COVx-RDA COVID-19 (SARS-CoV-2) Antigen Test Kit
by Vivera Advanced Diagnostics
RAPID RESULTS
Results in 10 minutes.
Clear Results in 10 Minutes.
USER FRIENDLY
Everything needed for specimen collection in one box.
The specimen collection kit comes with everything needed for 20 tests with both nasal and saliva specimen collection available.
ANTIGEN DETECTION
Antigen presence indicates current infection.
Intended for detection of nucleocapsid protein from SARS-CoV-2 in nasal or saliva specimens only.
COMPLETE CARE
Rapid test results for better-informed patient care.
Our COVx-RDA rapid tests are highly accurate with an over 98% specificity and 92% sensitivity to the novel COVID-19 coronavirus.
Less Invasive Approach
Test Box Contents
For Professional Use
Additional Resources
General Information from the Centers for Disease Control
Healthcare Professional Resource from the Centers for Disease Control
Isolation Precautions in Healthcare Settings from the Centers for Disease Control
Infection Control Information from the Centers for Disease Control
Healthcare Professional Checklist from the Centers for Disease Control
Instructions For Use
- This test has not been reviewed by the FDA. In accordance with the most recent FDA guidance Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) – Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, Vivera Pharmaceuticals has submitted Emergency Use Authorization packages to the FDA. COVx-RDA is limited to laboratories certified to perform high complexity testing, including testing at the point-of-care when the site is covered by the laboratory’s CLIA certificate for high-complexity testing.
- This test is meant for viral antigen detection only and not meant as a definitive method for determing SARS-CoV-2 infection.
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from viral antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus stains, such as coronavirus strains, such as coronavirus HKU1, NL63, OC43 or 229E.
- Specimens should always be treated as if infectious and/or biohazardous in accordance with safe laboratory procedures.
- Not for the screening of donated blood.
- Follow necessary precautions when handling specimens. Use personal protect equipment (PPE) consistent with current guidelines for the handling of potentially infectious samples.
- Modifications to assay reagents, assay protocol, or instrumentation are not permitted.
- Do not eat, drink, smoke, apply cosmetics, or handle contact lenses in areas where reagents and/or human specimens are handled.
- Dispose of waste in compliance with local, state, and federal regulations.