Test Highlight: New Test Live February 21, 2023

Test Code Test Name
3006079 Epstein-Barr Virus by Quantitative NAAT, Plasma

Epstein-Barr virus (EBV), also known as human herpesvirus 4, is one of the most common human viruses and many people are infected by the virus at some point in their lives. Following the initial infection, the virus becomes latent and can reactivate if the immune system is weakened. EBV causes infectious mononucleosis as well as a range of other illnesses in those with weakened immune systems.1 The main complication involving EBV infection, both in recipients of hematopoietic stem cells and solid organs, is posttransplant lymphoproliferative disease.

Diagnosis of EBV-related diseases can be challenging. Timely detection and quantification of the viral load are especially important in the care and treatment of immunocompromised patients. To assist in the detection and surveillance of EBV infection and EBV-related complications of transplantation, ARUP now offers an FDA-cleared assay for the quantification of EBV DNA in plasma specimens.

Benefits of the New Test

  • The FDA-cleared assay is more sensitive than the inactivated test, 0051352, Epstein-Barr Virus by Quantitative PCR.
  • The assay supports the standardization of EBV results across the laboratory industry to optimize treatment.
    • Results will now be reported in international units (IU) instead of copies.
  • Transition to FDA-cleared assays supports more stringent vendor quality, which works hand in hand with ARUP’s overall quality plan.
  • The test involves a consistent specimen type, which is preferred for patient monitoring.
  • Testing that is FDA-approved is easier to bill to Medicare. You will no longer need to submit an additional code on claims to be reimbursed for this testing. Also, insurance reimbursement is more consistent for FDA-approved tests.

Frequently Asked Questions

What are the differences between the inactivated Epstein-Barr Virus by Quantitative PCR (0051352) and the new Epstein-Barr Virus by Quantitative NAAT, Plasma test (3006079)?

 

 0051352 Epstein-Barr Virus by Quantitative PCR
(inactivation 2-21-23)		 3006079 Epstein-Barr Virus by Quantitative NAAT, Plasma

Reference range

2.6–7.6 log copies/mL
390–39,000,000 copies/mL

1.54–8.00 log IU/mL
35–100,000,000 IU/mL

TAT

1–4 days

1–4 days

Sample types

Serum, plasma, whole blood, CSF

Plasma

Sample stability

Ambient: 24 hours
Refrigerated: 5 days
Frozen: 1 year

Ambient: unacceptable
Refrigerated: 6 days
Frozen: 6 months

Category

LDT
NY approved

FDA cleared 
NY approved

Sample volume

1 mL

2 mL

CPT code

87799

87799

Which genotypes are detected by the Epstein-Barr Virus by Quantitative NAAT, Plasma, test (3006079)?

The test detects Epstein-Barr virus genotypes 1 and 2.

I would like to submit a specimen other than plasma. What should I order? ?

For specimen types other than plasma, order 0050246, Epstein-Barr Virus by Qualitative PCR.

I am tracking my patient’s viral load. Is there a need to rebaseline?

Based on verification studies, one IU/mL of EBV DNA measured by 3006079, Epstein-Barr Virus by Quantitative NAAT, Plasma, is approximately equal to 0.12 copies/mL reported by 0051352, Epstein-Barr Virus by Quantitative PCR. This conversion factor between IU/mL and copies/mL was established during verification of 3006079, Epstein-Barr Virus by Quantitative NAAT, Plasma. 

References

  1. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Epstein-Barr and mononucleosis: for healthcare providers. [Updated: Sep 2020; Accessed: Dec 2022]