Evaluation of diagnostic methods for the detection of cytomegalovirus in recipients of allogeneic stem cell transplants

Background: Although several diagnostic methods are available for the surve illance of patients at risk of human cytomegalovirus (CMV) infection and di sease, little data is available on their comparative performances in the di agnostic setting. Objectives: To compare different assays for CMV detection , especially assays based on (quantitative) DNA and mRNA detection. Study d esign: Eight allogeneic bone marrow and stem cell transplant recipients at high risk for developing CMV disease (donor CMV-negative, recipient positiv e) were regularly tested for 7-20 weeks post-transplant by spin-amplificati on rapid culture from urine (viruria), antigenemia (pp65 assay), pp67 mRNA in whole blood (NASBA). and CMV DNA both qualitatively tin-house PCR, whole blood) and quantitatively tin-house PCR, plasma, Cobas Amplicor(TM) CMV Mo nitor Test, plasma and whole blood, Hybrid Capture(TM), whole blood). Resul ts: Four patients (50%) suffered CMV reactivation during follow-up. Out of 104 sample dates, 41 (39.4%) yielded a positive CMV result in at least one assay. Out of the 28 samples tested by all assays, the highest percentage o f positive results was obtained with the in-house quantitative PCR (60.7%), followed by the Hybrid Capture(TM) system (39.3%), the Cobas Amplicor(TM) CMV Monitor Test, plasma version (35.7%), the Cobas Amplicor(TM) CMV Monito r Test, whole blood version (32.1%), in-house qualitative PCR (28.6%), and the mRNA assay (21.4%). Viruria was positive in one sample and pp65 antigen emia was found in two samples. Conclusions: Despite a considerable incidenc e of CMV reactivations, pre-emptive anti-CMV chemotherapy prevented the dev elopment of CMV disease with the exception of one case. The molecular assay s had superior sensitivity to conventional ones. The antigenemia assay prov ed unsuitable for the surveillance of hematological transplant patients. Ho wever, none of the tests recognized all timepoints with CMV reactivation. F urther comparative studies are needed to determine their respective diagnos tic values. (C) 2001 Elsevier Science B.V. All rights reserved.