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 detection of CMV-specific IgG antibodies in a single sample indicates a previous exposure to CMV but is not sufficient to distinguish between an acute or latent infection.

The CMV IgM and IgG results should not be used alone to diagnose CMV infection. Results should be considered in conjunction with clinical presentation, patient history and other laboratory findings.

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.

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 IgG with varicella-zoster virus IgG, measles IgG, mumps IgG and parvovirus B19 IgG and could not be ruled out. The potential cross-reactivity with E. coli and autoimmune markers could not be ruled out.

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.