The US Food and Drug Administration (FDA) has permitted the marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age.
‘Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential to cause serious illness for people with weak immune systems and in newborn babies,’ said Tim Stenzel, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Centre for Devices and Radiological Health.
‘This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help healthcare providers more quickly identify the virus in newborns and determine the best approach for the child.’
According to the Centres for Disease Control and Prevention, more than half of adults by age 40 have been infected with CMV. Most people infected with CMV show no signs or symptoms of infection. However, CMV infection can cause serious health problems for people with weakened immune systems and for some newborns. Congenital CMV occurs when a baby is infected with CMV during pregnancy. Although most babies with CMV will not have any signs or symptoms of infection, some babies can develop hearing problems or other long-term health problems.
The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. Test results should be used only in conjunction with the results of other diagnostic tests and clinical information.