Test Catalog

Test Id : LEBV

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Epstein-Barr Virus (EBV), Molecular Detection, PCR, Varies

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Overview

Test Catalog

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test EBVPV.

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

Rapid qualitative detection of Epstein-Barr virus (EBV) DNA in specimens

 

Diagnosis of disease due to EBV

 

This test should not be used to screen asymptomatic patients.

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

Real-Time Polymerase Chain Reaction (PCR)/DNA 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

Epstein-Barr Virus PCR

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

EBV (Epstein-Barr Virus)

EBV Detection by PCR (Polymerase Chain Reaction)

EBV Detection by PCR (Polymerase Chain Reaction), Spinal Fluid

EBV Detection by Real-Time PCR

Epstein-Barr Virus Detection by PCR (Polymerase Chain Reaction

Epstein-Barr Virus Detection by PCR (Polymerase Chain Reaction), CSF

Epstein-Barr Virus Detection by Polymerase Chain Reaction (PCR)

Epstein-Barr Virus Detection by Polymerase Chain Reaction (PCR), CSF

Epstein-Barr Virus Detection by Real-Time PCR

Infectious Mononucleosis

LightCycler EBV

PCR (Polymerase Chain Reaction)

PCR, Epstein-Barr

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test EBVPV.

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SRC67 Specimen Source

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

Submit only 1 of the following specimens:

 

Specimen Type: Body fluid

Sources: Spinal, peritoneal, ascites, pericardial, pleural, thoracentesis, amniotic, or ocular

Supplies: Sarstedt Aliquot Tube, 5mL (T914)

Container/Tube:

Preferred: Sterile, screw cap, 5-mL aliquot tube

Acceptable: Sterile container

Specimen Volume: 0.5 mL

Collection Instructions: Do not centrifuge.

 

Specimen Type: Respiratory fluid

Sources: Bronchial washing, bronchoalveolar lavage, nasopharyngeal aspirate or washing, sputum, or tracheal aspirate

Supplies: Sarstedt Aliquot Tube, 5mL

Container/Tube:

Preferred: Sterile, screw cap, 5-mL aliquot tube

Acceptable: Sterile container

Specimen Volume: 1.5 mL

Collection Instructions: Do not centrifuge.

 

Specimen Type: Swab

Sources: Eye and upper respiratory (nasal, throat)

Supplies:

-Culturette (BBL Culture Swab) (T092)

-M4-RT (T605)

Container/Tube: Multimicrobe media (M4-RT) and Eswabs

Collection Instructions: Place swab back into multimicrobe media (M4-RT, M4 or M5)

 

Specimen Type: Bone marrow

Container/Tube: Lavender top (EDTA)

Specimen Volume: 0.5 mL

Additional Information: Clotted specimens will be rejected.

 

Specimen Type: Tissue

Sources: Brain, colon, kidney, liver, lung, cornea, etc.

Supplies: M4-RT (T605)

Container/Tube:

Preferred: Multimicrobe medium (M4-RT)

Acceptable: Sterile container containing 1 to 2 mL of sterile saline or multimicrobe medium (M4-RT, M4 or M5)

Specimen Volume: Entire collection

Collection Instructions: Submit only fresh tissue

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Fluids: 0.3 mL; Respiratory Specimens: 1 mL; Tissue: 2 x 2-mm biopsy; Swab: See Specimen Required

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

Calcium alginate-tipped swab
Wood swab
Transport swab containing gel
Formalin-fixed and paraffin-embedded tissues
Heat inactivated specimens 		Reject

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
Varies Refrigerated (preferred) 7 days
Frozen 7 days

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test EBVPV.

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

Rapid qualitative detection of Epstein-Barr virus (EBV) DNA in specimens

 

Diagnosis of disease due to EBV

 

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

Epstein-Barr virus (EBV) is the causative agent of infectious mononucleosis, Burkitt lymphoma, and in Southern China, nasopharyngeal carcinoma. EBV-associated central nervous system (CNS) disease is most frequently associated with primary CNS lymphoma in patients with AIDS. In addition, CNS infection associated with the detection of EBV DNA can be seen in immunocompetent patients.

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.

Negative

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Detection of Epstein-Barr virus (EBV) DNA in cerebrospinal fluid (CSF) supports the clinical diagnosis of central nervous system (CNS) disease due to the virus. EBV DNA is not detected in CSF from patients without CNS disease caused by this virus.

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

A negative result does not eliminate the possibility of Epstein-Barr virus (EBV) infection of the central nervous system.

 

This assay may detect viremia or viral shedding in asymptomatic individuals. However, this assay is only to be used for patients with a clinical history and symptoms consistent with EBV infection and must be interpreted in the context of the clinical picture.

Supportive Data

The following validation data supports the use of this assay for clinical testing.

