Epstein-Barr Virus (EBV) DNA, Quantitative PCR, Plasma
Test Mnemonic
EBVQNT
CPT Codes
- 87799 - QTY (1)
LOINC ®
47982-4
Aliases
- EBVQNT
- SQEBVQNT
- viral load
- PTLD
- EBV DNA
- EBVDNA
Includes
- EBV DNA
- EBV DNA (IU/mL)
- EBV DNA (log IU/mL)
Performing Laboratory
Cleveland Clinic Laboratories
FDA Category
In Vitro Diagnostic
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA PPT (White) | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Separate plasma by centrifugation (at 1,100 RCF for a minimum of 10 minutes) within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA (Lavender) | Centrifuge, aliquot and refrigerate ASAP. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. | |
| 2 mL | Plasma | Pink KEDTA | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1 mL | Minimum volume for testing is 1.0 mL of plasma. Aliquots must be made from specimen prior to testing in any lab outside of Molecular Microbiology, and must be placed in a sterile aliquot tube. |
Stability
| Environmental Condition | Description |
|---|---|
| Refrigerated | 6 days for plasma separated from whole blood within 24 hours; 24 hours for whole blood unspun/unseparated |
| Ambient | 24 hours for plasma or for whole blood unspun/unseparated |
| Frozen | 6 months for plasma if separated from whole blood and aliquoted into a secondary tube within 24 hours (plasma cannot be frozen in PPT tubes) |
Days Performed
7 days a week
Turnaround Time
1 - 3 days
Methodology
| Name | Description |
|---|---|
| Polymerase Chain Reaction (PCR), Quant |
Reference Range
| EBV DNA | |||||
|---|---|---|---|---|---|
| Sex | Age From | Age To | Type | Range | Range Unit |
| Normal | Not detected |
Clinical Info
Epstein-Barr virus (EBV) is a common viral pathogen that can cause disease in transplant recipients through reactivation of latent virus or through a new primary infection, especially in EBV-negative transplant recipients who receive grafts from EBV-positive donors. For these patients, the most severe form of EBV-related disease is post-transplant lymphoproliferative disorder (PTLD), which results from uncontrolled proliferation of lymphocytes, typically B cells. Early identification of primary EBV infections and DNA level monitoring can support prompt therapeutic intervention to prevent progression to EBV-related disease. cobas EBV is an FDA-approved in vitro nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA in human EDTA plasma. cobas EBV is intended for use as an aid in the management of EBV in transplant patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess response to treatment. The results from cobas EBV are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Negative test results do not preclude EBV infection or EBV disease. Test results must not be the sole basis for patient management decisions. cobas EBV is not intended for use as a screening test for donors of blood or blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps). The assay is a quantitative PCR assay that targets highly-conserved regions of the EBV located in the EBV EBNA-1 gene and the EBV BMRF gene, and is reported out in international units (IU/mL). The linear range of the assay is 35.0 to 100,000,000 IU/mL (1.54 - 8.00 log IU/mL). The lower limit of detection of the assay is 18.8 IU/mL.
Clinical Limitation
For full limitations, refer to the assay instructions for use available on the manufacturer's website. The most important limitations are summarized as follows. Recommendations regarding monitoring EBV viral load post-transplant and medically relevant EBV DNA thresholds vary among transplant type and transplant institutions. While elevated EBV viral load may suggest post-transplant lymphoproliferative disorders (PTLD), the diagnosis of PTLD is made based on histological evaluation of tissue biopsy. PTLD may be present without detectable EBV viral load, and an increase in EBV viral load is not necessarily diagnostic of PTLD. As with any molecular test, mutations within the target regions of cobas EBV could affect primer and/or probe binding resulting in the under-quantitation of virus or failure to detect the presence of virus. Due to the potential for variability in EBV DNA measurements across different EBV assays, it is recommended that the same device be used for the serial quantitation of EBV DNA when managing individual patients.
Clinical Reference
1. Styczynski J, van der Velden W, Fox CP, Engelhard D, de la Camara R, Cordonnier C, Ljungman P; Sixth European Conference on Infections in Leukemia, a joint venture of the Infectious Diseases Working Party of the European Society of Blood and Marrow Transplantation (EBMT-IDWP), the Infectious Diseases Group of the European Organization for Research and Treatment of Cancer (EORTC-IDG), the International Immunocompromised Host Society (ICHS) and the European Leukemia Net (ELN). Management of Epstein-Barr Virus infections and post-transplant lymphoproliferative disorders in patients after allogeneic hematopoietic stem cell transplantation: Sixth European Conference on Infections in Leukemia (ECIL-6) guidelines. Haematologica. 2016 Jul;101(7):803-11. doi: 10.3324/haematol.2016.144428. PMID: 27365460 2. U.S. Food and Drug Administration (FDA). De Novo Evaluation of Automatic Class III Designation for cobas EBV DEN200015. Accessed July 5, 2024. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN200015.pdf.