Highlights

This assay is a screening test for IgM-class antibodies to Zika virus. A presumptive positive result by this assay is not diagnostic for Zika virus infection and confirmatory testing may be required as determined by your local health department. Confirmatory testing by a molecular assay for detection of Zika virus RNA may also be considered.

This assay should be used in patients presenting at least 2 weeks post-symptom onset or last possible exposure to Zika virus. Reverse transcription-polymerase chain reaction (RT-PCR) for Zika virus RNA detection should be ordered in patients with less than 2 weeks of symptoms or postexposure.

A single negative result by the Zika IgM enzyme-linked immunosorbent assay (ELISA) should not be used to rule-out infection as the specimen may have been collected prior to the development of detectable antibodies.

Asymptomatic pregnant women with ongoing exposure to Zika virus (eg, residence in Zika virus endemic region) should not be tested for IgM antibodies to Zika virus, but rather by molecular assays for Zika virus at least 3 times during pregnancy. Due to seropersistence of IgM-class antibodies to Zika virus for months after infection, they cannot be used to reliably distinguish recent from past infection.

Testing of asymptomatic pregnant women without ongoing exposure to Zika virus is no longer routinely recommended. Testing consideration should be made using a shared patient-provider decision-making model, one in which patients and providers work together to make decisions about testing and care plans.