In response to encouragement from a number of stakeholders, the U.S. Food and Drug Administration has broadened its emergency use authorization process for tests to detect the virus that causes COVID-19.
Approximately 11,000 labs are now permitted to develop their own tests.
High-complexity labs became eligible under new FDA guidance issued on Feb. 29 to create their own diagnostic test kits.
The new guidance says that labs must apply for emergency use authorization within 15 days of beginning testing, and public health labs can also still obtain test kits from the Centers for Disease Control and Prevention. Labs can also choose to purchase test kits commercially and there is one lot number of test kits so far that has been validated and authorized by the CDC.
On Capitol Hill, lawmakers expressed skepticism about U.S. health officials' claims that testing for the new virus should be widely available by the end of the week. Authorities have said labs across the country should have the capacity to run as many as 1 million tests by then.
But testing so far has faced delays and missteps, and "I'm hearing from health professionals that's unrealistic," Democratic Sen. Patty Murray of Washington state said at a Senate hearing.
FDA Commissioner Dr. Stephen Hahn said the FDA has been working with a private company to get as many as 2,500 test kits out to labs by the end of the week. Each kit should be able to allow a lab to run about 500 tests, he said. But health officials were careful about making hard promises.
"I am optimistic, but I want to remain humble," said Dr. Anne Schuchat of the CDC.
The Association of Public Health Labs and the American Association of Clinical Chemistry had urged the FDA to expand its authorization to allow labs to develop tests.
"I'm thrilled that the FDA is allowing high-complexity laboratories to do this testing," said Carmen Wiley, president of AACC.
Labs can now develop what are essentially their own tests to use on patient samples, with hundreds of those labs affiliated with hospitals and health systems, including about 400 academic medical centers.
"When you are certified as a high-complexity laboratory, it means that the types of laboratory professionals you have on your staff are credentialed to do laboratory-developed tests, which are tests that are not FDA-cleared," Wiley explained. These labs have experts who can design, validate, and report out patient results, she said.
More testing means the likelihood of finding more positive cases, Wiley said, but it will be critical to help people understand that a likely increase in the number of cases is due to the ability to test more people not necessarily to the virus spreading.
Labs in New York state were the first to obtain clearance, with a test authorized for emergency use shortly after the new FDA guidance was issued on Saturday. The state currently has two cases of COVID-19.
The process is contigent on labs using RNA or inactive SARS-CoV-2 strains to validate their tests.
"This is somewhat of a sticking point, because this is not easy to get a hold of," Wiley said.
Ideally, labs will also have a "true positive" sample to compare against, but each lab will be doing its validation study in its own way.
In a webinar with labs on Monday, Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health said that the agency encourages labs to contact their local public health authorities prior to testing patients, as these authorities may need to do confirmatory testing on presumptive positive samples.
Stenzel said the FDA, BARDA, and the CDC will prioritize and coordinate shipments of viral materials to labs when they are ready to validate tests.
There is also viral RNA material available from the National Institute of Allergy and Infectious Diseases' BEI Resources Repository, but Stenzel acknowledged that there is a limitation on availability and requested that people reach out to the FDA if they have issues obtaining material. "We will work with you," he said.
Furthermore, "The procedures for validations in this new guidance are suggestions and recommendations—if you have ideas for alternative approaches, please reach out" to FDA, he said.
A version of this story first appeared in our sister publication, Genomeweb.
