Special Precautions/Comments:

Interferences: Interference may be encountered with certain sera containing antibodies directed against reagent components. For this reason, assay results should be interpreted taking into consideration the patient’s medical history and the results of any other tests performed.

Method: Enzyme-Linked Fluorescent Assay (ELFA). Calibration: VIDAS assay kit standard. EQA scheme: NEQAS.  IQC: VIDAS commercial preparations.

Interpretation: Results are reported as NOT detected, Equivocal, or DETECTED.

Additional Information:

Background information:  Cytomegalovirus (CMV) is a herpesvirus which can cause serious diseases in infants and adults. CMV can persist in the human body for several years and can cause recurrent infections or be transmitted to other individuals. CMV infections are very common; 60 to 85% of the population have been infected but most cases are asymptomatic. The detection of anti-CMV IgM can be useful in the diagnosis of current primary infection, particularly in pregnant women In immunocompromised patients (HIV positive or organ transplanted), CMV infections can be severe. The detection of IgM antibodies to CMV can be useful in the diagnosis of current primary infection . The detection of anti-cytomegalovirus IgG is useful in assessing the immune status of patients.