The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for a new assay designed to detect Zika virus infection.
The Aptima® Zika Virus assay is a molecular diagnostic tool that can be used to detect RNA from the Zika virus in human serum and plasma specimens.
The assay has not been FDA-cleared or approved. An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.
The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.
This means the Aptima Zika Virus assay is only authorized as long as circumstances exist to justify the authorization of the emergency use of in vitro diagnostics for the detection of Zika virus under section 564(b)(1) of the Federal Food, Drug & Cosmetic Act, 21 U.S.C.§360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About the assay
The Aptima Zika Virus assay was developed by Hologic, Inc. The assay runs on the Hologic Panther® system, an integrated platform that fully automates all aspects of nucleic acid amplification testing.
The Aptima Zika Virus assay will be available for use in all 50 states, Puerto Rico, and US territories.
The assay is designed to be used in individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (eg, clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the US that are certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-US laboratories.
For more information about the Aptima Zika Virus assay, visit www.hologic.com/zika.
About Zika testing
The FDA has granted EUAs for 4 other tests designed to detect Zika virus:
- RealStar® Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH)
- Zika Virus RNA Qualitative Real-Time RT-PCR test (Focus Diagnostics)
- Trioplex Real-time RT-PCR Assay (CDC)
- Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA, CDC).
The FDA has also authorized use of the cobas® Zika test (Roche) to screen blood donations for Zika virus. The test may be used under an investigational new drug application for screening donated blood in areas with active mosquito-borne transmission of the virus.
