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Journal of Clinical Microbiology, May 1998, p. 1333-1337, Vol. 36, No. 5
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Evaluation of Murex CMV DNA Hybrid Capture Assay for Detection and Quantitation of Cytomegalovirus Infection in Patients following Allogeneic Stem Cell Transplantation

Holger Hebart,1,* Daphne Gamer,1 Juergen Loeffler,1 Claudia Mueller,1 Christian Sinzger,2 Gerhard Jahn,2 Peter Bader,3 Thomas Klingebiel,3 Lothar Kanz,1 and Hermann Einsele1

Medizinische Klinik und Poliklinik, Abteilung II und Sektion für Transplantationsimmunologie und Immunhämatologie,1 Institut für Epidemiologie und Klinik der Viruskrankheiten,2 and Universitätskinderklinik, Abteilung Kinderheilkunde 1,3 72076 Tübingen, Germany

Received 2 October 1997/Returned for modification 2 December 1997/Accepted 26 January 1998

Murex hybrid capture DNA assay (HCS) is a solution hybridization antibody capture assay for detection and quantitation of cytomegalovirus (CMV) DNA in leukocytes. To determine whether CMV HCS is sensitive enough to initiate and monitor antiviral therapy after allogeneic stem cell transplantation (SCT), 51 consecutive SCT recipients were prospectively screened for the appearance of CMV infection by HCS, PCR, and culture assays from blood samples. Preemptive antiviral therapy was initiated after the second positive PCR result in all patients, as previously reported, and HCS was not considered for clinical decision making. A total of 417 samples were analyzed. Of these, 21 samples were found to be positive by PCR and HCS, 88 samples were PCR positive but HCS negative, and 308 were negative by both assays. Concordance of results between PCR and HCS and between HCS and blood culture was observed in 78.9 and 95.9% of the samples assayed, respectively. PCR was found to be more sensitive than HCS, and HCS was more sensitive than the blood culture assay (P < 0.0001). Four patients with symptomatic CMV infection were PCR positive prior to the onset of CMV-related symptoms, whereas HCS detected CMV DNA in three patients prior to and one at onset of CMV disease. The numbers of genomes per milliliter of blood were higher in patients with symptomatic CMV infection than in those with asymptomatic CMV infection (P = 0.06). None of the HCS-negative patients developed CMV disease. Thus, all patients with CMV disease were correctly identified by HCS; however, the lower sensitivity limit of the HCS assay may still be insufficient to allow diagnosis of CMV infection early enough to prevent CMV disease in patients following allogeneic SCT.

* Corresponding author. Mailing address: Medizinische Klinik und Poliklinik, Abteilung II, Otfried-Müller-Str.10, D-72076 Tübingen, Germany. Phone: 0049 7071 2982712. Fax: 0049 7071 293179. E-mail: holger.hebart{at}uni-tuebingen.de.

Journal of Clinical Microbiology, May 1998, p. 1333-1337, Vol. 36, No. 5
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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