Test Id : CMVMS
Cytomegalovirus Antibody, IgM, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in the diagnosis of acute infection with cytomegalovirus
Highlights
Detection of IgM-class antibodies to cytomegalovirus may be useful to assess for recent infection with cytomegalovirus.
Method Name
A short description of the method used to perform the test
Electrochemiluminescence Immunoassay (ECLIA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
CMV (Cytomegalovirus) Antibody IgM
CMV IgM
Torch IgM
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
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.
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.
See Specimen Required
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 |
| Additives (eg, biocides, antioxidants) | Reject |
| Heat inactivated | 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) | 28 days | |
| Ambient | 7 days | ||
| Frozen | 90 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in the diagnosis of acute infection with 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. 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
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
Reference values apply to all ages.
Interpretation
Provides information to assist in interpretation of the test results
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
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) 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.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. 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;21(4):539-546. doi:10.1002/lt.24078
2. Dioverti MV, Razonable RR. Cytomegalovirus. Microbiol Spectr. 2016;4(4):10.1128/microbiolspec.DMIH2-0022-2015. doi:10.1128/microbiolspec.DMIH2-0022-2015
3. Fowler K, Mucha J, Neumann M, et al. A systematic literature review of the global seroprevalence of cytomegalovirus: possible implications for treatment, screening, and vaccine development. BMC Public Health. 2022;22(1):1659. Published 2022 Sep 1. doi:10.1186/s12889-022-13971-7
4. Limaye AP, Babu TM, Boeckh M. Progress and challenges in the prevention, diagnosis, and management of cytomegalovirus infection in transplantation. Clin Microbiol Rev. 2020;34(1):e00043-19. Published 2020 Oct 28. doi:10.1128/CMR.00043-19
5. Leber AL. Maternal and congenital human cytomegalovirus infection: laboratory testing for detection and diagnosis [published correction appears in J Clin Microbiol. 2024 Sep 11;62(9):e0116424. doi: 10.1128/jcm.01164-24.]. J Clin Microbiol. 2024;62(4):e0031323. doi:10.1128/jcm.00313-23
Method Description
Describes how the test is performed and provides a method-specific reference
The electrochemiluminescence immunoassay for the in vitro qualitative determination of IgM antibodies to cytomegalovirus (CMV) in human serum is a micro-capture test principle. During the first incubation, 6 mcL of sample are automatically prediluted 1:20 with Diluent Universal. Biotinylated monoclonal anti-h-IgM-specific antibodies are added. The second incubation, CMV-specific recombinant antigen labeled with a ruthenium complex and streptavidin-coated microparticles are added. The complex becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration.(Package insert: Elecsys CMV IgM. Roche Diagnostics GmbH; 11/2022)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
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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.
CPT codes are provided by the performing laboratory.
86645
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 |
|---|---|---|
| CMVMS | CMV Ab, IgM, S | 30325-5 |
| 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.
|
|---|---|---|
| MCMV | CMV Ab, IgM, S | 30325-5 |