Molecular assay for the detection of congenital CMV. Alethia provides a quick, accurate and reliable molecular assay for congenital CMV detection.

Catalog Number: 481325

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Why Alethia?

Alethia provides a versatile workflow that can help labs of any size function at their best. With Alethia, your core lab, hospital lab, reference lab, or physician’s office lab can run more efficiently and deliver accurate results to clinicians and patients.

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Our support materials for our congenital CMV testing solution.

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  • 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.
  1. Alethia CMV Package Insert, SN11118
  2. Gabrielli, et al, Salivary Glands and Human Congenital Cytomelagovirus Infection: What Happens in Early Fetal Life?, J Med Virol 89:318-323, 2017
  3. Rawlinson, et al, Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis and therapy, The Lancer,, pub Mar 10, 2017.
  4. 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.
  5. Congenital CMV Facts. Centers for Disease Control and Prevention. Published 2018. Accessed October 17.

Alethia CMV – 87496

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