title: Evaluation of the COBAS Amplicor HCMV Monitor for early detection and monitoring of human cytomegalovirus infection after allogeneic stem cell transplantation.
abstract: Early diagnosis of human cytomegalovirus (HCMV) infection and the introduction of preemptive antiviral therapy have reduced HCMV-related mortality after allogeneic stem cell transplantation. A critical goal remains stratifying risk profiles and minimizing potential harm owing to antiviral overtreatment. We compared the commercially available standardized COBAS Amplicor CMV Monitor (CACM) to an in-house PCR assay, for the monitoring of HCMV infection. Seventy-two patients were surveyed by an in-house PCR of whole blood, quantitative viral load assessment by CACM and virus culture assays in a prospective and a retrospective study. A high concordance between CACM and PCR was documented. The viral load at onset correlated with the peak viral load (Spearman rank correlation R=0.634, P=0.0004). In patients developing HCMV disease, both viral loads were in trend higher (P=0.823, respectively P=0.053), and the viremic episodes longer (P=0.015), as compared to asymptomatically HCMV-infected patients. The serological pre-transplant status was the major risk factor for the development of HCMV disease, showing highest risk for seropositive patients receiving a seronegative graft, whereas donor type (related or unrelated) and graft type (bone marrow or peripheral blood mobilized stem cells) did not have an influence. HCMV infection proved to be a risk factor for the development of non-viral opportunistic infections (P=0.002).
authors.affiliation: Department of Hematology/Oncology, University of Tübingen Medical Center, Tübingen, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Lengerke
authors.forename: T
authors.initials: T
authors.lastname: Ljubicic
authors.forename: C
authors.initials: C
authors.lastname: Meisner
authors.forename: J
authors.initials: J
authors.lastname: Loeffler
authors.forename: C
authors.initials: C
authors.lastname: Sinzger
authors.forename: H
authors.initials: H
authors.lastname: Einsele
authors.forename: H
authors.initials: H
authors.lastname: Hebart
mesh_terms: D000328:Adult; D000368:Aged; D003586:Cytomegalovirus Infections / Q000097:blood* / Q000175:diagnosis* / Q000628:therapy; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005347:Fibroblasts / Q000821:virology; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D012189:Retrospective Studies; D012307:Risk Factors; D012680:Sensitivity and Specificity; D012698:Serologic Tests; D014184:Transplantation, Homologous; D019562:Viral Load
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic