), ensuring compliance with relevant standards. A timer is required for accurate result timing, which is not included in the kit.