Description
The InnoScreen™ COVID-19 Antigen Rapid Test Device offers a reliable solution for the quick detection of SARS-CoV-2 antigens. Developed by Innovation Scientific Pty Ltd, this test is designed for both self-testing and professional use, providing flexibility in various settings.
Key Features
- Lateral Flow Immunoassay: Utilizes highly sensitive monoclonal antibodies to detect nucleocapsid protein antigens, ensuring accurate results.
- Versatile Sample Collection: Compatible with nasal, nasopharyngeal, and oropharyngeal swabs, though the latter two are intended for professional use.
Intended Use
This test is suitable for individuals with or without symptoms, offering a practical tool for those suspected of COVID-19 infection. It is not recommended for children under 2 years old, and for those aged 2 to 15, adult supervision is required.
Kit Components
Each kit includes:
- Single-use swabs
- Test cassettes
- Extraction tubes with buffer
- Waste bag
- Instructional materials
Professional kits also include nozzles with buffer caps and a tube stand.
Testing Procedure
- Specimen Collection: Use the provided swab to collect the sample.
- Sample Preparation: Insert the swab into the extraction tube, secure the cap, and mix.
- Testing: Add drops to the test device and read results at 15 minutes.
Result Interpretation
- Positive: Two lines appear.
- Negative: One line at the control region.
- Invalid: No line at the control region.
Performance
- Sensitivity: Varies based on symptoms and testing conditions, with high specificity around 99%.
- Reproducibility: Consistent results across different operators and devices.
- Variant Detection: Effective against multiple SARS-CoV-2 variants.
Storage and Handling
- Store between 2–30°C and avoid freezing.
- Use immediately after opening.
- Handle as a biohazard and follow safety precautions.
Limitations
Negative results should be interpreted with caution and may require confirmatory testing. The test should not be the sole basis for clinical decisions.
With a shelf life of 24 months, the InnoScreen™ COVID-19 Antigen Rapid Test Device remains a dependable tool in managing public health during the pandemic.
