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Journal of Clinical Microbiology, February 2000, p. 600-606, Vol. 38, No. 2
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Evaluation of the COBAS AMPLICOR CMV MONITOR Test for Detection of Viral DNA in Specimens Taken from Patients after Liver Transplantation

Irene G. Sia,1 Jennie A. Wilson,1,2 Mark J. Espy,3 Carlos V. Paya,1,2,3 and Thomas F. Smith1,*

Division of Clinical Microbiology,3 Division of Infectious Diseases,1 and Transplantation Center,2 Mayo Clinic and Foundation, Rochester, Minnesota 55905

Received 21 May 1999/Returned for modification 25 June 1999/Accepted 8 November 1999

Detection of cytomegalovirus (CMV) DNA in blood by PCR is a sensitive method for the detection of infection in patients posttransplantation. The test, however, has low specificity for the identification of overt CMV disease. Quantitative CMV PCR has been shown to overcome this shortcoming. The COBAS AMPLICOR CMV MONITOR test was evaluated by using consecutive serum and peripheral blood mononuclear cell (PBMN) samples from liver transplant patients. Twenty-five patients had CMV viremia (by shell vial cell culture assay) and/or tissue-invasive disease (by biopsy); 20 had no active infection. A total of 262 serum and 62 PBMN specimens were tested. Of 159 serum specimens from patients with overt CMV infection, the COBAS assay detected CMV DNA in 21 patients (sensitivity, 84%). Only 1 of 103 samples from patients with no evidence of active infection had detectable CMV DNA (341 copies/ml). By comparison of 62 matching serum and PBMN samples by the same assay, 12 PBMN samples were exclusively positive, whereas only 2 serum samples were exclusively positive (P < 0.05). At the time of clinical CMV infection, viral copy numbers were higher in PBMNs than serum from four of five patients. The COBAS AMPLICOR CMV MONITOR test is a sensitive and specific test for the quantitative detection of CMV DNA in blood. Clinical applications of the assay will require further validation with samples from a larger population of transplant patients.

* Corresponding author. Mailing address: Division of Clinical Microbiology, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905. Phone: (507) 284-8146. Fax: (507) 284-4272. E-mail: tfsmith{at}mayo.edu.

Journal of Clinical Microbiology, February 2000, p. 600-606, Vol. 38, No. 2
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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