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Epstein-Barr virus (EBV) is a common virus. Half of all adults have been infected by EBV at some point. Most infections do not cause symptoms. EBV persists in a latent state after the initial infection and can reactivate in individuals whose immune systems are compromised by immunosuppressive drugs, viral infections, or genetic changes. This reactivation can progress from a virus that is only detected in the blood (viremia), to the involvement of tissues and organs (disease), which can result in major illness. In transplant recipients, EBV can cause post-transplant lymphoma-like disease.

Reactivation of EBV is accompanied by loss of cell-based immunity to the virus. Currently available antiviral drugs are not very effective. In transplant patients, reactivation leads physicians to lower immunosuppression. The reduction of immunosuppression can lead to rejection in some patients. In transplant patients, a first-time EBV infection or reactivation of the virus can lead to the persistence of the virus in the blood. The persistence of a high viral load in the blood can lead to tissue invasive EBV disease or post-transplant lymphoma. Knowing whether cell-based immunity to EBV is intact or decreased can further guide how to best manage immunosuppression.

PlexEBVTM is a lab-developed blood test that measures the level of cellular immunity to the Epstein-Barr virus (EBV). Decreased anti-EBV immunity increases the risk of EBV infection*.

Knowledge about immunity to EBV and therefore the risk of EBV infection can be combined with available clinical data to plan additional treatment for your patient.

Establishing the level of anti-EBV immunity at baseline and during periods of high dose immunosuppression permits the level of anti-EBV immunity to be assessed in each patient allowing for adequate treatment planifcation.

PlexEBVTM measures functional cell-mediated immunity to EBV. EBV-specific T-cells and their subsets, which express the inflammatory marker, CD154 are measured after stimulation with EBV antigen. Simultaneously, recipient T-cell stimulation with mitogen measures general T-cell responsiveness.

 

# CATEGORY DETAILS

1

Assay Category

Lab-developed test, antigen-specific T-cell function.

2

Intended Use

To measure cell-mediated immunity to the Epstein-Barr virus (EBV).

3

Methodology

Stimulation of peripheral blood leukocytes with EBV lysate, Flow Cytometry. Mitogen-stimulation of peripheral blood leukocytes serves as the positive control.

4

Test Report

Available within 30 hours of receiving the blood sample.

5

Test Readout

Frequency (%) of EBV-specific T-cells that express CD154, an inflammatory marker.

6

Reference Range

In 29 healthy adults the mean (SD) frequency of EBV-specific T-cells was 32.6% (14.3) (95% CI 27.4 - 37.8%). Median frequencies (range) were 31.3% (11 - 63).

In 12 children and young adults with liver or intestine transplants the mean (SD) frequency of EBV-specific T-cells was 18.8% (12.7) (95% CI 15.2 - 29.5%). Median frequencies (range) were 22.4% (3 - 43.6%). Post-transplant lymphoproliferative disorder due to EBV was associated with a mean (SD) EBV-specific T-cell frequency of 5.5% (8) (95% CI 0 - 14.6%). Median frequencies (range) were 1.6% (0.2 - 14.7%).

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Test Interpretation

EBV-specific T-cell frequency <5.5% implies decreased cell-mediated immunity to EBV.

Purpose

Knowledge about immunity to EBV and therefore the risk of EBV infection can be combined with available clinical data to plan additional treatment for your patient.

Rationale

First-time or primary infections with EBV or reactivation of EBV is accompanied by loss of cell-based immunity to the virus. Currently available antiviral drugs are not very effective. In transplant patients, EBV infection leads physicians to lower immunosuppression. The reduction of immunosuppression can lead to rejection in some patients. In transplant patients, EBV infection can lead to the persistence of the virus in the blood. The persistence of high viral load in the blood can lead to tissue-invasive EBV disease. Post-transplant lymphoma is a severe form of EBV disease. Recovery of cell-based immunity helps fight an EBV infection. Knowing whether cell-based immunity to EBV is intact or decreased can further guide how to best manage immunosuppression.

Intended Use

To measure the level of cellular immunity to Epstein-Barr virus (EBV). Decreased anti-EBV immunity increases the risk of EBV infection*.

Procedure

PlexEBVTM measures functional cell-mediated immunity to EBV.

