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Order Code CCMVU Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Urine


Ordering Guidance


This test should be ordered to test urine specimens from patients aged 21 days or younger. To test urine from patients older than 21 days, order CMVPV / Cytomegalovirus (CMV) Molecular Detection, PCR, Varies.

 

To test saliva specimens from patients aged 21 days or younger, order CCMVS / Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Saliva. To test saliva from patients older than 21 days, order CMVPV / Cytomegalovirus (CMV) Molecular Detection, PCR, Varies.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Container/Tube: Plastic sterile container, 5 mL

Specimen Volume: 0.2 mL

Collection Instruction:

1. Collect a random urine from a urine bag, container, or catheter.

2. Transfer urine to sterile container.

3. No preservative


Useful For

Aiding in the rapid diagnosis of cytomegalovirus infections in neonates 21 days of age or younger using urine specimens

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

Congenital CMV, PCR, Urine

Specimen Type

Urine

Specimen Minimum Volume

0.1 mL

Specimen Stability Information

Specimen Type Temperature Time
Urine Frozen 72 hours

Reject Due To

  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Reference Values

Negative

Method Description

The Simplexa Congenital CMV (cytomegalovirus) Direct assay is a real-time polymerase chain reaction system that enables the direct amplification and detection of CMV DNA from either saliva swab or urine specimens without nucleic acid extraction. The system consists of the Simplexa Congenital CMV Direct Reaction Mix, the LIAISON MDX (with LIAISON MDX Studio Software), the direct amplification disc, and associated accessories.

 

In the Simplexa Congenital CMV Direct assay, bifunctional fluorescent probe-primers are used together with corresponding reverse primers to amplify CMV DNA. A well-conserved region of the CMV UL83 gene is targeted to identify CMV DNA. An internal control is used to detect PCR failure and/or inhibition.(Package insert: Simplexa Congenital CMV Direct. Diasorin; REF MOL2255. Rev. 01, 11/2022)

Day(s) Performed

Monday through Sunday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87496