Updated 2:20 p.m. April 8
Researchers at the University of Pennsylvania are helping develop an at-home test that would detect COVID-19 in less than an hour, without any special equipment.
The technology is being developed by Connecticut-based 4Catalyzer, a medical technology incubator known for inventing a portable ultrasound machine. Its founder, Jonathan Rothberg, was awarded the National Medal of Technology Innovation by then-President Barack Obama in 2016.
A number of at-home tests are in development around the country. Some work by detecting the antibodies the immune system produces in response to the virus. Others allow people to collect the specimen at home, but send the results to a lab for testing.
This test, called a nucleic acid test, detects the virus directly through its genetic material, and its developers say the results should be ready to interpret within an hour.
Picture the coronavirus as a spiky sphere, with a tough outer shell guarding RNA material inside. Nucleic acid tests work to break the virus’s shell open and access the genetic material.
The advantage of this technique is that it is designed to detect the virus as soon as it is moving through the body. By contrast, antibody tests take a few days, since they are measuring the immune system’s response to the virus, not the virus itself.
For the nucleic acid test, an individual would collect a sample from either the back of the throat, the nose or simply use saliva — those details are still being worked out.
Penn’s lab comes into play because researchers there have the capacity to work with the virus itself, and they can compare the new technology with the gold standard test used in labs, to see how accurate it is.
The test’s manufacturers caution that it may not necessarily count as an official COVID-19 diagnosis, but more as a screening tool to discuss with a health care professional, analogous to a home pregnancy test.
“It’s not our role to provide medical advice to people, for example giving diagnosis and telling them what to do,” said Eric Kabrams, one of the project leads on Rothberg’s team. “It’s our role to make the test and tell them as accurately as we can what the test does, and what it doesn’t do, and then really all we can do is refer people to their doctors.”
Kabrams said his team is in conversation with a range of manufacturers and hopes to have regulatory authorization from the Food and Drug Administration within weeks. By then, he said, he hopes to have the pieces in place to produce 10 million tests per month, which would be made affordable or even free in partnership with suppliers like drugstores and grocery stores.
The FDA has created a fast track to approve diagnostic testing through its Emergency Use Authorization process, but the policy guidelines don’t apply to home testing kits.
The agency encourages those entities developing at-home, self-collection tests to “discuss their validation of home use and/or self-collection tests with us early in their development process.” Kabrams said his team has had productive conversations with the FDA so far.
But the lack of regulation on home testing means a lot of tests made it to market without FDA approval. The agency issued a letter last week warning consumers of a number of fraudulent home test kits, reminding people that the agency has not yet approved any such tests.
Philadelphia Health Commissioner Thomas Farley said Friday that due to this lack of regulation, the quality of these tests is hard to gauge.
“The Department of Public Health is looking into this to see if we can support or not support certain tests, but at the moment, we are not recommending people use those tests because we are not certain how accurate they are,” Farley said. He added that once the department reviewed more of the tests, it would release further guidance.
The lack of widespread testing is, in part, what thwarted U.S. health officials’ attempts to contain the virus in the way that countries like South Korea were able to. But since the United States has moved into the mitigation phase of the virus, testing has actually become less of a priority.
Testing capacity at hospitals and Philadelphia’s drive-through testing site is still limited, leading to strict eligibility criteria. Health officials have instructed anyone with mild symptoms who is otherwise healthy to skip getting tested, so as not to waste the test kits and personal protective equipment worn by nurses, both in short supply. Instead, officials say, they should simply proceed as if they have the virus: self-quarantine, and only seek medical help if the symptoms become severe.
This article was updated to clarify what the project team is seeking from the Food and Drug Administration.
How, then, would a do-it-yourself take-home test help?
If someone was exposed to a person who later tested positive, a rapid response at-home test could be a good way to determine whether the exposed individual should self-quarantine immediately, so as not to infect others. Although if the test came back negative, that could offer a false sense of security in the event that the virus had simply not yet incubated in the body.
The test could also prove useful in demonstrating to institutions wary of accepting new patients that an individual does not have the virus. Numerous reports have indicated that nursing homes and other rehab facilities are wary now of taking patients after they have been discharged from hospitals. A nucleic acid test could help demonstrate that someone was no longer contagious.
A nucleic acid test could also work as a companion to the antibody tests under development — also known as serological tests — since they use different mechanisms to test for the virus. Because antibody tests detect the immune system’s response to the virus, they determine whether a person has had the virus, even if that person no longer has symptoms — or never had symptoms
That could ultimately prove useful in determining who has been exposed to the virus, is presumably immune at least for the time being, and can re-enter the workforce, said Jon Epstein, chief scientific officer at Penn Medicine.
“It would be awfully nice to know who they were so that we could get portions of the economy up and running as soon as possible,” Epstein said.