Charles River Laboratories Endosafe Trillium
 


16th October 2020  Product update: rapidmicrobiology staff writer

FDA Authorizes Point-of-Care Rapid Antigen Test for COVID-19 & Influenza A/B


The US FDA has granted Emergency Use Authorization (EUA) to Quidel's rapid diagnostic test, which can detect SARS-CoV-2 and Influenza A & B from a single swab sample in 15 minutes. 

The FDA-EUA Sofia® 2 Flu + SARS Antigen FIA, also known as ABC Test, is a rapid point-of-care test to be used with the Sofia® 2 Fluorescent Immunoassay Analyzer. 

The Sofia® 2 instrument also offers two distinct workflows: depending upon the user’s choice, the Sofia® 2 SARS Antigen FIA cartridge is placed inside Sofia® 2 for automatically timed development (WALK AWAY Mode); or test cartridges can be placed on the counter or benchtop for a manually timed development and then placed into Sofia® 2 to be scanned (READ NOW Mode), allowing the user to increase testing throughput per hour markedly.

The Sofia® 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time.

"The new Sofia® 2 Flu + SARS Antigen FIA offers excellent performance for SARS-2 (95.2% PPA versus PCR and 100% NPA versus PCR), as well as for Influenza A (90% sensitivity versus culture and 95% specificity versus culture) and Influenza B (89% sensitivity versus culture and 96% specificity versus culture) in nasal swabs," said a Quidel spokesperson. 


    

Tags:


Date Published: 16th October 2020

Source article link: View

Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


View full company details





safe and easy sterility testing patented dual needle unique sterisart septum watch video
 

Data Integrity as an Indicator of Quality Control Issues
 

BioMerieux at PDA 2023
 

Condalab Brochure Download
 

Charles River Webinar Recombinant Cascade Reagent
 

Get our eNewsletter
Over 7,000 microbiology professionals get our weekly eNewsletter - subscribe now and find out why!

LATEST MICROBIOLOGY NEWS

MICROBIOLOGY EVENTS