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Test Code CMVMS Cytomegalovirus Antibody, IgM, Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.6 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Useful For

Aiding in the diagnosis of acute infection with cytomegalovirus

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

CMV Ab, IgM, S

Specimen Type

Serum

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 28 days
  Frozen  90 days
  Ambient  7 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Additives (eg, biocides, antioxidants) Reject
Heat inactivated Reject

Clinical Information

Cytomegalovirus (CMV) is a member of the Herpesviridae family of viruses and usually causes asymptomatic infection after which it remains latent in patients, primarily within bone marrow-derived cells. Primary CMV infection in immunocompetent individuals may also manifest as a mononucleosis-type syndrome, similar to primary Epstein-Barr virus infection, with fever, malaise, and lymphadenopathy.

 

Cytomegalovirus is a significant cause of morbidity and mortality among bone marrow or solid organ transplant recipients, individuals with AIDS, and other immunosuppressed patients due to virus reactivation or from a newly acquired infection. Infection in these patient populations can affect almost any organ and lead to multiorgan failure. CMV is also responsible for congenital disease among newborns and is one of the TORCH infections (toxoplasmosis, other infections including syphilis, rubella, CMV, and herpes simplex virus).

 

Cytomegalovirus seroprevalence increases with age. In the US the prevalence of CMV specific antibodies increases from approximately 36% in children aged 6 to 11 years to over 91% in adults older than 80 years.

 

A negative CMV IgM result suggests that the patient is not experiencing acute or active infection. However, a negative result does not rule-out primary CMV infection. It has been reported that CMV-specific IgM antibodies were not detectable in 10% to 30% of cord blood sera from infants demonstrating infection in the first week of life. In addition, up to 23% (3/13) of pregnant women with primary CMV infection did not demonstrate detectable CMV IgM responses within 8 weeks postinfection. In cases of primary infection where the time of seroconversion is not well defined, as high as 28% (10/36) of pregnant women did not demonstrate CMV-IgM antibody.

Reference Values

Negative

 

Reference values apply to all ages.

Interpretation

Negative:

No IgM to cytomegalovirus (CMV) detected. False negative results may occur in immunocompromised patients.

 

Borderline:

Recommend follow-up testing in 10 to 14 days if clinically indicated.

 

Positive:

CMV IgM antibodies detected, which may indicate active or recent infection. Low level IgM antibodies may persist for more than 12 months following disease resolution.

Cautions

Sera collected very early during the acute stage of infection may have undetectable levels of cytomegalovirus (CMV) IgM.

 

The CMV IgM assay should not be used alone to diagnose CMV infection. Results should be considered in conjunction with clinical presentation, patient history, and other laboratory findings. In cases of suspected disease, submit a second specimen for testing in 10 to 14 days.

 

The detection of CMV-specific IgM antibodies in a single sample is not sufficient to prove an acute infection. In single cases elevated IgM antibody levels may persist even for years after initial infection.

 

Performance characteristics have not been evaluated in immunosuppressed patients or organ transplant recipients and have not been established for cord blood or for testing of neonates. Immunocompromised patients may have impaired immune responses and nonreactive IgG results may be due to delayed seroconversion and, therefore, do not rule out current infection.

 

Sera from patients with primary EBV infections can demonstrate positive results in the Elecsys CMV IgM assay. This is not unexpected as both viruses belong to the herpes virus family and this potential interference is known for the CMV IgM assays. Potential cross-reactivity with autoimmune markers and antibodies against influenza vaccination could not be ruled out. As with many micro-capture assays, an interference with unspecific IgM is observed. Increasing amounts of unspecific IgM may lead to a decrease in the recovery of positive samples with the Elecsys CMV IgM assay.

 

Samples should not be taken from patients receiving therapy with high biotin doses (ie, >5 mg/day) until at least 8 hours following the last biotin administration.

Day(s) Performed

Monday through Saturday

Report Available

Same day/1 to 3 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

86645

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CMVMS CMV Ab, IgM, S 30325-5

 

Result ID Test Result Name Result LOINC Value
MCMV CMV Ab, IgM, S 30325-5