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Coronavirus SARS-CoV-2 inSIGHT™ T Cell Immunity

Test Code: 33042

Examining T Cell Immune Response for Critical Decisions

Eurofins Viracor’s inSIGHT™ T cell immunity test delivers a deeper understanding of a patient's response to viral antigens and gives healthcare providers critical insight to aid in treatment decisions.

Cell Function Testing requires special attention to specimen collection and shipping in order to ensure the integrity of the sample. Please watch Eurofins Viracor’s video for complete specimen collection and shipping instructions. Watch Video Link

Patients, you must contact your physician to order Coronavirus COVID-19 testing.
Eurofins 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 inSIGHT™ T Cell Immunity Panel 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 inSIGHT™ T Cell Immunity Panel self-pay price is $665. Additional charges may apply for specimen collection, logistics or expedited turnaround testing.

MORE INFORMATION ON COVID-19

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Clinical and Procedure
Clinical Utility

The Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity test measures the strength of T cell responses to SARS-CoV-2 specific antigens (Spike and/or Nucleocapsid protein). The test evaluates and reports the activity of CD4 and CD8 T cell responses independently.

About Coronavirus SARS-CoV-2
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.

About SARS-CoV-2 Antigens and Proteins
SARS-CoV-2’s single-stranded RNA genome encodes for a number of different proteins including spike (S), envelope (E), membrane (M), and nucleocapsid (N). The coronavirus is named for the notable spike glycoproteins evident on the viral envelope, (coronam is latin for crown). The spike glycoprotein is composed of two subunits, S1 and S2. The S1 domain contains the receptor binding region of the viral spike protein that mediates binding of the viral particle to the surface protein on the host cells. The S2 subunit specifically is highly conserved which is why it is a primary target for most vaccine development. The nucleocapsid (N) protein is an RNA-binding protein that the virus needs for replication and transcription. The N protein is also conserved and has shown to both produce an immune response and due to ample expression, is detectable during infection.

About SARS-CoV-2 Cell Mediated Immunity
The immune status of individuals who have recovered from SARS-CoV-2 has been found to be highly variable depending on the intensity of the infection, the treatments received while infected and the length of time since recovering from the infection. Additionally, the immune response developed by study participants in vaccine trials is also variable and wanes over time. The ability to determine the proportion of antigen specific T cells that respond to stimulation with SARS-CoV-2 antigens in a functional manner could be an important tool for evaluating an individual’s immunological memory to the SARS-CoV-2 virus and perhaps indicate a level of protection from further infection with this virus.

Procedure

Whole blood is stimulated with SEB, SARS-CoV-2 Spike (S) and/or Nucleocapsid (N) proteins, or left unstimulated as a negative control and incubated at 37ºC. During the incubation Brefeldin A is added, causing the cytokines (interferon (IFN)-gamma, IL-2 and tumor necrosing factor (TNF)- alpha) to be retained inside the cell. Following the stimulation phase, cells are recovered, stained for cellular markers (CD3, CD4, CD8, CD69) and the cytokines above, and analyzed by flow cytometry. This test was developed and its performance characteristics determined by Eurofins Viracor. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

Test will measure single and polyfuntional cytokine responses to both spike and nucleocapsid peptides.

Turnaround Time

3 - 4 business days from receipt of specimen.

Specimen Information
Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
whole blood 33042 86352 x 4 Yes

10 mL

Qualitative, Detected/Not Detected

  • Collect 10 mL whole blood in a sodium heparin tube. Tube must be at least ¾ full to maintain proper ratio of blood to anticoagulant.
  • Blood must be drawn Monday through Friday after 7:00 AM CST.
  • DO NOT SHIP on days when a holiday follows the shipping or set up day.
  • Ship samples priority overnight Monday through Friday, at ambient temperature on the same day as collection.

Causes for Rejection:

  • Whole blood received after stability (32 hours after collection)
  • Whole blood received cold or frozen
  • Tubes received less than 3/4 full
  • Specimens received in lithium heparin, ACD tubes or EDTA anticoagulants

Please contact Client Services at 1-800-305-5198 if it is your first time sending Viracor a live cell test.
Client Services will assist in setting up live cell shippers with you, or your courier.

For Pediatric Patients

  • Minimum volume is 3 mL. Tube must be at least ¾ full to maintain proper ratio of blood to anticoagulant. Tubes that can be accepted for pediatric patients:
    • Three 1mL tubes completely full (any less will be rejected)
    • Two 2 mL tubes containing a minimum of 1.5 mL of blood in both tubes
    • One 4 mL tube containing a minimum of 3 mL of blood .
  • Blood must be drawn Monday through Friday after 7:00 AM CST.
  • DO NOT SHIP on days when a holiday follows the shipping or set up day.
  • Ship samples priority overnight Monday through Friday, at ambient temperature on the same day as collection.

Causes for Rejection:

  • Whole blood received after stability (32 hours after collection)
  • Whole blood received cold or frozen
  • Tubes received less than 3/4 full
  • Specimens received in lithium heparin, ACD tubes or EDTA anticoagulants

Please contact Client Services at 1-800-305-5198 if it is your first time sending Viracor a live cell test. Client Services will assist in setting up live cell shippers with you, or your courier.

Shipping

Ship Monday through Friday. All specimens must be labeled with patient's name and collection date. A Eurofins Viracor test requisition form or manifest must accompany each specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Causes for Rejection

Whole blood received after stability (32 hours after collection), whole blood received cold or frozen, and tubes received less than ¾ full are not accepted and are cause for rejection.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins Viracor's 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. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

Cascella M, Rajnik M, Cuomo A, et al. Features, Evaluation, and Treatment of Coronavirus (COVID-19) [Updated 2021 Mar 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554776/

Chatterjee, Sidharta, Understanding the Nature of Variations in Structural Sequences coding for Coronavirus Spike, Envelope, Membrane and Nucleocapsid Proteins of SARS-CoV-2 (March 28, 2020). Available at SSRN: https://ssrn.com/abstract=3562504 or http://dx.doi.org/10.2139/ssrn.3562504

Dutta N, Mazumdar K, Gordy J. The Nucleocapsid Protein of SARS–CoV-2: a Target for Vaccine Development. Journal of Virology Jun 2020, 94 (13) e00647-20; DOI: 10.1128/JVI.00647-20

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