Zika Virus Real-time RT-PCR

The Zika Virus Real-time RT-PCR Test, offered through our Eurofins partner lab Viracor IBT Laboratories, detects RNA from the Zika virus in human plasma or urine (collected alongside a patient matched plasma specimen) samples. The test is FDA Emergency Use Authorized and New York State Approved. The test identifies Zika infection during the first two weeks post exposure*. This technology allows early and accurate accurate patient diagnosis of the Zika virus, enabling proper pregnancy planning and management.

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*The test identifies Zika infection during viremia which occurs in the initial weeks following exposure.

Disclaimer: The Zika Virus Real-time RT-PCR test is a laboratory test designed to detect Zika virus. The U.S. Food and Drug Administration (FDA) has not cleared or approved this test. No FDA-cleared or approved tests exist that can tell whether you have Zika virus infection. However, FDA has authorized the use of this test under an Emergency Use Authorization (EUA). Like all other EUA authorizations, this test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S. C. § 360bbb-3(b)(1 ), unless the authorization is terminated or revoked sooner. Information regarding the Zika virus is changing regularly, the information in this brochure was accurate as of the date of publication. For the most current Zika news and updates, please visit www.cdc.gov/zika.