Development of a quantitative assay to measure EBV viral load in patients with autoimmune type 1 diabetes and healthy subjects.

Clinical studies of immune modulating agents such as otelixizumab, an anti-CD3 monoclonal antibody that is being investigated as a possible treatment for type 1 diabetes, required a sensitive, specific, reproducible method of quantifying Epstein-Barr virus (EBV) load in healthy adults and in patients with conditions not generally associated with increased EBV levels. An assay was developed using a commercial kit and was fully validated. To enhance assay sensitivity and reproducibility, viral load was quantified per 10(6) peripheral blood mononuclear cells (PBMCs) rather than per ml blood.