Description

The 2San COVID-19 Rapid Antigen Nasal Self-Test Kit offers a convenient and reliable solution for at-home testing. Designed for easy use by individuals without medical training, this test kit provides quick results, making it suitable for both adults and children. Adult supervision is recommended for children under 16 or 18, and the test is not intended for use in children under 2 years old.

Key Features

• Design: The test kit features a pen-like, self-enclosed design, eliminating the need for separate solution vials or cassettes. This all-in-one format enhances hygiene and portability, with each unit individually sealed.
• Comfort: The nasal swab is foam-covered, ensuring a comfortable sample collection experience with minimal insertion depth (1–2 cm).
• Quick Results: Results are available within 15 minutes. A positive result is indicated by two colored lines, while a negative result shows one colored line. An invalid result occurs if no control line appears.

Performance

• Sensitivity: Ranges from 95.0% to 99.0%, depending on the source.
• Specificity: Between 99.6% and 99.9%.
• Accuracy: Overall accuracy reported at 97.8%.

The test demonstrates high accuracy in clinical and usability studies, with no cross-reactivity with 41 tested microorganisms. It effectively detects all known COVID-19 variants.

Limitations

• Less reliable in asymptomatic individuals and after seven days of symptom onset.
• Does not detect other respiratory viruses such as influenza or RSV.
• Results should not be the sole basis for diagnosis, as false negatives are possible.

Safety Instructions

• For in vitro diagnostic use only.
• Avoid ingesting reagents and contact with skin or eyes.
• Ensure proper disposal of used tests in household waste.
• Do not use if the package is damaged or beyond the expiration date.

Storage

Store the kit at temperatures between 2–30°C, away from direct sunlight, and do not freeze. The shelf life ranges from 18 to 24 months, depending on packaging.

Packaging

The pen version is a self-contained unit with package dimensions of 18.8 x 6.1 x 3 cm and a weight of 70 grams. It is available in single, 2-pack, and 5-pack sizes, making it ideal for personal self-screening at home, travel, workplace, or school settings.