EVALUATION OF THE DIGENE HYBRID CAPTURE SYSTEM FOR DETECTION AND QUANTITATION OF HUMAN CYTOMEGALOVIRUS VIREMIA IN HUMAN IMMUNODEFICIENCY VIRUS-INFECTED PATIENTS

The Digene Hybrid Capture System (DHCS) is a solution hybridization an tibody capture assay for the chemiluminescent detection and quantitati on of cytomegalovirus (CMV) DNA in leukocytes. This assay was compared with the CMV antigenemia assay and shell vial and tube cultures for t he detection of CMV in 234 blood specimens from 72 patients with human immunodeficiency virus. Intra- and interrun precision of the DHCS ass ay gave coefficients of variation of 17.8 and 16.3%, respectively. The correlation coefficient for the quantitative results obtained by the DHCS assay and the antigenemia assay was 0.911 (95% confidence interva l, 0.885 to 0.930). Agreement between the DHCS assay and the other thr ee assays ranged from 83 to 86%, The DHCS assay detected 71, 87, and 8 4% of specimens that were positive by antigenemia, shell vial cultures , and tube culture, respectively. A total of 92% of specimens that wer e positive by the DHCS assay were also positive by at least one of the other assays. Evaluation of the usefulness of quantitation of CMV DNA by using the DHCS assay and its correlation,vith clinical disease dem onstrated that, with some exceptions, patients with clinical CMV disea se tended to have high levels of DNA whereas asymptomatic patients ten ded to have low or undetectable levels. Overall, the DHCS assay provid ed a rapid, quantitative, and objective measure of CMV activity in leu kocytes, but results did not always correlate with clinical disease.