Scientists around the world are working on inexpensive at-home COVID test kits that they say could be game-changers in the effort to slow the disease’s spread.
The U.S. Food and Drug Administration requires high levels of around 80% accuracy for Covid-19 tests like the nose swab tests people get at doctor’s offices or testing centers, according to NPR. But, these tests require elaborate machines and labs and can take days to produce results.
The rapid tests, which the scientists say are as easy to administer as home pregnancy tests, may not be as accurate as the deep nasal swab tests. But scientists say, these tests would allow hundreds of millions of people to test themselves regularly and have a strong sense of whether they are infectious in the moment, not days later, said Eric Topol of Scripps Research.
“Frequency is a really big booster of performance of the test accuracy,” Topol said. “We're talking about relying on a kit that's at home in 20 minutes or so.”
Topol and other scientists say efforts to develop rapid at-home tests are being stymied by the FDA, which so far has refused to fast-track their approval. So, companies may have difficulty finding funding they need to develop and mass-produce the tests.
“The government hasn’t done anything to get behind these tests to fund them, to make production,” Topol said. “You can’t have a start-up company that can’t get FDA approval and then has to make hundreds of millions of tests.”
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The FDA has already approved several saliva-based tests, including SalivaDirect from Yale researchers. But these tests still do have to go to a lab.
The development of the daily at-home tests is crucial, the scientists say. This is because in the U.S., contact tracing programs — where people are hired by the government to call or text possibly infected individuals and tell them to quarantine — may not be able to stop the spread of coronavirus effectively.
For example, KPBS reported in July that San Diego County the county failed to meet its goal to contact trace within 24 hours. The county set a goal that 70% of new case investigations would begin within 24 hours — at the time, just 11% of case investigations met that goal.
In a phone conversation a FDA official, who did not want to be named, told KPBS that the agency has been continuously open to novel testing strategies and reviews them, while weighing the risks and benefits.
KPBS asked how many companies had submitted an application for at-home testing kits for emergency use authorization approval. The official declined to answer that question, but confirmed no at-home tests had been approved.
Topol said the at-home tests could be manufactured and sold for around a dollar a test. But, he said, the government should pay for them so they are free.
“It requires an investment to get millions, tens of millions, if not hundreds of millions of test kits made. And there's a lot to choose from. There's at least 20 companies and academic labs [working on this],” Topol said.
“Whereas the government has funded billions, tens of billions of dollars for vaccine companies, it hasn't put in one dollar to the rapid test pathway. Lack of funding, lack of regulatory path, lack of production. Those three are holding us back.”
