Test Catalog

Test Id : EBVQN

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Epstein-Barr Virus DNA Detection and Quantification, Plasma

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis of Epstein-Barr virus (EBV)-associated infectious mononucleosis in individuals with equivocal or discordant EBV serologic marker test results

 

Diagnosis of post-transplant lymphoproliferative disorders (PTLD), especially in EBV-seronegative organ transplant recipients receiving antilymphocyte globulin for induction immunosuppression and OKT-3 treatment for early organ rejection

 

Monitoring progression of EBV-associated PTLD in organ transplant recipients

 

This test should not be used to screen asymptomatic patients.

Highlights

This assay detects and quantifies the level of Epstein-Barr virus (EBV) DNA present in the plasma of organ transplant recipients who are at risk of developing EBV-associated post-transplant lymphoproliferative disorder and in individuals with infectious mononucleosis. The assay is calibrated to the First World Health Organization International Standard for EBV for nucleic acid amplification techniques.

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (RT-PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

EBV DNA Detect/Quant, P

Aliases
Lists additional common names for a test, as an aid in searching

EBV DNA

EBV

EBV DNA level

EBV DNA PCR

EBV DNA quant

EBV PCR

EBV quant

EBV viral load

Epstein-Barr virus

Infectious mononucleosis

PTLD

Specimen Type
Describes the specimen type validated for testing

Plasma EDTA

Shipping Instructions

1. Ship specimen frozen on dry ice only.

2. If shipment will be delayed for more than 24 hours, freeze plasma at -20 to -80 degrees C (up to 84 days) until shipment on dry ice.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot plasma into plastic vial.

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 84 days
Refrigerated 6 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis of Epstein-Barr virus (EBV)-associated infectious mononucleosis in individuals with equivocal or discordant EBV serologic marker test results

 

Diagnosis of post-transplant lymphoproliferative disorders (PTLD), especially in EBV-seronegative organ transplant recipients receiving antilymphocyte globulin for induction immunosuppression and OKT-3 treatment for early organ rejection

 

Monitoring progression of EBV-associated PTLD in organ transplant recipients

 

This test should not be used to screen asymptomatic patients.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Primary infection with Epstein-Barr virus (EBV), a DNA virus in the Herpesviridae family, may cause infectious mononucleosis resulting in a benign lymphoproliferative condition characterized by fever, fatigue, sore throat, and lymphadenopathy. Infection occurs early in life, and by 10 years of age, 70% to 90% of children have been infected with this virus. Usually, infection in children is asymptomatic or mild and may be associated with minor illnesses, such as upper respiratory tract infection, pharyngitis, tonsillitis, bronchitis, and otitis media.

 

The target cell for EBV infection is the B lymphocyte. Immunocompromised individuals lacking antibody to EBV are at risk for acute EBV infection that may cause lymphoproliferative disorders in organ transplant recipients (post-transplant lymphoproliferative disorders: PTLD) and AIDS-related lymphoma. The incidence of PTLD ranges from 1% for kidney transplant recipients to as high as 9% for heart/lung transplants and 12% for pancreas transplant patients.

 

EBV DNA can be detected in the blood of patients with this viral infection. Increasing serial levels of EBV DNA in plasma have been shown to correlate highly with subsequent (in 3-4 months) development of PTLD in susceptible patients. Organ transplant recipients (at risk for primary EBV infection) who are seronegative  for EBV (most often children) and receive antilymphocyte globulin for induction immunosuppression and OKT-3 treatment for early organ rejection are at the highest risk for developing PTLD when compared to immunologically normal individuals with prior EBV infection.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Undetected

Interpretation
Provides information to assist in interpretation of the test results

The quantification range of this assay is 35 to 100,000,000 IU/mL (1.54 log to 8.00 log IU/mL), with a limit of detection (95% detection rate) at 19 IU/mL.

 

Increasing levels of Epstein-Barr virus (EBV) DNA in serial plasma specimens of a given organ transplant recipient may indicate possible development of post-transplant lymphoproliferative disorder (PTLD).

 

An "Undetected" result indicates that EBV DNA is not detected in the plasma specimen (see Cautions). If clinically indicated, repeat testing in 1 to 2 months is recommended.

