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
ARAB HEALTH - INFORMA

QUIDEL

Develops, manufactures and markets rapid diagnostic tests at the point-ofcare (POC) that focus on infectious diseases... read more Featured Products: More products

Download Mobile App





Quidel Receives Amended EUA for Rapid Antigen COVID-19 Diagnostic Assay Using Sofia 1 Instrument

By HospiMedica International staff writers
Posted on 10 Jun 2020
Print article
Image: Quidel Corporation’s Sofia 2 SARS Antigen FIA (Photo courtesy of Quidel Corporation)
Image: Quidel Corporation’s Sofia 2 SARS Antigen FIA (Photo courtesy of Quidel Corporation)
Quidel Corporation (San Diego, CA, USA) has received an amended Emergency Use Authorization (EUA) from the US FDA, allowing the company to run its Sofia SARS Antigen FIA on its first generation Sofia Fluorescent Immunoassay Analyzer (Sofia 1).

The Sofia SARS Antigen FIA is to be used as an aid in the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Prevention’s (CDC) criteria for suspected COVID-19 infection. The assay is currently available for sale in the US States under EUA, and Quidel is now shipping the product to its customers.

Quidel has previously received EUA to run the Sofia SARS Antigen FIA, a rapid point-of-care test for COVID-19, on the second-generation Sofia 2 instrumented system. Sofia 1 provides an accurate, objective and automated result in 15 minutes. Like the Sofia 2, the original Sofia 1 instrument offers two distinct workflows. Depending upon the user’s choice, the Sofia SARS Antigen FIA cartridge is placed inside the instrument for automatically timed development (WALK AWAY Mode); or test cartridges can be placed on the counter or bench top for a manually timed development and then placed into the instrument to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour. There are approximately 20,000 Sofia 1 instruments installed in hospitals and physician offices worldwide.

“This EUA amendment permits our novel Sofia SARS Antigen test to be used on both models of our Sofia instruments, leveraging our worldwide installed base of over 43,000 combined placements, allowing many of our larger healthcare facilities to be able to quickly diagnose first responders, healthcare workers, and other high priority personnel,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “The demand for the Sofia SARS Antigen test kits and Sofia instruments has been phenomenal. In under 10 days, we had over 1,000 sites on contract and continue to expect that we will ship every cartridge that we can manufacture for the foreseeable future.”

Additionally, the Biomedical Advanced Research and Development Authority {(BARDA) Washington, DC, USA} has awarded funding to Quidel for the development of its SARS-CoV-2 test. BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS), has awarded USD 634,643 to Quidel for the development of a four-analyte antigen test on the company’s Sofia 2 instrumented system. Quidel will develop the test to detect SARS-CoV-2, respiratory syncytial virus, influenza A, and influenza B. According to BARDA, the sample-to-answer, point-of-care assay is being developed to be CLIA waived, enabling possible use in doctors’ offices and to be sensitive enough for the early detection of SARS-CoV-2 in samples from people who have COVID-19 symptoms.


Gold Member
12-Channel ECG
CM1200B
Gold Member
POC Blood Gas Analyzer
Stat Profile Prime Plus
New
Neonatal and Pediatric Tracheostomy Tubes
Portex Bivona FlexTend TTS Tracheostomy Tubes
New
Mobile Cart
MS400

Print article

Channels

Critical Care

view channel
Image: The active substance TVEC led to a reduction in the size of the basal cell carcinoma in all study participants (Photo courtesy of 123RF)

Basal Cell Carcinoma Treatment Reduces Tumor Size, Improves Surgical Removal

Basal cell carcinomas, the most prevalent type of skin cancer, often appear in areas exposed to the sun, such as the face. Locally advanced tumors, in particular, present challenges for surgical treatment.... Read more

Surgical Techniques

view channel
Image: LumiSystem is the combination of two FDA approved products: LUMISIGHT (pegulicianine) and Lumicell Direct Visualization System (Photo courtesy of Lumicell)

Pioneering Technology Enables Real-Time Detection of Residual Breast Cancer During Lumpectomy

Breast cancer is the most frequently diagnosed cancer in women, with lumpectomies being the most common treatment approach. About 65% of women diagnosed with breast cancer undergo a lumpectomy, also referred... Read more

Patient Care

view channel
Image: The portable biosensor platform uses printed electrochemical sensors for the rapid, selective detection of Staphylococcus aureus (Photo courtesy of AIMPLAS)

Portable Biosensor Platform to Reduce Hospital-Acquired Infections

Approximately 4 million patients in the European Union acquire healthcare-associated infections (HAIs) or nosocomial infections each year, with around 37,000 deaths directly resulting from these infections,... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.