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Specimen Collection Manual and Test Catalog

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CONGENITAL CYTOMEGALOVIRUS DIRECT QUALITATIVE PCR

Geisinger Epic Procedure Code:  LAB3979    Geisinger Epic ID:  790015272
Test Restriction:  Testing is only performed from saliva swabs and urine from infants less than 21 days of age.

SPECIMEN COLLECTION
Specimen type: 

Saliva swab (primary), Urine (confirmatory).


Preferred collection container: 
Alternate collection container: 
Sterile specimen container
Specimen required: 

Saliva swab: Universal Transport Media (UTM) : Urine: Low volume sterile container.



SPECIMEN PROCESSING
Processing instructions: 

GMC campus: Saliva swab specimens in UTM must be stored and transported to the lab refrigerated at 2-8°C (on ice). Upon receipt, saliva specimens must be stored refrigerated at 2-8°C. Urine specimens must be transported immediately to the laboratory refrigerated at 2-8°C (on ice). Upon receipt in the Microbiology Lab, urine specimens must be immediately frozen at -20°C +/- 10°C.
All other non-GMC sites: Saliva swab specimens in UTM must be stored and transported to the lab refrigerated at 2-8°C (on ice). Upon receipt, saliva specimens must be stored refrigerated at 2-8°C until transported to the GMC Microbiology Lab. Urine specimens must be transported immediately to the laboratory refrigerated at 2-8°C (on ice). Once received into the laboratory, the specimen must be immediately frozen at -20°C +/- 10°C. for transport to GMC Microbiology lab.


Transport temperature: 

GMC campus: Saliva swab specimens in UTM must be stored and transported refrigerated to the lab at 2-8°C (on ice). Urine specimens must be transported immediately to the laboratory refrigerated at 2-8°C (on ice). Upon receipt in the Microbiology Lab, urine specimens must be immediately frozen at -20°C +/- 10°C.
All other non-GMC sites: Saliva swab specimens in UTM must be stored and transported to the lab refrigerated at 2-8°C (on ice). Saliva specimens must be transported the GMC Microbiology Lab refrigerated at 2-8°C. Urine specimens must be transported immediately to the laboratory refrigerated at 2-8°C (on ice). Once received into the laboratory, the specimen must be immediately frozen at -20°C +/- 10°C. for transport to GMC Microbiology lab. Urine specimens must be transported to the GMC Microbiology Lab frozen at -20°C +/- 10°C.


Specimen stability: 

Saliva swab specimens in UTM: Specimen is stable for 7 days at 2-8°C and for 14 days at -20°C +/- 10°C. If there is a delay of greater than 14-days before testing, the specimen can be stored at >-70°C. Specimens left at room temperature (18-25°C) are only stable for up to 48 hours.
Urine specimens: Urine specimens are stable for 3 days frozen at -20°C +/- 10°C. If there is a greater than 3-day delay in testing, store the specimen at >-70°C. Urine specimens are only stable for 2 hours post collection at room temperature (18-25°C) or 8 hours if stored refrigerated at 2-8°C. Specimens beyond this time frame will be rejected. Be sure to immediately freeze upon receipt.


Rejection criteria: 

Specimens stored or transported at incorrect temperature. Stability limits exceeded, improper collection tube used, insufficient volume, improperly labeled. mis-identified specimens. Patients are greater than 21 days of age.



TEST DETAILS
Reference interval: 

Specimens stored or transported at incorrect temperature. Stability limits exceeded, improper collection tube used, insufficient volume, improperly labeled. mis-identified specimens. Patients are greater than 21 days of age.


Interpretation guide: 

For saliva:  A Presumptive Positive. Cytomegalovirus detected by PCR (amplified probe) should be confirmed with urine testing. For urine: A Positive. Cytomegalovirus detected by PCR (amplified probe) is confirmatory.


Critical values/courtesy alerts: 
: For saliva: Presumptive Positive. Cytomegalovirus detected by PCR (amplified probe). Confirm results with urine testing. For urine: Positive. Cytomegalovirus detected by PCR (amplified probe).
CPT code(s):  87496
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.
The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

Test includes: 

Molecular detection of Cytomegalovirus.


Methodology: 
Real-time Polymerase Chain Reaction (PCR)
Synonyms: 

CMV, Cytomegalovirus, Congenital.


Clinical significance: 

Congenital CMV infection is the most common congenital infection worldwide. An estimated incidence in developed countries ranges from 0.6 to 0.7% of all live births, resulting in approximately 60,000 neonates born every year with congenital CMV infection in the United States and the European Union combined.
Congenital CMV is also the leading non-genetic cause of childhood hearing loss and a significant cause of neurodevelopmental delays like cognitive deficit and vision impairment. At birth, infected infants can be symptomatic (10% to 15%) or asymptomatic (85% to 90%), and in both subgroups, infants can develop hearing defects.
 Timely diagnosis of congenital CMV is critical for disease management and intervention. Antiviral medications such as valganciclovir and ganciclovir, along with appropriate follow-up care may improve congenital CMV related hearing and developmental outcomes. Infants with congenital CMV shed high levels of the virus in their urine and saliva, and direct detection from these samples can provide a definitive diagnosis.


Doctoral Director(s): 
Donna Wolk PhD, D(ABMM)
Julie Hirschhorn, PhD, HCLD(ABB)
Review Date:  03/30/2026

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