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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Our support materials for our congenital CMV testing solution.
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- The CPT code for Alethia cCMV is 87496.
- 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 (I.E., dry) or put in viral transport media (1mL, 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