The Digene Hybrid Capture (HC) System is a new molecular assay used for the detection of CMV DNA from blood specimens (Digene Diagnostics, Inc.). The assay is performed on white blood cell pellets and does not require molecular amplification or cell culture. Results are available in 4-6 hours. METHODS: We compared the Digene HC with a 48 hour shell vial assay (SVA), conventional tissue culture (TC), and/or polymerase chain reaction (PCR) assay for CMV. All patients were evaluated and followed clinically by one of the authors. RESULTS: Fifty-six specimens were obtained from 40 patients, most of whom were persons with AIDS with suspected CMV disease. HC was negative (-) in 39; of these HC(-) specimens, PCR was performed on 33 and SVA/TC performed on 34. Five of the HC(-) specimens were consensus (+) by conventional methods. Of these discrepant samples, 2 were PCR(-) and 2 were PCR(+). The Digene HC was positive in 16 specimens. Fifteen of the HC(+) specimens were tested by PCR and 15/15 were PCR(+). There were 3 HC(+) specimens which were TC(-) and SVA(-). These discrepant samples were obtained from patients with proven visceral CMV disease (CMV polyradiculopathy and CMV proctitis) and were considered true positives. One specimen was HC equivocal, TC(+), PCR(+); this was treated as a HC(+). CONCLUSIONS: The Digene HC System is a rapid and accurate assay for detecting CMV. When compared with TC, the sensitivity is 88% and specificity is 100%.

Acquired Immunodeficiency Syndrome/COMPLICATIONS Comparative Study Cytomegalovirus/GENETICS/*ISOLATION & PURIF Cytomegalovirus Infections/BLOOD/COMPLICATIONS/*DIAGNOSIS DNA, Viral/BLOOD Human *Nucleic Acid Hybridization Polymerase Chain Reaction ABSTRACT

www.aegis.org