HEALTH

'Totally unacceptable': Testing delays force labs to prioritize COVID-19 tests for some, not others

David Rohlfing, a Queens resident and high school English teacher, attended outdoor picnics, an outdoor bar and a Black Lives Matter protest earlier this summer. Though he did not feel sick, he wanted to get tested for COVID-19 before visiting his sister in Connecticut.

On July 6, he was tested at a New York City-run site and was told results could take a week. He checked a patient testing portal every day. On July 23 – 17 days after he took the test – he learned he did not have the disease. 

Now Rohlfing wonders whether there will be enough testing when he returns to the classroom in September. He wants a guarantee he can take a test with quick results if he interacts with an infected student or staffer. If there is no such assurance, and testing has not improved, he might not go back to class.

“I’m not going to do it,” he said. “I will join any effort to not open the schools if that part of the piece is not in place.”

The slow turnaround time for patients like Rohlfing could harm efforts to curtail outbreaks. Professional athletes and private businesses that purchase lab testing can get access to quick tests. Teachers, students and others who rely on traditional retail clinics or doctors' offices, however, might wait days for results.

Federal officials and private labs acknowledge they must prioritize the nation's limited supply of coronavirus tests for hospitalized patients, health care workers and other high-risk individuals. But many Americans worried about contracting the sometimes deadly virus often must wait in long lines and several days for results. 

Without a national plan on how to best allocate hundreds of thousands of COVID-19 tests each day, there simply is not enough capacity now to screen Americans who might unwittingly pass the virus to others.

And some warn the problem will be further strained when universities and K-12 schools resume classes, more companies bring employees back to the workplace and influenza testing spikes this winter.

Dr. Howard Koh, a professor at Harvard T. H. Chan School of Public Health and former Department of Health and Human Services Assistant Secretary during the Obama administration, said the testing shortage has created a pattern of unequal access.

“Some privileged parts of our country are getting daily access and others have no access at all,” Koh said. “We’re never going to solve this pandemic until we give everybody access, particularly high-risk groups. That’s the public health principle we always try to follow.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said testing delays are "totally unacceptable" and need to be fixed.

Speaking at a forum hosted Wednesday by the Harvard public health school , Fauci said in some communities "the gap between the time you get the test and the time you get the result, in some respects, obviates the reason why you did the test ... We’ve got to correct that."

More:'States duking it out for supply': Lack of federal plan leads to coronavirus testing delays

More:'Pushing the frontiers': Long lines for COVID tests, stressed labs delay results as demand spikes

More:FDA opens door to rapid, at-home testing for COVID-19

Adm. Brett Giroir, director of U.S. coronavirus diagnostic testing, looks on as he testifies during a House Subcommittee on the Coronavirus Crisis hearing on a national plan to contain the COVID-19 pandemic, on Capitol Hill in Washington, July 31, 2020.

The federal government wants to expand testing on several fronts, including more “point of care” machines that can deliver results in minutes at a clinic or doctor's office. The National Institutes of Health has launched a $1.5 billion, Shark Tank-style competition called Rapid Acceleration of Diagnostics to bring capacity up to 6 million daily tests by December.

Some want federal regulators to loosen oversight of rapid tests, similar to pregnancy tests, that can be taken at home and deliver immediate results, albeit without the sensitivity, or accuracy, of lab tests.

States also are taking more control. Louisiana, Maryland, Massachusetts, Michigan, North Carolina, Ohio, Utah and Virginia this week announced a pact with The Rockefeller Foundation to each purchase a half-million rapid antigen tests from two manufacturers.  

The nation's labs have never been asked to test such a large portion of the population, especially those without symptoms. 

"We don’t design tests normally for people who aren’t experiencing symptoms," said Kelly Wroblewski, the Association of Public Health Laboratories' director of infectious disease. "It’s not normally who you target when you’re planning to test people."

But as officials race to expand testing, Assistant Secretary for Health Adm. Brett Giroir acknowledged not everyone will get results at the same time. Some patients must be prioritized.

 “We are going to have more prioritization in the future,” Giroir said last week in a call with reporters. “There are certain people. I am not going to say it’s an unnecessary test, but, you know, if you have to have a test to go on vacation somewhere, that’s not the same priority as a nursing home or a person in the hospital.”

Testing differs for teachers, pro athletes 

In mid-July, Kathy Martin of Silver Spring, Maryland, felt nauseous followed by a sore throat and extreme fatigue. She described her symptoms to her cousin, a doctor, as well as her actual doctor. Both recommended a COVID-19 test.

It took her three days to find a clinic – a CVS drive-thru where she received a kit, self-administered a swab, sealed the sample and dropped it off in a collection box.

Over the following week, she isolated herself from others. She felt better by the time she received her negative results eight and a half days after she was tested. 

