Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

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
Immunochromatographic Assay
CRYPTO Cassette
POC Helicobacter Pylori Test Kit
Hepy Urease Test
Homocysteine Quality Control
Liquichek Homocysteine Control
Capillary Blood Collection Tube
IMPROMINI M3
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

Molecular Diagnostics

view channel
Image: The diagnostic device can tell how deadly brain tumors respond to treatment from a simple blood test (Photo courtesy of UQ)

Diagnostic Device Predicts Treatment Response for Brain Tumors Via Blood Test

Glioblastoma is one of the deadliest forms of brain cancer, largely because doctors have no reliable way to determine whether treatments are working in real time. Assessing therapeutic response currently... Read more

Immunology

view channel
Image: Circulating tumor cells isolated from blood samples could help guide immunotherapy decisions (Photo courtesy of Shutterstock)

Blood Test Identifies Lung Cancer Patients Who Can Benefit from Immunotherapy Drug

Small cell lung cancer (SCLC) is an aggressive disease with limited treatment options, and even newly approved immunotherapies do not benefit all patients. While immunotherapy can extend survival for some,... Read more

Microbiology

view channel
Image: New evidence suggests that imbalances in the gut microbiome may contribute to the onset and progression of MCI and Alzheimer’s disease (Photo courtesy of Adobe Stock)

Comprehensive Review Identifies Gut Microbiome Signatures Associated With Alzheimer’s Disease

Alzheimer’s disease affects approximately 6.7 million people in the United States and nearly 50 million worldwide, yet early cognitive decline remains difficult to characterize. Increasing evidence suggests... Read more

Technology

view channel
Image: Vitestro has shared a detailed visual explanation of its Autonomous Robotic Phlebotomy Device (photo courtesy of Vitestro)

Robotic Technology Unveiled for Automated Diagnostic Blood Draws

Routine diagnostic blood collection is a high‑volume task that can strain staffing and introduce human‑dependent variability, with downstream implications for sample quality and patient experience.... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.