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Journal of Clinical Microbiology, April 1999, p. 958-963, Vol. 37, No. 4
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Multicenter Comparison of the Digene Hybrid Capture CMV DNA Assay (Version 2.0), the pp65 Antigenemia Assay, and Cell Culture for Detection of Cytomegalovirus Viremia

Tony Mazzulli,1,2,3,* Lawrence W. Drew,2,4,5 Belinda Yen-Lieberman,6 Dragana Jekic-McMullen,4,5 Debra J. Kohn,6 Carlos Isada,6 George Moussa,1,2 Robert Chua,1,2 and Sharon Walmsley1,2,3,7

Mt. Sinai Hospital,1 Princess Margaret Hospital,2 The Toronto Hospital,7 and University of Toronto,3 Toronto, Ontario, Canada; Mount Zion Medical Center4 and University of California,5 San Francisco, California; and Cleveland Clinic Foundation, Cleveland, Ohio6

Received 25 June 1998/Returned for modification 2 September 1998/Accepted 15 January 1999

We compared the Digene Hybrid Capture CMV DNA Assay version 2.0, the pp65 antigenemia assay, traditional tube culture, and shell vial culture for the detection of cytomegalovirus (CMV) viremia in several patient populations at three centers. Of 561 blood specimens collected from 402 patients, complete clinical and laboratory data were available for 489. Using consensus definitions for true positives and true negatives, the sensitivities of the Hybrid Capture assay, antigenemia, shell vial, and tube culture were 95, 94, 43, and 46%, respectively. The specificities of the Hybrid Capture assay and antigenemia were 95 and 94%, respectively. At all three study sites, the detected level of CMV viremia was significantly higher with the Hybrid Capture assay or antigenemia than with shell vial and tube culture. In a group of 131 healthy nonimmunosuppressed volunteers, the Hybrid Capture assay demonstrated a specificity of over 99%. The Hybrid Capture assay is a standardized assay that is simple to perform and can utilize whole blood specimens that have been stored for up to 48 h. The high sensitivity and specificity of the Hybrid Capture assay along with its simplicity and flexibility make it a clinically useful assay for the detection of CMV viremia in immunocompromised or immunosuppressed patients. Further evaluation to determine its role in predicting CMV disease and for monitoring the therapeutic response to anti-CMV therapy is needed.

* Corresponding author. Mailing address: Department of Microbiology, Mount Sinai Hospital, 600 University Ave., Toronto, Ontario M5G 1X5, Canada. Phone: (416) 586-4695. Fax: (416) 586-8746. E-mail: tmazzulli{at}mtsinai.on.ca.

Journal of Clinical Microbiology, April 1999, p. 958-963, Vol. 37, No. 4
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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