Public health officials call it a “game changer.” Abbott Laboratories’ new COVID-19 test promises results in as little as five minutes. It’s part of a wave of new rapid coronavirus tests that are coming online as scientists rush to develop new tools to fight the global pandemic.
Why are rapid results so important right now? What kind of public health decisions can they inform? And what’s the next frontier in coronavirus testing?
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Five minutes: The Abbott test uses what’s known as “isothermal nucleic acid amplification” technology in order to find COVID-19 viruses. The nucleic acid inside a virus contains the genetic instructions that make up COVID-19, but they’re covered in an outer protein shell. Abott’s tests use chemicals that can quickly crack open those shells, access the genetic material inside, and tell if it’s a match for the coronavirus faster than the typical polymerase chain reaction methods (PCR) used in most tests. A positive result takes just five minutes to show, the company claims, and a negative result takes only 13 minutes.
Abott’s tests are point-of-care systems, meaning you’d still have to go to a primary care provider to get one. More importantly, the company said it expects to be able to ramp up its production of the instant tests soon to nearly one million tests a week.
Faster results, better decisions: When Abbott Laboratories first announced, former FDA commissioner Scott Gottlieb called it a potential “game changer”—a characterization echoed by public health experts.
“It’s really a major development of great importance to the health care system,” says Dr. Irwin Redlener, a public health professor at Columbia University and an expert on disaster preparedness. “Right now people are waiting three to four days to a week to get results back from the usual [polymerase chain reaction] three-stage test. It’s incredibly problematic. We’ve been missing critical data because the entire system of doing mass screening for the coronavirus has been a disaster of incompetence since the beginning.”
In the hardest-hit places in America right now, public health officials are focused on maintaining social distancing and flattening the curve of infections to keep hospitals from getting overwhelmed. In other words, we’re not really doing South Korea-style contact tracing to find, follow, and isolate individual infected patients right now because we’ve got to manage the wave of hospitalizations first. So what kinds of decisions can rapid results of a COVID-19 actually inform?
Important ones.
First, there’s triage. “Let’s think about the emergency rooms. It’s really important that doctors and nurses know whether a patient is a COVID-19 patient or not,” said Redlener. “When patients are coming in, to know in five minutes is a very different thing than not knowing for days. “
That’s particularly true at facilities like the USNS Comfort, the U.S. Navy hospital ship that just docked in New York City. The state is planning to use the ship to treat regular patients, and being able to tell in just five minutes whether someone is infected can help keep those who are already sick safe from the coronavirus.
Second, rapid results can help maintain the first line of defense against the virus: health-care workers. It’s bad enough when anyone gets infected, but when a health-care worker gets infected, it’s especially bad. Being able to quickly find out and send home doctors and nurses who might be infected before they spread it to patients or co-workers would be a crucial help. “I would recommend that the health-care workforce be tested regularly. If we could do it, I would do it daily,” said Redlener.
Finally, a five-minute test could also help take the pressure off the existing testing regimen. Right now, polymerase chain reaction or PCR tests are the most common COVID-19 tests Americans take. Like the Abbott Laboratories test, they also search for viral RNA to confirm infection. But PCR tests require a lab to process the results, which can take hours. In a pandemic like this one, those delays can—and have—added up to backlogs that force patients to wait days for results.
If deployed in large numbers, rapid point-of-care tests could help ease the backlog from regular testing and help speed up processing times for PCR tests.
All of that, however, is dependent on the tests performing as promised.
Rapid growth in rapid testing: The Abbott tests are part of a rush of rapid testing products released on the market since the pandemic broke out.
Cepheid, a California-based testing company, recently announced that the FDA has approved an emergency use authorization for a point-of-care test that can turn around results in just 45 minutes. The tests use small, palm-sized cartridges that look like instant coffee pods and run on a small diagnostic box.
And there are more reportedly in the works. 4Catalyzer, a startup incubator based in Connecticut, is working with researchers at the University of Pennsylvania to develop an in-home test that, like the Cepheid and Abbott tests, looks for viral genes and takes only an hour to get results. While they’re still in development and would require FDA approval, teams working on rapid COVID-19 tests include researchers at Indiana University.
Much more work to do: As of Monday, data from the COVID Tracking Project counted over 830,000 coronavirus tests performed in the U.S. since the outbreak began, with roughly 172,000 of those tests in New York state alone.
But that’s still a drop in the bucket compared to what many point to as the gold standard in using testing to find, trace, and contain the spread of COVID-19, South Korea. On a per capita basis, South Korea has carried out about eight tests for every thousand citizens while the U.S. has only carried out about 2.5 tests for every thousand Americans. While individual hotspots like New York have tested more than even South Korea has, on a national basis, we would have to almost triple the current amount of testing to reach South Korean levels.
Antibody testing and immunity passports: Once the wave of infections currently straining health care systems has passed, rapid testing can also help states and cities get back to the business of finding and isolating COVID-19 infections with surgical precision.
The next frontier in testing that European countries are mulling involves a different kind of rapid testing. Both Germany and the U.K. are working on plans to issue millions of antibody tests to residents in the coming weeks.
Antibody tests work differently than the gene-searching tests most Americans have received and the faster ones that companies like Abbott are working on. Instead of searching for the virus itself, antibody tests search for the antibodies you make once your body has begun to fight off a COVID-19 infection. The downside of the tests is that if you’re asymptomatic or only in the early stages of an infection, an antibody test could give you a false negative. The upside is that they’re much quicker and can be distributed as in-home tests.
Since the tests are more appropriately used to find a previous infection than a current one, they could be important tools not in diagnoses but in helping countries bring back essential services and economic activity. The presence of COVID-19 antibodies in someone’s system is a strong sign that they’re now immune to the disease, meaning it’s unlikely they’d become infected or infect others for some time. Given that scientists think a large number of those infected are silent spreaders who caught the virus with few or no symptoms, antibody testing could clear a significant number of otherwise unwitting former COVID-19 infected to return to normal life.
German researchers are planning to study immunity through mass antibody testing, and one researcher involved with the project floated the possibility of issuing immunity “certificates” to those with proven COVID-19 antibodies to sidestep quarantine rules and start resuming normal economic activities.
The U.K. has already planned to buy at least 3.5 million antibody tests with the intent to purchase several million more. British Health Secretary Matt Hancock has said the tests “will allow people to see whether they have had the virus and are immune to it and can go back to work.”
The U.S. may also soon have its own rapid antibody test. On Tuesday, the FDA announced an emergency use authorization for a two minute antibody test made by Biosphere Inc. In a press release announcing the clearance, the company claimed it could "have millions of test kits on the front lines in weeks."
