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
PURITAN MEDICAL

Download Mobile App





LumiraDx’s FDA EUA Authorized SARS-CoV-2 Antigen Test Expanded to Include Screening of Asymptomatic Individuals

By LabMedica International staff writers
Posted on 04 Nov 2021

LumiraDx (London, UK) has announced that the intended use for its Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authorized SARS-CoV-2 Antigen Test has been expanded to include screening of asymptomatic individuals. More...

This claim builds on its existing claim that covers use of the test in individuals suspected of COVID-19 by their healthcare provider within 12 days of symptom onset. The LumiraDx SARS-CoV-2 Antigen Test initially received EUA from the FDA in August of 2020 after demonstrating a 97.6% positive agreement and 96.6% negative agreement with RT-PCR in symptomatic patients. Asymptomatic individuals are defined as those without symptoms or other epidemiological reasons to suspect COVID-19.

The FDA authorized the expansion of the EUA for LumiraDx after reviewing company data on the performance of its SARS-CoV-2 Antigen Test in individual asymptomatic subjects collected between June 2020 and March 2021. Results indicated high sensitivity and specificity in asymptomatic individuals with the LumiraDx SARS-CoV-2 Ag Test, demonstrating an 82.1% positive agreement and 100% negative agreement with RT-PCR test in 222 subjects. These results illustrate high sensitivity offered by a microfluidic test compared to lateral flow SARS-CoV-2 antigen tests, which independent studies have shown to have sensitivities of less than 50% in asymptomatic populations.

“We understand that one of the most important challenges in keeping infection rates low is to be able to quickly and accurately identify SARS-CoV-2 infection in asymptomatic individuals,” said Nigel Lindner, PhD, LumiraDx Chief Innovation Officer. “Widespread testing in both symptomatic and asymptomatic individuals is a critical tool in preventing transmission of COVID-19. With this FDA authorization we can enable rapid, high sensitivity mass screening programs with our partners across schools, events, workplaces, clinics, travel and other settings and have the testing manufacturing capacity to support these new nation-wide testing mandates.”

Related Links:
LumiraDx 


Gold Member
Universal Transport Solution
Puritan®UniTranz-RT
Serological Pipet Controller
PIPETBOY GENIUS
New
Staining Management Software
DakoLink
New
Gold Member
Blood Gas Analyzer
Stat Profile pHOx
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








DIASOURCE (A Biovendor Company)

Channels

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: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more

Pathology

view channel
Image: Pancreatic cancer diagnosis (Photo courtesy of World Journal of Gastroenterology)

AI-Driven Preliminary Testing for Pancreatic Cancer Enhances Prognosis

Pancreatic cancer poses a major global health threat due to its high mortality rate, with 467,409 deaths and 510,992 new cases reported worldwide in 2022. Often referred to as the "king" of all cancers,... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.