The key to rebounding from the coronavirus may be antibody testing. But there are many warnings.

Still, disease specialists are wary of this new approach.

“I hope these tests will be the next good thing, but I’m still not sure what the unknown is unknown,” says Yale University Professor of Medicine and Director of Yale University New Haven Hospital Center. Said one Harlan Kulmholtz. Outcome research and evaluation.

Early this month, Federal regulators have approved the first antibody test created by a company based in North Carolina. New relaxed rules from the US Food and Drug Administration allow companies to develop and distribute tests without FDA review, unless they claim to have their tests verified internally and FDA-approved. And last weekend, Trump administration It also paved the way for these tests and provided guidance that they should be provided free of charge to those with health insurance.

Currently, dozens of companies are rushing for blood tests for antibodies. Employers, big and small, are looking to tests and wonder how costly and available they are. Still, Kulmholtz and other disease specialists are concerned about whether these tests will prove effective.

“It’s still a little bit of the wild west there,” said Kulmholtz. “Testing has taken place from many locations, many from abroad.”

Officials in London last week admitted that millions of tests ordered from China, designed for use by residents to use at home for blood, did not meet British standards. Does not help.

Many unknowns continue to have disease specialists at night. How many antibodies need to be immunized against this coronavirus? How long will that immunity last? Does the test mistake the new coronavirus for another virus in human blood?

“We are not 100% sure,” says Dr. Shira Doron, an infectious disease doctor at the Tufts Medical Center and a hospital epidemiologist. Is that season just like the flu? Or is it less? Or is it more? “

On Monday, World Health Organization officials said early research would suggest that not all people who recover from coronavirus have a detectable marker in their blood. Their remarks cast doubt on whether patients will develop immunity after the survival of COVID-19.

Companies writing tests also address these concerns.

“It’s not the test design that matters to us; we need to better understand how the infection progresses,” said Greg Frank, Director of Infectious Diseases Control. Biotechnology Innovation Organization, It represents more than 1,000 biotechnology companies and academic institutions in dozens of countries.

Antibody tests are different from the tests currently used to diagnose COVID-19. COVID-19 will swab the patient’s nostrils to see if they have the virus. Antibody tests look for proteins in the patient’s blood that may have developed immunity due to exposure to coronavirus.

Antibody testing is not new. Doctors use them to help diagnose many diseases such as arthritis, HIV, lupus, and to determine if someone has developed immunity to a virus such as the virus that causes chickenpox.

According to Frank, the difference with the COVID-19 antibody test is that companies are learning about this coronavirus in real time as it continues to spread worldwide.

“Antibody tests are usually created when we have a better understanding of the bug we are trying to investigate,” says Frank. “But there is a sense of urgency here.”

Framingham-based Boston Heart Diagnostics said the antibody tests that started last week will initially only be offered to hospitals. .

“We will distribute the test to the hospital and let the hospital decide who gets the test,” said Pat Noland.

The company, which has already contracted with 12 hospitals, said it didn’t give out its name and can perform up to 4,800 tests a day in Boston Heart, Noland said. He acknowledged many uncertainties surrounding the COVID-19 antibody test and said the company proposed that hospitals wait at least 14 days after a patient was infected before performing the test. Thus, their bodies have enough time to produce antibodies.

The State Department of Health has partnered with a company to set up a large drive-through site to provide a nasal swab test to diagnose COVID-19, but there appears to be no similar plan for antibody testing. Dr Larry Madoff, director of medicine at the Department of Health at the Institute of Infectious Diseases, said there are still too many questions about the test.

“The Medical Advisory Group at the COVID-19 Command Center is reviewing blood-based antibody testing in Massachusetts,” he said in a statement. “Like most lab tests, these tests are available to providers who can assess the usefulness of a particular individual.”

Employers across the state have already appreciated the safe and gradual resumption method and are strongly interested in antibody testing. But John Hurst, president of the Massachusetts Retail Association, which has 4,000 members, said he was worried about costs and availability, especially for smaller employers, as daunting as the test. .

“Whether it’s this test, a mask, or some other form of test, what BJ can do is [Wholesale Club] Walmart may not be the same for small businesses if it is a state-owned enterprise, “Hurst said. “If the supply of these tests is limited, they [big companies] Instead of moms and pop shops? “

The emergence of new popular tests also raises the question of who gets when and when.

The directive issued on Saturday by the Trump administration requires insurance companies to provide free antibody testing to insured patients, but it is unclear what the employer will incur.

Blue Cross Blue Shield in Massachusetts, the state’s largest health insurance company, is reviewing this directive. The company’s doctor, Dr. Bruce Nash, said that premiums will ultimately be affected, whether paid by the government or by private insurance companies.

“As payers in major countries, we work with national and state leaders to implement policies in the best interests of the community,” he said.

Blue Cross has 3,800 employees and is one of the state’s largest employers. Nash also said that he had many questions about antibody testing and wasn’t in a hurry to reopen until he knew more about its accuracy and the virus itself.

“For epidemiologists, it’s a powerful tool. It may tell us how prevalent this is in our community. That’s the main use,” he said. “But how can we use tests to re-open society? It’s a more dangerous place.”

Kay Lazar [email protected] Follow her on Twitter Azuki. Andrew Ryan can be reached at [email protected] Follow him on Twitter Azuki.