Description

The 2SAN COVID COMBO RAT PEN COVID 19 FLU A/B is an advanced rapid antigen test kit designed for the simultaneous detection of SARS-CoV-2 (COVID-19), Influenza A, and Influenza B. Manufactured by Assure Tech in China and distributed by 2San Pty Ltd in Australia, this test kit is intended for personal use, providing a convenient solution for symptomatic individuals seeking quick and reliable results at home.

Key Features

• Regulatory Approval: This test kit is CE marked and approved for home use in Australia, with an ARTG number of 462767, ensuring compliance with relevant health standards.
• Ease of Use: Designed for self-administration using anterior nasal swab specimens, it is suitable for individuals aged 2 and above, with adult supervision recommended for children.
• Rapid Results: The test employs a Lateral Flow Immunochromatographic Assay (LFIA) method, delivering results within 15 to 20 minutes.

Kit Components

Each kit includes:

• Individually packed test cassettes
• Lysis buffer and dropper
• Anterior nasal swabs
• Instructions for use
• Bio-safety/waste bag

The kit is available in various packaging options, offering flexibility with boxes containing 1, 2, 5, 20, or 25 tests.

Storage and Handling

• Storage Conditions: Maintain at temperatures between 2°C and 30°C, avoiding freezing and direct sunlight.
• Shelf Life: 24 months, with the recommendation to use the test within one hour of opening the foil pouch.

Performance Characteristics

• Sensitivity: Diagnostic sensitivity for COVID-19 is 96.2%, with a specificity of 100%.
• Result Interpretation: Clear instructions are provided for interpreting results, with built-in control lines ensuring test validity.

Limitations

This test is intended for symptomatic individuals and should not be the sole basis for medical decisions. It does not determine virus viability or infectiousness, and false negatives may occur, particularly in asymptomatic cases or beyond the recommended testing window.

Quality Assurance

The package includes comprehensive instructions, warnings, and information on potential cross-reactivity and interfering substances, ensuring users are well-informed.

The 2SAN COVID COMBO RAT PEN COVID 19 FLU A/B test kit offers a practical and efficient means of managing respiratory illness detection, empowering individuals with timely information to make informed health decisions.