WASHINGTON — Nevermind the shortage of coronavirus test kits. The U.S. has a new problem: A lack of chemical ingredients needed to actually process the results.
The big international companies that make the chemicals, known as “reagents,” say they’re working overtime to crank out as much as they can. But demand is surging so wildly that seemingly no one to predict when, or whether, global supply will catch up.
The deficit is slowing down diagnostic operations and threatening to put a national speed limit on the country’s rate of testing for the indefinite future, according to lab specialists, medical experts and officials from Maryland to California and in Washington DC.
“Everybody is scrambling right now for the same reagents,” Dr. David Smith, head of the infectious diseases division and director of the virology lab at U.C. San Diego School of Medicine, told VICE News. “The reagents we need are in short supply, for sure.”
A spokesman for Roche, a Swiss diagnostic giant that’s pumping out reagents in overdrive, said it’s impossible to predict whether private companies will be able to supply the marketplace with enough raw materials to conduct a test on everyone who should get one.
“Nobody knows at the moment how it’s going to develop,” Roche spokesman Karsten Kleine said by phone from Basel, Switzerland. “We can’t speculate about that, because nobody knows.”
A global shortage
The shortage threatens to put a handbrake on America’s drive to catch up with other countries that have zoomed ahead with testing capabilities.
The U.S. stumbled through February with a series of scientific and administrative blunders that allowed the virus to spread undetected through American communities for weeks with negligible testing, a failure that stopped the U.S. from isolating early cases and containing the outbreak in its opening stages.
Now, test kits are heading out the door. But without reagents, those test kits are like “printers without ink,” California Governor Gavin Newsom told a press conference on Thursday.
California has more than 8,000 coronavirus tests, Newsom said, but county public health labs can’t use them all for lack of reagents.
“The kits don't work if you don't have everything you need to use the kits,” Donald Milton, a professor at the University of Maryland’s School of Public Health and coronavirus expert, told VICE News. “It will create a bottleneck, just as bad as not having kits,”
Dr. Smith said his lab has been operating at a fraction of its capacity for lack of reagents, at a rate of about 20 diagnostic tests per day last week. This week, after scoring a new supplier, he said he can now ramp up to 130 tests per day starting Wednesday.
Labs across the state of Maryland have a similar problem, Fran Phillips, the Maryland state deputy secretary for public health, said Monday.
“That’s a logjam that every hospital in this state is experiencing as well as every commercial lab.”
“That’s a logjam that every hospital in this state is experiencing as well as every commercial lab,” Phillips said. “This is a shortage of the kits, and, actually, the chemicals that go into the lab processing of these tests.”
“We have kits,” Dawn White, vice president of government and community relations at Baptist Health South Florida, which runs multiple urgent care centers in Broward county, told The Miami Herald.
But, she said, “we are looking for that reagent, using all sources available to us, and as soon as we have that reagent and can be approved and certified to run the test, we’ll start testing.”
How tests are processed
Several different types of solutions are used in the standard test for COVID-19, the disease that results from the new coronavirus, and in good times there’s plenty to go round.
The procedure starts with a nasal or throat swab, which gets placed in one reagent to store and stabilize it. A further series of different chemicals are then used to extract, isolate and identify the RNA in the sample that’s the key marker to the presence of the virus.
Smaller testing operations at local labs and hospitals seem to be having a harder time scoring reagents than the big diagnostic giants, for the moment.
A spokeswoman for Quest Diagnostics, a multi-billion dollar clinical behemoth headquartered in New Jersey, said the company has enough reagents for now. But she declined to make any predictions about the future.
“We are managing supply and believe we have adequate supply at least for the time being,” the spokeswoman wrote in an email to VICE News. She didn’t respond when asked what “the time being” means.
Some local labs are switching into food-drive mode, and issuing public appeals to ask others to round up spare materials and pass them on.
Some the reagents used to test for COVID-19 are also used in other procedures, including tests for HIV, according to Dr. Smith.
Joy Wu, a physician at Stanford University, tweeted out a call for chemicals to help run tests for hospitals in the San Francisco area from anyone who might not be using them late Monday night.
Michelle Monje, a Stanford neuroscientist, tweeted out a picture of a van loaded with reagents heading to the clinical lab to help diagnose COVID-19.
Democratic Congressman Ted Lieu from California demanded Tuesday that Vice President Mike Pence, chair of the White House coronavirus task force, outline a plan to fix the problem.
“Without these reagents, which are required to extract the genetic material, COVID-19 testing kits will be functionally useless,” Lieu wrote. “If the reagent shortage is not addressed quickly, we will continue to undercount infected patients and our efforts to contain the pandemic will be hindered.”
But as the spread of the virus has entered what appears to be an exponential rise, state and local officials are looking beyond testing as a means to contain the coronavirus, and instituting social distancing measures and boosting hospital capacity to mitigate the damage.
“We’ve moved on from testing, quite frankly,” Maryland governor Larry Hogan told MSNBC on Friday. “At some point soon, we’re probably not going to be into testing as much, because the hospitals will be overwhelmed and unable to do the tests.”
Cover: A close up of a test kit for testing for the coronavirus, Covid-19 is seen at Newton-Wellesley Hospital in Newton, Massachusetts on March 18, 2020. (Photo: JOSEPH PREZIOSO/AFP via Getty Images)