Ordering Recommendation

Not recommended as a standalone test. If using serologic testing, IgM combined with IgG is preferred; refer to Cytomegalovirus Antibodies, IgG and IgM (0050622). Do not use for diagnosis in immunocompromised individuals. Preferred test to detect CMV infection is Cytomegalovirus by Quantitative NAAT, Plasma (3005895).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum Separator Tube (SST).

Specimen Preparation

Allow specimen to clot completely at room temperature. Separate from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.5 mL) Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens.

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Contaminated, heat-inactivated or grossly hemolyzed specimens.

Remarks

Label specimens plainly as acute or convalescent.

Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (Avoid repeated freeze/thaw cycles)

Methodology

Semi-Quantitative Chemiluminescent Immunoassay (CLIA)

Performed

Sun-Sat

Reported

Within 24 hours

Reference Interval

29.9 AU/mL or less: Not Detected.
30.0-34.9 AU/mL: Indeterminate - Repeat testing in 10-14 days may be helpful.
35.0 AU/mL or greater: Detected - IgM antibody to CMV detected, which may indicate a current or recent infection.  However, low levels of IgM antibodies may occasionally persist for more than 12 months post-infection.

Interpretive Data

A negative result does not rule out primary infection, please correlate clinically. CMV serology is not useful for the evaluation of active or reactivated infection in immunocompromised patients. Molecular diagnostic tests (i.e., PCR) are preferred in these cases.

This test should not be used for blood donor screening, associated re-entry protocols, or for screening Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P).

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

86645

Components

Component Test Code* Component Chart Name LOINC
0050553 CMV Antibody IgM 7853-5
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • CMV
  • CMV Antibody
  • CMV IgM
Cytomegalovirus Antibody, IgM