Seven months into the pandemic, the U.S. is struggling with COVID-19 testing. Healthcare experts say that a shift to cheaper at-home testing is badly needed. Could this way of testing be more effective? The pressure is on from experts on the issue.
Experts are adamant that cheaper and faster testing will be able to detect and contain coronavirus outbreaks before they explode.
Rapid testing, some used at home, aren’t the gold standard and can miss some infections but experts say they make up for it through their speed and low cost. Because they’re cheaper, they could be made available to millions of people to use several times a month, experts say.
The tests are thought to be helpful because of its ability to detect the virus when it matters most: at high or peak levels, when an individual is most contagious to others.
“If you want to be certain about whether somebody is infected or not these tests are not so great. If you want to identify whether they’re infectious or not going to go out and spread to other people, these tests are actually quite good,” said Ashish Jha, a physician and director of the Harvard Global Health Institute.
Reluctance from FDA
The Food and Drug Administration (FDA) has been said to be reluctant to approve at-home tests in the U.S. because they are typically less accurate or unable to detect small amounts of virus compared to the gold standard, high-sensitivity lab tests the U.S. has been relying on.
Governors of six states announced Tuesday they would band together to buy 300 million rapid antigen tests to be used with BD and Quidel machines to “better detect outbreaks more quickly” and expand long-term testing in congregate settings such as schools, workplaces and nursing homes.
“The FDA standard is over 80 percent and I think with what we’re seeing with the antigen tests, that is not too high of a bar to achieve because several have achieved it,” Adm. Brett Giroir, the administration’s testing czar, told reporters last week, referring to the BD and Quidel machines.
“There are several more that are very low cost that would be in that range that are being considered,” added Girior.
Continued demand for new testing
Demand for tests is expected to grow in the fall, as students and teachers are returning to school and preemptively for flu season. The need to detect the difference between COVID-19 and the seasonal flu is a growing concern.
Experts say rapid tests would allow individuals to regularly screen themselves for COVID-19 before they go to work, school, or other areas where they could potentially spread the virus to others.
Harvard’s Michael Mina envisions a $1 antigen paper strip test — similar to pregnancy tests — that could be manufactured by the government and distributed to millions of people to regularly screen themselves.
Several companies are working on similar tests now, but have been slow to ask for FDA approval because it doesn’t meet the agency’s standard for high sensitivity.
“Our goal is to make an at-home test, but because of FDA criteria, we believe there’s a longer path to get there,” said Carlos-Henri Ferré, spokesman for E25Bio Inc., a company that has its roots in developing rapid tests for mosquito-borne illnesses.
Within the next few weeks, E25Bio plans to ask the FDA to approve a rapid antigen test that will initially only be available in clinical settings because that is what the FDA will approve.
But eventually, the company hopes to have a home-based test that could be easily used and accessible to anyone.