SARS-CoV-2 Antigen Test Kit (LFIA), Self-Test, EO Sterile, 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 Antigen Test Kit (LFIA) for self-testing is an in vitro diagnostic medical device designed for the detection of COVID-19 infection. 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 COVID-19 antigen test uses colloidal gold immunochromatography technology to qualitatively detect SARS-CoV-2 nucleocapsid antigens in human anterior nasal swab samples.

It is intended to assist in identifying active infection in symptomatic individuals within seven days of symptom onset, when viral load is highest.

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

Background on Coronavirus Infection

Coronaviruses are within the Coronaviridae family, divided into four genera: alpha, beta, gamma and delta. Alpha and beta infect mammals, including humans, while gamma and delta mainly affect birds.

Transmission occurs through respiratory droplets, aerosols, direct contact, and possibly faecal-oral routes. Seven human coronaviruses cause respiratory disease, including SARS-CoV-2, responsible for COVID-19.

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 SARS-CoV-2 infection or infection caused by other respiratory viruses, particularly in individuals with known exposure. Testing beyond seven days from symptom onset may increase the likelihood of false negative results.

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 24 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 the provided biosafety bag, securely sealed and disposed of in a household waste bin in accordance with local disposal guidelines.

Compliance

This single-use SARS-CoV-2 Antigen Test Kit provides results within 15 to 20 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 (#380739) and CE certified, ensuring compliance with recognised medical device standards.

Product Features

• Rapid Detection: Delivers clear test results within 15 to 20 minutes, supporting timely decision-making.
• High Sensitivity Performance: Designed for early-stage infection detection when viral load is highest.
• One-Step Testing Process: Simplifies self-testing with minimal handling and straightforward operation.
• 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.
• Variant Detection Capability: Validated to detect current SARS-CoV-2 variants with ongoing evaluation of emerging strains.
• 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.