Dr. Michael Mina sees a future coming that worries him: a glut of patients stuck waiting for laboratory results to find out whether they have the new coronavirus that is spreading around the world.
Many of these patients may simply have a bad cold or the flu. But while they wait for test results, they will need to be placed in temporary isolation “using very precious bed space in the hospital," says Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health.
Currently, coronavirus lab confirmations can only be obtained using a limited supply of test kits from the Centers for Disease Control and Prevention (CDC). The tests take at least a day or two, Mina says.
“They provided something like 70,000 tests for the entire country,” he says.
On Friday, federal officials announced changes to the test kits that will allow more state laboratories, including those in Massachusetts, to conduct their own testing. State officials estimate they will get results from the tests in 24 hours. Any positive results will still have to be confirmed by the CDC, which may take longer.
If the new coronavirus begins spreading in the U.S., testing delays could hamstring hospitals’ ability to accept and treat patients with coronavirus and other serious illnesses, researchers warn.
“We don’t want to wait hours for a person with a negative result to be discharged,” Mina says. “We would get a long queue of people, and that would do real damage to the care we can give. That’s the last place we want to find ourselves.”
But Mina, who is an associate medical director of pathology at Brigham and Women’s Hospital, doesn’t have to wait 24 hours for coronavirus testing because he can cook up a diagnostic in his own lab and get results far more quickly. And like many scientists around the country, that’s exactly what he’s doing — in his case, using the CDC's test as a blueprint.
“The test kits that the CDC sent out are like a Blue Apron meal. They have ingredients that you can pick up at a store anywhere, and there’s a recipe in it," Mina says. “We can buy our own ingredients and download the protocol from the CDC website and actually completely replicate the test kit.”
Mina says the lab at Brigham and Women’s has a device called the Panther that can run the tests. Once his team programs the machine, Mina says it will be able to complete a coronavirus diagnostic in a couple of hours.
But unless Mina and other researchers get a green light from the Food and Drug Administration, they won't be able to use their own labs to test for coronavirus. First, they have to submit applications to the FDA, including evidence their tests are valid and reliable. The FDA announced on Saturday that scientists will be allowed to perform the test while the application is pending.
Other researchers around the country are building other types of coronavirus diagnostics. They too are wary of the possibility of local outbreaks, and they worry about being unable to quickly confirm if patients do or do not have the virus.
“The labs that can actually run these tests right now are completely overwhelmed," says Sam Sia, a biomedical engineering professor at Columbia University. "That started in China, but it’s now starting across the world.”
Sia is working on a diagnostic that could be even simpler to use than Mina’s replication of the CDC test kit.
“It’s a rapid test like a pregnancy test,” he says. “This would probably be an oral swab of some kind. Anyone can do it, and it’d be really cheap as well.”
While the CDC test kit works by searching for the presence of the virus’ genetic code, Sia’s test strips would detect viral proteins. If the virus is in someone’s oral swab, then those viral proteins would react with a chemical in the test strip, and a line would appear on the paper.
“It’s probably weeks to months away [from being completed and tested],” Sia says. “Having these rapid tests would serve as a sentinel for us to know what to do. Otherwise, you could have a lot of confusion, and you’re not identifying the patients that are truly infected. That’s really not going to help contain the spread of an epidemic like this.”
Massachusetts Institute of Technology researchers are also working on a coronavirus test strip, one that could give a result within minutes. Unlike Sia's test, these strips would detect pieces of the virus’ genetic material.
“You see if the strip has one or two lines,” says Feng Zhang, a biochemist at MIT and the Broad Institute. “We’re working on trying to develop it as quickly as we can.”
All of the scientists are working quickly because an outbreak may very well be on its way, Mina says.
“The writing has been on the wall,” he says. “The chances of stopping [coronavirus’] spread have dwindled to a very, very low probability.”
Although no labs have received authorization from the FDA so far, the agency says a completed application can be approved within a day in emergencies. The paperwork takes time to put together, but Mina says his lab has already begun that process.
"FDA has engaged with over 70 developers working on tests," a spokeswoman from the agency told WBUR in an email, adding that the FDA "remains committed to working with developers and the community to ensure the public health need for testing is met."
This post has been updated with new information from the CDC and state officials that the Massachusetts State Public Health Laboratory can now begin testing for coronavirus. The FDA also announced Saturday that it will allow other labs to begin testing while an emergency application is pending.
This article was originally published on February 28, 2020.
This segment aired on February 28, 2020.
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