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.
Please refer to the Society for Maternal Fetal Medicine for the latest information on SARS-CoV-2 and COVID-19 for expectant mothers and their caregivers
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
Turnaround Time= 1-3 days from specimen receipt
An accurate, fast test for measuring the presence of the SARS-CoV-2
virus in patients suspected of having active COVID-19 infection
The CDC recommends collection of a Nasopharyngeal (NP) sample, although Oropharyngeal (OP) samples remain an
acceptable specimen type.
• Refer to the CDC website (https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html) for guidance
on specimen collection and associated information.
• Do not use a calcium alginate swab or wood-shafted swab.
• Collect a specimen with the sterile swab and place it in the Universal Transport Media (UTM) contained in the provided sterile
tube – ensure the top of the tube is securely fastened.
• Samples can be shipped at ambient or refrigerated temperature Monday through Friday and must be received within 4 days of collection – please ensure applicable shipments are marked for Saturday delivery.
• All specimens must be labeled with the patient’s name, date of birth, and collection date.
Specimens are approved for testing in New York.
We will continue to follow federal and state requirements for both notification of results and any confirmatory testing that is required by another agency.
This test was developed and its performance characteristics determined by NTD Eurofins . It has been authorized by the FDA under an EUA for use by authorized laboratories. Results should be used in
conjunction with clinical findings and should not form the sole basis for a diagnosis or treatment decision
The CPT codes provided are based on NTD 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 NTD 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.