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.
Date Published: 16th October 2020
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.