Testing labs wrestle with shortage of key chemicals
Province forced to prioritize COVID-19 screening for the ‘sickest and most vulnerable’
As demand for COVID-19 tests continues to rise in Ontario and across North America, some laboratories are facing looming shortages of chemicals vital for the detection of the virus, forcing health systems to prioritize testing for those who need it most.
The global need for what are known as extraction reagents, chemicals used to isolate the genetic material, or RNA, of the virus so it can be analyzed, has outpaced the supply.
“That is why priority must be given to those who are the sickest and most vulnerable patients and those who treat patients,” an Ontario Ministry of Health spokesperson said.
The ministry said there is no imminent risk of running out of the reagents, and that the government is working “very closely with Public Health Ontario and partner laboratories to source reagents from several manufacturers and suppliers.”
As of Wednesday, 125,062 people had been tested for COVID-19 in Canada, with 1,959 confirmed cases.
In Ontario, 35,635 people have been approved for testing, with 688 confirmed positive, according to the provincial ministry of health. However, more than 10,000 tests are “currently under investigation,” meaning the number of people who have the virus in the province could be higher.
While health officials had said expansive testing is essential to curb the pandemic, the director of the U.S. Centers for Disease Control has publicly acknowledged that the crucial reagents needed for testing “now are in short supply.”
At least one major facility in Toronto, the Shared Hospital Lab, whose member institutions include North York General and Michael Garron hospitals, Sunnybrook Health Sciences Centre and Scarborough Health Network, began stockpiling extraction reagents in January in anticipation of soaring demand.
“Just like with every other aspect of pandemic planning, the whole supply chain is under pressure, so anything that is in heavy demand is harder to get,” said Dr. Kevin Katz, medical director of the Shared Hospital Laboratory and head of microbiology at Sunnybrook.
Katz said increased demand is not the only pressure on the supply chain. Jurisdictional shipping issues, including restrictions in countries where certain chemicals are manufactured, also impact how quickly labs can secure testing supplies.
Ensuring labs have enough chemicals is critical as the capacity to test for the virus increases, he said.
“If you go from 1,000 tests per day to over 3,000 tests per day, that’s great. It gets the backlog down. But you also burn up 3,000 reagent tests a day,” Katz said. “It will make that shortage more acute, so it is important to fix the issue as you ramp up testing because otherwise it will just precipitate more of a problem.”
At its most basic, testing for COVID-19 is a two-step process. The first is the extraction of the RNA from the virus using special chemical reagents. The second step is to amplify that genetic material and detect COVID-19’s presence. Some labs use kits with both steps built in while others have designed their own systems for testing, known as the “homebrew” method.
The reagents used in the extraction step are feeling the most supply pressure, said Dr. Tony Mazzulli, Microbiologistin-Chief at Mt. Sinai Hospital and University Health Network.
Mazzulli’s lab uses kits and says some of the suppliers of these kits can’t keep up with demand.
“Although it’s a kit that I buy from company A, the company that makes the kit buys some of the reagents from company B. And so company B can’t supply every single company because there are reagents that are common to all these tests,” he said.
To get around this supply issue, Mazzulli says some hospital labs are trying to develop alternative extraction methods that don’t rely on the reagents in high demand.
Last week, Health Canada expedited the approval of two COVID-19 diagnostic test kits. The manufacturers of eight other testing kits have also submitted their product to the health regulator for approval, according to Health Canada’s website.
Meanwhile, the Public Health Agency of Canada has sent an “urgent request” to some Canadian laboratories for spare reagents that can be used in COVID-19 testing, according to an online post by the Canadian Association for Neuroscience.
In Manitoba, the provincial testing lab is facing a backlog due to the reagent shortage, prompting the facility to begin making its own, according to the chief provincial public health officer, Dr. Brent Roussin. The lab is currently performing between 400 to 500 tests daily, a number the province expects to go up as the facility “develops new methods to increase capacity” over the coming weeks, a spokesperson said.
Qiagen, a major supplier of reagents to countries across the globe including Canada, said the rapid spread of COVID-19 “created extraordinary demand and was straining our capacity.”
In a statement to the Star, a company spokesperson said it is working with customers to provide shipments based on critical need “rather than just filling orders on a ‘first-come, first-served’ basis.”
The company is also beefing up its global production of reagents. It previously produced enough for roughly 1.5 million coronavirus tests per month. Qiagen aims to be making enough for 6.5 million tests by the end of April, and more than 10 million each month by the end of June.
In the United States, some health agencies are warning of dwindling supplies of testing materials.
The American Society of Microbiology, whose members include thousands working in public health labs, issued a statement saying, “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.”
“We know from past experience that reagent shortages can persist, and we understand there are limits on how rapidly companies can realistically accelerate production of the necessary reagents,” the group said.
In Ontario, the bulk of the daily testing is done at the provincial public health laboratory, though eight hospital labs are also conducting tests.
A health ministry spokesperson said test results for priority patients are being completed within two days of the lab receiving the specimen. For others, the target turnaround time is up to four days.
The spokesperson said the province is working with hospitals, academic centres and private labs “to aggressively ramp up testing capacity to meet increasing testing needs for the health system...The hope is to expand testing over the coming weeks.”
All current COVID-19 tests being used in Ontario require the use of these reagents, the ministry said. Health Canada is exploring alternative tests, and the national microbiology lab in Winnipeg is analyzing their efficacy.