Prediction and diagnosis of cytomegalovirus disease in renal transplant recipients using qualitative and quantitative polymerase chain reaction.

Abstract

Preemptive antiviral therapy against cytomegalovirus (CMV) disease after transplantation requires information from suitable laboratory markers. We examined the use of qualitative and quantitative polymerase chain reaction (PCR) to monitor renal transplant recipients. A cohort of 77 renal transplant recipients was monitored using an in-house and a commercial (Amplicor; Roche Diagnostic, Basel, Switzerland) PCR on leukocytes and plasma. Quantitative plasma viral load was determined using a commercial PCR kit (CMV Monitor; Roche Diagnostic). Patients were analyzed according to their pretransplantation CMV serological status (R- or R+). Seventeen patients developed CMV disease after transplantation. Qualitative leukocyte PCRs had the best overall sensitivity (54-69%) and specificity (75-87%) in identifying R- recipients with CMV disease before onset. The specificities of qualitative PCRs for R+ recipients were poor and, if used, could result in unnecessary preemptive treatment in up to 50% of patients. Symptomatic and asymptomatic R+, but not R-, recipients could be distinguished using a plasma viral load of 25,000 copies/ml. An increase in viral load of >0.7 log (fivefold) per week also distinguished between symptomatic and asymptomatic R+ recipients with high sensitivity (100%) and specificity (95%). Qualitative leukocyte PCRs were the best assays to predict CMV disease for R- recipients who received R+ kidneys. None of the qualitative assays could be used to guide preemptive therapy of R+ recipients, but plasma viral load and its incremental rate could be used as diagnostic tools in R+ recipients.