Testing Bottlenecks Again Grip U.S. With Coronavirus Surge

(Bloomberg) -- A surge in coronavirus cases, paired with rising demand for testing before the holidays and continued supply shortages, are putting renewed pressure on U.S. testing systems.

The American Clinical Laboratory Association, whose members do about half of the country’s testing, said late last week it is seeing a big increase in test orders with the demand expected to continue ahead of Thanksgiving. As a result, turnaround times of around two days could increase as labs reach or exceed their testing capacities in the coming days, the group warned.

Meanwhile, labs are also grappling with supply shortages, including pipette tips -- used to transport samples during the testing process -- and swabs. Though the government has invested in manufacturers to build out capacity, that will take into 2021 to pan out, said Scott Becker, head of the Association of Public Health Laboratories.

“All of the issues we uncovered in the spring and lived through in the summer haven’t gone away completely,” Becker said by telephone. “With this massive surge in cases, it’s natural to see that testing will unfortunately slow down.”

While there’s been positive developments with new Covid-19 vaccines, with Pfizer Inc. and Moderna Inc. both reporting higher than 90% effectiveness in interim testing, it will take months for those products to be useful in slowing the pandemic.

In the meantime, America’s testing apparatus has remained in a state of continued strain. Test-positivity rates have exceeded a World Health Organization-recommended threshold of 5% in the vast majority of U.S. states, according to Johns Hopkins data.

Some of the highest numbers were in Iowa, South Dakota and Kansas, where more than half of tests done in the last week returned positive results. That suggests testing is only capturing a fraction of total cases.

Critics have long faulted the Trump administration’s lack of a nationally coordinated testing strategy. The White House has deferred many issues of policy and procurement to states.

At the same time, rising cases have limited the ability to use a technology known as pooling to process multiple samples at a time, as pooling is most efficient in areas of low virus prevalence, according to Becker. And although new rapid screening technologies have become more widely available, they haven’t relieved the burden on more conventional testing infrastructure.

Large commercial lab Quest Diagnostics Inc., which is an ACLA member, said on Tuesday it has seen about a 50% increase in demand for its Covid-19 tests since late September, resulting in a slight increase in turnaround times. Tests for all patients now take just over two days to return results, on average, according to Quest. Still, the lab warned that it expects demand to keep growing and waits could increase further.

As cases rose in recent weeks, the federal government set up “surge” virus testing sites offering gold-standard polymerase chain reaction tests within 10 states. It’s also been deploying surge shipments of Abbott Laboratories’ BinaxNOW, a cheap, rapid test that doesn’t need to be sent to a lab, to Wisconsin and now Utah and Pennsylvania, Brett Giroir, an HHS official who leads the administration’s Covid-19 diagnostic testing efforts, said at a Monday briefing.

At the briefing, Giroir also said the U.S. Department of Health and Human Services was taking measures to ensure laboratory-developed tests undergo a voluntary review by the Food and Drug Administration within 14 days, so universities and other developers like health systems can get Covid-19 testing up and running.

Giroir, meanwhile, maintained that turnaround times have remained reasonable in most of the country.

Critical Point

Asked specifically about long lines reported in states, “I’m sure what’s causing it is we have 180,000 new cases and the pandemic is really at a critical point,” Giroir said.

“This is not like a few Ebola cases that you can test and trace. We cannot test our way out of this,” he said. “We have to do the large-scale mitigation efforts,” such as masking and social distancing.

In New York City, where rising test positivity has resulted in new restrictions and threatened to close schools, urgent care provider CityMD said late last week that demands for Covid-19 tests and other care had made long lines “a daily fact” at most of its locations, keeping providers late. Starting on Monday, the facilities will close about an hour and a half earlier, helping curtail lines, the company said.

Test-seekers in New York City also encountered lines early this week with hours-long waits. Noting that the state has long had some of the most robust testing capacity in the country, New York Governor Andrew Cuomo said on Friday that the issue likely reflects that “the problem exists in every state and is worse in every other state.”

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