Description

The ALLTEST COVID-19 Oral RA Test offers a convenient and efficient solution for at-home detection of SARS-CoV-2 antigens using oral fluid samples. Designed for both symptomatic and asymptomatic individuals, this rapid antigen test provides results within 15 to 30 minutes, allowing for timely decision-making.

Key Features

• Ease of Use: The test is designed for self-administration, requiring no professional supervision. Simply collect an oral fluid sample, mix it with the provided buffer, and apply it to the test device.
• Quick Results: Results are easy to interpret, with visible lines indicating positive or negative outcomes.
• Single-Use: Each test is intended for single use only, ensuring hygiene and accuracy.

Regulatory Approval

This test is approved by the Therapeutic Goods Administration (TGA) in Australia, with ARTG number 376310. Such endorsement underscores its reliability and compliance with diagnostic standards.

Performance

• Sensitivity: Manufacturer-reported sensitivity ranges from 82.1% to 86.4%, with variations noted in independent studies.
• Specificity: High specificity is consistently reported, ranging from 97.9% to 100%, minimizing the likelihood of false positives.

Limitations

Users should be aware that sensitivity may vary in real-world, unsupervised settings, potentially leading to false negatives. A negative result does not conclusively rule out infection, so continued adherence to health guidelines is recommended.

Kit Contents

The kit includes:

• Test device
• Buffer solution
• Sterile swab
• Tube holder
• Instructions for use

Users will need to provide a timer and tissue. Proper disposal of the test components after use is essential.

Storage Instructions

Store the test kit at temperatures between 2°C and 30°C. Avoid freezing to maintain the integrity of the test components.

Manufacturer Information

Produced by Hangzhou Alltest Biotech Co Ltd, with AM Diagnostics serving as the Australian sponsor, this test is backed by reputable entities in the field of biotechnology.

Precautions

• Do not reuse test components.
• Keep out of reach of children.
• Follow instructions carefully to ensure accurate results.

By adhering to these guidelines, the ALLTEST COVID-19 Oral RA Test serves as a valuable tool in managing personal and public health during the ongoing pandemic.