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Amid testing concerns, US officials unveil new coronavirus test kits and streamline commercial development

Laboratory technicians work on testing samples from people to be tested for the COVID-19 coronavirus at a laboratory in Shenyang in China’s northeastern Liaoning province on February 12, 2020.

STR | AFP | Getty Images

U.S. health officials said Friday that federal agencies are increasing coronavirus testing capabilities at state and local labs, and plan to streamline the process for private development of test kits.

The announcements come after California officials criticized the Centers for Disease Control and Prevention for delaying testing on a state resident who has COVID-19.

The Trump administration plans to release guidelines “very soon” that will expedite the commercial development of test kits, Health and Human Services Secretary Alex Azar told reporters in front of the White House on Friday.

“We also very soon through the FDA will be rolling out streamlined guidance that will allow private labs to create their own tests based on essentially the recipe the CDC has used in their test kit,” Azar said. “Private labs throughout the country will be able to come forward and get very streamlined access to approval by the FDA to be able to use that test to really enhance the capacities that we have here in the United States on testing.”

Separately, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, announced earlier on Friday on a conference call that the agency has released a new diagnostic test for COVID-19. The CDC, she said, also rolled out guidelines for how state and local health labs can correct previously faulty test kits sent out by the CDC.

The changes, she said, will improve the country’s ability to quickly identify and treat COVID-19 patients.

“Labs can start testing with existing CDC test kits … This will increase testing capacity at state and local health departments,” she said. “Additionally, CDC has manufactured brand new test kits.”

The CDC sent test kits earlier in the outbreak to public health labs around the country, but those kits were problematic, CDC officials have since said, and potentially inaccurate. Because local clinicians can’t depend on the test kits, some have had to ship samples to a laboratory with the ability to run the tests, delaying the process of diagnosis and treatment.

Earlier this week, Messonnier said that the CDC was “working to modify the kit and hope to send out a new” one soon.

Messonnier declined to provide specific numbers on how many states and labs have the ability to test for the coronavirus.

“Our goal is to have every state and local health department online, doing their own testing by the end of next week,” she said.

The new kits come after epidemiologists and public health officials raised questions earlier this week about the U.S. capacity to conduct tests amid a potential epidemic in the U.S. California Governor Gavin Newsom said Thursday that the state is currently monitoring more than 8,400 people for the coronavirus. He added that California health officials have 200 testing kits on hand and will be receiving more over the next few days. “That’s simply inadequate to do justice to the kind of testing that is required to address this issue head on,” Newsom said.

On Wednesday, U.S. health officials confirmed the first possible community transmission of the coronavirus in California, a troubling sign that the virus could be spreading unknown in local cities and towns. Amid potential community spread, pathologists have called for improved testing capacity.

“We are working as quickly as we can to get CDC test kits to state and local public health authorities,” Messonnier said. “Our priority remains to get accurate diagnostic capacity and doing so quickly because we know public health surveillance is critical to our fight against this novel coronavirus.”