Zika Virus Antibody, IgM

Serum

2 mL

1 mL

Gel-barrier tube or red-top tube or serum transfer tube

Presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (eg, a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).

Interpretation of Zika IgM results must account for the possibility of false-negative and false-positive results.

False-negative results can arise from:

a) Specimen collection conducted before IgM has reached detectable levels (typically around 4 days post onset of symptoms);

b) Specimen collection conducted after IgM levels have decreased below detectable levels (around 12 weeks post onset of symptoms);

c) Improper collection, storage, or transport of specimens.

False-positive results can arise from:

a) Specific cross-reactivity with IgM for other flaviviruses (eg, Dengue virus);

b) Non-specific cross-reactivity with other immunoglobulins;

c) Cross-reactivity with Dengue IgM, Parvovirus B19 IgM, Chikungunya virus IgM, and Rheumatoid Factor.

This assay has not been evaluated in a pediatric population.This assay is not indicated for testing blood or plasma donors. Screening of the general population should not be performed.

Antibody Capture Chemiluminescence Immunoassay (CLIA)

IgM levels are variable, but typically become positive starting in the first week after onset of symptoms and continuing for up to 12 weeks post symptom onset or exposure, but may persist for months to years. Zika virus antibody testing is complicated by cross-reactivity with other flaviviruses, which may make conclusive determination of which flavivirus is responsible for the person's recent infection difficult. Negative results do not preclude infection with Zika virus, past or present, and should not be the sole basis of a patient treatment/management or public health decision. All results should be interpreted by a trained professional in conjunction with review of the patient's history and clinical signs and symptoms.