Description

The ALLTEST COVID-19 Oral RA Test, developed by Hangzhou Alltest Biotech Co Ltd, is a rapid antigen test designed for the qualitative detection of SARS-CoV-2 nucleocapsid antigen. This test is intended for use with direct anterior nasal swabs or oral fluid specimens, providing a convenient and efficient method for individuals suspected of COVID-19 within the first eight days of symptom onset.

Key Features

• Lateral Flow Immunoassay: Utilizes a latex microsphere-based lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid and spike proteins.
• Quick Results: Delivers results in approximately 15 to 20 minutes, offering timely information for healthcare decision-making.
• Ease of Use: The kit includes all necessary components such as nasal swabs, solution vials, and test cassettes, ensuring straightforward sample collection and processing.

Regulatory Information

This test is authorized under the FDA Emergency Use Authorization (EUA) in the USA, allowing use by authorized laboratories and at Point of Care (POC) settings with appropriate CLIA certification. It is important to note that the test is not FDA cleared or approved and is authorized only for the duration of the emergency declaration. In Australia, it holds ARTG number 376310 and was approved on 13 October 2021.

Performance and Limitations

• Detection Limit: Claimed limit of detection is 78 TCID50/mL, with recommended sample volume between 75–100 μL.
• Cross-Reactivity: No cross-reactivity observed with common respiratory viruses, though cross-reactivity with SARS-CoV is likely.
• Result Interpretation: Negative results are presumptive and may require confirmation with a molecular assay, especially in asymptomatic individuals.

Storage and Handling

The test should be stored at temperatures between 2–30°C and used before the expiration date. The test device must remain sealed until use and should be used within 60 minutes of opening. Proper disposal of used components according to local regulations is advised.

Safety Precautions

Contains Triton X-100 and ProClin 300, which may cause mild skin or eye irritation. Users should handle the test components with care and follow local disposal guidelines.

Conclusion

The ALLTEST COVID-19 Oral RA Test provides a reliable and rapid testing solution for detecting SARS-CoV-2 antigens, supporting timely diagnosis and management of COVID-19 cases. Its ease of use and quick results make it a valuable tool in various healthcare settings.