CMV antigenemia and quantitative viral load assessments in hematopoietic stem cell transplant recipients

摘要: Abstract Background Sensitive and reliable diagnostic tests are essential for the prevention of cytomegalovirus (CMV) disease after hematopoietic stem cell transplantation (HSCT). pp65 antigenemia polymerase chain reaction (PCR) assays commonly used to monitor CMV in HSCT recipients. However, there is considerable intra- inter-laboratory variability results, which impact comparability clinical practice. Objectives/study design Using 380 samples from 135 recipients, we compared new FDA approved quantitative PCR assay, COBAS ® AmpliPrep/COBAS TaqMan test (CAP/CTM test) developed standardized using 1st WHO International Standard with AMPLICOR MONITOR tests. Results The median time between testing was 57 days (range, 0–207 days). load (log 10 ) 3.17 IU/mL (3.21 copies/mL). Among detectable load, 52% were negative by antigenemia. loads higher antigenemia-positive than samples. One pp65-antigenemia-positive per 100,000 leukocytes corresponded a 1200 IU/mL. determined CAP/CTM slightly lower ones (−0.15 [95% CI, −0.18 −0.13] copies/mL), but slope differences indicated only limited co-linearity. Conclusions more sensitive limit quantification co-linearity international standard renders suitable future trials defining viral thresholds therapy.