SARS-CoV-2/FluA/FluB+ADV/RSV Antigen 5-IN-1 Combo Rapid Test Kit (LFIA), 1/Pack

It is intended for in vitro diagnostic use only and is designed exclusively for self-testing. Carefully read and follow the instructions for use before performing the test.

This SARS-CoV-2/Influenza A+B/ADV/RSV Antigen 5-IN-1 Combo Rapid Test Kit (LFIA) for self-testing is an in vitro diagnostic medical device designed for the detection of SARS-CoV-2, Influenza A, Influenza B, and ADV/RSV virus antigen in anterior nasal swabs. As a rapid antigen test, it is intended for single use only and must be used within one hour of opening the inner foil packaging.

Users must carefully read and follow the instructions for use before testing to ensure accurate results. The test is suitable for self-administration by adults and complies with applicable regulatory requirements for in vitro diagnostic devices.

Intended Use & Testing Population

This rapid antigen test is intended to assist in identifying active infection in symptomatic individuals within seven days of symptom onset for SARS-CoV-2 infection or within the first four days of symptom onset for influenza A/B, ADV or RSV infection.

The test is suitable for self-testing by adults aged 18 years and over, with younger users between requiring adult assistance or supervision. It may also be used at the point of care by healthcare professionals.

Background on Coronavirus Infection & Influenza

Coronaviruses are within the Coronaviridae family, divided into four genera: alpha, beta, gamma and delta. Alpha and beta infect mammals, including humans. Transmission occurs through respiratory droplets, aerosols, direct contact, and possibly faecal-oral routes.

Influenza, or flu, is a highly contagious acute respiratory infection caused by influenza viruses, mainly spread through coughing and sneezing. Influenza A viruses are more variable, prevalent, and severe than Influenza B.

Warnings, Precautions & Limitations

The test kit is for in vitro diagnostic use only and must not be reused. All components should be brought to room temperature before testing, and only the supplied anterior nasal swab should be used for specimen collection.

The buffer solution must not be ingested or used in the eyes, and the kit should not be used if the packaging is damaged, contaminated or expired.

Negative results do not exclude infection or infections caused by other viruses, particularly in individuals with known exposure.

Storage & Handling

This self-test should be stored in a dry, well-ventilated environment between 2°C and 30°C and protected from direct sunlight. Freezing is not permitted.

It has a shelf life of 36 months and must be used within one hour of opening the foil pouch to maintain test performance.

Disposal & Environmental Considerations

After use, all test components, including the cassette, swab and buffer, should be placed into a biosafety bag, securely sealed and disposed of in accordance with local disposal guidelines.

Compliance

This single-use SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Test Kit provides results within 15 to 30 minutes and is sufficient for one test. The device is ethylene oxide sterilised and classified as an IVD Class 3 medical device. It is ARTG listed (#520868) and CE certified, ensuring compliance with recognised medical device standards.

Product Features

• Rapid Detection: Delivers clear test results within 15 to 30 minutes, supporting timely decision-making.
• High Sensitivity Performance: Designed for early-stage infection detection when viral load is highest.
• Anterior Nasal Sampling: Less invasive sample collection improves user comfort and compliance.
• Single-Use Safety Design: Reduces cross-contamination risks and supports hygienic testing practices.
• User-Friendly Kit Format: Includes all required components for convenient at-home or point-of-care testing.
• Regulatory Approved Device: ARTG listed and CE certified to meet medical diagnostic standards.