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Rapid qualitative detection of Epstein-Barr virus DNA in specimens for laboratory diagnosis of disease due to this virus
Epstein-Barr virus (EBV) is the causative agent of infectious mononucleosis, Burkitt's lymphoma, and in Southern China, nasopharyngeal carcinoma. EBV-associated central nervous system (CNS) disease is most commonly associated with primary CNS lymphoma in patients with AIDS. In addition, CNS infection associated with the detection of EBV DNA can be seen in immunocompetent patients.
Detection of Epstein-Barr virus (EBV) DNA in cerebrospinal fluid (CSF) supports the clinical diagnosis of central nervous system (CNS) disease due to the virus. EBV DNA is not detected in CSF from patients without CNS disease caused by this virus.
A negative result does not eliminate the possibility of Epstein-Barr virus (EBV) infection of the central nervous system.
This assay may detect viremia or viral shedding in asymptomatic individuals. However, this assay is only to be used for patients with a clinical history and symptoms consistent with EBV infection, and must be interpreted in the context of the clinical picture. This test should not be used to screen asymptomatic patients.
Thirty negative specimens of each matrix accepted for this assay were spiked with Epstein-Barr positive control plasmid at the approximate limit of detection (10-20 targets/mcL). The 30 spiked specimens of each type were run in a blinded manner along with 30 negative (nonspiked) specimens; 93% to 100% of the spiked specimens were positive and 100% of the nonspiked specimens were negative.
Analytical Sensitivity/Limit of Detection (LoD):
The 95% LoD for this assay is <10 targets per microliter using plasmid and whole virus spiked into matrix. The LoD was confirmed in each matrix type that is accepted for testing with this assay.
No PCR signal was obtained from extracts of 40 bacterial and viral isolates that could cause similar symptoms including herpes simplex virus 1 and 2; cytomegalovirus; varicella zoster virus; and human herpesvirus (HHV) 6, HHV 7, and HHV 8.
Interassay precision was 100% and intra-assay precision was 100%.
This is a qualitative assay and results are reported as either negative of positive for targeted EBV DNA.
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