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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

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, especially 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 urine and saliva 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 viral nucleic acid is present at a level that is below the analytical sensitivity of the assay or 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.

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

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