Providers and public health officials hope that more COVID-19 testing will help contain spread of the disease. But efforts to get tests done faster and results quicker are hindered by how many tests can be quickly deployed and how accurate they prove to be.
Three decentralized tests for SARS-CoV-2, the virus that causes COVID-19, have been granted Emergency Use Authorization from the U.S. Food and Drug Administration in the past 10 days.
Decentralized molecular tests are meant to bring lab-quality test results while the patient is with the provider so that they can guide treatment decisions. These tests, and any accompanying equipment, need to be small or portable, require minimum sample processing, and little training to use correctly in low-complexity testing environments. The newly authorized tests from Cepheid, Mesa Biotech, and Abbott Laboratories use instruments that have already been for other indications, such as influenza testing.
New York Gov. Andrew Cuomo this week said the COVID-19 epidemic might be resolved with "an inexpensive home test or point-of-care test that can be brought to volume," while former FDA Commissioner Scott Gottlieb declared the authorization of the Abbott ID Now test to be a "game changer" on Twitter.
Experts in clinical virology, however, are somewhat more cautious.
Richard Hodinka, a professor of microbiology at the University of South Carolina School of Medicine in Greenville and former director of the clinical virology laboratory and the Children's Hospital of Philadelphia, is an authority in molecular testing at the point of care.
"Having these systems available for SARS CoV-2 testing may be extremely impactful and offer a number of distinct advantages," Hodinka said in an email. However, "companies need time to ramp up their manufacturing capacity and product inventory in order to supply material to any and all customers desiring to use their products," he said.
Frederick Nolte, director of clinical laboratories at the Medical University of South Carolina in Charleston, said his lab went live a week ago with the Abbott high-throughput system and is now testing 400 patients a day, adding staff, and hoping to max out at about 1,000 tests a day, but the lab has not yet been able to get any decentralized testing up and running.
Alex Greninger, assistant director of the University of Washington clinical virology laboratory, said, "every new test is helpful" since they can build capacity and relieve the existing strain on the supply chain of other testing. "What's interesting about these [decentralized] platforms is that there's no particular logistics for the sample, so you don't have to drive or fly them to a reference lab," he said.