Description

The COMBO RAT NASAL SWAB SARS-CoV-2 & FLU A/B is an innovative self-testing rapid antigen kit designed for the qualitative detection of SARS-CoV-2, Influenza A, and Influenza B. This in vitro diagnostic tool employs a lateral flow immunoassay, making it suitable for use in non-laboratory environments such as homes.

Intended Use

• Target Users: Symptomatic individuals, typically over the age of 15 or 18, within the first 7 days of symptom onset.
• Sample Type: Anterior nasal swab samples.
• Environment: Ideal for laypersons conducting tests at home or similar settings.

Test Principle

The test utilizes monoclonal antibodies specific to the antigens of SARS-CoV-2, Influenza A, and Influenza B. Results are visually interpreted through colored lines on the test cassette:

• C Line: Control
• N Line: SARS-CoV-2
• A Line: Influenza A
• B Line: Influenza B

A visible line, regardless of intensity, indicates a positive result. A valid test requires the presence of the control line (C).

Kit Contents

Each kit includes:

• Individually packed test cassette(s) with desiccant
• Sterilized anterior nasal swab(s)
• Extraction/lysis buffer with dropper or extraction tube
• Biohazard specimen bag
• Instructions for use

Some kits may also include a tube stand, particularly in multi-test packages. Packaging options vary, offering configurations of 1, 2, 5, 20, or 25 tests per box.

Test Procedure

1. Sample Collection: Insert the swab approximately 2cm into each nostril and swirl five times.
2. Sample Processing: Mix the swab in the extraction/lysis buffer.
3. Application: Apply the specified number of drops to the test cassette.
4. Result Waiting Time: Typically 15–20 minutes.
5. Result Interpretation: Based on the appearance of colored lines.

Performance

• Sensitivity: Approximately 98.85% for SARS-CoV-2, 98.12% for Influenza A, and 98.33% for Influenza B.
• Specificity and Accuracy: High relative specificity and accuracy, ensuring reliable results.

Storage and Shelf Life

• Shelf Life: 24 months from the date of manufacture if unopened.
• Storage Conditions: Store between 2°C and 30°C, away from direct sunlight. Use the test within 1 hour of opening the foil pouch.

Disposal

All used materials should be disposed of in the provided biohazard bag or according to local regulations. The kit is intended for single use only.

Certifications

• CE Marked
• TGA Listed (Australia)
• ARTG Number: 395591

This test is not affected by known SARS-CoV-2 mutations and requires no special training or equipment, providing a convenient and reliable testing solution for individuals managing respiratory symptoms at home.