Aug. 13, 2020 -- The lack of supplies for doing enough COVID-19 diagnostic testing within a useful turnaround time will likely last and will continue to hamper the nation's response to the pandemic, public health experts and health care professionals say.
It will also likely begin to delay diagnostic testing for other conditions, they warned. The demand for COVID-19 testing is exploding as schools and businesses try to reopen and as hospitals begin bringing patients back for elective procedures.
Laboratories say that "many molecular tests are being delayed as they simply cannot all be offered while attempting to meet the demands for COVID-19 testing," according to leaders from several medical groups.
The American Medical Association, the American College of Medical Genetics and Genomics, the American Society for Clinical Pathology, the Association for Molecular Pathology, the Association of Pathology Chairs, the College of American Pathologists, and the Infectious Diseases Society of America wrote a letter to U.S. Health and Human Services Secretary Alex Azar to express their concerns.
"We are increasingly concerned about the serious strains being placed on testing services for COVID-19, the impact those strains have on our ability to provide timely medical care to our patients, and ultimately on our ability to contain the spread of this dangerous virus," they wrote.
The groups said laboratories have continued to struggle to maintain a consistent supply of reagents, viral transport media, plastics (such as pipette tips), and other items essential for both COVID-19 and non-COVID-19 testing. Many testing platforms also depend on proprietary supplies, which cannot be manufactured fast enough.
The groups say "it has been made clear that, despite the best efforts of many, no additional manufacturing capacity for many testing supplies is likely to be available through the remainder of this year."
That alarm was echoed by state health officials.
"There's going to be continued issues with supply chain," Eric Blank, DrPH, chief program officer of the Association of Public Health Laboratories, said on a call with reporters.
Although the current situation is not as bad as it was in March or April, the lack of supplies needed for testing "is something we're going to be faced with throughout this response because this response is going to go on for some time," said Blank.
At least 30 components go into a COVID test, and many of those are generic lab items that are used for a variety of other tests, said Blank. If any one of those is in short supply, it means not doing the test, he said. Shortages are for supplies that are used in all tests, Blank continued.
Public health laboratories are competing with hospitals and private labs in the United States and around the world for the same supplies, Blank said.
From swabs to viral media in sterile tubes needed for transport, to chemicals needed for extracting viral DNA to actual testing platforms -- "We've seen shortages in every single component of that chain," Rachel Levine, MD, secretary of health at the Pennsylvania Department of Health, said on the call.
Levine, who’s also president of the Association of State and Territorial Health Officials, said the federal government has been sending viral transport media and sterile tubes to states for COVID-19 diagnostics. But shortages of other supplies mean that not enough testing is being done and that turnaround times are too long for the tests to be worthwhile, she said.
Pennsylvania's state health lab uses COVID-19 testing platforms from a handful of manufacturers so that it can switch when supplies are short for one type or another. The state -- along with many others -- is having trouble getting reagents for a device made by Hologic and another made by Roche, said Levine.
The state's laboratory is doing about 1,000 COVID-19 diagnostic tests daily, mostly for priority patients, such as people at nursing homes. Most of those tests are molecular and rely on polymerase chain reaction technology to identify the virus's genetic materials. The turnaround time is 24 to 48 hours for those tests.
Levine noted that around the country, wait times for COVID-19 tests have been as long as a week to 10 or 14 days as demand exploded in the South and West and as commercial labs were overwhelmed.
Health and Human Services testing czar Brett Giroir, MD, announced on Aug. 11 that two of the nation's biggest commercial labs, Quest Diagnostics and LabCorp, have promised to reduce turnaround to 2 to 3 days by week's end. "Combined with our continued expansion of point of care testing, we estimate that nearly 90% of all tests are being completed within 3 days," Giroir said in a statement emailed to reporters.
"The wait times are improving" with Quest and LabCorp, agreed Levine. But other commercial laboratories still have much longer wait times for results, she said.
National Strategy Needed
No one has a good handle on turnaround times because that information is not being shared publicly, said Jennifer Nuzzo, DrPH, a senior scholar at the Johns Hopkins Center for Health Security and an associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore.
Result times vary for inpatients, outpatients, by laboratory, and by geographic area, said Nuzzo on the call with reporters. "From the public's perspective, there's no way to know where to go in order to get the faster tests," she said. "I just really lament that we don't have better data other than these highly summarized statistics."
Some epidemiologists have said they believe the national averages cited by the federal government are driven by inpatient testing, which has the fastest turnaround times. "But again, this is not an area where there's publicly available data that we can vet," Nuzzo said.
She said the federal government should help determine what's causing the bottlenecks in testing capabilities and that states need their help getting supplies and finding out who should be tested. "This is something we should not be doing on a 50-state by 50-state basis," she said. "This is something for which we should have a national approach."
The American Medical Association and others that signed the letter to the Department of Health and Human Services urged the Trump administration to come up with a national strategy to conserve scarce resources.
"Updated guidelines are critical to manage the ever-increasing demand for COVID-19 testing," they wrote. They said such guidelines "will also allow physicians and laboratories to better manage the surging demand for non-medically indicated tests, as the current capacity will not be able to meet all demands."
The groups noted that using more rapid screening tests -- such as the two antigen tests that have received emergency use authorization from the FDA -- could help relieve the pressure on molecular testing, and they urged support for the development of those technologies.
The Centers for Medicare & Medicaid Services has been sending rapid antigen test kits and machines to states to test nursing home residents and staff. Once those initial supplies are gone, "there will be competition for the kits, which will make it challenging," said Levine.
She also noted that Bethlehem, PA-based diagnostics maker OraSure Technologies is developing a rapid test that could be used at home. The company says it aims to secure emergency use authorization from the FDA by the end of 2020.