Quidel’s Sofia 2 SARS Antigen FIA Becomes First COVID-19 Antigen Test to Secure FDA Emergency Use Authorization
|
By LabMedica International staff writers Posted on 11 May 2020 |
|
Image: Quidel Corporation’s Sofia 2 SARS Antigen FIA (Photo courtesy of Quidel Corporation)
Quidel Corporation’s (San Diego, CA, USA) Sofia 2 SARS Antigen FIA has become the first COVID-19 antigen test to be granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).
The Sofia 2 SARS Antigen FIA is a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for 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 United States under EUA, and Quidel is now shipping the product to its customer
Sofia 2, Quidel’s next-generation version of its Sofia instrumented system, utilizes the original Sofia fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, objective and automated result in 15 minutes. The next-generation 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 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 bench top for a manually timed development and then placed into Sofia 2 to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour.
“In the fight against COVID-19, our employees are truly making a difference, and I am tremendously proud of our organization’s ability to quickly develop and mobilize an accurate rapid antigen test,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient.”
Related Links:
Quidel Corporation
The Sofia 2 SARS Antigen FIA is a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for 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 United States under EUA, and Quidel is now shipping the product to its customer
Sofia 2, Quidel’s next-generation version of its Sofia instrumented system, utilizes the original Sofia fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, objective and automated result in 15 minutes. The next-generation 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 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 bench top for a manually timed development and then placed into Sofia 2 to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour.
“In the fight against COVID-19, our employees are truly making a difference, and I am tremendously proud of our organization’s ability to quickly develop and mobilize an accurate rapid antigen test,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient.”
Related Links:
Quidel Corporation
Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
New
Silver Member
ACTH Assay
ACTH ELISA
New
Vaginitis Test
Allplex Vaginitis Screening Assay
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants
Channels
Clinical Chemistry
view channel
‘Brilliantly Luminous’ Nanoscale Chemical Tool to Improve Disease Detection
Thousands of commercially available glowing molecules known as fluorophores are commonly used in medical imaging, disease detection, biomarker tagging, and chemical analysis. They are also integral in... Read more
Low-Cost Portable Screening Test to Transform Kidney Disease Detection
Millions of individuals suffer from kidney disease, which often remains undiagnosed until it has reached a critical stage. This silent epidemic not only diminishes the quality of life for those affected... Read more
New Method Uses Pulsed Infrared Light to Find Cancer's 'Fingerprints' In Blood Plasma
Cancer diagnoses have traditionally relied on invasive or time-consuming procedures like tissue biopsies. Now, new research published in ACS Central Science introduces a method that utilizes pulsed infrared... Read more
Molecular Diagnostics
view channel
Simple Blood Test Improves Heart Attack and Stroke Risk Prediction
Troponin is a protein found in heart muscle cells that is released into the bloodstream when the heart is damaged. High-sensitivity troponin blood tests are commonly used in hospitals to diagnose heart... Read more
Blood Biomarker Test Could Detect Genetic Predisposition to Alzheimer’s
New medications for Alzheimer’s disease, the most common form of dementia, are now becoming available. These treatments, known as “amyloid antibodies,” work by promoting the removal of small deposits from... Read more
Novel Autoantibody Against DAGLA Discovered in Cerebellitis
Autoimmune cerebellar ataxias are strongly disabling disorders characterized by an impaired ability to coordinate muscle movement. Cerebellar autoantibodies serve as useful biomarkers to support rapid... Read more
Gene-Based Blood Test Accurately Predicts Tumor Recurrence of Advanced Skin Cancer
Melanoma, an aggressive form of skin cancer, becomes extremely difficult to treat once it spreads to other parts of the body. For patients with metastatic melanoma tumors that cannot be surgically removed... Read moreHematology
view channel
New Scoring System Predicts Risk of Developing Cancer from Common Blood Disorder
Clonal cytopenia of undetermined significance (CCUS) is a blood disorder commonly found in older adults, characterized by mutations in blood cells and a low blood count, but without any obvious cause or... Read more
Non-Invasive Prenatal Test for Fetal RhD Status Demonstrates 100% Accuracy
In the United States, approximately 15% of pregnant individuals are RhD-negative. However, in about 40% of these cases, the fetus is also RhD-negative, making the administration of RhoGAM unnecessary.... Read more
Immunology
view channel
Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer
Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more
Machine Learning-Enabled Blood Test Predicts Immunotherapy Response in Lymphoma Patients
Chimeric antigen receptor (CAR) T-cell therapy has emerged as one of the most promising recent developments in the treatment of blood cancers. However, over half of non-Hodgkin lymphoma (NHL) patients... Read more
Microbiology
view channel
Handheld Device Delivers Low-Cost TB Results in Less Than One Hour
Tuberculosis (TB) remains the deadliest infectious disease globally, affecting an estimated 10 million people annually. In 2021, about 4.2 million TB cases went undiagnosed or unreported, mainly due to... Read more
New AI-Based Method Improves Diagnosis of Drug-Resistant Infections
Drug-resistant infections, particularly those caused by deadly bacteria like tuberculosis and staphylococcus, are rapidly emerging as a global health emergency. These infections are more difficult to treat,... Read more
Breakthrough Diagnostic Technology Identifies Bacterial Infections with Almost 100% Accuracy within Three Hours
Rapid and precise identification of pathogenic microbes in patient samples is essential for the effective treatment of acute infectious diseases, such as sepsis. The fluorescence in situ hybridization... Read more
Pathology
view channel
Spit Test More Accurate at Identifying Future Prostate Cancer Risk
Currently, blood tests that measure the level of a protein called prostate-specific antigen (PSA) are commonly used to identify men at higher risk for prostate cancer. This test is typically used based... Read more
DNA Nanotechnology Boosts Sensitivity of Test Strips
Since the Covid-19 pandemic, most people have become familiar with paper-based rapid test strips, also known as lateral flow immunoassays (LFIAs). These tests are used to quickly detect biomarkers that... Read more
Novel UV and Machine Learning-Aided Method Detects Microbial Contamination in Cell Cultures
Cell therapy holds great potential in treating diseases such as cancers, inflammatory conditions, and chronic degenerative disorders by manipulating or replacing cells to restore function or combat disease.... Read more
Technology
view channel
Disposable Microchip Technology Could Selectively Detect HIV in Whole Blood Samples
As of the end of 2023, approximately 40 million people globally were living with HIV, and around 630,000 individuals died from AIDS-related illnesses that same year. Despite a substantial decline in deaths... Read more
Pain-On-A-Chip Microfluidic Device Determines Types of Chronic Pain from Blood Samples
Chronic pain is a widespread condition that remains difficult to manage, and existing clinical methods for its treatment rely largely on self-reporting, which can be subjective and especially problematic... Read more
Innovative, Label-Free Ratiometric Fluorosensor Enables More Sensitive Viral RNA Detection
Viruses present a major global health risk, as demonstrated by recent pandemics, making early detection and identification essential for preventing new outbreaks. While traditional detection methods are... Read more
Industry
view channel
Cepheid and Oxford Nanopore Technologies Partner on Advancing Automated Sequencing-Based Solutions
Cepheid (Sunnyvale, CA, USA), a leading molecular diagnostics company, and Oxford Nanopore Technologies (Oxford, UK), the company behind a new generation of sequencing-based molecular analysis technologies,... Read more
Grifols and Tecan’s IBL Collaborate on Advanced Biomarker Panels
Grifols (Barcelona, Spain), one of the world’s leading producers of plasma-derived medicines and innovative diagnostic solutions, is expanding its offer in clinical diagnostics through a strategic partnership... Read more
