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Description
ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from anterior nasal or nasopharyngeal swab specimens obtained from patients who are suspected of COVID-19 by their healthcare provider, within the first five days of onset of symptoms.
Features
- Efficient: 1 sample – 3 results to aid in a differential diagnosis at the point of care
- Rapid: actionable results at 15 minutes to help improve patient management decisions during the patient visit
- Instrument-free: user-friendly test procedure for non-lab settings
Product Specifications
| Time to results: | 15 minutes |
|---|---|
| Sample type: | Anterior nasal or nasopharyngeal swab specimen |
| Interpretation: | Visually read (no instrument required) |
| Method: | Lateral flow |
|---|---|
| Storage conditions: | 2 to 30°C (35 to 86°) |
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Frequently Asked Questions (FAQs)
The ViraDx test targets the nucleocapsid antigen SARS-CoV-2, influenza A and influenza B
The ViraDx test should be stored at 2-30°C (35-86°F) in the original sealed pouch, away from direct sunlight.
The ViraDx test should be used with freshly collected anterior nasal or nasopharyngeal swab specimens. Samples must not be placed in any viral transport media.
Freshly collected specimens should be tested immediately. Ifnecessary, swab samples can bestored for up to 4 hours at room temperature or up to 8 hours at 2-8°C.
No. Only the swabs provided in the kit are to be used for collecting specimens. Other swabs may not work properly.
The test results should be read at 15 minutes. Do not read the results after 20 minutes.
The test line may vary in shade and intensity (light or dark, weak or strong) depending on the concentration of antigen detected. Even if the test line is light or faint, the test must be interpreted as a positive result.
A reddish-purple line should always appear at the Control line position (C position). If a line does not form at the Control line positionin15 minutes, the test result is invalid, and the test should be repeated with a new ViraDx test.
A negative test result does not exclude infection with SARS-CoV-2, influenza A or B. Negative test results are presumptive and may need to be confirmed with a molecular test. Therefore, results obtained with the ViraDx test should be used in conjunction with clinical findings to make an accurate diagnosis.