In tandem with the increasingly robust public network, the Los Angeles County Public Health Department and USC researchers are ramping up another form of coronavirus testing — for antibodies.
The effort comes as the U.S. Food and Drug Administration on Thursday, April 16, encouraged those who have recovered from COVID-19 to donate their blood — rich with antibodies — to help others fight it.
Antibodies are the body’s crime fighters, binding to alien invaders in your blood. They attack antigens — like viruses — with the hope of destroying them. And ultimately, they will become a key force in how soon the region opens back up from a full-on shutdown that has brought down the economy as hundreds of died.
The county has teamed up with USC Price School of Public Policy and Lieberman Research Worldwide for the region’s COVID-19 antibody study, which began over the weekend at six testing sites.
Researchers tapped a random sample of 1,000 adults living within 10 miles of the testing sites. The idea, officials said, is to create a representative sample of the county’s adult population. A first batch of results are said to begin emerging publicly by this weekend or early next week. Officials say results from a corresponding study in Santa Clara County will come first, followed by L.A. County and then those from Major League Baseball employees, which has partnered with USC and Standford on the study.
If researchers can measure a person’s COVID-19 antibodies via blood tests, they’ll learn how the body’s immune system is responding to the infection. This could be pivotal in determining when stay-home orders might be eased — currently they’ve been extended until at least May 15.
On a larger scale, researchers are aiming to have a vital tool in:
- Detecting current and past COVID-19 infections. For instance, maybe somebody has it, but doesn’t realize they have it, because somehow they’ve got antibodies that are dealing with it.
- Understanding the spread of the virus in the county. Over a period of months, public health experts will be able to track the spread better — including gaining a better sense of demographic data that could ultimately help in containing it.
- Assessing future hospital bed and ventilator needs. If they better know the body’s immune response, they’ll better understand who is the most vulnerable to becoming sick, and when.
- Examining the differences in COVID-19 infection rates between men and women, different age groups and by race and ethnicity, experts said. And they could help in developing treatments gleaned from the plasma of those who have built defenses against the disease.
- Preparing for any more waves of the virus.
“This gives us powerful information about how many people have already been infected in L.A County, regardless if they ever have became sick or had a molecular test on whether they had the virus,” said Barbara Ferrer, the county’s public health director.
A more accurate picture
The focus on blood testing comes as testing for the virus itself continues to ramp-up across the region.
The antibody tests are not the same as the molecular-based tests, during which health worker swabs your mouth or nasal passages for a specimen. These tests determine if you have the virus so you can be directed for treatment.
These tests are available at more than two dozen public sites in L.A. County and are still limited to those who are showing symptoms of the virus, such as shortness of breath, fever and coughing.
That sluggish rollout of testing in the county, researchers say, has led to an “incomplete picture” of the effect of the pandemic.
Dr. Neeraj Sood, the USC researcher leading the study, has put the reliance on the swab molecular testing in the context of the mortality rate of the common flu, about.1%. That is, of all who are infected with the regular flu, 1 in 1,000 will die from it.
But if the only people tested were the ones who were sick and hospitalized, that rate would be much higher — and it would be inaccurate, skewed to only those who were seriously ill or were showing severe symptoms.
If antibody testing can show that the death rate of COVID-19 is, say, several times that of the flu, then it boosts the strict “stay home” measures blanketing the Southland.
But antibody testing could help researchers find that the mortality rate is actually much lower, which could ease anxiety lead to the loosening of physical distancing measures.
“Our project is specifically a surveillance project, to better understand the scope of infection here,” said Paul Simon, chief science officer with the L.A. County Department of Public Health.
“We’re planning to continue surveys at regular intervals, every two to three weeks,” he said.
“It will also give us an understanding of how many people have experienced infection with no or minimal symptoms,” Simon added. “That’s important for prevention efforts.”
