More hospitals and academic medical centers are turning to their own labs to develop in-house COVID-19 tests to bypass the long wait for results.
But a dwindling supply of reagents necessary to perform the tests could derail progress, experts say.
The lack of tests has been one of the biggest issues facing medical systems across the country as the number of COVID-19 cases has increased. Normally, a hospital buys a test and then sends the results to their local health department to get the results.
“It became increasingly clear to us that it was just not going to be adequate and take days and would impair ability to rapidly treat these patients,” said Michelle Gong, chief of critical care medicine at Montefiore Medical Center in the Bronx in New York City, on a livestream held earlier this week by the Journal of the American Medical Association.
So Montefiore’s epidemiologists and hospital leadership sought to bring testing in-house, and that, so far, has “changed the game,” Gong said.
“We basically went from no in-house testing to do hundreds of testing within about three days,” she added.
On Feb. 29, the Food and Drug Administration gave hospital labs permission to use their own tests for three business weeks. Since then, major hospital systems across the country have moved to develop their own tests.
Over the weekend, the Centers for Medicare and Medicaid Services told hospitals to report COVID-19 testing data daily to the federal government in addition to their daily reports about bed capacity and supplies.
Dealing with the backlog
UC Davis Health in Sacramento, California, had a huge backlog of coronavirus tests awaiting results.
So March 2, the system put together a group from its pathology lab, clinicians, in-house scientists and researchers and decided to ramp up testing in-house.
“It is not something that can be done overnight,” Allison Brashear, M.D., dean of the UC Davis School of Medicine, told FierceHealthcare. “Last week did 20 tests, shortly 40 tests and yesterday we were able to move up to 200 tests. In a couple of weeks, we will be at about 1,400 tests per day.”
Brashear said that the testing has been critical to helping determine which patients need potential drugs.
“People are now more easily rolled into clinical trials, more easily evaluated and we know which patients need personal protective equipment,” she added.
Johns Hopkins Hospital in Baltimore announced March 14 it had developed a test that could screen as many as 1,000 people a day.
VCU Health in Richmond, Virginia, also rolled out a test March 25 that the system hopes can get results in the same day.
“Being able to determine whether a patient does or does not have COVID-19 quickly is of critical importance,” said Christopher Doern, Ph.D., director of microbiology at VCU Health, in a release. “Being able to do that in our own laboratory will be a game-changer in how we manage patients with potential COVID-19 symptoms.”
The massive $2 trillion economic stimulus package Congress passed Friday also requires insurers to cover hospital-developed tests.
But experts say in-house testing operations could face a shortage of reagents needed to diagnose a patient.
“Many local tests use same reagents and at the moment many of the reagents are in short supply,” said Ross McKinney, chief scientific officer for the Association of American Medical Colleges, during a call with reporters Friday on the outbreak.
Another issue is getting swabs that are manufactured in northern Italy, which is grappling with a major outbreak of the virus.
“Even though we have local labs doing these very important tests there are still barriers to doing it as frequently and as often as we would like to,” McKinney said.