Zika Virus Assays Authorized for Emergency Use

On February 26, 2016, Sylvia Burwell, Secretary of Health and Human Services (HHS), decided that Zika virus had significant potential to cause a public health emergency that might affect national security or the health and security of United States citizens living abroad. The Secretary of HHS then declared that circumstances existed to justify authorization of the emergency use of in vitro diagnostics for detection of Zika virus and/or diagnosis of Zika virus infection.

Since that time, FDA has issued an Emergency Use Authorization (EUA) for the emergency use of seven different assays for the qualitative detection of RNA from Zika virus in human serum, plasma, urine. The seven molecular assays and their approval dates are listed below:

• xMAP multiflex Zika RNA Assay (Luminex), August 4, 2016
• Versant Zika RNA 1.0 Assay (kPCR) kit (Siemens Healthcare Diagnostics Inc), July 29, 2016
• Viracor-IBT Laboratories, Inc. Zika Virus Real-time RT-PCR test , July 19, 2016
• Aptima Zika Virus Assay (Hologic, Inc), July 17, 2016
• RealStar Zika Virus RT-PCR kit U.S. (Altona Diagnostics), May 13, 2016
• Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics), April 28, 2016
• Zika MAC-ELISA (CDC), February 26, 2016
• Trioplex Real-time RT-PCR assay (CDC), March 17, 2016

These assays can be used by laboratories in the United States that are certified under CLIA 1988 to perform high complexity tests or similarly qualified non-U.S. laboratories. The Viracor test is limited to testing in their own facility. Testing should be limited to detection of Zika virus in specimens collected from individuals meeting the Centers for Disease Control and Prevention’s clinical criteria and/or epidemiological criteria for Zika virus infection.

FDA has also issued an EUA for the CDC’s Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid. Testing can be performed by qualified laboratories designated by CDC and certified by CLIA 1988.

Reference:

https://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm