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.
Benefits of using ViraDx
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
Accurate
- COVID-19 (Anterior nasal swab): Sensitivity 93.8%; Specificity 100%
- COVID-19 (Nasopharyngeal): Sensitivity 93.1%; Specificity 100%
- Flu A: Sensitivity 92.2%; Specificity 94.2%
- Flu B: Sensitivity 90.0%; Specificity 94.3%
Time to result |
15 minutes |
Sample type |
Anterior nasal or nasopharyngeal swab specimen |
Interpretation |
Visually read (no instrument required) |
Method |
Lateral flow |
Storage conditions |
2 to 30oC (35 to 86oF) |
Background information
Influenza (flu) is a highly contagious acute viral infection of the respiratory tract. It is a communicable disease easily transmitted from person to person through aerosol droplets excreted when sneezing and coughing. There are two main types of influenza - type A and type B.2
Early differential diagnosis of influenza type A or type B can allow for proper treatment. Early diagnosis and treatment are of particular value in a clinical setting where an accurate diagnosis can assist the healthcare professional with the management of influenza patients who are at risk for complications.3
COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. Similar to influenza, the virus can spread from an infected person's mouth or nose ranging from larger respiratory droplets to smaller aerosols.4 COVID-19 symptoms can range from mild to severe.
As the early symptoms of COVID-19 are like those of seasonal influenza type A or B, a rapid, point- of-care test can help support the differential diagnosis of COVID-19, influenza A and B.
- For in vitro diagnostic use.
- For Rx use only.
Is it COVID-19 or FLU?4 |
|---|
SHARED SYMPTOMS |
| Fever or chills |
| Sore throat |
| Runny or stuffy nose |
| Cough |
| Muscle or body aches |
| Headache |
| Fatigue |
| Nausea and vomiting |
| Diarrhea |
- ViraDx [package insert] PM-169.2. Carlsbad, CA: Lumos Diagnostics; 2023.
- Centers for Disease Control and Prevention (CDC) - Frequently Asked Influenza (Flu) Questions: 2021-2022 Season - https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm.
- World Health Organization (WHO) recommendations on the use of rapid testing for influenza diagnosis, July 2005.
- Centers for Disease Control and Prevention (CDC) - Similarities and Differences between Flu and COVID-19. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm.
- Refer to the Package Insert for complete instructions. Read the complete test procedure, including recommended Quality Control procedures, before performing the test.
- All clinical specimens must be at room temperature before beginning the assay.
- Expiration date: Check expiration on each individual test package or outer box before using. Do not use any test past the expiration date on the label.
- For in vitro diagnostic use.
- For Rx use only.
ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test |
||
|---|---|---|
Region |
Part number |
Kit size |
| USA | CP0031 | 25 tests |
- For in vitro diagnostic use.
- For Rx use only.
ViraDx Emergency Use Authorization Number (EUA): EUA220131 |
|---|
| This product has not been FDA cleared or approved, but has been authorized by FDA under and EUA for use by authorized laboratories. |
| This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. |
| The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vito diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. |
