Bootstrapping gear for coronavirus tests: How companies innovated to solve a critical shortage
During the first few months of the American coronavirus outbreak, the country experienced an acute shortage of test kits and related equipment — the supplies needed to track the spread of the virus and trace infected individuals.
Since late April, shortages have eased, and testing capability has expanded in many parts of the country. This has been possible, in part, because of collaborative efforts among scientists, health experts and businesses that retooled operations to produce COVID-19 testing kit components.
At the outset of the pandemic, Ramy Arnaout, associate director of the Clinical Microbiology Laboratories at Beth Israel Deaconess Medical Center in Boston, knew that the first COVID-19 testing bottleneck hospitals would face was the shortage of nasopharyngeal (NP) swabs needed for sample collection. “The reason why is that these swabs are manufactured by a company in northern Italy called Copan, and northern Italy, as everybody knows, was hit very hard, especially in the early going of the pandemic,” Arnaout told Yahoo News.
Only a few factories in the world, including Copan, produce these swabs, generally by traditional plastic-fabricating techniques: either extrusion (forcing plastic through a small opening), or injection molding (pouring liquid plastic into a mold).
The NP swabs are not your typical Q-tip. They are usually a 15-centimeter (nearly 6-inch) plastic stick, with a head that's about a centimeter and a half long and 3 millimeters wide. The neck of the swab is a little narrower, flexible and usually coated with a velvet-like material called flock, which allows efficient collection of the virus from deep in the upper respiratory passage.
Once the sample has been collected, the swab’s tip is snapped off into a vial containing a preservative fluid known as viral transport medium (VTM) and sealed. Then, lab technicians test the VTM for the presence of the virus, using a genetic test called a polymerase chain reaction, or PCR.
Arnaout says it is important that the material composing the swabs does not leach into the VTM. “Some materials can inhibit chemistry. It’d be no fun if you put in the swab, and some particles go into the test tube and then the PCR test fails because some residue on the swab has inhibited it.”
All these requirements make manufacturing NP swabs complicated. In an effort to address the nationwide swab shortages, Arnaout reached out to old classmates from the Massachusetts Institute of Technology, who pointed him in the direction of 3D printing.
“The beauty of 3D printing is that the time between a development of a design and a prototype in hand is a matter of hours. So you can get on a computer and you can draw on a computer the shape of the swab … and then you hit ‘enter,’ and it sends that design to a printer, and it is printed out just like that. … And if you look at it and decide it doesn’t work for you, you can change the design and get a new prototype back in again, in a matter of hours.”
Arnaout says he knew right away that this was going to be the technology to get the job done. So he led a multidisciplinary team of experts that included Beth Israel health care workers and scientists and 3D printing manufacturers to develop new NP swabs and have them evaluated clinically. After 22 days, they had the first of four prototypes ready for immediate mass production by 3D printing.
Origin, a California-based 3D printing company, was one of the four manufacturers whose swab prototype was clinically validated by Arnaout’s team. Shortly after, the company quickly shifted its resources from being a 3D printer producer to become a medical device manufacturer.
So far, Origin has produced approximately a half-million swabs, at the current rate of 70,000 a day. CEO Chris Prucha told Yahoo News that having his NP swab prototype clinically evaluated and validated by Arnaout’s team was very important to his company. “The first rule of medicine is ‘do no harm.’... We were very concerned about seeing people 3D-print equipment, especially swabs, which are semi-invasive devices. It was important for us to develop a product that was absolutely safe and effective.”
While successful clinical trials are not necessarily required to sell this type of product, NP swabs are still a medical device, and Arnaout says their manufacture “should be taken seriously.”
The effort led to the formation of a new industry consortium called PrintedSwabs.org, which enables hospitals and health care providers to order directly from validated manufacturers around the country. According to the website, it is “now poised to rapidly produce up to 4 million 3D printed swabs per week.” The consortium’s swabs are all FDA-registered.
Arnaout says the process was speeded greatly by transparency. His team created an open-source repository to share results, data, best practices and everything it learned in the process of engineering these swabs.
“We made it possible for anybody and everybody else to add what they found, to what we had. … If we had gone a more traditional method waiting for, you know, being cagey about it and trying to make our reputations on it, or for the companies trying to make contracts out of it, as a sort of a competitive advantage, this would never have happened.”
But swabs were not the only component of COVID-19 testing kits in short supply. Worldwide supplies of VTM were also severely disrupted. This too motivated many scientists, chemists and companies to come up with innovative solutions.
In Chico, Calif., Sierra Nevada Brewing Co. partnered with Enloe Medical Center, a local hospital, to produce the substance. Sierra Nevada CEO Ken Grossman told Yahoo News that his beer company already had sophisticated laboratories for quality control, so he knew it could also easily produce VTM.
“Our laboratory produces media all the time to use for testing for yeast and bacteria,” Grossman said. “We obviously don’t test for viruses, but the media is a solution that’s used to stabilize the sample, and preserve it essentially ... so we’ve got a lot of experience mixing media and doing it in a sterile way.”
Sierra Nevada has supplied 1,000 vials of VTM to Enloe Medical Center and has the capacity to make 10 times that amount, Grossman said.
The beer company has donated all the materials and labor. It has received requests from other institutions and plans to work with them as well.
Despite these efforts, most states are still falling short of the level of testing needed to continue the process of safely reopening businesses, schools and parks.
As of June 1, some 17,340,680 people in the U.S. had been tested for COVID-19, per CDC data. A recent report by economist Paul Romer concluded that to responsibly reopen, the U.S. “should make the investment necessary to test people every two weeks, which would mean 25 million tests per day on an ongoing basis.”
“We’re really disappointed with the lack of testing, from hospitals and governments locally and federally. It hasn’t scaled, even though we’ve definitely had the time to scale it.” Origin’s Prucha said.
Origin does not plan on slowing down its swab production anytime soon. It has hired more workers in recent weeks for the effort.
“It’s been a huge morale boost to the existing team, to do something that has a direct impact on this crisis,” Prucha said. “You know, every swab that we ship is one additional test that could be done.”
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