Zika Virus Comprehensive Profile, NAA, Serum and Urine

Detection of Zika virus. This test is intended for the qualitative detection of RNA from the Zika virus in serum and urine from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria.

• This test has not been FDA cleared or approved;

• This test has been authorized by FDA under an Emergency Use Authorization (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, and not for any other viruses or pathogens; and

• 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.