FDA Approves Quidel’s Sofia 2, First Antigen Test to Help in the Rapid Detection of COVID-19

Source: Quidel

Quidel, which makes diagnostic tests for a variety of conditions including acute conjunctivitis and dry eye disease, announced that it has received Emergency Use Authorization (EUA) from the FDA to market its Sofia 2 SARS Antigen FIA, a rapid point-of-care test for the detection of COVID-19.  Sofia 2 is the first antigen test approved by the FDA, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs, according to the FDA.

“PCR [polymerase chain reaction] tests can be incredibly accurate, but running the tests and analyzing the results can take time. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes,” according to an FDA news release. “However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test. Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.”

Antigen tests are also important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests, the FDA stated. Once multiple manufacturers enter the market, they can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time.

The Sofia 2 instrument offers 2 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, according to Quidel.

“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,” Douglas Bryant, president and chief executive officer of Quidel, said in the news release. “The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our health care 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.”

Sofia 2, which is used with the Sofia 2 Fluorescent Immunoassay Analyzer, 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, according to a company news release. 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 assay is currently available for sale in the United States under EUA, and Quidel is now shipping the product to its customers. Quidel offers several other Sofia assays for sale, which are FDA cleared and CLIA waived, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 12-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia tests for Lyme Disease, Legionella, and S. pneumoniae in Europe.

Health care professionals can purchase the Sofia 2 SARS Antigen FIA through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein, or McKesson.


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