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
LGC Clinical Diagnostics

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.”



Gold Member
Troponin T QC
Troponin T Quality Control
Serological Pipet Controller
PIPETBOY GENIUS
New
Giardia Assay
AccuDiag Giardia
New
Toxoplasma Gondii Test
Toxo IgG ELISA
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: Ear wax could be a possible screening medium for Parkinson’s disease (Photo courtesy of 123RF)

Earwax Test Accurately Detects Parkinson’s by Identifying Odor Molecules

Current tests for Parkinson’s disease (PD) rely heavily on clinical scales and neuroimaging, which are often subjective, expensive, and ill-suited for routine screening. Since most treatments only slow... Read more

Molecular Diagnostics

view channel
Image: Capsule sponge opened to reveal the sponge (Photo courtesy of StillVision)

Capsule Sponge Test Could Replace Endoscopies for Monitoring Esophageal Cancer Risk

Esophageal cancer remains a challenging disease to treat, with fewer than 20% of patients surviving beyond five years of diagnosis—a statistic that has remained largely unchanged for decades.... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: The new tool shines a light on elusive genomic patterns (Photo courtesy of Adobe Stock)

Computational Tool Exposes Hidden Cancer DNA Changes Influencing Treatment Resistance

Structural changes in tumor DNA are among the most damaging genetic alterations in cancer, yet they often go undetected, particularly when tissue samples are degraded or of low quality. These hidden genomic... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.