Testing will be repeated, each time with a new representative sample of L.A. County residents, to track trends and help determine if interventions are working. That data, in turn, can allow officials to figure out when it might be safe to begin the recovery phase, Simon said.
Ferrer said she hopes to dig deeper into how the virus is spreading among:
- Adults at large;
- Healthcare workers;
- Staff and residents at nursing homes and longer-term care facilities;
- And underserved populations, where there’s concern that the pandemic is taking a disproportionate toll.
Ferrer stressed that there are no FDA-approved tests that do both — as of yet.
Even if you have developed antibodies to the coronavirus, it doesn’t necessarily mean you are immune to it. But there’s hope you could be. Ferrer said future testing will look specifically at that question: If you had it, are you immune? (Stay tuned).
Not a panacea — yet
Public officials have been cautious about the tests being perceived as a panacea.
The county’s public health experts don’t have confidence in individual tests being offered through the private market.
“An imperfect test works fine in a research study, because in the analysis you can sort of account for that inaccuracy, but when you’re dealing with an individual patient, you have to be right,” he said. “And so I’m very concerned that the quality of the tests are highly variable, with very little oversight,” said Simon.
More than 70 companies have signed up to sell so-called antibody tests in recent weeks, according to U.S. regulators. The tests often use a finger-prick of blood on a test strip.
But be warned: With almost no FDA oversight of the tests, “Right now it’s a Wild West show out there,” Eric Blank of the Association for Public Health Laboratories, told the Associated Press. “It really has created a mess that’s going to take a while to clean up.”
“In the meantime, you’ve got a lot of companies marketing a lot of stuff and nobody has any idea of how good it is,” he said.
Members of Blank’s group, which represents state and local lab officials, have urged the FDA to revisit its lax approach toward the tests, according to the AP. That approach essentially allows companies to launch as long as they notify the agency and include disclaimers. Companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected.
Simon said local officials were looking for guidance from the federal government on the most quality tests.
In March, the FDA issued a policy that allows developers of certain serological tests to begin to market and use them once they have determined their reliability. To date, the FDA has authorized only one Emergency Use Authorization for a serological test, which is intended for use by clinical laboratories.
Some firms are falsely claiming that their tests are FDA approved or authorized, or falsely claim that they can diagnose COVID-19.
“Please don’t fall for the scams that are out there that offer you serologic tests in your home,” Ferrer said.
“There are no FDA-approved home tests for antibodies,” she added. “But I hope you all know, if it’s not an FDA-approved test, and if you are not working with a provider to determine whether you need to be tested, you should stay away from products that are marketed under false pretense.”
Funding for more widespread and accessible blood testing is still limited. Garcetti hoped that ultimately the tests would be free, with funding arrangements made, perhaps, through the federal government and employers.
“We want to make sure they are reliable, they are available, and we want to make sure they are affordable,” Garcetti said.
Widespread serological testing can’t happen until a valid test is identified, he added though he envisioned a scenario where both kinds of tests are given at the same time, eventually.
“If we can identify a population that is potentially immune,” Garcetti said, “these are the people who can actually be on the front line, take care of the elderly, take care of the people in the ICUs and restart our economy.”
A call for plasma
The FDA on Thursday called out for anyone who has recovered from a bout with COVID-19 to donate their blood.
FDA officials pointed to “limited data” emerging from China — where the pandemic originated — that plasma, made from antibody-rich blood from those who have fought off the respiratory illness, has shown signs of halting it.
The FDA was still calling this a “potential treatment,” so it’s still early. Clinical trials were continuing Thursday, leveraging government, university, and private research. But a program led by the Mayo Clinic , in coordination with the FDA, seeks to expand access to treatment across the country.
So far, 1,290 sites and 1,478 physicians have registered for the program. And 876 patients have enrolled, including 200 who have completed a transfusion.
The FDA launched a new web page Thursday guiding people who have beaten the virus to donate: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/donate-covid-19-plasma.
Reporter Teri Sforza contributed to this story.
