Idaho lab goes ‘maverick’ to offer antibody tests, especially for health care workers
A local laboratory, frustrated by delays in testing for the novel coronavirus, has quietly rolled out a blood test that could help screen people for COVID-19.
The lab found several people, including health care workers, whose blood contained antibodies to the virus.
The Idaho Department of Health and Welfare warned that the test “could be more misleading than helpful, and takes away resources from our (or the health systems’) other work,” said department spokeswoman Niki Forbing-Orr.
Shortly after the Food and Drug Administration announced on March 16 that it was giving states and laboratories more leeway on COVID-19 testing “to achieve more rapid testing capacity in the U.S.,” Cole Diagnostics of Garden City placed an order for thousands of COVID-19 antibody tests.
The lab has since begun testing first responders, health care workers and some local residents.
Among a group of 118 people tested between Tuesday and Wednesday, about 7% had antibodies to COVID-19, said Ryan Cole, a pathologist who owns Cole Diagnostics.
Five people who tested positive for antibodies had not yet received the test that is state-approved for diagnosing COVID-19 patients, Cole said. At least one of them said they weren’t eligible for that test because they didn’t meet the criteria for symptoms, he said.
The antibody test can determine whether someone’s blood contains antibodies to the novel coronavirus. It is accurate about 90% of the time.
That style of test — checking not for the pathogen itself, but for an immune reaction to the pathogen — is used for other viruses such as mononucleosis and hepatitis, Cole said.
Health and Welfare told the Statesman, and Cole Diagnostics says on its website, that:
- This test has not been reviewed by the FDA.
- Negative results do not rule out (COVID-19) infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude (COVID-19) infection or to inform infection status.
- Positive results may be due to past or present infection with (certain other coronavirus strains).
Rapid coronavirus test isn’t bulletproof
Idaho’s most prevalent test right now is one that checks the mucus from a patient’s nose and throat for genetic material of the novel coronavirus. That test is FDA-authorized and is considered the gold standard for COVID-19 testing in the U.S.
One major concern about tests that aren’t FDA-authorized, such as antibody tests, is the potential for “false negatives” or “false positives.” Someone with a false negative result could assume they don’t have the virus and go on to infect others. A false positive from an antibody test could lead someone to believe they have immunity when they do not.
“We urge state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests,” the FDA said in its March 16 announcement. “Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients.”
The coronavirus test currently used for diagnoses in Idaho also has the potential for inaccurate results. There can be several reasons for that, from faulty collection of the mucus sample to a lower-than-detectable presence of the virus.
Cole cautions patients that a negative result on the rapid antibody test is not a guarantee that they don’t have COVID-19. And a positive result doesn’t guarantee they do have it.
Cole, who is not an epidemiologist, hopes antibody testing could help estimate how much of the local population has been exposed but is asymptomatic. That isn’t possible with the current limitations on testing.
Cole said antibody testing also could help to screen large numbers of people quickly and inexpensively. It could flag some people who likely were infected but don’t have the symptoms to qualify for the gold standard test, he said.
“When the government says we’re on a wartime footing, (and) you’re dropping your bombs and 90% of them are hitting their target, that’s pretty good,” Cole said.
Cole reached out to the Idaho Department of Health and Welfare about two weeks ago to see if officials would support his efforts to start offering the antibody tests, he said.
He was concerned about moving forward without state approval or support. Buying the tests would be a very large financial investment, and he believed the tests wouldn’t be covered by health insurance. He also didn’t want his lab to lose its certification for using tests that hadn’t been authorized by the FDA for emergency use.
He continued to check with the state, up until the FDA announced it wouldn’t stand in the way.
The day after that announcement, a department official responded, saying the Division of Public Health could not recommend the antibody test because there was no guidance on it from the U.S. Centers for Disease Control and Prevention.
Cole “went maverick” and ordered the tests anyway, he said.
In Idaho, the coronavirus ‘horse is out of the barn’
Cole said his focus is on testing first responders and health care workers, including those without symptoms.
He urges everyone else to stay home.
“The horse is out of the barn,” he said. “It’s here, it’s spreading. If we do testing (of the general population), we’re only telling people how many horses are in the stampede. What we need, for the community, is for the horses to go back in the barn and (to) test the ranchers and farmers,” meaning the health care providers and first responders.
“We called the clinics and offered it to anyone who will listen,” he said. “We are then just sending a courier to their office and bringing their blood back to our lab to test. ... Some of them are sending patient samples that way as well.”
He said Wednesday evening that he was also contacted by a local nursing home to test a resident.
Even though the test is not FDA-authorized to diagnose COVID-19, health care providers are “scrambling” for ways to quickly spot potential infections, Cole said.
The antibody test takes about 20 minutes to run, from when the blood sample gets to the lab to when the results are ready. Cole immediately calls anyone who has a positive result, so they can self-isolate and try to get the FDA-authorized diagnostic test, he said.
That test is processed by either the state laboratory in Boise or a private commercial lab out of state. The state lab can process tests for hospitalized patients within a day. For everyone else, samples are generally sent to the private labs, where it can take as long as 10 days to get a result due to transit time and other factors.
The Statesman on Tuesday heard from a local health care worker who had been waiting in self-isolation for more than a week to get her results from the FDA-authorized test, after exposure to someone with COVID-19.
How many Idahoans have it but aren’t sick?
While the medical and scientific communities are still learning about the new coronavirus and COVID-19, they believe it can take up to 14 days to show symptoms. Some people may never have symptoms, or could mistake their symptoms for a cold.
“Right now we simply have no idea how many Americans are infected with the coronavirus,” two doctors who have worked at the national level in health care and health policy wrote Tuesday in the publication STAT.
That knowledge could help predict the point at which there are enough COVID-19 survivors that “herd immunity” — when enough people are immune to a virus that they protect the rest of the population — “can begin to blunt the outbreak,” the doctors wrote.
Cole said that’s one of his goals: to help gather data on how many people are carrying the virus and don’t know it.
Between Tuesday and Wednesday, eight people had positive results for antibodies to the virus. The majority of them had early antibodies. Many of the people didn’t have symptoms.
Cole said he plans to follow up with some of the patients to see if they develop antibodies that would show up later in the infection, and to find out if they have been able to get the state-approved test.
Correction: This story has been edited to reflect that the most widely used COVID-19 test has an FDA emergency use authorization, not FDA approval.
This story was originally published March 26, 2020 at 8:02 AM.
