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Test Code CCMVS Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Saliva


Ordering Guidance


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

 

To test urine specimens from patients 21 days or younger, order CCMVU / Congenital Cytomegalovirus (cCMV), Molecular Detection, PCR, Urine. To test urine from patients older than 21 days, order CMVPV / Cytomegalovirus (CMV) Molecular Detection, PCR, Varies.

 

For CMV testing on plasma specimens, order CMVQN / Cytomegalovirus (CMV) DNA Detection and Quantification by Real-Time PCR, Plasma.



Specimen Required


Supplies: BD UVT with minitip flocked swab (T971)

Collection Container/Tube: Flocked swab

Submission Container/Tube: Sterile, screw-capped, tube containing viral transport media with flocked swab containing saliva

Specimen Volume: 1 Swab in viral transport media

Collection Instructions: Collect and send specimen per swab manufacturer instructions.


Useful For

Aiding in the rapid diagnosis of cytomegalovirus (CMV) infections in neonates 21 days of age or younger using saliva specimens

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

Congenital CMV, PCR, Saliva

Specimen Type

Swab

Specimen Minimum Volume

Saliva swab submitted in minimum volume of 0.3 mL of viral transport media.

Specimen Stability Information

Specimen Type Temperature Time Special Container
Swab Frozen 7 days

Reject Due To

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

Clinical Information

Cytomegalovirus (CMV) is a double-stranded DNA virus of the Herpesviridae family. CMV is transmitted through direct contact from a variety of infected body fluids, as well as through sexual contact, organ transplantation, and intrauterine transmission during pregnancy.(1) CMV infection may be asymptomatic but can cause a wide range of symptoms in immunocompromised individuals. Congenitally acquired CMV (cCMV) may lead to long-term sequelae, including visual and hearing impairments, and cognitive and motor deficits.(2) Current recommendations indicate testing urine and saliva swabs for cCMV using a nucleic acid amplification detection method.(3)

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.

Cautions

This test is not validated for sample types other than saliva swab and urine specimens from infants 21 days of age or younger.

 

Negative results do not preclude cytomegalovirus (CMV) infection and should not be used as the sole basis for treatment or other patient management decisions.

 

False-negative results may occur if the viral nucleic acid is present at a level below the analytical sensitivity of the assay, if the virus has genomic mutations, insertions, deletions, or rearrangements, or if the assay is performed very early in the course of illness.

 

The performance of this test has not been established for monitoring treatment of CMV infection.

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
CCMVS Congenital CMV, PCR, Saliva 83065-3

 

Result ID Test Result Name Result LOINC Value
620659 Congenital CMV, PCR, Saliva 83065-3