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

Test Code: 8372

Provider collected Saliva Coronavirus SARS-CoV-2 RT-PCR Testing.

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 of $100 for patients who do not have health insurance or for those who intentionally choose not to submit a claim to their insurance company. 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-2 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 betacoronavirus, 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 Saliva 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 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. We will continue to follow federal and state requirements for both notification of results and any confirmatory testing that is required by another agency. 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
saliva 8372 U0003 No

See Special Instructions

Qualitative, Detected / Not Detected

  • Patient should not eat, drink, smoke or chew gum for 30 minutes prior to collection.
  • Fill the tube with saliva up to the black wavy line, not including bubbles – this can take 15-30 minutes.
    Note: yawn or smell food to increase flow of saliva.
  • Replace the funnel with the fluid cap, screw the cap down tightly to release the blue solution that will stabilize the saliva sample.
  • Gently shake the tube for at least 5 seconds.
  • Can be shipped at ambient temperature Monday through Friday.
  • Samples are stable ambient for 14 days.
  • Specimen must be collected in validated saliva collection container. Please contact 1-800-305-5198 to order collection devices. 

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

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 general 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 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. We will continue to follow federal and state requirements for both notification of results and any confirmatory testing that is required by another agency. Results should be used in conjunction with clinical findings, and should not form the sole basis for a diagnosis or treatment decision.

References

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

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