FDA Authorizes Emergency Use Test to Detect Zika

The FDA authorized emergency use (EUA) of Focus Diagnostics, Inc.’s Zika Virus RNA Qualitative Real-Time RT-PCR test to detect Zika virus in the blood of patients who have symptoms of Zika virus infection and live in, or have traveled to, an area with ongoing Zika virus transmission. This is the first commercial test to detect Zika virus authorized by FDA for emergency use.

An EUA is a tool that FDA can use to allow the use of certain medical products for emergencies based on scientific data. The U.S. Secretary of Health and Human Services (HHS) has declared that circumstances exist to allow the emergency use of authorized diagnostic tests for Zika virus infection, such as the Zika MAC-ELISA.

More about the Trioplex rRT-PCR, including fact sheets and instructions for use.

• About
• Latest Posts

Follow me

Renee Dustman

Executive Editor at AAPC

Renee Dustman, BS, AAPC MACRA Proficient, is an executive editor at AAPC. She holds a Bachelor of Science degree in Media Communications - Journalism. Renee has more than 20 years experience in print production and content management. Follow her on Twitter @dustman_aapc.

Follow me

Latest posts by Renee Dustman (see all)

• Add These OIG Watch Items to Your Audit List - October 18, 2019
• Final Rule Revises Discharge Planning Requirements - October 10, 2019
• Scary Good Advice for Medical Coders and Billers - September 13, 2019