About Coronavirus (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19)
Please refer to the CDC website for the most up-to-date information on SARS-CoV-2 and COVID-19 at https://www.cdc.gov/coronavirus/2019-ncov/summary.html.
For information about Eurofins Corporation’s global response to COVID-19, please click here.
About Coronavirus (SARS-CoV-2) RT-PCR Testing
Our SARS-CoV-2 RT-PCR test is intended for the qualitative detection of SARS-CoV-2.
Extraction of SARS-CoV-2 virus nucleic acid from specimen, followed by combined reverse transcription of viral RNA and PCR amplification using real-time reverse transcriptase PCR (RT-PCR) methods. An internal control is added to ensure that extraction was performed correctly and that the RT-PCR reaction was not inhibited. This test authorized by FDA under current EUA guidance for use by CLIA certified high-complexity laboratories. This test has been authorized only for the detection of RNA from SARS-CoV-2 virus and diagnosis of COVID-19, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus, unless the authorization is terminated or revoked sooner. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.
Coronavirus SARS-CoV-2 RT-PCR testing is performed through our sister laboratory, Viracor Eurofins.
Viracor Eurofins is a leader in specialty clinical diagnostics with over 35 years and 3000 test offerings in infectious diseases, transplantation, immunology and allergy, to aid diagnosis, treatment and monitoring. Viracor Eurofins is committed to helping medical professionals, transplant teams, reference laboratories and biopharmaceutical companies get results faster, when it matters most.
Please visit the following webpage for full test information:https://www.viracor-eurofins.com/test-menu/8300-coronavirus-covid-19-sars-cov-2-rt-pcr/
Specimens are approved for testing in New York only when indicated in the Specimen Information field above.
The CPT codes provided are based on Viracor Eurofins’ interpretation of the American Medical Association’s Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
This test has been validated but FDA’s independent review of the validation is pending. This test is performed as a laboratory developed test; independent review of the validation under the FDA’s Emergency Use Authorization (EUA) authority will be performed according to current guidance requirements.
This test was developed and its performance characteristics determined by Viracor Eurofins. It has not been cleared or approved by the U.S. Food and Drug Administration. Results should be used in conjunction with clinical findings, and should not form the sole basis for a diagnosis or treatment decision.