​ZIKADetect™ IgM Capture ELISA Test Now Offered At UNILAB.

Updated: March 27, 2017

​

• This test has been authorized by the FDA under an EUA (Emergency Use Authorization) for use by authorized laboratories.

• This test has been authorized only for diagnosis of the Zika virus infection and not for any other viruses or pathogens.

• This test is only authorized for the duration of the declaration that circumstance exit justifying the authorization of emergency use the in vitro diagnostic test for detection of the ZIKA virus and or diagnosis or Zika v virus infection under section 564(b) (1) of Act, 21 U.S.C. 360bbb-3 (b) (1), unless the authorization is terminated or revoked sooner.

• This test has not been FDA cleared or approved. 

• ALL patients must read, understand, and sign the Fact Sheet for Patients: Understanding Results from the Zika Detect IgM Capture ELISA.

• UNILAB is requiring one SST and one lavender top be submitted for each patient

• No advertising or promotional descriptive printed matter to the use of the authorized ZikaDetect IgM Capture ELISA may represent or suggest that this test is safe or effective for the diagnosis of the Zika virus infection.