Molecular assay for the detection of congenital CMV. Alethia™ provides a quick, accurate and reliable molecular assay for congenital CMV detection.
Catalog Number: 481325
Support & Documents
Our support materials for our congenital CMV testing solution.
Webinars & Videos
- Because 1 in 200 babies are born with congenital CMV, making it the most common congenital infection in newborns
- It is the main cause of deafness in children
- 1 in 5 babies will develop health problems and complications; therefore, early diagnosis and proper treatment are important to the physician and the family
- Alethia CMV provides accurate and timely results in less than 1 hour empowering physicians with actionable results that can positively impact patient care
- Saliva is an easy to collect sample. A swab moistened with saliva is enough to run the test (no more than a flocked swab moistened with saliva needed)
- Antigen rich sample due to the fact that CMV replicates in the salivary glands, high level of shedding
- Recommended sample by the CMV consensus guidelines
- In studies saliva performs equal or better than urine in the detection of congenital CMV
- Urine collection can be a challenge, squeezing diapers or inserting a catheter is more complicated than collection of saliva
- Alethia CMV detects the presence of the CMV virus in newborns younger than 21 days, hence confirming that the newborn has a congenital infection, meaning the fetus was infected during pregnancy
- A positive result after 21 days may no longer be considered congenital, but an acquired infection after birth
- It is indicated that the saliva samples should be collected at least 1 hour after breastfeeding
- Transmission of CMV through breastmilk is not a congenital infection, but rather one acquired after birth
- Compared to 2 PCR’s and bi-directional sequencing the performance was: PPA 100% and NPA 99.8% with a population > 1,400 samples.
- Alethia CMV Package Insert, SN11118
- Gabrielli, et al, Salivary Glands and Human Congenital Cytomelagovirus Infection: What Happens in Early Fetal Life?, J Med Virol 89:318-323, 2017
- Rawlinson, et al, Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis and therapy, The Lancer, https://dx.doi.org/10.1016/51473-3099(17)30143-3, pub Mar 10, 2017.
- Ross, et al, Detection of Congenital Cytomegalovirus Infection by Real-Time Polymerase Chain Reaction Analysis of Saliva or Urine Specimens, J Inf Dis Brief Report doi:10.1093/infdis/jiu263, pub Jun 24, 2014.
- Congenital CMV Facts. Centers for Disease Control and Prevention. https://www.cdc.gov/features/cytomegalovirus/index.html. Published 2018. Accessed October 17.
Alethia™ CMV – 87496