CONGENITAL CYTOMEGALOVIRUS

Laboratory: Newborn Screening

Test Description: Detection of cytomegalovirus (CMV) in samples submitted from hospitals on newborns that fail the primary hearing screen.

Order Approval Required? No

Specimen Type: Saliva swab in 1mL of Viral Transport Media (VTM)

Collection Container: Sterile tube containing 1 mL VTM

Optimal Volume: 1mL VTM

Collection Guidelines:

• cCMV Specimen Collection and Transport Instructions (35124)
• Hospitals may request collection kits by emailing DCLS_SSSKits@dgs.virginia.gov

Storage Instructions: Specimen should be stored at 2-8°C from collection until shipment

Transportation Instructions:  The DCLS courier will pick up cCMV coolers at the same location as they pick up the dried bloodspot newborn screening cards following the entry of a request for pickup in the ACE Courier system website. Samples should be placed in a cooler with ice packs for transport. Testing must take place within 7 days of collection.

Test Methodology: DiaSorin Simplexa Congenital CMV Direct

Additional Information: Sample submission must be completed through the Virginia Infant Screening and Infant Tracking System (VISITS).

Causes for Rejection:

• Incorrect specimen type
• Incorrect VTM volume
• Specimen collected >21 days of age
• Specimen received at <2°C, >8°C to <18°C, or >25°C
• Broken or leaking VTM tubes
• Specimen submitted without a time of collection
• Specimen received >7 days after collection if received at 2-8°C
• Specimen received >2 days after collection if received at 18-25°C

Possible Results:

• Positive – Cytomegalovirus DNA was detected
• Negative – No cytomegalovirus DNA detected
• Inconclusive – No reportable result