Test Catalog

Test Id : CMVG

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Cytomegalovirus (CMV) Antibodies, IgG, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Determining whether a patient (especially transplant recipients and organ and blood donors) has had a recent infection or previous exposure to cytomegalovirus

Method Name
A short description of the method used to perform the test

Multiplex Flow Immunoassay (MFI)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Cytomegalovirus Ab, IgG, S

Aliases
Lists additional common names for a test, as an aid in searching

CMV (Cytomegalovirus) Antibody

Torch IgG

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.4 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-inactivated specimen Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
Frozen 14 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Determining whether a patient (especially transplant recipients and organ and blood donors) has had a recent infection or previous exposure to cytomegalovirus

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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)

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative (reported as positive, negative, or equivocal)

Interpretation
Provides information to assist in interpretation of the test results

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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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%

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Soderberg-Naucler C, Fish KN, Nelson JA: Reactivation of latent human cytomegalovirus by allogeneic stimulation of blood cells from healthy donors. 1997 Oct 3;91(1):119-126

2. Kusne S, Shapiro R, Fung J: Prevention and treatment of cytomegalovirus infection in organ transplant recipients. Transpl Infect Dis. 1999 Sep;1(3):187-203

3. Rubin RH: Importance of CMV in the transplant population. Transpl Infect Dis. 1999;1 Suppl 1:3-7

4. Staras SA, Dollard SC, Radford KW, Flanders WD, Pass RF, Cannon MJ: Seroprevalence of cytomegalovirus infection in the United States, 1998-1994. Clin Infect Dis. 2006 Nov 143(9):1143-1151

5. Bruminhent J, Thongprayoon C, Dierkhising RA, Kremers WK, Theel ES, Razonable RR: Risk factors for cytomegalovirus reactivation after liver transplantation: can pre-transplant cytomegalovirus antibody titers predict outcome? Liver Transpl. 2015 Apr;21(4):539-546

6. Dioverti MV, Razonable RR: Cytomegalovirus. Microbiol Spectr. 2016;4(4). doi: 10.1128/microbiolspec.DMIH2-0022-2015

Method Description
Describes how the test is performed and provides a method-specific reference

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 degrees 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 degrees 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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86644

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CMVG Cytomegalovirus Ab, IgG, S 13949-3
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
CMVG Cytomegalovirus Ab, IgG, S 13949-3

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports