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.
Why cant we just use WHO tests? This is absurd! and abusive We will become like Italy on this issue, and why??
From Qiagen manual:
The RNeasy procedure represents a well-established technology for RNA purification. This technology combines the selective binding properties of a silica-based membrane with the speed of microspin technology. A specialized high-salt buffer system allows up to 100 μg of RNA longer than 200 bases to bind to the RNeasy silica membrane. Biological samples are first lysed and homogenized in the presence of a highly denaturing guanidine-thiocyanate– containing buffer, which immediately inactivates RNAses to ensure purification of intact RNA. Ethanol is added to provide appropriate binding conditions, and the sample is then applied to an RNeasy Mini spin column, where the total RNA binds to the membrane and contaminants are efficiently washed away. High-quality RNA is then eluted in 30–100 μl water.
I doubt it is any of the materials that are running low – all should be easy to obtain. Putting them together as kits, QC, etc. is probably the bottleneck.
Re the last sentence: “Industry has been prepared to engage for a while, but there was little receptivity on the other side until last week,” Pellini said.
Who is the other side???
“Other side” is FDA + CDC + HHS, which have been engaged in a turf war over COVID-19 testing.
I use Qiagen kits and Invitrogen kits in my lab. I know many others who do too. I stock extra kits so I never run out at a critical moment. If CDC or NIH let researchers know they are short on reagents (and what they are), I bet most of us would give them our unopened reagents immediately! I know I would! Use the resources we have before freaking out about getting more.
Welcome to the wonderful world of globalization. We were all told that globalization and the decimation of our manufacturing capabilities were all positive benefits, because of reduced costs, improved efficiency, etc.etc. Critics of globalization who cited threats to a country’s autonomy and self-independence were laughed out of the room.
Yet who’s laughing now? We now have supply chains for dozens of critical medicines almost entirely reliant on countries like China and India. India has now started to block export of critical ingredients for medicine production because there is a shortage and they will keep it for themselves. It is also utterly insane to rely on a hostile country like China for many of our most important medications, plus their factories are shutdown. China also produces tons and tons of chemicals and other reagents for an inordinate amount of bilogical kits.
Now look at what’s happened. We are completely vulnerable to supply shocks that threaten the national security of the country because we can’t produce anything. We listened to globalists too much.
Bingo! I would though say it is outsourcing of supply chains and not globalization as culprits. As I raised that question 15 years ago across Silicon Valley as to what the next employer and value creation step would be if we outsource all I was met with blank stares and silence. The problem is not new, the US has failed to answer, Germany has faced it in the 70s and 90s and found a different path. Oh yes, and Qiagen was German – until a week ago when TF bought them.
It’s not just “hostile” countries like China we need to worry about holding us hostage. I just read a story that Germany blocked a shipment of n95 respirators that was supposed to go to Switzerland. They have banned all critical supplies from leaving the country. I wouldn’t be surprised if other countries do the same. You can’t depend on any foreign country… Even a so-called ally… In a crisis situation.
We MUST bring the manufacturing of anything critical to health or national security back to the US.
In case it was not noticed, India did already restrict export of pain, antiviral and antibiotic APIs. India and China supply virtually all chemical APIs.
Give me a break! Can someone tell me why is it that SOuth Korea wsa able to test tens and thousand of suspected people (especially that evil Church’s members) so quickly and decisively (within two weeks of the first case)? Is the US health care system so inferior to South Korea’s? Can someone ask VP Pence, HHS Secretary Azzar or even President Trump this question at a news conference? Our superb CA Governor Newsome announced during the noon teleconference that CA has now something like 9,500 kits currently available. and the uqiquitous Qwest Ls can do this immediately.
The CDC are playing games with people lives. They could have use the Who kits but they decided to make their own and test kits which end up defective. This limit the testing that can be done. Add to that their very narrow sets of testing qualifications.
Now the head of CDC was saying time matters. Well, if he knows time matters why not use the Who kit in the very beginning while they make their own kits.
Do they want to control the rights to the kits and get more government funding in return? Their gamble backfired. They are one of the reasons it was so widespread in the US. For some reason, I have not seen the head of the CDC removed from his positions for all the blunders the CDC had committed.
Now Mike Pence is telling the public not to wear mask, knowing asymptomatic people can infect others. And people are infectious a few days before showing symptoms. I am starting to lose faith in our government.
First, the Democrat decided to play political game by hostaging the country in an impeachment trial when we should be focusing on preparing for the coronavirus before it reach our shore. Now they start saying they care for the people. If they really care for the people, they would set aside the impeachmengt on another time and focus on preparing for coronavirus. But no, Nancy Pelosi cannot resist the temptation to score a political points. They took away people attention from the impending epidemics and distracted the administration. House democrats needs to be voted out in the coming elections.
Our politicians need to stop playing games and pay attention on how combating this epidemic together with their counterpart in the Senate. At least the Democratic governor are more decent than them and are really taking care of their constituents in this epidemic.
Democrats need to shut up from their always opposing Trump whether his proposal is good or bad. Trump need to face reality that without solving the pandemic, it doesn’t matter how much he tries to help the business. He is right that the virus will go away, eventually all pandemics run its course. But how many people will die before it runs its course this time?
Trump needs to show leadership on handling this pandemic on the same way he showed leadership in handling the economy. You can defeat this pandemic by facing the truth about it. No more trying to downplay it, that will worsen the situation since people will become complacent instead of getting educated on how to fight it.
The Impeachment happened because Trump tried to rig an election smear by extorting made up stories. If any real trial was ever allowed, this would have been clear, even to Trumpsters. Let’s leave it out of the coronavirus response. Slowness to reacte lies with the Administration, who still cannot admit the pandemic or the lack ot testing capability. Those who fight science with half-truths and misinformation will ultimately be held accountable for the delay. Stupid statements like “it’ll go away” apply to killer viruses that wipe out the earth’s population.
Regulations that obama put in place do not allow CDC from using any kits that arent approved and certified by the….CDC. so ONLY the CDC can make and do the tests. This was implemented after the Ebola outbreak. Trump killed that reg but because of the reimbursement issues labs were not geared up to make their own testing kits and therefore no reagents
This article is not very useful or illuminating because it talks around the necessary reagents in short supply but never gets around to actually naming or even describing them. That makes it really difficult to understand just how big of a problem this is or is not.
These plants can only make the reagents so quickly. What happens if the plants need to close?
Is this a global shortage or a shortage only in the USA? How about buying some kits and reagents from other countries perhaps Canada or maybe China, they got the testing right apparently. Industrial or academic labs that have the reagents unopen should donate them to the testing labs. There should be massive cooperation among the different research sectors to get the tests produced. And where is NIH in all this why aren’t they making tests and testing people? People have to be tested BEFORE they are symptomatic to stop the community spread. Not a day before the patient is about to die as seems to be the strategy. Or alternatively the whole country takes the next two weeks off, go into isolation and let the virus reveal itself and then those who become sick quarantined until they are well?
Great points that apparently never occurred to the authors of this piece.
D. Ransom – Or why doesn’t the U.S. contact the World Health Org and ask for the tests that the U.S. originally turned down because we had “better” tests? The WHO tests are working just fine for the rest of the world and the U.S. Government in its arrogance is risking the lives of tens of thousands. Time to swallow a bit of humble pie and admit that they were wrong.