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SARS-CoV-2 Plus Quantitative RSV RT-PCR

Test Code: see Specimen Information section

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.

Viracor-Eurofins.com/covid19

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Clinical Utility

The SARS-CoV-2 Plus Quantitative RSV RT-PCR test is intended for the qualitative detection of SARS-CoV-2, and the quantitative detection of RSV.

 

About SARS-CoV-2 and RSV

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.

Human respiratory syncytial virus (RSV), a negative-sense, single-stranded RNA, causes a variety of respiratory illnesses. In at risk infants and children, it can cause bronchitis, croup, and lower respiratory infections like bronchiolitis and pneumonia. Premature infants, very young infants, and those with chronic (always present) lung or heart disease or with suppressed (weakened) immune systems have a greater chance of having a more severe infection such as a lower respiratory tract infection. Symptomatic RSV infections may occur in adults, particularly in healthcare workers or caretakers of small children. High-risk adults, such as those with certain chronic illnesses or immunosuppression, may have more severe symptoms consistent with a lower respiratory tract infection, such as pneumonia.

Procedure

Extraction of SARS-CoV-2* and RSV 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. Results should be used in conjunction with clinical findings, and should not form the sole basis for a diagnosis or treatment decision.

*The Coronavirus SARS-CoV-2 RT-PCR 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.

Specificity

Coronavirus SARS-CoV-2 RT-PCR

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.

 

RSV qRT-PCR

The primers and probes used in the RSV assays are specific for known RSVA and RSVB strains. Additionally, no cross reactivity was detected when tested against ADV, CMV, EBV, HSV-1, HSV-2, Enterovirus, Coronavirus 229E, SARS CoV-2, Rhinovirus, Influenza H1N1 2009 Pandemic, Influenza H1N1 Seasonal, Influenza H3N2, Influenza B, C. pneumoniae and Group A Strep. In silico analysis has demonstrated that Viracor’s RSV assays are not expected to cross-react with other respiratory viruses, bacteria or fungal pathogens/commensals. This assay does not differentiate between RSVA or RSVB.

During this unprecedented time of high volume, the turnaround time for most samples is 24-48 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 [Quant] PFL8023 U0003, 87634 No

2 mL

SARS-CoV-2: Detected / Not Detected
RSV: 579 - 1.00E+09 copies/mL

  • Volume requirements: 2 mL
  • 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 28 days when frozen.
bronch wash [Quant] PFL8023 U0003, 87634 No

2 mL

SARS-CoV-2: Detected / Not Detected
RSV: 579 - 1.00E+09 copies/mL

  • 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 28 days when frozen.
nasal swab [Quant] PFL8022 U0003, 87634 No

3 mL

SARS-CoV-2: Detected / Not Detected
RSV: 459 - 1.00E+09 copies/mL

  • Place sterile swab in 2-3 mL sterile buffered saline or transport media 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 28 days when frozen.
NP swab [Quant] PFL8022 U0003, 87634 No

3 mL

SARS-CoV-2: Detected / Not Detected
RSV: 459 - 1.00E+09 copies/mL

  • Place sterile swab in 2-3 mL sterile buffered saline or transport media 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 28 days when frozen.
BAL [Qual] PFL8025 U0003, 87634 No

2 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 28 days when frozen.
bronch wash [Qual] PFL8025 U0003, 87634 No

2 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 28 days when frozen.
bronch wash [Qual] PFL8024 U0003, 87634 No

3 mL

Detected / Not Detected

  • Place sterile swab in 2-3 mL sterile buffered saline or transport media 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 28 days when frozen.
NP swab [Qual] PFL8024 U0003, 87634 No

3 mL

Detected / Not Detected

  • Place sterile swab in 2-3 mL sterile buffered saline or transport media 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 28 days when frozen.
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.

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