Detection of human cytomegalovirus in urine samples by cell culture, early antigen assay and polymerase chain reaction.

With the advent of effective therapy rapid, sensitive and reliable assays for diagnosis of human cytomegalovirus (HCMV) infections are required. In a total of 1,928 urine samples, detection of HCMV-immediate early antigen in a spin amplified microplate culture by a monoclonal antibody and immunoperoxidase staining (EA-assay) was compared with virus isolation in cell culture. Sensitivity of the EA assay was 85.5% and specificity was 99.5% compared with virus isolation. Overall agreement of both assays was 97.8%. In addition, in 235/1,928 urine samples amplification of HCMV-DNA was performed by means of polymerase chain reaction (PCR) using primers from the immediate early (IE1) gene region and 141/1,928 using primers from the late region (LA). The sensitivity of PCR compared with virus isolation was 67.8% for IE1 primers and 94.1% for LA primers (statistical significance: p < 0.01, Chi-square-test). Overall agreement between virus isolation and PCR was 88.5% for IE1-PCR and 84.4% for LA-PCR. Discordant results were more often found in adults with acute infection and immunocompromised patients than in infants.