Abstract
BackgroundLow levels of Cytomegalovirus (CMV) viral load are frequently detected following allogeneic stem cell transplantation (SCT) and CMV disease may still develop in some allogeneic SCT patients who have negative pp65-antigenemia (pp65-Ag) or undetectable DNA. Pp65Ag is a sensitive method to diagnose CMV infection. Quantitative CMV-DNA PCR assay in plasma has been proposed to monitor CMV infection in SCT patients. We evaluated the clinical utility of pp65Ag and PCR assay in plasma of SCT recipients.MethodsIn a prospective longitudinal study, 38 consecutive patients at risk of CMV infection (donor and/or recipient CMV seropositive) were weekly monitored for CMV infection by both quantitative CMV-PCR in plasma (COBAS AMPLICOR CMV MONITOR) and pp65 Ag, during the first 100 days after SCT.ResultsA total of 534 blood samples were simultaneously analysed for pp65Ag and PCR. Overall, 28/38 patients (74%) had active CMV infection within 100 days from SCT. In 16 patients, CMV was first detected by pp65 Ag alone; in 5 patients by both methods and in 6 by PCR assay alone; one patient had CMV biopsy-proven intestinal disease without pp65Ag and PCR assays positivity before CMV disease. Overall, three patients developed intestinal CMV disease (7.9%): one had negative both pp65Ag and PCR assays before CMV disease, one had disease and concomitant positivity of both methods, while in the remaining patient, only pp65Ag was positive before CMV disease.ConclusionPlasma PCR(COBAS AMPLICOR CMV MONITOR) and pp65Ag assays were effective in detecting CMV infection, however, discordance between both methods were frequently observed. Plasma PCR and pp65Ag assays may be complementary for diagnosis and management of CMV infection.
Highlights
Low levels of Cytomegalovirus (CMV) viral load are frequently detected following allogeneic stem cell transplantation (SCT) and CMV disease may still develop in some allogeneic SCT patients who have negative pp65antigenemia or undetectable DNA
Four of the engrafted patients died within 100 days after SCT: two for progression of acute myeloid leukemia and colon carcinoma, respectively; one for acute GVHD and one for CMV disease associated with acute GVHD
Detection of CMV by pp65 antigenemia, and by the Cobas CMV PCR assays Overall, 568 blood samples were analysed for pp65Ag and/or PCR; of the 35 (6.2%) samples obtained from patients in whom the pp65 Ag assay could not be performed because of the low number of cells, none was positive by plasma PCR assay
Summary
Low levels of Cytomegalovirus (CMV) viral load are frequently detected following allogeneic stem cell transplantation (SCT) and CMV disease may still develop in some allogeneic SCT patients who have negative pp65antigenemia (pp65-Ag) or undetectable DNA. Cytomegalovirus (CMV) infection still causes significant morbidity and mortality following allogeneic stem cell transplantation (SCT) [1] The impact of this infection on transplantation extends beyond the direct clinical manifestations (e.g. pneumonitis, gastrointestinal diseases, hepatitis, marrow suppression) and includes indirect effects such as increased incidence of other opportunistic infections and decreased patient survival [2,3]. Pre-emptive therapy based on pp antigen detection in PBL is associated with a reduction in the incidence of CMV disease in allogeneic SCT recipients [11]. The antigen based diagnostic test has some disadvantages: low sensitivity for detecting early active CMV infection or disease that may occur before engraftment due to the lack of leukocytes during the period of aplasia (requirement of neutrophil counts >0.5 × 109cells/L) and low positive predictive value for the occurrence of CMV gastroenteritis [12,13]. Pp65Ag assay requires processing of the blood samples within few hours, is time consuming, and cannot be automated
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