Test ID: LEBV
Epstein-Barr Virus (EBV), Molecular Detection, PCR
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Rapid qualitative detection of Epstein-Barr virus DNA in specimens for laboratory diagnosis of disease due to this virus
Method Name A short description of the method used to perform the test
Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
EBV Detection by PCR (Polymerase Chain Reaction)
EBV Detection by Real-Time PCR
Epstein-Barr Virus Detection by PCR (Polymerase Chain Reaction)
Epstein-Barr Virus Detection by Polymerase Chain Reaction (PCR)
Epstein-Barr Virus Detection by Real-Time PCR
Infectious Mononucleosis
LightCycler EBV
PCR (Polymerase Chain Reaction)
PCR, Epstein-Barr
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Specimen source is required.
Submit only 1 of the following specimens:
Preferred:
Specimen Type: Body fluid
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Collection Instructions: Do not centrifuge.
Specimen Stability Information: Refrigerated (preferred) 7 days/Frozen 7 days
Specimen Type: Ocular (eye) or spinal fluid
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Collection Instructions: Do not centrifuge.
Specimen Stability Information: Refrigerated (preferred) 7 days/Frozen 7 days
Specimen Type: Respiratory
Sources: Bronchial washing, bronchoalveolar lavage, nasopharyngeal aspirate or washing, sputum, or tracheal aspirate
Container/Tube: Sterile container
Specimen Volume: 1.5 mL
Specimen Stability Information: Refrigerated 7 days
Acceptable:
Specimen Type: Amniotic fluid
Container/Tube: Amniotic fluid container
Specimen Volume: 0.5 mL
Specimen Stability Information: Refrigerated (preferred) 7 days/Frozen 7 days
Specimen Type: Bone marrow
Container/Tube: Lavender top (EDTA) only
Specimen Volume: 0.5 mL
Specimen Stability Information: Refrigerated 7 days
Specimen Type: Tissue
Container/Tube: Sterile container
Specimen Volume: Entire collection
Specimen Stability Information: Refrigerated 7 days
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Varies | 7 days |
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's lymphoma, and in Southern China, nasopharyngeal carcinoma. EBV-associated central nervous system (CNS) disease is most commonly 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.
Not applicable
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. This test should not be used to screen asymptomatic patients.
Supportive Data
The following validation data supports the use of this assay for clinical testing.
Accuracy/Diagnostic Sensitivity and Specificity:
30 negative specimens of each matrix accepted for this assay were spiked with Epstein-Barr positive control plasmid at the approximate limit of detection (10-20 targets/mcL). The 30 spiked specimens of each type were run in a blinded manner along with 30 negative (non-spiked) specimens. 93% to 100% of the spiked specimens were positive and 100% of the non-spiked specimens were negative.
Analytical Sensitivity/Limit of Detection (LoD):
The 95% LoD for this assay is <10 targets/mcL 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 herpesvirus (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 of positive for targeted EBV DNA.
Clinical Reference Provides recommendations for further 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
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. 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
4. 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
5. Lau AH, Soltys K, Sindhi RK, et al: Chronic high Epstein-Barr viral load carriage in pediatric small bowel transplant recipients. Pediatr Transplant Jan 20
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 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. (Espy MJ, Patel R, Paya C, Smith TF: Quantification of Epstein-Barr virus viral load in transplant patients by LightCycler PCR. Abstr Gen Meet Am Soc Microbiol 2001;May:20-24)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 6 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87798
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| SRC67 | Specimen Source | 31208-2 |
| 81239 | Result | 23858-4 |
| 6170 | Special Information | 48767-8 |
| 6171 | Report Status | N/A |
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