REF:

C1309 (Cassette)

INTENDED PURPOSE:

NOVAtest® Cytomegalovirus IgM Antibody Joint Test is an immunochromatographic assay that use immuno-capture method for qualitative detection of anti-cytomegalovirus IgM antibodies from serum or plasma specimens of human. It’s used as an aid in the diagnosis of the cytomegalovirus infection. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Cytomegalovirus (CMV) is a DNA herpesvirus that is endemic worldwide. Like all herpesviruses, CMV is a lifelong infection. In utero transmission to the infant can lead to congenital CMV infection. Congenital CMV infection is the most common intrauterine infection and a leading cause of infectious disability. Permanent hearing and vision loss and neurological disability are among the most severe sequelae of congenital infection.

CMV prevalence varies by population. Seroprevalence tends to be highest in lower socio-economic groups, racial and ethnic minority populations, and women of higher parity and advanced maternal age. Transmission of CMV from mother to child (vertical transmission) can occur in utero, intrapartum, or during breastfeeding. Intrapartum and postnatal transmission can occur by ingestion or aspiration of cervicovaginal secretions during delivery, and by breast feeding or horizontal transmission routes.