Clinical scientists found themselves challenged when the SARS-CoV-2 virus showed up last December. Questions about the virus’ origin and initial comparisons with flu symptoms – due to the coincidental timing with typical flu season – began immediately in an effort to name the virus and find a cure for it as fast as modern testing and treatment would allow. Ultimately, clinicians were able to successfully differentiate between SARS-CoV-2 and the flu, despite any initial confusion the virus presented.
As scientists have worked hard to identify the SARS-CoV-2 virus, and even harder to get a handle on the COVID-19 disease it was responsible for, certain facts have become painfully obvious to the lab industry. The effects of emerging diseases always have the potential to create tragic loss of life, and with COVID-19, it was no different. COVID-19 was clearly a disease that scientists were unprepared for when it arrived, and any historic comparisons with the flu do nothing to alleviate the devastation COVID-19 has already left in its wake.
In the rush to develop a test to identify suspected COVID-19 cases, problems with initial tests presented themselves and required more attention to getting it right versus getting it fast. Once additional new tests proved themselves viable and successful testing options, the U.S. Food and Drug Administration (FDA) began issuing Emergency Usage Authorizations (EUA) to quickly make additional tests available. This faster pace created its share of QA/QC issues and spurred comments from the FDA which encouraged due diligence in the using the tests, despite any EUA that may have been granted.
In early May, the FDA issued an update to a policy from mid-March on antibody tests for COVID-19. Anand Shah, MD, Deputy Commissioner for Medical and Scientific Affairs, and Jeff Shuren, MD, Director, Center for Devices and Radiological Health summed up the importance of FDA test authorization.
“It is not accurate for developers to claim their test was authorized by the FDA if an EUA was not granted for the tests, nor should they be distributing their test if it has not been properly validated. To be clear, the March 16 policy did not change that an EUA is a key tool to making critical products for COVID-19, including antibody tests, available in a public health emergency. We continue to encourage all developers to submit EUA requests, so the FDA is able to examine data on the test’s performance and make a formal determination of whether to authorize it for emergency use.”
They also pointed out, “almost half of the tests offered by commercial manufacturers are already the subject of an EUA review or a pre-EUA, a pre-submission that provides an opportunity for the developer to begin to share data with or seek advice from the FDA. To date, 12 antibody tests have been authorized under an individual EUA, most within just the past few days, and over 200 antibody tests are currently the subject of a pre-EUA or EUA review.”
As such, clinicians are encouraged to use FDA-approved tests, and to document their successes and failures so scientists can learn from each experience, which will also serve to benefit both the lab industry and patients as well.
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