Molecular Diagnostics | EBV Quantitative by PCR

UWHC Lab Test Details
Test NameEBV Quantitative by PCR
Test Code(s)HCEBVPCR
CPT Code(s)87799
MethodologyReal-Time PCR
Clinical Information

Detect and quantitate Epstein-Barr Virus (EBV) in blood.

Days PerformedMon-Fri.
In-Lab Turnaround Time2 - 3 days.
Stat In-Lab Turnaround TimeNot available stat.
Collection Requirements
Patient Preparation

Testing is performed Monday-Friday in batched runs. Specimens received by the Molecular Diagnostic lab by 8:30am will be run same day. If received after 8:30am it will be held to following day.

SpecimenBlood
Collection Container
Collection ContainerLavender top
Also AcceptablePink top tube
Collection Volume6 mL
Pediatric Collection Volume2 mL
Specimen Processing Requirements
Stability
Stability Ambient

72 hours

Stability Refrigerated

72 hours

Stability Frozen
Whole Blood Not acceptable
Plasma

Indefinitely at -70°C
7 days at -20°C
Sample AnalyzedPlasma
Testing Volume3 mL
Pediatric Testing Volume1.2 mL
Specimen Processing

For optimal specimen, separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube or Inpeco tube preferrably within 6 hours of collection. EDTA plasma may be stored at either 2°C to 8°C for up to 72 hours or frozen at -20°C for up to 7 days.

Outreach Specimen Processing

Transport specimen to Laboratory using priority overnight delivery only. If frozen, transport separated plasma on dry ice and keep frozen.

Specimen Transport

Transport specimen to Laboratory immediately. If frozen, transport separated plasma on dry ice and keep frozen.

Unacceptable Criteria

LIMIT: One specimen every 48 hours.

Interpretation
Expected Results

Not detected or low levels

 

The reported concentration of Epstein-Barr virus particles in blood or body fluids may indicate viremia levels and treatment efficacy.

 

Detection of low levels of EBV in specimens containing leukocytes is not unexpected, due to the ubiquitous nature of EBV infection in the population.

 

While detection of EBV in blood is considered more sensitive, clinical studies suggest that cell-free plasma PCR is most specific in the diagnosis of EBV-related disease, including post-transplant lymphoproliferative disorder (PTLD). [Wagner HJ et al., Transplantation, Sept. 27, 2001; vol 72, 1012-1019.]

Test Limitations

Analytical measurement range for this test is 200-5,000,000 IU/mL (2.30-6.70 log10 IU/mL) of specimen.

 

Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation.

 

 

Additional Information

For specimens in which EBV DNA is detected between the analytical measurement range (AMR), a quantitative value (IU/mL) will be reported. If EBV DNA is detected outside the analytical measurement range (AMR), a result of <200 IU/mL or >5,000,000 IU/mL will be reported. If EBV DNA is not detected, a result of "Not Detected" will be reported.

 

A result of "not detected" does not rule out the presence of EBV DNA or the absence of infection. False negative results may be due to the suppression of viral replication to levels below the detection threshold, or to inhibitory substances that may be present in the specimen.

 

DNA sequence polymorphisms in EBV strains may underestimate viral levels. The presence of variations in EBV DNA sequences are monitored in the real-time PCR assay and, if detected, the sample is retested using reagents to alternate amplification targets to verify EBV detection and quantification. This assay does not genotype the virus, and consequently does not provide any information with regard to EBV drug resistance.  

 

The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.