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Molecular assay for the detection of congenital Cytomegalovirus (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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    Quick
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    Accurate
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    Reliable

Definitive answers, confidence in results

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Definitive answers, confidence in results

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"The Alethia CMV assay is an accurate method for identifying neonates with cCMV infection and, given its simplicity, appears suitable for CMV testing using neonatal saliva outside a reference laboratory, including remote and resource-limited settings."

Support & Documents

Our support materials for our congenital CMV testing solution.

Downloadable PDFs

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FAQs

  • The CPT code for Alethia cCMV is 481325
  • Saliva is an easy to collect sample, a swab moistened with saliva is enough to run the test (do not need any more than a flocked swab moistened with saliva)
  • 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 having to put a catheter is more complicated than collecting a saliva sample
  • Compared to 2 PCR’s and bi-directional sequencing the performance was: PPA 100% and NPA 99.8% with a population > 1,400 samples.
  • Saliva samples after collection on a flocked swab can be transported as is or put in a viral transport media (VTM or UTM)
  • It can last 48 hrs at room temperature, 7 days at 2-8C, or 14 days at -20C
  • Alethia CMV detects the presence of the CMV virus in newborns younger than 21 days, hence determining if 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 1 hr after breastfeeding
  • Transmission of CMV through breastmilk is not a congenital infection, but an acquired infection after birth
  •  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 results in less than 1 hr, which empowers physicians with actionable results that can positively impact patient care

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