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 FDA Emergency Use Authorization for QuickVue SARS Rapid Antigen Test for COVID-19 Diagnosis

By LabMedica International staff writers
Posted on 22 Dec 2020
Quidel Corporation (San Diego, CA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to market its QuickVue SARS Antigen test.

The point-of-care assay is intended for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

Quidel’s new QuickVue SARS Antigen test requires no supplemental instrumentation and is visually read. More...
It offers excellent performance for the detection of SARS-CoV-2 (96.6% PPA versus PCR and 99.3% NPA versus PCR) in anterior nares swab samples, yielding results in just 10 minutes, thereby providing quick, reliable results to patients, their families and healthcare workers alike.

“We are proud to introduce yet another powerful diagnostic tool to aid the fight against COVID-19,” said Douglas Bryant, president and CEO of Quidel Corporation. “The QuickVue rapid antigen test for coronavirus leverages our proven QuickVue visually read diagnostic platform for influenza A+B to further democratize access to affordable and highly accurate COVID-19 testing across a diverse range of medical and point-of-care locations.”

“The flexibility of QuickVue for meeting the urgent testing needs of everyone from school systems to rural areas and even locations without electricity gives us the opportunity to do enormous good in communities across our nation and the world,” Mr. Bryant noted. “We will scale immediately to supply the more than 30,000 QuickVue professional market customers we serve today and look forward to extending the benefits of this technology as broadly and rapidly as possible in the months and years ahead.”



Platinum Member
Fully Automatic ACLIA Analyzer
MAGLUMI X8
Gold Member
SARS-CoV-2 PCR Test
Macurra SARS-CoV-2 PCR Kit
Hematology Consumables
Bioblood Devices
Food Allergy Screening ELISA Kit
Allerquant 14G B 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: The method combines ultrasonic and fluorescence techniques to track amyloid aggregation in real time (Image Credit: Shutterstock)

Blood Test Measures Amyloid Seeding Activity to Detect Alzheimer’s Disease

Early, accurate diagnosis of Alzheimer’s disease (AD) remains challenging in routine practice, despite its role as the leading cause of dementia worldwide. Confirmation typically relies on cerebrospinal... Read more

Pathology

view channel
Image: TRUECAM automatically eliminates ambiguous or uninformative regions in whole-slide pathology images, enhancing the reliability of diagnostic analysis. (Photo courtesy of PolyU)

AI-Pathologist Framework Improves Accuracy and Reliability in Cancer Diagnosis

Ensuring reliable cancer diagnosis from digital pathology remains a critical challenge as clinical decisions rely on accurate slide interpretation. While artificial intelligence (AI) has accelerated whole-slide... Read more

Industry

view channel
Image: HealthTab will distribute the Abbott Afinion 2 Analyzer to NHS-linked pharmacies for hemoglobin A1c (HbA1c) and lipid profile testing. (Photo courtesy of Abbott)

New Collaboration Expands Point-of-Care Testing Across UK Community Pharmacies

HealthTab, a wholly owned subsidiary of Avricore Health, has entered a formal collaboration agreement with Abbott to supply and distribute Abbott’s point-of-care testing products in the UK through the... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.