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Cytomegalovirus DNA, Quantitative Real-Time PCR, Saliva
Test Code37017
CPT Codes
87497
Preferred Specimen
Saliva collected in an ORACollection OCDC-100 collection device
Patient Preparation
Saliva samples should be collected at least 30 minutes after eating or drinking. Ensure the sponge tip does NOT come into contact with any surface prior to collection.
Minimum Volume
One ORACollection OCDC-100 collection device
Instructions
Collection procedure
1. Open package and remove collector without touching sponge tip. Place the saliva sponge into the child's mouth in the cheek pouch (the space between the gums and the inner cheek).
2. Gently move the saliva sponge around the upper and lower cheek pouches on both sides of the mouth to soak up as much saliva as possible. There is no need to 'scrape' the inner cheek with saliva sponge - collect as much saliva as possible from the cheek pouches. The sponge will absorb more saliva if it is left in the child's mouth for a longer time (up to 60 seconds).
3. Once collected, hold the tube upright to prevent stabilizing liquid inside the tube from spilling. Unscrew the blue cap from the collection tube without touching the sponge.
4. Insert the sponge into the tube and close cap tightly.
5. Invert the capped tube and shake vigorously 10 times.
1. Open package and remove collector without touching sponge tip. Place the saliva sponge into the child's mouth in the cheek pouch (the space between the gums and the inner cheek).
2. Gently move the saliva sponge around the upper and lower cheek pouches on both sides of the mouth to soak up as much saliva as possible. There is no need to 'scrape' the inner cheek with saliva sponge - collect as much saliva as possible from the cheek pouches. The sponge will absorb more saliva if it is left in the child's mouth for a longer time (up to 60 seconds).
3. Once collected, hold the tube upright to prevent stabilizing liquid inside the tube from spilling. Unscrew the blue cap from the collection tube without touching the sponge.
4. Insert the sponge into the tube and close cap tightly.
5. Invert the capped tube and shake vigorously 10 times.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 48 hours
Refrigerated: 14 days
Frozen: 30 days
Refrigerated: 14 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Specimen sources other than saliva submitted in ORACollection OCDC-100 collection device • Saliva specimens not received in ORACollection OCDC-100 collection device
Methodology
Real-Time Polymerase Chain Reaction
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Sets up 7 days a week.
Report Available
Reports in 1 to 3 days.
Clinical Significance
Cytomegalovirus (CMV) is the most common congenital infection in newborns, and a leading cause of non-genetic hearing loss and other neurologic complications including microcephaly, developmental delay, and vision impairment.
Most infants with congenital CMV (cCMV) infection are asymptomatic at birth. Symptomatic neonates born with hepatosplenomegaly, hepatitis, thrombocytopenia, structural brain malformations, and other abnormalities are recognized and provided appropriate medical care, but asymptomatic infants appear normal at birth, so miss the opportunity for early diagnosis and close monitoring for hearing loss or developmental delay.
Infants congenitally infected with CMV may benefit from antiviral therapy, especially if treatment is initiated within the first month of life.
Most infants with congenital CMV (cCMV) infection are asymptomatic at birth. Symptomatic neonates born with hepatosplenomegaly, hepatitis, thrombocytopenia, structural brain malformations, and other abnormalities are recognized and provided appropriate medical care, but asymptomatic infants appear normal at birth, so miss the opportunity for early diagnosis and close monitoring for hearing loss or developmental delay.
Infants congenitally infected with CMV may benefit from antiviral therapy, especially if treatment is initiated within the first month of life.
