COVID-19 RT-PCR TEST
by Vivera Advanced Diagnostics + OmeCare
The Vivera + OmeCare COVID-19 RT-PCR test is designed for use by healthcare professionals only and is not intended for home use. Samples are collected and sent overnight back to our CLIA-certified laboratory partners for immediate processing. With 20 test swabs per box, the OmeCare COVID-19 RT-PCR test saves time and resources when screening large patient populations.
Results available via secure online portal within 24-48 hours.
Once received by our CLIA-Certified and CAP-Accredited laboratory for analysis, results are available by secure online portal in as little as 24 to 48 hours.
Everything needed for specimen collection and shipment in one box.
The specimen collection kit comes with everything needed for 20 tests as well as a return label to ensure the samples are returned to our CLIA-certified and CAP-accredited laboratory for analysis.
RT-PCR is the gold standard in COVID-19 diagnostics.
This is a molecular diagnostic test intended for the detection of nucleic acid (RNA) from SARS-CoV-2 detected in nasopharyngeal or oropharyngeal swab specimens collected by a trained healthcare professional.
Rapid test results for better informed patient care.
Utilizing real-time, reverse-transcriptase polymerase chain reaction, or, RT-PCR, our Vivera + OmeCare COVID-19 RT-PCR tests are highly accurate with an over 96% specificity and sensitivity to the novel COVID-19 coronavirus.
Our team is available to discuss the needs of your facility Monday through Friday 8am to 8pm PST.
A new tab window will open to Vivera + OmeCare’s test results portal.
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 been submitted to the FDA for Emergency Use Authorization (EUA).
- For in vitro diagnostic use only.
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
- Specimens should always be treated as if infectious and/or biohazardous in accordance with safe laboratory procedures.
- Follow necessary precautions when handling specimens. Use personal protective equipment (PPE) consistent with current guidelines for the handling of potentially infectious samples.
- Handle all samples and controls as if they are capable of transmitting infectious agents.
- Positive results are indicative of the presence of SARS-CoV-2 (coronavirus).
- Modifications to assay reagents, assay protocol, or instrumentation are not permitted and are in violation of the product Emergency Use Authorization.
- 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.
- FOR EXPORT ONLY UNTIL AN EMERGENCY USE AUTHORIZATION IS GRANTED BY THE FDA.
- THIS TEST HAS NOT BEEN REVIEWED BY THE FDA.
- FOR PROFESSIONAL USE ONLY IN QUALIFIED CLIA-CERTIFIED.
- Specimen collection is limited to trained healthcare professionals.
- Specimen processing is limited to CLIA-certified and CAP-accredited facilities.
- Results from 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.