 

A result of "<35 IU/mL" indicates that the EBV DNA level present in the plasma specimen is below 35 IU/mL (1.54 log IU/mL), and the assay cannot accurately quantify the EBV DNA present below this level.

 

A quantitative value (reported in IU/mL and log IU/mL) indicates the EBV DNA level (ie, viral load) present in the plasma specimen.

 

A result of ">100,000,000 IU/mL" indicates that the EBV DNA level present in the plasma specimen is above 100,000,000 IU/mL (8.00 log IU/mL), and this assay cannot accurately quantify the EBV DNA present above this level.

 

An "Inconclusive" result indicates that the presence or absence of EBV DNA in the plasma specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to polymerase chain reaction inhibition or presence of interfering substance. Submission of a new specimen for testing is recommended if clinically indicated.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Serial determination of plasma specimens from organ transplant recipients may be necessary to monitor increasing (risk of development of post-transplant lymphoproliferative disorders) or decreasing (treatment efficacy) levels of Epstein-Barr virus (EBV) DNA.

 

Nonsymptomatic EBV viremia or viral shedding may occasionally occur in healthy individuals. Therefore, this test should be used only for patients with a clinical history and symptoms consistent with EBV infection. Test results must be interpreted in the context of patient's clinical history, signs, and symptoms.

 

Due to potential differences in assay performance, serial monitoring of a patient's EBV viral load should be performed using the same exact assay. On average, this assay quantifies EBV DNA in plasma 3-fold (about 0.48 log IU/mL) higher than the laboratory-developed quantitative EBV DNA assay previously performed at Mayo Clinic Laboratories due to differences in the specimen extraction method and design in the amplification primers and probes for the viral target sequences.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. San-Juan R, Comoli P, Caillard S, et al: Epstein-Barr virus-related post-transplant lymphoproliferative disorder in solid organ transplant recipients. Clin Microbiol Infect. 2014 Sep;20(Suppl 7):109-118. doi: 10.1111/1469-0691.12534

2. Jiang SY, Yang JW, Shao JB, Liao XL, Lu ZH, Jiang H: Real-time polymerase chain reaction for diagnosing infectious mononucleosis in pediatric patients: A systematic review and meta-analysis. J Med Virol. 2016 May;88(5):871-876. doi: 10.1002/jmv.24402

3. Allen UD, Preiksaitis JK, AST Infectious Diseases Community of Practice: Post-transplant lymphoproliferative disorders, Epstein-Barr virus infection, and disease in solid organ transplantation: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep;33(9):e13652. doi: 10.1111/ctr.13652

4. Kimura H, Kwong YL: EBV Viral Loads in diagnosis, monitoring, and response assessment. Front Oncol. 2019 Feb 12;9:62. doi: 10.3389/fonc.2019.00062

Method Description
Describes how the test is performed and provides a method-specific reference

The cobas Epstein-Barr virus (EBV) assay is a US Food and Drug Administration-approved, in vitro nucleic acid amplification test for the quantification of EBV DNA in human EDTA-plasma using the cobas 6800 or 8800 system for fully automated viral nucleic acid extraction (generic silica-based capture technique) and automated amplification and detection of the viral RNA. This dual-target polymerase chain reaction (PCR) assay amplifies 2 highly-conserved target regions within the EBV genome (EBNA-1 and BMRF gene regions) for real-time detection and quantification by 2 target-specific TaqMan probes. A non-EBV armored DNA quantitation standard (DNA-QS) is introduced into each specimen during sample preparation to serve as internal control for nucleic acid extraction and PCR amplification and detection processes. Fluorescent reporter dye-labeled TaqMan probes hybridized to the complementary EBV target sequences and DNA-QS sequence undergo hydrolysis during PCR amplification step to generate fluorescent signal detected in 3 different dye channels. Concentration of the EBV DNA in a patient's plasma sample is determined by a ratio of the intensity of the fluorescent dye from the cleaved EBV target sequence probes to that of the DNA-QS target probe detected throughout the PCR process.(Package insert: cobas EBV-Quantitative nucleic acid test for use on the cobas 6800/8800 Systems. Roche Molecular Systems, Inc; Rev 1.0, 08/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

30 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
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  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87799

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
EBVQN EBV DNA Detect/Quant, P 43730-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
615297 EBV DNA Detect/Quant, P 43730-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports