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Pooled COVID-19 Lab Test for SARS-CoV-2

Test Code: 8396
Pooled COVID-19 PCR testing is an efficient, cost-effective tool for monitoring low-risk groups with a low prevalence of COVID-19 infection.
  • Accepted Specimen Types: Nasal Swab, NP Swab

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 Specimen Information section for more information

Viracor-Eurofins.com/covid19

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Clinical Utility

Pooled Coronavirus SARS-CoV-2 RT-PCR test is intended for the qualitative detection of SARS-CoV-2 in populations where the positivity rate is expected to be low.

Positive Pooled Coronavirus SARS-CoV-2 RT-PCR tests will reflex to:
>> 8398 Coronavirus (COVID-19) SARS-CoV-2 Test 

About Pooled COVID-19 Lab Testing

Pooling allows larger numbers of COVID-19 samples to be tested at one time, and can be used to continuously and cost-effectively monitor prescreened, low-risk groups that show a low prevalence of COVID-19 infection. It can also be used as part of surveillance testing for positive individuals in quarantine. Pooled testing can help labs be mindful of resources while creating efficiencies in testing to better utilize supplies and increase capacity. When negative, all specimens in that pooled test can be presumed negative. If the pooled result is positive, all specimens will be re-tested to identify which individual samples are positive.

Pooling COVID-19 testing, in combination with other Eurofins’ U.S. Clinical Diagnostics' SARS-CoV-2 antibody, surface, wastewater, air and used-mask testing, can help organizations reduce the risk of spreading the virus for significantly less than using regular PCR tests. LEARN MORE

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 Pooled 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 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.

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.

The turnaround time for most Pooled Coronavirus SARS-CoV-2 RT-PCR (COVID-19) samples is 24-72  hours from receipt of specimen in the lab.  If a result is a part of a positive pool, there will be an additional 24-48 hours from the time pooled testing is resulted.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
nasal swab 8396 No

2 mL (min. 2 mL)

Pooled Positive / Not Detected

  • Samples must be ordered in multiples of 5.
  • Place sterile swab placed in 2 mL (minimum 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.
NP swab 8396 No

2 mL (min. 2 mL)

Pooled Positive / Not Detected

  • Samples must be ordered in multiples of 5.
  • Place sterile swab placed in 2 mL (minimum 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.

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 or manifest must accompany each specimen. For additional testing, please send a separate specimen. 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 

https://www.cdc.gov/coronavirus/2019-ncov/lab/pooling-procedures.html

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