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Journal of Clinical Microbiology, October 1999, p. 3124-3132, Vol. 37, No. 10
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Evaluation of New Quantitative Assays for Diagnosis and Monitoring of Cytomegalovirus Disease in Human Immunodeficiency Virus-Positive Patients

Isabelle Pellegrin,1,* Isabelle Garrigue,1 Christine Binquet,2 Genevieve Chene,2 Didier Neau,3 Pascal Bonot,1 Fabrice Bonnet,3 Herve Fleury,1 and Jean-Luc Pellegrin3

Laboratoire de Virologie,1 INSERM U330,2 and Services de Medecine Interne et de Maladies Infectieuses,3 Centre Hospitalier Regional et Université Victor Segalen, Bordeaux, France

Received 11 March 1999/Returned for modification 25 May 1999/Accepted 5 July 1999

Cobas Amplicor CMV Monitor (CMM) and Quantiplex CMV bDNA 2.0 (CMV bDNA 2.0), two new standardized and quantitative assays for the detection of cytomegalovirus (CMV) DNA in plasma and peripheral blood leukocytes (PBLs), respectively, were compared to the CMV viremia assay, pp65 antigenemia assay, and the Amplicor CMV test (P-AMP). The CMV loads were measured in 384 samples from 58 human immunodeficiency virus (HIV) type 1-infected, CMV-seropositive subjects, including 13 with symptomatic CMV disease. The assays were highly concordant (agreement, 0.88 to 0.97) except when the CMV load was low. Quantitative results for plasma and PBLs were significantly correlated (Spearman rho  = 0.92). For PBLs, positive results were obtained 125 days before symptomatic CMV disease by CMV bDNA 2.0 and 124 days by pp65 antigenemia assay, whereas they were obtained 46 days before symptomatic CMV disease by CMM and P-AMP. At the time of CMV disease diagnosis, the sensitivity, specificity, and positive and negative predictive values of CMV bDNA 2.0 were 92.3, 97.8, 92.3, and 97.8%, respectively, whereas they were 92.3, 93.3, 80, and 97.8%, respectively, for the pp65 antigenemia assay; 84.6, 100, 100, and 95.7%, respectively, for CMM; and 76.9, 100, 100, and 93.8%, respectively, for P-AMP. Considering the entire follow-up, the sensitivity, specificity, and positive and negative predictive values of CMV bDNA 2.0 were 92.3, 73.3, 52.1, and 97.1%, respectively, whereas they were 100, 55.5, 39.4, and 100%, respectively, for the pp65 antigenemia assay; 92.3, 86.7, 66.7, and 97.5%, respectively, for CMM; and 84.6, 91.1, 73.3, and 95.3%, respectively, for P-AMP. Detection of CMV in plasma is technically easy and, despite its later positivity (i.e., later than in PBLs), can provide enough information sufficiently early so that HIV-infected patients can be effectively treated. In addition, these standardized quantitative assays accurately monitor the efficacy of anti-CMV treatment.

* Corresponding author. Mailing address: Laboratoire de Virologie, Hopital Pellegrin, Place Amélie Raba Léon, 33076 Bordeaux, France. Phone: 33-5 56 79 55 10. Fax: 33-5 56 79 56 73. E-mail: isabelle.pellegrin{at}chu-aquitaine.fr.

Journal of Clinical Microbiology, October 1999, p. 3124-3132, Vol. 37, No. 10
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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Antimicrob. Agents Chemother. Clin. Microbiol. Rev.
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Copyright © 1999 by the American Society for Microbiology. All rights reserved.