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HelpTest Code LABCMVG Cytomegalovirus (CMV) Antibodies, IgG, Serum
Additional Codes
| Test Name in EPIC | EPIC Test Code | Mnemonic | Mayo Test ID |
|---|---|---|---|
| CYTOMEGALOVIRUS (CMV) ANTIBODIES, IGG | LABCMVG | CMVG | CMVG |
Reporting Name
Cytomegalovirus Ab, IgG, SUseful For
Determining whether a patient (especially transplant recipients and organ and blood donors) has had a recent infection or previous exposure to cytomegalovirus
Method Name
Multiplex Flow Immunoassay (MFI)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumSpecimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Specimen Minimum Volume
0.4 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 14 days | |
| Frozen | 14 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
| Heat-inactivated specimen | Reject |
Reference Values
Negative (reported as positive, negative, or equivocal)
Day(s) Performed
Monday through Saturday
CPT Code Information
86644
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CMVG | Cytomegalovirus Ab, IgG, S | 13949-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| CMVG | Cytomegalovirus Ab, IgG, S | 13949-3 |
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.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.(1) 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.
CMV 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.(2,3) 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).
CMV seroprevalence increases with age. In the United States the prevalence of CMV specific antibodies increases from approximately 36% in children from 6 to 11 years old to over 91% in adults over 80 years old.(4)
Interpretation
Positive cytomegalovirus (CMV) IgG results indicate past or recent CMV infection. These individuals may transmit CMV to susceptible individuals through blood and tissue products.
Equivocal CMV IgG results may occur during acute infection or may be due to nonspecific binding reactions. Submit an additional sample for testing if clinically indicated.
Individuals with negative CMV IgG results are presumed to not have had prior exposure or infection with CMV and are, therefore, considered susceptible to primary infection.
Cautions
Sera collected very early during the acute stage of infection may have undetectable levels of cytomegalovirus (CMV) IgG. The CMV IgG 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 performance characteristics of this assay have not been evaluated in immunosuppressed patients or organ transplant recipients and have not been established for cord blood or for testing of neonates.
Immune complexes or other immunoglobulin aggregates present in patient specimens may cause increased nonspecific binding and produce false-positive results.
Potential cross-reactivity for CMV with human chorionic gonadotropin, HIV IgG, multiple myeloma IgG, rheumatoid factor IgM, and Toxoplasma gondii IgG have not be ruled out.
Supportive Data
To evaluate the accuracy of the BioPlex cytomegalovirus (CMV) IgG multiplex flow immunoassay, 598 prospective serum samples submitted for routine CMV IgG testing by the VIDAS enzyme-linked fluorescence immunoassay (ELFA; bioMerieux) were also analyzed in a blinded fashion by the BioPlex assay within a 24-hour period. Samples with discordant results after initial testing were repeated by both assays during the same freeze/thaw cycle. Further resolution of discrepant results was performed by using the Diamedix CMV IgG enzyme immunoassay. The results are summarized in the table below:
Table. CMV IgG Comparison
|
|
CMV IgG (VIDAS ELFA) |
|||
|
BioPlex CMV IgG |
|
Positive |
Negative |
Equivocal |
|
Positive |
336 |
2(a) |
0 |
|
|
Negative |
3(b) |
254 |
3 |
|
|
Equivocal |
0 |
0 |
0 |
|
a) Both serum samples were negative by the Diamedix CMV IgG EIA
b) All three serum samples were negative by the Diamedix CMB IgG EIA
Sensitivity: 99.1% (336/339); 95% CI: 97.3%-99.8%
Specificity: 99.2% (254/256); 95% CI: 97.0%-100%)
Overall Percent Agreement: 98.7% (590/598); 95% CI: 97.3%-99.4%
Method Description
The BioPlex 2200 cytomegalovirus (CMV) IgG assay uses multiplex flow immunoassay technology. Briefly, CMV antigen-coated fluorescent beads are mixed with an aliquot of patient sample and sample diluent and incubated at 37° C. During this time IgG anti-CMV antibodies in the specimen will bind to the CMV antigen on the beads. After a wash cycle, a fluorescently labeled antihuman IgG-antibody conjugate is added to the mixture and incubated at 37° C. Following a wash step to remove unbound conjugate, the bead mixture is passed through a detector that identifies the bead based on dye fluorescence and determines the amount of antibody captured by the antigen based on fluorescence of the antihuman IgG conjugate. Raw data are calculated in relative fluorescence intensity and is converted to an antibody index for interpretation. Antibody index (AI) values 0.8 and lower are considered negative. AI values of 0.9 and 1.0 are equivocal. AI values 1.1 and above are considered positive. Three additional dyed beads, an internal standard bead, a serum verification bead, and a reagent black bead are present in each reaction mixture to verify detector response, the addition of serum to the reaction vessel and the absence of significant nonspecific binding in serum, respectively.(Package insert: BioPlex 2200 System, ToRC IgG, Bio-Rad Laboratories;03/2012)
Report Available
Same day/1 to 3 daysSpecimen Retention Time
14 daysForms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.