Description

The 2San COVID Nasal RAT Pen is a rapid antigen test kit designed for the quick and efficient detection of COVID-19. Manufactured by Assure Tech in China, this test kit offers a convenient at-home solution for individuals seeking timely results without the need for clinical intervention.

Key Features

• Ease of Use: Designed for self-testing, this kit is suitable for adults and children, with adult supervision recommended for those under 16 or 18 years of age. It is not intended for use in children under 2 years old.

• Rapid Results: Provides results in approximately 15 minutes, allowing for prompt decision-making.

• Non-Intrusive Sampling: Utilizes a gentle nasal swab, making the process comfortable and straightforward.

• Compact Design: Available in a pen-type or cassette format, the kit is travel-friendly and includes all necessary components such as a sterile swab, pre-filled extraction tube, and instructions.

Testing Technology

The test employs a colloidal gold immunochromatographic assay, a type of lateral flow test, to detect the presence of SARS-CoV-2 antigens. Results are visually interpreted through colored bands on the test strip:

• Two lines indicate a positive result.
• One line indicates a negative result.
• Absence of a control line signifies an invalid test.

Performance and Accuracy

• Sensitivity: 95.0–95.9%
• Specificity: 98.9–99.6%
• Overall Accuracy: Approximately 97.8%

The test is rated as having "very high sensitivity" by the Therapeutic Goods Administration (TGA) in Australia and is capable of detecting multiple variants of the virus, including alpha, beta, gamma, kappa, and delta.

Regulatory Compliance

Approved for self-testing in over 41 countries, the kit is registered with ARTG numbers 462948 and 374507 for different variants. It is intended for in vitro diagnostic use only.

Storage Instructions

• Store at temperatures between 2–30°C.
• Ensure components are not frozen or damaged.
• Observe the expiry date for optimal performance.

Safety and Disposal

The kit includes a biosafety bag for safe disposal of used components. It is crucial not to reuse or mix components from different kits. Proper disposal in household waste is recommended.

Packaging

Available in packs of 1, 2, or 5 tests, the kit is lightweight and compact, making it ideal for home use, travel, or pre-event screening. A timer is required for the test but is not included in the kit.

This comprehensive testing solution provides peace of mind with its reliable performance and user-friendly design, ensuring accessibility and accuracy for individuals across various settings.