Diagnosis of EBV-associated infectious mononucleosis in individuals with equivocal or discordant Epstein-Barr virus (EBV) serologic marker test results.
Diagnosis of posttransplant lymphoproliferative disorders (PTLD), especially in EBV-seronegative organ transplant recipients receiving antilymphocyte globulin for induction immunosuppression and OKT-3 treatment for early organ rejection.
Monitoring progression of EBV-associated PTLD in organ transplant recipients.
Nonsymptomatic EBV viremia or viral shedding may occur occasionally in healthy individuals. Therefore, this test should be used only for patients with a clinical history and symptoms consistent with EBV infection, and must be interpreted in the context of patient's clinical history, signs and symptoms. This test should not be used to screen asymptomatic patients.
Only plasma specimens are acceptable for testing with this assay, and lipemic plasma specimens may result in reduced assay sensitivity or assay failure.
Serial determination of plasma specimens from organ transplant recipients may be necessary to monitor increasing (risk of development of posttransplant lymphoproliferative disorders: PTLD) or decreasing (treatment efficacy) levels of Epstein-Barr virus (EBV) DNA.
Due to potential differences in assay performance, serial monitoring of a patient's EBV viral load should be performed using the same exact assay.
Reportable Range: 100-5,000,000 IU/mL (or 2.00-6.70 log IU/mL), with a limit of detection (based on a 95% detection rate) at 45 IU/mL (1.65 log IU/mL).
Increasing levels of Epstein-Barr virus (EBV) DNA in serial plasma specimens of a given organ transplant recipient may indicate possible development of posttransplant lymphoproliferative disorder (PTLD).
An "Undetected" result indicates that EBV DNA is not detected in the plasma specimen (see Cautions). If clinically indicated, repeat testing in 1 to 2 months is recommended.
A result of "<100 IU/mL" indicates that the EBV DNA level present in the plasma specimen is below 100 IU/mL (or 2.00 log IU/mL), and the assay cannot accurately quantify the EBV DNA present below this level.
A quantitative value (reported in IU/mL and log IU/mL) indicates the EBV DNA level (ie, viral load) present in the plasma specimen.
A result of ">5,000,000 IU/mL" indicates that the EBV DNA level present in the plasma specimen is above 5,000,000 IU/mL (6.70 log IU/mL), and this assay cannot accurately quantify the EBV DNA present above this level.
An "Inconclusive" result indicates that the presence or absence of EBV DNA in the plasma specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to PCR inhibition or presence of interfering substance. Submission of a new specimen for testing is recommended if clinically indicated.