Real-time PCR-based testing of saliva for cytomegalovirus at birth

Evaluation of: Boppana SB, Ross SA, Shimamura M et al. Saliva polymerase-chain-reaction assay for cytomegalovirus screening in newborns. N. Engl. J. Med. 364, 2111-2118 (2011). Cytomegalovirus (CMV) commonly causes congenital infection. As such, CMV is a prominent etiology for nongenetic sensori-neural hearing loss. However, screening examination in the perinatal and early infant period fails to identify most children at risk for CMV-produced hearing loss because of the absence of symptoms early in life. Furthermore, generalized screening for congenital CMV infection has yet to be implemented. Currently, newborns are tested via means of a rapid saliva culture but large-scale automation of this test would be difficult. Fortunately, newer potential replacement tests have been created. An important advance includes testing newborns via means of PCR using liquid or dried saliva samples. In a large-scale, prospective, multi-institutional study both types of salivary samples were compared with the gold standard of saliva culture. Of the 34,989 neonates tested, 0.5% or 177 samples tested positive for CMV. Testing of both liquid and dried saliva were sensitive (>97%) as well as specific (>98%) when measured against CMV culture. PCR testing of dried saliva has the potential benefit of adapting to generalized screening of neonates for congenital CMV infection. The advantages of early detection, intervention for and treatment of cases that are not clinically apparent needs to be carefully evaluated before proposing universal newborn screening for CMV infection as a valuable public health strategy.