  • A whole blood sample of 3 mL from children, 5 mL from adults. The whole blood must be in sodium heparin (green-top) tubes. The sample is to be shipped at ambient temperature overnight to Plexision’s reference laboratory.
  • EBV-specific T-cells and their subsets, which express the inflammatory marker, CD154 are measured after stimulation with EBV antigen.
  • Simultaneously, recipient T-cell stimulation with mitogen measures general T-cell responsiveness.
  • Results are reported within 30 hours after the blood samples reach the laboratory.
  • Results are reported as frequencies of EBV-specific T-cells and their subsets along with thresholds for the level of EBV immunity. These thresholds have been established from studies of transplant recipients with high and low viral loads in blood. These thresholds determine whether immunity to EBV is decreased or not.
  • For reference, the range of EBV-specific T-cells in healthy adults and transplant recipients with low and intermediate levels of viral load are provided. Also provided is the range of frequencies of EBV-specific T-cells in individuals with post-transplant lymphoproliferative disorder. These reference ranges can be used to assess whether a patient has cell-mediated immunity to EBV infection or not.

Performance

EBV-specific T-cell frequency <5.5% implies decreased cell-mediated immunity to EBV.

Benefits

Establishing the level of anti-EBV immunity at baseline and during periods of high dose immunosuppression allows the level of anti-EBV immunity to be assessed in each patient. This can help formulate personalized preventive measures or treatment.

Sample & Shipping

# CATEGORY DETAILS

1

Sample Type

Whole blood is collected in a sodium heparin (green-top) tube.

2

Volume

3 mL for children and 5 mL for adults.

3

Transport Conditions

Ship priority overnight, at room temperature. The sample must get to Plexision within 30 hours of the phlebotomy.

4

Specimen Stability

30 hours at room temperature from the time of the phlebotomy.

5

Sample Discard Criteria

  • Transport time more than 30 hours from phlebotomy.
  • Lithium heparin (green-top) tube or ACD (yellow-top) tube.
  • Clotted, hemolyzed, frozen, refrigerated, or broken vacutainer seal.

How to order

# CATEGORY DETAILS

1

Test Brochure View and download the product brochure here.

2

Ordering Tests

Please complete this form, print, and fax it to 412-224-2776.

PlexEBVTM is a blood test that helps your healthcare provider determine your level of protection from EBV infection after transplantation.

Transplant recipients of any age, individuals that have low general immunity, and those who are at risk for EBV infection can benefit from the PlexEBVTM test.

The PlexEBVTM test must be ordered by your healthcare provider. The test requires a sample of blood of half to one teaspoon. This sample is shipped overnight to Plexision’s laboratory for analysis. Results are sent to your healthcare provider within 24 hours of your sample arriving at the laboratory. Your healthcare provider will help you understand the results.

Test results are available 24 hours after the laboratory receives the blood sample.

The PlexEBVTM test determines whether the recipient has low levels of cell-mediated immunity for EBV infection or not. This immunity is measured by a type of white blood cell called the T-lymphocyte. Low levels immunity to EBV are associated with increased risk of EBV infection. When combined with other clinical and laboratory information, the results of this test can help your healthcare provider decide whether to use more or less immunosuppressive medications or other stronger medications.

The results are reported as the frequency of EBV-specific T-cells. EBV-specific T-cell frequencies of 5.5% or less are associated with increased risk of EBV infection in transplant recipients.

Determining when to increase or lower immunosuppression during EBV infection can help resolve EBV infection or avoid transplant rejection. Knowledge about the level of cell-based immunity to EBV can be combined with other clinical data by your healthcare provider to make such clinical decisions.

The PlexEBVTM test must be ordered by your healthcare provider. The test requisition form is provided here. The completed form can be faxed to 412-224-2776. If there are any questions, please contact (855) PLE.XISION (753.9474) or 412-224-2504.

Plexision will bill your healthcare facility or your insurance plan as indicated on the requisition form. Plexision’s patient assistance plans will assist with the cost of PlexEBVTM if there is no insurance coverage.

US Patent 9606109

*PlexEBVTM is not FDA-approved

About

Plexision develops cellular biomarkers for personalized diagnosis and drug development in solid organ transplantation and immunological disorders. We also pioneer in R&D projects centered on integrating biomarker targets in all phases of drug development, from preclinical to post-marketing. Plexision’s technology can be adapted to

  • - Assess disease risk for several immunological disorders.
  • - Predict the success of a drug for a specific patient.
  • - Develop dosing recommendations for new immunological drugs.

Our state-of-the-art laboratory is CLIA-certified and located in Pittsburgh, PA.

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