ABSTRACT

Fact Sheet for Healthcare Providers: Interpreting Gene-RADAR Zika Virus Test Results   [open pdf - 267KB]

"Public health officials have determined that Zika virus poses a potential public health emergency. Current information on Zika virus infection for healthcare providers, including case definitions and information about signs and symptoms, is available at www.cdc.gov/zika/hcproviders/index.html. All information and guidance, including those on Zika virus laboratory testing, may change as more data are gathered on this virus. Please check CDC's [US Centers for Disease Control and Prevention] Zika virus website regularly for the most current information (www.cdc.gov/zika/index.html). The U.S. Secretary of Health and Human Services (HHS) has declared that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection. This EUA [End User Agreement] will terminate when the HHS [US Department of Health and Human Services] Secretary's declaration terminates, unless the FDA [US Food and Drug Administration] revokes it sooner. At this time, there are no FDA-approved/cleared tests available that can detect Zika virus in clinical specimens in the U.S."

Publisher:
Date:
2017-03-23
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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