COVx-RT COVID-19 (SARS-CoV-2 IgM/IgG) Rapid Test Kit
by Vivera Advanced Diagnostics
Results in 15 minutes.
Improved Patient Outcomes
By providing faster results, medical professionals can offer earlier therapeutic interventions without needing additional resources or third party labs. Screening allows for limited resources to be used more efficiently.
Less invasive testing.
A quick process with minimal discomfort
No uncomfortable nasal swabs or invasive venous blood draw required. A quick fingerstick and patients can be screened for IgM and IgG antibodies.
While PCR tests may be able to determine pre-symptomatic, active, infections, they are not designed to detect antibodies indicative of a prior immune response.
SCALABLE & EFFICIENT
Simple screening for triage environments.
When used as part of a larger screening protocol, lateral flow assays are an efficient way to screen for suspected COVID-19 positive patients.
The COVx-RT rapid test is designed for use by healthcare professionals in CLIA-certified facilities. With 10 test kits per box, the COVx-RT rapid test saves valuable time and resources when screening large patient populations.
On-site results in 15 minutes.
Specialized equipment not required.
Patient friendly testing procedure.
Quickly screen for patient exposure.
For use by healthcare professionals only.
Test with 2 drops of fingerprick blood.
• Specificity: 96%
• Sensitivity: 91.4%
• Overall Percent Positive Agreement (PPA): 94.1%
• Overall Early Stage (IgM): 96.08%
• Overall Late Stage (IgG): 98.04%
• Sample Type: Whole Blood or Serum
• Tested for cross-reactivity with 18 other pathogens with no false positivity or false negativity found.
• Test Read Time: 15 minutes
• For Professional Use Only. Not for the Screening of Donated Blood.
• This Test has not Been Reviewed by the FDA.
• 12 month shelf life. Do not freeze. Refrigeration not required.
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 is distributed in accordance with the most current FDA guidance. Notice has been submitted and the Vivera Pharma COVx-RT Rapid Test is currently on the FDA website under “Manufacturers that have notified FDA that they have validated and intend to distribute serology tests as set forth in Section IV.D” found at the following link: FDA Notification List under “Vivera Pharmaceuticals, Inc. COVx-RT.”
We are proud to work with FDA and NCI in their quest to provide independent third party validation.
- THIS TEST IS NOT FOR THE SCREENING OF DONATED BLOOD.
- THIS TEST HAS NOT BEEN REVIEWED BY THE FDA.
- FOR PROFESSIONAL USE ONLY IN QUALIFIED CLIA CERTIFIED HIGH COMPLEXITY SETTINGS.
- 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 antibody 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 strains, such as coronavirus HKU1, NL63, OC43, or 229E.