USEFULNESS OF DNA VIRAL LOAD QUANTIFICATION FOR CYTOMEGALOVIRUS DISEASE MONITORING IN RENAL AND PANCREAS RENAL TRANSPLANT RECIPIENTS/

Background. The purpose of this prospective study was to evaluate the usefulness of quantifying DNA-cytomegalovirus (CMV) load for the diagn osis and monitoring of CMV disease among renal and pancreas transplant patients under immunosuppressive drugs. Methods. A longitudinal study was conducted among 34 consecutive, unselected renal and pancreas/ren al transplanted patients in our unit, During the first 3 posttransplan t months, weekly monitoring of CMV infection and CMV disease was done, involving the determination of viremia by the shell vial assay, quali tative DNAemia by semi-nested polymerase chain reaction (PCR) and quan titative DNAemia by the hybrid capture system (HCS), a new and origina l hybridization method (337 samples were collected for each test). Qua litative and quantitative DNAemia results were blinded to physicians a nd three grades of disease were defined according to CMV related sympt om occurrence. Results. PCR was the most sensitive (100%) but the leas t specific (78%) method for the diagnosis of CMV disease. HCS was spec ific for CMV genome detection, sensitive and reproducible. flood DNA l evels above 60 pg/ml were predictive of severe or moderate CMV disease (sensitivity, 92%; specificity, 100%). A significant decrease in vira l load was observed after ganciclovir administration, and a positive P CR or HCS result at the end of the antiviral treatment was associated with relapse of CMV infection or disease. Conclusions. It is concluded that quantitative DNAemia detection, with this new commercially avail able method, can predict disease and may be useful for a rational eval uation of ganciclovir preemptive therapy in such patients.