Evaluating CMV DNA qPCR Assay and Serological Concordance in Diagnosing Congenital CMV Infection in Indonesian Newborns.

This study investigated the diagnostic accuracy of the quantitative polymerase chain reaction (qPCR) DNA assay in urine and saliva samples, as well as its concordance with serum cytomegalovirus (CMV) IgM/IgG testing in infants suspected of congenital cytomegalovirus (cCMV) infection. Furthermore, the study sought to elucidate the correlation between various diagnostic parameters in suspected cases of cCMV. A cross-sectional analysis was conducted on newborns suspected of having cCMV infection at Rumah Sakit Saiful Anwar (RSSA) Malang. CMV serology, complete blood count, and qPCR of urine and saliva samples were collected. Statistical analysis was performed on these data with a P-value(P) < 0.05. A significant difference in urine PCR CT value distinguished positive from negative CMV IgM serology groups. A strong correlation (r = 0.728, P < 0.001) and high agreement (kappa = 0.693, P < 0.001) between urine and saliva PCR testing suggested saliva as a reliable and non-invasive alternative for newborn screening. The findings of this study underscore the necessity of a comprehensive screening protocol for cCMV, particularly considering the high seroprevalence of CMV in the Indonesian population.