Cytomegalovirus (CMV) IgG Avidity

CPT: 86644
Updated on 12/4/2024
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Special Instructions

This assay currently is not available in New York state.

This test is not approved for New York state clients.

This assay currently is not available in New York state.


Expected Turnaround Time

5 days


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Specimen Requirements


Specimen

Serum


Volume

1 mL


Minimum Volume

0.5 mL (Note: This volume does not allow for repeat testing.)


Container

Red-top tube or gel-barrier tube


Storage Instructions

Maintain specimen at room temperature.


Stability Requirements

TemperaturePeriod
Room temperature14 days
Refrigerated14 days
Frozen14 days
Freeze/thaw cyclesStable x3

Causes for Rejection

Gross hemolysis; visible microbial contamination


Test Details


Use

The intended use of this test is to determine the avidity of CMV IgG antibody in patients known to be positive for CMV IgG antibody.

IgG avidity testing is used to support the diagnosis of recent primary Cytomegalovirus (CMV) infection during pregnancy. In addition, discrimination between recent (primary) and past CMV infection can be an important tool in the clinical management of transplant recipients. Maternal infections by Cytomegalovirus can cause severe complications to the fetus or congenital abnormalities. As a rule, the risk of maternal transmission is critically related to the time of infection; hence, it is important to determine the timing of infection in pregnant individuals. Cytomegalovirus (CMV) can cause central nervous system damage in the fetus and can lead to long-term sequelae, including sensorineural hearing loss and chorioretinitis, respectively. Since the risk to the fetus is critically related to the time of infection, it is essential to accurately determine whether a pregnant person has acquired a primary infection of CMV during gestation or earlier.

IgG avidity assays measure the binding strength between IgG antibodies and pathogen that can help distinguish a primary infection from a past infection. Following primary CMV infection, IgG antibodies have low binding strength (low avidity) then over 2-4 months mature to high binding strength (high avidity).


Limitations

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.


Methodology

ELISA


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