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

Abstract

Summary:Early diagnosis of CMV infection based on sensitive diagnostic assays has helped to reduce CMV-related mortality after allogeneic stem cell transplantation (SCT). In this study, the commercialized Murex CMV DNA Hybrid Capture assay (version 2.0) (HCS) was prospectively compared to an in-house CMV-DNA PCR assay from whole blood in patients after allogeneic stem cell transplantation. Overall, a high concordance between HCS and PCR was documented (kappa = 0.686; n = 385). The HCS assay was found to be as sensitive as the PCR indicating active CMV infection at a median of 35 and 34 days after transplantation, respectively. None of the HCS-negative patients developed CMV-related symptoms (negative predictive value 100%). Declining CMV DNA load in the blood was found to be an indicator for effective antiviral therapy, whereas persistence of a high viral load was associated with fatal CMV disease. In conclusion, the Hybrid Capture CMV DNA assay (v 2.0) allows early diagnosis of CMV infection after allogeneic SCT and assessment of the efficacy of antiviral therapy. Bone Marrow Transplantation (2001) 28, 213-218.

Evaluation of the COBAS Amplicor HCMV Monitor for early detection and monitoring of human cytomegalovirus infection after allogeneic stem cell transplantation

“…11,17 More recently, pp65-antigenemia assays and PCR methods have been established for HCMV monitoring of patients at risk. 14,18,19 Preemptive antiviral therapy based on pp65-antigenemia and HCMV-DNA PCR assays has been shown to significantly reduce both HCMV disease incidence and HCMV-associated mortality following allogeneic SCT in the early post transplant period, 11,12,[20][21][22][23] and has become a standard of care in many transplant centers. Preemptive ganciclovir therapy based on HCMV-pp65-antigenemia has resulted in an HCMV disease rate of approximately 14%.…”

Valganciclovir is safe and effective as pre-emptive therapy for CMV infection in allogeneic hematopoietic stem cell transplantation

“…The negative predictive value for hybrid capture assay was 100%. 23,24 Cultures from urine, bronchoalveolar lavage, or organ tissues were prepared by shell vial culture when indicated by the clinical setting.…”

Management of CMV infections: recommendations from the infectious diseases working party of the EBMT

“…[10][11][12][13] Other techniques for detecting DNA such as the hybrid capture assay have also been introduced. 14 The specimen used for PCR varies between different laboratories and whole blood, or peripheral blood leukocytes, or plasma can be used. The previously used shell vial (rapid culture or DEAFF test) is today regarded as too insensitive for monitoring at least high-risk allogeneic SCT patients.…”