The performances of a commercially available qualitative plasma PCR assay (AMPLICOR CMV test; Roche Diagnostics) and the pp65 antigenemia assay (AG) were evaluated for the monitoring of cytomegalovirus (CMV) viremia in 43 allogeneic stem cell transplant recipients. In addition, the suitabilities of both assays for triggering the initiation of preemptive ganciclovir therapy were assessed. A total of 37 CMV viremic episodes were detected in 28 patients. Positivity of plasma PCR testing in one or more consecutive specimens was the only marker of CMV viremia in 18 of the 37 episodes (PCR positive and AG negative, n ؍ 50 specimens). Five episodes were diagnosed on the basis of a single positive AG result (AG positive and PCR negative, n ؍ 5 specimens); both assays were eventually positive (PCR positive and AG positive, n ؍ 27 specimens) for 14 viremic episodes; for these episodes, conversion of the PCR assay result to a positive result occurred an average of 1 week before conversion of the AG result. Overall, the concordance between the two methods was 90%, and the sensitivities of the plasma PCR assay and AG for the detection of CMV viremic episodes were 86.5 and 51.3%, respectively. Two patients who tested positive by both assays simultaneously progressed to CMV end-stage organ disease, despite the initiation of preemptive ganciclovir therapy. Conversion of the AG result to a negative result upon administration of preemptive ganciclovir therapy occurred a median of 7.5 days earlier than conversion of the plasma PCR assay result. Nineteen of the 28 patients with CMV viremia received AG-guided preemptive ganciclovir therapy; had the positivity of the plasma PCR assay triggered the initiation of preemptive therapy, 9 additional patients would have been unnecessarily treated since none of them developed CMV end-stage organ disease. Although the AMPLICOR CMV assay is more sensitive than AG, the latter appears to be more suitable both for guiding the initiation of preemptive therapy and for monitoring a patient's response to antiviral therapy.Cytomegalovirus (CMV) infection remains a significant cause of morbidity and mortality in allogeneic stem cell or bone marrow transplant recipients (23,24). The prevention of CMV end-stage organ disease is therefore a major goal in the clinical management of these patients. Three major therapeutic strategies have been developed to this effect: universal administration of ganciclovir (12, 27), selective use of ganciclovir for patients displaying viremia before CMV end-stage organ disease occurs (so-called preemptive therapy) (13,25), and a risk-adapted preemptive therapy by which only patients at the highest risk of developing CMV end-stage organ disease (i.e., those with high-grade graft-versus-host disease or high-level CMV antigenemia) receive ganciclovir upon detection of CMV viremia (20). Of these, the last two approaches are the most commonly used since the indiscriminate use of ganciclovir causes myelosuppression, resulting in an increased incidence of fungal and bacteri...