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Coronavirus (COVID-19) SARS-CoV-2 RT-PCR

Test Code: 8398

Patients, you must contact your physician to order Coronavirus COVID-19 testing.
Viracor will not see patients at our facility or collect samples on site.

An account must be set up to order testing. See the Specimen Information section for more information. 

Coronavirus (COVID-19) SARS-CoV-2 PCR is available with a self-pay price for patients who do not have health insurance or for those who intentionally choose not to submit a claim to their insurance company.  The Coronavirus (COVID-19) SARS-CoV-2 PCR self-pay price is $100.  Additional charges may apply for specimen collection, logistics or expedited turnaround testing.

Viracor-Eurofins.com/covid19

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Clinical Utility

The lab test for Coronavirus SARS-CoV-2 RT-PCR is intended for the qualitative detection of SARS-CoV-2.

About Coronavirus SARS-CoV-2 RT-PCR and COVID-19

Please refer to the CDC website for the most up to date information on SARS-CoV-19 or COVID-19 at
https://www.cdc.gov/coronavirus/2019-ncov/summary.html.

At the end of 2019, an outbreak of the virus initially referred to as 2019 novel Coronavirus, later identified as SARS-CoV-2, occurred in Wuhan, Hubei Province, China. A betacrononvirus, like MERS-CoV and SARS-CoV, the virus originates from bats. As of January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization declared a “public health emergency of international concern.”

The disease caused by SARS-CoV-2 has been named coronavirus disease 2019, abbreviated as COVID-19. Main symptoms of the disease include fever, cough and shortness of breath. The CDC recommends reaching out to a physician if you develop symptoms and have been in close contact with a person known to have COVID-19; or if you have recently traveled from an area with widespread or ongoing community spread of COVID-19. The virus is spread via person-to-person contact through respiratory droplets produced when a person coughs or sneezes. The best preventative measures are to avoid close contact with people who are sick; avoid touching nose, eyes and mouth; cover a cough or sneeze with a tissue and discard immediately; and clean and disinfect frequently touched objects and surfaces using a household cleaning spray or wipe. Washing your hands with soap and water for at least 20 seconds frequently is one of the best preventative measures and hand sanitizer can be used when soap and water are not available.

Procedure

Viracor's Coronavirus (COVID-19) SARS-CoV-2 RT-PCR
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 has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection, 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 and/or diagnosis of SARS-CoV-2 virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

COVID-19 EUA LDT for Healthcare Providers

COVID-19 EUA LDT for Patients


Abbot RealTime SARS-CoV-2
The Abbott RealTime SARS-CoV-2 assay is real-time reverse transcription polymerase chain reaction (rRT-PCR) test on the Abbott m2000 System.The SARS-CoV-2 primer and probe sets are designed to detect RNA from SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from patients with
signs and symptoms of infection who are suspected of COVID-19. 

The Abbott RealTime SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Abbott RealTime SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Abbott Fact Sheet for Healthcare Providers


Diatherix Eurofins' SARS-CoV-2 TEM-PCRTM 

Target Enriched Multiplex PCRTM diagnostic panel testing consists of three major steps: extraction, amplification and detection. The key to making TEM-PCRTM occur successfully lies in these primer mixes and how they allow the enrichment of multiple targets. The use of target-specific nested primers at low concentrations at the initial enrichment step allows high specificity of multiplexing amplification. After initial target enrichment is complete, Super Primers within the reaction carry out the exponential amplification and produce tagged PCR products for subsequent detection. The detection phase of the process is accomplished by measuring the fluorescence of special tags that are bound to the target sequences, which have been attached during amplification. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Testing performed utilizing TEM-PCR (Target Enriched Multiplex Polymerase Chain Reaction) technology. Testing laboratory is Diatherix Eurofins, 601 Genome Way, Suite 2100 / Huntsville, AL 35806 CLIA ID: 01D1085737.

The Diatherix TEM-PCR test has been validated but FDA's independent review of the validation is pending. These tests are 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 the performance characteristics determined by Diatherix Eurofins. This test 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. 

Specificity

In silico analysis has demonstrated that Viracor’s SARS-CoV-2 RT-PCR is not expected to cross-react with other coronaviruses (including other SARS viruses and other common respiratory coronaviruses). Additionally, this assay will not cross-react with other respiratory viruses, bacteria or fungal pathogens/commensals.

During this unprecedented time of high volume, the turnaround time for most Coronavirus SARS-CoV-2 (COVID-19) samples is 24 hours from receipt of specimen in the lab.  As daily volume can have an impact on workflow, we are monitoring this closely and will provide updates as the situation changes.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
BAL 8398 U0003 Yes

1 mL

Detected / Not Detected

  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 30 days when frozen.
nasal swab 8398 U0003 Yes

2 mL

Detected / Not Detected

  • Place sterile swab placed in 2 mL sterile buffered saline or transport media in a sterile, screw top tube.
  • Do not use calcium alginate swab or wood shafted swab.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 30 days when frozen.
nasal wash 8398 U0003 Yes

1 mL

Detected / Not Detected

  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 30 days when frozen.
NP swab 8398 U0003 Yes

2 mL

Detected / Not Detected

  • Place sterile swab placed in 2 mL sterile buffered saline or transport media in a sterile, screw top tube.
  • Do not use calcium alginate swab or wood shafted swab.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 30 days when frozen.
  • CDC only recommends collection of NP swabs and no longer recommends collections of both OP and NP swabs. Clients that send in two samples per patient, one NP and one OP swab, we will only run the NP swab and will TNP the OP Swab.
NP wash 8398 U0003 Yes

1 mL

Detected / Not Detected

  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 30 days when frozen.
OP swab 8398 U0003 Yes

2 mL

Detected / Not Detected

  • Place sterile swab placed in 2 mL sterile buffered saline or transport media in a sterile, screw top tube.
  • Do not use calcium alginate swab or wood shafted swab.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient or refrigerated temperature must be received within 7 days of collection, or 30 days when frozen.
  • CDC only recommends collection of NP swabs and no longer recommends collections of both OP and NP swabs. Clients that send in two samples per patient, one NP and one OP swab, we will only run the NP swab and will TNP the OP Swab.

To Setup an Account:
Prior to sending samples for the first time, all new clients must set up a Viracor Account. Please visit our Account Setup page to begin this process.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. For additional testing, please send a separate specimen. Refer to our website for accepted specimen types. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Causes for Rejection

Dry swab, wood shafted swab, calcium alginate swab, specimens received in trap containers, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

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.

We will continue to follow federal and state requirements for both notification of results and any confirmatory testing that is required by another agency.

References

https://www.cdc.gov/coronavirus/2019-ncov/index.html 

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