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Nevada Revokes Halt on Rapid Antigen Testing in Nursing Homes

A week later, however, Admiral Giroir cracked down on Nevada’s “illegal” prohibition on BD’s and Quidel’s tests, which he said had imperiled the residents and staff of nursing homes across the state. “They cannot supersede the PREP Act,” he said.

The false positives that had emerged, Admiral Giroir said, were not only expected but “actually an outstanding result.” No test is perfect, he said.

In the Nevada statement, Dr. Azzam reaffirmed his concerns with the number of false positives that had arisen. “If this laboratory data discrepancy had been reported to Dr. Giroir, we would hope he would have taken the same action as Nevada,” he said. “We too want more testing with rapid turnaround in Nevada, but the results of those tests must be accurate, as they affect clinical care.”

The state’s nursing facilities can resume use of BD’s and Quidel’s products, according to a new Nevada directive issued on Oct. 9. But Nevada’s department of health also recommended that all antigen test results, positive or negative, be confirmed by a laboratory test that relies on a slow but very accurate and reliable technique called polymerase chain reaction, or P.C.R. False negatives, officials noted, risk exposing healthy people in nursing homes to someone who is unknowingly contagious. False positives, on the other hand, could prompt the placement of a person who is well into a unit with sick people, also increasing the chance of infection.

“Both of these scenarios could result in causing harm to a population that we have collectively worked so hard to protect,” the directive said. State health officials, it said, would also continue to investigate the use of BD’s and Quidel’s products.

“We need to better understand the issue before encouraging mass use of such tools among our most vulnerable citizens,” Dr. Azzam said. “We are not saying the tests have no use, we are just saying pause for further review and additional training.”

In a statement, Admiral Giroir said he and his colleagues were “pleased” about Nevada’s reversal. “This serves as a valuable public policy discussion that benefits the public interest by deterring unilateral prohibitions or similar actions in other states or jurisdictions,” he said.

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Trump Antigen Testing Fail; COVID Stimulus Waste; Politicians vs Public Health

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Trump’s Antigen Testing Fail

Eschewing evidence, the White House has favored antigen testing for COVID-19 over the more reliable PCR tests, Kaiser Health News reported, citing one potential reason for the disease outbreak there.

Antigen tests do not need to be processed in traditional labs and yield results more quickly, making them more favorable to the Trump administration. But BinaxNOW, the new antigen test now used in the White House, has not been independently verified for accuracy and reliability. BinaxNOW received an FDA emergency use authorization in August.

The Department of Health and Human Services recently inked a $760-million contract with Abbott, which makes BinaxNOW, to distribute 150 million tests to places including historically black colleges and universities, state governors (to help them potentially reopen schools), and nursing homes. The Big Ten football conference also decided to play this fall — after originally punting on the season — in part because of the availability of the more rapid antigen tests, “following Trump’s political pressure,” KHN reported.

The White House does not report antigen test results to the Washington, D.C., health department — “a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments,” the article stated.

Why the COVID Stimulus Was a ‘Waste’

Much of the $4 trillion handed out by the federal government during the pandemic went to large companies that didn’t need the help, rather than struggling medical practices, public health departments, and other healthcare entities, according to a Washington Post analysis.

“The legislation bestowed billions in benefits on companies and wealthy individuals largely unscathed by the pandemic, leaving some local public health efforts struggling for money to conduct testing and other prevention efforts,” according to the analysis, which was based on data from the Committee for a Responsible Federal Budget.

More than half of the aid ($2.3 trillion) went to businesses that weren’t required to show that they were hurt by the pandemic, or that they kept workers on the job, the Post reported.

Only $25 billion was earmarked for coronavirus testing via the most recent relief bill on April 24. Nobel Prize-winning economist Paul Romer and bipartisan groups of experts have called for $100 billion or more for testing.

Many public companies received CARES Act tax breaks, including Tenet Healthcare, as did companies unaffected by the pandemic. Medical equipment maker Owens & Minor, for example, plans to claim $13 million in tax breaks while personal protective equipment demand has sent its stock price soaring.

The healthcare and social services sector received 12.9% of the $670 billion Paycheck Protection Program loans while accounting for 10% of job losses. Construction and manufacturing, by comparison, received 12.4% and 10.3%, while accounting for just 4.7% and 6.4% of job losses, respectively.

By following traditional methods of propping up businesses instead of addressing

Millions of Rapid COVID-19 Antigen Tests May Help Fill the Testing Gap

Editor’s Note (9/29/20): This story has been updated and republished in light of the Trump administration’s newly announced plans to ship millions of antigen tests to states and vulnerable communities.

An inexpensive coronavirus test that millions of Americans could use at a pharmacy, in a workplace or even at home could prove to be a vital asset in allowing people to return to jobs and school. Deborah Birx, the White House’s coronavirus-response coordinator, has called rapid antigen tests the “breakthrough innovation” that is needed to perform hundreds of millions of such assays a day. The remarks echoed her previous statements that antigen tests might be used to examine broad swaths of the public.

The technique often involves a technology—called a lateral flow assay—similar to that employed in home pregnancy tests. In the test, an antibody can bind to one of the spike proteins (the antigens) that cover the surface of the virus like the spines on a puffer fish. The tests are inexpensive to produce and simple to use, and they deliver results in minutes. On September 28, several months after this story was originally published, the Trump administration announced a plan to distribute 150 million of these assays, developed by Abbott Laboratories. The test, called BinaxNOW, correctly identifies 97.1 percent of positive cases and 98.5 percent of negative cases, and it provides results in 15 minutes. An Abbott spokesperson declined to comment on the record about the test’s accuracy.

The goal is also to field a test that is just as accurate as the current standard, which uses  polymerase chain reaction (PCR) to process the virus’s genetic material and amplify it for detection. But major technical hurdles still remain. “What you would want in terms of a breakthrough is that [an antigen] test is more sensitive, [or less prone to false negatives], and easier to use than a PCR-based test. And that is not so easy to do,” says Bettina Fries, chief of the infectious diseases division at Stony Brook Medicine. “Normally, PCR-based tests are more sensitive.”

The urgent need to conduct massive levels of testing means that any feasible technology is being considered. OraSure Technologies, a medical device company in Bethlehem, Pa., received a $710,310 federal contract last month for an in-home assay that can potentially detect a coronavirus antigen in saliva in as little as 20 minutes. Stephen Tang, the company’s CEO, says such antigen tests are needed to screen millions of people per day. “You can’t be dependent on the throughput of laboratories and the availability of medical and laboratory professionals,” as PCR assays typically require, to conduct widespread testing, he says.

Because a PCR test makes thousands of copies of its target RNA, it is able to detect a virus at far lower concentrations, called the limit of detection, than antigen tests typically can. PCR’s limits of detection “are on the order of a few hundred virus particles in a milliliter of transport liquid,” says Geoffrey Baird, acting chair of laboratory medicine at