QUANTIFICATION OF CYTOMEGALOVIRUS DNA IN PERIPHERAL-BLOOD LEUKOCYTES BY A BRANCHED-DNA SIGNAL AMPLIFICATION ASSAY

Quantification of cytomegalovirus (CMV) DNA in blood may aid in the id entification of patients at highest risk for developing CMV disease, t he evaluation of new therapeutics, and the prompt recognition of drug- resistant CMV strains. A branched-DNA (bDNA) assay was developed for t he reliable quantification of CMV DNA in peripheral blood leukocytes, The bDNA assay allowed for the highly specific and reproducible quanti fication of CMV DNA in clinical specimens, Furthermore, the bDNA assay was at least as sensitive as culture techniques and displayed a nearl y 3 log(10) dynamic range in quantification. Changes in CMV DNA levels measured by the bDNA assay in a human immunodeficiency virus-positive patient undergoing therapy were consistent with CMV culture, antigen, and genotype results and correlated with disease progression and resi stance markers. The bDNA assay for the quantification of CMV DNA may p rovide a useful tool that can be used to aid physicians in monitoring disease progression, evaluating therapeutic regimens, and recognizing viral resistance and drug failure.