The xMAP MultiFlex Zika RNA Assay detects six genetic targets of the virus using a sample of serum, plasma or urine from a potentially infected patient.
The assay was co-developed by Austin, Texas-based Luminex and Rockville, Md.-based GenArraytion.
While the test has not earned FDA approval, the agency will permit the test‘s use for as long as Zika remains a national concern to the public health.
The agency has previously provided emergency use authorizations for several other Zika diagnostic tests within the past few months in an effort to control the spread of the virus.
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