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Zika Virus Real-time RT-PCR is intended for the qualitative detection of RNA from Zika virus in human plasma, serum or urine. Healthcare providers are strongly encouraged to collect serum specimens alongside other specimen types to provide additional opportunities for diagnosing Zika virus infection in cases when PCR tests are negative.Zika Virus Real-time RT-PCR Test
ZIKV Detect™ IgM Capture ELISA is intended for the presumptive detection of Zika virus IgM antibodies in serum samples. Both tests are intended for individuals meeting Zika virus clinical criteria and/or Zika virus epidemiological criteria. No FDA-cleared or approved tests exists for Zika virus infection. However, the FDA has authorized the use of these tests under an Emergency Use Authorization (EUA).Zika Virus ZIKV DetectTM IgM Capture ELISA
*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.