NEW YORK – While the COVID-19 pandemic was a boon to manufacturers of lateral flow and at-home diagnostic tests, it also cast a shadow in the form of the plastic waste generated by these assays.
In April 2022, for example, the innovation company Cambridge Design Partnership estimated that the UK alone had burned through 2 billion lateral flow tests during the pandemic. The production of each test, the company said, created about 61 grams of carbon dioxide, roughly half of which was accounted for by its plastic housing and packaging materials.
Estimates vary, but each plastic lateral flow test generates on average about 10 to 12 grams of plastic waste. To reduce the environmental impact caused by conventional lateral flow tests, several companies and institutions have been working to develop sustainable test platforms.
Last September, for example, Abingdon Health, a York, UK-based lateral flow test manufacturer, partnered with Morrama, an industrial design consultancy in London, to create plastic-free lateral flow tests. In 2022, Morrama introduced the concept of a sustainable lateral flow test kit design. With Abingdon Health’s technical input, they collaboratively designed Eco-Flo, which is produced using recyclable cellulose pulp, claiming it would degrade within a month in a landfill. As part of the deal, Abingdon Health and Morrama invested in a new company, called Eco-Flo Innovations, that is focused on creating sustainable product designs for the lateral flow market. The IP around the design was assigned to Eco-Flo Innovations.
At the time of the agreement, the companies pledged to make their first plastic-free, biodegradable cassettes available to customers within a year, or by September 2024, noting the new cassettes would reduce CO2 emissions by 80 percent compared to single-use plastic and would reduce the amount of plastic used in its test by 62 percent overall.
Liam Currivan, head of sales and marketing at Abingdon Health, said this week that the catalyst for Abingdon's cooperation with Morrama was simple: The company wanted to reduce the amount of plastic waste created by lateral flow tests, which was highlighted during the pandemic. "It was off the back of that reality," remarked Currivan. Morrama had similar reasons for designing its Eco-Flo prototype.
"They saw a problem and wanted to fix it," he said. As such, the partnership was a natural fit.
Currivan said the first cassettes are on track to reach customers by September with work ongoing, and that the company is taking an iterative approach. "There are some exciting and interesting projects that we're working on with this particular cassette, but it will be offered as a standard product to our customer service base," Currivan confirmed.
There are also efforts to further reduce the amount of plastic in each kit, he said. While the cassette can be replaced by biodegradable housing, the test strip itself is made of a nitrocellulose membrane, and there are other nonbiodegradable components inside each test kit, such as the foil pouch or pipettes.
"The first stage is the cassette, but, in theory, anything that is lateral flow and has a plastic housing can be molded with this material and produced at scale," he said. "It gives you sort of insight into how we're thinking and approaching this particular product." Abingdon Health's ambition is for the new design to become the "gold standard of lateral flow housings," Currivan added, and to eventually replace the plastic designs on the market.
Currivan noted that since Abingdon Health not only makes its own kits but manufactures them for others, these innovations could have market-wide ramifications as others adopt them. Companies that partner with Abingdon Health as a contract service provider will also be offered to have their tests made using the new sustainable design. The first kits manufactured in the new format will most likely be its own, he said. Abingdon Health also noted that it does not expect a material change in cost for tests made with these alternative materials.
'Gelassette'
Like the designers at Morrama and their partners in Abingdon Health, Sander Brus, cofounder of Leiden, the Netherlands-based Okos Diagnostics, said he was inspired to develop sustainable lateral flow tests because of waste issues that were magnified during the pandemic.
Brus is a Dutch entrepreneur who also cofounded PrevViral, a provider of SARS-CoV-2 tests, in 2020. He is also a self-described "nature lover and surfer."
"I became really frustrated with all the waste coming from these single-use tests," Brus said.
Even before the pandemic, he said, about 2 billion lateral flow tests were being used per year for infectious disease testing, as well as pregnancy tests. The waste was hitting developing countries particularly hard, where a significant portion ends up in landfills, adding to a "plastic soup problem." But the pandemic encouraged him to create a company that could address this.
In 2021, Brus set up Okos with Luis Fernando Barrios, a Mexican industrial designer, who had created a cellulose-based, biodegradable housing for lateral flow tests. But while the original composition of this invention certainly was sustainable, Brus said that it did not fit into the existing infrastructure that produces lateral flow test cassettes for the IVD industry and relies on molds that can be injected with material, typically plastic, and mass-produced at low price.
The company therefore set out to identify biomaterials that could be fitted into the existing production infrastructure. Both gelatin and plant-based polymers emerged as possibilities.
"Gelatin is a rest product from the food industry, biodegradable, and widely available," said Brus. Following injection molding trials, the company created a lateral flow casing called the "gelassette" as a prototype.
"We are currently improving the formula for a better fit with the injection mold machines, and this looks promising and disruptive," he said.
The company has also been able to deliver plant-based cassettes to the market that can be manufactured using existing injection-based molds. "Because the infrastructure remains the same, we offer a price-competitive product to the IVD sector" that shows "a reduction in carbon footprint and will not contribute to the plastic pollution," said Brus. The company has also demonstrated in internal studies that results of antigen tests for SARS-CoV-2, influenza, and RSV were comparable using its biodegradable cassettes and standard plastic cassettes.
Okos is currently working with different IVD companies, academic institutions, and hospitals to advance its line of gelatin and plant-based cassettes. "Our goal is to replace most of the plastic test kits worldwide, and to start a revolution to make this conservative diagnostic sector more eco-friendly," he said.
Making millions
Another sustainable lateral flow test concept has been developed at Heriot-Watt University in Edinburgh, Scotland, within the group of Maïwenn Kersaudy-Kerhoas, a professor in microfluidic engineering in the university's School of Engineering and Physical Sciences. Kersaudy-Kerhoas is also the co-academic lead on the Global Research Institute in Health & Care Technologies at the university, which works with industry and other stakeholders to advance new technologies.
Kersaudy-Kerhoas' research interests include microfluidic and lab-on-a-chip technologies for isolating circulating cell-free nucleic acids, as well as medical device development. She has been interested in making her research more sustainable since 2007 and was encouraged by the pandemic to create a sustainable lateral flow test platform.
"During the pandemic, we saw the use of these devices at home, people throwing them away, the NHS consuming them at scale," recalled Kersaudy-Kerhoas. "Even unused tests were being trashed, sometimes non-intentionally. In some cases, donations to lower-income countries expired before governments could use the tests."
Kersaudy-Kerhoas' group set to work to see if they could use more sustainable materials in lateral flow tests. They found a partner, Great Central Plastics, a Daventry, UK-based plastic injection molder to help them create LFA cassettes from a variety of environmentally responsible sources, including recycled plastic from refrigerators and other white goods and post-consumer chewing gum.
The latter is obtained from a company called Gumdrop, based in London, that manufactures a material called Gum-Tec, made from chewing gum waste obtained from bins they have placed in several towns and cities in England, as well as pre-consumer chewing gum waste sourced from gum manufacturers. Kersaudy-Kerhoas said that prototyping has been successful, and the tests could be manufactured based on demand.
The advantage of these materials is that they are available at high volume and compatible with conventional injection molding. "We can immediately produce these cartridges," said Kersaudy-Kerhoas. "We can make millions if needed."
Her lab in the meantime is studying whether the new LFA cassettes perform as well as their virgin plastic equivalents. The next step is to understand the regulatory landscape around the use of recycled materials in medical devices, she said.
"We are working with several manufacturers to accompany them through these processes," said Kersaudy-Kerhoas. "And we believe that with upcoming changes in regulatory and more green procurement initiatives, there is a real opportunity for first-to-market products."