Description

The Medomics SARS-CoV-2 Influenza A/B Antigen Rapid Self-test Kit offers a convenient and efficient solution for detecting key respiratory infections. Designed for self-administration, this in vitro diagnostic device provides rapid qualitative results for SARS-CoV-2, Influenza A, and Influenza B antigens using anterior nasal swab samples.

Key Features

• Intended for Use by Individuals Aged 15 and Older: Suitable for those with symptoms indicative of these infections. Adults can administer the test for children aged 2 and above.
• Quick Results: Obtain results within 15 to 20 minutes, allowing timely decision-making.
• Lateral Flow Immunoassay Technology: Utilizes a double antibody sandwich method with colloidal gold immunochromatography for reliable detection.

Usage Guidelines

• Optimal Testing Window: For SARS-CoV-2, use within the first 7 days of symptom onset. For Influenza A/B, use within the first 4 days.
• Result Interpretation:
• Positive: Presence of both control and test lines.
• Negative: Only the control line appears.
• Invalid: Absence of the control line.

Kit Contents

Each kit includes:

• Test cassette(s)
• Lysis buffer and dropper
• Anterior nasal swab
• Instructions for use
• Bio-safety bag

Available in various packaging options, accommodating 1, 2, 5, 20, or 25 tests per box.

Storage Instructions

• Temperature Range: Store between 2°C and 30°C.
• Shelf Life: 24 months.
• Usage Conditions: Use the test within 1 hour of opening the foil pouch. Ensure the pouch is intact and not past its expiration date.

Performance Metrics

• SARS-CoV-2 Detection: Sensitivity 98.8%, Specificity 99.5%
• Influenza A Detection: Sensitivity 95.0%, Specificity 96.9%
• Influenza B Detection: Sensitivity 92.6%, Specificity 98.6%

No cross-reactivity with common respiratory viruses, ensuring accurate results. The kit effectively detects major SARS-CoV-2 variants, including Omicron and Delta.

Safety Precautions

• Single Use Only: Dispose of the kit responsibly after use.
• Keep Out of Reach of Children: Ensure safe handling and disposal.
• Follow Instructions Carefully: Adhere to all guidelines, especially regarding the buffer solution.

Additional Requirements

A timer is recommended for accurate result reading, and gloves are advised for safe handling. The test should be conducted by adults or under adult supervision, ensuring proper procedure adherence.

This comprehensive kit empowers individuals to manage their health with confidence, providing crucial information swiftly and accurately.