Health and industry experts are calling for more federal coordination to mitigate a recurrence of testing complications that risk reversing the gains labs have made since the early days of the coronavirus pandemic.

Cases are surging in a number of states, while some hospitals in hard-hit areas are reaching capacity. The United States is conducting between 700,000 and 800,000 tests per day, but delays for results are reaching nearly two weeks for some, and labs are beginning to restrict how many samples they’ll accept.

The worsening situation is a harbinger of what the U.S. will likely face this fall, when the seasonal flu is expected to further strain demands on hospitals and labs. 

“I don’t know if it’s ever going to be enough, but if we can bend the curve back down on incidence, we have a fighting chance going into the fall to be able to maintain a reasonable level of testing and expectation,” Scott Becker, CEOAssociation of Public Health Laboratories told CQ Roll Call. “But if demand continues to exceed the capacity and capability of labs across the country, then we’re in for a world of hurt as we head into the flu season.”

The Department of Health and Human Services is coordinating with states to distribute supplies, the amount and quality of which have improved over time. Nasal swabs that were either brittle or shipped en masse before July are now sterile and individually packaged, Becker said. 

On Tuesday, HHS announced a public program to solicit ongoing feedback from the private sector on how to improve issues like supply shortages. HHS also directs some free surge testing sites in areas where the White House coronavirus task force projects there could be high rates of asymptomatic transmission, such as Arizona and Texas. The department is working on introducing more point-of-care testing machines into the market to allay the pressure on labs and is sending machines to nursing homes in coronavirus hot spots.

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But the department lacks a comprehensive national strategy, instead focusing on working with states on individual plans. The approach leaves gaps in the response, such as where overburdened states could locate excess testing capacity.

“We are not able to really easily load-balance the testing that is available to provide enough testing for Florida and Texas at the moment, using the tests that are available in Massachusetts, for example,” Michael Mina, Harvard University assistant professor of epidemiology, said during an online forum earlier this month.

Massachusetts is currently exceeding its goals with a 2 percent positivity rate, well below the recommended 5 percent, according to a New York Times tracker. Florida and Texas are far from hitting their targets, with positivity rates of 19 percent and 16 percent, respectively.

HHS spokeswoman Mia Heck said state testing plans posted by the department include processing capacity at each lab within a state, and that the administration is encouraging labs to work together as a network to balance the load.

Heck added that a new data system — HHS Protect, which sparked controversy when it recently replaced the well-known Centers for Disease Control and Prevention’s data collection system — can identify where lab capacity might be. But that unproven process “needs a little more validation,” she noted.

Excess capacity doesn’t always account for shortages of supplies needed to conduct the tests, according to Becker. Supply shortages vary from state to state, from protective equipment and chemical reagents used to conduct the tests to pipettes used to transfer liquids and to the testing machines themselves. More transparency surrounding supply and capacity metrics would aid labs and public health officials in the response.

Long waits at national labs

Quest Diagnostics — one of the two dominant lab companies in the U.S., along with the Laboratory Corporation of America, or LabCorp — said in a statement that it is struggling with a lack of instruments and reagents. The lab said its efforts to “modulate” orders for low-priority patients had helped stabilize the number of incoming orders, but turnaround times for high-priority patients are now at two days instead of one. Others may take a week to two weeks, which undercuts the goal of limiting additional transmission while patients wait for results.

The complex nature and individual technologies associated with each machine also make them more difficult to produce, unlike masks and swabs that were ramped up under the Defense Production Act.

The National Independent Laboratory Association told CQ Roll Call that some of its members are reporting excess capacity. Tapping into smaller labs is important as turnaround times lengthen at national labs like Quest and LabCorp, where samples often have to be shipped.

“Looking at that allocation is really essential,” spokeswoman Erin Morton said.

Brookside Clinical Laboratory, a facility outside Philadelphia that serves nursing homes and long-term care homes across three states, began conducting its own in-house COVID-19 tests for residents on June 30. Test samples for nursing home staff are still shipped out to LabCorp, but President Annette Iacono said residents usually receive the in-house results within 48 hours.

Brookside’s clients range from 900-bed facilities to homes with just 30 beds, which makes it hard to judge the day’s caseload, Iacono said.

“We don’t know one day to the next what will come in,” she said.

LabCorp halved the number of COVID-19 test samples it’s accepting, Iacono said. Brookside currently sends out around 35 staff member samples from each of its client nursing homes per day to LabCorp but processes 122 patient samples in-house.

LabCorp did not comment on the number of specimens it is accepting but said it processes 165,000 tests per day.

Conversely, reports of testing shortages can sometimes mean that states aren’t hitting their benchmarks because of a lack of demand rather than a supply shortage, according to Assistant Secretary for Health Brett Giroir, who oversees the Trump administration’s testing strategy. 

On a call with reporters last week, Giroir pointed to Baton Rouge, Louisiana, where HHS temporarily ran surge testing sites earlier this month.

“We’re trying to create demand by really ginning up the population,” he said.

Clinical guidelines

Labs are also asking medical providers to adhere to clinical guidelines for different testing methods and strategies for different patients, saying that federal guidance could help create uniformity in how tests are ordered and processed.

“We’ve been fighting fires, and at this point we also need to look forward and try and see what else we haven’t thought of,” Becker said.

Quest asked the medical community in a weekly release to adhere to its guidelines, including limiting the number of lower-risk patient samples that providers send. 

HHS plans to issue guidelines on combining samples into “pools” for group testing, which would theoretically cut down on resources and time needed to run them. Quest received the first emergency authorization from the Food and Drug Administration on Saturday to conduct pool testing.

But pooling is only viable in areas of low transmission, where samples are unlikely to test positive. Otherwise, if one sample is positive, then each sample must be processed again individually. 

New strategies offer modest benefits in a broader plan to fix the testing shortfall, but the advantages are limited. Point-of-care testing machines that the administration is sending to nursing homes will allow rapid processing in the facility within minutes, but they are unrealistic for mass testing. Antigen tests, which detect viral proteins and are easier to process for large populations, can be less accurate.

If Americans continue to flout safety measures like wearing masks and limiting their physical proximity to one another, particularly in indoor bars and restaurants, the nation’s testing infrastructure has little chance of ever catching up. 

“The bottom line is we know what to do to stop the current outbreak,” Giroir said.