Zika Virus Emergency Use Authorized Test Now Available

The test, developed by the CDC, was granted Emergency Use by the FDA last February
The test, developed by the CDC, was granted Emergency Use by the FDA last February

LabCorp announced the launch of the CDC Zika MAC-ELISA Test for the qualitative detection of Zika virus IgM antibodies in serum or cerebrospinal fluid. It is intended for use in the diagnosis of Zika infection in individuals meeting the CDC established criteria for Zika virus infection risk. 

The Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) was developed by the Centers for Disease Control and Prevention (CDC), and granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) in February 2016. 

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The CDC's epidemiological criteria for testing with Zika MAC-ELISA include a recent history of travel to a region of active Zika transmission at the time of travel or other criteria for which Zika virus testing may be indicated as part of a public health response. The clinical criteria for testing include a history of clinical signs and symptoms associated with Zika virus infection.

The test is appropriate for administering soon after the onset of symptoms through ~12 weeks following infection. It is used in serum or cerebrospinal fluid when submitted with a patient-matched serum sample. 

The real time reverse transcriptase-polymerase chain reaction (rRT-PCR) tests for Zika has a shorter testing window of 7–14 days after symptom onset depending on the sample type tested. The RealStar Zika Virus RT-PCR Kit U.S., which is tested on urine paired with serum, is appropriate up to the first 7 days following an infection. 

Although authorized by the FDA, the test has not yet been FDA approved or cleared, as it is only authorized for the duration of the declaration that circumstances exist justifying the EUA.

For more information visit LabCorp.com

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