Photo by Graham Colm
Blood samples
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Thermo Fisher Scientific’s TaqPath Zika Virus Kit.
This means the TaqPath Zika Virus Kit is authorized for the qualitative detection of RNA from Zika virus and diagnosis of Zika virus infection in human serum and urine (collected alongside a patient-matched serum specimen) from individuals meeting the US Centers for Disease Control and Prevention’s criteria for testing.
The EUA does not mean the TaqPath Zika Virus Kit is 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.
The EUA for the TaqPath Zika Virus Kit means the test is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.
Testing using the TaqPath Zika Virus Kit is authorized to be conducted 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.
More information on the TaqPath Zika Virus Kit and other Zika tests granted EUAs can be found on the FDA’s EUA page.
