COVID-19 testsThere Are Many COVID-19 Tests in the U.S. – How Are They Being Regulated?
When it comes to COVID-19 testing in the United States, the situation is about as messy as it gets. The U.S. went from having no tests, or assays, available for COVID-19 diagnostics to having multiple different tests available in a span of just a few weeks. Today more than 230 test developers have alerted the Food and Drug Administration that they are requesting emergency authorization for their tests; 20 have been granted. And 110 laboratories around the country, including my own, are also using their own tests. Having this number of diagnostic tests available to detect a single virus in such a short time frame is unprecedented.
When it comes to COVID-19 testing in the United States, the situation is about as messy as it gets.
The U.S. went from having no tests, or assays, available for COVID-19 diagnostics to having multiple different tests available in a span of just a few weeks. Today more than 230 test developers have alerted the Food and Drug Administration that they are requesting emergency authorization for their tests; 20 have been granted. And 110 laboratories around the country, including my own, are also using their own tests. Having this number of diagnostic tests available to detect a single virus in such a short time frame is unprecedented.
Which tests are good and which tests are bad isn’t immediately apparent. According to a March 30 press release from the FDA, “The FDA revised the process to allow labs to begin testing prior to FDA review of their validation data. This policy change was an unprecedented action to expand access to testing.” The guidance the FDA provides to test makers requires laboratories provide some evidence of their assay’s performance and consistency in results. It also ensures that reasonable thought is put into assay design. Assays meeting these requirements may then be permitted for clinical use prior to receiving approval by the FDA.
I am a physician scientist who studies viruses in my research laboratory and directs a clinical microbiology facility for a large hospital system. Since COVID-19 made it to the U.S., laboratory directors like me haven’t had a spare moment to focus on anything other than developing tests to respond to this pandemic.
There’s Still a Lot to Learn
SARS-CoV-2 is the virus that causes the disease. It is a novel virus from the coronavirus family that was first identified in November 2019 in Wuhan, China. Like other viruses, this one is believed to have first infected animals and then jumped over to humans. Because of their zoonotic origins, these viruses are often ill-suited to spread from person to person. What makes COVID-19 so different is it’s readily spread between people, which lies at the heart of the current pandemic.
There is a lot that we just don’t yet know about COVID-19.
