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Long motorcades of volunteers converged at three Stanford University research sites this week, donating blood for a new test that identifies the prevalence of coronavirus in our community – and could help reveal the full scope of Santa Clara County’s epidemic.
The 2,500 test slots on Friday and Saturday filled up within hours, as news of the project — the first large scale study of its type in the U.S. — spread quickly through the county.
The test detects protective antibodies to the virus rather than the virus itself.
This gives scientists a snapshot of how many people in the county have already been infected, but weren’t seriously sick and didn’t realize it. And it tells residents whether they carry potentially protective antibodies – so may be immune to future infection.
“This is critical information,” said principal investigator Dr. Eran Bendavid, an infectious disease specialist and professor of medicine with Stanford Health Policy.
“We will show the country what to do and how to do it,” he said.
The project, coordinated with the Santa Clara County Department of Health, was applauded by Gov. Gavin Newsom during a Saturday press conference in Sacramento, who called it “the first home-grown serum test in the state of California.”
It can guide public health measures and policies – showing where the epidemic is heading, when it is safe to lift shelter-in-place restrictions and how far away we are from “herd immunity,” when it becomes harder for a virus to spread.
The new test finds antibodies in the blood — molecules made by the immune system — in response to a viral attack.
Even though the pathogen is brand new, scientists have already discovered the two antibodies — called IgM and IgG — that are triggered by infection and have built a test that detects their unique signature.
Because the COVID-19 virus may cause few or no symptoms, many people don’t know they’ve been infected. Or perhaps they were mildly ill before COVID-19 made headlines, and simply dismissed it as a cold or flu.
This approach, called a “serological test,” remains a research tool and is not yet widely available in the United States.
Stanford is working on a second test that will be deployed for more widespread use. U.S. Food and Drug Administration approval is imminent – “within hours, not days,” Newsom said.
“Stanford’s partnership is critical in looking at that innovative technology to scale up testing across the state,” said Dr. Charity Dean of the California Department of Public Health at the Saturday press briefing.
Development of other commercial tests is underway but supplies are still limited, slowing the rollout. This week, the Food and Drug Administration approved a test by the Research Triangle Park, North Carolina-based Cellex. There’s also a Mayo Clinic test in the pipeline.
Meanwhile, a global effort to study antibodies is being coordinated by the World Health Organization. Called Solidarity II, more than a half dozen countries will pool their findings from large-scale testing.
Once mass-marketed, experts say the test will be easy, cheap and very different from current diagnostic tests, which use throat swabs and an expensive technology called Polymerase Chain Reaction to find genetic evidence of ongoing infection. There is a major shortage of these existing tests, so many people never learn if they’re infected.
At three churches — in Mountain View, San Jose and Los Gatos — long and patient lines of motorists drove into parking lots, rolled down their car windows and offered a finger.
The pinprick took just a moment.
Teams of Stanford medical students, nurses, physician assistants and other staff scurried around each site, directing traffic and processing every sample. Volunteers got a $10 Amazon gift certificate for participating.
“It’s an opportunity for me to know if I’m positive for the antibodies – and it’s very important for the community to know how many people have been unknowingly infected,” said Linda Sanders of Los Altos, who arrived for an early morning test in Mountain View’s First Presbyterian Church.
Laura Forrest of Palo Alto, a healthcare worker, said she volunteered because “Stanford is a great facility and I want to support them.”
She also sought to learn if she acquired antibodies from recent on-the-job exposure. “I would like to return back to working,” she said. “Having this information would be very important to me.”
If positive, they’ll get results in several days. If negative, they’ll get no news.
A positive result means they had the virus and recovered. It could also mean they are currently infected and could still transmit the disease.
Antibodies act like sentinels of disease, launching an immediate response if a familiar virus returns. They’re normally produced in a person’s body around seven to 10 days after the initial onset of a virus. The IgM antibodies are generally detectable in blood several days after initial infection, although levels over the course of infection are not well-characterized. The IgG antibodies become detectable later following infection. Positive results for both IgG and IgM indicate recent infection.
It is not yet proven that these antibodies actually provide protection. Related coronaviruses offer a spotty record. Some, which cause the common cold, return again and again. The antibodies to Middle East respiratory syndrome lasted merely a year.
But there are promising clues that COVID-19 might act like it’s closest cousin, the SARS virus, which triggers an immune response that persists for at least three years. In a Chinese study of rhesus monkeys, COVID-19 antibodies protected the animals from a second infection.
If protected, people could potentially return to work. There is also the prospect that the antibodies could be used as therapy against the disease.
Dozens of companies are working to develop antibody tests, as are researchers at the Centers for Disease Control and Prevention.
In March, New York City’s Icahn School of Medicine at Mount Sinai started a website where scientists can order the chemicals, other lab ingredients and standardized protocols needed to get tests up and running.
A similar strategy will soon be deployed in the small Colorado ski town of Telluride in partnership with the pharmaceutical company United Biomedical Inc. and its subsidiary c19. It will test all 8,000 of its residents for free, starting health care workers, first responders, teachers and their families. The town was chosen because c19’s co-founders have a home there.
“When we reported this in our county meeting, the entire team cried,” Dr. Sharon Grundy, Medical Director of Primary Care at the Telluride Medical Center, said in a statement.
The test is also being deployed in some countries in Asia.
Until commercial tests are widely available, Bay Area residents urged that Stanford’s research be expanded to more residents in Santa Clara County, as well as adjoining counties.
“There is so much mystery and uncertainty around the virus,” said Palo Alto’s Susie Richardson. “Participating in the study might be a way to both contribute to what we know and to possibly learn something about myself.”
