The push to increase testing in the U.S. for the novel coronavirus
that causes Covid-19 has hit a new stumbling block: shortages of key
chemicals needed to start up and run the tests.
In particular, one key product, made by the diagnostics testing giant
Qiagen, is in dwindling supply. The chemical is used to isolate the
virus’ genetic material, or RNA, so that it can be tested.
Robert Redfield, the director of the Centers for Disease Control and Prevention,
told Politico, which first reported the story, that he is worried about the supplies labs have of the chemicals, known as reagents.
“The availability of those reagents is obviously being looked at,”
Redfield said Tuesday. “I’m confident of the actual test that we have,
but as people begin to operationalize the test, they realize there’s
other things they need to do the test.”
A Qiagen spokesperson acknowledged that “extraordinary” demand was
limiting the company’s ability to supply some products, and said workers
at its Hilden, Germany, and Barcelona, Spain, manufacturing sites were
moving to work three shifts, seven days a week in order to ramp up
production. The company is also bringing on new staff and making better
use of a site in Germantown, Md., to try and make the test kits.
Still, that and other shortages related to test kits represent
another hurdle in the effort to roll out diagnostics to detect whether
patients are infected with the new coronavirus, a key step in preventing
or slowing its spread. Other countries, such as China and South Korea,
have tested many thousands of patients. But the U.S. has lagged even as
the virus has started to spread — there have been 647 cases of Covid-19
in the U.S. and 25 deaths so far — having conducted only 5,000 tests to
date. The American Enterprise Institute estimates that the country may
now have the capacity to run 15,000 tests a day, but that assumes that
reagents are available.
“We are deeply concerned that as the number of tests increases
dramatically over the coming weeks, clinical labs will be unable to
deploy them without these critical components,” the American Society of
Microbiology
said on its website. “Increased demand for testing has the potential to exhaust supplies needed to perform the testing itself.”
The kits in short supply appear to include varieties of the Qiagen
QIAamp Viral Mini Kit and the Qiagen EZ1 Virus Mini-Kit and the Roche
MagnaPure nucleic acid kit.
Michael Mina, a pathologist and assistant professor in the Center for
Communicable Disease Dynamics at the Harvard T.H. Chan School of Public
Health, said that the lack of the Qiagen kit and a similar one made by
Roche represent “a very big problem.”
“These are usually very commercially available tests that every
research lab uses; molecular biology labs across the world use these,”
Mina said. “They’re very common and we don’t normally worry about them
going out of stock. But at the moment, they are out of stock.’’
Mina said that not only is the Qiagen product on backorder, so is
another that might be used, from Roche. But part of the problem is that
those reagents are used on different pieces of laboratory equipment made
by their respective manufacturers. All labs wouldn’t have both.
“I would love to say, yes, there’s all these different options,” Mina
said. “But we really run into problems because we can’t actually use
these kits if we don’t have the instruments for them.”
The Food and Drug Administration said that it is monitoring the issue, and it hosted a
webinar and
town hall
last week for the laboratory community as well as fielded questions
from manufacturers about “alternative reagents, extraction methods, and
platforms.” The agency also posted an
FAQ page
Tuesday on coronavirus diagnostic testing that lists potential
alternatives. Mina said he was unsure that the page would speed up
getting tests running, but said it at least clarified what needed to be
done.
But the chemical for extracting RNA did not seem to be the only
product running short as the U.S. tries to quickly ramp up its testing
capacity. On Friday, Christopher Freeman, a laboratory administrator at
Columbia University, sent an email to colleagues pleading for another
product, used for storing RNA, made by Invitrogen, a unit of lab tools
giant Thermo Fisher. He said his lab hoped to validate its Covid-19 test
over the weekend, but that it needed the “a basic yet critical reagent
that is required as per the FDA submission.” He asked if any laboratory
had the reagent stocked in its laboratory.
A Columbia spokesperson said that the lab received a six-month supply
of the necessary reagent from New York state and is in the process of
validating its test. A Thermo Fisher spokesman said that the Invitrogen
product should not be in short supply.
But some experts in the laboratory industry say that shortages may
partly be the result of trying to have labs ready their diagnostics too
quickly, and that preparations should have begun months ago.
Mike Pellini, a doctor and longtime diagnostics executive, said that
it has been too difficult for new tests to come online and be
reimbursed. In this case, work that should have taken two months has had
to be “crammed into a few days or a week,” said Pellini, now a
managing partner at Section 32, a venture capital firm.
“Industry has been prepared to engage for a while, but there was
little receptivity on the other side until last week,” Pellini said.
Shortage of crucial chemicals creates new obstacle to U.S. coronavirus testing
