Company offers COVID-19 antibody tests without a doctor visit. Are results reliable?
A diagnostics company has made coronavirus antibody tests more widely available, but the effectiveness and reliability of such tests remain in question.
Quest Diagnostics on Tuesday announced its launch of a “consumer-initiated” COVID-19 antibody test that allows people to buy the tests online for $119 each.
The New Jersey-based company previously allowed health care providers to order tests for a patient, but now people can request one themselves.
Antibody testing can be used to determine if someone has been exposed to the coronavirus and developed antibodies against it, which could indicate some immunity, the U.S. Food and Drug Administration says.
Experts say it’s important to know how many people are immune to the virus as states begin to reopen their economies.
Some countries have considered giving those found to have antibodies “immunity passports” or “risk-free certificates” that would allow them go back to work and travel, CNBC reports.
But such tests have not been proven as a surefire way to determine whether people are immune.
The FDA still does not know if people are “fully protected from reinfection” if they’ve developed antibodies. And even if they are, it’s still unclear how long that immunity lasts.
The World Health Organization has also warned against relying too much on such testing.
“The serologic tests are the blood tests that test whether you’ve had the infection, to a greater or lesser extent of accuracy can say you’ve had the infection,” Dr. Mike Ryan, executive director of the WHO’s emergencies program, told CNBC. “It’s a very different question to say, are you protected from another infection.”
But the FDA says more widespread antibody testing could help track the spread of coronavirus and inform response efforts.
The agency says it has issued four Emergency Use Authorizations for antibody tests as of earlier this month and expects to continue issuing them.
The Quest Diagnostics services are “based on tests” that already have such authorization or are expected to get it, the company said in a news release. The testing service is provided under the Public Readiness and Emergency Preparedness Act.
Consumers can purchase a test online through QuestDirect, and then a licensed physician must approve the order, according to the news release.
Then the consumer must schedule an appointment to have blood drawn at one of the company’s service centers. (Quest Diagnostics says it has 2,200 locations across the United States.)
Those who visit the centers must wear a mask and cannot have had coronavirus symptoms for at least 10 days. They must also pass a temperature check.
Results are then available within a day or two and licensed physicians are available to discuss them, according to the company.
Quest Diagnostics said tests should not be used in people with “active COVID-19 infection” or in people with symptoms.
The tests are only used to find people with “adaptive immune response,” meaning they’ve previously or recently been infected, the company said.
Additionally, the FDA says antibody tests should not be used as the only basis to “diagnose or exclude” infection with COVID-19, as antibodies may not be detected in the early days of infection.
Jay Wohlgemuth, senior vice president and chief medical officer for Quest Diagnostics, said in the release that the new services give people easier access to antibody testing.
“While the science on COVID-19 is evolving, testing for antibodies may identify people who have likely been exposed to COVID-19 and might have mounted an immune response to the virus,” Wohlgemuth said in the release. “Our goal is to empower individuals and their physicians to make informed decisions about their risk of infection and of spreading the virus.”
