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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.
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