Detect Epstein-Barr Virus (EBV) in body fluids.

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.

Transport specimen to Laboratory immediately. Transport fluid on coolant pack or if frozen on dry ice.

LIMIT: One specimen every 48 hours.

Not detected

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

A "Not detected" result may be the result of PCR inhibitors, virus levels below the level of detection of this test, or virus diluted in a large sampling volume. Virus quantitation is not possible due to the nature of the 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.

False negative results may be due to the suppression of viral replication to levels below the detection threshold, insufficient specimen collection volumes, or to inhibitory substances that may be present in the specimen. Note that low specimen collection volumes (such as may be expected from vitreous fluid specimens) will affect the sensitivity of the lower limit of viral detection by this assay. 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 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.