University labs in the US that have been certified to test for the coronavirus and are ready to collaborate with clinics and hospitals are facing regulatory and logistical obstacles to distributing their tests, reports Nature. As a result, some labs are operating at half capacity or less, despite the demands for COVID-19 tests.
Human geneticist Stacey Gabriel of the Broad Institute of MIT and Harvard says that her lab could be analyzing 2,000 tests per day. “But we aren’t doing that many,” she tells Nature. “Yesterday was around 1,000. What is holding us back? That is the question.”
Several academic laboratories, including the Broad Institute, have invested in adapting their facilities so that they can use PCR to test for SARS-CoV-2, rapidly changing their scientific protocols and meeting federal regulations, as it became clear in late February that tests issued by the US Centers for Disease Control and Prevention were in short supply, according to Nature.
Scientists report that the barriers to making those tests available are formidable. “There is a misconception that you only need a PCR machine and a PhD—that is 10% of what you need,” says Fyodor Urnov of the Innovative Genomics Institute at the University of California, Berkeley, in remarks to Nature. On March 30, Urnov’s facility launched its testing operation after facing weeks of challenges. “My life is waking up at 3 in the morning, and thinking of the 24 things that will go wrong today,” he says.
The difficulties arise from the bureaucracy of the US health care system, where hospitals use different platforms for electronic health records and also face daunting administrative obstacles when setting up new accounts with labs, according to Nature. Researchers say this is why many hospitals chose to remain working with the same commercial labs despite a shortage of tests kits during the pandemic.
“The business of American medicine and the way it is organized is astonishingly unprepared for this,” Urnov tells Nature. He says that hospitals rejected 20,000 free tests from his lab, after which his team contacted Lifelong Medical Care, a nonprofit that has now sent the lab samples from homeless individuals.
Researchers across the country have been forced to come up with their own solutions in order to clear similar hurdles. George Murphy, a stem cell biologist at Boston University School of Medicine, tells Nature that a graduate student in his lab wrote a special computer script that allows patients’ test results to be sent directly to the hospital’s electronic health record system. “The hospital said, normally, this would take six months,” Murphy tells Nature. He has since shared the code online for other academic labs to use.
A representative from the Sutter Health hospital system in northern California tells Nature that the organization requires an “electronic interface between the lab provider and Sutter Health,” and has plans to develop its own internal testing rather than partnering with academic labs.
Nature reports that it obtained a letter to the White House in which scientists described the bottlenecks involving COVID-19 testing kits and offered a plan to help make more tests available nationwide.
Epidemiologist Patrick Ayscue, who investigates biosecurity for the Chan Zuckerberg Biohub, tells Nature that testing will become even more crucial as social distancing decreases, and that what the US needs is “a national framework for states to make decisions on testing.”