Name: EBV Quantitative by PCR
Test Name: EBV Quantitative by PCR
Health Link Test Code: HCEBVPCR
LIS Test Code: EBVPCR
CPT Code(s): 87799
Methodology: Real-Time PCR
Detect and quantitate Epstein-Barr Virus (EBV) in blood.
Days Performed: Mon-Fri.
In-Lab Turnaround Time: 2 - 3 days.
Stat In-Lab Turnaround Time: Not available stat.
Collection Container: Lavender top
Also Acceptable: Yellow top(with ACD-A/B anticoagulant)
Collection Volume: 6 mL
Pediatric Collection Volume: 2 mL
|Whole Blood||Not acceptable|
||Indefinitely at -70°C|
|7 days at -20°C|
Sample Analyzed: Plasma
Testing Volume: 3 mL
Pediatric Testing Volume: 1.2 mL
For optimal specimen, separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube preferrably within 6 hours of collection. Freeze plasma at -60°C to -80°C (preferred). Prior to freezing, EDTA plasma may also 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.
Transport specimen to Laboratory immediately. If frozen, transport separated plasma on dry ice and keep frozen.
LIMIT: One specimen every 48 hours.
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.]
Interpretation Type: Expected Results
Analytical measurement range for this test is 250-1,000,000 IU/mL (2.40-6.00 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.
DNA sequence polymorphisms in EBV strains may result in underestimation of viral levels. The presence of variations in EBV DNA sequences are monitored in the real-time PCR assay. This assay does not genotype the virus and consequently does not provide any information regarding EBV drug resistance.
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 <250 IU/mL or >1,000,000 IU/mL will be reported. If EBV DNA is not detected, a result of "Not detected" will be reported.
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.