As the United States deals with the coronavirus, Quidel Corporation’s 1,300 employees have produced the first FDA-approved rapid COVID-19 antigen test, with 96.7% sensitivity when used in the first five days of infection. While this accomplishment helps solve the life-threatening problem of days-long test result delays, it raises new challenges.
Rapid tests like our Sofia 2 SARS Antigen FIA give healthcare workers the immediate confirmation they need to isolate, treat and contact-trace patients and those who have been exposed to infected individuals. Speedy intervention, along with frequency of testing, are key to controlling the spread of the coronavirus.
Quidel is producing over a million antigen tests per week, but demand for our tests, testing instruments and reagents far outstrips supply, and will for months to come. This raises the question of how best to allocate tests among those hospitals, clinics, medical practices, agencies, employers and others eager to protect their patients, employees, communities and constituents.
Our goal is to serve the greatest number of those in the greatest need for testing, while continuing to satisfy the interests of our longstanding influenza customers, many of whom are well-positioned to provide antigen testing in their communities. Fair pricing and rational, compassionate allocation of materials should help achieve this objective.
Public health agencies are vital partners. The U.S. Department of Health and Human Services said it will purchase a large quantity of Quidel tests and instruments for distribution to nursing homes nationally, starting in COVID-19 hotspots. As HHS put it, “Through this crucial action, nursing homes will be able to augment their current capacity for coronavirus testing, bolstering their response and helping to prevent the spread of SARS-CoV-2.”
We are prioritizing customers who are treating first responders and healthcare workers. We are also serving existing customers who can conduct tests without delays tied to validations, installation or training. And we’re supporting higher-volume customers who serve more respiratory patients and may maximize efficiency by running a variety of tests on the same Quidel instrument. Finally, we are also prioritizing those customers who are willing to transmit their anonymized test results via our Virena data management system in order to provide critical disease mapping solutions free to public health organizations.
Quidel is hiring now to meet the demand, but undoubtedly near-term shortages of tests, equipment and raw materials will lead to objections from some healthcare providers whose access will be frustratingly delayed. We share their concern for patient welfare and are increasing test production and introducing improvements in rapid testing for COVID-19 and other diseases.
We are now developing a rapid combination influenza A, influenza B and SARS antigen test, and we are partnering with the Biomedical Advanced Research and Development Authority to develop a rapid simultaneous test for COVID-19, influenza A and B, and respiratory syncytial virus. We hope to have these tests available in the fall of 2020 and the first quarter of 2021, respectively, when the flu season will coincide with the coronavirus pandemic, presenting additional diagnostic challenges.
Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, recently cautioned, “I do think the fall and the winter of 2020 is probably going to be one of the most difficult times that we’ve experienced in American public health.”
As individuals, we all must do our part to limit the spread and impact of the coronavirus. As a corporation, we are committing all our considerable scientific knowledge, talent and energy to supply our healthcare system with the best tools imaginable. We’re all in this together.
Douglas Bryant is president and chief executive officer of Quidel Corporation, a San Diego-based developer of rapid diagnostics for a wide range of disease conditions. The company also has research and manufacturing operations in Ohio, Massachusetts, China, Ireland and Germany.