Evaluation of the Murex CMV DNA Hybrid Capture assay (version 2.0) for early diagnosis of cytomegalovirus infection in recipients of an allogeneic stem cell transplant

Early diagnosis of CMV infection based on sensitive diagnostic assays has h elped to reduce CMV-related mortality after allogeneic stem cell transplant ation (SCT). In this study, the commercialized Murex CMV DNA Hybrid Capture assay (version 2.0) (HCS) was prospectively compared to an in-house CMV-DN A PCR assay from whole blood in patients after allogeneic stem cell transpl antation. Overall, a high concordance between HCS and PCR was documented (k appa = 0.686; n = 385). The HCS assay was found to be as sensitive as the P CR indicating active CMV infection at a median of 35 and 34 days after tran splantation, respectively. None of the HCS-negative patients developed CMV- related symptoms (negative predictive value 100%). Declining CMV DNA load i n the blood was found to be an indicator for effective antiviral therapy, w hereas persistence of a high viral load was associated with fatal CMV disea se. In conclusion, the Hybrid Capture CMV DNA assay (v 2.0) allows early di agnosis of CMV infection after allogeneic SCT and assessment of the efficac y of antiviral therapy.