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Test Code CMVLR Cytomegalovirus (CMV) Molecular Detection, PCR, Lower Respiratory


Ordering Guidance


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



Necessary Information


Specimen source is required.



Specimen Required


Specimen Type: Lower respiratory

Source: Bronchial washing, bronchoalveolar lavage, fluid/washings from lung, sputum, tracheal secretions, tracheal aspirates

Container/Tube:

Preferred: Sterile, screwcap, 5-mL aliquot tube

Acceptable: Sterile container

Specimen Volume: 1 mL

Collection Instructions: Do not centrifuge.


Useful For

Rapid qualitative detection of cytomegalovirus (CMV) DNA in lower respiratory specimens

 

This test is not intended for the monitoring of CMV disease progression or response to therapy.

Method Name

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

Reporting Name

Cytomegalovirus, PCR, Lower Resp

Specimen Type

Varies

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Varies Refrigerated (preferred) 7 days
  Frozen  7 days

Reject Due To

Lower respiratory swab
Calcium alginate-tipped swab
Wood swab
Transport swab containing gel
Feces
Paraffin blocks
Tissue specimens
Tissue biopsy
Bronchial brushings
Heat-inactivated specimens
Lower respiratory in transport media		 Reject

Clinical Information

Cytomegalovirus (CMV) is a double-stranded DNA virus of the Herpesviridae family. CMV is transmitted through infected body fluids, as well as through sexual contact, organ transplantation, and intrauterine transmission during pregnancy. CMV infection may be asymptomatic but can cause a wide range of symptoms in immunocompromised individuals. Detection of CMV DNA in lower respiratory specimens may support the clinical diagnosis of CMV pneumonitis. Infection with CMV is a significant cause of morbidity and mortality in transplant recipients and other immunocompromised hosts.

Reference Values

Negative

 

Reference values apply to all ages.

Interpretation

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

 

A negative result indicates the absence of CMV DNA in the patient specimen but does not rule out possible infection with CMV.

 

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

Cautions

This test is not validated for lung tissue or biopsy specimens; it is only validated for the lower respiratory specimens indicated in Specimen Required.

 

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.

Method Description

The Simplexa Congenital CMV (cytomegalovirus) Direct assay is a real-time polymerase chain reaction (PCR) system that enables the direct amplification and detection of CMV DNA from lower respiratory 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 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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87496

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CMVLR Cytomegalovirus, PCR, Lower Resp 104760-4

 

Result ID Test Result Name Result LOINC Value
CMVSS Specimen Source 31208-2
621771 CMVLR, PCR 104760-4