Test Catalog

Test Id : EBVQU

Epstein-Barr Virus DNA Detection and Quantification, Plasma

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

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

 

Diagnosis of posttransplant 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

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

Real-Time Polymerase Chain Reaction (PCR) Followed by Minor Groove-Binding (MGB) Probe Hybridization

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

No

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

EBV DNA

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. Freeze plasma specimen immediately, and ship specimen frozen on dry ice.

2. If shipment will be delayed for more than 7 days, freeze plasma specimen at -20 degrees C (up to 30 days) until shipment on dry ice.

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

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions.

2. Pour off plasma into aliquot tube.

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

0.8 mL

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

Gross hemolysis OK
Gross lipemia 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) 30 days
Refrigerated 7 days

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

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

 

Diagnosis of posttransplant 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

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 (posttransplant lymphoproliferative disorders [PTLD]) and AIDS-related lymphoma. The incidence of PTLD ranges from 1% for renal 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, and 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 who are sero-negative (at risk for primary EBV infection) for EBV (most often children) who receive antilymphocyte globulin for induction immunosuppression and OKT-3 treatment for early organ rejection are at 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 100 to 5,000,000 IU/mL (or 2.00-6.70 log IU/mL), with a limit of detection (based on a 95% detection rate) at 45 IU/mL (1.65 log 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 posttransplant 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 "<100 IU/mL" indicates that the EBV DNA level present in the plasma specimen is below 100 IU/mL (or 2.00 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 ">5,000,000 IU/mL" indicates that the EBV DNA level present in the plasma specimen is above 5,000,000 IU/mL (6.70 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 PCR 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 posttransplant lymphoproliferative disorders: PTLD) or decreasing (treatment efficacy) levels of Epstein-Barr virus (EBV) DNA.

 

Nonsymptomatic EBV viremia or viral shedding may occur occasionally in healthy individuals. Therefore, this test should be used only for patients with a clinical history and symptoms consistent with EBV infection, and must be interpreted in the context of patient’s clinical history, signs and symptoms. This test should not be used to screen asymptomatic patients.

 

Only plasma specimens are acceptable for testing with this assay, and lipemic plasma specimens may result in reduced assay sensitivity or assay failure.

 

Due to potential differences in assay performance, serial monitoring of a patient's EBV viral load should be performed using the same exact assay.

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

1. Kimura H, Ito Y, Suzuki R, et al: Measuring Epstein-Barr virus (EBV) load: the significance and application for each EBV-associated disease. Rev Med Virol 2008;18(5):305-319

2. Gulley ML, Tang W: Using Epstein-Barr viral load assays to diagnose, monitor, and prevent post-transplant lymphoproliferative disorder. Clin Microbiol Rev 2010;23(2):350-366

3. Ruf S, Wagner HJ: Determining EBV load: current best practice and future requirements. Expert Rev Clin Immunol 2013;9(2):139-151

4. 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;20(Suppl 7):109-118

5. Jiang SY, Yang JW, Shao JB, et al: Real-time polymerase chain reaction for diagnosing infectious mononucleosis in pediatric patients: a systematic review and meta-analysis. J Med Virol 2016;88(5):871-876.   

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

Testing is performed using a combination of MGB Alert EBV Primer and Probe ASRs (ELITechGroup Molecular Diagnostics, Inc.) and 2x MGB Alert PCR Master Mix with the Abbott m2000 RealTime System (Abbott Molecular, Inc.). The MGB Alert reagents are designed based on minor groove-binding Pleiades probe chemistry. This assay amplifies the p140 region of the BNRF1 gene of Epstein-Barr virus (EBV) for detection and quantification of EBV DNA in human plasma.

 

The Abbott mSample Preparation System kit is used with the automated Abbott m2000sp sample preparation system to extract and purify viral DNA from human plasma specimens, based on magnetic particle technology. An internal control template is introduced into each specimen during sample preparation to assess extraction failure or inhibition during the sample preparation and qPCR processes, respectively. Amplification and detection of target sequence is performed on the Abbott m2000rt instrument. The assay is calibrated to the First World Health Organization International Standard for EBV, NIBSC code: 09/260 by using commercially available EBV verification panels consisting of multiple panel members calibrated to the WHO standard and with EBV DNA levels ranging over 4 log IU/mL.(Unpublished Mayo method)

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, Wednesday, Friday

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.

2 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

14 days

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

Phoenix

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. 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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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

Test Id Test Order Name Order LOINC Value
EBVQU EBV DNA Detect / Quant, P 43730-1
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
65754 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 | 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