Finding it hard to get tested for COVID-19 and wondering who’s to blame? We’ve got answers

More people than ever are getting tested for the coronavirus as its highly contagious omicron variant shatters records with about a half million new cases every day.

But the fast-moving variant has exposed the nation’s testing capacity as insufficient, a situation exacerbated by the holidays as companies test returning employees and schools and universities screen students and staff. Confronted with empty store shelves or lengthy lines at testing sites nearly two years into the COVID-19 pandemic, frustrated consumers, doctors and public health workers wonder who's at fault. 

The answer may be as complicated as the course of the pandemic itself. Medical experts point to missteps by both Biden and Trump administrations, a fragmented health care system heavily reliant on the private sector and a political divide that's held down vaccination rates and left the nation more vulnerable to outbreaks that drive testing demand. 

An average of more than 2 million Americans got tested each day for the coronavirus over the past week, according to Johns Hopkins University's testing tracker that compiles testing data reported by federal, state and local governments. The tracker does not include results from many home tests. 

That hasn't been enough to meet demand. Biden administration officials warned the omicron wave could severely test hospitals and push demand for daily tests up to 3 million to 5 million over the coming weeks. 

The share of positive tests reached a pandemic record of 25% over the past week. The World Health Organization considers that anything over 5% indicates that not enough tests are being done, leaving too many asymptomatic people to unknowingly spread the virus.

A year ago, President Joe Biden touted plans to expand testing while executing an unprecedented vaccine rollout. Although tens of millions of Americans got vaccinated and cases declined last spring, some said the administration missed an opportunity to shore up the nation’s home testing market when a slowdown prompted testmakers to scale back production.

Biden’s latest testing fix includes a plan to offer 500 million free home testing kits to Americans, which would be mailed to the homes of those who want them, possibly starting in the coming weeks. Manufacturers restarted closed factories and are working round-the-clock to make hundreds of millions of tests to meet the nation’s persistent demand.  

"We can't be complacent," said Mara Aspinall, an Arizona State University professor who runs the Rockefeller Foundation's national testing action program. "What we've learned is our optimism got ahead of reality, and we can't let that happen again."

Shoring up testing is important, but doctors said the nation must continue to promote vaccines that protect people from serious illness, keep them out of the hospital and reduce the need for more testing. 

"The underlying reason that's led to the current crash is we don't have enough people vaccinated," said Emily Volk, president of the College of American Pathologists. 

'Too late to help people'

Biden took office last Jan. 20 promising that his administration would improve testing for the virus and get the deadly pandemic under control.

While campaigning, he excoriated the Trump administration for its handling of the health crisis, arguing that the failure to make testing widely available allowed the virus to spiral out of control.

A year later, Biden conceded at least twice last month that his administration was caught off guard by the omicron surge and should have done more.

“It’s clearly not enough,” Biden told the nation’s governors Dec. 27 during a virtual meeting when discussing the distribution of at-home tests. “If we had known, we would have gone harder, quicker if we could have.”

In an interview Dec. 22 with ABC News, Biden said he wished he had ordered the at-home tests two months ago. “You could argue that we should have known a year ago, six months ago, two months ago, a month ago,” he said.

As omicron rages across the country, public health officials said the planned distribution of a half billion home tests has come too late.

“It would have been much better if we had had a couple hundred million accurate, proven tests available way before now,” said Irwin Redlener, a pediatrician and founder of the National Center for Disaster Preparedness at Columbia University in New York.

“I appreciate the purchasing of this additional testing supply and its distribution,” Redlener said. “But in terms of omicron, it is very likely to be too late to help people cope with a much more immediate problem.”

White House officials pushed back on any suggestion that the country has lost control of the virus.

“We’re in a very different place than we were a year ago,” White House press secretary Jen Psaki said Tuesday, pointing to the more than 200 million Americans who are vaccinated and the 20,000 sites across the country where people can get tested for free. 

“We have taken steps to prepare for any contingency, any moment,” Psaki said, “and we’re working to implement and build on that from here.”

The White House insisted that tests have become more widely available in the past year and that the lines at testing centers have been caused by a surge of people seeking tests amid the rise of the highly infectious omicron variant.

Since September, the administration has spent more than $2 billion to accelerate the production of rapid tests and $1 billion in procuring at-home tests. The first at-home test was approved one month before Biden took office last January; there are now one dozen rapid antigen tests authorized by the FDA.

The administration spent billions of dollars to help states set up testing programs in schools and to support testing in rural health clinics, hospitals and underserved communities, such as those with large numbers of racial and ethnic minorities.