She said the long delay makes the test "not very good for the purpose of treating you or contact tracing," Martin said. "By then, you are either in a hospital on a respirator or you are all better."

Now most test results from CVS take three to seven days, a spokeswoman said. 

While consumers like Martin struggle to get timely results, the same is not true for professional athletes who get tested several times each week by private labs with quick answers or expensive point-of-care machines with immediate results.

Major League Baseball is testing players several times each week with results typically available in a day or two. Tests are administered daily at the National Basketball Association's bubble near Orlando, Florida. And the National Football League's protocol calls for daily testing during the first two weeks of training camp. 

Private labs are conducting tests for these professional leagues. Terms of the agreements are not public, but one requirement is known. Labs must get results back to the leagues quickly enough so teams can take necessary steps if there's a positive test.

Outbreaks among MLB teams such as the Miami Marlins and St. Louis Cardinals prompted the league to cancel games, adjust schedules and quarantine players until testing showed the teams cleared the threat. The goal: prevent infections from spreading to other teams. 

More choices for some companies

Businesses also are looking for quick testing at private labs. 

Dr. Rajaie Batniji is co-founder and chief health officer at Collective Health, a San Francisco firm that helps companies manage health insurance benefits. The company started a new app, Collective Go, for large companies to screen, monitor and test for COVID-19.

Batniji said employers have the option to test at traditional sites such as a doctor's office, a pharmacy, or community testing sites. But many employers and their workers are choosing at-home testing kits.

"That’s the option we’re seeing take off for a lot of organizations," Batniji said.

An employee orders the test through the app, and a test kit is mailed to their home. The employee self-administers a nasal swab, puts it in a tube and mails it to the lab. Results are typically ready within two days, Batniji said.

Collective Go offers choices beyond large commercial labs such as Quest Diagnostics and LabCorp traditionally used by doctors, hospitals and pharmacies. Other private labs, including ones set up to do genetic analysis, have the equipment and wherewithal to do thousands of tests each day.  He describes these labs as "alternative supply chains" that he believes will become increasingly important as the nation ramps up testing.

"Where we as a country have fallen short is rapid turnaround testing in a health care setting," Batniji said. "I think (the nation is) going to need to tap into a lot of this alternative supply."

Urban Sitter, a San Francisco-based service that matches families with child care providers, began using the Collective Go recently. Families and sitters wanted the service as a way to learn about each other's COVID-19 status, arrange testing and track daily health status. 

Co-Founder and CEO Lynn Perkins said hundreds of the company's 1 million families and sitters already have signed up for the service. The two driving things families and sitters want: convenience and quick testing.

"Having somebody in your home is crucial for getting parents back to work," Perkins said. 

Time for testing approach rethink?

The varying turnaround times might be a symptom of a fragmented lab system. Public health labs are focused on tracking diseases in any given communities. Large commercial labs deliver accurate results to properly diagnose patients. And private labs can provide specific services to their customers.  

"Because of the way the laboratory system is structured in the U.S., there is this ability to buy capacity for large corporations," said Wroblewski, with the Association of Public Health Laboratories. "It does make it challenging to develop a thoughtful, strategic plan when you have this fragmented system that serves all these different goals.

Dr. Geoffrey Baird, interim chair of the University of Washington's Department of Laboratory Medicine, said labs that perform tests for pro sports leagues or businesses that require quick turnaround time must have access to chemical reagents and other testing materials that are in short supply.

"There is an implicit judgment in the idea that we would be testing some people over other people right now," Baird said. "That’s what happens when demand outstrips supply, which is the case right now. There’s more demand than there is supply."

With all the challenges labs face, some academics and public health doctors say the time is right to change thinking on testing altogether.

These doctors argue at-home tests can be fast and cheap and provide instants results. The drawback is these tests might not be as sensitive, or accurate, as lab tests.

The Food and Drug Administration set rules for rapid test manufacturers on accuracy and how samples must be collected and analyzed. No such tests have been approved yet.

Dr. Ashish Jha, director of the Harvard Global Health Institute, argues these at-home tests are a better option than "flogging the system" of lab tests.

Lab tests more accurately detect whether a person is infected with coronavirus. The rapid tests might miss some cases when a person has no symptoms or a mild case. But the test can detect when a person has higher levels of the virus and is more likely to infect others, Jha said. 

The key is frequency. If these tests are widely used and cheap enough to take a couple of times each week, more people will learn they are positive, self-quarantine and reduce spread. 

"The current system is missing so many cases, not because the tests are not sensitive, but we can only test so many people," Jha said. "I’m worried our federal government is still stuck in a mental model that doesn’t make sense for this pandemic."

Alltucker is on Twitter as @kalltucker or can be emailed at alltuck@usatoday.com.