 

Epstein-Barr Virus:

Accuracy/Diagnostic Sensitivity and Specificity:

To assess the accuracy of the Epstein-Barr virus (EBV) laboratory-developed test (LDT), known previously positive clinical specimens (20 positive, 30 negative) were tested, and the results compared to those of a laboratory-developed reference polymerase chain reaction (PCR) method.

 

EBV LDT

EBV reference LDT

Positive

Negative

Positive

20

0

Negative

0

30

Total

20

30

 

Sensitivity (95% CI): 100% (81-100)

Specificity (95% CI): 100% (86-100)

 

Analytical Sensitivity/Limit of Detection:

The 95% limit of detection (LOD) for this assay is less than 10 targets per microliter using plasmid and whole virus spiked into matrix. The LOD was confirmed in each matrix type that is accepted for testing with this assay. 

 

Analytical Specificity:

No PCR signal was obtained from extracts of 40 bacterial and viral isolates that could cause similar symptoms including herpes simplex virus 1 and 2; cytomegalovirus; varicella zoster virus; and human herpes virus (HHV) 6, HHV 7, and HHV 8.

 

Precision:

Interassay precision was 100%, and intraassay precision was 100%.

 

Reportable Range:

This is a qualitative assay, and results are reported as either negative or positive for targeted EBV DNA.

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

1. Tachikawa N, Goto M, Hoshino Y, et al: Detection of Toxoplasma gondii, Epstein-Barr virus, and JC virus DNAs in the cerebrospinal fluid in acquired immunodeficiency syndrome patients with focal central nervous system complications. Intern Med. 1999;38(7):556-562. doi: 10.2169/internalmedicine.38.556

2. Antinori A, Cingolani A, De Luca A, et al: Epstein-Barr virus in monitoring the response to therapy of acquired immunodeficiency syndrome-related primary central nervous system lymphoma. Ann Neurol. 1999;45(2):259-261

3. Cingolani A, De Luca A, Larocca LM, et al: Minimally invasive diagnosis of acquired immunodeficiency syndrome-related primary central nervous system lymphoma. J Natl Cancer Inst. 1998;90(8):364-369. doi: 10.1093/jnci/90.5.364

4. Niller HH, Wolf H, Minarovits J: Regulation and dysregulation of Epstein-Barr virus latency: implications for the development of autoimmune disease. Autoimmunity. 2008:41(4):298-328. doi: 10.1080/08916930802024772

5. Studahl M, Hagberg L, Rekvdar E, Bergstrom T: Herpesvirus DNA detection in cerebrospinal fluid: difference in clinical presentation between alph-, beta-, and gamma-herpes viruses. Scand J Infect Dis. 2000;32(3):237-248. doi: 10.1080/00365540050165857

6. Lau AH, Soltys K, Sindhi RK, Bond G, Mazariegos GV, Green M: Chronic high Epstein-Barr viral load carriage in pediatric small bowel transplant recipients. Pediatr Transplant. 2010;14(4):549-553. doi: 10.1111/j.1399-3046.2009.01283.x

7. Fugl A, Andersen CL: Epstein-Barr virus and its association with disease - a review of relevance to general practice. BMC Fam Pract. 2019 May 14;20(1):62. doi: 10.1186/s12875-019-0954-3

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test EBVPV.

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

Viral nucleic acid is extracted by the MagNA Pure automated instrument (Roche Applied Science) from clinical specimens. Primers are directed to the target gene (latent membrane protein). The LightCycler instrument amplifies and monitors by fluorescence the development of target nucleic acid sequences after the annealing step during polymerase chain reaction (PCR) cycling. This is an automated PCR system that can rapidly detect (30-40 minutes) amplicon development through stringent air-controlled temperature cycling in capillary cuvettes. The detection of amplified products is based on the fluorescence resonance energy transfer (FRET) principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3' end is excited by an external light source and emits light that is absorbed by a second hybridization probe with an acceptor fluorophore, LC-Red 640, at the 5' end. The acceptor fluorophore then emits a light of a different wavelength that can be measured with a signal that is proportional to the amount of specific PCR product. Melting curve analysis is performed following PCR amplification. Starting at 45 degrees C, the temperature in the thermal chamber is slowly raised to 80 degrees C and the fluorescence is measured at frequent intervals. Analysis of the PCR amplification and probe melting curves is accomplished through the use of LightCycler software.(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 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.

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

Jacksonville

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test EBVPV.

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 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 was developed using an analyte specific reagent. Its performance characteristics were 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.

87798

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
LEBV Epstein-Barr Virus PCR 23858-4
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.
SRC67 Specimen Source 31208-2
81239 Epstein-Barr Virus PCR 23858-4

This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test EBVPV.

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