Home testing market slow to develop

Providing adequate testing has been a persistent challenge since the beginning of the COVID-19 pandemic.

Under the Trump administration, the initial test kits the Centers for Disease Control and Prevention sent to state public health labs were contaminated and contained a design flaw, delaying efforts to track the virus during the critical early weeks of the pandemic.  

Congress authorized billions of dollars to bolster testing, including reimbursing private labs to provide widespread testing that public health labs could not complete on their own. In the summer of 2020, as the virus swept through the Sun Belt during a second wave, overwhelmed labs took a week or longer to process tests. The delayed results were of little use to track and trace the virus.

The rapid antigen testing market emerged, first with small testing machines used in doctor's offices and urgent care centers, then in disposable, portable testing strips that could be used at home. They were a quick, easy and inexpensive way to track the virus. 

Antigen tests detect proteins found on the surface of the coronavirus, don’t need a lab and deliver quick results. Laboratory-based PCR tests detect a virus's genetic material, are more expensive and take longer to process. Lab tests are more sensitive and can detect traces of the virus over a longer period, but advocates of antigen tests said the kits can more quickly alert someone who is infectious and at risk of passing the virus to others. 

The Trump administration purchased the first 150 million BinaxNow antigen tests made by Abbott Laboratories and purchased tests made by Quidel and Becton, Dickinson.

The large government purchases of the antigen tests were necessary to sustain the testing market, said Brett Giroir, a pediatrician who served as assistant secretary of health overseeing the Trump administration’s testing efforts. 

“We basically bought everything, and the industry knew as much as they could make, we would buy,” Giroir said.

The Food and Drug Administration granted emergency use authorization last March for the Abbott and Quidel home tests. The home tests don’t need a prescription and are sold directly to consumers through retailers such as Walmart, Amazon, CVS and Walgreens.

The home test supply crunch came after Abbott Laboratories and Quidel cut production in the spring when testing demand dropped. As the delta variant drove a surge in testing over the summer and fall, the companies had to again hire factory workers and restart production.

Because the two largest testmakers slowed production, the kits have been hard to find for consumers, “and we’re just playing catch-up right now,” Giroir said.

The United Kingdom and Germany have been large purchasers of home tests and provided the kits to their residents for little or no charge.

The United States has allocated tens of billions for testing since the beginning of the pandemic, and Giroir said the federal government should play a larger role in sustaining the home testing market though federal contracts.

“I would tell the manufacturers to make as many tests as you can, as quickly as you can, for the next six months, and I’ll buy all of them,” said Giroir, adding that the purchases could be limited once manufacturers reached a certain threshold.

Giroir said such a commitment would allow the manufacturers to hire workers, purchase materials and run production lines knowing they would not be left with excess tests when coronavirus surges pass and testing demand wanes.

Lagging vaccinations leave US vulnerable

As long as vaccination rates in the USA lag other countries, the need to stockpile tests is likely to remain. 

Two-thirds of Americans age 5 and older are fully vaccinated. In North and South America, 19 countries and territories have higher vaccination rates than the USA, according to World Health Organization data.

Surveys suggest political divisions hold down U.S. vaccination rates. A Kaiser Family Foundation analysis last September found counties that voted for President Donald Trump in 2020 were far more likely to have lower vaccination rates. 

The nation's lagging vaccination campaign means there's less resistance to emerging variants such as delta and omicron, driving the need for testing.  

Despite the home test shortages that emerged last year, major manufacturers crank out millions of tests every day. One dozen companies have received FDA emergency use authorization to market home antigen tests. That includes large manufacturers Roche and Siemens, which are new entrants to the U.S. home coronavirus testing market but supply tests overseas. 

Abbott said it has opened new U.S. factories, hired thousands of workers and invested in automation to ramp up test production. "We’re running 24/7 to make 70 million BinaxNOW rapid tests per month with plans to surpass that – and we look forward to others contributing at similar levels," the company said in a statement. 

Aspinall, the Arizona State professor who closely tracks the testing market, projected home test capacity will soar to at least 500 million each month by March. 

As testing supplies become more widely available, it will be important to ensure poorer communities and remote communities that don't have access to chain pharmacies can get the tests, said Andrew Sweet, the Rockefeller Foundation’s managing director of COVID-19 response and recovery. 

Sweet said the Biden plan to add a half billion tests is a "good first step," but the nation must maintain testing. 

"There are likely more steps that are needed," Sweet said. "I don't want to assume this is one and done."

Ken Alltucker is on Twitter at @kalltucker, or email at alltuck@usatoday.com. Michael Collins is on Twitter @mcollinsNEWS or email at mcollins2@gannett.com.