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Test 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 Special Container
Urine Frozen 72 hours

Reference Values

Negative

Interpretation

A positive result indicates the presence of cytomegalovirus (CMV) DNA in the patient sample.

 

A negative result indicates the absence of CMV DNA in the patient sample.

 

An invalid result indicates inability to conclusively determine presence or absence of CMV DNA in the patient sample.

Clinical Reference

1. Manicklal S, Emery VC, Lazzarotto T, Boppana SB, Gupta RK. The "silent" global burden of congenital cytomegalovirus. Clin Microbiol Rev. 2013;26(1):86-102. doi:10.1128/CMR.00062-12

2. Cannon MJ, Griffiths PD, Aston V, Rawlinson WD. Universal newborn screening for congenital CMV infection: what is the evidence of potential benefit?. Rev Med Virol. 2014;24(5):291-307. doi:10.1002/rmv.1790

3. Rawlinson WD, Boppana SB, Fowler KB, et al. Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy. Lancet Infect Dis. 2017;17(6):e177-e188. doi:10.1016/S1473-3099(17)30143-3

4. Binnicker MJ, Espy ME. Comparison of six real-time PCR assays for qualitative detection of cytomegalovirus in clinical specimens. J Clin Microbiol. 2013;51(11):3749-3752. doi:10.1128/JCM.02005-13

5. Fernholz EC, Vidal-Folch N, Hasadsri L. Rapid and direct detection of congenital cytomegalovirus using a commercial real-time PCR assay. J Clin Microbiol. 2023;61(3):e0178122. doi:10.1128/jcm.01781-22

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 to 2 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87496

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CCMVU Congenital CMV, PCR, Urine 4999-9

 

Result ID Test Result Name Result LOINC Value
620658 Congenital CMV, PCR, Urine 4999-9