Multicenter comparison of the digene Hybrid Capture CMV DNA assay (version2.0), the pp65 antigenemia assay, and cell culture for detection of cytomegalovirus viremia

We compared the Digene Hybrid Capture CMV DNA Assay version 2.0, the pp65 a ntigenemia assay, traditional tube culture, and shell vial culture for the detection of cytomegalovirus (CMV) viremia in several patient populations a t three centers, Of 561 blood specimens collected from 402 patients, comple te clinical and laboratory data were available for 489, Using consensus def initions for true positives and true negatives, the sensitivities of the Hy brid Capture assay, antigenemia, shell vial, and tube culture were 95, 94, 43, and 46%, respectively. The specificities of the Hybrid Capture assay an d antigenemia were 95 and 94%, respectively. At all three study sites, the detected level of CMV viremia was significantly higher with the Hybrid Capt ure assay or antigenemia than with shell vial and tube culture. In a group of 131 healthy nonimmunosuppressed volunteers, the Hybrid Capture assay dem onstrated a specificity of over 99%. The Hybrid Capture assay is a standard ized 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 immunocomp romised or immunosuppressed patients. Further evaluation to determine its r ole in predicting CMV disease and for monitoring the therapeutic response t o anti-CMV therapy is needed.