- The Washington Times - Thursday, April 9, 2020

Americans will be adding a wonkish term — “serological test” — to their vocabularies in the coming days as federal and state officials point to immunity-screening as the key to getting back to normal when coronavirus cases tail off.

The blood tests, which measure antibodies to COVID-19, will give hospitals a sense of which health workers might be immune to the disease and can work on the front lines of the pandemic.

More broadly, policymakers will detect which members of society have levels of protection and can potentially re-enter the workforce safely.

New York Gov. Andrew Cuomo, who on Thursday reported another single-day record for coronavirus deaths in his hard-hit state, has been talking about the tests for weeks.

The Trump administration, meanwhile, says it is working with companies at home and abroad to ramp up production of the tests.



“There are several out there — some are validated to show that they’re consistent and others are in the process of being validated,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Thursday on NBC’s “Today” show. “We are told by the people, the companies that make them that very soon — when they say soon, they’re talking days to weeks — that we’d be able to have a large number of these tests available.”

The U.S. coronavirus-testing czar, Admiral Brett Giroir, has said he wants to have “millions” of the tests on the market by May.

The tests will be revealing, showing how far COVID-19 has spread, particularly among people who had the disease and didn’t know it. The results will also give federal and state leaders a sense of whether stay-at-home orders and elbow bumps are still necessary.

“It is important to figure out who has immunity to this disease in order to understand how far this virus is spread in a community. That can help to gauge hospital capacity needs as well as understand what social distancing needs to be in place,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

Scientists say there are some limits. Immunity to COVID-19 won’t last forever and, in all likelihood, only a small portion of the population will have antibodies.

Still, governors and others are excited about the possibilities.

“How do you start getting back to work as quickly as possible? It’s going to come down to testing,” Mr. Cuomo said this week. “You’re going to have to know who had the virus, who resolved the virus, who never had it and that’s going to be testing. And that is an entirely new field that we’re just developing now.”

Federal regulators are hoping to approve a treatment that stymies the virus, while drug makers also work on a vaccine.

The president cited a drug candidate from Pfizer that might prevent the virus from replicating.

“They have great feelings for this particular therapy,” Mr. Trump said.

In the meantime, Mr. Trump has urged Americans to work and learn at home and avoid gatherings of more than 10 until April 30.

The idea is to stamp out the rapid transmission of the coronavirus, though his federal guidance and stay-at-home orders in all but a few states effectively shut down the economy.

Mr. Trump is eager to open things up as he faces reelection in November, so mapping out the disease’s footprint is vital.

The president said he’s confident the U.S. will be prepared to detect the disease through front-end diagnostics, despite the belated rollout of testing in February and March.

“There are certain sections of the country that are in phenomenal shape already,” he said, though acknowledged that testing all Americans for the disease is “not going to happen.”

A serological test that determines who’s had the disease and built up natural defenses is the other half of the equation.

“This is a really central part of the back-to-work plan,” Food and Drug Commissioner Stephen A. Hahn told Fox News on Thursday.

Dr. Hahn said he’s working with domestic and foreign companies to figure out which serological tests will “best serve” U.S. needs over the coming months. He said the agency will ramp up the supply of the tests in the summer and into the fall.

The FDA issued its first emergency-use authorization to Cellex, a biotech company with U.S. headquarters in Research Triangle Park, North Carolina.

Another North Carolina company, BioMedomics, said it developed a rapid test that can confirm current or past exposure to COVID-19 within 15 minutes.

BioMedomics spokesman Troy Kirkpatrick said the company will ship 50,000 tests to its distribution company, which will then push them out to market. The company’s test is validated and filed with the FDA, which under federal guidance from March 16 allows it to deliver the product to customers.

United Biomedical Inc., of Telluride, Colorado, teamed up with the San Miguel County in a bid to be the first in the U.S. to test an entire county with their COVID-19 antibody test.

But even with a test in hand, the results may be nuanced.

“It will be important to develop a standard to understand who has immunity that is protective and who does not,” Dr. Adalja said. “It is also important to understand if immunity is completely sterilizing or if individuals can be reinfected and be contagious again though they may not have any symptoms.”

Immunity to human coronaviruses tends to wane after a year or so, so people should see the COVID-19 tests as a bridge to when there is a potential vaccine next year, said William Schaffner, an infectious disease specialist at Vanderbilt University.

Also, it’s unclear if the tests will satisfy the lofty hopes of top officials. The percentage of those who show antibodies may be astoundingly large, but experts say it is just as likely to be a low figure, maybe 5%.

New York City has been hit so hard, however, that the percentage may be much higher and prove valuable in terms of opening up society.

Policymakers also have to decide what happens once they know who is immune.

“Lots of organizations are thinking about how these tests might be useful. You get excited on the front end and then all of a sudden you divide the world into positive [for antibodies] and negative —what do we do now?” Dr. Schaffner said. “Do we just allow the positives to go back to work, or give them tasks that are different?”

A clear upside of the test, however, is that it can root out potential donors of antibody-rich blood plasma. In a therapy known as “convalescent plasma,” the substance can be injected into sicker patients to fight off the disease.

The coronavirus was discovered in Wuhan, China, in December and killed thousands in East Asia before spreading to every corner of the globe. It’s devastated Italy and Spain, in particular, and upended everyday life in America.

Roughly 1.5 million cases had been reported worldwide as of late Thursday.

More than 16,000 people have died from the virus in the U.S., as nationwide infections approach half a million.

Scientists believe warming temperatures may tamp down on transmission in the coming weeks or months, though not completely.

Dr. Fauci and others say because the coronavirus might be seasonal, there could be a debilitating second wave if social-distancing guidelines are relaxed too quickly, even as hospitalization rates appear to be slowing in some hot spots like New York.

Mr. Cuomo said hospitalization rates and other indicators continued to trend downward Thursday even as he reported another single-day high for deaths, at 799, bringing the state total to over 7,000 among New York’s population of nearly 20 million people.

“It’s gotten to the point, frankly, that we’re going to bring in additional funeral directors to deal with the number of people who have passed,” Mr. Cuomo said at his daily briefing. “If you ever told me that as governor I would have to take these actions, I couldn’t even contemplate where we are now,” he said.

There are more than 159,900 positive cases in New York state, which is the most in the country. More than 391,500 people have been tested.

On the bright side, Mr. Cuomo said overnight changes in hospitalizations and intensive care unit (ICU) admissions were the lowest in at least three weeks or so.

“We’re flattening the curve so far,” he said, adding this is no time to relax. “Don’t underestimate this virus.”

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