“The FDA has authorized the use of those tests by using just the first and second step to provide a definitive diagnostic,” Health and Human Services Secretary Alex Azar said during a congressional hearing Thursday.
Forty labs — local and state public health labs as well as select department of defense labs — across the U.S. are already authorized to start using the modified test, and all 93 labs should be able to start testing by next week, Azar said.
The move was welcomed by public health officials, who have been frustrated by the testing snag.
“It’s really good news,” says Kelly Wroblewski, director of infectious diseases for the Association of Public Health Laboratories, which represents public health labs around the United States. “Testing is incredibly important.”
Without wide-scale testing, she says, there’s no way to know if the virus is spreading silently.
“This is a critical time,” Wroblewski says. “We don’t think it’s spreading very widely yet, but if you’re not looking for something, you won’t find it.”
Cases could go undiagnosed, delaying treatment and allowing infected people to spread the virus to others, she says.
“Once you know that it’s there, you can take appropriate steps to encourage people who might have the disease to stay home — to self-quarantine. You would probably go ahead and test their family members to see if their close contacts have also got the disease,” she says. “You can maybe limit the spread if you catch it early.”
Frustrated by the problems with the CDC kits, the association had asked the FDA to allow individual states to develop and use their own tests. But Wroblewski says the resolution of the problem with the CDC will hopefully make that unnecessary
“Having these additional laboratories on board and ready to test is going to put us in a much, much better position to respond,” Wroblewski says.
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