Stanford Scientists Create COVID-19 Antibody Test Which Could Help Alleviate Shelter-in-Place Orders

Scientists in the U.S. have created an antibody test which they say can reveal whether a person has been infected with the new coronavirus. Created by a team at Stanford Medicine, the test can detect antibodies which the immune system creates to attack SARS-CoV-2, the new coronavirus which causes COVID-19 (not to be confused with the SARS virus). It takes two to three days to get results back, according to a statement by the institution. The team used samples from COVID-19 patients and two-year-old blood plasma (therefore not containing SARS-CoV-2) as the control to verify the test. Dr. Thomas Montine, professor and chair of pathology at the School of Medicine, explained in a statement that looking for antibodies in blood plasma "gives us a more comprehensive view of what's happening in an individual who is infected, or has been infected, with the virus."

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Montine admitted the test "isn't a perfect tool, but it's one that I suspect we'll use to help devise protocols for unwinding shelter-in-place orders." The approach could also help with investigating a potential COVID-19 treatment known as convalescent plasma therapy, where antibodies are taken for a person who has survived an illness, in this case COVID-19, and transferred to someone sick. "That approach could be very important in this period when we don't have vaccines or other definitive therapies," said Montine. Antibody tests are being developed worldwide, but they can vary in quality, Montine said. "We thought this was an urgent medical need, and the usual supply chains were unreliable, so we decided to build our own." The test picks up what are known as IgM and IgG antibodies. While evidence suggests COVID-19 patients create the former in the early stages of infection, the latter are believed to be in abundance in the later stages and stick around longer in the body. But as the virus is so new, we don't know how long antibodies linger, Montine suggested. As a serological test, the approach is different to screenings used to diagnose suspected COVID-19 patients, where a swab of respiratory secretions is taken from deep inside a person's nose to find SARS-CoV-2's genetic material. Montine said the team has enough supplies to run the tests for six months, but are limited by the number of machines they have to run tests. "Ultimately, we aspire to provide serological testing to as many people in Northern California as we can," he said. The researchers have applied to the U.S. Food and Drug Administration for an Emergency Use Authorization for their serological test, which Stanford Health Care launched on Monday. On Tuesday, the U.S. Food and Drug Administration commissioner Dr. Stephen Hahn said the agency issued a policy in March: "to allow developers of certain serological tests to begin to market or use their tests once they have performed the appropriate evaluation to determine that their tests are accurate and reliable" At the time he said 70 developers had notified the agency their tests are available for use, but warned some creators are falsely claiming their methods are FDA approved or can diagnose COVID-19. As shown in the Statista map below, people in almost every corner of the world have been diagnosed with COVID-19. Since the pandemic started late last year, more than 103,000 people have died in 1.7 million known cases, according to Johns Hopkins University. More than 378,800 people have survived.

What are known as serosurveys, where the blood of a group of people is tested for antibodies against infections, are being rolled out by organizations including the WHO. But Dr. Peter Drobac, a physician and specialist in infectious diseases and public health at the Saïd Business School at the University of Oxford, previously told Newsweek: "We don't actually know much about immunity to the novel coronavirus yet, but early signs suggest that people who have recovered from COVID-19 are unlikely to be reinfected, at least in the short term. "So knowing who has been infected can help determine who might safely go back to work or re-enter society, so to speak." But he said "immunity certificates" floated in some countries which in theory would state whether a person is immune and could be used to decide who can go back to work are potentially "dangerous" as it's not clear whether a positive antibody test means a person is immune, or for how long. "Imagine two employees of the same business, and one is allowed to come back because she has a certificate while the other has to remain out of work. Might you see people desperate to get back to work actively trying to get infected? Absolutely. Might you see people try to defraud the system to get a certificate even if they're still vulnerable to infection? Absolutely," Drobac said.