We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
Vicotex

QuidelOrtho

Develops, manufactures and markets rapid diagnostic tests that focus on infectious diseases, reproductive health, and... read more Featured Products: More products

Download Mobile App




Quidel Receives Amended FDA Emergency Use Authorization for New AI-Powered Sofia Q Rapid Antigen Test Device

By LabMedica International staff writers
Posted on 15 Jun 2021
Quidel Corporation (San Diego, CA, USA) has received an amended Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) allowing the company to market Sofia Q, its latest addition to the Sofia and Sofia 2 line of Fluorescent Immunoassay Analyzers (FIA). More...


Sofia Q utilizes Sofia fluorescent technology to provide an accurate, objective, and automated result in 15 minutes. Sofia Q features a sleek, miniaturized design that reads the same Sofia SARS Antigen FIA tests as Sofia and Sofia 2 - with equal accuracy. Quidel’s innovative design allows the Sofia Q device to be paired with the downloadable Sofia Q mobile application, which guides the user through the workflow and interprets the test result using a proprietary AI model. Sales of Sofia Q device will initially be limited to use with the Sofia SARS Antigen FIA in the CLIA and CLIA-waived professional segments.

“Sofia Q is our latest powerful diagnostic instrument designed to democratize access to the many benefits of our Sofia SARS rapid antigen tests and, ultimately, our full portfolio of Sofia tests for influenza, RSV, Strep and other conditions,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We designed Sofia Q to be very affordably priced and conducive to widespread adoption across the ever-expanding global point-of-care and telemedicine marketplace. In the future, we believe Sofia Q will be ideal to serve consumers at home, as well as in schools and workplaces.”



Platinum Member
Automated Coagulation Analyzer
Hemolumi H6
Gold Member
Electrolyte Analyzer
CBS-4000 (CBS-400)
New
Gold Member
Pre- Eclampsia Control
Acusera Pre-Eclampsia Control
LAIR2 Antibody Pair Set
LAIR2 Antibody Pair [Biotin]
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Clinical Chemistry

view channel
Image: Graphical abstract (Pola, I., Akinyemi, T., Tan, K. et al. Nature Communications(2026). https://doi.org/10.1038/s41467-026-74971-4)

Blood Biomarker Study Reveals Population-Specific Differences in Alzheimer’s Disease

Blood-based biomarkers are emerging as tools for detecting Alzheimer’s disease–related changes without relying on advanced brain imaging or cerebrospinal fluid (CSF) analysis. However, much of the foundational... Read more

Molecular Diagnostics

view channel
Image Credit: Shutterstock

Blood Test for Lung Cancer Screening Receives FDA Breakthrough Device Designation

Lung cancer remains the leading cause of cancer death in the United States, yet only about 18% of people eligible for screening undergo low-dose computed tomography, the current guideline-recommended method.... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.